FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 100000052Report Type:Expedited (15-DaCompany Report #USA/97/02823/LEX Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozaril PS ORAL 600 MG Professional Date:11/03/97ISR Number: 100000052Report Type:Expedited (15-DaCompany Report #USA/97/01841/LEX Age:46 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Adenocarcinoma Health Clozaril PS ORAL 600 MG Renal Cell Carcinoma Professional Stage Unspecified Date:11/03/97ISR Number: 100000052Report Type:Expedited (15-DaCompany Report #D/97/03124/LEX Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Foreign Leponex/Clozaril PS ORAL 2000 MG ORAL Initial or Prolonged Grand Mal Convulsion Health Required Overdose Professional Intervention to Sedation Prevent Permanent Suicide Attempt Impairment/Damage Tachycardia Date:11/03/97ISR Number: 100000064Report Type:Expedited (15-DaCompany Report #USA/96/03492/LEX Age:86 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neoplasm Malignant Study Clozaril (Clozapine) PS ORAL 75 MG ORAL Hospitalization - Pneumonia Health Depakote (Valproate Initial or Prolonged Professional Semisodium) C Other Sinemet Required (Levodopa-Carbidopa) C Intervention to Ativan (Lorazepam) C Prevent Permanent Thyroid C Impairment/Damage Colace (Docusate Sodium) C Tylenol #3 (Panadeine Co) C Baby Asa (Acetylsalicylic Acid) C Date:11/03/97ISR Number: 100000065Report Type:Expedited (15-DaCompany Report #F/97/01554/LEX Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Intestinal Obstruction Health Leponex/Clozaril PS ORAL 200 MG ORAL Required Professional Lepticur SS ORAL 20 MG ORAL Intervention to Haldol Decanonas C Prevent Permanent Anafranil C Impairment/Damage Deroxat C C10 Concomitant 22-Feb-2006 08:30 AM Page: 1 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Medical Products: C Date:11/03/97ISR Number: 100000068Report Type:Expedited (15-DaCompany Report #FLUV001970128 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Foreign Floxyfral Akathisia Literature (Fluvoxamine Anxiety Maleate) PS ORAL 100 - 200 - Bronchitis 300 MG DAILY, Confusional State PER ORAL Coordination Abnormal Leponex (Clozapine) SS ORAL 200 MG, PER Dysarthria ORAL Extrapyramidal Disorder Tranxeme Gait Disturbance (Clorazepate Hyperhidrosis Dipotassium) SS ORAL 50 MG, PER Insomnia ORAL Pyrexia Tremor Vertigo Vomiting Date:11/03/97ISR Number: 100000076Report Type:Expedited (15-DaCompany Report #D/97/02552/LEX Age:25 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Leponex/Clozaril PS ORAL 125 MG ORAL Cardiac Failure Professional Truxal SS ORAL ORAL Deep Vein Thrombosis Glianimon SS 8 MG Pulmonary Embolism Atosil SS ORAL 100 MG ORAL Pravidel/Parlodel SS ORAL 5 MG INTRAMUSCULAR /ORAL Date:11/03/97ISR Number: 1993086-5Report Type:Expedited (15-DaCompany Report #9722143 Age: Gender:Male I/FU:U Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Interaction Health Zoloft PS ORAL Drug Level Above Professional Clozapine SS ORAL Therapeutic Dysphagia Vomiting Date:11/06/97ISR Number: 100000180Report Type:Expedited (15-DaCompany Report #USA/97/02852/LEX Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozaril PS ORAL 900MG ORAL Professional Date:11/06/97ISR Number: 100000180Report Type:Expedited (15-DaCompany Report #I/97/00002/LEX Age:31 YR Gender:Male I/FU:I Outcome Hospitalization - Initial or Prolonged 22-Feb-2006 08:30 AM Page: 2 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Required Intervention to Prevent Permanent PT Report Source Product Role Manufacturer Route Dose Duration Impairment/Damage Agitation Health Clozaril PS ORAL 100 MG ORAL Diabetes Mellitus Professional Not Reported C Diabetic Coma Hyperglycaemia Date:11/06/97ISR Number: 100000184Report Type:Expedited (15-DaCompany Report #8-97299-005N Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Pain Consumer Pondimin PS ORAL 20 MG DAILY Chest Pain ORAL Circulatory Collapse Clozaril SS UNKNOWN Drug Ineffective Phentermine SS Dyspnoea Unspecified Diet Feeling Jittery Pill SS Lethargy Axid C Nausea Clozaril C Palpitations Phentermine C Paraesthesia Unspecified Diet Personality Disorder Pill C Pulmonary Oedema Syncope Vomiting Date:11/06/97ISR Number: 100000190Report Type:Expedited (15-DaCompany Report #GB/97/01164/LEX Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Clozaril PS ORAL 300 MG ORAL Myocardial Infarction Professional Date:11/07/97ISR Number: 100000184Report Type:Expedited (15-DaCompany Report #USA/97/02743/LEX Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bronchitis Health Clozaril PS ORAL 400 MG ORAL Required Cardiomegaly Professional Ranitidine C Intervention to Cardiomyopathy Prevent Permanent Dyspnoea Impairment/Damage Pneumonia Viral Date:11/07/97ISR Number: 100000185Report Type:Expedited (15-DaCompany Report #USA/97/02866/LEX Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Basal Cell Carcinoma Health Clozaril (Clozapine) PS ORAL 2 YR Professional 22-Feb-2006 08:30 AM Page: 3 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/07/97ISR Number: 100000186Report Type:Expedited (15-DaCompany Report #USA/97/01958/LEX Age:68 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delirium Health Clozaril (Clozapine) PS ORAL 2 YR Initial or Prolonged Overdose Professional Eskalith (Lithium Other Carbonate) SS Required Flagyl Intervention to (Metronidazole) C Prevent Permanent Erythromcin C Impairment/Damage Amitriptyline C Temazepam C Wellbutrin (Amfebutamone) C Synthroid (Levothyroxine Soduim) C Pepcid C Date:11/07/97ISR Number: 100000187Report Type:Expedited (15-DaCompany Report #USA/97/02686/LEX Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Lymphopenia Health Clozaril (Clozapine) PS ORAL Initial or Prolonged Professional Effexor (Venlafaxine Required Hydrochloride) C Intervention to Prevent Permanent Impairment/Damage Date:11/07/97ISR Number: 100000188Report Type:Expedited (15-DaCompany Report #LIT/97/00273/LEX Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Pain Literature Leponex PS ORAL 600MG 4 MON Enteritis Necroticans Health Benztropine Mesylate SS 2 MG Hypotension Professional Cisapride C Malaise Omeprazole C Metabolic Acidosis Docusate Sodium C Nausea Psyllium Hydrophilic Salivary Hypersecretion Mucilloid C Sedation Shock White Blood Cell Count Increased Date:11/07/97ISR Number: 100000190Report Type:Expedited (15-DaCompany Report #CDN/97/00701/LEX Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Clozaril (Clozapine) PS ORAL Other Intentional Overdose Professional Losec (Omprazole) C 22-Feb-2006 08:30 AM Page: 4 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/07/97ISR Number: 100000190Report Type:Expedited (15-DaCompany Report #LIT/97/00228/LEX Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diarrhoea Literature Leponex/Clozaril Initial or Prolonged Eosinophilia Health (Clozapine) PS ORAL 2 WK Required Gastroenteritis Professional Intervention to Eosinophilic Prevent Permanent Nausea Impairment/Damage Pyrexia Vomiting Date:11/07/97ISR Number: 100000191Report Type:Expedited (15-DaCompany Report #D/97/02284/LEX Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coronary Artery Disease Health Leponex/Clozaril Myocardial Infarction Professional (Clozapine) PS ORAL Date:11/07/97ISR Number: 100000192Report Type:Expedited (15-DaCompany Report #D/97/03425/LEX Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiac Failure Health Leponex/Clozapine Congestive Professional (Clozaril) PS ORAL Cardiac Valve Disease Date:11/07/97ISR Number: 100000193Report Type:Expedited (15-DaCompany Report #USA/97/00944/LEX Age:35 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acute Abdomen Health Clozaril PS ORAL 200 MG ORAL Initial or Prolonged Appendicitis Perforated Professional Zocor C Required Leukocytosis Cipro C Intervention to Prevent Permanent Impairment/Damage Date:11/07/97ISR Number: 100000193Report Type:Expedited (15-DaCompany Report #CDN/97/00530/LEX Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abdominal Pain Health Clozaril PS ORAL 475MG Hospitalization - Agranulocytosis Professional Lithium Carbonate C Initial or Prolonged Hiccups Required Neutrophil Count Intervention to Decreased Prevent Permanent Vomiting Impairment/Damage White Blood Cell Count Decreased Date:11/07/97ISR Number: 100000196Report Type:Expedited (15-DaCompany Report #D/97/03283/LEX Age:60 YR Gender:Male I/FU:F Outcome Hospitalization - Initial or Prolonged 22-Feb-2006 08:30 AM Page: 5 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other PT Report Source Product Role Manufacturer Route Dose Duration Cutaneous Vasculitis Foreign Leponex PS ORAL 25 MG ORAL Dermatitis Health Quilonum Retard SS ORAL 1350 MG ORAL Vasculitis Necrotising Professional Dociton SS ORAL 120 MG ORAL Melleretten C Date:11/07/97ISR Number: 100000199Report Type:Expedited (15-DaCompany Report #USA/97/02230/LEX Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Confusional State Health Clozaril PS ORAL 600 TO 700 MG Other Delirium Professional ORAL Required Overdose Intervention to Prevent Permanent Impairment/Damage Date:11/10/97ISR Number: 100000227Report Type:Expedited (15-DaCompany Report #CDN/97/00301/LEX Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accident Health Clozaril PS ORAL 500 MG ORAL Hospitalization - Injury Professional Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage Date:11/12/97ISR Number: 3000179-2Report Type:Expedited (15-DaCompany Report #LIT/97/00279/LEX Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Upper Literature Leponex/Clozaril Initial or Prolonged Acidosis Health (Clozapine) PS ORAL 600 MG ORAL 1 YR Required Anaemia Professional Buspirone SS 20 MG UNKNOWN 5 WK Intervention to Gastrointestinal Lorazepam C Prevent Permanent Haemorrhage Clonazepam C Impairment/Damage Haematemesis Beta-Blockers C Haematocrit Decreased Caffeine C Hyperglycaemia Nausea Date:11/12/97ISR Number: 3000180-9Report Type:Expedited (15-DaCompany Report #LIT/97/00281/LEX Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Chest Pain Literature Leponex/Clozaril Required Dyspnoea Health (Clozapine) PS ORAL 300 MG ORAL 10 DAY Intervention to Hyperglycaemia Professional Prevent Permanent Hyperkalaemia Impairment/Damage Ketoacidosis Sedation Thirst 22-Feb-2006 08:30 AM Page: 6 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/12/97ISR Number: 3000182-2Report Type:Expedited (15-DaCompany Report #D/97/02147/LEX Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asthma Health Leponex (Clozapine) PS ORAL UNSPECIFIED Bronchospasm Professional ORAL Completed Suicide Ditec C Intentional Overdose Zyrtec (Cetirizine Vomiting Hydrochloride C Date:11/12/97ISR Number: 3000183-4Report Type:Expedited (15-DaCompany Report #CDN/97/00710/LEX Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Gastrointestinal Health Clozaril (Clozapine) PS ORAL 600 MG ORAL Initial or Prolonged Haemorrhage Professional Renal Failure Acute Date:11/12/97ISR Number: 3000184-6Report Type:Expedited (15-DaCompany Report #F/97/01698/LEX Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hypoxia Health Leponex (Clozapine) PS ORAL UNSPECIFIED Required Immunodeficiency Professional ORAL 3 WK Intervention to Pneumonia Prevent Permanent Respiratory Distress Impairment/Damage Date:11/12/97ISR Number: 3000188-3Report Type:Expedited (15-DaCompany Report #LIT/97/00228/LEX Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diarrhoea Literature Leponex/Clozaril Initial or Prolonged Gastroenteritis Health (Clozapine) PS ORAL 2 WK Required Eosinophilic Professional Intervention to Nausea Prevent Permanent Pyrexia Impairment/Damage Vomiting Date:11/12/97ISR Number: 3000292-XReport Type:Expedited (15-DaCompany Report #USA/97/02932/LEX Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Coma Health Clozaril (Clozapine) PS ORAL 50 MG ORAL Hypertonia Professional Zoloft(Sertraline Infection Hydrochloride) C Muscle Contractions Sinemet C Involuntary Cardopa (Arbidopa) C Muscle Rigidity Inderal (Propranolol Pyrexia Hydrochloride) C Date:11/12/97ISR Number: 3000568-6Report Type:Expedited (15-DaCompany Report #USA/97/02644/LEX Age: Gender:Female I/FU:F Outcome PT Death Cardiac Failure Congestive 22-Feb-2006 08:30 AM Page: 7 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Condition Aggravated Pneumonia Report Source Product Role Manufacturer Route Dose Duration Health Clozaril (Clozapine) PS ORAL 100 MG ORAL Professional Date:11/12/97ISR Number: 3000591-1Report Type:Expedited (15-DaCompany Report #CH/96/00014/LEX Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Anaemia Health Leponex/Clozaril PS ORAL 100 MG ORAL Required Haemolysis Professional Betaseron SS MIO 8 IU Intervention to Haemolytic Uraemic Priadel C Prevent Permanent Syndrome Impairment/Damage Renal Failure Acute Date:11/13/97ISR Number: 3000469-3Report Type:Expedited (15-DaCompany Report #USA/97/02069/LEX Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Large Cell Carcinoma Of Health Clozaril (Clozapine) PS ORAL The Respiratory Tract Professional Stage Unspecified Pneumonitis Date:11/13/97ISR Number: 3000684-9Report Type:Expedited (15-DaCompany Report #USA/97/02536/LEX Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Carotid Artery Thrombosis Health Clozaril PS ORAL 400 MG ORAL Initial or Prolonged Cerebrovascular Accident Professional Florinef Hemiparesis (Fludrocortisone Hypotension Acetate) C Prozac (Fluoxetine Hydrochloride) C Asa (Acetylsalicylic Acid) C Date:11/17/97ISR Number: 3001079-4Report Type:Expedited (15-DaCompany Report #D/97/01880/LEX Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozaril PS ORAL 200 MG ORAL Hospitalization - Chills Professional Paracetamol SS RECTAL 1000 MG Initial or Prolonged Pneumonia RECTAL Required Pyrexia Acetylsalicylic Acid SS UNSPECIFIED Intervention to UNKNOWN Prevent Permanent Augmentin SS UNSPECIFIED Impairment/Damage Digimerck Minor C Ismo Retard C Mucosolvan C 22-Feb-2006 08:30 AM Page: 8 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/17/97ISR Number: 3001093-9Report Type:Expedited (15-DaCompany Report #D/97/03419/LEX Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatinine Health Leponex/Clozaril PS ORAL 250 MG Initial or Prolonged Increased Professional Convulex (Valproate Blood Urea Increased Sodium) C Leukocytosis Tavor (Lorazepam) C Pyrexia Date:11/17/97ISR Number: 3001108-8Report Type:Expedited (15-DaCompany Report #D/97/02552/PLO Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Bromacriptine PS ORAL 5 MG ORAL Deep Vein Thrombosis Professional Beneperidol SS 8 MG Pulmonary Embolism Clozapine SS ORAL 125 MG ORAL Mesylate SS INTRAMUSCULAR INTRAMUSCULAR , ORAL Promethazine SS ORAL 100 MG ORAL Chlorprothixen (Chlorprothixene) SS ORAL 200 MG ORAL Date:11/17/97ISR Number: 3001110-6Report Type:Expedited (15-DaCompany Report #D/97/03529/LEX Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Health Leponex PS ORAL 3 G ORAL Initial or Prolonged Salivary Hypersecretion Professional Lasix SS ORAL UNSPECIFIED Sedation ORAL Suicide Attempt Valium SS ORAL UNSPECIFIED ORAL Date:11/17/97ISR Number: 3001308-7Report Type:Expedited (15-DaCompany Report #D/97/01632/LEX Age:55 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Alcoholism Clozaril PS ORAL 400 MG ORAL Peripheral Circulatory Bifiteral Failure (Lactulose) C Atosil (Isopromethazine Hydrochloride) C Date:11/17/97ISR Number: 3001311-7Report Type:Expedited (15-DaCompany Report #D/97/00754/LEX Age:50 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Health Clozaril PS ORAL 350 MG ORAL Initial or Prolonged Cardiac Murmur Professional Bicalm C Cardiomegaly Faustan C Dyspnoea Influenza Like Illness Myocarditis Pericardial Effusion Pyrexia 22-Feb-2006 08:30 AM Page: 9 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/17/97ISR Number: 3001312-9Report Type:Expedited (15-DaCompany Report #CDN/97/00420/LEX Age:73 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Clozaril PS ORAL 300 MG ORAL Congestive Professional Tardive Dyskinesia Date:11/17/97ISR Number: 3005580-9Report Type:Direct Company Report # Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukocytosis Clozaril PS ORAL 900 MG HS PO Initial or Prolonged Date:11/18/97ISR Number: 3001331-2Report Type:Expedited (15-DaCompany Report #LIT/97/00170/LEX Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bronchospasm Literature Clozaril PS ORAL 500 MG ORAL Required Chest Pain Health Ventolin C Intervention to Circulatory Collapse Professional Becotide Prevent Permanent Constipation (Beclometasone Impairment/Damage Cyanosis Dipropionate) C Diarrhoea Aurorix Dyspepsia (Moclobemide) C Dyspnoea Epilim (Valproate Faecaloma Sodium) C Nausea Pulmicort Oesophagitis (Budesonide) C Pulmonary Oedema Pulse Absent Shock Vomiting Date:11/18/97ISR Number: 3001337-3Report Type:Expedited (15-DaCompany Report #LIT/96/00261/LEX Age:33 YR Gender:Male I/FU:I Outcome PT Hospitalization - Blood Creatine Increased Initial or Prolonged Blood Creatine Phosphokinase Increased Blood Fibrinogen Decreased Blood Urea Increased Confusional State Dehydration Delirium Depressed Level Of Consciousness Diarrhoea Disorientation Disseminated Intravascular Coagulation Illusion Lethargy Neuroleptic Malignant Syndrome Orthostatic Hypotension 22-Feb-2006 08:30 AM Page: 10 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Platelet Count Decreased Pyrexia Sedation Report Source Product Role Manufacturer Route Dose Duration Tachycardia Literature Leponex/Clozaril PS 125 MG 5 DAY Thrombocytopenia Health Professional Date:11/18/97ISR Number: 3001342-7Report Type:Expedited (15-DaCompany Report #CH/97/00011/MEL Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardio-Respiratory Arrest Health Melleril PS Novartis Hospitalization - Circulatory Collapse Professional Pharmaceuticals Initial or Prolonged Pulse Absent Corp. UNSPECIFIED Other Leponex/Clozaril SS ORAL 25 MG ORAL 1 Required DOSE Intervention to Propranolol C Prevent Permanent Trimipramin C Impairment/Damage Date:11/18/97ISR Number: 3001346-4Report Type:Expedited (15-DaCompany Report #GB/94/00859/MEL Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Melleril PS ORAL 200 MG ORAL Cardio-Respiratory Arrest Professional Leponex/Clozaril SS ORAL 600 MG ORAL Circulatory Collapse Haloperidol SS UNSPECIFIED Shock Clopixol SS ORAL MG/3W 200 ORAL Lithium C Salbutamol C Ranitidine C Benzhexol C Date:11/18/97ISR Number: 3001382-8Report Type:Expedited (15-DaCompany Report #USA/97/02693/LEX Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aortic Atherosclerosis Health Clozaril PS ORAL 600 MG ORAL Arrhythmia Professional Depakote C Cardiomegaly Trazodone C Coronary Artery Disease Cogentin C Myocardial Infarction Ventricular Hypertrophy Date:11/18/97ISR Number: 3001385-3Report Type:Expedited (15-DaCompany Report #USA/97/02985/LEX Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiomyopathy Health Clozaril PS ORAL 75-100 MG Initial or Prolonged Pneumonia Professional ORAL Sedation Depakote C Klonopin C Benadryl C 22-Feb-2006 08:30 AM Page: 11 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/18/97ISR Number: 3001387-7Report Type:Expedited (15-DaCompany Report #LIT/97/00171/LEX Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Chills Literature Leponex PS ORAL 150 MG ORAL 6 DAY Hospitalization - Oedema Peripheral Health Nifedipine C Initial or Prolonged Pneumonia Aspiration Professional Required Productive Cough Intervention to Pyrexia Prevent Permanent Salivary Hypersecretion Impairment/Damage Sedation Tachycardia Date:11/18/97ISR Number: 3001514-1Report Type:Expedited (15-DaCompany Report #LEX/F-02/0/11/57/1/F Age:72 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arrhythmia Study Clozapine PS ORAL 100 MG ORAL Initial or Prolonged Bradycardia Health Sinemet C Cardiomyopathy Professional Rivotril C Coma Athymil C Convulsion Apomorphine C Loss Of Consciousness Tachycardia Date:11/18/97ISR Number: 3001515-3Report Type:Expedited (15-DaCompany Report #GB/97/00749/LEX Age:35 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Health Clozaril PS ORAL 300 MG ORAL Constipation Professional Dothiepin Diarrhoea Hydrochloride SS ORAL 250 MG ORAL Faecaloma Procyclidine C Malaise Phosphate Enema Syncope Vasovagal (Phosphates Enema) C Lactulose C Paracetamol C Date:11/18/97ISR Number: 3001516-5Report Type:Expedited (15-DaCompany Report #D/97/01300/LEX Age:22 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Amylase Increased Health Leponex/Clozaril Initial or Prolonged Diabetic Ketoacidosis Professional (Clozapine) PS ORAL 400 MG ORAL 14 MON Pancreatitis Orfiril (Valproate Sodium) SS UNSPECIFIED 14 MON Lorazepam C Contraceptivum Nos (Contraceptivum E) C Date:11/18/97ISR Number: 3005878-4Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome Life-Threatening Hospitalization - Initial or Prolonged Required 22-Feb-2006 08:30 AM Page: 12 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Intervention to Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Ventricular Tachycardia Clozaril PS ORAL 200MG/QHS( THERAPY DURATION: UNKNOWN - MONTHS TO Ativan C Date:11/19/97ISR Number: 3001625-0Report Type:Expedited (15-DaCompany Report #USA/97/01879/LEX Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozaril PS ORAL Professional Depakote (Valproate Semisodium) C Risperdal (Risperidone) C Librium (Chlordiazepoxide Hydrochloride) C Date:11/19/97ISR Number: 3001868-6Report Type:Expedited (15-DaCompany Report #LIT/95/00079/LEX Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coma Literature Leponex/Clozaril PS ORAL 1000 MG ORAL 1 DAY Hospitalization - Overdose Initial or Prolonged Pancreatitis Other Suicide Attempt Required Intervention to Prevent Permanent Impairment/Damage Date:11/20/97ISR Number: 3001906-0Report Type:Expedited (15-DaCompany Report #D/97/03645/LEX Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatinine Health Leponex PS ORAL 200 MG ORAL Initial or Prolonged Increased Professional L-Thyroxin Drug Level Above (Levothyroxine Therapeutic Sodium) C Dytide H (Dyazide) C Date:11/20/97ISR Number: 3001910-2Report Type:Expedited (15-DaCompany Report #USA/97/02083/LEX Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Clozaril PS ORAL 300 MG Initial or Prolonged Convulsion Ativan (Lorazepam) C Required Dysarthria Alcohol (Ethanol) C Intervention to Headache Tylenol Prevent Permanent Lethargy (Paracetamol) C Impairment/Damage Weight Decreased 22-Feb-2006 08:30 AM Page: 13 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/20/97ISR Number: 3001916-3Report Type:Expedited (15-DaCompany Report #LIT/97/00263/LEX Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dermatitis Literature Leponex/Clozaril PS UNSPECIFIED 6 WK Hospitalization - Leukocytosis Health Iskedyl C Initial or Prolonged Multi-Organ Failure Professional Required Pyrexia Intervention to Rash Erythematous Prevent Permanent Rash Pustular Impairment/Damage Shock Date:11/20/97ISR Number: 3001924-2Report Type:Expedited (15-DaCompany Report #LIT/97/00196/LEX Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coma Literature Clozapine PS ORAL G 6-8 ORAL 1 DAY Other Gastritis Erosive Health Required Gastritis Haemorrhagic Professional Intervention to Haematemesis Prevent Permanent Hyperreflexia Impairment/Damage Hypotension Intentional Overdose Mydriasis Date:11/20/97ISR Number: 3001928-XReport Type:Expedited (15-DaCompany Report #LIT/97/00177/LEX Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Potassium Literature Leponex PS ORAL 2200 MG 1 DAY Initial or Prolonged Coma Health Other Convulsion Professional Required Osteoarthritis Intervention to Overdose Prevent Permanent Sedation Impairment/Damage Suicide Attempt Tachycardia Date:11/20/97ISR Number: 3001931-XReport Type:Expedited (15-DaCompany Report #LIT/97/00266/LEX Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Literature Leponex/Clozaril PS 100 MG 5 DAY Required Cellulitis Health Verapamil C Intervention to Chest Pain Professional Prevent Permanent Cough Impairment/Damage Diarrhoea Eosinophilia Nausea Oedema Peripheral Pain In Extremity Pleural Effusion Pyrexia Rash Erythematous Tenderness Vomiting White Blood Cell Count Increased 22-Feb-2006 08:30 AM Page: 14 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/20/97ISR Number: 3001981-3Report Type:Expedited (15-DaCompany Report #GB/97/01164/LEX Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Clozaril PS ORAL 300 MG Myocardial Infarction Professional Dothiepin (Dosulepin) C Haloperidol C Date:11/20/97ISR Number: 3002046-7Report Type:Expedited (15-DaCompany Report #D/97/03283/LEX Age:60 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Vasculitis Necrotising Foreign Leponex PS ORAL 25 MG ORAL Initial or Prolonged Health Quilonum Retard SS ORAL 1350 MG ORAL Other Professional Dociton SS ORAL 120 MG ORAL Required Melleretten SS ORAL 20 MG ORAL Intervention to Prevent Permanent Impairment/Damage Date:11/20/97ISR Number: 3002049-2Report Type:Expedited (15-DaCompany Report #F/97/00478/LEX Age:62 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Haematemesis Health Clozaril PS ORAL 600 MG ORAL Professional Imovane C Mopral C Loxen C Gaviscon C Duphalac C Klean-Prep C Date:11/21/97ISR Number: 3002101-1Report Type:Expedited (15-DaCompany Report #89733 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Hypertension Health Tegison Capsules Intervention to Professional (Etretinate) PS ORAL ORAL Prevent Permanent Other Clozaril (Clozapine) SS ORAL 200.000 MG Impairment/Damage DAILY ORAL 49 DAY Atarax (Hydroxyzine Hydrochloride) C Ativan (Lorazepam) C Benadryl (Diphenhydramine Hydrochloride) C Ventolin Inhaler (Albuterol) C Lithium (Lithium Nos) C Date:11/21/97ISR Number: 3002249-1Report Type:Expedited (15-DaCompany Report #9722143 Age: Gender:Male I/FU:I Outcome PT Death Choking Drug Interaction 22-Feb-2006 08:30 AM Page: 15 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Drug Level Above Therapeutic Vomiting Report Source Product Role Manufacturer Route Dose Duration Health Zoloft PS ORAL Professional Clozapine SS ORAL Date:11/21/97ISR Number: 3002578-1Report Type:Expedited (15-DaCompany Report #8-97299-005N Age:22 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Pain Health Pondimin PS ORAL 20 MG THREE Chest Pain Professional TIMES DAILY Circulatory Collapse ORAL Drug Ineffective Clozaril SS 12.5 MG; 400 Dyspnoea MG Feeling Jittery Unspecified Diet Lethargy Pill SS Nausea Adipex SS 37.5 MG DAILY Pain Axid C Palpitations Clozaril C Paraesthesia Phentermine C Pulmonary Oedema Unspecified Diet Syncope Pill C Vomiting White Blood Cell Count Date:11/24/97ISR Number: 3005370-7Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Toxicity Health Chlorpromazine PS 100 MG PRN Q Professional 2 HRS Clozaril SS Sandoz 50 MG AM, 500 MG PM Date:11/25/97ISR Number: 3002568-9Report Type:Expedited (15-DaCompany Report #USA/97/03021/LEX Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Emphysema Health Clozaril PS ORAL 500MG ORAL Professional Date:11/25/97ISR Number: 3002569-0Report Type:Expedited (15-DaCompany Report #USA/97/03020/LEX Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hypertension Health Clozaril PS ORAL UNSPECIFIED Professional ORAL Date:11/25/97ISR Number: 3002571-9Report Type:Expedited (15-DaCompany Report #USA/97/02690/LEX Age:48 YR Gender:Female I/FU:I Outcome PT Death Adenoma Benign Adrenal Adenoma Cardiac Arrest 22-Feb-2006 08:30 AM Page: 16 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Cholelithiasis Dyspnoea Hepatic Artery Embolism Report Source Product Role Manufacturer Route Dose Duration Myocarditis Health Clozaril (Clozapine) PS ORAL 800 MG ORAL Nephrosclerosis Professional Paxil C Pericarditis Trazadone Pulmonary Embolism Hydrochloride C Pyelonephritis Chronic Renal Arteriosclerosis Splenomegaly Syncope Date:11/25/97ISR Number: 3002575-6Report Type:Expedited (15-DaCompany Report #GB/97/00927/LEX Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Health Clozaril PS ORAL 600 MG ORAL Required Constipation Professional Benzatropine SS UNKNOWN Intervention to Faecaloma Lactulose C Prevent Permanent Hypertonia Fybogel C Impairment/Damage Ileus Paralytic Drapolene C Megacolon Salivary Hypersecretion Vomiting Date:11/26/97ISR Number: 3002733-0Report Type:Expedited (15-DaCompany Report #USA/97/01550/LEX Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Health Clozaril PS ORAL 600 MG ORAL Initial or Prolonged Abscess Professional Prozac C Required Acute Abdomen Depakote C Intervention to Acute Respiratory Amphotericin-B C Prevent Permanent Distress Syndrome Aluminum C Impairment/Damage Breath Sounds Abnormal Ativan C Candidiasis Haloperidol C Diverticulitis Hespan C Gastritis Prilosec C Intestinal Perforation Inderal C Nosocomial Infection Pain Productive Cough Pyrexia Rales Respiratory Disorder Rhonchi Sepsis Tachycardia White Blood Cell Count Increased Date:11/26/97ISR Number: 3002734-2Report Type:Expedited (15-DaCompany Report #USA/97/01555/LEX Age:33 YR Gender:Female I/FU:F Outcome Other Required Intervention to 22-Feb-2006 08:30 AM Page: 17 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Lymphadenopathy Consumer Clozaril PS ORAL ORAL Lymphoma Health Depakote C Toxoplasmosis Professional Norvasc C White Blood Cell Count Altace C Abnormal Pericolace C Proventil Mdi C Birth Control Pills C Date:11/26/97ISR Number: 3002737-8Report Type:Expedited (15-DaCompany Report #USA/97/01754/LEX Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Clozaril PS ORAL 200 MG ORAL Initial or Prolonged Blood Creatine Increased Professional Inderal C Required Blood Creatine Xanax C Intervention to Phosphokinase Increased Clonidine C Prevent Permanent Blood Urea Increased Depakote C Impairment/Damage Coagulation Time Pepcid C Shortened Synthroid C Coagulopathy Cognitive Disorder Dysarthria Hypertonia Hypotension Hypoxia Muscle Rigidity Pyrexia Speech Disorder Date:11/26/97ISR Number: 3002741-XReport Type:Expedited (15-DaCompany Report #AUS/97/00055/LEX Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Toxicity Health Clozaril PS ORAL 300 MG ORAL Other Overdose Professional Heroine SS UNSPECIFIED Voltaren SS UNSPECIFIED Panadol SS UNSPECIFIED Bricanyl SS UNSPECIFIED Temaze SS UNSPECIFIED Desipramine C Date:11/26/97ISR Number: 3002743-3Report Type:Expedited (15-DaCompany Report #USA/97/03045/LEX Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperlipidaemia Health Clozaril PS ORAL 200MG ORAL Initial or Prolonged Multi-Organ Failure Professional Depakote C Required Pancreatitis Acute Zoloft C Intervention to Pancreatitis Necrotising Ativan C Prevent Permanent Impairment/Damage 22-Feb-2006 08:30 AM Page: 18 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/26/97ISR Number: 3002745-7Report Type:Expedited (15-DaCompany Report #AUS/97/00070/LEX Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Oesophageal Carcinoma Foreign Clozaril PS ORAL 350MG ORAL Other Health Alprazalam C Professional Date:11/26/97ISR Number: 3002748-2Report Type:Expedited (15-DaCompany Report #GB/97/01170/LEX Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyskinesia Health Clozaril PS ORAL 200MG ORAL Initial or Prolonged Extrapyramidal Disorder Professional Tongue Disorder Date:11/26/97ISR Number: 3002817-7Report Type:Expedited (15-DaCompany Report #S/97/00082/LEX Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Myocardial Infarction Health Leponex PS ORAL UNSPECIFIED Initial or Prolonged Professional ORAL Required Intervention to Prevent Permanent Impairment/Damage Date:11/26/97ISR Number: 3002819-0Report Type:Expedited (15-DaCompany Report #LIT/97/00335/LEX Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chills Literature Leponex PS ORAL ORAL 1 WK Initial or Prolonged Dyspnoea Health Sertraline C Required Hyperhidrosis Professional Busiprone C Intervention to Pericardial Effusion Prevent Permanent Pericarditis Impairment/Damage Pleural Effusion Pneumonia Polyserositis Pyrexia Date:11/26/97ISR Number: 3002821-9Report Type:Expedited (15-DaCompany Report #USA/97/01788/LEX Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Accidental Overdose Health Clozaril PS ORAL 900MG ORAL Required Depressed Level Of Professional Risperdal C Intervention to Consciousness Depakote C Prevent Permanent Sedation Impairment/Damage Date:11/26/97ISR Number: 3002823-2Report Type:Expedited (15-DaCompany Report #USA/97/00087/LEX Age:38 YR Gender:Male I/FU:F Outcome Life-Threatening Other 22-Feb-2006 08:30 AM Page: 19 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Required Intervention to Prevent Permanent PT Report Source Product Role Manufacturer Route Dose Duration Impairment/Damage Leukopenia Health Clozaril PS ORAL 400 MG ORAL Metastases To Lymph Nodes Professional Bleomycin C Metastases To The Vp-16 C Mediastinum Cisplatinum C Neutropenia Testis Cancer Date:11/26/97ISR Number: 3002861-XReport Type:Expedited (15-DaCompany Report #USA/97/01833/LEX Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozaril PS ORAL 700 MG ORAL Cardiomegaly Professional Lithium Carbonate C Coma Luvox C Delirium Congentin C Goitre Neuroleptic Malignant Syndrome Pulmonary Oedema Pyrexia Date:11/26/97ISR Number: 3002863-3Report Type:Expedited (15-DaCompany Report #USA/97/03048/LEX Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Consumer Clozaril PS ORAL 550MG DAILY 6 YR Health Zyprexa C Professional Date:11/26/97ISR Number: 3002865-7Report Type:Expedited (15-DaCompany Report #USA/97/02162/LEX Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Health Clozaril PS ORAL 550 MG ORAL Initial or Prolonged Respiratory Failure Professional Depakote C Other Ativan C Klonopin C Date:11/26/97ISR Number: 3002871-2Report Type:Expedited (15-DaCompany Report #CDN/97/00701/LEX Age:55 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Foreign Clozaril PS ORAL 500.00MG ORAL Other Completed Suicide Health Losec C Intentional Overdose Professional Colace C Lactulose C Dulcolax C Cogentin C Clonazepam C 22-Feb-2006 08:30 AM Page: 20 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/26/97ISR Number: 3002873-6Report Type:Expedited (15-DaCompany Report #CDN/97/00788/LEX Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Clozaril PS ORAL ORAL Drug Ineffective Health Professional Other Date:11/26/97ISR Number: 3002874-8Report Type:Expedited (15-DaCompany Report #CDN/97/00764/LEX Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Choking Health Clozaril PS ORAL ORAL Foreign Body Aspiration Professional Date:11/26/97ISR Number: 3002875-XReport Type:Expedited (15-DaCompany Report #CDN/97/00792/LEX Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Suicide Attempt Health Clozaril PS ORAL 400 MG ORAL Initial or Prolonged Professional Clozaril SS Date:11/26/97ISR Number: 3002876-1Report Type:Expedited (15-DaCompany Report #B/97/00081/LEX Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Health Leponex/Clozaril PS ORAL 300MG Initial or Prolonged Dyskinesia Professional Tegretol C Other Hypotension Euglucon C Required Shock Zantac C Intervention to Asaflow C Prevent Permanent Paramol C Impairment/Damage Prolopa C Sympatol C Date:11/26/97ISR Number: 3002877-3Report Type:Expedited (15-DaCompany Report #D/97/01430/LEX Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Overdose Health Leponex/Clozaril PS ORAL 400MG Initial or Prolonged Cognitive Disorder Professional Bifiteral C Other Disturbance In Attention Required Dizziness Intervention to Sedation Prevent Permanent Impairment/Damage Date:11/26/97ISR Number: 3002879-7Report Type:Expedited (15-DaCompany Report #USA/96/01629/LEX Age:33 YR Gender:Female I/FU:F Outcome PT Life-Threatening Dementia Hospitalization - Hypertension Initial or Prolonged Hypertonia Other Medication Error Mental Impairment 22-Feb-2006 08:30 AM Page: 21 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Muscle Rigidity Overdose Renal Failure Acute Report Source Product Role Manufacturer Route Dose Duration Tachycardia Health Clozaril PS Novartis Professional Pharmaceuticals ORAL 600 MG Date:12/02/97ISR Number: 3003632-0Report Type:Expedited (15-DaCompany Report #USA/97/02799/LEX Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arrhythmia Consumer Clozaril PS ORAL 2 TABLES Initial or Prolonged Dizziness Marijuana SS 2"JOINTS" Other Drug Interaction Fatigue Loss Of Consciousness Overdose Stupor Date:12/02/97ISR Number: 3003634-4Report Type:Expedited (15-DaCompany Report #USA/97/03106/LEX Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Level Above Health Clozaril PS ORAL 175MG ORAL Initial or Prolonged Therapeutic Professional Lithium C Required Renal Failure Acute Intervention to Prevent Permanent Impairment/Damage Date:12/02/97ISR Number: 3003694-0Report Type:Expedited (15-DaCompany Report #USA/95/00043/LEX Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chronic Myeloid Leukaemia Health Clozaril PS ORAL 825 MG ORAL Required Eosinophilia Professional Lopid C Intervention to Leukaemia Granulocytic Famotidine C Prevent Permanent Leukocytosis Riopan Plus C Impairment/Damage Milk Of Magnesia With Cascara C Multivitamin C Min. C Oxybutynin C Date:12/02/97ISR Number: 3003707-6Report Type:Expedited (15-DaCompany Report #USA/97/027430/LEX Age:31 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthma Health Clozaril PS ORAL 400 MG ORAL Required Bronchitis Professional Ranitidine C Intervention to Cardiomegaly Prevent Permanent Cardiomyopathy Impairment/Damage Coxsackie Viral Infection Dyspnoea Left Ventricular Failure Pneumonia Viral Upper Respiratory Tract Infection 22-Feb-2006 08:30 AM Page: 22 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/02/97ISR Number: 3003720-9Report Type:Expedited (15-DaCompany Report #USA/96/01472/LEX Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Appendicitis Health Clozaril PS ORAL 500 MG ORAL Professional Klonopin C Lithium C Depakote C Date:12/02/97ISR Number: 3003726-XReport Type:Expedited (15-DaCompany Report #USA/97/02686/LEX Age:72 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Lymphopenia Health Clozaril PS ORAL 400 MG ORAL Initial or Prolonged Thrombocythaemia Professional Efexor C Ativan C Date:12/02/97ISR Number: 3003728-3Report Type:Expedited (15-DaCompany Report #CDN/97/00792/LEX Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Health Clozaril PS ORAL 400 MG ORAL Initial or Prolonged Suicide Attempt Professional Clozaril SS Other Required Intervention to Prevent Permanent Impairment/Damage Date:12/02/97ISR Number: 3003730-1Report Type:Expedited (15-DaCompany Report #USA/97/01525/LEX Age:73 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coma Health Clozaril PS ORAL ORAL Hospitalization - Intestinal Obstruction Professional Anafranil C Initial or Prolonged Neoplasm Malignant Dilantin C Other Neurontin C Prednisone C Date:12/02/97ISR Number: 3003741-6Report Type:Expedited (15-DaCompany Report #USA/97/02199/LEX Age:46 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Intestinal Perforation Health Clozaril PS ORAL 600 MG ORAL Hospitalization - Large Intestine Professional Lithium C Initial or Prolonged Perforation Sepsis Date:12/02/97ISR Number: 3003744-1Report Type:Expedited (15-DaCompany Report #D/97/03283/LEX Age:60 YR Gender:Male I/FU:F Outcome Hospitalization - Initial or Prolonged Other Required Intervention to 22-Feb-2006 08:30 AM Page: 23 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Aortic Valve Stenosis Health Leponex PS ORAL 25 MG ORAL Dermatitis Professional Quilonum Retard SS ORAL 1350 MG ORAL Gangrene Melleretten SS ORAL 20 MG ORAL Vasculitis Necrotising Dociton C Date:12/02/97ISR Number: 3003912-9Report Type:Expedited (15-DaCompany Report #NZ/97/00026/LEX Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozaril PS ORAL 300 MG Hospitalization - Carotid Artery Thrombosis Professional Leucomax SS Initial or Prolonged Hemianopia Chlorpromazine C Disability Hemiparesis Lithium Carbonate C Required Hemiplegia Intervention to Neutrophil Count Prevent Permanent Decreased Impairment/Damage Pyrexia Thrombosis White Blood Cell Count Decreased Date:12/02/97ISR Number: 3004115-4Report Type:Expedited (15-DaCompany Report #N/96/00043/LEX Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypercapnia Health Leponex PS ORAL 100 MG ORAL Initial or Prolonged Hypoxia Professional Risperdal SS ORAL 8 MG ORAL Required Respiratory Disorder Petidin SS 100 MG Intervention to Dormicum SS UNSPECIFIED Prevent Permanent Rapifen SS UNSPECIFIED Impairment/Damage Date:12/02/97ISR Number: 3006968-2Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Level Above Chlorpramazine PS 100 MG PRN Q Therapeutic 2 HRS Overdose Clozaril SS 50 MG AM, 500 Therapeutic Agent MGPM Toxicity Date:12/05/97ISR Number: 3004268-8Report Type:Expedited (15-DaCompany Report #S/96/00071/LEX Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Leponex/Clozaril PS UNSPECIFIED 22-Feb-2006 08:30 AM Page: 24 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/05/97ISR Number: 3004275-5Report Type:Expedited (15-DaCompany Report #GB/97/00927/LEX Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Health Clozaril PS ORAL 600MG ORAL Required Constipation Professional Benzatropine SS Intervention to Hypertonia Lactulose C Prevent Permanent Ileus Paralytic Fybogel C Impairment/Damage Megacolon Drapolene C Muscle Rigidity Salivary Hypersecretion Date:12/05/97ISR Number: 3004280-9Report Type:Expedited (15-DaCompany Report #USA/97/01555/LEX Age:33 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Lymphadenopathy Consumer Clozaril PS ORAL 600 MG ORAL Required Lymphoma Health Depakote C Intervention to Toxoplasmosis Professional Norvasc C Prevent Permanent White Blood Cell Count Altace C Impairment/Damage Decreased Pericolace C Proventil Mdi C Birth Control Pills C Date:12/05/97ISR Number: 3004330-XReport Type:Expedited (15-DaCompany Report #GB/97/01082/LEX Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Constipation Health Clozaril PS ORAL 450 MG ORAL Hospitalization - Duodenal Ulcer Professional Initial or Prolonged Hypokalaemia Required Vomiting Intervention to Weight Decreased Prevent Permanent Impairment/Damage Date:12/08/97ISR Number: 3004908-3Report Type:Expedited (15-DaCompany Report #8933/18276 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Sodium Abnormal Foreign Xanax PS ORAL .5 MG Initial or Prolonged Coma Consumer 3Q1DY;ORAL Other Inappropriate Company Flumitrazepam SS 3MG/DAY ORAL Antidiuretic Hormone Representative Cyamemazine SS ORAL 300MG/DAY Secretion ORAL Polydipsia Paroxetine SS 20MG/DAY ORAL Clozapine SS ORAL 50MG/DAY ORAL Date:12/09/97ISR Number: 3004903-4Report Type:Expedited (15-DaCompany Report #CDN/97/00895/LEX Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bradycardia Clozaril PS ORAL 12.5 MG ORAL Hypotension Prozac C Captopril C Lasix C Calcium Carbonate C Propanolol C 22-Feb-2006 08:30 AM Page: 25 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Norvasc C Date:12/09/97ISR Number: 3004946-0Report Type:Expedited (15-DaCompany Report #USA/96/02566/LEX Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Health Clozaril PS ORAL ORAL Professional Date:12/09/97ISR Number: 3004947-2Report Type:Expedited (15-DaCompany Report #USA/95/02434/LEX Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Clozaril (Clozapine) PS ORAL 400 MG ORAL Initial or Prolonged Hyperglycaemia Depakote C Other Ketoacidosis Cogentin C Required Prolixin C Intervention to Prevent Permanent Impairment/Damage Date:12/10/97ISR Number: 3006057-7Report Type:Expedited (15-DaCompany Report #I/96/00063/LEX Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Acute Myeloid Leukaemia Health Leponex PS ORAL 325 MG Hospitalization - Agranulocytosis Professional Initial or Prolonged Leukaemia Granulocytic White Blood Cell Count Decreased Date:12/10/97ISR Number: 3006065-6Report Type:Expedited (15-DaCompany Report #GB/97/01196/LEX Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neuropathy Peripheral Health Clozaril PS ORAL 125 MG Paraesthesia Professional Paresis Sensory Disturbance Sensory Loss Date:12/10/97ISR Number: 3006066-8Report Type:Expedited (15-DaCompany Report #GB/97/01205/LEX Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abdominal Mass Health Clozaril PS ORAL 100 MG Constipation Professional Faecaloma Intestinal Perforation Large Intestine Perforation Lower Respiratory Tract Infection Malaise 22-Feb-2006 08:30 AM Page: 26 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/10/97ISR Number: 3006134-0Report Type:Expedited (15-DaCompany Report #D/97/03952/LEX Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Leponex/Clozarail PS ORAL 3000MG;ORAL Initial or Prolonged Delirium Professional Antiderpressants SS Overdose Tavor SS Suicide Attempt Timonil SS Date:12/10/97ISR Number: 3006136-4Report Type:Expedited (15-DaCompany Report #GB/97/01055/LEX Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Toxicity Health Clozaril PS ORAL 900MG ORAL Hospitalization - Dysarthria Professional Paracetamol SS Initial or Prolonged Malaise Sodium Valproate C Overdose Lithium Carbonate C Date:12/10/97ISR Number: 3006137-6Report Type:Expedited (15-DaCompany Report #D/97/00705/LEX Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Chloroma Health Leponex/Clozaril PS ORAL 200 MG Other Convulsion Professional Saroten SS ORAL 75MG Leukaemia Granulocytic Psychotic Disorder Simple Partial Seizures Date:12/10/97ISR Number: 3006139-XReport Type:Expedited (15-DaCompany Report #USA/97/03045/LEX Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Hyperlipidaemia Health Clozaril PS ORAL 225 BID = Hospitalization - Multi-Organ Failure Professional 450MG Initial or Prolonged Pancreatitis Acute TOTAL DAILY Required DOSE Intervention to Depakote C Prevent Permanent Zoloft C Impairment/Damage Ativan C Hydroxyzine C Glyburide C Date:12/10/97ISR Number: 3006143-1Report Type:Expedited (15-DaCompany Report #LIT/97/00346/LEX Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Literature Leponex / Clozaril PS ORAL 350 MG ORAL 21 MON Initial or Prolonged Pancreatitis Chronic Health Lorazepam C Required Weight Decreased Professional Haloperidol C Intervention to Acetaminophen C Prevent Permanent Guaifenesin C Impairment/Damage Magaldrate C Aluminium/Magnesium Hydroxide C Cephalexin C Metronidazole C Acetaminophen With Codeine C 22-Feb-2006 08:30 AM Page: 27 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Multivitamin With Folate C Lithium C Date:12/12/97ISR Number: 3006623-9Report Type:Expedited (15-DaCompany Report #D/96/01816/LEX Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Disseminated Health Leponex/Clozaril PS ORAL 150MG Hospitalization - Intravascular Coagulation Professional Perazine SS ORAL 400 MG Initial or Prolonged Enterocolitis Required Haemorrhagic Intervention to Hyperthyroidism Prevent Permanent Ileus Paralytic Impairment/Damage Renal Failure Acute Thrombocytopenia Date:12/12/97ISR Number: 3006624-0Report Type:Expedited (15-DaCompany Report #F/97/00986/LEX Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agranulocytosis Health Leponex PS ORAL 500 MG ORAL Required Escherichia Sepsis Professional Gardenal C Intervention to Pyrexia Tercian C Prevent Permanent Tachypnoea Lactulose C Impairment/Damage Date:12/12/97ISR Number: 3006625-2Report Type:Expedited (15-DaCompany Report #CDN/97/00935/LEX Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Diabetes Mellitus Health Clozaril PS ORAL UNSPECIFIED Diabetic Ketoacidosis Professional ORAL Date:12/12/97ISR Number: 3006626-4Report Type:Expedited (15-DaCompany Report #USA/97/03204/LEX Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Neoplasm Malignant Health Clozaril PS ORAL 400 MG ORAL Professional Cogentin C Morphine C Date:12/12/97ISR Number: 3006627-6Report Type:Expedited (15-DaCompany Report #USA/97/03202/LEX Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Intestinal Perforation Health Clozaril PS ORAL UNSPECIFIED Professional ORAL Date:12/12/97ISR Number: 3006630-6Report Type:Expedited (15-DaCompany Report #D/97/03645/LEX Age:68 YR Gender:Female I/FU:F Outcome PT Hospitalization - Blood Creatinine Initial or Prolonged Increased 22-Feb-2006 08:30 AM Page: 28 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Blood Urea Increased Drug Level Above Therapeutic Report Source Product Role Manufacturer Route Dose Duration Renal Impairment Health Leponex PS ORAL 200 MG ORAL Professional Triamteren SS Hydrochlorothiazid SS 5 Dytide H SS Captopril SS L-Thyroxin C Date:12/15/97ISR Number: 3006983-9Report Type:Direct Company Report # Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Iron Decreased Other Clozapine PS 12.5 MG BID Microcytic Anaemia Effexor SS Wellbutrin SS Klonopin SS Date:12/15/97ISR Number: 3008568-7Report Type:Expedited (15-DaCompany Report #USA/97/01788/LEX Age:70 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Overdose Health Clozaril PS ORAL 900 MG ORAL Initial or Prolonged Medication Error Professional (1 DAY LESS Other Sedation THAN) 1 DAY Required Risperdal C Intervention to Depakote C Prevent Permanent Accolate C Impairment/Damage Amoxicillin C Zocor C Serevent C Trental C Date:12/15/97ISR Number: 3008575-4Report Type:Expedited (15-DaCompany Report #USA/97/02985/LEX Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiomyopathy Health Clozaril PS ORAL 75-125 MG Initial or Prolonged Ejection Fraction Professional ORAL Required Abnormal Depakote C Intervention to Inflammation Klonopin C Prevent Permanent Pneumonia Primary Benadryl C Impairment/Damage Atypical Effexor C Pulmonary Oedema Artane C Respiratory Distress Sedation Date:12/15/97ISR Number: 3008576-6Report Type:Expedited (15-DaCompany Report #CDN/97/00764/LEX Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Foreign Body Aspiration Health Clozaril PS ORAL UNSPECIFIED Professional ORAL 22-Feb-2006 08:30 AM Page: 29 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/15/97ISR Number: 3008578-XReport Type:Expedited (15-DaCompany Report #GB/97/01117/LEX Age:66 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Choking Clozaril PS ORAL 325 MG; ORAL Dysphagia Orphenadrine C Frumil C Ispaghula C Senna C Date:12/15/97ISR Number: 3008581-XReport Type:Expedited (15-DaCompany Report #D/97/04077/LEX Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiovascular Disorder Health Leponex/Clozaril PS ORAL 25 MG ORAL 2 DAY Initial or Prolonged Coma Professional Haldol C Hypotension Dapotum C Loss Of Consciousness Malaise Nausea Pulse Pressure Decreased Tardive Dyskinesia Date:12/15/97ISR Number: 3008584-5Report Type:Expedited (15-DaCompany Report #USA/97/03050/LEX Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dementia Health Clozaril PS ORAL 12MG; ORAL Professional Date:12/15/97ISR Number: 3008597-3Report Type:Expedited (15-DaCompany Report #USA/97/03208/LEX Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Pain Health Clozaril PS ORAL 400 MG Hospitalization - Arrhythmia Professional Unspecified Diet Initial or Prolonged Chest Pain Other Pill SS Other Dizziness Pondimin SS Required Dyspnoea Adipex SS Intervention to Lethargy Prevent Permanent Nausea Impairment/Damage Paraesthesia Pulmonary Oedema Tremor Vomiting Weight Increased Date:12/15/97ISR Number: 3008622-XReport Type:Expedited (15-DaCompany Report #USA/97/03040/LEX Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aphasia Health Clozaril PS ORAL 200MG; ORAL Cerebrovascular Accident Professional Paxil C Dry Mouth 22-Feb-2006 08:30 AM Page: 30 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/15/97ISR Number: 3008626-7Report Type:Expedited (15-DaCompany Report #F/97/02190/LEX Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Health Leponex PS ORAL 50MG ORAL Initial or Prolonged Hyponatraemia Professional Rohypnol SS ORAL 3MG ORAL Required Inappropriate Xanax SS ORAL 1.5MG ORAL Intervention to Antidiuretic Hormone Tercian SS ORAL 300MG ORAL Prevent Permanent Secretion Deroxat SS ORAL 20MG ORAL Impairment/Damage Polydipsia Thirst Date:12/15/97ISR Number: 3008628-0Report Type:Expedited (15-DaCompany Report #AUS/97/00132/LEX Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Foreign Clozaril PS ORAL 200 MG ORAL Initial or Prolonged Encephalopathy Health Nitrazepam C Required Muscle Contractions Professional Intervention to Involuntary Prevent Permanent Pyrexia Impairment/Damage Tachycardia Date:12/15/97ISR Number: 3008632-2Report Type:Expedited (15-DaCompany Report #AUS/97/00131/LEX Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Disorder Health Clozaril PS ORAL 300 MG ORAL Initial or Prolonged Cardiac Enzymes Increased Professional Required Cardiomyopathy Intervention to Confusional State Prevent Permanent Coordination Abnormal Impairment/Damage Electrocardiogram T Wave Inversion Left Ventricular Failure Myocardial Infarction Pyrexia Date:12/15/97ISR Number: 3009477-XReport Type:Direct Company Report # Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Constipation Clozapine PS Sandoz 100 MG 3/DAY Headache Salivary Hypersecretion Sedation Tachycardia Tremor Date:12/16/97ISR Number: 3008353-6Report Type:Expedited (15-DaCompany Report #USA/97/01594/LEX Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril PS ORAL 700MG; ORAL Myocardial Infarction Professional Lisinopril C Motrin C Dilicor C Artane C 22-Feb-2006 08:30 AM Page: 31 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Depakote C Error C Error C Error C Error C Error C Date:12/17/97ISR Number: 3011547-7Report Type:Direct Company Report # Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Acute Psychosis Clozaril PS ORAL 300 MG PO Drug Interaction TWICE A DAY; SEVERAL YEARS Lamisil SS ORAL 250 MG PO QD 2 WK Date:12/18/97ISR Number: 3009286-1Report Type:Direct Company Report # Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Disorientation Clozaril PS ORAL 250 MG PO BID Initial or Prolonged Grand Mal Convulsion Clozaril SS ORAL Date:12/18/97ISR Number: 3009288-5Report Type:Direct Company Report # Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Clonic Convulsion Clozaril PS ORAL 200 MG PO, Initial or Prolonged Movement Disorder BID Other Muscle Twitching Date:12/18/97ISR Number: 3009292-7Report Type:Direct Company Report # Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutrophil Count Clozaril PS ORAL 200 MG/DAY Decreased PO White Blood Cell Count Decreased Date:12/19/97ISR Number: 3009082-5Report Type:Expedited (15-DaCompany Report #CDN/97/00751/LEX Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Dehydration Health Clozaril PS ORAL 600 MG ORAL Hospitalization - Delirium Professional Contac SS ORAL 15 TABLETS Initial or Prolonged Nausea ORAL Required Neutropenia Epival C Intervention to Overdose Prevent Permanent Pulmonary Oedema Impairment/Damage Renal Impairment Renal Tubular Necrosis Vomiting White Blood Cell Count Decreased 22-Feb-2006 08:30 AM Page: 32 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/19/97ISR Number: 3009216-2Report Type:Expedited (15-DaCompany Report #USA/96/01988/LEX Age:53 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intestinal Obstruction Health Clozaril PS ORAL 250 MG ORAL Initial or Prolonged Leukopenia Professional Multivits C Required Neutropenia Intervention to Prevent Permanent Impairment/Damage Date:12/22/97ISR Number: 3012612-0Report Type:Expedited (15-DaCompany Report #D/97/04078/LEX Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Alanine Aminotransferase Health Leponex PS ORAL Hospitalization - Increased Professional Taxilan SS OCCLUSIVE Initial or Prolonged Aspartate DRESSING 100MG Aminotransferase Lorazepam SS ORAL 2MG Increased Fluanxol C Blood Urea Increased Haloperidol C Hepatic Failure Lipid Metabolism Disorder Prothrombin Level Increased Date:12/22/97ISR Number: 3013996-XReport Type:Expedited (15-DaCompany Report #D/97/04224/LEX Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diplopia Health Leponex/Clozaril PS ORAL 525 MG Keratoconus Professional Date:12/22/97ISR Number: 3014000-XReport Type:Expedited (15-DaCompany Report #D/97/03645/LEX Age:68 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatinine Health Leponex / Clozaril PS ORAL 200 MG ORAL Initial or Prolonged Increased Professional Triamteren/Hydrochlo Drug Interaction rthiazid SS Potentiation Captopril SS L-Thyroxin C Date:12/22/97ISR Number: 3014005-9Report Type:Expedited (15-DaCompany Report #D/97/03952/LEX Age:32 YR Gender:Male I/FU:F Outcome PT Hospitalization - Amnesia Initial or Prolonged Clonic Convulsion Confusional State Convulsion Delirium Disorientation Enuresis Eye Movement Disorder Muscle Contractions Involuntary Overdose 22-Feb-2006 08:30 AM Page: 33 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Salivary Hypersecretion Sedation Suicide Attempt Report Source Product Role Manufacturer Route Dose Duration Tachycardia Health Leponex/Clozaril PS ORAL 5500 MG ORAL Urinary Incontinence Professional Timonil SS ORAL Anafranil SS ORAL Aponal SS ORAL Fluctin SS ORAL Tavor SS ORAL Effortil C Date:12/24/97ISR Number: 3012797-6Report Type:Expedited (15-DaCompany Report #8883-AR Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Pain Health Adipex-P PS 37.5MG DAILY Chest Pain Professional Pondimin SS ORAL 20MG 3 X Drug Ineffective Other DAILY ORAL Dyspnoea Clozaril SS 400 MG Lethargy Axid SS Palpitations Unspecified Diet Paraesthesia Pills SS Personality Change Pulmonary Oedema Syncope Vomiting Weight Increased Date:12/29/97ISR Number: 3013503-1Report Type:Expedited (15-DaCompany Report #SF/97/00135/LEX Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Toxicity Health Clozaril PS ORAL 250 MG ORAL Initial or Prolonged Eosinophilia Professional Hepatic Necrosis Hepatitis Myalgia Pyrexia Date:12/29/97ISR Number: 3013504-3Report Type:Expedited (15-DaCompany Report #USA/97/01039/LEX Age:26 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutrophil Count Health Clozaril PS ORAL 400 MG ORAL Initial or Prolonged Decreased Professional Phenergan SS Other Overdose Trazodone C Suicide Attempt White Blood Cell Count Decreased Date:12/29/97ISR Number: 3013505-5Report Type:Expedited (15-DaCompany Report #USA/97/01398/LEX Age:51 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death No Adverse Drug Effect Health Clozaril PS ORAL 300 MG ORAL Professional Ditropan C Glucotol C 22-Feb-2006 08:30 AM Page: 34 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/29/97ISR Number: 3013507-9Report Type:Expedited (15-DaCompany Report #USA/97/01806/LEX Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Distension Health Clozaril PS ORAL 100 MG ORAL Hospitalization - Constipation Professional Initial or Prolonged Dehydration Haemorrhoids Hiatus Hernia Large Intestine Perforation Nausea Oesophagitis Vomiting Date:12/30/97ISR Number: 3014473-2Report Type:Expedited (15-DaCompany Report #GB/97/01205/LEX Age:56 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Constipation Health Clozaril PS ORAL 100 MG Faecaloma Professional Large Intestine Perforation Lower Respiratory Tract Infection Date:12/30/97ISR Number: 3014477-XReport Type:Expedited (15-DaCompany Report #D/97/04252/LEX Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Health Leponex/Clozaril PS UNSPECIFIED Professional Zyprexia SS Date:12/30/97ISR Number: 3014478-1Report Type:Expedited (15-DaCompany Report #LEX/F-02/0/1/6/1/F Age:80 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dementia Study Leponex PS ORAL 12.5 MG ORAL Pyrexia Health Sinemet C Vomiting Professional Temesta C Paracetamol C Dextropropoxyphene C Di-Antalvic C Date:12/30/97ISR Number: 3014489-6Report Type:Expedited (15-DaCompany Report #USA/97/02532/LEX Age:62 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asphyxia Health Clozaril PS ORAL ORAL Other Fall Professional Lithium C Therapeutic Agent Lithobid C Toxicity Xanax (Alproazolam) C Mylanta C Tylenol (Paracetamol) C Afrin C 22-Feb-2006 08:30 AM Page: 35 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/30/97ISR Number: 3014491-4Report Type:Expedited (15-DaCompany Report #USA/96/01988/LEX Age:53 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Intestinal Obstruction Health Clozaril PS 250 MG ORAL Hospitalization - Leukopenia Professional Multivits C Initial or Prolonged Neutropenia Required Intervention to Prevent Permanent Impairment/Damage Date:12/30/97ISR Number: 3014492-6Report Type:Expedited (15-DaCompany Report #USA/97/03351/LEX Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pseudomonas Infection Health Clozaril PS ORAL 125 MG ORAL Professional Zestril C Propulsid C Rifampin C Depakote C Date:12/30/97ISR Number: 3014493-8Report Type:Expedited (15-DaCompany Report #USA/97/02690/LEX Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Benign Renal Neoplasm Health Clozaril PS ORAL 800 MG Cardiac Arrest Professional Paxil (Paroxetine Cardio-Respiratory Arrest Hydrochloride) C Cholelithiasis Trazadone Dyspnoea Hydrochloride Hepatic Steatosis (Trazodone Myocarditis Hydrochloride) C Pericarditis Pulmonary Embolism Pyelonephritis Renal Arteriosclerosis Splenomegaly Syncope Date:12/30/97ISR Number: 3014494-XReport Type:Expedited (15-DaCompany Report #USA/97/01832/LEX Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Health Clozaril PS ORAL 600 MG Other Confusional State Professional Convulsion Disorientation Dizziness Fall Syncope Therapeutic Agent Toxicity Ventricular Hypertrophy 22-Feb-2006 08:30 AM Page: 36 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/04/98ISR Number: 3177853-0Report Type:Expedited (15-DaCompany Report #GB/96/00842/LEX Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Level Above Health Clozaril PS ORAL 300MG ORAL Therapeutic Professional Amitriptyline SS Myocardial Infarction Date:01/07/98ISR Number: 3013158-6Report Type:Direct Company Report # Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Bronchitis Clozapine PS 500MG /DAY Hospitalization - Cough YEARS YR Initial or Prolonged Pleural Effusion Required Intervention to Prevent Permanent Impairment/Damage Date:01/09/98ISR Number: 3015946-9Report Type:Expedited (15-DaCompany Report #F/97/01554/LEX Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dyspnoea Foreign Leponex/Clozaril PS ORAL 200 MG ORAL Hospitalization - Hypotension Health Lepticur SS ORAL 20 MG ORAL Initial or Prolonged Intestinal Obstruction Professional Haldol Decanonas C Required Volvulus Of Bowel Anafranil C Intervention to Deroxat C Prevent Permanent Impairment/Damage Date:01/09/98ISR Number: 3015947-0Report Type:Expedited (15-DaCompany Report #USA/97/01805/LEX Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozaril PS ORAL 750MG/ ORAL Professional Navane C Lithium C Date:01/09/98ISR Number: 3015949-4Report Type:Expedited (15-DaCompany Report #D/95/01377/LEX Age:41 YR Gender:Male I/FU:I Outcome PT Hospitalization - Blood Creatine Initial or Prolonged Phosphokinase Increased Other Blood Lactate Required Dehydrogenase Increased Intervention to Dermatitis Prevent Permanent Haematoma Impairment/Damage Leukocytosis Muscle Necrosis Myalgia Myositis Neuropathy Peripheral Rash Erythematous Red Blood Cell Sedimentation Rate 22-Feb-2006 08:30 AM Page: 37 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Increased Report Source Product Role Manufacturer Route Dose Duration Health Leponex PS ORAL 400 MG ORAL Professional Truxal C Date:01/09/98ISR Number: 3015951-2Report Type:Expedited (15-DaCompany Report #N/97/00043/LEX Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiomegaly Health Leponex PS ORAL 500 MG ORAL Hospitalization - Cardiomyopathy Professional Digitalis C Initial or Prolonged Dyspnoea Required Pulmonary Congestion Intervention to Prevent Permanent Impairment/Damage Date:01/09/98ISR Number: 3015954-8Report Type:Expedited (15-DaCompany Report #GB/97/01217/LEX Age:71 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Health Clozaril PS ORAL 225 MG ORAL Life-Threatening Cyanosis Professional Sodium Valproate C Respiratory Failure Augmentin C Sedation Sertraline C Date:01/09/98ISR Number: 3015956-1Report Type:Expedited (15-DaCompany Report #GB/97/01207/LEX Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cough Health Clozaril PS ORAL Dysphagia Professional Guillain-Barre Syndrome Neuritis Neurological Examination Abnormal Date:01/09/98ISR Number: 3179453-5Report Type:Expedited (15-DaCompany Report #IRL/96/01254/LEX Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Interaction Health Clozaril PS ORAL 400 MG ORAL Drug Level Above Professional Sodium Valproate SS Therapeutic Grand Mal Convulsion Status Epilepticus Date:01/12/98ISR Number: 3016634-5Report Type:Expedited (15-DaCompany Report #USA/97/02039/LEK Age:28 YR Gender:Female I/FU:I Outcome PT Death Blood Thyroid Stimulating Hormone Increased Myocardial Infarction Nausea 22-Feb-2006 08:30 AM Page: 38 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Vomiting Report Source Product Role Manufacturer Route Dose Duration Health Clozaril PS ORAL 400 MG ORAL/3 Professional WEEKS 3 WK Prozac C Depakote C Zyprexa C Revia C Synthroid C Date:01/12/98ISR Number: 3016636-9Report Type:Expedited (15-DaCompany Report #USA/97/03402/LEX Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coma Health Clozaril PS ORAL UNSPECIFIED Hospitalization - Convulsion Professional ORAL Initial or Prolonged Pupil Fixed Haldol C Salivary Hypersecretion Date:01/12/98ISR Number: 3018569-0Report Type:Direct Company Report # Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Creatine Olanzapine PS 10MG BID Hospitalization - Phosphokinase Increased Clozaril SS Initial or Prolonged Muscle Rigidity Neuroleptic Malignant Syndrome Date:01/13/98ISR Number: 3015620-9Report Type:Expedited (15-DaCompany Report #LIT/93/01144/LEX Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Clostridium Colitis Literature Leponex PS ORAL 200 MG 6 WK Required Diarrhoea Health Diazepam C Intervention to Hypotension Professional Promethazine C Prevent Permanent Lymphopenia Procyclidine C Impairment/Damage Renal Failure Acute Urinary Incontinence Date:01/13/98ISR Number: 3015624-6Report Type:Expedited (15-DaCompany Report #USA/97/02039/LEX Age:28 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Thyroid Stimulating Health Clozaril PS ORAL 400 MG ORAL 3 WK Required Hormone Increased Professional Prozac C Intervention to Myocardial Infarction Depakote C Prevent Permanent Nausea Zyprexa C Impairment/Damage Vomiting Revia C Synthroid C 22-Feb-2006 08:30 AM Page: 39 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/14/98ISR Number: 3018597-5Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Clozaril PS ORAL 75 MG QD Propulsid C Date:01/14/98ISR Number: 3018600-2Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Health Clozaril PS 400 MG DAILY 6 MON Professional Date:01/14/98ISR Number: 3076010-6Report Type:Periodic Company Report #7394336 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancreatitis Necrotising Health Depakote PS Abbott ORAL 2.750 GM PO Initial or Prolonged Professional QD Other Clozaril SS Zoloft C Date:01/15/98ISR Number: 3018379-4Report Type:Direct Company Report # Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pruritus Clozaril PS TITRATING UP Initial or Prolonged Rash Macular Docuate Sodium C Required Lithium Carbonate C Intervention to Prevent Permanent Impairment/Damage Date:01/16/98ISR Number: 3016922-2Report Type:Expedited (15-DaCompany Report #USA/97/03420/LEX Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Complications Of Maternal Health Clozaril PS ORAL 250MG ORAL Exposure To Therapeutic Professional Insulin C Drugs Feeding Disorder Neonatal Gastrooesophageal Reflux Disease Date:01/16/98ISR Number: 3016934-9Report Type:Expedited (15-DaCompany Report #USA/97/01802/LEX Age:65 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Respiratory Distress Health Clozaril PS ORAL UNSPECIFIED Hospitalization - Professional ORAL Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage 22-Feb-2006 08:30 AM Page: 40 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/16/98ISR Number: 3016939-8Report Type:Expedited (15-DaCompany Report #B/98/00001/LEX Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Health Leponex/Clozaril PS ORAL ORAL Dysphagia Professional Date:01/20/98ISR Number: 3017936-9Report Type:Expedited (15-DaCompany Report #CDN/97/00283/LEX Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Clozaril PS ORAL ORAL Death Professional Lamictral C Overdose Flurazerpam C Diazepam C Date:01/20/98ISR Number: 3017960-6Report Type:Expedited (15-DaCompany Report #RA/98/00083/LEX Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS ORAL 12.5 MG Professional Date:01/20/98ISR Number: 3017963-1Report Type:Expedited (15-DaCompany Report #CDN/98/00014/LEX Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Clozaril PS ORAL Health Professional Date:01/20/98ISR Number: 3018825-6Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozapine PS 100 MG BID, Neutropenia Professional 400 MGHS 6 MON Colace C Zantac C Date:01/20/98ISR Number: 3085832-7Report Type:Periodic Company Report #M97-237 (1) Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Clozapine PS 18.75 MG/DAY 3 MON Initial or Prolonged Drug Interaction Professional Cipro SS ORAL 500MG PO Drug Level Above Glyburide C Therapeutic Trazodone C Melatonin C Date:01/21/98ISR Number: 3015832-4Report Type:Expedited (15-DaCompany Report #USA/97/03419/LEX Age:48 YR Gender:Male I/FU:I Outcome Hospitalization - Initial or Prolonged 22-Feb-2006 08:30 AM Page: 41 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Required Intervention to Prevent Permanent PT Report Source Product Role Manufacturer Route Dose Duration Impairment/Damage Convulsion Health Clozaril PS ORAL 300 MG ORAL Intracranial Pressure Professional Cogentin C ORAL 300 MG ORAL Increased Date:01/26/98ISR Number: 3019387-XReport Type:Expedited (15-DaCompany Report #CDN/98/00023/LEX Age:67 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Colon Cancer Health Clozaril PS ORAL Other Professional Date:01/26/98ISR Number: 3019585-5Report Type:Expedited (15-DaCompany Report #USA/98/00114/LEX Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypotension Health Clozaril PS ORAL Renal Impairment Professional Vitamin E C Anti-Hypertensives C Date:01/26/98ISR Number: 3019618-6Report Type:Expedited (15-DaCompany Report #F/98/00060/LEX Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Choreoathetosis Health Leponex PS ORAL 550MG ORAL Initial or Prolonged Dyskinesia Professional Seresta SS ORAL 125 MG ORAL Required Intervention to Prevent Permanent Impairment/Damage Date:01/26/98ISR Number: 3019619-8Report Type:Expedited (15-DaCompany Report #USA/97/03018/LEX Age:76 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Health Clozaril PS ORAL 13 MG ORAL Respiratory Arrest Professional Pepcid C Sinemet Cr C Sinement C Date:01/26/98ISR Number: 3019621-6Report Type:Expedited (15-DaCompany Report #D/98/00156/LEX Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Health Leponex PS ORAL TAB 100 ORAL Hospitalization - Pneumonia Professional Tranxilium SS Initial or Prolonged Suicide Attempt 22-Feb-2006 08:30 AM Page: 42 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/26/98ISR Number: 3019622-8Report Type:Expedited (15-DaCompany Report #GB/97/01218/LEX Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Health Clozaril PS ORAL 250 MG ORAL Initial or Prolonged Acute Respiratory Professional Chloral Hydrate C Required Distress Syndrome Dothiepin C Intervention to Blood Amylase Increased Lansoprazole C Prevent Permanent Cholelithiasis Impairment/Damage Hypoxia Jaundice Cholestatic Pancreatitis Date:01/26/98ISR Number: 3019624-1Report Type:Expedited (15-DaCompany Report #USA/97/03351/LEX Age:77 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Deep Vein Thrombosis Health Clozaril PS ORAL 125 MG ORAL Hospitalization - Pneumonia Staphylococcal Professional Zestril C Initial or Prolonged Pseudomonas Infection Propulsid C White Blood Cell Count Rifampin C Increased Depakote C Date:01/27/98ISR Number: 3019881-1Report Type:Expedited (15-DaCompany Report #GB/98/01205/LEX Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Clozaril PS ORAL 250 MG ORAL Professional Date:01/28/98ISR Number: 3020820-8Report Type:Expedited (15-DaCompany Report #USA/97/00932/LEX Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Gastric Ulcer Study Clozaril PS ORAL 450 MG ORAL Life-Threatening Gastrointestinal Consumer Haemorrhage Health White Blood Cell Count Professional Decreased Date:01/28/98ISR Number: 3020824-5Report Type:Expedited (15-DaCompany Report #F/98/00011/LEX Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypotonia Health Leponex PS ORAL 25 MG ORAL Initial or Prolonged Loss Of Consciousness Professional Tranxene SS 300 MG Required Sedation Rivotril SS 6 MG Intervention to Prevent Permanent Impairment/Damage Date:01/28/98ISR Number: 3020832-4Report Type:Expedited (15-DaCompany Report #CDN/97/00540/LEX Age:51 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozaril PS ORAL 250 MG ORAL Professional Risperdal C 22-Feb-2006 08:30 AM Page: 43 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tagamet C Levothyroxine C Lorazepam C Luvox C Ranitidine C Haldol C Date:01/28/98ISR Number: 3021827-7Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Hypotension Clozapine PS Neuroleptic Malignant Syndrome Renal Failure Acute Date:01/30/98ISR Number: 3021681-3Report Type:Expedited (15-DaCompany Report #CDN/97/00897/LEX Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Health Clozaril PS ORAL ORAL Initial or Prolonged Professional Other Date:01/30/98ISR Number: 3021684-9Report Type:Expedited (15-DaCompany Report #USA/98/00159/LEX Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Angiopathy Health Clozaril PS ORAL 500 MG ORAL Initial or Prolonged Aortic Thrombosis Professional Inderal C Sepsis Neurontin C Metamucil C Colace C Lavaquin C Heparin C Zantac C K Cl (Potassium Chloride) C Morphine C Valium C Anapsine C Nitroglycerin Sl C Tylenol C Clindamycin C Vancomycin C Date:02/02/98ISR Number: 3021967-2Report Type:Expedited (15-DaCompany Report #USA/98/00160/LEX Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Faeces Discoloured Health Clozaril PS ORAL 350 MG Initial or Prolonged Gastrointestinal Professional Haemorrhage Influenza Like Illness Pyrexia Thrombocytopenia 22-Feb-2006 08:30 AM Page: 44 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/02/98ISR Number: 3022103-9Report Type:Expedited (15-DaCompany Report #F/98/00155/LEX Age:69 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Health Leponex PS ORAL 62.5 MG ORAL Initial or Prolonged Professional Tranxene SS ORAL 10 MG ORAL 1 WK Date:02/02/98ISR Number: 3022624-9Report Type:Expedited (15-DaCompany Report #GB/98/01032/LEX Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Health Clozaril PS Polyuria Professional Date:02/02/98ISR Number: 3022815-7Report Type:Expedited (15-DaCompany Report #USA/98/00167/LEX Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Health Clozaril PS ORAL 500 MG ORAL Initial or Prolonged Weight Increased Professional Depakote C Required Doss C Intervention to Prevent Permanent Impairment/Damage Date:02/03/98ISR Number: 3022394-4Report Type:Expedited (15-DaCompany Report #D/98/00292/LEX Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Complications Of Maternal Health Leponex PS ORAL 600 MG Initial or Prolonged Exposure To Therapeutic Professional Haldol SS Drugs Convulsion Neonatal Drug Withdrawal Syndrome Neonatal Electrolyte Imbalance Fever Neonatal Infection Leukopenia Neonatal Pyrexia Date:02/03/98ISR Number: 3022544-XReport Type:Expedited (15-DaCompany Report #USA/97/01951/LEX Age:42 YR Gender:Male I/FU:I Outcome PT Death Atelectasis Hospitalization - Brain Hypoxia Initial or Prolonged Brain Oedema Required Cardiomegaly Intervention to Cerebral Ischaemia Prevent Permanent Coma Impairment/Damage Convulsion Encephalopathy Gliosis Myocardial Fibrosis Pneumonia Pulmonary Congestion Respiratory Arrest 22-Feb-2006 08:30 AM Page: 45 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Respiratory Depression Report Source Product Role Manufacturer Route Dose Duration Study Clozaril PS ORAL 550 MG ORAL Health Professional Date:02/03/98ISR Number: 3022545-1Report Type:Expedited (15-DaCompany Report #USA/97/02339/LEX Age:87 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Pain Health Clozaril PS ORAL 25 MG ORAL Hospitalization - Atrial Fibrillation Professional Initial or Prolonged Blood Magnesium Decreased Required Decubitus Ulcer Intervention to Dehydration Prevent Permanent Hypokalaemia Impairment/Damage Intestinal Obstruction Lethargy Lung Infiltration Nausea Normochromic Normocytic Anaemia Rectal Haemorrhage Vomiting Date:02/03/98ISR Number: 3022561-XReport Type:Expedited (15-DaCompany Report #D/97/01778/LEX Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anorexia Health Leponex PS ORAL ORAL Initial or Prolonged Cerebral Haemorrhage Professional Neonatal Complications Of Maternal Exposure To Therapeutic Drugs Premature Baby Small For Dates Baby Date:02/03/98ISR Number: 3022563-3Report Type:Expedited (15-DaCompany Report #D/97/04077/LEX Age:61 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiovascular Disorder Health Leponex PS ORAL 25 MG 2 DAY Initial or Prolonged Coma Professional Akineton SS Hypotension Haldol C Loss Of Consciousness Dapotum C Malaise Nausea Pulse Pressure Decreased Date:02/03/98ISR Number: 3022564-5Report Type:Expedited (15-DaCompany Report #RA/98/00173/LEX Age:35 YR Gender:Male I/FU:I Outcome Life-Threatening Hospitalization - 22-Feb-2006 08:30 AM Page: 46 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Initial or Prolonged Other Required Intervention to PT Report Source Product Role Manufacturer Route Dose Duration Prevent Permanent Acute Myeloid Leukaemia Health Lapenax PS ORAL 700 MG ORAL Impairment/Damage Dermatitis Professional Atenolol C Leukopenia Clonazepam C Neutropenia Date:02/03/98ISR Number: 3022566-9Report Type:Expedited (15-DaCompany Report #USA/97/01987/LEX Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Dyspnoea Health Clozaril PS ORAL ORAL Hospitalization - Lung Infiltration Professional Haldol C Initial or Prolonged Pneumonia Cogentin C Disability Pyrexia Required Respiratory Failure Intervention to Prevent Permanent Impairment/Damage Date:02/03/98ISR Number: 3022570-0Report Type:Expedited (15-DaCompany Report #USA/97/02340/LEX Age:79 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bone Neoplasm Malignant Health Clozaril PS ORAL ORAL Haemoglobin Decreased Professional Naprosyn C Lung Neoplasm Malignant Digoxin C Pathological Fracture Date:02/03/98ISR Number: 3022572-4Report Type:Expedited (15-DaCompany Report #USA/97/01224/LEX Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Study Clozaril PS ORAL 350 MG ORAL Obesity Health Theodur C Professional Lasix C Atrovent C Albuterol Inhaler C Date:02/04/98ISR Number: 3027248-5Report Type:Direct Company Report # Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pharyngolaryngeal Pain Clozaril PS Norvest ORAL 350MG./ DAY White Blood Cell Count ORAL DAILY Decreased Date:02/06/98ISR Number: 3025325-6Report Type:Expedited (15-DaCompany Report #LIT/98/00027/LEX Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Interaction Literature Leponex PS ORAL 200 MG 9 MON Drug Level Above Health Fluvoxamine SS ORAL 100 MG Therapeutic Professional 22-Feb-2006 08:30 AM Page: 47 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/06/98ISR Number: 3025343-8Report Type:Expedited (15-DaCompany Report #F/98/00208/LEX Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Foreign Leponex PS ORAL 3G ORAL LT 1 Initial or Prolonged Intentional Overdose Health DAY 1 DAY Other Pneumonia Aspiration Professional Required Suicide Attempt Intervention to Prevent Permanent Impairment/Damage Date:02/06/98ISR Number: 3025344-XReport Type:Expedited (15-DaCompany Report #CDN/98/00023/LEX Age:67 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Colon Cancer Health Clozaril PS ORAL ORAL Other Professional Sinemet C Artane C Motilium C Date:02/06/98ISR Number: 3025346-3Report Type:Expedited (15-DaCompany Report #GB/98/01205/LEX Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Clozaril PS ORAL 250MG ORAL Life-Threatening Professional Date:02/06/98ISR Number: 3025348-7Report Type:Expedited (15-DaCompany Report #D/97/04224/LEX Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diplopia Consumer Leponex PS ORAL 550 MG ORAL Keratoconus Health Professional Date:02/06/98ISR Number: 3026741-9Report Type:Expedited (15-DaCompany Report #D/98/00338/LEX Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Renal Cell Carcinoma Health Leponex PS ORAL UNSPECIFIED Stage Unspecified Professional ORAL Date:02/06/98ISR Number: 3026742-0Report Type:Expedited (15-DaCompany Report #CDN/97/00979/LEX Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Condition Aggravated Study Clozaril PS ORAL 400 MG ORAL Craniopharyngioma Health L-Thyroxine C Hydrocephalus Professional Prednisone C Leukocytosis Haldol C Cpz C Fluphenazine C 22-Feb-2006 08:30 AM Page: 48 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/06/98ISR Number: 3081621-8Report Type:Expedited (15-DaCompany Report #LIT/98/00026/LEX Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Literature Leponex / Clozaril PS ORAL 1 YR Other Drug Interaction Health Phenytoin SS ORAL Drug Level Above Professional Therapeutic Date:02/09/98ISR Number: 3026837-1Report Type:Expedited (15-DaCompany Report #S/98/00021/LEX Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neuroleptic Malignant Leponex PS Syndrome Date:02/09/98ISR Number: 3026840-1Report Type:Expedited (15-DaCompany Report #CDN/98/00081/LEX Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Arrhythmia Neonatal Health Clozaril PS ORAL UNSPECIFIED Cardiac Murmur Professional ORAL Jaundice Neonatal Date:02/09/98ISR Number: 3026849-8Report Type:Expedited (15-DaCompany Report #GB/98/01012/LEX Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Clozaril PS ORAL Ejaculation Failure Professional Depixol C Date:02/10/98ISR Number: 3027415-0Report Type:Direct Company Report # Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neutropenia Health Clozaril PS ORAL Hospitalization - Professional Clozapine SS TAB 100MG Initial or Prolonged Clozapine SS ORAL T 3 TAB Required Intervention to Prevent Permanent Impairment/Damage Date:02/11/98ISR Number: 3029082-9Report Type:Expedited (15-DaCompany Report #USA/98/00257/LEX Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Health Clozaril PS ORAL 600 MG ORAL Lung Disorder Professional Pneumonia 22-Feb-2006 08:30 AM Page: 49 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/11/98ISR Number: 3029085-4Report Type:Expedited (15-DaCompany Report #GB/98/00051/LEX Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Disorder Health Clozaril PS ORAL 100 MG ORAL Left Ventricular Failure Professional Malaise Date:02/11/98ISR Number: 3029089-1Report Type:Expedited (15-DaCompany Report #BR/98/00268/LEX Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Apathy Health Leponex PS ORAL 200 MG Hospitalization - Cardiac Arrest Professional Initial or Prolonged Dehydration Required Diabetes Mellitus Intervention to Dizziness Prevent Permanent Hyperglycaemia Impairment/Damage Hypotension Ketoacidosis Sedation Sepsis Urinary Tract Infection Date:02/12/98ISR Number: 3029280-4Report Type:Direct Company Report # Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Clozapine PS ORAL 500MG PO OD Date:02/12/98ISR Number: 3029282-8Report Type:Direct Company Report # Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dysarthria Clozapine PS ORAL 200 MG BID PO Joint Stiffness Muscle Twitching Restlessness Date:02/17/98ISR Number: 3030653-4Report Type:Direct Company Report # Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Respiratory Clozapine PS ORAL 50 MG BID PO, Life-Threatening Distress Syndrome 50 MG PO QD & Agranulocytosis 100 MG HS Bradycardia Haldol C Cardiac Arrest Ativan C Neutropenia Bumex C Pneumonia Vearonium C Respiratory Failure Lovenox C White Blood Cell Count Aztreonam C Decreased Gent C Dopramine C Phenylephrine C Pip C Compazine C Flunisolide C 22-Feb-2006 08:30 AM Page: 50 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Apap C Date:02/17/98ISR Number: 3030979-4Report Type:Expedited (15-DaCompany Report #GB/98/01032/LEX Age:27 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Health Clozaril PS ORAL 450 MG Polyuria Professional Date:02/17/98ISR Number: 3030987-3Report Type:Expedited (15-DaCompany Report #USA/98/00324/LEX Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Cancer Female Health Clozaril PS ORAL UNSPECIFIED Leukopenia Professional Date:02/17/98ISR Number: 3030989-7Report Type:Expedited (15-DaCompany Report #D/98/00444/LEX Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Diabetic Hyperglycaemic Health Leponex PS ORAL 400 MG 10 YR Hospitalization - Coma Professional Initial or Prolonged Weight Increased Date:02/17/98ISR Number: 3031003-XReport Type:Expedited (15-DaCompany Report #D/98/00338/LEX Age:49 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cachexia Health Leponex PS ORAL 750 MG Other Renal Cell Carcinoma Professional Tavor SS ORAL 3 MG 10 YR Stage Unspecified Fluanxol SS 25 MG Taxilan SS ORAL 200 MG 10 YR Eunerpan SS ORAL 100 MG 10 YR N/A C N/A C Date:02/17/98ISR Number: 3031014-4Report Type:Expedited (15-DaCompany Report #USA/98/00167/LEX Age:37 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Health Clozaril PS ORAL 500 MG Initial or Prolonged Weight Increased Professional Depakote C Required Doss C Intervention to Prevent Permanent Impairment/Damage Date:02/17/98ISR Number: 3031018-1Report Type:Expedited (15-DaCompany Report #SF/98/00409/LEX Age:60 YR Gender:Female I/FU:I Outcome PT Hospitalization - Neutropenia Initial or Prolonged Pyelonephritis Pyrexia Red Blood Cell 22-Feb-2006 08:30 AM Page: 51 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sedimentation Rate Increased Report Source Product Role Manufacturer Route Dose Duration Health Leponex PS ORAL 200 MG Professional Deprakine C Specicor C Zovirax C Na C Na C Na C Date:02/17/98ISR Number: 3031023-5Report Type:Expedited (15-DaCompany Report #USA/97/02692/LEX Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Study Clozaril PS ORAL 600 MG ORAL Life-Threatening Health Vitamin E C Professional Date:02/17/98ISR Number: 3031025-9Report Type:Expedited (15-DaCompany Report #USA/97/01951/LEX Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anoxia Study Clozaril PS ORAL 525 MG ORAL Hospitalization - Atelectasis Health Haldol C Initial or Prolonged Brain Oedema Professional Ativan C Required Cardiac Arrest Intervention to Central Nervous System Prevent Permanent Function Test Abnormal Impairment/Damage Coma Convulsion Encephalopathy Gliosis Hypoxic Encephalopathy Myocardial Fibrosis Pneumonia Pulmonary Congestion Respiratory Arrest Respiratory Depression Vasculitis Date:02/17/98ISR Number: 3031029-6Report Type:Expedited (15-DaCompany Report #GB/97/00080/LEX Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Ineffective Health Clozaril PS ORAL 600 MG ORAL Other Renal Cell Carcinoma Professional Stage Unspecified Date:02/17/98ISR Number: 3031032-6Report Type:Expedited (15-DaCompany Report #LIT/95/00058/LEX Age:39 YR Gender:Male I/FU:I Outcome Hospitalization - Initial or Prolonged Required Intervention to 22-Feb-2006 08:30 AM Page: 52 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Anaemia Literature Leponex PS ORAL 300 MG ORAL 3 WK Arthralgia Health Chlorpromazine C Chest Pain Professional Haloperidol C Chills Coagulation Time Prolonged Cough Drug Toxicity Electrocardiogram Abnormal Fatigue Flushing Hypoproteinaemia Pneumonitis Polyserositis Pyrexia Red Blood Cell Sedimentation Rate Increased Respiratory Disorder Systemic Lupus Erythematosus Tachycardia Date:02/17/98ISR Number: 3031441-5Report Type:Expedited (15-DaCompany Report #USA/97/03420/LEX Age:26 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Complications Of Maternal Health Clozaril PS ORAL 200MG ORAL Exposure To Therapeutic Professional Regular Insulin C Drugs Folate C Gastrooesophageal Reflux Metamucil C Disease Nph Insulin C Prenatal Vitamin C Date:02/17/98ISR Number: 3031570-6Report Type:Expedited (15-DaCompany Report #USA/98/00312/LEX Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Disorder Health Clozaril PS ORAL 400 MG ORAL Professional Date:02/17/98ISR Number: 3031592-5Report Type:Expedited (15-DaCompany Report #CDN/97/00539/LEX Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Study Clozaril PS ORAL 75 MG ORAL Fall Health Bromocriptine C Injury Asphyxiation Professional Diclofenac C Neutrophil Count Sinemet C White Blood Cell Count 22-Feb-2006 08:30 AM Page: 53 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/17/98ISR Number: 3031598-6Report Type:Expedited (15-DaCompany Report #NZ/98/00009/LEX Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Atrial Fibrillation Health Clozaril PS ORAL ORAL Hospitalization - Bundle Branch Block Left Professional Initial or Prolonged Tachycardia Required Intervention to Prevent Permanent Impairment/Damage Date:02/17/98ISR Number: 3031602-5Report Type:Expedited (15-DaCompany Report #LIT/97/00355/LEX Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Clozaril PS ORAL 400 MG ORAL 6 WK Hospitalization - Death Consumer Initial or Prolonged Suicide Attempt Date:02/17/98ISR Number: 3087538-7Report Type:Expedited (15-DaCompany Report #IRL/97/01075/LEX Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Asthenia Health Leponex PS ORAL 275 MG ORAL Coma Professional Thioridazine C Disorientation Trifluoperazine C Fall Clomipramine C Grand Mal Convulsion Loss Of Consciousness Sedation Syncope Date:02/18/98ISR Number: 3036425-9Report Type:Direct Company Report # Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Aggression Clozaril PS ORAL 350 MG AM; Hospitalization - Blood Pressure Decreased 500 MG PM PO 3 YR Initial or Prolonged Circulatory Collapse Benztropine C Disability Colitis Ischaemic Colace C Gastrointestinal Haldol C Infection Imipramine C Gastrointestinal Necrosis Trazedone C Heart Rate Decreased Na C Mesenteric Occlusion Pallor Pyrexia Sepsis Date:02/20/98ISR Number: 3032592-1Report Type:Expedited (15-DaCompany Report #LIT/95/00058/LEX Age:39 YR Gender:Male I/FU:I Outcome Hospitalization - Initial or Prolonged Required Intervention to 22-Feb-2006 08:30 AM Page: 54 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Anaemia Literature Leponex PS ORAL 300 MG ORAL 3 WK Arthralgia Health Chlorpromazine C Chest Pain Professional Haloperidol C Chills Coagulation Time Prolonged Cough Electrocardiogram Abnormal Fatigue Flushing Hypoproteinaemia Pneumonitis Polyserositis Pyrexia Red Blood Cell Sedimentation Rate Increased Respiratory Disorder Systemic Lupus Erythematosus Tachycardia Date:02/20/98ISR Number: 3032594-5Report Type:Expedited (15-DaCompany Report #RL/98/00065/LEX Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agranulocytosis Leponex PS 200 MG Hospitalization - Pneumonia Largactil C Initial or Prolonged Thrombocytopenia Benzhexol C White Blood Cell Count Decreased Date:02/20/98ISR Number: 3032708-7Report Type:Expedited (15-DaCompany Report #98HQ-10103 Age:45 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Haematocrit Decreased Foreign Carbamazepine PS DAILY Hospitalization - Leukopenia Literature Clozapine SS Initial or Prolonged Neutropenia Health Lithium C Pyrexia Professional Clonazepam C Respiratory Arrest Other Benzatropine C Respiratory Distress Thrombocytopenia Date:02/23/98ISR Number: 3036456-9Report Type:Expedited (15-DaCompany Report #USA/98/00360/LEX Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Haematocrit Decreased Health Clozaril PS ORAL 400MG ORAL Initial or Prolonged Haemoglobin Decreased Professional Iron C Haemorrhage Vitamin C C Iron Deficiency Anaemia Ensure C Mean Cell Volume Abnormal Menorrhagia 22-Feb-2006 08:30 AM Page: 55 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/24/98ISR Number: 3032464-2Report Type:Expedited (15-DaCompany Report #USA/98/00399/LEX Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Optic Atrophy Health Clozaril PS ORAL 500 MG ORAL Professional Date:02/24/98ISR Number: 3032465-4Report Type:Expedited (15-DaCompany Report #USA/98/00418/LEX Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Parotid Gland Enlargement Health Clozaril PS ORAL ORAL Initial or Prolonged Professional Company Representative Date:02/24/98ISR Number: 3032467-8Report Type:Expedited (15-DaCompany Report #USA/98/00422/LEX Age:81 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozaril PS ORAL 12.5 MG ORAL Hospitalization - Pneumonia Professional Initial or Prolonged Sepsis Date:02/24/98ISR Number: 3032470-8Report Type:Expedited (15-DaCompany Report #USA/98/00373/LEX Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Insipidus Health Clozaril PS ORAL 200 MG ORAL Professional Ddavp C Albuterol C Insulin C Cipro C Paxil C Pepcid C Kefzol C Inapsine C Date:02/25/98ISR Number: 3037145-7Report Type:Expedited (15-DaCompany Report #98-01-0016 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Suicidal Ideation Health Clozapine PS Zenith Goldline Initial or Prolonged Professional Pharm. ORAL UNK ORAL CAP Date:02/27/98ISR Number: 3040808-0Report Type:Expedited (15-DaCompany Report #LIT/98/00042/LEX Age:45 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Leukopenia Literature Leponex PS Pyrexia Health Carbamazepine C Respiratory Arrest Professional Lithium C Respiratory Distress Benzatropine C Thrombocytopenia Clonazepam C 22-Feb-2006 08:30 AM Page: 56 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/27/98ISR Number: 3040816-XReport Type:Expedited (15-DaCompany Report #CDN/98/00171/LEX Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acidosis Hyperchloraemic Health Clozaril PS ORAL 100 MG/ORAL Initial or Prolonged Diabetic Ketoacidosis Professional Zoloft C Hypernatraemia Date:02/27/98ISR Number: 3041982-2Report Type:Direct Company Report # Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Grand Mal Convulsion Health Clozapine PS 800MG QD Professional Date:02/27/98ISR Number: 3041983-4Report Type:Direct Company Report # Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Grand Mal Convulsion Health Clozaril PS 200 MG AM / Professional 300 MG HS Date:02/27/98ISR Number: 3043664-XReport Type:Direct Company Report # Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Clonic Convulsion Clozapine PS 250MG HS Enuresis Urinary Incontinence Date:03/01/98ISR Number: 3071805-7Report Type:Direct Company Report # Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Neutropenia Clozaril PS Sandoz ORAL 300 MG PO. Intervention to White Blood Cell Count BID 18 MON Prevent Permanent Decreased Impairment/Damage Date:03/02/98ISR Number: 3039837-2Report Type:Expedited (15-DaCompany Report #CDN/98/00022/LEX Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Study Clozaril PS ORAL 400 MG ORAL Health Prozac C Professional Zantac C Date:03/03/98ISR Number: 3049967-7Report Type:Direct Company Report # Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Deep Vein Thrombosis Health Genora PS ORAL 1/35-28 PO Initial or Prolonged Feeling Hot Professional Clozaril SS 150 MG BID Oedema Peripheral 200MG HS Pain In Extremity Lithium C Depakote C 22-Feb-2006 08:30 AM Page: 57 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Adderall C Zantac C Benadryl C Motrin C Beconase Nasal Spray C Erythromycin Topical C Date:03/04/98ISR Number: 3041860-9Report Type:Expedited (15-DaCompany Report #USA/98/00514/LEX Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bronchopneumonia Health Clozaril- PS ORAL 500 MG ORAL Other Drug Level Above Professional Paxil C Therapeutic Depakote C Zyprexa C Date:03/04/98ISR Number: 3041863-4Report Type:Expedited (15-DaCompany Report #USA/98/00515/LEX Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiomegaly Health Clozaril PS ORAL 725 MG ORAL Initial or Prolonged Professional Depakote C Date:03/05/98ISR Number: 3047519-6Report Type:Expedited (15-DaCompany Report #D/97/01281/LEX Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Gestational Diabetes Health Leponex PS ORAL 25 MG ORAL Initial or Prolonged Professional Date:03/06/98ISR Number: 3127458-2Report Type:Periodic Company Report #8-97058-001B Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Health Effexor PS ORAL GRADUALLY Drug Level Changed Professional INCREASED TO Grand Mal Convulsion 225 MG DAILY; Hypertension ORAL Tachycardia Clozaril SS ORAL 800 MG TO 900 MG DAILY ORAL Clorazil C Date:03/06/98ISR Number: 3127898-1Report Type:Periodic Company Report #8-97084-001B Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyspnoea Health Effexor PS ORAL 225MG IN AM & Professional 150MG IN PM ORAL Clozaril SS ORAL ORAL Xanax SS ORAL 1MG THREE TIMES DAILY AND 2MG AT BEDTIME ORAL Zeprexa SS ORAL ORAL Clozaril C 22-Feb-2006 08:30 AM Page: 58 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Zyprexa C Atenolol C Provera C Premarin C Lithium C Mellaril C Date:03/09/98ISR Number: 3049565-5Report Type:Expedited (15-DaCompany Report #YV/98/00563/LEX Age:49 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cyanosis Health Leponex PS ORAL 200 MG ORAL Hospitalization - Dyspnoea Professional Moditen C Initial or Prolonged Pneumonia Required Intervention to Prevent Permanent Impairment/Damage Date:03/09/98ISR Number: 3050052-9Report Type:Expedited (15-DaCompany Report #YV/98/00563/LEX Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agranulocytosis Health Leponex PS ORAL ORAL 11 WK Hospitalization - Cyanosis Professional Initial or Prolonged Dyspnoea Required Pneumonia Intervention to Prevent Permanent Impairment/Damage Date:03/09/98ISR Number: 3050054-2Report Type:Expedited (15-DaCompany Report #USA/97/01085/LEX Age:44 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Toxicity Consumer Clozaril PS 800 MG ORAL Initial or Prolonged Overdose Health Ativan C Required Professional Intervention to Prevent Permanent Impairment/Damage Date:03/09/98ISR Number: 3050057-8Report Type:Expedited (15-DaCompany Report #USA/98/00360/LEX Age:37 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Haematocrit Decreased Health Clozaril PS ORAL 400 MG ORAL Initial or Prolonged Haemoglobin Decreased Professional Iron Tablets C Iron Deficiency Anaemia Vitamin C C Leukocytosis Ensure C Mean Cell Volume Decreased Menorrhagia 22-Feb-2006 08:30 AM Page: 59 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/09/98ISR Number: 3050061-XReport Type:Expedited (15-DaCompany Report #D/98/00726/LEX Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Macular Degeneration Health Leponex PS ORAL 100 MG ORAL 2 YR Visual Disturbance Professional Aponal SS ORAL ORAL 2 YR Date:03/09/98ISR Number: 3050221-8Report Type:Expedited (15-DaCompany Report #1998-02-0571 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Foreign Claratyne PS ORAL 10 MG QD ORAL Cardiac Failure Other Clozapine SS ORAL 600 MG QD Congestive ORAL Circulatory Collapse Electrocardiogram Change Haematuria Hypoxia Periorbital Oedema Proteinuria Respiratory Failure Shock Date:03/09/98ISR Number: 3050505-3Report Type:Expedited (15-DaCompany Report #GB/98/00416/LEX Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Clozaril PS ORAL 700 MG ORAL Initial or Prolonged Haemoglobin Decreased Lorazepam C Hepatic Function Abnormal Cimetidine C Renal Failure Acute Sodium Bicarbonate C Titralac C Iron Sulphate C Flucloxacillin C Date:03/09/98ISR Number: 3050507-7Report Type:Expedited (15-DaCompany Report #S/98/00037/LEX Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Leponex PS Date:03/09/98ISR Number: 3050510-7Report Type:Expedited (15-DaCompany Report #S/98/00036/LEX Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Leponex PS Date:03/10/98ISR Number: 3055083-0Report Type:Expedited (15-DaCompany Report #RL/98/00065/LEX Age:45 YR Gender:Male I/FU:F Outcome Death Hospitalization - Initial or Prolonged Required Intervention to Prevent Permanent 22-Feb-2006 08:30 AM Page: 60 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Agranulocytosis Leponex PS ORAL 200 MG ORAL Infection Largactil C Pneumonia Benzhexol C Thrombocytopenia White Blood Cell Count Decreased Date:03/10/98ISR Number: 3055085-4Report Type:Expedited (15-DaCompany Report #D/98/00444/LEX Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Diabetes Mellitus Health Leponex PS ORAL 400 MG ORAL 10 YR Hospitalization - Non-Insulin-Dependent Professional Initial or Prolonged Diabetic Hyperglycaemic Required Coma Intervention to Ileus Paralytic Prevent Permanent Weight Increased Impairment/Damage Date:03/10/98ISR Number: 3055086-6Report Type:Expedited (15-DaCompany Report #USA/98/00594/LEX Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Activated Partial Health Clozaril PS ORAL 550 MG ORAL Initial or Prolonged Thromboplastin Time Professional Glucotrol Xl C Required Prolonged Intervention to Antibody Test Abnormal Prevent Permanent Impairment/Damage Date:03/10/98ISR Number: 3055088-XReport Type:Expedited (15-DaCompany Report #D/98/00740/LEX Age:69 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukaemia Health Leponex PS ORAL 200 MG ORAL Required Leukocytosis Professional Tavor C Intervention to White Blood Cell Count Prevent Permanent Increased Impairment/Damage Date:03/13/98ISR Number: 3055413-XReport Type:Expedited (15-DaCompany Report #AUS/98/00022/LEX Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Health Clozaril PS ORAL 200 MG ORAL Initial or Prolonged Diabetes Mellitus Professional Required Intervention to Prevent Permanent Impairment/Damage 22-Feb-2006 08:30 AM Page: 61 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/13/98ISR Number: 3055420-7Report Type:Expedited (15-DaCompany Report #NZ/98/00004/LEX Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abortion Spontaneous Clozaril PS Intra-Uterine Death Date:03/13/98ISR Number: 3055527-4Report Type:Expedited (15-DaCompany Report #YV/98/00563/LEX Age:49 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agranulocytosis Health Leponex PS ORAL 200 MG ORAL Hospitalization - Cyanosis Professional Moditen C Initial or Prolonged Dyspnoea Required Genital Haemorrhage Intervention to Neutrophil Count Prevent Permanent Decreased Impairment/Damage Platelet Count Decreased Pneumonia Respiratory Failure White Blood Cell Count Decreased Date:03/13/98ISR Number: 3066745-3Report Type:Direct Company Report # Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypertriglyceridaemia Clozaril PS 500MG QD Thiothrxene C Depkakote C Cogentin C Vasotec C Date:03/13/98ISR Number: 3066746-5Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Clozaril PS 400MG QD Insulin-Dependent Insulin C Date:03/13/98ISR Number: 3066747-7Report Type:Direct Company Report # Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Weight Increased Clozaril PS 500MG QD Initial or Prolonged Depakote C Other Ihn C Metaprolol C Insulin C Date:03/16/98ISR Number: 3055213-0Report Type:Expedited (15-DaCompany Report #CDN/98/00217/LEX Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Circulatory Collapse Health Clozaril PS ORAL 100 MG ORAL Initial or Prolonged Diabetic Coma Professional 22-Feb-2006 08:30 AM Page: 62 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/16/98ISR Number: 3055217-8Report Type:Expedited (15-DaCompany Report #CDN/98/00219/LEX Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Influenza Study Clozaril PS ORAL 255 MG ORAL Hospitalization - Renal Failure Acute Health Initial or Prolonged Respiratory Arrest Professional Respiratory Depression Sepsis Date:03/16/98ISR Number: 3055222-1Report Type:Expedited (15-DaCompany Report #D/97/01279/LEX Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Health Leponex PS ORAL 400 MG ORAL Initial or Prolonged Drug Level Below Professional Rifampicin SS ORAL 600 MG ORAL 19 DAY Required Therapeutic Isoniazid C Intervention to Psychotic Disorder Pyrazinamid C Prevent Permanent Impairment/Damage Date:03/16/98ISR Number: 3055350-0Report Type:Expedited (15-DaCompany Report #USA/98/00622/LEX Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Toxicity Health Clozaril PS ORAL 300 MG ORAL Retinal Disorder Professional Ditropan C Visual Disturbance Cogentin C Date:03/16/98ISR Number: 3055358-5Report Type:Expedited (15-DaCompany Report #USA/98/00422/LEX Age:81 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozaril PS ORAL 12.5 MG ORAL Hospitalization - Pneumonia Professional Symmetrel C Initial or Prolonged Sepsis Date:03/16/98ISR Number: 3056150-8Report Type:Expedited (15-DaCompany Report #1998-02-0571 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Foreign Claratyne PS ORAL 10MG QD ORAL Circulatory Collapse Other TAB Electrocardiogram Change Clozapine SS ORAL 600MG QD ORAL Haematuria TAB Hypoxia Proteinuria Respiratory Failure Shock Date:03/16/98ISR Number: 3056357-XReport Type:Expedited (15-DaCompany Report #BR/98/00554/LEX Age:29 YR Gender:Male I/FU:I Outcome Death Hospitalization - Initial or Prolonged 22-Feb-2006 08:30 AM Page: 63 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Required Intervention to Prevent Permanent PT Report Source Product Role Manufacturer Route Dose Duration Impairment/Damage Confusional State Health Leponex PS ORAL 500 MG ORAL Haemorrhagic Stroke Professional Hemiplegia Intracranial Aneurysm Date:03/16/98ISR Number: 3056377-5Report Type:Expedited (15-DaCompany Report #USA/96/00381/LEX Age:33 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Unevaluable Event Health Clozaril PS ORAL 550 MG ORAL Professional Date:03/16/98ISR Number: 3056379-9Report Type:Expedited (15-DaCompany Report #NZ/98/00021/LEX Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Health Clozaril PS ORAL 300 MG ORAL 5 DAY Required Drug Interaction Professional Ranitidine SS 300 MG Intervention to Potentiation Fluoxetine C Prevent Permanent Muscle Contractions Sodium Valproate C Impairment/Damage Involuntary Benztropine C Sedation Date:03/16/98ISR Number: 3056381-7Report Type:Expedited (15-DaCompany Report #GB/98/00429/LEX Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ketoacidosis Foreign Clozaril PS ORAL 250 MG ORAL Initial or Prolonged Minocycline C Required Intervention to Prevent Permanent Impairment/Damage Date:03/16/98ISR Number: 3057482-XReport Type:Expedited (15-DaCompany Report #1998-02-0571 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Foreign Claratyne PS ORAL 10 MG QD Congestive Other ORAL Circulatory Collapse Clozapine SS ORAL 600 MG QD Electrocardiogram Change ORAL Haematuria Hypoxia Periorbital Oedema Proteinuria Respiratory Failure Shock 22-Feb-2006 08:30 AM Page: 64 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/17/98ISR Number: 3055975-2Report Type:Expedited (15-DaCompany Report #N/98/00068/LEX Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiomyopathy Leponex PS Date:03/18/98ISR Number: 3056383-0Report Type:Direct Company Report # Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Influenza Like Illness Clozaril PS Novartis TAB; Neutropenia 3/12-12.5MG, 3/13 25MG, 3/14 37.5MG Haldol Decanoate C Trazodone C Date:03/19/98ISR Number: 3057514-9Report Type:Expedited (15-DaCompany Report #CDN/98/00047/LEX Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Gastroenteritis Health Clozaril PS ORAL 350MG ORAL Hospitalization - Pneumonia Professional Ativan C Initial or Prolonged Viral Pericarditis Kemadrin C Required Intervention to Prevent Permanent Impairment/Damage Date:03/19/98ISR Number: 3057515-0Report Type:Expedited (15-DaCompany Report #USA/98/00657/LEX Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Joint Stiffness Health Clozaril PS ORAL 400MG ORAL Initial or Prolonged Movement Disorder Professional Diazepam C Required Muscle Rigidity Depakote C Intervention to Myopathy Prevent Permanent Nervousness Impairment/Damage Salivary Hypersecretion Sedation Date:03/19/98ISR Number: 3057532-0Report Type:Expedited (15-DaCompany Report #USA/98/00663/LEX Age:87 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Respiratory Failure Health Clozaril PS ORAL ORAL Professional Date:03/19/98ISR Number: 3057533-2Report Type:Expedited (15-DaCompany Report #TR/98/00105/LEX Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cachexia Health Leponex PS ORAL 800MG ORAL Hospitalization - Confusional State Professional Initial or Prolonged Drug Ineffective Eating Disorder 22-Feb-2006 08:30 AM Page: 65 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/20/98ISR Number: 3059608-0Report Type:Expedited (15-DaCompany Report #1998-02-0571 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Atrioventricular Block Foreign Claratyne PS ORAL 10 MG / QD / Cardiac Failure Other ORAL Congestive Clozapine SS ORAL 600 MG / QD / Circulatory Collapse ORAL Electrocardiogram Change Haematuria Hypoxia Proteinuria Respiratory Failure Shock Date:03/23/98ISR Number: 3059875-3Report Type:Expedited (15-DaCompany Report #USA/98/00514/LEX Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bronchopneumonia Health Clozaril PS ORAL 500 MG ORAL Other Cardiomegaly Professional Zyprexa C Drug Level Above Paxil C Therapeutic Depakote C Fatigue Hyperaemia Pulmonary Haemorrhage Pulmonary Oedema Sedation Sleep Apnoea Syndrome Date:03/23/98ISR Number: 3059881-9Report Type:Expedited (15-DaCompany Report #USA/98/00681/LEX Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozaril PS ORAL 100 MG ORAL Professional Date:03/23/98ISR Number: 3060658-9Report Type:Expedited (15-DaCompany Report #D/98/00922/LEX Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Apnoea Health Leponex PS ORAL 12.5 MG ORAL Hospitalization - Bradycardia Professional Beloc SS Initial or Prolonged Cerebral Artery Embolism Ass (Acetylsalicylic Required Coma Acid) C Intervention to Hypotension Furosemid C Prevent Permanent Labile Blood Pressure Impairment/Damage Nervous System Disorder Pulse Pressure Decreased Respiratory Depression Sick Sinus Syndrome Date:03/23/98ISR Number: 3060659-0Report Type:Expedited (15-DaCompany Report #GB/98/00428/LEX Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Ketoacidosis Clozaril PS ORAL 275 MG ORAL Initial or Prolonged Ketoacidosis Flupenthixol 22-Feb-2006 08:30 AM Page: 66 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Flupentixol) C Chlorpromazine C Procyclidine C Date:03/24/98ISR Number: 3067432-8Report Type:Expedited (15-DaCompany Report #GB/98/00525/LEX Age:66 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coordination Abnormal Health Clozaril PS ORAL 75 MG ORAL Initial or Prolonged Dizziness Professional Joint Stiffness Lower Respiratory Tract Infection Pyrexia Tachycardia Date:03/24/98ISR Number: 3067435-3Report Type:Expedited (15-DaCompany Report #USA/98/00360/LEX Age:37 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Haematocrit Decreased Health Clozaril PS ORAL 400 MG ORAL Initial or Prolonged Haemoglobin Decreased Professional Vitamin C C Required Iron Deficiency Anaemia Ensure C Intervention to Leukocytosis Prevent Permanent Mean Cell Volume Impairment/Damage Decreased Menorrhagia Date:03/24/98ISR Number: 3068962-5Report Type:Expedited (15-DaCompany Report #F/98/00629/LEX Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Colitis Foreign Leponex PS ORAL ORAL Initial or Prolonged Health Professional Date:03/24/98ISR Number: 3068963-7Report Type:Expedited (15-DaCompany Report #F/98/00630LEX Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pulmonary Tuberculosis Foreign Leponex PS ORAL ORAL 2 YR Health Professional Date:03/25/98ISR Number: 3060566-3Report Type:Direct Company Report # Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Medication Error Clozaril PS ORAL TAB 100 MG Initial or Prolonged Sedation QID ORAL Required Intervention to Prevent Permanent Impairment/Damage 22-Feb-2006 08:30 AM Page: 67 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/26/98ISR Number: 3060583-3Report Type:Expedited (15-DaCompany Report #F/98/00597/LEX Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Antinuclear Antibody Health Leponex PS ORAL 550 MG ORAL Initial or Prolonged Positive Professional Topaal C Required Asthenia Prepulsid C Intervention to Lymphopenia Prevent Permanent Platelet Count Decreased Impairment/Damage Systemic Lupus Erythematosus Date:03/27/98ISR Number: 3060700-5Report Type:Expedited (15-DaCompany Report #898077004D Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Drug Interaction Health Ativan / Intervention to Fall Professional Clozaril PS ORAL ONE MG ORAL Prevent Permanent Loss Of Consciousness Clozaril SS ORAL 25MG IN Impairment/Damage Respiratory Depression MORNING AND 50 MG AT BEDTIME ORAL Depakote C Moban C Multi-Vit C Robitussin C Thiamine C Date:03/27/98ISR Number: 3062223-6Report Type:Direct Company Report # Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Clozaril PS ORAL 500 MG ORAL / DAY IN DIVIDED DOSAGES Date:03/30/98ISR Number: 3058391-2Report Type:Expedited (15-DaCompany Report #D/98/00292/LEX Age:30 YR Gender:Female I/FU:F Outcome PT Hospitalization - Agitation Initial or Prolonged Clonic Convulsion Congenital Anomaly Complications Of Maternal Exposure To Therapeutic Drugs Convulsion Drug Withdrawal Syndrome Neonatal Ear Malformation Electroencephalogram Abnormal Electrolyte Imbalance Eructation Feeding Disorder Neonatal Fever Neonatal Hyperhidrosis Hypertonia Hypocalcaemia 22-Feb-2006 08:30 AM Page: 68 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Infection Leukopenia Neonatal Livedo Reticularis Report Source Product Role Manufacturer Route Dose Duration Nervous System Disorder Health Leponex PS ORAL 900 MG ORAL Nervousness Professional Haldol Deconoate SS INTRAMUSCULAR 100 MG Neuropathy Peripheral .... C Regurgitation Of Food ... C Skin Disorder Sleep Disorder Tremor Neonatal Date:03/30/98ISR Number: 3058405-XReport Type:Expedited (15-DaCompany Report #USA/98/00733/LEX Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Study Clozaril PS ORAL 38 MG ORAL Extrapyramidal Disorder Health Parkinson'S Disease Professional Date:03/30/98ISR Number: 3058406-1Report Type:Expedited (15-DaCompany Report #USA/94/00452/LEX Age:50 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Appendicitis Health Clozaril PS ORAL 400 MG ORAL Intestinal Perforation Professional Ritalin C Peritonitis Sepsis Date:03/30/98ISR Number: 3058410-3Report Type:Expedited (15-DaCompany Report #CDN/97/00653/LEX Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Burns Third Degree Health Clozaril PS ORAL 500 MG ORAL Coma Professional Epival (Valproate Confusional State Semisodium) C Convulsion Dalmane (Flurazepam Pulmonary Oedema Hydrochloride) C Tremor Phenergan White Blood Cell Count (Promethazine Increased Hydrochloride) C K-Dur (Potassium Chloride) C Hydrodiuril (Hydrochlorothiazide ) C Tenormin (Atenolol) C Kemadrin (Procyclidine Hydrochloride) C Date:03/30/98ISR Number: 3058661-8Report Type:Expedited (15-DaCompany Report #D/98/01021/LEX Age:28 YR Gender:Female I/FU:I Outcome Life-Threatening Required Intervention to 22-Feb-2006 08:30 AM Page: 69 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Sedation Study Leponex PS ORAL 350 MG ORAL Suicide Attempt Tavor SS ORAL 50 MG ORAL Fevarin SS ORAL 75 MG ORAL Date:03/30/98ISR Number: 3058662-XReport Type:Expedited (15-DaCompany Report #USA/98/00582/LEX Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Chronic Obstructive Health Clozaril PS ORAL 175 MG ORAL Pulmonary Disease Professional Amantadine C Emphysema Haldol C Leukocytosis Depakote C Pulmonary Fibrosis Prozac C Propulsid C Divalproex C Date:03/30/98ISR Number: 3058663-1Report Type:Expedited (15-DaCompany Report #AUS/98/00036/LEX Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Health Clozaril PS ORAL F 8-10 ORAL Initial or Prolonged Loss Of Consciousness Professional Other Overdose Required Renal Failure Acute Intervention to Prevent Permanent Impairment/Damage Date:03/30/98ISR Number: 3058665-5Report Type:Expedited (15-DaCompany Report #GB/97/01051/LEX Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Clozaril PS ORAL 200 MG ORAL Initial or Prolonged Extrapyramidal Disorder Chlorpromazine C Other Hepatic Function Abnormal Clopixol C Required Hepatitis Cholestatic Intervention to Liver Function Test Prevent Permanent Abnormal Impairment/Damage Pyrexia Tremor Date:03/30/98ISR Number: 3058967-2Report Type:Expedited (15-DaCompany Report #1998-02-0571 Age:40 YR Gender:Male I/FU:F Outcome PT Death Atrioventricular Block Cardiac Failure Circulatory Collapse Electrocardiogram Change Haematuria Hypoxia Periorbital Oedema Proteinuria Respiratory Failure 22-Feb-2006 08:30 AM Page: 70 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Shock Report Source Product Role Manufacturer Route Dose Duration Foreign Claratyne PS ORAL 10MG QD ORAL Other Clozapine SS ORAL 600MG QD ORAL Date:03/31/98ISR Number: 3058954-4Report Type:Expedited (15-DaCompany Report #USA/98/00515/LEX Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiomegaly Health Clozaril PS ORAL 725 MG ORAL Initial or Prolonged Professional Depakote C Antihypertensives C Date:03/31/98ISR Number: 3058956-8Report Type:Expedited (15-DaCompany Report #USA/97/02393/LEX Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Inflammation Health Clozaril PS ORAL ORAL Professional Date:03/31/98ISR Number: 3061436-7Report Type:Expedited (15-DaCompany Report #CDN/98/00217/LEX Age:32 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Creatine Study Clozaril PS ORAL 100 MG ORAL Hospitalization - Phosphokinase Increased Health Sertraline C Initial or Prolonged Diabetic Coma Professional Required Diabetic Ketoacidosis Intervention to Hypernatraemia Prevent Permanent Liver Function Test Impairment/Damage Abnormal Neuroleptic Malignant Syndrome Pancreatitis Respiratory Depression Date:04/01/98ISR Number: 3071848-3Report Type:Direct Company Report # Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Asthenia Clozaril PS ORAL 50 MG PO BID Intervention to Rash Erythematous Prevent Permanent Tachycardia Impairment/Damage Date:04/01/98ISR Number: 3071856-2Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Ileus Paralytic Clozapine PS ORAL 700 MG / DAY PO BID Lithun Carbonate SS 300MG TID 22-Feb-2006 08:30 AM Page: 71 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/02/98ISR Number: 3154911-8Report Type:Periodic Company Report #98-01-0017 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Health Clozapine PS Zenith Goldline Professional Pharm. ORAL ORAL User Facility Date:04/02/98ISR Number: 3154913-1Report Type:Periodic Company Report #98-02-0022 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Delusion Health Clozapine PS Zenith Goldline Hallucination, Auditory Professional Pharm. ORAL 400-700MG/DAY Loose Associations User Facility ORAL Psychotic Disorder Date:04/02/98ISR Number: 3154915-5Report Type:Periodic Company Report #98-02-0033 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Health Clozapine PS Zenith Goldline Decreased Professional Pharm. ORAL 650MG/DAY ORAL Date:04/02/98ISR Number: 3154917-9Report Type:Periodic Company Report #98-02-0034 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bronchitis Health Clozapine PS Zenith Goldline Initial or Prolonged Myocardial Infarction Professional Pharm. ORAL 500MG/DAY Pneumonia ORAL White Blood Cell Count Decreased Date:04/02/98ISR Number: 3154918-0Report Type:Periodic Company Report #98-01-0007 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Ineffective Health Clozapine PS ORAL 125MG/DAY Professional ORAL Date:04/03/98ISR Number: 3061177-6Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dizziness Postural Clozaril PS ORAL 200MG PO BID Fall Loss Of Consciousness Date:04/03/98ISR Number: 3063157-3Report Type:Expedited (15-DaCompany Report #ENA/01-RA/0/50/5007/1/RA Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Death Cardio-Respiratory Arrest Study Health 22-Feb-2006 08:30 AM Page: 72 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Product Role Manufacturer Route Dose Duration Clozaril PS ORAL 12.5MG ORAL Klonopin SS ORAL 1.5MG ORAL No Study Medication Received C Date:04/03/98ISR Number: 3063160-3Report Type:Expedited (15-DaCompany Report #USA/98/00663/LEX Age:87 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Clozaril PS ORAL 25MG ORAL Pneumonia Professional Sinemet C Respiratory Failure Permax C Lasix C Digoxin C Norvasc C Nitrate C Xanax C Potassium C Date:04/03/98ISR Number: 3063928-3Report Type:Expedited (15-DaCompany Report #LIT/98/00109/LEX Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Atrial Fibrillation Literature Clozaril PS ORAL 350 MG ORAL 14 MON Hospitalization - Blood Creatine Health Initial or Prolonged Phosphokinase Increased Professional Required Catatonia Intervention to Delirium Prevent Permanent Hypertension Impairment/Damage Neuroleptic Malignant Syndrome Pyrexia Date:04/03/98ISR Number: 3150983-5Report Type:Periodic Company Report #7394336 Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancreatitis Necrotising Health Depakote PS ORAL 2.750 GM PO Initial or Prolonged Professional QD Other Clozaril SS Zoloft C Date:04/03/98ISR Number: 3151343-3Report Type:Periodic Company Report #98-01-0016 Age:33 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Clozapine PS Zenith Goldline Initial or Prolonged Condition Aggravated Professional Pharm. ORAL 450MG/DAY Hallucination, Auditory ORAL TAB Suicidal Ideation 22-Feb-2006 08:30 AM Page: 73 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/06/98ISR Number: 3062710-0Report Type:Expedited (15-DaCompany Report #98HQ-10129 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatitis Foreign Lopressor PS DAILY Initial or Prolonged Hepatocellular Damage Literature Clozapine SS 300 MG DAILY Health Professional Other Date:04/07/98ISR Number: 3072707-2Report Type:Direct Company Report # Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Triglycerides Clozaril PS Novartis SEE IMAGE Increased ..... C Date:04/08/98ISR Number: 3061822-5Report Type:Expedited (15-DaCompany Report #RA/98/00809/LEX Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agitation Health Lapenax (Clozapine) PS ORAL 2 GRAMS ORAL Hospitalization - Extrapyramidal Disorder Professional Nozinan Initial or Prolonged Hypertonia (Levomepromazine) SS Muscle Rigidity Lithium C Overdose Bronchodilator C Respiratory Depression Suicide Attempt Date:04/08/98ISR Number: 3061824-9Report Type:Expedited (15-DaCompany Report #CDN/98/00171/LEX Age:31 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acidosis Hyperchloraemic Health Clozaril PS ORAL 100 MG ORAL Initial or Prolonged Hypernatraemia Professional Zoloft C Ketoacidosis Neuroleptic Malignant Syndrome Pancreatitis Date:04/08/98ISR Number: 3061826-2Report Type:Expedited (15-DaCompany Report #USA/98//00808/LEX Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Health Clozaril PS ORAL ORAL Coma Professional White Blood Cell Count Decreased Date:04/08/98ISR Number: 3150592-8Report Type:Periodic Company Report #USA/97/02922/LEX Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Leukopenia Health Clozaril PS ORAL 300 MG ORAL Hospitalization - Thinking Abnormal Professional Depakote (Valproate Initial or Prolonged Semisodium) C Zocor (Simvastatin) C 22-Feb-2006 08:30 AM Page: 74 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/08/98ISR Number: 3150594-1Report Type:Periodic Company Report #USA/97/02941/LEX Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Clozaril PS ORAL 150 MG ORAL Initial or Prolonged Hyponatraemia Professional Mellaril (Thrioridazine Hydrochloride) C Risperdal (Risperidone) C Ativan (Lorazepam) C Date:04/08/98ISR Number: 3150595-3Report Type:Periodic Company Report #USA/97/02986/LEX Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Leukopenia Health Clozaril PS ORAL 75 MG ORAL Neutropenia Professional Olanzapine (Olanzapine) C Levoxyl (Levothyroxine Sodium) C Lanoxin (Digoxin) C Melatonin C Date:04/08/98ISR Number: 3150597-7Report Type:Periodic Company Report #USA/97/03019/LEX Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril PS ORAL 175 MG ORAL Professional Date:04/08/98ISR Number: 3150617-XReport Type:Periodic Company Report #USA/97/01844/LEX Age:18 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Ejaculation Disorder Health Clozaril (Clozapine) PS ORAL 300 MG Intervention to Weight Increased Professional Luvox (Fluvoxamine Prevent Permanent Maleate) C Impairment/Damage Buspar (Buspirone Hydrochloride) C Depakote (Valproate Semisodium) C Date:04/08/98ISR Number: 3150619-3Report Type:Periodic Company Report #USA/97/01842/LEX Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Supraventricular Health Clozaril PS ORAL Intervention to Tachycardia Professional Mevacor (Lovastatin) C Prevent Permanent Tachycardia Haldol Deconoate Impairment/Damage (Haloperidol Decanoate) C Depakote (Valproate Semisodium) C 22-Feb-2006 08:30 AM Page: 75 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/08/98ISR Number: 3150621-1Report Type:Periodic Company Report #USA/97/01839/LEX Age:38 YR Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Health Clozaril PS ORAL 400 MG Initial or Prolonged Professional Sertraline C Risperidone C Vasotec (Enalapril Maleate) C Date:04/08/98ISR Number: 3150623-5Report Type:Periodic Company Report #USA/97/01795/LEX Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Salivary Hypersecretion Health Clozaril PS ORAL 300 MG Intervention to Professional Ativan (Lorazepam) C Prevent Permanent Impairment/Damage Date:04/08/98ISR Number: 3150625-9Report Type:Periodic Company Report #USA/97/01770/LEX Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Abdominal Pain Health Clozaril PS ORAL 400 MG Intervention to Diarrhoea Professional Depakote (Valproate Prevent Permanent Haematuria Semisodium) C Impairment/Damage Hepatic Function Abnormal Nausea Vomiting Date:04/08/98ISR Number: 3150626-0Report Type:Periodic Company Report #USA/97/01769/LEX Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Health Clozaril PS ORAL Initial or Prolonged Professional Required Intervention to Prevent Permanent Impairment/Damage Date:04/08/98ISR Number: 3150744-7Report Type:Periodic Company Report #USA/97/03049/LEX Age:83 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) PS ORAL 50 MG ORAL Professional Date:04/08/98ISR Number: 3150745-9Report Type:Periodic Company Report #USA/97/03099/LEX Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukocytosis Health Clozaril PS ORAL 3000 MG ORAL Medication Error Professional Risperdal Sedation (Risperidone) C Cogentin (Benzatropine 22-Feb-2006 08:30 AM Page: 76 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Mesilate) C Date:04/08/98ISR Number: 3150746-0Report Type:Periodic Company Report #USA/97/03102/LEX Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pancreatitis Health Clozaril PS ORAL 300 MG ORAL Professional Date:04/08/98ISR Number: 3150747-2Report Type:Periodic Company Report #USA/97/03203/LEX Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Clozaril PS ORAL 375 MG ORAL Life-Threatening Diabetes Mellitus Professional Antidepressant Intentional Overdose (Unspecified) C Insulin C Date:04/08/98ISR Number: 3150748-4Report Type:Periodic Company Report #USA/97/03206/LEX Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anaemia Consumer Clozaril PS ORAL 500 MG ORAL Polycythaemia Health Professional Date:04/08/98ISR Number: 3150749-6Report Type:Periodic Company Report #USA/97/03213/LEX Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Level Above Health Clozaril PS ORAL 700 MG ORAL Therapeutic Professional Risperdal (Risperidone) C Anafranil (Clomipromine Hydrochloride) C Date:04/08/98ISR Number: 3150750-2Report Type:Periodic Company Report #USA/97/03215/LEX Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Myocardial Infarction Health Clozaril PS ORAL 225 MG ORAL Initial or Prolonged Tachycardia Professional Date:04/08/98ISR Number: 3150891-XReport Type:Periodic Company Report #USA/97/02193/LEX Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blood Creatine Health Clozaril (Clozapine) PS ORAL 175 MG ORAL Intervention to Phosphokinase Increased Professional Alprazolam C Prevent Permanent Joint Stiffness Impairment/Damage Pyrexia 22-Feb-2006 08:30 AM Page: 77 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/08/98ISR Number: 3150893-3Report Type:Periodic Company Report #USA/97/02194/LEX Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Eosinophilia Health Clozaril (Clozapine) PS ORAL 75 MG ORAL Initial or Prolonged Leukocytosis Professional Sinemet C Inderal La C Ativan C Aricept C Date:04/08/98ISR Number: 3150894-5Report Type:Periodic Company Report #USA/97/02088/LEX Age:50 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Laboratory Test Abnormal Health Clozaril (Clozapine) PS ORAL 500 MG ORAL Intervention to Professional Prevent Permanent Impairment/Damage Date:04/08/98ISR Number: 3150897-0Report Type:Periodic Company Report #USA/97/02089/LEX Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Hypotension Health Clozaril (Clozapine) PS ORAL 12.5 MG ORAL Syncope Professional Restoril C Dilantin C Moban C Prozac C Date:04/08/98ISR Number: 3150900-8Report Type:Periodic Company Report #USA/97/02163/LEX Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) PS ORAL 25 MG ORAL Professional Olanzapine C Date:04/08/98ISR Number: 3150903-3Report Type:Periodic Company Report #USA/97/02086/LEX Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Hypertension Health Clozaril (Clozapine) PS ORAL 450 MG ORAL Intervention to Professional Prevent Permanent Impairment/Damage Date:04/08/98ISR Number: 3150906-9Report Type:Periodic Company Report #USA/97/02082/LEX Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperglycaemia Health Clozaril (Clozapine) PS ORAL 400 MG ORAL Initial or Prolonged Professional Cogentin C Miconazole C Glyburide C 22-Feb-2006 08:30 AM Page: 78 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/08/98ISR Number: 3150909-4Report Type:Periodic Company Report #USA/97/02040/LEX Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Tachycardia Health Clozaril (Clozapine) PS ORAL 600 MG ORAL Intervention to Professional Prevent Permanent Impairment/Damage Date:04/08/98ISR Number: 3150911-2Report Type:Periodic Company Report #USA/97/02045/LEX Age:24 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Tachycardia Health Clozaril (Clozapine) PS ORAL 700 MG ORAL Intervention to Professional Vistraril C Prevent Permanent Buspar C Impairment/Damage Date:04/08/98ISR Number: 3150914-8Report Type:Periodic Company Report #USA/97/02076/LEX Age:17 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Tachycardia Health Clozaril (Clozapine) PS ORAL 200 MG ORAL Intervention to Weight Increased Professional Prevent Permanent Impairment/Damage Date:04/08/98ISR Number: 3150917-3Report Type:Periodic Company Report #USA/97/02012/LEX Age:71 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Health Clozaril (Clozapine) PS ORAL 150 MG ORAL Initial or Prolonged Professional Depakote C Date:04/08/98ISR Number: 3150920-3Report Type:Periodic Company Report #USA/97/02022/LEX Age:49 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Health Clozaril (Clozapine) PS ORAL 600 MG ORAL Required Asthenia Professional Intervention to Hepatic Function Abnormal Prevent Permanent Sedation Impairment/Damage Date:04/08/98ISR Number: 3150923-9Report Type:Periodic Company Report #USA/97/02002/LEX Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cognitive Disorder Health Clozaril (Clozapine) PS ORAL 18.75 MG ORAL Initial or Prolonged Nervousness Professional Sinemet C Required Pneumonia Norvasc C Intervention to Propulsid C Prevent Permanent Impairment/Damage 22-Feb-2006 08:30 AM Page: 79 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/08/98ISR Number: 3150924-0Report Type:Periodic Company Report #USA/97/01990/LEX Age:55 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Diarrhoea Health Clozaril (Clozapine) PS ORAL 300 MG ORAL Intervention to Eosinophilia Professional Prevent Permanent Leukocytosis Impairment/Damage Urinary Tract Infection Date:04/08/98ISR Number: 3150928-8Report Type:Periodic Company Report #USA/97/01985/LEX Age:58 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Health Clozaril (Clozapine) PS ORAL 400 MG ORAL Initial or Prolonged Professional Lopressor C Required Ativan C Intervention to Prevent Permanent Impairment/Damage Date:04/08/98ISR Number: 3150929-XReport Type:Periodic Company Report #USA/97/01981/LEX Age:28 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Hepatitis Health Clozaril (Clozapine) PS ORAL 400 MG ORAL Intervention to Professional Prevent Permanent Impairment/Damage Date:04/08/98ISR Number: 3150931-8Report Type:Periodic Company Report #USA/97/01960/LEX Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Neutropenia Health Clozaril (Clozapine) PS ORAL 400 MG ORAL Intervention to Pyrexia Professional Depakote C Prevent Permanent Impairment/Damage Date:04/08/98ISR Number: 3150933-1Report Type:Periodic Company Report #USA/97/01926/LEX Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ileus Paralytic Health Clozaril (Clozapine) PS ORAL 400 MG ORAL Initial or Prolonged Professional Depakote C Klonopin C Colace C Date:04/08/98ISR Number: 3150936-7Report Type:Periodic Company Report #USA/97/01901/LEX Age:46 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Drug Withdrawal Syndrome Health Clozaril (Clozapine) PS ORAL 150 MG ORAL Intervention to Dyskinesia Professional Navane C Prevent Permanent Depakote C Impairment/Damage Prozac C 22-Feb-2006 08:30 AM Page: 80 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/08/98ISR Number: 3150940-9Report Type:Periodic Company Report #USA/97/01893/LEX Age:10 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Leukopenia Health Clozaril (Clozapine) PS ORAL 125 MG ORAL Intervention to Professional Haldol C Prevent Permanent Benadryl C Impairment/Damage Bethanecol C Dexedrine C Nortriptyline C Lotrimin C Urecholine C Date:04/08/98ISR Number: 3151297-XReport Type:Periodic Company Report #USA/97/02626/LEX Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Nausea Health Clozaril PS ORAL 700 MG ORAL Intervention to Vomiting Professional Cogentin C Prevent Permanent Blood Pressure Impairment/Damage Medication C Date:04/08/98ISR Number: 3151299-3Report Type:Periodic Company Report #USA/97/02587/LEX Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Leukopenia Health Clozaril PS ORAL 350 MG ORAL Intervention to Professional Colace C Prevent Permanent Vitamins C Impairment/Damage Lithium C Date:04/08/98ISR Number: 3151302-0Report Type:Periodic Company Report #USA/97/02577/LEX Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypertension Health Clozaril PS ORAL 240 MG ORAL Initial or Prolonged Speech Disorder Professional Diabeta C Tachycardia Sinequan C Tegretol C Risperdal C Benadryl C Cholesterol Pill C Date:04/08/98ISR Number: 3151304-4Report Type:Periodic Company Report #USA/97/02524/LEX Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pyrexia Health Clozaril PS ORAL 6.25 MG ORAL Initial or Prolonged Tachycardia Professional Haldol C Required Ativan C Intervention to Prevent Permanent Impairment/Damage 22-Feb-2006 08:30 AM Page: 81 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/08/98ISR Number: 3151307-XReport Type:Periodic Company Report #USA/97/02534/LEX Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intestinal Obstruction Health Clozaril PS ORAL ORAL Initial or Prolonged Professional Date:04/08/98ISR Number: 3151309-3Report Type:Periodic Company Report #USA/97/02535/LEX Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Infection Health Clozaril PS ORAL 300 MG ORAL Intervention to Leukocytosis Professional Lithium C Prevent Permanent Impairment/Damage Date:04/08/98ISR Number: 3151311-1Report Type:Periodic Company Report #USA/97/02522/LEX Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Health Clozaril PS ORAL ORAL Professional Date:04/08/98ISR Number: 3151312-3Report Type:Periodic Company Report #USA/97/02521/LEX Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Leukopenia Health Clozaril PS ORAL 400 MG ORAL Professional Vistaril C Date:04/08/98ISR Number: 3151313-5Report Type:Periodic Company Report #USA/97/02476/LEX Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neuroleptic Malignant Health Clozaril PS LESS THAN 200 Syndrome Professional MG Risperdal C Date:04/08/98ISR Number: 3151325-1Report Type:Periodic Company Report #USA/97/02474/LEX Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Convulsion Consumer Clozaril PS ORAL 400 MG ORAL Intervention to Leukocytosis Health Prevent Permanent Weight Decreased Professional Impairment/Damage Date:04/08/98ISR Number: 3151328-7Report Type:Periodic Company Report #USA/9702475/LEX Age:34 YR Gender:Female I/FU:I Outcome Hospitalization - Initial or Prolonged Required Intervention to Prevent Permanent 22-Feb-2006 08:30 AM Page: 82 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Consumer Clozaril PS ORAL 900 MG ORAL Health Professional Date:04/08/98ISR Number: 3151331-7Report Type:Periodic Company Report #USA/97/02464/LEX Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Dyskinesia Health Clozaril PS ORAL 400 MG ORAL Intervention to Orthostatic Hypotension Professional Paxil C Prevent Permanent Salivary Hypersecretion Prilosec C Impairment/Damage Sedation Relafen C Syncope Lodine C Carisoprodol C Vicodin C Date:04/08/98ISR Number: 3151335-4Report Type:Periodic Company Report #USA/97/02393/LEX Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril PS ORAL ORAL Professional Date:04/08/98ISR Number: 3151348-2Report Type:Periodic Company Report #USA/97/02338/LEX Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril PS ORAL ORAL Professional Date:04/08/98ISR Number: 3151350-0Report Type:Periodic Company Report #USA/97/02337/LEX Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril PS ORAL 450 MG ORAL Professional Date:04/08/98ISR Number: 3151352-4Report Type:Periodic Company Report #USA/97/02336/LEX Age:95 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Clozaril PS ORAL 150 MG ORAL Health Professional Date:04/08/98ISR Number: 3151353-6Report Type:Periodic Company Report #USA/97/02266/LEX Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pyrexia Health Clozaril PS ORAL ORAL Initial or Prolonged Urinary Tract Infection Professional 22-Feb-2006 08:30 AM Page: 83 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/08/98ISR Number: 3151356-1Report Type:Periodic Company Report #USA/97/02231/LEX Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Health Clozaril PS ORAL 132 MG ORAL Initial or Prolonged Pyrexia Professional Risperdal C Required Depakote C Intervention to Prevent Permanent Impairment/Damage Date:04/08/98ISR Number: 3151357-3Report Type:Periodic Company Report #USA/97/02222/LEX Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Health Clozaril PS ORAL 400 MG ORAL Initial or Prolonged Viral Infection Professional Haldol C Required Ativan C Intervention to Prevent Permanent Impairment/Damage Date:04/08/98ISR Number: 3151360-3Report Type:Periodic Company Report #USA/97/02206/LEX Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril PS ORAL ORAL Professional Date:04/08/98ISR Number: 3151426-8Report Type:Periodic Company Report #USA/98/00354/LEX Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutropenia Health Clozaril PS ORAL 50 MG ORAL Initial or Prolonged Professional Haldol (Haloperidol) C Depakote (Valproate Semisodium) C Date:04/08/98ISR Number: 3151429-3Report Type:Periodic Company Report #USA/98/00315/LEX Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Leukopenia Health Clozaril PS ORAL 400 MG ORAL Hospitalization - Neutropenia Professional Initial or Prolonged Pyrexia Required Intervention to Prevent Permanent Impairment/Damage Date:04/08/98ISR Number: 3151432-3Report Type:Periodic Company Report #USA/98/00304/LEX Age:85 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril PS 12.5 MG Professional 22-Feb-2006 08:30 AM Page: 84 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/08/98ISR Number: 3151437-2Report Type:Periodic Company Report #USA/98/00307/LEX Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril PS ORAL 175 MG ORAL Professional Date:04/08/98ISR Number: 3151441-4Report Type:Periodic Company Report #USA/98/00280/LEX Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intestinal Obstruction Health Clozaril PS ORAL 50 MG ORAL Initial or Prolonged Leukopenia Professional Required Intervention to Prevent Permanent Impairment/Damage Date:04/08/98ISR Number: 3151443-8Report Type:Periodic Company Report #USA/98/00250/LEX Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Leukopenia Health Clozaril PS ORAL 500 MG ORAL Intervention to Neutropenia Professional Lithium C Prevent Permanent Klonopin Impairment/Damage (Clonazepam) C Date:04/08/98ISR Number: 3151445-1Report Type:Periodic Company Report #USA/98/00251/LEX Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Leukopenia Health Clozaril PS ORAL 650 MG ORAL Intervention to Professional Prevent Permanent Impairment/Damage Date:04/08/98ISR Number: 3151447-5Report Type:Periodic Company Report #USA/98/00254/LEX Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril PS ORAL 600 MG ORAL Professional Date:04/08/98ISR Number: 3151448-7Report Type:Periodic Company Report #USA/98/00258/LEX Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Sedation Health Clozaril PS ORAL 375 MG ORAL Intervention to Professional Prozac (Fluoxetine Prevent Permanent Hydrochloride0 C Impairment/Damage Procardia (Nifedipine) C Risperdal (Risperidone) C 22-Feb-2006 08:30 AM Page: 85 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/08/98ISR Number: 3151449-9Report Type:Periodic Company Report #USA/98/00224/LEX Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril PS ORAL 25 MG ORAL Professional Date:04/08/98ISR Number: 3151451-7Report Type:Periodic Company Report #USA/98/00223/LEX Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) PS ORAL 400 MG ORAL Professional Date:04/08/98ISR Number: 3152891-2Report Type:Periodic Company Report #USA/96/02032/LEX Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Grand Mal Convulsion Clozaril PS ORAL 900 MG ORAL Initial or Prolonged Leukopenia Atenolol C Required Oxybutynin C Intervention to Prevent Permanent Impairment/Damage Date:04/08/98ISR Number: 3152894-8Report Type:Periodic Company Report #USA/96/02798/LEX Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Stevens-Johnson Syndrome Health Clozaril PS ORAL ORAL Hospitalization - Professional Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage Date:04/08/98ISR Number: 3152895-XReport Type:Periodic Company Report #USA/96/02892/LEX Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Urinary Incontinence Health Clozaril PS ORAL 300 MG ORAL Initial or Prolonged Professional Cogentin Required (Benzatropine Intervention to Mesilate) C Prevent Permanent Klonopin Impairment/Damage (Clonazepam) C Trilafon (Perphenazine) C Lithium C Insulin C Oxybutynin C 22-Feb-2006 08:30 AM Page: 86 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/08/98ISR Number: 3152896-1Report Type:Periodic Company Report #USA/96/02963/LEX Age:17 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pyrexia Clozaril PS ORAL 200 MG ORAL Initial or Prolonged Red Blood Cell Depakote C Required Sedimentation Rate Cogentin C Intervention to Increased Zoloft C Prevent Permanent Lithium Carbonate C Impairment/Damage Vitamin C C Vitamin E C Date:04/08/98ISR Number: 3152900-0Report Type:Periodic Company Report #USA/97/00249/LEX Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Constipation Health Clozaril PS ORAL ORAL Initial or Prolonged Leukocytosis Professional Required Priapism Intervention to Sedation Prevent Permanent Impairment/Damage Date:04/08/98ISR Number: 3152903-6Report Type:Periodic Company Report #USA/97/00263/LEX Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozaril PS ORAL 350 MG ORAL 12 DAY Hospitalization - Professional Haldol C Initial or Prolonged Ativan C Required Chloral Hydrate C Intervention to Prevent Permanent Impairment/Damage Date:04/08/98ISR Number: 3152906-1Report Type:Periodic Company Report #USA/97/00931/LEX Age:54 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Leukopenia Health Clozaril PS ORAL 300 MG ORAL Hospitalization - Nausea Professional Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage Date:04/08/98ISR Number: 3152909-7Report Type:Periodic Company Report #USA/97/00939/LEX Age:19 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancreatitis Health Clozaril PS ORAL ORAL Initial or Prolonged Professional Depakote C 22-Feb-2006 08:30 AM Page: 87 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/08/98ISR Number: 3152913-9Report Type:Periodic Company Report #USA/97/00941/LEX Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Extrasystoles Health Clozaril PS ORAL 2OO MG ORAL Initial or Prolonged Influenza Like Illness Professional Klonopin C Pyrexia Trazodone C Date:04/08/98ISR Number: 3152916-4Report Type:Periodic Company Report #USA/97/00981/LEX Age:43 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutropenia Health Clozaril PS ORAL 500 MG ORAL Initial or Prolonged Professional Depakote C Required Prozac C Intervention to Hydroxyzine C Prevent Permanent Impairment/Damage Date:04/08/98ISR Number: 3152919-XReport Type:Periodic Company Report #USA/97/01234/LEX Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutropenia Health Clozaril PS ORAL 400 MG ORAL Initial or Prolonged Pyrexia Professional Required Intervention to Prevent Permanent Impairment/Damage Date:04/08/98ISR Number: 3152924-3Report Type:Periodic Company Report #USA/97/01311/LEX Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Clozaril PS ORAL 750 MG ORAL Initial or Prolonged Professional Depakote C Procardia C Preicolace C Date:04/08/98ISR Number: 3152926-7Report Type:Periodic Company Report #USA/97/01360/LEX Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eosinophilia Health Clozaril PS ORAL 150 MG ORAL Professional Depakote C Inderal C Date:04/08/98ISR Number: 3152931-0Report Type:Periodic Company Report #USA/97/01362/LEX Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Health Clozaril PS ORAL 150 MG ORAL Leukopenia Professional Bethanechol C Urinary Incontinence Depakote C 22-Feb-2006 08:30 AM Page: 88 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/08/98ISR Number: 3152932-2Report Type:Periodic Company Report #USA/97/01400/LEX Age:64 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Health Clozaril PS ORAL 50 MG ORAL Required Death Professional Zoloft C Intervention to Lasix C Prevent Permanent Multivitamins C Impairment/Damage Dilantin (Phenytoin Sodium) C Ec Asa C Colace (Docusate Sodium) C Folate (Folate Solium) C Ventolin Inhaler (Salbutamol) C Atrovent Inhaler (Ipratropium Bromide) C Milk Of Magnesia (Magnesium Hydroxide) C Neurontin (Gabapentin) C Dulcolax (Bisacodyl) C Date:04/08/98ISR Number: 3152935-8Report Type:Periodic Company Report #USA/97/01533/LEX Age:44 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Health Clozaril PS ORAL 400 MG ORAL Initial or Prolonged Professional Zyprexa C Date:04/08/98ISR Number: 3152937-1Report Type:Periodic Company Report #USA/97/01548/LEX Age:34 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Muscle Necrosis Health Clozaril PS ORAL 350 MG ORAL Professional Neurontin C Depakote C Date:04/08/98ISR Number: 3152941-3Report Type:Periodic Company Report #USA/97/01552/LEX Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dizziness Health Clozaril PS ORAL 700 MG ORAL Initial or Prolonged Intestinal Obstruction Professional Citrucel C Required Mevacor C Intervention to Prevent Permanent Impairment/Damage 22-Feb-2006 08:30 AM Page: 89 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/08/98ISR Number: 3152942-5Report Type:Periodic Company Report #USA/97/01565/LEX Age:51 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozaril PS ORAL 450 MG ORAL Required Professional Tagamet C Intervention to Prevent Permanent Impairment/Damage Date:04/08/98ISR Number: 3152946-2Report Type:Periodic Company Report #USA/97/01662/LEX Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mental Disorder Consumer Clozaril PS ORAL 400 MG ORAL Initial or Prolonged Neutropenia Health Antibiotics C Professional Date:04/08/98ISR Number: 3153381-3Report Type:Periodic Company Report #USA/97/02633/LEX Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Health Clozaril PS ORAL 300 MG ORAL Professional Naprosyn C Zantac C Pericolace C Zoloft C Date:04/08/98ISR Number: 3153384-9Report Type:Periodic Company Report #USA/97/02719/LEX Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Effect Decreased Health Clozaril PS ORAL 200 MG ORAL Initial or Prolonged Leukocytosis Professional Effexor C Required Urinary Tract Infection Colace C Intervention to Hydrochlorthiazide C Prevent Permanent Ogen C Impairment/Damage Ritalin C Date:04/08/98ISR Number: 3153387-4Report Type:Periodic Company Report #USA/97/02731/LEX Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Influenza Like Illness Health Clozaril PS ORAL 125 MG ORAL Intervention to Neutropenia Professional Prevent Permanent Impairment/Damage Date:04/08/98ISR Number: 3153391-6Report Type:Periodic Company Report #USA/97/02751/LEX Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Infection Health Clozaril PS ORAL 250 MG ORAL Intervention to Leukocytosis Professional Zyrtec C Prevent Permanent Pharyngitis Impairment/Damage Sinusitis 22-Feb-2006 08:30 AM Page: 90 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/08/98ISR Number: 3153394-1Report Type:Periodic Company Report #USA/97/02765/LEX Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pericarditis Health Clozaril PS ORAL UNSPECIFIED Pleural Effusion Professional ORAL Date:04/08/98ISR Number: 3153398-9Report Type:Periodic Company Report #USA/97/02766/LEX Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Clozaril PS ORAL 625 MG ORAL Initial or Prolonged Professional Prozac SS 10 MG Depakote C Date:04/08/98ISR Number: 3153401-6Report Type:Periodic Company Report #USA/97/02798/LEX Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Consumer Clozaril PS ORAL 2 TABLETS Initial or Prolonged Dizziness ORAL Other Gait Disturbance Overdose Sedation Speech Disorder Date:04/08/98ISR Number: 3153406-5Report Type:Periodic Company Report #USA/97/02800/LEX Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Consumer Clozaril PS ORAL 2 TABLETS Initial or Prolonged Dizziness MORE Other Overdose Stupor Date:04/08/98ISR Number: 3153410-7Report Type:Periodic Company Report #USA/97/02801/LEX Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Consumer Clozaril PS ORAL 2 TABLETS Initial or Prolonged Dizziness ORAL Other Overdose Sedation Stupor Date:04/08/98ISR Number: 3153416-8Report Type:Periodic Company Report #USA/97/02802/LEX Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Consumer Clozaril PS ORAL 2 TABLETS Initial or Prolonged Dizziness ORAL Other Overdose Sedation Stupor 22-Feb-2006 08:30 AM Page: 91 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/08/98ISR Number: 3153418-1Report Type:Periodic Company Report #USA/97/02803/LEX Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Consumer Clozaril PS ORAL 2 TABLETS Initial or Prolonged Dizziness ORAL Other Overdose Sedation Stupor Date:04/08/98ISR Number: 3153419-3Report Type:Periodic Company Report #USA/97/02819/LEX Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril PS ORAL 300 MG ORAL Professional Thorazine C Cogentin C Artane C Date:04/08/98ISR Number: 3153421-1Report Type:Periodic Company Report #USA/97/02820/LEX Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril PS ORAL 50 MG ORAL Professional Sinemet C Permax C Symmetrel C Congentin C Sinemet Sr C Date:04/08/98ISR Number: 3153423-5Report Type:Periodic Company Report #USA/97/02834/LEX Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozaril PS ORAL 300 MG ORAL Professional Prolixin C Klonopin C Ambien C Cogentin C Date:04/08/98ISR Number: 3153430-2Report Type:Periodic Company Report #USA/97/02886/LEX Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril PS ORAL ORAL Life-Threatening Professional Hospitalization - Initial or Prolonged Date:04/08/98ISR Number: 3153432-6Report Type:Periodic Company Report #USA/97/02890/LEX Age:80 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Clozaril PS ORAL 75 MG ORAL Health Professional 22-Feb-2006 08:30 AM Page: 92 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/08/98ISR Number: 3153434-XReport Type:Periodic Company Report #USA/97/02892/LEX Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyspnoea Health Clozaril PS ORAL 350 MG ORAL Required Leukocytosis Professional Anafranil C Intervention to Oedema Depakote C Prevent Permanent Pyrexia Impairment/Damage Sedation Tachycardia Date:04/08/98ISR Number: 3153438-7Report Type:Periodic Company Report #USA/97/02894/LEX Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Health Clozaril PS ORAL 800 MG ORAL Initial or Prolonged Pneumonia Professional Procardia C Speech Disorder Allopurinol C Hctz C Micro-K C Tenormin C Lithium C Baby Asa C Motrin C Colace C Date:04/08/98ISR Number: 3153442-9Report Type:Periodic Company Report #USA/97/02898/LEX Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozaril PS ORAL 250 MG ORAL Hospitalization - Pyrexia Professional Glucophage C Initial or Prolonged Glyburide C Disability Date:04/08/98ISR Number: 3153446-6Report Type:Periodic Company Report #USA/97/02915/LEX Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozaril PS ORAL 550 MG ORAL Hospitalization - Professional Procardia Xl C Initial or Prolonged Date:04/08/98ISR Number: 3154023-3Report Type:Periodic Company Report #USA/98/00212/LEX Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) PS ORAL 200 MG ORAL Professional Date:04/08/98ISR Number: 3154026-9Report Type:Periodic Company Report #USA/98/00183/LEX Age:41 YR Gender:Female I/FU:I Outcome Hospitalization - Initial or Prolonged Required 22-Feb-2006 08:30 AM Page: 93 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Intervention to Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Bronchitis Health Clozaril (Clozapine) PS ORAL 600 MG ORAL Pneumonia Professional Depakote C Zoloft C Klonopin C Date:04/08/98ISR Number: 3154028-2Report Type:Periodic Company Report #USA/98/00079/LEX Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutropenia Health Clozaril (Clozapine) PS ORAL 600 MG ORAL Initial or Prolonged Pyrexia Professional Depakote C Required Albuterol C Intervention to Peri-Colace C Prevent Permanent Impairment/Damage Date:04/08/98ISR Number: 3154031-2Report Type:Periodic Company Report #USA/98/00080/LEX Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Health Clozaril (Clozapine) PS ORAL 75 MG ORAL Required Respiratory Depression Professional Ativan SS Intervention to Stupor Moban (Molindone) C Prevent Permanent Depakote (Valproate Impairment/Damage Semisodium) C Robitussin (Guaifenesin) C Thiamine C Multivitamins C Date:04/08/98ISR Number: 3154033-6Report Type:Periodic Company Report #USA/98/00071/LEX Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Leukopenia Health Clozaril (Clozapine) PS ORAL 250 MG ORAL Neutropenia Professional Atenolol C Lithium C Date:04/08/98ISR Number: 3154036-1Report Type:Periodic Company Report #USA/98/00042/LEX Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Health Clozaril (Clozapine) PS ORAL 400 MG ORAL Salivary Hypersecretion Professional Klonopin Sedation (Clonazepam) C Tremor Paxil (Paroxetine Hydrochloride) C Olanzapine C Depakote (Valproate Semisodium) C Verapaml C 22-Feb-2006 08:30 AM Page: 94 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/08/98ISR Number: 3154037-3Report Type:Periodic Company Report #USA/98/00036/LEX Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Pleural Effusion Health Clozaril (Clozapine) PS ORAL 500 MG ORAL Hospitalization - Professional Prozac (Fluoxetine Initial or Prolonged Hydrochloride) C Required Klonopin Intervention to (Clonazepam) C Prevent Permanent Depakote (Valproate Impairment/Damage Semisodium) C Lopid (Gemfibrozil) C Micronor (Norethisterone) C Albuterol Inhaler (Salbutamol) C Tylenol (Paracetamol) C Centrum C Date:04/08/98ISR Number: 3154040-3Report Type:Periodic Company Report #USA/97/03457/LEX Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dysphagia Health Clozaril (Clozapine) PS ORAL 350 MG ORAL Initial or Prolonged Professional Folic Acid C Clonidine C Cogentin (Benzatropine Mesilate) C Date:04/08/98ISR Number: 3154043-9Report Type:Periodic Company Report #USA/97/03426/LEX Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypotension Health Clozaril (Clozapine) PS ORAL 25 TO 125 MG Nephritis Interstitial Professional ORAL Lithium C Date:04/08/98ISR Number: 3154045-2Report Type:Periodic Company Report #USA/97/03408/LEX Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukocytosis Health Clozaril (Clozapine) PS ORAL 350 MG ORAL Initial or Prolonged Professional Ativan (Lorazepam) C Risperdal (Risperidone) C Depakote (Valproate Semisodium) C Date:04/08/98ISR Number: 3154048-8Report Type:Periodic Company Report #USA/97/03369/LEX Age:67 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) PS ORAL 125 MG ORAL Professional 22-Feb-2006 08:30 AM Page: 95 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/08/98ISR Number: 3154049-XReport Type:Periodic Company Report #USA/97/03370/LEX Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Health Clozaril (Clozapine) PS ORAL 650 MG Professional ORAL Cardizem (Diltiazem Hydrochloride) C Date:04/08/98ISR Number: 3154153-6Report Type:Periodic Company Report #USA/97/03378/LEX Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Health Clozaril (Clozapine) PS ORAL 250MG ORAL Initial or Prolonged Professional Other Date:04/08/98ISR Number: 3154155-XReport Type:Periodic Company Report #USA/97/03349/LEX Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Clozaril (Clozapine) PS ORAL ORAL Health Professional Date:04/08/98ISR Number: 3154157-3Report Type:Periodic Company Report #USA/97/03353/LEX Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Clozaril (Clozapine) PS ORAL ORAL Life-Threatening Date:04/08/98ISR Number: 3154159-7Report Type:Periodic Company Report #USA/97/03296/LEX Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) PS Professional Date:04/08/98ISR Number: 3154161-5Report Type:Periodic Company Report #USA/97/03242/LEX Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Study Clozaril (Clozapine) PS ORAL 550MG ORAL Initial or Prolonged Health Cogentin C Required Professional Depakene C Intervention to Unspecified Prevent Permanent Laxatives C Impairment/Damage Date:04/08/98ISR Number: 3154164-0Report Type:Periodic Company Report #USA/97/03288/LEX Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucination Health Clozaril (Clozapine) PS ORAL 450MG ORAL Initial or Prolonged Thrombocytopenia Professional 22-Feb-2006 08:30 AM Page: 96 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/08/98ISR Number: 3154167-6Report Type:Periodic Company Report #USA/97/03278/LEX Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pyrexia Health Clozaril (Clozapine) PS ORAL 150MG ORAL Initial or Prolonged Thrombocythaemia Professional Zyprexa C Depakote C Risperdal C Date:04/08/98ISR Number: 3154169-XReport Type:Periodic Company Report #USA/97/03244/LEX Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Clozaril (Clozapine) PS ORAL 600MG ORAL Initial or Prolonged Professional Depakote C Klonopin C Date:04/08/98ISR Number: 3154171-8Report Type:Periodic Company Report #USA/97/03241/LEX Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Health Clozaril (Clozapine) PS ORAL 100MG ORAL Initial or Prolonged Professional Prolixin C Ativan C Vitamins C Axid C Colace C Cogentin C Potassium C Restoril C Date:04/08/98ISR Number: 3154174-3Report Type:Periodic Company Report #USA/97/03221/LEX Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bundle Branch Block Health Clozaril (Clozapine) PS ORAL 75MG ORAL Initial or Prolonged Professional Klonopin C Date:04/08/98ISR Number: 3154394-8Report Type:Periodic Company Report #USA/97/01756/LEX Age:31 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Consumer Clozaril (Clozapine) PS ORAL 600 MG ORAL Initial or Prolonged Health Required Professional Intervention to Prevent Permanent Impairment/Damage Date:04/09/98ISR Number: 3074842-1Report Type:Direct Company Report # Age:42 YR Gender:Female I/FU:I Outcome Life-Threatening Hospitalization - Initial or Prolonged Required 22-Feb-2006 08:30 AM Page: 97 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Intervention to Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Cardiac Tamponade Clozaril PS Pericardial Effusion Pericarditis Date:04/10/98ISR Number: 3062768-9Report Type:Expedited (15-DaCompany Report #8-98077-004D Age:55 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Agitation Health Ativan PS ORAL ONE MG ORAL Intervention to Drug Interaction Professional Clozaril SS ORAL 25 MG IN Prevent Permanent Fall MORNING AND Impairment/Damage Loss Of Consciousness 50 MG AT Psychotic Disorder BEDTIME ORAL Respiratory Depression Depakote C Syncope Moban C Tachycardia Multi-Vit C Robitussin C Thiamine C Date:04/10/98ISR Number: 3064501-3Report Type:Expedited (15-DaCompany Report #F/98/00208/LEX Age:26 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Leponex PS ORAL 3 G ORAL Initial or Prolonged Coma Professional Other Overdose Required Pneumonia Aspiration Intervention to Suicide Attempt Prevent Permanent Impairment/Damage Date:04/10/98ISR Number: 3064505-0Report Type:Expedited (15-DaCompany Report #IRL/98/00139/LEX Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypothyroidism Health Clozaril PS ORAL 350 MG ORAL Required Professional Valproate Sodium C Intervention to Prevent Permanent Impairment/Damage Date:04/10/98ISR Number: 3064508-6Report Type:Expedited (15-DaCompany Report #AUS/98/00021/LEX Age:52 YR Gender:Male I/FU:I Outcome PT Other Circulatory Collapse Condition Aggravated Congestive Cardiomyopathy Convulsion Dizziness Neutrophil Count Increased Sinus Tachycardia White Blood Cell Count 22-Feb-2006 08:30 AM Page: 98 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Increased Report Source Product Role Manufacturer Route Dose Duration Health Clozaril PS ORAL 725 MG ORAL Professional Metamucil C Chlorpromazine C Alprazolam C Benztropine C Date:04/13/98ISR Number: 3063885-XReport Type:Expedited (15-DaCompany Report #USA/98/00864/LEX Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Leukaemia Health Clozaril PS ORAL 400 MG ORAL Hospitalization - Professional Prozac C Initial or Prolonged Other Date:04/13/98ISR Number: 3064168-4Report Type:Expedited (15-DaCompany Report #IND/98/00150/LEX Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agranulocytosis Health Leponex PS Life-Threatening Coma Professional Date:04/14/98ISR Number: 3066301-7Report Type:Expedited (15-DaCompany Report #USA/98/00880/LEX Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pulmonary Oedema Health Clozaril PS ORAL 550 MG ORAL Initial or Prolonged Professional Anafranil C Date:04/14/98ISR Number: 3066302-9Report Type:Expedited (15-DaCompany Report #USA/98/00307/LEX Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Neoplasm Malignant Health Clozaril PS ORAL 175 MG ORAL Other Professional Date:04/14/98ISR Number: 3066303-0Report Type:Expedited (15-DaCompany Report #USA/98/00733/LEX Age:72 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Study Clozaril PS ORAL 38 MG ORAL Cardiac Disorder Health Condition Aggravated Professional Coronary Artery Disease Parkinson'S Disease Date:04/14/98ISR Number: 3066304-2Report Type:Expedited (15-DaCompany Report #USA/98/00889/LEX Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozaril PS ORAL 750 MG ORAL Professional 22-Feb-2006 08:30 AM Page: 99 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/14/98ISR Number: 3066305-4Report Type:Expedited (15-DaCompany Report #D/98/01290/LEX Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Disorder Health Leponex PS ORAL 800 MG ORAL Initial or Prolonged Cardiomyopathy Professional Haldol C Other Tachycardia Date:04/14/98ISR Number: 3066307-8Report Type:Expedited (15-DaCompany Report #GB/98/00582/LEX Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Tachycardia Health Clozaril PS ORAL 38 MG ORAL Professional Valproate Sodium C Date:04/14/98ISR Number: 3066308-XReport Type:Expedited (15-DaCompany Report #USA/98/00272/LEX Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Respiratory Health Clozaril PS ORAL 150 MG ORAL Required Distress Syndrome Professional Haldol C Intervention to Agranulocytosis Ativan C Prevent Permanent Bradycardia Bumex C Impairment/Damage Cardiac Arrest Vecuronium C Neutrophil Count Lovenox C Decreased Azteronam C Pneumonia Gentamycin C Respiratory Failure Dopamine C White Blood Cell Count Phenylephrine C Decreased Compazine C Flunisolide C Apap C Date:04/14/98ISR Number: 3066310-8Report Type:Expedited (15-DaCompany Report #USA/98/00663/LEX Age:87 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Study Clozaril PS ORAL 25 MG ORAL Pneumonia Health Sinemet C Respiratory Failure Professional Permax C Lasix C Digoxin C Norvasc C Nitrate C Xanax C Potassium C Date:04/14/98ISR Number: 3066314-5Report Type:Expedited (15-DaCompany Report #CDN/98/00299/LEX Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Health Clozaril PS ORAL ORAL Professional 22-Feb-2006 08:30 AM Page: 100 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/15/98ISR Number: 3066256-5Report Type:Expedited (15-DaCompany Report #D/98/00740/LEX Age:69 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukocytosis Health Leponex PS ORAL 200 MG ORAL Lymphocytic Leukaemia Professional Tavor C Glibenclamid C Akineton Retard C Hydrochloride C Stilnox C Dominal C Atropin C Esiteren C Lefax C Pk-Merz C Lasix C Cedur C Sinquan C Insulin C Date:04/15/98ISR Number: 3071773-8Report Type:Direct Company Report # Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Faecaloma Clozaril PS ORAL 300MG PO BID Intervention to Intestinal Obstruction TAB 4 YR Prevent Permanent Impairment/Damage Date:04/15/98ISR Number: 3071775-1Report Type:Direct Company Report # Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Hypertensive Crisis Clozaril PS ORAL 75MG PO BID 1 WK Intervention to Overdose Prevent Permanent Tachycardia Impairment/Damage Date:04/15/98ISR Number: 3071890-2Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required White Blood Cell Count Clozaril PS Novartis 575 MG DAY 3 YR Intervention to Decreased Prevent Permanent Impairment/Damage Date:04/17/98ISR Number: 3065297-1Report Type:Expedited (15-DaCompany Report #USA/97/01754/LEX Age:53 YR Gender:Male I/FU:F Outcome PT Hospitalization - Agitation Initial or Prolonged Blood Creatine Required Phosphokinase Increased Intervention to Blood Creatinine Prevent Permanent Increased Impairment/Damage Blood Urea Increased Coagulopathy 22-Feb-2006 08:30 AM Page: 101 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dysarthria Hypotension Hypoxia Report Source Product Role Manufacturer Route Dose Duration Mental Impairment Health Clozaril PS ORAL 200 MG ORAL Muscle Rigidity Professional Inderal C Neuroleptic Malignant Xanax C Syndrome Clonidine C Pyrexia Depakote C Pepcid C Synthroid C Date:04/17/98ISR Number: 3065298-3Report Type:Expedited (15-DaCompany Report #D/98/00026/LEX Age:77 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neutropenia Health Leponex PS ORAL 12.5 MG ORAL Hospitalization - Pneumonia Primary Professional Amitriptyline SS Initial or Prolonged Atypical L-Dopa SS Required Sepsis Intervention to Prevent Permanent Impairment/Damage Date:04/17/98ISR Number: 3065299-5Report Type:Expedited (15-DaCompany Report #GB/98/00592/LEX Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Clozaril PS ORAL ORAL Neutrophil Count Professional Decreased White Blood Cell Count Decreased Date:04/17/98ISR Number: 3065300-9Report Type:Expedited (15-DaCompany Report #BG/98/00597/LEX Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Malaise Health Clozaril PS ORAL 300 MG ORAL Pyrexia Professional Clopixol C Chlorpromazine C Date:04/17/98ISR Number: 3065301-0Report Type:Expedited (15-DaCompany Report #BG/98/00591/LEX Age:74 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pancreatic Carcinoma Health Clozaril PS ORAL 450 MG ORAL Professional Date:04/20/98ISR Number: 3068683-9Report Type:Expedited (15-DaCompany Report #USA/98/00933/LEX Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Breast Cancer Female Health Clozaril PS ORAL Professional 22-Feb-2006 08:30 AM Page: 102 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/20/98ISR Number: 3068691-8Report Type:Expedited (15-DaCompany Report #USA/98/00904/LEX Age:24 MON Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Dyspnoea Health Clozaril PS ORAL Hospitalization - Hypoventilation Professional Initial or Prolonged Lethargy Other Medication Error Required Respiratory Disorder Intervention to Sedation Prevent Permanent Impairment/Damage Date:04/20/98ISR Number: 3073125-3Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Clozaril PS Novartis 200 MG AM / Thrombocytopenia 350 MG HS Multivitamin Qd C Cogentin C Date:04/21/98ISR Number: 3067194-4Report Type:Expedited (15-DaCompany Report #D/98/00156/LEX Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Intentional Overdose Health Leponex PS ORAL TAB 100 ORAL Hospitalization - Pneumonia Aspiration Professional Tranxilium SS Initial or Prolonged Suicide Attempt Other Date:04/21/98ISR Number: 3067195-6Report Type:Expedited (15-DaCompany Report #RA/98/00942/LEX Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Respiratory Disorder Lapenax PS ORAL 250 MG ORAL Initial or Prolonged Respiratory Failure Required Intervention to Prevent Permanent Impairment/Damage Date:04/21/98ISR Number: 3067197-XReport Type:Expedited (15-DaCompany Report #RA/98/00940/LEX Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Myeloid Leukaemia Lapenax PS ORAL 700 MG ORAL Date:04/23/98ISR Number: 3071831-8Report Type:Direct Company Report # Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Depression Health Clozaril PS ORAL 100MG QAM, Hallucination Professional 50MG QNOON, Nocturia 300MG QHS Suicidal Ideation Risperdal SS ORAL 3MG QAM + Urinary Retention 1.5MG QHS 22-Feb-2006 08:30 AM Page: 103 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/26/98ISR Number: 3066741-6Report Type:Direct Company Report # Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Clozaril PS 75MG QD Insulin-Dependent Zyprexa C Date:04/27/98ISR Number: 3070639-7Report Type:Expedited (15-DaCompany Report #RA/98/00970/LEX Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Health Lapenax PS ORAL 600 MG ORAL Initial or Prolonged Cardiomegaly Professional Etumina C Required Cardiovascular Disorder Halopidol C Intervention to Trapax C Prevent Permanent Artane C Impairment/Damage Date:04/27/98ISR Number: 3071098-0Report Type:Expedited (15-DaCompany Report #GB9800623LEX Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lower Respiratory Tract Health Clozaril PS ORAL 200 MG ORAL Infection Professional Date:04/27/98ISR Number: 3071182-1Report Type:Expedited (15-DaCompany Report #98033 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Health Trazondone Hcl PS White Blood Cell Count Professional Clozaril SS 300 MG DAILY YR Decreased Distributor Prozac C Depakote C Glucophage C Alcohol C Date:04/27/98ISR Number: 3071663-0Report Type:Expedited (15-DaCompany Report #GB/98/00622/LEX Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Health Clozaril PS ORAL 300 MG ORAL Circulatory Collapse Professional Convulsion Date:04/27/98ISR Number: 3071665-4Report Type:Expedited (15-DaCompany Report #CDN/97/00653/LEX Age:49 YR Gender:Male I/FU:I Outcome PT Death Bronchopneumonia Burns Third Degree Coma Confusional State Convulsion Haemorrhage Hypoxic Encephalopathy Injury Nephritis Interstitial 22-Feb-2006 08:30 AM Page: 104 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pulmonary Oedema Tremor Report Source Product Role Manufacturer Route Dose Duration Study Clozaril PS ORAL 700 MG ORAL Health Epival C Professional Dalmane C Phenegran C K-Dur C Hydrodiuril C Tenormin C Kemadrin C Date:04/27/98ISR Number: 3071666-6Report Type:Expedited (15-DaCompany Report #S/98/00042/LEX Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diarrhoea Leponex PS ORAL 300MG ORAL Initial or Prolonged Gastroenteritis Imovane C Required Jugular Vein Thrombosis Intervention to Localised Oedema Prevent Permanent Lymphadenopathy Impairment/Damage Pyrexia Vomiting Date:04/27/98ISR Number: 3073086-7Report Type:Direct Company Report # Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Clozaril PS 400 MG Sandoz SS 100MG AM + 300MG HS Date:04/27/98ISR Number: 3073109-5Report Type:Direct Company Report # Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypotension Clozaril PS 45 MG AT Initial or Prolonged BEDTIME Lithium Carbonate C Date:04/27/98ISR Number: 3075318-8Report Type:Expedited (15-DaCompany Report #1998-02-0571 Age:40 YR Gender:Male I/FU:F Outcome PT Death Atrioventricular Block Cardiac Failure Congestive Cardiomegaly Circulatory Collapse Collapse Of Lung Electrocardiogram Abnormal Emphysema Haematuria Hypoxia Proteinuria Pulmonary Congestion 22-Feb-2006 08:30 AM Page: 105 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pulmonary Oedema Respiratory Failure Shock Report Source Product Role Manufacturer Route Dose Duration Foreign Claratyne PS ORAL 10 MG QD ORAL Other Clozapine SS ORAL 600 MG QD ORAL Date:04/28/98ISR Number: 3071033-5Report Type:Expedited (15-DaCompany Report #CDN/98/00299/LEX Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Epilepsy Health Clozaril PS ORAL 450MG ORAL Pneumonia Aspiration Professional Neurontin C Epival C Date:04/28/98ISR Number: 3072028-8Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Haemoglobin Decreased Clozapine PS Novartis 100MG Initial or Prolonged Leukopenia GAM;300MG Q Required Nausea HS Intervention to Neutropenia Depakote C Prevent Permanent Neutrophil Count Abnormal Ferrous Sulfate C Impairment/Damage Pyrexia Triphasil-28 C Thrombocytopenia Vomiting Date:04/28/98ISR Number: 3072266-4Report Type:Expedited (15-DaCompany Report #RA/98/00942/LEX Age:30 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Health Lapenax PS ORAL 250 MG ORAL Initial or Prolonged Candidiasis Professional Other Lung Disorder Required Pharyngitis Intervention to Pyrexia Prevent Permanent Respiratory Failure Impairment/Damage Date:04/29/98ISR Number: 3071630-7Report Type:Expedited (15-DaCompany Report #USA/98/01014/LEX Age:82 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Clozaril PS ORAL 75 MG ORAL Professional Date:04/29/98ISR Number: 3073013-2Report Type:Expedited (15-DaCompany Report #RA/98/00173/LEX Age:35 YR Gender:Male I/FU:F Outcome Death Hospitalization - Initial or Prolonged Required Intervention to 22-Feb-2006 08:30 AM Page: 106 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Acute Myeloid Leukaemia Health Lapenax PS ORAL 700 MG ORAL Dermatitis Professional Atenolol C Leukopenia Clonazepam C Neutropenia Date:04/29/98ISR Number: 3073016-8Report Type:Expedited (15-DaCompany Report #USA/98/00619/LEX Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Health Clozaril PS ORAL 450 MG ORAL Initial or Prolonged Hallucination Professional Risperdal SS ORAL 4.5 MG ORAL Required Nocturia Prozac C Intervention to Suicidal Ideation Prevent Permanent Urinary Retention Impairment/Damage Date:04/29/98ISR Number: 3073018-1Report Type:Expedited (15-DaCompany Report #GB/98/00626/LEX Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozaril PS ORAL ORAL Convulsion Professional Chlorpromazine C Loss Of Consciousness Cimetidine C Shock Cisapride C Date:04/30/98ISR Number: 3071110-9Report Type:Expedited (15-DaCompany Report #AUS/98/00039/LEX Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Disturbance In Attention Health Clozaril PS ORAL 1200 MG Required Dizziness Professional Thyroxine C Intervention to Hallucination Ferrogradumet C Prevent Permanent Malaise Impairment/Damage Overdose Personality Disorder Pyrexia Suicide Attempt Date:04/30/98ISR Number: 3071114-6Report Type:Expedited (15-DaCompany Report #USA/98/01030/LEX Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Colitis Ulcerative Health Clozaril PS ORAL 700 MG Diarrhoea Professional Haldol C Weight Decreased Depakote C Zoloft C Date:04/30/98ISR Number: 3071119-5Report Type:Expedited (15-DaCompany Report #USA/98/01040/LEX Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Health Clozaril PS ORAL 500 MG Initial or Prolonged Intestinal Perforation Professional 22-Feb-2006 08:30 AM Page: 107 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/30/98ISR Number: 3071123-7Report Type:Expedited (15-DaCompany Report #GB/98/00552/LEX Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coronary Artery Disease Health Clozaril PS ORAL 200 MG Myocardial Ischaemia Professional Clopixol C Date:04/30/98ISR Number: 3071126-2Report Type:Expedited (15-DaCompany Report #USA/98/00715/LEX Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Health Clozaril PS ORAL 550 MG ORAL 6 YR Initial or Prolonged Clonic Convulsion Professional Anafranil C Coma Biaxin C Confusional State Atenolol C Coordination Abnormal Dysarthria Fall Joint Dislocation Loss Of Consciousness Movement Disorder Muscle Contractions Involuntary Pathological Fracture Pneumonia Serotonin Syndrome Speech Disorder Date:04/30/98ISR Number: 3073313-6Report Type:Direct Company Report # Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutrophil Count Clozaril PS Novartis 375 MG HS 2 YR Required Decreased Intervention to White Blood Cell Count Prevent Permanent Decreased Impairment/Damage Date:05/04/98ISR Number: 3073498-1Report Type:Expedited (15-DaCompany Report #US_980402279 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Constipation Foreign Clozapine PS Initial or Prolonged Diverticulitis Study Tavor C Health Rohypnol C Professional Date:05/04/98ISR Number: 3073904-2Report Type:Expedited (15-DaCompany Report #GB/98/00656/LEX Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Clozaril PS ORAL 500 MG ORAL Life-Threatening Professional 22-Feb-2006 08:30 AM Page: 108 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/04/98ISR Number: 3074289-8Report Type:Expedited (15-DaCompany Report #GB/98/00623/LEX Age:61 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Health Clozaril PS ORAL 200 MG ORAL Dyspnoea Professional Nifedipine C Lower Respiratory Tract Infection Myocardial Infarction Date:05/05/98ISR Number: 3081699-1Report Type:Direct Company Report # Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Clozapine PS ORAL 100MG PO BID Drug Level Above Depakote C Therapeutic Lopid C Neutropenia Paxil C White Blood Cell Count Niaspan C Decreased Date:05/06/98ISR Number: 3072734-5Report Type:Direct Company Report # Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sedation Gabapentin PS Parke-Davis ORAL 600MG TID ORAL Clozapine SS Novartic ORAL 12.5 MG BID ORAL Divalproex C Fluphenazine C Levothyroxine C Lithium Carbonate C Benztropine C Lorazepam C Date:05/06/98ISR Number: 3074128-5Report Type:Expedited (15-DaCompany Report #98-04-0089 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Respiratory Failure Health Clozapine PS Zenith Goldline Hospitalization - Professional Pharm. ORAL ORAL Initial or Prolonged Date:05/08/98ISR Number: 3075029-9Report Type:Expedited (15-DaCompany Report #USA/92/00574/LEX Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozaril PS ORAL 325 MG ORAL Hospitalization - Myocarditis Professional Cogentin C Initial or Prolonged Neuroleptic Malignant Inderal C Other Syndrome Artane C Pyrexia Lithium C Torsade De Pointes Klonopin C Ventricular Tachycardia Acetaminophen C Navane C 22-Feb-2006 08:30 AM Page: 109 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/08/98ISR Number: 3075053-6Report Type:Expedited (15-DaCompany Report #CDN/98/00371/LEX Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Obsessive-Compulsive Health Clozaril PS ORAL 175 MG ORAL Initial or Prolonged Disorder Professional Buspar C Date:05/08/98ISR Number: 3075055-XReport Type:Expedited (15-DaCompany Report #CDN/98/00081/LEX Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Apgar Score Low Health Clozaril PS ORAL 150 MG ORAL Arrhythmia Neonatal Professional Cardiac Murmur Complications Of Maternal Exposure To Therapeutic Drugs Jaundice Neonatal Date:05/08/98ISR Number: 3075056-1Report Type:Expedited (15-DaCompany Report #USA/98/01069/LEX Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Gastrointestinal Health Clozaril PS ORAL 400 MG ORAL 2 YR Haemorrhage Professional Oesophagitis Pancreatitis Date:05/11/98ISR Number: 3075160-8Report Type:Expedited (15-DaCompany Report #GB/98/00656/LEX Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Clozaril PS ORAL 500 MG ORAL Life-Threatening Professional Date:05/11/98ISR Number: 3075188-8Report Type:Expedited (15-DaCompany Report #USA/98/01076/LEX Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatinine Health Clozaril PS ORAL 200 MG Increased Professional Blood Urea Increased Cholelithiasis Jaundice Nephritis Date:05/11/98ISR Number: 3075198-0Report Type:Expedited (15-DaCompany Report #GB/98/00622/LEX Age:61 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Circulatory Collapse Health Clozaril PS ORAL 300 MG Required Convulsion Professional Intervention to Deep Vein Thrombosis Prevent Permanent Pulmonary Embolism Impairment/Damage 22-Feb-2006 08:30 AM Page: 110 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/11/98ISR Number: 3075203-1Report Type:Expedited (15-DaCompany Report #GB/98/00666/LEX Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Clozaril PS ORAL OTH ORAL Initial or Prolonged Congestive Cardiomyopathy Prednisolone C Required Hypokinesia Lactulose C Intervention to Malaise Ventolin C Prevent Permanent Tachycardia Co-Amilofruse C Impairment/Damage Date:05/11/98ISR Number: 3075207-9Report Type:Expedited (15-DaCompany Report #F/98/00630/LEX Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pulmonary Tuberculosis Health Leponex PS ORAL 400 MG ORAL Initial or Prolonged Professional Tegretol SS ORAL 800 MG ORAL Required Sulfarlem C Intervention to Prevent Permanent Impairment/Damage Date:05/12/98ISR Number: 3075372-3Report Type:Direct Company Report # Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Cataplexy Clozapine PS 375 MG QD; Intervention to Hypotonia THERAPY: Prevent Permanent Muscular Weakness SEVEARL YEARS Impairment/Damage Lithium C Date:05/12/98ISR Number: 3077360-XReport Type:Expedited (15-DaCompany Report #GB/98/00597/LEX Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Influenza Like Illness Health Clozaril PS ORAL 300 MG Malaise Professional Clopixol Myocarditis (Zuclopenthixol Pyrexia Decanoate) C Vomiting Chlorpromazine (Chlorpromazine) C Date:05/14/98ISR Number: 3078280-7Report Type:Expedited (15-DaCompany Report #CDN/98/00014/LEX Age:57 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Clozaril PS ORAL 500 MG ORAL Professional Date:05/14/98ISR Number: 3078306-0Report Type:Expedited (15-DaCompany Report #USA/98/01155/LEX Age:38 YR Gender:Male I/FU:I Outcome PT Hospitalization - Bronchitis Initial or Prolonged Coma Cyanosis Dehydration 22-Feb-2006 08:30 AM Page: 111 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Heart Rate Increased Hypotension Ileus Paralytic Report Source Product Role Manufacturer Route Dose Duration Renal Failure Acute Health Clozaril PS ORAL 850 MG ORAL Respiratory Failure Professional Risperdal C Respiratory Rate Prozac C Increased Depakote C Sepsis Benadryl C Shock Tylenol C Small Intestinal Tums C Obstruction Urinary Tract Infection Date:05/15/98ISR Number: 3079145-7Report Type:Expedited (15-DaCompany Report #98F--10363 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pulmonary Tuberculosis Foreign Tegretol PS ORAL 400 MG, BID, Initial or Prolonged Health ORAL Professional Tercian SS ORAL 100 MG, DAILY, ORAL Leponex SS ORAL 400 MG, DAILY, ORAL Tranxene SS ORAL 100 MG, DAILY, ORAL Prozac SS ORAL 20 MG, DAILY, ORAL Sulfarlem C Date:05/15/98ISR Number: 3079411-5Report Type:Expedited (15-DaCompany Report #CDN/98/00338/LEX Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiac Failure Health Clozaril PS ORAL ORAL Hospitalization - Congestive Professional Chlorpromazine C Initial or Prolonged Myocarditis Cogentin C Other Pulmonary Oedema Nozinan C Required Clonazepam C Intervention to Folic Acid C Prevent Permanent Lorazepam C Impairment/Damage Restoril C Date:05/15/98ISR Number: 3079413-9Report Type:Expedited (15-DaCompany Report #D/98/01290/LEX Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiomyopathy Health Leponex PS ORAL 800 MG ORAL Hospitalization - Tachycardia Professional Haldol C Initial or Prolonged Other Date:05/15/98ISR Number: 3079415-2Report Type:Expedited (15-DaCompany Report #USA/98/01154/LEX Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Cancer Female Health Clozaril PS ORAL ORAL Leukopenia Professional 22-Feb-2006 08:30 AM Page: 112 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/18/98ISR Number: 3079425-5Report Type:Direct Company Report # Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Fall Health Clozapine PS Sandoz ORAL 350 MG BID PO Hypotonia Professional Syncope Date:05/18/98ISR Number: 3080664-8Report Type:Expedited (15-DaCompany Report #USA/98/01228/LEX Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Appendicitis Perforated Health Clozaril PS ORAL 600 MG ORAL 6 YR Initial or Prolonged Pyrexia Professional Prozac C Sepsis Ativan C Darvocet C Tylenol C Zeebac C Date:05/21/98ISR Number: 3082308-8Report Type:Expedited (15-DaCompany Report #USA/98/01237/LEX Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozaril PS ORAL 325 MG ORAL Required Convulsion Professional Effexor C Intervention to Pneumonia Prevent Permanent Impairment/Damage Date:05/21/98ISR Number: 3082378-7Report Type:Expedited (15-DaCompany Report #USA/98/01246/LEX Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Health Clozaril PS ORAL 300 MG ORAL Required Professional Intervention to Prevent Permanent Impairment/Damage Date:05/21/98ISR Number: 3082379-9Report Type:Expedited (15-DaCompany Report #GB/98/00682/LEX Age:69 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozaril PS ORAL 200 MG ORAL Professional Date:05/21/98ISR Number: 3082382-9Report Type:Expedited (15-DaCompany Report #GB/98/00681/LEX Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozaril PS ORAL 250 MG ORAL Professional 22-Feb-2006 08:30 AM Page: 113 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/21/98ISR Number: 3082387-8Report Type:Expedited (15-DaCompany Report #AUS/98/00062/LEX Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Study Clozaril PS Other Overdose Health Amphetamine SS Professional Date:05/22/98ISR Number: 3082163-6Report Type:Expedited (15-DaCompany Report #USA/98/01247/LEX Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Health Clozaril PS ORAL 415 MG ORAL Professional Zoloft C Date:05/22/98ISR Number: 3082216-2Report Type:Expedited (15-DaCompany Report #GB/98/00681/LEX Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Clozail PS ORAL 250 MG ORAL Myocardial Infarction Professional Date:05/26/98ISR Number: 3082558-0Report Type:Expedited (15-DaCompany Report #USA/98/01314/LEX Age:86 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Health Clozaril PS ORAL Life-Threatening Professional Date:05/26/98ISR Number: 3082590-7Report Type:Expedited (15-DaCompany Report #98-05-0105 Age:87 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Clozapine PS ORAL ORAL Professional Date:05/26/98ISR Number: 3082908-5Report Type:Expedited (15-DaCompany Report #98033 Age:36 MON Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Interaction Health Trazodone PS ORAL 200 MG PO AT White Blood Cell Count Professional BEDTIME 1 YR Decreased Distributor Clozaril SS 300 MG DAILY Prozac C Depakote C Glucophage C Alcohol C Date:05/26/98ISR Number: 3082997-8Report Type:Expedited (15-DaCompany Report #CDN/98/00014/LEX Age:57 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Study Clozaril PS ORAL 500 MG ORAL Health Professional 22-Feb-2006 08:30 AM Page: 114 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/26/98ISR Number: 3082998-XReport Type:Expedited (15-DaCompany Report #GB/98/00703/LEX Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Intestinal Obstruction Health Clozaril PS ORAL 550 MG ORAL Volvulus Of Bowel Professional Senna C Lactulose C Fybogel C Date:05/26/98ISR Number: 3082999-1Report Type:Expedited (15-DaCompany Report #AUS/98/00076/LEX Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Distension Study Clozaril PS ORAL 300 MG ORAL Initial or Prolonged Cardiac Failure Health Lithium C Required Cardiomyopathy Professional Intervention to Cough Prevent Permanent Dyspnoea Impairment/Damage Fatigue Lethargy Oedema Peripheral Sedation Date:05/26/98ISR Number: 3083000-6Report Type:Expedited (15-DaCompany Report #F/98/00587/LEX Age:76 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatinine Health Leponex PS ORAL 300 MG ORAL 4 MON Initial or Prolonged Increased Professional Lepticur SS UNKNOWN UNKNOWN 4 MON Blood Urea Increased C-Reactive Protein Increased Nephritis Interstitial Renal Failure Acute Date:05/26/98ISR Number: 3083024-9Report Type:Expedited (15-DaCompany Report #USA/98/01306/LEX Age:83 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozaril PS ORAL 25MG ORAL Professional Date:05/26/98ISR Number: 3083032-8Report Type:Expedited (15-DaCompany Report #NL/98/00018/LEX Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Atrioventricular Block Health Leponex PS ORAL 200MG ORAL Complete Professional Bradycardia Syncope Date:05/26/98ISR Number: 3083034-1Report Type:Expedited (15-DaCompany Report #USA/98/01030/LEX Age:43 YR Gender:Male I/FU:F Outcome PT Other Colitis Ulcerative Diarrhoea 22-Feb-2006 08:30 AM Page: 115 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Weight Decreased Report Source Product Role Manufacturer Route Dose Duration Health Clozaril PS ORAL 700MG ORAL Professional Haldol C Depakote C Zoloft C Date:05/26/98ISR Number: 3083045-6Report Type:Expedited (15-DaCompany Report #USA/98/01228/LEX Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Appendicitis Perforated Health Clozaril PS ORAL 600MG ORAL 6 YR Hospitalization - Pyrexia Professional Prozac C Initial or Prolonged Sepsis Ativan C Darvocet C Tylenol C Zeebac C Date:05/26/98ISR Number: 3083112-7Report Type:Expedited (15-DaCompany Report #GB/98/00682/LEX Age:69 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozaril PS ORAL 200 MG ORAL Professional Date:05/28/98ISR Number: 3084816-2Report Type:Expedited (15-DaCompany Report #GB/98/00711/LEX Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Neoplasm Malignant Health Clozaril PS ORAL 400 MG ORAL Metastasis Professional Date:05/28/98ISR Number: 3084820-4Report Type:Expedited (15-DaCompany Report #GB/98/00730/LEX Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Cataract Clozaril PS ORAL 400 MG ORAL Retinitis Pigmentosa Orphenadrine C Date:06/02/98ISR Number: 3088038-0Report Type:Expedited (15-DaCompany Report #D/98/01864/LEX Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fatigue Health Leponex PS ORAL 5000 MG ORAL Initial or Prolonged Hallucination Professional Fluctin SS Other Salivary Hypersecretion Required Sedation Intervention to Suicide Attempt Prevent Permanent Torticollis Impairment/Damage 22-Feb-2006 08:30 AM Page: 116 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/02/98ISR Number: 3088699-6Report Type:Expedited (15-DaCompany Report #GB/98/00726/LEX Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Clozaril PS ORAL 200 MG ORAL Date:06/02/98ISR Number: 3088702-3Report Type:Expedited (15-DaCompany Report #GB/98/00725/LEX Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Health Clozaril PS ORAL 600 MG ORAL Initial or Prolonged Congestive Professional Ferrous Sulphate C Required Cardiomyopathy Intervention to Ejection Fraction Prevent Permanent Abnormal Impairment/Damage Date:06/02/98ISR Number: 3088705-9Report Type:Expedited (15-DaCompany Report #D/98/01896/LEX Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiac Arrest Health Leponex PS ORAL 50 MG ORAL Hospitalization - Deep Vein Thrombosis Professional Haldol Decanoate C Initial or Prolonged Diabetes Mellitus Antidiabetics C Other Non-Insulin-Dependent Required Embolism Intervention to Hyperglycaemia Prevent Permanent Intervertebral Disc Impairment/Damage Protrusion Polyuria Weight Increased Date:06/04/98ISR Number: 3088574-7Report Type:Direct Company Report # Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abnormal Behaviour Clozapine PS GENERIC; 500 Catatonia MG/DAY Condition Aggravated DIVIDED DOSES Drug Abuser Psychotic Disorder Date:06/04/98ISR Number: 3091206-5Report Type:Expedited (15-DaCompany Report #98-05-0119 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Road Traffic Accident Health Clozapine PS Zenith Goldline Professional Pharm. ORAL ORAL Date:06/05/98ISR Number: 3089599-8Report Type:Direct Company Report # Age:49 YR Gender:Female I/FU:I Outcome PT Other Agitation Condition Aggravated Delusion Hallucination, Auditory 22-Feb-2006 08:30 AM Page: 117 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hostility Insomnia Irritability Report Source Product Role Manufacturer Route Dose Duration Clozapine PS ORAL PO TID 675MG TOTAL Date:06/05/98ISR Number: 3089601-3Report Type:Direct Company Report # Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Clozapine PS ORAL 300MG PO BID Dizziness Fatigue Hostility Psychotic Disorder Sedation Date:06/05/98ISR Number: 3089952-2Report Type:Expedited (15-DaCompany Report #AUS/98/00087/LEX Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Overdose Study Clozapine PS ORAL 4 G ORAL 1 DAY Initial or Prolonged Suicide Attempt Health Required Professional Intervention to Prevent Permanent Impairment/Damage Date:06/05/98ISR Number: 3089954-6Report Type:Expedited (15-DaCompany Report #CDN/98/00219/LEX Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebral Ischaemia Study Clozaril PS ORAL 250 MG ORAL Hospitalization - Hypoxia Health Initial or Prolonged Influenza Like Illness Professional Multi-Organ Failure Pneumonia Renal Failure Acute Respiratory Arrest Sepsis Date:06/05/98ISR Number: 3089957-1Report Type:Expedited (15-DaCompany Report #CDN/98/00446/LEX Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril PS ORAL 125 MG ORAL Professional Date:06/05/98ISR Number: 3090705-XReport Type:Expedited (15-DaCompany Report #CDN/98/00219/LEX Age:32 YR Gender:Male I/FU:F Outcome PT Death Cerebral Ischaemia Hospitalization - Hypoxia Initial or Prolonged Influenza Like Illness Multi-Organ Failure 22-Feb-2006 08:30 AM Page: 118 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pneumonia Renal Failure Acute Respiratory Arrest Report Source Product Role Manufacturer Route Dose Duration Sepsis Study Clozaril PS ORAL 250 MG ORAL Health Professional Date:06/05/98ISR Number: 3094137-XReport Type:Expedited (15-DaCompany Report #CDN/97/00788/LEX Age:36 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Clozaril PS ORAL 125 MG ORAL Professional Date:06/05/98ISR Number: 3094138-1Report Type:Expedited (15-DaCompany Report #CDN/98/00446/LEX Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril PS ORAL 125 MG ORAL Professional Date:06/08/98ISR Number: 3090090-3Report Type:Direct Company Report # Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutrophil Count Clozaril PS ORAL 50 MG BID PO Initial or Prolonged Decreased Date:06/08/98ISR Number: 3090091-5Report Type:Direct Company Report # Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tachycardia Clozaril PS 350 MG QD 3 WK Date:06/08/98ISR Number: 3090094-0Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Bladder Obstruction Clozaril PS 450 MG QD Intervention to Faecaloma Prevent Permanent Impairment/Damage Date:06/08/98ISR Number: 3090096-4Report Type:Direct Company Report # Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Fall Clozaril PS ORAL 400 MG PO BID Sedation 22-Feb-2006 08:30 AM Page: 119 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/08/98ISR Number: 3091469-6Report Type:Expedited (15-DaCompany Report #USA 9801375 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Health Clozaril PS ORAL 325 MG ORAL Initial or Prolonged Dehydration Professional Depakote C Depressed Level Of Lithium C Consciousness Insulin C Diarrhoea Dizziness Pneumonia Sepsis Date:06/08/98ISR Number: 3092008-6Report Type:Expedited (15-DaCompany Report #98-05-0118 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Health Clozapine PS Zenith Goldline Pneumonia Aspiration Professional Pharm. ORAL 25-50 MG QAM ORAL Sinemet Cr C Hydrochlorothiazide C Oruvail C Lasix C Permax C Date:06/09/98ISR Number: 3091142-4Report Type:Expedited (15-DaCompany Report #D/97/03529/LEX Age:26 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypotension Health Leponex PS ORAL 3G ORAL Initial or Prolonged Overdose Professional Lasix SS ORAL ORAL Required Salivary Hypersecretion Intervention to Sedation Prevent Permanent Suicide Attempt Impairment/Damage Tachycardia Urinary Retention Date:06/09/98ISR Number: 3091143-6Report Type:Expedited (15-DaCompany Report #CDN/98/0038/LEX Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiac Failure Health Clozaril PS ORAL 250MG ORAL Hospitalization - Congestive Professional Chlorpromazine C Initial or Prolonged Influenza Like Illness Congentin C Other Malaise Nozinan C Required Myocarditis Folic Acid C Intervention to Pulmonary Oedema Lorazepam C Prevent Permanent Impairment/Damage Date:06/09/98ISR Number: 3091145-XReport Type:Expedited (15-DaCompany Report #USA/98/00880/LEX Age:24 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pulmonary Oedema Health Clozaril PS ORAL 550MG ORAL Initial or Prolonged Professional Anafranil SS 22-Feb-2006 08:30 AM Page: 120 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/09/98ISR Number: 3091147-3Report Type:Expedited (15-DaCompany Report #CDN/98/00467/LEX Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Injury Study Clozaril PS ORAL ORAL Initial or Prolonged Neutrophil Count Health Increased Professional Suicide Attempt Date:06/09/98ISR Number: 3091755-XReport Type:Direct Company Report # Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Clozapine PS 200MG AM, 300 Initial or Prolonged Diabetic Ketoacidosis MG PM 6 MON Disability Nausea Pallor Vomiting Date:06/09/98ISR Number: 3091785-8Report Type:Direct Company Report # Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Orthostatic Hypotension Clozapine PS Saudoz ORAL 100 MG IN AM Initial or Prolonged Pyrexia & 20 MG IN PM Other PO Date:06/09/98ISR Number: 3091793-7Report Type:Direct Company Report # Age:69 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypotension Clozapine PS Novoxtis ORAL 25MG PO IN Initial or Prolonged Syncope AM; 50MG PO HS Date:06/09/98ISR Number: 3092707-6Report Type:Direct Company Report # Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutropenia Clozapine PS Novartis ORAL 2POAM AND PM 2 YR Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage Date:06/10/98ISR Number: 3092789-1Report Type:Direct Company Report # Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Clozapine PS ORAL 275MG BID OI 3 MON Initial or Prolonged Asthenia Colace C Other Cough Procardia Xl C Malaise Tylenol C Pharyngitis Pharyngolaryngeal Pain Pyrexia 22-Feb-2006 08:30 AM Page: 121 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/11/98ISR Number: 3092737-4Report Type:Expedited (15-DaCompany Report #GB/98/00578/LEX Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Albuminuria Health Clozaril PS ORAL 500 MG ORAL Initial or Prolonged Confusional State Professional Orphenadrine C Required Diabetes Mellitus Intervention to Heart Rate Increased Prevent Permanent Hyperglycaemia Impairment/Damage Labile Blood Pressure Lethargy Polyuria Sedation Thirst Urine Abnormality Weight Decreased Date:06/11/98ISR Number: 3092738-6Report Type:Expedited (15-DaCompany Report #GB/98/00711/LEX Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Carcinoma Cell Type Health Clozaril PS ORAL 400 MG ORAL Unspecified Stage Iv Professional Date:06/11/98ISR Number: 3092742-8Report Type:Expedited (15-DaCompany Report #USA/98/01030/LEX Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Colitis Ulcerative Health Clozaril PS ORAL 700 MG ORAL Diarrhoea Professional Haldol C Weight Decreased Depakote C Zoloft C Date:06/11/98ISR Number: 3092744-1Report Type:Expedited (15-DaCompany Report #USA/98/00831/LEX Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Health Clozaril PS ORAL 300 MG ORAL Initial or Prolonged Clostridium Colitis Professional Depo-Provera C Required Dysphagia Intervention to Nausea Prevent Permanent Pharyngitis Impairment/Damage Sepsis Staphylococcal Infection Vomiting Date:06/11/98ISR Number: 3092748-9Report Type:Expedited (15-DaCompany Report #LIT/98/00131/LEX Age:48 YR Gender:Male I/FU:I Outcome PT Hospitalization - Abdominal Pain Upper Initial or Prolonged Ammonia Increased Required Anorexia Intervention to Aspartate Prevent Permanent Aminotransferase Impairment/Damage Blood Alkaline Phosphatase Blood Bilirubin Increased 22-Feb-2006 08:30 AM Page: 122 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Chromaturia Cough Eosinophilia Report Source Product Role Manufacturer Route Dose Duration Gamma-Glutamyltransferase Literature Leponex PS ORAL 150 MG ORAL 2 WK Increased Health Risperidone SS Haematuria Professional Lithium C Headache Clonazepam C Hepatitis B Niacin-Hypercholeste Hyperglycaemia rolemia C Malaise Pantothenic Acid C Nausea Multivitamin C Pleural Effusion Chromium Picolonate C Pleuritic Pain Proteinuria White Blood Cell Count Increased Date:06/11/98ISR Number: 3093415-8Report Type:Expedited (15-DaCompany Report #GB/98/00725/LEX Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Health Clozaril PS ORAL 600 MG ORAL Initial or Prolonged Cardiomyopathy Professional Ferrous Sulphate C Required Ejection Fraction Intervention to Abnormal Prevent Permanent Impairment/Damage Date:06/12/98ISR Number: 3093849-1Report Type:Expedited (15-DaCompany Report #98-05-0120 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Health Clozapine PS ORAL 350-450 Initial or Prolonged Staphylococcal Infection Professional MG/DAY ORAL Lasix C Aldomet C Date:06/12/98ISR Number: 3093856-9Report Type:Expedited (15-DaCompany Report #98-05-0123 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Multi-Organ Failure Health Clozapine PS ORAL 150MG/DAY Professional ORAL Date:06/12/98ISR Number: 3093858-2Report Type:Expedited (15-DaCompany Report #98-05-0105 Age:87 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Clozapine PS ORAL 25MG PER DAY Professional ORAL Desyrel C Risperdal C Aricept C 22-Feb-2006 08:30 AM Page: 123 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/15/98ISR Number: 3093168-3Report Type:Direct Company Report # Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Pain Clozaril PS ORAL 400 MG PO QD; Life-Threatening Appendix Disorder DOSE VARIED Hospitalization - Confusional State FROM 400-600 Initial or Prolonged Diarrhoea MG QD Required Disorientation Intervention to Hyperpyrexia Prevent Permanent Nausea Impairment/Damage Neuroleptic Malignant Syndrome Date:06/15/98ISR Number: 3093484-5Report Type:Direct Company Report # Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required White Blood Cell Count Health Clozaril PS 175 MG TID Intervention to Decreased Professional Prevent Permanent Impairment/Damage Date:06/15/98ISR Number: 3094189-7Report Type:Expedited (15-DaCompany Report #CDN/97/00788/LEX Age:36 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Clozaril PS ORAL 125 MG ORAL Professional Date:06/15/98ISR Number: 3094190-3Report Type:Expedited (15-DaCompany Report #CDN/98/00446/LEX Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril PS ORAL 125 MG ORAL Professional Date:06/16/98ISR Number: 3094548-2Report Type:Expedited (15-DaCompany Report #GB/98/00754/LEX Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asthenia Health Clozaril PS ORAL 200 MG ORAL Required Clostridium Colitis Professional Intervention to Diarrhoea Prevent Permanent Impairment/Damage Date:06/16/98ISR Number: 3094712-2Report Type:Direct Company Report # Age:50 YR Gender:Female I/FU:I Outcome Life-Threatening Hospitalization - Initial or Prolonged Required Intervention to Prevent Permanent 22-Feb-2006 08:30 AM Page: 124 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Blood Creatine Clozaril PS ORAL 200MG PO BID Phosphokinase Increased ESCALATED UP Blood Urea Increased Dermatitis Hypochloraemia Hyponatraemia Neutropenia Pyrexia Date:06/16/98ISR Number: 3095036-XReport Type:Expedited (15-DaCompany Report #GB/98/00759/LEX Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Study Clozaril PS ORAL 75 MG ORAL Sedation Health Stelazine C Professional Thioridazine C Diazepam C Priadel Liquid C Date:06/16/98ISR Number: 3095041-3Report Type:Expedited (15-DaCompany Report #GB/98/00582/LEX Age:77 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Study Clozaril PS ORAL 38 MG ORAL Myocarditis Health Valproate Sodium C Tachycardia Professional Date:06/18/98ISR Number: 3095486-1Report Type:Expedited (15-DaCompany Report #USA/98/01492/LEX Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozaril PS ORAL 400 MG ORAL Professional Date:06/19/98ISR Number: 3096978-1Report Type:Expedited (15-DaCompany Report #F/98/00587/LEX Age:75 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatinine Health Leponex PS ORAL 300 MG ORAL Initial or Prolonged Increased Professional Lepticur SS 20 MG C-Reactive Protein Increased Nephritis Interstitial Renal Failure Acute Date:06/19/98ISR Number: 3096989-6Report Type:Expedited (15-DaCompany Report #F/98/01273/LEX Age: Gender:Female I/FU:I Outcome PT Hospitalization - Drug Withdrawal Syndrome Initial or Prolonged Dyskinesia Extrapyramidal Disorder Hyperhidrosis 22-Feb-2006 08:30 AM Page: 125 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pneumonia Productive Cough Report Source Product Role Manufacturer Route Dose Duration Health Leponex PS ORAL ORAL Professional Zyprexa SS Date:06/19/98ISR Number: 3096990-2Report Type:Expedited (15-DaCompany Report #F/98/01272/LEX Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Withdrawal Syndrome Health Leponex PS ORAL ORAL Initial or Prolonged Dyskinesia Professional Zyprexa C ORAL Required Extrapyramidal Disorder Intervention to Hyperhidrosis Prevent Permanent Productive Cough Impairment/Damage Date:06/19/98ISR Number: 3097008-8Report Type:Expedited (15-DaCompany Report #98-05-0128 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine PS Zenith Goldline Professional Pharm. ORAL 350MG/DAY ORAL Albuterol Inhaler C Date:06/19/98ISR Number: 3097009-XReport Type:Expedited (15-DaCompany Report #98-06-0138 Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Senile Dementia Health Clozapine PS Zenith Goldline Professional Pharm. ORAL 50MG/DAY ORAL Sinemet C Citracal C Vitamin C C Aspirin C Tylenol Prn C Calcium Supplement C Propranolol C Prozac C Unicap-M C Zinc C Date:06/22/98ISR Number: 3097032-5Report Type:Expedited (15-DaCompany Report #CDN/97/00788/LEX Age:36 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Clozaril PS ORAL 125 MG ORAL Professional Date:06/23/98ISR Number: 3097403-7Report Type:Expedited (15-DaCompany Report #GB/98/00775/LEX Age:48 YR Gender:Female I/FU:I Outcome PT Death Choking Dysphagia 22-Feb-2006 08:30 AM Page: 126 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Respiratory Arrest Report Source Product Role Manufacturer Route Dose Duration Study Clozaril PS ORAL 500 MG ORAL Health Olanzapine C Professional Co-Danthron (Coloxyl With Danthron) C Fybogel (Ispaghula) C Date:06/23/98ISR Number: 3097442-6Report Type:Expedited (15-DaCompany Report #USA/98/01516/LEX Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Infection Health Clozaril PS ORAL 600 MG ORAL Required Pyrexia Professional No Concomitant Intervention to Medication Prevent Permanent Information Was Impairment/Damage Provided C Date:06/23/98ISR Number: 3097675-9Report Type:Expedited (15-DaCompany Report #USA/98/01517/LEX Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hepatic Failure Health Clozaril PS ORAL 600 MG ORAL Lung Disorder Professional Pickwickian Syndrome Sleep Apnoea Syndrome Date:06/23/98ISR Number: 3098141-7Report Type:Expedited (15-DaCompany Report #1998AP46398 Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocarditis Foreign Clozapine PS 1 MON Life-Threatening Tachycardia Health Seroquel SS Professional Olanzapine SS Aspirin "Bayer" C Sodium Valproate C Digoxin C Fybogel C Date:06/24/98ISR Number: 3098684-6Report Type:Direct Company Report # Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Coordination Abnormal Clozapine PS ORAL 25MG BID PO Speech Disorder Date:06/25/98ISR Number: 3098729-3Report Type:Direct Company Report # Age:37 YR Gender:Female I/FU:I Outcome Hospitalization - Initial or Prolonged Disability Required Intervention to 22-Feb-2006 08:30 AM Page: 127 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Cardiomegaly Health Clozaril PS Sandoz UNKNOWN 350 MG QHS; Congestive Cardiomyopathy Professional 100 MG Q AM 2 YR Ejection Fraction Effexor C Abnormal Beconase C Oedema Peripheral Verapamel Sr C Vasodilatation Albuterol C Date:06/25/98ISR Number: 3098746-3Report Type:Expedited (15-DaCompany Report #S/98/00059/LEX Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alveolitis Allergic Leponex PS ORAL 150 MG ORAL Initial or Prolonged Atelectasis Stesolid SS ORAL 15 MG ORAL Required C-Reactive Protein Clomipramine SS ORAL 100 MG ORAL Intervention to Increased Zyprexa SS ORAL 15 MG ORAL Prevent Permanent Cold Sweat Diuretic C Impairment/Damage Condition Aggravated Dermatitis Ejection Fraction Abnormal Eosinophilia Eosinophilic Pneumonia Hyperhidrosis Hypertension Oedema Pleural Effusion Stress Date:06/25/98ISR Number: 3098748-7Report Type:Expedited (15-DaCompany Report #S/98/00061/LEX Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Leponex PS ORAL 200 MG ORAL Initial or Prolonged Cardiomyopathy Levaxin Dyspnoea (Levothyroxine Ejection Fraction Sodium) C Abnormal Tachycardia Date:06/25/98ISR Number: 3098750-5Report Type:Expedited (15-DaCompany Report #F/98/01363/LEX Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Health Leponex PS ORAL 500 MG ORAL Required Agitation Professional Intervention to Drug Ineffective Prevent Permanent Drug Withdrawal Syndrome Impairment/Damage Leukocytosis 22-Feb-2006 08:30 AM Page: 128 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/25/98ISR Number: 3098752-9Report Type:Expedited (15-DaCompany Report #NZ/98/00316/LEX Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiomyopathy Clozaril PS ORAL 600 MG ORAL Date:06/25/98ISR Number: 3098804-3Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dysarthria Clozaril PS 100 MG QHS Orthostatic Hypotension AND 5MG BID Sedation Gabapeutur C Tachycardia Clorazepam C Date:06/25/98ISR Number: 3098807-9Report Type:Direct Company Report # Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Flushing Clozaril PS ORAL X 1 PO QHS Initial or Prolonged Lethargy Klonopin C Medication Error Sulfadine C Salivary Hypersecretion Tachycardia Date:06/25/98ISR Number: 3098909-7Report Type:Expedited (15-DaCompany Report #USA/98/01523/LEX Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozaril PS ORAL Hospitalization - Professional Initial or Prolonged Date:07/02/98ISR Number: 3101662-1Report Type:Expedited (15-DaCompany Report #F/98/01385/LEX Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperglycaemia Leponex PS ORAL 175 MG ORAL Initial or Prolonged Hyperventilation Xanax (Alprazolam) C Required Increased Bronchial Artane Intervention to Secretion (Trihexyphenidyl Prevent Permanent Ketoacidosis Hydrochloride) C Impairment/Damage Productive Cough Respiratory Failure Tachypnoea Date:07/02/98ISR Number: 3101663-3Report Type:Expedited (15-DaCompany Report #AUS/98/00104/LEX Age:45 YR Gender:Male I/FU:I Outcome PT Hospitalization - Alveolitis Allergic Initial or Prolonged Cardiac Failure Required Cough Intervention to Dyspnoea Prevent Permanent Eosinophilia Impairment/Damage Gallop Rhythm Present Hypertension 22-Feb-2006 08:30 AM Page: 129 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lethargy Myocarditis Pleural Effusion Report Source Product Role Manufacturer Route Dose Duration Pyrexia Health Clozaril PS ORAL 400 MG ORAL Red Blood Cell Professional Sedimentation Rate Increased Sedation Tachycardia Urinary Incontinence Urinary Tract Infection Venous Pressure Increased Date:07/02/98ISR Number: 3102487-3Report Type:Expedited (15-DaCompany Report #D/98/02309/LEX Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agranulocytosis Health Leponex PS ORAL ORAL Life-Threatening Leukopenia Professional Hospitalization - Sepsis Initial or Prolonged Date:07/02/98ISR Number: 3102488-5Report Type:Expedited (15-DaCompany Report #USA/98/01314/LEX Age:86 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abnormal Behaviour Health Clozaril PS ORAL 12.5 MG Life-Threatening Asthenia Professional ORAL Cerebrovascular Accident Condition Aggravated Pneumonia Date:07/02/98ISR Number: 3102491-5Report Type:Expedited (15-DaCompany Report #USA/98/01375/LEX Age:44 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Health Clozaril PS ORAL 150MG ORAL Initial or Prolonged Dehydration Professional Depakote C Depressed Level Of Lithium C Consciousness Insulin C Diarrhoea Risperdal C Dizziness Infection Pneumonia Sepsis Date:07/06/98ISR Number: 3102431-9Report Type:Expedited (15-DaCompany Report #98-06-0139 Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Health Clozapine PS Zenith Goldline Hospitalization - Cerebrovascular Accident Professional Pharm. ORAL 50 MG/DAY Initial or Prolonged ORAL Vicodin C Tylenol W/Codeine No. 3 C Macrodantin C 22-Feb-2006 08:30 AM Page: 130 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prilosec C Date:07/07/98ISR Number: 3102591-XReport Type:Expedited (15-DaCompany Report #USA/98/01492/LEX Age:68 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozaril PS ORAL 400 MG ORAL Professional Date:07/07/98ISR Number: 3102807-XReport Type:Expedited (15-DaCompany Report #RA/98/01568/LEX Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agranulocytosis Health Lapenax (Clozapine) PS ORAL 50MG ORAL Hospitalization - Cardio-Respiratory Arrest Professional Clonazepam C Initial or Prolonged Pyrexia Tegretol C Required Ventricular Fibrillation Intervention to Prevent Permanent Impairment/Damage Date:07/07/98ISR Number: 3102811-1Report Type:Expedited (15-DaCompany Report #GB/98/00775/LEX Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Choking Study Clozaril Croup Infectious Health (Clozapine) PS ORAL 650 MG Dysphagia Professional ORAL Pneumonia Olanzapine C Purulent Discharge Co-Danthron C Respiratory Arrest Fybogel C Fluoxetine C Date:07/08/98ISR Number: 3103239-0Report Type:Expedited (15-DaCompany Report #98-06-0144 Age:87 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine PS ORAL 25MG, BID, Professional ORAL Demadex C Potassium Chloride C Aspirin C Date:07/08/98ISR Number: 3103240-7Report Type:Expedited (15-DaCompany Report #98-06-0143 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Haemorrhagic Stroke Health Clozapine PS ORAL ORAL Professional 22-Feb-2006 08:30 AM Page: 131 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/08/98ISR Number: 3103752-6Report Type:Expedited (15-DaCompany Report #LIT/97/00198/LEX Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dehydration Literature Leponex / Clozaril PS ORAL 425 MG ORAL Initial or Prolonged Diabetic Ketoacidosis Health Required Hyperglycaemia Professional Intervention to Hypotension Prevent Permanent Palpitations Impairment/Damage Salivary Hypersecretion Sedation Urinary Incontinence Date:07/08/98ISR Number: 3103919-7Report Type:Direct Company Report # Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Clozaril PS ORAL 500 MG PO Speech Disorder Date:07/09/98ISR Number: 3185313-6Report Type:Periodic Company Report #98-03-0063 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Health Clozapine - Zenith Hallucination Professional Goldline Pharm. Irritability Tablets PS Zenith Goldline Pharm. ORAL 400MG/DAY ORAL Date:07/09/98ISR Number: 3185314-8Report Type:Periodic Company Report #98-03-0064 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Psychotic Disorder Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 500 MG/DAY ORAL Atenolol C Hydrochlorothiazide C Date:07/09/98ISR Number: 3185315-XReport Type:Periodic Company Report #98-03-0065 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Health Clozapine - Zenith Delusion Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 300MG/DAY ORAL Glucophage C Prinivil C 22-Feb-2006 08:30 AM Page: 132 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/09/98ISR Number: 3185316-1Report Type:Periodic Company Report #98-03-0066 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hallucination Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 525MG/DAY ORAL Date:07/09/98ISR Number: 3185317-3Report Type:Periodic Company Report #98-03-0145 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozapine - Zenith Professional Goldline Pharm. Talbets PS Zenith Goldline Pharm. ORAL 550 MG/DAY ORAL Date:07/09/98ISR Number: 3185318-5Report Type:Periodic Company Report #98-04-0073 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Delusion Health Clozapine - Zenith Restlessness Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm ORAL 500MG/DAY ORAL Date:07/09/98ISR Number: 3185319-7Report Type:Periodic Company Report #98-04-0077 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Delusion Health Clozapine - Zenith Restlessness Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 175 MG/DAY ORAL Date:07/09/98ISR Number: 3185320-3Report Type:Periodic Company Report #98-04-0078 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Ineffective Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 400MG/DAY ORAL Date:07/09/98ISR Number: 3185321-5Report Type:Periodic Company Report #98-04-0079 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Ineffective Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline 22-Feb-2006 08:30 AM Page: 133 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pharm. ORAL 500-600MG/DAY ORAL Date:07/09/98ISR Number: 3185322-7Report Type:Periodic Company Report #98-04-0080 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Ineffective Health Clozapine -Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 675 MG/DAY ORAL Date:07/09/98ISR Number: 3185323-9Report Type:Periodic Company Report #98-04-0082 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 312.5MG/DAY ORAL Date:07/09/98ISR Number: 3185324-0Report Type:Periodic Company Report #98-04-0083 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 75 MG/DAY ORAL Date:07/09/98ISR Number: 3185325-2Report Type:Periodic Company Report #98-04-0084 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 900MG/DAY ORAL Date:07/09/98ISR Number: 3185326-4Report Type:Periodic Company Report #98-04-0085 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 275MG/DAY ORAL 22-Feb-2006 08:30 AM Page: 134 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/09/98ISR Number: 3185327-6Report Type:Periodic Company Report #98-04-0095 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Confusional State Clozapine - Zenith Delusion Goldline Pharm. Hallucination, Auditory Tablets PS Zenith Goldline Insomnia Pharm. ORAL 350-400MG/DAY Thinking Abnormal ORAL Zoloft C Klonopin C Date:07/09/98ISR Number: 3185328-8Report Type:Periodic Company Report #98-04-0097 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Platelet Count Decreased Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 200MG/DAY ORAL Date:07/09/98ISR Number: 3185329-XReport Type:Periodic Company Report #98-04-0100 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eosinophilia Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 75MG BID ORAL 6 WK Risperdal C Date:07/09/98ISR Number: 3185330-6Report Type:Periodic Company Report #98-05-0113 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Health Clozapine - Zenith Decreased Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL ORAL Date:07/09/98ISR Number: 3185331-8Report Type:Periodic Company Report #98-05-0114 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Health Clozapine - Zenith Decreased Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm ORAL ORAL Date:07/09/98ISR Number: 3185332-XReport Type:Periodic Company Report #98-05-0124 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Ineffective Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline 22-Feb-2006 08:30 AM Page: 135 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pharm. ORAL 400MG PER DAY ORAL Paxil C Insulin C Claritin-D C Date:07/09/98ISR Number: 3185333-1Report Type:Periodic Company Report #98-05-0125 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Ineffective Health Clozapine -Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL ORAL Date:07/09/98ISR Number: 3185334-3Report Type:Periodic Company Report #98-05-0146 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Clozapine -Zenith Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 400MG/DAY ORAL Date:07/09/98ISR Number: 3185335-5Report Type:Periodic Company Report #98-02-0022 Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Health Clozapine - Zenith Delusion Professional Goldline Pharm. Hallucination, Auditory User Facility Capsules PS Zenith Goldline Loose Associations Pharm ORAL 400-700MG/DAY Psychotic Disorder ORAL Potassium C Baclofen C Benadryl C Chlorpromazine C Adalat C Lasix C Metamucil Bid C Docuste C Cipro C Date:07/09/98ISR Number: 3185337-9Report Type:Periodic Company Report #98-02-0033 Age:46 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Emotional Disorder Health Clozapine PS Zenith Goldline Initial or Prolonged White Blood Cell Count Professional Pharm. ORAL 650 Decreased MG/DAY/ORAL 22-Feb-2006 08:30 AM Page: 136 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/09/98ISR Number: 3185338-0Report Type:Periodic Company Report #98-03-0099 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Health Clozapine PS Zenith Goldmine Initial or Prolonged Professional Pharm. ORAL 1000MG/DAY/OR AL Adriamycin Injecatable SS INTRAVENOUS 80MG INTRAVENOUS Date:07/09/98ISR Number: 3185339-2Report Type:Periodic Company Report #98-04-0070 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Clozapine PS Zenith Goldline Initial or Prolonged Professional Pharm. ORAL 400MG/DAY ORAL Date:07/09/98ISR Number: 3185340-9Report Type:Periodic Company Report #98-04-0081 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - White Blood Cell Count Health Clozapine PS Zenith Goldline Initial or Prolonged Decreased Professional Pharm. ORAL 700MG QD ORAL Date:07/09/98ISR Number: 3185341-0Report Type:Periodic Company Report #98-04-0102 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozapine PS Goldline Pharm. ORAL 150MG BID Hospitalization - Streptococcal Infection Professional ORAL Initial or Prolonged Premarin C Lithium C Provera C Date:07/09/98ISR Number: 3185343-4Report Type:Periodic Company Report #98-05-0116 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delusion Health Clozapine PS Zenith Goldline Initial or Prolonged Hallucination Professional Pharm. ORAL ORAL Paranoia Date:07/09/98ISR Number: 3185344-6Report Type:Periodic Company Report #98-03-0053 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abnormal Behaviour Health Clozapine PS Zenith Goldline Professional Pharm. ORAL 500MG/DAY ORAL 22-Feb-2006 08:30 AM Page: 137 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/09/98ISR Number: 3185345-8Report Type:Periodic Company Report #98-03-0054 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abnormal Behaviour Health Clozapine PS Zenith Goldline Professional Pharm. ORAL 800MG/DAY ORAL Date:07/09/98ISR Number: 3185346-XReport Type:Periodic Company Report #98-03-0055 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abnormal Behaviour Health Clozapine PS Zenith Goldline Professional Pharm. ORAL 400MG PER DAY ORAL Date:07/09/98ISR Number: 3185347-1Report Type:Periodic Company Report #98-03-0058 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dysstasia Health Clozapine PS Goldline Pharm. ORAL 25MG X 1 ORAL Movement Disorder Professional Alprazolam C Speech Disorder Sinemet C Syncope Aricept C Tongue Oedema Date:07/09/98ISR Number: 3185348-3Report Type:Periodic Company Report #98-04-0091 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Platelet Count Decreased Health Clozapine PS Zenith Goldline Platelet Morphology Professional Pharm. ORAL 600MG/DAY Abnormal ORAL Date:07/09/98ISR Number: 3185349-5Report Type:Periodic Company Report #98-04-0093 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Platelet Count Decreased Health Clozapine PS Zenith Goldline Platelet Morphology Professional Pharm. ORAL 200MG PER DAY Abnormal ORAL Date:07/09/98ISR Number: 3185350-1Report Type:Periodic Company Report #98-04-0094 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Influenza Like Illness Health Clozapine PS Zenith Goldline Professional Pharm. ORAL 375MG/DAY ORAL Date:07/09/98ISR Number: 3185351-3Report Type:Periodic Company Report #98-05-0109 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Platelet Morphology Health Clozapine PS Zenith Goldline Abnormal Professional Pharm. ORAL 700MG/DAY 22-Feb-2006 08:30 AM Page: 138 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL Date:07/09/98ISR Number: 3185352-5Report Type:Periodic Company Report #98-03-0049 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Level Above Health Clozapine PS Zenith Goldline Therapeutic Professional Pharm. ORAL 700MG/DAY ORAL Luvox Capsules SS ORAL 200MG ORAL Date:07/09/98ISR Number: 3185353-7Report Type:Periodic Company Report #98-03-0056 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Health Clozapine PS Zenith Goldline Decreased Professional Pharm. ORAL 500MG PER DAY ORAL Neupogen C Date:07/09/98ISR Number: 3185354-9Report Type:Periodic Company Report #98-03-0059 Age: Gender:Not SpecifiI/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Health Clozapine PS Zenith Goldline Irritability Professional Pharm. ORAL ORAL Paranoia Date:07/09/98ISR Number: 3185355-0Report Type:Periodic Company Report #98-03-0060 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hallucination Health Clozapine PS Goldline Pharm. ORAL 700MG/DAY Malaise Professional ORAL Sleep Phase Rhythm Disturbance Date:07/09/98ISR Number: 3185356-2Report Type:Periodic Company Report #98-03-0061 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Oedema Peripheral Health Clozapine PS Zenith Goldline Professional Pharm. ORAL 125MG/DAY ORAL Zyprexa C Lithium C Depakote C Coumadin C Lasix C Date:07/09/98ISR Number: 3185357-4Report Type:Periodic Company Report #98-03-0062 Age:62 YR Gender:Female I/FU:I Outcome PT Other Palpitations Psychotic Disorder 22-Feb-2006 08:30 AM Page: 139 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tachycardia Report Source Product Role Manufacturer Route Dose Duration Health Clozapine PS Zenith Goldline Professional Pharm. ORAL 250MG/DAY ORAL Date:07/10/98ISR Number: 3103782-4Report Type:Expedited (15-DaCompany Report #98-06-0149 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine PS ORAL 700MG/DAY Professional ORAL Olanzapine C Date:07/10/98ISR Number: 3104011-8Report Type:Expedited (15-DaCompany Report #USA/98/01687/LEX Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Health Clozaril PS ORAL 575 MG ORAL Insulin-Dependent Professional Insulin C Date:07/10/98ISR Number: 3104016-7Report Type:Expedited (15-DaCompany Report #USA/98/01677/LEX Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetic Hyperosmolar Health Clozaril PS ORAL 500 MG ORAL Coma Professional Micronase C Ketoacidosis Lasix C Respiratory Failure Tenormin C Date:07/10/98ISR Number: 3104023-4Report Type:Expedited (15-DaCompany Report #LEX/F-02/0/2/5/1/F Age:66 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Brain Oedema Study Leponex PS ORAL 37.5 MG ORAL Coma Health Mixtard C Computerised Tomogram Professional Rivotril C Abnormal Sinemet C Malaise Valium C Date:07/10/98ISR Number: 3104142-2Report Type:Expedited (15-DaCompany Report #USA/98/01431/LEX Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fatigue Health Clozaril PS ORAL 550 MG ORAL Initial or Prolonged Hyperglycaemia Professional Depakote C Required Lethargy Lasix C Intervention to Lung Infiltration Asa C Prevent Permanent Pneumonitis Centrum C Impairment/Damage Sedation Zantac C K-Dur C Tylenol C Vancomycin C Hydralazine C Humulin N C 22-Feb-2006 08:30 AM Page: 140 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Humulin R C Uniphyl C Nicoderm Patch C Atrovent C Prednisone C Dulcolax Suppositories C Serevent C Flagyl C Azmacort C Peri-Colace C Vitamin B-12 C Fleets Enema C Ceftin C Citracal C Albuterol C Mylanta C Date:07/10/98ISR Number: 3104144-6Report Type:Expedited (15-DaCompany Report #USA/98/00657/LEX Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Muscle Rigidity Health Clozaril PS ORAL 400 MG ORAL Initial or Prolonged Myopathy Professional Diazepam C Nervousness Depakote C Salivary Hypersecretion Sedation Date:07/10/98ISR Number: 3104311-1Report Type:Expedited (15-DaCompany Report #CDN/98/00338/LEX Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiac Failure Health Clozaril PS ORAL 250 MG ORAL Hospitalization - Cardiac Failure Professional Chlorpromazine C Initial or Prolonged Congestive Cogentin Other Influenza Like Illness (Benzatropine) C Required Malaise Nozinan Intervention to Pulmonary Oedema (Levomepromazine) C Prevent Permanent Viral Myocarditis Clonazepam C Impairment/Damage Folic Acid C Lorazepam C Restoril (Temazepam) C Date:07/10/98ISR Number: 3104457-8Report Type:Expedited (15-DaCompany Report #LIT/97/00198/LEX Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dehydration Literature Leponex PS ORAL 425 MG ORAL Initial or Prolonged Diabetic Ketoacidosis Health Required Hyperglycaemia Professional Intervention to Hyperkalaemia Prevent Permanent Hypotension Impairment/Damage Palpitations Salivary Hypersecretion Sedation Urinary Incontinence 22-Feb-2006 08:30 AM Page: 141 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/14/98ISR Number: 3104787-XReport Type:Expedited (15-DaCompany Report #USA/98/01492/LEX Age:68 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozaril PS ORAL 400 MG ORAL Professional Date:07/14/98ISR Number: 3105007-2Report Type:Expedited (15-DaCompany Report #LIT/98/00171/LEX Age:69 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Anxiety Literature Leponex/Clozaril PS ORAL 6.25 MG ORAL 1 DAY Condition Aggravated Health Carbidopa-Levodopa Confusional State Professional (Sinemet) C Hallucination Pergolide Paranoia (Pergolide) C Psychotic Disorder Date:07/14/98ISR Number: 3105008-4Report Type:Expedited (15-DaCompany Report #LIT/98/00170/LEX Age:71 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aggression Literature Leponex / Clozaril PS ORAL 12.5 MG ORAL 2 DAY Required Agitation Carbidopa-Levodopa Intervention to Anger (Sinemet) C Prevent Permanent Confusional State Impairment/Damage Delusion Dementia Drug Ineffective Hallucination Paranoia Date:07/14/98ISR Number: 3108192-1Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Movement Disorder Clozapine PS Novartis ORAL 300 MG BID PO Resperidone SS Janssen ORAL 1 MG BID PO Date:07/14/98ISR Number: 3108195-7Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypotonia Clozapine PS Novartis ORAL 300 MG OD AM PO; 325 MG PM PO Date:07/14/98ISR Number: 3184100-2Report Type:Periodic Company Report #98-02-0033 Age:46 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Emotional Disorder Health Clozapine PS Zenith Goldline Initial or Prolonged White Blood Cell Count Professional Pharm ORAL 650MG/DAY ORAL 22-Feb-2006 08:30 AM Page: 142 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/14/98ISR Number: 3184102-6Report Type:Periodic Company Report #98-03-0099 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Health Clozapine PS ORAL 100MG/DAY Initial or Prolonged Professional ORAL Adriamycin SS INTRAVENOUS 80MG INTRAVENOUS Date:07/14/98ISR Number: 3184104-XReport Type:Periodic Company Report #98-04-0070 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Clozapine PS ORAL 400 MG DAY Initial or Prolonged Professional ORAL Date:07/14/98ISR Number: 3184107-5Report Type:Periodic Company Report #98-04-0081 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - White Blood Cell Count Health Clozapine PS ORAL 700MG QD ORAL Initial or Prolonged Decreased Professional Date:07/14/98ISR Number: 3184111-7Report Type:Periodic Company Report #98-04-0102 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozapine PS ORAL 150MG BID Hospitalization - Streptococcal Infection Professional ORAL Initial or Prolonged Premarin C Lithium C Provera C Date:07/14/98ISR Number: 3184116-6Report Type:Periodic Company Report #98-05-0116 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delusion Health Clozapine PS Zenith Goldline Initial or Prolonged Hallucination Professional Pharm ORAL ORAL Paranoia Date:07/14/98ISR Number: 3184120-8Report Type:Periodic Company Report #98-03-0053 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abnormal Behaviour Health Clozapine PS Zenith Goldline Professional Pharm ORAL 500MG/DAY ORAL Date:07/14/98ISR Number: 3184125-7Report Type:Periodic Company Report #98-03-0054 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abnormal Behaviour Health Clozapine PS Zenith Goldline Professional Pharm ORAL 800MG/DAY ORAL 22-Feb-2006 08:30 AM Page: 143 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/14/98ISR Number: 3184128-2Report Type:Periodic Company Report #98-03-0055 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abnormal Behaviour Health Clozapine PS Zenith Goldline ORAL 400MG PER DAY Professional ORAL Date:07/14/98ISR Number: 3184129-4Report Type:Periodic Company Report #98-03-0058 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Movement Disorder Health Clozapine PS Zenith Goldline ORAL 25MG X 1 ORAL Speech Disorder Professional Alprazolam C Tongue Oedema Sinemet C Aricept C Date:07/14/98ISR Number: 3184133-6Report Type:Periodic Company Report #98-04-0091 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Platelet Count Decreased Health Clozapine PS ORAL 600MG/DAY Platelet Morphology Professional ORAL Abnormal Date:07/14/98ISR Number: 3184136-1Report Type:Periodic Company Report #98-04-0093 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Platelet Count Decreased Health Clozapine PS Zenith Goldline ORAL 200MG PER DAY Platelet Morphology Professional ORAL Abnormal Date:07/14/98ISR Number: 3184140-3Report Type:Periodic Company Report #98-04-0094 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Influenza Like Illness Health Clozapine PS Znith Goldline ORAL 375MG/DAY Professional ORAL Date:07/14/98ISR Number: 3184143-9Report Type:Periodic Company Report #98-05-0109 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Platelet Morphology Health Clozapine PS Zenith Goldline ORAL 700MG/DAY Abnormal Professional ORAL Date:07/14/98ISR Number: 3184147-6Report Type:Periodic Company Report #98-03-0049 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Level Above Health Clozapine PS Zenith Goldline ORAL 700MG/DAY Therapeutic Professional ORAL Luvox Capsules SS ORAL 200MG ORAL 22-Feb-2006 08:30 AM Page: 144 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/14/98ISR Number: 3184150-6Report Type:Periodic Company Report #98-03-0056 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Health Clozapine PS Zenith Goldline ORAL 500MG PER DAY Decreased Professional ORAL Neupogen C Date:07/14/98ISR Number: 3184155-5Report Type:Periodic Company Report #98-03-0059 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Health Clozapine PS Zenith Goldline0 ORAL ORAL Irritability Professional Paranoia Date:07/14/98ISR Number: 3184160-9Report Type:Periodic Company Report #98-03-0060 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hallucination Health Clozapine PS ORAL 700MG/DAY Malaise Professional ORAL Sleep Disorder Date:07/14/98ISR Number: 3184163-4Report Type:Periodic Company Report #98-03-0061 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Oedema Peripheral Health Clozapine PS Zenith Goldline ORAL 125MG/DAY Professional ORAL Zyprexa C Lithium C Depakote C Coumadin C Lasix C Date:07/14/98ISR Number: 3184166-XReport Type:Periodic Company Report #98-03-0062 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Palpitations Health Clozapine PS Zenith Goldline ORAL 250MG/DAY Psychotic Disorder Professional ORAL Tachycardia Date:07/14/98ISR Number: 3184172-5Report Type:Periodic Company Report #98-03-0063 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Health Clozapine-Zenith Hallucination Professional Goldline Pharm. Irritability Tablets PS Zenith Goldline Pharm. ORAL 400 MG/DAY ORAL 22-Feb-2006 08:30 AM Page: 145 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/14/98ISR Number: 3184176-2Report Type:Periodic Company Report #98-03-0064 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abnormal Behaviour Health Clozapine-Zenith Psychotic Disorder Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 500 MG/DAY ORAL Atenolol C Hydrochlorothiazide C Date:07/14/98ISR Number: 3184179-8Report Type:Periodic Company Report #98-03-0065 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Health Clozapine-Zenith Delusion Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 300 MG/DAY ORAL Glucophage C Prinivil C Date:07/14/98ISR Number: 3184187-7Report Type:Periodic Company Report #98-03-0145 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozapine-Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 550 MG/DAY ORAL Date:07/14/98ISR Number: 3184196-8Report Type:Periodic Company Report #98-04-0078 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Ineffective Health Clozapine-Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 400 MG/DAY ORAL Date:07/14/98ISR Number: 3184199-3Report Type:Periodic Company Report #98-04-0079 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Ineffective Health Clozapine-Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 500-600 MG/DAY ORAL 22-Feb-2006 08:30 AM Page: 146 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/14/98ISR Number: 3184201-9Report Type:Periodic Company Report #98-04-0080 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Ineffective Health Clozapine-Zenith Professional Goldine Pharm. Tablets PS Zenith Goldline Pharm. ORAL 675 MG/DAY ORAL Date:07/14/98ISR Number: 3184204-4Report Type:Periodic Company Report #98-04-0082 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Unevaluable Event Health Clozapine-Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 312.5 MG/DAY ORAL Date:07/14/98ISR Number: 3184210-XReport Type:Periodic Company Report #98-04-0084 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Unevaluable Event Health Clozapine-Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 900 MG/DAY ORAL Date:07/14/98ISR Number: 3184221-4Report Type:Periodic Company Report #98-04-0100 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eosinophilia Health Clozapine-Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 75 MG BID ORAL 6 WK Risperdal C Date:07/14/98ISR Number: 3184224-XReport Type:Periodic Company Report #98-05-0113 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Health Clozapine-Zenith Decreased Professional Goldline Pharm PS Zenith Goldline Pharm. ORAL ORAL Date:07/14/98ISR Number: 3184227-5Report Type:Periodic Company Report #98-05-0114 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Health Clozapine-Zenith Decreased Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL ORAL 22-Feb-2006 08:30 AM Page: 147 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/14/98ISR Number: 3184230-5Report Type:Periodic Company Report #98-05-0124 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Health Clozapine-Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 400 MG PER DAY ORAL Paxil C Insulin C Claritin-D C Date:07/14/98ISR Number: 3184234-2Report Type:Periodic Company Report #98-05-0146 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Clozapine-Zenith Goldline Pharm. PS Zenith Goldline Pharm. ORAL 400 MG/DAY ORAL Date:07/14/98ISR Number: 3184236-6Report Type:Periodic Company Report #98-02-0022 Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Health Clozapine-Zenith Delusion Professional Goldline Pharm. Hallucination, Auditory User Facility Capsules PS Zenith Goldline Loose Associations Pharm. ORAL 400-700 Psychotic Disorder MG/DAY ORAL Potassium Chloride C Baclofen C Benadryl C Chlorpromazine C Adalat C Lasix C Metamucil C Docusate C Cipro C Date:07/15/98ISR Number: 3105477-XReport Type:Expedited (15-DaCompany Report #D/98/02584/LEX Age:29 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Leponex PS ORAL Initial or Prolonged Cardiomyopathy Left Ventricular Failure Date:07/15/98ISR Number: 3105478-1Report Type:Expedited (15-DaCompany Report #D/98/02489/LEX Age:45 YR Gender:Male I/FU:I Outcome Life-Threatening Hospitalization - Initial or Prolonged Required Intervention to 22-Feb-2006 08:30 AM Page: 148 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Cardiac Arrest Health Leponex PS ORAL 600 MG Grand Mal Convulsion Professional Tavor SS ORAL 3 MG Respiratory Arrest Respiratory Depression Schizophrenia Shock Date:07/15/98ISR Number: 3105479-3Report Type:Expedited (15-DaCompany Report #USA/98/00223/LEX Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Health Clozaril PS ORAL 400 MG Professional Depakote (Valproate Semisodium) C Date:07/17/98ISR Number: 3108382-8Report Type:Direct Company Report # Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drooling Clozaril PS ORAL 250 MG PO Initial or Prolonged Fatigue DAILY Pain Urinary Incontinence White Blood Cell Count Decreased Date:07/21/98ISR Number: 3107270-0Report Type:Expedited (15-DaCompany Report #USA/98/01527/LEX Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Health Clozaril PS ORAL 500 MG ORAL Initial or Prolonged Dermatitis Professional Klonopin C Diarrhoea Depakote C Graft Versus Host Disease Luvox C Haemoglobin Abnormal Dilantin C Hepatic Function Abnormal Lasix C Platelet Count Abnormal Vitamin K C Prothrombin Time Abnormal Respiratory Failure Sepsis Thrombocytopenia White Blood Cell Count Abnormal Date:07/21/98ISR Number: 3107279-7Report Type:Expedited (15-DaCompany Report #USA / 98 / 01246/ LEX Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Health Clozaril PS ORAL 300 MG ORAL Required Professional Intervention to Prevent Permanent Impairment/Damage 22-Feb-2006 08:30 AM Page: 149 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/21/98ISR Number: 3107281-5Report Type:Expedited (15-DaCompany Report #USA / 98/ 00257 /LEX Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Apnoea Health Clozaril PS ORAL 600 MG ORAL Cardiac Disorder Professional Lithobid C Lung Disorder Colace C Pneumonia Trinalin C Date:07/21/98ISR Number: 3107296-7Report Type:Expedited (15-DaCompany Report #GB/98/00834/LEX Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocarditis Clozaril PS 1 MON Seroquel SS 25 MG Date:07/21/98ISR Number: 3107322-5Report Type:Expedited (15-DaCompany Report #USA/98/01742 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozaril PS ORAL 275 MG ORAL Required Osteomyelitis Professional Vancomycin SS INTRAVENOUS 1 G Intervention to INTRAVENOUS Prevent Permanent Lithium C Impairment/Damage Vicodin C Date:07/23/98ISR Number: 3107995-7Report Type:Expedited (15-DaCompany Report #GB/98/00839/LEX Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Study Clozaril PS ORAL 450 MG ORAL Overdose Health Seroquel SS Professional Fluoxetine C Diazepam C Loratadine C Fybogel C Kwells C Date:07/23/98ISR Number: 3108126-XReport Type:Expedited (15-DaCompany Report #USA/98/01777/LEX Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Clozaril PS ORAL 700 MG ORAL 2 YR Initial or Prolonged Diabetes Mellitus Professional Theo-Dur C Potassium C Nicotine C Depakote C Vasotec C Lasix C Plavix C Date:07/23/98ISR Number: 3108164-7Report Type:Expedited (15-DaCompany Report #USA/98/01753/LEX Age:39 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aneurysm Health Clozaril PS ORAL 400 MG ORAL Leukopenia Professional 22-Feb-2006 08:30 AM Page: 150 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/23/98ISR Number: 3108167-2Report Type:Expedited (15-DaCompany Report #USA/98/01259/LEX Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dyspnoea Study Clozaril PS ORAL 400 MG ORAL Pericardial Effusion Health Ativan C Professional Prozac C Antihypertensive C Date:07/27/98ISR Number: 3109229-6Report Type:Expedited (15-DaCompany Report #98-07-0160 Age:80 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine PS Zenith Goldine Professional Pharm. ORAL 125 MG/DAY ORAL Prevacid C Potassium Chloride C Trental C Glucotrol Xl C Albuterol C Azmacort C Tylenol C Hydroxyzine C Docusate C Lasix C Aspirin (E.C.) C Date:07/27/98ISR Number: 3109231-4Report Type:Expedited (15-DaCompany Report #98-07-0159 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Health Clozapine PS Zenith Goldline Initial or Prolonged Congestive Professional Pharm. ORAL 125 MG/DAY Condition Aggravated ORAL; 250 MG/DAY ORAL Lasix C K-Dur C Brethine C Date:07/27/98ISR Number: 3109233-8Report Type:Expedited (15-DaCompany Report #98-05-0119 Age:50 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Injury Health Clozapine PS Zenith Goldline Road Traffic Accident Professional Pharm. ORAL 650 MG/DAY ORAL Date:07/28/98ISR Number: 3109768-8Report Type:Expedited (15-DaCompany Report #USA/98/01790/LEX Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Health Clozaril PS ORAL 325 MG ORAL 4 YR Hepatic Neoplasm Professional Chemotherapy White Blood Cell Count (Chemotherapeutics) C Decreased Cytoxan (Cyclophosphamide) C Adriamycin 22-Feb-2006 08:30 AM Page: 151 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Doxorubicin) C Date:07/28/98ISR Number: 3110655-XReport Type:Expedited (15-DaCompany Report #98-05-0105 Age:87 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Clozapine PS Zentih Goldline Professional Pharmacy ORAL 25MG PER DAY ORAL Desyrel C Risperdal C Aricept C Date:07/28/98ISR Number: 3110662-7Report Type:Expedited (15-DaCompany Report #98-07-0171 Age:86 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline Professional Pharm. ORAL 12.5MG/DAY ORAL Permax C Date:07/28/98ISR Number: 3110665-2Report Type:Expedited (15-DaCompany Report #98-07-0178 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Clozapine PS Zentih Goldline Hospitalization - Chest Pain Professional Pharm. ORAL 400MG/DAY Initial or Prolonged ORAL Date:07/28/98ISR Number: 3110688-3Report Type:Expedited (15-DaCompany Report #98-06-0138 Age:77 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Condition Aggravated Health Clozapine PS Zentih Goldline Senile Dementia Professional Pharmacy ORAL 50MG/DAY ORAL Sinemet C Citracal C Vitamin C C Aspirin C Tylenol Prn C Calcium Supplement C Propranolol C Prozac C Unicap-M C Zinc C Date:07/28/98ISR Number: 3110748-7Report Type:Expedited (15-DaCompany Report #USA/98/01782/LEX Age:38 YR Gender:Female I/FU:I Outcome PT Death Accident Cardiac Arrest Cardiomyopathy Coma Drug Level Above Therapeutic 22-Feb-2006 08:30 AM Page: 152 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Fall Loss Of Consciousness Report Source Product Role Manufacturer Route Dose Duration Health Clozaril PS ORAL 325 MG ORAL Professional Dilantin C Lithium C Klonopin C Date:07/28/98ISR Number: 3110751-7Report Type:Expedited (15-DaCompany Report #USA/98/01798/LEX Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozaril PS ORAL ORAL Professional Date:07/28/98ISR Number: 3113136-2Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Clozaril PS ORAL 250MG PO BID Decreased Date:08/03/98ISR Number: 3112351-1Report Type:Expedited (15-DaCompany Report #USA/98/01129/LEX Age:85 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Health Clozaril PS ORAL UNSPECIFIED Colon Cancer Professional ORAL Metastasis Date:08/03/98ISR Number: 3112353-5Report Type:Expedited (15-DaCompany Report #USA/98/01316/LEX Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Level Below Health Clozaril PS ORAL 700 MG ORAL Other Therapeutic Professional Depakote C Required Grand Mal Convulsion Thorazine C Intervention to Prevent Permanent Impairment/Damage Date:08/04/98ISR Number: 3112691-6Report Type:Direct Company Report # Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Clozaril PS ORAL 100MG BID PO Initial or Prolonged Chest X-Ray Abnormal Synthroid C Dyspnoea Vitamin B12 C Hypotension Depakote C Tachycardia Prinivil C Prevacid C 22-Feb-2006 08:30 AM Page: 153 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/04/98ISR Number: 3112904-0Report Type:Expedited (15-DaCompany Report #D/98/02489/LEX Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiac Arrest Health Leponex PS ORAL 600 MG ORAL Hospitalization - Condition Aggravated Professional Tavor SS ORAL 3 MG ORAL Initial or Prolonged Grand Mal Convulsion Required Respiratory Depression Intervention to Shock Prevent Permanent Impairment/Damage Date:08/04/98ISR Number: 3112989-1Report Type:Expedited (15-DaCompany Report #USA/98/00503/LEX Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Lung Consolidation Health Clozaril PS ORAL 400 MG ORAL Tuberculosis Professional Albuterol C Atrovent C Thiamine C Folic Acid C Depakote C Verapamil C Diazepam C Vitamins C Ambien C Nifedipine C Colace C Vitamin B6 C Isoniazid C Rifampin C Date:08/04/98ISR Number: 3112993-3Report Type:Expedited (15-DaCompany Report #GB/98/00626/LEX Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Health Clozaril PS ORAL 450 MG ORAL Circulatory Collapse Professional Chlorpromazine C Coma Cimetidine C Loss Of Consciousness Cisapride C Muogel C Lactulose C Date:08/06/98ISR Number: 3115304-2Report Type:Expedited (15-DaCompany Report #USA/98/01742/LEX Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozaril PS ORAL 275 MG ORAL Required Osteomyelitis Professional Vancomycin SS INTRAVENOUS 1 G Intervention to INTRAVENOUS Prevent Permanent Lithium C Impairment/Damage Vicodin C 22-Feb-2006 08:30 AM Page: 154 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/07/98ISR Number: 3114241-7Report Type:Expedited (15-DaCompany Report #98-017 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Akinesia Foreign Selegiline PS 10MG/DAY 34 DAY Nocturia Health Midodrine SS Professional Clozapine SS Distributor Bromocriptine SS Levodopa W/ Benserazide SS Entacapone SS Date:08/11/98ISR Number: 3115205-XReport Type:Expedited (15-DaCompany Report #98-07-0183 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Faecaloma Health Clozapine PS ORAL 600MG PER DAY Hospitalization - Scrotal Infection Professional ORAL Initial or Prolonged White Blood Cell Count Lithium C Increased Levothyroxine C Docusate C Date:08/11/98ISR Number: 3115207-3Report Type:Expedited (15-DaCompany Report #98-07-0185 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Appendicitis Perforated Health Clozapine PS ORAL 600MG PER DAY Initial or Prolonged Professional ORAL Required Depakote C Intervention to Lorazepam C Prevent Permanent Impairment/Damage Date:08/11/98ISR Number: 3115368-6Report Type:Expedited (15-DaCompany Report #D/98/02728/LEX Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatomegaly Health Leponex PS ORAL 400 MG ORAL Initial or Prolonged Influenza Like Illness Professional Lithium SS 1 G Required Pericardial Effusion Recephin C Intervention to Pleural Effusion Prevent Permanent Pyrexia Impairment/Damage Rash Erythematous Date:08/11/98ISR Number: 3115373-XReport Type:Expedited (15-DaCompany Report #USA/98/01873/LEX Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatitis C Health Clozaril PS ORAL 600 MG ORAL 2 YR Required Professional Intervention to Prevent Permanent Impairment/Damage 22-Feb-2006 08:30 AM Page: 155 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/11/98ISR Number: 3115376-5Report Type:Expedited (15-DaCompany Report #D/98/02834/LEX Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Sedation Health Leponex PS ORAL ORAL Initial or Prolonged Suicide Attempt Professional Date:08/12/98ISR Number: 3116273-1Report Type:Expedited (15-DaCompany Report #F/98/01614/LEX Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatinine Health Leponex PS ORAL 250 MG ORAL Initial or Prolonged Increased Professional Tranxene Required Ileus Paralytic (Clorazepate Intervention to Intestinal Obstruction Dipotassium) C Prevent Permanent Oliguria Zyloric Impairment/Damage Renal Failure (Allopurinol) C Volvulus Of Bowel Adalate (Nifedipine) C Ercefuryl (Nifuroxazide) C Hept-A-Myl (Heptaminol Hydrochloride) C Date:08/12/98ISR Number: 3116957-5Report Type:Direct Company Report # Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coronary Artery Disease Clozapine PS 50 MG Q 4PM AND 75 MG Q HS Sertraline SS 50 MG BID Theo-Dur (Theophylline) C Date:08/13/98ISR Number: 3116784-9Report Type:Expedited (15-DaCompany Report #USA/98/01634/LEX Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiomyopathy Health Clozaril PS ORAL 450 MG ORAL 3 YR Professional Effexor C Date:08/13/98ISR Number: 3116789-8Report Type:Expedited (15-DaCompany Report #USA/98/01777/LEX Age:53 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Health Clozaril PS ORAL 800 MG ORAL Initial or Prolonged Professional Theo-Dur C Required Potassium Chloride C Intervention to Nicotine Patch C Prevent Permanent Depakote C Impairment/Damage Vasotec C Lasix C Plavix C 22-Feb-2006 08:30 AM Page: 156 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/13/98ISR Number: 3116797-7Report Type:Expedited (15-DaCompany Report #D/98/02728/LEX Age:28 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatomegaly Health Leponex PS ORAL 600 MG ORAL Initial or Prolonged Influenza Like Illness Professional Lithium SS ORAL 100 MG ORAL Required Juvenile Arthritis Recephin C Intervention to Leukocytosis Prevent Permanent Pericardial Effusion Impairment/Damage Pleural Effusion Pyrexia Rash Erythematous Date:08/14/98ISR Number: 3116796-5Report Type:Expedited (15-DaCompany Report #D/98/02930/LEX Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Leponex PS ORAL ORAL Professional Date:08/14/98ISR Number: 3117001-6Report Type:Direct Company Report # Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dizziness Clozaril PS Novartis 700MG QD 1 YR Initial or Prolonged Drooling Gait Disturbance Hypotension Listless Tachycardia Date:08/14/98ISR Number: 3117015-6Report Type:Direct Company Report # Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Clozaril PS ORAL 12.5MG PO QD 1 DAY Required Heart Rate Decreased Intervention to Orthostatic Hypotension Prevent Permanent Pallor Impairment/Damage Date:08/14/98ISR Number: 3117183-6Report Type:Expedited (15-DaCompany Report #LIT/98/00183-LEX Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neurosis Literature Clozapine PS ORAL 500 MG ORAL 6 MON Initial or Prolonged Obsessive-Compulsive Health Required Disorder Professional Intervention to Salivary Hypersecretion Prevent Permanent Sedation Impairment/Damage Tic 22-Feb-2006 08:30 AM Page: 157 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/14/98ISR Number: 3117186-1Report Type:Expedited (15-DaCompany Report #LIT/98/00184 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Obsessive-Compulsive Literature Clozapine PS ORAL 0 MG ORAL 3 YR Initial or Prolonged Disorder Health Required Professional Intervention to Prevent Permanent Impairment/Damage Date:08/14/98ISR Number: 3117189-7Report Type:Expedited (15-DaCompany Report #D/98/01864/LEX Age:42 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Chills Health Clozapine PS ORAL 5000 MG ORAL Hospitalization - Delirium Professional Initial or Prolonged Dystonia Other Fatigue Required Hallucination Intervention to Overdose Prevent Permanent Pneumonia Impairment/Damage Respiratory Failure Salivary Hypersecretion Sedation Suicide Attempt Torticollis Date:08/17/98ISR Number: 3117316-1Report Type:Direct Company Report # Age:76 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Respiratory Distress Clozaril PS ORAL 2T (200MG) Initial or Prolonged BID; 1 DOSE ONLY PO Date:08/17/98ISR Number: 3118043-7Report Type:Expedited (15-DaCompany Report #D/98/02955/LEX Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Health Leponex PS ORAL UNSPECIFIED Initial or Prolonged Asthenia Professional ORAL Cough Fatigue Pancytopenia Pyrexia Tonsillitis Date:08/17/98ISR Number: 3118049-8Report Type:Expedited (15-DaCompany Report #GB/98/00184/LEX Age:38 YR Gender:Female I/FU:I Outcome Death Hospitalization - Initial or Prolonged Required Intervention to Prevent Permanent 22-Feb-2006 08:30 AM Page: 158 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Bronchiolitis Health Clozaril PS ORAL 600 MG ORAL Cardiomegaly Professional Co-Amilofruse C Cardiomyopathy Aerolin C Chronic Obstructive Aerobic Forte C Pulmonary Disease Ferrous Sulphate C Condition Aggravated Prednisolone C Cough Lactulose C Ejection Fraction Abnormal Electroencephalogram Abnormal Haemorrhage Intracranial Left Ventricular Failure Lower Respiratory Tract Infection Pneumonia Pneumonia Klebsiella Respiratory Arrest Respiratory Depression Subdural Haematoma Thrombocytopenia Viral Myocarditis Date:08/17/98ISR Number: 3118050-4Report Type:Expedited (15-DaCompany Report #LIT/98/00181/LEX Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dystonia Literature Leponex PS ORAL ORAL Muscle Hypertrophy Health Torticollis Professional Date:08/17/98ISR Number: 3118051-6Report Type:Expedited (15-DaCompany Report #USA/98/01957/LEX Age:86 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dementia Health Clozaril PS ORAL 50 MG ORAL Professional Date:08/18/98ISR Number: 3119578-3Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Clozaril PS Sandoz ORAL 12.5 MG PO QD Phosphokinase Increased Zyprexa SS Lilly ORAL 30MG PO QD (DIVIDED) Date:08/19/98ISR Number: 3119070-6Report Type:Direct Company Report # Age:38 YR Gender:Male I/FU:I Outcome Life-Threatening Hospitalization - Initial or Prolonged Required 22-Feb-2006 08:30 AM Page: 159 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Intervention to Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Myocardial Infarction Clozapine PS Date:08/19/98ISR Number: 3119073-1Report Type:Direct Company Report # Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Convulsion Clozapine PS Intervention to Prevent Permanent Impairment/Damage Date:08/20/98ISR Number: 3119483-2Report Type:Expedited (15-DaCompany Report #GB/98/01008/LEX Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ketoacidosis Study Clozaril PS ORAL Initial or Prolonged Health Professional Date:08/20/98ISR Number: 3119593-XReport Type:Expedited (15-DaCompany Report #GB/98-00582/LEX Age:77 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Pain Study Clozaril PS ORAL 38 MG ORAL Required Anaemia Health Valproate Sodium Intervention to Atrial Fibrillation Professional (Valproate Sodium) C Prevent Permanent Bronchopneumonia Digoxin (Digoxin) C Impairment/Damage Cardiac Failure Chest Pain Circulatory Collapse Coronary Artery Disease Cyanosis Deep Vein Thrombosis Diarrhoea Dyspnoea Electrocardiogram St Segment Depression Haemoglobin Decreased Myocardial Ischaemia Myocarditis Pulmonary Embolism Tachycardia Vasculitis Date:08/24/98ISR Number: 3120721-0Report Type:Periodic Company Report #98-08-0195 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coma Health Clozapine PS ORAL 25MG / DAY Life-Threatening Dyspnoea Professional ORAL Lethargy Aricept C Pneumonia Aspiration Lopressor C Sinemet C Albuterol C 22-Feb-2006 08:30 AM Page: 160 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Erythromycin C Opthalmic Ointment C Heparin C Injectable C Tylenol C Date:08/24/98ISR Number: 3120722-2Report Type:Expedited (15-DaCompany Report #98-07-0171 Age:86 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sepsis Health Clozapine PS ORAL 12.5MG / DAY Life-Threatening Urinary Tract Infection Professional ORAL Permax C Date:08/24/98ISR Number: 3120724-6Report Type:Expedited (15-DaCompany Report #98-05-0128 Age:53 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine PS ORAL 350MG / DAY Professional ORAL Albuterol Inhaler C Date:08/25/98ISR Number: 3122141-1Report Type:Expedited (15-DaCompany Report #USA/98/01784/LEX Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Health Clozaril PS ORAL 325 MG ORAL Initial or Prolonged Drug Withdrawal Syndrome Professional Required Intervention to Prevent Permanent Impairment/Damage Date:08/25/98ISR Number: 3122826-7Report Type:Expedited (15-DaCompany Report #USA/98/01985/LEX Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiac Arrest Health Clozapine PS ORAL 850MG / ORAL 10 YR Gastrointestinal Necrosis Professional Imipramine C Large Intestine Haldol C Anastomosis Mesenteric Artery Embolism Sepsis Date:08/25/98ISR Number: 3122828-0Report Type:Expedited (15-DaCompany Report #USA/98/01782/LEX Age:38 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozapine PS ORAL 400MG / ORAL Coma Professional Dilantin C Congestive Cardiomyopathy Lithium C Drug Level Above Klonopin C Therapeutic Fall Loss Of Consciousness 22-Feb-2006 08:30 AM Page: 161 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/27/98ISR Number: 3121880-6Report Type:Expedited (15-DaCompany Report #D/98/02930/LEX Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Leponex PS ORAL ORAL Professional Date:08/27/98ISR Number: 3121881-8Report Type:Expedited (15-DaCompany Report #D/98/00726/LEX Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Macular Degeneration Health Leponex PS ORAL 100 MG ORAL Visual Disturbance Professional Aponal SS ORAL ORAL Tavor SS ORAL 2 MG ORAL Ximovan SS ORAL 1 OTH ORAL Melleril SS Date:08/27/98ISR Number: 3122716-XReport Type:Expedited (15-DaCompany Report #D/98/03104/LEX Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Abuser Health Leponex PS ORAL 200 MG ORAL Initial or Prolonged Salivary Hypersecretion Professional Tavor SS ORAL 1.5 MG ORAL Required Sedation Nefadar SS Intervention to Suicide Attempt Prevent Permanent Impairment/Damage Date:08/27/98ISR Number: 3122720-1Report Type:Expedited (15-DaCompany Report #GB/98/01008/LEX Age:36 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Circulatory Collapse Study Clozaril PS ORAL 250 MG ORAL Required Ketoacidosis Health Epilim (Valproate Intervention to Shock Professional Sodium) C Prevent Permanent Vomiting Promazine Impairment/Damage (Promazine) C Date:08/27/98ISR Number: 3122722-5Report Type:Expedited (15-DaCompany Report #D/98/02931/LEX Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Apallic Syndrome Health Leponex PS ORAL TAB 2 ORAL Life-Threatening Cardiac Arrest Professional Methadone SS Hospitalization - Drug Abuser Cocaine SS Initial or Prolonged Encephalopathy Rohypnol SS Other Hyperthermia Malignant Required Shock Intervention to Prevent Permanent Impairment/Damage 22-Feb-2006 08:30 AM Page: 162 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/27/98ISR Number: 3122766-3Report Type:Expedited (15-DaCompany Report #USA/98/01312/LEX Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Health Clozaril PS ORAL 500 MG ORAL Required White Blood Cell Count Professional Glucophage C Intervention to Decreased Depakote C Prevent Permanent Synthroid C Impairment/Damage Neurontin C Date:09/01/98ISR Number: 3124870-2Report Type:Expedited (15-DaCompany Report #LIT/98/00202/LEX Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatinine Literature Leponex PS ORAL 300 MG 5 MON Initial or Prolonged Increased Health Minocycline Required Blood Ph Decreased Professional (Minocycline) - Intervention to Dehydration Hidradenitis C Prevent Permanent Hyperglycaemia Impairment/Damage Hypokalaemia Hyponatraemia Ketoacidosis Vomiting Date:09/02/98ISR Number: 3125226-9Report Type:Expedited (15-DaCompany Report #98-08-0205 Age:98 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Clozapine PS Zenith Goldline Congestive Professional Pharm. ORAL 25MG DAILY ORAL Date:09/02/98ISR Number: 3125474-8Report Type:Expedited (15-DaCompany Report #98-07-0183 Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Faecaloma Health Clozapine PS Zenith Goldline Hospitalization - Leukocytosis Professional Pharm. ORAL 600 MG PER Initial or Prolonged Scrotal Infection DAY ORAL Urinary Tract Infection Lithium C Levothyroxine C Docusate C Date:09/02/98ISR Number: 3125475-XReport Type:Expedited (15-DaCompany Report #98-08-0195 Age:76 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coma Health Clozapine PS Zenith Goldline Life-Threatening Dysphagia Professional Pharm. ORAL 25 MG/DAY Dyspnoea ORAL Lethargy Aricept C Oral Intake Reduced Lopressor C Pneumonia Aspiration Sinemet C Albuterol C Erythromycin C Ophthalmic Ointment C Heparin C Tylenol C 22-Feb-2006 08:30 AM Page: 163 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/02/98ISR Number: 3125476-1Report Type:Expedited (15-DaCompany Report #98-08-0205 Age:98 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Clozapine PS Zenith Goldline Congestive Professional Pharm. ORAL 25 MG DAILY ORAL Date:09/02/98ISR Number: 3125477-3Report Type:Expedited (15-DaCompany Report #98-08-0209 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Infection Health Clozapine PS Zenith Goldline Hospitalization - Pneumonia Primary Professional Pharm. ORAL 150 MG / DAY Initial or Prolonged Atypical ORAL Respiratory Failure Date:09/03/98ISR Number: 3125622-XReport Type:Expedited (15-DaCompany Report #CDN/98/00648/LEX Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Salivary Gland Cancer Health Clozaril PS ORAL 350 MG ORAL Initial or Prolonged Professional Other Date:09/03/98ISR Number: 3125741-8Report Type:Expedited (15-DaCompany Report #USA/98/02086/LEX Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Health Clozaril PS ORAL 575 MG ORAL Life-Threatening Professional Date:09/03/98ISR Number: 3125743-1Report Type:Expedited (15-DaCompany Report #USA/96/02643/LEX Age:69 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrial Fibrillation Health Clozaril PS ORAL 325 MG ORAL Initial or Prolonged Cardiac Failure Professional Doxazosin C Required Congestive Intervention to Cardiomegaly Prevent Permanent Heart Rate Irregular Impairment/Damage Orthostatic Hypotension Date:09/03/98ISR Number: 3125745-5Report Type:Expedited (15-DaCompany Report #D/98/03258/LEX Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Thrombosis Health Clozapine PS ORAL 600 MG ORAL Initial or Prolonged Professional Pipamperone SS Required Intervention to Prevent Permanent Impairment/Damage 22-Feb-2006 08:30 AM Page: 164 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/03/98ISR Number: 3125746-7Report Type:Expedited (15-DaCompany Report #N/97/00043/LEX Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiomegaly Health Leponex PS ORAL 500 MG ORAL Required Congestive Cardiomyopathy Professional Intervention to Dyspnoea Prevent Permanent Ejection Fraction Impairment/Damage Abnormal Lung Disorder Date:09/04/98ISR Number: 3126186-7Report Type:Expedited (15-DaCompany Report #N/97/00043/LEX Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiomegaly Health Leponex PS ORAL 500 MG ORAL Required Congestive Cardiomyopathy Professional Intervention to Dyspnoea Prevent Permanent Ejection Fraction Impairment/Damage Abnormal Pulmonary Congestion Date:09/04/98ISR Number: 3126187-9Report Type:Expedited (15-DaCompany Report #N/98/00068/LEX Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiomyopathy Leponex PS Date:09/08/98ISR Number: 3126344-1Report Type:Expedited (15-DaCompany Report #D/98/02931/LEX Age:21 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Apallic Syndrome Health Leponex PS ORAL TAB 2 ORAL Life-Threatening Cardiac Arrest Professional Methadon SS Hospitalization - Drug Abuser Cocaine SS Initial or Prolonged Encephalopathy Rohypnol SS Other Hyperthermia Malignant Required Sepsis Intervention to Shock Prevent Permanent Impairment/Damage Date:09/08/98ISR Number: 3130593-6Report Type:Direct Company Report # Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Bipolar Disorder Clozapine PS 275MG/DAY Drug Effect Decreased (GENERIC) Depakote C Date:09/09/98ISR Number: 3127284-4Report Type:Expedited (15-DaCompany Report #USA/98/01985/LEX Age:38 YR Gender:Male I/FU:I Outcome Life-Threatening Hospitalization - Initial or Prolonged 22-Feb-2006 08:30 AM Page: 165 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Disability Required Intervention to PT Report Source Product Role Manufacturer Route Dose Duration Prevent Permanent Circulatory Collapse Health Clozaril PS ORAL 850 MG ORAL 3 YR Impairment/Damage Fall Professional Imipramine C Gastrointestinal Necrosis Haldol C Head Injury Cogentin C Peripheral Embolism Colace C Pyrexia Trazodone C Sepsis Date:09/09/98ISR Number: 3127799-9Report Type:Expedited (15-DaCompany Report #GB/97/01137/LEX Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Health Clozaril PS ORAL 250 MG ORAL Coronary Artery Disease Professional Myocardial Ischaemia Date:09/11/98ISR Number: 3128463-2Report Type:Expedited (15-DaCompany Report #GB/97/01182/LEX Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Epilepsy Health Clozaril PS ORAL 400 MG ORAL Myocardial Infarction Professional Date:09/11/98ISR Number: 3128465-6Report Type:Expedited (15-DaCompany Report #GB/97/01179/LEX Age:71 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Parkinson'S Disease Health Clozaril PS ORAL 13 MG ORAL Pneumonia Professional Sepsis Date:09/11/98ISR Number: 3128468-1Report Type:Expedited (15-DaCompany Report #GB/97/01023/LEX Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bronchopneumonia Health Clozaril PS ORAL ORAL Salmonellosis Professional Sepsis Date:09/11/98ISR Number: 3128470-XReport Type:Expedited (15-DaCompany Report #CDN/98/00648/LEX Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Salivary Gland Cancer Health Clozaril PS ORAL 350 MG ORAL Initial or Prolonged Professional Other 22-Feb-2006 08:30 AM Page: 166 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/11/98ISR Number: 3128710-7Report Type:Expedited (15-DaCompany Report #USA/98/02156/LEX Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Health Clozaril PS ORAL 300 MG ORAL Hyperglycaemia Professional Risperdal Thrombocytopenia (Risperidone) C Imipramine C Glucophage (Metformin Hydrochloride) C Date:09/15/98ISR Number: 3129198-2Report Type:Expedited (15-DaCompany Report #D/97/02802/LEX Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Breech Presentation Leponex PS ORAL 450 MG ORAL Initial or Prolonged Caesarean Section Complications Of Maternal Exposure To Therapeutic Drugs Maternal Drugs Affecting Foetus Small For Dates Baby Date:09/15/98ISR Number: 3129199-4Report Type:Expedited (15-DaCompany Report #D/97/02501/LEX Age:4 MON Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anorexia Leponex PS UNKNOWN 450 MG IN Initial or Prolonged Complications Of Maternal UTERO Exposure To Therapeutic Drugs Feeding Disorder Neonatal Small For Dates Baby Date:09/15/98ISR Number: 3129842-XReport Type:Expedited (15-DaCompany Report #D/98/02834/LEX Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Overdose Health Leponex PS ORAL 10 OTH ORAL Initial or Prolonged Sedation Professional Suicide Attempt Date:09/15/98ISR Number: 3129847-9Report Type:Expedited (15-DaCompany Report #USA/ 98/ 00904/ LEX Age:24 MON Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Accidental Exposure Health Clozaril PS ORAL 400 MG ORAL Hospitalization - Dyspnoea Professional 1 EPISODE Initial or Prolonged Lethargy Other Respiratory Depression Required Sedation Intervention to Prevent Permanent Impairment/Damage 22-Feb-2006 08:30 AM Page: 167 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/15/98ISR Number: 3129853-4Report Type:Expedited (15-DaCompany Report #CDN/98/00669/LEX Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiomegaly Health Clozaril PS ORAL 300 MG ORAL Initial or Prolonged Chest Pain Professional Required Electrocardiogram T Wave Intervention to Inversion Prevent Permanent Eosinophilia Impairment/Damage Leukocytosis Pericarditis Pleural Effusion Pleural Infection Date:09/16/98ISR Number: 3130952-1Report Type:Expedited (15-DaCompany Report #GB/97/01158/LEX Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pulmonary Embolism Health Clozaril PS ORAL 375 MG ORAL Professional Date:09/16/98ISR Number: 3131130-2Report Type:Direct Company Report # Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Clozapine PS ORAL T1T PO Q Initial or Prolonged Syndrome Loxapine Succinate SS ORAL T5C PO Q Acetaminophen C Aloh/Mgoh/ Simth Xtra Strength Liq C Benztropine Mesylate C Lithium Carbonate C Quinapril C Lorazepam C Date:09/16/98ISR Number: 3131133-8Report Type:Expedited (15-DaCompany Report #GB/97/01158/LEX Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Clozaril PS ORAL 375 MG ORAL Date:09/16/98ISR Number: 3132495-8Report Type:Expedited (15-DaCompany Report #LIT/98/00223/LEX Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Literature Leponex PS ORAL 500 MG ORAL 2 WK Leukopenia Health Zidovudine SS UNKNOWN UNKNOWN 2 WK Lymphocytosis Professional Lamivudine SS UNKNOWN UNKNOWN 2 WK Neutropenia Stavudine Polyneuropathy (Stavudine) C Psychotic Disorder 22-Feb-2006 08:30 AM Page: 168 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/17/98ISR Number: 3131646-9Report Type:Expedited (15-DaCompany Report #USA/98/02203/LEX Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Ovarian Cancer Health Clozaril PS ORAL 325 MG ORAL 9 YR Professional Cogentin C Klonopin C Diflucan C Reserpine C Florinef C Date:09/17/98ISR Number: 3131647-0Report Type:Expedited (15-DaCompany Report #USA/98/02202/LEX Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozaril PS ORAL 600 MG ORAL Hospitalization - Renal Failure Professional Initial or Prolonged Date:09/17/98ISR Number: 3131662-7Report Type:Expedited (15-DaCompany Report #D/98/02309/LEX Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agranulocytosis Health Leponex PS ORAL 100 MG ORAL Life-Threatening Anaemia Professional Diazempam C Hospitalization - Leukopenia Tiapridex C Initial or Prolonged Multi-Organ Failure Required Sepsis Intervention to Thrombocytopenia Prevent Permanent Impairment/Damage Date:09/17/98ISR Number: 3131663-9Report Type:Expedited (15-DaCompany Report #D/98/03407/LEX Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Health Leponex PS ORAL 200 MG ORAL Professional Tofranil C Akineton C Date:09/17/98ISR Number: 3131667-6Report Type:Expedited (15-DaCompany Report #USA/98/02222/LEX Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Respiratory Health Clozaril PS ORAL 450 MG ORAL Distress Syndrome Professional Date:09/17/98ISR Number: 3131767-0Report Type:Expedited (15-DaCompany Report #98-08-0217 Age:87 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline Professional Pharm. ORAL 25MG QD ORAL Furosemide C Multivitamins C Sinemet Cr C Carbamide Peroxide C 22-Feb-2006 08:30 AM Page: 169 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Heparin C Vitamin A + D Ointment C Docusate C Albuterol C Lactulose C Aspirin C Levofloxacin C Kcl-Zyma C Midodrine C Date:09/17/98ISR Number: 3131770-0Report Type:Expedited (15-DaCompany Report #98-08-0205 Age:98 YR Gender:Not SpecifiI/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Clozapine PS Zenith Goldline Congestive Professional Pharm. ORAL 25MG DAILY Condition Aggravated ORAL Sinemet Cr C Sinemet C Date:09/17/98ISR Number: 3131773-6Report Type:Expedited (15-DaCompany Report #98-06-0143 Age:46 YR Gender:Not SpecifiI/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Haemorrhagic Stroke Health Clozapine PS Zenith Goldline Professional Pharm. ORAL 600-800MG/DAY ORAL Clonazepam C Paxil C Benztropine Mesylate C Loxitane C Axid C Date:09/17/98ISR Number: 3131780-3Report Type:Expedited (15-DaCompany Report #98-08-0218 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Intentional Overdose Health Clozapine PS Zenith Goldline Professional Pharm. ORAL 200MG QD ORAL Date:09/18/98ISR Number: 3132461-2Report Type:Expedited (15-DaCompany Report #F/98/01272/LEX Age:52 YR Gender:Male I/FU:F Outcome PT Hospitalization - Agitation Initial or Prolonged Anxiety Required Bronchial Obstruction Intervention to Cholinergic Syndrome Prevent Permanent Confusional State Impairment/Damage Disorientation Drug Ineffective Drug Withdrawal Syndrome Dyskinesia Dyspnoea Enuresis Extrapyramidal Disorder 22-Feb-2006 08:30 AM Page: 170 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hyperhidrosis Increased Bronchial Secretion Report Source Product Role Manufacturer Route Dose Duration Lung Disorder Health Leponex PS ORAL 700 MG ORAL Pleural Infection Professional Zyprexa SS ORAL 10 MG ORAL Pneumonia Hept-A-Myl C Productive Cough Barnetil C Pyrexia Loxapac C Tremor Date:09/18/98ISR Number: 3132497-1Report Type:Expedited (15-DaCompany Report #S/98/00071/LEX Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Bilirubin Increased Leponex PS ORAL 300 MG ORAL Blood Creatinine Disipal Increased (Orphenadrine C-Reactive Protein Hydrochloride) C Increased Effortil Prolongatum Gastrointestinal (Etilefrine Infection Hydrochloride) C Hyponatraemia Cipramil Pancytopenia (Citalopram) C Pulmonary Oedema Pyrexia Shock Ulcer Date:09/18/98ISR Number: 3132605-2Report Type:Expedited (15-DaCompany Report #USA/98/02198/LEX Age:71 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Aspiration Health Clozaril PS ORAL 75 MG ORAL Professional Date:09/18/98ISR Number: 3132610-6Report Type:Expedited (15-DaCompany Report #GB/98/01008/LEX Age:36 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Circulatory Collapse Study Clozaril PS ORAL 250 MG ORAL Required Diabetic Ketoacidosis Health Epilim C Intervention to Sepsis Professional Promazine C Prevent Permanent Shock Impairment/Damage Vomiting Date:09/18/98ISR Number: 3132613-1Report Type:Expedited (15-DaCompany Report #USA/98/02234/LEX Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozaril PS ORAL 450 MG ORAL Professional 22-Feb-2006 08:30 AM Page: 171 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/18/98ISR Number: 3132633-7Report Type:Expedited (15-DaCompany Report #D/98/03104/LEX Age:39 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Overdose Health Leponex PS ORAL 200 MG ORAL Initial or Prolonged Salivary Hypersecretion Professional Tavor SS ORAL 2 MG ORAL Required Sedation Intervention to Suicide Attempt Prevent Permanent Impairment/Damage Date:09/23/98ISR Number: 3133952-0Report Type:Direct Company Report # Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypoglycaemia Clozapine PS Initial or Prolonged Hypotension Required Intervention to Prevent Permanent Impairment/Damage Date:09/24/98ISR Number: 3134767-XReport Type:Expedited (15-DaCompany Report #USA/98/02086/LEX Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Health Clozaril PS ORAL 757 MG ORAL Life-Threatening Professional Depakote C Neutrontin C Date:09/24/98ISR Number: 3134769-3Report Type:Expedited (15-DaCompany Report #USA/98/02247/LEX Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocarditis Health Clozaril PS ORAL 300 MG ORAL Professional Depakote C Date:09/24/98ISR Number: 3134853-4Report Type:Expedited (15-DaCompany Report #98-09-0221 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mania Health Clozapine PS Zenith Goldline Initial or Prolonged Upper Respiratory Tract Professional Pharm. ORAL 175-300 Infection MG/DAY ORAL Synthroid C Isoniazid C Pyridoxine C Clonidine C Colace C Date:09/24/98ISR Number: 3234241-6Report Type:Periodic Company Report #98-09-0219 Age:67 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sepsis Health Clozapine PS Zenith Goldline Urinary Tract Infection Professional Pharm. ORAL 100 MG QD ORAL 22-Feb-2006 08:30 AM Page: 172 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Synthroid C Sinemet C Date:09/25/98ISR Number: 3134991-6Report Type:Expedited (15-DaCompany Report #USA/98-02154-LEX Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Health Clozaril PS ORAL 350 MG ORAL Initial or Prolonged Cerebrovascular Disorder Professional Fortaz (Ceftazidime) C Congenital Anomaly Cholecystitis Valium (Diazepam) C Required Delirium Aspirin (Baby) C Intervention to Gallbladder Disorder Tolvin (Mianserin Prevent Permanent Hyperglycaemia Hydrochloride) C Impairment/Damage Leukocytosis Speech Disorder White Blood Cell Count Increased Date:09/25/98ISR Number: 3135083-2Report Type:Expedited (15-DaCompany Report #SF/98/01618/LEX Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chills Health Leponex PS ORAL 200 MG ORAL Required Dermatitis Exfoliative Professional Cisordinol C Intervention to Eczema Levozin C Prevent Permanent Oedema Impairment/Damage Pain Rash Erythematous Date:09/25/98ISR Number: 3135084-4Report Type:Expedited (15-DaCompany Report #USA/98/02068/LEX Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Health Clozaril PS ORAL 450 MG ORAL Initial or Prolonged Cerebrovascular Disorder Professional Inderal La C Required Chills Tylenol C Intervention to Condition Aggravated Saline Gargle C Prevent Permanent Delirium Impairment/Damage Glossitis Glossodynia Hemianopia Homonymous Hemiparesis Hyperhidrosis Joint Stiffness Musculoskeletal Stiffness Nausea Pharyngitis Pharyngolaryngeal Pain Pyrexia Speech Disorder Vomiting 22-Feb-2006 08:30 AM Page: 173 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/25/98ISR Number: 3135085-6Report Type:Expedited (15-DaCompany Report #GB/98/01008/LEX Age:36 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Circulatory Collapse Study Clozaril PS ORAL 250 MG ORAL Required Diabetic Ketoacidosis Health Epilim C Intervention to Sepsis Professional Promazine C Prevent Permanent Shock Impairment/Damage Staphylococcal Infection Vomiting Date:09/25/98ISR Number: 3135086-8Report Type:Expedited (15-DaCompany Report #GB/98/00957/LEX Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Arrhythmia Health Clozaril PS ORAL 175 MG ORAL Lower Respiratory Tract Professional Infection Date:09/25/98ISR Number: 3135088-1Report Type:Expedited (15-DaCompany Report #LIT/98/00228/LEX Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Amnesia Literature Leponex PS ORAL 600 MG ORAL 3 MON Initial or Prolonged Clonic Convulsion Health Required Confusional State Professional Intervention to Disturbance In Attention Prevent Permanent Dysarthria Impairment/Damage Dysphagia Electroencephalogram Abnormal Encephalopathy Extensor Plantar Response Hepatic Function Abnormal Hyperreflexia Loss Of Consciousness Motor Dysfunction Muscle Contractions Involuntary Orthostatic Hypotension Salivary Hypersecretion Sedation Social Avoidant Behaviour Speech Disorder Syncope Tremor Date:09/28/98ISR Number: 3136153-5Report Type:Expedited (15-DaCompany Report #USA/98/02248/LEX Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril PS ORAL 300 MG ORAL Life-Threatening Professional 22-Feb-2006 08:30 AM Page: 174 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/01/98ISR Number: 3137247-0Report Type:Expedited (15-DaCompany Report #USA/98/02328/LEX Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accident Health Clozaril PS ORAL UNKNOWN ORAL Initial or Prolonged Convulsion Professional Insulin C Diabetes Mellitus Diabetes Mellitus Inadequate Control Fall Neck Crushing Syncope Date:10/01/98ISR Number: 3137527-9Report Type:Expedited (15-DaCompany Report #USA/98/02154/LEX Age:58 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Health Clozaril PS ORAL 350 MG ORAL Initial or Prolonged Cerebrovascular Accident Professional Fortaz C Disability Cerebrovascular Disorder Valium C Required Delirium Aspirin C Intervention to Dyspnoea Tolvin C Prevent Permanent Gallbladder Disorder Impairment/Damage Hyperglycaemia Leukocytosis Neutrophilia Pyrexia Speech Disorder Tachycardia White Blood Cell Count Increased Date:10/01/98ISR Number: 3137532-2Report Type:Expedited (15-DaCompany Report #CDN/98/00703/LEX Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eye Disorder Clozaril PS ORAL 300 MG ORAL 2 YR Muscle Contractions Involuntary Skin Discolouration Tic Urinary Incontinence Date:10/02/98ISR Number: 3137603-0Report Type:Expedited (15-DaCompany Report #F/98/00060/LEX Age:29 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alcohol Poisoning Health Leponex PS ORAL 550 MG ORAL Initial or Prolonged Choreoathetosis Professional Seresta SS ORAL 125 MG ORAL Dyskinesia Deroxat SS ORAL 20 MG ORAL Hept-A-Myl (Heptaminol Hydrochloride) C Duphaston (Dydrogesterone) C 22-Feb-2006 08:30 AM Page: 175 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/02/98ISR Number: 3137606-6Report Type:Expedited (15-DaCompany Report #USA/98/02257/LEX Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatitis C Health Clozaril PS ORAL ORAL Professional Date:10/05/98ISR Number: 3138963-7Report Type:Expedited (15-DaCompany Report #GB/98/00703/LEX Age:56 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Intestinal Obstruction Health Clozaril PS ORAL 550 MG ORAL Volvulus Of Bowel Professional Senna C Lactulose C Fybogel C Date:10/06/98ISR Number: 3138792-4Report Type:Expedited (15-DaCompany Report #D/98/03761/LEX Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancytopenia Health Leponex PS ORAL 25 MG ORAL 7 WK Initial or Prolonged Professional Orfiril C Lasix (Furosemide) C Tiklyd (Ticlopidine Hydrochloride) C Date:10/06/98ISR Number: 3138794-8Report Type:Expedited (15-DaCompany Report #MEX/98/02363/LEX Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Gastrointestinal Health Leponex PS ORAL 100 MG ORAL Carcinoma Professional Date:10/06/98ISR Number: 3138799-7Report Type:Expedited (15-DaCompany Report #D/98/02584/LEX Age:29 YR Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Congestive Cardiomyopathy Foreign Leponex PS ORAL ORAL Initial or Prolonged Dyspnoea Required Left Ventricular Failure Intervention to Tachycardia Prevent Permanent Impairment/Damage Date:10/06/98ISR Number: 3138803-6Report Type:Expedited (15-DaCompany Report #LIT/98/00235/LEX Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Circadian Rhythm Sleep Literature Leponex PS ORAL 400 MG; ORAL Required Disorder Health Intervention to Condition Aggravated Professional Prevent Permanent Psychotic Disorder Impairment/Damage Sedation 22-Feb-2006 08:30 AM Page: 176 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/06/98ISR Number: 3138814-0Report Type:Expedited (15-DaCompany Report #USA/98/02336/LEX Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Testis Cancer Health Clozaril PS ORAL 475 MG; ORAL Initial or Prolonged Professional Klonopin C Required Intervention to Prevent Permanent Impairment/Damage Date:10/06/98ISR Number: 3138830-9Report Type:Expedited (15-DaCompany Report #GB/98/01008/LEX Age:36 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acidosis Study Clozaril PS ORAL 250 MG; ORAL Required Cold Sweat Health Epilim C Intervention to Hyperhidrosis Professional Promazine C Prevent Permanent Ketoacidosis Impairment/Damage Pallor Sepsis Shock Staphylococcal Infection Vomiting Date:10/07/98ISR Number: 3139059-0Report Type:Direct Company Report # Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coma Clozapine PS Novartis ORAL 1 PILL X1 PO Hospitalization - Hyporeflexia Initial or Prolonged Sedation Required Intervention to Prevent Permanent Impairment/Damage Date:10/07/98ISR Number: 3139494-0Report Type:Expedited (15-DaCompany Report #GB/98/00582/LEX Age:77 YR Gender:Female I/FU:F Outcome PT Death Abdominal Pain Anaemia Arrhythmia Arterial Occlusive Disease Atrial Fibrillation Bronchopneumonia Cardiac Failure Chest Pain Circulatory Collapse Coronary Artery Disease Cyanosis Deep Vein Thrombosis Diarrhoea Dyspnoea Electrocardiogram St Segment Depression Haemoglobin Decreased 22-Feb-2006 08:30 AM Page: 177 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Heart Rate Irregular Myocardial Infarction Myocardial Ischaemia Report Source Product Role Manufacturer Route Dose Duration Myocarditis Study Clozaril PS ORAL 37.5 MG ORAL Pallor Health Valproate Sodium C Pneumonia Professional Digoxin C Pulmonary Embolism Fybogel C Shock Aspirin C Tachycardia Olanzapine C Vasculitis Quetiepine C Vomiting Date:10/07/98ISR Number: 3139546-5Report Type:Direct Company Report # Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Enuresis Clozaril PS CLOZARIL 100 MG Q HS 6 WK Zoloft SS 75 MG QD Date:10/07/98ISR Number: 3139796-8Report Type:Expedited (15-DaCompany Report #USA/98/02356/LEX Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Anaemia Health Clozaril PS ORAL 300 MG ORAL Intervention to Coma Professional Lithium C Prevent Permanent Diabetes Mellitus Depakote C Impairment/Damage Lung Disorder Prozac C Pneumonia Cipro C Pneumonia Aspiration Clindamycin C Respiratory Failure Date:10/08/98ISR Number: 3140136-9Report Type:Expedited (15-DaCompany Report #D/98/02834/LEX Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Overdose Health Leponex PS ORAL 10 OTH ORAL Initial or Prolonged Sedation Professional Suicide Attempt Date:10/08/98ISR Number: 3140181-3Report Type:Expedited (15-DaCompany Report #GB/98/00578/LEX Age: Gender: I/FU:I Outcome PT Hospitalization - Albuminuria Initial or Prolonged Blood Ketone Body Required Confusional State Intervention to Diabetes Mellitus Prevent Permanent Insulin-Dependent Impairment/Damage Headache Heart Rate Increased Hyperglycaemia Hypotension Lethargy Polydipsia Polyuria Proteinuria 22-Feb-2006 08:30 AM Page: 178 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sedation Tachycardia Thirst Report Source Product Role Manufacturer Route Dose Duration Urine Abnormality Clozaril PS ORAL 500 MG Weight Decreased Orphenadrine (Orphenadrine) C Date:10/08/98ISR Number: 3140198-9Report Type:Expedited (15-DaCompany Report #98-06-0143 Age:46 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Haemorrhagic Stroke Health Clozapine PS Zenith Goldline Professional Pharm ORAL 600-800MG/DAY ORAL Clonazepam C Paxil C Benztropine Mesylate C Loxitane C Axid C Date:10/08/98ISR Number: 3261852-4Report Type:Periodic Company Report #98-06-0157 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Health Clozapine - Zenith Initial or Prolonged Professional Goldline Pharm Tablets PS Zenith Goldline ORAL 500-650 MG/DAY ORAL Date:10/08/98ISR Number: 3261856-1Report Type:Periodic Company Report #98-06-0158 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Health Clozapine - Zenith Initial or Prolonged Professional Goldline Pharm Tablets PS Zenith Goldline Pharm ORAL 300 MG /DAY ORAL Clozapine - Zenith Goldline Pharm. Tablets SS Zenith Goldline Pharm. ORAL 50 - 100 MG /DAY ORAL Date:10/08/98ISR Number: 3261863-9Report Type:Periodic Company Report #98-06-0167 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Iron Deficiency Anaemia Health Clozapine - Zenith Initial or Prolonged Leukopenia Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 25-50 MG/DAY ORAL 22-Feb-2006 08:30 AM Page: 179 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/08/98ISR Number: 3261865-2Report Type:Periodic Company Report #98-07-0169 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Clozapine - Zenith Initial or Prolonged Psychotic Disorder Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 575 MG/DAY ORAL Seroquel C Asacol C Isosorbide C Date:10/08/98ISR Number: 3261868-8Report Type:Periodic Company Report #98-07-0173 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Clozapine - Zenith Initial or Prolonged Mental Disorder Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 600 - 625 MG/DAY ORAL Date:10/08/98ISR Number: 3261873-1Report Type:Periodic Company Report #98-07-0179 Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Convulsion Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 62.5 MG/DAY ORAL Date:10/08/98ISR Number: 3261884-6Report Type:Periodic Company Report #98-07-0194 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophrenia Health Clozapine - Zenith Initial or Prolonged Professional Goldline Pharm. PS Zenith Goldline Pharm. ORAL 200 MG/DAY ORAL Depakote C Pepcid C Glucotrol C Date:10/08/98ISR Number: 3261887-1Report Type:Periodic Company Report #98-08-0214 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Paranoia Health Clozapine- Zenith Initial or Prolonged Thinking Abnormal Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 800 MG/DAY ORAL 22-Feb-2006 08:30 AM Page: 180 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/08/98ISR Number: 3261890-1Report Type:Periodic Company Report #98-08-0215 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucination Health Clozapine - Zenith Initial or Prolonged Psychotic Disorder Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 350 MG/DAY ORAL Clozapine Tablets SS ORAL 700 MG/DAY ORAL Date:10/08/98ISR Number: 3261893-7Report Type:Periodic Company Report #98-08-0216 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Convulsion Health Clozapine - Zenith Professional Goldline Pharm. PS Zenith Goldline Pharm. ORAL 500 MG/DAY ORAL Dilantin C Date:10/08/98ISR Number: 3261894-9Report Type:Periodic Company Report #98-02-0034 Age:59 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bronchitis Health Clozapine - Zenith Initial or Prolonged Myocardial Infarction Professional Goldline Pharm. PS Zenith Goldline Pneumonia Pharm. ORAL 500 MG/DAY White Blood Cell Count ORAL Decreased Date:10/08/98ISR Number: 3261903-7Report Type:Periodic Company Report #98-06-0152 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 300 MG PER DAY ORAL Date:10/08/98ISR Number: 3261953-0Report Type:Periodic Company Report #98-06-0155 Age:67 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abnormal Behaviour Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 100 MG QHS ORAL Clozapine - Zenith Goldline Pharm Tablets SS Zenith Goldline Pharm. ORAL 100 MG QHS ORAL 22-Feb-2006 08:30 AM Page: 181 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/08/98ISR Number: 3261957-8Report Type:Periodic Company Report #98-07-0190 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Stupor Health Clozapine- Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 37.5 MG/DAY ORAL Date:10/08/98ISR Number: 3261959-1Report Type:Periodic Company Report #98-07-0191 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hallucination Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL ORAL Trazodone C Xanax C Risperdal C Klonopin C Date:10/08/98ISR Number: 3261962-1Report Type:Periodic Company Report #98-08-0196 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Ear Infection Health Clozapine- Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 500 MG/DAY ORAL Propulsid C Insulin C Famotidine C Date:10/08/98ISR Number: 3261966-9Report Type:Periodic Company Report #98-08-0204 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Nausea Health Clozapine - Zenith Professional Goldline Pharm. PS Zenith Goldline Pharm. ORAL 200-400 MG/DAY ORAL Date:10/08/98ISR Number: 3261968-2Report Type:Periodic Company Report #98-08-0207 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Urinary Tract Infection Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 12.5 MG/DAY ORAL 22-Feb-2006 08:30 AM Page: 182 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/08/98ISR Number: 3261971-2Report Type:Periodic Company Report #98-05-0130 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eosinophilia Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 73 MG QHS ORAL Risperdal C Lorazepam C Date:10/08/98ISR Number: 3261975-XReport Type:Periodic Company Report #98-05-0131 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombocytopenia Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 550 MG PER DAY ORAL Dilantin C Klonopin C Zoloft C Date:10/08/98ISR Number: 3261983-9Report Type:Periodic Company Report #98-05-0132 Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Ineffective Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 75 MG/DAY ORAL Date:10/08/98ISR Number: 3261987-6Report Type:Periodic Company Report #98-06-0133 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 75MG/DAY ORAL; 75MG DAY ORAL Interferon Injectable SS INTRAMUSCULAR 1-3 MEGA UNIT INTRAMUSCU Date:10/08/98ISR Number: 3261990-6Report Type:Periodic Company Report #98-06-0140 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 550 MG/DAY 22-Feb-2006 08:30 AM Page: 183 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL Tegretol C Lorazepam C Ddavp Qhs Nasal Spray C Date:10/08/98ISR Number: 3261991-8Report Type:Periodic Company Report #98-06-0153 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Health Clozapine - Zenith Panic Attack Professional Goldline Pharm. Tachycardia Tablets PS Zenith Goldline Pharm. ORAL 150 MG QHS ORAL Lithium Carbonate C Toprol Xl C Loxitane C Date:10/08/98ISR Number: 3261993-1Report Type:Periodic Company Report #98-06-0156 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Depression Health Clozapine - Zenith Drooling Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 200 MG/DAY ORAL Date:10/08/98ISR Number: 3261995-5Report Type:Periodic Company Report #98-06-0162 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Ineffective Health Clozapine PS Zenith Goldline Professional Pharm. ORAL 500 MG/DAY ORAL Fluoxetine C Date:10/08/98ISR Number: 3261998-0Report Type:Periodic Company Report #98-06-0163 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Ineffective Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 175-200 MG/DAY ORAL Fluoxetine C Date:10/08/98ISR Number: 3262001-9Report Type:Periodic Company Report #98-06-0164 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Ineffective Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 450 MG/DAY 22-Feb-2006 08:30 AM Page: 184 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL Artane C Colace C Ditropan C Date:10/08/98ISR Number: 3262005-6Report Type:Periodic Company Report #98-06-0198 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Ineffective Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 275 MG/DAY ORAL Date:10/08/98ISR Number: 3262010-XReport Type:Periodic Company Report #98-06-0199 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Ineffective Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 725 MG/DAY ORAL Date:10/08/98ISR Number: 3262013-5Report Type:Periodic Company Report #98-07-0166 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sedation Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 25-200 MG/DAY ORAL Prolixin C Zoloft C Date:10/08/98ISR Number: 3262016-0Report Type:Periodic Company Report #98-07-0168 Age:67 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Health Clozapine - Zenith Decreased Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 112-150 MG/DAY ORAL Date:10/08/98ISR Number: 3262020-2Report Type:Periodic Company Report #98-07-0176 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 300 MG/DAY ORAL Clozapine - Zenith 22-Feb-2006 08:30 AM Page: 185 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Goldline Pharm. Tablets SS Zenith Goldline Pharm. ORAL 300 MG/DAY ORAL Date:10/08/98ISR Number: 3262022-6Report Type:Periodic Company Report #98-07-0177 Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 200 MG/DAY ORAL Date:10/08/98ISR Number: 3262024-XReport Type:Periodic Company Report #98-07-0181 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Ineffective Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 400 MG/DAY ORAL Cogentin Tablets C Date:10/08/98ISR Number: 3262025-1Report Type:Periodic Company Report #98-07-0182 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Ineffective Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 300-400 MG/DAY ORAL Date:10/08/98ISR Number: 3262027-5Report Type:Periodic Company Report #98-07-0188 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abnormal Behaviour Health Clozapine - Zenith Sedation Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 750 MG/DAY ORAL Date:10/08/98ISR Number: 3262030-5Report Type:Periodic Company Report #98-07-0192 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Ineffective Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 800 MG/DAY ORAL 22-Feb-2006 08:30 AM Page: 186 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/08/98ISR Number: 3262032-9Report Type:Periodic Company Report #98-07-0193 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Ineffective Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 900 MG/DAY ORAL Date:10/08/98ISR Number: 3262036-6Report Type:Periodic Company Report #98-07-0200 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 75-400 MG/DAY ORAL Date:10/08/98ISR Number: 3262806-4Report Type:Periodic Company Report #98-08-0201 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozapine-Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 500 MG DAY ORAL Date:10/08/98ISR Number: 3262809-XReport Type:Periodic Company Report #98-08-0202 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Health Clozapine -Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm ORAL 75 MG DAY ORAL Zoloft C Ferrous Sulfate C Klorcon C Multivitamins C Date:10/08/98ISR Number: 3262812-XReport Type:Periodic Company Report #98-08-0203 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Ineffective Health Clozapine -Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm ORAL 50 MG DAY ORAL 22-Feb-2006 08:30 AM Page: 187 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/08/98ISR Number: 3262814-3Report Type:Periodic Company Report #98-08-0206 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Health Clozapine -Zenith Decreased Professional Goldline Pharm. Tablets PS Zentih Goldline Pharm. ORAL 37.5 MG DAY ORAL Date:10/08/98ISR Number: 3262817-9Report Type:Periodic Company Report #98-03-0054 Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Health Clozapine -Zenith Delusion Professional Goldline Pharm. Irritability Tablets PS Zenith Goldline Pharm. ORAL 800 MG DAY ORAL Date:10/08/98ISR Number: 3262819-2Report Type:Periodic Company Report #98-03-0053 Age:53 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Delusion Health Clozapine -Zenith Irritability Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 500 MG DAY ORAL Date:10/08/98ISR Number: 3262821-0Report Type:Periodic Company Report #98-03-0055 Age:46 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Delusion Health Clozapine -Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 400 MF PER DAY ORAL Date:10/08/98ISR Number: 3262824-6Report Type:Periodic Company Report #98-03-0061 Age:58 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Faecal Incontinence Health Clozapine -Zenith Oedema Peripheral Professional Goldline Pharm. Urinary Incontinence Tablets PS Zenith Goldline Pharm. ORAL 100-125 MG DAY ORAL Zyprexa C Lithium C Depakote C Coumadin C Lasix C 22-Feb-2006 08:30 AM Page: 188 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/08/98ISR Number: 3262828-3Report Type:Periodic Company Report #98-04-0078 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Ineffective Health Clozapine -Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm ORAL 500 MG DAY ORAL Neurontin C Date:10/08/98ISR Number: 3262832-5Report Type:Periodic Company Report #98-04-0079 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Health Clozapine -Zenith Drug Ineffective Professional Goldline Pharm. Fatigue Other Tablets PS Zenith Goldline Sedation Pharm. ORAL 300 MG BID ORAL Date:10/08/98ISR Number: 3262836-2Report Type:Periodic Company Report #98-04-0080 Age:49 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Ineffective Health Clozapine -Zenith Professional Goldline Pharm. Other Tablets PS Zenith Goldline Pharm. ORAL 225 MG TID ORAL Date:10/08/98ISR Number: 3262838-6Report Type:Periodic Company Report #98-04-0082 Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abnormal Behaviour Health Clozapine -Zenith Condition Aggravated Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm ORAL 312.5 MG DAY ORAL Date:10/08/98ISR Number: 3262840-4Report Type:Periodic Company Report #98-04-0083 Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abnormal Behaviour Health Clozapine -Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Phamr. ORAL 400 MG DAY ORAL Date:10/08/98ISR Number: 3262844-1Report Type:Periodic Company Report #98-04-0084 Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abnormal Behaviour Health Clozapine -Zenith Professional Goldline Pharm. 22-Feb-2006 08:30 AM Page: 189 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tablets PS Zenith Goldline Pharm. ORAL 900 MG DAY ORAL Date:10/08/98ISR Number: 3262846-5Report Type:Periodic Company Report #98-04-0085 Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abnormal Behaviour Health Clozapine -Zenith Condition Aggravated Professional Goldline Pharm. Tablets PS Zentih Goldline Pharm. ORAL 275 MG DAY ORAL Date:10/08/98ISR Number: 3262848-9Report Type:Periodic Company Report #98-05-0113 Age:70 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Health Clozapine -Zenith Decreased Professional Goldline Pharm. Tablets PS Zentih Goldline Pharm. ORAL 25 MG DAY ORAL Date:10/08/98ISR Number: 3262850-7Report Type:Periodic Company Report #98-05-0124 Age:41 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Health Clozapine -Zenith Fatigue Professional Goldline Pharm. Sedation Tablets PS Zenith Goldline Pharm. ORAL 400 MG PER DAY ORAL Paxil C Insulin C Claritin-D C Date:10/08/98ISR Number: 3262852-0Report Type:Periodic Company Report #98-05-0125 Age:37 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Ineffective Health Clozapine -Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL ORAL Date:10/09/98ISR Number: 3141084-0Report Type:Expedited (15-DaCompany Report #BR/98/02364/LEX Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agranulocytosis Health Leponex PS ORAL 600 MG ORAL Hospitalization - Pyrexia Professional Levothyroxine C Initial or Prolonged White Blood Cell Count Required Decreased Intervention to Prevent Permanent Impairment/Damage 22-Feb-2006 08:30 AM Page: 190 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/09/98ISR Number: 3141085-2Report Type:Expedited (15-DaCompany Report #USA/98/02361/LEX Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Chest Pain Health Clozaril PS ORAL 400 MG ORAL Infection Professional Antibiotics C Leukocytosis Cogentin C Lymphocyte Count Decreased Mass Neutrophilia White Blood Cell Count Increased Date:10/09/98ISR Number: 3142304-9Report Type:Expedited (15-DaCompany Report #GB/97/01023/LEX Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bacterial Infection Health Clozaril PS ORAL ORAL Bronchopneumonia Professional Gastroenteritis Salmonella Pneumonia Sepsis Date:10/13/98ISR Number: 3141727-1Report Type:Expedited (15-DaCompany Report #N/98/00189/LEX Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Leponex PS ORAL 10 G ORAL Required Loss Of Consciousness Professional Cipramil SS ORAL 40 MG ORAL 1 DAY Intervention to Metabolic Acidosis Prevent Permanent Muscle Spasms Impairment/Damage Overdose Respiratory Arrest Suicide Attempt Date:10/13/98ISR Number: 3141956-7Report Type:Direct Company Report # Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pyrexia Remeron PS 15 MG HS Initial or Prolonged White Blood Cell Count Clozaril SS 200 MG AM, Decreased 500 MG HS Date:10/13/98ISR Number: 3142118-XReport Type:Expedited (15-DaCompany Report #GB/98/00582/LEX Age:77 YR Gender:Female I/FU:F Outcome PT Death Abdominal Pain Required Anaemia Intervention to Arrhythmia Prevent Permanent Atrial Fibrillation Impairment/Damage Bronchopneumonia Cardiac Arrest Cardiac Failure Chest Pain Circulatory Collapse 22-Feb-2006 08:30 AM Page: 191 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Coronary Artery Disease Cyanosis Deep Vein Thrombosis Report Source Product Role Manufacturer Route Dose Duration Diarrhoea Study Clozaril PS ORAL 37.5MG ORAL Drug Tolerance Decreased Health Valproate Sodium C Dyspnoea Professional Digoxin C Electrocardiogram St Fybogel C Segment Depression Aspirin C Haemoglobin Decreased Olanzapine C Hypertension Questiepine C Myocardial Infarction Myocardial Ischaemia Myocarditis Pallor Pneumonia Pulmonary Embolism Shock Tachycardia Vasculitis Vomiting Date:10/13/98ISR Number: 3142123-3Report Type:Expedited (15-DaCompany Report #F/98/02184/LEX Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Grand Mal Convulsion Leponex PS ORAL ORAL Initial or Prolonged Hyponatraemia Minirin SS Required Status Epilepticus Intervention to Water Intoxication Prevent Permanent Impairment/Damage Date:10/13/98ISR Number: 3144560-XReport Type:Expedited (15-DaCompany Report #USA/98/02203/LEX Age:53 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Leukopenia Health Clozaril PS ORAL 325 MG ORAL Required Neutropenia Professional Cogentin C Intervention to Ovarian Cancer Klonopin C Prevent Permanent Diflucan C Impairment/Damage Reserpine C Florinef C Albuterol C Multi-Vitamins C Iron C Date:10/13/98ISR Number: 3144562-3Report Type:Expedited (15-DaCompany Report #USA/98/02202/LEX Age:50 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozaril PS ORAL 500 MG ORAL 3 YR Hospitalization - Renal Failure Chronic Professional Initial or Prolonged 22-Feb-2006 08:30 AM Page: 192 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/13/98ISR Number: 3144589-1Report Type:Expedited (15-DaCompany Report #USA/98/02373/LEX Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatitis Infectious Health Clozaril (Clozapine) PS ORAL 300 MG ORAL Jaundice Professional Vomiting Date:10/13/98ISR Number: 3144591-XReport Type:Expedited (15-DaCompany Report #USA/98/02384/LEX Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lymphoma Health Clozaril (Clozapine) PS ORAL 400 MG ORAL Professional Date:10/15/98ISR Number: 3142037-9Report Type:Expedited (15-DaCompany Report #USA/98/02388/LEX Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Health Clozaril PS ORAL 775 MG ORAL Initial or Prolonged Gastrointestinal Disorder Professional Depakote C Intestinal Obstruction Benadryl C Intestinal Perforation Date:10/15/98ISR Number: 3142039-2Report Type:Expedited (15-DaCompany Report #USA/98/02391/LEX Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Colon Cancer Health Clozaril PS ORAL 600 MG ORAL Professional Tavist C Diltiazem C Asa C Date:10/15/98ISR Number: 3142128-2Report Type:Expedited (15-DaCompany Report #USA/98/02386/LEX Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Choking Health Clozaril PS ORAL 400 MG; ORAL Dysphagia Professional Date:10/15/98ISR Number: 3142765-5Report Type:Direct Company Report # Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Lung Infiltration Health Clozaril PS ORAL PO BID Initial or Prolonged Pneumonia Professional White Blood Cell Count Decreased Date:10/16/98ISR Number: 3142876-4Report Type:Expedited (15-DaCompany Report #USA/98/02436/LEX Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Uterine Cancer Health Clozaril PS ORAL 200 MG ORAL Initial or Prolonged Vaginal Haemorrhage Professional 22-Feb-2006 08:30 AM Page: 193 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/16/98ISR Number: 3143074-0Report Type:Expedited (15-DaCompany Report #USA/98/02387/LEX Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Health Clozaril PS ORAL 25 MG ORAL Renal Failure Acute Professional Lithium SS Zyprexa C Date:10/16/98ISR Number: 3143076-4Report Type:Expedited (15-DaCompany Report #LIT/98/00259/LEX Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Literature Leponex PS ORAL 300 MG ORAL 2 MON Initial or Prolonged Anxiety Health Chloral Hydrate C Required Asthenia Professional Intervention to Blood Creatine Prevent Permanent Phosphokinase Increased Impairment/Damage Blood Creatine Phosphokinase Mb Increased Convulsion Fatigue Haemoglobin Decreased Haemoglobinuria Hallucination Hypokalaemia Hyponatraemia Leukocytosis Muscle Necrosis Myoglobinuria Polydipsia Psychogenic Polyuria Sedation Thirst Water Intoxication Date:10/16/98ISR Number: 3143135-6Report Type:Expedited (15-DaCompany Report #USA/98/02411/LEX Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Brain Neoplasm Benign Health Clozaril (Clozapine) PS ORAL 475MG ORAL Hypotonia Professional Dilantin C Muscular Weakness Zoloft C Urinary Tract Infection Cylert C Zyprexa C Prevacid C Milk Of Magnesia C Peri-Colace C Metamucil C Levofloxacin C Date:10/16/98ISR Number: 3143379-3Report Type:Direct Company Report # Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancreatitis Clozaril PS ORAL 200MG PO QD 2 WK Initial or Prolonged Pyrexia 22-Feb-2006 08:30 AM Page: 194 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/16/98ISR Number: 3143380-XReport Type:Direct Company Report # Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anticholinergic Syndrome Clozaril PS ORAL 250MG QD PO Cognitive Disorder Disturbance In Attention Date:10/19/98ISR Number: 3143584-6Report Type:Expedited (15-DaCompany Report #GB/98/00747/LEX Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Catatonia Health Clozaril PS ORAL 500 MG ORAL Other Coma Professional Required Convulsion Intervention to Mental Impairment Prevent Permanent Impairment/Damage Date:10/19/98ISR Number: 3143747-XReport Type:Expedited (15-DaCompany Report #LIT/98/00268/LEX Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Literature Clozaril PS ORAL 500 MG ORAL Initial or Prolonged Chorea Health Required Choreoathetosis Professional Intervention to Dyskinesia Prevent Permanent Dystonia Impairment/Damage Gait Disturbance Hallucination Hallucinations, Mixed Hyperhidrosis Restlessness Tremor Date:10/19/98ISR Number: 3143752-3Report Type:Expedited (15-DaCompany Report #USA/98/02435/LEX Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Cancer Female Health Clozaril PS ORAL 600 MG ORAL Professional Depakote C Anafranil C Vistaril C Date:10/20/98ISR Number: 3143819-XReport Type:Expedited (15-DaCompany Report #98-09-0228 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Gastrointestinal Health Clozapine PS ORAL 425 MG/DAY Haemorrhage Professional ORAL Cogentin C Multivitamins W/Minerals C Ativan C 22-Feb-2006 08:30 AM Page: 195 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/20/98ISR Number: 3143822-XReport Type:Expedited (15-DaCompany Report #98-09-0228 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Gastrointestinal Health Clozapine PS Zenith Goldline Haemorrhage Professional Pharm ORAL 425 MG/DAY ORAL Cogentin C Multivitamins W/Minerals C Ativan C Date:10/20/98ISR Number: 3143838-3Report Type:Expedited (15-DaCompany Report #98-09-0227 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Haemorrhagic Stroke Health Clozapine PS Zenith Goldline Initial or Prolonged Professional Pharm ORAL 350 MG; DAY ORAL Depakote C Phenobarbital C Pepcid C Calcium C Date:10/20/98ISR Number: 3143845-0Report Type:Expedited (15-DaCompany Report #USA/98/02460/LEX Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bronchospasm Health Clozaril PS ORAL 300 MG ORAL Required Hypertonia Professional Aspirin C Intervention to Muscle Rigidity Buspirone C Prevent Permanent Chloral Hydrate C Impairment/Damage Estradiol C Prozac C Furosemide C Leuprolide C Lithium C Propranolol C Risperidone C Simvastatin C Date:10/20/98ISR Number: 3143847-4Report Type:Expedited (15-DaCompany Report #F/98/02314/LEX Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypothyroidism Health Leponex PS ORAL 600 MG ORAL Initial or Prolonged Professional Tranxene C Date:10/20/98ISR Number: 3143850-4Report Type:Expedited (15-DaCompany Report #USA/98/02448/LEX Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Health Clozaril PS ORAL 300 MG ORAL Cardiomegaly Professional Zyprexa C Ativan C Multivitamins C 22-Feb-2006 08:30 AM Page: 196 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/20/98ISR Number: 3143853-XReport Type:Expedited (15-DaCompany Report #USA/98/02417/LEX Age:91 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Disorder Health Clorazil PS ORAL 175 MG ORAL Tracheitis Professional Pepcid C Laxative C Date:10/20/98ISR Number: 3143875-9Report Type:Expedited (15-DaCompany Report #USA/98/02440/LEX Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetic Ketoacidosis Health Clozaril PS ORAL 100 MG ORAL Hyperglycaemia Professional Zoloft SS ` Urinary Incontinence Date:10/20/98ISR Number: 3143887-5Report Type:Expedited (15-DaCompany Report #D/98/03761/LEX Age:70 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Haemoglobin Decreased Health Leponex PS ORAL 37.5 MG ORAL Initial or Prolonged Pancytopenia Professional Orfiril C Required Thrombocytopenia Lasix C Intervention to Tiklyd C Prevent Permanent Impairment/Damage Date:10/20/98ISR Number: 3143888-7Report Type:Expedited (15-DaCompany Report #LIT/98/00259/LEX Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Literature Leponex PS ORAL 300 MG ORAL 2 MON Initial or Prolonged Anxiety Health Chloral Hydrate C Asthenia Professional Blood Creatine Phosphokinase Increased Convulsion Fatigue Haemoglobin Decreased Hallucination Hypokalaemia Hyponatraemia Leukocytosis Muscle Necrosis Myoglobinuria Polydipsia Psychogenic Polyuria Sedation Thirst Urine Osmolarity Increased Water Intoxication 22-Feb-2006 08:30 AM Page: 197 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/20/98ISR Number: 3143890-5Report Type:Expedited (15-DaCompany Report #D/98/03407/LEX Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Health Leponex PS ORAL 200 MG ORAL Hyperglycaemia Professional Tofranil C Akineton C Date:10/21/98ISR Number: 3144242-4Report Type:Direct Company Report # Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Eosinophilic Myocarditis Clozapine PS ORAL 150 MG Q AM < 7/24; 150 MG PO BID > 7/24 Valproic Acid C Albuterol C Cefuroxime C Date:10/21/98ISR Number: 3144517-9Report Type:Expedited (15-DaCompany Report #GB/98/01045/LEX Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abdominal Pain Study Clozaril PS ORAL 900 MG ORAL Required Constipation Health Intervention to Intestinal Perforation Professional Prevent Permanent Leukocytosis Impairment/Damage Pyrexia Date:10/21/98ISR Number: 3144518-0Report Type:Expedited (15-DaCompany Report #LIT/98/00222/LEX Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agitation Foreign Clozaril PS ORAL 5000 MG ORAL 1 DAY Required Anticholinergic Syndrome Literature Intervention to Bowel Sounds Abnormal Health Prevent Permanent Drug Level Above Professional Impairment/Damage Therapeutic Heart Rate Increased Hypotension Intentional Overdose Sedation Sinus Tachycardia Suicide Attempt Date:10/21/98ISR Number: 3144519-2Report Type:Expedited (15-DaCompany Report #D/98/03983/LEX Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coma Health Leponex PS ORAL 2000 MG ORAL Hospitalization - Delirium Professional Initial or Prolonged Overdose Required Suicide Attempt Intervention to Prevent Permanent Impairment/Damage 22-Feb-2006 08:30 AM Page: 198 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/22/98ISR Number: 3145402-9Report Type:Expedited (15-DaCompany Report #I/98/00057/LEX Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psoriasis Health Leponex PS ORAL 300 MG ORAL Initial or Prolonged Professional Elopram C Required Intervention to Prevent Permanent Impairment/Damage Date:10/22/98ISR Number: 3145404-2Report Type:Expedited (15-DaCompany Report #LIT/98/00269/LEX Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chorea Literature Leponex PS ORAL 250 MG ORAL Initial or Prolonged Confusional State Health 3.5 MONTHS Required Dyskinesia Professional Fluvoxamine C Intervention to Hyperhidrosis Lorazepam C Prevent Permanent Speech Disorder Impairment/Damage Tardive Dyskinesia Tremor Vomiting Date:10/22/98ISR Number: 3145405-4Report Type:Expedited (15-DaCompany Report #LIT/98/00270/LEX Age:18 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Choreoathetosis Literature Leponex / Clozaril Initial or Prolonged Dyskinesia Health (Clozapine) PS ORAL 400 MG ORAL Required Dystonia Professional Risperidone Intervention to Nausea (Risperidone) SS 5 MG Prevent Permanent Opisthotonus Perphenazine Impairment/Damage Retching (Perphenazine) C Date:10/22/98ISR Number: 3145408-XReport Type:Expedited (15-DaCompany Report #USA/98/02247/LEX Age:47 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Leukocytosis Health Clozaril (Clozapine) PS ORAL 300 MG ORAL Myocarditis Professional Valproic Acid C Albuterol (Salbutamol) C Cefuroxime C Date:10/23/98ISR Number: 3146043-XReport Type:Expedited (15-DaCompany Report #GB/98/00843/LEX Age:52 YR Gender:Female I/FU:I Outcome PT Death Abdominal Distension Hospitalization - Abdominal Mass Initial or Prolonged Benign Ovarian Tumour Required Constipation Intervention to Faecaloma Prevent Permanent Intestinal Obstruction Impairment/Damage Neoplasm Pneumonia Uterine Leiomyoma 22-Feb-2006 08:30 AM Page: 199 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Vomiting Report Source Product Role Manufacturer Route Dose Duration Study Clozaril PS ORAL 800 MG; ORAL Health Lithium Carbonate C Professional Lisinopril C Procyclidine C Date:10/26/98ISR Number: 3147274-5Report Type:Expedited (15-DaCompany Report #USA/98/02487/LEX Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Intestinal Perforation Health Clozaril PS ORAL 550 MG ORAL Professional Actifed C Benadryl C Ativan C Risperdal C Cogentin C Date:10/26/98ISR Number: 3147302-7Report Type:Expedited (15-DaCompany Report #USA/98/02490/LEX Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Health Clozaril PS ORAL 700 MG ORAL Initial or Prolonged Muscle Contractions Professional Fentanyl SS Involuntary Ms-Contin SS Muscle Twitching Acetaminophen SS Cogentin C Dilantin C Date:10/26/98ISR Number: 3147347-7Report Type:Expedited (15-DaCompany Report #USA/98/02493/LEX Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Health Clozaril PS ORAL 700 MG ORAL Other Subarachnoid Haemorrhage Professional Date:10/26/98ISR Number: 3147439-2Report Type:Expedited (15-DaCompany Report #LIT/98/00270/LEX Age:18 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Literature Leponex PS ORAL 400MG ORAL Initial or Prolonged Choreoathetosis Health Risperidone SS ORAL 5MG ORAL Required Drug Withdrawal Syndrome Professional Perphenazine C Intervention to Dyskinesia Prevent Permanent Dystonia Impairment/Damage Movement Disorder Nausea Retching Date:10/26/98ISR Number: 3147440-9Report Type:Expedited (15-DaCompany Report #GB/98/01045/LEX Age:26 YR Gender:Male I/FU:F Outcome Life-Threatening Required 22-Feb-2006 08:30 AM Page: 200 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Intervention to Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Pain Foreign Clozaril PS ORAL 800MG ORAL Constipation Health Sertraeline C Large Intestine Professional Perforation Leukocytosis Peritonitis Pyrexia Vomiting White Blood Cell Count Increased Date:10/26/98ISR Number: 3147764-5Report Type:Expedited (15-DaCompany Report #USA/98/02481/LEX Age:24 MON Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Complications Of Maternal Health Clozaril (Clozapine) PS ORAL ORAL Exposure To Therapeutic Professional Drugs Congenital Anomaly Date:10/26/98ISR Number: 3147778-5Report Type:Expedited (15-DaCompany Report #F/98/02359/LEX Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Health Leponex (Clozapine) PS ORAL 200 MG ORAL Initial or Prolonged Phosphokinase Increased Professional Loxapac (Loxapine Required Blood Lactate Succinate) SS Intervention to Dehydrogenase Increased Prevent Permanent Impairment/Damage Date:10/26/98ISR Number: 3150729-0Report Type:Expedited (15-DaCompany Report #D/98/04118/LEX Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Health Leponex PS ORAL 400MG ORAL Initial or Prolonged Phosphokinase Increased Professional Risperdal C Cardiac Failure Euthyrox C Date:10/26/98ISR Number: 3150730-7Report Type:Expedited (15-DaCompany Report #USA/98/02494/LEX Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Injury Health Clozaril PS ORAL 500MG ORAL Road Traffic Accident Professional Date:10/26/98ISR Number: 3150732-0Report Type:Expedited (15-DaCompany Report #USA/98/01790/LEX Age: Gender:Female I/FU:F Outcome PT Other Agranulocytosis Breast Cancer Female Liver Disorder 22-Feb-2006 08:30 AM Page: 201 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report White Blood Cell Count Decreased Report Source Product Role Manufacturer Route Dose Duration Health Clozaril PS ORAL 325MG ORAL 4 YR Professional Chemptherapy C Date:10/27/98ISR Number: 3148366-7Report Type:Expedited (15-DaCompany Report #98-08-0209 Age:51 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Gases Abnormal Health Clozapine PS Zenith Goldline Hospitalization - Bronchospasm Professional Pharm ORAL 150 MG/DAY Initial or Prolonged Chest X-Ray Abnormal ORAL TAB Cough Colace C Dyspnoea Lorazepam C Pneumonia Primary Milk Of Magnesia C Atypical Glycerin Postnasal Drip Suppositories C Respiratory Failure Westcort Cream C Sinus Congestion Duricef C Total Lung Capacity Decreased Upper Respiratory Tract Infection Date:10/29/98ISR Number: 3149895-2Report Type:Direct Company Report # Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required White Blood Cell Count Clozapine PS 200 MG BID Intervention to Decreased INCREASED TO Prevent Permanent 300 MG / PM Impairment/Damage Date:10/30/98ISR Number: 3149793-4Report Type:Expedited (15-DaCompany Report #97-05-0356 Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Foreign Intron A (Interferon Hospitalization - Angina Pectoris Literature Alfa-2b Recombinant Initial or Prolonged Cellulitis Health Soluble Powder PS SUBCUTANEOUS 5 MU TIW Other Condition Aggravated Professional SUBCUTANEOUS Dyspnoea Leponex Tablets SS ORAL 100-250 MG QD Laryngeal Oedema ORAL Leukopenia Lymphadenopathy Odynophagia Pyrexia Respiratory Failure Sepsis Staphylococcal Infection Streptococcal Infection Thrombocytopenia 22-Feb-2006 08:30 AM Page: 202 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/30/98ISR Number: 3150377-2Report Type:Expedited (15-DaCompany Report #D/98/04073/LEX Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Level Above Health Leponex PS ORAL 400 MG ORAL Therapeutic Professional Suicide Attempt Date:10/30/98ISR Number: 3150449-2Report Type:Expedited (15-DaCompany Report #GB/98/00843/LEX Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Distension Study Clozaril PS ORAL 800 MG ORAL Hospitalization - Abdominal Mass Health Lisinopril C Initial or Prolonged Benign Ovarian Tumour Professional Procyclidine C Required Condition Aggravated Lithium Carbonate C Intervention to Constipation Prevent Permanent Faecaloma Impairment/Damage Intestinal Obstruction Neoplasm Pneumonia Uterine Leiomyoma Vomiting Date:10/30/98ISR Number: 3150472-8Report Type:Expedited (15-DaCompany Report #USA/98/02531/LEX Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cerebrovascular Accident Health Clozaril PS ORAL 750 MG ORAL 3 YR Cerebrovascular Disorder Professional Depakote C Coma Cogentin C Convulsion Synthroid C Diabeta C Aspirin C Date:10/30/98ISR Number: 3150476-5Report Type:Expedited (15-DaCompany Report #USA/98/02328/LEX Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Clozaril PS ORAL UNSPECIFIED Initial or Prolonged Diabetes Mellitus Professional ORAL Fall Insulin C Spinal Fracture Syncope Date:11/03/98ISR Number: 3151401-3Report Type:Expedited (15-DaCompany Report #98-10-0238 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Ascites Health Clozapine PS Zenith Goldine Pharm ORAL 100MG/DAY Hospitalization - Cardiac Arrest Professional ORAL; 150 Initial or Prolonged Oedema MG/DAY ORAL Sleep Apnoea Syndrome Catapres C Trihexyphenidyl C Ventolin C Vanceril C 22-Feb-2006 08:30 AM Page: 203 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/98ISR Number: 3151403-7Report Type:Expedited (15-DaCompany Report #98-09-0228 Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Gastric Ulcer Health Clozapine PS Zenith Goldline Gastritis Professional Pharm ORAL 425MG/DAY Gastrointestinal ORAL Haemorrhage Cogentin C Multivitamins W/Minerals C Ativan C Date:11/03/98ISR Number: 3151404-9Report Type:Expedited (15-DaCompany Report #98-10-0241 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline Professional Pharm ORAL 125MG/DAY ORAL Date:11/03/98ISR Number: 3151406-2Report Type:Expedited (15-DaCompany Report #98-10-0235 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Health Clozapine PS Zenith Goldline Failure To Thrive Professional Pharm. ORAL 25MG/DAY ORAL Sinemet C Zantac C Dolobid C Date:11/03/98ISR Number: 3152178-8Report Type:Expedited (15-DaCompany Report #USA/98/02555/LEX Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acute Respiratory Health Clozaril PS ORAL ORAL Initial or Prolonged Distress Syndrome Professional Date:11/03/98ISR Number: 3152225-3Report Type:Expedited (15-DaCompany Report #D/98/03761/LEX Age:70 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Erythropenia Health Leponex (Clozapine) PS ORAL 37.5 MG ORAL Initial or Prolonged Leukopenia Professional Orfiril C Required Pancytopenia Lasix C Intervention to Tiklyd C Prevent Permanent Impairment/Damage Date:11/03/98ISR Number: 3152226-5Report Type:Expedited (15-DaCompany Report #D/98/02955/LEX Age:46 YR Gender:Female I/FU:F Outcome Life-Threatening Hospitalization - Initial or Prolonged Required Intervention to 22-Feb-2006 08:30 AM Page: 204 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Angina Pectoris Health Leponex (Clozapine) PS ORAL 300 MG ORAL Asthenia Professional Amaryl C Cachexia Acerbon C Cough Fatigue Influenza Like Illness Pancytopenia Pyrexia Tonsillitis Date:11/03/98ISR Number: 3152229-0Report Type:Expedited (15-DaCompany Report #LIT/98/00269/LEX Age:37 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Literature Leponex /Clozaril Initial or Prolonged Confusional State Health (Clozapine) PS ORAL 250 MG ORAL 4 MON Required Disorientation Professional Fluvoxamine C Intervention to Drug Withdrawal Syndrome Lorazepam C Prevent Permanent Dyskinesia Impairment/Damage Hyperhidrosis Speech Disorder Tremor Vomiting Date:11/03/98ISR Number: 3152233-2Report Type:Expedited (15-DaCompany Report #USA/98/02460/LEX Age:41 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bronchospasm Health Clozaril (Clozapine) PS ORAL 300 MG ORAL Required Hypertonia Professional Anectine Intervention to Muscle Rigidity (Suxamethonium Prevent Permanent Chloride) SS Impairment/Damage Aspirin C Buspirone C Chloral Hydrate C Estradiol C Prozac C Furosemide C Leuprolide C Lithium C Propranolol C Risperidone C Simvastatin C Date:11/03/98ISR Number: 3152234-4Report Type:Expedited (15-DaCompany Report #CDN/98/00785/LEX Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Embolism Study Clozaril (Clozapine) PS ORAL ORAL Initial or Prolonged Leg Amputation Health Professional 22-Feb-2006 08:30 AM Page: 205 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/04/98ISR Number: 3151773-XReport Type:Expedited (15-DaCompany Report #D/98/04073/LEX Age:20 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Leponex PS ORAL 500 MG ORAL Drug Level Above Professional Therapeutic Electroencephalogram Abnormal Extrapyramidal Disorder Hepatic Function Abnormal Liver Function Test Abnormal Date:11/04/98ISR Number: 3151775-3Report Type:Expedited (15-DaCompany Report #USA/98/02569/LEX Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozaril PS ORAL 500 MG ORAL Required Lung Neoplasm Malignant Professional Effexor C Intervention to Lamictal C Prevent Permanent Synthroid C Impairment/Damage Date:11/04/98ISR Number: 3151849-7Report Type:Direct Company Report # Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Grand Mal Convulsion Clozapine PS ORAL 6.25MG PO HS Required Sinemet C Intervention to Potassium Chloride C Prevent Permanent Benazepril C Impairment/Damage Donepazil C Date:11/04/98ISR Number: 3152172-7Report Type:Expedited (15-DaCompany Report #LIT/98/00273/LEX Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Constipation Literature Leponex / Clozaril PS ORAL 350 MG ORAL Drug Level Above Health Therapeutic Professional Ejaculation Disorder Erectile Dysfunction Micturition Disorder Date:11/05/98ISR Number: 3152351-9Report Type:Expedited (15-DaCompany Report #9835427 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetic Ketoacidosis Consumer Zoloft PS Enuresis Health Clozaril SS ORAL 100.00 MG Hyperglycaemia Professional TOTAL ORAL 22-Feb-2006 08:30 AM Page: 206 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/05/98ISR Number: 3152746-3Report Type:Expedited (15-DaCompany Report #USA/98/02361/LEX Age:39 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Chest Pain Health Clozaril (Clozapine) PS ORAL 400 MG ORAL Infection Professional Antibiotics C Leukocytosis Cogentin C Lymphocyte Count Decreased Mass Neutrophilia Date:11/05/98ISR Number: 3152747-5Report Type:Expedited (15-DaCompany Report #USA/98/02589/LEX Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Disorder Health Clozaril (Clozapine) PS ORAL 450 MG ORAL Initial or Prolonged Cardiac Failure Professional Benadryl C Required Congestive Intervention to Cardiomegaly Prevent Permanent Impairment/Damage Date:11/05/98ISR Number: 3152748-7Report Type:Expedited (15-DaCompany Report #USA/98/02587/LEX Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Malignant Ovarian Cyst Health Clozaril (Clozapine) PS ORAL 800 MG ORAL Ovarian Cancer Professional Date:11/05/98ISR Number: 3152750-5Report Type:Expedited (15-DaCompany Report #LIT/98/00279/LEX Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electroencephalogram Literature Leponex/Clozaril Initial or Prolonged Abnormal Health (Clozapine) PS ORAL 200 MG ORAL 6 MON Grand Mal Convulsion Professional Date:11/05/98ISR Number: 3152751-7Report Type:Expedited (15-DaCompany Report #LIT/98/00280/LEX Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Literature Leponex/Clozaril Grand Mal Convulsion Health (Clozapine) PS ORAL 12.5 MG ORAL 4 DAY Professional Ciprofloxacin (Ciprofloxacin) SS ORAL 500 MG ORAL Sinemet C Oxazepam C Naproxen C Allopurinol C Date:11/05/98ISR Number: 3152915-2Report Type:Expedited (15-DaCompany Report #USA/98/02154/LEX Age:58 YR Gender:Male I/FU:F Outcome Hospitalization - Initial or Prolonged 22-Feb-2006 08:30 AM Page: 207 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Disability Required Intervention to PT Report Source Product Role Manufacturer Route Dose Duration Prevent Permanent Blood Glucose Increased Health Clozaril (Clozapine) PS ORAL 450 MG ORAL Impairment/Damage Cerebrovascular Disorder Professional Fortaz C Delirium Valium C Dyspnoea Aspirin C Gallbladder Disorder Tolvin C Hemianopia Inderal-La C Hyperhidrosis Peri-Colace C Lethargy Leukocytosis Neutrophilia Nuclear Magnetic Resonance Imaging Brain Abnormal Pyrexia Sedation Speech Disorder Tachycardia Date:11/05/98ISR Number: 3152922-XReport Type:Expedited (15-DaCompany Report #D/98/03407/LEX Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Glucose Increased Health Leponex PS ORAL 200 MG ORAL Diabetes Mellitus Professional Tofranil C Glycosylated Haemoglobin Akineton C Increased Date:11/06/98ISR Number: 3153244-3Report Type:Direct Company Report # Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Clozapine PS ESCALATING Cardiac Output Decreased Professional DOSAGE TO 200 Cardiomegaly MG Ejection Fraction Prolixin C Abnormal Lithium C Eosinophilia Vistaril C Myocarditis Cipro C Pyrexia Renal Failure Date:11/09/98ISR Number: 3153659-3Report Type:Direct Company Report # Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Grand Mal Convulsion Clozapine PS Novartis 575 MG QD HAS Hospitalization - TAKEN SEVERAL Initial or Prolonged YEARS. YR Depokate C Ditropan C Micronase C Lopid C Zantac C Lactulose C Colace C 22-Feb-2006 08:30 AM Page: 208 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Synthroid C Ferrous Sulfate C Vitamin C C Date:11/09/98ISR Number: 3154705-3Report Type:Expedited (15-DaCompany Report #USA/98/02602/LEX Age:74 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Lymphoma Health Clozaril PS ORAL 187.5 MG Required Professional ORAL; MANY Intervention to YEARS Prevent Permanent Hydrochlorothiazide C Impairment/Damage Carbidopa C Levodopa C Date:11/09/98ISR Number: 3154714-4Report Type:Expedited (15-DaCompany Report #GB/98/01079/LEX Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Brain Neoplasm Malignant Health Clozaril PS ORAL 350 MG ORAL Required Professional Intervention to Prevent Permanent Impairment/Damage Date:11/12/98ISR Number: 3156557-4Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Balance Disorder Clozapine PS ORAL 250MG DAILY Intervention to Difficulty In Walking Prevent Permanent Hypoaesthesia Impairment/Damage Insomnia Movement Disorder Nausea Restlessness Date:11/12/98ISR Number: 3156615-4Report Type:Expedited (15-DaCompany Report #LIT/98/00269/LEX Age:37 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Choreoathetosis Literature Leponex PS ORAL 250 MG ORAL Initial or Prolonged Confusional State Health 3.5 MONTHS Required Drug Withdrawal Syndrome Professional Fluvoxamine C Intervention to Dyskinesia Lorazepam C Prevent Permanent Hyperhidrosis Impairment/Damage Speech Disorder Tardive Dyskinesia Tremor Vomiting 22-Feb-2006 08:30 AM Page: 209 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/12/98ISR Number: 3156634-8Report Type:Expedited (15-DaCompany Report #SKA/98/00551/LEX Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Respiratory Health Clozapine PS ORAL 500 MG ORAL Required Distress Syndrome Professional Trimepranol C Intervention to Agranulocytosis Prothazin C Prevent Permanent Multi-Organ Failure Endiaron C Impairment/Damage Pneumonia Timoptol C Pulmonary Oedema Celaskon C Pyrexia Respiratory Failure Sepsis Shock Date:11/12/98ISR Number: 3156636-1Report Type:Expedited (15-DaCompany Report #CDN/98/00785/LEX Age:63 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arterial Thrombosis Limb Study Clozapine PS ORAL 125 MG ORAL Initial or Prolonged Leg Amputation Health Lithium Carbonate C Professional Date:11/13/98ISR Number: 3157030-XReport Type:Expedited (15-DaCompany Report #D/98/04349/LEX Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dystonia Study Leponex PS ORAL 500MG ORAL Initial or Prolonged Posture Abnormal Health Hypnorex SS 600MG Required Professional Bifiteral C Intervention to Sostril C Prevent Permanent Impairment/Damage Date:11/13/98ISR Number: 3157877-XReport Type:Direct Company Report # Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Vomiting Cloazapine PS Zenith Goldline ORAL 225 MG/DAY ORAL Haloperidol C Cogentin C Date:11/16/98ISR Number: 3158083-5Report Type:Expedited (15-DaCompany Report #SKA/98/00551/LEX Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Respiratory Health Leponex PS ORAL 500 MG ORAL Required Distress Syndrome Professional Trimepranol C Intervention to Agranulocytosis Prothazin C Prevent Permanent Bronchopneumonia Endiaron C Impairment/Damage Multi-Organ Failure Timoptol C Pulmonary Oedema Celaskon C Pyrexia Respiratory Failure Sepsis Shock 22-Feb-2006 08:30 AM Page: 210 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/16/98ISR Number: 3158247-0Report Type:Expedited (15-DaCompany Report #USA/98/02377/LEX Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Health Clozaril PS ORAL 600 MG ORAL Initial or Prolonged Tachycardia Professional Paxil SS ORAL 20 MG ORAL Required Propulsid SS ORAL 80 MG ORAL Intervention to Prilosec C Prevent Permanent Impairment/Damage Date:11/16/98ISR Number: 3158264-0Report Type:Expedited (15-DaCompany Report #USA/98/02640/LEX Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Cancer Female Health Clozaril PS ORAL 525 MG Required Professional Zoloft (Sertraline Intervention to Hydrochloride) C Prevent Permanent Colace (Docusate Impairment/Damage Sodium) C Pepcid (Famotidine) C Ditropan C Gaviscon (Gaviscon Tablet) C Date:11/17/98ISR Number: 3158208-1Report Type:Expedited (15-DaCompany Report #98-10-0242 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline Professional Pharm. ORAL 225 MG/DAY ORAL Date:11/17/98ISR Number: 3158211-1Report Type:Expedited (15-DaCompany Report #98-10-0240 Age:92 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cachexia Health Clozapine PS Zenith Goldline Professional Pharm. ORAL 25MG/DAY ORAL Morphine C Date:11/17/98ISR Number: 3158250-0Report Type:Expedited (15-DaCompany Report #D/98/03407/LEX Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Glucose Increased Health Leponex (Clozapine) PS ORAL 200MG ORAL Diabetes Mellitus Professional Tofranil C Glycosylated Haemoglobin Akineton C Increased Date:11/17/98ISR Number: 3158610-8Report Type:Expedited (15-DaCompany Report #USA/98/02384/LEX Age:40 YR Gender:Female I/FU:F Outcome PT Death Adenocarcinoma Benign Mediastinal Neoplasm 22-Feb-2006 08:30 AM Page: 211 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Condition Aggravated Cough Dyspnoea Report Source Product Role Manufacturer Route Dose Duration Lymphoma Health Clozaril (Clozapine) PS ORAL 400 MG ORAL Malaise Professional Zyprexa C Pulmonary Embolism Ativan C Date:11/17/98ISR Number: 3158611-XReport Type:Expedited (15-DaCompany Report #USA/98/02656/LEX Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Health Clozaril (Clozapine) PS ORAL 200 MG ORAL Initial or Prolonged Condition Aggravated Professional Biaxin Required Confusional State (Clarithromycin) SS Intervention to Delirium Zinacef (Cefuroxime) SS Prevent Permanent Drug Interaction Depakote (Valproate Impairment/Damage Drug Level Above Semisodium) SS Therapeutic Synthroid C Encephalopathy Isordil C Lasix C Prempro C Isordil C Date:11/17/98ISR Number: 3158624-8Report Type:Expedited (15-DaCompany Report #SKA/98/00551/LEX Age:51 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Respiratory Health Leponex PS ORAL 500 MG ORAL Required Distress Syndrome Professional Trimepranol C Intervention to Agranulocytosis Prothazin C Prevent Permanent Multi-Organ Failure Endiaron C Impairment/Damage Pneumonia Timoptol C Pulmonary Oedema Celaskon C Pyrexia Respiratory Failure Sepsis Shock Date:11/17/98ISR Number: 3158625-XReport Type:Expedited (15-DaCompany Report #USA/98/02689/LEX Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Health Clozaril PS ORAL 400 MG ORAL Professional Date:11/17/98ISR Number: 3158627-3Report Type:Expedited (15-DaCompany Report #A/96/00001/LEX Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Leponex PS ORAL 400 MG ORAL Required Laryngeal Oedema Professional Neurotop Ret SS ORAL 600 MG ORAL Intervention to Multi-Organ Failure Quilonom Ret C Prevent Permanent Pharyngolaryngeal Pain Seropram C Impairment/Damage Pyrexia Sepsis 22-Feb-2006 08:30 AM Page: 212 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/18/98ISR Number: 3159599-8Report Type:Expedited (15-DaCompany Report #98-10-0247 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Atrial Fibrillation Health Clozapine PS ORAL 825-900MG/DAY Respiratory Arrest Professional ORAL Lithium C Date:11/19/98ISR Number: 3160488-3Report Type:Expedited (15-DaCompany Report #USA/98/02707/LEX Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Non-Hodgkin'S Lymphoma Health Clozaril PS ORAL UNSPECIFIED Professional ORAL Date:11/19/98ISR Number: 3160564-5Report Type:Expedited (15-DaCompany Report #F/98/02184/LEX Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Grand Mal Convulsion Foreign Leponex (Clozapine) PS ORAL 600 MG ORAL Initial or Prolonged Hyponatraemia Ditropan SS ORAL 15 MG ORAL Required Status Epilepticus Minirin C Intervention to Prevent Permanent Impairment/Damage Date:11/20/98ISR Number: 3160572-4Report Type:Expedited (15-DaCompany Report #98-10-0252 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Parkinson'S Disease Health Clozapine PS Zenith Goldline Professional Pharm. ORAL 25MG/DAY ORAL Date:11/20/98ISR Number: 3160574-8Report Type:Expedited (15-DaCompany Report #98-10-0249 Age:92 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine PS Zenith Goldline Professional Pharm. ORAL 25MG DAY ORAL Ipratropium Inhaler C Nitro-Dur 0.6mg/Hr C Multivitamins C Aspirin Baby C Tylenol C Suppositories Prn C Date:11/20/98ISR Number: 3160801-7Report Type:Expedited (15-DaCompany Report #USA/98/0753/LEX Age:39 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Leukopenia Consumer Clozaril PS ORAL 500 MG ORAL Pulmonary Embolism Health Professional 22-Feb-2006 08:30 AM Page: 213 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/23/98ISR Number: 3161583-5Report Type:Expedited (15-DaCompany Report #USA/98/02695/LEX Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Rectal Prolapse Health Clozaril PS ORAL 200 MG ORAL Initial or Prolonged Weight Increased Professional Prozac C Depakote C Zyprexa C Colace C Reglan C Date:11/23/98ISR Number: 3161584-7Report Type:Expedited (15-DaCompany Report #GB/98/00140/LEX Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Health Clozaril PS ORAL 150 MG ORAL Required Ketoacidosis Professional Seroxat C Intervention to Benzhexol C Prevent Permanent Impairment/Damage Date:11/23/98ISR Number: 3161585-9Report Type:Expedited (15-DaCompany Report #USA/98/02589/LEX Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Health Clozaril PS ORAL 450 MG ORAL Initial or Prolonged Congestive Professional Benadryl C Required Cardiomegaly Intervention to Cardiomyopathy Prevent Permanent Red Blood Cell Impairment/Damage Sedimentation Rate Increased Date:11/23/98ISR Number: 3161721-4Report Type:Expedited (15-DaCompany Report #A/96/00001/LEX Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Leponex PS ORAL 400 MG ORAL Hospitalization - Laryngeal Oedema Professional Neurotop Ret SS ORAL 600 MG ORAL Initial or Prolonged Multi-Organ Failure Quilonom Ret C Required Pharyngitis Seropram C Intervention to Sepsis Prevent Permanent Impairment/Damage Date:11/23/98ISR Number: 3161722-6Report Type:Expedited (15-DaCompany Report #N/98/00189/LEX Age:35 YR Gender:Female I/FU:F Outcome PT Death Blood Ph Decreased Required Cardiac Arrest Intervention to Completed Suicide Prevent Permanent Drug Level Above Impairment/Damage Therapeutic Loss Of Consciousness Metabolic Acidosis Muscle Spasms Overdose 22-Feb-2006 08:30 AM Page: 214 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Respiratory Depression Report Source Product Role Manufacturer Route Dose Duration Health Leponex (Clozapine) PS ORAL 10 G ORAL Professional Cipramil (Citalopram) SS ORAL 40 MG ORAL 1 DAY Date:11/24/98ISR Number: 3161845-1Report Type:Expedited (15-DaCompany Report #98-10-0238 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Ascites Health Clozapine PS Zenith Goldline Hospitalization - Asthma Professional Pharm ORAL 100MG/DAY Initial or Prolonged Cardiac Arrest ORAL Cardiac Disorder Clozapine SS ORAL 150MG/DAY Cardiac Failure ORAL Congestive Combivent SS ORAL BID ORAL AER Drooling INH Dyspnoea Catapres C Oedema Trihexyphenidyl C Sleep Apnoea Syndrome Ventolin Inhaler C Swelling Vanceril C Date:11/24/98ISR Number: 3161847-5Report Type:Expedited (15-DaCompany Report #98-09-0227 Age:57 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Brain Neoplasm Malignant Health Clozapine PS Zenith Coldline Hospitalization - Brain Oedema Professional Pharm. ORAL 150-350MG/DAY Initial or Prolonged Haemorrhagic Stroke ORAL Depakote C Phenobarbital C Pepcid C Calcium C Date:11/24/98ISR Number: 3275959-9Report Type:Periodic Company Report #USA/98/02009/LEX Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperglycaemia Health Clozaril (Clozapine) PS ORAL 200 MG ORAL Required Professional Hydrochlorothiazide C Intervention to Pepcid C Prevent Permanent Benadryl C Impairment/Damage Clonidine C Vitamin C C Vitamin D C Date:11/24/98ISR Number: 3275963-0Report Type:Periodic Company Report #USA/98/02007/LEX Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Clozaril (Clozapine) PS ORAL 200 MG ORAL 22-Feb-2006 08:30 AM Page: 215 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/24/98ISR Number: 3275966-6Report Type:Periodic Company Report #USA/98/01983/LEX Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dizziness Health Clozaril (Clozapine) PS ORAL 400 MG (ON Initial or Prolonged Dyspnoea Professional CLOZARIL Fall SINCE JAN Overdose 1992) ORAL Date:11/24/98ISR Number: 3275969-1Report Type:Periodic Company Report #USA/98/01958/LEX Age:83 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) PS ORAL 13 MG ORAL Professional Date:11/24/98ISR Number: 3275972-1Report Type:Periodic Company Report #USA/98/01938/LEX Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Tachycardia Health Clozaril (Clozapine) PS ORAL 300 MG ORAL 3 WK Initial or Prolonged Professional Required Intervention to Prevent Permanent Impairment/Damage Date:11/24/98ISR Number: 3275975-7Report Type:Periodic Company Report #USA/98/01929/LEX Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Health Clozaril (Clozapine) PS ORAL 200 MG ORAL Initial or Prolonged Hepatic Function Abnormal Professional Synthroid C Pulmonary Embolism Depakote C Vitamin B12 C Prinivil C Prevacid C Date:11/24/98ISR Number: 3275978-2Report Type:Periodic Company Report #USA/98/01910/LEX Age:33 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anticholinergic Syndrome Health Clozaril (Clozapine) PS ORAL 600 MG ORAL Initial or Prolonged Convulsion Professional Depakote C Inderal C Vivactil C Date:11/24/98ISR Number: 3275980-0Report Type:Periodic Company Report #USA/98/01899/LEX Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pain Health Clozaril (Clozapine) PS ORAL 100 MG ORAL Initial or Prolonged Sedation Professional Lorazepam C Required White Blood Cell Disorder Intervention to Prevent Permanent Impairment/Damage 22-Feb-2006 08:30 AM Page: 216 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/24/98ISR Number: 3275982-4Report Type:Periodic Company Report #USA/98/01900/LEX Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Clozaril (Clozapine) PS ORAL 300 MG ORAL Initial or Prolonged White Blood Cell Count Professional Abnormal Date:11/24/98ISR Number: 3275986-1Report Type:Periodic Company Report #USA/98/01893/LEX Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Constipation Health Clozaril (Clozapine) PS ORAL 50 MG TO 500 Required Delusion Professional MG ORAL Intervention to Dizziness Fludrocortisone C Prevent Permanent Haematemesis Albuterol C Impairment/Damage Hypotension Atrovent C Leukocytosis Triamcinolone C Ativan C Pepcid C Beclovent C Sorbitol C Milk Of Magnesia C Cascara C Metamucil C Colace C Benadryl C Tylenol C Date:11/24/98ISR Number: 3275989-7Report Type:Periodic Company Report #USA/98/01867/LEX Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Confusional State Health Clozaril (Clozapine) PS ORAL 350 MG ORAL Convulsion Professional Risperdal C Deafness Pollakiuria Speech Disorder Visual Disturbance Date:11/24/98ISR Number: 3275992-7Report Type:Periodic Company Report #USA/98/01865/LEX Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Myocardial Infarction Health Clozaril (Clozapine) PS ORAL UNSPECIFIED Initial or Prolonged Professional ORAL Date:11/24/98ISR Number: 3275995-2Report Type:Periodic Company Report #USA/98/01833/LEX Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Clozaril (Clozapine) PS ORAL 800 MG ORAL Initial or Prolonged Mental Retardation Professional Atenolol C Required Severity Unspecified Lopid C Intervention to Loxapine C Prevent Permanent Cogentin C Impairment/Damage Restoril C Dilantin C 22-Feb-2006 08:30 AM Page: 217 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Surfak C Depakote C Neurontin C Date:11/24/98ISR Number: 3275998-8Report Type:Periodic Company Report #USA/98/01820/LEX Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Health Clozaril (Clozapine) PS ORAL 600 MG ORAL Initial or Prolonged Drug Level Above Professional Luvox (Fluvoxamine Required Therapeutic Maleate) SS Intervention to Psychotic Disorder Prevent Permanent Impairment/Damage Date:11/24/98ISR Number: 3276001-6Report Type:Periodic Company Report #USA/98/01783/LEX Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozaril (Clozapine) PS ORAL 400 MG ORAL Professional Company Representative Date:11/24/98ISR Number: 3276003-XReport Type:Periodic Company Report #USA/98/01759/LEX Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Health Clozaril (Clozapine) PS ORAL 175 MG ORAL Initial or Prolonged Professional Depakote C Required Intervention to Prevent Permanent Impairment/Damage Date:11/24/98ISR Number: 3276004-1Report Type:Periodic Company Report #USA/98/01703/LEX Age:86 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozaril) PS ORAL 12.5 MG ORAL Professional Date:11/24/98ISR Number: 3276007-7Report Type:Periodic Company Report #USA/98/01693/LEX Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Health Clozaril (Clozapine) PS ORAL 400 MG ORAL 1 YR Required Professional Klonopin C Intervention to Ditropan C Prevent Permanent Impairment/Damage 22-Feb-2006 08:30 AM Page: 218 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/24/98ISR Number: 3276008-9Report Type:Periodic Company Report #USA/98/01660/LEX Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Health Clozaril (Clozapine) PS ORAL 425 MG ORAL Required Professional Wellbutrin C Intervention to Seroquel C Prevent Permanent Cogentin C Impairment/Damage Glucophage C Date:11/24/98ISR Number: 3276009-0Report Type:Periodic Company Report #USA/98/01661/LEX Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bronchitis Health Clozaril (Clozapine) PS ORAL 150 MG ORAL Initial or Prolonged Pyrexia Professional Required Intervention to Prevent Permanent Impairment/Damage Date:11/24/98ISR Number: 3276021-1Report Type:Periodic Company Report #USA/98/01653/LEX Age:83 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozaril (Clozapine) PS ORAL 25 MG ORAL Hospitalization - Professional Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage Date:11/24/98ISR Number: 3276024-7Report Type:Periodic Company Report #USA/98/01643/LEX Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Health Clozaril (Clozapine) PS ORAL 200 MG ORAL Initial or Prolonged Asthenia Professional Ativan C Chest Pain Paxil C Dermatitis Zyrtec C Pharyngitis Medrol C Salivary Hypersecretion Sedation Urinary Incontinence Date:11/24/98ISR Number: 3276029-6Report Type:Periodic Company Report #USA/98/01647/LEX Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) PS ORAL ORAL Professional 22-Feb-2006 08:30 AM Page: 219 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/24/98ISR Number: 3276030-2Report Type:Periodic Company Report #USA/98/01629/LEX Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Health Clozaril (Clozapine) PS ORAL 350 MG ORAL 2 YR Professional Date:11/24/98ISR Number: 3276031-4Report Type:Periodic Company Report #USA/98/01617/LEX Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) PS ORAL 250 MG ORAL Professional Date:11/24/98ISR Number: 3276033-8Report Type:Periodic Company Report #USA/98/01618/LEX Age:95 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) PS ORAL 19 MG ORAL Professional Date:11/24/98ISR Number: 3276036-3Report Type:Periodic Company Report #USA/98/01608/LEX Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Health Clozaril (Clozapine) PS ORAL ORAL Initial or Prolonged Professional Date:11/24/98ISR Number: 3276038-7Report Type:Periodic Company Report #USA/98/01603/LEX Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Health Clozaril (Clozapine) PS ORAL 600 MG ORAL Initial or Prolonged Gait Disturbance Professional Lipitor C Required Hypotension Norvasc C Intervention to Muscular Weakness Atenolol C Prevent Permanent Labetalol C Impairment/Damage K-Dur C Zantac C Reglan C Cogentin C Date:11/24/98ISR Number: 3276040-5Report Type:Periodic Company Report #USA/98/01598/LEX Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Clozaril (Clozapine) PS ORAL 450 MG ORAL Fall Professional Zyprexa C Fracture Tremor 22-Feb-2006 08:30 AM Page: 220 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/24/98ISR Number: 3276042-9Report Type:Periodic Company Report #USA/98/01595/LEX Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Health Clozaril (Clozapine) PS ORAL 700 MG ORAL Professional Pepcid C Navane C Date:11/24/98ISR Number: 3276045-4Report Type:Periodic Company Report #USA/98/01557/LEX Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Study Clozaril (Clozapine) PS ORAL 700 MG ORAL 5 YR Health Professional Date:11/24/98ISR Number: 3276046-6Report Type:Periodic Company Report #USA/98/01527/LEX Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Respiratory Distress Health Clozaril (Clozapine) PS ORAL 500 MG ORAL Initial or Prolonged Professional Klonopin C Depakote C Luvox C Dilantin C Lasix C Date:11/24/98ISR Number: 3276060-0Report Type:Periodic Company Report #USA/98/01518/LEX Age:77 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) PS ORAL ORAL Professional Sinemet C Date:11/24/98ISR Number: 3276064-8Report Type:Periodic Company Report #USA/98/01493/LEX Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Health Clozaril (Clozapine) PS ORAL 600 MG ORAL Professional Date:11/24/98ISR Number: 3276067-3Report Type:Periodic Company Report #USA/98/01481/LEX Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Clozaril (Clozapine) PS ORAL ORAL Required Professional Dilantin C Intervention to Depakote C Prevent Permanent Impairment/Damage 22-Feb-2006 08:30 AM Page: 221 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/24/98ISR Number: 3276069-7Report Type:Periodic Company Report #USA/98/01484/LEX Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Eosinophilia Health Clozaril (Clozapine) PS ORAL 18.75 MG ORAL Initial or Prolonged Leukocytosis Professional Zoloft C Required Depakote C Intervention to Lithium C Prevent Permanent Enteric Asa C Impairment/Damage Colace C Mvi C Date:11/24/98ISR Number: 3276073-9Report Type:Periodic Company Report #USA/98/01465/LEX Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) PS ORAL ORAL Professional Date:11/24/98ISR Number: 3276075-2Report Type:Periodic Company Report #USA/98/01447/LEX Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Health Clozaril (Clozapine) PS ORAL 700 MG ORAL Initial or Prolonged Eosinophilia Professional Lithium Carbonate C Vasotec C Lasix C Date:11/24/98ISR Number: 3276079-XReport Type:Periodic Company Report #USA/98/01445/LEX Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fatigue Health Clozaril (Clozapine) PS ORAL 12.5 MG ORAL Initial or Prolonged Hypotension Professional Sinemet C Sedation Zoloft C Docusate C Darvocet-N C Requip C Asa C Tylenol C Hctz C Date:11/24/98ISR Number: 3276082-XReport Type:Periodic Company Report #USA/98/01442/LEX Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Confusional State Health Clozaril (Clozapine) PS ORAL 150 MG ORAL Required Neuroleptic Malignant Professional Intervention to Syndrome Prevent Permanent Impairment/Damage 22-Feb-2006 08:30 AM Page: 222 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/24/98ISR Number: 3276106-XReport Type:Periodic Company Report #USA/98/02355/LEX Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Clozaril (Clozapine) PS ORAL 575 MG ORAL Professional Sertraline C Date:11/24/98ISR Number: 3276113-7Report Type:Periodic Company Report #USA/98/02349/LEX Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Health Clozaril (Clozapine) PS ORAL 500 MG ORAL Initial or Prolonged Infection Professional Pyridoxine C Isoniazid C Rifampin C Pyrazinamide C Tylenol C Date:11/24/98ISR Number: 3276115-0Report Type:Periodic Company Report #USA/98/02338/LEX Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Health Clozaril (Clozapine) PS ORAL 800 MG ORAL 4 MON Convulsion Professional Depakote C Date:11/24/98ISR Number: 3276116-2Report Type:Periodic Company Report #USA/98/02322/LEX Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Myalgia Health Clozaril (Clozapine) PS ORAL 450 MG ORAL Thrombocytopenia Professional Depakote C Zoloft C Lamictal C Synthroid C Date:11/24/98ISR Number: 3276117-4Report Type:Periodic Company Report #USA/98/02312/LEX Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Confusional State Health Clozaril (Clozapine) PS ORAL 900 MG ORAL Hospitalization - Dermatitis Professional Depot Provera C Initial or Prolonged Dyspnoea Depakote C Hallucination Headache Hyperpyrexia Muscle Necrosis Tachycardia Vomiting Date:11/24/98ISR Number: 3276120-4Report Type:Periodic Company Report #USA/98/02301/LEX Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) PS ORAL 50 MG ORAL Professional 22-Feb-2006 08:30 AM Page: 223 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/24/98ISR Number: 3276121-6Report Type:Periodic Company Report #USA/98/02253/LEX Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Clozaril (Clozapine) PS ORAL 900 MG ORAL 6 YR Fracture Professional Date:11/24/98ISR Number: 3276123-XReport Type:Periodic Company Report #USA/98/02238/LEX Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Constipation Health Clozaril (Clozapine) PS ORAL 350 MG ORAL Initial or Prolonged Professional Depakote C Required Intervention to Prevent Permanent Impairment/Damage Date:11/24/98ISR Number: 3276126-5Report Type:Periodic Company Report #USA/98/02233/LEX Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coma Health Clozaril (Clozapine) PS ORAL 650 MG ORAL Hospitalization - Overdose Professional Iv Fluids C Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage Date:11/24/98ISR Number: 3276128-9Report Type:Periodic Company Report #USA/98/02196/LEX Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Study Clozaril (Clozapine) PS ORAL 73 MG ORAL Health Professional Date:11/24/98ISR Number: 3276129-0Report Type:Periodic Company Report #USA/98/02197/LEX Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozaril (Clozapine) PS ORAL ORAL Professional Date:11/24/98ISR Number: 3276130-7Report Type:Periodic Company Report #USA/98/02204/LEX Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Clozaril (Clozapine) PS ORAL 250 MG ORAL Professional 22-Feb-2006 08:30 AM Page: 224 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/24/98ISR Number: 3276131-9Report Type:Periodic Company Report #USA/98/02149/LEX Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) PS ORAL 300 MG ORAL Professional Date:11/24/98ISR Number: 3276132-0Report Type:Periodic Company Report #USA/98/02124/LEX Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pulmonary Embolism Health Clozaril (Clozapine) PS ORAL ORAL Professional Date:11/24/98ISR Number: 3276134-4Report Type:Periodic Company Report #USA/98/02062/LEX Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) PS ORAL 250 MG ORAL 3 YR Professional Cogentin C Depakote C Date:11/24/98ISR Number: 3276136-8Report Type:Periodic Company Report #USA/98/02063/LEX Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) PS ORAL ORAL Professional Date:11/24/98ISR Number: 3276137-XReport Type:Periodic Company Report #USA/98/02031/LEX Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Clozaril (Clozapine) PS ORAL 300 MG ORAL Professional Clomipramine C Depakote C Date:11/24/98ISR Number: 3276139-3Report Type:Periodic Company Report #USA/98/02019/LEX Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Leukopenia Study Clozaril (Clozapine) PS ORAL 300 MG ORAL Consumer Chemotherapy C Date:11/24/98ISR Number: 3276143-5Report Type:Periodic Company Report #USA/98/02020/LEX Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Leukopenia Study Clozaril (Clozapine) PS ORAL 400 MG ORAL Consumer Chemotherapy C Health Professional 22-Feb-2006 08:30 AM Page: 225 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/24/98ISR Number: 3276147-2Report Type:Periodic Company Report #USA/98/02021/LEX Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Leukopenia Study Clozaril (Clozapine) PS ORAL 125 MG ORAL Neutropenia Health Professional Date:11/24/98ISR Number: 3280201-9Report Type:Periodic Company Report #USA/98/01297/LEX Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Consumer Clozaril (Clozapine) PS ORAL ORAL Required Zyprexa C Intervention to Prevent Permanent Impairment/Damage Date:11/24/98ISR Number: 3280202-0Report Type:Periodic Company Report #USA/98/01268/LEX Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) PS ORAL ORAL Professional Date:11/24/98ISR Number: 3280203-2Report Type:Periodic Company Report #USA/98/01253/LEX Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozaril (Clozapine) PS ORAL 125 MG ORAL Hospitalization - Professional Serzone C Initial or Prolonged Ativan C Vitamin E C Date:11/24/98ISR Number: 3280204-4Report Type:Periodic Company Report #USA/98/01242/LEX Age:81 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) PS ORAL 25 MG ORAL Professional Date:11/24/98ISR Number: 3280205-6Report Type:Periodic Company Report #USA/98/01227/LEX Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Leukopenia Health Clozaril (Clozapine) PS ORAL 400 MG ORAL Hospitalization - Neutropenia Professional Depakote C Initial or Prolonged Date:11/24/98ISR Number: 3280206-8Report Type:Periodic Company Report #USA/98/01213/LEX Age:66 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) PS ORAL 300 MG ORAL Professional Cogentin C Seroquel C 22-Feb-2006 08:30 AM Page: 226 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/24/98ISR Number: 3280207-XReport Type:Periodic Company Report #USA/98/01160/LEX Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Health Clozaril (Clozapine) PS ORAL 600 MG ORAL Initial or Prolonged Professional Hytrin C Glucophage C Accupril C Zoloft C Lasix C Glucotrol C Date:11/24/98ISR Number: 3280208-1Report Type:Periodic Company Report #USA/98/01161/LEX Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukocytosis Health Clozaril (Clozapine) PS ORAL 500 MG ORAL Initial or Prolonged Pneumonia Professional Depakote C Required Klonopin C Intervention to Robitussin C Prevent Permanent Impairment/Damage Date:11/24/98ISR Number: 3280209-3Report Type:Periodic Company Report #USA/98/01162/LEX Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Health Clozaril (Clozapine) PS ORAL 900 MG ORAL Initial or Prolonged Professional Cogentin C Required Klonopin C Intervention to Zyprexa C Prevent Permanent Diovan C Impairment/Damage Lipitor C Date:11/24/98ISR Number: 3280210-XReport Type:Periodic Company Report #USA/98/01153/LEX Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Angina Pectoris Health Clozaril (Clozapine) PS ORAL 400 MG ORAL Professional Haldol C Ativan C Cogentin C Mellaril C Date:11/24/98ISR Number: 3280211-1Report Type:Periodic Company Report #USA/98/01136/LEX Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Health Clozaril (Clozapine) PS ORAL ORAL Initial or Prolonged Professional Tegretol (Carbamazepine) SS ORAL 600 MG ORAL 22-Feb-2006 08:30 AM Page: 227 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/24/98ISR Number: 3280212-3Report Type:Periodic Company Report #USA/98/01078/LEX Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Effect Decreased Health Clozaril (Clozapine) PS ORAL ORAL Initial or Prolonged Professional Clozapine SS ORAL ORAL Date:11/24/98ISR Number: 3280213-5Report Type:Periodic Company Report #USA/98/01048/LEX Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neuroleptic Malignant Health Clozaril (Clozapine) PS ORAL 200 MG ORAL Required Syndrome Professional Zyprexa C Intervention to Klonopin C Prevent Permanent Benadryl C Impairment/Damage Serentil C Date:11/24/98ISR Number: 3280214-7Report Type:Periodic Company Report #USA/98/00973/LEX Age:90 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) PS ORAL 50 MG ORAL Hospitalization - Professional Initial or Prolonged Date:11/24/98ISR Number: 3280215-9Report Type:Periodic Company Report #USA/98/00969/LEX Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Health Clozaril (Clozapine) PS ORAL 300 MG ORAL Initial or Prolonged Salivary Hypersecretion Professional Ativan C Required Ritalin C Intervention to Depakote C Prevent Permanent Impairment/Damage Date:11/24/98ISR Number: 3280216-0Report Type:Periodic Company Report #USA/98/00950/LEX Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Health Clozaril (Clozapine) PS ORAL 600 MG ORAL Initial or Prolonged Salivary Hypersecretion Professional Albuterol C Required Lansoprazole C Intervention to Combivent C Prevent Permanent Impairment/Damage Date:11/24/98ISR Number: 3280217-2Report Type:Periodic Company Report #USA/98/00924/LEX Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Clozaril (Clozapine) PS ORAL 200 MG ORAL Initial or Prolonged Professional Naprosyn C Required Intervention to Prevent Permanent Impairment/Damage 22-Feb-2006 08:30 AM Page: 228 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/24/98ISR Number: 3280227-5Report Type:Periodic Company Report #USA/98/00934/LEX Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypertension Health Clozaril (Clozapine) PS ORAL 550 MG ORAL Initial or Prolonged Vertigo Professional Multivitamins C Required Intervention to Prevent Permanent Impairment/Damage Date:11/24/98ISR Number: 3280230-5Report Type:Periodic Company Report #USA/98/00916/LEX Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Clozaril (Clozapine) PS ORAL ORAL Initial or Prolonged Dizziness Professional Prozac C Pyrexia Xanax C Date:11/24/98ISR Number: 3280233-0Report Type:Periodic Company Report #USA/98/00906/LEX Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dehydration Health Clozaril (Clozapine) PS ORAL 600 MG ORAL Required Dizziness Professional Depakote C Intervention to Orthostatic Hypotension Klonopin C Prevent Permanent Syncope Cogentin C Impairment/Damage Lopressor C Date:11/24/98ISR Number: 3281067-3Report Type:Periodic Company Report #USA/97/02082/LEX Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperglycaemia Health Clozaril (Clozapine) PS ORAL 400 MG ORAL Initial or Prolonged Professional Cogentin Required (Benzatropine Intervention to Mesilate) C Prevent Permanent Miconazole C Impairment/Damage Glyburide (Glibenclamide) C Date:11/24/98ISR Number: 3281070-3Report Type:Periodic Company Report #USA/96/03304/LEX Age:46 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Leukocytosis Health Clozaril (Clozaril) PS ORAL 800 MG ORAL Hospitalization - Leukopenia Professional Vistaril Initial or Prolonged (Hydroxyzine Required Embonate) C Intervention to Prevent Permanent Impairment/Damage 22-Feb-2006 08:30 AM Page: 229 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/24/98ISR Number: 3281072-7Report Type:Periodic Company Report #USA/97/01754/LEX Age:53 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coagulopathy Health Clozaril (Clozapine) PS ORAL 200 MG ORAL Initial or Prolonged Neuroleptic Malignant Professional Inderal (Propranolol Required Syndrome Hydrochloride) C Intervention to Speech Disorder Xanax (Alprazolam) C Prevent Permanent Clonidine C Impairment/Damage Depakote (Valproate Semisodium) C Pepcid (Famotidine) C Synthroid (Levothyroxine Sodium) C Date:11/24/98ISR Number: 3281893-0Report Type:Periodic Company Report #USA/98/00893/LEX Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Ketoacidosis Health Clozaril (Clozapine) PS ORAL 250 MG ORAL Professional Lansopasol C Nefazodone C Lefothyroxine C Docusate C Date:11/24/98ISR Number: 3281900-5Report Type:Periodic Company Report #USA/98/00842/LEX Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pyrexia Health Clozaril (Clozapine) PS ORAL ORAL Initial or Prolonged Professional Zyprexa C Paxil C Date:11/24/98ISR Number: 3281902-9Report Type:Periodic Company Report #USA/98/00792/LEX Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Health Clozaril (Clozapine) PS ORAL 850 MG ORAL Initial or Prolonged Phosphokinase Increased Professional Prozac C Required Confusional State Risperidone C Intervention to Drug Level Above Biaxin C Prevent Permanent Therapeutic Impairment/Damage Pneumonia Date:11/24/98ISR Number: 3281903-0Report Type:Periodic Company Report #USA/98/00758/LEX Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Health Clozaril (Clozapine) PS ORAL ORAL Professional 22-Feb-2006 08:30 AM Page: 230 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/24/98ISR Number: 3281905-4Report Type:Periodic Company Report #USA/98/00754/LEX Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Health Clozaril (Clozapine) PS ORAL 650 MG ORAL Initial or Prolonged Drug Level Above Professional Digoxin SS Therapeutic Date:11/24/98ISR Number: 3281906-6Report Type:Periodic Company Report #USA/98/00741/LEX Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) PS ORAL 700 MG ORAL Professional Date:11/24/98ISR Number: 3281907-8Report Type:Periodic Company Report #USA/98/00721/LEX Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Clozaril (Clozapine) PS ORAL 100 MG ORAL Initial or Prolonged Headache Professional Lithium C Required Haldol C Intervention to Depakote C Prevent Permanent Impairment/Damage Date:11/24/98ISR Number: 3281908-XReport Type:Periodic Company Report #USA/98/00706/LEX Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) PS ORAL ORAL Professional Date:11/24/98ISR Number: 3281909-1Report Type:Periodic Company Report #USA/98/00685/LEX Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Health Clozaril (Clozapine) PS ORAL ORAL 2 WK Initial or Prolonged Professional Other Required Intervention to Prevent Permanent Impairment/Damage Date:11/24/98ISR Number: 3281910-8Report Type:Periodic Company Report #USA/98/00673/LEX Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Health Clozaril (Clozapine) PS ORAL 100 MG ORAL Required Professional Lithium C Intervention to Mellaril C Prevent Permanent Depakote C Impairment/Damage Clonidine C Colace C Multivitamins C Tolnaftate C 22-Feb-2006 08:30 AM Page: 231 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Cogentin C Date:11/24/98ISR Number: 3281911-XReport Type:Periodic Company Report #USA/98/00676/LEX Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Health Clozaril (Clozapine) PS ORAL ORAL Initial or Prolonged Professional Date:11/24/98ISR Number: 3281912-1Report Type:Periodic Company Report #USA/98/00677/LEX Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutropenia Health Clozaril (Clozapine) PS ORAL 125 MG ORAL Initial or Prolonged Professional Risperdal C Required Intervention to Prevent Permanent Impairment/Damage Date:11/24/98ISR Number: 3281913-3Report Type:Periodic Company Report #USA/98/00662/LEX Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) PS ORAL 200 MG ORAL Professional Date:11/24/98ISR Number: 3281915-7Report Type:Periodic Company Report #USA/98/00644/LEX Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Health Clozaril (Clozapine) PS ORAL 475 MG ORAL Drug Level Above Professional Keflex C Therapeutic Famvir C Fatigue Weight Decreased Date:11/24/98ISR Number: 3281916-9Report Type:Periodic Company Report #USA/98/00639/LEX Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozaril (Clozapine) PS ORAL 600 MG ORAL Hospitalization - Professional Depakote C Initial or Prolonged Carafate C Required Prilosec C Intervention to Steroid Cream C Prevent Permanent Impairment/Damage Date:11/24/98ISR Number: 3281918-2Report Type:Periodic Company Report #USA/98/00624/LEX Age:59 YR Gender:Female I/FU:I Outcome Other Required 22-Feb-2006 08:30 AM Page: 232 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Intervention to Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Agranulocytosis Study Clozaril (Clozapine) PS ORAL 200 MG ORAL Leukopenia Health Ativan C Sedation Professional Date:11/24/98ISR Number: 3281919-4Report Type:Periodic Company Report #USA/98/00584/LEX Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Health Clozaril (Clozapine) PS 400 MG Initial or Prolonged Anaemia Professional Depakote C Required Leukopenia Fe So4 C Intervention to Thrombocytopenia Prevent Permanent Impairment/Damage Date:11/24/98ISR Number: 3281921-2Report Type:Periodic Company Report #USA/98/00601/LEX Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Health Clozaril (Clozapine) PS ORAL 400 MG ORAL Professional Date:11/24/98ISR Number: 3281922-4Report Type:Periodic Company Report #USA/98/00494/LEX Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Fatigue Health Clozaril (Clozapine) PS ORAL 600 MG ORAL Professional Ativan C Date:11/24/98ISR Number: 3281924-8Report Type:Periodic Company Report #USA/98/00467/LEX Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperglycaemia Health Clozaril (Clozapine) PS ORAL 300 MG ORAL Initial or Prolonged Polyuria Professional Depakote C Required Urinary Incontinence Intervention to Prevent Permanent Impairment/Damage Date:11/24/98ISR Number: 3294067-4Report Type:Periodic Company Report #USA/98/01414/LEX Age:76 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) PS Usa/98/01414/Lex ORAL Professional 22-Feb-2006 08:30 AM Page: 233 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/24/98ISR Number: 3294068-6Report Type:Periodic Company Report #USA/98/01428/LEX Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukocytosis Health Clozaril (Clozapine) PS Novartis Initial or Prolonged Pyrexia Professional Pharmaceutical Corp. ORAL 200 MG Required Respiratory Depression Paxil (Paroxetine Intervention to Tachycardia Hydrochloride) C Prevent Permanent Prolixin Impairment/Damage (Fluphenazine Hydrochloride) C Date:11/24/98ISR Number: 3294069-8Report Type:Periodic Company Report #USA/98/01430/LEX Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Arthralgia Health Clozaril (Clozapine) PS Novartis Diarrhoea Professional Pharmaceuticals Fatigue Corp. ORAL Nausea Synthroid C Overdose Depakote C Sedation Buspar C Speech Disorder Zyprexa C Urinary Incontinence Date:11/24/98ISR Number: 3294070-4Report Type:Periodic Company Report #USA/98/01432/LEX Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Health Clozaril (Clozapine) PS Novartis Professional Pharmaceuticals Corp ORAL Date:11/24/98ISR Number: 3294071-6Report Type:Periodic Company Report #USA/98/01412/LEX Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anorexia Health Clozaril (Clozapine) PS Novartis Initial or Prolonged Asthenia Professional Pharmaceuticals Insomnia Corp. ORAL 400MG Stupor Baclofen C Syncope Vitamin E (Tocopherol) C Docusate Sodium C Date:11/24/98ISR Number: 3294072-8Report Type:Periodic Company Report #USA/98/10408/LEX Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Clozaril (Clozapine) PS Novartis Initial or Prolonged Hypokinesia Professional Pharmaceuticals Weight Decreased Corp. ORAL 300 MG 3 YR Effexor C Seroquel C 22-Feb-2006 08:30 AM Page: 234 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/24/98ISR Number: 3294073-XReport Type:Periodic Company Report #USA/98/01383/LEX Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) PS Novartis Professional Pharmaceuticals Corp. ORAL 400 MG Effexor (Venlafaxine Hydrochloride) C Imipramine C Ditropan (Oxybutynin) C Date:11/24/98ISR Number: 3294074-1Report Type:Periodic Company Report #USA/98/01385/LEX Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Clozaril (Clozapine) PS Novartis Professional Pharmaceuticals Corp. ORAL 850 MG Zypreza C Tegratol C Ativan C Date:11/24/98ISR Number: 3294075-3Report Type:Periodic Company Report #USA/98/01386/LEX Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Clozaril (Clozapine) PS Novartis Professional Pharmaceuticals Corp. ORAL 800 MG Date:11/24/98ISR Number: 3294076-5Report Type:Periodic Company Report #USA/98/01381/LEX Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Priapism Health Clozaril (Clozapine) PS Novartis Required Professional Pharmaceuticals Intervention to Corp. 200MG Prevent Permanent Impairment/Damage Date:11/24/98ISR Number: 3294077-7Report Type:Periodic Company Report #USA/98/01379/LEX Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Health Clozaril (Clozapine) PS ORAL 300 MG Initial or Prolonged Professional Required Intervention to Prevent Permanent Impairment/Damage 22-Feb-2006 08:30 AM Page: 235 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/24/98ISR Number: 3294078-9Report Type:Periodic Company Report #USA/98/01352/LEX Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dehydration Health Clozaril (Clozapine) PS Novartis Initial or Prolonged Diarrhoea Professional Pharmaceuticals Corp ORAL 200MG Eosinophilia Depakote C Leukocytosis Prozac C Neutropenia Haldol C Sedation Cogentin C Vomiting Ativan (Lorazepam) C K-Dur C Levaquin C Imodium C Date:11/24/98ISR Number: 3294079-0Report Type:Periodic Company Report #USA/98/01339/LEX Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozaril (Clozapine) PS Novartis Hospitalization - Professional Pharmaceuticals Corp ORAL 450MG Initial or Prolonged Disability Required Intervention to Prevent Permanent Impairment/Damage Date:11/24/98ISR Number: 3294080-7Report Type:Periodic Company Report #USA/98/01340/LEX Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Health Clozaril (Clozapine) PS Novartis Initial or Prolonged Professional Pharmaceuticals Corp. ORAL 400MG 6 YR Date:11/24/98ISR Number: 3294081-9Report Type:Periodic Company Report #USA/98/01335/LEX Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Health Clozaril (Clozapine) PS Novartis Initial or Prolonged Professional Pharmaceuticals Required Corp. ORAL 400MG Intervention to Prevent Permanent Impairment/Damage Date:11/24/98ISR Number: 3294082-0Report Type:Periodic Company Report #USA/98/01309/LEX Age:83 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) PS Novartis Professional Pharmaceuticals Corp ORAL 22-Feb-2006 08:30 AM Page: 236 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/24/98ISR Number: 3294083-2Report Type:Periodic Company Report #USA/98/01310/LEX Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Clozaril (Clozapine) PS Novartis Professional Pharmaceuticals Corp. ORAL Date:11/24/98ISR Number: 3294084-4Report Type:Periodic Company Report #USA/98/01311/LEX Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Clozaril (Clozapine) PS Novartis Professional Pharmaceuticals Corp. ORAL 600MG Zyprexa (Olanzapine) C Date:11/24/98ISR Number: 3294085-6Report Type:Periodic Company Report #USA/98/01317/LEX Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Health Clozaril (Clozapine) PS Novartis Initial or Prolonged Delirium Professional Pharmaceuticals Required Myocardial Infarction Corp. ORAL 800 MG Intervention to Sedation Prevent Permanent Impairment/Damage Date:11/24/98ISR Number: 3294086-8Report Type:Periodic Company Report #USA/98/01296/LEX Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Constipation Health Clozaril (Clozapine) PS Novartis Required Hyperhidrosis Professional Pharmaceutical Corp. ORAL 20 MG Intervention to Pneumonia Prevent Permanent Pyrexia Impairment/Damage Salivary Hypersecretion Tachycardia Date:11/24/98ISR Number: 3294167-9Report Type:Periodic Company Report #USA/98/00459/LEX Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) PS ORAL 25 MG ORAL Professional Zyprexa C Clonidine C Baclofen C Benadryl C Date:11/24/98ISR Number: 3294168-0Report Type:Periodic Company Report #USA/98/00455/LEX Age:26 YR Gender:Male I/FU:I Outcome Hospitalization - Initial or Prolonged Required Intervention to 22-Feb-2006 08:30 AM Page: 237 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Health Clozaril (Clozaril) PS ORAL 400 MG ORAL Pneumonia Professional Date:11/24/98ISR Number: 3294169-2Report Type:Periodic Company Report #USA/98/00449/LEX Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Health Clozaril (Clozapine) PS ORAL 125 MG ORAL Professional Depakote C Wellbutrin C Date:11/24/98ISR Number: 3295297-8Report Type:Periodic Company Report #USA/98/00411/LEX Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) PS ORAL 600 MG Life-Threatening Professional ORAL Date:11/24/98ISR Number: 3295300-5Report Type:Periodic Company Report #USA/98/00403/LEX Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozaril (Clozapine) PS ORAL 475 MG ORAL Neutropenia Professional Lithium C Zoloft C Depakote C Date:11/24/98ISR Number: 3295304-2Report Type:Periodic Company Report #USA/98/00390/LEX Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Health Clozaril (Clozapine) PS ORAL 300 MG Initial or Prolonged Pneumonia Professional ORAL Claritin C Klonopin C Ceclor C Ambien C Flonase Nasal Spray C Depakote C Date:11/24/98ISR Number: 3295307-8Report Type:Periodic Company Report #USA/98/00315/LEX Age:39 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Leukopenia Health Clozaril (Clozapine) PS ORAL 400 MG ORAL Hospitalization - Neutropenia Professional Cogentin C Initial or Prolonged Pyrexia Colace C Required Synthroid C Intervention to Prevent Permanent Impairment/Damage 22-Feb-2006 08:30 AM Page: 238 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/24/98ISR Number: 3295310-8Report Type:Periodic Company Report #USA/98/00280/LEX Age:70 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Health Clozaril (Clozapine) PS ORAL 100 MG Initial or Prolonged Intestinal Obstruction Professional ORAL Required Leukopenia Digoxin C Intervention to Neutropenia Pepcid C Prevent Permanent Psychotic Disorder Depakote C Impairment/Damage Navane C Cogentin C Lorazepam C Dss C Milk Of Magnesia C Date:11/24/98ISR Number: 3295313-3Report Type:Periodic Company Report #USA/98/00262/LEX Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Study Clozaril (Clozapine) PS ORAL 500 MG Health ORAL Professional Date:11/24/98ISR Number: 3295314-5Report Type:Periodic Company Report #USA/98/00238/LEX Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Sedation Health Clozaril (Clozapine) PS ORAL 25 MG Initial or Prolonged Professional ORAL Required Intervention to Prevent Permanent Impairment/Damage Date:11/24/98ISR Number: 3295316-9Report Type:Periodic Company Report #USA/98/00183/LEX Age:41 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bronchitis Health Clozaril (Clozapine) PS ORAL 400 MG ORAL Initial or Prolonged Pneumonia Professional Depakote C Required Zoloft C Intervention to Klonopin C Prevent Permanent Theo-Dur C Impairment/Damage Diflucan C Prednisone C Combivent C Azmacort C Synthroid C Date:11/24/98ISR Number: 3295317-0Report Type:Periodic Company Report #USA/98/00080/LEX Age:55 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Health Clozaril (Clozapine) PS ORAL 75 MG ORAL Required Respiratory Depression Professional Ativan SS Intervention to Syncope Moban C Prevent Permanent Tachycardia Depakote C Impairment/Damage Robitussin C 22-Feb-2006 08:30 AM Page: 239 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Thiamine C Multi-Vit (Multivit) C Date:11/24/98ISR Number: 3295319-4Report Type:Periodic Company Report #USA/98/00036/LEX Age:43 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Pleural Effusion Health Clozaril (Clozapine) PS ORAL 500 MG Hospitalization - Professional ORAL Initial or Prolonged Prozac C Required Klonopin C Intervention to Depakote C Prevent Permanent Lopid C Impairment/Damage Micronor C Albuterol Inhalor Prn C Tylenol C Centrum C Date:11/24/98ISR Number: 3295322-4Report Type:Periodic Company Report #USA/98/00042/LEX Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Medication Error Health Clozaril (Clozapine) PS ORAL 400 MG ORAL Initial or Prolonged Nervousness Professional Paxil (Paroxetine Other Salivary Hypersecretion Hydrochloride) SS Required Sedation Klonopin C Intervention to Vomiting Olanzapine C Prevent Permanent Depakote C Impairment/Damage Verapamil C Date:11/24/98ISR Number: 3295323-6Report Type:Periodic Company Report #USA/97/03365/LEX Age:28 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Eosinophilia Health Clozaril (Clozapine) PS ORAL 600 MG Initial or Prolonged Leukocytosis Professional ORAL Required Neutrophilia Laxatives C Intervention to Psychotic Disorder Lithium C Prevent Permanent Impairment/Damage Date:11/24/98ISR Number: 3295325-XReport Type:Periodic Company Report #USA/97/03370/LEX Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hypertension Health Clozaril (Clozapine) PS ORAL 650 MG Professional ORAL Cardizem C Prolixin C Klonopin C Cogentin C 22-Feb-2006 08:30 AM Page: 240 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/24/98ISR Number: 3295326-1Report Type:Periodic Company Report #USA/97/03242/LEX Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Study Clozaril (Clozapine) PS ORAL 550 MG Initial or Prolonged Health ORAL Required Professional Cogentin C Intervention to Depakene C Prevent Permanent Unspecified Impairment/Damage Laxatives C Date:11/24/98ISR Number: 3295329-7Report Type:Periodic Company Report #USA/97/02915/LEX Age:56 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozaril (Clozapine) PS ORAL 550 MG Hospitalization - Pyrexia Professional ORAL Initial or Prolonged Procardia Xl C Date:11/24/98ISR Number: 3295331-5Report Type:Periodic Company Report #USA/97/03099/LEX Age:61 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukocytosis Health Clozaril (Clozapine) PS ORAL 300 MG Medication Error Professional ORAL Sedation Risperdal C Cogentin C Date:11/24/98ISR Number: 3295332-7Report Type:Periodic Company Report #USA/97/01894/LEX Age:77 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Clozaril (Clozapine) PS ORAL 250 MG Required Professional ORAL Intervention to Effexor C Prevent Permanent Vitamin C C Impairment/Damage Colace C Synthroid C Lasix C Naprosyn C K-Lyte C Zaroxolyn C Date:11/25/98ISR Number: 3163414-6Report Type:Expedited (15-DaCompany Report #USA/98/02741/LEX Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Neoplasm Malignant Health Clozaril (Clozapine) PS ORAL 300 MG ORAL Professional Date:11/25/98ISR Number: 3163416-XReport Type:Expedited (15-DaCompany Report #GB/98/00865/LEX Age:82 YR Gender:Male I/FU:I Outcome PT Death Aggression Life-Threatening Agitation Bronchopneumonia 22-Feb-2006 08:30 AM Page: 241 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Cardiac Arrest Cholestasis Confusional State Report Source Product Role Manufacturer Route Dose Duration Coronary Artery Disease Study Clozaril (Clozapine) PS ORAL ORAL Drug Toxicity Health Augmentin (Clavulin) C Hepatic Encephalopathy Professional Melleril Hepatic Steatosis (Thioridazine Hepatocellular Damage Hydrochloride) C Hyperglycaemia Hypoglycaemia Liver Function Test Abnormal Lower Respiratory Tract Infection Pulmonary Oedema Stupor Tongue Oedema Urinary Tract Infection White Blood Cell Count Increased Date:11/27/98ISR Number: 3163866-1Report Type:Expedited (15-DaCompany Report #SKA/98/00551/LEX Age:51 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Respiratory Health Leponex PS ORAL 500 MG ORAL Required Distress Syndrome Professional Trimepranol C Intervention to Agranulocytosis Prothazin C Prevent Permanent Bronchopneumonia Endiaron C Impairment/Damage Multi-Organ Failure Timoptol C Pneumonia Celaskon C Pulmonary Oedema Pyrexia Respiratory Failure Sepsis Shock Date:11/30/98ISR Number: 3163976-9Report Type:Expedited (15-DaCompany Report #GB/98/01165/LEX Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bacterial Infection Health Clozaril PS ORAL 250 MG ORAL Initial or Prolonged Clostridial Infection Professional Colitis Ulcerative Constipation Megacolon Date:11/30/98ISR Number: 3164010-7Report Type:Expedited (15-DaCompany Report #GB/98/00839/LEX Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Study Clozaril (Clozapine) PS ORAL 450 MG ORAL Health Fluoxetine C Professional Diazepam C Loratadine C Fybogel C Kwells C Seroquel C 22-Feb-2006 08:30 AM Page: 242 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/30/98ISR Number: 3164017-XReport Type:Expedited (15-DaCompany Report #USA/98/02793/LEX Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Megacolon Health Clozaril (Clozapine) PS ORAL UNSPECIFIED Professional ORAL Date:11/30/98ISR Number: 3164021-1Report Type:Expedited (15-DaCompany Report #GB/98/00865/LEX Age:82 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aggression Study Clozaril (Clozapine) PS ORAL ORAL Life-Threatening Agitation Health Augmentin C Bronchopneumonia Professional Melleril C Cardiac Arrest Procyclidine C Confusional State Coronary Artery Disease Drug Toxicity Hepatic Encephalopathy Hepatic Steatosis Hepatitis Cholestatic Hepatocellular Damage Hypoglycaemia Leukocytosis Liver Function Test Abnormal Pulmonary Oedema Stupor Tongue Oedema Urinary Tract Infection Date:11/30/98ISR Number: 3164024-7Report Type:Expedited (15-DaCompany Report #AUS/98/00104/LEX Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alveolitis Allergic Health Clozaril (Clozapine) PS ORAL 400 MG ORAL Initial or Prolonged Blood Creatine Professional Required Phosphokinase Increased Intervention to Cardiac Failure Prevent Permanent Cough Impairment/Damage Dyspnoea Eosinophilia Gallop Rhythm Present Inflammation Lethargy Myocarditis Pleural Effusion Pyrexia Red Blood Cell Sedimentation Rate Increased Sedation Tachycardia Urinary Incontinence Urine Odour Abnormal Venous Pressure Increased 22-Feb-2006 08:30 AM Page: 243 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/30/98ISR Number: 3164039-9Report Type:Expedited (15-DaCompany Report #LIT/98/00294/LEX Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Literature Clozapine PS ORAL 150 MG ORAL 2 MON Required Weight Increased Health Intervention to Professional Prevent Permanent Impairment/Damage Date:11/30/98ISR Number: 3164043-0Report Type:Expedited (15-DaCompany Report #LIT/98/00295/LEX Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Ketone Body Absent Literature Clozapine PS ORAL 400 MG ORAL 18 MON Required Diabetes Mellitus Health Intervention to Hyperglycaemia Professional Prevent Permanent Metabolic Acidosis Impairment/Damage Weight Increased Date:11/30/98ISR Number: 3164064-8Report Type:Expedited (15-DaCompany Report #LIT/98/00296/LEX Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Literature Clozapine PS ORAL 100 MG ORAL 6 MON Initial or Prolonged Hyperglycaemia Health Required Weight Increased Professional Intervention to Prevent Permanent Impairment/Damage Date:12/02/98ISR Number: 3165848-2Report Type:Expedited (15-DaCompany Report #98-11-0261 Age:81 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozapine PS Zenith Goldline Oral Intake Reduced Professional Pharm. ORAL 6.25-50MG/ DAY ORAL Date:12/02/98ISR Number: 3165849-4Report Type:Expedited (15-DaCompany Report #98-11-0257 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine PS Zenith Goldline Professional Pharm. ORAL 337.5MG/ DAY ORAL Date:12/03/98ISR Number: 3166418-2Report Type:Expedited (15-DaCompany Report #USA/98/02560/LEX Age:60 YR Gender:Female I/FU:I Outcome PT Other Anaemia Required Asthenia Intervention to Dizziness Prevent Permanent Dyspnoea Impairment/Damage Fatigue Leukocytosis 22-Feb-2006 08:30 AM Page: 244 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lymphoma Neutrophilia Red Blood Cell Count Report Source Product Role Manufacturer Route Dose Duration Decreased Health Clozaril PS ORAL 300 MG ORAL Thrombocythaemia Professional Axid C Prozac C Date:12/03/98ISR Number: 3166638-7Report Type:Expedited (15-DaCompany Report #LIT/98/00297/LEX Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Anxiety Literature Clozapine PS ORAL 200 MG 5 WK Hospitalization - Blood Amylase Increased Health Initial or Prolonged Diabetes Mellitus Professional Required Glucose Tolerance Intervention to Impaired Prevent Permanent Mental Impairment Impairment/Damage Date:12/04/98ISR Number: 3167070-2Report Type:Expedited (15-DaCompany Report #AUS/98/00182/LEX Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Abuser Health Clozaril (Clozapine) PS ORAL 800 MG ORAL Professional Valproate C Date:12/04/98ISR Number: 3167157-4Report Type:Expedited (15-DaCompany Report #1998-002914 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Ascites Health Combivent PS RESPIRATORY Hospitalization - Asthma Professional (INHALATION) IH Initial or Prolonged Cardiac Arrest Clozaril SS ORAL 150 MG/PO Cardiac Disorder Catapres C Cardiac Failure Trihexyphenidyl C Congestive Ventolin C Condition Aggravated Vanceril C Drooling Dyspnoea Fluid Retention Hallucination, Auditory Oedema Peripheral Sleep Apnoea Syndrome Date:12/04/98ISR Number: 3167333-0Report Type:Expedited (15-DaCompany Report #GB/98/00597/LEX Age:33 YR Gender:Male I/FU:F Outcome PT Death Aspiration Required Asthenia Intervention to Back Pain Prevent Permanent Bone Disorder Impairment/Damage Cardiomegaly Chest Discomfort Chest Pain Circulatory Collapse Constipation 22-Feb-2006 08:30 AM Page: 245 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Convulsion Diarrhoea Dizziness Report Source Product Role Manufacturer Route Dose Duration Dyspnoea Health Clozaril PS ORAL 300 MG ORAL Dysuria Professional Clopixol C Eosinophil Count Chlorpromazine C Increased Zuclopenthixol C Gastrointestinal Infection Headache Hyperhidrosis Hypersensitivity Influenza Like Illness Joint Stiffness Malaise Myocarditis Nausea Oedema Pericardial Effusion Pulse Absent Pyrexia Renal Colic Respiratory Failure Sedation Shock Tachycardia Ventricular Fibrillation Vomiting Date:12/04/98ISR Number: 3168568-3Report Type:Expedited (15-DaCompany Report #GB/98/00597/LEX Age:33 YR Gender:Male I/FU:F Outcome PT Death Aspiration Required Asthenia Intervention to Autoimmune Disorder Prevent Permanent Back Pain Impairment/Damage Chest Discomfort Chest Pain Circulatory Collapse Constipation Convulsion Diarrhoea Dizziness Dyspnoea Dysuria Eosinophil Count Increased Gastrointestinal Infection Headache Hyperhidrosis Influenza Like Illness Joint Stiffness Malaise Myocardial Fibrosis Myocardial Infarction Myocarditis Nausea Pericardial Effusion 22-Feb-2006 08:30 AM Page: 246 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pulse Absent Pyrexia Renal Colic Report Source Product Role Manufacturer Route Dose Duration Sedation Health Clozaril PS ORAL 300 MG Shock Professional Clopixol C Tachycardia Chlorpromazine C Ventricular Fibrillation Zuclopenthixol C Ventricular Hypertrophy Vomiting Date:12/07/98ISR Number: 3167981-8Report Type:Expedited (15-DaCompany Report #7397398 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bone Marrow Depression Health Depakote PS ORAL 4.000 GM PO Required Neutropenia Professional Clozaril SS ORAL 50.000 MG PO Intervention to Thrombocytopenia Other QD Prevent Permanent White Blood Cell Count Clozaril C Impairment/Damage Decreased K-Tab C Hydrochlorothiazide C Procardia C Date:12/09/98ISR Number: 3168925-5Report Type:Expedited (15-DaCompany Report #LIT/98/00297/LEX Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Amylase Increased Literature Clozapine Hospitalization - Diabetes Mellitus Health (Clozapine) PS ORAL 200 MG ORAL 5 WK Initial or Prolonged Glucose Tolerance Professional Required Impaired Intervention to Hyperglycaemia Prevent Permanent Mental Impairment Impairment/Damage Thinking Abnormal Date:12/09/98ISR Number: 3169169-3Report Type:Expedited (15-DaCompany Report #D/98/04732/LEX Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Complications Of Maternal Health Leponex PS ORAL 100 MG ORAL 2 YR Initial or Prolonged Exposure To Therapeutic Professional Lithium SS Required Drugs Intervention to Congenital Anomaly Prevent Permanent Intra-Uterine Death Impairment/Damage Date:12/09/98ISR Number: 3169171-1Report Type:Expedited (15-DaCompany Report #USA/98/02689/LEX Age:46 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozaril PS ORAL 400 MG ORAL Professional 22-Feb-2006 08:30 AM Page: 247 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/09/98ISR Number: 3169203-0Report Type:Expedited (15-DaCompany Report #USA/98/02388/LEX Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Health Clorazil PS ORAL 775 MG ORAL Initial or Prolonged Blood Creatinine Professional Depakote C Required Increased Benadryl C Intervention to Blood Urea Increased Prevent Permanent Dehydration Impairment/Damage Hypotension Inguinal Hernia Intestinal Obstruction Pulse Pressure Decreased Vomiting Date:12/09/98ISR Number: 3169205-4Report Type:Expedited (15-DaCompany Report #AUS/98/00184/LEX Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cough Health Clozaril (Clozapine) PS ORAL 300 MG ORAL Required Dyspnoea Professional Diazepam C Intervention to Hypoxia Valproate C Prevent Permanent Lung Infiltration Impairment/Damage Pyrexia Date:12/09/98ISR Number: 3169506-XReport Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mental Impairment Clozapine PS ORAL 100MG PO BID Initial or Prolonged Neutropenia Quetiapine SS ORAL 25MG PO Other Pyrexia Streptococcal Sepsis Date:12/09/98ISR Number: 3169541-1Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pyrexia Clozoril PS 100MG PO Q Initial or Prolonged White Blood Cell Count AM; 200MG PO Other Decreased Q HS Date:12/09/98ISR Number: 3169669-6Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Grand Mal Convulsion Clozaril PS 250MG PO BID Initial or Prolonged Other Date:12/09/98ISR Number: 3169847-6Report Type:Direct Company Report # Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Health Quetiapine PS ORAL 25 MG PO BID Initial or Prolonged Neutropenia Professional Clozaril SS ORAL 100 MG PO TID Other Pyrexia 22-Feb-2006 08:30 AM Page: 248 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/10/98ISR Number: 3168833-XReport Type:Expedited (15-DaCompany Report #AUS/98/00104/LEX Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alveolitis Allergic Health Clozaril PS 400 MG ORAL Initial or Prolonged Blood Creatine Professional Required Phosphokinase Increased Intervention to Cardiac Failure Prevent Permanent Chest X-Ray Abnormal Impairment/Damage Cough Dyspnoea Eosinophilia Gallop Rhythm Present Lethargy Myocarditis Pleural Effusion Pyrexia Red Blood Cell Sedimentation Rate Increased Sedation Tachycardia Urinary Incontinence Urine Odour Abnormal Venous Pressure Increased Date:12/10/98ISR Number: 3168898-5Report Type:Expedited (15-DaCompany Report #98-03-0099 Age:61 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Breast Cancer Female Health Clozapine PS Zenith Goldline Hospitalization - Leukopenia Professional Pharm ORAL 100MG/DAY Initial or Prolonged Neoplasm Malignant Adriamycin SS INTRAVENOUS 80MG INJ White Blood Cell Count Decreased Date:12/10/98ISR Number: 3168902-4Report Type:Expedited (15-DaCompany Report #98-11-0265 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Catatonia Health Clozapine PS Zenith Goldline Initial or Prolonged Dysphagia Professional Pharm ORAL 600MG/DAY Lethargy Mellaril C Date:12/10/98ISR Number: 3168903-6Report Type:Expedited (15-DaCompany Report #98-11-0262 Age:73 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline Professional Pharm ORAL 12.5MG/ DAY/ TAB Date:12/10/98ISR Number: 3168906-1Report Type:Expedited (15-DaCompany Report #98-11-0264 Age:78 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Respiratory Arrest Health Clozapine PS ORAL 150-200MG/DAY Professional 22-Feb-2006 08:30 AM Page: 249 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/10/98ISR Number: 3169925-1Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Drooling Clozapine PS ORAL 75 MG BID Intervention to ORAL Prevent Permanent Impairment/Damage Date:12/11/98ISR Number: 3169693-3Report Type:Expedited (15-DaCompany Report #USA/98/01748/LEX Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acquired Health Clozaril PS ORAL 300 MG ORAL Initial or Prolonged Tracheo-Oesophageal Professional Prozac C Required Fistula Axid C Intervention to Leukopenia Multivitamins C Prevent Permanent Lung Neoplasm Malignant Impairment/Damage Metastases To Central Nervous System Pericardial Disease Date:12/11/98ISR Number: 3169695-7Report Type:Expedited (15-DaCompany Report #USA/98/02862/LEX Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatitis C Health Clozaril PS ORAL 400 MG ORAL Vomiting Professional Anafranil C Colace C Date:12/11/98ISR Number: 3169717-3Report Type:Expedited (15-DaCompany Report #AUS/98/00160/LEX Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Study Clozaril (Clozapine) PS ORAL 700 MG ORAL Hospitalization - Bone Marrow Depression Health Risperidone Initial or Prolonged Dementia Professional (Risperidone) SS ORAL 4 MG ORAL Required Leukopenia Lithium (Lithium) C Intervention to Mental Impairment Fluoxetine Prevent Permanent Sepsis (Fluoxetine) C Impairment/Damage Thrombocytopenia Valproate (Valproate Sodium) C Date:12/11/98ISR Number: 3169718-5Report Type:Expedited (15-DaCompany Report #USA/98/02234/LEX Age:56 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozaril (Clozapine) PS ORAL 450 MG ORAL Professional Date:12/11/98ISR Number: 3169720-3Report Type:Expedited (15-DaCompany Report #S/98/00061/LEX Age:46 YR Gender:Female I/FU:F Outcome PT Hospitalization - Cardiac Failure Initial or Prolonged Cardiomyopathy Condition Aggravated 22-Feb-2006 08:30 AM Page: 250 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dyspnoea Ejection Fraction Abnormal Report Source Product Role Manufacturer Route Dose Duration Tachycardia Health Leponex (Clozapine) PS ORAL 200 MG ORAL Professional Levaxin (Levothyroxine Sodium) C Date:12/11/98ISR Number: 3169722-7Report Type:Expedited (15-DaCompany Report #USA/98/02587/LEX Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Respiratory Health Clozaril (Clozapine) PS ORAL 400 MG ORAL Hospitalization - Distress Syndrome Professional Prozac (Fluoxetine Initial or Prolonged Infection Hydrochloride) C Malignant Ovarian Cyst Tranxene Sepsis (Clorazepate Dipotassium) C Date:12/11/98ISR Number: 3169726-4Report Type:Expedited (15-DaCompany Report #USA/98/02839/LEX Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Constipation Health Clozaril (Clozapine) PS ORAL 900 MG ORAL Life-Threatening Drug Toxicity Professional Docusate C Mental Impairment Psillium (Psilo Respiratory Disorder Balsam) C Thinking Abnormal Valproic Acid C Date:12/11/98ISR Number: 3169771-9Report Type:Expedited (15-DaCompany Report #USA/98/02754/LEX Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agranulocytosis Health Clozaril PS ORAL 300 MG Hospitalization - Infection Professional Seroquel C Initial or Prolonged Influenza Like Illness Colace C Leukopenia Date:12/11/98ISR Number: 3169772-0Report Type:Expedited (15-DaCompany Report #USA/98/02829/LEX Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Aspiration Health Clozaril PS ORAL 650 MG Professional Cogentin (Benzatropine Mesilate) C Gabapentin C Prevacid (Lansoprazole) C Ativan (Lorazepam) C Synthroid (Levothyroxine Sodium) C Multivitamin (Multivitamins) C Sorbitol C Vitamin E 22-Feb-2006 08:30 AM Page: 251 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Tocopherol) C Date:12/11/98ISR Number: 3169773-2Report Type:Expedited (15-DaCompany Report #A/96/00001/LEX Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Leponex PS ORAL 400 MG Hospitalization - Laryngitis Professional Neurotop SS ORAL 600 MG Initial or Prolonged Multi-Organ Failure Quilonom Ret C Required Pharyngolaryngeal Pain Seropram C Intervention to Pyrexia Prevent Permanent Sepsis Impairment/Damage Stupor Tonsillitis Date:12/14/98ISR Number: 3170219-9Report Type:Expedited (15-DaCompany Report #98HQ-10419 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Coma Foreign Carbamazepine PS DAILY Haemolytic Anaemia Literature Clozapine SS Hepatic Failure Health Hypersensitivity Professional Pancreatitis Renal Impairment Toxic Epidermal Necrolysis Date:12/14/98ISR Number: 3170524-6Report Type:Expedited (15-DaCompany Report #USA/98/02388/LEX Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Adhesions Health Clozaril (Clozapine) PS ORAL 775 MG Initial or Prolonged Abdominal Pain Professional Depakote (Valproate Other Appendicitis Semisodium) C Required Appendix Disorder Benadryl Intervention to Blood Creatinine (Diphenhydramine Prevent Permanent Increased Hydrochloride) C Impairment/Damage Blood Urea Increased Haematocrit Increased Haemoglobin Increased Hernia Impaired Healing Inguinal Hernia Intestinal Obstruction Intestinal Perforation Pulse Pressure Decreased Sepsis Vomiting Date:12/15/98ISR Number: 3171616-8Report Type:Expedited (15-DaCompany Report #F/98/02287/LEX Age:33 YR Gender:Female I/FU:I Outcome Hospitalization - Initial or Prolonged Required Intervention to 22-Feb-2006 08:30 AM Page: 252 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Face Oedema Leponex PS ORAL 900 MG ORAL Pyrexia Depo Provera SS INTRAMUSCULAR 150 MG Date:12/16/98ISR Number: 3170948-7Report Type:Expedited (15-DaCompany Report #USA/98/02866/LEX Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Health Clozaril PS ORAL 50 MG Initial or Prolonged Leukocytosis Professional (INCREASED TO Required Ovarian Cyst 150 MG AM/150 Intervention to Pyrexia MG PM AT Prevent Permanent White Blood Cell Count UNSPECIFIED Impairment/Damage Increased Proventil C Atrovent C Date:12/16/98ISR Number: 3170956-6Report Type:Expedited (15-DaCompany Report #LIT/98/00309/LEX Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coma Literature Clozapine PS Hospitalization - Haemolytic Anaemia Health Carbamazepine SS Initial or Prolonged Hepatic Failure Professional Hypersensitivity Pancreatitis Renal Impairment Date:12/16/98ISR Number: 3172645-0Report Type:Expedited (15-DaCompany Report #USA/98/02386/LEX Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dysphagia Health Clozaril (Clozapine) PS ORAL 400 MG ORAL Obstructive Airways Professional Disorder Date:12/16/98ISR Number: 3172646-2Report Type:Expedited (15-DaCompany Report #GB/98/01206/LEX Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mitral Valve Incompetence Clozaril (Clozapine) PS ORAL 600 MG ORAL Initial or Prolonged Myocarditis Procyclidine Pulmonary Oedema (Procyclidine) C Domperidone (Domperidone) C Omeprazole (Omeprazole) C Frusemide (Furosemide) C 22-Feb-2006 08:30 AM Page: 253 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/17/98ISR Number: 3172425-6Report Type:Direct Company Report # Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Platelet Disorder Clozapine PS 75 MG HS Valproic Acid C Date:12/18/98ISR Number: 3172159-8Report Type:Expedited (15-DaCompany Report #USA/98/02919/LEX Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cerebrovascular Accident Health Clozaril PS ORAL 300 MG ORAL 5 YR Drug Interaction Professional Omnicef SS UNSPECIFIED Drug Level Above Coumadin (Warfarin Therapeutic Sodium) C Eye Infection Date:12/18/98ISR Number: 3176091-5Report Type:Direct Company Report # Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dizziness Clozapine PS ORAL 25 MG AM, 50 Headache MG HS INC Orthostatic Hypotension TITRATED DOSE Depakote C Olanzapine C Senna C Date:12/21/98ISR Number: 3172130-6Report Type:Expedited (15-DaCompany Report #USA/98/02921/LEX Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arrhythmia Health Clozaril PS ORAL 375 MG ORAL Initial or Prolonged Diabetes Mellitus Professional Luvox C Other Multivitamins C Colace C Oxazepam C Tylenol C Date:12/21/98ISR Number: 3172157-4Report Type:Expedited (15-DaCompany Report #GB/98/01079/LEX Age:53 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Brain Neoplasm Malignant Health Clozaril PS ORAL 350 MG ORAL Professional Date:12/21/98ISR Number: 3172415-3Report Type:Expedited (15-DaCompany Report #USA/98/02411/LEX Age:59 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Brain Neoplasm Health Clozaril (Clozapine) PS ORAL 525 MG Brain Neoplasm Benign Professional Dilantin (Phenytoin Hypotonia Sodium0 C Muscular Weakness Zoloft (Sertraline Urinary Tract Infection Hydrochloride) C Ventriculo-Peritoneal Cylert (Pemoline Shunt Magnesium) C 22-Feb-2006 08:30 AM Page: 254 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Zyprexa (Olanzapine) C Prevacid (Lansoprazole) C Milk Of Pamnesia (Magnesium Hydroxide) C Peri-Colace C Metamucil (Psyllium Hydrophilic Mucilloid) C Levofloxacin C Cylert (Pemoline Magnesium) C Olanzapine C Dilantin (Phenytoin Sodium) C Date:12/21/98ISR Number: 3172698-XReport Type:Expedited (15-DaCompany Report #AUS/98/00191/LEX Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Study Clozaril (Clozapine) PS ORAL 650 MG ORAL Required Drug Level Above Health Sodium Valproate Intervention to Therapeutic Professional (Valproate Sodium) SS ORAL 1500 MG ORAL Prevent Permanent Impairment/Damage Date:12/21/98ISR Number: 3172699-1Report Type:Expedited (15-DaCompany Report #AUS/98/00190/LEX Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Renal Failure Acute Health Clozaril (Clozapine) PS ORAL 275 MG ORAL Professional Paroxetine (Paroxetine) C Thyroxine (Levothyroxine Sodium) C Date:12/21/98ISR Number: 3172700-5Report Type:Expedited (15-DaCompany Report #USA/98/02640/LEX Age:38 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Cancer Female Health Clozaril (Clozapine) PS ORAL 625 MG ORAL Required Leukocytosis Professional Zoloft (Sertraline Intervention to Hydrochloride) C Prevent Permanent Colace (Docusate Impairment/Damage Sodium) C Pepcid (Famotidine) C Ditropan (Oxybutynin) C Gaviscon (Gaviscon Tablet) C Zantac (Ranitidine Hydrochloride) C Multivitamins C Peridex (Chlorhexidine Gluconate) C 22-Feb-2006 08:30 AM Page: 255 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Phos-Flur (Gel Flur) C Date:12/21/98ISR Number: 3172701-7Report Type:Expedited (15-DaCompany Report #USA/98/02915/LEX Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Health Clozaril PS ORAL 800MG ORAL Professional Date:12/21/98ISR Number: 3173146-6Report Type:Direct Company Report # Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening White Blood Cell Count Clozapine PS 200 MG, BID; Required Decreased PM DOSE Intervention to INCREASED TO Prevent Permanent 300 MG ON Impairment/Damage 8/23/98 Date:12/21/98ISR Number: 3174009-2Report Type:Expedited (15-DaCompany Report #F/98/02997/LEX Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Intestinal Obstruction Consumer Leponex PS ORAL ORAL Hospitalization - Respiratory Failure Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage Date:12/21/98ISR Number: 3174015-8Report Type:Expedited (15-DaCompany Report #D/98/03843/LEX Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Creatine Health Leponex PS ORAL 400 MG ORAL Hospitalization - Phosphokinase Increased Professional Neurocil Initial or Prolonged Blood Creatinine (Levomepromazine Required Increased Maleate) C Intervention to Blood Urea Increased Haldol Decanoate Prevent Permanent Haemodialysis (Haloperidol Impairment/Damage Muscle Necrosis Decanoate) C Neuroleptic Malignant .. C Syndrome Pyrexia Renal Failure Acute Rhabdomyolysis Date:12/22/98ISR Number: 3172231-2Report Type:Expedited (15-DaCompany Report #98-11-0270 Age:88 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Health Clozapine PS Zenith Goldline Initial or Prolonged Hip Fracture Professional Pharm. ORAL 12.5 -25MG/DAY ORAL 22-Feb-2006 08:30 AM Page: 256 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/22/98ISR Number: 3172233-6Report Type:Expedited (15-DaCompany Report #98-11-0257 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Health Clozapine PS Zenith Goldlind Hospitalization - Hypoxia Professional Pharm. ORAL 337.5MG/DAY Initial or Prolonged Pleural Effusion ORAL Pneumonia Respiratory Failure Date:12/22/98ISR Number: 3172234-8Report Type:Expedited (15-DaCompany Report #98-10-0241 Age:70 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS ORAL 25MG/DAY ORAL Professional Sinemet C Date:12/22/98ISR Number: 3172707-8Report Type:Expedited (15-DaCompany Report #98-11-0268 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine PS Zenith Goldline Professional Pharm ORAL 500-600MG/DAY ORAL Date:12/22/98ISR Number: 3173495-1Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Cognitive Disorder Lithium PS ORAL 600 BID ORAL Drug Interaction Clozaril SS ORAL 175 MG DAILY Drug Toxicity PO Leukocytosis Ativan SS ORAL 1 MG PO TID Polydipsia Date:12/24/98ISR Number: 3173345-3Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neutropenia Clozapine PS ORAL 300 MG PO QD Oxygen Saturation Quetiapine SS ORAL 50 MG PO QD Decreased Norplant Insertion C Pneumonia Nyquil C Sepsis Theraflu C Shock Iburprofen C White Blood Cell Count Decreased Date:12/24/98ISR Number: 3173805-5Report Type:Expedited (15-DaCompany Report #A0076634 Age:65 YR Gender:Female I/FU:I Outcome PT Hospitalization - Coma Initial or Prolonged Confusional State Delirium Drug Interaction Drug Level Above 22-Feb-2006 08:30 AM Page: 257 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Therapeutic Metabolic Encephalopathy Report Source Product Role Manufacturer Route Dose Duration Health Zinacef PS INTRAVENOUS Professional Clozapine SS ORAL 200 MG Other Valproate SS Clarithromcyin SS Thyroxine Sodium C Frusemide C Prempro C Isosorbide Dinitrate C Date:12/24/98ISR Number: 3174013-4Report Type:Expedited (15-DaCompany Report #USA/98/02962/LEX Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Health Clozaril PS ORAL 50 MG Initial or Prolonged Orthostatic Hypotension Professional (INCREASED TO Required Psychotic Disorder 75 MG ON 05 Intervention to Renal Haemorrhage DEC 1998) Prevent Permanent Vaginal Haemorrhage ORAL Impairment/Damage Minipres SS Sinemet C Synthroid C Verapamil C Colace (Docusate Sodium) C Vitamin E (Tocopherol) C Date:12/28/98ISR Number: 3175802-2Report Type:Expedited (15-DaCompany Report #USA/98/02448/LEX Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Health Clozaril PS ORAL 300 MG ORAL Cardiomegaly Professional Zyprexa C Ativan C Multivitamins C Date:12/28/98ISR Number: 3175994-5Report Type:Expedited (15-DaCompany Report #LIT/98/00337/LEX Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Interaction Literature Clozapine Drug Level Above Health (Clozapine) PS ORAL 400 MG ORAL 18 MON Therapeutic Professional Valproate (Valproate Grand Mal Convulsion Sodium) SS ORAL 1000 MG ORAL 18 MON Amitriptyline (Amitriptyline) SS ORAL 150 MG ORAL 18 MON Date:12/28/98ISR Number: 3176000-9Report Type:Expedited (15-DaCompany Report #GB/96/00842/LEX Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Level Above Health Clozaril (Clozapine) PS ORAL 300 MG ORAL Therapeutic Professional Amitriptyline SS Myocardial Infarction 22-Feb-2006 08:30 AM Page: 258 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/28/98ISR Number: 3176005-8Report Type:Expedited (15-DaCompany Report #USA/98/02708/LEX Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Influenza Like Illness Health Clozaril (Clozapine) PS ORAL 150 MG ORAL Initial or Prolonged Neuroleptic Malignant Professional Depakote C Required Syndrome Wellbutrin C Intervention to Pulmonary Oedema Prevent Permanent Thrombocytopenia Impairment/Damage Date:12/28/98ISR Number: 3176009-5Report Type:Expedited (15-DaCompany Report #AUS/98/00194/LEX Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Glioma Health Clozaril (Clozapine) PS ORAL 450 MG ORAL Professional Date:12/28/98ISR Number: 3176017-4Report Type:Expedited (15-DaCompany Report #D/98/04073/LEX Age:20 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Leponex (Clozapine) PS ORAL ORAL Completed Suicide Professional Cyanosis Drug Level Above Therapeutic Drug Toxicity Electroencephalogram Abnormal Liver Function Test Abnormal Malaise Metabolic Disorder Nausea Respiratory Disorder Vomiting Date:12/28/98ISR Number: 3176446-9Report Type:Expedited (15-DaCompany Report #USA/98/02992/LEX Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukaemia Health Clozaril (Clozapine) PS ORAL 500 MG ORAL Required Leukopenia Professional Intervention to Prevent Permanent Impairment/Damage Date:12/28/98ISR Number: 3176477-9Report Type:Expedited (15-DaCompany Report #GB/98/01240/LEX Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Ketoacidosis Clozaril PS ORAL 250 MG ORAL Initial or Prolonged Pyrexia Paroxetine C Procyclidine C Oestradiol C 22-Feb-2006 08:30 AM Page: 259 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/28/98ISR Number: 3176479-2Report Type:Expedited (15-DaCompany Report #D/98/05176/LEX Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Lymphocytic Leukaemia Health Leponex PS ORAL 400 MG ORAL Initial or Prolonged Professional Promethazine Other (Promethazine) C Required Intervention to Prevent Permanent Impairment/Damage Date:12/28/98ISR Number: 3176564-5Report Type:Expedited (15-DaCompany Report #USA/98/02971/LEX Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Obstructive Airways Health Clozaril (Clozapine) PS ORAL 150 MG ORAL Initial or Prolonged Disorder Professional Ativan (Lorazepam) C Date:12/28/98ISR Number: 3176568-2Report Type:Expedited (15-DaCompany Report #USA/98/02959/LEX Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Clozaril (Clozapine) PS ORAL 500 MG ORAL Initial or Prolonged Hepatitis A Professional Other Psychotic Disorder Date:12/28/98ISR Number: 3176839-XReport Type:Expedited (15-DaCompany Report #USA/98/00137/LEX Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Study Clozaril (Clozapine) PS ORAL 200 MG ORAL Myocarditis Health Diazepam C Professional Olanzapine C Date:12/28/98ISR Number: 3176844-3Report Type:Expedited (15-DaCompany Report #USA/98/02962/LEX Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Health Clozaril (Clozapine) PS ORAL 50 MG ORAL Initial or Prolonged Haematocrit Decreased Professional Minipres (Prazosin Required Haemoglobin Decreased Hydrochloride) SS Intervention to Orthostatic Hypotension Sinemet C Prevent Permanent Renal Haemorrhage Aynthroid C Impairment/Damage Vaginal Haemorrhage Colace C Vitamin E C Date:12/28/98ISR Number: 3176846-7Report Type:Expedited (15-DaCompany Report #USA/98/01798/LEX Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozaril (Clozapine) PS ORAL 25 MG ORAL Professional Sinemet C Parlodel C Flexeril C 22-Feb-2006 08:30 AM Page: 260 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/29/98ISR Number: 3176481-0Report Type:Expedited (15-DaCompany Report #GB/98/01239/LEX Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bacterial Infection Clozaril PS ORAL 550 MG ORAL Cellulitis Paroxetine Haemophilus Infection (Paroxetine) C Hypogammaglobulinaemia Pleural Effusion Pneumonia Date:12/29/98ISR Number: 3177441-6Report Type:Expedited (15-DaCompany Report #USA/98/02555/LEX Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acute Respiratory Health Clozaril (Clozapine) PS ORAL 800 MG ORAL Initial or Prolonged Distress Syndrome Professional Depakote (Valproate Required Agitation Semisodium) C Intervention to Chronic Obstructive Benzamycin C Prevent Permanent Pulmonary Disease Impairment/Damage Cough Disorientation Dyspnoea Exacerbated Hypercapnia Hyperventilation Lung Disorder Malaise Nasopharyngitis Pneumonia Respiratory Failure Date:12/29/98ISR Number: 3177443-XReport Type:Expedited (15-DaCompany Report #USA/98/02754/LEX Age:35 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agranulocytosis Health Clozaril (Clozapine) PS ORAL 300 MG ORAL Hospitalization - Drug Interaction Professional Seroquel SS Initial or Prolonged Infection Colace (Docusate Influenza Like Illness Sodium) C Leukopenia Date:12/29/98ISR Number: 3177449-0Report Type:Expedited (15-DaCompany Report #USA/98/02602/LEX Age:74 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Lymphoma Health Clozaril (Clozapine) PS ORAL 97.5 MG ORAL Required Professional Hydrochlorothiazide C Intervention to Carbidopa C Prevent Permanent Levodopa C Impairment/Damage Date:12/30/98ISR Number: 3177444-1Report Type:Expedited (15-DaCompany Report #D/98/04073/LEX Age:20 YR Gender:Male I/FU:F Outcome PT Death Cardiac Arrest Cyanosis Drug Level Above 22-Feb-2006 08:30 AM Page: 261 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Therapeutic Drug Toxicity Electroencephalogram Abnormal Report Source Product Role Manufacturer Route Dose Duration Liver Function Test Health Leponex (Clozapine) PS ORAL ORAL Abnormal Professional Malaise Metabolic Disorder Nausea Overdose Psychotic Disorder Respiratory Disorder Suicide Attempt Vomiting Date:12/30/98ISR Number: 3177472-6Report Type:Expedited (15-DaCompany Report #USA/98/02939/LEX Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coronary Artery Disease Health Clozaril (Clozapine) PS ORAL 350 MG ORAL Dyspepsia Professional Ventricular Fibrillation Date:12/31/98ISR Number: 3176882-0Report Type:Expedited (15-DaCompany Report #USA/98/03011/LEX Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiomyopathy Health Clozaril PS ORAL ORAL Professional Date:01/06/99ISR Number: 3178811-2Report Type:Expedited (15-DaCompany Report #GB/98/01266/LEX Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Condition Aggravated Foreign Clozaril Dyspepsia Health (Clozapine) PS ORAL 900 MG ORAL Myocardial Infarction Professional Date:01/06/99ISR Number: 3178829-XReport Type:Expedited (15-DaCompany Report #GB/98/00597/LEX Age:33 YR Gender:Male I/FU:F Outcome PT Death Asthenia Required Autoimmune Disorder Intervention to Back Pain Prevent Permanent Cardiac Arrest Impairment/Damage Cardiomegaly Chest Pain Constipation Convulsion Diarrhoea Dizziness Drug Hypersensitivity Dyspnoea Dysuria Eosinophil Count Increased Gastrointestinal 22-Feb-2006 08:30 AM Page: 262 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Infection Headache Hyperhidrosis Influenza Like Illness Report Source Product Role Manufacturer Route Dose Duration Jaundice Health Clozaril PS ORAL 300 MG ORAL Joint Stiffness Professional Chlorpromazine C Lethargy Chlorpromazine C Malaise Chlorpromazine C Myocarditis Zuclopenthixol C Nausea Zuclopenthixol C Oedema Omeprazole C Palpitations Multivitamins C Pericardial Effusion Pneumonia Aspiration Pyrexia Sedation Shock Tachycardia Ventricular Fibrillation Vomiting Date:01/07/99ISR Number: 3177758-5Report Type:Expedited (15-DaCompany Report #98-12-0280 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Adenoma Benign Health Clozapine PS Zenith Goldline Professional Pharm. ORAL 400MG PER DAY ORAL Compazine C Date:01/07/99ISR Number: 3177759-7Report Type:Expedited (15-DaCompany Report #98-11-0265 Age:61 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Catatonia Health Clozapine PS Zenith Goldline Initial or Prolonged Coma Professional Pharm. ORAL 600MG DAY Dehydration ORAL Difficulty In Walking Paxil Tablets SS ORAL 15MG QAM ORAL Dysphagia Mellaril C Eating Disorder Haemorrhagic Stroke Lethargy Date:01/07/99ISR Number: 3190915-7Report Type:Periodic Company Report #98-10-0250 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozapine PS Zenith Goldline Professional Pharm ORAL 900 MG/DAY ORAL Clozapine SS ORAL ORAL Haldol C 22-Feb-2006 08:30 AM Page: 263 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/07/99ISR Number: 3190916-9Report Type:Periodic Company Report #98-10-0251 Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozapine PS Zenith Goldline Professional Pharm. ORAL 25MG/DAY ORAL Date:01/07/99ISR Number: 3190917-0Report Type:Periodic Company Report #98-11-0253 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Iron Decreased Consumer Clozapine PS Zenith Goldline Haemoglobin Decreased Pharm. ORAL ORAL Obsessive Thoughts Buspar C Vistaril C Date:01/07/99ISR Number: 3190919-4Report Type:Periodic Company Report #98-11-0254 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eosinophil Count Health Clozapine PS Zenith Goldline Increased Professional Pharm. ORAL 200-350 MG/DAY ORAL Imipramine C Date:01/07/99ISR Number: 3190922-4Report Type:Periodic Company Report #98-11-0255 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozapine PS Zenith Goldline Professional Pharm. ORAL 50-150 MG/DAY ORAL Date:01/07/99ISR Number: 3190925-XReport Type:Periodic Company Report #98-11-0258 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Ineffective Health Clozapine PS Zenith Goldline Professional Pharm. ORAL 600MG/DAY ORAL Date:01/07/99ISR Number: 3190927-3Report Type:Periodic Company Report #98-11-0266 Age:18 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Health Clozapine PS Zenith Goldline Decreased Professional Pharm. ORAL 200 MG/DAY ORAL Date:01/07/99ISR Number: 3190930-3Report Type:Periodic Company Report #98-11-0269 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Psychomotor Hyperactivity Health Clozapine PS Zenith Goldline Thinking Abnormal Professional Pharm. ORAL 12.5 MG QD ORAL 22-Feb-2006 08:30 AM Page: 264 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prozac C Cytomel C Restoril C Klonopin C Depakote C Date:01/07/99ISR Number: 3190941-8Report Type:Periodic Company Report #98-03-0056 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Health Clozapine PS Zenith Goldline Decreased Professional Pharm. ORAL 500 MG PER DAY ORAL Neupogen C Tamoxifen C Date:01/07/99ISR Number: 3190944-3Report Type:Periodic Company Report #98-03-0145 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozapine PS Zenith Goldline Professional Pharm. ORAL 550 MG/DAY ORAL Date:01/07/99ISR Number: 3190947-9Report Type:Periodic Company Report #98-04-0078 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Ineffective Health Clozapine PS Zenith Goldline Professional Pharm. ORAL 500 MG/DAY ORAL Neurontin C Date:01/07/99ISR Number: 3190951-0Report Type:Periodic Company Report #98-04-0080 Age:49 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Ineffective Health Clozapine PS Zenith Goldline Professional Pharm. ORAL 225 MG TID Other ORAL Date:01/07/99ISR Number: 3190954-6Report Type:Periodic Company Report #98-05-0132 Age:77 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Ineffective Health Clozapine PS Zenith Goldline Professional Pharm. ORAL 75 MG/DAY ORAL Date:01/07/99ISR Number: 3190957-1Report Type:Periodic Company Report #98-06-0156 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Depression Health Clozapine PS Zenith Goldline Drooling Professional Pharm. ORAL 200 MG/DAY 22-Feb-2006 08:30 AM Page: 265 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL Chlorpromazine C Lamictal C Lithobid C Clonazepam C Wellbutrin C Dexedrine C Triazolam C Date:01/07/99ISR Number: 3190959-5Report Type:Periodic Company Report #98-07-0176 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozapine PS Zenith Goldline Professional Pharm. ORAL 300 MG/DAY ORAL Clozapine SS Zenith Goldline Pharm. ORAL 300 MG/DAY ORAL Depakote C Date:01/07/99ISR Number: 3190961-3Report Type:Periodic Company Report #98-07-0191 Age:47 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hallucination Health Clozapine PS Zenith Goldline Professional Pharm. ORAL 12.5 MG/DAY ORAL Alprazolam C Clonazepam C Trazodone C Wellbutrin C Prozac C Risperdal C Date:01/07/99ISR Number: 3190964-9Report Type:Periodic Company Report #98-08-0202 Age:66 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Health Clozapine PS Zenith Goldline Professional Pharm. ORAL 75MG/DAY ORAL Zoloft C Ferrous Sulfate C Klorcon C Multivitamins C Date:01/07/99ISR Number: 3190966-2Report Type:Periodic Company Report #98-08-0204 Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Distension Health Clozapine PS Zenith Goldline Abdominal Pain Professional Pharm. ORAL 200-400 Constipation MG/DAY ORAL Nausea Zantac C Levsinex C Propulsid C 22-Feb-2006 08:30 AM Page: 266 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/07/99ISR Number: 3190967-4Report Type:Periodic Company Report #98-08-0206 Age:76 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Health Clozapine PS Zenith Goldline Decreased Professional Pharm. ORAL 37.5 MG/DAY ORAL Prozac C Sinemet C Date:01/07/99ISR Number: 3192732-0Report Type:Periodic Company Report #98-10-0243 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Musculoskeletal Stiffness Health Clozapine- Zenith Initial or Prolonged Pyrexia Professional Goldline Pharm. Tachycardia Tablets PS Zenith Goldline Pharm ORAL 400 MG DAY ORAL Trazodone C Date:01/07/99ISR Number: 3192734-4Report Type:Periodic Company Report #98-11-0267 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozapine-Zentih Professional Goldline Pharm. Tablets PS Zentih Goldline Pharm. ORAL 25-40 MG/ DAY ORAL Serevent C Terbutaline C Lithium C Gabapentin C Prednisone C Fluconazole C Soma C Ranitidine C Dicyclomine Hydrochloride C Benzatropine C Clonazepam C Tegretol C Date:01/07/99ISR Number: 3192739-3Report Type:Periodic Company Report #98-06-0157 Age:53 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Pneumonia Health Clozapine-Zenith Hospitalization - Professional Goldline Pharm. Initial or Prolonged Tablets PS Zentih Goldline Pharm. ORAL 500-650 MG DAY ORAL Clozapine Tablets SS ORAL 400-600 MG DAY ORAL Paxil C Buspar C Ativan C Cogentin C 22-Feb-2006 08:30 AM Page: 267 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/07/99ISR Number: 3192743-5Report Type:Periodic Company Report #98-06-0158 Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Hypotension Health Clozapine-Zenith Hospitalization - Pneumonia Professional Goldline Pharm. Initial or Prolonged White Blood Cell Count Tablets PS Zentih Goldline Decreased Pharm. Tablets ORAL 300 MG DAY ORAL-50-100 MG DAY ORAL Propranolol C Depakote C Date:01/07/99ISR Number: 3192748-4Report Type:Periodic Company Report #98-06-0198 Age:53 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bipolar Disorder Health Clozapine-Zenith Initial or Prolonged Bipolar I Disorder Professional Goldline Pharm. Gastrointestinal Disorder Tablets PS Zentih Goldline Pharm. ORAL 275 MG/ DAY ORAL Depakote C Lorazepam C Date:01/07/99ISR Number: 3192752-6Report Type:Periodic Company Report #98-07-0173 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucination, Auditory Health Clozapine-Zenith Initial or Prolonged Professional Goldline Pharm. Tablets PS Zentih Goldline Pharm. ORAL 600-625 MG DAY ORAL Date:01/07/99ISR Number: 3192755-1Report Type:Periodic Company Report #98-07-0179 Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Convulsion Health Clozapine-Zenith Professional Goldline Pharm. Tablets PS -Zentih Goldline Pharm. ORAL 62.5 MG/ DAY ORAL Depakote C Date:01/07/99ISR Number: 3192757-5Report Type:Periodic Company Report #98-07-0194 Age:54 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delusion Health Clozapine-Zentih Initial or Prolonged Psychotic Disorder Professional Goldline Pharm. Tablets PS Zentih Goldline Pharm. ORAL 200 MG/ DAY ORAL Depakote C Pepcid C Glucotrol C 22-Feb-2006 08:30 AM Page: 268 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/07/99ISR Number: 3192759-9Report Type:Periodic Company Report #98-08-0201 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Health Clozapine-Zenith Initial or Prolonged Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 500 MG/ DAY ORAL Date:01/07/99ISR Number: 3192762-9Report Type:Periodic Company Report #98-08-0216 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Condition Aggravated Health Clozapine-Zenith Convulsion Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 500 MG DAY ORAL Dilantin C Lithium C Paxil C Haldol C Cogentin C Date:01/07/99ISR Number: 3192767-8Report Type:Periodic Company Report #98-09-0222 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Salivary Hypersecretion Health Clozapine-Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 450 MG PER DAY ORAL Cogentin C Date:01/07/99ISR Number: 3192769-1Report Type:Periodic Company Report #98-09-0223 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozapine-Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 600-800 MG DAY ORAL Depakote C Molindone C Date:01/07/99ISR Number: 3192771-XReport Type:Periodic Company Report #98-09-0224 Age:78 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Ineffective Health Clozapine-Zenith White Blood Cell Count Professional Goldline Pharm. Decreased Tablets PS Zenith Goldline Pharm. ORAL 250 MG DAY ORAL Depakote C 22-Feb-2006 08:30 AM Page: 269 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Zoloft C Date:01/07/99ISR Number: 3192773-3Report Type:Periodic Company Report #98-10-0229 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozapine-Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 137.5 MG DAY ORAL Haldol C Darvocet-N C Ativan C Docusate C Milk Of Magnesia C Tylenol C Dilantin C Multivitamins C Date:01/07/99ISR Number: 3192775-7Report Type:Periodic Company Report #98-10-0230 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dermatitis Health Clozapine-Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 25 MG PER DAY ORAL Date:01/07/99ISR Number: 3192777-0Report Type:Periodic Company Report #98-10-0233 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Mood Altered Health Clozapine-Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 300 MG DAY ORAL Date:01/07/99ISR Number: 3192779-4Report Type:Periodic Company Report #98-10-0234 Age:74 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozapine-Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 25 MG DAY ORAL Date:01/07/99ISR Number: 3192781-2Report Type:Periodic Company Report #98-10-0236 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Disorder Health Clozapine-Zenith Professional Goldline Pharm. 22-Feb-2006 08:30 AM Page: 270 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tablets PS Zenith Goldline Pharm. ORAL 175 MG DAY ORAL Seroquel C Ativan C Date:01/07/99ISR Number: 3192784-8Report Type:Periodic Company Report #98-10-0246 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozapine-Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 900 MG DAY ORAL Date:01/07/99ISR Number: 3192786-1Report Type:Periodic Company Report #98-10-0248 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozapine-Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 400 MG DAY ORAL Date:01/11/99ISR Number: 3179394-3Report Type:Expedited (15-DaCompany Report #GB/98/01240/LEX Age:41 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Clozaril PS ORAL 250 MG ORAL Initial or Prolonged Ketoacidosis Paroxetine C Pyrexia Procyclidine C Oestradiol C Date:01/11/99ISR Number: 3179412-2Report Type:Expedited (15-DaCompany Report #LIT/98/00343/LEX Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Literature Leponex PS 37.5 MG 3 WK Required Disseminated Health L-Dopa C Intervention to Intravascular Coagulation Professional Selegiline C Prevent Permanent Eosinophilia Biperiden C Impairment/Damage Epistaxis Amantadine C Gingival Bleeding Haemorrhage International Normalised Ratio Increased Leukopenia Pneumonia Respiratory Failure Sepsis Shock Thrombocytopenia 22-Feb-2006 08:30 AM Page: 271 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/11/99ISR Number: 3179635-2Report Type:Direct Company Report # Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Cataplexy Clozapine PS Novarits ORAL 100 MG PO AM Intervention to Fall AND 200 MG Prevent Permanent Movement Disorder HS; DURATION Impairment/Damage SEVERAL YEARS Ranitidine C Levothyroxine C Atorvastatin C Ortho-Novum C Date:01/11/99ISR Number: 3193101-XReport Type:Periodic Company Report #7397371 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Overdose Health Abbott-Depakote PS Abbott Initial or Prolonged Sedation Professional Clozaril SS 200.000 MG Other Other Haldol C Ativan C Trazodone C Lithium C Zoloft C Synthroid C Vistaril C ... C Date:01/19/99ISR Number: 3181917-5Report Type:Expedited (15-DaCompany Report #1998UW49478 Age:35 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agranulocytosis Health Seroquel PS ORAL 50 MG QD Hospitalization - Bacterial Sepsis Professional Seroquel SS ORAL 100 MG QD Initial or Prolonged Megakaryocytes Increased Clozaril SS ORAL 300 MG QD Neutropenia Colace C Pneumonia Cold Capsules C Sepsis White Blood Cell Count Decreased Date:01/19/99ISR Number: 3182027-3Report Type:Expedited (15-DaCompany Report #USA/98/02915/LEX Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Health Clozaril (Clozapine) PS ORAL 800 MG ORAL Loss Of Consciousness Professional Date:01/19/99ISR Number: 3182037-6Report Type:Expedited (15-DaCompany Report #AUS/99/00006/LEX Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pulmonary Oedema Health Clozaril (Clozapine) PS ORAL ORAL Initial or Prolonged Pyrexia Professional 22-Feb-2006 08:30 AM Page: 272 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/19/99ISR Number: 3182038-8Report Type:Expedited (15-DaCompany Report #GB/99/00006/LEX Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Abuser Health Clozaril (Clozapine) PS ORAL ORAL Overdose Professional Sedation Suicide Attempt Date:01/19/99ISR Number: 3182043-1Report Type:Expedited (15-DaCompany Report #CDN/98/00669/LEX Age:49 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiomegaly Health Clozaril PS ORAL 300 MG ORAL Initial or Prolonged Chest Pain Professional Required Electrocardiogram T Wave Intervention to Inversion Prevent Permanent Eosinophilia Impairment/Damage Leukocytosis Pericarditis Pleural Effusion Pleural Infection Date:01/19/99ISR Number: 3182061-3Report Type:Expedited (15-DaCompany Report #USA/98/02493/LEX Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anoxia Health Clozaril PS ORAL 700 MG ORAL Hospitalization - Balance Disorder Professional Zyprexa C Initial or Prolonged Convulsion Ativan C Other Encephalopathy Investigational Drug Subarachnoid Haemorrhage From Hoechst C Date:01/19/99ISR Number: 3182758-5Report Type:Expedited (15-DaCompany Report #CDN/99/00021/LEX Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Angiopathy Health Clozaril PS ORAL ORAL Thromboangiitis Professional Obliterans Date:01/21/99ISR Number: 3184170-1Report Type:Expedited (15-DaCompany Report #99F--10026 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Level Above Foreign Tegretol PS ORAL DAILY ORAL Initial or Prolonged Therapeutic Health Teralithe SS Encephalopathy Professional Leponex SS ORAL Other Depamide SS Barnetil SS ORAL ORAL Deroxat SS 22-Feb-2006 08:30 AM Page: 273 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/22/99ISR Number: 3184508-5Report Type:Expedited (15-DaCompany Report #AUS/99/00006/LEX Age:68 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Dyspnoea Health Clozaril (Clozapine) PS ORAL 100 MG ORAL Required Electrocardiogram Professional Amoxycillin Intervention to Abnormal (Amoxicillin) C Prevent Permanent Leukocytosis Impairment/Damage Pulmonary Oedema Pyrexia Respiratory Rate Increased Date:01/22/99ISR Number: 3184511-5Report Type:Expedited (15-DaCompany Report #USA/99/00052/LEX Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ammonia Increased Health Clozaril (Clozapine) PS ORAL 550 MG ORAL Initial or Prolonged Professional Depakote (Valproate Semisodium) C Loxapine C Augmentin (Clavulin) C Date:01/25/99ISR Number: 3184795-3Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Medication Error Clozapine PS Zenith Goldline ORAL 500 MG/DAY Initial or Prolonged Schizophrenia Disability Date:01/25/99ISR Number: 3185403-8Report Type:Expedited (15-DaCompany Report #AUS/99/00033/LEX Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiomegaly Health Clozaril PS ORAL 200 MG ORAL Dyspnoea Professional Digoxin C Pulmonary Oedema Aspirine C Iron C Vitamin B Complex C Date:01/25/99ISR Number: 3185527-5Report Type:Expedited (15-DaCompany Report #USA/99/00080/LEX Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Infection Health Clozaril (Clozapine) PS ORAL 600 MG ORAL Professional Date:01/25/99ISR Number: 3185630-XReport Type:Expedited (15-DaCompany Report #GB/98/00009/LEX Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Health Clozaril PS ORAL 800 MG ORAL Convulsion Professional 22-Feb-2006 08:30 AM Page: 274 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/25/99ISR Number: 3185632-3Report Type:Expedited (15-DaCompany Report #GB/99/00006/LEX Age:24 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Abuser Health Clozaril PS ORAL ORAL Mental Disorder Professional Cannabis SS Sedation Amphetamines SS Suicide Attempt Date:01/25/99ISR Number: 3185635-9Report Type:Expedited (15-DaCompany Report #USA/98/02900/LEX Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neoplasm Malignant Health Clozaril PS ORAL UNSPECIFIED Professional ORAL Date:01/25/99ISR Number: 3185637-2Report Type:Expedited (15-DaCompany Report #F/99/00037/LEX Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Level Above Leponex PS ORAL ORAL Initial or Prolonged Therapeutic Tegretol SS ORAL ORAL Required Encephalopathy Depamide SS Intervention to Barnetil SS Prevent Permanent Teralithe SS ORAL ORAL Impairment/Damage Deroxat SS ORAL 40 MG ORAL Date:01/25/99ISR Number: 3185646-3Report Type:Expedited (15-DaCompany Report #CDN/98/00941/LEX Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Distension Health Clozaril PS ORAL 600 MG ORAL Other Agitation Professional Dalmane C Required Anorexia Nozinan C Intervention to Dyspnoea Tylenol C Prevent Permanent Emotional Distress Impairment/Damage Hyponatraemia Hypotension Impaired Healing Infection Intestinal Obstruction Nausea Pain In Extremity Respiratory Distress Sepsis Date:01/25/99ISR Number: 3185725-0Report Type:Expedited (15-DaCompany Report #GB/99/00023/LEX Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Clozaril PS ORAL 75 MG ORAL Initial or Prolonged Hyperglycaemia Gliclazide C Required Intervention to Prevent Permanent Impairment/Damage 22-Feb-2006 08:30 AM Page: 275 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/25/99ISR Number: 3185832-2Report Type:Expedited (15-DaCompany Report #USA/99/00073/LEX Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Accident Health Clozaril PS ORAL 575 MG ORAL Constipation Professional Peri-Colace C Dysphagia Milk Of Magnesia C Injury Depakote C Oesophageal Spasm Date:01/25/99ISR Number: 3185833-4Report Type:Expedited (15-DaCompany Report #USA/99/00068/LEX Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Post Procedural Health Clozaril (Clozapine) PS ORAL 300 MG ORAL Complication Professional Date:01/27/99ISR Number: 3186868-8Report Type:Expedited (15-DaCompany Report #USA/98/02695/LEX Age:37 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anorectal Disorder Health Clozaril (Clozapine) PS ORAL 200 MG ORAL Initial or Prolonged Constipation Professional Prozac (Fluoxetine Required Rectal Prolapse Hydrochloride) C Intervention to Weight Increased Depakote (Valproate Prevent Permanent Semisodium) C Impairment/Damage Zyprexa (Olanzapine) C Colace (Docusate Sodium) C Reglan (Metoclopramide) C Date:01/27/99ISR Number: 3186869-XReport Type:Expedited (15-DaCompany Report #D/98/03842/LEX Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutropenia Health Leponex (Clozapine) PS ORAL 75 MG ORAL Initial or Prolonged Professional Nacom (Sinemet) C Parkotil (Pergolide Mesilate) C Sormodren (Bornaprine Hydrochloride) C Dytide H (Dyazide) C Fragmin (Heparin-Fraction, Sodium Salt) C Date:01/28/99ISR Number: 3187240-7Report Type:Expedited (15-DaCompany Report #1998UW49478 Age:35 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agranulocytosis Health Seroquel PS ORAL 50 MG QD PO; Hospitalization - Bone Marrow Depression Professional 100 MG QD PO Initial or Prolonged Gram Stain Negative Clozaril SS ORAL 300 MG QD PO Neutropenia Colace C Pneumonia Cold Capsules C Sepsis 22-Feb-2006 08:30 AM Page: 276 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/29/99ISR Number: 3188651-6Report Type:Expedited (15-DaCompany Report #GB/98/00597/LEX Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Apnoea Health Clozaril PS ORAL 300 MG ORAL Required Aspiration Professional Chlorpromazine C Intervention to Asthenia Zuclopenthixol C Prevent Permanent Back Pain Omeprazoleq C Impairment/Damage Blood Pressure Decreased Multivitamins C Cardiac Arrest Chest Discomfort Chest Pain Circulatory Collapse Constipation Convulsion Diarrhoea Dizziness Drug Hypersensitivity Dyspnoea Dysuria Eosinophil Count Increased Gastrointestinal Infection Headache Hyperhidrosis Inflammation Influenza Like Illness Joint Stiffness Lethargy Malaise Mental Impairment Myocarditis Nausea Oedema Palpitations Pericardial Effusion Pulse Absent Pyrexia Sedation Tachycardia Ventricular Fibrillation Ventricular Hypertrophy Vomiting Date:01/29/99ISR Number: 3188669-3Report Type:Expedited (15-DaCompany Report #D/99/00035/LEX Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Leponex (Clozapine) PS ORAL 100 MG ORAL Initial or Prolonged Gastrointestinal Disorder Professional Required Ileus Paralytic Intervention to Vomiting Prevent Permanent Impairment/Damage 22-Feb-2006 08:30 AM Page: 277 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/29/99ISR Number: 3188847-3Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bronchial Obstruction Clozaril PS ORAL 100 MG ORALLY Cardiac Failure 3X/DAY 6 YR Congestive Prozac C Cardiomegaly Zyprexa C Lymphadenopathy Lymphoma Neoplasm Malignant Oedema Pulmonary Oedema Weight Increased Date:02/01/99ISR Number: 3188533-XReport Type:Expedited (15-DaCompany Report #99-01-0005 Age:88 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldine Professional Pharm. ORAL 12.5-25MG/DAY ORAL Lasix C K-Dur C Lanoxin C Acetaminophen C Date:02/01/99ISR Number: 3188534-1Report Type:Expedited (15-DaCompany Report #98-11-0261 Age:81 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozapine PS Zenith Goldine Hyperphagia Professional Pharm. ORAL 6.25-50MG/DAY ORAL Sinemet C Date:02/01/99ISR Number: 3189545-2Report Type:Expedited (15-DaCompany Report #GB/99/00063/LEX Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abdominal Pain Health Clozaril (Clozapine) PS ORAL 200MG ORAL Hospitalization - Gastrointestinal Disorder Professional Initial or Prolonged Malaise Pneumonia Date:02/01/99ISR Number: 3189546-4Report Type:Expedited (15-DaCompany Report #USA/98/01306/LEX Age:83 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Haemoglobin Decreased Health Clozaril (Clozapine) PS ORAL 25MG ORAL Platelet Count Decreased Professional Paxil C Pneumonia Depakote C Red Blood Cell Count Sinemet C Decreased Tylenol C Ferrous Sulfate C 22-Feb-2006 08:30 AM Page: 278 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/01/99ISR Number: 3189548-8Report Type:Expedited (15-DaCompany Report #USA/98/02754/LEX Age:35 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agranulocytosis Health Clozaril (Clozapine) PS ORAL 300MG ORAL Hospitalization - Bacterial Sepsis Professional Seroquel SS 100MG Initial or Prolonged Drug Interaction Colace C Required Infection Intervention to Influenza Like Illness Prevent Permanent Leukopenia Impairment/Damage Neutropenia Pneumonia Date:02/01/99ISR Number: 3189549-XReport Type:Expedited (15-DaCompany Report #USA/98/02829/LEX Age:51 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pleural Effusion Health Clozaril (Clozapine) PS ORAL 650MG ORAL Pneumonia Aspiration Professional Cogentin C Pulmonary Oedema Neurontin C Prevacid C Ativan C Synthroid C Multivitamin C Sorbitol C Vitamin E C Date:02/01/99ISR Number: 3189550-6Report Type:Expedited (15-DaCompany Report #D/98/04073/LEX Age:20 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Leponex (Clozapine) PS ORAL ORAL Completed Suicide Professional Cyanosis Drug Level Above Therapeutic Drug Toxicity Electroencephalogram Abnormal Extrapyramidal Disorder Inborn Error Of Metabolism Intentional Overdose Liver Function Test Abnormal Malaise Nausea Respiratory Distress Stomach Discomfort Suicide Attempt Vomiting Date:02/01/99ISR Number: 3189552-XReport Type:Expedited (15-DaCompany Report #USA/99/00123/LEX Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Health Clozaril (Clozapine) PS ORAL 400MG ORAL Professional Lithium C Ddavp C 22-Feb-2006 08:30 AM Page: 279 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Risperdal C Dilantin C Ambien C Pamelor C Prilosec C Propulsid C Antabuse C Avapro C Date:02/01/99ISR Number: 3189553-1Report Type:Expedited (15-DaCompany Report #USA/99/00124/LEX Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Procedural Complication Health Clozaril (Clozapine) PS ORAL 100MG ORAL Professional Date:02/01/99ISR Number: 3189721-9Report Type:Expedited (15-DaCompany Report #USA/99/00125/LEX Age:81 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Clozaril PS ORAL 25 MG ORAL Congestive Professional Date:02/01/99ISR Number: 3407672-9Report Type:Periodic Company Report #M079210 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Interaction Health Trazodone Tabs PS ORAL ORAL Leukopenia Professional Clozaril SS ORAL 300 MG OD ORAL Prozac C Depakote C Glucophage Tabs C Alcohol C Date:02/02/99ISR Number: 3190414-2Report Type:Expedited (15-DaCompany Report #D/99/00035/LEX Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Clozapine PS ORAL 100 MG Initial or Prolonged Injury Asphyxiation Professional Required Intestinal Stenosis Intervention to Small Intestinal Prevent Permanent Obstruction Impairment/Damage Vomiting Date:02/04/99ISR Number: 3192069-XReport Type:Expedited (15-DaCompany Report #GB/99/00062/LEX Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Confusional State Health Clozaril PS ORAL 450 MG ORAL Drug Interaction Professional Prozac (Fluoxetine Hydrochloride) SS 22-Feb-2006 08:30 AM Page: 280 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/04/99ISR Number: 3192076-7Report Type:Expedited (15-DaCompany Report #D/98/05176/LEX Age:26 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acute Lymphocytic Health Leponex PS ORAL 400 MG ORAL Initial or Prolonged Leukaemia Professional Promethazine C Required Anorexia Intervention to B-Cell Type Acute Prevent Permanent Leukaemia Impairment/Damage Decreased Appetite Epistaxis Leukocytosis Malaise Pelvic Pain Thrombocytopenia Date:02/04/99ISR Number: 3192111-6Report Type:Expedited (15-DaCompany Report #GB/97/01205/LEX Age:56 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Distension Health Clozaril PS ORAL 100 MG ORAL Abdominal Mass Professional Abdominal Pain Confusional State Constipation Faecaloma Large Intestine Perforation Lower Respiratory Tract Infection Multi-Organ Failure Peritonitis Pneumonia Aspiration Pneumonia Bacterial Date:02/04/99ISR Number: 3192114-1Report Type:Expedited (15-DaCompany Report #F/98/02997/LEX Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Intestinal Obstruction Health Leponex PS ORAL 500 MG ORAL Hospitalization - Pneumonia Aspiration Professional Tranxene C Initial or Prolonged Respiratory Failure Required Intervention to Prevent Permanent Impairment/Damage Date:02/04/99ISR Number: 3192117-7Report Type:Expedited (15-DaCompany Report #GB/97/01022/LEX Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Clozaril PS ORAL 200 MG ORAL 22-Feb-2006 08:30 AM Page: 281 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/04/99ISR Number: 3192119-0Report Type:Expedited (15-DaCompany Report #GB/98/01210/LEX Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Potassium Decreased Study Clozaril PS ORAL 600 MG ORAL Required Clonic Convulsion Health Intervention to Electrocardiogram Professional Prevent Permanent Abnormal Impairment/Damage Electrocardiogram Qt Interval Heart Rate Abnormal Hypocalcaemia Hypokalaemia Muscle Contractions Involuntary Date:02/05/99ISR Number: 3192867-2Report Type:Expedited (15-DaCompany Report #1998-002914 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Ascites Health Combivent PS ORAL DOSAGE UNK/IH Hospitalization - Asthma Professional Clozaril SS ORAL TABLETS, Initial or Prolonged Cardiac Arrest 150MG/PO Cardiac Disorder Catapres C Cardiac Failure Trihexyphenidyl C Congestive Ventolin C Drooling Vanceril C Dyspnoea Fluid Retention Hallucination, Auditory Oedema Peripheral Sleep Apnoea Syndrome Date:02/05/99ISR Number: 3192895-7Report Type:Expedited (15-DaCompany Report #GB/99/00091/LEX Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Grand Mal Convulsion Health Clozaril (Clozapine) PS ORAL 400 MG ORAL Initial or Prolonged Hypokalaemia Professional Hyponatraemia Date:02/05/99ISR Number: 3192899-4Report Type:Expedited (15-DaCompany Report #F/99/00096/LEX Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Pain Health Leponex PS ORAL 450 MG ORAL 2 MON Required Hypotension Professional Intervention to Intestinal Obstruction Prevent Permanent Vomiting Impairment/Damage Date:02/05/99ISR Number: 3193016-7Report Type:Expedited (15-DaCompany Report #USA/99/00139/LEX Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Cancer Stage Ii Health Clozaril (Clozapine) PS ORAL ORAL Professional 22-Feb-2006 08:30 AM Page: 282 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/05/99ISR Number: 3193023-4Report Type:Expedited (15-DaCompany Report #CDN/98/00941/LEX Age:49 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Study Clozaril (Clozapine) PS ORAL 600 MG ORAL Other Angiopathy Health Dalmane (Flurazepam Required Anorexia Professional Hydrochloride) C Intervention to Ascites Nozinan Prevent Permanent Dyspnoea (Levomepromazine) C Impairment/Damage Emotional Distress Tylenol Hyponatraemia (Paracetamol) C Hypotension Impaired Healing Infection Intestinal Obstruction Nausea Pain In Extremity Respiratory Distress Sepsis Date:02/05/99ISR Number: 3198943-2Report Type:Periodic Company Report #FLUV002980219 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Health Luvox Tablets Initial or Prolonged Drug Level Above Professional (Fluvoxamine Therapeutic Maleate) PS ORAL PER ORAL Psychotic Disorder Clozaril (Clozapine) SS ORAL 600 MG , PER ORAL Date:02/05/99ISR Number: 3199376-5Report Type:Periodic Company Report #FLUV002980074 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Health Luvox Tablets 50 Mg Parotid Gland Enlargement Professional (Fluvoxamine Salivary Hypersecretion Maleate) PS ORAL 150 MG, PER ORAL Clozaril (Clozapine) SS ORAL PER ORAL Date:02/08/99ISR Number: 3193707-8Report Type:Direct Company Report # Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Autonomic Neuropathy Clozapine PS 500MG AM; Blood Pressure Abnormal 400MG HS Constipation Divaproex C Faecaloma Docaisate C Hallucination Psyllium C Ileus Paralytic Megacolon Pulse Abnormal Respiratory Rate Increased 22-Feb-2006 08:30 AM Page: 283 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/08/99ISR Number: 3193879-5Report Type:Expedited (15-DaCompany Report #F/98/01273/LEX Age:34 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Health Leponex (Clozapine) PS ORAL 800 MG ORAL Initial or Prolonged Asthenia Professional Zyprexa (Olanzapine) SS Required Drug Withdrawal Syndrome Seresta (Oxazepam) C Intervention to Dyskinesia Chronadalate Prevent Permanent Extrapyramidal Disorder (Nifedipine) C Impairment/Damage Hyperhidrosis Lipanthyl Increased Bronchial (Fenofibrate) C Secretion Lung Disorder Salivary Hypersecretion Date:02/08/99ISR Number: 3193921-1Report Type:Expedited (15-DaCompany Report #GB/99/00062/LEX Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Confusional State Health Clozaril PS ORAL 450 MG ORAL Drug Interaction Professional Prozac SS Date:02/09/99ISR Number: 3194469-0Report Type:Expedited (15-DaCompany Report #001-0983-990002 Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cerebrovascular Accident Health Omnicef (Cefdinir) PS Drug Interaction Professional Clozaril (Clozapine) SS ORAL 300 MG PER Drug Level Above ORAL Therapeutic Coumadin C Eye Infection Date:02/10/99ISR Number: 3194383-0Report Type:Expedited (15-DaCompany Report #99-01-0011 Age:77 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zeinth ORAL 18.25 MG/DAY Professional ORAL Date:02/10/99ISR Number: 3195588-5Report Type:Expedited (15-DaCompany Report #GB/99/00048/LEX Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Grand Mal Convulsion Health Clozaril (Clozapine) PS ORAL 750 MG ORAL Hypoglycaemia Professional Haloperidol Loss Of Consciousness (Haloperidol) SS 20 MG Date:02/10/99ISR Number: 3195597-6Report Type:Expedited (15-DaCompany Report #LIT/99/00006/LEX Age:44 YR Gender:Male I/FU:I Outcome PT Death Chronic Obstructive Pulmonary Disease Drug Interaction Drug Level Above Therapeutic Ecchymosis 22-Feb-2006 08:30 AM Page: 284 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Emphysema Eosinophilia Excoriation Report Source Product Role Manufacturer Route Dose Duration Fibrosis Literature Leponex/Clozaril Gastroenteritis Health (Clozapine) PS ORAL ORAL Haemorrhage Professional Prozac (Fluoxetine Hepatic Cirrhosis Hydrochloride) SS ORAL ORAL Hepatic Congestion Hepatitis C Ileus Paralytic Oesophagitis Overdose Pulmonary Oedema Date:02/10/99ISR Number: 3195610-6Report Type:Expedited (15-DaCompany Report #LIT/99/00007/LEX Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Literature Clozapine Initial or Prolonged Agranulocytosis Health (Clozapine) PS ORAL 125 MG ORAL 3 MON Disability Anaemia Professional Required Cytomegalovirus Infection Intervention to Diarrhoea Prevent Permanent Haemoglobin Decreased Impairment/Damage Intestinal Perforation Pyrexia White Blood Cell Count Increased Date:02/11/99ISR Number: 3195530-7Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Oculogyration Clozapine PS Novartis 300MG BID Gabapentin C Lorazepam C Divalproex C Docusate Sod C Date:02/11/99ISR Number: 3196018-XReport Type:Expedited (15-DaCompany Report #USA/00/00199/LEX Age:42 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetic Coma Health Clozaril (Clozapine) PS ORAL 300 MG ORAL Professional Date:02/11/99ISR Number: 3196020-8Report Type:Expedited (15-DaCompany Report #USA/99/00203/LEX Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Respiratory Disorder Health Clozaril (Clozapine) PS ORAL 450 MG ORAL Professional 22-Feb-2006 08:30 AM Page: 285 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/11/99ISR Number: 3196022-1Report Type:Expedited (15-DaCompany Report #F/98/02455/LEX Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Pain Leponex (Clozapine) PS ORAL 600 MG ORAL Life-Threatening Anuria Mepronizine SS ORAL 1 OTH ORAL Required Circulatory Collapse Theralene Intervention to Encopresis (Alimemazine Prevent Permanent Intestinal Obstruction Tartrate) SS ORAL ORAL Impairment/Damage Renal Failure Acute Rohypnol C Renal Impairment Seresta C Sepsis Deroxat C Shock Date:02/11/99ISR Number: 3196026-9Report Type:Expedited (15-DaCompany Report #USA/99/00125/LEX Age:80 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Clozaril (Clozapine) PS ORAL 25 MG ORAL Congestive Professional Date:02/11/99ISR Number: 3196028-2Report Type:Expedited (15-DaCompany Report #USA/99/00073/LEX Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dysphagia Health Clozaril (Clozapine) PS ORAL 575 MG ORAL Initial or Prolonged Oesophageal Spasm Professional Peri-Colace C Milk Of Magnesia C Depakote C Prozac C Date:02/11/99ISR Number: 3196170-6Report Type:Expedited (15-DaCompany Report #USA/99/00209/LEX Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukaemia Health Clozaril PS ORAL 600 MG ORAL Leukocytosis Professional Cogentin C Depakote C Folic Acid C Vitamin E C Pepcid C Date:02/11/99ISR Number: 3196192-5Report Type:Direct Company Report # Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ileus Paralytic Clozaril PS ORAL 600MG PO QD 12 MON Initial or Prolonged Malaise Vitamin E C Orthostatic Hypotension Systhroid C Vomiting Date:02/11/99ISR Number: 3196196-2Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Hospitalization - Blood Bilirubin Increased Initial or Prolonged Hyperglycaemia 22-Feb-2006 08:30 AM Page: 286 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hyperlipidaemia Report Source Product Role Manufacturer Route Dose Duration Clozaril PS ORAL 400MG PO QD Chloral Hlydrale C Risperidane C Date:02/12/99ISR Number: 3198083-2Report Type:Expedited (15-DaCompany Report #USA/98/02939/LEX Age:50 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coronary Artery Disease Health Clozaril (Clozapine) PS ORAL 350 MG ORAL Dyspepsia Professional Myocardial Infarction Ventricular Fibrillation Date:02/12/99ISR Number: 3258511-0Report Type:Expedited (15-DaCompany Report #99-04-0113 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine - Zenith Pulmonary Embolism Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 200 MG/DAY ORAL Date:02/16/99ISR Number: 3198372-1Report Type:Expedited (15-DaCompany Report #99-01-0014 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Clozapine PS Zenith Goldline Fall Professional Pharm. ORAL 250MG/DAY Myocardial Infarction ORAL Date:02/16/99ISR Number: 3198373-3Report Type:Expedited (15-DaCompany Report #99-01-0015 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Clozapine Tablet PS Zenith Goldline Professional Pharm. ORAL 300MG DAY ORAL Date:02/16/99ISR Number: 3199846-XReport Type:Expedited (15-DaCompany Report #USA/98/02477/LEX Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Brain Hypoxia Health Clozaril (Clozapine) PS ORAL 100 MG ORAL Encephalopathy Professional Ventricular Fibrillation 22-Feb-2006 08:30 AM Page: 287 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/16/99ISR Number: 3199850-1Report Type:Expedited (15-DaCompany Report #F/98/01930/LEX Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Health Leponex (Clozapine) PS ORAL 100 MG ORAL Initial or Prolonged Hyperglycaemia Professional Laroxyl C Required Medication Error Seresta C Intervention to Prevent Permanent Impairment/Damage Date:02/16/99ISR Number: 3199852-5Report Type:Expedited (15-DaCompany Report #GB/98/01266/LEX Age:50 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coronary Artery Disease Health Clozaril (Clozapine) PS ORAL 900 MG ORAL Drug Level Above Professional Therapeutic Dyspepsia Myocardial Infarction Date:02/16/99ISR Number: 3199854-9Report Type:Expedited (15-DaCompany Report #GB/99/00058/LEX Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Angina Pectoris Health Clozaril (Clozapine) PS ORAL 50 MG ORAL Hospitalization - Chest Pain Professional Olanzapine C Initial or Prolonged Hypoglycaemia Metformin C Required Hypotension Intervention to Tachycardia Prevent Permanent Impairment/Damage Date:02/16/99ISR Number: 3199916-6Report Type:Expedited (15-DaCompany Report #USA/99/00124/LEX Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) PS ORAL 100 MG ORAL Professional Date:02/16/99ISR Number: 3199919-1Report Type:Expedited (15-DaCompany Report #GB/98/01238/LEX Age:67 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Study Clozaril (Clozapine) PS ORAL 175 MG ORAL Chronic Obstructive Health Carbamazepine C Pulmonary Disease Professional Diazepam C Condition Aggravated Becotide C Coronary Artery Disease Ventolin C Infection In An Simvastatin C Immunocompromised Host Amoxycillin C Lower Respiratory Tract Erythromycin C Infection Diazepam C Malaise Oxybutynin C Myocardial Ischaemia Prednisolone C Salbutamol Nebs C Atrovent Nebs C 22-Feb-2006 08:30 AM Page: 288 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/18/99ISR Number: 3203024-5Report Type:Expedited (15-DaCompany Report #GB/99/00091/LEX Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abnormal Behaviour Health Clozaril (Clozapine) PS ORAL 400 MG ORAL Hospitalization - Agitation Professional Reboxetine Initial or Prolonged Crying (Reboxetine) C Required Cyanosis Thioridazine Intervention to Grand Mal Convulsion (Thioridazine) C Prevent Permanent Hypokalaemia Procyclidine Impairment/Damage Hyponatraemia (Procyclidine0 C Leukocytosis Gaviscon (Hydromag) C Neutrophil Count Abnormal Obstructive Airways Disorder Respiratory Arrest Tongue Disorder Vomiting White Blood Cell Count Increased Date:02/18/99ISR Number: 3203377-8Report Type:Expedited (15-DaCompany Report #AUS/99/00072/LEX Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Respiratory Depression Health Clozaril (Clozapine) PS ORAL 300MG ORAL Professional Date:02/18/99ISR Number: 3203380-8Report Type:Expedited (15-DaCompany Report #AUS/99/00075/LEX Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Leukocytosis Health Clozaril (Clozapine) PS ORAL 125MG ORAL Pneumonia Professional Date:02/18/99ISR Number: 3203384-5Report Type:Expedited (15-DaCompany Report #USA/99/00259/LEX Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Health Clozaril (Clozapine) PS ORAL 500MG ORAL Life-Threatening Professional Date:02/18/99ISR Number: 3203538-8Report Type:Expedited (15-DaCompany Report #USA/98/02741/LEX Age:62 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Neoplasm Malignant Health Clozaril (Clozapine) PS ORAL 300 MG ORAL Professional Date:02/19/99ISR Number: 3202977-9Report Type:Expedited (15-DaCompany Report #GB/99/00141/LEX Age:42 YR Gender:Male I/FU:I Outcome Other Required Intervention to Prevent Permanent 22-Feb-2006 08:30 AM Page: 289 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Hypogammaglobulinaemia Clozaril (Clozapine) PS ORAL 55 MG ORAL Infection Date:02/19/99ISR Number: 3202978-0Report Type:Expedited (15-DaCompany Report #USA/99/00272/LEX Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Albumin Decreased Health Clozaril (Clozapine) PS ORAL 550 MG ORAL 8 YR Initial or Prolonged Diabetes Mellitus Professional Zoloft C Non-Insulin-Dependent Atenolol C Hypogammaglobulinaemia Hypoproteinaemia Leukocytosis Pneumonia White Blood Cell Count Increased Date:02/19/99ISR Number: 3202979-2Report Type:Expedited (15-DaCompany Report #USA/99/00080/LEX Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetes Mellitus Health Clozaril PS ORAL 600 MG ORAL Gastroenteritis Professional Depakote C Peritonitis Ativan C Peri-Colace C Dulcolax C Propulsid C Zyprexa C Theragran C Humulin N C Humulin R C Spectazole C Date:02/22/99ISR Number: 3204454-8Report Type:Expedited (15-DaCompany Report #USA/98/02839/LEX Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Autonomic Nervous System Health Clozaril (Clozapine) PS ORAL 900 MG ORAL Life-Threatening Imbalance Professional Docusate C Hospitalization - Constipation Psyllium C Initial or Prolonged Drug Toxicity Divalproex C Faecaloma Hallucination Hypotension Ileus Paralytic Megacolon Respiratory Disorder Respiratory Rate Increased Tachycardia Thinking Abnormal Urinary Incontinence 22-Feb-2006 08:30 AM Page: 290 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/22/99ISR Number: 3204466-4Report Type:Expedited (15-DaCompany Report #USA/98/02248/LEX Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Toxicity Health Clozaril (Clozapine) PS ORAL 300 MG ORAL Life-Threatening Professional Date:02/22/99ISR Number: 3204468-8Report Type:Expedited (15-DaCompany Report #USA/99/00327/LEX Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozaril (Clozapine) PS ORAL 25 MG ORAL Professional Sinemet C Ativan C Metamucil C Benadryl C Date:02/22/99ISR Number: 3204472-XReport Type:Expedited (15-DaCompany Report #CDN/98/00941/LEX Age:49 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Distension Study Clozaril (Clozapine) PS ORAL 600 MG ORAL Other Agitation Health Dalmane C Required Angiopathy Professional Nozinan C Intervention to Anorexia Tylenol C Prevent Permanent Ascites Impairment/Damage Condition Aggravated Dyspnoea Emotional Distress Foot Amputation Hyponatraemia Hypotension Impaired Healing Infection Intestinal Obstruction Nausea Pain In Extremity Respiratory Distress Sepsis Skin Ulcer Superinfection Toe Amputation Date:02/22/99ISR Number: 3204595-5Report Type:Expedited (15-DaCompany Report #USA/99/00123/LEX Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Health Clozaril (Clozapine) PS ORAL 400 MG ORAL Convulsion Professional Lithium C Vomiting Ddavp C Risperdal C Dilantin C Ambien C Pamelor C Prilosec C Propulsid C Antabuse C Avapro C 22-Feb-2006 08:30 AM Page: 291 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/24/99ISR Number: 3206033-5Report Type:Direct Company Report # Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Abnormal Behaviour Clozaril 100 Mg 1 Intervention to Confusional State Qam 2 Q Hs Generic PS 100 MG 1 Q AM Prevent Permanent Fear 2 Q HS Impairment/Damage Musculoskeletal Stiffness Paranoia Thinking Abnormal Tremor Date:02/24/99ISR Number: 3207228-7Report Type:Expedited (15-DaCompany Report #D/99/00197/LEX Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Health Leponex (Clozapine) PS ORAL ORAL Initial or Prolonged Professional Required Intervention to Prevent Permanent Impairment/Damage Date:02/24/99ISR Number: 3207232-9Report Type:Expedited (15-DaCompany Report #GB/98/01165/LEX Age:66 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Clostridial Infection Health Clozaril (Clozapine) PS ORAL 300 MG ORAL Required Colitis Ulcerative Professional Bendrofluazide Intervention to Diarrhoea (Bendroflumethiazide Prevent Permanent Hypokalaemia ) C Impairment/Damage Intestinal Perforation Peritonitis Sedation Date:02/24/99ISR Number: 3207234-2Report Type:Expedited (15-DaCompany Report #USA/98/02708/LEX Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Toxicity Health Clozaril (Clozapine) PS ORAL 150 MG ORAL Initial or Prolonged Influenza Like Illness Professional Depakote (Valproate Required Neuroleptic Malignant Semisodium) C Intervention to Syndrome Wellbutrin Prevent Permanent Pulmonary Oedema (Amfebutamone Impairment/Damage Thrombocytopenia Hydrochloride) C Date:02/25/99ISR Number: 3212192-0Report Type:Periodic Company Report #JAUSA-34357 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Weight Increased Consumer Risperdal (Risperidone), Janssen, Tablet PS ORAL ORAL Olanzapine (Olanzapine) Capsules SS ORAL 10 MG 1 DAILY ORAL Clozaril (Clozapine) SS 22-Feb-2006 08:30 AM Page: 292 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3213093-4Report Type:Periodic Company Report #JAUSA-32384 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Salivary Hypersecretion Study Risperdal Initial or Prolonged Sedation Health (Risperdone) PS Janssen ORAL 6 MG DAILY Speech Disorder Professional ORAL Clozapine (Clozapine) SS ORAL -- , DAILY, ORAL Depakote (Valproate Sodium) C Trazodone (Trazodone) C Date:02/25/99ISR Number: 3213152-6Report Type:Periodic Company Report #JAUSA-33926 Age:80 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Parkinsonism Health Risperdal Professional (Risperidone), Janssen PS Janssen ORAL .5 MG DAILY ORAL Clozaril (Clozapine) SS ORAL ORAL Sinemet (Sinemet(R)) C Date:02/25/99ISR Number: 3213244-1Report Type:Periodic Company Report #JAUSA-34289 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Health Risperdal Convulsion Professional (Risperidone) Sedation Janssen Tablet PS ORAL SEE IMAGE Urinary Incontinence Clozaril (Clozapine) SS ORAL SEE IMAGE Desmopressin (Desmopressin) SS INHALATION Date:02/26/99ISR Number: 3208615-3Report Type:Expedited (15-DaCompany Report #USA/99/00331/LEX Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Delusion Health Clozaril (Clozapine) PS ORAL 10100 MG Hospitalization - Depressed Level Of Professional APPROX ORAL Initial or Prolonged Consciousness Zyprexa C Required Dysphagia Klonopin C Intervention to Electrocardiogram Nembutal C Prevent Permanent Abnormal Impairment/Damage Electrocardiogram T Wave Amplitude Decreased Hallucination Heart Rate Increased Hypertension Overdose Stupor Suicide Attempt 22-Feb-2006 08:30 AM Page: 293 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/99ISR Number: 3208907-8Report Type:Direct Company Report # Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Leukocytosis Clozapine PS ORAL 500MG , Hospitalization - DAILY, ORAL Initial or Prolonged Diphenhydramine C Ranitidine C Haloperidol C Date:03/01/99ISR Number: 3208260-XReport Type:Direct Company Report # Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Clozapine PS ORAL 25MG PO QHS 2 DAY Oculogyration Klonopin C Sinemet C Digoxin C Furosemide C Potassium Cloride C Metamucil C Date:03/01/99ISR Number: 3208511-1Report Type:Direct Company Report # Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Health Clozaril PS Novaritis ORAL 250MG PO Neutropenia Professional BID 4 MIN Date:03/01/99ISR Number: 3209160-1Report Type:Expedited (15-DaCompany Report #GB/99/00175/LEX Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Respiratory Depression Health Clozaril (Clozapine) PS ORAL 450 MG ORAL Respiratory Failure Professional Date:03/01/99ISR Number: 3209163-7Report Type:Expedited (15-DaCompany Report #USA/99/00358/LEX Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depressed Level Of Health Clozaril (Clozapine) PS ORAL 700 MG ORAL Initial or Prolonged Consciousness Professional Diabetes Mellitus Hypoglycaemia Date:03/01/99ISR Number: 3219541-8Report Type:Periodic Company Report #98USA10390 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coordination Abnormal Health Anafranil PS ORAL 150 MG, Initial or Prolonged Drug Interaction Professional DAILY, ORAL Dysarthria Clozaril Tablet Dyskinesia (Clozapine) SS ORAL 550 MG , DAILY, ORAL Biaxin Film-Coated Tablet (Clarithromycin) SS ORAL ORAL 22-Feb-2006 08:30 AM Page: 294 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/01/99ISR Number: 3432393-6Report Type:Periodic Company Report #9445-AR Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Interaction Health Trazodone Leukopenia Professional Hydrochloride Other Tablets Usp, 100 Mg PS ORAL 200 MG PO QHS 1 YR Clozaril (Clozapine) SS ORAL 300 MG ORAL Prozac (Fluoxetine Hydrochloride) C Depakote (Valproate Semisodium) C Glucophage (Metformin Hydrochloride) C Alcohol (Ethanol) C Date:03/01/99ISR Number: 3440063-3Report Type:Periodic Company Report #M078659 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Consumer Glucophage Tabs PS ORAL Clozaril SS ORAL 300 MG QD ORAL Trazodone SS Prozac C Depakote C Alcohol C Date:03/03/99ISR Number: 3211537-5Report Type:Expedited (15-DaCompany Report #GB/99/00058/LEX Age:19 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Angina Pectoris Health Clozaril (Clozapine) PS ORAL 50 MG ORAL Hospitalization - Chest Pain Professional Olanzapine C Initial or Prolonged Hypoglycaemia Metformin C Other Hypotension Propranolol C Required Tachycardia Intervention to Prevent Permanent Impairment/Damage Date:03/03/99ISR Number: 3211546-6Report Type:Expedited (15-DaCompany Report #GB/99/00189/LEX Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Clozaril (Clozapine) PS ORAL 200 MG ORAL Medication Error Professional Date:03/03/99ISR Number: 3211576-4Report Type:Expedited (15-DaCompany Report #GB/98/01165/LEX Age:66 YR Gender:Female I/FU:F Outcome PT Death Clostridial Infection Required Colitis Ulcerative Intervention to Diarrhoea Prevent Permanent Hypokalaemia Impairment/Damage Large Intestine 22-Feb-2006 08:30 AM Page: 295 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Perforation Megacolon Peritonitis Sedation Report Source Product Role Manufacturer Route Dose Duration Health Clozaril (Clozapine) PS ORAL 300 MG ORAL Professional Bendrofluazide (Bendroflumethiazide ) C Date:03/03/99ISR Number: 3211599-5Report Type:Expedited (15-DaCompany Report #USA/98/03011/LEX Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiomyopathy Health Clozaril (Clozapine) PS ORAL UNSPECIFIED Professional ORAL Date:03/03/99ISR Number: 3211626-5Report Type:Expedited (15-DaCompany Report #GB/99/00167/LEX Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Constipation Health Clozaril (Clozapine) PS ORAL 250 MG ORAL Other Intestinal Obstruction Professional Anesthetics C Myocardial Infarction Date:03/03/99ISR Number: 3211630-7Report Type:Expedited (15-DaCompany Report #GB/99/00170/LEX Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrial Flutter Health Clozaril (Clozapine) PS ORAL 250 MG ORAL Initial or Prolonged Blood Creatine Professional Phosphokinase Increased Cardiac Failure Haematuria Muscle Necrosis Renal Impairment Rhabdomyolysis Date:03/03/99ISR Number: 3211632-0Report Type:Expedited (15-DaCompany Report #GB/99/00174/LEX Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Respiratory Arrest Health Clozaril (Clozapine) PS ORAL 300 MG ORAL Respiratory Failure Professional Date:03/05/99ISR Number: 3214056-5Report Type:Expedited (15-DaCompany Report #F/99/00379/LEX Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Benign Neoplasm Health Leponex (Clozapine) PS ORAL UNSPECIFIED Initial or Prolonged Professional ORAL Required Intervention to Prevent Permanent Impairment/Damage 22-Feb-2006 08:30 AM Page: 296 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/05/99ISR Number: 3214328-4Report Type:Expedited (15-DaCompany Report #GB/99/00174/LEX Age:55 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Respiratory Arrest Health Clozaril (Clozapine) PS ORAL 300 MG ORAL Respiratory Failure Professional Date:03/05/99ISR Number: 3214340-5Report Type:Expedited (15-DaCompany Report #GB/99/00175/LEX Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Clozaril (Clozapine) PS ORAL 450 MG ORAL Chronic Obstructive Professional Pulmonary Disease Respiratory Arrest Respiratory Depression Upper Respiratory Tract Infection Weight Increased Date:03/05/99ISR Number: 3214369-7Report Type:Expedited (15-DaCompany Report #USA/99/00392/LEX Age:69 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Health Clozaril (Clozapine) PS ORAL 450 MG Initial or Prolonged Confusional State Professional Risperdal Required Disorientation (Risperidone) C Intervention to Fall Calan Sr (Verapamil Prevent Permanent Head Injury Hydrochloride) C Impairment/Damage Urinary Tract Infection Cipro (Ciprofloxacin Hydrochloride) C Zantac (Ranitidine Hydrochloride) C Date:03/08/99ISR Number: 3214888-3Report Type:Expedited (15-DaCompany Report #USA/99/00271/LEX Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Difficulty In Walking Health Clozaril (Clozapine) PS ORAL ORAL Initial or Prolonged Hypotension Professional Seroquel C Required Paresis Neurontin Intervention to Pneumonia (Gabapentin) C Prevent Permanent Pyrexia Valproic Acid C Impairment/Damage Viral Infection Date:03/08/99ISR Number: 3214889-5Report Type:Expedited (15-DaCompany Report #USA/99/00203/LEX Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozaril (Clozapine) PS ORAL ORAL Respiratory Disorder Professional Seroquel C Effexor (Venlafaxine Hydrochloride) C Depakote (Valproate Semisodium) C 22-Feb-2006 08:30 AM Page: 297 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/08/99ISR Number: 3214890-1Report Type:Expedited (15-DaCompany Report #USA/99/00199/LEX Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozaril (Clozapine) PS ORAL 300 MG ORAL Diabetic Coma Professional Nph (Insulin Pneumonia Injection, Isophane) C Docusate Sodium C Date:03/08/99ISR Number: 3214894-9Report Type:Expedited (15-DaCompany Report #NL/99/00010/LEX Age:67 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delirium Health Leponex (Clozapine) PS ORAL 350 MG ORAL Initial or Prolonged Drug Level Above Professional Temesta (Lorazepam) C Required Therapeutic Intervention to Infection Prevent Permanent Impairment/Damage Date:03/08/99ISR Number: 3214895-0Report Type:Expedited (15-DaCompany Report #GB/99/00175/LEX Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Clozaril (Clozapine) PS ORAL 450 MG ORAL Chronic Obstructive Professional Pulmonary Disease Lung Disorder Myocardial Infarction Respiratory Arrest Upper Respiratory Tract Infection Weight Increased Date:03/08/99ISR Number: 3214897-4Report Type:Expedited (15-DaCompany Report #GB/99/00174/LEX Age:55 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Level Below Health Clozaril (Clozapine) PS ORAL 300 MG ORAL Therapeutic Professional Ranitidine C Respiratory Arrest Frumil C Respiratory Failure Prednisolone C Combivent C Pulmicort C Date:03/08/99ISR Number: 3215010-XReport Type:Expedited (15-DaCompany Report #D/99/00255/LEX Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Diabetic Coma Health Leponex (Clozapine) PS ORAL 200 MG ORAL Hospitalization - Hyperglycaemia Professional Initial or Prolonged Ketoacidosis Required Pancreatitis Intervention to Prevent Permanent Impairment/Damage 22-Feb-2006 08:30 AM Page: 298 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/08/99ISR Number: 3215358-9Report Type:Expedited (15-DaCompany Report #USA/99/00431/LEX Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Cancer In Situ Health Clozaril (Clozapine) PS ORAL 425 MG ORAL Breast Neoplasm Professional Depakote (Valproate Semisodium) C Paxil (Paroxetine Hydrochloride) C Date:03/08/99ISR Number: 3219220-7Report Type:Expedited (15-DaCompany Report #USA/99/00442/LEX Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukaemia Health Clozaril (Clozapine) PS ORAL 350 MG ORAL Leukocytosis Professional Tylenol #3 C Date:03/08/99ISR Number: 3326039-5Report Type:Periodic Company Report #1998UW49743 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Health Seroquel PS ORAL 400 MG QD PO Bipolar I Disorder Professional Clozaril SS 100 MG QD Confusional State Drug Interaction Intermittent Explosive Disorder Mania Date:03/09/99ISR Number: 3214928-1Report Type:Expedited (15-DaCompany Report #99-02-0034 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Colon Cancer Health Clozapine-Zenith Condition Aggravated Professional Goldline Pharm. Peritonitis Tablets PS ORAL 75-300 MG / Respiratory Failure DAY ORAL Paxil C Surfak C Tylenol C Iron C Vitamin C C Pepcid C Date:03/09/99ISR Number: 3214930-XReport Type:Expedited (15-DaCompany Report #99-02-0033 Age:90 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death White Blood Cell Count Health Clozapine - Zenith Increased Professional Goldline Pharm. Tablets PS ORAL 100 MG/DAY ORAL 22-Feb-2006 08:30 AM Page: 299 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/09/99ISR Number: 3214933-5Report Type:Expedited (15-DaCompany Report #99-02-0032 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Health Clozapine - Zenith Respiratory Arrest Professional Goldline Pharm. Tablets PS ORAL 37.5 MG / DAY ORAL Vistaril C Demerol C Duragesic C Zantac C Date:03/09/99ISR Number: 3214935-9Report Type:Expedited (15-DaCompany Report #99-02-0031 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cough Health Clozapine - Zenith Dyspnoea Professional Goldline Pharm. Lung Infiltration Tablets PS ORAL 700 MG / DAY ORAL Zoloft C Risperdal C Trazodone C Depakote C Inderal C Buspar C Minocin C Mylanta C Ventolin C Azmacort C Date:03/12/99ISR Number: 3218243-1Report Type:Expedited (15-DaCompany Report #99-02-0038 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening White Blood Cell Count Health Clozapine PS ORAL 300-500MG/DAY Hospitalization - Increased Professional ORAL Initial or Prolonged Zyprexa C Date:03/12/99ISR Number: 3218246-7Report Type:Expedited (15-DaCompany Report #99-02-0039 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Breast Cancer Female Health Clozapine PS ORAL 550-700MG/DAY Initial or Prolonged White Blood Cell Count Professional ORAL Decreased Thorzine C Risperdal C Clonidine C Depakote C Synthroid C Neupogen C 22-Feb-2006 08:30 AM Page: 300 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/99ISR Number: 3218247-9Report Type:Expedited (15-DaCompany Report #99-02-0040 Age:78 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS ORAL 400MG / DAY Professional ORAL Tylenol C Lactulose C Megace C Vitamin E C Eskalith Cr C Propulsid 20 C Depakote C Multivitamins C Niferex C Date:03/15/99ISR Number: 3221105-7Report Type:Expedited (15-DaCompany Report #GB/97/01213/LEX Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Influenza Like Illness Health Clozaril PS ORAL 100 MG ORAL Initial or Prolonged Loss Of Consciousness Professional Other Muscle Necrosis Renal Failure Acute Rhabdomyolysis Date:03/15/99ISR Number: 3221107-0Report Type:Expedited (15-DaCompany Report #GB/99/00063/LEX Age:57 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Distension Health Clozaril (Clozapine) PS ORAL 100 MG ORAL Initial or Prolonged Abdominal Pain Professional Lorazepam Required Asthenia (Lorazepam) C Intervention to Atrial Fibrillation Lactulose Prevent Permanent Dyspnoea (Lactulose) C Impairment/Damage Ileus Paralytic Trifluoperazine Intestinal Obstruction (Trifluoperazine) C Leukocytosis Malaise Pleural Effusion Pneumonia Pyrexia Stupor Date:03/15/99ISR Number: 3221243-9Report Type:Expedited (15-DaCompany Report #GB/99/00189/LEX Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Clozaril (Clozapine) PS ORAL 200 MG ORAL Professional Risperidone (Risperidone) C Date:03/15/99ISR Number: 3221247-6Report Type:Expedited (15-DaCompany Report #GB/99/00218/LEX Age:44 YR Gender:Male I/FU:I Outcome PT Death Abdominal Distension Circulatory Collapse 22-Feb-2006 08:30 AM Page: 301 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Shock Report Source Product Role Manufacturer Route Dose Duration Health Clozaril (Clozapine) PS ORAL 600 MG ORAL Professional Itraconazole (Itraconazole) C Date:03/15/99ISR Number: 3221249-XReport Type:Expedited (15-DaCompany Report #GB/99/00195/LEX Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Overdose Health Clozaril (Clozapine) PS ORAL 900 MG ORAL Aortic Dissection Professional Haloperidol Cardiac Tamponade (Haloperidol) C Pericardial Haemorrhage Zopiclone (Zopiclone) C Procyclidine (Procyclidine) C Date:03/15/99ISR Number: 3221305-6Report Type:Expedited (15-DaCompany Report #KOR/99/00101/LEX Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agranulocytosis Health Leponex (Clozapine) PS ORAL 400 MG ORAL Hospitalization - Pyrexia Professional Propylthiouracil Initial or Prolonged (Propylthiouracil) SS ORAL ORAL Required Intervention to Prevent Permanent Impairment/Damage Date:03/15/99ISR Number: 3221308-1Report Type:Expedited (15-DaCompany Report #AUS/99/00077/LEX Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Collapse Of Lung Health Clozaril (Clozapine) PS ORAL 27G ORAL Required Drug Level Above Professional Sodium Valproate C Intervention to Therapeutic Prevent Permanent Infection Impairment/Damage Overdose Date:03/15/99ISR Number: 3221693-0Report Type:Expedited (15-DaCompany Report #USA/99/00327/LEX Age:83 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozaril (Clozapine) PS ORAL 25 MG ORAL Myocardial Infarction Professional Sinemet C Sinemet Cr C Ativan C Metamucil C Benadryl C 22-Feb-2006 08:30 AM Page: 302 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/15/99ISR Number: 3221694-2Report Type:Expedited (15-DaCompany Report #D/99/00283/LEX Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aortic Valve Incompetence Health Leponex (Clozapine) PS ORAL 400 MG ORAL 8 YR Initial or Prolonged Cardiac Failure Professional Insulin C Chronic Obstructive Pulmonary Disease Condition Aggravated Cor Pulmonale Diabetes Mellitus Infection Mitral Valve Incompetence Pericardial Effusion Sedation Tachycardia Tricuspid Valve Incompetence Urinary Tract Infection Date:03/15/99ISR Number: 3221696-6Report Type:Expedited (15-DaCompany Report #D/99/00035/LEX Age:58 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Health Leponex (Clozapine) PS ORAL 100 MG ORAL Initial or Prolonged Condition Aggravated Professional Required Ileus Paralytic Intervention to Intestinal Stenosis Prevent Permanent Nausea Impairment/Damage Vomiting Date:03/15/99ISR Number: 3221698-XReport Type:Expedited (15-DaCompany Report #F/99/00096/LEX Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Distension Health Leponex (Clozapine) PS ORAL 200 MG ORAL Required Abdominal Pain Professional Risordan C Intervention to Aortic Dissection Aspegic C Prevent Permanent Coronary Artery Disease Zestril C Impairment/Damage Hypotension Gaviscon C Intestinal Obstruction Temesta C Vomiting White Blood Cell Count Increased Date:03/17/99ISR Number: 3222548-8Report Type:Expedited (15-DaCompany Report #001-0983-990002 Age:73 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Health Omnicef Drug Level Above Professional Therapeutic (Cefdinir) PS Eye Infection Clozaril (Clozapine) SS ORAL 300 MG, PER ORAL Coumadin C 22-Feb-2006 08:30 AM Page: 303 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/18/99ISR Number: 3222741-4Report Type:Expedited (15-DaCompany Report #99-02-0024 Age:51 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Distension Health Clozapine PS Zenith Goldline Initial or Prolonged Frequent Bowel Movements Professional Pharm. ORAL 100 MG/DAY Ileus Paralytic ORAL TABLETS Impaired Gastric Emptying Oliguria Urine Abnormality Date:03/18/99ISR Number: 3222784-0Report Type:Expedited (15-DaCompany Report #99-03-0045 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline Professional Pharm. ORAL 500 MG / DAY ORAL Date:03/18/99ISR Number: 3222790-6Report Type:Expedited (15-DaCompany Report #98-11-0264 Age:78 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asthenia Health Clozapine PS Zenith Goldline Cachexia Professional Pharm. ORAL 150-200 MG / Myocardial Infarction DAY ORAL Pulse Absent Coumadin C Respiratory Arrest Lanoxin C Risperdal C Date:03/18/99ISR Number: 3222795-5Report Type:Expedited (15-DaCompany Report #99-03-0046 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Differential White Blood Health Clozapine PS Zenith Goldline Cell Count Abnormal Professional Pharm. ORAL 500 MG/DAY ORAL Date:03/18/99ISR Number: 3222801-8Report Type:Expedited (15-DaCompany Report #99-02-0044 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death White Blood Cell Count Health Clozapine PS ORAL 300 MG/DAY Abnormal Professional ORAL Date:03/22/99ISR Number: 3223937-8Report Type:Expedited (15-DaCompany Report #GB/99/00170/LEX Age:43 YR Gender:Male I/FU:F Outcome PT Life-Threatening Atrial Flutter Hospitalization - Blood Creatine Initial or Prolonged Phosphokinase Increased Required Cardiac Disorder Intervention to Cardiac Failure Prevent Permanent Haematuria Impairment/Damage Hyperhidrosis Liver Function Test 22-Feb-2006 08:30 AM Page: 304 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Abnormal Muscle Necrosis Pyrexia Renal Impairment Report Source Product Role Manufacturer Route Dose Duration Rhabdomyolysis Health Clozaril (Clozapine) PS ORAL 250 MG ORAL Professional Chlorpromazine C Risperidone C Date:03/22/99ISR Number: 3223990-1Report Type:Expedited (15-DaCompany Report #F/99/00487/LEX Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Foreign Leponex (Clozapine) PS ORAL 600 MG ORAL 3 YR Initial or Prolonged Electroencephalogram Health Primperan SS ORAL ORAL Required Abnormal Professional Importal SS ORAL ORAL Intervention to Hypokalaemia Loxen (Nicardipine Prevent Permanent Hyponatraemia Hydrochloride) SS ORAL ORAL Impairment/Damage Oesophagitis Daflon (Diosmin) C ORAL 4 OTH ORAL Polydipsia Psychogenic Vomiting Date:03/22/99ISR Number: 3224191-3Report Type:Expedited (15-DaCompany Report #GB/98/00009/LEX Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Health Clozaril PS ORAL 800 MG ORAL Convulsion Professional Epilepsy Date:03/22/99ISR Number: 3224194-9Report Type:Expedited (15-DaCompany Report #CDN/99/00229/LEX Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Confusional State Study Clozaril (Clozapine) PS ORAL 100 MG ORAL Required Delirium Health Intervention to Drooling Professional Prevent Permanent Drug Withdrawal Syndrome Impairment/Damage Dystonia Extrapyramidal Disorder Salivary Hypersecretion Date:03/22/99ISR Number: 3224201-3Report Type:Expedited (15-DaCompany Report #USA/99/00495/LEX Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Health Clozaril (Clozapine) PS ORAL 250 MG ORAL Hospitalization - Neuroleptic Malignant Professional Thorazine C Initial or Prolonged Syndrome Neurontin C Pyrexia Cogentin C Pravachol C Tagamet C 22-Feb-2006 08:30 AM Page: 305 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/22/99ISR Number: 3224252-9Report Type:Expedited (15-DaCompany Report #USA/99/00209/LEX Age:50 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukocytosis Health Clozaril Lymphocytic Leukaemia Professional (Clozapine) PS ORAL 900 MG ORAL Cogentin (Benzatropine Mesilate) C Depakote (Valproate Semisodium) C Folic Acid C Vitamin E (Tocopherol) C Pepcid (Famotidine) C Date:03/22/99ISR Number: 3224527-3Report Type:Expedited (15-DaCompany Report #D/98/03983/LEX Age:24 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coma Health Leponex (Clozapine) PS ORAL 2000 MG ORAL Hospitalization - Delirium Professional Zyprexa (Olanzapine) C Initial or Prolonged Overdose Required Sedation Intervention to Suicide Attempt Prevent Permanent Impairment/Damage Date:03/23/99ISR Number: 3225631-6Report Type:Direct Company Report # Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tachycardia Health Clozaril PS 300 MG IN AM Professional 200 MG IN PM Date:03/23/99ISR Number: 3225645-6Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Catatonia Health Clozapine PS Zenith Initial or Prolonged Professional Pharmaceuticals ORAL 100 MG HS (PO) 3 MON Paxil C Depakote C Date:03/25/99ISR Number: 3225692-4Report Type:Expedited (15-DaCompany Report #99-02-0034 Age:83 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Intestinal Obstruction Health Clozapine PS Zenith Goldline Leukocytosis Professional Pharm. ORAL 75-300 MG DAY Respiratory Arrest ORAL Paxil C Surfax C Tylenol C Iron C Vitamin C C Pepcid C 22-Feb-2006 08:30 AM Page: 306 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/25/99ISR Number: 3225695-XReport Type:Expedited (15-DaCompany Report #99-02-0031 Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cough Health Clozapine PS Zenith Goldline Dyspnoea Professional Pharm. ORAL 700 MG DAY Medication Error ORAL Zoloft C Risperdal C Trazodone C Depakote C Inderal C Buspar C Minocin C Mylanta C Ventolin C Azmacort C Date:03/25/99ISR Number: 3225698-5Report Type:Expedited (15-DaCompany Report #99-03-0061 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Leukocytosis Health Clozapine PS Zenith Goldline Professional Pharm ORAL 100-500 MG DAY ORAL Date:03/25/99ISR Number: 3225701-2Report Type:Expedited (15-DaCompany Report #99-03-0047 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death White Blood Cell Count Health Clozapine PS Zenith Goldline Increased Professional Pharm. ORAL 75-100 MG ORAL Date:03/26/99ISR Number: 3227680-0Report Type:Expedited (15-DaCompany Report #LIT/99/00052/LEX Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Urea Increased Literature Clozapine Initial or Prolonged Dehydration Health (Clozapine) PS ORAL 200 MG ORAL Required Depressed Level Of Professional Intervention to Consciousness Prevent Permanent Hyperglycaemia Impairment/Damage Hypokalaemia Ketoacidosis Ketonuria Sedation Weight Increased Date:03/26/99ISR Number: 3227918-XReport Type:Expedited (15-DaCompany Report #990323-008011173 Age:42 YR Gender:Female I/FU:I Outcome PT Hospitalization - Anticholinergic Syndrome Initial or Prolonged Blood Pressure Systolic Decreased Coma Heart Rate Increased 22-Feb-2006 08:30 AM Page: 307 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hypokalaemia Report Source Product Role Manufacturer Route Dose Duration Foreign Haloperidol Tablets PS ORAL 80 MG, ONCE, Literature ORAL Health Clozapine SS ORAL 10 G, ONCE, Professional ORAL Prothipendyl C Bromazepam C Date:03/26/99ISR Number: 3229397-5Report Type:Expedited (15-DaCompany Report #USA/99/00600/LEX Age:56 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatinine Health Clozaril (Clozapine) PS ORAL 700MG ORAL Initial or Prolonged Increased Professional Prozac C Renal Failure Acute Date:03/26/99ISR Number: 3229405-1Report Type:Expedited (15-DaCompany Report #D/99/00283/LEX Age:58 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cachexia Health Leponex (Clozapine) PS ORAL 400 MG ORAL 8 YR Initial or Prolonged Cardiac Failure Professional Insulin C Required Cardiac Valve Disease Intervention to Chronic Obstructive Prevent Permanent Pulmonary Disease Impairment/Damage Cor Pulmonale Diabetes Mellitus Hyperglycaemia Left Ventricular Failure Pericardial Effusion Pericarditis Pleural Effusion Sedation Tachycardia Upper Respiratory Tract Infection Urinary Tract Infection Date:03/26/99ISR Number: 3229407-5Report Type:Expedited (15-DaCompany Report #USA/99/00611/LEX Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Lymphopenia Health Clozaril (Clozapine) PS ORAL 600MG ORAL Initial or Prolonged White Blood Cell Count Professional Decreased Date:03/29/99ISR Number: 3228730-8Report Type:Expedited (15-DaCompany Report #CDN/99/00250/LEX Age:55 YR Gender:Female I/FU:I Outcome Hospitalization - Initial or Prolonged Required Intervention to Prevent Permanent 22-Feb-2006 08:30 AM Page: 308 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Aggression Study Clozaril (Clozapine) PS ORAL ORAL Aspiration Health Chest X-Ray Abnormal Professional Coma Dehydration Leukocytosis Neutrophilia Date:03/29/99ISR Number: 3228745-XReport Type:Expedited (15-DaCompany Report #CDN/99/00229/LEX Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Confusional State Study Clozaril (Clozapine) PS ORAL 100 MG ORAL Required Delirium Health Haldol C Intervention to Drooling Professional Levothyroxine C Prevent Permanent Drug Withdrawal Syndrome Cogentin C Impairment/Damage Dystonia Extrapyramidal Disorder Hyperhidrosis Leukocytosis Neutrophilia Salivary Hypersecretion Urinary Incontinence Date:03/29/99ISR Number: 3229082-XReport Type:Expedited (15-DaCompany Report #GB/99/00250/LEX Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Health Clozaril (Clozapine) PS ORAL 175 MG ORAL Weight Increased Professional Date:03/29/99ISR Number: 3229084-3Report Type:Expedited (15-DaCompany Report #AUS/99/00006/LEX Age:68 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Dyspnoea Health Clozaril (Clozapine) PS ORAL 100 MG ORAL Required Electrocardiogram Professional Amoxycillin C Intervention to Abnormal Prevent Permanent Electrocardiogram T Wave Impairment/Damage Inversion Leukocytosis Pulmonary Oedema Pyrexia Date:03/29/99ISR Number: 3229092-2Report Type:Expedited (15-DaCompany Report #USA/99/00570/LEX Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atelectasis Health Clozaril (Clozapine) PS ORAL 900 MG ORAL Initial or Prolonged Collapse Of Lung Professional Trazodone C Required Pneumonia Cogentin C Intervention to Pneumonia Aspiration Ativan C Prevent Permanent Ect C Impairment/Damage 22-Feb-2006 08:30 AM Page: 309 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/29/99ISR Number: 3229100-9Report Type:Expedited (15-DaCompany Report #USA/99/00572/LEX Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Health Clozaril (Clozapine) PS ORAL 500 MG ORAL Dysphagia Professional Malaise Date:03/29/99ISR Number: 3229104-6Report Type:Expedited (15-DaCompany Report #USA/99/00545/LEX Age:47 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Toxicity Health Clozaril (Clozapine) PS ORAL 900 MG ORAL Professional Date:03/29/99ISR Number: 3229107-1Report Type:Expedited (15-DaCompany Report #USA/99/00546/LEX Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Clozaril (Clozapine) PS ORAL 300 MG ORAL Professional Date:03/29/99ISR Number: 3229304-5Report Type:Expedited (15-DaCompany Report #USA/99/00571/LEX Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Health Clozaril PS ORAL 900 MG ORAL Malaise Professional Cogentin C Ativan C Neurontin C Date:03/31/99ISR Number: 3230780-2Report Type:Expedited (15-DaCompany Report #GB/99/00238/LEX Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hepatocellular Damage Health Clozaril (Clozapine) PS ORAL 100 MG ORAL Myocardial Infarction Professional Date:03/31/99ISR Number: 3230781-4Report Type:Expedited (15-DaCompany Report #GB/99/00264/LEX Age:69 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Atrioventricular Block Health Clozaril (Clozapine) PS ORAL 50 MG ORAL Electrocardiogram Qt Professional Prolonged Date:03/31/99ISR Number: 3418489-3Report Type:Periodic Company Report #980518-107053642 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Injection Site Reaction Health Haldol Decanoate 100 Professional (Haloperidol) PS INTRAMUSCULAR 200 MG, 1X/2WK, IM (INTRAMUSCULA R) Clozapine SS 1000 MG, 22-Feb-2006 08:30 AM Page: 310 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/02/99ISR Number: 3231444-1Report Type:Expedited (15-DaCompany Report #99-03-0062 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozapine PS Zenith Goldline Hospitalization - Cardiac Disorder Professional Pharm. ORAL 50-100 MG/DAY Initial or Prolonged Condition Aggravated ORAL Pneumonia Pyrexia Date:04/02/99ISR Number: 3231446-5Report Type:Expedited (15-DaCompany Report #99-03-0076 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Respiratory Failure Health Clozapine PS Zenith Goldline White Blood Cell Count Professional Pharm. ORAL 25-100MG/DAY Increased ORAL Date:04/02/99ISR Number: 3231452-0Report Type:Expedited (15-DaCompany Report #99-03-0069 Age:76 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine PS Zenith Goldline Respiratory Arrest Professional Pharm. ORAL 150-200MG ORAL Benzotropine C Date:04/02/99ISR Number: 3231454-4Report Type:Expedited (15-DaCompany Report #99-03-0075 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Catatonia Health Clozapine PS Zenith Goldline Initial or Prolonged Condition Aggravated Professional Pharm. ORAL 100MG/DAY Fatigue ORAL Psychotic Disorder Paxil C Sexual Dysfunction Depakote C White Blood Cell Count Decreased Date:04/02/99ISR Number: 3231459-3Report Type:Expedited (15-DaCompany Report #99-03-0077 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline Professional Pharm. ORAL 200MG/DAY ORAL Date:04/02/99ISR Number: 3231461-1Report Type:Expedited (15-DaCompany Report #99-03-0079 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Empyema Health Clozapine PS Zenith Goldline Initial or Prolonged Leukocytosis Professional Pharm. ORAL 600-700MG/DAY ORAL Prozac C 22-Feb-2006 08:30 AM Page: 311 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/02/99ISR Number: 3231463-5Report Type:Expedited (15-DaCompany Report #99-03-0046 Age:58 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hepatic Neoplasm Health Clozapine PS Zenith Goldline Malignant Professional Pharm. ORAL 500MG/DAY ORAL Docusate Sodium C Lorazepam C Hydromorphone C Climetidine C Phenergan C Levothroid C Trimethobenzamide C Cephalexin C Prochlorperazine C Amoxicillin C Lamisil C Date:04/02/99ISR Number: 3231466-0Report Type:Expedited (15-DaCompany Report #99-03-0045 Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Neoplasm Malignant Health Clozapine PS Zenith Goldline Professional Pharm. ORAL 500MG/DAY ORAL Date:04/02/99ISR Number: 3231468-4Report Type:Expedited (15-DaCompany Report #99-03-0081 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline Professional Pharm. ORAL ORAL Date:04/02/99ISR Number: 3232129-8Report Type:Expedited (15-DaCompany Report #USA/99/00646/LEX Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Health Clozaril (Clozapine) PS ORAL ORAL Professional Prilosec C Date:04/02/99ISR Number: 3232130-4Report Type:Expedited (15-DaCompany Report #CDN/99/00229/LEX Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Confusional State Study Clozaril (Clozapine) PS ORAL 100MG ORAL Required Delirium Health Haldol C Intervention to Drug Withdrawal Syndrome Professional Levothyroxine C Prevent Permanent Dystonia Cogentin C Impairment/Damage Extrapyramidal Disorder Hyperhidrosis Leukocytosis Neutrophilia Salivary Hypersecretion Urinary Incontinence 22-Feb-2006 08:30 AM Page: 312 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/02/99ISR Number: 3232132-8Report Type:Expedited (15-DaCompany Report #F/99/00379/LEX Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Benign Salivary Gland Health Leponex (Clozapine) PS ORAL ORAL Initial or Prolonged Neoplasm Professional Required Intervention to Prevent Permanent Impairment/Damage Date:04/02/99ISR Number: 3232159-6Report Type:Expedited (15-DaCompany Report #F/93/00671/LEX Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Benign Salivary Gland Health Leponex (Clozapine) PS ORAL 400 MG ORAL Initial or Prolonged Neoplasm Professional Nozinan C Required Salivary Gland Intervention to Enlargement Prevent Permanent Sialoadenitis Impairment/Damage Date:04/02/99ISR Number: 3232423-0Report Type:Expedited (15-DaCompany Report #AUS/99/00006/LEX Age:68 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Dyspnoea Health Clozaril (Clozapine) PS ORAL 100 MG ORAL Required Electrocardiogram Professional Amoxycillin C Intervention to Abnormal Prevent Permanent Electrocardiogram T Wave Impairment/Damage Inversion Leukocytosis Pulmonary Oedema Pyrexia Respiratory Rate Increased Date:04/05/99ISR Number: 3232917-8Report Type:Expedited (15-DaCompany Report #AUS/99/00202/LEX Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Diabetes Mellitus Health Clozaril (Clozapine) PS ORAL 225 MG ORAL Required Fatigue Professional Losec C Intervention to Hyperglycaemia Prevent Permanent Increased Appetite Impairment/Damage Weight Decreased Date:04/05/99ISR Number: 3232918-XReport Type:Expedited (15-DaCompany Report #USA/99/00641/LEX Age:94 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Health Clozaril (Clozapine) PS ORAL 300 MG ORAL Cerebrovascular Accident Professional Lasix C Cerebrovascular Disorder Depressed Level Of Consciousness Hemiparesis Medication Error 22-Feb-2006 08:30 AM Page: 313 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/05/99ISR Number: 3232919-1Report Type:Expedited (15-DaCompany Report #GB/99/00309/LEX Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozaril (Clozapine) PS ORAL 75 MG ORAL Professional Date:04/05/99ISR Number: 3235234-5Report Type:Expedited (15-DaCompany Report #USA/99/00655/LEX Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Idiopathic Health Clozaril (Clozapine) PS ORAL 175 MG ORAL Thrombocytopenic Purpura Professional Omeprazole C Pyrexia Colace C Thrombocytopenia Synthroid C Inderal C Insulin C Tylenol C Depakote C Ceftriaxone C Date:04/07/99ISR Number: 3234286-6Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutrophil Count Clozaril PS ORAL 100MG BID PO Decreased Risperidone SS ORAL 4MG AM 2MG HS White Blood Cell Count PO Decreased Date:04/08/99ISR Number: 3235130-3Report Type:Expedited (15-DaCompany Report #99-01-0014 Age:75 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Clozapine Tablets PS Zenith Goldline Fall Professional Pharm ORAL 250 MG/DAILY Myocardial Infarction ORAL Tegretol C Desyrel C Date:04/08/99ISR Number: 3235947-5Report Type:Expedited (15-DaCompany Report #USA/99/00358/LEX Age:35 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depressed Level Of Health Clozaril (Clozapine) PS ORAL 700 MG ORAL Initial or Prolonged Consciousness Professional Cogentin C Required Diabetes Mellitus Dilantin C Intervention to Hypoglycaemia Glucophage C Prevent Permanent Novolin C Impairment/Damage Prozac C Date:04/08/99ISR Number: 3235948-7Report Type:Expedited (15-DaCompany Report #USA/99/00693/LEX Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozaril Professional (Clozapine) PS ORAL 500 MG ORAL 22-Feb-2006 08:30 AM Page: 314 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/08/99ISR Number: 3236014-7Report Type:Expedited (15-DaCompany Report #GB/99/00250/LEX Age:37 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril (Clozapine) PS ORAL 175 MG ORAL Hyperglycaemia Health Sertraline Weight Increased Professional (Sertraline Unknown) C Date:04/08/99ISR Number: 3237906-5Report Type:Expedited (15-DaCompany Report #D/99/00459/LEX Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiac Failure Health Leponex PS ORAL UNSPECIFIED Hospitalization - Hepatic Failure Professional ORAL Initial or Prolonged Hepatorenal Syndrome Liver Function Test Abnormal Renal Failure Acute Respiratory Failure Date:04/09/99ISR Number: 3235133-9Report Type:Expedited (15-DaCompany Report #99-03-0047 Age:74 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sepsis Health Clozapine PS Zenith Goldline Professional Pharm ORAL 75-100 MG ORAL Monopril C Bactrim C Cogentin C Pepcid C Zantac C Albuterol C Clindamycin C Valproic Acid C Date:04/09/99ISR Number: 3235136-4Report Type:Expedited (15-DaCompany Report #99-01-0221 Age:28 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Clozapine PS Zenith Goldline Congestive Professional Pharm. ORAL 100 MG PER Gastrooesophageal Reflux DAY ORAL Disease Zyprexa C Pneumonia Gabapentin C Depakote C Date:04/09/99ISR Number: 3235142-XReport Type:Expedited (15-DaCompany Report #99-03-0083 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Brain Neoplasm Malignant Health Clozapine PS Zenith Goldine Professional Pharm. ORAL 400-500 MG/DAY ORAL 22-Feb-2006 08:30 AM Page: 315 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/09/99ISR Number: 3236558-8Report Type:Expedited (15-DaCompany Report #JAGER-43823 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anhedonia Foreign Risperdal Hospitalization - Dizziness Health (Risperidone) PS Janssen ORAL 7 MG DAILY Initial or Prolonged Fall Professional ORAL Lethargy Risperdal Memory Impairment (Risperidone) SS ORAL 6 MG DAILY Radius Fracture Risperdal Sedation (Risperidone) SS ORAL 8 MG DAILY Leponex (Clozapine) SS 300 MG DAILY Leponex (Clozapine) SS 275 MG DAILY 4 DAY Leponex (Clozapine) SS 250 MG DAILY Aponal (Doxepin) SS 150 MG DAILY 29 MON Aponal (Doxepin) SS 75 MG DAILY Fevarin (Fluvoxamin) SS ORAL 50 MG DAILY Date:04/09/99ISR Number: 3237475-XReport Type:Periodic Company Report #99-01-0018 Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypotension Health Clozapine PS Zenith Goldline Professional Pharm. ORAL 25-50 MG/DAY ORAL Sinemet C Motrin C Neptazine C Vitamin E C Requip C Date:04/09/99ISR Number: 3237478-5Report Type:Periodic Company Report #99-01-0019 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Health Clozapine PS Zenith Goldline Increased Professional Pharm. ORAL 450 MG/DAY ORAL Date:04/09/99ISR Number: 3237482-7Report Type:Periodic Company Report #99-01-0020 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Health Clozapine PS Zenith Goldline Increased Professional Pharm. ORAL 900MG/DAY ORAL Haldol C Cogentin C Zyprexa C Flurazepam C Date:04/09/99ISR Number: 3237486-4Report Type:Periodic Company Report #99-02-0023 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozapine PS Zenith Goldline Professional Pharm. ORAL 450MG/DAY ORAL 22-Feb-2006 08:30 AM Page: 316 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Coumadin C Date:04/09/99ISR Number: 3237488-8Report Type:Periodic Company Report #99-02-0025 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Red Blood Cell Count Health Clozapine PS Zenith Goldline Increased Professional Pharm. ORAL 650 MG/DAY ORAL Date:04/09/99ISR Number: 3237490-6Report Type:Periodic Company Report #99-02-0027 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozapine PS Zenith Goldline Professional Pharm. ORAL 25MG/DAILY ORAL Clozapine Tablets SS ORAL 37.5 MG/DAILY ORAL Date:04/09/99ISR Number: 3237494-3Report Type:Periodic Company Report #99-02-0028 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozapine PS ORAL ORAL Professional Date:04/09/99ISR Number: 3237500-6Report Type:Periodic Company Report #99-02-0030 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozapine PS Zenith Goldline Professional Pharm. ORAL 200-300 MG DAY ORAL Date:04/09/99ISR Number: 3237502-XReport Type:Periodic Company Report #99-02-0035 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozapine PS Zenith Goldline Professional Pharm. ORAL 225-450/MG ORAL Date:04/09/99ISR Number: 3237504-3Report Type:Periodic Company Report #99-02-0036 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alcoholism Health Clozapine PS Goldline Pharm. ORAL 400-425MG/DAY Professional ORAL 22-Feb-2006 08:30 AM Page: 317 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/09/99ISR Number: 3237506-7Report Type:Periodic Company Report #99-02-0037 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alcoholism Health Clozapine PS Zenith Goldline Drug Abuser Professional Pharm. ORAL 350MG/DAY ORAL Date:04/09/99ISR Number: 3237510-9Report Type:Periodic Company Report #99-02-0041 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tardive Dyskinesia Health Clozapine PS Zenith Goldline Professional Pharm. ORAL ORAL Estraderm C Date:04/09/99ISR Number: 3237513-4Report Type:Periodic Company Report #99-02-0043 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Clonic Convulsion Health Clozapine PS ORAL 100MG/DAY Confusional State Professional ORAL Gait Disturbance Depakote C Urinary Incontinence Date:04/09/99ISR Number: 3237515-8Report Type:Periodic Company Report #99-02-0073 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Ineffective Health Clozapine PS Zenith Goldline Professional Pharm. ORAL 450MG DAY ORAL Lorazepam C Perphrnazine C Depakote C Date:04/09/99ISR Number: 3237517-1Report Type:Periodic Company Report #99-02-0074 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Ineffective Health Clozapine PS Zenith Goldline Professional Pharm. ORAL 500 MG DAY ORAL Zyprexa C Trihexyphenidyl C Date:04/09/99ISR Number: 3237520-1Report Type:Periodic Company Report #98-06-0133 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozapine PS Zenith Goldline Professional Pharm. ORAL 75MG/DAY ORAL Interferon SS INTRAMUSCULAR 1-3 MEGA UNIT INTRAMUSCULAR 22-Feb-2006 08:30 AM Page: 318 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/09/99ISR Number: 3237523-7Report Type:Periodic Company Report #98-11-0255 Age:50 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozapine PS Zenith Goldline Lymphoma Professional Pharm. ORAL 50-150MG/DAY ORAL Haldol C Depakote C Zoloft C Cogentin C Date:04/09/99ISR Number: 3237527-4Report Type:Periodic Company Report #98-11-0258 Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Ineffective Health Clozapine PS Zenith Goldline Professional Pharm. ORAL 600 MG/DAY ORAL Prozac C Trazodone C Reglan C Mellaril C Date:04/09/99ISR Number: 3237531-6Report Type:Periodic Company Report #98-11-0266 Age:18 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Health Clozapine PS Zenith Goldline Decreased Professional Pharm. ORAL 200MG/DAY ORAL Date:04/09/99ISR Number: 3239021-3Report Type:Periodic Company Report #98-10-0246 Age:62 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Health Clozapine PS ORAL 900MG/DAY Initial or Prolonged Professional Clozapine Tablets SS ORAL 900MG/DAY Dilantin C Depakote C Ativan C Date:04/09/99ISR Number: 3239025-0Report Type:Periodic Company Report #98-11-0267 Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozapine PS ORAL 12.5-400MG/DA Professional Serevent 2 Puff C Terbutaliine C Lithium C Gabapentin C Prednisone C Fluconazole C Soma Prn C Ranitidine C Dicyclomine Hydrochloride Qid C Benzatropine C 22-Feb-2006 08:30 AM Page: 319 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Clonazepam Qid C Tegretol C Date:04/09/99ISR Number: 3239027-4Report Type:Periodic Company Report #99-01-0001 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ileus Paralytic Consumer Clozapine PS ORAL 750MG/DAY Initial or Prolonged Zyprexa C Depakote C Ativan C Date:04/09/99ISR Number: 3239029-8Report Type:Periodic Company Report #99-01-0004 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Health Clozapine PS ORAL 800MG/DAY Initial or Prolonged Obsessive Thoughts Professional Date:04/09/99ISR Number: 3239030-4Report Type:Periodic Company Report #99-01-0016 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Clozapine PS ORAL 900MG/DAY Initial or Prolonged Delusion Professional Zyprexa C Date:04/09/99ISR Number: 3239032-8Report Type:Periodic Company Report #99-02-0022 Age:76 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozapine PS ORAL 75MG/DAY Professional Date:04/09/99ISR Number: 3239035-3Report Type:Periodic Company Report #99-02-0029 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Health Clozapine PS ORAL 200MG/DAY Professional Clozapine Tablets SS ORAL 100MG/DAY Date:04/09/99ISR Number: 3239057-2Report Type:Periodic Company Report #99-02-0042 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Health Clozapine PS ORAL 350MG/DAY Initial or Prolonged Professional Date:04/09/99ISR Number: 3239060-2Report Type:Periodic Company Report #98-11-0274 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Health Clozapine PS ORAL 600-900MG Decreased Professional Haldol C Depakote C 22-Feb-2006 08:30 AM Page: 320 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Vistaril C Date:04/09/99ISR Number: 3239063-8Report Type:Periodic Company Report #98-12-0271 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozapine PS ORAL 375MG/DAY Professional Date:04/09/99ISR Number: 3239066-3Report Type:Periodic Company Report #98-12-0273 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozapine PS ORAL 250-300MG/DAY Professional Date:04/09/99ISR Number: 3239067-5Report Type:Periodic Company Report #98-12-0279 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Elevated Mood Health Clozapine PS ORAL 25MG Sedation Professional Date:04/09/99ISR Number: 3239069-9Report Type:Periodic Company Report #98-12-0281 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozapine PS ORAL 25-75MG/DAY Professional Date:04/09/99ISR Number: 3239072-9Report Type:Periodic Company Report #98-12-0283 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozapine PS ORAL 250-400MG/DAY Professional Clozapine Tablets SS ORAL 400MG/DAY Tegretol C Prolixin C Date:04/09/99ISR Number: 3239075-4Report Type:Periodic Company Report #99-01-0003 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Ineffective Health Clozapine PS ORAL 400-800MG/DAY Professional Depakote C Perphenazine C Cogentin C Date:04/09/99ISR Number: 3239078-XReport Type:Periodic Company Report #99-01-0006 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dermatitis Exfoliative Health Clozapine PS ORAL 300MG/DAY Professional 22-Feb-2006 08:30 AM Page: 321 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/09/99ISR Number: 3239083-3Report Type:Periodic Company Report #99-01-0007 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Health Clozapine PS ORAL 125-150MG/DAY Agitation Professional Claritin C Drug Ineffective Date:04/09/99ISR Number: 3239087-0Report Type:Periodic Company Report #99-01-0008 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Influenza Health Clozapine PS ORAL 150-300MG/DAY Leukopenia Professional Date:04/09/99ISR Number: 3239089-4Report Type:Periodic Company Report #99-01-0012 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Folate Decreased Health Clozapine PS ORAL 250MG/DAY Hepatic Function Abnormal Professional Leukopenia Thrombocythaemia Date:04/09/99ISR Number: 3239093-6Report Type:Periodic Company Report #99-01-0013 Age:86 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozapine PS ORAL 6.25MG/DAY Professional Relefen C Date:04/12/99ISR Number: 3237832-1Report Type:Direct Company Report # Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram St Clozaril PS ORAL 150MG AM & Segment Abnormal 200MG HS Malaise Date:04/12/99ISR Number: 3237875-8Report Type:Expedited (15-DaCompany Report #GB/99/00309/LEX Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozaril (Clozapine) PS ORAL 75 MG ORAL Coagulopathy Professional Convulsion Haemorrhagic Stroke Malaise Pulmonary Embolism Date:04/12/99ISR Number: 3238000-XReport Type:Expedited (15-DaCompany Report #USA/99/00259/LEX Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Health Clozaril (Clozapine) PS ORAL 500 MG ORAL Life-Threatening Professional 22-Feb-2006 08:30 AM Page: 322 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/12/99ISR Number: 3238499-9Report Type:Direct Company Report # Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Platelet Count Decreased Health Clozaril PS 400 MG TOTAL Professional DAILY Date:04/12/99ISR Number: 3238508-7Report Type:Direct Company Report # Age:33 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Glucose Increased Health Clozaril PS ORAL 150 MG AM + Glycosylated Haemoglobin Professional 250 MG PM Increased Date:04/12/99ISR Number: 3238511-7Report Type:Direct Company Report # Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Health Clozaril PS ORAL 150 MG AM + Abnormal Professional 200 MG PM PO Malaise Date:04/13/99ISR Number: 3238388-XReport Type:Expedited (15-DaCompany Report #99-03-0085 Age:81 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Leukopenia Health Clozapine PS Zenith Goldline Professional Pharm ORAL 62.5-75 MG ORAL Date:04/13/99ISR Number: 3238389-1Report Type:Expedited (15-DaCompany Report #99-03-0086 Age:67 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bulbar Palsy Health Clozapine - Zenith Condition Aggravated Professional Goldline Pharma Parkinsonism Tablets PS Zenith Goldline Pharm. ORAL 25 MG DAY ORAL Sinemet C Clonopin C Date:04/13/99ISR Number: 3238393-3Report Type:Expedited (15-DaCompany Report #99-03-0076 Age:75 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Respiratory Failure Health Clozapine PS Zenith Goldline Professional Pharm ORAL 25-100 MG DAY ORAL Nortriptyline C Zoloft C 22-Feb-2006 08:30 AM Page: 323 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/14/99ISR Number: 3239805-1Report Type:Expedited (15-DaCompany Report #GB/99/00262/LEX Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Neoplasm Malignant Foreign Clozaril (Clozapine) PS ORAL 300 MG ORAL Health Professional Date:04/14/99ISR Number: 3239839-7Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Grand Mal Convulsion Clozapine Mfd By Initial or Prolonged Loss Of Consciousness Novartis PS Novartis 500MG Q HS 6 MON Lithium C Cogentin C Date:04/14/99ISR Number: 3239840-3Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Convulsion Clozapine Mfd By Hospitalization - Dyspnoea Novartis PS Novartis SEE ITEM B5 1 YR Initial or Prolonged Grand Mal Convulsion Fluphenazine C Benztropine C Benztropine C Lithium Carbonate C Verapamil C Zantac C Metamucil C Date:04/15/99ISR Number: 3246252-5Report Type:Periodic Company Report #116/63165 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Health Adriamycin Pfs Initial or Prolonged Professional Sterile Solution PS INTRAVENOUS 80 MG DAY IV Other Clozapine SS ORAL 100 MG DAY ORAL Taxol C Nolvadex C Haldol C Clozaril C Date:04/16/99ISR Number: 3241351-6Report Type:Expedited (15-DaCompany Report #CDN/99/0064/LEX Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Complications Of Maternal Health Clozaril (Clozapine) PS ORAL 350MG ORAL 3 YR Initial or Prolonged Exposure To Therapeutic Professional Syntocinon C Required Drugs Intervention to Foetal Distress Syndrome Prevent Permanent Impairment/Damage 22-Feb-2006 08:30 AM Page: 324 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/16/99ISR Number: 3241537-0Report Type:Expedited (15-DaCompany Report #D/97/02896/LEX Age:57 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Foreign Leponex (Clozapine) PS ORAL 250 MG ORAL Life-Threatening Coronary Artery Disease Study Risperdal SS 6 MG Required Dizziness Health Aponal SS 75MG Intervention to Dysphagia Professional Xanef C Prevent Permanent Embolism Isoket Retard C Impairment/Damage Fall Ximovan C Pulmonary Embolism Fevarin C Radius Fracture Ass C Respiratory Arrest Bella Isodonnys C Respiratory Depression Heparin C Tremor Vertigo Date:04/16/99ISR Number: 3241724-1Report Type:Expedited (15-DaCompany Report #USA/99/00364/LEX Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Pressure Decreased Health Clozaril (Clozapine) PS ORAL 300 MG ORAL Hospitalization - Cardio-Respiratory Arrest Professional Depakote C Initial or Prolonged Cellulitis Klonopin C Required Chronic Obstructive Haldol C Intervention to Pulmonary Disease Cogentin C Prevent Permanent Dermatitis Keflex C Impairment/Damage Hypothermia Infection Lung Disorder Mental Impairment Pneumonia Pulmonary Embolism Respiratory Depression Thinking Abnormal Toxic Shock Syndrome Date:04/19/99ISR Number: 3241324-3Report Type:Direct Company Report # Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Clozaril PS Novartis Required Neutropenia Pharmaceuticals Corp ORAL 150 MG PO QHS Intervention to Lithium C Prevent Permanent Prozac C Impairment/Damage Synthroid C Date:04/19/99ISR Number: 3242596-1Report Type:Expedited (15-DaCompany Report #USA/99/00712/LEX Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Health Clozaril (Clozapine) PS ORAL 600 MG ORAL Professional 22-Feb-2006 08:30 AM Page: 325 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/19/99ISR Number: 3242642-5Report Type:Expedited (15-DaCompany Report #USA/99/00347/LEX Age:81 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Influenza Health Clozaril (Clozapine) PS ORAL 100 MG ORAL Life-Threatening Professional Date:04/19/99ISR Number: 3242647-4Report Type:Expedited (15-DaCompany Report #USA/99/00656/LEX Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Albumin Globulin Ratio Health Clozaril (Clozapine) PS ORAL 600 MG ORAL Initial or Prolonged Abnormal Professional Prednisone C Drug Level Above Prilosec C Therapeutic Haldol C Leukocytosis Zestril C Zoloft C Lasix C Asa C Synthroid C Isosorbide Dinitrate C Lovastatin C Ativan C Klonopin C Date:04/19/99ISR Number: 3242650-4Report Type:Expedited (15-DaCompany Report #CDN/98/00924/LEX Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Health Clozaril (Clozapine) PS ORAL 400 MG ORAL 1 YR Required Non-Insulin-Dependent Professional Intervention to Hyperglycaemia Prevent Permanent Obesity Impairment/Damage Tachycardia Date:04/19/99ISR Number: 3242717-0Report Type:Expedited (15-DaCompany Report #USA/99/00608/LEX Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Health Clozaril (Clozapine) PS ORAL 200 MG ORAL Initial or Prolonged Insulin-Dependent Professional Lithium C Required Pancreatitis Acute Levothyroxine C Intervention to Prevent Permanent Impairment/Damage Date:04/19/99ISR Number: 3242719-4Report Type:Expedited (15-DaCompany Report #USA/99/00739/LEX Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dementia Health Clozaril (Clozapine) PS ORAL 25 MG ORAL Professional Sinemet C Antihypertnesives C 22-Feb-2006 08:30 AM Page: 326 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/19/99ISR Number: 3243098-9Report Type:Direct Company Report # Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Hyperhidrosis Clozapine PS ORAL 300 MG QD Hospitalization - Hypertension ORAL Initial or Prolonged Movement Disorder Required Muscle Spasms Intervention to Nausea Prevent Permanent Neuroleptic Malignant Impairment/Damage Syndrome Pyrexia Tongue Disorder Date:04/21/99ISR Number: 3243437-9Report Type:Expedited (15-DaCompany Report #99-04-0088 Age:79 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Health Clozapine - Zenith Hypertension Professional Goldine Pharm. Renal Failure Chronic Tablets PS Zenith Goldine Subdural Haematoma Pharm. ORAL 37.5-600 MG/ D ORAL Date:04/21/99ISR Number: 3243832-8Report Type:Direct Company Report # Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Clozaril PS ORAL PO NONE KNOW 2 MON Initial or Prolonged Pyrexia White Blood Cell Count Decreased Date:04/21/99ISR Number: 3244136-XReport Type:Expedited (15-DaCompany Report #GB/99/00285/LEX Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiomyopathy Foreign Clozaril (Clozapine) PS ORAL 475 MG ORAL Health Professional Date:04/22/99ISR Number: 3244281-9Report Type:Expedited (15-DaCompany Report #99-03-0075 Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Catatonia Health Clozapine - Zenith Initial or Prolonged Condition Aggravated Professional Goldline Pharm. Fatigue Tablets PS Zenith Goldline Neutrophil Count Pharm. ORAL 100MG/DAY Decreased ORAL Psychotic Disorder Paxil C Sexual Dysfunction Depakote C 22-Feb-2006 08:30 AM Page: 327 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/22/99ISR Number: 3244286-8Report Type:Expedited (15-DaCompany Report #99-03-0069 Age:76 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozapine - Zenith Myocardial Infarction Professional Goldline Pharm. Respiratory Arrest Tablets PS Zenith Goldline Pharm. ORAL 150-200MG ORAL Benzotropine C Nitro Patch C Aas C Date:04/22/99ISR Number: 3244289-3Report Type:Expedited (15-DaCompany Report #99-03-0079 Age:58 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Empyema Health Clozapine - Zenith Initial or Prolonged Professional Goldline Pharm. Required Tablets PS Zenith Goldline Intervention to Pharm. ORAL 300-700MG/DAY Prevent Permanent ORAL Impairment/Damage Prozac C Date:04/22/99ISR Number: 3244293-5Report Type:Expedited (15-DaCompany Report #99-04-0091 Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL ORAL Date:04/22/99ISR Number: 3244547-2Report Type:Direct Company Report # Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Condition Aggravated Clozaril PS 20 BID 150 HS Intervention to Grand Mal Convulsion Depakote SS 500MG BID Prevent Permanent 250MG 1 D Impairment/Damage SINCE 4/7 Date:04/22/99ISR Number: 3244631-3Report Type:Direct Company Report # Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Convulsion Health Clozaril PS 20 BID 150 HS 1 MON Intervention to Grand Mal Convulsion Professional Vpa(Depakote) SS 500 MG BID Prevent Permanent Impairment/Damage Date:04/23/99ISR Number: 3245963-5Report Type:Expedited (15-DaCompany Report #8-99106-125A Age:47 YR Gender:Female I/FU:I Outcome PT Hospitalization - C-Reactive Protein Initial or Prolonged Increased 22-Feb-2006 08:30 AM Page: 328 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lipase Increased Pancreatitis White Blood Cell Count Report Source Product Role Manufacturer Route Dose Duration Increased Foreign Temesta (Lorzepam) PS ORAL DOSE UNKNOWN Health ORAL Professional Leponex (Clozapine) SS ORAL 500 MG/DAY IN 3 DIVIDED DOSES 200, 100, 200 MG ORAL Atarax C Depakine C Date:04/26/99ISR Number: 3246392-0Report Type:Direct Company Report # Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Attention Clozaril PS SEE ATTACHED Intervention to Deficit/Hyperactivity SCHEDULE Prevent Permanent Disorder Impairment/Damage Bite Grand Mal Convulsion Date:04/26/99ISR Number: 3246670-5Report Type:Direct Company Report # Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pyrexia Health Clozapine PS Novartis ORAL 75 MG OD PO Professional Date:04/26/99ISR Number: 3247166-7Report Type:Expedited (15-DaCompany Report #D/99/00255/LEX Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Bilirubin Increased Health Leponex (Clozapine) PS ORAL 200 MG ORAL Hospitalization - Blood Glucose Increased Professional Imopromen C Initial or Prolonged Diabetes Mellitus Required Diabetic Coma Intervention to Diabetic Hyperglycaemic Prevent Permanent Coma Impairment/Damage Hyperglycaemia Lipase Increased Oedema Pancreatitis Urine Amylase Abnormal White Blood Cell Count Increased Date:04/26/99ISR Number: 3247169-2Report Type:Expedited (15-DaCompany Report #GB/99/00262/LEX Age:59 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Malaise Health Clozaril (Clozapine) PS ORAL 300 MG ORAL Professional 22-Feb-2006 08:30 AM Page: 329 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/26/99ISR Number: 3247173-4Report Type:Expedited (15-DaCompany Report #GB/99/00309/LEX Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asthenia Health Clozaril (Clozapine) PS ORAL 75 MG ORAL Other Cardiac Arrest Professional Required Coagulopathy Intervention to Convulsion Prevent Permanent Depression Impairment/Damage Euphoric Mood Fall Hypersomnia Muscle Twitching Pulmonary Embolism Respiratory Arrest Sedation Snoring Date:04/28/99ISR Number: 3249049-5Report Type:Expedited (15-DaCompany Report #9916533 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Trovafloxacin Hospitalization - Drug Interaction Professional Tablets PS ORAL 200.00 MG Initial or Prolonged Lethargy TOTAL; DAILY; Required Respiratory Arrest ORAL Intervention to Sedation Clozaril SS ORAL 250.00 MG Prevent Permanent TOTAL; BID; Impairment/Damage ORAL Lithium C Synthroid C Neurontin C Haldol C Date:04/29/99ISR Number: 3249759-XReport Type:Expedited (15-DaCompany Report #USA/99/00789/LEX Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coma Health Clozaril (Clozapine) PS ORAL 400 MG ORAL Hospitalization - Hyperglycaemia Professional Initial or Prolonged Pallor Pyrexia Renal Failure Acute Tremor Date:04/29/99ISR Number: 3249762-XReport Type:Expedited (15-DaCompany Report #USA/99/00333/LEX Age:73 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozaril (Clozapine) PS ORAL 37.5 MG ORAL Hospitalization - Professional Sinemet C Initial or Prolonged Zestril (Lisinopril) C Lasix (Furosemide) C Asa (Acetylsalicylic Acid) C Vitamin E (Tocopherol) C K-Dur (Potassium Chloride) C 22-Feb-2006 08:30 AM Page: 330 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Coumadin (Warfarin Sodium) C Date:04/29/99ISR Number: 3249971-XReport Type:Expedited (15-DaCompany Report #GB/99/00341/LEX Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Health Clozaril (Clozapine) PS ORAL 350 MG ORAL Hyperlipidaemia Professional Date:04/29/99ISR Number: 3249972-1Report Type:Expedited (15-DaCompany Report #AUS/99/00257/LEX Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Health Clozaril (Clozapine) PS ORAL 400 MG ORAL Professional Sosium Valporate C Date:04/29/99ISR Number: 3249973-3Report Type:Expedited (15-DaCompany Report #GB/99/00303/LEX Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Arthralgia Health Clozaril (Clozapine) PS ORAL 200 MG ORAL Chills Professional Procyclidine C Feeling Cold Ensure C Hyperkeratosis Paroxetine C Infection Influenza Like Illness Neutropenia Neutrophil Count Increased Oedema Peripheral Pyrexia Rash Erythematous Rash Pruritic Rash Psoriaform Skin Disorder Skin Exfoliation Stevens-Johnson Syndrome Vomiting White Blood Cell Count Increased Date:04/29/99ISR Number: 3249974-5Report Type:Expedited (15-DaCompany Report #F/99/00909/LEX Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Confusional State Health Leponex (Clozapine) PS ORAL 4 G ORAL Intentional Overdose Professional Rohypnol C Suicide Attempt Depamide C Anafranil C 22-Feb-2006 08:30 AM Page: 331 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/29/99ISR Number: 3249976-9Report Type:Expedited (15-DaCompany Report #CDN/98/00944/LEX Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Infection Health Clozaril (Clozapine) PS ORAL UNSPECIFIED Initial or Prolonged Leukocytosis Professional ORAL Neutrophilia Pneumonia Date:04/30/99ISR Number: 3250754-5Report Type:Expedited (15-DaCompany Report #D/99/00551/LEX Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Health Leponex (Clozapine) PS ORAL 500 MG ORAL Initial or Prolonged Phosphokinase Increased Professional Valiquid C Required Blood Creatinine Dociton C Intervention to Increased Prevent Permanent Blood Urea Increased Impairment/Damage Muscle Necrosis Rhabdomyolysis Sedation Date:04/30/99ISR Number: 3250758-2Report Type:Expedited (15-DaCompany Report #AUS/99/00257/LEX Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Health Clozaril (Clozapine) PS ORAL 400 MG ORAL Convulsion Professional Sodium Valproate C Injury Asphyxiation Date:04/30/99ISR Number: 3250759-4Report Type:Expedited (15-DaCompany Report #B/99/00025/LEX Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypothermia Health Leponex (Clozapine) PS ORAL 112.5 MG ORAL Initial or Prolonged Pneumonia Professional Lasix C Flunitrazepam C Asaflow C Permax C Prolopa C Date:04/30/99ISR Number: 3250775-2Report Type:Expedited (15-DaCompany Report #CH/99/00022/LEX Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Macular Degeneration Health Leponex (Clozapine) PS ORAL MG 50-100 Visual Disturbance Professional ORAL Date:04/30/99ISR Number: 3251163-5Report Type:Expedited (15-DaCompany Report #USA/99/00331/LEX Age:56 YR Gender:Female I/FU:F Outcome Life-Threatening Hospitalization - Initial or Prolonged Required Intervention to 22-Feb-2006 08:30 AM Page: 332 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Delusion Health Clozaril (Clozapine) PS 2500 MG Dysphagia Professional APPROX Electrocardiogram Cogentin C Abnormal Zyprexa C Hallucination Klonopin C Hypertension Nembutal C Intentional Overdose Loss Of Consciousness Neutrophil Count Increased Neutrophilia Stupor Suicide Attempt Tachycardia White Blood Cell Count Increased Date:04/30/99ISR Number: 3251167-2Report Type:Expedited (15-DaCompany Report #AUS/99/00242/LEX Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Lymphoma Health Clozaril (Clozapine) PS ORAL ORAL Initial or Prolonged Professional Date:04/30/99ISR Number: 3251170-2Report Type:Expedited (15-DaCompany Report #AUS/99/00243/LEX Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pleural Infection Health Clozaril (Clozapine) PS Initial or Prolonged Professional Date:04/30/99ISR Number: 3251181-7Report Type:Expedited (15-DaCompany Report #USA/99/00553/LEX Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Gastrointestinal Disorder Health Clozaril (Clozapine) PS Professional Date:04/30/99ISR Number: 3251621-3Report Type:Direct Company Report # Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Leukocytosis Clozapine PS ORAL 500MG, DAILY, Hospitalization - ORAL Initial or Prolonged Diphennhydramine C Ranitidine C Haloperidol C 22-Feb-2006 08:30 AM Page: 333 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/03/99ISR Number: 3252652-XReport Type:Expedited (15-DaCompany Report #99-04-0095 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death White Blood Cell Count Health Clozapine - Zenith Increased Professional Goldline Pharm. Tablets PS ORAL 150MG/DAY Date:05/03/99ISR Number: 3252726-3Report Type:Expedited (15-DaCompany Report #99-02-0032 Age:76 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Apnoea Health Clozapine - Zenith Aspiration Professional Goldline Pharm. PS Zenith Goldline Pneumonia Pharm. ORAL 37.5 MG/DAY ORAL Vistaril C Demerol C Duragesic C Zantac C Date:05/03/99ISR Number: 3252730-5Report Type:Expedited (15-DaCompany Report #99-03-0085 Age:81 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Infection Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 62.5-75 MG ORAL Cipro C Date:05/03/99ISR Number: 3252735-4Report Type:Expedited (15-DaCompany Report #99-04-0099 Age:87 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death White Blood Cell Count Health Clozapine Tablets - Increased Professional Zenith Goldline Pharm. PS Zenith Goldline Pharm. ORAL 25-37.5 MG/DAY ORAL Date:05/03/99ISR Number: 3252739-1Report Type:Expedited (15-DaCompany Report #99-04-0097 Age:69 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Clozapine Tablets - Zenith Goldline Pharm. PS Zenith Goldline Pharm. ORAL 225-750 MG/DAY ORAL 22-Feb-2006 08:30 AM Page: 334 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/03/99ISR Number: 3252741-XReport Type:Expedited (15-DaCompany Report #F/99/00943/LEX Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Intestinal Obstruction Health Leponex (Clozapine) PS ORAL UNSPECIFIED Required Professional ORAL 4 YR Intervention to Prevent Permanent Impairment/Damage Date:05/04/99ISR Number: 3252226-0Report Type:Direct Company Report # Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bipolar Disorder Clozaril PS 50MG QAM Cardiac Arrest 200MG QHS Cough Reserpine SS 0.1MG QAM Influenza 0.2 QHS Lethargy Trovan SS ORAL 200MG PO Malaise Neurontin C Nasopharyngitis Eskalith C Nervous System Disorder Synthroid C Periorbital Oedema Timoptic C Respiratory Arrest Date:05/04/99ISR Number: 3253017-7Report Type:Expedited (15-DaCompany Report #8-99106-125A Age:47 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death C-Reactive Protein Foreign Temesta (Lorazepam) PS ORAL ORAL Hospitalization - Increased Health Leponex (Clozapine) SS ORAL 500 MG/DAY IN Initial or Prolonged Leukocytosis Professional 3 DIVIDED Lipase Increased DOSES 200, Pancreatitis 100, 200 ORAL Atarax C Depakine C Date:05/04/99ISR Number: 3253430-8Report Type:Expedited (15-DaCompany Report #GB/99/00212/LEX Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dizziness Health Clozaril (Clozapine) PS ORAL 800 MG ORAL Initial or Prolonged Drug Interaction Professional Paroxetine Required Muscle Contractions (Paroxetine) SS Intervention to Involuntary Prevent Permanent Petit Mal Epilepsy Impairment/Damage Syncope Date:05/04/99ISR Number: 3253691-5Report Type:Expedited (15-DaCompany Report #FLUV00399000044 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Fall Foreign Fevarin PS ORAL PO Grand Mal Convulsion Health Leponex SS Joint Dislocation Professional Hypnorex- Slow Release SS Gastrozepin C 22-Feb-2006 08:30 AM Page: 335 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/05/99ISR Number: 3253771-4Report Type:Direct Company Report # Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozapine PS Zenith 25MG 2TT BID; Medication Error Professional 100MG 1T BID Benztropine C Haloperidol C Valproic Acid C Date:05/05/99ISR Number: 3254444-4Report Type:Expedited (15-DaCompany Report #99-03-0086 Age:67 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dysphagia Health Clozapine PS Zenith Goldline Hospitalization - Oral Intake Reduced Professional Pharm. ORAL 25 MG/DAY Initial or Prolonged Parkinson'S Disease ORAL Respiratory Failure Sinemet C Clonopin C Date:05/05/99ISR Number: 3254447-XReport Type:Expedited (15-DaCompany Report #99-04-0107 Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Urinary Tract Infection Clozapine Tablets PS Zenith Goldline White Blood Cell Count Pharm. ORAL 25 MG/DAY Increased ORAL Date:05/05/99ISR Number: 3254491-2Report Type:Expedited (15-DaCompany Report #99-04-0106 Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline Professional Pharm ORAL 25-37.5MG/DAY ORAL Date:05/06/99ISR Number: 3255087-9Report Type:Direct Company Report # Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pyrexia Clozapine 25mg- Novartis PS Novosities 12.5MG BID Date:05/06/99ISR Number: 3255333-1Report Type:Expedited (15-DaCompany Report #USA/99/00848/LEX Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Health Clozaril (Clozapine) PS ORAL 400 MG ORAL Initial or Prolonged Congestive Professional Benadryl C Diabetes Mellitus Lasix C Polydipsia Polyuria Thirst 22-Feb-2006 08:30 AM Page: 336 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/06/99ISR Number: 3255622-0Report Type:Expedited (15-DaCompany Report #AUS/99/00077/LEX Age:27 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Aspiration Foreign Clozaril (Clozapine) PS ORAL 27 G, ONCE A Required Collapse Of Lung Health DAY, ORAL Intervention to Crepitations Professional Sodium Valproate Prevent Permanent Depressed Level Of (Valproic Acid) Impairment/Damage Consciousness (Valproate Sodium) C Infection Overdose Sinusitis Vomiting Date:05/07/99ISR Number: 3257056-1Report Type:Expedited (15-DaCompany Report #GB/99/00238/LEX Age:76 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Balance Disorder Foreign Clozaril (Clozapine) PS 100MG, ONCE A Other Clumsiness Health DAY 3 WK Coordination Abnormal Professional Hepatic Cirrhosis Myocardial Infarction Orthostatic Hypotension Date:05/07/99ISR Number: 3257057-3Report Type:Expedited (15-DaCompany Report #D/99/00568/LEX Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agranulocytosis Foreign Leponex (Clozapine) PS ORAL 200MG, ORAL Health Professional Date:05/07/99ISR Number: 3261855-XReport Type:Periodic Company Report #98USA10561 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agranulocytosis Health Tegretol Tablet Professional (Carbamazepine) PS ORAL 600 MG, DAILY, ORAL Clozaril Tablet (Clozapine) SS ORAL ORAL Date:05/10/99ISR Number: 3257881-7Report Type:Expedited (15-DaCompany Report #99DK-10019 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Anafranil Retard Other Extended Release Tablet (Clomipramine Hydrochloride) PS ORAL 300 MG , ONCE, ORAL Leponex Tablet (Clozapine) SS ORAL 200 MG, ONCE, ORAL Trileptal Tablet (Oxcarbazepine) SS ORAL 600 MG, DAILY, ORAL 22-Feb-2006 08:30 AM Page: 337 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Deprakine Retard Extended Release Tablet (Valproate Sodium) SS ORAL 1 G, DAILY, ORAL Lamictal Tablet (Lamotrigine) SS ORAL 400 MG , DAILY, ORAL Date:05/10/99ISR Number: 3258621-8Report Type:Expedited (15-DaCompany Report #9425/18276 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Foreign Xanax Tablets (.5 Other Infection Consumer Mg) PS ORAL .5 MG-3Q1DY; Leukopenia Company ORAL Spinal Myelogram Abnormal Representative Trihexyphenidyl Hydrochloride (5 Mg) SS ORAL 10 MG/DAY; ORAL Clozapin (100mg) SS ORAL 300 MG/DAY; ORAL Heptaminol C Lactilol C Lithium C Date:05/11/99ISR Number: 3258989-2Report Type:Expedited (15-DaCompany Report #USA/ 99/ 00789 / LEX Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coma Health Clozaril (Clozapine) PS 400MG Life-Threatening Feeling Jittery Professional Hospitalization - Hyperglycaemia Initial or Prolonged Hyperpyrexia Pallor Pyrexia Renal Failure Acute Sepsis Tremor Date:05/11/99ISR Number: 3259034-5Report Type:Expedited (15-DaCompany Report #D/99/00459/LEX Age:70 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardio-Respiratory Arrest Foreign Leponex (Clozapine) PS ORAL UNSPECIFIED, Hospitalization - Hepatic Failure Health ORAL Initial or Prolonged Hepatic Function Abnormal Professional Hepatomegaly Hepatorenal Syndrome Liver Function Test Abnormal Renal Failure Acute 22-Feb-2006 08:30 AM Page: 338 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/11/99ISR Number: 3259036-9Report Type:Expedited (15-DaCompany Report #USA/99/00856/LEX Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Amylase Increased Health Clozaril (Clozapine) PS ORAL UNSPECIFIED, Hospitalization - Blood Triglycerides Professional ORAL Initial or Prolonged Increased Benzodiazepines C Cardio-Respiratory Arrest Haldol C Lipase Increased Metabolic Acidosis Pancreatitis Acute Date:05/12/99ISR Number: 3258508-0Report Type:Expedited (15-DaCompany Report #99-04-0110 Age:84 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death White Blood Cell Count Health Clozapine - Zenith Decreased Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 50 MG/DAY ORAL Sinemetcr C Propulsid C Lanoxin C Date:05/12/99ISR Number: 3258514-6Report Type:Expedited (15-DaCompany Report #99-04-0114 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 75MG/DAY ORAL Glucotrol C Depakote C Date:05/12/99ISR Number: 3259081-3Report Type:Expedited (15-DaCompany Report #99-03-0083 Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Brain Damage Health Clozapine - Zenith Hospitalization - Nasal Sinus Cancer Professional Goldline Pharm. Initial or Prolonged Tablets PS Zenith Goldline Pharm. ORAL 200-500MG/DAY ORAL Procardia Xl C Date:05/12/99ISR Number: 3259082-5Report Type:Expedited (15-DaCompany Report #99-04-0116 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Colon Cancer Health Clozapine - Zenith Initial or Prolonged Leukocytosis Professional Goldline Pharm. Leukopenia Tablets PS Zenith Goldline Pharm. ORAL 300-500MG/DAY ORAL 22-Feb-2006 08:30 AM Page: 339 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/12/99ISR Number: 3259083-7Report Type:Expedited (15-DaCompany Report #99-04-0088 Age:79 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Depressed Level Of Health Clozapine - Zenith Consciousness Professional Goldline Pharm. Fall Tablets PS Zenith Goldline Subdural Haematoma Pharm ORAL 37.5 - 600MG/D ORAL Zocor C Hydrochlorothiazide C Trazon C Date:05/12/99ISR Number: 3259921-8Report Type:Expedited (15-DaCompany Report #1999-05-0211 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Decreased Appetite Foreign Trilafon Dekanoat PS INTRAMUSCULAR UNKNOWN Initial or Prolonged Depressed Level Of Health INTRAMUSCULAR Consciousness Professional Nozinan SS ORAL UNKNOWN ORAL Dysphagia Other Cisordinol Dystonia Injectable SS INTRAMUSCULAR UNKNOWN Electrocardiogram St INTRAMUSCULAR Segment Abnormal Cisordinol-Acutard SS INTRAMUSCULAR UNKNOWN Muscle Rigidity INTRAMUSCULAR Neuroleptic Malignant Leponex SS ORAL UNKNOWN ORAL Syndrome Clonazepam C Pain In Extremity Imovane C Pyrexia Date:05/12/99ISR Number: 3260127-7Report Type:Expedited (15-DaCompany Report #205025 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Foreign Loxen (Nicardipine Initial or Prolonged Diarrhoea Other Hydrochloride) PS ORAL ORAL Electroencephalogram Primperan Abnormal (Metoclopramide Hypokalaemia Hydrochloride) SS Hyponatraemia Importal (Lactitol) SS Nausea Daflon (Diosmin) SS Oesophagitis Leponex (Clozapine) SS 1096 DAY Thirst Vomiting Date:05/13/99ISR Number: 3261194-7Report Type:Expedited (15-DaCompany Report #D/99/00138/LEX Age:19 YR Gender:Male I/FU:I Outcome PT Other Anaemia Asthenia Fatigue Hodgkin'S Disease Leukocytosis Lymphadenopathy Lymphoma Red Blood Cell Sedimentation Rate Increased 22-Feb-2006 08:30 AM Page: 340 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Thrombocythaemia Report Source Product Role Manufacturer Route Dose Duration Foreign Leponex (Clozapine) PS ORAL 475 MG , ORAL Health Professional Date:05/13/99ISR Number: 3263931-4Report Type:Expedited (15-DaCompany Report #GB/99/00367/LEX Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bladder Obstruction Foreign Clozaril (Clozapine) PS ORAL 800 MG ORAL Hydronephrosis Health Renal Failure Acute Professional Date:05/13/99ISR Number: 3263934-XReport Type:Expedited (15-DaCompany Report #GB/99/00368/LEX Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Foreign Clozaril (Clozapine) PS ORAL 475 MG ORAL Initial or Prolonged Congestive Other Cardiomyopathy Date:05/13/99ISR Number: 3263938-7Report Type:Expedited (15-DaCompany Report #D/97/00333/LEX Age:27 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sexual Assault Victim Foreign Leponex (Clozapine) PS ORAL 350 MG ORAL Health Professional Other Date:05/14/99ISR Number: 3263576-6Report Type:Expedited (15-DaCompany Report #D/99/00624/LEX Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatinine Foreign Leponex (Clozapine) PS 300 MG Initial or Prolonged Increased Health Truxal Blood Urea Increased Professional (Chlorprothixene Intentional Overdose Hydrochloride) SS 1 OTH Leukocytosis Nephritis Interstitial Suicide Attempt White Blood Cell Count Increased Date:05/14/99ISR Number: 3263577-8Report Type:Expedited (15-DaCompany Report #GB/99/00382/LEX Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Foreign Clozaril (Clozapine) PS 550 MG Health Professional 22-Feb-2006 08:30 AM Page: 341 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/14/99ISR Number: 3263578-XReport Type:Expedited (15-DaCompany Report #D/99/00138/LEX Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Foreign Leponex (Clozapine) PS ORAL 475 MG Asthenia Health Fatigue Professional Haematocrit Decreased Hodgkin'S Disease Stage Iv Leukocytosis Lymphadenopathy Red Blood Cell Sedimentation Rate Increased Thrombocythaemia Date:05/14/99ISR Number: 3263580-8Report Type:Expedited (15-DaCompany Report #USA/98/02919/LEX Age:73 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cerebrovascular Accident Health Clozapine Cerebrovascular Disorder Professional (Clozapine) PS 300 MG Drug Interaction Omnicef (Cefdinir) SS Drug Level Above Coumadin (Warfarin Therapeutic Sodium) C Eye Infection Date:05/14/99ISR Number: 3263581-XReport Type:Expedited (15-DaCompany Report #CDN/98/00924/LEX Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril (Clozapine) PS ORAL 400 MG Required Non-Insulin-Dependent Health Intervention to Hyperglycaemia Professional Prevent Permanent Obesity Impairment/Damage Tachycardia Date:05/14/99ISR Number: 3263582-1Report Type:Expedited (15-DaCompany Report #USA/99/00952/LEX Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozaril (Clozapine) PS 250 MG Hospitalization - Respiratory Arrest Professional Antibiotics C Initial or Prolonged Respiratory Depression Respiratory Distress Date:05/14/99ISR Number: 3263583-3Report Type:Expedited (15-DaCompany Report #USA/99/00546/LEX Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Clozaril (Clozapine) PS 300 MG Professional Seroquel (Seroquel) C Prodixin Decanoate (Dijene) C 22-Feb-2006 08:30 AM Page: 342 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/14/99ISR Number: 3263844-8Report Type:Expedited (15-DaCompany Report #USA/99/00960/LEX Age:77 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Health Clozaril (Clozapine) PS 13 MG Life-Threatening Professional Date:05/14/99ISR Number: 3263849-7Report Type:Expedited (15-DaCompany Report #USA/99/00924/LEX Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Respiratory Health Clozaril (Clozapine) PS ORAL 400 MG ORAL Distress Syndrome Professional Date:05/17/99ISR Number: 3263481-5Report Type:Expedited (15-DaCompany Report #DK/99/00012/LEX Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiomyopathy Foreign Leponex (Clozapine) PS ORAL 75 MG ORAL 5 YR Initial or Prolonged Other Required Intervention to Prevent Permanent Impairment/Damage Date:05/17/99ISR Number: 3263579-1Report Type:Expedited (15-DaCompany Report #D/99/00138/LEX Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Foreign Leponex (Clozapine PS 475 MG 3 YR Asthenia Health Fatigue Professional Hodgkin'S Disease Stage Iv Leukocytosis Lymphadenopathy Lymphoma Red Blood Cell Sedimentation Rate Increased Thrombocythaemia Date:05/17/99ISR Number: 3263590-0Report Type:Expedited (15-DaCompany Report #USA/99/00739/LEX Age:70 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dementia Health Clozaril (Clozapine) PS ORAL 25 MG ORAL Professional Sinemet C Antihypertensives C Date:05/17/99ISR Number: 3263755-8Report Type:Expedited (15-DaCompany Report #9919325 Age:47 YR Gender:Female I/FU:I Outcome PT Death C-Reactive Protein Increased Lipase Increased 22-Feb-2006 08:30 AM Page: 343 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pancreatitis White Blood Cell Disorder Report Source Product Role Manufacturer Route Dose Duration Foreign Atarax Tablets PS ORAL 25.00 MG Health TOTAL:DAILY: Professional ORAL Lorazepam SS ORAL 1.00 MG TOTAL: DAILY: ORAL Valproate Sodium SS ORAL 200.00 MG TOTAL: DAILY: ORAL Clozapine SS ORAL 500.00 MG TOTAL:DAILY: ORAL Date:05/17/99ISR Number: 3263884-9Report Type:Expedited (15-DaCompany Report #B006577 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Lamictal Tablet PS ORAL ORAL Other Clozapine (Formulation Unknown) SS ORAL ORAL Clomipramine Hcl (Formulation Unknown) SS ORAL ORAL Valproate Sodium (Formulation Unknown) SS ORAL ORAL Oxcarbazepine (Formulation Unknown) SS ORAL ORAL Date:05/17/99ISR Number: 3264060-6Report Type:Expedited (15-DaCompany Report #USA/99/00813/LEX Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Crohn'S Disease Health Clozaril (Clozapine) PS ORAL 400 MG, ORAL Initial or Prolonged Ileitis Professional Gemfibrozil C Required Intestinal Obstruction Intervention to Prevent Permanent Impairment/Damage Date:05/18/99ISR Number: 3265266-2Report Type:Expedited (15-DaCompany Report #99-04-0120 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dysphagia Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 22-Feb-2006 08:30 AM Page: 344 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/18/99ISR Number: 3265269-8Report Type:Expedited (15-DaCompany Report #99-04-0119 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 600MG/DAY Date:05/19/99ISR Number: 3265119-XReport Type:Expedited (15-DaCompany Report #99-05-0125 Age:88 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS ORAL 75MG ORAL Date:05/20/99ISR Number: 3265115-2Report Type:Expedited (15-DaCompany Report #99-04-0106 Age:73 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Infection Health Clozapine - Zenith Hospitalization - Mental Impairment Professional Goldline Pharm. Initial or Prolonged Tablets PS Zenith Goldline Pharm. ORAL 25.5-5MG/DAY ORAL Sinemet C Morphine C Darvocet-N C Date:05/20/99ISR Number: 3265116-4Report Type:Expedited (15-DaCompany Report #99-05-0123 Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL ORAL Date:05/20/99ISR Number: 3265120-6Report Type:Expedited (15-DaCompany Report #99-04-0099 Age:87 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine - Zenith White Blood Cell Count Professional Goldline Pharm. Increased Tablets PS Zenith Goldline Pharm. ORAL 12.5-37.5MG/D ORAL Ativan C Prinzide C Colace C Reglan C 22-Feb-2006 08:30 AM Page: 345 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/21/99ISR Number: 3267842-XReport Type:Expedited (15-DaCompany Report #99DK-10019 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Poisoning Foreign Anafranil Retard Aggression Other Extended Release Agitation Tablet (Clomipramine Cardiac Arrest Hydrochloride) PS ORAL 300 MG, ONCE, Loss Of Consciousness ORAL Medication Error Leponex Tablet (Clozapine) -- SS ORAL 200 MG, ONCE, ORAL Trileptal Tablet (Oxcarbazepine) SS ORAL 600 MG, DAILY, ORAL Deprakine Retard Extended Release Tablet (Valproate Sodium) SS ORAL 1 G, DAILY, ORAL Lamictal Tablet (Lamotrigine) SS ORAL 400 MG, DAILY, ORAL Date:05/21/99ISR Number: 3267988-6Report Type:Expedited (15-DaCompany Report #1999-05-0211 Age:44 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Trilafon Dekanoat Initial or Prolonged Decreased Appetite Health Injectable Solution Depressed Level Of Professional "Like Trilafon Consciousness Other Injection" PS INTRAMUSCULAR INTRAMUSCULAR Dysphagia Nozinan Tablets SS ORAL ORAL Dystonia Cisordinol Electrocardiogram St Injectable Solution SS INTRAMUSCULAR INTRAMUSCULAR Segment Abnormal Cisordinol-Acutard Muscle Rigidity Injectable Solution SS INTRAMUSCULAR INTRAMUSCULAR Neuroleptic Malignant Leponex Tablets SS ORAL ORAL Syndrome Clonazepman C Pain In Extremity Imovane C Pyrexia Disipal C Akineton C Duroferon C Flunitrazepam C Date:05/21/99ISR Number: 3268155-2Report Type:Expedited (15-DaCompany Report #GB/99/00408/LEX Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Clozaril (Clozapine) PS 150 MG, Peptic Ulcer Haemorrhage Health UNKNOWN Professional Date:05/21/99ISR Number: 3268156-4Report Type:Expedited (15-DaCompany Report #GB/99/00386/LEX Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Renal Failure Acute Foreign Clozaril (Clozapine) PS 400 MG, TWICE Initial or Prolonged Other A 22-Feb-2006 08:30 AM Page: 346 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Diazepam C Dothiepin C Date:05/21/99ISR Number: 3270577-0Report Type:Expedited (15-DaCompany Report #AUS/99/00308/LEX Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Gastric Cancer Stage Iv Foreign Clozaril (Clozapine) PS ORAL 250 MG, ORAL Hepatic Neoplasm Health Professional Date:05/21/99ISR Number: 3270578-2Report Type:Expedited (15-DaCompany Report #USA/99/00980/LEX Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozaril (Clozapine) PS ORAL 200 MG ORAL Hospitalization - Professional Initial or Prolonged Date:05/24/99ISR Number: 3268273-9Report Type:Expedited (15-DaCompany Report #99-05-0127 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm ORAL ORAL Date:05/24/99ISR Number: 3268760-3Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril 450 Mg/Day PS 450 MG HS 5 YR Professional Topamax 200 Mg Bid SS 200 MG BID Date:05/24/99ISR Number: 3268761-5Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Health Clozaril 400 Mg/Day PS 400 MG/DAY 5 YR Anxiety Professional Topamax 25mg Bid SS 25MG BID Condition Aggravated Delusion Hallucination Thirst Ventricular Hypertrophy Date:05/24/99ISR Number: 3269391-1Report Type:Expedited (15-DaCompany Report #SF/99/01676/LEX Age:31 YR Gender:Male I/FU:I Outcome Life-Threatening Required Intervention to Prevent Permanent 22-Feb-2006 08:30 AM Page: 347 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Pericarditis Foreign Leponex (Clozapine) PS ORAL 200 MG, ORAL Pneumonia Other Date:05/24/99ISR Number: 3269395-9Report Type:Expedited (15-DaCompany Report #DK/99/00014/LEX Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Overdose Foreign Leponex (Clozapine) PS ORAL 200 MG, ORAL Required Aggression Health Anafranil Retard Intervention to Agitation Professional (Clomipramine Prevent Permanent Cardiac Arrest Other Hydrochloride) SS ORAL 300 MG, ORAL Impairment/Damage Iatrogenic Injury Depakine (Valproate Loss Of Consciousness Sodium) SS ORAL 1 G, ORAL Medication Error Trileptal Therapeutic Agent (Oxcarbazepine) SS ORAL 600 MG, ORAL Toxicity Lamictal (Lamotrigine) C Date:05/24/99ISR Number: 3269397-2Report Type:Expedited (15-DaCompany Report #SF/99/01677/LEX Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pharyngitis Foreign Leponex (Clozapine) PS ORAL 200 MG, ORAL Initial or Prolonged Pharyngolaryngeal Pain Other Linatil (Enalapril Required Pyrexia Maleate) C Intervention to Sinusitis Primaspan Prevent Permanent (Acetylsalicylic Impairment/Damage Acid) C Cipramin (Citalopram Hydrobromide) C Date:05/24/99ISR Number: 3269398-4Report Type:Expedited (15-DaCompany Report #GB/99/00406/LEX Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Ketoacidosis Foreign Clozaril (Clozapine) PS ORAL 300 MG, ORAL Initial or Prolonged Hyperglycaemia Health Required Professional Intervention to Prevent Permanent Impairment/Damage Date:05/24/99ISR Number: 3269403-5Report Type:Expedited (15-DaCompany Report #F/99/00943/LEX Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Pain Foreign Leponex (Clozapine) PS ORAL 100 MG, FOUR Required Intestinal Obstruction Health TIMES A DAY, Intervention to Professional ORAL Prevent Permanent Artane C Impairment/Damage Tranxene C 22-Feb-2006 08:30 AM Page: 348 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/24/99ISR Number: 3269407-2Report Type:Expedited (15-DaCompany Report #AUS/99/00316/LEX Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dehydration Foreign Clozaril (Clozapine) PS ORAL 800 MG, ORAL Initial or Prolonged Diarrhoea Health Malaise Professional Renal Failure Acute Date:05/25/99ISR Number: 3269588-0Report Type:Expedited (15-DaCompany Report #GB/99/00382/LEX Age:50 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Foreign Clozaril (Clozapine) PS ORAL 550 MG, ORAL Weight Increased Health Professional Date:05/25/99ISR Number: 3269932-4Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Hypertriglyceridaemia Clozaril PS 100MG QAM Intervention to 200MG QHS >1 Prevent Permanent YR 1 YR Impairment/Damage Date:05/26/99ISR Number: 3269927-0Report Type:Expedited (15-DaCompany Report #99-05-0128 Age:86 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm ORAL ORAL Date:05/26/99ISR Number: 3269931-2Report Type:Expedited (15-DaCompany Report #99-05-0129 Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Clozapine - Zenith Hospitalization - Congestive Goldline Pharm. Initial or Prolonged Tablets PS Zenith Goldline Pharm. ORAL 25 MG QD ORAL Date:05/26/99ISR Number: 3269936-1Report Type:Expedited (15-DaCompany Report #99-04-0120 Age:65 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Back Disorder Health Clozapine - Zenith Dysphagia Professional Goldline Pharm. Surgery Tablets PS ORAL ORAL 22-Feb-2006 08:30 AM Page: 349 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/27/99ISR Number: 3271248-7Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Erection Increased Clozaril By Novartis PS Novartis TITRATED Intervention to Penile Pain (FROM 37.5MG Prevent Permanent TO 400MG) Impairment/Damage Date:05/27/99ISR Number: 3271390-0Report Type:Expedited (15-DaCompany Report #GB/99/00430/LEX Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bronchopneumonia Foreign Clozaril (Clozapine) PS ORAL 600 MG, ONCE Health A DAY, ORAL Professional Date:05/27/99ISR Number: 3271391-2Report Type:Expedited (15-DaCompany Report #GB/99/00428/LEX Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Circulatory Collapse Foreign Clozaril (Clozapine) PS ORAL 225 MG, ORAL Deep Vein Thrombosis Health Epilim C Embolism Professional Date:05/27/99ISR Number: 3271426-7Report Type:Expedited (15-DaCompany Report #99-02-0040 Age:78 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine PS ORAL 400MG/DAY Professional Tylenol C Lactulose C Megace C Vitamin E C Eskalith Cr C Propulsid 20 C Kepakote C Multivitamins C Niferex C Date:05/27/99ISR Number: 3274141-9Report Type:Expedited (15-DaCompany Report #USA/99/01029/LEX Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Cancer Female Health Clozaril (Clozapine) PS 700 MG, Required Condition Aggravated Professional UNKNOWN Intervention to Delusion Prevent Permanent Impairment/Damage Date:05/28/99ISR Number: 3272895-9Report Type:Expedited (15-DaCompany Report #USA/99/00506/LEX Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hypertensive Heart Health Clozaril (Clozapine) PS 750 MG, Life-Threatening Disease Professional Lithium C Tenormin C 22-Feb-2006 08:30 AM Page: 350 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/28/99ISR Number: 3272899-6Report Type:Expedited (15-DaCompany Report #USA/99/00991/LEX Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Chronic Obstructive Health Clozaril (Clozapine) PS ORAL 175 MG ORAL Pulmonary Disease Professional Respiratory Failure Date:05/28/99ISR Number: 3272903-5Report Type:Expedited (15-DaCompany Report #USA/99/00572/LEX Age:60 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Health Clozaril (Clozapine) PS ORAL 700 MG ORAL Cardio-Respiratory Arrest Professional Cardizem C Dysphagia Zoloft C Malaise Zantac C Synthroid C Aspirin C Surfak C Humulin Nph C Date:05/28/99ISR Number: 3272906-0Report Type:Expedited (15-DaCompany Report #USA/99/00856/LEX Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Amylase Increased Health Clozaril (Clozapine) PS ORAL ORAL Life-Threatening Cardio-Respiratory Arrest Professional Benzodiazepines C Hospitalization - Hypertriglyceridaemia Haldol C Initial or Prolonged Lipase Increased Required Metabolic Acidosis Intervention to Pancreatitis Prevent Permanent Impairment/Damage Date:05/28/99ISR Number: 3272978-3Report Type:Expedited (15-DaCompany Report #9916533 Age:56 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Trovafloxacin Hospitalization - Depressed Level Of Professional Tablets PS ORAL 200.00 MG Initial or Prolonged Consciousness TOTAL:DAILY:O Required Drug Interaction RAL Intervention to Lethargy Clozaril SS ORAL 250.00 MG Prevent Permanent Respiratory Arrest TOTAL:BIDL:OR Impairment/Damage Sedation AL Lithium C Synthroid C Neurontin C Haldol C Date:05/28/99ISR Number: 3273153-9Report Type:Expedited (15-DaCompany Report #B0066577 Age:43 YR Gender:Male I/FU:F Outcome PT Death Aggression Hospitalization - Agitation Initial or Prolonged Asthenia Other Cardiac Failure 22-Feb-2006 08:30 AM Page: 351 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Cholecystitis Chronic Emphysema Hepatic Fibrosis Report Source Product Role Manufacturer Route Dose Duration Hyperchlorhydria Foreign Lamictal Tablet PS ORAL ORAL Loss Of Consciousness Clozapine Medication Error (Formulation Pulmonary Oedema Unknown) SS ORAL ORAL Therapeutic Agent Clomipramine Hcl Toxicity (Formulation Weight Decreased Unknown) SS ORAL ORAL Valproate Sodium (Formulation Unknown) SS ORAL ORAL Oxcarbazepine (Formulation Unknown) SS ORAL ORAL Date:06/01/99ISR Number: 3274223-1Report Type:Expedited (15-DaCompany Report #GB/99/00367/LEX Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Foreign Clozaril (Clozapine) PS ORAL 850 MG, THREE Bladder Disorder Health TIMES A DAY, Bladder Neck Obstruction Professional ORAL Hydronephrosis Valproate Sodium C Renal Failure Acute Fybogel C Urinary Incontinence Lactulose C Date:06/01/99ISR Number: 3274295-4Report Type:Expedited (15-DaCompany Report #GB/99/00408/LEX Age:54 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Clozaril (Clozapine) PS ORAL 150 MG, ORAL Hypertension Health Procyclidine C Hypertensive Heart Professional Valproate Sodium C Disease Peptic Ulcer Haemorrhage Date:06/01/99ISR Number: 3274297-8Report Type:Expedited (15-DaCompany Report #GB/99/00167/LEX Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Distension Foreign Clozaril (Clozapine) PS ORAL 250 MG ORAL Abdominal Pain Health Anesthetics C Colon Cancer Professional Valproate Sodium C Constipation Intestinal Obstruction Myocardial Infarction Date:06/01/99ISR Number: 3274302-9Report Type:Expedited (15-DaCompany Report #GB/99/00412/LEX Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Angioneurotic Oedema Foreign Clozaril (Clozapine) PS ORAL 13 MG, Health UNKNOWN, ORAL Professional 22-Feb-2006 08:30 AM Page: 352 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/01/99ISR Number: 3274382-0Report Type:Expedited (15-DaCompany Report #9910509 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Foreign Abbott - Depakene PS Abbott ORAL 1.000 GM PO Other QD Clozapine SS ORAL 200.000 MG PO QD Clomipramine Bydroch C Oxcarbazepine C Lamotrigine C Date:06/01/99ISR Number: 3274384-4Report Type:Expedited (15-DaCompany Report #99DK-10019 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Poisoning Foreign Anafranil Retard Aggression Other Extended Release Agitation Tablet(Clomipramine Cardiac Arrest Hydrochloride) PS ORAL 300 MG, ONCE, Loss Of Consciousness ORAL Medication Error Leponex Tablet (Clozapine) SS ORAL 200 MG, ONCE, ORAL Trileptal Tablet (Oxcarbazepine) SS ORAL 1.5 G, DAILY, ORAL Lamictal Tablet (Lamotrigine) SS ORAL 400 MG, DAILY, ORAL Deprakine Retard Extended Release Tablet (Valproate Sodium) SS ORAL 1 G, DAILY, ORAL Stilnoct C Oxazepam C Serevase C Dogmatil C Plendil C Corodil C Date:06/01/99ISR Number: 3275646-7Report Type:Expedited (15-DaCompany Report #IRL/99/00426/LEX Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Haemoglobin Decreased Foreign Clozaril (Clozapine) PS ORAL 500 MG, ONCE Required Iron Metabolism Disorder Health A DAY; ORAL Intervention to Oesophageal Ulcer Professional Benzatropine Prevent Permanent Oesophagitis (Benzatropine) C Impairment/Damage Clomipramine (Clomipramine) C Date:06/01/99ISR Number: 3275650-9Report Type:Expedited (15-DaCompany Report #GB/99/00440/LEX Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Death Completed Suicide Foreign Health 22-Feb-2006 08:30 AM Page: 353 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Product Role Manufacturer Route Dose Duration Clozaril (Clozapine) PS ORAL 200 MG, UNKNOWN, ORAL; Date:06/01/99ISR Number: 3275652-2Report Type:Expedited (15-DaCompany Report #GB/99/00437/LEX Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Gastric Haemorrhage Foreign Clozaril (Clozapine) PS ORAL 450 MG, ONCE Haematemesis Health A DAY, ORAL Intra-Abdominal Professional Haemorrhage Date:06/01/99ISR Number: 3275654-6Report Type:Expedited (15-DaCompany Report #IRL/99/00427/LEX Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Upper Foreign Clozaril (Clozapine) PS ORAL 400 MG, ONCE Required Drug Ineffective Health A DAY, ORAL Intervention to Dyspepsia Professional Prevent Permanent Oesophagitis Impairment/Damage Date:06/02/99ISR Number: 3274504-1Report Type:Expedited (15-DaCompany Report #99-05-0137 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Brain Neoplasm Health Clozapine- Zenith Initial or Prolonged Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 200MG ORAL Date:06/02/99ISR Number: 3274505-3Report Type:Expedited (15-DaCompany Report #99-05-0136 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine- Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 50-200MG/DAY ORAL Haldol C Date:06/02/99ISR Number: 3274506-5Report Type:Expedited (15-DaCompany Report #99-05-0135 Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine-Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 100MG/DAY ORAL Lasix C 22-Feb-2006 08:30 AM Page: 354 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/02/99ISR Number: 3274509-0Report Type:Expedited (15-DaCompany Report #99-05-0134 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine-Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 50-150MG/DAY ORAL Date:06/02/99ISR Number: 3274543-0Report Type:Expedited (15-DaCompany Report #99-05-0133 Age:83 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Colon Cancer Health Clozapine - Zenith Initial or Prolonged Professional Goldline Pharm. Tablets PS ORAL 25MG ORAL Date:06/02/99ISR Number: 3274547-8Report Type:Expedited (15-DaCompany Report #99-05-0132 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS ORAL 200-300MG/DAY ORAL Date:06/02/99ISR Number: 3274550-8Report Type:Expedited (15-DaCompany Report #99-05-0125 Age:88 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coronary Artery Disease Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS ORAL 75MG QD ORAL Nitroderm C Celex C Adalat C Date:06/02/99ISR Number: 3274554-5Report Type:Expedited (15-DaCompany Report #99-04-0114 Age:75 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS ORAL 75 MG/DAY ORAL Glucotrol C Depakote C Date:06/02/99ISR Number: 3283025-1Report Type:Periodic Company Report #98USA10561 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Health Tegretol Tablet Initial or Prolonged Professional (Carbamazepine) PS ORAL 600 MG, DAILY, ORAL Clozaril Tablet 22-Feb-2006 08:30 AM Page: 355 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Clozapine) SS ORAL ORAL Date:06/03/99ISR Number: 3275782-5Report Type:Expedited (15-DaCompany Report #8-99106-125A Age:47 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Alkaline Foreign Temesta (Lorazepam) PS ORAL DOSE UNKNOWN Hospitalization - Phosphatase Decreased Health ORAL Initial or Prolonged C-Reactive Protein Professional Leponex (Clozapine) SS ORAL 500 MG/DAY IN Increased 3 DIVIDED Lipase Increased DOSES 200, Pancreatitis 100, 200 MG White Blood Cell Count ORAL Increased Atarax (Hydroxyzine) C Depakine (Sodium Valproate) C Date:06/03/99ISR Number: 3276250-7Report Type:Expedited (15-DaCompany Report #DK/99/00014/LEX Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aggression Foreign Leponex (Clozapine) PS ORAL 200 MG ORAL Required Agitation Health Anafranil Retard Intervention to Cardiac Arrest Professional (Clomipramine Prevent Permanent Coma Other Hydrochloride) SS ORAL 300 MG ORAL Impairment/Damage Drug Toxicity Depakine (Valproate Medication Error Sodium) SS ORAL 1 G ORAL Overdose Trileptal Sleep Disorder (Oxcarbazepine) SS ORAL 600 MG ORAL Lamictal (Lamotrigine) SS ORAL 200 MG TWICE A DAY ORAL Dogmatil C Serenase C Stilnoct C Pendil C Corodil C Oxazepam C Date:06/03/99ISR Number: 3276259-3Report Type:Expedited (15-DaCompany Report #AUS/99/00335/LEX Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Clozaril (Clozapine) PS ORAL ORAL 1 DAY Intentional Overdose Health Alcohol (Ethanol) SS Professional Date:06/03/99ISR Number: 3276263-5Report Type:Expedited (15-DaCompany Report #GB/99/00309/LEX Age:44 YR Gender:Male I/FU:F Outcome PT Death Abdominal Distension Other Asthenia Required Cardiac Arrest Intervention to Cerebrovascular Accident Prevent Permanent Circulatory Collapse Impairment/Damage Coagulopathy Colonic Atony 22-Feb-2006 08:30 AM Page: 356 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Constipation Convulsion Euphoric Mood Report Source Product Role Manufacturer Route Dose Duration Malaise Foreign Clozaril (Clozapine) PS ORAL 75 MG ORAL Muscle Twitching Health Oxygen Saturation Professional Decreased Other Paresis Pulmonary Embolism Respiratory Arrest Respiratory Depression Sedation Sleep Disorder Snoring Date:06/07/99ISR Number: 3277338-7Report Type:Expedited (15-DaCompany Report #AUS/99/00345/LEX Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Congestive Cardiomyopathy Foreign Clozaril (Clozapine) PS Initial or Prolonged Health Professional Date:06/08/99ISR Number: 3277460-5Report Type:Direct Company Report # Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Parotid Gland Enlargement Clozaril PS 400 MG Salivary Hypersecretion Depakote C Date:06/08/99ISR Number: 3277638-0Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required White Blood Cell Count Clozapine 100 Mg By Intervention to Decreased (Sandoz) PS Sandoz 150 MG BID Prevent Permanent Impairment/Damage Date:06/08/99ISR Number: 3278469-8Report Type:Direct Company Report # Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Glucose Increased Health Clozaril (Clozapine) Diabetic Complication Professional 25mg + 100mg Tabs PS UNKNOWN 150MG AM + Glucose Tolerance 350 MG HS Impaired Glycosuria Urinary Tract Infection Urine Analysis Abnormal 22-Feb-2006 08:30 AM Page: 357 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/09/99ISR Number: 3279022-2Report Type:Expedited (15-DaCompany Report #USA/99/01100/LEX Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Rectal Cancer Health Clozaril (Clozapine) PS ORAL 600MG ORAL Professional Haldol Decanoate C Date:06/09/99ISR Number: 3279024-6Report Type:Expedited (15-DaCompany Report #GB/99/00448/LEX Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Lung Neoplasm Malignant Foreign Clozaril (Clozapine) PS ORAL ORAL Health Professional Date:06/09/99ISR Number: 3279028-3Report Type:Expedited (15-DaCompany Report #USA/99/00924/LEX Age:59 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Respiratory Health Clozaril (Clozapine) PS ORAL 200MG, TWICE Distress Syndrome Professional DAY ORAL Sepsis Prevacid C Prozac C Premarin C Provera C Calcium C Date:06/09/99ISR Number: 3279031-3Report Type:Expedited (15-DaCompany Report #USA/99/00570/LEX Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atelectasis Health Clozaril (Clozapine) PS ORAL 900MG, ORAL Initial or Prolonged Collapse Of Lung Professional Trazodone C Required Lung Abscess Cogentin C Intervention to Pneumonia Aspiration Ativan C Prevent Permanent Ect C Impairment/Damage Colace C Date:06/10/99ISR Number: 3281009-0Report Type:Expedited (15-DaCompany Report #IRL/99/00458/LEX Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Clozaril (Clozapine) PS 350 MG Health Professional Date:06/11/99ISR Number: 3281490-7Report Type:Expedited (15-DaCompany Report #NZ/99/00099/LEX Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrial Fibrillation Foreign Clozaril (Clozapine) PS 300 MG, Initial or Prolonged Hypotension Other UNKNOWN Diclofenac C Ferrous Sulfate C Metformin C Thyroxine C 22-Feb-2006 08:30 AM Page: 358 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/11/99ISR Number: 3281527-5Report Type:Expedited (15-DaCompany Report #USA/99/01135/LEX Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozaril (Clozapine) PS ORAL 400 MG; ORAL Life-Threatening Professional Date:06/11/99ISR Number: 3281619-0Report Type:Expedited (15-DaCompany Report #GB/99/00428/LEX Age:25 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Pain Foreign Clozaril (Clozapine) PS 225 MG, ONCE Circulatory Collapse Health A Constipation Professional Epilim C Deep Vein Thrombosis Other Orphenadrine C Embolism Chlorpromazine C Dothiepin C Mebeverine C Fybogel C Date:06/11/99ISR Number: 3281620-7Report Type:Expedited (15-DaCompany Report #USA/99/00980/LEX Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozaril (Clozapine) PS 200 MG, Hospitalization - Professional UNKNOWN, Initial or Prolonged Date:06/14/99ISR Number: 3282634-3Report Type:Expedited (15-DaCompany Report #GB/99/00469/LEX Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Pain Foreign Clozaril Required Circulatory Collapse Health (Clozpapine) PS ORAL 400 MG ORAL Intervention to Coma Professional Prevent Permanent Malaise Impairment/Damage Post Procedural Complication Removal Of Foreign Body Shock Wound Infection Date:06/14/99ISR Number: 3282638-0Report Type:Expedited (15-DaCompany Report #USA/99/00991/LEX Age:60 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Chronic Obstructive Health Clozaril (Clozapine) PS ORAL 150 MG THREE Pulmonary Disease Professional TIMES A DAY Respiratory Failure ORAL Theophylline C Zosyn C Gentamicin C Steroids C Cefotaxime C 22-Feb-2006 08:30 AM Page: 359 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/14/99ISR Number: 3282639-2Report Type:Expedited (15-DaCompany Report #USA/99/01136/LEX Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hepatic Function Abnormal Health Clozaril (Clozapine) PS ORAL 550 MG ORAL Life-Threatening Liver Disorder Professional Date:06/14/99ISR Number: 3282641-0Report Type:Expedited (15-DaCompany Report #USA/99/00641/LEX Age:94 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Asthenia Health Clozaril (Clozapine) PS ORAL 300 MG ORAL Hospitalization - Cerebrovascular Accident Professional Lasix C Initial or Prolonged Cerebrovascular Disorder Disability Depressed Level Of Consciousness Dysphagia Hemiparesis Medication Error Sedation Speech Disorder Urinary Incontinence Date:06/14/99ISR Number: 3282674-4Report Type:Expedited (15-DaCompany Report #AUS/99/00385/LEX Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Albuminuria Foreign Clozaril (Clozapine) PS ORAL 600 MG , ORAL Arrhythmia Other Loratadine Cardiac Disorder (Loratadine) SS ORAL 10 MG, ORAL Cardiac Failure Cardiomegaly Cardiomyopathy Collapse Of Lung Emphysema Fibrosis Haematuria Hypoxia Myocardial Infarction Pulmonary Congestion Respiratory Failure Shock Date:06/14/99ISR Number: 3282676-8Report Type:Expedited (15-DaCompany Report #USA/99/01140/LEX Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Health Clozaril (Clozapine) PS ORAL 400 MG, ORAL Initial or Prolonged Heat Stroke Professional Required Hyperthermia Malignant Intervention to Malaise Prevent Permanent Pneumonia Impairment/Damage 22-Feb-2006 08:30 AM Page: 360 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/14/99ISR Number: 3282677-XReport Type:Expedited (15-DaCompany Report #USA/99/00571/LEX Age:51 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Distension Health Clozaril (Clozapine) PS ORAL 650 MG, ORAL Life-Threatening Anorexia Professional Cogentin C Hospitalization - Aspiration Ativan C Initial or Prolonged Malaise Neurontin C Required Nasopharyngitis Prevacid C Intervention to Pyrexia Synthroid C Prevent Permanent Respiratory Arrest Lorazepam C Impairment/Damage Respiratory Disorder Date:06/14/99ISR Number: 3282684-7Report Type:Expedited (15-DaCompany Report #USA/99/01151/LEX Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozaril (Clozapine) PS ORAL 200 MG , ORAL Professional Date:06/14/99ISR Number: 3282686-0Report Type:Expedited (15-DaCompany Report #AUS/99/00381/LEX Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acidosis Other Clozaril (Clozapine) PS ORAL 400 MG, ORAL Death Metforming C Hyperkalaemia Lisinopril C Pericardial Effusion Thyroxine Sodium C Renal Failure Acute Gemfibrozol C Syncope Gliclazide C Date:06/15/99ISR Number: 3285202-2Report Type:Expedited (15-DaCompany Report #LIT/99/00277/LEX Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Sodium Decreased Foreign Clozapine Initial or Prolonged Confusional State Literature (Clozapine) PS ORAL ORAL 16 DAY Required Diabetic Ketoacidosis Health Intervention to Hyperkalaemia Professional Prevent Permanent Hypertension Impairment/Damage Sedation Urinary Incontinence Date:06/17/99ISR Number: 3283696-XReport Type:Expedited (15-DaCompany Report #99-05-0145 Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Haemorrhage Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS ORAL 50-200MG ORAL Date:06/17/99ISR Number: 3283699-5Report Type:Expedited (15-DaCompany Report #99-05-0153 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death White Blood Cell Count Health Clozapine - Zenith Increased Professional Goldline Pharm. 22-Feb-2006 08:30 AM Page: 361 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tablets PS ORAL 50MG ORAL Date:06/17/99ISR Number: 3283702-2Report Type:Expedited (15-DaCompany Report #99-05-0144 Age:87 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS ORAL 100MG / DAY ORAL Date:06/17/99ISR Number: 3283706-XReport Type:Expedited (15-DaCompany Report #99-05-0123 Age:71 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Apnoea Health Clozapine - Zenith Hospitalization - Blood Glucose Abnormal Professional Goldline Pharm. Initial or Prolonged Cardiac Arrest Tablets PS ORAL 300MG/DAY Foreign Body Aspiration ORAL Hyperglycaemia Sinemet C White Blood Cell Count Premarin C Increased Date:06/17/99ISR Number: 3283798-8Report Type:Expedited (15-DaCompany Report #99-04-0110 Age:84 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine - Zenith Hospitalization - Upper Respiratory Tract Professional Goldline Pharm. Initial or Prolonged Infection Tablets PS ORAL 50MG/DAY ORAL Sinemet Cr C Propulsid C Lanoxin C Date:06/17/99ISR Number: 3286230-3Report Type:Expedited (15-DaCompany Report #AUS/99/00405/LEX Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Foreign Clozaril (Clozapine) PS 500 MG Blood Creatine Other Haloperidol C Phosphokinase Increased Captopril C Blood Urea Increased Metoprolol C Confusional State Indapamide C Convulsion Sertraline C Dehydration Dyskinesia Haematemesis Hyperhidrosis Hypertension Hypotension Leukocytosis Neuroleptic Malignant Syndrome 22-Feb-2006 08:30 AM Page: 362 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/17/99ISR Number: 3286245-5Report Type:Expedited (15-DaCompany Report #AUS/99/00383/LEX Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Constipation Foreign Clozaril (Clozapine) PS ORAL 600 MG, ORAL Cyanosis Other Ventolin Dyspnoea (Salbutamol) C Faecaloma Becotide C Pneumonia Pulmicort C Pulmonary Oedema Epilim C Mylanta C Date:06/17/99ISR Number: 3286246-7Report Type:Expedited (15-DaCompany Report #AUS/99/00382/LEX Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Creatine Foreign Clozaril (Clozapine) PS ORAL 300 MG, ORAL Phosphokinase Increased Other Blood Urea Increased Cardiac Arrest Delirium Influenza Like Illness Leukocytosis Myocarditis Neuroleptic Malignant Syndrome Pyrexia Renal Failure Acute Respiratory Disorder Tachycardia Date:06/17/99ISR Number: 3286291-1Report Type:Expedited (15-DaCompany Report #F/99/00909/LEX Age:27 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Leponex (Clozapine) PS ORAL 4 G, ONCE A Initial or Prolonged Phosphokinase Increased Health DAY, ORAL Required Confusional State Professional Rohypnol C Intervention to Overdose Depamide C Prevent Permanent Sinus Tachycardia Anafranil C Impairment/Damage Suicide Attempt Tachycardia Date:06/17/99ISR Number: 3287397-3Report Type:Expedited (15-DaCompany Report #AUS/99/00384/LEX Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Constipation Foreign Clozaril (Clozapine) PS 200 MG Cyanosis Other Ventolin Dyspnoea (Salbutamol) C Pulmonary Oedema Becotide Stridor (Beclomethasone Syncope Dipropionate) C Epilim (Valproate Sodium) C Pulmicort (Budesonide) C 22-Feb-2006 08:30 AM Page: 363 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/17/99ISR Number: 3287409-7Report Type:Expedited (15-DaCompany Report #AUS/99/00423/LEX Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pneumonia Foreign Clozaril (Clozapine) PS ORAL 300 MG, ORAL Pyrexia Health Amitriptyline Tachycardia Professional (Amitriptyline) C Other Date:06/17/99ISR Number: 3287415-2Report Type:Expedited (15-DaCompany Report #AUS/99/00418/LEX Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Atrioventricular Block Foreign Clozaril (Clozapine) PS ORAL 125 MG ORAL Health Professional Other Date:06/17/99ISR Number: 3287421-8Report Type:Expedited (15-DaCompany Report #GB/99/00353/LEX Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Gastrointestinal Disorder Foreign Clozaril (Clozapine) PS ORAL 300 MG ORAL Intestinal Obstruction Health Professional Date:06/17/99ISR Number: 3287426-7Report Type:Expedited (15-DaCompany Report #AUS/99/00410/LEX Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Distension Foreign Clozaril (Clozapine) PS ORAL 300 MG, ORAL Initial or Prolonged Anorexia Health Lithium Carbonate Required Biopsy Heart Abnormal Professional (Lithium Carbonate) C Intervention to Cardiomegaly Other Prevent Permanent Congestive Cardiomyopathy Impairment/Damage Cough Dyspnoea Fibrosis Pericardial Effusion Ultrasound Scan Abnormal Date:06/21/99ISR Number: 3287319-5Report Type:Direct Company Report # Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Convulsion Health Clozapine PS Intervention to Professional Prevent Permanent Impairment/Damage Date:06/21/99ISR Number: 3288001-0Report Type:Expedited (15-DaCompany Report #10015303 Age:16 YR Gender:Male I/FU:I Outcome PT Hospitalization - Confusional State Initial or Prolonged Delirium Delusion 22-Feb-2006 08:30 AM Page: 364 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Depressed Level Of Consciousness Dysarthria Report Source Product Role Manufacturer Route Dose Duration Tremor Foreign Buspirone Hcl PS ORAL 20 Health MILLIGRAM,1/1 Professional DAY ORAL Other Clozapine SS ORAL 300 MILLIGRAM,1/1 DAY ORAL Lorazepam C Date:06/21/99ISR Number: 3288003-4Report Type:Expedited (15-DaCompany Report #GB/99/00430/LEX Age:65 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Aspiration Foreign Clozaril (Clozapine) PS ORAL 600 MG, ONCE Urinary Tract Infection Health A DAY, ORAL; Professional Date:06/21/99ISR Number: 3288122-2Report Type:Expedited (15-DaCompany Report #JACGER1999000126 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutropenia Foreign Risperdal Initial or Prolonged Health (Unspecified Tablet) Professional (Risperidone) PS ORAL 6 MG, DAILY, ORAL Leponex (Clozapine) SS 12.5 MG, DAILY Diazepam C Date:06/21/99ISR Number: 3288157-XReport Type:Expedited (15-DaCompany Report #GB/99/00474/LEX Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Foreign Clozaril (Clozapine) PS ORAL 300 MG ORAL Initial or Prolonged Pulmonary Embolism Health Professional Date:06/21/99ISR Number: 3288158-1Report Type:Expedited (15-DaCompany Report #GB/99/00477/LEX Age:18 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril (Clozapine) PS ORAL 500 MG, ORAL Insulin-Dependent Health Professional Date:06/21/99ISR Number: 3288166-0Report Type:Expedited (15-DaCompany Report #D/99/00777/LEX Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Amylase Increased Foreign Leponex (Clozapine) PS ORAL 125 MG Initial or Prolonged Condition Aggravated Health ORAL Lipase Increased Professional Lipid Metabolism Disorder 22-Feb-2006 08:30 AM Page: 365 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/21/99ISR Number: 3289093-5Report Type:Expedited (15-DaCompany Report #USA/99/01215/LEX Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Breast Cancer Female Health Clozaril (Clozapine) PS ORAL 600 MG, ORAL Life-Threatening Professional Date:06/21/99ISR Number: 3289095-9Report Type:Expedited (15-DaCompany Report #GB/99/00311/LEX Age:67 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Mass Foreign Clozaril (Clozapine) PS ORAL 300 MG, TWICE Other Lower Respiratory Tract Health A DAY, ORAL Infection Professional Lansoprazole C Weight Decreased Salbutamol C Amoxicillin C Date:06/21/99ISR Number: 3289098-4Report Type:Expedited (15-DaCompany Report #USA/99/00960/LEX Age:77 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebral Infarction Health Clozaril (Clozapine) PS ORAL 12 MG, ORAL Life-Threatening Cerebrovascular Disorder Professional Zoloft C Hospitalization - Coma Trazodone C Initial or Prolonged Gastrointestinal Prilosec C Required Haemorrhage Vasotec C Intervention to Haematemesis Lodine C Prevent Permanent Hemiplegia Impairment/Damage Malaise Oesophageal Ulcer Date:06/22/99ISR Number: 3288566-9Report Type:Expedited (15-DaCompany Report #99-03-0062 Age:57 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Brain Scan Abnormal Health Clozapine - Zenith Hospitalization - Cardiac Arrest Professional Goldline Pharm. Initial or Prolonged Cardiac Failure Tablets PS Zenith Goldline Confusional State Pharm. ORAL 50-100MG/DAY Dehydration ORAL Fall Nitrostat C Injury Milk Of Magnesia C Mental Impairment Depakote C Nervous System Disorder Fluphenazine C Pneumonia Ranitidine C Pyrexia Imdur C White Blood Cells Urine Positive Date:06/22/99ISR Number: 3288571-2Report Type:Expedited (15-DaCompany Report #99-05-0136 Age:25 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 50-200 MG/ DAY ORAL 22-Feb-2006 08:30 AM Page: 366 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Haldol C Decanoate C Haloperidol C Date:06/23/99ISR Number: 3290015-1Report Type:Expedited (15-DaCompany Report #GB/99/00382/LEX Age:50 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Clozaril (Clozapine) PS 550 MG, Required Fall Health Valproate Sodium C Intervention to Malaise Professional Omeprazole Prevent Permanent Myocardial Infarction (Omerazole) C Impairment/Damage Obesity Date:06/23/99ISR Number: 3290017-5Report Type:Expedited (15-DaCompany Report #N/99/00138/LEX Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Foreign Leponex (Clozapine) PS 300 MG Initial or Prolonged Difficulty In Walking Health Glucofag (Metformin Other Immunosuppression Professional Hydrochloride) C Required Infection Daonil Intervention to Schizophrenia (Glibenclamide) C Prevent Permanent Furosemid Impairment/Damage (Furoseide) C Renitec (Enalapril Maleate) C Fenergan (Promethazine) C Vival (Diazepam) C Date:06/23/99ISR Number: 3290019-9Report Type:Expedited (15-DaCompany Report #D/99/00791/LEX Age:12 MON Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Exposure Foreign Leponex (Clozapine) PS 50 MG Initial or Prolonged Health Professional Date:06/24/99ISR Number: 3290875-4Report Type:Expedited (15-DaCompany Report #GB/99/00440/LEX Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Clozaril (Clozapine) PS ORAL 200 MG ORAL Health Professional Date:06/24/99ISR Number: 3290876-6Report Type:Expedited (15-DaCompany Report #D/99/00824/LEX Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Foreign Leponex (Clozapine) PS ORAL ORAL Health Professional 22-Feb-2006 08:30 AM Page: 367 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/28/99ISR Number: 3291718-5Report Type:Expedited (15-DaCompany Report #99-05-0128 Age:86 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL ORAL Date:06/28/99ISR Number: 3291722-7Report Type:Expedited (15-DaCompany Report #99-06-0169 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Health Clozapine - Zenith Loss Of Consciousness Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 825MG/DAY ORAL Date:06/28/99ISR Number: 3292883-6Report Type:Expedited (15-DaCompany Report #USA/99/01224/LEX Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Clozaril PS ORAL 75 MG ORAL Congestive Professional Date:06/28/99ISR Number: 3292885-XReport Type:Expedited (15-DaCompany Report #D/99/00836/LEX Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Foreign Leponex PS ORAL ORAL Initial or Prolonged Muscle Necrosis Health Rhabdomyolysis Professional Date:06/28/99ISR Number: 3293004-6Report Type:Expedited (15-DaCompany Report #D/99/00817/LEX Age:14 MON Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Medication Error Foreign Leponex (Clozapine) PS Initial or Prolonged Overdose Health Sedation Professional Date:06/28/99ISR Number: 3293021-6Report Type:Expedited (15-DaCompany Report #GB/99/00491/LEX Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Back Pain Foreign Clozaril (Clozapine) PS ORAL 900 MG, PO Constipation Study Valproate C Cyanosis Health Lithium C Faecaloma Professional Lactulose C Intestinal Obstruction Procyclidine C Pain Amoxicillin C Paracetamol C Diazepam C Chlorpromazine C 22-Feb-2006 08:30 AM Page: 368 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/28/99ISR Number: 3293024-1Report Type:Expedited (15-DaCompany Report #GB/99/00496/LEX Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Balance Disorder Foreign Clozaril (Clozapine) PS ORAL 50 MG, Blood Pressure Decreased Other Aspirin C Confusional State Gliclazide C Coordination Abnormal Fall Hemiparesis Tachycardia Date:06/28/99ISR Number: 3293031-9Report Type:Expedited (15-DaCompany Report #GB/99/00502/LEX Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril (Clozapine) PS ORAL 550 MG, Health Professional Date:06/28/99ISR Number: 3293033-2Report Type:Expedited (15-DaCompany Report #GB/99/00501/LEX Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Oesophagitis Foreign Clozaril (Clozapine) PS ORAL 450 MG, ONCE Initial or Prolonged Health A Required Professional Intervention to Prevent Permanent Impairment/Damage Date:06/28/99ISR Number: 3293035-6Report Type:Expedited (15-DaCompany Report #D/99/00397/LEX Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Foreign Leponex (Clozapine) PS ORAL 150 MG, FOUR Initial or Prolonged Hyperglycaemia Health TIMES A DAY, Required Increased Appetite Professional ORAL Intervention to Tremarit C Prevent Permanent Bifiteral C Impairment/Damage Risperdal C Date:06/28/99ISR Number: 3293039-3Report Type:Expedited (15-DaCompany Report #D/99/00624/LEX Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Urea Increased Foreign Leponex (Clozapine) PS ORAL 400 MG, ORAL, Initial or Prolonged Leukocytosis Health 900 MG, Nephritis Interstitial Professional SINGLE DOSE, Overdose Truxal Renal Failure Acute (Chlorprothixene Suicide Attempt Hydrochloride) SS ORAL 200 MG,ORAL Beloc Mite C 22-Feb-2006 08:30 AM Page: 369 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/30/99ISR Number: 3295318-2Report Type:Expedited (15-DaCompany Report #USA/99/00712/LEX Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Health Clozaril (Clozapine) PS 600 MG Professional Date:06/30/99ISR Number: 3295321-2Report Type:Expedited (15-DaCompany Report #USA/99/01249/LEX Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozaril (Clozapine) PS 900 MG Hospitalization - Confusional State Professional Navane C Initial or Prolonged Convulsion Sulfacetamide C Required Disorientation Intervention to Muscle Rigidity Prevent Permanent Muscle Twitching Impairment/Damage Tachycardia Date:07/01/99ISR Number: 3297320-3Report Type:Expedited (15-DaCompany Report #1999-001453 Age:71 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Foreign Catapres PS ORAL 0.15MG/PO Initial or Prolonged Lung Disorder Other Insuline SS Spinal Myelogram Abnormal Modopar SS ORAL DOSAGE UNK/PO Trivastal SS ORAL DOSAGE UNK/PO Chronadalate Lp SS ORAL 30 MG/PO Leponex SS ORAL 30 MG/PO Date:07/01/99ISR Number: 3297438-5Report Type:Expedited (15-DaCompany Report #USA/99/01290/LEX Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozaril PS ORAL 350 MG, ONCE Life-Threatening Professional A DAY, ORAL; Dalmane C Benadryl C Date:07/01/99ISR Number: 3297442-7Report Type:Expedited (15-DaCompany Report #USA/99/01308/LEX Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Clozaril (Clozapine) PS ORAL 650 MG, ORAL Required Lymphoma Zofran (Ondansetron Intervention to Hydrochloride) C Prevent Permanent Impairment/Damage Date:07/02/99ISR Number: 3297855-3Report Type:Expedited (15-DaCompany Report #99-06-0177 Age:80 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Delirium Health Clozapine PS Goldline Pharm ORAL 37-100 MG/DAY Professional ORAL 22-Feb-2006 08:30 AM Page: 370 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/02/99ISR Number: 3297858-9Report Type:Expedited (15-DaCompany Report #99-05-0144 Age:87 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline Professional Pharm. ORAL 100 MG/DAY ORAL Date:07/02/99ISR Number: 3297862-0Report Type:Expedited (15-DaCompany Report #99-04-0095 Age:65 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Disorder Health Clozapine PS Zenith Goldline Leukocytosis Professional Pharm. ORAL 150 MG/DAY Respiratory Failure ORAL Date:07/02/99ISR Number: 3297865-6Report Type:Expedited (15-DaCompany Report #99-03-0081 Age:72 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline Professional Pharm ORAL 50 MG ORAL Eldepryl C Sinemet C Requip C Date:07/02/99ISR Number: 3297868-1Report Type:Expedited (15-DaCompany Report #99-06-0180 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Health Clozapine PS Zenith Goldline Myocardial Infarction Professional Pharm. ORAL ORAL Anxiolytics C Date:07/02/99ISR Number: 3297872-3Report Type:Expedited (15-DaCompany Report #99-05-0153 Age:72 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dehydration Health Clozapine PS Zenith Goldline Dysphagia Professional Pharm. ORAL 50 MG ORAL Haemorrhagic Stroke Date:07/02/99ISR Number: 3297882-6Report Type:Expedited (15-DaCompany Report #99-06-0182 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Health Clozapine - Zenith Initial or Prolonged Condition Aggravated Professional Goldline Pharm. Diarrhoea Tablets PS Zenith Goldline Faeces Discoloured Pharm. ORAL 200-550MG/DAY Hypotension ORAL Leg Amputation Valproic Acid C White Blood Cell Count Bupropion C Increased Lescol C 22-Feb-2006 08:30 AM Page: 371 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/02/99ISR Number: 3298274-6Report Type:Expedited (15-DaCompany Report #GB/99/00515/LEX Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amnesia Foreign Clozaril PS ORAL 650 MG, ONCE Anxiety Health A DAY, ORAL; Cold Sweat Professional Confusional State Drug Withdrawal Syndrome Hyperhidrosis Hyponatraemia Hypothermia Insomnia Leukopenia Tremor Vomiting Date:07/02/99ISR Number: 3298275-8Report Type:Expedited (15-DaCompany Report #USA/99/01294/LEX Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Intestinal Obstruction Health Clozaril PS ORAL 700 MG; ORAL Necrosis Professional Haldol C Cogentin C Restoril C Date:07/02/99ISR Number: 3298277-1Report Type:Expedited (15-DaCompany Report #NL/99/00666/LEX Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Alanine Aminotransferase Foreign Leponex (Clozapine) PS ORAL 100 MG, TWICE Required Increased Health A DAY, ORAL; Intervention to Aspartate Professional Akineton (Biperiden Prevent Permanent Aminotransferase Hydrochloride) C Impairment/Damage Increased Blood Glucose Increased Blood Ph Increased Cardiac Murmur Cardiomyopathy Confusional State Crepitations Cyanosis Electrocardiogram T Wave Amplitude Decreased Haematocrit Decreased Haemoglobin Decreased Hypotension Pyrexia Respiratory Disorder Respiratory Failure Sepsis Shock Sinus Tachycardia Tachycardia 22-Feb-2006 08:30 AM Page: 372 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/02/99ISR Number: 3299184-0Report Type:Expedited (15-DaCompany Report #USA/99/00952/LEX Age:51 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Atrial Fibrillation Health Clozaril (Clozapine) PS ORAL 350 MG, Life-Threatening Atrophic Vulvovaginitis Professional ORAL; Hospitalization - Encephalopathy Antibiotics C Initial or Prolonged Iron Deficiency Anaemia Required Pneumonia Intervention to Respiratory Arrest Prevent Permanent Respiratory Depression Impairment/Damage Respiratory Distress Ventricular Arrhythmia Ventricular Extrasystoles Date:07/06/99ISR Number: 3297969-8Report Type:Expedited (15-DaCompany Report #E/99/00090/CMT Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Chest Pain Foreign Comtan PS ORAL UNSPECIFIED, Feeling Cold Health UNKNOWN, Professional ORAL; 15 DAY Leponex SS UNSPECIFIED, UNKNOWN, UNKNOWN; Date:07/06/99ISR Number: 3298175-3Report Type:Expedited (15-DaCompany Report #GB/99/00469/LEX Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Pain Foreign Clozaril (Clozapine) PS ORAL 400 MG, ORAL Required Abscess Health Sertraline C Intervention to Cardio-Respiratory Arrest Professional Lactulose C Prevent Permanent Circulatory Collapse Senna C Impairment/Damage Coma Foreign Body Trauma Loss Of Consciousness Malaise Postoperative Infection Sepsis Shock Date:07/06/99ISR Number: 3298184-4Report Type:Expedited (15-DaCompany Report #USA/99/01151/LEX Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozaril (Clozapine) PS ORAL 200 MG, ORAL Professional Date:07/06/99ISR Number: 3298185-6Report Type:Expedited (15-DaCompany Report #USA/99/01100/LEX Age:41 YR Gender:Male I/FU:F Outcome Hospitalization - Initial or Prolonged Other Required Intervention to 22-Feb-2006 08:30 AM Page: 373 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Anal Cancer Health Clozaril (Clozapine) PS ORAL 600 MG, ORAL Professional Haldol Decanoate C Date:07/06/99ISR Number: 3298186-8Report Type:Expedited (15-DaCompany Report #GB/99/00508/LEX Age:67 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Gastrointestinal Disorder Foreign Clozaril (Clozapine) PS ORAL 700 MG, ONCE Respiratory Disorder Health A DAY, ORAL Tuberculosis Professional Date:07/06/99ISR Number: 3298187-XReport Type:Expedited (15-DaCompany Report #N/99/00182/LEX Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiomyopathy Foreign Leponex (Clozapine) PS Vertigo Health Professional Other Date:07/06/99ISR Number: 3298438-1Report Type:Expedited (15-DaCompany Report #N/99/00138/LEX Age:52 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Foreign Leponex (Clozapine) PS ORAL 100 MG, ORAL; Initial or Prolonged Amnesia Health 225 MG, ORAL; Other Blood Bilirubin Increased Professional 300 MG, ORAL Required Blood Glucose Increased Glucofag C Intervention to C-Reactive Protein Daonil C Prevent Permanent Increased Furosemid C Impairment/Damage Decreased Activity Renitec C Difficulty In Walking Fenergan C Gait Disturbance Vival C Glycosuria Cisordinol C Immunosuppression Infection Pneumonia Suicidal Ideation Date:07/07/99ISR Number: 3297724-9Report Type:Expedited (15-DaCompany Report #9921101 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Convulsion Health Zithromax Capsules PS ORAL 250.00 MG Intervention to Drug Interaction Professional TOTAL DAILY Prevent Permanent Faecal Incontinence ORAL Impairment/Damage Fall Clozaril SS ORAL 175.00 MG TOTAL DAILY ORAL Zocor C Premarin C Colace C Calcium Carbonate C 22-Feb-2006 08:30 AM Page: 374 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/08/99ISR Number: 3298893-7Report Type:Expedited (15-DaCompany Report #99-04-0119 Age:37 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Colonic Atony Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm ORAL 600 MG /DAY ORAL Date:07/08/99ISR Number: 3298899-8Report Type:Expedited (15-DaCompany Report #99-03-0062 Age:57 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozapine - Zenith Hospitalization - Confusional State Professional Goldline Pharm. Initial or Prolonged Delirium Tablets PS Zenith Goldline Dementia Pharm. ORAL 12.5 - 100 MG Disorientation ORAL Memory Impairment Platelet Count Decreased Pneumonia Pyrexia Renal Failure White Blood Cells Urine Positive Date:07/08/99ISR Number: 3298906-2Report Type:Expedited (15-DaCompany Report #99-06-0184 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm ORAL 500 MG ORAL Date:07/08/99ISR Number: 3298922-0Report Type:Expedited (15-DaCompany Report #99-03-0075 Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Catatonia Health Clozapine - Zenith Initial or Prolonged Dysarthria Professional Goldline Pharm. Fatigue Tablets PS Zenith Goldline Muscle Rigidity Pharm ORAL 100 MG / DAY Neutrophil Count ORAL Decreased Paxil C Psychotic Disorder Depakote C Sedation Lithium C Sexual Dysfunction Date:07/08/99ISR Number: 3298929-3Report Type:Expedited (15-DaCompany Report #99-05-0128 Age:86 YR Gender:Male I/FU:F Outcome PT Death Cerebrovascular Accident Coma Dysphagia Dyspnoea 22-Feb-2006 08:30 AM Page: 375 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lethargy Report Source Product Role Manufacturer Route Dose Duration Health Clozapine-Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm ORAL ORAL Date:07/08/99ISR Number: 3299701-0Report Type:Periodic Company Report #99-01-0016 Age:46 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Clozapine PS ORAL 900MG/DAY Initial or Prolonged Delusion Professional ORAL Zyprexa C Date:07/08/99ISR Number: 3299706-XReport Type:Periodic Company Report #99-02-0022 Age:76 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozapine PS ORAL 75MG/DAY ORAL Professional Zyprexa C Date:07/08/99ISR Number: 3299709-5Report Type:Periodic Company Report #99-02-0029 Age:44 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozapine PS ORAL 200MG/DAY Required Professional ORAL Intervention to Clozapine Tablets SS ORAL 100MG/DAY Prevent Permanent ORAL Impairment/Damage Lorazepam C Levlen C Date:07/08/99ISR Number: 3299713-7Report Type:Periodic Company Report #99-02-0042 Age:19 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukocytosis Health Clozapine PS ORAL 350MG/DAY Initial or Prolonged Pleural Effusion Professional ORAL Pneumonia Zoloft C Pyrexia Vanceril C Ventolin C Prednisone C Zithromax C Doxycycline C Date:07/08/99ISR Number: 3299716-2Report Type:Periodic Company Report #99-03-0049 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Constipation Health Clozapine PS ORAL 25-500MG/DAY Enuresis Professional ORAL Prolixin C Mellaril C 22-Feb-2006 08:30 AM Page: 376 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/08/99ISR Number: 3299722-8Report Type:Periodic Company Report #99-02-0053 Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Influenza Like Illness Health Clozapine PS Zenith Goldline ORAL 250-300 Pulmonary Congestion Professional MG/DAY ORAL Pyrexia Depakote C Date:07/08/99ISR Number: 3299726-5Report Type:Periodic Company Report #99-03-0055 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Mood Swings Health Clozapine PS Zenith Goldline ORAL 600-650MG/DAY Thinking Abnormal Professional ORAL Date:07/08/99ISR Number: 3299731-9Report Type:Periodic Company Report #99-03-0063 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Insomnia Health Clozapine PS ORAL ORAL Pain In Extremity Professional Tremor Date:07/08/99ISR Number: 3299736-8Report Type:Periodic Company Report #99-03-0084 Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Ineffective Health Clozapine PS ORAL 150-400MG/DAY Professional ORAL Date:07/08/99ISR Number: 3299739-3Report Type:Periodic Company Report #99-03-0087 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Body Temperature Health Clozapine PS Zenith Goldline ORAL 350-400MG/DAY Increased Professional ORAL Heart Rate Increased Klonopin C Hypertension Valium C Leukocytosis Inderal C Psychotic Disorder Toothache Tremor Date:07/08/99ISR Number: 3299743-5Report Type:Periodic Company Report #99-04-0089 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Lethargy Health Clozapine PS Zenith Goldline ORAL 6.25MG/DAY Professional ORAL Multivitamins C Multivitamins And Iron C Prevacid C Acetaminophen C Vancocin C Cyanocobalamin C 22-Feb-2006 08:30 AM Page: 377 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/08/99ISR Number: 3299747-2Report Type:Periodic Company Report #99-04-0109 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Laboratory Test Abnormal Health Clozapine PS ORAL 200MG/DAY Professional ORAL Depakote C Vistaril C Cogentin C Date:07/08/99ISR Number: 3299749-6Report Type:Periodic Company Report #99-01-0006 Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dermatitis Exfoliative Health Clozapine PS ORAL 300MG/DAY Professional ORAL Date:07/08/99ISR Number: 3299753-8Report Type:Periodic Company Report #99-01-0008 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Influenza Health Clozapine PS Zenith Goldline ORAL 150-300MG/DAY Leukopenia Professional ORAL Paxil C Cogentin C Haldol Decanoate C Dilantin C Date:07/08/99ISR Number: 3299767-8Report Type:Periodic Company Report #99-02-0030 Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozapine PS Zenith Goldline Professional Pharm ORAL 200-300MG/DAY ORAL Benzatropine C Haloperidol C Depakote C Date:07/08/99ISR Number: 3299771-XReport Type:Periodic Company Report #99-02-0035 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozapine PS Zenith Goldline ORAL 100-450MG/DAY Professional ORAL Zoloft C Lithium C Carbonate C Glucophage C Date:07/08/99ISR Number: 3299776-9Report Type:Periodic Company Report #99-02-0036 Age:43 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alcoholism Health Clozapine PS ORAL 400-425MG/DAY Professional ORAL Lithium C 22-Feb-2006 08:30 AM Page: 378 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/08/99ISR Number: 3299781-2Report Type:Periodic Company Report #99-02-0041 Age:52 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tardive Dyskinesia Health Clozapine PS Zenith Goldline Professional Pharm ORAL 400MG/DAY ORAL Estraderm C Clonazepam C Date:07/08/99ISR Number: 3299783-6Report Type:Periodic Company Report #99-02-0043 Age:51 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Clonic Convulsion Health Clozapine PS Zenith Goldline ORAL 12.5 - Confusional State Professional 300MG/D ORAL Feeling Abnormal Depakote C Gait Disturbance Benadryl C Urinary Incontinence Date:07/08/99ISR Number: 3299789-7Report Type:Periodic Company Report #99-02-0073 Age:39 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Ineffective Health Clozapine PS ORAL 500MG/DAY Professional ORAL Lorazepam C Perphenazine C Depakote C Date:07/08/99ISR Number: 3299792-7Report Type:Periodic Company Report #99-02-0074 Age:29 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Ineffective Health Clozapine PS Zenith Goldline ORAL 500MG/DAY Professional ORAL Zyprexa C Trihexyphenidyl C Date:07/08/99ISR Number: 3299810-6Report Type:Periodic Company Report #99-03-0054 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fatigue Health Clozapine- Zenith Initial or Prolonged Leukopenia Professional Goldine Pharm. Nausea Tablets PS ORAL 100-150 MG Pharyngolaryngeal Pain DAY ORAL Pyrexia Prolixin Decanoate C Date:07/08/99ISR Number: 3299814-3Report Type:Periodic Company Report #99-03-0056 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS ORAL 100-350MG DAY ORAL 22-Feb-2006 08:30 AM Page: 379 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/08/99ISR Number: 3299816-7Report Type:Periodic Company Report #99-03-0082 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Health Clozapine - Zenith Initial or Prolonged Professional Goldline Pharm. Tablets PS ORAL 200-400 MG DAY ORAL Date:07/08/99ISR Number: 3299820-9Report Type:Periodic Company Report #99-04-0093 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ileus Paralytic Health Clozapine-Zenith Initial or Prolonged Intestinal Obstruction Professional Goldline Pharm. Required Tablets PS ORAL 100-450 MG Intervention to DAY ORAL Prevent Permanent Klonopin C Impairment/Damage Paxil C Effexor Xr C Serzone C Date:07/08/99ISR Number: 3299824-6Report Type:Periodic Company Report #99-04-0101 Age:80 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancytopenia Health Clozapine - Zenith Initial or Prolonged Professional Goldline Pharm. Tablets PS ORAL 12.5-25.0 MG ORAL Seroquel C Date:07/08/99ISR Number: 3299827-1Report Type:Periodic Company Report #99-04-0102 Age:75 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dizziness Health Clozapine - Zenith Initial or Prolonged Hallucination, Auditory Professional Goldline Pharm. Tablets PS ORAL 25-30 MG DAY ORAL Date:07/08/99ISR Number: 3299830-1Report Type:Periodic Company Report #99-04-0105 Age:93 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Hypotension Health Clozapine - Zenith Required Respiratory Depression Professional Goldline Pharm. Intervention to Tablets PS ORAL 12.5 MG Prevent Permanent ORAL Impairment/Damage Vitamin C C Synthroid C Nitroglicerina C 22-Feb-2006 08:30 AM Page: 380 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/08/99ISR Number: 3299834-9Report Type:Periodic Company Report #99-04-0115 Age:73 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozapine - Zenith Hospitalization - Professional Goldline Pharm. Initial or Prolonged Tablets PS ORAL 25-30 MG ORAL Levodopa-Carbidopa C Rifampin C Vitamin E C Ropinirole C Date:07/08/99ISR Number: 3299838-6Report Type:Periodic Company Report #99-05-0130 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS ORAL 70-700 MG DAY ORAL Tylenol Prn C Albuterol C Colace C Effexor C Atrovent C Prevacid C Milk Of Magnesia Prn C Date:07/08/99ISR Number: 3299841-6Report Type:Periodic Company Report #99-05-0131 Age:89 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Health Clozapine - Zenith Myocardial Infarction Professional Goldline Pharm. Pulmonary Embolism Tablets PS ORAL 150 MG OQ Sudden Death ORAL Date:07/08/99ISR Number: 3299846-5Report Type:Periodic Company Report #99-05-0139 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Health Clozapine - Zenith Initial or Prolonged Professional Goldline Pharm. Tablets PS ORAL 350-400 MG ORAL Date:07/08/99ISR Number: 3299850-7Report Type:Periodic Company Report #99-05-0140 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucination Health Clozapine - Zenith Initial or Prolonged Professional Goldline Pharm. Tablets PS ORAL 400-500 MG ORAL 22-Feb-2006 08:30 AM Page: 381 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/08/99ISR Number: 3299851-9Report Type:Periodic Company Report #99-05-0141 Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS ORAL ORAL Date:07/08/99ISR Number: 3299854-4Report Type:Periodic Company Report #99-05-0142 Age:77 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine- Zenith Professional Goldline Pharm. Tablets PS ORAL 12.5 MG DAY ORAL Date:07/08/99ISR Number: 3299855-6Report Type:Periodic Company Report #99-05-0143 Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Clozapine - Zenith Initial or Prolonged Professional Goldline Pharm. Tablets PS ORAL 50 MG DAY ORAL Date:07/08/99ISR Number: 3299857-XReport Type:Periodic Company Report #99-04-0147 Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Health Clozapine - Zenith Initial or Prolonged Professional Goldline Pharm. Tablets PS ORAL 200-900 MG DAY ORAL Date:07/08/99ISR Number: 3299859-3Report Type:Periodic Company Report #99-04-0148 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Health Clozapine - Zenith Initial or Prolonged Professional Goldline Pharm. Tablets PS ORAL 12.5 - 300 MG/D ORAL Date:07/08/99ISR Number: 3299860-XReport Type:Periodic Company Report #99-04-0149 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mental Disorder Health Clozapine - Zenith Initial or Prolonged Professional Goldline Pharm. Tablets PS ORAL 75-100 MG DAY ORAL 22-Feb-2006 08:30 AM Page: 382 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/08/99ISR Number: 3299862-3Report Type:Periodic Company Report #99-05-0150 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS ORAL 150-500 MG DAY ORAL Date:07/08/99ISR Number: 3299864-7Report Type:Periodic Company Report #99-05-0173 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS ORAL 300 MG ORAL Date:07/08/99ISR Number: 3301000-5Report Type:Periodic Company Report #99-04-0124 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 250 MG ORAL Cytoxan Tablets SS ORAL ORAL Date:07/08/99ISR Number: 3301493-3Report Type:Expedited (15-DaCompany Report #USA/99/01365/LEX Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neoplasm Malignant Health Clozaril (Clozapine) PS ORAL 500 MG, ORAL Professional Diflucan C Loxitane C Date:07/12/99ISR Number: 3301486-6Report Type:Expedited (15-DaCompany Report #USA/99/00848/LEX Age:60 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiac Failure Health Clozaril (Clozapine) PS ORAL 400 MG, ORAL Hospitalization - Cardiac Failure Professional Benadryl C Initial or Prolonged Congestive Lasix C Required Diabetes Mellitus Intervention to Hyperglycaemia Prevent Permanent Myocardial Infarction Impairment/Damage Polydipsia Polyuria Thirst Date:07/12/99ISR Number: 3301489-1Report Type:Expedited (15-DaCompany Report #D/99/00890/MEL Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Hospitalization - Ileus Paralytic Foreign Initial or Prolonged Study Health 22-Feb-2006 08:30 AM Page: 383 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Product Role Manufacturer Route Dose Duration Melleril (Lic. To Asta Medica) PS ORAL 600 MG, ORAL Leponex (Clozapine) SS ORAL 900 MG, ORAL Gastrozepin (Pirenzepine Dihydrochloride) SS ORAL 150 MG, ORAL Akineton (Biperiden Hydrochloride) SS ORAL 4 MG, ORAL Glianimon C Date:07/12/99ISR Number: 3301518-5Report Type:Expedited (15-DaCompany Report #CDN/99/00250/LEX Age:55 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Foreign Clozaril (Clozapine) PS Initial or Prolonged Aspiration Study Required Chest X-Ray Abnormal Health Intervention to Coma Professional Prevent Permanent Dehydration Impairment/Damage Leukocytosis Loss Of Consciousness Neutrophilia Date:07/12/99ISR Number: 3301521-5Report Type:Expedited (15-DaCompany Report #USA/99/01397/LEX Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abscess Oral Health Clozaril (Clozapine) PS 400 MG Initial or Prolonged Leukopenia Professional Required Tooth Abscess Intervention to Tooth Extraction Prevent Permanent Impairment/Damage Date:07/13/99ISR Number: 3302765-9Report Type:Expedited (15-DaCompany Report #IRL/99/00458/LEX Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Clozaril (Clozapine) PS ORAL 350 MG; ORAL Health Priadel C Professional Haloperidol C Chlorpromazine C Cogentin C Date:07/13/99ISR Number: 3302766-0Report Type:Expedited (15-DaCompany Report #GB/99/00508/LEX Age:67 YR Gender:Male I/FU:F Outcome Death Hospitalization - Initial or Prolonged Required Intervention to Prevent Permanent 22-Feb-2006 08:30 AM Page: 384 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Gastrointestinal Disorder Foreign Clozaril ( Grand Mal Convulsion Health Clozapine) PS ORAL 750 MG, ONCE Hyponatraemia Professional A DAY, ORAL Respiratory Disorder Rifater C Tuberculosis Seroxat C Weight Decreased Pyridoxine C Fybogel C Diazepam C Benzhexol C Date:07/14/99ISR Number: 3303224-XReport Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Drug Interaction Mirtazapine PS ORAL 3.75 PO QHS Intervention to White Blood Cell Count Clozapine SS ORAL 25MG PO QHS 2 YR Prevent Permanent Decreased Impairment/Damage Date:07/14/99ISR Number: 3303606-6Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Grand Mal Convulsion Clozaril PS 30MG/600MG Date:07/14/99ISR Number: 3304120-4Report Type:Expedited (15-DaCompany Report #GB/99/00549/LEX Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Disorder Foreign Clozaril (Clozapine) PS ORAL 250 MG, ORAL Pneumonia Health Professional Date:07/15/99ISR Number: 3304104-6Report Type:Expedited (15-DaCompany Report #99-06-0188 Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Clozapine - Zenith Goldline Pharm. Tablets PS Zenith Goldline Pharm ORAL 12.5 MG ORAL Date:07/15/99ISR Number: 3304106-XReport Type:Expedited (15-DaCompany Report #99-06-0191 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Health Clozapine - Zenith Initial or Prolonged Acute Respiratory Professional Goldline Pharm. Distress Syndrome Tablets PS Zenith Goldline Dyspnoea Pharm. ORAL 600MG ORAL Vomiting Stelazine C White Blood Cell Count Artane C Increased Prilosec C 22-Feb-2006 08:30 AM Page: 385 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/15/99ISR Number: 3304109-5Report Type:Expedited (15-DaCompany Report #99-06-0189 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 450MG/DAY ORAL Date:07/15/99ISR Number: 3304112-5Report Type:Expedited (15-DaCompany Report #99-06-0194 Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL ORAL Date:07/15/99ISR Number: 3304115-0Report Type:Expedited (15-DaCompany Report #99-02-0039 Age:54 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Breast Cancer Female Health Clozapine - Zenith Initial or Prolonged Leukopenia Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 550-700MG/DAY ORAL Thorazine C Risperdal C Clonidine C Depakote C Synthroid C Neupogen C Date:07/16/99ISR Number: 3305379-XReport Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatinine Clozaril PS Novartis ORAL 200MG BID Initial or Prolonged Increased ORAL Blood Urea Increased Risperidone SS Renal Failure Acute Levothyroxine C Fluphenazine C Benztropine C Diphenhydramine C Aspirin C Docusate C Atorvastatin C Divalproex Sodium C Trazodone C Enalapril C Atenolol C 22-Feb-2006 08:30 AM Page: 386 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/19/99ISR Number: 3306451-0Report Type:Expedited (15-DaCompany Report #CDN/99/00467/LEX Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Respiratory Failure Foreign Clozaril (Clozapine) PS ORAL 250 MG ORAL Study Anafranil C Health Ritalin C Professional Chlorpromazine C Gabapentin C Atrovent C Topamax C Erythromycin C Olanzapine C Effexor C Date:07/19/99ISR Number: 3306453-4Report Type:Expedited (15-DaCompany Report #GB/99/00478/LEX Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Anaemia Foreign Clozaril (Clozapine) PS ORAL 700 MG Hospitalization - Angiopathy Health ORAL Initial or Prolonged Aortic Thrombosis Professional Amiodarone C Required Atrial Fibrillation Erythromycin C Intervention to C-Reactive Protein Lithium C Prevent Permanent Increased Haloperidol C Impairment/Damage Coagulation Factor Viii Procyclidine C Level Increased Coagulation Factor Xii Level Decreased Coagulation Time Shortened Coagulopathy Embolism Gastroenteritis Gastrointestinal Disorder Hypernatraemia Leg Amputation Lipid Metabolism Disorder Nephrogenic Diabetes Insipidus Postoperative Infection Red Blood Cell Sedimentation Rate Increased Sepsis Thrombocytopenia Date:07/19/99ISR Number: 3306501-1Report Type:Expedited (15-DaCompany Report #USA/99/01447/LEX Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Non-Small Cell Lung Health Clozaril (Clozapine) PS ORAL 200 MG ORAL Cancer Professional 22-Feb-2006 08:30 AM Page: 387 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/19/99ISR Number: 3306676-4Report Type:Expedited (15-DaCompany Report #GB/99/00501/LEX Age:19 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Foreign Clozaril (Clozapine) PS ORAL 800 MG ONCE Initial or Prolonged Condition Aggravated Health A DAY Required Constipation Professional ORAL Intervention to Oesophageal Ulcer Oxytetracycline C Prevent Permanent Oesophagitis Lactulose C Impairment/Damage Vomiting Date:07/19/99ISR Number: 3306680-6Report Type:Expedited (15-DaCompany Report #GB/99/00555/LEX Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypertension Foreign Clozaril (Clozapine) PS Phaeochromocytoma Health Bendrofluazide C Tachycardia Professional Atrovent C Urine Abnormality Date:07/19/99ISR Number: 3306684-3Report Type:Expedited (15-DaCompany Report #AUS/99/00498/LEX Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypokalaemia Foreign Clozaril (Clozapine) PS ORAL 25 MG Initial or Prolonged Oral Intake Reduced Health ORAL Professional Date:07/19/99ISR Number: 3306694-6Report Type:Expedited (15-DaCompany Report #USA/99/01366/LEX Age:78 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Clozaril (Clozapine) PS ORAL ORAL Professional Date:07/19/99ISR Number: 3306696-XReport Type:Expedited (15-DaCompany Report #USA/99/00915/LEX Age:69 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Health Clozaril (Clozapine) PS ORAL 12.5 MG Initial or Prolonged Phosphokinase Increased Professional ORAL Required Blood Urea Increased Permax C Intervention to Chills Sinemet C Prevent Permanent Confusional State Tasmar C Impairment/Damage Dehydration Dysarthria Fall Hyperhidrosis Joint Stiffness Lethargy Muscle Rigidity Nystagmus Pyrexia Sedation Urinary Incontinence 22-Feb-2006 08:30 AM Page: 388 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/19/99ISR Number: 3306700-9Report Type:Expedited (15-DaCompany Report #CDN/99/00489/LEX Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Foreign Clozaril (Clozapine) PS ORAL 450 MG Cardiovascular Disorder Study ORAL Hypotension Health Moditen C Salivary Hypersecretion Professional Shock Subdural Haematoma Date:07/19/99ISR Number: 3307074-XReport Type:Expedited (15-DaCompany Report #USA/ 99 / 01428/ LEX Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatinine Health Clozaril (Clozapine) PS 200 MG, TWICE Initial or Prolonged Increased Professional A Other Blood Urea Increased Levothyroxine C Hyponatraemia Anafranil C Metabolic Acidosis Atenolol C Renal Failure Acute Fluphenazine C Trazodone C Risperidone C Benzatropine C Divalproex Sodium C Lorazepam C Lipitor C Colace C Diphenhydramine C Asa C Date:07/20/99ISR Number: 3306474-1Report Type:Expedited (15-DaCompany Report #99-05-0145 Age:84 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coma Health Clozapine - Zenith Gastrointestinal Professional Goldline Pharm. Haemorrhage Tablets PS Zenith Goldline Gastrointestinal Ulcer Pharm. ORAL 50-200MG/DAY Haematochezia ORAL Ranitidine C Propulsid C Prevacid C Daypro C Ferrous Sulfate C Date:07/21/99ISR Number: 3308039-4Report Type:Direct Company Report # Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Convulsion Clozapine PS Intervention to Prevent Permanent Impairment/Damage 22-Feb-2006 08:30 AM Page: 389 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/21/99ISR Number: 3308139-9Report Type:Expedited (15-DaCompany Report #1999-06-0167 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Abuser Health Subutex Initial or Prolonged Medication Error Professional (Buprenorphine Hcl) PS SUBLINGUAL Overdose Other Leponex SS ORAL 900 MG QD ORAL 30 MON Date:07/22/99ISR Number: 3308868-7Report Type:Expedited (15-DaCompany Report #8-99196-082A Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Lethargy Health Cordarone Tablets PS ORAL 400 MG ONCE Initial or Prolonged Liver Function Test Professional DAILY ORAL Other Abnormal Clozapine Tablets SS ORAL 525 MG TO 650 MG DAILY ORAL Date:07/22/99ISR Number: 3310376-4Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Clozapine PS Initial or Prolonged Date:07/23/99ISR Number: 3310191-1Report Type:Expedited (15-DaCompany Report #USA/99/01508/LEX Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Anuria Health Clozaril (Clozapine) PS ORAL 200 MG, TWICE Hospitalization - Back Pain Professional A DAY, ORAL Initial or Prolonged Groin Pain Depakote C Disability Lymphoma Theo-Dur C Pain In Extremity Lasix C Paraesthesia K-Dur C Albuterol C Date:07/23/99ISR Number: 3310446-0Report Type:Direct Company Report # Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Photosensitivity Reaction Clozapine 100 Mg Initial or Prolonged Tablets PS 200 MG HS Required Procardia C Intervention to Prolixin C Prevent Permanent Doxepin C Impairment/Damage Hytrin C Benztropine C Claritin C Date:07/26/99ISR Number: 3310745-2Report Type:Expedited (15-DaCompany Report #9919325 Age:47 YR Gender:Female I/FU:F Outcome PT Death C-Reactive Protein Increased Diarrhoea 22-Feb-2006 08:30 AM Page: 390 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Laboratory Test Abnormal Lipase Increased Pancreatitis Report Source Product Role Manufacturer Route Dose Duration Weight Decreased Foreign Atarax Tablets PS ORAL 25.00 MG White Blood Cell Count Health TOTAL:DAILY:O Increased Professional RAL Lorazepam SS ORAL 1.00 MG TOTAL:DAILY:O RAL Valproate Sodium SS ORAL 200.00 MG TOTAL:DAILY:O RAL Clozapine SS ORAL 500.00 MG TOTAL:DAILY:O RAL Date:07/26/99ISR Number: 3311115-3Report Type:Expedited (15-DaCompany Report #GB/99/00581/LEX Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anaemia Foreign Clozaril (Clozapine) PS ORAL 25 MG, ORAL Required Medication Error Health Intervention to Oesophagitis Professional Prevent Permanent Peptic Ulcer Haemorrhage Impairment/Damage Date:07/26/99ISR Number: 3311116-5Report Type:Expedited (15-DaCompany Report #GB/99/00430/LEX Age:65 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Level Above Foreign Clozaril (Clozapine) PS ORAL 600 MG, ONCE Therapeutic Health A DAY, ORAL Pneumonia Aspiration Professional Urinary Tract Infection Date:07/26/99ISR Number: 3311143-8Report Type:Expedited (15-DaCompany Report #GB/99/00579/LEX Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coronary Artery Disease Foreign Clozaril (Clozapine) PS ORAL 600 MG, ORAL Myocardial Ischaemia Health Professional Date:07/26/99ISR Number: 3311260-2Report Type:Expedited (15-DaCompany Report #USA/99/01294/LEX Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Pain Health Clozaril (Clozapine) PS ORAL 700 MG, Colostomy Professional UNKNOWN, ORAL Intestinal Obstruction Haldol Postoperative Wound (Haloperidol) C Complication Cogentin (Benzatropine Mesilate) C Restoril (Temazepam) C 22-Feb-2006 08:30 AM Page: 391 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/27/99ISR Number: 3310633-1Report Type:Direct Company Report # Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Clozaril Mfd By Increased Novartis PS Novartis Date:07/27/99ISR Number: 3311600-4Report Type:Expedited (15-DaCompany Report #7398832 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Creatine Other Abbott-Depakote PS Abbott Hospitalization - Phosphokinase Increased Clozaril SS Initial or Prolonged Coma Depo-Provera C Required Compartment Syndrome Intervention to Confusional State Prevent Permanent Dermatitis Impairment/Damage Disorientation Electroencephalogram Abnormal Feeling Jittery Haematocrit Decreased Hallucination Hyperhidrosis Hypertension Ketonuria Neuroleptic Malignant Syndrome Oliguria Pyrexia Respiratory Rate Decreased Rhabdomyolysis Thrombocythaemia White Blood Cell Count Increased Date:07/27/99ISR Number: 3311697-1Report Type:Expedited (15-DaCompany Report #USA/99/01598/LEX Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asthenia Health Clozaril (Clozapine) PS ORAL 600 MG Life-Threatening Heat Exhaustion Professional Date:07/27/99ISR Number: 3311703-4Report Type:Expedited (15-DaCompany Report #USA/99/01638/LEX Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Lung Neoplasm Malignant Health Clozaril (Clozapine) PS ORAL 300 MG, ONCE Hospitalization - Pneumonia Professional A DAY Initial or Prolonged Glucophage Disability (Metformin Required Hydrochloride) C Intervention to Insulin C Prevent Permanent Impairment/Damage 22-Feb-2006 08:30 AM Page: 392 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/27/99ISR Number: 3311718-6Report Type:Expedited (15-DaCompany Report #NL/99/00875/LEX Age:85 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agranulocytosis Foreign Leponex (Clozapine) PS 50 MG Required C-Reactive Protein Health Intervention to Increased Professional Prevent Permanent Pneumonia Other Impairment/Damage Pyrexia Serum Ferritin Increased White Blood Cell Count Decreased Date:07/27/99ISR Number: 3311735-6Report Type:Expedited (15-DaCompany Report #GB/99/00553/LEX Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chills Foreign Clozaril (Clozapine) PS Initial or Prolonged Decreased Activity Health Disability Dyskinesia Professional Infertility Female Muscle Rigidity Overdose Paralysis Sedation Upper Motor Neurone Lesion Wheelchair User Date:07/29/99ISR Number: 3313934-6Report Type:Expedited (15-DaCompany Report #D/99/00551/LEX Age:61 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accident Foreign Leponex (Clozapine) PS ORAL 500 MG, ORAL Initial or Prolonged Blood Creatine Health Valiquid C Required Phosphokinase Increased Professional Prostagutt Forte C Intervention to Blood Creatinine Prevent Permanent Increased Impairment/Damage Blood Urea Increased Muscle Necrosis Renal Failure Acute Rhabdomyolysis Sedation Date:07/29/99ISR Number: 3313974-7Report Type:Direct Company Report # Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Autonomic Nervous System Topamax (Topiramate) PS 200MG BID Imbalance Clozaril (Clozapine) SS 500MG HS Coma Risperdal C Confusional State Celexa C Hyperpyrexia Depakote C Weight Increased 22-Feb-2006 08:30 AM Page: 393 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/29/99ISR Number: 3314043-2Report Type:Expedited (15-DaCompany Report #AUS/99/01020/LEX Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Deafness Foreign Clozaril PS ORAL; Health (THERAPY Professional DATES: SEVERAL WEEKS) Date:07/29/99ISR Number: 3314066-3Report Type:Expedited (15-DaCompany Report #GB/99/00566/LEX Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Foreign Clozaril (Clozapine) PS ORAL 500 MG, Required Fatigue Health UNKNOWN, Intervention to Lower Respiratory Tract Professional ORAL; Prevent Permanent Infection Impairment/Damage Malaise Myocarditis Pallor Renal Failure Acute Date:07/29/99ISR Number: 3314067-5Report Type:Expedited (15-DaCompany Report #USA/99/00638/LEX Age:85 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Albuminuria Health Clozaril (Clozapine) PS 600 MG, Initial or Prolonged Blood Creatine Professional UNKNOWN, Phosphokinase Increased ORAL; Blood Creatinine Lipitor Increased (Atorvastatin) C Diabetes Mellitus Colace (Docusate Non-Insulin-Dependent Sodium) C Nephritis Dulcolax (Bisacodyl) C Proteinuria Pimozide (Pimozide) C Haldol (Haloperidol) C Date:07/29/99ISR Number: 3314070-5Report Type:Expedited (15-DaCompany Report #USA/99/01365/LEX Age:43 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Neoplasm Malignant Health Clozaril (Clozapine) PS ORAL 500 MG, Professional UNKNOWN, ORAL; Diflucan C Loxitane C Date:07/30/99ISR Number: 3313279-4Report Type:Expedited (15-DaCompany Report #99-07-0200 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL ORAL 22-Feb-2006 08:30 AM Page: 394 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/30/99ISR Number: 3313292-7Report Type:Expedited (15-DaCompany Report #99-07-0203 Age:69 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Parkinson'S Disease Health Clozapine - Zenith White Blood Cell Count Professional Goldline Pharm. Increased Tablets PS Zenith Goldline Pharm. ORAL 12.5-50MG ORAL Date:07/30/99ISR Number: 3313299-XReport Type:Expedited (15-DaCompany Report #99-07-0209 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Parkinson'S Disease Clozapine - Zenith Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 37.5 MG ORAL Date:07/30/99ISR Number: 3313304-0Report Type:Expedited (15-DaCompany Report #99-07-0205 Age:74 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dementia Alzheimer'S Type Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 12.5 - 125 MG ORAL Date:07/30/99ISR Number: 3313307-6Report Type:Expedited (15-DaCompany Report #99-03-0047 Age:74 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Creatinine Health Clozapine - Zenith Increased Professional Goldline Pharm. Blood Urea Increased Tablets PS Zenith Goldline Dehydration Pharm. ORAL 75-100MG ORAL Depressed Level Of Monopril C Consciousness Bactrim C Enterococcal Bacteraemia Haematocrit Decreased Haemoglobin Decreased Myocardial Infarction Pneumonitis Pyrexia Respiratory Distress Sepsis Date:07/30/99ISR Number: 3315140-8Report Type:Expedited (15-DaCompany Report #USA/99/01645/LEX Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozaril (Clozapine) PS ORAL 500 MG; ORAL Life-Threatening Professional 22-Feb-2006 08:30 AM Page: 395 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/30/99ISR Number: 3315529-7Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Echocardiogram Abnormal Clozaril PS 400MG >1YR 1 YR Date:07/30/99ISR Number: 3315535-2Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Neutrophil Count Clozaril PS 175MG Q DAY Intervention to Decreased Prevent Permanent Impairment/Damage Date:07/30/99ISR Number: 3315544-3Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eosinophilia Clozaril PS 100MG Date:08/02/99ISR Number: 3316297-5Report Type:Expedited (15-DaCompany Report #JACGER1999000126 Age:47 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutropenia Foreign Risperdal Initial or Prolonged Health (Unspecified Tablet) Professional (Risperidone) PS ORAL 6MG DAILY ORAL Leponex (Clozapine) SS 12.5MG DAILY Diazepam C Date:08/02/99ISR Number: 3316408-1Report Type:Expedited (15-DaCompany Report #GB/99/00600/LEX Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anaemia Foreign Clozaril (Clozapine) PS ORAL UNKNOWN, Hospitalization - Brain Damage Health UNKNOWN, ORAL Initial or Prolonged Convulsion Professional Required Encephalopathy Intervention to Haemoglobin Decreased Prevent Permanent Myocardial Infarction Impairment/Damage Necrotising Fasciitis Thrombocythaemia Date:08/02/99ISR Number: 3316412-3Report Type:Expedited (15-DaCompany Report #D/99/00961/LEX Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Disturbance In Attention Foreign Leponex (Clozapine) PS ORAL 300 MG, Initial or Prolonged Drug Interaction Health UNKNOWN, Fatigue Professional ORAL; Schizophrenia Fraxiparin Surgery (Heparin-Fraction, Calcium Salt) SS INTRAMUSCULAR .3 XX, UNKNOWN, 22-Feb-2006 08:30 AM Page: 396 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/02/99ISR Number: 3316764-4Report Type:Expedited (15-DaCompany Report #GB/99/00527/LEX Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypertension Foreign Clozaril (Clozapine) PS 400 MG Required Norepinephrine Increased Health Intervention to Phaeochromocytoma Professional Prevent Permanent Tachycardia Impairment/Damage Urine Abnormality Date:08/02/99ISR Number: 3317011-XReport Type:Expedited (15-DaCompany Report #USA/99/01707/LEX Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Chronic Leukaemia Health Clozaril (Clozapine) PS ORAL 300MG TWICE A Professional DAY ORAL Depakote C Ativan C Cogentin C Dyazide C Dilantin C Folic Acid C Antivert C Allegra C Date:08/02/99ISR Number: 3317060-1Report Type:Expedited (15-DaCompany Report #LIT/99/00311/LEX Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Creatine Foreign Clozapine Hospitalization - Phosphokinase Increased Literature (Clozapine) PS ORAL 125 MG, TWICE Initial or Prolonged Blood Urea Increased Health A DAY, ORAL 16 DAY Required Cardiomegaly Professional Intervention to Chills Prevent Permanent Hypotension Impairment/Damage Influenza Like Illness Leukocytosis Musculoskeletal Stiffness Neuroleptic Malignant Syndrome Pneumonia Pyrexia Respiratory Rate Decreased Tachycardia Date:08/02/99ISR Number: 3317071-6Report Type:Expedited (15-DaCompany Report #USA/99/01698/LEX Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Renal Cell Carcinoma Health Clozaril (Clozapine) PS ORAL 500 MG; ORAL Disability Stage Unspecified Professional 22-Feb-2006 08:30 AM Page: 397 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/02/99ISR Number: 3317074-1Report Type:Expedited (15-DaCompany Report #USA/99/01672/LEX Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Clozaril (Clozapine) PS ORAL 400 MG, ORAL Hospitalization - Professional Initial or Prolonged Date:08/02/99ISR Number: 3358834-0Report Type:Periodic Company Report #001-0991-990946 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Interaction Other Rezulin Drug Level Below (Troglitazone) PS 400 MG Therapeutic (DAILY) Clozapine SS 400 MG (DAILY) Glucophage C Prinivil C Depakote C Cogentin C Date:08/03/99ISR Number: 3316573-6Report Type:Direct Company Report # Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyskinesia Health Clozaril 800 Mg 1 Eye Movement Disorder Professional Day PS 800 MG 1 DAY Gaze Palsy Hallucination Oculogyration Date:08/03/99ISR Number: 3317523-9Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Diabetes Mellitus Clozapine PS 400MG Q HS Intervention to Prevent Permanent Impairment/Damage Date:08/03/99ISR Number: 3318057-8Report Type:Expedited (15-DaCompany Report #99-06-0194 Age:85 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS ORAL Date:08/05/99ISR Number: 3317449-0Report Type:Expedited (15-DaCompany Report #99-06-0180 Age:51 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Health Clozapine - Zenith Loss Of Consciousness Professional Goldline Pharm Myocardial Infarction Tablets PS ORAL 10 MG ORAL Anxiolytics C 22-Feb-2006 08:30 AM Page: 398 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Klonopin C Vistaril C Serzone C Date:08/05/99ISR Number: 3317480-5Report Type:Expedited (15-DaCompany Report #99-07-0222 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Clozapine- Zenith Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 175 MG ORAL Date:08/05/99ISR Number: 3317488-XReport Type:Expedited (15-DaCompany Report #99-07-0217 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Alcohol Poisoning Health Clozapine - Zenith Aspiration Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 350 MG ORAL Date:08/05/99ISR Number: 3319539-5Report Type:Expedited (15-DaCompany Report #D/99/00791/LEX Age:12 MON Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - No Adverse Drug Effect Foreign Leponex (Clozapine) PS 50 MG Initial or Prolonged Health Professional Date:08/05/99ISR Number: 3319547-4Report Type:Expedited (15-DaCompany Report #GB/99/00527/LEX Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypertension Foreign Clozaril (Clozapine) PS 400 MG Required Phaeochromocytoma Health Fluoxetine C Intervention to Polyuria Professional Prevent Permanent Tachycardia Impairment/Damage Urine Abnormality Date:08/05/99ISR Number: 3319804-1Report Type:Expedited (15-DaCompany Report #USA/99/01638/LEX Age:76 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Neoplasm Malignant Health Clozaril (Clozapine) PS ORAL 300 MG, ONCE Life-Threatening Professional A DAY, ORAL Hospitalization - Glucophage Initial or Prolonged (Metoformin Disability Hydrochloride) C Required Insulin C Intervention to Prevent Permanent Impairment/Damage 22-Feb-2006 08:30 AM Page: 399 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/05/99ISR Number: 3319811-9Report Type:Expedited (15-DaCompany Report #USA/99/01754/LEX Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Cancer Female Health Clozaril (Clozapine) PS 600 MG, Required Professional UNKNOWN, Intervention to Depakote (Valproate Prevent Permanent Semisodium) C Impairment/Damage Compazine (Prochlorperazine Edisylate) C Date:08/09/99ISR Number: 3321673-0Report Type:Expedited (15-DaCompany Report #USA/99/01764/LEX Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cerebrovascular Accident Health Clozaril (Clozapine) PS ORAL 650 MG, ORAL Hospitalization - Cerebrovascular Disorder Professional Zyprexa C Initial or Prolonged Date:08/09/99ISR Number: 3321826-1Report Type:Expedited (15-DaCompany Report #D/99/01020/LEX Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arrhythmia Neonatal Foreign Leponex (Clozapine) PS 100 MG, Initial or Prolonged C-Reactive Protein Health UNKNOWN Increased Professional Chest X-Ray Abnormal Complications Of Maternal Exposure To Therapeutic Drugs Congenital Musculoskeletal Anomaly Gastric Dilatation Gastrointestinal Motility Disorder Nausea Neonatal Respiratory Distress Syndrome Red Blood Cell Sedimentation Rate Increased Tachycardia Date:08/09/99ISR Number: 3321828-5Report Type:Expedited (15-DaCompany Report #GB/99/00239/LEX Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Foreign Clozaril (Clozapine) PS ORAL 300 MG, Dermatitis Health UNKNOWN, ORAL Haematochezia Professional Trimethoprim C Haemoglobin Decreased Leukocytosis Melaena Oesophageal Stenosis Oesophagitis Pyrexia Thrombocythaemia Urinary Tract Infection 22-Feb-2006 08:30 AM Page: 400 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/09/99ISR Number: 3321832-7Report Type:Expedited (15-DaCompany Report #GB/99/00608/LEX Age:67 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anorexia Foreign Clozaril (Clozapine) PS Diabetes Mellitus Study Myocardial Infarction Health Oral Intake Reduced Professional Sudden Death Date:08/09/99ISR Number: 3321860-1Report Type:Expedited (15-DaCompany Report #USA/99/01401/LEX Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dry Mouth Health Clozaril (Clozapine) PS 500 MG, Hepatic Function Abnormal Professional Trazodone C Hepatitis C Dimetapp C Leukopenia Colace C 500 MG Liver Function Test Trazodone C Abnormal Dimetapp C Thrombocytopenia Colace C Date:08/09/99ISR Number: 3321863-7Report Type:Expedited (15-DaCompany Report #USA/99/01761/LEX Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Disorder Health Clozaril (Clozapine) PS Pulmonary Congestion Professional Propanolol C Date:08/12/99ISR Number: 3324686-8Report Type:Expedited (15-DaCompany Report #99-07-0223 Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death White Blood Cell Count Health Clozapine - Zenith Increased Professional Goldline Pharm. Tablets PS ORAL 150MG/DAY ORAL 12 MON Date:08/12/99ISR Number: 3324687-XReport Type:Expedited (15-DaCompany Report #99-06-0189 Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Foreign Body Trauma Health Clozapine - Zenith Gastrointestinal Professional Goldline Pharm. Obstruction Tablets PS ORAL 450MG/DAY Gastrointestinal ORAL 1 MON Perforation Prozac C Sepsis Colace C Prevacid C Date:08/13/99ISR Number: 3325601-3Report Type:Expedited (15-DaCompany Report #S/99/00163/LEX Age:72 YR Gender:Male I/FU:I Outcome Death Hospitalization - Initial or Prolonged 22-Feb-2006 08:30 AM Page: 401 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Required Intervention to Prevent Permanent PT Report Source Product Role Manufacturer Route Dose Duration Impairment/Damage Agranulocytosis Foreign Leponex (Clozapine) PS ORAL 300 MG, ORAL Drug Ineffective Health Disipal C Gastrointestinal Disorder Professional Effortil Prolongatum C Infection Other Cipramil C Neutrophil Count Abnormal Pulmonary Oedema Pyrexia Shock White Blood Cell Count Decreased Date:08/13/99ISR Number: 3325605-0Report Type:Expedited (15-DaCompany Report #LIT/99/00316/LEX Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bipolar Disorder Foreign Clozapine Initial or Prolonged Clonic Convulsion Literature (Clozapine) PS ORAL 150 MG; ORAL Required Coordination Abnormal Health Lithium Carbonate Intervention to Drug Interaction Professional (Lithium Carbonate) SS 600 MG Prevent Permanent Dyskinesia Impairment/Damage Gait Disturbance Hyperreflexia Mania Muscle Contractions Involuntary Neuropathy Peripheral Neurotoxicity Tremor Date:08/13/99ISR Number: 3361488-0Report Type:Periodic Company Report #1999-001686 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hallucination, Auditory Health Flomax (Tamsulosin) Professional Capsules/0.4 Mg PS DOSAGE UNK/NR Clozaril SS 350 MG/NR Paxil C Date:08/16/99ISR Number: 3326742-7Report Type:Expedited (15-DaCompany Report #USA/99/00993/LEX Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agranulocytosis Health Clozaril (Clozapine) PS ORAL 250 MG, ORAL Life-Threatening Aspiration Bone Marrow Professional Lasix C Hospitalization - Abnormal Lisinopril C Initial or Prolonged Hypotension Aspirin C Required Neutrophil Count Bromide C Intervention to Decreased Albuterol C Prevent Permanent Pneumonia Benzotropine C Impairment/Damage Sepsis Simvastatin C Upper Respiratory Tract Glyburide C Infection White Blood Cell Count Decreased 22-Feb-2006 08:30 AM Page: 402 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/16/99ISR Number: 3326743-9Report Type:Expedited (15-DaCompany Report #USA/99/01428/LEX Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acidosis Health Clozaril (Clozapine) PS ORAL 200 MG, TWICE Initial or Prolonged Blood Creatinine Professional A DAY, ORAL Other Increased Levothyroxine C Required Blood Urea Increased Anafranil C Intervention to Hyponatraemia Atenolol C Prevent Permanent Metabolic Acidosis Fluphenazine C Impairment/Damage Renal Failure Acute Trazodone C Risperidone C Benzatropine C Divalproex Sodium C Lorazepam C Lipitor C Colace C Diphenhydramine C Asa C Enalapril C Atorvastatin C Date:08/16/99ISR Number: 3326929-3Report Type:Expedited (15-DaCompany Report #USA/99/ 01447/ LEX Age:49 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Non-Small Cell Lung Health Clozaril (Clozapine) PS ORAL 200 MG, Cancer Professional UNKNOWN; ORAL Roxanol C Vicodin C Combivent C Carboplatin C Novelbine C Date:08/16/99ISR Number: 3327092-5Report Type:Expedited (15-DaCompany Report #USA/99/01645/LEX Age:59 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozaril (Clozapine) PS ORAL 500 MG,ORAL Life-Threatening Professional Date:08/16/99ISR Number: 3327096-2Report Type:Expedited (15-DaCompany Report #USA/99/01781/LEX Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozaril (Clozapine) PS ORAL ORAL Life-Threatening Professional Date:08/16/99ISR Number: 3327098-6Report Type:Expedited (15-DaCompany Report #USA/99/01811/ LEX Age:69 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Intestinal Perforation Health Clozaril (Clozapine) PS ORAL ORAL Hospitalization - Leukocytosis Professional Haldol C Initial or Prolonged Pneumonia Seroquel C Renal Failure Acute Cogentin C Sepsis Zyprexa C Wellbutrin C 22-Feb-2006 08:30 AM Page: 403 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Vitamin E C Date:08/17/99ISR Number: 3326996-7Report Type:Expedited (15-DaCompany Report #99-03-0085 Age:81 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozapine-Zenith Cardiac Failure Professional Goldline Pharm. Cardiomyopathy Tablets PS Zenith Goldline Myocardial Ischaemia Pharm. Tablets ORAL 62.5-75 MG ORAL 1 YR Date:08/17/99ISR Number: 3327666-1Report Type:Expedited (15-DaCompany Report #USA/99/01833/LEX Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dermatitis Health Clozaril (Clozapine) PS ORAL 450 MG, ORAL Fatigue Professional Prevacid Heat Exhaustion (Lansoprazole) C Heat Rash Pyrexia Date:08/17/99ISR Number: 3327668-5Report Type:Expedited (15-DaCompany Report #USA/99/01215/LEX Age:46 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Breast Cancer Female Health Clozaril (Clozapine) PS ORAL 300 MG, TWICE Life-Threatening Professional A DAY, ORAL; YR Date:08/17/99ISR Number: 3327669-7Report Type:Expedited (15-DaCompany Report #USA/99/01840/LEX Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Lung Neoplasm Malignant Health Clozaril (Clozapine) PS ORAL 400 MG, ONCE Required Professional A DAY, ORAL; Intervention to Glucophage Prevent Permanent (Metformin Impairment/Damage Hydrochloride) C Glucotrol (Glipizide) C Date:08/17/99ISR Number: 3327671-5Report Type:Expedited (15-DaCompany Report #USA/99/01841/LEX Age:73 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Leukopenia Health Clozaril (Clozapine) PS ORAL 400 MG, ORAL; Other Lung Neoplasm Malignant Professional Zocor (Simvastatin) C Hydroxyzine C Lopressor (Metoprolol Tartrate) C Gemfibrozil C 22-Feb-2006 08:30 AM Page: 404 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/17/99ISR Number: 3327688-0Report Type:Expedited (15-DaCompany Report #GB/99/00502/LEX Age:51 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Confusional State Foreign Clozaril (Clozapine) PS 350 MG Diabetes Mellitus Health Non-Insulin-Dependent Professional Hyperglycaemia Thirst Date:08/17/99ISR Number: 3327689-2Report Type:Expedited (15-DaCompany Report #GB/99/00412/LEX Age:28 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Angioneurotic Oedema Foreign Clozaril (Clozapine) PS 12.5 MG Face Oedema Health Fluoxetine C Professional Trifluoperazine C Procyclidine C Risperidone C Date:08/17/99ISR Number: 3327691-0Report Type:Expedited (15-DaCompany Report #GB/99/00608/LEX Age:67 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anorexia Foreign Clozaril (Clozapine) PS ORAL ORAL Hospitalization - Diabetes Mellitus Study Propranolol C Initial or Prolonged Myocardial Infarction Health Cyproterone C Oral Intake Reduced Professional Metformin C Sudden Death Lisinopril C Amlodipine C Zopiclone C Glipazide C Date:08/17/99ISR Number: 3327780-0Report Type:Expedited (15-DaCompany Report #GB/99/00406/LEX Age:31 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Foreign Clozaril (Clozapine) PS ORAL 300 MG, ONCE Initial or Prolonged Diabetic Ketoacidosis Health A DAY, ORAL Required Professional Amoxicillin C Intervention to Prevent Permanent Impairment/Damage Date:08/18/99ISR Number: 3328602-4Report Type:Expedited (15-DaCompany Report #GB/99/00579/LEX Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Clozaril (Clozapine) PS 600 MG Coronary Artery Disease Health Paroxetine C Myocardial Infarction Professional Myocardial Ischaemia 22-Feb-2006 08:30 AM Page: 405 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/18/99ISR Number: 3328630-9Report Type:Expedited (15-DaCompany Report #USA/99/01874/LEX Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Level Above Health Clozaril (Clozapine) PS ORAL Therapeutic Professional Intestinal Obstruction Intestinal Perforation Sepsis Date:08/18/99ISR Number: 3328632-2Report Type:Expedited (15-DaCompany Report #USA/99/01867/LEX Age:50 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Infection Health Clozaril (Clozapine) PS ORAL UNSPECIFIED, Peritonitis Professional UNKNOWN, ORAL Date:08/18/99ISR Number: 3328635-8Report Type:Expedited (15-DaCompany Report #USA/99/01863/LEX Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Difficulty In Walking Health Clozaril (Clozapine) PS ORAL 800 MG, Initial or Prolonged Myopathy Professional UNKNOWN, ORAL Zoloft (Sertraline Hydrochloride) C Klonopin (Clonazepam) C Date:08/18/99ISR Number: 3328636-XReport Type:Expedited (15-DaCompany Report #GB/99/00600/LEX Age:49 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anaemia Foreign Clozaril (Clozapine) PS ORAL ORAL Hospitalization - Brain Damage Initial or Prolonged Convulsion Required Encephalopathy Intervention to Fasciitis Prevent Permanent Myocardial Infarction Impairment/Damage Thrombocythaemia Date:08/20/99ISR Number: 3331026-7Report Type:Expedited (15-DaCompany Report #USA/99/01883/LEX Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Gastroenteritis Health Clozaril (Clozapine) PS ORAL 500 MG, ORAL Initial or Prolonged Helicobacter Professional Depakene C Required Gastrointestinal Cogentin C Intervention to Haemorrhage Prevent Permanent Impairment/Damage Date:08/20/99ISR Number: 3331061-9Report Type:Expedited (15-DaCompany Report #PRIUSA1999004463 Age:35 YR Gender:Female I/FU:I Outcome PT Death Agitation Arrhythmia 22-Feb-2006 08:30 AM Page: 406 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Cardiac Disorder Confusional State Report Source Product Role Manufacturer Route Dose Duration Health Topamax (Tablet) Professional (Topiramate) PS ORAL 25 MG, 1 IN 1 DAILY, ORAL Clozaril (Clozapine) SS ORAL 300 MG, DAILY, ORAL Risperdal C Prozac C Levothyroxine C Date:08/20/99ISR Number: 3331066-8Report Type:Expedited (15-DaCompany Report #PRIUSA1999004462 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Health Topamax (Tablet) Confusional State Professional (Topiramate) PS ORAL 25 MG, 1 IN 1 DAILY, ORAL (SEE IMAGE) Clozaril (Clozapine) SS ORAL 450 MG, 1 IN 1 DAILY, ORAL Anafranil C Mevacor C Hydrochlorothiazide C Date:08/20/99ISR Number: 3331069-3Report Type:Expedited (15-DaCompany Report #PRIUSA1999004461 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anoxia Health Topamax (Tablet) Coma Professional (Topiramate) PS ORAL 200 MG, 2 IN Malaise 1 DAILY, ORAL Pyrexia Clozaril (Clozapine) SS ORAL 500 MG, 1 IN 1 DAILY, ORAL Celexan C Risperdal C Depakote C Date:08/20/99ISR Number: 3331075-9Report Type:Expedited (15-DaCompany Report #GB/99/00629/LEX Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Appendicitis Perforated Foreign Clozaril (Clozapine) PS ORAL 600 MG, ORAL Hospitalization - Peritonitis Health Metoprolol Initial or Prolonged Renal Failure Acute Professional (Metoprolol) C Vomiting Hyoscine (Hyoscine) C Zopiclone (Zopiclone) C Date:08/20/99ISR Number: 3331078-4Report Type:Expedited (15-DaCompany Report #USA/99/00638/LEX Age:44 YR Gender:Male I/FU:F Outcome PT Other Albuminuria Blood Creatine Phosphokinase Increased 22-Feb-2006 08:30 AM Page: 407 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Diabetes Mellitus Non-Insulin-Dependent Nephritis Report Source Product Role Manufacturer Route Dose Duration Proteinuria Health Clozaril (Clozapine) PS ORAL 600 MG, ORAL Professional Lipitor (Atorvastatin) C Colace (Docusate Sodium) C Dulcolax (Bisacodyl) C Pimozide (Pimozide) C Haldol (Haloperidol) C Date:08/20/99ISR Number: 3331081-4Report Type:Expedited (15-DaCompany Report #USA/99/00915/LEX Age:69 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Health Clozaril (Clozapine) PS ORAL 12.5 MG, Initial or Prolonged Phosphokinase Increased Professional ORAL Required Blood Urea Increased Permax (Pergolide Intervention to Chills Mesilate) C Prevent Permanent Confusional State Sinemet C Impairment/Damage Dehydration Tasmar (Tolcapone) C Dysarthria Fall Hyperhidrosis Joint Stiffness Lethargy Muscle Rigidity Nystagmus Oral Intake Reduced Pyrexia Sedation Speech Disorder Urinary Incontinence Date:08/20/99ISR Number: 3331083-8Report Type:Expedited (15-DaCompany Report #USA/99/01882/LEX Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozaril (Clozapine) PS ORAL 175 MG, ORAL Hospitalization - Neoplasm Malignant Professional Chemotherapy Initial or Prolonged (Chemothearpy) SS Other Required Intervention to Prevent Permanent Impairment/Damage Date:08/20/99ISR Number: 3331089-9Report Type:Expedited (15-DaCompany Report #AUS/99/00453/LEX Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Foreign Clozaril (Clozapine) PS ORAL 250 MG, Initial or Prolonged Circulatory Collapse Health UNKNOWN, Required Haemorrhagic Stroke Professional ORAL;, 500 Intervention to Hemiplegia MG, ORAL Prevent Permanent Psychotic Disorder Impairment/Damage Shock 22-Feb-2006 08:30 AM Page: 408 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/24/99ISR Number: 3332437-6Report Type:Expedited (15-DaCompany Report #99-08-0235 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abdominal Pain Health Clozapine - Zenith Hospitalization - Dialysis Professional Goldline Pharm. Initial or Prolonged Pyrexia Tablets PS Zenith Goldline Renal Failure Pharm. ORAL 300-400 MG Respiratory Failure ORAL Sepsis Date:08/24/99ISR Number: 3332441-8Report Type:Expedited (15-DaCompany Report #99-08-0233 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Clozapine - Zenith Intentional Overdose Professional Goldline Pharm. Capsules PS ORAL 700-750MG/DAY ORAL Date:08/24/99ISR Number: 3332454-6Report Type:Expedited (15-DaCompany Report #99-07-0200 Age:76 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Health Clozapine - Zenith Coma Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL ORAL Date:08/24/99ISR Number: 3332457-1Report Type:Expedited (15-DaCompany Report #99-07-0203 Age:69 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Mental Impairment Health Clozapine - Zenith Parkinson'S Disease Professional Goldline Pharm. White Blood Cell Count Tablets PS ORAL 12.5-50MG Increased ORAL 1 YR Date:08/24/99ISR Number: 3332460-1Report Type:Expedited (15-DaCompany Report #99-04-0116 Age:51 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Colectomy Health Clozapine- Zenith Hospitalization - Colon Cancer Professional Goldline Pharm. Initial or Prolonged White Blood Cell Count Tablets PS Zenith Goldline Abnormal Pharm. ORAL 300-500MG/DAY ORAL 1 YR Zyprexa C Prozac C Date:08/24/99ISR Number: 3332464-9Report Type:Expedited (15-DaCompany Report #99-08-0240 Age:94 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death White Blood Cell Count Health Clozapine - Zenith Increased Professional Goldline Pharm. Tablets PS Zenith Goldline 22-Feb-2006 08:30 AM Page: 409 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pharm. ORAL 12.5-25MG ORAL Date:08/24/99ISR Number: 3332467-4Report Type:Expedited (15-DaCompany Report #99-08-0239 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Oesophageal Perforation Health Clozapine - Zenith Initial or Prolonged Professional Goldline Pharm. Required Tablets PS Zenith Goldline Intervention to Pharm. ORAL 125-700MG Prevent Permanent ORAL Impairment/Damage Date:08/24/99ISR Number: 3332469-8Report Type:Expedited (15-DaCompany Report #99-06-0165 Age:87 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Health Clozapine - Zenith Initial or Prolonged Hip Fracture Professional Goldline Pharm. PS Zenith Goldline Pharm. 6.2MG/DAY Sinemet C Date:08/24/99ISR Number: 3332477-7Report Type:Expedited (15-DaCompany Report #99-08-0238 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Appendicitis Perforated Health Clozapine- Zenith Initial or Prolonged White Blood Cell Count Professional Goldline Pharm. Increased Tablets PS Zenith Goldline Pharm. ORAL 50-275MG ORAL Date:08/24/99ISR Number: 3332480-7Report Type:Expedited (15-DaCompany Report #99-08-0237 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Health Clozapine- Zenith Initial or Prolonged Hip Fracture Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 12.5-25MG ORAL Date:08/24/99ISR Number: 3333405-0Report Type:Expedited (15-DaCompany Report #USA/99/01947/LEX Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiac Failure Health Clozaril (Clozapine) PS ORAL 12.5 MG ORAL Required Congestive Professional Intervention to Cardiomegaly Prevent Permanent Dizziness Impairment/Damage Dyspnoea Dyspnoea Exertional Fatigue Fluid Retention 22-Feb-2006 08:30 AM Page: 410 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/24/99ISR Number: 3333406-2Report Type:Expedited (15-DaCompany Report #USA/99/01867/LEX Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Infection Health Clozaril (Clozapine) PS ORAL 400 MG ORAL Life-Threatening Peritonitis Professional Lorazepam C Disability Date:08/24/99ISR Number: 3333407-4Report Type:Expedited (15-DaCompany Report #USA/99/00638/LEX Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Albuminuria Health Clozaril (Clozapine) PS ORAL 600 MG ORAL Blood Creatine Professional Lipitor C Phosphokinase Increased Colace C Diabetes Mellitus Dulcolax C Non-Insulin-Dependent Pimozide C Nephritis Haldol C Proteinuria Date:08/24/99ISR Number: 3333408-6Report Type:Expedited (15-DaCompany Report #AUS/99/01152/LEX Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Foreign Clozaril (Clozapine) PS ORAL 750 MG ORAL Initial or Prolonged Cardiomyopathy Consumer Ranitidine C Chest Pain Dyspnoea Headache Hypoaesthesia Panic Attack Date:08/24/99ISR Number: 3333409-8Report Type:Expedited (15-DaCompany Report #D/99/01020/LEX Age:34 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arrhythmia Neonatal Foreign Leponex (Clozapine) PS ORAL 100 MG ORAL Initial or Prolonged Complications Of Maternal Health 25 MG ORAL Exposure To Therapeutic Professional Drugs Congenital Musculoskeletal Anomaly Gastric Dilatation Gastrointestinal Motility Disorder Nausea Neonatal Respiratory Distress Syndrome Red Blood Cell Sedimentation Rate Increased Tachycardia 22-Feb-2006 08:30 AM Page: 411 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/24/99ISR Number: 3333410-4Report Type:Expedited (15-DaCompany Report #GB/99/00428/LEX Age:25 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Pain Foreign Clozaril (Clozapine) PS ORAL 225 MG ONCE A Circulatory Collapse Health DAY ORAL Constipation Professional Epilim C Deep Vein Thrombosis Other Orphenadrine C Drug Level Above Chlorpromazine C Therapeutic Dothiepin C Embolism Mebeverine C Obstruction Fybogel C Date:08/26/99ISR Number: 3334773-6Report Type:Expedited (15-DaCompany Report #99-08-0251 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Road Traffic Accident Health Clozapine - Zenith Initial or Prolonged Professional Goldline Pharm. Capsules PS Zenith Goldline Pharm. ORAL 550MG ORAL 14 MON Date:08/26/99ISR Number: 3335400-4Report Type:Expedited (15-DaCompany Report #GB/99/00665/LEX Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Foreign Clozaril (Clozapine) PS ORAL ORAL Initial or Prolonged Cerebrovascular Accident Health Dysarthria Professional Hemiparesis Date:08/26/99ISR Number: 3335404-1Report Type:Expedited (15-DaCompany Report #D/99/01116/LEX Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Leponex (Clozapine) PS ORAL 325 MG Initial or Prolonged Phosphokinase Increased Health ORAL; 50 MG, Hypergammaglobulinaemia Professional THREE TIMES A Muscle Necrosis DAY ORAL Myoglobin Blood Increased Renal Failure Acute Rhabdomyolysis Date:08/26/99ISR Number: 3335408-9Report Type:Expedited (15-DaCompany Report #GB/99/00679/LEX Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aspartate Foreign Clozaril (Clozapine) PS ORAL 600 MG ORAL Initial or Prolonged Aminotransferase Health Increased Professional Cardiomyopathy Hepatic Function Abnormal Malaise Myocardial Infarction Pulmonary Oedema 22-Feb-2006 08:30 AM Page: 412 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/30/99ISR Number: 3336243-8Report Type:Direct Company Report # Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Grand Mal Convulsion Clozaril PS ORAL 400MG AM/ Hospitalization - 500MG HS ORAL Initial or Prolonged Lithium SS 450MG BID Date:08/30/99ISR Number: 3336271-2Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neutropenia Health Clozaril PS ORAL 250MG AM Hospitalization - Professional /350MG HS / Initial or Prolonged ORAL 4 MON Valproic Acid SS ORAL 750MG/BID/OR AL 4 MON Trovan C Clindamycin C Gabapentin C Warfarin C Digoxin C Date:08/30/99ISR Number: 3337452-4Report Type:Expedited (15-DaCompany Report #GB/99/00681/LEX Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Hepatic Failure Foreign Clozaril (Clozapine) PS ORAL 400MG ORAL Other Vision Blurred Study Visual Disturbance Health Professional Date:08/30/99ISR Number: 3337607-9Report Type:Expedited (15-DaCompany Report #CDN/99/00712/LEX Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatic Neoplasm Foreign Clozaril (Clozapine) PS ORAL ORAL Hepatocellular Damage Health Professional Date:08/31/99ISR Number: 3338230-2Report Type:Expedited (15-DaCompany Report #USA/99/02019/LEX Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coma Health Clozaril (Clozapine) PS ORAL 475 MG, ONCE Hospitalization - Professional DAY, ORAL; Initial or Prolonged Celexa C Date:08/31/99ISR Number: 3338232-6Report Type:Expedited (15-DaCompany Report #USA/99/02022/LEX Age:60 YR Gender:Female I/FU:I Outcome Life-Threatening Disability Other Required Intervention to 22-Feb-2006 08:30 AM Page: 413 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Ovarian Cancer Health Clozaril (Clozapine) PS ORAL 200 MG, TWICE Professional A DAY; ORAL Date:08/31/99ISR Number: 3338325-3Report Type:Expedited (15-DaCompany Report #USA/99/02021/LEX Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coma Health Clozaril (Clozapine) PS ORAL ORAL Required Hyperglycaemia Professional Intervention to Ketoacidosis Prevent Permanent Impairment/Damage Date:08/31/99ISR Number: 3338327-7Report Type:Expedited (15-DaCompany Report #USA/99/02042/LEX Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Other Clozaril Initial or Prolonged Leukopenia (Clozapine) PS ORAL 500 MG, ORAL Pulmonary Embolism Date:08/31/99ISR Number: 3338342-3Report Type:Expedited (15-DaCompany Report #USA/99/02063/LEX Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Colon Cancer Health Clozaril (Clozapine) PS ORAL 300 MG, ONCE Required Pseudo Lymphoma Professional A DAY, ORAL Intervention to Depakote C Prevent Permanent Cogentin C Impairment/Damage Date:08/31/99ISR Number: 3338367-8Report Type:Expedited (15-DaCompany Report #AUS/99/00242/LEX Age:57 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Biopsy Lymph Gland Foreign Clozaril (Clozapine) PS ORAL 350 MG, TWICE Initial or Prolonged Abnormal Health A DAY, ORAL Required Lymphadenopathy Professional Phenytoin C Intervention to Lymphoma Theophylline C Prevent Permanent Ventolin C Impairment/Damage Atrovent C Vincristine C Lymphoma C Date:08/31/99ISR Number: 3338370-8Report Type:Expedited (15-DaCompany Report #IL/99/00388/LEX Age:35 YR Gender:Female I/FU:I Outcome PT Death Agranulocytosis Required Leukopenia Intervention to Pharyngitis Streptococcal Prevent Permanent Sepsis Impairment/Damage Upper Respiratory Tract 22-Feb-2006 08:30 AM Page: 414 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Infection Report Source Product Role Manufacturer Route Dose Duration Foreign Leponex (Clozapine) PS ORAL 500 MG, Health UNKNOWN, ORAL Professional Valporal C Date:08/31/99ISR Number: 3338373-3Report Type:Expedited (15-DaCompany Report #AUS/99/00243/LEX Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Constipation Foreign Clozaril (Clozapine) PS ORAL 400 MG, ONCE Initial or Prolonged Haemoptysis Health A DAY, ORAL Required Hyperhidrosis Professional Duphalac C Intervention to Night Sweats Prevent Permanent Pleural Infection Impairment/Damage Pneumonia Productive Cough Pyrexia Sedation Sputum Discoloured White Blood Cell Count Increased Date:08/31/99ISR Number: 3338375-7Report Type:Expedited (15-DaCompany Report #USA/99/01308/LEX Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Clozaril (Clozapine) PS ORAL 650 MG; ORAL Required Lymphoma Zofran (Ondansetron Intervention to Nausea Hydrochloride) SS Prevent Permanent White Blood Cell Count Chemotherapy C Impairment/Damage Increased Date:08/31/99ISR Number: 3338429-5Report Type:Expedited (15-DaCompany Report #USA/99/01707/LEX Age:54 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Chronic Leukaemia Health Clozaril (Clozapine) PS ORAL 300 MG TWICE Professional A DAY ORAL Depakote C Ativan C Cogentin C Dyazide C Dilantin C Folic Acid C Antivert C Allegra C Date:08/31/99ISR Number: 3338431-3Report Type:Expedited (15-DaCompany Report #USA/99/02018/LEX Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neoplasm Malignant Health Clozaril (Clozapine) PS Professional Radiation C 22-Feb-2006 08:30 AM Page: 415 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/01/99ISR Number: 3338175-8Report Type:Expedited (15-DaCompany Report #99-08-0248 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Appendicectomy Health Clozapine - Zenith Hospitalization - Appendicitis Professional Goldline Pharm. Initial or Prolonged Tablets PS ORAL 450MG ORAL 1 YR Elavil C Date:09/01/99ISR Number: 3338179-5Report Type:Expedited (15-DaCompany Report #99-05-0135 Age:68 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Clozapine - Zenith Renal Failure Professional Goldline Pharm. Tablets PS ORAL 100MG/DAY ORAL 2 MON Lasix C Date:09/01/99ISR Number: 3338180-1Report Type:Expedited (15-DaCompany Report #99-08-0247 Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS ORAL 75-100MG ORAL 4 MON Date:09/02/99ISR Number: 3339927-0Report Type:Expedited (15-DaCompany Report #047-0981-990043 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Foreign Lipitor Initial or Prolonged Blood Creatine Health (Atorvastatin) PS ORAL 20 MG DAILY Other Phosphokinase Increased Professional PER ORAL Drug Interaction Leponex (Clozapine) SS ORAL 125 MG DAILY Insomnia PER ORAL Liver Function Test Abnormal Nausea Neuroleptic Malignant Syndrome Restlessness Schizophrenia Tremor Vomiting Date:09/03/99ISR Number: 3339770-2Report Type:Direct Company Report # Age:76 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Clozaril 25mg PS ORAL 50MG PO BID 3 WK Initial or Prolonged Atrial Fibrillation Depakote C Difficulty In Walking Risperidol C Heart Rate Increased Calcium C Pneumonia Vit D C Pyrexia Fosamax C Rales Neurontin C Thrombocytopenia 22-Feb-2006 08:30 AM Page: 416 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/03/99ISR Number: 3341312-2Report Type:Expedited (15-DaCompany Report #USA/99/02075/LEX Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chronic Obstructive Health Clozaril (Clozapine) PS ORAL 525 MG, ORAL Initial or Prolonged Pulmonary Disease Professional Required Lung Disorder Intervention to Tachycardia Prevent Permanent Impairment/Damage Date:09/03/99ISR Number: 3341314-6Report Type:Expedited (15-DaCompany Report #USA/99/01840/LEX Age:57 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Loss Of Consciousness Health Clozaril (Clozapine) PS ORAL 400 MG , ONCE Other Lung Neoplasm Malignant Professional A DAY, ORAL Required Glucophage C Intervention to Glucotrol C Prevent Permanent Impairment/Damage Date:09/03/99ISR Number: 3341317-1Report Type:Expedited (15-DaCompany Report #USA/99/01754/LEX Age:41 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Cancer Female Health Clozaril (Clozapine) PS ORAL ORAL Required Radical Mastectomy Professional Clozapine Intervention to (Clozapine) SS ORAL 600 MG, ORAL Prevent Permanent Depakote C Impairment/Damage Compazine C Tylenol C Oscal C Dulcolax C Date:09/03/99ISR Number: 3341320-1Report Type:Expedited (15-DaCompany Report #USA/99/01734/LEX Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozaril (Clozapine) PS Hospitalization - Professional Initial or Prolonged Date:09/03/99ISR Number: 3341494-2Report Type:Expedited (15-DaCompany Report #GB/99/00738/LEX Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiac Arrest Foreign Clozaril (Clozapine) PS ORAL 100 MG, ONCE Cardiac Failure Health A DAY; ORAL Pulmonary Oedema Professional Dothiepin C Respiratory Arrest Aminophylline C Respiratory Depression Oxybutynin C Ventricular Tachycardia Aspirin C Cloral Betaine C 22-Feb-2006 08:30 AM Page: 417 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/03/99ISR Number: 3342313-0Report Type:Expedited (15-DaCompany Report #GB/99/00629/LEX Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Appendicitis Perforated Foreign Clozaril (Clozapine) PS ORAL 600 MG ORAL Life-Threatening Obstruction Health Hyoscine C Hospitalization - Peritonitis Professional Zopiclone C Initial or Prolonged Renal Failure Acute Metoprolol C Shock Toxic Shock Syndrome Vomiting Date:09/07/99ISR Number: 3340622-2Report Type:Expedited (15-DaCompany Report #99-05-0173 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abdominal Pain Health Clozapine - Zenith Hospitalization - Agranulocytosis Professional Goldline Pharm. Initial or Prolonged Leukopenia Tablets PS Zenith Goldline Oesophagitis Pharm. ORAL 300MG ORAL 1 MON Date:09/07/99ISR Number: 3340624-6Report Type:Expedited (15-DaCompany Report #99-08-0256 Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine- Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 12.5MG ORAL 2 MON Date:09/07/99ISR Number: 3340626-XReport Type:Expedited (15-DaCompany Report #99-07-0222 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 175MG ORAL 17 MON Date:09/07/99ISR Number: 3342321-XReport Type:Expedited (15-DaCompany Report #CDN/99/00772/LEX Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Circulatory Collapse Foreign Clozaril (Clozapine) PS ORAL 425 MG ORAL Coma Health Orap C Electrocardiogram Qt Professional Serzone C Prolonged Prepulsid C Loss Of Consciousness Syncope Torsade De Pointes Ventricular Arrhythmia Ventricular Fibrillation 22-Feb-2006 08:30 AM Page: 418 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/07/99ISR Number: 3342326-9Report Type:Expedited (15-DaCompany Report #USA/99/02090/LEX Age:74 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aneurysm Health Clozaril (Clozapine) PS ORAL 50 MG, ONCE A Myocardial Infarction Professional DAY, ORAL Vitamin E C Trazodone C Vitamin C C Date:09/07/99ISR Number: 3342489-5Report Type:Expedited (15-DaCompany Report #USA/99/02136/LEX Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neoplasm Malignant Health Clozaril (Clozapine) PS ORAL 100 MG, ORAL Professional Date:09/07/99ISR Number: 3342495-0Report Type:Expedited (15-DaCompany Report #GB/99/00745/LEX Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Gastric Outlet Foreign Clozaril (Clozapine) PS ORAL 600 MG, ORAL Initial or Prolonged Obstruction Health Pyrexia Professional Date:09/07/99ISR Number: 3342498-6Report Type:Expedited (15-DaCompany Report #USA/99/02123/LEX Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Breast Cancer Female Consumer Clozaril (Clozapine) PS ORAL 500 MG, ORAL Leukopenia Neutropenia Date:09/07/99ISR Number: 3342503-7Report Type:Expedited (15-DaCompany Report #USA/99/02154/LEX Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Medication Error Health Clozaril (Clozapine) PS ORAL 400 MG, ORAL Respiratory Acidosis Professional Respiratory Disorder Sedation Date:09/07/99ISR Number: 3342507-4Report Type:Expedited (15-DaCompany Report #USA/99/02169/LEX Age:77 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Health Clozaril (Clozapine) PS ORAL 31.5 MG, ORAL Hospitalization - Sepsis Professional Aricept (Donepezil Initial or Prolonged Vomiting Hydrochloride) C Date:09/07/99ISR Number: 3342511-6Report Type:Expedited (15-DaCompany Report #USA/98/03062/LEX Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukaemia Health Clozaril (Clozapine) PS ORAL 500 MG, ORAL Leukopenia Professional Pravacol 22-Feb-2006 08:30 AM Page: 419 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Pravastatin Sodium) C Lactulose C Atenolol C Senokot (Senna Fruit) C Trazodone C Docusate C Prochlorperazine C Nicotine Patch (Nicotine) C Purinethol (Mercaptopurine) C Date:09/08/99ISR Number: 3342592-XReport Type:Expedited (15-DaCompany Report #99-08-0237 Age:78 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Health Clozapine -Zenith Initial or Prolonged Hip Fracture Professional Goldline Pharm. Required Nervousness Tablets PS ORAL 12.5-25MG Intervention to ORAL 2 MON Prevent Permanent Impairment/Damage Date:09/08/99ISR Number: 3342599-2Report Type:Expedited (15-DaCompany Report #99-08-0268 Age:86 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrial Fibrillation Health Clozapine - Zenith Initial or Prolonged Dehydration Professional Coldline Pharm. Diarrhoea Tablets PS ORAL ORAL Lanoxin C Atenolol C Date:09/08/99ISR Number: 3343950-XReport Type:Expedited (15-DaCompany Report #PRIUSA1999004462 Age:42 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Health Topamax (Tablet) Atelectasis Professional (Topiramate) PS ORAL 25MG 1 IN 1 Bronchitis DAILY ORAL Confusional State Clozaril (Clozapine) SS ORAL SEE IMAGE Coronary Artery Disease Anafranil C Coronary Artery Occlusion Mevacor C Myocarditis Hydrochlorothiazide C Pneumonia Sudden Death Toxicologic Test Abnormal Date:09/10/99ISR Number: 3344641-1Report Type:Direct Company Report # Age:35 YR Gender:Male I/FU:I Outcome Hospitalization - Initial or Prolonged Required Intervention to Prevent Permanent 22-Feb-2006 08:30 AM Page: 420 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Grand Mal Convulsion Clozaril Tab Sandoz PS Sandoz ORAL 400MG PO BID; STARTED SEVERAL YRS AGO Lithium Cr C Lactulose C Das Na C Depakote C Date:09/13/99ISR Number: 3345548-6Report Type:Expedited (15-DaCompany Report #D/99/00817/LEX Age:14 MON Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Exposure Foreign Leponex (Clozapine) PS ORAL ORAL Initial or Prolonged Overdose Health Sedation Professional Date:09/13/99ISR Number: 3345551-6Report Type:Expedited (15-DaCompany Report #RA/99/01733/LEX Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agranulocytosis Foreign Lapenax (Clozapine) PS ORAL 300 MG, ORAL Hospitalization - Anaemia Study Lorazepam C Initial or Prolonged Bacterial Infection Health Cardiac Arrest Professional Cellulitis Hepatocellular Damage Hypovolaemia Leukopenia Lung Disorder Neutropenia Oliguria Pyrexia Sepsis Skin Infection Surgery Surgical Procedure Repeated Thrombocytopenia Date:09/13/99ISR Number: 3345682-0Report Type:Expedited (15-DaCompany Report #F/99/01691/LEX Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Foreign Leponex (Clozapine) PS ORAL 300 MG, Initial or Prolonged Convulsion Health UNKNOWN, ORAL Required Headache Professional Tranxene C Intervention to Hemiplegia Rohypnol C Prevent Permanent Malaise Impairment/Damage Vertigo 22-Feb-2006 08:30 AM Page: 421 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/13/99ISR Number: 3346072-7Report Type:Expedited (15-DaCompany Report #USA/99/02214/LEX Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozaril (Clozapine) PS ORAL ORAL Professional Date:09/13/99ISR Number: 3346075-2Report Type:Expedited (15-DaCompany Report #GB/99/00753/LEX Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alveolitis Allergic Foreign Clozaril (Clozapine) PS ORAL 300 MG , ORAL Initial or Prolonged Antinuclear Antibody Health Ventolin C Positive Professional Becotide C Bronchospasm Other Cardiolipin Antibody Positive Dyspnoea Pyrexia Date:09/13/99ISR Number: 3346093-4Report Type:Expedited (15-DaCompany Report #LIT/99/00361/LEX Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Foreign Clozapine Obsessive-Compulsive Literature (Clozapine) PS ORAL 325 MG ORAL Disorder Health Psychiatric Symptom Professional Date:09/13/99ISR Number: 3346100-9Report Type:Expedited (15-DaCompany Report #LIT/99/00360/LEX Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Pain Foreign Clozapine Required Colitis Ischaemic Literature (Clozapine) PS 700 MG 3 YR Intervention to Diarrhoea Health Tropatepine C Prevent Permanent Shock Professional Impairment/Damage Vomiting Date:09/13/99ISR Number: 3346105-8Report Type:Expedited (15-DaCompany Report #USA/99/01643/LEX Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coma Health Clozaril (Clozapine) PS ORAL 800 MG, ORAL Hospitalization - Hyperglycaemia Professional Paxil C Initial or Prolonged Hypoventilation Colace C Required Kussmaul Respiration Intervention to Lethargy Prevent Permanent Impairment/Damage Date:09/13/99ISR Number: 3347058-9Report Type:Expedited (15-DaCompany Report #M034030 Age:33 YR Gender:Male I/FU:F Outcome PT Hospitalization - Abdominal Distension Initial or Prolonged Abdominal Pain 22-Feb-2006 08:30 AM Page: 422 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Abdominal Pain Upper Acidosis Drug Interaction Report Source Product Role Manufacturer Route Dose Duration Gastrointestinal Health Buspar Tabs Haemorrhage Professional (Buspirone Hcl) PS ORAL 20 MILLIGRAM, Haematemesis 1/1/ DAY ORAL Haematocrit Decreased Clozapine SS ORAL 600 Hyperglycaemia MILLIGRAM, Vomiting 1/1 DAY ORAL 1 YR Date:09/14/99ISR Number: 3346221-0Report Type:Direct Company Report # Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Clozapine (Clozaril) PS ORAL 750 MG ORAL Initial or Prolonged Neutropenia Benztropine C Divalproex C Paroxetine C Date:09/14/99ISR Number: 3346236-2Report Type:Direct Company Report # Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diarrhoea Clozapine (Clozaril) PS 1 MON Initial or Prolonged Eosinophil Count Valproic Acid C Increased Lisinopril C Pyrexia Furosemide C Date:09/14/99ISR Number: 3347315-6Report Type:Expedited (15-DaCompany Report #F/99/02155/LEX Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Foreign Leponex (Clozapine) PS ORAL 600MG ORAL 1 YR Initial or Prolonged Coombs Negative Health Lysanxia (Prazepam) C Haemolytic Anaemia Professional Akineton (Biperiden Hydrochloride) C Hept-A-Myl (Heptaminol Hydrochloride) C Theralene (Alimemazine Tartrate) C Date:09/14/99ISR Number: 3347316-8Report Type:Expedited (15-DaCompany Report #GB/99/00478/LEX Age:44 YR Gender:Female I/FU:F Outcome PT Death Anaemia Hospitalization - Aortic Thrombosis Initial or Prolonged Atrial Fibrillation Required Cardiolipin Antibody Intervention to Positive Prevent Permanent Coagulation Factor Impairment/Damage Increased Coagulation Time Shortened Deep Vein Thrombosis 22-Feb-2006 08:30 AM Page: 423 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dehydration Diabetes Mellitus Insulin-Dependent Report Source Product Role Manufacturer Route Dose Duration Embolism Foreign Clozaril (Clozapine) PS ORAL 700MG ORAL Gastroenteritis Health Haloperidol C Leg Amputation Professional Procyclodine C Lipid Metabolism Disorder Amiodarone C Mesenteric Occlusion Erythromycin C Nephrogenic Diabetes Lithium C Insipidus Peripheral Ischaemia Renal Failure Acute Sepsis Shock Thrombocytopenia Date:09/14/99ISR Number: 3347317-XReport Type:Expedited (15-DaCompany Report #RA/99/01733/LEX Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agranulocytosis Foreign Lapenax (Clozapine) PS ORAL 300MG ORAL Hospitalization - Anaemia Study Lorazepam C Initial or Prolonged Bacterial Infection Health Other Cardiac Arrest Professional Required Cellulitis Intervention to Hepatocellular Damage Prevent Permanent Hypovolaemia Impairment/Damage Leukopenia Lung Disorder Neutropenia Oliguria Pyrexia Sepsis Skin Infection Surgery Thrombocytopenia Date:09/15/99ISR Number: 3348262-6Report Type:Expedited (15-DaCompany Report #PRIUSA1999004463 Age:35 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Health Topamax (Tablet) Arrhythmia Professional (Topiramate) PS ORAL 25 MG, 1 IN 1 Atrial Septal Defect DAILY, ORAL Cardiac Disorder (SEE IMAGE) Cardiomegaly Clozaril (Clozapine) SS ORAL 400 MG, Confusional State NIGHT(S), Drug Level Above ORAL Therapeutic Prolixin C Risperdal C Prozac C Levothyroxine C Cytomel C Prilosec C Corgard C Fibercon C Ditropan C 22-Feb-2006 08:30 AM Page: 424 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/15/99ISR Number: 3348263-8Report Type:Expedited (15-DaCompany Report #PRIUSA1999004461 Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acidosis Health Topamax (Tablet) Hospitalization - Activated Partial Professional (Topiramate) PS ORAL 400 MG, 2 IN Initial or Prolonged Thromboplastin Time 1 DAILY, ORAL Shortened Clozaril (Clozapine) SS ORAL 500 MG, 1 IN Apathy 1 DAILY, ORAL Coma Celexa C Convulsion Risperdal C Disorientation Depakote C Disseminated Proscar C Intravascular Coagulation Colace C Fatigue Heart Rate Increased Hyperpyrexia Hypotension Leukopenia Oxygen Saturation Decreased Pharyngolaryngeal Pain Pneumonia Aspiration Respiratory Depression Restlessness Sepsis Tachycardia Thrombocytopenia Date:09/15/99ISR Number: 3348337-1Report Type:Expedited (15-DaCompany Report #GB/99/00428/LEX Age:25 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Pain Foreign Clozaril (Clozapine) PS ORAL 225 MG, ONCE Circulatory Collapse Health A DAY, ORAL; Constipation Professional Dothiepin C Deep Vein Thrombosis Other Mebeverine C Drug Level Above Fybogel C Therapeutic Epilim C Embolism Orphenadrine C Sudden Death Chlorpromazine C Date:09/17/99ISR Number: 3349433-5Report Type:Expedited (15-DaCompany Report #99-08-0283 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zinith Goldline Pharm. ORAL 175MG ORAL Date:09/17/99ISR Number: 3349434-7Report Type:Expedited (15-DaCompany Report #99-08-0284 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death White Blood Cell Count Health Clozapine - Zenith Increased Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 600MG ORAL 22-Feb-2006 08:30 AM Page: 425 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Depakote C Benadryl C Ativan C Zestril C Cogentin C Date:09/17/99ISR Number: 3349436-0Report Type:Expedited (15-DaCompany Report #99-08-0285 Age:77 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death White Blood Cell Count Health Clozapine - Zenith Increased Professional Goldline Pharm. Tablets PS ORAL ORAL Date:09/17/99ISR Number: 3350095-1Report Type:Direct Company Report # Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Clozapine PS 650 MG /DAY Neutrophil Count Risperidone SS 5MG/ DAY Decreased Lithium C White Blood Cell Count Benztropine C Decreased Date:09/20/99ISR Number: 3350759-XReport Type:Direct Company Report # Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neutrophil Count Health Clozaril 100mg Decreased Professional Novartis PS Novartis ORAL 200MG PO BID 57 DAY Fluphenazine C Paroxetine C Benztropine C Date:09/20/99ISR Number: 3351792-4Report Type:Expedited (15-DaCompany Report #D/97/00328/LEX Age:24 MON Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Benign Congenital Foreign Leponex PS ORAL IN UTERO;, Initial or Prolonged Hypotonia Health 125 MG, ORAL Complications Of Maternal Professional Exposure To Therapeutic Drugs Somnolence Neonatal Date:09/20/99ISR Number: 3351795-XReport Type:Expedited (15-DaCompany Report #D/97/01116/LEX Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abortion Induced Foreign Leponex PS ORAL 100 MG,ORAL;, Initial or Prolonged Health 500 MG, ORAL Professional 22-Feb-2006 08:30 AM Page: 426 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/20/99ISR Number: 3351825-5Report Type:Expedited (15-DaCompany Report #F/97/01132/LEX Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Foreign Leponex PS ORAL 400 MG, ONCE Diarrhoea Health A DAY, ORAL Sudden Death Professional Vomiting Other Date:09/20/99ISR Number: 3351829-2Report Type:Expedited (15-DaCompany Report #AUS/97/00057/LEX Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dehydration Foreign Clozaril PS ORAL 100 MG, TWICE Initial or Prolonged Diabetes Mellitus Health A DAY, ORAL Required Diabetic Ketoacidosis Professional Omeprazole C Intervention to Haematemesis Prevent Permanent Hyperglycaemia Impairment/Damage Date:09/20/99ISR Number: 3351835-8Report Type:Expedited (15-DaCompany Report #S/97/00025/LEX Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Leponex PS ORAL SEE IMAGE Other Overdose Health Haldol SS Sudden Death Professional Suicide Attempt Other Date:09/20/99ISR Number: 3351840-1Report Type:Expedited (15-DaCompany Report #F/97/00036/LEX Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Tamponade Foreign Leponex PS ORAL 600 MG, Myocardial Infarction Health UNKNOWN, ORAL Professional Date:09/20/99ISR Number: 3351846-2Report Type:Expedited (15-DaCompany Report #F/97/01698/LEX Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Respiratory Foreign Leponex PS ORAL 450 MG, Required Distress Syndrome Health UNKNOWN, ORAL Intervention to Hypoxia Professional Xanax C Prevent Permanent Immunodeficiency Rohypnol C Impairment/Damage Pneumonia Pneumococcal Stomedine C Pulmonary Fibrosis Sepsis Date:09/20/99ISR Number: 3351861-9Report Type:Expedited (15-DaCompany Report #GB/97/01177/LEX Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Foreign Clozaril PS ORAL 400 MG, ONCE Health A DAY, ORAL Professional 22-Feb-2006 08:30 AM Page: 427 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/20/99ISR Number: 3351866-8Report Type:Expedited (15-DaCompany Report #HK/97/00196/LEX Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agranulocytosis Foreign Clozaril PS ORAL SEE IMAGE Required Pseudomonas Infection Health Intervention to Pyrexia Professional Prevent Permanent Sepsis Impairment/Damage White Blood Cell Count Decreased Date:09/20/99ISR Number: 3351868-1Report Type:Expedited (15-DaCompany Report #USA/97/01989/LEX Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alcoholism Health Clozaril (Clozapine) PS ORAL 800 MG, Initial or Prolonged Cardiac Failure Professional OTHER, ORAL Congestive Alcohol C Drug Abuser Date:09/20/99ISR Number: 3351884-XReport Type:Expedited (15-DaCompany Report #D/97/03283/MEL Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aortic Valve Stenosis Foreign Melleretten PS ORAL 10 MG, TWICE Initial or Prolonged Gangrene Health A DAY ORAL Other Leukocytoclastic Professional Leponex SS ORAL 25 MG, ORAL Required Vasculitis Quilonum Retard SS ORAL 450 MG, THREE Intervention to Polyarteritis Nodosa TIMES A DAY, Prevent Permanent Rash Macular ORAL Impairment/Damage Vasculitis Dociton SS ORAL 40 MG, THREE Vasculitis Necrotising TIMES A DAY, ORAL Date:09/20/99ISR Number: 3352021-8Report Type:Expedited (15-DaCompany Report #DK/97/00089/LEX Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Level Below Foreign Leponex PS ORAL 700 MG ORAL Initial or Prolonged Therapeutic Health Trileptal C Required Professional Intervention to Other Prevent Permanent Impairment/Damage Date:09/20/99ISR Number: 3352025-5Report Type:Expedited (15-DaCompany Report #I/97/00053/LEX Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bacterial Infection Foreign Leponex PS ORAL 400 MG ORAL Hospitalization - Cyanosis Health Initial or Prolonged Dyspnoea Professional Required Leukopenia Intervention to Neutropenia Prevent Permanent Pyrexia Impairment/Damage Sepsis 22-Feb-2006 08:30 AM Page: 428 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/20/99ISR Number: 3352028-0Report Type:Expedited (15-DaCompany Report #F/97/00867/LEX Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Polycythaemia Foreign Leponex PS ORAL 600 MG ORAL Initial or Prolonged Health Required Professional Intervention to Other Prevent Permanent Impairment/Damage Date:09/20/99ISR Number: 3352031-0Report Type:Expedited (15-DaCompany Report #CDN/97/00044/LEX Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Arrest Foreign Clozaril PS ORAL 300 MG ORAL Initial or Prolonged Cardiomyopathy Health Kemadrin C Required Peripheral Ischaemia Professional Rivotril C Intervention to Pulmonary Oedema Restoril C Prevent Permanent Tachycardia Depakene C Impairment/Damage Date:09/20/99ISR Number: 3352047-4Report Type:Expedited (15-DaCompany Report #D/97/01603/LEX Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Non-Hodgkin'S Lymphoma Foreign Leponex PS ORAL 300 MG, ORAL Initial or Prolonged Health Fluanxol Depot C Other Professional Promethazine C Required Chloradurat C Intervention to Prevent Permanent Impairment/Damage Date:09/20/99ISR Number: 3352051-6Report Type:Expedited (15-DaCompany Report #D/97/01631/LEX Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agranulocytosis Foreign Leponex PS ORAL 300 MG, ORAL Life-Threatening Anaemia Health Diazepam C Hospitalization - Blood Disorder Professional Buteridol C Initial or Prolonged Escherichia Sepsis Required Haemoglobin Decreased Intervention to Leukopenia Prevent Permanent Pyrexia Impairment/Damage Red Blood Cell Sedimentation Rate Increased Sepsis Date:09/20/99ISR Number: 3352053-XReport Type:Expedited (15-DaCompany Report #D/97/01857/LEX Age:58 YR Gender:Male I/FU:I Outcome Life-Threatening Hospitalization - Initial or Prolonged Other 22-Feb-2006 08:30 AM Page: 429 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Required Intervention to Prevent Permanent PT Report Source Product Role Manufacturer Route Dose Duration Impairment/Damage Rectal Cancer Foreign Leponex PS ORAL 125 MG, ORAL Health Lyogen C Professional Isoptin C Marcumar C Date:09/20/99ISR Number: 3352055-3Report Type:Expedited (15-DaCompany Report #D/99/01193/LEX Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Haematoma Foreign Leponex (Clozapine) PS ORAL 100 MG, ORAL; Idiopathic Health Stilnox (Zolpidem) C Thrombocytopenic Purpura Professional Petechiae Thrombocytopenia Thrombotic Thrombocytopenic Purpura Date:09/20/99ISR Number: 3352058-9Report Type:Expedited (15-DaCompany Report #D/97/02029/LEX Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiomyopathy Foreign Leponex PS ORAL 200 MG, ORAL 7 YR Initial or Prolonged Electrocardiogram Health Abnormal Professional Date:09/20/99ISR Number: 3352061-9Report Type:Expedited (15-DaCompany Report #GB/99/00778/LEX Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Foreign Clozaril (Clozapine) PS ORAL 400 MG, ORAL; Initial or Prolonged Health Professional Date:09/20/99ISR Number: 3352186-8Report Type:Expedited (15-DaCompany Report #USA/99/02214/LEX Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Health Clozaril (Clozapine) PS 1 WK Initial or Prolonged Phosphokinase Increased Professional Seroquel C Required Chest Pain Intervention to Electrocardiogram Prevent Permanent Abnormal Impairment/Damage Myocardial Infarction Date:09/20/99ISR Number: 3352516-7Report Type:Expedited (15-DaCompany Report #NL/97/00026/LEX Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Caesarean Section Foreign Leponex PS ORAL 225 MG, Eclampsia Health UNKNOWN; ORAL Premature Labour Professional 400 MG, UNKNOWN, ORAL Temesta C 22-Feb-2006 08:30 AM Page: 430 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/21/99ISR Number: 3352940-2Report Type:Direct Company Report # Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutropenia Clozapine PS ORAL 500MG PO QD Initial or Prolonged Divalfrex C Pesphtnazne C Date:09/22/99ISR Number: 3352778-6Report Type:Expedited (15-DaCompany Report #99-07-0223 Age:68 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death White Blood Cell Count Health Clozapine Tablets - Increased Professional Zenith Goldline Pharm. PS Zenith Goldline Pharm. ORAL 150MG/DAY ORAL 12 MON Date:09/22/99ISR Number: 3352786-5Report Type:Expedited (15-DaCompany Report #99-08-0233 Age:29 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Clozapine Capsules - Overdose Professional Zenith Goldline Pharm. PS Zenith Goldline Pharm. ORAL 300-750MG/DAY ORAL Zyprexa C Date:09/22/99ISR Number: 3352791-9Report Type:Expedited (15-DaCompany Report #99-08-0265 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death White Blood Cell Count Health Clozapine Tablets - Increased Professional Zenith Goldline Pharm. PS Zenith Goldline Pharm. ORAL ORAL 1 DAY Date:09/22/99ISR Number: 3352796-8Report Type:Expedited (15-DaCompany Report #99-08-0266 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Heat Stroke Health Clozapine Tablets - Professional Zenith Goldline Pharm. PS Zenith Goldline Pharm. ORAL 125-200MG ORAL 1 YR Date:09/22/99ISR Number: 3352801-9Report Type:Expedited (15-DaCompany Report #99-08-0272 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bladder Cancer Health Clozapine Tablets - Initial or Prolonged Leukocytosis Professional Zenith Goldline Metastases To Central Pharm. PS Zenith Goldline Nervous System Pharm. ORAL 600MG ORAL 12 MON 22-Feb-2006 08:30 AM Page: 431 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/22/99ISR Number: 3352888-3Report Type:Expedited (15-DaCompany Report #99-08-0275 Age:86 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets - Professional Zenith Goldline Pharm. PS Zenith Goldline Pharm. ORAL 12.5MG ORAL 3 MON Date:09/22/99ISR Number: 3352894-9Report Type:Expedited (15-DaCompany Report #99-09-0299 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets - Professional Zenith Goldline Pharm. PS Zenith Goldline Pharm. ORAL 175-700MG ORAL Date:09/22/99ISR Number: 3352897-4Report Type:Expedited (15-DaCompany Report #99-08-0286 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets - Professional Zenith Goldline Pharm. PS Zenith Goldline Pharm. ORAL 400-600MG ORAL Date:09/22/99ISR Number: 3352901-3Report Type:Expedited (15-DaCompany Report #99-08-0287 Age:85 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets - Professional Zenith Goldline Pharm. PS Zenith Goldline Pharm. ORAL 50-300MG ORAL 5 MON Date:09/22/99ISR Number: 3352906-2Report Type:Expedited (15-DaCompany Report #99-09-0297 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Decubitus Ulcer Health Clozapine Tablets - Initial or Prolonged Impaired Healing Professional Zenith Goldline White Blood Cell Count Pharm. PS Zenith Goldline Increased Pharm. ORAL 400MG ORAL 13 MON Date:09/22/99ISR Number: 3352908-6Report Type:Expedited (15-DaCompany Report #99-09-0298 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ulcer Haemorrhage Health Clozapine Tablets - Initial or Prolonged Professional Zenith Goldline Required Pharm. PS Zenith Goldline Intervention to Pharm. ORAL 150-200MG Prevent Permanent ORAL Impairment/Damage Micro-K C 22-Feb-2006 08:30 AM Page: 432 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Furosemide C Hyzaar C Date:09/22/99ISR Number: 3354595-XReport Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Pharyngolaryngeal Pain Health Clozaril PS ORAL 350 MG ORALLY Intervention to Urinary Tract Infection Professional DAILY 10 WK Prevent Permanent White Blood Cell Count Impairment/Damage Decreased Date:09/22/99ISR Number: 3354953-3Report Type:Expedited (15-DaCompany Report #AUS/99/01272/LEX Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Foreign Clozaril (Clozapine) PS ORAL 450 MG, ORAL Initial or Prolonged Convulsion Health Epilim C Haemorrhagic Stroke Professional Hemiparesis Irritability Date:09/22/99ISR Number: 3354956-9Report Type:Expedited (15-DaCompany Report #GB/99/00738/LEX Age:74 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Clozaril (Clozapine) PS ORAL 100 MG, ONCE Required Cardiac Failure Health A DAY, ORAL Intervention to Cardio-Respiratory Arrest Professional Aspirine C Prevent Permanent Pulmonary Fibrosis Cloral Betaine C Impairment/Damage Pulmonary Oedema Dothiepin C Respiratory Depression Aminophylline C Respiratory Disorder Oxybutynin C Ventricular Tachycardia Date:09/22/99ISR Number: 3354959-4Report Type:Expedited (15-DaCompany Report #USA/99/00442/LEX Age:44 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Leukaemia Health Clozaril (Clozapine) PS ORAL 350 MG, ORAL White Blood Cell Count Professional Tylenol #3 C Increased Date:09/22/99ISR Number: 3355019-9Report Type:Expedited (15-DaCompany Report #IRL/99/00809/LEX Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril (Clozapine) PS ORAL 350 MG, ORAL Required Health Intervention to Professional Prevent Permanent Impairment/Damage 22-Feb-2006 08:30 AM Page: 433 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/22/99ISR Number: 3355032-1Report Type:Expedited (15-DaCompany Report #F/99/02206/LEX Age:67 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Kidney Infection Foreign Leponex (Clozapine) PS ORAL ORAL Consumer Date:09/22/99ISR Number: 3355085-0Report Type:Expedited (15-DaCompany Report #JACGER1999000529 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dizziness Foreign Risperdal Hospitalization - Fall Health (Unspecified Tablet) Initial or Prolonged Lethargy Professional (Risperidone) PS ORAL SEE IMAGE Required Mental Retardation Leponex (Clozapine) SS SEE IMAGE Intervention to Severity Unspecified Aponal (Doxepin Prevent Permanent Radius Fracture Hydrochloride) SS SEE IMAGE Impairment/Damage Sedation Fevarin (Fluvoxamine Maleate) SS ORAL DAILY, ORAL Ass C Xanef C Date:09/23/99ISR Number: 3355959-0Report Type:Expedited (15-DaCompany Report #LIT/96/00206/LEX Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Foreign Leponex PS SEE IMAGE Initial or Prolonged Confusional State Literature Carbamazepine C Required Depressed Level Of Health Haloperidol C Intervention to Consciousness Professional Perphenazine C Prevent Permanent Disorientation Lithium Carbonate C Impairment/Damage Drug Level Below Valproic Acid C Therapeutic Encephalopathy Hypokinesia Illusion Mania Psychomotor Retardation Sedation Stupor Thinking Abnormal Date:09/23/99ISR Number: 3355990-5Report Type:Expedited (15-DaCompany Report #CDN/96/00005/LEX Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Basal Ganglion Foreign Clozaril PS ORAL XX Degeneration Health Insulin - Diabetes Professional Mellitus C Pergolide - Striatonigral Degeneration C Amantadine - Striatonigral Degeneration C Trihexyphenidyl - Unspecified C 22-Feb-2006 08:30 AM Page: 434 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/23/99ISR Number: 3355996-6Report Type:Expedited (15-DaCompany Report #D/96/03143/LEX Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Foreign Leponex PS 150 MG Initial or Prolonged Hypoglycaemia Health Required Pancreatic Disorder Professional Intervention to Prevent Permanent Impairment/Damage Date:09/23/99ISR Number: 3355999-1Report Type:Expedited (15-DaCompany Report #D/96/01428/LEX Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Foreign Leponex PS ORAL 400 MG ORAL; Initial or Prolonged Health 700 MG ORAL Required Professional Dogmatil C Intervention to Sostril C Prevent Permanent Impairment/Damage Date:09/23/99ISR Number: 3356001-8Report Type:Expedited (15-DaCompany Report #GB/96/01193/LEX Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abscess Foreign Clozaril PS ORAL 650, MG ORAL; Initial or Prolonged Diabetes Mellitus Health 700 MG ORAL Required Professional Propranolol C Intervention to Other Lorazepam C Prevent Permanent Impairment/Damage Date:09/23/99ISR Number: 3356003-1Report Type:Expedited (15-DaCompany Report #SF/96/00090/LEX Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Leukocytosis Foreign Leponex PS Lymphoma Health Levozin C Professional Diurex C Date:09/23/99ISR Number: 3356006-7Report Type:Expedited (15-DaCompany Report #I/96/00062/LEX Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hepatocellular Damage Foreign Leponex PS ORAL 150 MG, TWICE Leukocytosis Health A DAY, ORAL Megacolon Professional Depakin SS ORAL 1 G, TWICE A Thrombocythaemia DAY, ORAL Urobilinuria Carbolithium C Prozin C Rilaten C 22-Feb-2006 08:30 AM Page: 435 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/23/99ISR Number: 3356021-3Report Type:Expedited (15-DaCompany Report #GB/96/00373/LEX Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Clozaril PS ORAL 25 MG, ORAL; Drug Ineffective Health 400 MG ORAL Professional Date:09/23/99ISR Number: 3356027-4Report Type:Expedited (15-DaCompany Report #AUS/96/00080/LEX Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cellulitis Foreign Clozaril (Clozapine) PS ORAL 25 MG, ORAL; Required Renal Failure Acute Health 300 MG ORAL Intervention to Sleep Apnoea Syndrome Professional Prevent Permanent Impairment/Damage Date:09/23/99ISR Number: 3356032-8Report Type:Expedited (15-DaCompany Report #D/96/02814/LEX Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diarrhoea Foreign Leponex PS ORAL 600 MG, ORAL Eosinophilia Health Timonil Retard SS ORAL 300 MG, ORAL Fungal Infection Professional Decentan SS Leukocytoclastic Haldol SS Vasculitis Leukocytosis Multi-Organ Failure Pneumonia Pyrexia Rash Erythematous Sepsis Date:09/23/99ISR Number: 3356752-5Report Type:Expedited (15-DaCompany Report #8-99247-014A Age:66 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - C-Reactive Protein Foreign Trevilor Retard Initial or Prolonged Increased Study (Venlafaxine Extrapyramidal Disorder Hydrochloride) PS ORAL 300 MG ONCE Red Blood Cell DAILY ORAL Sedimentation Rate Leponex (Clozapine) SS ORAL 200 MG DAILY Increased ORAL Orfiril (Valproate Sodium) C Gastrozepine (Pirenzepine) C Date:09/23/99ISR Number: 3356797-5Report Type:Expedited (15-DaCompany Report #CDN/96/00091/LEX Age:36 YR Gender:Male I/FU:I Outcome Hospitalization - Initial or Prolonged Required Intervention to Prevent Permanent 22-Feb-2006 08:30 AM Page: 436 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Adhesions Foreign Clozaril PS ORAL 750 MG, ONCE Abdominal Distension Health A DAY, ORAL Crepitations Professional Lorazepam C Diabetes Mellitus Cogentin C Diabetic Ketoacidosis Dyspnoea Hernia Hyperglycaemia Hyperkalaemia Intestinal Obstruction Neutrophilia Pleuritic Pain Pneumonia Pneumonia Aspiration Pneumonitis White Blood Cell Disorder Date:09/23/99ISR Number: 3356799-9Report Type:Expedited (15-DaCompany Report #CDN/96/00281/LEX Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Clozaril PS 300 MG Drug Ineffective Professional Clonazepam C Date:09/24/99ISR Number: 3356798-7Report Type:Direct Company Report # Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Health Clozaril 25mg Bid PS ORAL 25MG BID PO 4 DAY Confusional State Professional Gait Disturbance Pulmonary Oedema Date:09/24/99ISR Number: 3357492-9Report Type:Expedited (15-DaCompany Report #GB/99/00778/LEX Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Lactate Foreign Clozaril (Clozapine) PS ORAL 400 MG, Initial or Prolonged Dehydrogenase Increased Health UNKNOWN,ORAL Diabetes Mellitus Professional Fluoxetine C Gamma-Glutamyltransferase Increased Date:09/24/99ISR Number: 3357495-4Report Type:Expedited (15-DaCompany Report #F/99/02219/LEX Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatitis Foreign Leponex (Clozapine) PS Initial or Prolonged Health Required Professional Intervention to Prevent Permanent Impairment/Damage 22-Feb-2006 08:30 AM Page: 437 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/24/99ISR Number: 3357496-6Report Type:Expedited (15-DaCompany Report #USA/99/01947/LEX Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bronchospasm Health Clozaril (Clozapine) PS 12.5 MG Required Cardiac Failure Professional Dexedrine C Intervention to Cardiac Failure Synthroid C Prevent Permanent Congestive Inderal La C Impairment/Damage Cardiomegaly Asa C Dizziness Melatonin C Dyspnoea Exertional Fatigue Pallor Date:09/24/99ISR Number: 3357554-6Report Type:Expedited (15-DaCompany Report #JAGER43823 Age:57 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dizziness Foreign Risperdal (Tablet) Hospitalization - Fall Health (Risperidone) PS ORAL MG, DAILY, Initial or Prolonged Lethargy Professional ORAL Required Memory Impairment Leponex (Clozapine) SS MG, DAILY Intervention to Radius Fracture Aponal (Doxepin Prevent Permanent Sedation Hydrochloride) SS MG, DAILY Impairment/Damage Fevarin (Fluvoxamine Maleate) SS Ass C Xanef C Date:09/24/99ISR Number: 3357785-5Report Type:Expedited (15-DaCompany Report #AUS/99/01272/LEX Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebral Artery Embolism Foreign Clozaril (Clozapine) PS ORAL 450 MG, ORAL Initial or Prolonged Cerebrovascular Accident Health Epilim C Required Coma Professional Prozac C Intervention to Convulsion Prevent Permanent Hemiparesis Impairment/Damage Irritability Loss Of Consciousness Date:09/24/99ISR Number: 3357832-0Report Type:Expedited (15-DaCompany Report #USA/99/01698/LEX Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Renal Cell Carcinoma Health Clozaril (Clozapine) PS 500 MG Disability Stage Unspecified Professional Required Intervention to Prevent Permanent Impairment/Damage Date:09/27/99ISR Number: 3358236-7Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome Required Intervention to 22-Feb-2006 08:30 AM Page: 438 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Health Clozaril PS ORAL 350MG ORALLY Pharyngolaryngeal Pain Professional DAILY 2 MON Upper Respiratory Tract Infection Date:09/27/99ISR Number: 3358517-7Report Type:Direct Company Report # Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neutropenia Health Clozapine Hospitalization - White Blood Cell Count Professional 162.5mg/D-Novartis PS Novaritis 1621/2 MG/D Initial or Prolonged Decreased 121/2 MG AM Required 150 MG HS 9 DAY Intervention to Prevent Permanent Impairment/Damage Date:09/27/99ISR Number: 3359215-6Report Type:Expedited (15-DaCompany Report #USA/99/00876/LEX Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Health Clozaril (Clozapine) PS ORAL 400 MG, Arrhythmia Professional UNKNOWN, ORAL Atrial Septal Defect Topamax (Topiramate) SS ORAL 25 MG, Cardiac Disorder UNKNOWN, ORAL Cardiomegaly Prolixin C Confusional State Risperdal C Drug Level Above Prozac C Therapeutic Levothyroxine C Cytomel C Prilosec C Corgard C Fibercon C Ditropan C Date:09/27/99ISR Number: 3360017-5Report Type:Expedited (15-DaCompany Report #GB/99/00428/LEX Age:25 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Pain Foreign Clozaril (Clozapine) PS ORAL 225 MG, ONCE Required Circulatory Collapse Health A DAY, ORAL Intervention to Constipation Professional Epilim (Valproate Prevent Permanent Deep Vein Thrombosis Other Sodium) C Impairment/Damage Drug Interaction Orphenadrine Drug Level Above (Orphenadrine) C Therapeutic Chlorpromazine Drug Toxicity (Chlorpromazine) C Embolism Dothiepin Sudden Death (Dosulepin) C Mebeverine (Mebeverine) C Fybogel (Ispaghula) C 22-Feb-2006 08:30 AM Page: 439 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/27/99ISR Number: 3360018-7Report Type:Expedited (15-DaCompany Report #USA/99/02123/LEX Age:57 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Breast Cancer Female Consumer Clozaril (Clozapine) PS ORAL 500 MG, ORAL Required Leukopenia Intervention to Neutropenia Prevent Permanent Impairment/Damage Date:09/27/99ISR Number: 3360020-5Report Type:Expedited (15-DaCompany Report #USA/99/01249/LEX Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Confusional State Health Clozaril (Clozapine) PS ORAL 900 MG, ORAL Life-Threatening Convulsion Professional Navane C Hospitalization - Disorientation Sulfacetamide C Initial or Prolonged Drug Toxicity Required Joint Stiffness Intervention to Muscle Twitching Prevent Permanent Tachycardia Impairment/Damage Date:09/27/99ISR Number: 3360022-9Report Type:Expedited (15-DaCompany Report #USA/99/02326/LEX Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coma Consumer Clozaril (Clozapine) PS ORAL 500 MG, ORAL Hospitalization - Confusional State Health Topamax (Topiramate) SS 400 MG Initial or Prolonged Convulsion Professional Citalopram Required Cough Hydrobromide C Intervention to Disorientation Risperdal Prevent Permanent Encephalopathy (Risperidone) C Impairment/Damage Fatigue Depakote (Valproate Hyperpyrexia Semisodium) C Hypotension Proscar Hypoxia (Finasteride) C Leukopenia Colace (Docusate Lung Infiltration Sodium) C Pharyngitis Pneumonia Aspiration Prothrombin Time Prolonged Sinusitis Tachycardia Thrombocytopenia Weight Decreased Weight Increased Date:09/27/99ISR Number: 3360023-0Report Type:Expedited (15-DaCompany Report #USA/99/00877/LEX Age:42 YR Gender:Female I/FU:I Outcome PT Death Agitation Atelectasis Bronchitis Confusional State Coronary Artery Disease Myocarditis 22-Feb-2006 08:30 AM Page: 440 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Obesity Pneumonia Ventricular Hypertrophy Report Source Product Role Manufacturer Route Dose Duration Health Clozaril (Clozapine) PS ORAL 450 MG, ORAL Professional Topamax (Topiramate) SS ORAL 25 MG, ORAL Mevacor (Lovastatin) C Anafranil (Clomipramine Hydrochloride) C Ibuprofen C Hctz (Hydrochlorothiazide ) C Depakote (Valproate Semisodium) C Date:09/27/99ISR Number: 3360035-7Report Type:Expedited (15-DaCompany Report #USA/99/02330/LEX Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Consumer Clozaril (Clozapine) PS Health Professional Date:09/28/99ISR Number: 3359667-1Report Type:Expedited (15-DaCompany Report #8-99196-082A Age:66 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depressed Level Of Health Cordarone Tablet PS ORAL 400 MG 1 X Initial or Prolonged Consciousness Professional PER 1 DAY, Lethargy ORAL Liver Function Test Clozapine SS ORAL 525 MG TO 650 Abnormal MG DAILY, Pneumonia ORAL Stupor Clozapine C Zoloft C Zebeta C Beclovent C Coumadin C Clozaril C Synthroid C Peri-Colace C Lasix C Cozaar C Tylenol C Date:09/28/99ISR Number: 3360205-8Report Type:Expedited (15-DaCompany Report #99-09-0307 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine - Zenith Professional Goldline Pharm PS Zenith Goldline Pharm. ORAL 200 MG ORAL 22-Feb-2006 08:30 AM Page: 441 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/28/99ISR Number: 3360209-5Report Type:Expedited (15-DaCompany Report #99-09-0303 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Fall Health Clozapine Tablets Lung Adenocarcinoma Professional -Zenith Goldline Metastases To Central Pharm PS Zenith Goldline Nervous System Pharm. ORAL 200-300 MG ORAL 2 MON Date:09/28/99ISR Number: 3360221-6Report Type:Expedited (15-DaCompany Report #99-09-0304 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coma Health Clozapine Tablets Other Professional -Zenith Goldline Pharm PS Zenith Goldline Pharm. ORAL 200-225 MG ORAL Date:09/28/99ISR Number: 3360231-9Report Type:Expedited (15-DaCompany Report #99-06-0188 Age:84 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets- Professional Zenith Goldline Pharm PS Zenith Goldline Pharm. ORAL 12.5 MG ORAL 1 DAY Date:09/28/99ISR Number: 3360234-4Report Type:Expedited (15-DaCompany Report #99-09-0305 Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets- Professional Zenith Goldline Pharm PS Zenith Goldline Pharm ORAL 650 MG ORAL Date:09/28/99ISR Number: 3360332-5Report Type:Expedited (15-DaCompany Report #99-08-0247 Age:77 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death White Blood Cell Count Health Clozapine Tablets Increased Professional -Zenith Goldline Pharm. PS Zenith Goldline Pharm. ORAL 75-100 MG ORAL 4 MON Date:09/29/99ISR Number: 3360745-1Report Type:Expedited (15-DaCompany Report #GB/99/00746/LEX Age:25 YR Gender:Female I/FU:I Outcome PT Life-Threatening Encephalopathy Required Hepatic Function Abnormal Intervention to Hepatocellular Damage Prevent Permanent Hyperbilirubinaemia Impairment/Damage Jaundice 22-Feb-2006 08:30 AM Page: 442 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Liver Function Test Abnormal Vomiting Report Source Product Role Manufacturer Route Dose Duration Foreign Clozaril (Clozapine) PS 300 MG Health Professional Date:09/29/99ISR Number: 3360746-3Report Type:Expedited (15-DaCompany Report #USA/99/02364/LEX Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Cancer Female Health Clozaril (Clozapine) PS ORAL 100 MG ORAL Required Malignant Breast Lump Professional Haldol C Intervention to Removal Depakote C Prevent Permanent Lithium C Impairment/Damage Date:09/30/99ISR Number: 3360729-3Report Type:Expedited (15-DaCompany Report #99-09-0310 Age:81 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 6.2 - 18.7/MG Date:09/30/99ISR Number: 3360731-1Report Type:Expedited (15-DaCompany Report #99-09-0309 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. 400MG Date:09/30/99ISR Number: 3360733-5Report Type:Expedited (15-DaCompany Report #99-08-0251 Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Road Traffic Accident Health Clozapine - Zenith Initial or Prolonged Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 550MG Depakote C Date:09/30/99ISR Number: 3366461-4Report Type:Expedited (15-DaCompany Report #1999-08-0245 Age:37 YR Gender:Male I/FU:I Outcome PT Life-Threatening Aphasia Hospitalization - Asthenia Initial or Prolonged Drug Interaction Other Fatigue Malaise Pallor Pyrexia 22-Feb-2006 08:30 AM Page: 443 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report White Blood Cell Count Decreased Report Source Product Role Manufacturer Route Dose Duration Health Intron A (Interferon Professional Alfa-2b Recombinant) Injectable PS Clozapine Tablets SS ORAL 500 MG QD ORAL Lithium Carbonate C Thorazine C Date:10/01/99ISR Number: 3362779-XReport Type:Expedited (15-DaCompany Report #USA/99/01598/LEX Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asthenia Health Clozaril (Clozapine) PS ORAL 300 MG, Life-Threatening Heat Exhaustion Professional TWICE A DAY; ORAL Lithium C Zantac (Ranitidine Hydrochloride) C Anaprox (Naproxen Sodium) C Tylenol (Paracetamol) C Date:10/01/99ISR Number: 3362781-8Report Type:Expedited (15-DaCompany Report #USA/99/02366/LEX Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Cancer Female Health Clozaril (Clozapine) PS ORAL ORAL Professional Date:10/01/99ISR Number: 3362855-1Report Type:Expedited (15-DaCompany Report #GB/99/00837/LEX Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Foreign Clozaril (Clozapine) PS 600 MG Initial or Prolonged Health Professional Date:10/01/99ISR Number: 3362972-6Report Type:Expedited (15-DaCompany Report #USA/99/02373/LEX Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukocytosis Health Clozaril (Clozapine) PS 800 MG Lung Neoplasm Malignant Professional Date:10/01/99ISR Number: 3363036-8Report Type:Expedited (15-DaCompany Report #GB/99/00581/LEX Age:57 YR Gender:Male I/FU:F Outcome Death Required Intervention to Prevent Permanent 22-Feb-2006 08:30 AM Page: 444 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Pain Foreign Clozaril (Clozapine) PS ORAL 25 MG, ONCE A Anaemia Health DAY ORAL;, Cardiac Arrest Professional 300 MG, ONCE Constipation A DAY, ORAL Duodenal Ulcer Haemorrhage Gastrointestinal Haemorrhage Haemoglobin Decreased Medication Error Oesophagitis Peptic Ulcer Schizophrenia Date:10/01/99ISR Number: 3363039-3Report Type:Expedited (15-DaCompany Report #USA/99/02019/LEX Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coma Health Clozaril (Clozapine) PS ORAL 475 MG, ONCE Life-Threatening Loss Of Consciousness Professional A DAY, ORAL; Hospitalization - Celexa (Citalopram Initial or Prolonged Hydrobromide) C Date:10/01/99ISR Number: 3363125-8Report Type:Expedited (15-DaCompany Report #F/99/02221/LEX Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Foreign Leponex (Clozapine) PS ORAL 300 MG, ORAL 2 YR Initial or Prolonged Coma Health Imovane (Zopiclone) SS Required Loss Of Consciousness Professional Athymil (Mianserin Intervention to Hydrochloride) SS Prevent Permanent Equanil Impairment/Damage (Meprobamate) SS Date:10/04/99ISR Number: 3362359-6Report Type:Direct Company Report # Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Anion Gap Increased Clozaril (Clozapine) PS ORAL 150MG QAM Coordination Abnormal 200MG QHS Diabetic Ketoacidosis BOTH PO Electrolyte Imbalance (STARTED ON Lethargy 8/24/99 WITH Polydipsia Risperidol C Polyuria Depakore C Atenolol C Clonidine Patch C Date:10/04/99ISR Number: 3363472-XReport Type:Expedited (15-DaCompany Report #USA/99/02392/LEX Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Multiple Myeloma Health Clozaril (Clozapine) PS ORAL 200 MG, TWICE Professional A DAY, ORAL; 22-Feb-2006 08:30 AM Page: 445 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Paxil (Paroxetine Hydrochloride) C Date:10/04/99ISR Number: 3363474-3Report Type:Expedited (15-DaCompany Report #USA/99/02389/LEX Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Brain Neoplasm Malignant Health Clozaril (Clozapine) PS ORAL 350 MG, ORAL Required Leukocytosis Professional Intervention to Lung Neoplasm Malignant Prevent Permanent Impairment/Damage Date:10/04/99ISR Number: 3363476-7Report Type:Expedited (15-DaCompany Report #USA/99/01672/LEX Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Clozaril (Clozapine) PS ORAL 400 MG, ORAL Hospitalization - Professional Initial or Prolonged Other Date:10/04/99ISR Number: 3363478-0Report Type:Expedited (15-DaCompany Report #AUS/99/01326/LEX Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Condition Aggravated Foreign Clozaril (Clozapine) PS ORAL 100 MG, Required Fluid Retention Study UNNKWON, Intervention to Oedema Peripheral Health Prevent Permanent Pneumonia Professional Impairment/Damage Upper Respiratory Tract Infection Date:10/04/99ISR Number: 3363481-0Report Type:Expedited (15-DaCompany Report #AUS/ 99 / 01325 / LEX Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Foreign Clozaril (Clozapine) PS ORAL 25 MG, ONCE Required Haemoglobin Decreased Health A DAY Intervention to Myalgia Professional Diazepam (Diazepam) SS Prevent Permanent Neuroleptic Malignant Temazepam Impairment/Damage Syndrome (Temazepam) SS Neutrophil Count Losec (Omeprazole) C Decreased Timoptol Eyedrops Pancytopenia (Timolol Maleate) C Platelet Count Decreased Tilade Puffer Pyrexia (Nedoctrol Sodium) C Date:10/04/99ISR Number: 3363484-6Report Type:Expedited (15-DaCompany Report #USA/ 99/ 01290/ LEX Age:51 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozaril (Clozapine) PS ORAL 350 MG, ONCE Life-Threatening Professional A DAY, ORAL Dalmane (Flurazepam Hydrochloride) C Benadryl 22-Feb-2006 08:30 AM Page: 446 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Diphenhydramine Hydrochloride) C Date:10/04/99ISR Number: 3363487-1Report Type:Expedited (15-DaCompany Report #CDN/ 99/ 00772 / LEX Age:32 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coma Foreign Clozaril (Clozapine) PS ORAL 425 MG, Hospitalization - Electrocardiogram Qt Health UNKNWON, ORAL Initial or Prolonged Prolonged Professional Orap (Pimozide) C Syncope Serzone (Nefazodone Torsade De Pointes Hydrochloride) C Ventricular Fibrillation Prepulsid (Cisapride) C Date:10/05/99ISR Number: 3363771-1Report Type:Expedited (15-DaCompany Report #99-09-0308 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonectomy Health Clozapine - Zenith Initial or Prolonged White Blood Cell Count Professional Goldline Pharm. Increased Tablets PS Zenith Goldline Pharm. ORAL 700MG ORAL Date:10/05/99ISR Number: 3363773-5Report Type:Expedited (15-DaCompany Report #99-08-0265 Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death No Adverse Drug Effect Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL ORAL 1 DAY Date:10/05/99ISR Number: 3363777-2Report Type:Expedited (15-DaCompany Report #99-08-0287 Age:68 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Creatinine Health Clozapine - Zenith Increased Professional Goldline Pharm. Blood Sodium Increased Tablets PS Zenith Goldline Dehydration Pharm. ORAL 50-300MG ORAL Depressed Level Of Consciousness Hypotension Lung Infection Pseudomonal Oral Intake Reduced Renal Impairment Sepsis Urinary Tract Infection White Blood Cell Count Increased 22-Feb-2006 08:30 AM Page: 447 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/05/99ISR Number: 3363782-6Report Type:Expedited (15-DaCompany Report #99-06-0169 Age:27 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Health Clozapine - Zenith Loss Of Consciousness Professional Goldline Pharm. Medication Error Tablets PS Zenith Goldline Pharm. ORAL 825MG / DAY ORAL 6 MON Trazodone C Date:10/06/99ISR Number: 3365444-8Report Type:Direct Company Report # Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Anion Gap Increased Health Clozaril (Clozapine) PS ORAL 150MG QAM Coordination Abnormal Professional 200MG QHS Diabetic Ketoacidosis BOTH PO Lethargy Resperidol C Polydipsia Depakene Elixir C Polyuria Atenolol C Clonidine Patch C Date:10/06/99ISR Number: 3365896-3Report Type:Expedited (15-DaCompany Report #GB/99/00841/LEX Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Foreign Clozaril (Clozapine) PS ORAL 400 MG ORAL Coordination Abnormal Health Myocardial Infarction Professional Nervousness Salivary Hypersecretion Tremor Date:10/07/99ISR Number: 3365920-8Report Type:Expedited (15-DaCompany Report #99-08-0291 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Gastrointestinal Disorder Health Clozapine-Zenith Initial or Prolonged Injury Professional Goldline Pharm. Pneumonia Tablets PS ORAL 300 MG QD Suicide Attempt ORAL 1 MON Thrombophlebitis Septic Trihexyphenidyl C Date:10/07/99ISR Number: 3365927-0Report Type:Expedited (15-DaCompany Report #99-08-0282 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Colitis Ulcerative Health Clozapine-Zenith Initial or Prolonged Professional Goldline Pharm. Tablets PS ORAL 200MG ORAL 1 MON 22-Feb-2006 08:30 AM Page: 448 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/07/99ISR Number: 3365940-3Report Type:Expedited (15-DaCompany Report #99-09-0338 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Meningioma Health Clozapine-Zenith Initial or Prolonged Professional Goldline Pharm. Tablets PS ORAL 300MG ORAL Date:10/07/99ISR Number: 3365942-7Report Type:Expedited (15-DaCompany Report #99-09-0323 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine-Zenith Professional Goldline Pharm. Tablets PS ORAL 125MG ORAL Date:10/07/99ISR Number: 3365954-3Report Type:Expedited (15-DaCompany Report #99-08-0280 Age:82 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Unevaluable Event Health Clozapine - Zenith Initial or Prolonged Professional Goldline Pharm. Tablets PS ORAL 12.5-38MG ORAL Date:10/07/99ISR Number: 3365956-7Report Type:Expedited (15-DaCompany Report #99-08-0279 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hernia Hiatus Repair Health Clozapine - Zenith Initial or Prolonged White Blood Cell Count Professional Goldline Pharm. Increased Tablets PS ORAL 200MG ORAL 15 MON Date:10/07/99ISR Number: 3365961-0Report Type:Expedited (15-DaCompany Report #99-04-0097 Age:69 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Distension Clozapine - Zenith Cardiac Disorder Goldline Pharm. Hyperhidrosis Tablets PS ORAL 225-750MG/DAY Intestinal Obstruction ORAL 1 YR Procardia Xl 30mg/Day C Ferrous Sulphate 325mg/Day C Lasix 20mg/Day C Date:10/07/99ISR Number: 3365964-6Report Type:Expedited (15-DaCompany Report #99-08-0281 Age:86 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arteriosclerosis Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS ORAL 50MG ORAL 1 MON 22-Feb-2006 08:30 AM Page: 449 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/08/99ISR Number: 3368921-9Report Type:Expedited (15-DaCompany Report #GB/99/00679/LEX Age:46 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiac Murmur Foreign Clozaril (Clozapine) PS 600 MG, THREE Hospitalization - Cardiomyopathy Health Vallergan Initial or Prolonged Crepitations Professional (Alimemazine Required Dyspnoea Tartrate)- Intervention to Dyspnoea Paroxysmal Unspecified C Prevent Permanent Nocturnal Impairment/Damage Echocardiogram Abnormal Electrocardiogram Change Hepatic Function Abnormal Infection Left Ventricular Failure Malaise Mitral Valve Incompetence Orthopnoea Pilonidal Cyst Pulmonary Oedema Sinus Tachycardia Staphylococcal Infection Streptococcal Infection Tachycardia Date:10/08/99ISR Number: 3369030-5Report Type:Expedited (15-DaCompany Report #NL/99/01436/LEX Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Leponex (Clozapine) PS ORAL 50 MG, ORAL 4 MON Drug Toxicity Health Hepatic Failure Professional Hypersensitivity Other Medication Error Pulmonary Oedema Renal Failure Acute Stasis Syndrome Date:10/08/99ISR Number: 3369169-4Report Type:Expedited (15-DaCompany Report #GB/99/00746/LEX Age:25 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Encephalopathy Foreign Clozaril (Clozapine) PS ORAL 300 MG, ORAL Life-Threatening Hepatocellular Damage Health Required Hyperbilirubinaemia Professional Intervention to Jaundice Prevent Permanent Liver Function Test Impairment/Damage Abnormal Nausea Pneumonia Sepsis Staphylococcal Sepsis Vomiting 22-Feb-2006 08:30 AM Page: 450 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/12/99ISR Number: 3369319-XReport Type:Periodic Company Report #99-05-0152 Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Salivary Hypersecretion Health Clozapine - Zenith Sedation Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm ORAL 300-400 MG DAY ORAL 2 MON Depakote C Valproate Semisodium C Trihexyphenidyl C Hydrochloride C Trihexyphenidyl C Fibercon C Depakote C Date:10/12/99ISR Number: 3369322-XReport Type:Periodic Company Report #99-05-0154 Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Consumer Clozapine - Zenith Suicidal Ideation Goldline Pharm. Tablets PS Zenith Goldline Pharm ORAL 350MG DAY ORAL 1 DAY Date:10/12/99ISR Number: 3369325-5Report Type:Periodic Company Report #99-06-0161 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hallucination Health Clozapine - Zenith Muscle Spasms Professional Goldline Pharm. Nausea Tablets PS Zenith Goldline Pharm ORAL 25-50MG X 1 WEEK ORAL 1 DAY Date:10/12/99ISR Number: 3369329-2Report Type:Periodic Company Report #99-06-0164 Age:12 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Retching Health Clozapine - Zenith Salivary Hypersecretion Professional Goldline Pharm. Upper Respiratory Tract Tablets PS Zenith Goldline Infection Pharm ORAL 50-300MG Vomiting DAY ORAL Lithium C Zyprexa C Neurontin C Date:10/12/99ISR Number: 3369333-4Report Type:Periodic Company Report #99-06-0166 Age:30 YR Gender:Female I/FU:I Outcome PT Other Dry Mouth Suicide Attempt 22-Feb-2006 08:30 AM Page: 451 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Weight Increased Report Source Product Role Manufacturer Route Dose Duration Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm ORAL 600-700MG DAY ORAL Depakote C Tofranil C Ativan C Thioril C Date:10/12/99ISR Number: 3369336-XReport Type:Periodic Company Report #99-06-0179 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Mania Health Clozapine - Zenith Psychotic Disorder Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm ORAL 200-700MG DAY ORAL 4 MON Date:10/12/99ISR Number: 3369338-3Report Type:Periodic Company Report #99-06-0181 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Health Clozapine - Zenith Psychotic Disorder Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm ORAL 200-300MG DAY ORAL 1 YR Date:10/12/99ISR Number: 3369339-5Report Type:Periodic Company Report #99-06-0186 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Schizophrenia Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm ORAL 200-350MG DAY ORAL Lithium Carbonate C Lithium Carbonate C Buspar C Date:10/12/99ISR Number: 3369343-7Report Type:Periodic Company Report #99-07-0196 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alopecia Health Clozapine - Zenith Hyperhidrosis Professional Goldline Pharm. Other Tablets PS Zenith Goldline Pharm ORAL 300MG ORAL Cogentin C Clonazepam C 22-Feb-2006 08:30 AM Page: 452 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/12/99ISR Number: 3369348-6Report Type:Periodic Company Report #99-07-0204 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Schizophrenia Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm ORAL 900MG QD ORAL Prozac C Date:10/12/99ISR Number: 3369352-8Report Type:Periodic Company Report #99-07-0206 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Health Clozapine - Zenith Agitation Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm ORAL 300-600MG DAY ORAL 15 MON Date:10/12/99ISR Number: 3369356-5Report Type:Periodic Company Report #99-07-0208 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Suicidal Ideation Health Clozapine - Zenith Professional Goldline Pharm. Capsules PS Zenith Goldline Pharm ORAL 100-300MG DAY ORAL Date:10/12/99ISR Number: 3369360-7Report Type:Periodic Company Report #99-07-0210 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Suicidal Ideation Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm ORAL 600MG ORAL 1 YR Buspar C Date:10/12/99ISR Number: 3369365-6Report Type:Periodic Company Report #99-07-0211 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Health Clozapine - Zenith Schizophrenia, Paranoid Professional Goldline Pharm. Type Tablets PS Zenith Goldline Pharm ORAL 400MG DAILY ORAL 2 MON 22-Feb-2006 08:30 AM Page: 453 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/12/99ISR Number: 3369370-XReport Type:Periodic Company Report #99-07-0212 Age:92 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Health Clozapine - Zenith Delusion Professional Goldline Pharm. Drug Ineffective Tablets PS Zenith Goldline Hallucination Pharm ORAL 6.2MG TO 50MG ORAL 3 MON Date:10/12/99ISR Number: 3369374-7Report Type:Periodic Company Report #99-07-0213 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Suicidal Ideation Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm ORAL 600MG DAY ORAL 15 MON Clonazepam C Date:10/12/99ISR Number: 3369379-6Report Type:Periodic Company Report #99-07-0215 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm ORAL 200-300MG ORAL Zyprexa C Florid C Date:10/12/99ISR Number: 3369383-8Report Type:Periodic Company Report #99-07-0216 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiac Failure Health Clozapine - Zenith Congestive Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm ORAL 350-650MG DAY ORAL 6 MON Date:10/12/99ISR Number: 3369386-3Report Type:Periodic Company Report #99-07-0218 Age:48 YR Gender:Female I/FU:I Outcome PT Other Haemoglobin Decreased Hypokalaemia Hyponatraemia Leukocytosis Leukopenia Malaise Pericardial Effusion Pleural Effusion Pneumonia Pyrexia Red Blood Cell 22-Feb-2006 08:30 AM Page: 454 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sedimentation Rate Decreased Thrombocythaemia Report Source Product Role Manufacturer Route Dose Duration Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm ORAL 25-250MG DAY ORAL Risperdal C Lorazepam C Valproate Sodium C Synthroid C Ativan C Date:10/12/99ISR Number: 3369391-7Report Type:Periodic Company Report #99-07-0221 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Paranoia Health Clozapine - Zenith Suicidal Ideation Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm ORAL 25-325MG ORAL Prozac C Depakote C Klonopin C Date:10/12/99ISR Number: 3369556-4Report Type:Periodic Company Report #99-05-0155 Age:85 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Aspiration Health Clozapine Initial or Prolonged Professional Tablets-Zenith Goldline Pharm. PS Zenith Goldline Pharm. ORAL 50MG/DAY ORAL 13 MON Date:10/12/99ISR Number: 3369563-1Report Type:Periodic Company Report #99-06-0159 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Liver Function Test Health Clozapine-Zenith Initial or Prolonged Abnormal Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 25-300 MG ORAL Trazodone C Tylenol C Effexor C Date:10/12/99ISR Number: 3369567-9Report Type:Periodic Company Report #99-06-0167 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Health Clozapine-Zenith Initial or Prolonged Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 400-575 22-Feb-2006 08:30 AM Page: 455 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report MG/DAY ORAL Date:10/12/99ISR Number: 3369571-0Report Type:Periodic Company Report #99-06-0168 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozapine-Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 500-600 MG ORAL 1 YR Date:10/12/99ISR Number: 3369576-XReport Type:Periodic Company Report #99-06-0170 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozapine-Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 175-400 MG ORAL 3 MON Date:10/12/99ISR Number: 3369577-1Report Type:Periodic Company Report #99-06-0175 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depressed Level Of Health Clozapine-Zenith Initial or Prolonged Consciousness Professional Goldline Pharm. Lethargy Tablets PS Zenith Goldline Liver Function Test Pharm. ORAL 525-650 MG Abnormal ORAL Amiodarone Tablets SS ORAL 400 MG/QD ORAL Amiodarone C Date:10/12/99ISR Number: 3369583-7Report Type:Periodic Company Report #99-06-0176 Age:77 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Health Clozapine-Zenith Initial or Prolonged Congestive Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 250-700 MG ORAL 4 MON Date:10/12/99ISR Number: 3369584-9Report Type:Periodic Company Report #99-06-0183 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozapine-Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 125-300 MG/DAY ORAL 1 YR Anafranil C Depakote C 22-Feb-2006 08:30 AM Page: 456 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/12/99ISR Number: 3369585-0Report Type:Expedited (15-DaCompany Report #99-06-0184 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pulmonary Embolism Health Clozapine Sudden Death Professional Tablets-Zenith Goldline Pharm. PS Zenith Goldline Pharm. ORAL 500MG ORAL 2 MON Bisacodyl C Acetaminophen C Depakote C Oxybutynin Hydrochloride C Banitidine C Date:10/12/99ISR Number: 3369586-2Report Type:Periodic Company Report #99-06-0187 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine-Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 25-900MG ORAL 14 MON Date:10/12/99ISR Number: 3369589-8Report Type:Periodic Company Report #99-06-0192 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Health Clozapine-Zenith Initial or Prolonged Convulsion Professional Goldline Pharm. Hyponatraemia Tablets PS Zenith Goldline Pharm. ORAL 800 MG/DAY ORAL 14 MON Monopril C Date:10/12/99ISR Number: 3369591-6Report Type:Periodic Company Report #99-06-0193 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Aspiration Health Clozapine-Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 200-800 MG ORAL 1 YR Date:10/12/99ISR Number: 3369593-XReport Type:Periodic Company Report #99-06-0195 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Respiratory Failure Health Clozapine-Zenith Initial or Prolonged Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 400MG ORAL 1 MON 22-Feb-2006 08:30 AM Page: 457 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/12/99ISR Number: 3369595-3Report Type:Periodic Company Report #99-07-0198 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozapine-Zenith Aphasia Professional Goldline Pharm. Body Temperature Tablets PS Zenith Goldline Increased Pharm. ORAL 500MG ORAL 2 MON Interferon SS Date:10/12/99ISR Number: 3369597-7Report Type:Periodic Company Report #99-07-0199 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dysphagia Health Clozapine -Zenith Hospitalization - Ileus Paralytic Professional Goldline Pharm. Initial or Prolonged Pneumonia Aspiration Tablets PS Zenith Goldline Pharm. ORAL 50MG ORAL 1 YR Date:10/12/99ISR Number: 3369599-0Report Type:Periodic Company Report #99-07-0219 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine Tablets- Professional Zenith Goldline Pharm. PS Zenith Goldline Pharm. ORAL 25-300MG ORAL 1 MON Date:10/12/99ISR Number: 3369601-6Report Type:Periodic Company Report #99-07-0220 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dehydration Health Clozapine Initial or Prolonged Influenza Like Illness Professional Tablets-Zenith Leukopenia Goldline Pharm. PS Zenith Goldline Pharm. ORAL 825-850MG ORAL Date:10/12/99ISR Number: 3369603-XReport Type:Periodic Company Report #99-07-0227 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Health Clozapine Initial or Prolonged Convulsion Professional Tablets-Zenith Psychotic Disorder Goldline Pharm. PS Zenith Goldline Pharm. ORAL 675-700MG ORAL 2 MON Date:10/12/99ISR Number: 3369604-1Report Type:Periodic Company Report #99-08-0234 Age:81 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bronchitis Acute Health Clozapine-Zenith Initial or Prolonged Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 70-150MG ORAL Acetaminophen C 22-Feb-2006 08:30 AM Page: 458 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Albuterol C Bisacodyl Suppositories C Date:10/12/99ISR Number: 3369606-5Report Type:Periodic Company Report #99-08-0242 Age:78 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Health Clozapine -Zenith Initial or Prolonged Professional Goldline Pharm. Injectable Solution PS Zenith Goldline Pharm. ORAL 175-300MG ORAL 12 MON Date:10/12/99ISR Number: 3369668-5Report Type:Periodic Company Report #99-08-0244 Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Upper Respiratory Tract Health Clozapine Tablets Initial or Prolonged Infection Professional -Zenith Goldline Pharm. PS Zenith Goldline Pharm. ORAL 100MG ORAL 1 YR Prilosec C Sinemet Cr C Date:10/12/99ISR Number: 3369669-7Report Type:Periodic Company Report #99-08-0245 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozapine Tablets Hospitalization - Professional -Zenith Goldline Initial or Prolonged Pharm. PS Zenith Goldline Pharm. ORAL 162-5 MG ORAL 20 DAY Neuopgen C Date:10/12/99ISR Number: 3369670-3Report Type:Periodic Company Report #99-08-0258 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Health Clozapine Tablets Initial or Prolonged Professional -Zenith Goldline Pharm. PS Zenith Goldline Pharm. ORAL 300MG ORAL Date:10/12/99ISR Number: 3369671-5Report Type:Periodic Company Report #99-08-0260 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozapine Tablets Professional -Zenith Goldline Pharm. PS Zenith Goldline Pharm. ORAL 200 MG ORAL Tamoxifen Unknown SS 22-Feb-2006 08:30 AM Page: 459 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/12/99ISR Number: 3369672-7Report Type:Periodic Company Report #99-08-0264 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bronchitis Health Clozapine Tablets Hospitalization - Pneumonia Professional -Zenith Goldline Initial or Prolonged Pharm. PS Zenith Goldline Pharm. ORAL 200-400 MG ORAL QD Date:10/12/99ISR Number: 3369674-0Report Type:Periodic Company Report #99-08-0267 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Respiratory Distress Health Clozapine Tablets Initial or Prolonged Professional -Zenith Goldline Pharm. PS Zenith Goldline Pharm. ORAL 50-125 MG ORAL Date:10/12/99ISR Number: 3369677-6Report Type:Periodic Company Report #99-08-0277 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intestinal Obstruction Health Clozapine Tablets Initial or Prolonged Professional -Zenith Goldline Pharm. PS Zenith Goldline Pharm. ORAL ORAL Date:10/12/99ISR Number: 3369680-6Report Type:Periodic Company Report #99-03-0055 Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Clozapine Tablets Initial or Prolonged Hallucination, Auditory Professional -Zenith Goldline Mood Swings Pharm. PS Zenith Goldline Thinking Abnormal Pharm. ORAL 600-650 MG DAY ORAL 1 YR Date:10/12/99ISR Number: 3369685-5Report Type:Periodic Company Report #99-03-0085 Age:81 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozapine Tablets Professional -Zenith Goldline Pharm. PS Zenith Goldline Pharm. ORAL 62.5-75 MG ORAL 1 YR Cipro C Date:10/12/99ISR Number: 3369686-7Report Type:Periodic Company Report #99-04-0097 Age:69 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Clozapine Tablets Intestinal Obstruction -Zenith Goldline Pharm. PS Zenith Goldline 22-Feb-2006 08:30 AM Page: 460 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pharm. ORAL 225-750 MG DAY ORAL 1 YR Procardia Xl C Ferrous Sulphate C Lasix C Date:10/12/99ISR Number: 3369689-2Report Type:Periodic Company Report #99-04-0119 Age:37 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Colonic Atony Health Clozapine Tablets Professional -Zenith Goldline Pharm. PS Zenith Goldline Pharm. ORAL 600MG/DAY ORAL 1 YR Date:10/12/99ISR Number: 3369692-2Report Type:Periodic Company Report #99-04-0124 Age:51 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozapine Tablets Professional -Zenith Goldline Pharm. PS Zenith Goldline Pharm. ORAL 250 MG ORAL Cytoxan Tablets SS ORAL Q 3-4 WEEKS ORAL 5-Fu Tablets SS ORAL Q 3-4 WEEK ORAL Adriamycin Tablets SS ORAL Q 3-4 WEEK ORAL Date:10/12/99ISR Number: 3369697-1Report Type:Periodic Company Report #99-05-0129 Age:63 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Clozapine Tablets Hospitalization - Congestive Professional -Zenith Goldline Initial or Prolonged Pharm. PS Zenith Goldline Pharm. ORAL 25 MG QD ORAL 7 DAY Date:10/12/99ISR Number: 3369700-9Report Type:Periodic Company Report #99-05-0130 Age:62 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozapine Tablets Professional -Zenith Goldline Pharm. PS Zenith Goldline Pharm. ORAL 700 MG DAY ORAL 6 MON Albuterol C Effexor C Atrovent C Milk Of Magnesium C Ipratropium C Docusate Sodium C Acetaminophen C 22-Feb-2006 08:30 AM Page: 461 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/12/99ISR Number: 3369702-2Report Type:Periodic Company Report #99-05-0134 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine Tablets Pulmonary Embolism Professional -Zenith Goldline Pharm. PS Zenith Goldline Pharm. ORAL 50-150 MG ORAL 1 MON Date:10/12/99ISR Number: 3369705-8Report Type:Periodic Company Report #99-05-0142 Age:77 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine Tablets Professional -Zenith Goldline Pharm. PS Zenith Goldline Pharm. ORAL 12.5 MG DAY ORAL 2 MON Date:10/12/99ISR Number: 3369708-3Report Type:Periodic Company Report #99-05-0150 Age:56 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozapine Tablets Professional -Zenith Goldline Pharm. PS Zenith Goldline Pharm. ORAL 150-500 MG/ DAY ORAL 5 MON Date:10/12/99ISR Number: 3369710-1Report Type:Periodic Company Report #99-06-0194 Age:85 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozapine Tablets Professional -Zenith Goldline Pharm. PS Zenith Goldline Pharm. ORAL ORAL 1 MON Date:10/12/99ISR Number: 3369714-9Report Type:Periodic Company Report #99-07-0200 Age:76 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozapine Tablets Professional -Zenith Goldline Pharm. PS Zenith Goldline Pharm. ORAL ORAL Date:10/12/99ISR Number: 3369720-4Report Type:Periodic Company Report #99-05-0151 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Micturition Urgency Health Clozapine Tablets Professional -Zenith Goldline Pharm. PS Zenith Goldline Pharm. ORAL 50 MG ORAL Prozac C 22-Feb-2006 08:30 AM Page: 462 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/12/99ISR Number: 3369729-0Report Type:Periodic Company Report #99-07-0224 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drooling Health Clozapine - Zenith Hallucination, Visual Professional Goldline Pharm. Weight Increased Tablets PS ORAL 350 MG QD ORAL Clonazepam C Date:10/12/99ISR Number: 3369733-2Report Type:Periodic Company Report #99-07-0226 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Joint Swelling Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS ORAL ORAL Ibuprofen C Date:10/12/99ISR Number: 3369737-XReport Type:Periodic Company Report #99-07-0229 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abnormal Behaviour Health Clozapine - Zenith Professional Goldline Pharm. Capsules PS ORAL 450-900 MG ORAL Date:10/12/99ISR Number: 3369742-3Report Type:Periodic Company Report #99-07-0232 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Schizophrenia Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS ORAL 600-700 MG ORAL Date:10/12/99ISR Number: 3369745-9Report Type:Periodic Company Report #99-08-0236 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Disturbance In Attention Health Clozapine - Zenith Nervousness Professional Goldline Pharm. Tablets PS ORAL 200-225MG ORAL Date:10/12/99ISR Number: 3369748-4Report Type:Periodic Company Report #99-08-0243 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Health Clozapine - Zenith Psychotic Disorder Professional Goldline Pharm. Tablets PS ORAL 250-600 MG ORAL 14 MON 22-Feb-2006 08:30 AM Page: 463 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/12/99ISR Number: 3369750-2Report Type:Periodic Company Report #99-08-0246 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Health Clozapine - Zenith Psychotic Disorder Professional Goldline Pharm. Tablets PS ORAL 400-500MG DAY ORAL 3 MON Date:10/12/99ISR Number: 3369754-XReport Type:Periodic Company Report #99-08-0249 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Fatigue Health Clozapine - Zenith Sedation Professional Goldline Pharm. Tablets PS ORAL 25-300MG QD ORAL Date:10/12/99ISR Number: 3369758-7Report Type:Periodic Company Report #99-08-0252 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abortion Spontaneous Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS ORAL 150-300MG ORAL 1 YR Date:10/12/99ISR Number: 3369762-9Report Type:Periodic Company Report #99-08-0253 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Consumer Clozapine - Zenith Goldline Pharm. Tablets PS ORAL 300MG ORAL Date:10/12/99ISR Number: 3369767-8Report Type:Periodic Company Report #99-08-0255 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hallucination, Auditory Health Clozapine - Zenith Suicidal Ideation Professional Goldline Pharm. Tablets PS ORAL 350-600MG ORAL Date:10/12/99ISR Number: 3369772-1Report Type:Periodic Company Report #99-08-0257 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Lymphocytosis Health Clozapine - Zenith Neutropenia Professional Goldline Pharm. Tablets PS ORAL 700MG DAY ORAL 22-Feb-2006 08:30 AM Page: 464 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/12/99ISR Number: 3369774-5Report Type:Periodic Company Report #99-08-0259 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Health Clozapine - Zenith Hallucination, Auditory Professional Goldline Pharm. Tablets PS ORAL 300-500 MG ORAL 1 YR Date:10/12/99ISR Number: 3369776-9Report Type:Periodic Company Report #99-08-0263 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Parotid Gland Enlargement Health Clozapine - Zenith Professional Goldline Pharm. Tablet PS ORAL 100-125MG QD ORAL Date:10/12/99ISR Number: 3369780-0Report Type:Periodic Company Report #99-08-0269 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sedation Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS ORAL 225MG QHS ORAL Mellaril C Date:10/12/99ISR Number: 3369783-6Report Type:Periodic Company Report #99-08-0270 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Lethargy Health Clozapine - Zenith Muscular Weakness Professional Goldline Pharm. Myalgia Tablets PS ORAL 200MG/QD Pharyngolaryngeal Pain ORAL Pyrexia Date:10/12/99ISR Number: 3369785-XReport Type:Periodic Company Report #99-08-0271 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Overdose Health Clozapine - Zenith Suicide Attempt Professional Goldline Pharm. Tablets PS ORAL 100-300MG QD ORAL 5 MON Docusate Sodium C Iron C Micronase C Risperdal C Serzone C 22-Feb-2006 08:30 AM Page: 465 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/12/99ISR Number: 3369787-3Report Type:Periodic Company Report #99-08-0273 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Health Clozapine - Zenith Hallucination, Auditory Professional Goldline Pharm. Obsessive-Compulsive Tablets PS ORAL 300-400 MG Disorder ORAL 2 MON Paranoia Suicidal Ideation Date:10/12/99ISR Number: 3369789-7Report Type:Periodic Company Report #99-08-0274 Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abnormal Behaviour Health Clozapine - Zenith Agitation Professional Goldline Pharm. Hallucination Tablets PS ORAL 200-600MG ORAL Date:10/12/99ISR Number: 3369790-3Report Type:Periodic Company Report #99-08-0278 Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Health Clozapine - Zenith Psychotic Disorder Professional Goldline Pharm. Tablets PS ORAL ORAL Neurontin C Date:10/12/99ISR Number: 3369792-7Report Type:Periodic Company Report #99-08-0288 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pneumonia Aspiration Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS ORAL 150MG ORAL Date:10/12/99ISR Number: 3369794-0Report Type:Periodic Company Report #99-03-0087 Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Heart Rate Increased Health Clozapine - Zenith Hypertension Professional Goldline Pharm. Leukocytosis Tablets PS ORAL 350-400MG Psychotic Disorder DAY ORAL Pyrexia Klonopin C Toothache Inderal C Tremor Valium C Date:10/12/99ISR Number: 3370288-7Report Type:Expedited (15-DaCompany Report #USA/99/02454/LEX Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cellulitis Health Clozaril (Clozapine) PS ORAL 400 MG, Initial or Prolonged Constipation Professional UNKNOWN, Other Faecaloma ORAL; 22-Feb-2006 08:30 AM Page: 466 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lasix (Furosemide) C Colace (Docusate Sodium) C Keflex (Cefalexin Monohydrate) C Lisinopril C Date:10/12/99ISR Number: 3370290-5Report Type:Expedited (15-DaCompany Report #USA/99/02326/LEX Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abnormal Behaviour Consumer Clozaril (Clozapine) PS ORAL 500 MG, Hospitalization - Coma Health UNKNOWN, ORAL Initial or Prolonged Confusional State Professional Topamax (Topiramate) SS 400 MG, Required Convulsion UNKNOWN, Intervention to Disorientation UNKNOWN; Prevent Permanent Encephalopathy Citalopram Impairment/Damage Fatigue Hydrobromide C Hypotension Risperdal Hypoxia (Risperidone) C Leukopenia Depakote (Valproate Pharyngolaryngeal Pain Semisodium) C Pneumonia Proscar Pneumonia Aspiration (Finasteride) C Prothrombin Time Colace (Docusate Prolonged Sodium) C Pyrexia Sedation Sinusitis Tachycardia Thrombocytopenia Weight Increased Date:10/12/99ISR Number: 3370605-8Report Type:Expedited (15-DaCompany Report #USA/99/02475/LEX Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Medication Error Health Clozaril (Clozapine) PS ORAL 125 MG, THREE Initial or Prolonged Tuberculosis Professional TIMES A DAY, Required ORAL Intervention to Depakote (Valproate Prevent Permanent Semisodium) C Impairment/Damage Lactulose C Prilosec (Omeprazole) C Klonopin (Clonazepam) C Ativan (Lorazepam) C Phoslo (Calcium Acetate) C Date:10/12/99ISR Number: 3370703-9Report Type:Expedited (15-DaCompany Report #DK/99/00014/LEX Age:43 YR Gender:Male I/FU:F Outcome Death Required Intervention to 22-Feb-2006 08:30 AM Page: 467 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Accidental Exposure Foreign Leponex (Clozapine) PS ORAL 200 MG, Aggression Health UNKNOWN, ORAL Agitation Professional Anafranil Retard Cardiac Arrest Other (Clomipramine Coma Hydrochloride) SS ORAL 300 MG, Loss Of Consciousness UNKNOWN, ORAL Medication Error Depakine (Valproate Overdose Sodium) SS ORAL 1 G, UNKNOWN, Sudden Death ORAL Therapeutic Agent Trileptal Toxicity (Oxcarbazepine) SS ORAL 600 MG, UNKNOWN, ORAL Lamictal (Lamotrigine) SS ORAL 200 MG, TWICE A DAY, ORAL Dogmatil (Sulpiride) C Serenase (Haloperidol) C Stilnoct (Zolpidem Tartrate) C Pendil (Felodipine) C Corodil (Enalapril) C Oxazepam (Oxazepam) C Date:10/12/99ISR Number: 3371454-7Report Type:Expedited (15-DaCompany Report #USA/99/00442/LEX Age:44 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Anaemia Health Clozaril (Clozapine) PS ORAL 350 MG, Leukaemia Professional UNKNOWN, ORAL Tylenol #3 (Panadeine Co) C Date:10/12/99ISR Number: 3371456-0Report Type:Expedited (15-DaCompany Report #GB/99/00866/LEX Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anorexia Foreign Clozaril (Clozapine) PS 300 MG Coma Health Diabetes Mellitus Professional Hypoglycaemia Nausea Weight Decreased Date:10/12/99ISR Number: 3371457-2Report Type:Expedited (15-DaCompany Report #DK/99/00044/LEX Age:66 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiomyopathy Foreign Leponex (Clozapine) PS ORAL 75 MG, Initial or Prolonged Health UNKNOWN, ORAL 5 YR Required Professional Intervention to Other Prevent Permanent Impairment/Damage 22-Feb-2006 08:30 AM Page: 468 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/12/99ISR Number: 3371513-9Report Type:Expedited (15-DaCompany Report #USA/99/02457/LEX Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Health Clozaril (Clozapine) PS ORAL 200 MG, ORAL Initial or Prolonged Medication Error Professional Aricept (Donepezil Hydrochloride) C K-Dur (Potassium Chloride) C Lanoxin (Digoxin) C Docusate C Lasix (Furosemide) C Oscal (Calcium Carbonate) C Sinemet C Sular (Nisoldipine) C Xanax (Alprazolam) C Date:10/12/99ISR Number: 3371515-2Report Type:Expedited (15-DaCompany Report #USA/99/02498/LEX Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hip Fracture Health Clozaril (Clozapine) PS ORAL ORAL Initial or Prolonged Professional Date:10/12/99ISR Number: 3371517-6Report Type:Expedited (15-DaCompany Report #USA/99/02458/LEX Age:67 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Health Clozaril (Clozapine) PS ORAL 200 MG, ORAL Professional Glipizide C Date:10/12/99ISR Number: 3371519-XReport Type:Expedited (15-DaCompany Report #USA/99/02473/LEX Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Clozaril (Clozapine) PS ORAL 25 MG, ONCE A Life-Threatening Congestive Professional DAY, ORAL Date:10/13/99ISR Number: 3368981-5Report Type:Expedited (15-DaCompany Report #99-08-0233 Age:29 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Clozapine - Zenith Intentional Overdose Professional Goldline Pharm. Capsules PS Zenith Goldline Pharm. ORAL 300-750MG/DAY ORAL Zyprexa C Zantac C Date:10/13/99ISR Number: 3368983-9Report Type:Expedited (15-DaCompany Report #99-08-0285 Age:77 YR Gender:Male I/FU:F Outcome PT Death Chronic Obstructive Pulmonary Disease 22-Feb-2006 08:30 AM Page: 469 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pneumonia Respiratory Disorder White Blood Cell Count Report Source Product Role Manufacturer Route Dose Duration Decreased Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL ORAL Date:10/13/99ISR Number: 3368985-2Report Type:Expedited (15-DaCompany Report #99-09-0318 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death White Blood Cell Count Health Clozapine - Zenith Decreased Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. 275MG-500MG 17 MON Date:10/13/99ISR Number: 3368995-5Report Type:Expedited (15-DaCompany Report #99-09-0336 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Renal Failure Health Clozapine-Zenith White Blood Cell Count Professional Goldline Pharm. Decreased Tablets PS Zenith Goldline Pharm. 350-400MG 4 MON Date:10/13/99ISR Number: 3370393-5Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eosinophil Count Clozaril, Novartis PS Novartis 300MG BID Decreased SEVERAL YEARS TO PRESENT Zoloft C Prolixin C Depakote C Date:10/14/99ISR Number: 3370291-7Report Type:Expedited (15-DaCompany Report #9941919 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Health Zoloft Tablets PS Initial or Prolonged Phosphokinase Increased Professional Clozapine SS Required Myopathy Intervention to Prevent Permanent Impairment/Damage Date:10/15/99ISR Number: 3372056-9Report Type:Expedited (15-DaCompany Report #99-09-0305 Age:63 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pulmonary Haemorrhage Health Clozapine Tablets- Professional Zenith Goldline Pharm. PS Zenith Goldline Pharm. ORAL 650 MG ORAL 22-Feb-2006 08:30 AM Page: 470 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/15/99ISR Number: 3372058-2Report Type:Expedited (15-DaCompany Report #99-08-0280 Age:82 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Unevaluable Event Health Clozapine-Zenith Initial or Prolonged Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm ORAL 12.5-38MG ORAL Sinemet 10/100 C Florinef C Rythmol C Tolcapone C Date:10/15/99ISR Number: 3372061-2Report Type:Expedited (15-DaCompany Report #99-09-0323 Age:70 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine - Zenith Professional Goldline Pharm PS Zenith Goldline Pharm ORAL 125 MG ORAL Date:10/15/99ISR Number: 3373976-1Report Type:Expedited (15-DaCompany Report #F/99/02324/LEX Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiomyopathy Foreign Leponex (Clozapine) PS ORAL 500 MG, Initial or Prolonged Dyspnoea Health UNKNOWN, Required Malaise Professional ORAL; 3 YR Intervention to Syncope Xanax (Alprazolam) C Prevent Permanent Euphylline Impairment/Damage (Theophylline) C Stediril (Eugynon) C Lipanthyl (Fenofibrate) C Date:10/15/99ISR Number: 3373995-5Report Type:Expedited (15-DaCompany Report #GB/99/00887/LEX Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril (Clozapine) PS ORAL 300 MG, ONCE Weight Increased Other A DAY, ORAL; Depo-Provera (Medroxyprogesterone Acetate) C Doxycycline (Doxycycline) C Date:10/15/99ISR Number: 3374001-9Report Type:Expedited (15-DaCompany Report #GB/99/00883/LEX Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Oesophageal Carcinoma Foreign Clozaril (Clozapine) PS ORAL UNKNOWN, Health UNKNOWN, Professional ORAL; 8 YR 22-Feb-2006 08:30 AM Page: 471 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/18/99ISR Number: 3374784-8Report Type:Expedited (15-DaCompany Report #USA/99/02540/LEX Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Abuser Health Clozaril (Clozapine) PS ORAL ORAL Professional Prozac (Fluoxetine Hydrochloride) C Date:10/18/99ISR Number: 3375025-8Report Type:Expedited (15-DaCompany Report #IRL /99/00888 / LEX Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Renal Cell Carcinoma Foreign Clozaril (Clozapine) PS 200 MG, Stage Unspecified Health UNKNOWN, Professional Date:10/18/99ISR Number: 3375227-0Report Type:Expedited (15-DaCompany Report #D/99/01312/LEX Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Foreign Leponex (Clozapine) PS 200 MG Initial or Prolonged Health Required Professional Intervention to Prevent Permanent Impairment/Damage Date:10/18/99ISR Number: 3375228-2Report Type:Expedited (15-DaCompany Report #GB/99/00355/LEX Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Drug Interaction Foreign Clozaril (Clozapine) PS ORAL 250 MG, ONCE Lower Respiratory Tract Study DAY Infection Health Chlorpromazine Renal Failure Acute Professional (Chlorpromazine) C Cefaclor (Cefaclor) C Procyclidine (Procyclidine) C Temazepam (Temazepam) C Date:10/18/99ISR Number: 3375231-2Report Type:Expedited (15-DaCompany Report #GB/99/00856/LEX Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coma Foreign Clozaril (Clozapine) PS ORAL 400 MG Required Diabetes Mellitus Health Intervention to Diabetic Hyperglycaemic Professional Prevent Permanent Coma Impairment/Damage Hyperglycaemia Date:10/18/99ISR Number: 3375679-6Report Type:Expedited (15-DaCompany Report #GB/99/00428/LEX Age:25 YR Gender:Female I/FU:F Outcome Death Required 22-Feb-2006 08:30 AM Page: 472 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Intervention to Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Pain Foreign Clozaril (Clozapine) PS ORAL 225 MG , ONCE Circulatory Collapse Health A DAY; ORAL Constipation Professional Epilim (Valproate Deep Vein Thrombosis Other Sodium) C Drug Interaction Orphenadrine Drug Level Above (Orphenadrine) C Therapeutic Chlropromazine Drug Toxicity (Chlorpromazine) C Embolism Dothiepin Sudden Death (Dosulepin) C Mebeverine (Mebeverine) C Fybogel (Isapghula) C Date:10/18/99ISR Number: 3375680-2Report Type:Expedited (15-DaCompany Report #AUS/99/01326/LEX Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Oedema Peripheral Foreign Clozaril (Clozapine) PS ORAL 100 MG, Required Pneumonia Study UNKNOWN, ORAL Intervention to Upper Respiratory Tract Health Prevent Permanent Infection Professional Impairment/Damage Date:10/19/99ISR Number: 3376044-8Report Type:Expedited (15-DaCompany Report #LIT/99/00360/LEX Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Pain Foreign Clozapine Required Colitis Literature (Clozapine) PS ORAL 700 MG ORAL 3 YR Intervention to Colitis Ischaemic Health Tropatepine C Prevent Permanent Diarrhoea Professional Impairment/Damage Shock Vomiting Date:10/19/99ISR Number: 3376052-7Report Type:Expedited (15-DaCompany Report #LIT/99/00361/LEX Age:31 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Foreign Clozapine Obsessive Thoughts Literature (Clozapine) PS ORAL 325 MG ORAL Obsessive-Compulsive Health Flupenthixol Disorder Professional (Flupentixol) C Date:10/19/99ISR Number: 3376055-2Report Type:Expedited (15-DaCompany Report #USA/99/02042/LEX Age:38 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coma Health Clozaril (Clozapine) PS ORAL 500 MG ORAL Hospitalization - Leukopenia Professional Initial or Prolonged Pulmonary Embolism 22-Feb-2006 08:30 AM Page: 473 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/19/99ISR Number: 3376059-XReport Type:Expedited (15-DaCompany Report #USA/99/02090/LEX Age:74 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Infection Health Clozaril (Clozapine) PS ORAL 50 MG ONCE A Malaise Professional DAY ORAL Pneumonia Vitamin E Pyrexia (Tocopherol) C Trazodone C Vitamin C (Ascorbic Acid) C Date:10/19/99ISR Number: 3376060-6Report Type:Expedited (15-DaCompany Report #USA/99/02516/LEX Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Cancer Female Health Clozaril (Clozapine) PS ORAL 300 MG ORAL Required Professional Intervention to Prevent Permanent Impairment/Damage Date:10/19/99ISR Number: 3376065-5Report Type:Expedited (15-DaCompany Report #USA/99/01597/LEX Age:71 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Clozaril (Clozapine) PS ORAL 400 MG ORAL Life-Threatening Congestive Professional Hospitalization - Coronary Artery Disease Initial or Prolonged Infection Pneumonia Date:10/19/99ISR Number: 3376067-9Report Type:Expedited (15-DaCompany Report #GB/99/00859/LEX Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anxiety Foreign Clozaril (Clozapine) PS ORAL 500 MG TWICE Other Hepatomegaly Health A DAY ORAL Sudden Death Professional Benzodiazepine (Benzodiazepine Derivatives) C Valproate Sodium (Valproate Sodium) C Lansoprazole (Lansoprazole) C Date:10/19/99ISR Number: 3376089-8Report Type:Expedited (15-DaCompany Report #GB/99/00891/LEX Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Ovarian Cyst Foreign Clozaril (Clozapine) PS Weight Increased Health Clomipramine Professional (Clomipramine) C 22-Feb-2006 08:30 AM Page: 474 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/19/99ISR Number: 3376095-3Report Type:Expedited (15-DaCompany Report #GB/99/00852/LEX Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Condition Aggravated Foreign Clozaril (Clozapine) PS ORAL 12.5 MG ORAL Gait Disturbance Health Professional Date:10/19/99ISR Number: 3376153-3Report Type:Direct Company Report # Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Fatigue Clozaril (Novartis) Heat Stroke 150mg Am,300mg Hs Obesity Schizophrenia PS Novartis Prevacid C Date:10/20/99ISR Number: 3375864-3Report Type:Expedited (15-DaCompany Report #99-10-0350 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - White Blood Cell Count Health Clozapine - Zenith Initial or Prolonged Increased Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm 200-600MG 13 MON Date:10/20/99ISR Number: 3375868-0Report Type:Expedited (15-DaCompany Report #99-10-0346 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death White Blood Cell Count Health Clozapine - Zenith Decreased Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm 550MG 12 MON Chemotherapeutics C Date:10/20/99ISR Number: 3375948-XReport Type:Direct Company Report # Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dizziness Clozaril 100mg Ecchymosis Novartis PS Novartis ORAL 100MG PO Q AM Fall & HS Laceration Prevacid C Orthostatic Hypotension Propulsid C Pain In Extremity Trazodone C Glucotrol Xl C Risperdal C Date:10/20/99ISR Number: 3376064-3Report Type:Direct Company Report # Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Health Clozaril 100mg Professional Novartis PS Novartis ORAL 100MG,200MG AM,HS ORAL Clozaril 25mg 22-Feb-2006 08:30 AM Page: 475 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Novartis SS Novartis ORAL 75MG,50MG 11AM,5PM ORAL Ranitidine C Thiamine C Chlorphyllin C Docusate C Levothyroxine C Lico3 C Date:10/20/99ISR Number: 3377511-3Report Type:Expedited (15-DaCompany Report #USA/99/01840/LEX Age:57 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Loss Of Consciousness Health Clozaril (Clozapine) PS ORAL 400 MG, ONCE Life-Threatening Lung Neoplasm Malignant Professional A DAY, ORAL Other Glucophage Required (Metformin Intervention to Hydrochloride) C Prevent Permanent Glucotrol Impairment/Damage (Glipizide) C Date:10/20/99ISR Number: 3377516-2Report Type:Expedited (15-DaCompany Report #USA/99/01811/LEX Age:61 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Intestinal Perforation Health Clozaril (Clozapine) PS ORAL ORAL Hospitalization - Leukocytosis Professional Haldol (Laoperidol) C Initial or Prolonged Pneumonia Seroquel C Renal Failure Acute Cogentin Sepsis (Benzatropine Mesilate) C Zyprexa (Olanzapine) C Wellbutrin (Amfebutamone Hydrochloride) C Vitamin E (Tocopherol) C Date:10/20/99ISR Number: 3377522-8Report Type:Expedited (15-DaCompany Report #GB/99/00904/LEX Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril (Clozapine) PS ORAL 500 MG, ORAL Required Neuropathy Peripheral Health Gliclazine Intervention to Professional (Gliclazide) C Prevent Permanent Ranitidine Impairment/Damage (Ranitidine) C Date:10/21/99ISR Number: 3378202-5Report Type:Expedited (15-DaCompany Report #USA/99/01698/LEX Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Renal Cell Carcinoma Health Clozaril (Clozapine) PS ORAL 500 MG ORAL Disability Stage Unspecified Professional Required Intervention to Prevent Permanent Impairment/Damage 22-Feb-2006 08:30 AM Page: 476 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/21/99ISR Number: 3379036-8Report Type:Expedited (15-DaCompany Report #USA/99/01447/LEX Age:49 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Non-Small Cell Lung Health Clozaril (Clozapine) PS ORAL 200 MG, ORAL Cancer Professional Roxanol (Morphine Sulfate) C Vicodin C Combivent C Carboplatin C Novelbine C Date:10/21/99ISR Number: 3379043-5Report Type:Expedited (15-DaCompany Report #D/99/00283/LEX Age:58 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Foreign Leponex (Clozapine) PS ORAL 100 MG, ORAL; Initial or Prolonged Cardiac Valve Disease Health 400 MG, ORAL 8 YR Required Chronic Obstructive Professional Insulin (Insulin) C Intervention to Pulmonary Disease Prevent Permanent Cor Pulmonale Impairment/Damage Diabetes Mellitus Infection Left Ventricular Failure Pericardial Effusion Pleural Effusion Sedation Tachycardia Urinary Tract Infection Date:10/22/99ISR Number: 3379395-6Report Type:Expedited (15-DaCompany Report #GB/99/00883/LEX Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Oesophageal Carcinoma Foreign Clozaril (Clozapine) PS ORAL 700 MG, ONCE Health A DAY, ORAL Professional Losec (Omeprazole) C Venlafaxine (Venlafaxine) C Date:10/22/99ISR Number: 3379414-7Report Type:Expedited (15-DaCompany Report #GB/99/00910/LEX Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Cancer Female Foreign Clozaril (Clozapine) PS ORAL 300 MG, ORAL Health Professional Date:10/25/99ISR Number: 3379705-XReport Type:Direct Company Report # Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancreatitis Health Clozapine/ Zenith Initial or Prolonged Professional Goldline PS Zenith Goldline ORAL 100MG PO QD 22-Feb-2006 08:30 AM Page: 477 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/25/99ISR Number: 3380692-9Report Type:Expedited (15-DaCompany Report #USA/99/01883/LEX Age:62 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Benign Neoplasm Health Clozaril (Clozapine) PS ORAL 500 MG, Initial or Prolonged Gastric Ulcer Professional UNKNOWN, ORAL Required Gastroenteritis Depakene C Intervention to Helicobacter Cogentin C Prevent Permanent Gastrointestinal Impairment/Damage Haemorrhage Lung Disorder Date:10/25/99ISR Number: 3381870-5Report Type:Expedited (15-DaCompany Report #GB/99/00932/LEX Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Foreign Clozaril (Clozapine) PS ORAL ORAL Myocardial Infarction Health Professional Date:10/25/99ISR Number: 3382514-9Report Type:Expedited (15-DaCompany Report #USA/99/02577/LEX Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatitis A Health Clozaril (Clozapine) PS ORAL ORAL Hepatitis B Professional Clozapine SS ORAL 650 MG ORAL Hepatitis C Peri-Colace C Hepatitis Infectious Allegra-D (Fexofenadine Hydrochloride) C Glyburide (Glibenclamide) C Metoclopramide (Metoclopramide) C Multi-Vitamins (Multivitamins) C Omeprazole C Mesoridazine Besilate (Mesoridazine Besilate) C Date:10/25/99ISR Number: 3382515-0Report Type:Expedited (15-DaCompany Report #USA/99/01833/LEX Age:31 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dermatitis Health Clozaril (Clozapine) PS ORAL 450 MG, ORAL Fatigue Professional Prevacid Heat Stroke (Lansoprazole) C Hyperthermia Malignant Date:10/25/99ISR Number: 3382518-6Report Type:Expedited (15-DaCompany Report #USA/99/02590/LEX Age:42 YR Gender:Female I/FU:I Outcome Life-Threatening Hospitalization - Initial or Prolonged 22-Feb-2006 08:30 AM Page: 478 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Required Intervention to Prevent Permanent PT Report Source Product Role Manufacturer Route Dose Duration Impairment/Damage Colon Cancer Health Clozaril (Clozapine) PS ORAL 300 MG, ONCE Professional A DAY ORAL Risperdal (Risperidone) C Lorazepam C Propanolol (Propranolol) C Depakote (Valproate Semisodium) C Date:10/25/99ISR Number: 3382523-XReport Type:Expedited (15-DaCompany Report #USA/99/02591/LEX Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Urea Increased Health Clozaril (Clozapine) PS ORAL 500 MG, ORAL Initial or Prolonged Breast Cancer Female Professional Depakote (Valproate Other Nephritis Semisodium) C Respiratory Disorder Synthroid Vomiting (Levothyroxine Sodium) C Detrol C Triamterene/Hctz (Dyazide) C Date:10/25/99ISR Number: 3382524-1Report Type:Expedited (15-DaCompany Report #USA/99/01249/LEX Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abnormal Behaviour Health Clozaril (Clozapine) PS ORAL 900 MG, ORAL Life-Threatening Cardio-Respiratory Arrest Professional Navane (Tiotixene) SS ORAL 15 MG, THREE Hospitalization - Chest Pain TIMES A DAY, Initial or Prolonged Confusional State ORAL Required Convulsion Sulfacetamide C Intervention to Depression Prevent Permanent Disorientation Impairment/Damage Drug Level Above Therapeutic Joint Stiffness Leukocytosis Muscle Twitching Tachycardia Therapeutic Agent Toxicity Date:10/26/99ISR Number: 3381729-3Report Type:Expedited (15-DaCompany Report #99-08-0266 Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Health Clozapine - Zenith Heat Stroke Professional Goldline Pharm. Hepatic Steatosis Tablets PS ORAL 125-200 MG ORAL 1 YR Depakote C Zoloft C Cogentin C 22-Feb-2006 08:30 AM Page: 479 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/26/99ISR Number: 3381732-3Report Type:Expedited (15-DaCompany Report #99-10-0363 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine-Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 200-400MG ORAL Date:10/26/99ISR Number: 3381733-5Report Type:Expedited (15-DaCompany Report #99-10-0355 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neoplasm Malignant Health Clozapine-Zenith White Blood Cell Count Professional Goldline Pharm. Increased Tablets PS Zenith Goldline Pharm. 150-250 MG 15 MON Date:10/26/99ISR Number: 3381738-4Report Type:Expedited (15-DaCompany Report #99-10-0354 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Breast Cancer Female Health Clozapine - Zenith Intervention to Mastectomy Professional Goldline Pharm. Prevent Permanent Tablets PS Zenith Goldline Impairment/Damage Pharm. ORAL 600 MG ORAL Date:10/26/99ISR Number: 3381848-1Report Type:Expedited (15-DaCompany Report #99-10-0359 Age:73 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Pain Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 300MG ORAL Date:10/26/99ISR Number: 3381852-3Report Type:Expedited (15-DaCompany Report #99-09-0318 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death White Blood Cell Count Health Clozapine - Zenith Hospitalization - Increased Professional Goldline Pharm. Initial or Prolonged Tablets PS Zenith Goldline Pharm. 275MG-500MG Date:10/26/99ISR Number: 3381855-9Report Type:Expedited (15-DaCompany Report #99-09-0307 Age:59 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 200MG ORAL Depakote C Megace C Prevacid C 22-Feb-2006 08:30 AM Page: 480 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/26/99ISR Number: 3381856-0Report Type:Expedited (15-DaCompany Report #99-08-0233 Age:29 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Health Clozapine - Zenith Choking Professional Goldline Pharm. Completed Suicide Capsules PS Zenith Goldline Depression Pharm. ORAL 300-750MG/DAY Overdose ORAL Vomiting Zyprexa C Zantac Tablets C Zoloft Tablets C Propanolol C Date:10/29/99ISR Number: 3383853-8Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hyperglycaemia Health Clozapine (Dose Ketoacidosis Professional Unknown) PS Date:10/29/99ISR Number: 3383934-9Report Type:Direct Company Report # Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cough Health Clozaril PS Initial or Prolonged Diarrhoea Professional Prolixin Decanoate SS Lethargy Keflex C Nausea Rocephin C Orthostatic Hypotension Pyrexia Tachycardia Date:10/29/99ISR Number: 3384966-7Report Type:Expedited (15-DaCompany Report #99-09-0299 Age:42 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Leukocytosis Health Clozapine - Zenith Hospitalization - Respiratory Disorder Professional Goldline Pharm. Initial or Prolonged Tablets PS Zenith Goldline ORAL 175-700 MG ORAL Date:10/29/99ISR Number: 3384970-9Report Type:Expedited (15-DaCompany Report #99-10-0367 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Chronic Obstructive Clozapine - Zenith Pulmonary Disease Goldline Pharm. Sepsis Tablets PS Zenith Goldline ORAL 300 MG ORAL Shock White Blood Cell Count Increased 22-Feb-2006 08:30 AM Page: 481 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/29/99ISR Number: 3384971-0Report Type:Expedited (15-DaCompany Report #99-10-0368 Age:81 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine - Zenith White Blood Cell Count Professional Goldline Pharm. Increased Tablets PS Zenith Goldline ORAL 37.5 - 150 MG ORAL 1 YR Date:10/29/99ISR Number: 3384972-2Report Type:Expedited (15-DaCompany Report #99-10-0370 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death White Blood Cell Count Health Clozapine - Zenith Increased Professional Goldline Pharm. Tablets PS Zenith Goldline ORAL 500-600 MG ORAL Date:10/29/99ISR Number: 3384976-XReport Type:Expedited (15-DaCompany Report #99-08-0275 Age:86 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Atherosclerosis Health Clozapine - Zenith Cardiovascular Disorder Professional Goldline Pharm. Tablets PS Zenith Goldline ORAL 12.5 MG ORAL 3 MON Sinemet C Parlodel C Isordil C Choline Magnesium Trisalicylate C Nortriptyline C Date:10/29/99ISR Number: 3384977-1Report Type:Expedited (15-DaCompany Report #99-10-0372 Age:89 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline ORAL 12.5 MG ORAL Date:10/29/99ISR Number: 3385638-5Report Type:Expedited (15-DaCompany Report #USA/99/02473/LEX Age:83 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Clozaril (Clozapine) PS ORAL 25 MG, ONCE A Life-Threatening Congestive Professional DAY, ORAL Date:10/29/99ISR Number: 3385641-5Report Type:Expedited (15-DaCompany Report #GB/99/00732/LEX Age:66 YR Gender:Female I/FU:I Outcome PT Death Anaemia Required Anorexia Intervention to Ascites Prevent Permanent Cachexia Impairment/Damage Constipation Gait Disturbance 22-Feb-2006 08:30 AM Page: 482 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Intestinal Obstruction Ovarian Cancer Thrombocytopenia Report Source Product Role Manufacturer Route Dose Duration Foreign Clozaril (Clozapine) PS ORAL ORAL Health Professional Date:10/29/99ISR Number: 3392375-XReport Type:Periodic Company Report #8-98274-068A Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Health Ativan Tablets PS ORAL ORAL Initial or Prolonged Professional Clozaril (Clozapine) SS ORAL 550 MG ORAL Date:11/01/99ISR Number: 3386770-2Report Type:Expedited (15-DaCompany Report #USA/99/02366/LEX Age:62 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Cancer Female Health Clozaril (Clozapine) PS ORAL ORAL Professional Date:11/01/99ISR Number: 3386789-1Report Type:Expedited (15-DaCompany Report #D/99/01077/LEX Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dehydration Foreign Leponex (Clozapine) PS ORAL SEE IMAGE Required Diarrhoea Health Lovium (Diazepam) C Intervention to Gastroenteritis Professional Hypnorex (Lithum Prevent Permanent Escherichia Coli Carbonate) C Impairment/Damage Hypotension Tiapridex (Tiapride Leukocytosis Hydrochloride) C Shock Vomiting Date:11/01/99ISR Number: 3387149-XReport Type:Expedited (15-DaCompany Report #USA/99/02622/LEX Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Health Clozaril (Clozapine) PS ORAL ORAL 9 YR Initial or Prolonged Femur Fracture Professional Disability Thrombocytopenia Date:11/01/99ISR Number: 3387150-6Report Type:Expedited (15-DaCompany Report #USA/99/02392/LEX Age:59 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Multiple Myeloma Health Clozaril (Clozapine) PS ORAL 200 MG TWICE Other Professional A DAY ORAL Paxil (Paroxetine Hydrochloride) C 22-Feb-2006 08:30 AM Page: 483 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/01/99ISR Number: 3387151-8Report Type:Expedited (15-DaCompany Report #AUS/99/01428/LEX Age:76 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Lymphoma Foreign Clozaril (Clozapine) PS ORAL 350 MG ORAL Health Professional Date:11/01/99ISR Number: 3387152-XReport Type:Expedited (15-DaCompany Report #GB/99/00946/LEX Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Appendicectomy Foreign Clozaril (Clozapine) PS ORAL ORAL Initial or Prolonged Peritonitis Health Professional Date:11/01/99ISR Number: 3387153-1Report Type:Expedited (15-DaCompany Report #GB/99/00945/LEX Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthma Foreign Clozaril (Clozapine) PS ORAL 550 MG ORAL Bronchospasm Health Professional Date:11/01/99ISR Number: 3387154-3Report Type:Expedited (15-DaCompany Report #GB/99/00875/LEX Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intestinal Obstruction Foreign Clozaril (Clozapine) PS ORAL 350 MG ORAL Initial or Prolonged Metastasis Health Pelvic Peritoneal Professional Adhesions Date:11/01/99ISR Number: 3387155-5Report Type:Expedited (15-DaCompany Report #GB/99/00841/LEX Age:53 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Foreign Clozaril (Clozapine) PS ORAL 400 MG ORAL Coordination Abnormal Health Nervousness Professional Salivary Hypersecretion Date:11/01/99ISR Number: 3387156-7Report Type:Expedited (15-DaCompany Report #GB/99/00428/LEX Age:25 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Pain Foreign Clozaril (Clozapine) PS ORAL 255 MG ONCE A Required Circulatory Collapse Health DAY ORAL Intervention to Constipation Professional Epilim (Valproate Prevent Permanent Deep Vein Thrombosis Other Sodium) C Impairment/Damage Drug Level Above Orphenadrine Therapeutic (Orphenadrine) C Embolism Chlorpromazine Sudden Death (Chlorpromazine) C Dothiepin (Dosulepin) C Mebeverine 22-Feb-2006 08:30 AM Page: 484 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Mebeverine) C Fybogel (Ispaghula) C Date:11/01/99ISR Number: 3387160-9Report Type:Expedited (15-DaCompany Report #GB/99/00938/LEX Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Foreign Clozaril (Clozapine) PS ORAL 150 MG ONCE A Initial or Prolonged Diabetes Mellitus Other DAY ORAL Ketoacidosis Date:11/01/99ISR Number: 3387199-3Report Type:Expedited (15-DaCompany Report #USA/99/02714/LEX Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Health Clozaril (Clozapine) PS ORAL ORAL Professional Date:11/01/99ISR Number: 3387201-9Report Type:Expedited (15-DaCompany Report #CDN/99/00712/LEX Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Benign Hepatic Neoplasm Foreign Clozaril (Clozapine) PS ORAL 100 MG, ORAL Initial or Prolonged Hepatitis Cholestatic Health Eltroxin C Hepatocellular Damage Professional Liver Disorder Liver Function Test Abnormal Ultrasound Liver Abnormal Date:11/04/99ISR Number: 3388890-5Report Type:Expedited (15-DaCompany Report #D/95/02299/LEX Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Overdose Foreign Leponex PS ORAL 8 G, ONCE A Hospitalization - Suicide Attempt Health DAY, ORAL Initial or Prolonged Professional Other Date:11/04/99ISR Number: 3388936-4Report Type:Expedited (15-DaCompany Report #GB/99/00859/LEX Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anxiety Foreign Clozaril (Clozapine Drug Level Above Health ) PS ORAL 500 MG, TWICE Therapeutic Professional A DAY, ORAL Hepatomegaly Benzodiazepine Legal Problem (Benzodiazepine Sudden Death Derivatives) C Valproate Sodium (Valproate Sodium) C Lansoprazole (Lansoprazole) C 22-Feb-2006 08:30 AM Page: 485 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/04/99ISR Number: 3388937-6Report Type:Expedited (15-DaCompany Report #D/99/01372/LEX Age:66 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrioventricular Block Foreign Leponex (Clozapine) PS ORAL 6.25 MG ORAL Initial or Prolonged Study Madopar (Madopar) SS 1000 MG, (SEE Health IMAGE) Professional Tiapridex (Tiapride Hydrochloride) C Date:11/04/99ISR Number: 3388940-6Report Type:Expedited (15-DaCompany Report #GB/99/00746/LEX Age:25 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Bilirubin Increased Foreign Clozaril (Clozapine) PS ORAL 300 MG, ORAL Life-Threatening Encephalopathy Health Required Hepatic Enzyme Increased Professional Intervention to Hepatic Function Abnormal Prevent Permanent Hepatocellular Damage Impairment/Damage Hyperbilirubinaemia Jaundice Pneumonia Staphylococcal Sepsis Vomiting Date:11/04/99ISR Number: 3389011-5Report Type:Expedited (15-DaCompany Report #D/95/02958/LEX Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Leukopenia Foreign Leponex PS 175 MG, FOUR Other Neoplasm Malignant Health TIMES Required Viral Infection Professional Cisplatin SS ORAL A DAY ORAL Intervention to Haldol C Prevent Permanent Tavor C Impairment/Damage Date:11/04/99ISR Number: 3389025-5Report Type:Expedited (15-DaCompany Report #AUS/95/00010/LEX Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coma Foreign Clozaril PS ORAL 200 MG ONCE A Required Extradural Haematoma Health DAY ORAL 1 DAY Intervention to Professional Prevent Permanent Impairment/Damage Date:11/04/99ISR Number: 3389034-6Report Type:Expedited (15-DaCompany Report #AUS/95/00067/LEX Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Neoplasm Malignant Foreign Clozaril PS ORAL 200 MG, 300 Health MG, 325 MG, Professional 400 MG, 450 MG, 50 MG, 500 MG, 22-Feb-2006 08:30 AM Page: 486 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/04/99ISR Number: 3389042-5Report Type:Expedited (15-DaCompany Report #CDN/95/00109/LEX Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Clozaril PS ORAL 225 MG ORAL Health Elavil C Professional Date:11/04/99ISR Number: 3389047-4Report Type:Expedited (15-DaCompany Report #CDN/95/00208/LEX Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diarrhoea Foreign Clozaril PS Initial or Prolonged Ileitis Health Radiotherapy SS Required Neutropenia Professional Flagyl C Intervention to Gentamycin C Prevent Permanent Morphine C Impairment/Damage Date:11/04/99ISR Number: 3389053-XReport Type:Expedited (15-DaCompany Report #GB/95/00200/LEX Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bronchopneumonia Foreign Clozaril PS ORAL 500 MG ORAL Influenza Like Illness Health Temazepam C Intestinal Ischaemia Professional Chlorpromazine C Mesenteric Occlusion Pyrexia Vomiting Date:11/04/99ISR Number: 3389057-7Report Type:Expedited (15-DaCompany Report #GB/95/00210/LEX Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Clozaril PS ORAL 300 MG, TWICE Pulmonary Embolism Health A DAY, ORAL Professional Date:11/04/99ISR Number: 3389093-0Report Type:Expedited (15-DaCompany Report #D/95/00707/LEX Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cerebrovascular Disorder Foreign Leponex PS ORAL 25 MG, TWICE Required Cyanosis Health A DAY, ORAL; Intervention to Diabetes Mellitus Professional Melleril Retard 200 SS ORAL 200 MG, ONCE Prevent Permanent Inadequate Control A DAY, ORAL Impairment/Damage Hypotension Akineton Retard SS ORAL 4 MG, TWICE A Orthostatic Hypotension DAY, ORAL Tachycardia Transient Ischaemic Attack 22-Feb-2006 08:30 AM Page: 487 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/04/99ISR Number: 3389094-2Report Type:Expedited (15-DaCompany Report #F/95/07776/LEX Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Lymphoma Foreign Leponex PS ORAL 400 MG Required Other Imovane - Insomnia C Intervention to Levothyrox - Prevent Permanent Hypothyroidism C Impairment/Damage Levothyrox - Hypothyroidism C Corvasal - Angina C Lansoyl - Constipation C Date:11/04/99ISR Number: 3389096-6Report Type:Expedited (15-DaCompany Report #D/95/00707/MELR Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cerebrovascular Disorder Foreign Melleril Retard PS ORAL 200 MG, ONCE Required Cyanosis Health A DAY, ORAL Intervention to Hyperglycaemia Professional Leponex SS ORAL 25 MG, TWICE Prevent Permanent Hypotension A DAY, ORAL Impairment/Damage Orthostatic Hypotension Akineton Retard SS ORAL 4 MG, TWICE A Tachycardia DAY, ORAL Transient Ischaemic Euglucon N - Attack Diabetes Mellitus C Pepdul - Reflux Oesophagitis C Date:11/04/99ISR Number: 3390030-3Report Type:Expedited (15-DaCompany Report #B/95/00033/LEX Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Foreign Leponex PS ORAL 100 MG, ORAL; Hospitalization - Health 125 MG, ORAL; Initial or Prolonged Professional 15 MG, ORAL; Required 50 MG, ORAL, Intervention to 75 MG, ORAL Prevent Permanent Barnetil C Impairment/Damage Sabril C Dominal C Tegretol C Date:11/04/99ISR Number: 3390031-5Report Type:Expedited (15-DaCompany Report #GB/95/01424/LEX Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bronchopneumonia Foreign Clozaril PS ORAL 400 MG, ORAL Renal Failure Acute Health Professional Date:11/05/99ISR Number: 3389344-2Report Type:Expedited (15-DaCompany Report #GB/99/00841/LEX Age:53 YR Gender:Male I/FU:F Outcome PT Death Convulsion Coordination Abnormal Leukocytosis 22-Feb-2006 08:30 AM Page: 488 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lymphopenia Myocardial Infarction Nervousness Report Source Product Role Manufacturer Route Dose Duration Salivary Hypersecretion Foreign Clozaril (Clozapine) PS ORAL 400 MG, Sudden Death Health UNKNOWN, ORAL Professional Droperidol (Droperidol) C Date:11/05/99ISR Number: 3390079-0Report Type:Expedited (15-DaCompany Report #GB/94/00859/LEX Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aggression Foreign Clozaril PS ORAL 150 MG; 300 Required Cardiac Arrest Health MG, TWICE A Intervention to Cardio-Respiratory Arrest Professional DAY, ORAL Prevent Permanent Circulatory Collapse Clopixol SS 200MG Impairment/Damage Shock Haloperidol SS 2 MIN Melleril SS Lithium C Salbutamol C Ranitidine C Benzhexol C Date:11/05/99ISR Number: 3390081-9Report Type:Expedited (15-DaCompany Report #DK/94/00621/LEX Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aortic Valve Stenosis Foreign Leponex PS ORAL 25MG ORAL Arrhythmia Health Trilafon C Cardiomegaly Professional Akineton C Coronary Artery Disease Other Nozinan C Electrocardiogram Abnormal Electrocardiogram St Segment Abnormal Eosinophilia Left Ventricular Failure Myocardial Fibrosis Myocarditis Pyrexia Date:11/05/99ISR Number: 3390083-2Report Type:Expedited (15-DaCompany Report #DK/94/01243/LEX Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Headache Foreign Leponex PS ORAL 400MG ORAL Hospitalization - Pulmonary Infarction Other Nozinan C Initial or Prolonged Pyrexia Rohypnol C Required Intervention to Prevent Permanent Impairment/Damage 22-Feb-2006 08:30 AM Page: 489 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/05/99ISR Number: 3390098-4Report Type:Expedited (15-DaCompany Report #DW/94/00242/LEX Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Cataract Foreign Leponex PS ORAL SEE IMAGE Required Visual Disturbance Health Nipolept SS ORAL 25MG THREE Intervention to Professional TIMES A DAY Prevent Permanent ORAL Impairment/Damage Neurocil C Haldol C Date:11/05/99ISR Number: 3390099-6Report Type:Expedited (15-DaCompany Report #DW/94/00305/LEX Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Aspartate Foreign Leponex PS ORAL ORAL Other Aminotransferase Health Required Increased Professional Intervention to Electrocardiogram Prevent Permanent Abnormal Impairment/Damage Leukocytosis Overdose Respiratory Failure Suicide Attempt Date:11/05/99ISR Number: 3390100-XReport Type:Expedited (15-DaCompany Report #DW/94/00681/LEX Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coma Foreign Leponex PS ORAL 15G, Other Convulsion Health IRREGULAR Required Overdose Professional USE, ORAL Intervention to Suicide Attempt Prevent Permanent Supraventricular Impairment/Damage Tachycardia Date:11/05/99ISR Number: 3390101-1Report Type:Expedited (15-DaCompany Report #DW/94/00781/LEX Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Overdose Foreign Leponex PS ORAL 4300 MG, ORAL Required Suicide Attempt Health Intervention to Professional Prevent Permanent Impairment/Damage Date:11/05/99ISR Number: 3390102-3Report Type:Expedited (15-DaCompany Report #F/94/00632/LEX Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coma Foreign Leponex PS ORAL 500 MG, ORAL Hospitalization - Overdose Health Initial or Prolonged Suicide Attempt Professional Other Required Intervention to Prevent Permanent Impairment/Damage 22-Feb-2006 08:30 AM Page: 490 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/05/99ISR Number: 3390103-5Report Type:Expedited (15-DaCompany Report #N/94/00005/LEX Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hepatitis B Foreign Leponex PS ORAL 650 MG, ORAL Hepatitis C Health Graviscon Mixture C Hepatocellular Damage Professional Veractil C Other Date:11/05/99ISR Number: 3390104-7Report Type:Expedited (15-DaCompany Report #S/94/01276/LEX Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiomyopathy Foreign Leponex PS Other Date:11/08/99ISR Number: 3391225-5Report Type:Expedited (15-DaCompany Report #USA/99/01672/LEX Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetic Coma Health Clozaril (Clozapine) PS ORAL 400MG ORAL Hospitalization - Influenza Like Illness Professional Initial or Prolonged Other Date:11/08/99ISR Number: 3391227-9Report Type:Expedited (15-DaCompany Report #USA/99/02063/LEX Age:12 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Colon Cancer Health Clozaril (Clozapine) PS ORAL 300MG ONCE A Required Embolism Professional DAY ORAL Intervention to Lymphoma Depakote (Valproate Prevent Permanent Oedema Peripheral Semisodium) C Impairment/Damage Cogentin (Benzatropine Mesilate) C Synthroid (Levothyroxine Sodium) C Capoten (Captopril) C Hydrocel (Psyllium Hydrophilic Mucilloid) C Date:11/08/99ISR Number: 3391231-0Report Type:Expedited (15-DaCompany Report #USA/99/02761/LEX Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delirium Health Clozaril (Clozapine) PS ORAL 400MG ORAL Initial or Prolonged Enuresis Professional Effexor C Disability Haemodialysis Xanax C Other Hepatic Failure Ditropan C Hepatitis A Sudafed C Hepatitis B Hepatitis Infectious Muscle Necrosis Renal Failure Acute Rhabdomyolysis Urinary Incontinence 22-Feb-2006 08:30 AM Page: 491 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/08/99ISR Number: 3391232-2Report Type:Expedited (15-DaCompany Report #USA/99/02768/LEX Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Amylase Increased Health Clozaril (Clozapine) PS ORAL ORAL Initial or Prolonged Diverticulitis Professional Hyperglycaemia Date:11/08/99ISR Number: 3391242-5Report Type:Expedited (15-DaCompany Report #USA/99/02801/LEX Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Colitis Ulcerative Health Clozaril (Clozapine) PS ORAL ORAL Initial or Prolonged Professional Date:11/08/99ISR Number: 3391387-XReport Type:Expedited (15-DaCompany Report #IL/99/00502/LEX Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sepsis Foreign Leponex (Clozapine) PS ORAL ORAL Required Stridor Health Intervention to Professional Prevent Permanent Impairment/Damage Date:11/08/99ISR Number: 3391390-XReport Type:Expedited (15-DaCompany Report #AUS/99/01464/LEX Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Foreign Clozaril (Clozapine) PS ORAL 275 MG, ONCE Hepatitis Health A DAY, ORAL; Hypergammaglobulinaemia Professional Paroxetine Renal Failure Acute Other Hydrochloride (Paroxetine Hydrochloride) C Thyroxine Sodium (Levothyroxine Sodium) C Date:11/08/99ISR Number: 3391393-5Report Type:Expedited (15-DaCompany Report #GB/99/00978/LEX Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aneurysm Foreign Clozaril (Clozapine) PS ORAL 250 MG, ONCE Hypertension Health A DAY, ORAL; Subarachnoid Haemorrhage Professional Date:11/08/99ISR Number: 3391428-XReport Type:Expedited (15-DaCompany Report #USA/99/02802/LEX Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Amylase Increased Health Clozaril (Clozapine) PS ORAL ORAL Initial or Prolonged Colitis Professional Lipase Increased 22-Feb-2006 08:30 AM Page: 492 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/08/99ISR Number: 3391429-1Report Type:Expedited (15-DaCompany Report #USA/99/02803/LEX Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Health Clozaril (Clozapine) PS ORAL ORAL Initial or Prolonged Gastrointestinal Disorder Professional Irritable Bowel Syndrome Date:11/08/99ISR Number: 3391453-9Report Type:Expedited (15-DaCompany Report #USA/99/02727/LEX Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Breast Cancer Female Health Clozaril (Clozapine) PS 700 MG, Disability Professional UNKNOWN Other Dilantin (Phenytoin Sodium) C Cogentin (Benzatropine Mesilate) C Zinc Sulfate C Duragesic Patches (Fentanyl) C Dss (Docusate Sodium) C Mylanta C Tylenol #3 (Panadeine Co) C Roxanol (Morphine Sulfate) C Date:11/09/99ISR Number: 3391430-8Report Type:Direct Company Report # Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Thrombocythaemia Clozaril PS ORAL 300MG QD,PO Initial or Prolonged White Blood Cell Count Seroquel C Other Increased Lithium C Date:11/12/99ISR Number: 3396189-6Report Type:Expedited (15-DaCompany Report #AUS/99/01522/LEX Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Foreign Clozaril (Clozapine) PS ORAL ORAL Haemoglobin Decreased Health Malaise Professional Viral Pericarditis Date:11/12/99ISR Number: 3396191-4Report Type:Expedited (15-DaCompany Report #NZ/99/00080/LEX Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asthenia Foreign Clozaril (Clozapine) PS ORAL ORAL Cervix Carcinoma Health Professional 22-Feb-2006 08:30 AM Page: 493 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/15/99ISR Number: 3397379-9Report Type:Expedited (15-DaCompany Report #USA/99/02880/LEX Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Deep Vein Thrombosis Health Clozaril (Clozapine) PS 5 DAY Hospitalization - Pulmonary Embolism Professional Initial or Prolonged Renal Failure Acute Disability Other Date:11/15/99ISR Number: 3397380-5Report Type:Expedited (15-DaCompany Report #USA/99/02816/LEX Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Health Clozaril (Clozapine) PS ORAL 250 MG, TWICE Initial or Prolonged Hyperglycaemia Professional A DAY Prozac (Fluoxetine Hydrochloride) C Stelazine (Trifluoperazine Hydrochloride) C Date:11/15/99ISR Number: 3397919-XReport Type:Expedited (15-DaCompany Report #GB/99/00239/LEX Age:57 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Foreign Clozaril (Clozapine) PS ORAL 300 MG Dermatitis Health ORAL Eosinophilia Professional Trimethoprim Haemoglobin Decreased (Trimethoprim) C Leukocytosis Melaena Occult Blood Oesophageal Stenosis Oesophagitis Pyrexia Thrombocythaemia Urinary Tract Infection Date:11/15/99ISR Number: 3397999-1Report Type:Expedited (15-DaCompany Report #USA/99/02896/LEX Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Choking Consumer Clozaril (Clozapine) PS 400 M Hospitalization - Dysphagia Health Initial or Prolonged Professional Date:11/15/99ISR Number: 3398002-XReport Type:Expedited (15-DaCompany Report #USA/98/02862/LEX Age:44 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatitis C Health Clozaril (Clozapine) PS 400 MG Vomiting Professional Anafranil (Clomipramine Hydrochloride) C Colace (Docusate Sodium) C 22-Feb-2006 08:30 AM Page: 494 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/15/99ISR Number: 3398006-7Report Type:Expedited (15-DaCompany Report #USA/99/01867/LEX Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Constipation Health Clozaril (Clozapine) PS ORAL 400 MG Life-Threatening Infection Professional Lorazepam C Hospitalization - Intestinal Obstruction Diaphenydraminie C Initial or Prolonged Leukocytosis Premarin (Estrogens Disability Necrosis Ischaemic Conjugated) C Peritonitis Medroxyprogesterone C Date:11/15/99ISR Number: 3398009-2Report Type:Expedited (15-DaCompany Report #D/99/01312/LEX Age:46 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Foreign Leponex (Clozapine ) PS 400 MG Initial or Prolonged Hyperglycaemia Health Required Professional Intervention to Prevent Permanent Impairment/Damage Date:11/15/99ISR Number: 3398033-XReport Type:Expedited (15-DaCompany Report #IRL/99/01000/LEX Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Haematemesis Foreign Clozaril (Clozapine) PS 700 MG Hyperkalaemia Health Depixol (Flupentixol Leukocytosis Professional Decanoate) C Cipramil (Citalopram Hydrobromide) C Zimovane (Zopiclone) C Fybogel (Ispaghula) C Date:11/15/99ISR Number: 3398037-7Report Type:Expedited (15-DaCompany Report #AUS/99/01528/LEX Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Constipation Foreign Clozaril (Clozapine) PS 700 MG Initial or Prolonged Drug Effect Decreased Health Losec (Omeprazole) SS Required Drug Interaction Professional Plendil (Felodipine) Intervention to Drug Level Below - Hypertension C Prevent Permanent Therapeutic Impairment/Damage Headache Hyponatraemia Irritability Multi-Organ Failure Nervousness Polyuria Psychotic Disorder Sedation Thinking Abnormal Thirst 22-Feb-2006 08:30 AM Page: 495 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/16/99ISR Number: 3397789-XReport Type:Expedited (15-DaCompany Report #99-10-0381 Age:67 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hypertensive Heart Health Clozapine-Zenith Disease Professional Goldline Pharm. White Blood Cell Count Tablets PS ORAL 200-500MG Decreased ORAL White Blood Cell Count Increased Date:11/16/99ISR Number: 3397790-6Report Type:Expedited (15-DaCompany Report #99-09-0309 Age:60 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Ovarian Cancer Health Clozapine-Zenith Professional Goldline Pharm. Tablets PS ORAL 400MG ORAL Date:11/16/99ISR Number: 3397808-0Report Type:Expedited (15-DaCompany Report #99-10-0346 Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Breast Cancer Stage Iv Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline 550 MG 12 MON Date:11/16/99ISR Number: 3397810-9Report Type:Expedited (15-DaCompany Report #99-10-0363 Age:43 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Delusion Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline ORAL 200-400 MG ORAL Trazodone C Date:11/16/99ISR Number: 3397917-6Report Type:Expedited (15-DaCompany Report #USA/99/02885/LEX Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Level Above Health Clozaril (Clozapine) PS Therapeutic Professional Drug Toxicity Date:11/16/99ISR Number: 3398429-6Report Type:Expedited (15-DaCompany Report #9941919 Age: Gender:Male I/FU:F Outcome PT Hospitalization - Asthenia Initial or Prolonged Biopsy Muscle Abnormal Required Blood Creatine Intervention to Phosphokinase Increased Prevent Permanent Muscle Rigidity Impairment/Damage Myalgia Myopathy Myopathy Toxic 22-Feb-2006 08:30 AM Page: 496 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pain Report Source Product Role Manufacturer Route Dose Duration Health Zoloft Tablets PS Professional Clozapine SS Klonopin C Date:11/16/99ISR Number: 3412213-6Report Type:Periodic Company Report #1999-001686 Age:50 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hallucination, Auditory Health Flomax (Tamsulosin) Professional Capsules/0.4 Mg PS 0.4 MG Clozaril SS 350 MG Paxil C Date:11/22/99ISR Number: 3403652-8Report Type:Direct Company Report # Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Amnesia Wellbutrin Sr PS TITRATED FROM Drug Interaction 6/2-6/25 Loss Of Consciousness 150MG Q AM , Tonic Convulsion NOON & PM Clozapine 150mg SS 150MG Q HS Effexor Xr C Date:11/22/99ISR Number: 3405258-3Report Type:Expedited (15-DaCompany Report #GB/99/01024/LEX Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Amylase Increased Foreign Clozaril (Clozapine) PS ORAL 100 MG, TWICE Required Nausea Health A DAY, ORAL Intervention to Professional Risperidone Prevent Permanent Other (Risperidone) C Impairment/Damage Lansoprazole (Lansoprazole) C Lithium Carbonate (Lithium Carbonate) C Metoclopramide (Metoclopramide) C Date:11/22/99ISR Number: 3405259-5Report Type:Expedited (15-DaCompany Report #GB/99/00745/LEX Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Gastric Outlet Foreign Clozaril (Clozapine) PS ORAL 600 MG, ORAL Initial or Prolonged Obstruction Health Pilonidal Cyst Professional Pyrexia 22-Feb-2006 08:30 AM Page: 497 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/22/99ISR Number: 3405260-1Report Type:Expedited (15-DaCompany Report #USA/99/01882/LEX Age:74 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozaril (Clozapine) PS ORAL 175 MG, ORAL Hospitalization - Breast Cancer Female Professional Chemotherapy Initial or Prolonged Leukopenia (Chemotherapy SS Other Amantadine C Required Pepcid (Famotidine) C Intervention to Fluoxetine C Prevent Permanent Heparin C Impairment/Damage Multivitamins C Potassium C Date:11/22/99ISR Number: 3405261-3Report Type:Expedited (15-DaCompany Report #USA/99/02926/LEX Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Cancer Female Health Clozaril (Clozapine) PS ORAL 300 MG, ORAL Inflammatory Carcinoma Of Professional The Breast Date:11/22/99ISR Number: 3405325-4Report Type:Expedited (15-DaCompany Report #USA/99/02966/LEX Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Clozaril (Clozapine) PS ORAL 450 MG, ORAL Dehydration Professional Desipramine C Drug Level Above Stelazine Therapeutic (Trifluoperazine Overdose Hydrochloride) C Cogentin (Benzatropine Mesilate) C Docusate C Date:11/22/99ISR Number: 3405328-XReport Type:Expedited (15-DaCompany Report #USA/99/03001/LEX Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukaemia Health Clozaril (Clozapine) PS ORAL 500 MG, ORAL Leukocytosis Professional Neutropenia Date:11/22/99ISR Number: 3405330-8Report Type:Expedited (15-DaCompany Report #USA/99/02996/LEX Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozaril (Clozapine) PS ORAL 700 MG, ORAL Professional Date:11/22/99ISR Number: 3405333-3Report Type:Expedited (15-DaCompany Report #USA/99/02959/LEX Age:56 YR Gender:Female I/FU:I Outcome PT Hospitalization - Left Ventricular Failure Initial or Prolonged Supraventricular 22-Feb-2006 08:30 AM Page: 498 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tachycardia Ventricular Hypertrophy Report Source Product Role Manufacturer Route Dose Duration Health Clozaril (Clozapine) PS ORAL 300 MG, ORAL Professional Risperdal (Risperidone) C Date:11/22/99ISR Number: 3405869-5Report Type:Expedited (15-DaCompany Report #USA/99/02906/LEX Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Colon Cancer Health Clozaril (Clozapine) PS ORAL 300MG ORAL Required Leukopenia Professional Ativan (Lorazepam) C Intervention to Depakote (Valproate Prevent Permanent Semisodium) C Impairment/Damage Inderal (Propranolol Hydrochloride) C Date:11/22/99ISR Number: 3405894-4Report Type:Expedited (15-DaCompany Report #USA/99/02018/LEX Age:51 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neoplasm Malignant Health Clozaril (Clozapine) PS ORAL ORAL Professional Clozapine SS ORAL ORAL Radiation (Non-Drug : Radio-Therapy) C Date:11/23/99ISR Number: 3404167-3Report Type:Direct Company Report # Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Convulsion Health Clozapine PS ORAL 800MG PO QD Intervention to Drooling Professional Clozapine SS 100MG TABLETS Prevent Permanent Drug Level Above BRAND Impairment/Damage Therapeutic Fall Syncope Tremor Date:11/23/99ISR Number: 3406564-9Report Type:Periodic Company Report #USA/99/01812/LEX Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dystonia Health Clozaril (Clozapine) PS ORAL 100 MG, THREE Initial or Prolonged Hypotension Professional TIMES A DAY, Syncope ORAL Tardive Dyskinesia Ativan C Vitamin E C Date:11/23/99ISR Number: 3406565-0Report Type:Periodic Company Report #USA/99/01806/LEX Age:39 YR Gender:Female I/FU:I Outcome Other Required Intervention to 22-Feb-2006 08:30 AM Page: 499 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Convulsion Health Clozaril (Clozapine) PS ORAL 700 MG ORAL Drug Interaction Professional Paxil (Paroxetine Drug Level Above Hydrochloride) SS 40 MG Therapeutic Date:11/23/99ISR Number: 3406566-2Report Type:Periodic Company Report #USA/99/01736/LEX Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Priapism Health Clozaril (Clozapine) PS ORAL 400 MG, ORAL Initial or Prolonged Professional Depakote C Required Cogentin C Intervention to Prolixin C Prevent Permanent Buspar C Impairment/Damage Zyprexa C Prozac C Date:11/23/99ISR Number: 3406567-4Report Type:Periodic Company Report #USA/99/01718/LEX Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Clozaril (Clozapine) PS ORAL 700 MG, ONCE Initial or Prolonged Delusion Professional A DAY, ORAL Required Depression Luvox (Fluvoxamine Intervention to Hallucination Maleate) SS 150 MG Prevent Permanent Sedation Wellbutrin C Impairment/Damage Weight Increased Buspar C Date:11/23/99ISR Number: 3406568-6Report Type:Periodic Company Report #USA/99/01719/LEX Age:18 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Eosinophilia Health Clozaril (Clozapine) PS ORAL 250 MG, ORAL Leukocytosis Professional Valproate C Depakote C Date:11/23/99ISR Number: 3406569-8Report Type:Periodic Company Report #USA/99/01702/LEX Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozaril (Clozapine) PS ORAL 200 MG, ORAL Required Professional Lipitor C Intervention to Thorazine C Prevent Permanent Artane C Impairment/Damage Synthroid C Risperdal C Inapsine C Tradozone C 22-Feb-2006 08:30 AM Page: 500 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/23/99ISR Number: 3406570-4Report Type:Periodic Company Report #USA/99/01703/LEX Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozaril (Clozapine) PS ORAL 200 MG, ORAL Hospitalization - Confusional State Professional Klonopin C Initial or Prolonged Paranoia Vitamin E C Disability Colace C Required Intervention to Prevent Permanent Impairment/Damage Date:11/23/99ISR Number: 3406571-6Report Type:Periodic Company Report #USA/99/01709/LEX Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Clozaril (Clozapine) PS ORAL 900 MG, ORAL Professional Depakote C Haldol C Eskalith C Cogentin C Date:11/23/99ISR Number: 3406572-8Report Type:Periodic Company Report #USA/99/01675/LEX Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Pneumonia Health Clozaril (Clozapine) PS ORAL 257 MG, ORAL Hospitalization - Weight Increased Professional Zoloft C Initial or Prolonged Tylenol With Codeine C Morphine C Cefuroxime C Streptokinase C Vancomycin C Ceftriaxone C Potassium C Date:11/23/99ISR Number: 3406573-XReport Type:Periodic Company Report #USA/99/01667/LEX Age:83 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) PS ORAL 50 MG, ORAL Life-Threatening Professional Date:11/23/99ISR Number: 3406574-1Report Type:Periodic Company Report #USA/99/01668/LEX Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiovascular Disorder Health Clozaril (Clozapine) PS ORAL 450 MG, ONCE Hospitalization - Overdose Professional A DAY, ORAL Initial or Prolonged Zestril C Glucophage C Klonopin C Prozac C 22-Feb-2006 08:30 AM Page: 501 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/23/99ISR Number: 3406575-3Report Type:Periodic Company Report #USA/99/01673/LEX Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukocytosis Health Clozaril (Clozapine) PS ORAL 500 MG, ORAL Initial or Prolonged Leukopenia Professional Levaquia Required Neutropenia (Levofloxacin) SS ORAL 500 MG, ORAL Intervention to Neutrophilia Lithium C Prevent Permanent Pneumonia Impairment/Damage Date:11/23/99ISR Number: 3406576-5Report Type:Periodic Company Report #USA/99/01644/LEX Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) PS Professional Date:11/23/99ISR Number: 3406577-7Report Type:Periodic Company Report #USA/99/01641/LEX Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukocytosis Health Clozaril (Clozapine) PS ORAL 600 MG, ORAL Neuroleptic Malignant Professional Depakote C Syndrome Cogentin C Pyrexia Date:11/23/99ISR Number: 3406578-9Report Type:Periodic Company Report #USA/99/01570/LEX Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) PS ORAL ORAL Professional Date:11/23/99ISR Number: 3406579-0Report Type:Periodic Company Report #USA/99/01597/LEX Age:71 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) PS ORAL 200 TO 300 Hospitalization - Professional MG, ORAL Initial or Prolonged Date:11/23/99ISR Number: 3406580-7Report Type:Periodic Company Report #USA/99/01625/LEX Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intestinal Obstruction Health Clozaril (Clozapine) PS ORAL 300 MG, THREE Initial or Prolonged Professional TIMES A DAY, Required ORAL Intervention to Depakote C Prevent Permanent Prozac C Impairment/Damage 22-Feb-2006 08:30 AM Page: 502 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/23/99ISR Number: 3406581-9Report Type:Periodic Company Report #USA/99/01531/LEX Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperglycaemia Health Clozaril (Clozapine) PS Initial or Prolonged Professional Date:11/23/99ISR Number: 3406582-0Report Type:Periodic Company Report #USA/99/01509/LEX Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Clozaril (Clozapine) PS ORAL 250 MG, THREE Required Muscle Contractions Professional TIMES A DAY, Intervention to Involuntary ORAL Prevent Permanent Cogentin C Impairment/Damage Date:11/23/99ISR Number: 3406583-2Report Type:Periodic Company Report #USA/99/01448/LEX Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Health Clozaril (Clozapine) PS ORAL 300 MG, ORAL 5 YR Professional Date:11/23/99ISR Number: 3406584-4Report Type:Periodic Company Report #USA/99/01488/LEX Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Health Clozaril (Clozapine) PS ORAL 550 MG ORAL Initial or Prolonged Fall Professional Required Fatigue Intervention to Laboratory Test Abnormal Prevent Permanent Oedema Impairment/Damage Oliguria Pulmonary Embolism Date:11/23/99ISR Number: 3406585-6Report Type:Periodic Company Report #USA/99/01429/LEX Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Convulsion Health Clozaril (Clozapine) PS ORAL 700 MG, ORAL Required Professional Risperdal Intervention to (Risperidone) C Prevent Permanent Docusate Sodium C Impairment/Damage Cogentin (Benzatropine Mesilate) C Date:11/23/99ISR Number: 3406586-8Report Type:Periodic Company Report #USA/99/01408/LEX Age:79 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Study Clozaril (Clozapine) PS ORAL 88 MG, ORAL Health Professional 22-Feb-2006 08:30 AM Page: 503 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/23/99ISR Number: 3406587-XReport Type:Periodic Company Report #USA/99/01425/LEX Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Study Clozaril (Clozapine) PS ORAL 100 MG, ORAL Health Professional Date:11/23/99ISR Number: 3406588-1Report Type:Periodic Company Report #USA/99/01396/LEX Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) PS ORAL 400 MG, ORAL Professional Cogentin (Benzatropine Mesilate) C Date:11/23/99ISR Number: 3406589-3Report Type:Periodic Company Report #USA/99/01375/LEX Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pyrexia Health Clozaril (Clozapine) PS ORAL 175 MG, ORAL Initial or Prolonged Tachycardia Professional Depakote (Valproate Semisodium) C Date:11/23/99ISR Number: 3406590-XReport Type:Periodic Company Report #USA/99/01370/LEX Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Clozaril (Clozapine) PS ORAL 350 MG ,TWICE Electroencephalogram Professional A DAY, ORAL; Abnormal Depakote (Valproate Semisodium) C Ritalin (Methylphenidate Hydrochloride) C Date:11/23/99ISR Number: 3406591-1Report Type:Periodic Company Report #USA/99/01368/LEX Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Health Clozaril (Clozapine) PS ORAL 100 MG, TWICE Initial or Prolonged Neutropenia Professional A DAY, ORAL Required Benzatropine C Intervention to Prevent Permanent Impairment/Damage Date:11/23/99ISR Number: 3406592-3Report Type:Periodic Company Report #USA/99/01347/LEX Age:53 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) PS ORAL UNSPECIFIED, Professional ORAL 22-Feb-2006 08:30 AM Page: 504 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/23/99ISR Number: 3406593-5Report Type:Periodic Company Report #USA/99/01342/LEX Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Respiratory Depression Health Clozaril (Clozapine) PS ORAL 600 MG, ONCE Initial or Prolonged Professional A DAY, ORAL Required Alcohol (Ethanol) C Intervention to Marijuana (Cannabis) C Prevent Permanent Impairment/Damage Date:11/23/99ISR Number: 3406594-7Report Type:Periodic Company Report #USA/99/01336/LEX Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Clozaril (Clozapine) PS ORAL 300 MG, ORAL; Initial or Prolonged Professional Zyprexa (Olanzapine) SS Synthroid (Levothyroxine Sodium) C Date:11/23/99ISR Number: 3406595-9Report Type:Periodic Company Report #USA/99/01322/LEX Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Health Clozaril (Clozapine) PS ORAL UNSPECIFIED, Life-Threatening Professional ORAL Date:11/23/99ISR Number: 3406596-0Report Type:Periodic Company Report #USA/99/01300/LEX Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Study Clozaril (Clozapine) PS ORAL 750 MG, ORAL; Hospitalization - Health Initial or Prolonged Professional Date:11/23/99ISR Number: 3406597-2Report Type:Periodic Company Report #USA/99/01309/LEX Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Infection Health Clozaril (Clozapine) PS ORAL 500 MG, ORAL Initial or Prolonged Leukopenia Professional Risperdal Required (Risperidone) C Intervention to Depakote (Valproate Prevent Permanent Semisodium) C Impairment/Damage Date:11/23/99ISR Number: 3406598-4Report Type:Periodic Company Report #USA/99/01296/LEX Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intestinal Obstruction Health Clozaril (Clozapine) PS ORAL 550 MG, ORAL; Initial or Prolonged Professional Haldol (Haloperidol) C Required Depakote (Valproate Intervention to Semisodium) C Prevent Permanent Buspar (Buspirone Impairment/Damage Hydrochloride) C 22-Feb-2006 08:30 AM Page: 505 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Synthroid (Levothyroxine Sodium) C Date:11/23/99ISR Number: 3406599-6Report Type:Periodic Company Report #USA/99/01280/LEX Age:13 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperglycaemia Health Clozaril (Clozapine) PS ORAL 100 MG, ONCE Initial or Prolonged Polyuria Professional A DAY, ORAL Required Thirst Depakote (Valproate Intervention to Semisodium) C Prevent Permanent Paxil (Paroxetine Impairment/Damage Hydrohcloride) C Celex (Cefalexin Monohydrate) C Navane (Tiotixene) C Cogentin (Benzatropine Mesilate) C Date:11/23/99ISR Number: 3406600-XReport Type:Periodic Company Report #USA/99/01230/LEX Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) PS ORAL 400 MG, ORAL Professional Cogentin (Benzatropine Mesilate) C Date:11/23/99ISR Number: 3406601-1Report Type:Periodic Company Report #USA/99/01225/LEX Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) PS ORAL 75 MG, ORAL Professional Date:11/23/99ISR Number: 3406602-3Report Type:Periodic Company Report #USA/99/01197/LEX Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Drug Withdrawal Syndrome Health Clozaril (Clozapine) PS ORAL 700 MG, ORAL Psychotic Disorder Professional Carbamazepine C Haldol (Haloperidol) C Mellaril (Thioridazine Hydrochloride) C Ativan (Lorazepam) C Date:11/23/99ISR Number: 3406603-5Report Type:Periodic Company Report #USA/99/01199/LEX Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Level Above Health Clozaril (Clozapine) PS ORAL 600 MG, ORAL Therapeutic Professional 22-Feb-2006 08:30 AM Page: 506 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/23/99ISR Number: 3406604-7Report Type:Periodic Company Report #USA/99/01189/LEX Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrial Fibrillation Health Clozaril (Clozapine) PS 100 MG Initial or Prolonged Blood Creatine Professional Risperdal Required Phosphokinase Increased (Risperidone) C Intervention to Confusional State Cogentin Prevent Permanent Coordination Abnormal (Benzatropine Impairment/Damage Diarrhoea Mesilate) C Dyspnoea Depakote (Valproate Pyrexia Semisodium) C Sedation Lopressor Tachycardia (Metoprolol Urinary Incontinence Tartrate) C Digoxin C Coumadin (Warfarin Sodium) C Date:11/23/99ISR Number: 3406605-9Report Type:Periodic Company Report #USA/99/01142/LEX Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dizziness Health Clozaril (Clozapine) PS ORAL 525 MG ORAL Initial or Prolonged Orthostatic Hypotension Professional Date:11/23/99ISR Number: 3406606-0Report Type:Periodic Company Report #USA/99/01118/LEX Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ketoacidosis Health Clozaril (Clozapine) PS ORAL 25 MG ORAL Initial or Prolonged Professional Date:11/23/99ISR Number: 3406607-2Report Type:Periodic Company Report #USA/99/01130/LEX Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Health Clozaril (Clozapine) PS ORAL 400 MG ORAL Initial or Prolonged Neutropenia Professional Atenolol C Required Neutrophilia Klonopin Intervention to (Clonazepam) C Prevent Permanent Vitamin B12 Impairment/Damage (Cyanocobalamin) C Date:11/23/99ISR Number: 3406608-4Report Type:Periodic Company Report #USA/99/01104/LEX Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Diarrhoea Health Clozaril (Clozapine) PS ORAL 150 MG, TWICE Hospitalization - Dyspnoea Professional A DAY, ORAL Initial or Prolonged Pyrexia Olanzapine C Disability 22-Feb-2006 08:30 AM Page: 507 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/23/99ISR Number: 3406609-6Report Type:Periodic Company Report #USA/99/01105/LEX Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Diarrhoea Health Clozaril (Clozapine) PS ORAL 300 MG, ORAL Hospitalization - Dyspnoea Professional Olanzapine C Initial or Prolonged Pneumonia Disability Pyrexia Required Intervention to Prevent Permanent Impairment/Damage Date:11/23/99ISR Number: 3406610-2Report Type:Periodic Company Report #USA/99/01065/LEX Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Creatine Health Clozaril (Clozapine) PS ORAL 150 MG TWICE Required Phosphokinase Increased Professional A DAY, ORAL Intervention to Delirium Haldol C Prevent Permanent Hepatic Function Abnormal Impairment/Damage Hypertension Leukocytosis Pyrexia Date:11/23/99ISR Number: 3406611-4Report Type:Periodic Company Report #USA/99/01067/LEX Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delusion Health Clozaril (Clozapine) PS ORAL 350 MG ORAL Initial or Prolonged Depression Professional Flomax (Tamsulosin) SS 4 MG, Required Hallucination Paxil (Paroxetine Intervention to Micturition Urgency Hydrochloride) C Prevent Permanent Pollakiuria Impairment/Damage Prostatic Disorder Date:11/23/99ISR Number: 3406612-6Report Type:Periodic Company Report #USA/99/01073/LEX Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) PS ORAL 100 MG ORAL Professional Prolixin (Fluphenazine Hydrochloride) C Cogentin (Benzatropine Mesilate) C Date:11/23/99ISR Number: 3406613-8Report Type:Periodic Company Report #USA/99/01077/LEX Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozaril (Clozapine) PS ORAL 250 MG, ORAL Required Neutropenia Professional Valproic Acid C Intervention to Buspar (Buspirone Prevent Permanent Hydrochloride) C Impairment/Damage Effexor (Venlafaxine Hydrochloride) C 22-Feb-2006 08:30 AM Page: 508 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Naltrexone (Naltrexone) C Colace (Docusate Sodium) C Date:11/23/99ISR Number: 3406614-XReport Type:Periodic Company Report #USA/99/01027/LEX Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Back Disorder Health Clozaril (Clozapine) PS Dysphagia Professional Post Procedural Complication Refusal Of Treatment By Patient Surgery Date:11/23/99ISR Number: 3406615-1Report Type:Periodic Company Report #USA/99/01028/LEX Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anorexia Health Clozaril (Clozapine) PS 800 MG Initial or Prolonged Depression Professional Psychotic Disorder Date:11/23/99ISR Number: 3406616-3Report Type:Periodic Company Report #USA/99/01031/LEX Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pericarditis Health Clozaril (Clozapine) PS ORAL 700 MG ORAL Initial or Prolonged Syncope Professional Depakene (Valproate Sodium) C Neurontin (Gabapentin) C Date:11/23/99ISR Number: 3406617-5Report Type:Periodic Company Report #USA/99/01007/LEX Age:87 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) PS ORAL ORAL Professional Date:11/23/99ISR Number: 3406618-7Report Type:Periodic Company Report #USA/99/01013/LEX Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Attention Health Clozaril (Clozapine) PS ORAL 112.5 MG, Initial or Prolonged Deficit/Hyperactivity Professional ORAL Required Disorder Risperdal Intervention to Confusional State (Risperidone) SS Prevent Permanent Emotional Disorder Prozac C Impairment/Damage Extrapyramidal Disorder Cogentin C Hallucination Benadryl C Paranoia Tachycardia 22-Feb-2006 08:30 AM Page: 509 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/23/99ISR Number: 3406619-9Report Type:Periodic Company Report #USA/99/00970/LEX Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozaril (Clozapine) PS ORAL 700 MG, ORAL Hospitalization - Leukopenia Professional Haldol (Haloperidol) C Initial or Prolonged Prozac (Fluoxetine Required Hydrochloride) C Intervention to Multi-Vitamin Prevent Permanent (Multivitamins) C Impairment/Damage Date:11/23/99ISR Number: 3406620-5Report Type:Periodic Company Report #USA/99/00936/LEX Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) PS ORAL 775 MG, ORAL Professional Date:11/23/99ISR Number: 3406621-7Report Type:Periodic Company Report #USA/99/00932/LEX Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) PS ORAL 900 MG, ORAL Professional Prozac C Date:11/23/99ISR Number: 3406622-9Report Type:Periodic Company Report #USA/99/00911/LEX Age:67 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pyrexia Health Clozaril (Clozapine) PS ORAL 100 MG, THREE Initial or Prolonged Professional TIMES A DAY, Required ORAL 1 MON Intervention to Sinemet C Prevent Permanent Impairment/Damage Date:11/23/99ISR Number: 3406623-0Report Type:Periodic Company Report #USA/99/00895/LEX Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Leukopenia Health Clozaril (Clozapine) PS ORAL ORAL Required Neutropenia Professional Chemotherapy Intervention to (Chemotherapy) C Prevent Permanent Neupogen Impairment/Damage (Filgrastim) C Epogen C Date:11/23/99ISR Number: 3406700-4Report Type:Periodic Company Report #USA/98/03031/LEX Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Infection Health Clozaril (Clozapine) PS ORAL 600 MG ORAL Initial or Prolonged Psychotic Disorder Professional Depakote (Valproate Pyrexia Semisodium) C White Blood Cell Count Oral Hypoglycemic Decreased (Oral Antidiabetics) C 22-Feb-2006 08:30 AM Page: 510 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/23/99ISR Number: 3406701-6Report Type:Periodic Company Report #USA/98/03024/LEX Age:73 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) PS ORAL 25 MG, ORAL Professional Date:11/23/99ISR Number: 3406702-8Report Type:Periodic Company Report #USA/98/03027/LEX Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dizziness Health Clozaril (Clozapine) PS ORAL 300 MG, ORAL Initial or Prolonged Hypertension Professional Depakote (Valproate Required Sedation Semisodium) C Intervention to Tachycardia Vitamin B6 Prevent Permanent Unevaluable Event (Pyridoxine Impairment/Damage Hydrochloride) C Cogentin C Paxil C Dilantin C Calan C Peri-Colace C Haldol C Date:11/23/99ISR Number: 3406703-XReport Type:Periodic Company Report #USA/98/03001/LEX Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fatigue Health Clozaril (Clozapine) PS ORAL 400 MG, ORAL Initial or Prolonged Feeling Cold Professional Lithium C Required Leukopenia Intervention to Pharyngitis Prevent Permanent Impairment/Damage Date:11/23/99ISR Number: 3406704-1Report Type:Periodic Company Report #USA/98/02991/LEX Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Health Clozaril (Clozapine) PS ORAL 800 MG, ORAL Initial or Prolonged Blood Magnesium Decreased Professional Paxil (Paroxetine Required Hypokalaemia Hydrochloride) C Intervention to Orthostatic Hypotension Klonopin Prevent Permanent Pyrexia (Clonazepam) C Impairment/Damage Zyprexa( Olanzapine) C Cogentin (Benzatropine Mesilate) C Amnoxicillin C Risperdal (Risperidone) C Date:11/23/99ISR Number: 3406705-3Report Type:Periodic Company Report #USA/98/02977/LEX Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Health Clozaril (Clozapine) PS ORAL ORAL Professional 22-Feb-2006 08:30 AM Page: 511 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/23/99ISR Number: 3406706-5Report Type:Periodic Company Report #USA/98/02954/LEX Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Clozaril (Clozapine) PS ORAL 750 MG, ORAL Required Leukocytosis Professional Luvox (Fluvoxamine Intervention to Maleate) C Prevent Permanent Impairment/Damage Date:11/23/99ISR Number: 3406707-7Report Type:Periodic Company Report #USA/98/02927/LEX Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delirium Health Clozaril (Clozapine) PS ORAL 275 MG, ORAL Initial or Prolonged Drug Interaction Professional Depakote (Valproate Required Hyperglycaemia Semisodium) SS ORAL 1 G, ORAL Intervention to Muscular Weakness Lithium SS ORAL 300 MG, THREE Prevent Permanent Pyrexia TIMES A DAY, Impairment/Damage Salivary Hypersecretion ORAL Urinary Tract Infection Date:11/23/99ISR Number: 3406708-9Report Type:Periodic Company Report #USA/98/02917/LEX Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) PS 175 MG,ORAL Professional Date:11/23/99ISR Number: 3406709-0Report Type:Periodic Company Report #USA/99/00240/LEX Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutropenia Health Clozaril (Clozapine) PS ORAL 75 MG, ORAL Initial or Prolonged Pyrexia Professional Prolixin Required (Fluphenazine Intervention to Hydrochloride) C Prevent Permanent Digoxin C Impairment/Damage Betapace (Sotalol Hydrochloride) C Proventil (Salbutamol) C Asa (Acetylsallicyclic Acid) C Date:11/23/99ISR Number: 3406710-7Report Type:Periodic Company Report #USA/99/00235/LEX Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrial Fibrillation Health Clozaril (Clozapine) PS ORAL 150 MG, TWICE Initial or Prolonged Diarrhoea Professional A DAY, ORAL;, Required Drug Level Above 200 MG, TWICE Intervention to Therapeutic A DAY, ORAL;, Prevent Permanent Pneumonia UNKNOWN, Impairment/Damage Vomiting Risperidone C Depakote (Valproate Semisodium) C 22-Feb-2006 08:30 AM Page: 512 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Mesalamine (Mesalazine) C Levothyroxine C Prednisone C Inderal (Propranolol Hydrochloride) C Date:11/23/99ISR Number: 3406711-9Report Type:Periodic Company Report #USA/99/00227/LEX Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Health Clozaril (Clozapine) PS ORAL 800 MG, ORAL Initial or Prolonged Grand Mal Convulsion Professional Thorazine Hypotension (Chlorpromazine Speech Disorder Hydrochloride) C Cogentin (Benzatropine Mesilate) C Neurontin (Gabapentin) C Depakote (Valproate Semisodium) C Date:11/23/99ISR Number: 3406712-0Report Type:Periodic Company Report #USA/99/00207/LEX Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Consumer Clozaril (Clozapine) PS ORAL 650 MG, ORAL Hospitalization - Leukopenia Lorazepam C Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage Date:11/23/99ISR Number: 3406713-2Report Type:Periodic Company Report #USA/99/00175/LEX Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neutropenia Health Clozaril (Clozapine) PS ORAL 550 MG, Hospitalization - Professional UNKNOWN, ORAL Initial or Prolonged Olanzapine C Risperdal (Risperidone) C Depakote (Valproate Semisodium) C Gabapentin C Cogentin (Benzatropine Mesilate) C Multivitamin (Multivitamin) C Ferrous Sulfate C Docusate Sodium C 22-Feb-2006 08:30 AM Page: 513 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/23/99ISR Number: 3406714-4Report Type:Periodic Company Report #USA/99/00177/LEX Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Health Clozaril (Clozapine) PS ORAL 650 MG, ORAL Professional Prozac (Fluoxetine Hydrochloride) C Date:11/23/99ISR Number: 3406715-6Report Type:Periodic Company Report #USA/99/00157/LEX Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Nausea Health Clozaril (Clozapine) PS ORAL 900 MG, Initial or Prolonged Vomiting Professional UNKNOWN, ORAL Lipitor (Atorvastatin) C Prevacid (Lansoprazole) C Date:11/23/99ISR Number: 3406716-8Report Type:Periodic Company Report #USA/99/00133/LEX Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutropenia Health Clozaril (Clozapine) PS ORAL 700 MG, ORAL Initial or Prolonged Professional Depakote (Valproate Required Semisodium) C Intervention to Prevent Permanent Impairment/Damage Date:11/23/99ISR Number: 3406717-XReport Type:Periodic Company Report #USA/99/00128/LEX Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Coma Health Clozaril (Clozapine) PS ORAL 800 MG, Required Convulsion Professional OTHER, Intervention to Dizziness ORAL;,UNKNOWN Prevent Permanent Muscle Contractions , OTHER, Impairment/Damage Involuntary ORAL; Orthostatic Hypotension Remeron (Mirtazapine) C Eskalith (Lithium Carbonate) C Depakote (Valproate Semisodium) C Stelazine (Trifluoperazine Hydrochloride) C Date:11/23/99ISR Number: 3406718-1Report Type:Periodic Company Report #USA/99/00116/LEX Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cough Health Clozaril (Clozapine) PS ORAL 325 MG, ORAL Initial or Prolonged Leukopenia Professional Klonopin Other Lymphocytosis (Clonazepam) C Neutropenia Naltrexone C Pharyngitis 22-Feb-2006 08:30 AM Page: 514 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/23/99ISR Number: 3406719-3Report Type:Periodic Company Report #USA/99/00108/LEX Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Clozaril (Clozapine) PS ORAL 300 MG, Required Dizziness Professional OTHER, ORAL Intervention to Electroencephalogram Paxil (Paroxetine Prevent Permanent Abnormal Hydrochloride) C Impairment/Damage Fall Lithobid (Lithium Muscle Contractions Carbonate) C Involuntary Lopid (Gemfibrozil) C Premarin (Estrogens Conjugated) C Peri-Colace C Date:11/23/99ISR Number: 3406720-XReport Type:Periodic Company Report #USA/99/00109/LEX Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozaril (Clozapine) PS ORAL 400 MG, ORAL Hospitalization - Professional Haldol (Haloperidol) C Initial or Prolonged Cogentin (Benzatropine Mesilate) C Date:11/23/99ISR Number: 3406721-1Report Type:Periodic Company Report #USA/99/00071/LEX Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Tachycardia Health Clozaril (Clozapine) PS ORAL 600 MG, ORAL Initial or Prolonged Professional Lithium C Required Intervention to Prevent Permanent Impairment/Damage Date:11/23/99ISR Number: 3406722-3Report Type:Periodic Company Report #USA/99/00054/LEX Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) PS ORAL 250 MG, ORAL Professional Date:11/23/99ISR Number: 3406723-5Report Type:Periodic Company Report #USA/99/00056/LEX Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Health Clozaril (Clozapine) PS ORAL 325 MG, ORAL Initial or Prolonged Pharyngitis Professional Gabapentin C Required Pyrexia Cogentin Intervention to (Benzatropine Prevent Permanent Mesilate) C Impairment/Damage Depakote (Valproate Semisodium) C Axid (Nizatidine) C 22-Feb-2006 08:30 AM Page: 515 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/23/99ISR Number: 3406724-7Report Type:Periodic Company Report #USA/99/00042/LEX Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozaril (Clozapine) PS ORAL 400 MG, ORAL Hospitalization - Professional Glyburide Initial or Prolonged (Glibenclamide) C Required Intervention to Prevent Permanent Impairment/Damage Date:11/23/99ISR Number: 3406725-9Report Type:Periodic Company Report #USA/99/00029/LEX Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) PS ORAL 600 MG, ORAL Professional Date:11/23/99ISR Number: 3406726-0Report Type:Periodic Company Report #USA/99/00035/LEX Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Consumer Clozaril (Clozapine) PS ORAL 200 MG, ORAL Initial or Prolonged Hyperglycaemia Zyprexa (Olanzapine) C Pancreatitis Depakote (Valproate Semisodium) C Buspar (Buspirone Hydrochloride) C Remeron (Mirtazapine) C Date:11/23/99ISR Number: 3406727-2Report Type:Periodic Company Report #USA/99/00022/LEX Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ileus Paralytic Consumer Clozaril (Clozapine) PS ORAL 750 MG, ORAL Initial or Prolonged Health Depakote (Valproate Professional Semisodium) C Ativan (Lorazepam) C Zyprexa (Olanzapine) C Date:11/23/99ISR Number: 3406728-4Report Type:Periodic Company Report #USA/99/00021/LEX Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Palpitations Health Clozaril (Clozapine) PS ORAL 200 MG, TWICE Initial or Prolonged Tachycardia Professional A DAY, ORAL Cogentin SS ORAL .5 MG, TWICE A DAY, ORAL Chlorpheniramine SS ORAL 4 MG, FOUR TIMES A DAY, ORAL Lopid (Gemfibrozil) C 22-Feb-2006 08:30 AM Page: 516 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/23/99ISR Number: 3406729-6Report Type:Periodic Company Report #USA/98/02465/LEX Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Health Clozaril (Clozapine) PS ORAL 200MG, TWICE Initial or Prolonged Convulsion Professional A DAY, ORAL; Ativan (Lorazepam) C Date:11/23/99ISR Number: 3406730-2Report Type:Periodic Company Report #USA/98/02464/LEX Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutropenia Health Clozaril (Clozapine) PS ORAL 300 MG,ORAL Initial or Prolonged Professional Allegra (Fexofenadine Hydrochloride) C Colace (Docusate Sodium) C Cogentin (Benzatropine Mesilate) C Multivitamins C Cocaine Possible (Cocaine) C Date:11/23/99ISR Number: 3406731-4Report Type:Periodic Company Report #USA/98/02452/LEX Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Leukopenia Health Clozaril (Clozapine) PS ORAL 150MG,ORAL Required Professional Inderal (Propranolol Intervention to Hydrochloride) C Prevent Permanent Pepcid (Famotidine) C Impairment/Damage Lopid (Gemfibrozil) C Date:11/23/99ISR Number: 3406732-6Report Type:Periodic Company Report #USA/98/02437/LEX Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Clozaril (Clozapine) PS ORAL 400 MG, ORAL Professional Dilantin (Phenytoin Sodium) C Zyprexa (Olanzapine) C Date:11/23/99ISR Number: 3406733-8Report Type:Periodic Company Report #USA/98/02414/LEX Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Health Clozaril (Clozapine) PS ORAL 42 OTHER, Initial or Prolonged Professional ORAL Date:11/23/99ISR Number: 3406734-XReport Type:Periodic Company Report #USA/98/2409/LEX Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Leukopenia Health Clozaril (Clozapine) PS ORAL 900 MG, ORAL Neutropenia Professional Prozac (Fluoxetine 22-Feb-2006 08:30 AM Page: 517 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride) C Cogentin(Benzatropin e Mesilate) C Seroquel C Klonopin (Clonazepam) C Date:11/23/99ISR Number: 3406735-1Report Type:Periodic Company Report #USA/98/02312/LEX Age:19 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coma Consumer Clozaril (Clozapine) PS ORAL 900 MG, ORAL Hospitalization - Confusional State Health Depakote (Valproate Initial or Prolonged Dermatitis Professional Semisodium) SS Dyspnoea Depo Provera Hallucination (Medroxyprogesterone Headache Acetate) C Hyperpyrexia Muscle Necrosis Neuroleptic Malignant Syndrome Tachycardia Thrombocythaemia Vomiting Date:11/23/99ISR Number: 3406736-3Report Type:Periodic Company Report #USA/98/02323/LEX Age:57 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Sedation Health Clozaril (Clozapine) PS ORAL 450 MG, ORAL 1 YR Initial or Prolonged Professional Depakote (Valproate Required Semisodium) C Intervention to Klonopin Prevent Permanent (Clonazepam) C Impairment/Damage Date:11/23/99ISR Number: 3406737-5Report Type:Periodic Company Report #USA/98/02337/LEX Age:42 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dermatitis Health Clozaril (Clozapine) PS ORAL 200 MG, ORAL Initial or Prolonged Professional Seroquel SS Required Intervention to Prevent Permanent Impairment/Damage Date:11/23/99ISR Number: 3406738-7Report Type:Periodic Company Report #USA/98/02362/LEX Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozaril (Clozapine) PS ORAL UNSPECIFIED, Professional ORAL Steroids (Possible) C 22-Feb-2006 08:30 AM Page: 518 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/23/99ISR Number: 3406739-9Report Type:Periodic Company Report #USA/98/02374/LEX Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Clozaril (Clozapine) PS ORAL 800 MG, ORAL Professional Prolixine (Fluphenazine Hydrochloride) C Date:11/23/99ISR Number: 3406740-5Report Type:Periodic Company Report #USA/98/02404/LEX Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Clozaril (Clozapine) PS ORAL 350 MG, ORAL Professional Date:11/23/99ISR Number: 3406741-7Report Type:Periodic Company Report #USA/98/02405/LEX Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Health Clozaril (Clozapine) PS ORAL 750 MG, ORAL Initial or Prolonged Phosphokinase Increased Professional Risperdal Required Dysphagia (Risperidone) SS ORAL 2 MG, ORAL Intervention to Leukocytosis Sporanox C Prevent Permanent Muscle Contractions Clonidine C Impairment/Damage Involuntary Myalgia Pharyngitis Date:11/23/99ISR Number: 3406742-9Report Type:Periodic Company Report #USA/98/02406/LEX Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Sedation Clozaril (Clozapine) PS ORAL 200 MG, ORAL Initial or Prolonged Vistaril (Hydroxyzine Embonate) SS 25 MG, Depakot (Valproate Semisodium) SS 500 MG Haldol (Haloperidol) C Ativan (Lorazepam) C Trazodone C Cogentin (Benzatropine Mesilate) C Lithium C Zoloft (Sertraline Hydrochloride) C Synthroid (Levothyroxine Sodium) C Date:11/23/99ISR Number: 3406743-0Report Type:Periodic Company Report #USA/98/02718/LEX Age: Gender:Male I/FU:I Outcome Other Required 22-Feb-2006 08:30 AM Page: 519 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Intervention to Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Convulsion Health Clozaril (Clozapine) PS ORAL 200 MG, TWICE Drug Level Below Professional A DAY ORAL Therapeutic Depakote (Valproate Electroencephalogram Semisodium) SS Abnormal Prolixin Fall (Fluphenazine Gait Disturbance Hydrochloride) C Thinking Abnormal Cogentin (Benzatropine Mesilate) C Date:11/23/99ISR Number: 3406744-2Report Type:Periodic Company Report #USA/98/02742/LEX Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Health Clozaril (Clozapine) PS ORAL 200 MG, ONCE Initial or Prolonged Chills Professional A DAY ORAL Other Lymphadenopathy Tigabin C Required Malaise Lamictal Intervention to Pharyngitis (Lamotrigine) C Prevent Permanent Pyrexia Ativan (Lorazepam) C Impairment/Damage Premapaxil C Date:11/23/99ISR Number: 3406745-4Report Type:Periodic Company Report #USA/98/02748/LEX Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Grand Mal Convulsion Health Clozaril (Clozapine) PS ORAL UNSPECIFIED, Professional ORAL Date:11/23/99ISR Number: 3406746-6Report Type:Periodic Company Report #USA/98/02749/LEX Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Grand Mal Convulsion Health Clozaril (Clozapine) PS ORAL UNSPECIFIED, Professional ORAL Date:11/23/99ISR Number: 3406747-8Report Type:Periodic Company Report #USA/99/02391/LEX Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Lymphopenia Health Clozaril (Clozapine) PS ORAL 150 MG, ONCE Initial or Prolonged Monocytosis Professional A DAY ORAL Pneumonia Cogentin (Benzatropine Mesilate) C Haldol (Haloperidol) C Klonopin (Clonazepam) C Depakote (Valproate Semisodium) C Prozac (Fluoxetine Hydrochloride) C 22-Feb-2006 08:30 AM Page: 520 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/23/99ISR Number: 3406748-XReport Type:Periodic Company Report #USA/99/02404/LEX Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Clozaril (Clozapine) PS ORAL 350 MG, ORAL Sedation Professional Depakote (Valproate Weight Increased Semisodium) SS 1 MON Date:11/23/99ISR Number: 3406749-1Report Type:Periodic Company Report #USA/98/02781/LEX Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Health Clozaril (Clozapine) PS ORAL 100 MG, ORAL Professional Date:11/23/99ISR Number: 3406750-8Report Type:Periodic Company Report #USA/98/02794/LEX Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Salivary Gland Health Clozaril (Clozapine) PS ORAL 200 MG, ONCE Initial or Prolonged Enlargement Professional A DAY, ORAL Required Aspirin Enteric Intervention to Coated Prevent Permanent (Acetylsalicyclic Impairment/Damage Acid) C Lipitor (Atorvastatin) C Colace (Docusate Sodium) C Fluphenazine C Multiple Vitamins C Zoloft (Sertraline Hydrochloride) C Prilosec (Omeprazole) C Prolixin Decanoate (Fluphenazine Decanoate) C Date:11/23/99ISR Number: 3406751-XReport Type:Periodic Company Report #USA/98/02808/LEX Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dizziness Health Clozaril (Clozapine) PS ORAL 100 MG, Initial or Prolonged Muscle Contractions Professional OTHER, ORAL;, Required Involuntary 150 MG, Intervention to Muscle Spasms OTHER, ORAL; Prevent Permanent Pain Lithium Carbonate C Impairment/Damage Psychotic Disorder Depakote (Valproate Salivary Hypersecretion Semisodium) C Sedation Prozac (Fluoxetine Tremor Hydrochloride) C Urinary Incontinence Urinary Tract Infection Vomiting 22-Feb-2006 08:30 AM Page: 521 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/23/99ISR Number: 3406752-1Report Type:Periodic Company Report #USA/98/02845/LEX Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hypoxia Health Clozaril (Clozapine) PS ORAL 25 MG, Required Pulmonary Embolism Professional UNKNOWN, ORAL Intervention to Prevent Permanent Impairment/Damage Date:11/23/99ISR Number: 3406753-3Report Type:Periodic Company Report #USA/98/02846/LEX Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Health Clozaril (Clozapine) PS ORAL 650 MG, Initial or Prolonged Professional OTHER, ORAL Ativan (Lorazepam) C Date:11/23/99ISR Number: 3406754-5Report Type:Periodic Company Report #USA/98/02870/LEX Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Leukopenia Health Clozaril (Clozapine) PS ORAL ORAL Professional Date:11/23/99ISR Number: 3406755-7Report Type:Periodic Company Report #USA/98/02871/LEX Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Clozaril (Clozapine) PS ORAL 450 MG, ORAL Initial or Prolonged Hyponatraemia Professional Valproic Acid C Required Thirst Depakote (Valproate Intervention to Semisodium) C Prevent Permanent Benadryl Impairment/Damage (Diphenhydramine Hydrochloride) C Pepcid (Famotidine) C Phenergan (Promethazine Hydrochloride) C Date:11/23/99ISR Number: 3406756-9Report Type:Periodic Company Report #USA/98/02872/LEX Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Coma Health Clozaril (Clozapine) PS ORAL 500 MG, Required Convulsion Professional OTHER, ORAL Intervention to Dermatitis Prevent Permanent Hypertension Impairment/Damage Orthostatic Hypotension Date:11/23/99ISR Number: 3406757-0Report Type:Periodic Company Report #USA/98/02916/LEX Age:90 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) PS ORAL 37.5 MG, ORAL Professional 22-Feb-2006 08:30 AM Page: 522 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/23/99ISR Number: 3406758-2Report Type:Periodic Company Report #USA/98/02664/LEX Age:36 YR Gender:Not SpecifiI/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Grand Mal Convulsion Health Clozaril (Clozapine) PS ORAL 800 MG, ORAL Initial or Prolonged Overdose Professional Pravacol Required Syncope (Pravastatin Sodium) C Intervention to Prozac (Fluoxetine Prevent Permanent Hydrochloride) C Impairment/Damage Cogentin (Benzatropine Mesilate) C Levothyroxine C Albuterol Inhaler (Salbutamol) C Ultram (Tramadol Hydrochloride) C Date:11/23/99ISR Number: 3406759-4Report Type:Periodic Company Report #USA/98/02652/LEX Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tardive Dyskinesia Health Clozaril (Clozapine) PS ORAL 125 MG, TWICE Professional A DAY, ORAL Cogentin (Benzatropine Mesilate) C Date:11/23/99ISR Number: 3406760-0Report Type:Periodic Company Report #USA/98/02610/LEX Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diarrhoea Health Clozaril (Clozapine) PS ORAL 225 MG, TWICE Initial or Prolonged Gastritis Professional A DAY; ORAL Pneumonia Effexor (Venlafaxine Tachycardia Hydrochloride) C Vomiting Date:11/23/99ISR Number: 3406761-2Report Type:Periodic Company Report #USA/98/02611/LEX Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Supraventricular Health Clozaril (Clozapine) PS ORAL 87.5 MG, ORAL Required Tachycardia Professional Olanzapine C Intervention to Cogentin Prevent Permanent (Benzatropine Impairment/Damage Mesilate) C Depakote (Valproate Semisodium) C Date:11/23/99ISR Number: 3406762-4Report Type:Periodic Company Report #USA/98/02613/LEX Age:48 YR Gender:Female I/FU:I Outcome Hospitalization - Initial or Prolonged Required Intervention to 22-Feb-2006 08:30 AM Page: 523 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Convulsion Health Clozaril (Clozapine) PS ORAL 800 MG, ORAL Orthostatic Hypotension Professional Lescol (Fluvastatin Sodium) C Benadryl (Diphenhydramine Hydrochloride) C Date:11/23/99ISR Number: 3406763-6Report Type:Periodic Company Report #USA/98/02677/LEX Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Clozaril (Clozapine) PS ORAL 500 MG, ONCE Initial or Prolonged Professional A DAY, ORAL Required Lithium C Intervention to Prevent Permanent Impairment/Damage Date:11/23/99ISR Number: 3406764-8Report Type:Periodic Company Report #USA/98/02678/LEX Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Clozaril (Clozapine) PS ORAL 375 MG, TWICE Initial or Prolonged Professional A DAY, ORAL Required Lithium Carbonate C Intervention to Prevent Permanent Impairment/Damage Date:11/23/99ISR Number: 3406765-XReport Type:Periodic Company Report #USA/98/02702/LEX Age:86 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Leukopenia Health Clozaril (Clozapine) PS ORAL 25 MG, ORAL Professional Date:11/23/99ISR Number: 3406766-1Report Type:Periodic Company Report #USA/98/02712/LEX Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypercholesterolaemia Health Clozaril (Clozapine) PS ORAL 400 MG, ONCE Hyperlipidaemia Professional A DAY, ORAL Pancreatitis Propranolol C Weight Increased Paxil (Paroxetine Hydrochloride) C Buspar (Buspirone Hydrochloride) C Lipitor (Atorastatin) C Diabeta (Glibenclamide) C Precose (Acarbose) C Anafranil (Clomipramine 22-Feb-2006 08:30 AM Page: 524 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride) C Date:11/23/99ISR Number: 3406767-3Report Type:Periodic Company Report #USA/98/02713/LEX Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Health Clozaril (Clozapine) PS ORAL 700 MG, ORAL Initial or Prolonged Intestinal Obstruction Professional Synthroid Required Pain (Levothyroxine Intervention to Sodium) C Prevent Permanent Theo-Dur Impairment/Damage (Theophylline) C Date:11/23/99ISR Number: 3406768-5Report Type:Periodic Company Report #USA/98/02715/LEX Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Clozaril (Clozapine) PS ORAL 450 MG, ORAL Professional Wellbutrin (Amfebutamone Hydrochloride) C Klonopin (Clonazepam) C Date:11/23/99ISR Number: 3406769-7Report Type:Periodic Company Report #USA/98/02238/LEX Age:30 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Constipation Health Clozaril (Clozapine) PS ORAL 325 MG, ORAL 7 YR Initial or Prolonged Professional Depakote (Valproate Required Semisodium) C Intervention to Neurontin Prevent Permanent (Gabapentin) C Impairment/Damage Klonopin (Clonazepam) C Date:11/23/99ISR Number: 3406770-3Report Type:Periodic Company Report #USA/96/00238/LEX Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Priapism Health Clozaril (Clozapine) PS ORAL 350 MG, ORAL Initial or Prolonged Professional Date:11/23/99ISR Number: 3406771-5Report Type:Periodic Company Report #USA/97/01985/LEX Age:58 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Health Clozaril (Clozapine) PS ORAL 200 MG, TWICE Initial or Prolonged Professional A DAY, ORAL; Required ORAL Intervention to Lopressor Prevent Permanent (Metoprolol Impairment/Damage Tartrate) C Ativan (Lorazepam) C 22-Feb-2006 08:30 AM Page: 525 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/23/99ISR Number: 3406772-7Report Type:Periodic Company Report #USA/98/00414/LEX Age:51 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Leukopenia Health Clozaril (Clozapine) PS ORAL 250 MG, Disability Neutropenia Professional OTHER, ORAL;, Required 600 MG, Intervention to UNKNOWN, ORAL Prevent Permanent Remeron Impairment/Damage (Mirtazapine) SS Vasotec (Enalapril Maleate) C Buspar (Buspirone Hydrochloride) C Pamelor (Nortriptyline Hydrochloride) C Lithium C Hctz (Hydrochlorothiazide ) C Serozone (Nefazodone Hydrochloride) C Date:11/23/99ISR Number: 3406773-9Report Type:Periodic Company Report #USA/98/01222/LEX Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) PS ORAL 300 MG, Professional OTHER, ORAL Date:11/23/99ISR Number: 3406774-0Report Type:Periodic Company Report #USA/98/01530/LEX Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) PS ORAL 400 MG, Professional OTHER, ORAL Date:11/23/99ISR Number: 3406775-2Report Type:Periodic Company Report #USA/98/01783/LEX Age:23 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Dysphagia Health Clozaril (Clozapine) PS ORAL 400 MG, Hospitalization - Infection Professional UNKNOWN, ORAL 1 MON Initial or Prolonged Neutropenia Company Pharyngitis Representative Pyrexia Date:11/23/99ISR Number: 3406776-4Report Type:Periodic Company Report #USA/98/01929/LEX Age:70 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatic Function Abnormal Health Clozaril (Clozapine) PS ORAL 100 MG, TWICE Initial or Prolonged Pulmonary Embolism Professional A DAY, ORAL Synthroid (Levothyroxine Sodium) C Depakote (Valproate 22-Feb-2006 08:30 AM Page: 526 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Semisodium) C Vitamin B12 (Cyanocobalamin) C Prinivil (Lisinopril) C Prevacid (Lansoprazole) C Niferex (Polysaccharide-Iron Complex) C Date:11/23/99ISR Number: 3406777-6Report Type:Periodic Company Report #USA/98/01975/LEX Age:49 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Leukopenia Health Clozaril (Clozapine) PS ORAL 800 MG, ORAL Neutropenia Professional Atrovent (Via Nebulizer) C Vanceril (Beclometasone Dipropionate) C Date:11/23/99ISR Number: 3406778-8Report Type:Periodic Company Report #USA/98/01998/LEX Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Health Clozaril (Clozapine) PS ORAL 100 MG,ORAL 7 YR Initial or Prolonged Salivary Hypersecretion Professional Seroquel C Required Sedation Catapres (Clonidine) C Intervention to Weight Increased Colace (Docusate Prevent Permanent Sodium) C Impairment/Damage Date:11/23/99ISR Number: 3406779-XReport Type:Periodic Company Report #USA/98/02124/LEX Age:31 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pulmonary Embolism Health Clozaril (Clozapine) PS ORAL ORAL Professional Date:11/23/99ISR Number: 3406780-6Report Type:Periodic Company Report #USA/98/02204/LEX Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Clozaril (Clozapine) PS ORAL 250 MG, ORAL Required Professional Intervention to Prevent Permanent Impairment/Damage Date:11/23/99ISR Number: 3406781-8Report Type:Periodic Company Report #USA/95/02264/LEX Age:54 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Leukopenia Health Clozaril (Clozapine) PS ORAL 400 MG, ORAL Professional 22-Feb-2006 08:30 AM Page: 527 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/23/99ISR Number: 3406782-XReport Type:Periodic Company Report #USA/98/02466/LEX Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozaril (Clozapine) PS ORAL 200 MG, ORAL Sudden Death Professional Date:11/23/99ISR Number: 3406783-1Report Type:Periodic Company Report #USA/98/02467/LEX Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Clozaril (Clozapine) PS ORAL 12.5, Initial or Prolonged Professional UNKNOWN, ORAL Required Klonopin Intervention to (Clonazepam) SS Prevent Permanent Lamictal Impairment/Damage (Lamotrigine) C Moban (Molindone) C Ortho-Novum 1/35 (Conlunett) C Date:11/23/99ISR Number: 3406784-3Report Type:Periodic Company Report #USA/98/02483/LEX Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Health Clozaril (Clozapine) PS ORAL 700 MG, ORAL Initial or Prolonged Neutropenia Professional Depakote (Valproate Required Semisodium) C Intervention to Ativan (Lorazepam) C Prevent Permanent Impairment/Damage Date:11/23/99ISR Number: 3406785-5Report Type:Periodic Company Report #USA/98/02484/LEX Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Health Clozaril (Clozapine) PS ORAL 400 MG, ORAL Initial or Prolonged Convulsion Professional Inderal (Propranolol Required Urinary Incontinence Hydrochloride) C Intervention to Vomiting Ativan (Lorazepam) C Prevent Permanent Axid (Nizatidine) C Impairment/Damage Date:11/23/99ISR Number: 3406786-7Report Type:Periodic Company Report #USA/98/02486/LEX Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Leukopenia Health Clozaril (Clozapine) PS ORAL 100 MG, THREE Hospitalization - Neutropenia Professional TIMES A DAY, Initial or Prolonged ORAL Required Tegretol Intervention to (Carbamazepine) C Prevent Permanent Symmetrel Impairment/Damage (Amantadine Hydrochloride) C Cogentin (Benzatropine Mesilate) C 22-Feb-2006 08:30 AM Page: 528 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Klonopin (Clonazepam) C Date:11/23/99ISR Number: 3406787-9Report Type:Periodic Company Report #USA/98/02383/LEX Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Clozaril (Clozapine) PS ORAL 225 MG, TWICE Required Hypotension Professional A DAY, ORAL; Intervention to Weight Increased UNKNOWN, Prevent Permanent OTHER, ORAL 5 YR Impairment/Damage Depakote (Valproate Semisodium) SS Paxil (Paroxetine Hydrochloride) C Date:11/23/99ISR Number: 3406788-0Report Type:Periodic Company Report #USA/98/0257/LEX Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypotension Foreign Clozaril (Clozapine) PS ORAL 300 MG, TWICE Initial or Prolonged Pulmonary Embolism A DAY, ORAL Required Urinary Incontinence Depakote (Valproate Intervention to Semisodium) C Prevent Permanent Ddavp (Desmopressin) C Impairment/Damage Florinef (Fludrocortisone Acetate) C Zyprexa (Olanzapine) C Date:11/23/99ISR Number: 3406937-4Report Type:Periodic Company Report #USA/99/00834/LEX Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Health Clozaril (Clozapine) PS ORAL 900 MG, ORAL Initial or Prolonged Infection Professional Synthroid C Other Pyrexia Dilantin (Phenytoin Required Sodium) C Intervention to Prevent Permanent Impairment/Damage Date:11/23/99ISR Number: 3406942-8Report Type:Periodic Company Report #USA/99/00828/LEX Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Grand Mal Convulsion Health Clozaril (Clozapine) PS ORAL 137.5 MG, Hospitalization - Professional ORAL Initial or Prolonged Estrace (Estradiol) C Required Zoloft (Sertraline Intervention to Hydrochloride) C Prevent Permanent Clonazepam C Impairment/Damage Tylenol (Paracetamol) C Maalox C Mom (Magnesium Hydroxide) C 22-Feb-2006 08:30 AM Page: 529 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Klonopin (Clonasepam) C Date:11/23/99ISR Number: 3406944-1Report Type:Periodic Company Report #USA/99/02216/LEX Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Clozaril (Clozapine) PS ORAL 500 MG, ORAL Professional Date:11/23/99ISR Number: 3406945-3Report Type:Periodic Company Report #USA/99/00800/LEX Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neuroleptic Malignant Health Clozaril (Clozapine) PS ORAL 100 MG, TWICE Hospitalization - Syndrome Professional A DAY, ORAL Initial or Prolonged Haldol Decanote Required (Haloperidol Intervention to Decanoate) C Prevent Permanent Impairment/Damage Date:11/23/99ISR Number: 3406946-5Report Type:Periodic Company Report #USA/99/02002/LEX Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Convulsion Health Clozaril (Clozapine) PS ORAL 450 MG, ORAL Required Fall Professional Lithium SS 900 MG Intervention to Leukocytosis Risperdal Prevent Permanent Sedation (Risperidone) C Impairment/Damage Tachycardia Effexor (Venlafaxine Tremor Hydrochloride) C Lithobid (Lithium Carbonate) C Depakene (Valproate Sodium) C Date:11/23/99ISR Number: 3406947-7Report Type:Periodic Company Report #USA/99/00765/LEX Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Health Clozaril (Clozapine) PS ORAL 300 MG, ORAL Phosphokinase Increased Professional Lithium C Convulsion Prozac (Fluoxetine Hyponatraemia Hydrochloride) C Pneumonia Antabuse Thirst (Disulfiram) C Date:11/23/99ISR Number: 3406948-9Report Type:Periodic Company Report #USA/99/01214/LEX Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) PS ORAL 600 MG, ORAL Life-Threatening Professional 22-Feb-2006 08:30 AM Page: 530 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/23/99ISR Number: 3406949-0Report Type:Periodic Company Report #USA/99/00759/LEX Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Clozaril (Clozapine) PS ORAL 750 MG ORAL Leukocytosis Professional Depakote (Valproate Lymphopenia Semisodium) C Neutrophilia Cogentin (Benzatropine Mesilate) C Colace (Docusate Sodium) C Date:11/23/99ISR Number: 3406950-7Report Type:Periodic Company Report #USA/98/02508/LEX Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Grand Mal Convulsion Health Clozaril (Clozapine) PS ORAL 800 MG, ORAL Professional Date:11/23/99ISR Number: 3406952-0Report Type:Periodic Company Report #USA/98/02522/LEX Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) PS ORAL 75 MG, ORAL Professional Date:11/23/99ISR Number: 3406953-2Report Type:Periodic Company Report #USA/99/00756/LEX Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukocytosis Health Clozaril (Clozapine) PS ORAL 300 MG, ORAL Initial or Prolonged Pneumonia Professional Bumex (Bumetanide) C Trovafloxain (Trovafloxacin) C Combivent (Combivent) C Lorazepam (Lorazepam) C Atenolol C Paxil (Paroxetine Hydrochloride) C Valproate (Valproate Sodium) C Depakote (Valproate Semisodium) C Date:11/23/99ISR Number: 3406955-6Report Type:Periodic Company Report #USA/99/00734/LEX Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Influenza Like Illness Health Clozaril (Clozapine) PS ORAL 300 MG, ORAL Hospitalization - Leukopenia Professional Risperdal Initial or Prolonged Pyrexia (Risperidone) C Required Salivary Hypersecretion Haldol (Haloperidol) C Intervention to Pepcid (Famotidine) C Prevent Permanent Florinef Impairment/Damage (Fludrocottisone 22-Feb-2006 08:30 AM Page: 531 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Acetate) C Carisoprodol C Benzotropine (Benzatropine Mesilate) C Date:11/23/99ISR Number: 3406956-8Report Type:Periodic Company Report #USA/99/00736/LEX Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozaril (Clozapine) PS ORAL 300 MG, ORAL Hospitalization - Pyrexia Professional Serentil Initial or Prolonged (Mesoridazine) C Required Intervention to Prevent Permanent Impairment/Damage Date:11/23/99ISR Number: 3406958-1Report Type:Periodic Company Report #USA/98/02523/LEX Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Urea Increased Health Clozaril (Clozapine) PS ORAL 800 MG, ORAL Initial or Prolonged Pneumonia Professional Zithromax Required (Azithromycin) C Intervention to Rocephin Prevent Permanent (Ceftriaxone Sodium) C Impairment/Damage Lopressor (Metoprolol Tartrate) C Lasix (Furosemide) C Depakote (Valproate Semisodium) C Atrovent (Ipratropium Bromide) C Albuterol (Salbutamol) C Azmacort (Triamcinolone Acetonide) C Date:11/23/99ISR Number: 3406960-XReport Type:Periodic Company Report #USA/99/00725/LEX Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Myocardial Infarction Health Clozaril (Clozapine) PS Professional Date:11/23/99ISR Number: 3406961-1Report Type:Periodic Company Report #USA/98/02553/LEX Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bradycardia Health Clozaril (Clozapine) PS ORAL 300 MG, ORAL Pneumonia Professional Xanax (Alprazolam) C Depakote (Valproate Semisodium) C Lithium C 22-Feb-2006 08:30 AM Page: 532 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Nitrobid (Glyceryl Trinitrate) C Habitrol (Nicotine) C Lasix (Furosemide) C Potassium C Capoten (Captopril) C Zocor (Simvastatin) C Ventolin (Salbutamol) C Sulfa (Sulfabenzamide) C Levaquin (Levofloxacin) C Date:11/23/99ISR Number: 3406962-3Report Type:Periodic Company Report #USA/99/00710/LEX Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) PS ORAL 250 MG, ORAL Professional Date:11/23/99ISR Number: 3406963-5Report Type:Periodic Company Report #USA/98/02591/LEX Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anorexia Health Clozaril (Clozapine) PS ORAL 450 MG, ORAL Initial or Prolonged Eosinophilia Professional Lithium C Required Leukocytosis Depakote (Valproate Intervention to Nausea Semisodium) C Prevent Permanent Otitis Media Prolixin Impairment/Damage Salivary Hypersecretion (Fluphenazine Thrombocythaemia Hydrochloride) C Upper Respiratory Tract Fluconazole C Infection Cogentin (Benzatropine Mesilate) C Synthroid (Levothyroxine Sodium) C Clonidine C Mylanta C Vistaril (Hydroxyzine Embonate) C Vitamin C (Ascorbic Acid) C Tylenol (Paracetamol) C Pepcid (Famotidine) C Date:11/23/99ISR Number: 3406965-9Report Type:Periodic Company Report #USA/98/02574/LEX Age:35 YR Gender:Male I/FU:I Outcome Life-Threatening Hospitalization - Initial or Prolonged Required 22-Feb-2006 08:30 AM Page: 533 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Intervention to Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Drug Level Above Health Clozaril (Clozapine) PS ORAL 500 MG, ORAL Therapeutic Professional Ativan (Lorazepam) C Supraventricular Loxitane (Loxapine Tachycardia Succinate) C Tremor Depakote (Valproate Semisodium) C Cogentin (Benzatropine Mesilate) C Artane (Trihexyphenidyl Hydrochloride) C Clonidine C Date:11/23/99ISR Number: 3406966-0Report Type:Periodic Company Report #USA/99/00711/LEX Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozaril (Clozapine) PS ORAL 400 MG, ORAL Professional Date:11/23/99ISR Number: 3406968-4Report Type:Periodic Company Report #USA/99/02407/LEX Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Overdose Health Clozaril (Clozapine) PS ORAL 500 MG, ORAL Professional Depakote (Valproate Semisodium) C Paxil (Paroxetine Hydrochloride) C Cogentin (Benzatropine Mesilate) C Date:11/23/99ISR Number: 3406969-6Report Type:Periodic Company Report #USA/99/00676/LEX Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Clozaril (Clozapine) PS ORAL 800 MG, ORAL Professional Date:11/23/99ISR Number: 3406971-4Report Type:Periodic Company Report #USA/99/02388/LEX Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Health Clozaril (Clozapine) PS ORAL 125 MG, TWICE Initial or Prolonged Agranulocytosis Professional A DAY, ORAL Other Bacterial Infection Magnesium C Required Myocardial Ischaemia Synthroid Intervention to Nausea (Levothyroxine Prevent Permanent Pneumonia Sodium) C Impairment/Damage Vomiting Colace (Docusate Sodium) C Paxil (Paroxetine 22-Feb-2006 08:30 AM Page: 534 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride) C Lopressor (Metoprolol Tartrate) C Thiamine C Oscal (Calcium Carbonate) C Date:11/23/99ISR Number: 3406972-6Report Type:Periodic Company Report #USA/99/02361/LEX Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Convulsion Health Clozaril (Clozapine) PS ORAL 900 MG, ORAL Professional Depakote (Valproate Semisodium) C Cogentin (Benzatropine Mesilate) C Zyprexa (Olanzapine) C Effexor (Venlafaxine Hydrochloride) C Date:11/23/99ISR Number: 3406973-8Report Type:Periodic Company Report #USA/99/00645/LEX Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Health Clozaril (Clozapine) PS ORAL 350 MG, ONCE Initial or Prolonged Leukopenia Professional A DAY, ORAL Required Zoloft (Sertraline Intervention to Hydrochloride) C Prevent Permanent Effexor (Venlafaxine Impairment/Damage Hydrochloride) C Klonopin (Clonazepam) C Depakote (Valproate Semisodium) C Colace (Docusate Sodium) C Multivitamin (Multivitamins) C Metamucil (Psyllium Hydrophilic Mucilloid) C Risperdal (Risperidone) C Date:11/23/99ISR Number: 3406975-1Report Type:Periodic Company Report #USA/99/02363/LEX Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neuroleptic Malignant Health Clozaril (Clozapine) PS ORAL ORAL Required Syndrome Professional Intervention to Prevent Permanent Impairment/Damage 22-Feb-2006 08:30 AM Page: 535 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/23/99ISR Number: 3406976-3Report Type:Periodic Company Report #USA/99/00615/LEX Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Health Clozaril (Clozapine) PS ORAL 500 MG, ORAL Initial or Prolonged Professional Date:11/23/99ISR Number: 3406978-7Report Type:Periodic Company Report #USA/99/02340/LEX Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Leukopenia Health Clozaril (Clozapine) PS ORAL 50 MG, ONCE A Other Professional DAY, ORAL Required Ceftin (Cefuroxime Intervention to Axetil) C Prevent Permanent Remeron Impairment/Damage (Mirtazapine) C Date:11/23/99ISR Number: 3406979-9Report Type:Periodic Company Report #USA/99/02327/LEX Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pulmonary Embolism Health Clozaril (Clozapine) PS ORAL ORAL Professional Date:11/23/99ISR Number: 3406980-5Report Type:Periodic Company Report #USA/99/00598/LEX Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Clozaril (Clozapine) PS ORAL 100 MG, ORAL Syncope Professional Zyprexia (Olanzapine) C Synthroid (Levothyroxine Sodium) C Ritalain (Methylprednidate Hydrochloride) C Date:11/23/99ISR Number: 3406981-7Report Type:Periodic Company Report #USA/99/02268/LEX Age:67 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Grand Mal Convulsion Health Clozaril (Clozapine) PS ORAL 75 MG, TWICE Hospitalization - Hypokalaemia Professional A DAY, ORAL Initial or Prolonged Ascorbic Acid C Colace (Docusate Sodium) C Prempro (Provella-14) C Sucralfate (Sucralfate) C Enemas (Non-Drug: Procedure Nos) C Potassium Chloride C 22-Feb-2006 08:30 AM Page: 536 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/23/99ISR Number: 3406982-9Report Type:Periodic Company Report #USA/99/00594/LEX Age:89 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) PS ORAL 25 MG, ORAL Professional Date:11/23/99ISR Number: 3406983-0Report Type:Periodic Company Report #USA/99/02269/LEX Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozaril (Clozapine) PS ORAL 600 MG, ORAL Hospitalization - Professional Initial or Prolonged Date:11/23/99ISR Number: 3406984-2Report Type:Periodic Company Report #USA/99/00589/LEX Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Clozaril (Clozapine) PS ORAL 1500 MG, ORAL Initial or Prolonged Confusional State Serzone (Nefazodone Overdose Hydrochloride) C Vistaril (Hydroxyzine Embonate) C Neurontin (Gabapentin) C Synthroid (Levothyroxine Sodium) C Albuterol Inhaler (Salbutamol) C Pravachol (Pravastatin Sodium) C Glucophage (Metformin Hydrochloride) C Aspirin (Acetylaslicylic Acid) C Naprosyn (Naproxen) C Date:11/23/99ISR Number: 3406985-4Report Type:Periodic Company Report #USA/99/02271/LEX Age:73 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) PS ORAL ORAL Professional Date:11/23/99ISR Number: 3406986-6Report Type:Periodic Company Report #USA/99/02233/LEX Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypertension Health Clozaril (Clozapine) PS ORAL 125 MG, ORAL Initial or Prolonged Professional Risperdal (Risperidone) C Cogentin (Benzatropine 22-Feb-2006 08:30 AM Page: 537 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Mesilate) C Depakote (Valproate Semisodium) C Date:11/23/99ISR Number: 3406987-8Report Type:Periodic Company Report #USA/99/00574/LEX Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutropenia Health Clozaril (Clozapine) PS ORAL 725 MG, ORAL Initial or Prolonged Professional Prolixin Required (Fluphenazine Intervention to Hydrochloride) C Prevent Permanent Depakote (Valproate Impairment/Damage Semisodium) C Prozac (Fluoxetine Hydrochloride) C Klonopin (Clonazepam) C Valproic Acid C Date:11/23/99ISR Number: 3406988-XReport Type:Periodic Company Report #USA/99/02135/LEX Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Health Clozaril (Clozapine) PS ORAL ORAL Initial or Prolonged Neutropenia Professional Klonopin (Clonazepam) C Depakote (Valproate Semisodium) C Zyprexa (Olanzapine) C Cogentin (Benzatropine Mesilate) C Date:11/23/99ISR Number: 3406989-1Report Type:Periodic Company Report #USA/99/00551/LEX Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) PS ORAL 125 MG, ORAL Professional Elavil (Amitriptyline Hydrochloride) C Klonopin (Clonazepam) C Date:11/23/99ISR Number: 3406991-XReport Type:Periodic Company Report #USA/99/00565/LEX Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Health Clozaril (Clozapine) PS ORAL 12.5 MG, Initial or Prolonged Professional ORAL, 300 MG, Required ORAL Intervention to Cogentin Prevent Permanent (Benzatropine Impairment/Damage Mesilate) C Klonopin (Clonazepam) C Depakote (Valproate 22-Feb-2006 08:30 AM Page: 538 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Semisodium) C Lithium C Synthroid (Levothyroxine Sodium) C Atenolol C Zyprexa (Olanzapine) C Navane (Tiotixene) C Amoxicillin C Date:11/23/99ISR Number: 3406993-3Report Type:Periodic Company Report #USA/99/02138/LEX Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neutropenia Health Clozaril (Clozapine) PS ORAL 500 MG, ORAL Required Professional Intervention to Prevent Permanent Impairment/Damage Date:11/23/99ISR Number: 3406994-5Report Type:Periodic Company Report #USA/99/02153/LEX Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Health Clozaril (Clozapine) PS ORAL ORAL Professional Date:11/23/99ISR Number: 3406996-9Report Type:Periodic Company Report #USA/99/02132/LEX Age:73 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Health Clozaril (Clozapine) PS ORAL 600 MG, ORAL 3 YR Initial or Prolonged Leukocytosis Professional Required Neutrophilia Intervention to Pallor Prevent Permanent Pharyngitis Impairment/Damage Pyrexia Date:11/23/99ISR Number: 3406998-2Report Type:Periodic Company Report #USA/99/02117/LEX Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neutropenia Health Clozaril Professional (Clozapine) PS ORAL 800 MG, ORAL Colace (Docusate Sodium) C Klonopin (Clonazepam) C Cogentin (Benzatropine Mesilate) C Depakote (Valproate Semisodium) C Seroquel C 22-Feb-2006 08:30 AM Page: 539 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/23/99ISR Number: 3407000-9Report Type:Periodic Company Report #USA/99/02118/LEX Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Eosinophilia Health Clozaril (Clozapine) PS ORAL 400 MG, ORAL Neutropenia Professional Colace (Docusate Sodium) C Depakote (Valproate Semisodium) C Ativan (Lorazepam) C Risperdal (Risperidone) C ... C Date:11/23/99ISR Number: 3407007-1Report Type:Periodic Company Report #USA/99/02059/LEX Age:86 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) PS ORAL ORAL Professional Date:11/23/99ISR Number: 3407008-3Report Type:Periodic Company Report #USA/99/02068/LEX Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Consumer Clozaril (Clozapine) PS ORAL 550 MG, ONCE Initial or Prolonged Leukocytosis A DAY, ORAL Required Pyrexia Genora (Normensal) C Intervention to Tremor Mestranol C Prevent Permanent Depakote (Valproate Impairment/Damage Semisodium) C Cogentin (Benzatropine Mesilate) C Maalox C Date:11/23/99ISR Number: 3407009-5Report Type:Periodic Company Report #USA/99/02045/LEX Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dermatitis Health Clozaril (Clozapine) PS ORAL 250 MG, ORAL Initial or Prolonged Hypersensitivity Professional Restoril C Date:11/23/99ISR Number: 3407012-5Report Type:Periodic Company Report #USA/99/02046/LEX Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Grand Mal Convulsion Health Clozaril (Clozapine) PS ORAL ORAL Professional Zoloft (Sertraline Hydrochloride) C Ativan (Lorazepam) C 22-Feb-2006 08:30 AM Page: 540 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/23/99ISR Number: 3407014-9Report Type:Periodic Company Report #USA/99/02040/LEX Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Convulsion Health Clozaril (Clozapine) PS ORAL 200 MG, ORAL Hospitalization - Pathological Fracture Professional Cogentin Initial or Prolonged Salivary Hypersecretion (Benzatropine Sedation Mesilate) C Lithium C Date:11/23/99ISR Number: 3407015-0Report Type:Periodic Company Report #USA/99/02037/LEX Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Clozaril (Clozapine) PS ORAL 50 MG, ORAL Professional Depakote (Valproate Semisodium) C Neurontin (Gabapentin) C Date:11/23/99ISR Number: 3407017-4Report Type:Periodic Company Report #USA/99/01986/LEX Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) PS ORAL UNSPECIFIED, Hospitalization - Professional ORAL Initial or Prolonged Date:11/23/99ISR Number: 3407019-8Report Type:Periodic Company Report #USA/99/01987/LEX Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) PS ORAL 300 MG, ORAL Professional Date:11/23/99ISR Number: 3407022-8Report Type:Periodic Company Report #USA/99/01969/LEX Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Leukocytosis Health Clozaril (Clozapine) PS ORAL 800 MG, ORAL Hospitalization - Pneumonia Professional Albuterol Initial or Prolonged (Salbutamol) C Tegretol (Caramazepine) C Motrin (Ibuprofen) C Lithium Carbonate C Cytotec (Misoprostol) C Date:11/23/99ISR Number: 3407024-1Report Type:Periodic Company Report #USA/99/01946/LEX Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Study Clozaril (Clozapine) PS ORAL 87 MG, ORAL Life-Threatening Health Professional 22-Feb-2006 08:30 AM Page: 541 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/23/99ISR Number: 3407026-5Report Type:Periodic Company Report #USA/99/01870/LEX Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Leukopenia Health Clozaril (Clozapine) PS ORAL 400 MG, ORAL Neutropenia Professional Date:11/23/99ISR Number: 3407028-9Report Type:Periodic Company Report #USA/99/01871/LEX Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chest Pain Health Clozaril (Clozapine) PS ORAL 300 MG, ONCE Extrasystoles Professional A DAY, ORAL Date:11/23/99ISR Number: 3407030-7Report Type:Periodic Company Report #USA/99/01852/LEX Age:76 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Health Clozaril (Clozapine) PS ORAL 50 MG, TWICE Initial or Prolonged Atrial Fibrillation Professional A DAY, ORAL Gait Disturbance Neurontin Lung Disorder (Gabapentin) C Orthostatic Hypotension Depakote (Valproate Pyrexia Semisodium) C Tachycardia Risperdal Thrombocytopenia (Risperidone) C Calcium C Fosamax (Alendronate Sodium) C Date:11/23/99ISR Number: 3407032-0Report Type:Periodic Company Report #USA/99/01845/LEX Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Health Clozaril (Clozapine) PS ORAL 300 MG, TWICE Required Asthenia Professional A DAY, ORAL Intervention to Grand Mal Convulsion Thorazine Prevent Permanent Nervousness (Chlorpromazine Impairment/Damage Speech Disorder Hydrochloride) C Thinking Abnormal Luvox (Fluvoxamine Tremor Maleate) C Cogentin (Benzatropine Mesilate) C Depakote (Valproate Semisodium) C Risperdal (Risperidone) C Date:11/23/99ISR Number: 3407034-4Report Type:Periodic Company Report #USA/99/00543/LEX Age:34 YR Gender:Female I/FU:I Outcome Hospitalization - Initial or Prolonged Required Intervention to Prevent Permanent 22-Feb-2006 08:30 AM Page: 542 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Dermatitis Health Clozaril (Clozapine) PS ORAL 150 MG, ORAL Urinary Incontinence Professional Depakote (Valproate Semisodium) C Paxil (Paroxetine Hydrochloride) C Cogentin (Benzatropine Mesilate) C Prolixin (Fluphenazine Hydrochloride) C Klonopin (Clonazepam) C Prilosec (Omeprazole) C Propulsid (Cisapride) C Remeron (Mirtazapine) C Ephedrine C Date:11/23/99ISR Number: 3407035-6Report Type:Periodic Company Report #USA/99/01839/LEX Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pericarditis Health Clozaril (Clozapine) PS ORAL 250 MG, ORAL Initial or Prolonged Pleural Effusion Professional Pneumonia Pyrexia Red Blood Cell Sedimentation Rate Increased Thrombocythaemia Date:11/23/99ISR Number: 3407043-5Report Type:Periodic Company Report #USA/99/00537/LEX Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Health Clozaril (Clozapine) PS ORAL 400 MG, ORAL Initial or Prolonged Dyspnoea Professional Effexor (Venlafaxine Required Orthostatic Hypotension Hydrochloride) C Intervention to Pulmonary Embolism Depakote (Valproate Prevent Permanent Vomiting Semisodium) C Impairment/Damage Trazodone C Date:11/23/99ISR Number: 3407050-2Report Type:Periodic Company Report #USA/99/00509/LEX Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) PS ORAL 700 MG, ORAL Professional Depakote (Valproate Semisodium) C 22-Feb-2006 08:30 AM Page: 543 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/23/99ISR Number: 3407053-8Report Type:Periodic Company Report #USA/99/00513/LEX Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Consumer Clozaril (Clozapine) PS ORAL 300 MG, ORAL Required Pyrexia Health Fosamax (Alendronate Intervention to Professional Sodium) C Prevent Permanent Aldactone Impairment/Damage (Spironolactone) C Inderal (Propranolol Hydrochloride) C Actigall (Ursodeoxycholic Acid) C Citrucel (Methylcellulose) C Vitamin D (Ergocalciferol) C Multivitamin (Multivitamins) C Date:11/23/99ISR Number: 3407054-XReport Type:Periodic Company Report #USA/99/00515/LEX Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) PS ORAL 500 MG, ORAL Professional Date:11/23/99ISR Number: 3407056-3Report Type:Periodic Company Report #USA/99/00496/LEX Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukocytosis Health Clozaril (Clozapine) PS ORAL 900 MG, ORAL Initial or Prolonged Pyrexia Professional Ativan (Lorazepam) C Required Upper Respiratory Tract Trazodone C Intervention to Infection Cogentin Prevent Permanent (Benzatropine Impairment/Damage Mesilate) C Colace (Docusate Sodium) C Date:11/23/99ISR Number: 3407059-9Report Type:Periodic Company Report #USA/99/00502/LEX Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Clozaril (Clozapine) PS ORAL 600 MG, ORAL Initial or Prolonged Professional Depakene (Valproate Sodium) C Ativan (Lorazepam) C Lopid (Gemfibrozil) C Mom (Mom-Hot) C Cascara (Cascara) C Senokot (Senna Fruit) C Dulcolax (Bisacodyl) C 22-Feb-2006 08:30 AM Page: 544 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/23/99ISR Number: 3407060-5Report Type:Periodic Company Report #USA/99/00469/LEX Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Leukopenia Health Clozaril (Clozapine) PS ORAL 500 MG, ORAL Neutropenia Professional Depakote (Valproate Viral Infection Semisodium) C Buspar (Buspirone Hydrochloride) C Wellbutrin (Amfebutamone Hydrochloride) C Klonopin (Clonazepam) C Serentil (Mesoridazine) C Date:11/23/99ISR Number: 3407063-0Report Type:Periodic Company Report #USA/99/00438/LEX Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Health Clozaril (Clozapine) PS ORAL 300 MG, ORAL Initial or Prolonged Syndrome Professional Risperdal Required (Risperidone) C Intervention to Depakote (Valproate Prevent Permanent Semisodium) C Impairment/Damage Date:11/23/99ISR Number: 3407066-6Report Type:Periodic Company Report #USA/99/00443/LEX Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Clozaril (Clozapine) PS ORAL 150 MG, ORAL Professional Depakote (Valproate Semisodium) C Inderal (Propranolol Hydrochloride) C Zyprexa (Olanzapine) C Date:11/23/99ISR Number: 3407071-XReport Type:Periodic Company Report #USA/99/00425/LEX Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) PS ORAL 37.5 MG, ORAL Professional Sinemet Cr (Sinemet) C Carbidopa C Levodopa C Requip (Ropinirole Hydrochloride) C Date:11/23/99ISR Number: 3407072-1Report Type:Periodic Company Report #USA/99/00405/LEX Age:47 YR Gender:Male I/FU:I Outcome Hospitalization - Initial or Prolonged Required Intervention to 22-Feb-2006 08:30 AM Page: 545 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Agranulocytosis Health Clozaril (Clozapine) PS ORAL 400 MG, ORAL Dermatitis Professional Zoloft (Sertraline Leukocytosis Hydrochloride) C Monocytosis Cogentin Neutrophilia (Benzatropine Thrombocytopenia Mesilate) C Date:11/23/99ISR Number: 3407074-5Report Type:Periodic Company Report #USA/99/00395/LEX Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Leukopenia Health Clozaril (Clozapine) PS ORAL 25 MG, ONCE A Professional DAY, ORAL Date:11/23/99ISR Number: 3407084-8Report Type:Periodic Company Report #USA/99/00368/LEX Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Clozaril (Clozapine) PS ORAL 700 MG, ORAL Initial or Prolonged Leukopenia Professional Depakote (Valproate Other Neutropenia Semisodium) C Required Lopid (Gemfibrozil) C Intervention to Prevent Permanent Impairment/Damage Date:11/23/99ISR Number: 3407089-7Report Type:Periodic Company Report #USA/99/00351/LEX Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Health Clozaril (Clozapine) PS ORAL 800 MG, ORAL Initial or Prolonged Grand Mal Convulsion Professional Lithium C Required Pyrexia Depakote (Valproate Intervention to Urinary Incontinence Semisodium) C Prevent Permanent Urinary Tract Infection Klonopin Impairment/Damage (Clonazepam) C Haldol (Haloperidol) C Ambien (Zolpidem Tartrate) C Date:11/23/99ISR Number: 3407091-5Report Type:Periodic Company Report #USA/99/00326/LEX Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Circulatory Collapse Health Clozaril (Clozapine) PS ORAL 650 MG, ORAL Professional Xanax (Alprazolam) C Ativan (Lorazepam) C Depakote (Valproate Semisodium) C Hydrocortisone C Tylenol (Paracetamol) C 22-Feb-2006 08:30 AM Page: 546 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/23/99ISR Number: 3407094-0Report Type:Periodic Company Report #USA/99/00312/LEX Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Clozaril (Clozapine) PS ORAL 550 MG, ORAL Required Professional Cogentin Intervention to (Benzatropine Prevent Permanent Mesilate) C Impairment/Damage Prolixin (Fluphenazine Hydrochloride) C Lithium C Verapamil C Zantac (Ranitidine Hydrochloride) C Date:11/23/99ISR Number: 3407096-4Report Type:Periodic Company Report #USA/99/00307/LEX Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Clozaril (Clozapine) PS ORAL 150 MG, ORAL Initial or Prolonged Coordination Abnormal Professional Klonopin C Required Delirium Thiamine C Intervention to Hallucination Prozac (Fluoxetine Prevent Permanent Tremor Hydrochloride) C Impairment/Damage Trazodone C Ativan (Lorazepam) C Accupril (Quinapril Hydrochloride) C Novolin Insulin (Insulin Novolin 70/30) C Clonidine C Glyburide (Glibenclamide) C Date:11/23/99ISR Number: 3407099-XReport Type:Periodic Company Report #USA/99/00283/LEX Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozaril (Clozapine) PS ORAL 375, ORAL Required Professional Docusate C Intervention to Benadryl Prevent Permanent (Diphenhydramine Impairment/Damage Hydrochloride) C Date:11/23/99ISR Number: 3407103-9Report Type:Periodic Company Report #USA/99/00279/LEX Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) PS ORAL 600 MG, ORAL Hospitalization - Professional Initial or Prolonged 22-Feb-2006 08:30 AM Page: 547 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/24/99ISR Number: 3408955-9Report Type:Expedited (15-DaCompany Report #1999UW04185 Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Agranulocytosis Health Seroquel "Zeneca" PS Intervention to Neutrophil Count Professional Clorazil SS ORAL 250 MG PO Prevent Permanent Decreased Prozac C Impairment/Damage White Blood Cell Count Risperdal C Decreased Neurontin C Vitamin E C Ambien C Aspirin C Niferex C Vitamin C C Date:11/24/99ISR Number: 3409552-1Report Type:Expedited (15-DaCompany Report #GB/99/01038/LEX Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cerebrovascular Accident Foreign Clozaril (Clozapine) PS ORAL 100 MG, ORAL Transient Ischaemic Health Attack Professional Date:11/24/99ISR Number: 3409557-0Report Type:Expedited (15-DaCompany Report #GB/99/00837/LEX Age:58 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Embolic Stroke Foreign Clozaril (Clozapine) PS ORAL 600 MG, ORAL Initial or Prolonged Hemiparesis Health Required Professional Intervention to Prevent Permanent Impairment/Damage Date:11/24/99ISR Number: 3409943-9Report Type:Expedited (15-DaCompany Report #GB/99/00910/LEX Age:52 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Cancer Female Foreign Clozaril (Clozapine) PS 300 MG, Study UNKNOWN Health Professional Date:11/26/99ISR Number: 3408970-5Report Type:Expedited (15-DaCompany Report #AUS/99/01567/LEX Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Foreign Clozaril (Clozapine) PS ORAL 250 MG PO Initial or Prolonged Delirium Study Valproate (Valproate Drug Withdrawal Syndrome Health Sodium) C Hypotension Professional Hypoxia 22-Feb-2006 08:30 AM Page: 548 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/26/99ISR Number: 3409038-4Report Type:Expedited (15-DaCompany Report #LIT/98/00181/LEX Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Ceruloplasmin Increased Foreign Leponex / Clozaril Required Drug Ineffective Literature (Clozapine) PS ORAL 825 MG, ORAL Intervention to Dystonia Health Metformin Prevent Permanent Magical Thinking Professional (Metformin) C Impairment/Damage Memory Impairment Glyburide Movement Disorder (Glibenclamide) C Muscle Hypertrophy Muscle Twitching Posturing Thinking Abnormal Torticollis Date:11/26/99ISR Number: 3409301-7Report Type:Expedited (15-DaCompany Report #LIT/98/00181/LEX Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Ceruloplasmin Increased Foreign Leponex / Clozaril Required Clonic Convulsion Literature (Clozapine) PS ORAL ORAL Intervention to Dystonia Health Prevent Permanent Movement Disorder Professional Impairment/Damage Muscle Hypertrophy Posturing Tardive Dyskinesia Torticollis Date:11/26/99ISR Number: 3409305-4Report Type:Expedited (15-DaCompany Report #AUS/99/01522/LEX Age:21 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Foreign Clozaril (Clozapine) PS ORAL 400 MG Required Haemoglobin Decreased Health ONCE A DAY Intervention to Malaise Professional ORAL Prevent Permanent Viral Pericarditis Impairment/Damage Date:11/26/99ISR Number: 3409309-1Report Type:Expedited (15-DaCompany Report #GB/99/00428/LEX Age:25 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Pain Foreign Clozaril (Clozapine) PS ORAL 225 MG Required Circulatory Collapse Health ONCE A DAY Intervention to Constipation Professional ORAL Prevent Permanent Deep Vein Thrombosis Other Epilim (Valproate Impairment/Damage Drug Level Above Sodium) C Therapeutic Orphenadrine Embolism (Orphenadrine) C Malaise Chlorpromazine Sudden Death (Chlorpromazine) C Dothiepin (Dosulepin) C Mebeverine (Mebeverine) C Fybogel (Ispaghula) C 22-Feb-2006 08:30 AM Page: 549 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/26/99ISR Number: 3409310-8Report Type:Expedited (15-DaCompany Report #AUS/99/00345/LEX Age:23 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Foreign Clozaril (Clozapine) PS ORAL 750 MG Initial or Prolonged Cardiomyopathy Health ORAL Chest Pain Professional Ranitidine Dyspnoea (Ranitidine) C Headache Hypoaesthesia Panic Attack Date:11/26/99ISR Number: 3409312-1Report Type:Expedited (15-DaCompany Report #USA/99/03071/LEX Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Clozaril (Clozapine) PS ORAL 500 MG Diabetes Mellitus Professional ORAL Drug Level Above Wellbutrin Therapeutic (Amfebutamone Muscle Contractions Hydrochloride) C Involuntary Trazodone Muscle Twitching (Trazodone) C Cogentin (Benzatropine Mesilate) C Date:11/26/99ISR Number: 3409442-4Report Type:Expedited (15-DaCompany Report #USA/99/03085/LEX Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Gastrooesophageal Reflux Health Clozaril (Clozapine) PS ORAL 700 MG, ORAL Initial or Prolonged Disease Professional Buspar (Buspirone Oesophageal Perforation Hydrochloride) C Date:11/26/99ISR Number: 3409445-XReport Type:Expedited (15-DaCompany Report #USA/99/03077/LEX Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Health Clozaril (Clozapine) PS ORAL 300 MG, ONCE Oedema Professional A DAY, ORAL Zoloft (Sertraline Hydrochloride) C Date:11/26/99ISR Number: 3409448-5Report Type:Expedited (15-DaCompany Report #USA/99/00877/LEX Age:42 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Health Clozaril (Clozapine) PS ORAL 450 MG, ORAL Life-Threatening Atelectasis Professional Topamax (Topiramate) SS ORAL 200 MG, TWICE Bronchitis A DAY, ORAL Confusional State Mevacor (Lovastatin) C Coronary Artery Disease Anafranil Myocarditis (Clomipramine Obesity Hydrochloride) C Pneumonia Ibuprofen C Ventricular Hypertrophy Hctz (Hydrochlorothiazide C 22-Feb-2006 08:30 AM Page: 550 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Depakote (Valproate Semisodium) C Date:11/26/99ISR Number: 3409450-3Report Type:Expedited (15-DaCompany Report #AUS/99/01152/LEX Age:23 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Foreign Clozaril (Clozapine) PS ORAL 750 MG, ORAL Initial or Prolonged Cardiomyopathy Consumer Ranitidine Chest Pain Health (Ranitidine) C Dyspnoea Professional Headache Hypoaesthesia Panic Attack Date:11/26/99ISR Number: 3409970-1Report Type:Expedited (15-DaCompany Report #F/99/02219/LEX Age:21 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Bilirubin Increased Foreign Leponex (Clozapine) PS ORAL 500 MG ; ORAL 3 MON Initial or Prolonged Hepatic Enzyme Increased Health Nozinan Required Hepatitis Professional (Levomepromazine) C Intervention to Hepatocellular Damage Rohypnol Prevent Permanent Prothrombin Time (Flunitrazepam) C Impairment/Damage Prolonged Date:11/29/99ISR Number: 3409001-3Report Type:Direct Company Report # Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Clozaril 100mg Tabs PS 500MG HS Initial or Prolonged Medication Error Sedation Date:11/29/99ISR Number: 3409396-0Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Amylase Increased Clozaril PS 200MG BID Lactose Intolerance Lithium SS 300MG QD 1 YR Lipase Increased Pancreatitis Date:11/29/99ISR Number: 3409879-3Report Type:Expedited (15-DaCompany Report #1999UW04185 Age:72 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Agranulocytosis Health Seroquel "Zeneca" PS Zeneca Intervention to Neutropenia Professional Clorazil SS ORAL 250 MG PO Prevent Permanent Prozac C Impairment/Damage Risperdal C Neurontin C Ambien C Aspirin "Bayer" C Niferex C Vitamin C C 22-Feb-2006 08:30 AM Page: 551 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/30/99ISR Number: 3409787-8Report Type:Direct Company Report # Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Haematuria Clozaril 25mg Initial or Prolonged Liver Function Test Tablets PS ORAL PO DOSE Abnormal UNAVAILABLE Pyrexia BEING White Blood Cell Count TITRATED Increased Clonazepam C Trihexyphenidyl C Depakote C Zyprexa C Axid C Date:12/01/99ISR Number: 3411508-XReport Type:Expedited (15-DaCompany Report #99-11-0397 Age:81 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Parkinson'S Disease Health Clozapine- Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline ORAL 75 MG ORAL Date:12/01/99ISR Number: 3411512-1Report Type:Expedited (15-DaCompany Report #99-10-0367 Age:57 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Chronic Obstructive Health Clozapine-Zenith Pulmonary Disease Professional Goldline Pharm. Lung Disorder Tablets PS Zenith Goldline ORAL 300 MG ORAL Paraplegia Haldol C Sepsis Shock White Blood Cell Count Increased Date:12/01/99ISR Number: 3411515-7Report Type:Expedited (15-DaCompany Report #99-11-0398 Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine-Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline ORAL 100 MG ORAL Date:12/01/99ISR Number: 3411518-2Report Type:Expedited (15-DaCompany Report #99-11-0404 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Rectal Cancer Health Clozapine-Zenith Initial or Prolonged Professional Goldline Pharm. Other Tablets PS Zenith Goldline ORAL 600 MG ORAL Required Haldol Decanoate C Intervention to Prevent Permanent Impairment/Damage 22-Feb-2006 08:30 AM Page: 552 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/01/99ISR Number: 3411627-8Report Type:Expedited (15-DaCompany Report #99-10-0355 Age:46 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Large Cell Carcinoma Of Health Clozapine-Zenith The Respiratory Tract Professional Goldline Pharm. Stage Unspecified Tablets PS Zenith Goldline Metastases To Central Pharm. ORAL 150-250MG Nervous System ORAL 15 MON White Blood Cell Count Celex C Increased Date:12/01/99ISR Number: 3411631-XReport Type:Expedited (15-DaCompany Report #99-11-0408 Age:80 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death White Blood Cell Count Health Clozapine Increased Professional Tablets-Zenith Goldline Pharm. PS Zenith Goldline Pharm. ORAL 12.5-37.5MG ORAL 2 MON Date:12/01/99ISR Number: 3411812-5Report Type:Expedited (15-DaCompany Report #99-09-0336 Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hepatic Failure Health Clozapine - Zenith Leukopenia Professional Goldline Pharm. Tablets PS ORAL 350-400MG ORAL Artane C Zyprexa C Date:12/01/99ISR Number: 3411813-7Report Type:Expedited (15-DaCompany Report #99-11-0393 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Gallbladder Disorder Health Clozapine - Zenith Initial or Prolonged Professional Goldline Pharm. Tablets PS Zenith Goldline ORAL 300-350MG ORAL Date:12/01/99ISR Number: 3411814-9Report Type:Expedited (15-DaCompany Report #99-11-0392 Age:91 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death White Blood Cell Count Health Clozapine - Zenith Increased Professional Goldline Pharm. Tablets PS Zenith Goldline ORAL 75-200MG ORAL Date:12/02/99ISR Number: 3411947-7Report Type:Expedited (15-DaCompany Report #99-10-0363 Age:43 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Delusion Health Clozapine - Zenith Insomnia Professional Goldline Pharm. Tablets PS Zenith Goldline 22-Feb-2006 08:30 AM Page: 553 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pharm. ORAL 200-400 MG ORAL Trazodone C Diphenhydramine C Ferrous Sulphate C Date:12/02/99ISR Number: 3411949-0Report Type:Expedited (15-DaCompany Report #99-10-0354 Age:51 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Breast Cancer Female Health Clozapine Tablets - Intervention to Leukopenia Professional Zenith Goldline Prevent Permanent Pharm. Tablets PS Zenith Goldline Impairment/Damage Pharm. ORAL 600 MG ORAL Date:12/02/99ISR Number: 3412766-8Report Type:Expedited (15-DaCompany Report #NZ/99/00080/LEX Age:39 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asthenia Foreign Clozaril (Clozapine) PS ORAL 700 MG, ORAL Cervix Carcinoma Health Ranitidine Professional (Ranitidine) C Clonazepam (Clonazepam) C Ferrogradumet (Ferrous Sulfate)-Anemia C Date:12/02/99ISR Number: 3412767-XReport Type:Expedited (15-DaCompany Report #GB/99/00978/LEX Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Haemorrhage Intracranial Foreign Clozaril (Clozapine) PS ORAL 250 MG, ONCE Hypertension Health A DAY; ORAL Intracranial Aneurysm Professional Date:12/02/99ISR Number: 3413233-8Report Type:Expedited (15-DaCompany Report #DK/99/00014/LEX Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aggression Foreign Leponex (Clozapine) PS ORAL 200 MG ORAL Required Agitation Health Anafranil Retard Intervention to Cardiac Arrest Professional (Clomipramine Prevent Permanent Coma Other Hydrochloride) SS ORAL 300 MG ORAL Impairment/Damage Drug Toxicity Depakine (Valproate Medication Error Sodium) SS ORAL 1 G ORAL Overdose Trileptal (Oxcarbazepine) SS ORAL 600 MG ORAL Lamictal (Lamotrigine) SS ORAL 200 MG TWICE A DAY ORAL Dogmatil (Sulpiride) C Serenase (Haloperidol) C Stilnoct (Zolpidem Tartrate) C Pendil (Felodipine) C Corodil (Enalapril) C 22-Feb-2006 08:30 AM Page: 554 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Oxazepam (Oxazepam) C Date:12/02/99ISR Number: 3413234-XReport Type:Expedited (15-DaCompany Report #GB/99/00746/LEX Age:25 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Encephalopathy Foreign Clozaril (Clozapine) PS ORAL 300 MG ORAL Life-Threatening Hepatic Function Abnormal Health Required Hepatocellular Damage Professional Intervention to Hyperbilirubinaemia Prevent Permanent Jaundice Impairment/Damage Liver Function Test Abnormal Pneumonia Sepsis Staphylococcal Sepsis Vomiting Date:12/02/99ISR Number: 3413241-7Report Type:Expedited (15-DaCompany Report #GB/99/01084/LEX Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypertension Foreign Clozaril (Clozapine) PS ORAL 500 MG, ORAL Phaeochromocytoma Health Professional Date:12/02/99ISR Number: 3413242-9Report Type:Expedited (15-DaCompany Report #GB/99/00477/LEX Age:18 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril (Clozapine) PS ORAL 500 MG, TWICE Insulin-Dependent Health A DAY, ORAL Professional Epilim (Valproate Sodium) C Date:12/02/99ISR Number: 3413266-1Report Type:Expedited (15-DaCompany Report #GB/99/00936/LEX Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Bilirubin Increased Foreign Clozaril (Clozapine) PS ORAL 250 MG, ONCE Hepatic Function Abnormal Health A DAY, ORAL Lethargy Professional Sytron (Sodium Liver Function Test Feredetate) C Abnormal Gliclazide Sedation (Gliclazide) C Splenomegaly Amisulpride (Amisulpride) C Date:12/03/99ISR Number: 3413496-9Report Type:Expedited (15-DaCompany Report #AUS/99/01528/LEX Age:54 YR Gender:Male I/FU:F Outcome Hospitalization - Initial or Prolonged Required Intervention to 22-Feb-2006 08:30 AM Page: 555 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Acute Psychosis Foreign Clozaril (Clozapine) PS 600 MG, ORAL, Blood Sodium Decreased Study UNKNOWN/700 Constipation Health MG, UNKNOWN, Drug Ineffective Professional ORAL Drug Interaction Losec (Omeprazole) SS UNSPECIFIED Drug Level Below Plendil Therapeutic (Felodipine)-Hyperte Headache nsion C Hyponatraemia Irritability Nervousness Polydipsia Polyuria Salivary Hypersecretion Sedation Thinking Abnormal Thirst Date:12/03/99ISR Number: 3413498-2Report Type:Expedited (15-DaCompany Report #AUS/99/01556/LEX Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Health Clozaril (Clozapine) PS ORAL 500 MG, Initial or Prolonged Drug Level Above Professional UNKNOWN, ORAL Required Therapeutic Diazepam (Diazepam) SS ORAL 10 MG, THREE Intervention to Medication Error TIMES A DAY, Prevent Permanent ORAL; 10 MG, Impairment/Damage TWICE A DAY, UNKNOWN;, 5 Lipitor (Atorvastatin) C Valproate (Valproate Sodium) C Date:12/03/99ISR Number: 3413550-1Report Type:Expedited (15-DaCompany Report #USA/99/03103/LEX Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Health Clozaril (Clozapine) PS ORAL ORAL Professional Date:12/06/99ISR Number: 3414683-6Report Type:Expedited (15-DaCompany Report #AUS/99/00345/LEX Age:23 YR Gender:Male I/FU:F Outcome PT Hospitalization - Anxiety Initial or Prolonged Barrett'S Oesophagus Required Bronchospasm Intervention to Cardiomyopathy Prevent Permanent Chest Pain Impairment/Damage Dry Mouth Dyspnoea Ejection Fraction Abnormal Electrocardiogram T Wave 22-Feb-2006 08:30 AM Page: 556 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Amplitude Decreased Headache Hypoaesthesia Myocarditis Report Source Product Role Manufacturer Route Dose Duration Panic Attack Foreign Clozaril (Clozapine) PS ORAL 750 MG, ORAL Paraesthesia Health Ranitidine Pollakiuria Professional (Ranitidine) C Tremor Frusemide Urinary Incontinence (Furosemide) C Vertigo Perindopril Vision Blurred (Perindopril) C Visual Disturbance Aspirin (Acetylsalicylic Acid) C Date:12/06/99ISR Number: 3414684-8Report Type:Expedited (15-DaCompany Report #CDN/99/00489/LEX Age:53 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Foreign Clozaril (Clozapine) PS ORAL 450 MG, ORAL Cardiovascular Disorder Study Moditen Hypotension Health (Fluphenazine Salivary Hypersecretion Professional Hydrochloride) C Shock Subdural Haematoma Date:12/08/99ISR Number: 3415503-6Report Type:Expedited (15-DaCompany Report #99-11-0422 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL ORAL Date:12/08/99ISR Number: 3415515-2Report Type:Expedited (15-DaCompany Report #99-09-0303 Age:59 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Adenocarcinoma Health Clozapine - Zenith Lung Neoplasm Malignant Professional Goldline Pharm. Metastases To Central Tablets PS Zenith Goldline Nervous System Pharm. ORAL 200-300 MG ORAL 2 MON Depakote C Seroquel C Wellbutrin C Date:12/08/99ISR Number: 3416697-9Report Type:Expedited (15-DaCompany Report #GB/99/01106/LEX Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Circulatory Collapse Foreign Clozaril (Clozapine) PS ORAL 150 MG, ORAL; Confusional State Health 250 MG, ORAL Pulmonary Embolism Professional Shock 22-Feb-2006 08:30 AM Page: 557 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/10/99ISR Number: 3418082-2Report Type:Direct Company Report # Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Clonic Convulsion Health Clozaril 25mgtabs PS 50MG AM - 100 Required Dyskinesia Professional HS Intervention to Clozaril 100mgtabs SS 100 MG HS Prevent Permanent Benztropine C Impairment/Damage Levothyroxine C Propranolol C Acetaminophen C Lorazepam C Hydroxyzine Pamoate C Date:12/10/99ISR Number: 3418476-5Report Type:Expedited (15-DaCompany Report #D/99/01506/LEX Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Leponex (Clozapine) PS ORAL 600 MG, Initial or Prolonged Confusional State Health UNKNOWN, ORAL Drug Interaction Professional Aciclovir Electroencephalogram (Aciclovir) SS ORAL 800 MG, Abnormal UNKNOWN, ORAL Herpes Zoster Psychotic Disorder Date:12/10/99ISR Number: 3418545-XReport Type:Expedited (15-DaCompany Report #GB/99/01105/LEX Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Foreign Clozaril (Clozapine) PS ORAL 300 MG ORAL Initial or Prolonged Cerebrovascular Disorder Health Monoparesis Professional Urinary Incontinence Date:12/10/99ISR Number: 3418549-7Report Type:Expedited (15-DaCompany Report #GB/99/01112/LEX Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Lung Neoplasm Malignant Foreign Clozaril (Clozapine) PS ORAL 300 MG TWICE Health A DAY ORAL Professional Dexamethasone (Dexamethasone) C Haloperidol (Haloperidol) C Imipramine (Imipramine) C Date:12/10/99ISR Number: 3418568-0Report Type:Expedited (15-DaCompany Report #AUS/99/01614/LEX Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bladder Disorder Foreign Clozaril (Clozapine) PS ORAL UNSPECIFIED, Initial or Prolonged Consumer ORAL 22-Feb-2006 08:30 AM Page: 558 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/10/99ISR Number: 3418569-2Report Type:Expedited (15-DaCompany Report #GB/99/01122/LEX Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aortic Dissection Foreign Clozaril (Clozapine) PS ORAL 600 MG,ORAL Initial or Prolonged Lymphadenopathy Health Malaise Professional Mediastinal Disorder Pericardial Effusion Pericarditis Date:12/10/99ISR Number: 3418571-0Report Type:Expedited (15-DaCompany Report #AUS/99/01625/LEX Age:66 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Escherichia Sepsis Foreign Clozaril (Clozapine) PS ORAL 350 MG, ORAL Initial or Prolonged Malaise Health Aspirin Required Renal Failure Acute Professional (Acetylsalicylic Intervention to Acid) C Prevent Permanent Impairment/Damage Date:12/10/99ISR Number: 3418583-7Report Type:Expedited (15-DaCompany Report #USA/99/03220/LEX Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Health Clozaril (Clozapine) PS ORAL 200 MG, TWICE Required Electrocardiogram Professional A DAY ORAL Intervention to Abnormal Multivitamins C Prevent Permanent Weight Increased Flu Vaccine Impairment/Damage (Influenza Virus Vaccine Polyvalent) C Date:12/10/99ISR Number: 3418760-5Report Type:Expedited (15-DaCompany Report #USA/99/02214/LEX Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Health Clozaril (Clozapine) PS 250 MG, Initial or Prolonged Phosphokinase Increased Professional Seroquel C Required Chest Pain Intervention to Electrocardiogram St Prevent Permanent Segment Abnormal Impairment/Damage Electrocardiogram St Segment Depression Electrocardiogram St Segment Elevation Myocardial Infarction Date:12/10/99ISR Number: 3418762-9Report Type:Expedited (15-DaCompany Report #USA/99/03165/LEX Age:50 YR Gender:Male I/FU:I Outcome Hospitalization - Initial or Prolonged Disability Required Intervention to Prevent Permanent 22-Feb-2006 08:30 AM Page: 559 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Coma Health Clozaril (Clozapine) PS 450 MG Medication Error Professional Lithium C Sedation Multivitamin C Date:12/13/99ISR Number: 3420464-XReport Type:Expedited (15-DaCompany Report #SF/99/00643/LEX Age:71 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Foreign Leponex (Clozapine) PS ORAL 31.25 MG, Initial or Prolonged Diabetes Mellitus Health UNKNOWN, ORAL Required Inadequate Control Professional Comtess (Entacapone) SS ORAL 800 MG, Intervention to Difficulty In Walking UNKNOWN, ORAL Prevent Permanent Fatigue Madopar (Madopar) SS ORAL 100 MG, Impairment/Damage Gait Disturbance UNKNOWN, ORAL Parkinsonism Sinemet (Sinemet) SS ORAL 400 MG, UNKNOWN, ORAL Metforem (Metformin Hydrochloride) C Euglucon (Glibenclamide) C Protaphan (Insulin Isophane, Human Biosynthetic) C Digoxin (Digoxin) C Furesis (Furosemide) C Omnic (Tamsulosin Hydrochloride) C Renitec C Date:12/13/99ISR Number: 3420467-5Report Type:Expedited (15-DaCompany Report #GB/99/01138/LEX Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bronchiolitis Foreign Clozaril (Clozapine) PS ORAL 400 MG, Pneumonia Health UNKNOWN, ORAL 8 YR Purulence Professional Respiratory Failure Date:12/13/99ISR Number: 3420468-7Report Type:Expedited (15-DaCompany Report #B/99/00215/LEX Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Haemorrhagic Stroke Foreign Leponex (Clozapine) PS UNSPECIFIED Initial or Prolonged Health Professional Date:12/13/99ISR Number: 3420588-7Report Type:Expedited (15-DaCompany Report #AUS/99/01637/LEX Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Nephrolithiasis Foreign Clozaril (Clozapine) PS ORAL 225 MG, ORAL Initial or Prolonged White Blood Cell Count Study Increased Health Professional 22-Feb-2006 08:30 AM Page: 560 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/13/99ISR Number: 3420598-XReport Type:Expedited (15-DaCompany Report #USA/99/03201/LEX Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Colon Cancer Health Clozaril (Clozapine) PS ORAL 225 MG, ORAL Professional Serzone (Nefazodone Hydrochloride) C Zantac (Ranitidine Hydrochloride) C Valium (Diazepam) C Date:12/13/99ISR Number: 3420600-5Report Type:Expedited (15-DaCompany Report #USA/99/03199/LEX Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetes Mellitus Health Clozaril (Clozapine) PS ORAL 400 MG, ORAL Myocardial Infarction Professional Depakote (Valproate Semisodium) C Prozac (Fluoxetine Hydrochloride) C Date:12/13/99ISR Number: 3421057-0Report Type:Expedited (15-DaCompany Report #AUS/98/00137/LEX Age:27 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Viral Myocarditis Foreign Clozaril (Clozapine) PS ORAL 200 MG, Study UNKNOWN, ORAL Health Olanzapine Professional (Olanzapine) C Diazepam (Diazepam) C Date:12/13/99ISR Number: 3421061-2Report Type:Expedited (15-DaCompany Report #D/99/01623/LEX Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Foreign Leponex (Clozapine) PS ORAL 25 MG, Other Neutropenia Health UNKNOWN, White Blood Cell Count Professional ORAL; Decreased Date:12/13/99ISR Number: 3421063-6Report Type:Expedited (15-DaCompany Report #GB/99/00368/LEX Age:56 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Foreign Clozaril (Clozapine) PS ORAL 475 MG, Initial or Prolonged Congestive Other UNKNOWN, ORAL Cardiomyopathy Date:12/13/99ISR Number: 3421064-8Report Type:Expedited (15-DaCompany Report #GB/99/00285/LEX Age:57 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiomyopathy Foreign Clozaril (Clozapine) PS ORAL 475 MG, Other UNKNOWN, ORAL 22-Feb-2006 08:30 AM Page: 561 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/14/99ISR Number: 3421351-3Report Type:Expedited (15-DaCompany Report #221710 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Creatine Foreign Tasmar (Tolcapone) Hospitalization - Phosphokinase Increased Health 100 Mg PS ORAL 50 MG 2 PER Initial or Prolonged Coma Professional DAY ORAL Depression Other Madopar Dr Drug Interaction (Benserazide/Levodop Gastrointestinal Disorder a) 250 Mg SS ORAL 250 MG 3 PER Liver Disorder DAY ORAL Liver Function Test Ditropan (Oxybutynin Abnormal Chloride) 5 Mg SS ORAL 5 MG DAILY Mental Disorder ORAL Musculoskeletal Disorder Tryptizol Neuroleptic Malignant (Amitriptyline Syndrome Hydrochloride) 25 Mg SS ORAL 25 MG DAILY Parkinson'S Disease ORAL Prothrombin Time Motilium Shortened (Domperidone) 10 Mg SS ORAL 10 MG 3 PER Psychotic Disorder DAY ORAL Pyrexia Leponex (Clozapine) Thrombocytopenia 25 Mg SS ORAL 6.25 MG 3 PER DAY ORAL Celebrex (Celecoxib) 100 Mg SS ORAL 100 MG 3 PER DAY ORAL Pk-Merz (Amantadine Sulfate) C Konakion Injection (Phytonadione) C Date:12/15/99ISR Number: 3422519-2Report Type:Expedited (15-DaCompany Report #AUS/98/00172/LEX Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Foreign Clozaril (Clozapine) PS ORAL 300 MG ORAL Bronchospasm Study Chlorpromazine Cardiomyopathy Health (Chlorpromazine) C Inflammation Professional Clonazepam Liver Disorder (Clonazepam) C Myocarditis Panad (Panadeine Co) C Lactulose (Lactulose) C Date:12/15/99ISR Number: 3422734-8Report Type:Expedited (15-DaCompany Report #GB/99/01143/LEX Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril (Clozapine) PS XX, UNKNOWN Health Professional Date:12/15/99ISR Number: 3422735-XReport Type:Expedited (15-DaCompany Report #GB/99/01152/LEX Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Death Pneumonia Foreign Health 22-Feb-2006 08:30 AM Page: 562 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Product Role Manufacturer Route Dose Duration Clozaril (Clozapine) PS ORAL 600 MG, UNKNOWN; ORAL Date:12/16/99ISR Number: 3422675-6Report Type:Expedited (15-DaCompany Report #99-11-0428 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neoplasm Malignant Health Clozapine PS Zenith Goldline Professional Pharm ORAL 500MG ORAL 2 MON Date:12/16/99ISR Number: 3422676-8Report Type:Expedited (15-DaCompany Report #99-11-0424 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Metabolic Encephalopathy Health Clozapine PS Zenith Goldline Initial or Prolonged Toxic Induced Professional Pharm ORAL 250-400 MG Required Encephalopathy ORAL Intervention to Haloperidol C Prevent Permanent Impairment/Damage Date:12/16/99ISR Number: 3422677-XReport Type:Expedited (15-DaCompany Report #99-11-0426 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dyspnoea Health Clozapine PS Zenith Goldline ORAL 450 MG ORAL White Blood Cell Count Professional Increased Date:12/16/99ISR Number: 3422808-1Report Type:Periodic Company Report #99-06-0170 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozapine - Zenith Hospitalization - Pyrexia Professional Goldline Pharm. Initial or Prolonged Tablets PS Zenith Goldline Required Pharm. ORAL 175-400MG Intervention to ORAL 3 MON Prevent Permanent Impairment/Damage Date:12/16/99ISR Number: 3422810-XReport Type:Periodic Company Report #99-08-0260 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozapine Tablets - Professional Zenith Goldline Pharm. PS Zenith Goldline Pharm. ORAL 200MG ORAL Tamoxifen SS 22-Feb-2006 08:30 AM Page: 563 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/16/99ISR Number: 3422813-5Report Type:Expedited (15-DaCompany Report #99-08-0285 Age:77 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Chronic Obstructive Health Clozapine - Zenith Pulmonary Disease Professional Goldline Pharm. Pneumonia Tablets PS Zenith Goldline White Blood Cell Count Pharm. ORAL ORAL Increased Date:12/16/99ISR Number: 3422816-0Report Type:Expedited (15-DaCompany Report #99-08-0286 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozapine Tablets - Hospitalization - Pneumonia Professional Zenith Goldline Initial or Prolonged Pyrexia Pharm. PS Zenith Goldline Vomiting Pharm. ORAL 400-600MG ORAL Prochlorperazine C Pepcid C Date:12/16/99ISR Number: 3422819-6Report Type:Periodic Company Report #99-08-0292 Age:86 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 12.5MG ORAL Date:12/16/99ISR Number: 3422822-6Report Type:Periodic Company Report #99-09-0300 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dermatitis Health Clozapine Tablets - Initial or Prolonged Headache Professional Zenith Goldline Hypotension Pharm. PS Zenith Goldline Pulse Abnormal Pharm. ORAL 300MG/DAY Pyrexia ORAL Sepsis Peri-Colace C Tachycardia Multivitamins C Date:12/16/99ISR Number: 3422824-XReport Type:Periodic Company Report #99-09-0302 Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sepsis Health Clozapine - Zenith Urinary Tract Infection Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 100-600MG ORAL Bactrim Iv C Lasix C Rocephin C 22-Feb-2006 08:30 AM Page: 564 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/16/99ISR Number: 3422828-7Report Type:Periodic Company Report #99-09-0313 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Urinary Incontinence Health Clozapine - Zenith Initial or Prolonged Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 125MG ORAL Date:12/16/99ISR Number: 3422832-9Report Type:Periodic Company Report #99-09-0315 Age:87 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine Tablets - Professional Zenith Goldline Pharm. PS Zenith Goldline Pharm. ORAL 50MG ORAL 4 MON Date:12/16/99ISR Number: 3422833-0Report Type:Periodic Company Report #99-09-0320 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Clonic Convulsion Health Clozapine - Zenith Initial or Prolonged Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 300MG ORAL Neurontin C Paxil C Prozac C Ranitidine C Serevent Inhalation Solution C Artane C Coumadin C Accolate C Fluphenazine C Date:12/16/99ISR Number: 3422834-2Report Type:Periodic Company Report #99-09-0321 Age:83 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dehydration Health Clozapine - Zenith Hospitalization - Sepsis Professional Goldline Pharm. Initial or Prolonged Tablets PS Zenith Goldline Pharm. ORAL 12.5MG ORAL 1 DAY Date:12/16/99ISR Number: 3422835-4Report Type:Periodic Company Report #99-09-0322 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS ORAL 475 MG ORAL 12 MON 22-Feb-2006 08:30 AM Page: 565 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/16/99ISR Number: 3422836-6Report Type:Periodic Company Report #99-09-0326 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Health Clozapine - Zenith Initial or Prolonged Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 200MG ORAL Date:12/16/99ISR Number: 3422838-XReport Type:Periodic Company Report #99-09-0327 Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Health Clozapine - Zenith Initial or Prolonged Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 100MG ORAL Zyprexa C Gabapentin C Furosemide C Date:12/16/99ISR Number: 3422839-1Report Type:Periodic Company Report #99-09-0333 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dehydration Health Clozapine - Zenith Initial or Prolonged Hypotension Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL ORAL Date:12/16/99ISR Number: 3422841-XReport Type:Periodic Company Report #99-09-0335 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Health Clozapine Tablets - Initial or Prolonged Professional Zenith Goldline Pharm. PS ORAL 300-600MG ORAL Diphenhydramine C Docusate Sodium C Naproxen C Tamoxifen C Albuterol C Atrovent C Calcium (Supplement) C Date:12/16/99ISR Number: 3422843-3Report Type:Periodic Company Report #99-09-0337 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pulmonary Embolism Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 400-500MG ORAL 1 YR 22-Feb-2006 08:30 AM Page: 566 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/16/99ISR Number: 3422844-5Report Type:Periodic Company Report #99-09-0339 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Depression Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS ORAL 12.5-50MG ORAL Serzone C Klonopin C Doxepin C Date:12/16/99ISR Number: 3422846-9Report Type:Periodic Company Report #99-10-0349 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 600-900MG ORAL Date:12/16/99ISR Number: 3422848-2Report Type:Periodic Company Report #99-10-0352 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Health Clozapine - Zenith Initial or Prolonged Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 500MG ORAL Date:12/16/99ISR Number: 3422853-6Report Type:Periodic Company Report #99-10-0364 Age:66 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Health Clozapine - Zenith Initial or Prolonged Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 300MG ORAL Depakote C Date:12/16/99ISR Number: 3422855-XReport Type:Periodic Company Report #99-10-0365 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Health Clozapine - Zenith Initial or Prolonged Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 100MG ORAL Date:12/16/99ISR Number: 3422857-3Report Type:Periodic Company Report #99-10-0366 Age:43 YR Gender:Male I/FU:I Outcome Hospitalization - Initial or Prolonged Required 22-Feb-2006 08:30 AM Page: 567 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Intervention to Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Sepsis Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 500-600MG ORAL Solu-Medrol C Date:12/16/99ISR Number: 3422859-7Report Type:Periodic Company Report #99-10-0370 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 500-600MG ORAL Serzone C Zoloft C Depakote C Date:12/16/99ISR Number: 3422863-9Report Type:Periodic Company Report #99-10-0371 Age:86 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Aspiration Health Clozapine - Zenith Initial or Prolonged Professional Goldline Pharm. Tablets PS ORAL 6.2-12.5MG ORAL Date:12/16/99ISR Number: 3422873-1Report Type:Periodic Company Report #99-10-0380 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Health Clozapine - Zenith Initial or Prolonged Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 300-600MG ORAL Combivent C Albuterol C Bisacodyl C Depakote C Furosemide C Propranolol C Metamucil C Zestril C Date:12/16/99ISR Number: 3422875-5Report Type:Periodic Company Report #99-10-0384 Age:69 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucination Health Clozapine - Zenith Initial or Prolonged Parkinson'S Disease Professional Goldline Pharm. Tablets PS Zenith Goldline 22-Feb-2006 08:30 AM Page: 568 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pharm. ORAL 12.5-25.0MG ORAL Date:12/16/99ISR Number: 3422879-2Report Type:Periodic Company Report #99-11-0385 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperglycaemia Health Clozapine - Zenith Initial or Prolonged Pneumonia Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 12.5 - 62.5MG ORAL Date:12/16/99ISR Number: 3422880-9Report Type:Periodic Company Report #99-11-0391 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Clozapine - Zenith Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 12.5-300MG ORAL Date:12/16/99ISR Number: 3422881-0Report Type:Periodic Company Report #99-11-0395 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozapine - Zenith Hospitalization - Pneumonia Professional Goldline Pharm. Initial or Prolonged Tablets PS Zenith Goldline Pharm. ORAL 50-400MG ORAL Anafranil D/C C Risperdal C Paxil C Haldol C Buspar D/C C Date:12/16/99ISR Number: 3422883-4Report Type:Periodic Company Report #99-11-0399 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Clozapine - Zenith Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 500MG ORAL Date:12/16/99ISR Number: 3422884-6Report Type:Periodic Company Report #99-11-0400 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Health Clozapine - Zenith Initial or Prolonged Professional Goldline Pharm. PS Zenith Goldline Pharm. ORAL 300MG ORAL Imipramine C 22-Feb-2006 08:30 AM Page: 569 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/16/99ISR Number: 3422886-XReport Type:Periodic Company Report #99-11-0409 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozapine - Zenith Professional Goldline Pharm. PS Zenith Goldline Pharm. ORAL 25MG ORAL Date:12/16/99ISR Number: 3422888-3Report Type:Periodic Company Report #99-11-0411 Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Clozapine - Zenith Professional Goldline Pharm. PS Zenith Goldline Pharm. ORAL 300-350MG ORAL Date:12/16/99ISR Number: 3422889-5Report Type:Periodic Company Report #99-11-0412 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozapine - Zenith Hospitalization - Upper Respiratory Tract Professional Goldline Pharm. Initial or Prolonged Infection Tablets PS Zenith Goldline Pharm. ORAL 300MG ORAL Neurontin C Date:12/16/99ISR Number: 3422891-3Report Type:Periodic Company Report #99-11-0415 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Health Clozapine - Zenith Initial or Prolonged Pneumonia Professional Goldline Pharm. PS Zenith Goldline Pharm. ORAL 700MG ORAL Serax C Eskalith C Date:12/16/99ISR Number: 3422892-5Report Type:Periodic Company Report #99-11-0416 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pulmonary Embolism Health Clozapine - Zenith Initial or Prolonged Professional Goldline Pharm. PS Zenith Goldline Other Pharm. ORAL 400-500MG ORAL Date:12/16/99ISR Number: 3422894-9Report Type:Periodic Company Report #99-11-0418 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozapine - Zenith Professional Goldline Pharm. PS Zenith Goldline Pharm. ORAL 700MG ORAL 22-Feb-2006 08:30 AM Page: 570 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/16/99ISR Number: 3422896-2Report Type:Periodic Company Report #99-11-0419 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 250MG ORAL Date:12/16/99ISR Number: 3422897-4Report Type:Periodic Company Report #99-11-0421 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozapine - Zenith Professional Goldline Pharm. PS Zenith Goldline Pharm. ORAL 400MG ORAL Tegretol C Date:12/16/99ISR Number: 3422898-6Report Type:Periodic Company Report #99-05-0142 Age:77 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 12.5MG DAY ORAL 2 MON Sinemet C Topral Xl C Date:12/16/99ISR Number: 3422899-8Report Type:Periodic Company Report #99-06-0194 Age:85 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozapine - Zenith Pneumonia Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL ORAL 1 MON Sinemet C Amantadine C Synthroid C Atenolol C Date:12/16/99ISR Number: 3422900-1Report Type:Periodic Company Report #99-07-0219 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 25-30MG ORAL 1 MON Zyprexa C 22-Feb-2006 08:30 AM Page: 571 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/16/99ISR Number: 3422901-3Report Type:Periodic Company Report #99-07-0222 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozapine - Zenith Myocardial Infarction Professional Goldline Pharm. Parkinson'S Disease Tablets PS Zenith Goldling Pharm. ORAL 175MG ORAL 17 MON Date:12/16/99ISR Number: 3422902-5Report Type:Periodic Company Report #99-08-0242 Age:78 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Health Clozapine - Zenith Initial or Prolonged Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 175-300MG ORAL Clonidine C Date:12/16/99ISR Number: 3422903-7Report Type:Periodic Company Report #99-08-0244 Age:68 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Aspiration Health Clozapine - Zeniths Initial or Prolonged Upper Respiratory Tract Professional Goldline Pharm. Infection Tablets PS Zenith Goldline Pharm. ORAL 100MG ORAL 1 YR Prilosec C Sinemet Cr C Date:12/16/99ISR Number: 3422905-0Report Type:Periodic Company Report #99-08-0245 Age:50 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozapine - Zenith Hospitalization - Pyrexia Professional Goldline Pharm. Initial or Prolonged Tablets PS Zenith Goldline Pharm ORAL 162-5MG ORAL Neupogen C Claritin C Lithium Carbonate C Date:12/16/99ISR Number: 3422906-2Report Type:Periodic Company Report #99-08-0288 Age:64 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Aspiration Health Clozapine - Zenith Hospitalization - Professional Goldline Pharm. Initial or Prolonged Tablets PS Zenith Goldline Pharm ORAL 150MG ORAL Paxil C Valproic Acid C Chlorpromazine C 22-Feb-2006 08:30 AM Page: 572 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/16/99ISR Number: 3422909-8Report Type:Periodic Company Report #99-08-0289 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Ineffective Health Clozapine -Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm ORAL 50-300MG QD ORAL Date:12/16/99ISR Number: 3422910-4Report Type:Periodic Company Report #99-09-0311 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukocytosis Health Clozapine - Zenith Red Blood Cell Count Professional Goldline Pharm. Decreased Tablets PS Zeniths Goldling Pharm ORAL 150-600MG ORAL Date:12/16/99ISR Number: 3422911-6Report Type:Periodic Company Report #99-09-0316 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukocytosis Health Clozapine -Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm 500MG Date:12/16/99ISR Number: 3422912-8Report Type:Periodic Company Report #99-09-0319 Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tremor Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm ORAL 12.5MG ORAL Risperdal C Zestril C Aricept C Date:12/16/99ISR Number: 3422913-XReport Type:Periodic Company Report #99-09-0324 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Depression Health Clozapine - Zenith Suicidal Ideation Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm ORAL 150-550MG ORAL Date:12/16/99ISR Number: 3422914-1Report Type:Periodic Company Report #99-09-0325 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Delirium Health Clozapine - Zenith Professional Goldline Pharm. 22-Feb-2006 08:30 AM Page: 573 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tablets PS Zenith Goldline Pharm ORAL 250MG ORAL Date:12/16/99ISR Number: 3422915-3Report Type:Periodic Company Report #99-09-0328 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Schizophrenia Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm ORAL ORAL Date:12/16/99ISR Number: 3422916-5Report Type:Periodic Company Report #99-09-0329 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Schizophrenia Health Clozapine -Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm ORAL ORAL Date:12/16/99ISR Number: 3422917-7Report Type:Periodic Company Report #99-09-0330 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Health Clozapine - Zenith Schizoaffective Disorder Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 300MG ORAL Date:12/16/99ISR Number: 3422918-9Report Type:Periodic Company Report #99-09-0331 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Ineffective Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm ORAL 800MG ORAL Zyprexa C Klonopin C Zoloft C Cogentin C Navane C Date:12/16/99ISR Number: 3422919-0Report Type:Periodic Company Report #99-09-0332 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Ineffective Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm ORAL 450-900MG ORAL Depakote C Seroquel C 22-Feb-2006 08:30 AM Page: 574 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/16/99ISR Number: 3422920-7Report Type:Periodic Company Report #99-09-0334 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Health Clozapine - Zenith Mental Disorder Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm ORAL 12.5-200MG ORAL Date:12/16/99ISR Number: 3423241-9Report Type:Periodic Company Report #99-11-0401 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypotension Health Clozapine - Zenith Leukopenia Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 12.5 - 150 MG ORAL Date:12/16/99ISR Number: 3423244-4Report Type:Periodic Company Report #99-11-0403 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dysphoria Health Clozapine - Zenith Sedation Professional Goldline Pharm. Tension Tablets PS Zenith Goldline Pharm. ORAL 300 MG ORAL Zoloft Unknown SS Date:12/16/99ISR Number: 3423247-XReport Type:Periodic Company Report #99-11-0406 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 100-400 MG ORAL Lithium C Date:12/16/99ISR Number: 3423250-XReport Type:Periodic Company Report #99-11-0410 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Health Clozapine - Zenith Mental Disorder Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 125 MG ORAL Date:12/16/99ISR Number: 3423252-3Report Type:Periodic Company Report #99-11-0413 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Health Clozapine - Zenith Psychotic Disorder Professional Goldline Pharm. Tablets PS Zenith Goldline 22-Feb-2006 08:30 AM Page: 575 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pharm. ORAL 100-300 MG ORAL Date:12/16/99ISR Number: 3423255-9Report Type:Periodic Company Report #99-11-0414 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiac Failure Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 200 MG ORAL Date:12/16/99ISR Number: 3423264-XReport Type:Periodic Company Report #99-06-0159 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Liver Function Test Health Clozapine - Zenith Initial or Prolonged Abnormal Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 25-300 MG ORAL Trazodone C Tylenol 3.1 C Effexor C Date:12/16/99ISR Number: 3423269-9Report Type:Periodic Company Report #99-06-0164 Age:12 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Retching Health Clozapine - Zenith Salivary Hypersecretion Professional Goldline Pharm. Upper Respiratory Tract Tablets PS Zenith Goldline Infection Pharm. ORAL 50-300 MG/DAY Vomiting ORAL Lithium C Zyprexa C Neurontin C Cogentin C Date:12/16/99ISR Number: 3423273-0Report Type:Periodic Company Report #99-06-0179 Age:49 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Mania Health Clozapine - Zenith Psychotic Disorder Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 200-700 MG/DAY ORAL Depakote C Date:12/16/99ISR Number: 3423279-1Report Type:Periodic Company Report #99-07-0204 Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Schizophrenia Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline 22-Feb-2006 08:30 AM Page: 576 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pharm. ORAL 900 MG/QD ORAL Prozac C Date:12/16/99ISR Number: 3423282-1Report Type:Periodic Company Report #99-07-0211 Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 400 MG/DAY ORAL 2 MON Date:12/16/99ISR Number: 3423284-5Report Type:Periodic Company Report #99-09-0340 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Clozapine - Zenith Mental Disorder Professional Goldline Pharm. Tablets PS ORAL 750MG ORAL Date:12/16/99ISR Number: 3423286-9Report Type:Periodic Company Report #99-07-0226 Age:77 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Health Clozapine - Zenith Initial or Prolonged Constipation Professional Goldline Pharm. Dizziness Tablets PS Zenith Goldline Drooling Pharm. ORAL 12.5 - 25 MG Fatigue ORAL Joint Swelling Ibuprofen C Nausea Centrum Silver C Pharyngolaryngeal Pain Carbidopa C Pyrexia Levodopa C Sedation Date:12/16/99ISR Number: 3423288-2Report Type:Periodic Company Report #99-09-0341 Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Unevaluable Event Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS ORAL 150-500MG ORAL Depakote C Date:12/16/99ISR Number: 3423291-2Report Type:Periodic Company Report #99-09-0344 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sedation Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS ORAL 75-125MG ORAL 5 MON 22-Feb-2006 08:30 AM Page: 577 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/16/99ISR Number: 3423292-4Report Type:Periodic Company Report #99-07-0229 Age:31 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Health Clozapine - Zenith Initial or Prolonged Anxiety Professional Goldline Pharm. Depression Tablets PS Zenith Goldline Hallucination Pharm. ORAL 450-900 MG Hallucination, Auditory ORAL Psychotic Disorder Propanolol C Wellbutrin C Date:12/16/99ISR Number: 3423294-8Report Type:Periodic Company Report #99-10-0347 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pneumonia Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Date:12/16/99ISR Number: 3423295-XReport Type:Periodic Company Report #99-08-0236 Age:44 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Disturbance In Attention Health Clozapine - Zenith Nervousness Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 200-225 MG ORAL Depakote C Zyprexa C Klonopin C Prozac C Date:12/16/99ISR Number: 3423297-3Report Type:Periodic Company Report #99-10-0348 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Health Clozapine - Zenith Delusion Professional Goldline Pharm. Hallucination, Tactile Tablets PS ORAL 725-800 MG Psychotic Disorder ORAL Date:12/16/99ISR Number: 3423298-5Report Type:Periodic Company Report #99-08-0249 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Constipation Health Clozapine - Zenith Drooling Professional Goldline Pharm. Fatigue Tablets PS Zenith Goldline Feeling Abnormal Pharm. ORAL 25-300 MG QD Hallucination, Auditory ORAL Paraesthesia Clonazepam C Sedation 22-Feb-2006 08:30 AM Page: 578 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/16/99ISR Number: 3423300-0Report Type:Periodic Company Report #99-10-0351 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Schizophrenia Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS ORAL 50-300MG ORAL Date:12/16/99ISR Number: 3423302-4Report Type:Periodic Company Report #99-08-0270 Age:46 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Lethargy Health Clozapine - Zenith Migraine Professional Goldline Pharm. Muscular Weakness Tablets PS Zenith Goldline Myalgia Pharm. ORAL 200 MG/QD Nausea ORAL Pharyngolaryngeal Pain Effexor C Photophobia Desyrel C Pyrexia Date:12/16/99ISR Number: 3423303-6Report Type:Periodic Company Report #99-10-0353 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Salivary Hypersecretion Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS ORAL 600MG ORAL Date:12/16/99ISR Number: 3423304-8Report Type:Periodic Company Report #99-08-0274 Age:61 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abnormal Behaviour Health Clozapine - Zenith Agitation Professional Goldline Pharm. Hallucination Tablets PS Zenith Goldline Pharm. ORAL 200-600 MG ORAL Date:12/16/99ISR Number: 3423305-XReport Type:Periodic Company Report #99-10-0356 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Corneal Oedema Health Clozapine - Zenith Eye Irritation Professional Goldline Pharm. Tablets PS ORAL 300-400MG ORAL Date:12/16/99ISR Number: 3423306-1Report Type:Periodic Company Report #99-10-0369 Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hallucination Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS ORAL 6.2MG ORAL Selegiline C 22-Feb-2006 08:30 AM Page: 579 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/16/99ISR Number: 3423308-5Report Type:Periodic Company Report #99-10-0373 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abnormal Behaviour Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline/Baker Norton ORAL 350-800MG ORAL Date:12/16/99ISR Number: 3423309-7Report Type:Periodic Company Report #99-10-0374 Age:66 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Health Clozapine - Zenith Coma Professional Goldline Pharm. Tablets PS ORAL 150MG ORAL Haldol C Lithium C Fluphenazine C Date:12/16/99ISR Number: 3423311-5Report Type:Periodic Company Report #99-10-0376 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Urinary Incontinence Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS ORAL 400-500MG ORAL Date:12/16/99ISR Number: 3423313-9Report Type:Periodic Company Report #99-10-0377 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukocytosis Health Clozapine - Zenith Tooth Abscess Professional Goldline Pharm. Tablets PS ORAL 375MG ORAL Lithium C Date:12/16/99ISR Number: 3423318-8Report Type:Periodic Company Report #99-10-0379 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Health Clozapine - Zenith Psychotic Disorder Professional Goldline Pharm. Tablets PS ORAL 25-100MG ORAL Navane C Risperdal C Prozac C Date:12/16/99ISR Number: 3423322-XReport Type:Periodic Company Report #99-10-0382 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Level Above Health Clozapine - Zenith Therapeutic Professional Goldline Pharm. 22-Feb-2006 08:30 AM Page: 580 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tablets PS ORAL 150-750MG ORAL Paxil C Periactin C Prolixin C Synthroid C Date:12/16/99ISR Number: 3423328-0Report Type:Periodic Company Report #99-10-0383 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS ORAL 175MG ORAL Date:12/16/99ISR Number: 3423332-2Report Type:Periodic Company Report #99-11-0386 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sinus Tachycardia Health Clozapine - Zenith Syncope Professional Goldline Pharm. Tablets PS ORAL 250-300MG ORAL Promethazine C Date:12/16/99ISR Number: 3423338-3Report Type:Periodic Company Report #99-11-0389 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diarrhoea Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS ORAL 175MG ORAL Date:12/16/99ISR Number: 3423341-3Report Type:Periodic Company Report #99-11-0390 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Nausea Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS ORAL 250MG ORAL Date:12/16/99ISR Number: 3423343-7Report Type:Periodic Company Report #99-11-0396 Age:77 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pain Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS ORAL 12.5-18MG ORAL Date:12/16/99ISR Number: 3423586-2Report Type:Expedited (15-DaCompany Report #D/99/01645/LEX Age: Gender:Male I/FU:I Outcome Life-Threatening Hospitalization - 22-Feb-2006 08:30 AM Page: 581 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Initial or Prolonged PT Report Source Product Role Manufacturer Route Dose Duration Cardiac Failure Foreign Leponex (Clozapine) PS Congestive Cardiomyopathy Health Dyspnoea Professional Date:12/16/99ISR Number: 3423594-1Report Type:Expedited (15-DaCompany Report #D/99/01660/LEX Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Left Ventricular Failure Foreign Leponex (Clozapine) PS 600 MG Pulmonary Oedema Health Neurocil Shock Professional (Levomepromazine Sudden Death Maleate) C Diazepam (Diazepam) C Sostril (Ranitidine Hydrochloride) C Akineton (Biperiden Hydrochloride) C Haldol (Haloperidol) C Date:12/20/99ISR Number: 3425747-5Report Type:Expedited (15-DaCompany Report #USA/99/02975/LEX Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chronic Lymphocytic Health Clozaril (Clozapine) PS ORAL 200 MG, TWICE Leukaemia Professional A DAY; ORAL Leukocytosis Date:12/20/99ISR Number: 3425749-9Report Type:Expedited (15-DaCompany Report #USA/99/02727/LEX Age:46 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Breast Cancer Female Health Clozaril (Clozapine) PS ORAL 700 MG, ORAL; Disability Metastases To Bone Professional Dilantin (Phenytoin Other Metastases To Central Sodium) C Nervous System Cogentin (Benzatropine Mesilate) C Zinc Sulfate C Duragesic Patches (Fentanyl) C Dss (Docusate Sodium) C Mylanta C Tylenol #3 (Panadeine Co) C Roxanol (Morphine Sulfate) C Date:12/20/99ISR Number: 3425753-0Report Type:Expedited (15-DaCompany Report #USA/99/03255/LEX Age:42 YR Gender:Male I/FU:I Outcome Life-Threatening Disability 22-Feb-2006 08:30 AM Page: 582 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other PT Report Source Product Role Manufacturer Route Dose Duration Lung Neoplasm Malignant Health Clozaril (Clozapine) PS ORAL 800 MG, ORAL; Professional Morphine C Prolixin (Fluphenazine Hydrochloride) C Senokot (Senna Fruit) C Date:12/20/99ISR Number: 3425756-6Report Type:Expedited (15-DaCompany Report #USA/99/03286/LEX Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Injury Health Clozaril (Clozapine) PS ORAL 700 MG, ORAL; Professional Date:12/20/99ISR Number: 3425760-8Report Type:Expedited (15-DaCompany Report #USA/99/01863/LEX Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Difficulty In Walking Health Clozaril (Clozapine) PS ORAL 800 MG, ORAL; 10 YR Initial or Prolonged Myopathy Professional Zoloft (Sertraline Hydrochloride) C Klonopin (Clonazepam) C Date:12/20/99ISR Number: 3425763-3Report Type:Expedited (15-DaCompany Report #D/99/01676/LEX Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Leponex (Clozapine) PS ORAL 500 MG, ORAL Initial or Prolonged Drug Interaction Health Rifampicin Drug Level Below Professional (Rifampicin) SS Therapeutic Psychotic Disorder Tuberculosis Date:12/20/99ISR Number: 3425995-4Report Type:Expedited (15-DaCompany Report #HQ2988620OCT1999 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Effect Increased Health Effexor PS ORAL 75 MG 2X PER Drug Interaction Professional 1 DAY, ORAL Drug Level Above Caffeine SS Therapeutic Carbamazepine SS ORAL ORAL Overdose Clozapine SS Weight Decreased Methadone SS ORAL 40 MG INCREASED 10 MG DAILY TO 80 MG DAILY, ORAL 22-Feb-2006 08:30 AM Page: 583 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/20/99ISR Number: 3426115-2Report Type:Expedited (15-DaCompany Report #GB/99/00062/LEX Age:68 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Confusional State Foreign Clozaril (Clozapine) PS ORAL 450 MG Drug Interaction Health Prozac (Fluoxetine Professional Hydrochloride) SS Procyclidine (Procyclidine) C Zantac (Ranitidine Hydrochloride) C Ferrous Sulphate (Ferrous Sulfate) C Dioctyl (Docusate Sodium) C Date:12/20/99ISR Number: 3426116-4Report Type:Expedited (15-DaCompany Report #GB/99/00474/LEX Age:31 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Foreign Clozaril (Clozapine) PS ORAL 300 MG Initial or Prolonged White Blood Cell Count Health Increased Professional Date:12/20/99ISR Number: 3426563-0Report Type:Expedited (15-DaCompany Report #GB/99/00772/LEX Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Emphysema Foreign Clozaril (Clozapine) PS ORAL 650 MG, ORAL Initial or Prolonged Empyema Health Pleural Effusion Professional Date:12/20/99ISR Number: 3426564-2Report Type:Expedited (15-DaCompany Report #GB/99/01106/LEX Age:36 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Circulatory Collapse Foreign Clozaril (Clozapine) PS ORAL 150 MG, ORAL Confusional State Health Propanolol C Pulmonary Embolism Professional Ibuprofen C Shock Date:12/20/99ISR Number: 3426731-8Report Type:Expedited (15-DaCompany Report #D/98/03258/LEX Age:27 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Jugular Vein Thrombosis Foreign Leponex (Clozapine) PS ORAL 200 MG, THREE Initial or Prolonged Health TIMES A DAY, Required Professional ORAL Intervention to Dipiperon Prevent Permanent (Pipamperone) SS ORAL 80 MG, THREE Impairment/Damage TIMES A DAY, ORAL Haloperidol (Haloperidol) SS ORAL 2 MG, TWICE A DAY, ORAL 22-Feb-2006 08:30 AM Page: 584 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/20/99ISR Number: 3426734-3Report Type:Expedited (15-DaCompany Report #F/99/00909/LEX Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Leponex (Clozapine) PS ORAL 4 G, ONCE A Initial or Prolonged Phosphokinase Increased Health DAY, ORAL Required Confusional State Professional Rohypnol Intervention to Overdose Other (Flunitrazepam) C Prevent Permanent Sinus Tachycardia Depamide Impairment/Damage Suicide Attempt (Valpromide) C Anafranil (Clomipramine Hydrochloride) C Date:12/21/99ISR Number: 3426011-0Report Type:Direct Company Report # Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Clozaril By Required (Novartis) PS Novaritis ORAL 350MG PO /DAY Intervention to (125MG Prevent Permanent AM/225MG HS) 143 DAY Impairment/Damage Synthroid C Date:12/22/99ISR Number: 3428086-1Report Type:Direct Company Report # Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Glucose Increased Clozaril PS 1 DOSE ONLY Diabetes Mellitus (4 YEARS AGO) Zyprexa SS 5MG 2X/DAY Glyburide C Glucophage C Prevacid C Synthroid C Rmeron C Date:12/22/99ISR Number: 3431498-3Report Type:Expedited (15-DaCompany Report #D/99/01665/LEX Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebral Artery Foreign Leponex (Clozapine) PS ORAL ORAL Thrombosis Health Tavor C Cerebral Infarction Professional Cerebrovascular Disorder Coma Precerebral Artery Occlusion Vasculitis Date:12/23/99ISR Number: 3429804-9Report Type:Expedited (15-DaCompany Report #GB/99/01152/LEX Age:65 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Foreign Clozaril (Clozapine) PS ORAL 600 MG, ORAL Lower Respiratory Tract Health Infection Professional Pneumonia 22-Feb-2006 08:30 AM Page: 585 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/23/99ISR Number: 3430040-0Report Type:Expedited (15-DaCompany Report #USA/99/02926/LEX Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other No Adverse Drug Effect Health Clozaril (Clozapine) PS ORAL 300 MG, ORAL Professional Date:12/23/99ISR Number: 3430193-4Report Type:Expedited (15-DaCompany Report #GB/99/01173/LEX Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bronchopneumonia Foreign Clozaril (Clozapine) PS ORAL 250 MG, ORAL Lung Carcinoma Cell Type Health Unspecified Stage Iv Professional Pneumonia Date:12/23/99ISR Number: 3430194-6Report Type:Expedited (15-DaCompany Report #GB/99/01138/LEX Age:54 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bronchiolitis Foreign Clozaril (Clozapine) PS ORAL 400 MG, ONCE Pneumonia Health A DAY, ORAL 8 YR Respiratory Failure Professional Date:12/23/99ISR Number: 3430197-1Report Type:Expedited (15-DaCompany Report #GB/99/01105/LEX Age:49 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Foreign Clozaril (Clozapine) PS ORAL 400 MG, ORAL Initial or Prolonged Cerebrovascular Disorder Health Valproate Sodium Circulatory Collapse Professional (Valproate Sodium) C Confusional State Disorientation Faecal Incontinence Hemiparesis Paralysis Syncope Urinary Incontinence Date:12/23/99ISR Number: 3430199-5Report Type:Expedited (15-DaCompany Report #GB/99/01084/LEX Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypertension Foreign Clozaril (Clozapine) PS ORAL 500 MG, ORAL Phaeochromocytoma Health Professional Date:12/23/99ISR Number: 3430202-2Report Type:Expedited (15-DaCompany Report #B/99/00217/LEX Age:55 YR Gender:Male I/FU:I Outcome PT Death Cholestasis Required Coma Intervention to Dermatitis Exfoliative Prevent Permanent Eosinophilia Impairment/Damage Hepatocellular Damage Infection 22-Feb-2006 08:30 AM Page: 586 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Livedo Reticularis Myocardial Ischaemia Neurological Symptom Report Source Product Role Manufacturer Route Dose Duration Pericarditis Foreign Leponex (Clozapine) PS ORAL 400 MG, ORAL, Peripheral Ischaemia Health 600 MG, ORAL Pneumonia Professional Tegretol C Purpura Pyrexia Quadriplegia Rash Erythematous Renal Failure Acute Renal Failure Chronic Respiratory Failure Thrombocytopenia Date:12/23/99ISR Number: 3430511-7Report Type:Expedited (15-DaCompany Report #F/99/02997/LEX Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrioventricular Block Foreign Leponex (Clozapine) PS ORAL 100 MG, ONCE Initial or Prolonged Second Degree Health A DAY, ORAL 2 YR Required Professional Intervention to Prevent Permanent Impairment/Damage Date:12/23/99ISR Number: 3430564-6Report Type:Periodic Company Report #9839187 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Exposure Health Vistaril Capsules PS 25.00 MG Initial or Prolonged Sedation Professional TOTAL:DAILY Clozaril SS 200.00 MG TOTAL:DAILY Depakote SS 500.00 MG TOTAL:DAILY Haldol (Haloperidol) C Ativan (Lorazepam) C Trazadone C Cogentin (Benztropine Mesylate) C Lithium C Zoloft C Synthroid (Levothyroxine Sodium) C Date:12/27/99ISR Number: 3431423-5Report Type:Expedited (15-DaCompany Report #USA / 99 / 03382 / LEX Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Clozaril ( Professional Clozapine) PS ORAL UNSPECIFIED; ORAL 22-Feb-2006 08:30 AM Page: 587 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/27/99ISR Number: 3431461-2Report Type:Expedited (15-DaCompany Report #USA/99/03397/LEX Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozaril (Clozapine) PS ORAL 100 MG, ORAL Respiratory Arrest Professional Date:12/27/99ISR Number: 3431495-8Report Type:Expedited (15-DaCompany Report #D/99/01193/LEX Age:37 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Haematoma Foreign Leponex (Clozapine) PS ORAL 100 MG ORAL Required Idiopathic Health Stilnox C Intervention to Thrombocytopenic Purpura Professional Prevent Permanent Petechiae Impairment/Damage Date:12/27/99ISR Number: 3431496-XReport Type:Expedited (15-DaCompany Report #B/99/00214/LEX Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Circulatory Collapse Foreign Leponex (Clozapine) PS ORAL 100 MG, TWICE Required Malaise Health A DAY, ORAL; Intervention to Shock Professional 125 MG, TWICE Prevent Permanent Sudden Death A DAY, ORAL Impairment/Damage Tachycardia 25 MG TWICE A Femodene C Date:12/27/99ISR Number: 3431538-1Report Type:Expedited (15-DaCompany Report #D/99/01719/LEX Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Foreign Leponex (Clozapine) PS ORAL 175 MG ORAL Initial or Prolonged Hyperphagia Health Quilonum Retard Increased Appetite Professional (Lithium Acetate) C Polydipsia Polyuria Thirst Date:12/27/99ISR Number: 3432057-9Report Type:Expedited (15-DaCompany Report #USA/99/03312/LEX Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Cancer Female Health Clozaril (Clozapine) PS ORAL 150 MG, ORAL Leukopenia Professional Adriamycin Neutropenia (Doxorubicin) C Date:12/27/99ISR Number: 3432059-2Report Type:Expedited (15-DaCompany Report #USA/99/03201/LEX Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Colon Cancer Health Clozaril (Clozapine) PS ORAL 225 MG, ONCE Nausea Professional A DAY, ORAL Vomiting Serzone (Nefazodone Hydrochloride) C Zantac (Ranitidine Hydrochloride) C 22-Feb-2006 08:30 AM Page: 588 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Valium (Diazepam) C Leucovorin (Folinic Acid) C Date:12/27/99ISR Number: 3432064-6Report Type:Expedited (15-DaCompany Report #CDN/99/00646/LEX Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bladder Disorder Foreign Clozaril (Clozapine) PS ORAL 200 MG, ORAL Initial or Prolonged Bladder Obstruction Health Ciprofloxacin C Other Blood Creatinine Professional Nozinan Required Increased (Levomepromazine) C Intervention to Blood Sodium Decreased Enalapril C Prevent Permanent Blood Urea Increased Impairment/Damage Cognitive Disorder Confusional State Convulsion Dehydration Disorientation Dysarthria Hydronephrosis Hypertension Nocturia Sepsis Speech Disorder Stupor Date:12/27/99ISR Number: 3432067-1Report Type:Expedited (15-DaCompany Report #D/99/01623/LEX Age:70 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Leukopenia Foreign Leponex (Clozapine) PS ORAL 25 MG, ORAL Other Myocardial Infarction Health Digimerck Neutropenia Professional (Digitoxin) C Ass 100 (Acetylsalicylic Acid) C Madopar (Madopar) C Date:12/27/99ISR Number: 3432069-5Report Type:Expedited (15-DaCompany Report #AUS/99/01698/LEX Age:29 YR Gender:Male I/FU:I Outcome PT Other Alanine Aminotransferase Increased Aspartate Aminotransferase Increased Asthenia Blood Creatine Phosphokinase Increased Blood Creatine Phosphokinase Mb Increased Blood Urea Increased Dialysis Guillain-Barre Syndrome Haemoglobin Increased 22-Feb-2006 08:30 AM Page: 589 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Infection Malaise Red Blood Cell Report Source Product Role Manufacturer Route Dose Duration Sedimentation Rate Foreign Clozaril (Clozapine Increased Health ) PS ORAL 800 MG, ORAL Renal Failure Acute Professional Tremor White Blood Cell Count Increased Date:12/28/99ISR Number: 3431500-9Report Type:Expedited (15-DaCompany Report #99-11-0404 Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Rectal Cancer Health Clozapine - Zenith Initial or Prolonged Squamous Cell Carcinoma Professional Goldline Pharm. Required Tablets PS Zenith Goldline ORAL 600MG ORAL Intervention to Haldol Decanoate C Prevent Permanent Haloperidol C Impairment/Damage Date:12/28/99ISR Number: 3431502-2Report Type:Expedited (15-DaCompany Report #99-11-0392 Age:91 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Gangrene Health Clozapine - Zenith Oral Intake Reduced Professional Goldline Pharm. Tablets PS Zenith Goldline ORAL 75-200MG ORAL Acetaminophen C Aspirin C Digoxin C Effexor C Glyburide C Lorazepam C Pletaal C Maalox C Milk Of Magnesia C Date:12/28/99ISR Number: 3431506-XReport Type:Expedited (15-DaCompany Report #99-12-0446 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death White Blood Cell Count Health Clozapine - Zenith Increased Professional Goldline Pharm. Tablets PS ORAL 37.5MG ORAL Ativan C Date:12/28/99ISR Number: 3431510-1Report Type:Expedited (15-DaCompany Report #99-12-0447 Age:78 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dehydration Health Clozapine - Zenith White Blood Cell Count Professional Goldline Pharm. Increased Tablets PS Zenith Goldline ORAL 100-200MG ORAL 22-Feb-2006 08:30 AM Page: 590 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/28/99ISR Number: 3431513-7Report Type:Expedited (15-DaCompany Report #99-12-0436 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Catatonia Health Clozapine - Zenith Initial or Prolonged Medication Error Professional Goldline Pharm. Pneumonia Tablets PS Zenith Goldline ORAL 75-400MG ORAL White Blood Cell Count Increased Date:12/28/99ISR Number: 3431517-4Report Type:Expedited (15-DaCompany Report #99-12-0437 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aortic Aneurysm Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline ORAL 100-125MG ORAL Date:12/29/99ISR Number: 3434197-7Report Type:Expedited (15-DaCompany Report #GB/99/01128/LEX Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Confusional State Foreign Clozaril (Clozapine) PS ORAL 300 MG, Required Drug Interaction Health UNKNOWN, Intervention to Dysarthria Professional ORAL;, 400 Prevent Permanent Grand Mal Convulsion MG, UNKNOWN, Impairment/Damage ORAL;, 600 Fluoxetine (Fluoxetine) SS ORAL 60 MG, UNKNOWN, ORAL Valproate Sodium (Valproate Sodium) SS ORAL 300 MG, TWICE A DAY, ORAL, 400 MG, TWICE A DAY, ORAL Date:12/29/99ISR Number: 3434199-0Report Type:Expedited (15-DaCompany Report #GB/99/01185/LEX Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Blindness Foreign Clozaril (Clozapine) PS ORAL UNKNOWN ORAL Retinal Haemorrhage Health Vitreous Detachment Professional Vitreous Haemorrhage Date:12/29/99ISR Number: 3434201-6Report Type:Expedited (15-DaCompany Report #AUS/99/01428/LEX Age:76 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Lymphoma Foreign Clozaril (Clozapine) PS ORAL 350 MG Health UNKNOWN ORAL Professional Ascorbic Acid (Ascorbic Acid) C Haloperidol (Haloperidol) C Venlafaxine (Venlafaxine) C 22-Feb-2006 08:30 AM Page: 591 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Citalopram (Citalopram) C Ergocalciferol (Ergocalciferol) C Date:12/29/99ISR Number: 3434202-8Report Type:Expedited (15-DaCompany Report #AUS/99/01692/LEX Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Level Below Foreign Clozaril (Clozapine) PS ORAL 600 MG Initial or Prolonged Therapeutic Health UNKNOWN ORAL; Schizophrenia Professional MANY YEARS Date:12/30/99ISR Number: 3434198-9Report Type:Expedited (15-DaCompany Report #GB/99/01184/LEX Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abortion Spontaneous Foreign Clozaril (Clozapine) PS ORAL 900 MG Health UNKNOWN ORAL Professional Date:01/01/00ISR Number: 3434390-3Report Type:Direct Company Report # Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Clonic Convulsion Health Clozapine PS ORAL 25MG PO AM Intervention to Tachycardia Professional Clozapine SS ORAL 100MG PO HS Prevent Permanent White Blood Cell Count Impairment/Damage Increased Date:01/03/00ISR Number: 3436049-5Report Type:Expedited (15-DaCompany Report #GB/99/00978/LEX Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hypertension Foreign Clozaril (Clozapine) PS ORAL 250 MG, ONCE Intracranial Aneurysm Health A DAY, ORAL Subarachnoid Haemorrhage Professional Date:01/04/00ISR Number: 3436522-XReport Type:Expedited (15-DaCompany Report #JRFBEL1999002166 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyskinesia Foreign Haldol Decanoate Initial or Prolonged Dystonia Literature (Injection) Grand Mal Convulsion Health (Haloperidol Oral Intake Reduced Professional Decanoate) PS 150 MG, 1 IN Rib Fracture 2 WEEK (S) Scapula Fracture Clozapine Speech Disorder (Clozapine) SS MG, DAILY Tardive Dyskinesia 22-Feb-2006 08:30 AM Page: 592 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/05/00ISR Number: 3437786-9Report Type:Expedited (15-DaCompany Report #SF/99/04740/LEX Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cough Foreign Leponex (Clozapine) PS Initial or Prolonged Eosinophil Count Health Required Increased Professional Intervention to Gastroenteritis Prevent Permanent Influenza Impairment/Damage Iritis Urticaria White Blood Cell Count Increased Date:01/05/00ISR Number: 3437954-6Report Type:Expedited (15-DaCompany Report #USA/99/02727/LEX Age:46 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Breast Cancer Female Health Clozaril (Clozapine) PS ORAL 700 MG ORAL Life-Threatening Metastases To Bone Professional Dilantin C Disability Metastases To Central Cogentin C Other Nervous System Zinc Sulfate C Duragesic Patches C Dss C Mylanta C Tylenol C Roxanol C Date:01/06/00ISR Number: 3438018-8Report Type:Expedited (15-DaCompany Report #99-12-0449 Age:81 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldine Pharm. ORAL ORAL Date:01/06/00ISR Number: 3438024-3Report Type:Expedited (15-DaCompany Report #99-12-0448 Age:69 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death White Blood Cell Count Health Clozapine - Zenith Increased Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 500MG ORAL Date:01/06/00ISR Number: 3438030-9Report Type:Expedited (15-DaCompany Report #99-12-0450 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death White Blood Cell Count Health Clozapine - Zenith Increased Professional Goldline Pharm. Tablets PS Zentih Goldine Pharm. ORAL 425-450MG; ORAL 22-Feb-2006 08:30 AM Page: 593 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/06/00ISR Number: 3440054-2Report Type:Expedited (15-DaCompany Report #10170264 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Asthenia Health Glucophage Tabs 500 Blood Bicarbonate Professional Mg (Metformin Hcl) PS ORAL 1500 Decreased MILLIGRAM, 1 Fatigue DAY ORAL Feeling Abnormal Clozapine SS Lactic Acidosis Valproic Acid C Oxygen Saturation Lansoprazole C Decreased Levothyroxine C Pco2 Increased Vitamin E Acetate C Respiratory Rate Vitamin B C Increased Tylenol C Naproxen C Ativan C Loperamide C Simethicone C Maalox C Albuterol Inhaler C Beclomethasone Inhaler C Hydrocortisone C Multivitamin With Minerals C Date:01/07/00ISR Number: 3440291-7Report Type:Expedited (15-DaCompany Report #GB/99/00938/LEX Age:57 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Foreign Clozaril (Clozapine) PS ORAL 150 MG, ONCE Initial or Prolonged Diabetes Mellitus Other A DAY, ORAL Diabetic Ketoacidosis Hyperglycaemia Date:01/07/00ISR Number: 3440295-4Report Type:Expedited (15-DaCompany Report #USA/99/03439/LEX Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Health Clozaril (Clozapine) PS ORAL ORAL Professional Date:01/07/00ISR Number: 3440297-8Report Type:Expedited (15-DaCompany Report #GB/99/01106/LEX Age:36 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Circulatory Collapse Foreign Clozaril (Clozapine) PS ORAL 150, MG Confusional State Health ORAL;, 250 Pulmonary Embolism Professional MG, ORAL Shock Propanolol (Propranolol) C Ibuprofen (Ibuprofen) C 22-Feb-2006 08:30 AM Page: 594 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/07/00ISR Number: 3440323-6Report Type:Expedited (15-DaCompany Report #GB/99/00864/LEX Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Foreign Clozaril (Clozapine) PS ORAL 150 MG, Initial or Prolonged Blood Amylase Increased Health ORAL;, 450 Coma Professional MG, UNKNOWN, Diabetes Mellitus ORAL Hyperglycaemia Hyperpyrexia Hypoglycaemia Ketoacidosis Leukocytosis Loss Of Consciousness Overdose Pancreatitis Acute Sedation Tachycardia White Blood Cell Count Increased Date:01/07/00ISR Number: 3440326-1Report Type:Expedited (15-DaCompany Report #USA/99/00545/LEX Age:47 YR Gender:Not SpecifiI/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Toxicity Health Clozaril (Clozapine) PS ORAL 900 MG, ORAL Professional Prozac (Fluoxetine Hydrochloride) C Date:01/07/00ISR Number: 3440337-6Report Type:Expedited (15-DaCompany Report #GB/99/01106/LEX Age:36 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Circulatory Collapse Foreign Clozaril (Clozapine) PS ORAL 150 MG, ORAL; Confusional State Health 250 MG, ORAL Drug Level Above Professional Propanolol Therapeutic (Propranolol) C Pulmonary Embolism Ibuprofen Shock (Ibuprofen) C Date:01/10/00ISR Number: 3441810-7Report Type:Expedited (15-DaCompany Report #PRIUSA2000000054 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Colitis Consumer Topamax (Tablet) Initial or Prolonged Dialysis Health (Topiramate) PS ORAL SEE IMAGE Renal Failure Professional Lamictal Sepsis (Lamotrigine) SS ORAL ORAL 2 YR Thrombocytopenia Clozaril (Clozapine) SS ORAL ORAL 4 YR Vasculitis Date:01/10/00ISR Number: 3442255-6Report Type:Expedited (15-DaCompany Report #USA/00/00013/LEX Age:69 YR Gender:Male I/FU:I Outcome PT Death Emphysema Life-Threatening Encephalopathy Extrapyramidal Disorder 22-Feb-2006 08:30 AM Page: 595 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Parkinson'S Disease Respiratory Failure Report Source Product Role Manufacturer Route Dose Duration Health Clozaril (Clozapine) PS ORAL 13 MG, ORAL Professional Date:01/12/00ISR Number: 3443374-0Report Type:Expedited (15-DaCompany Report #AUS/00/00002/LEX Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Balance Disorder Health Clozaril (Clozapine) PS 100 MG, Blood Pressure Increased Professional UNKNOWN Cardiac Failure Condition Aggravated Coordination Abnormal Coronary Artery Disease Dizziness Hypercholesterolaemia Influenza Like Illness Lethargy Malaise Sedation Date:01/12/00ISR Number: 3443387-9Report Type:Expedited (15-DaCompany Report #GB/00/00016/LEX Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiomyopathy Foreign Clozaril (Clozapine) PS ORAL 350 MG. ORAL Initial or Prolonged Health Amitriptyline Professional (Amitriptyline) C Other Date:01/13/00ISR Number: 3443447-2Report Type:Expedited (15-DaCompany Report #99-12-0461 Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Condition Aggravated Health Clozapine-Zenith Gallbladder Disorder Professional Goldline Pharm. Tablets PS ORAL 100-350MG QD Date:01/13/00ISR Number: 3443449-6Report Type:Expedited (15-DaCompany Report #99-12-0460 Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine- Zenith Professional Goldline Pharm. Tablets PS ORAL 25-87. 5MG Date:01/13/00ISR Number: 3443452-6Report Type:Expedited (15-DaCompany Report #99-12-0459 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chronic Obstructive Health Clozapine-Zenith Initial or Prolonged Pulmonary Disease Professional Goldline Pharm. Tablets PS ORAL 300-500MG QD 22-Feb-2006 08:30 AM Page: 596 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/13/00ISR Number: 3443454-XReport Type:Expedited (15-DaCompany Report #99-12-0436 Age:59 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Catatonia Health Clozapine-Zenith Initial or Prolonged Delusion Professional Goldline Pharm. Medication Error Tablets PS ORAL 75-400MG Paranoia Date:01/13/00ISR Number: 3443455-1Report Type:Expedited (15-DaCompany Report #99-11-0428 Age:51 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neoplasm Malignant Health Clozapine-Zenith Hospitalization - Professional Goldline, Pharm. Initial or Prolonged Tablets PS ORAL 500MG 2 MON Date:01/13/00ISR Number: 3443532-5Report Type:Expedited (15-DaCompany Report #GB/00/00002/LEX Age:74 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Foreign Clozaril (Clozapine) PS ORAL 75 MG, ORAL Initial or Prolonged Health Professional Date:01/18/00ISR Number: 3444739-3Report Type:Direct Company Report # Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Effect Decreased Clozapine 25mg & Initial or Prolonged Emotional Disorder 100mg Zenith Gold Other Schizophrenia Line PS Zenith Gold Line Required Intervention to Prevent Permanent Impairment/Damage Date:01/18/00ISR Number: 3444966-5Report Type:Expedited (15-DaCompany Report #GB/99/01185/LEX Age:17 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Embolism Foreign Clozaril (Clozapine) PS ORAL 900 MG Retinal Haemorrhage Health UNKNOWN ORAL Vitreous Detachment Professional Procyclidine - Unspecified C Date:01/18/00ISR Number: 3444971-9Report Type:Expedited (15-DaCompany Report #AUS/99/01698/LEX Age:29 YR Gender:Male I/FU:F Outcome PT Hospitalization - Blood Creatine Initial or Prolonged Phosphokinase Increased Required Blood Creatine Intervention to Phosphokinase Mb Prevent Permanent Increased Impairment/Damage Blood Creatinine Increased 22-Feb-2006 08:30 AM Page: 597 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dialysis Guillain-Barre Syndrome Haemoglobin Increased Report Source Product Role Manufacturer Route Dose Duration Hepatic Enzyme Increased Foreign Clozaril (Clozapine) PS ORAL 1900 MG ONCE Hepatic Function Abnormal Health A DAY ORAL Infection Professional 800 MG ORAL Leukocytosis Malaise Medication Error Muscular Weakness Neutrophilia Overdose Renal Failure Acute Tremor Date:01/18/00ISR Number: 3445080-5Report Type:Expedited (15-DaCompany Report #GB/99/01122/LEX Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Aortic Dissection Foreign Clozaril (Clozapine) PS ORAL 600 MG, ONCE Required Autoimmune Disorder Health A DAY, ORAL Intervention to Cardiac Tamponade Professional Salbutamol C Prevent Permanent Lymphadenopathy Impairment/Damage Malaise Mediastinal Disorder Pericardial Effusion Pericarditis Viral Infection Date:01/18/00ISR Number: 3445303-2Report Type:Expedited (15-DaCompany Report #USA/99/03480/LEX Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Colitis Health Clozaril (Clozapine) PS ORAL ORAL Initial or Prolonged Renal Failure Acute Professional Vasculitis Date:01/18/00ISR Number: 3445304-4Report Type:Expedited (15-DaCompany Report #USA/99/03381/LEX Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Depression Health Clozaril (Clozapine) PS ORAL 400 MG, ONCE Drug Toxicity Professional A DAY, ORAL Medication Error Overdose Date:01/18/00ISR Number: 3445305-6Report Type:Expedited (15-DaCompany Report #CDN/99/01211/LEX Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Clozaril (Clozapine) PS ORAL 350 MG, ORAL Hospitalization - Coronary Artery Disease Study Initial or Prolonged Dyspnoea Health Fall Professional Sudden Death 22-Feb-2006 08:30 AM Page: 598 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/18/00ISR Number: 3445306-8Report Type:Expedited (15-DaCompany Report #AUS/00/00009/LEX Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hip Fracture Foreign Clozaril (Clozapine) PS ORAL 50 MG, Lower Respiratory Tract Health UNKNOWN,ORAL Infection Professional White Blood Cell Count Decreased Date:01/18/00ISR Number: 3445307-XReport Type:Expedited (15-DaCompany Report #USA/00/00049/LEX Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Injury Health Clozaril (Clozapine) PS ORAL 500 MG, Professional UNKNOWN,ORAL Date:01/18/00ISR Number: 3445308-1Report Type:Expedited (15-DaCompany Report #AUS/99/01547/LEX Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Deep Vein Thrombosis Foreign Clozaril (Clozapine) PS ORAL 650 MG, ONCE Injury Study A DAY, ORAL Pulmonary Embolism Health Efexor C Professional Doxycycline C Date:01/18/00ISR Number: 3445309-3Report Type:Expedited (15-DaCompany Report #GB/99/00841/LEX Age:53 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Foreign Clozaril Coordination Abnormal Health (Clozapine) PS ORAL 400 MG, Leukocytosis Professional UNKNOWN, ORAL Lymphopenia Droperidol C Myocardial Infarction Myocarditis Nervousness Salivary Hypersecretion Sudden Death Date:01/18/00ISR Number: 3446311-8Report Type:Expedited (15-DaCompany Report #NZ/99/00093/LEX Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Breast Cancer Female Foreign Clozaril (Clozapine) PS ORAL ORAL Malignant Ovarian Cyst Health Sodium Valproate Professional (Valproate Sodium) C Tamoxifen (Tamoxifen) C ORAL PO Date:01/18/00ISR Number: 3446419-7Report Type:Expedited (15-DaCompany Report #AUS/00/00003/LEX Age: Gender: I/FU:I Outcome PT Hospitalization - Condition Aggravated Initial or Prolonged Drug Level Below Therapeutic 22-Feb-2006 08:30 AM Page: 599 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Water Intoxication Report Source Product Role Manufacturer Route Dose Duration Foreign Clozaril (Clozapine) PS ORAL ORAL Health Professional Date:01/18/00ISR Number: 3446423-9Report Type:Expedited (15-DaCompany Report #USA/00/00053/LEX Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Health Clozaril (Clozapine) PS ORAL ORAL Professional Paxil (Paroxetine Hydrochloride) C Glucophage (Metformin Hydrochloride) C Nph (Insulin Injection, Isophane) C Depakote (Valproate Semisodium) C Date:01/18/00ISR Number: 3446425-2Report Type:Expedited (15-DaCompany Report #USA/99/03479/LEX Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Coma Health Clozaril (Clozapine) PS ORAL 100 MG, ORAL Hepatic Failure Professional Liver Function Test Abnormal Medication Error Sedation Date:01/20/00ISR Number: 3445403-7Report Type:Expedited (15-DaCompany Report #LIT/00/00020/LEX Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Distension Foreign Clozapine Required Abdominal Pain Lower Literature (Clozapine) PS 16 MON Intervention to Change Of Bowel Habit Health Prevent Permanent Constipation Professional Impairment/Damage Decreased Appetite Leukocytosis Peritonitis Sepsis Urinary Retention Date:01/20/00ISR Number: 3445983-1Report Type:Expedited (15-DaCompany Report #A000521 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Akathisia Health Zoloft Tablets PS ORAL ORAL Intervention to Drug Toxicity Professional Clozapine SS Prevent Permanent Dysphoria Impairment/Damage Sedation Tension 22-Feb-2006 08:30 AM Page: 600 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/20/00ISR Number: 3446717-7Report Type:Expedited (15-DaCompany Report #AUS/99/01698/LEX Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Foreign Clozaril (Clozapine) PS 1900 MG, ONCE Initial or Prolonged Blood Creatine Health A Required Phosphokinase Increased Professional Intervention to Blood Creatine Prevent Permanent Phosphokinase Mb Impairment/Damage Increased Guillain-Barre Syndrome Haemodialysis Haemoglobin Increased Hepatic Enzyme Increased Hepatic Function Abnormal Infection Leukocytosis Neutrophil Count Increased Overdose Red Blood Cell Sedimentation Rate Increased Renal Failure Acute Thinking Abnormal Tremor Date:01/20/00ISR Number: 3446723-2Report Type:Expedited (15-DaCompany Report #GB/99/01211/LEX Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Clozaril (Clozapine) PS Initial or Prolonged Phosphokinase Increased Health Required Dehydration Professional Intervention to Diabetes Mellitus Prevent Permanent Sedation Impairment/Damage Date:01/21/00ISR Number: 3445573-0Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Health Clozaril PS 300MG BID Initial or Prolonged Lethargy Professional Date:01/21/00ISR Number: 3445730-3Report Type:Expedited (15-DaCompany Report #GB/00/00002/LEX Age:74 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Foreign Clozaril (Clozapine) PS ORAL 75 MG ORAL Dysphagia Health Rectal Haemorrhage Professional 22-Feb-2006 08:30 AM Page: 601 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/21/00ISR Number: 3446090-4Report Type:Expedited (15-DaCompany Report #00-01-0002 Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dementia Alzheimer'S Type Clozapine - Zenith Goldline Pharm. Tablets PS ORAL 50MG ORAL Date:01/21/00ISR Number: 3446095-3Report Type:Expedited (15-DaCompany Report #00-01-0003 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Condition Aggravated Clozapine - Zenith Mental Disorder Goldline Pharm. Tablet PS ORAL 125-325MG ORAL Date:01/21/00ISR Number: 3446098-9Report Type:Expedited (15-DaCompany Report #99-10-0359 Age:73 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Pain Health Clozapine - Zenith Cardio-Respiratory Arrest Professional Goldline Pharm. Iron Deficiency Anaemia Tablets PS ORAL 300MG ORAL Occult Blood Positive Date:01/24/00ISR Number: 3446366-0Report Type:Expedited (15-DaCompany Report #USA/00/00102/LEX Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiovascular Disorder Consumer Clozaril (Clozapine) PS ORAL ORAL Influenza Like Illness Vomiting Projectile Date:01/24/00ISR Number: 3446368-4Report Type:Expedited (15-DaCompany Report #USA/99/03286/LEX Age:55 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accident Health Clozaril (Clozapine) PS ORAL 700 MG ORAL Injury Professional Date:01/24/00ISR Number: 3446380-5Report Type:Expedited (15-DaCompany Report #USA/00/00094/LEX Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abnormal Behaviour Health Clozaril (Clozapine) PS ORAL 750 MG, ORAL Eating Disorder Professional Klonopin Myocardial Infarction (Clonazepam) C Obesity Imdur (Isosorbide Mononitrate) C Nitro (Gylceryl Trinitrate) C Asa (Acetylsalicylic Acid) C Prilosec (Omeprazole) C Digoxin C 22-Feb-2006 08:30 AM Page: 602 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Reglan (Metoclopramide) C Colace (Ducosate Sodium) C Date:01/24/00ISR Number: 3446381-7Report Type:Expedited (15-DaCompany Report #USA/00/00103/LEX Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Health Clozaril (Clozapine) PS ORAL 275 MG, ORAL Initial or Prolonged Leukocytosis Professional Parkinsonism Sedation Date:01/24/00ISR Number: 3446383-0Report Type:Expedited (15-DaCompany Report #USA/00/00083/LEX Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Atrial Fibrillation Health Clozaril (Clozapine) PS ORAL 200 MG, ONCE Hospitalization - Blood Creatine Increased Professional A DAY, ORAL Initial or Prolonged Blood Urea Increased Depakote C Confusional State Trilafon C Dehydration Ativan C Dialysis Zyprexa C Diarrhoea Hepatic Function Abnormal Renal Failure Acute Respiratory Depression Date:01/24/00ISR Number: 3446387-8Report Type:Expedited (15-DaCompany Report #USA/00/00100/LEX Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiovascular Disorder Consumer Clozaril (Clozapine) PS ORAL ORAL Influenza Like Illness Vomiting Date:01/24/00ISR Number: 3446391-XReport Type:Expedited (15-DaCompany Report #USA/00/00112/LEX Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Clozaril (Clozapine) PS ORAL 100 MG, ORAL Hospitalization - Professional Initial or Prolonged Date:01/24/00ISR Number: 3446395-7Report Type:Expedited (15-DaCompany Report #SF/00/00019/LEX Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiomyopathy Foreign Leponex (Clozapine) PS ORAL 250 MG, ORAL Drug Level Below Health Therapeutic Professional Drug Toxicity Hepatocellular Damage Myocarditis 22-Feb-2006 08:30 AM Page: 603 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/24/00ISR Number: 3446397-0Report Type:Expedited (15-DaCompany Report #GB/00/00051/LEX Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Foreign Clozaril PS ORAL 400 MG , ORAL Initial or Prolonged Haemoglobin Decreased Health Required Professional Intervention to Prevent Permanent Impairment/Damage Date:01/24/00ISR Number: 3446400-8Report Type:Expedited (15-DaCompany Report #USA/00/00084/LEX Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Health Clozaril (Clozapine) PS ORAL 825 MG, ORAL Initial or Prolonged Non-Hodgkin'S Lymphoma Professional Disability Other Date:01/24/00ISR Number: 3446408-2Report Type:Expedited (15-DaCompany Report #USA/99/02801/LEX Age:25 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Health Clozaril (Clozapine) PS ORAL 350 MG, ORAL Initial or Prolonged Blood Amylase Increased Professional Valproate (Valproate Blood Glucose Increased Sodium) C Colitis Ulcerative Diarrhoea Pyrexia Vomiting Date:01/24/00ISR Number: 3446584-1Report Type:Expedited (15-DaCompany Report #D/99/01372/LEX Age:66 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrial Fibrillation Foreign Leponex (Clozapine) PS ORAL 6.25 MG, ORAL Initial or Prolonged Atrioventricular Block Study Madopar (Madopar) SS 1000 MG/500 Bradycardia Health MG Palpitations Professional Tiapridex (Tiapride Hydrochoride) C Date:01/27/00ISR Number: 3446854-7Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Clozapine PS 100MG 2TT BID Agitation , VI Q HS Condition Aggravated Confusional State Date:01/27/00ISR Number: 3447391-6Report Type:Expedited (15-DaCompany Report #225690 Age:35 YR Gender:Male I/FU:I Outcome PT Hospitalization - Confusional State Initial or Prolonged Hallucination, Visual 22-Feb-2006 08:30 AM Page: 604 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Medication Error Report Source Product Role Manufacturer Route Dose Duration Foreign Rivotril Other (Clonazepam) PS ORAL ORAL Tardyferon (Ferrous Sulfate) SS ORAL ORAL Tranxene (Clorazepate Dipotassium) SS ORAL 100 MG 1 PER 1 DAY ORAL Leponex (Clozapine) SS ORAL 600 MG 1 PER 1 DAY ORAL Mopral (Omeprazole) SS ORAL ORAL Neurontin (Gabapentin) SS ORAL 200 MG 1 PER 1 DAY ORAL Date:01/27/00ISR Number: 3447581-2Report Type:Expedited (15-DaCompany Report #D/99/01761/LEX Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Leponex (Clozapine) PS ORAL 25 MG, THREE Glycosylated Haemoglobin Health TIMES A DAY, Increased Professional ORAL; Hyperglycaemia Hyperphagia Date:01/27/00ISR Number: 3447583-6Report Type:Expedited (15-DaCompany Report #AUS/98/00155/LEX Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Toxicity Foreign Clozaril (Clozapine) PS ORAL 225 MG, ONCE Toxicologic Test Abnormal Study A DAY ORAL Health Heroin (Diamorphine) SS Professional Morphine (Morphine) C Date:01/27/00ISR Number: 3447896-8Report Type:Expedited (15-DaCompany Report #LITH00200000388 Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Lithium PS ORAL DAILY PO Initial or Prolonged Drug Level Above Professional Clozaril SS 500 MG DAILY, Therapeutic DAILY, DAILY Muscle Twitching Luvox SS 150 MG BID, 50 MG BID Depakote C Zyprexa C Loxapine C Date:01/28/00ISR Number: 3446993-0Report Type:Direct Company Report # Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Pulmonary Embolism Health Clozapine 175 Mg/Day PS 175 MG/ DAY Professional Celexa C Diazepam C 22-Feb-2006 08:30 AM Page: 605 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Gabapentin C Furosemide C Phenobarbital C Date:01/28/00ISR Number: 3446994-2Report Type:Direct Company Report # Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dizziness Health Clozaril PS 150MG BID Palpitations Professional Effexor C Pulmonary Embolism Congentin C Supraventricular Tachycardia Date:01/28/00ISR Number: 3447971-8Report Type:Expedited (15-DaCompany Report #HQ0645220JAN2000 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Literature Artane Tablet PS 10 MG DAILY, Initial or Prolonged Akathisia 2 MG, 15 MG Condition Aggravated DAILY Drug Withdrawal Syndrome Clozapine SS SEE IMAGE Dystonia Haloperidol SS 20 MG DAILY, Medication Error 10 MG DAILY Overdose Perphenazine SS 16 MG DAILY, Parkinsonism 4MG Psychotic Disorder DISCONTINUATI Suicide Attempt ON Procyclidine SS INTRAMUSCULAR 10 MG, INTRAMUSCULAR Date:01/28/00ISR Number: 3447985-8Report Type:Expedited (15-DaCompany Report #AUS/00/00003/LEX Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Level Below Foreign Clozaril (Clozapine) PS ORAL ORAL Initial or Prolonged Therapeutic Health Medication Error Professional Polydipsia Water Intoxication Date:01/28/00ISR Number: 3447991-3Report Type:Expedited (15-DaCompany Report #USA/99/03312/LEX Age:68 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Cancer Female Health Clozaril (Clozapine) PS ORAL 200 MG, ORAL Leukopenia Professional Adriamycin Neutropenia (Doxorubicin) C Atenolol C Tagamet (Cimetidine) C Zantac (Ranitidine Hydrochloride) C 22-Feb-2006 08:30 AM Page: 606 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/28/00ISR Number: 3448026-9Report Type:Expedited (15-DaCompany Report #D/99/01619/LEX Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Chronic Myeloid Leukaemia Foreign Leponex (Clozapine) PS ORAL 250 MG Hospitalization - Leukocytosis Health UNKNOWN ORAL Initial or Prolonged Professional Date:01/28/00ISR Number: 3448042-7Report Type:Expedited (15-DaCompany Report #USA/00/00097/LEX Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Consumer Clozaril (Clozapine) PS ORAL 25 MG UNKNOWN Legal Problem ORAL Seroquel C Flomax (Morniflumate) C Prozac (Fluoxetine Hydrochloride) C Date:01/28/00ISR Number: 3448088-9Report Type:Expedited (15-DaCompany Report #USA/00/00099/LEX Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiomyopathy Consumer Clozaril (Clozapine) PS ORAL ORAL Cardiovascular Disorder Date:01/28/00ISR Number: 3448090-7Report Type:Expedited (15-DaCompany Report #USA/00/00098/LEX Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Cannabinoids Consumer Clozaril (Clozapine) PS ORAL 150 MG ORAL Increased Cardiac Arrest Medication Error Nasopharyngitis Overdose Rhinitis Date:01/28/00ISR Number: 3448253-0Report Type:Expedited (15-DaCompany Report #D/00/00085/LEX Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abnormal Behaviour Foreign Leponex (Clozapine) PS ORAL ORAL Ejaculation Disorder Health Professional Date:01/31/00ISR Number: 3449252-5Report Type:Expedited (15-DaCompany Report #LIT/00/00062/LEX Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Foreign Clozapine Colonic Obstruction Literature (Clozapine) PS 22-Feb-2006 08:30 AM Page: 607 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/31/00ISR Number: 3449255-0Report Type:Expedited (15-DaCompany Report #LIT/00/00061/LEX Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Foreign Clozapine Constipation Literature (Clozapine) PS Faecaloma Pneumonia Sudden Death Vomiting Date:01/31/00ISR Number: 3449280-XReport Type:Expedited (15-DaCompany Report #USA/00/00168/LEX Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Balance Disorder Health Clozaril (Clozapine) PS ORAL 225 MG, ORAL Cerebral Infarction Professional Zyprexa Cerebrovascular Disorder (Olanazapine) C Coordination Abnormal Micronase Dysarthria (Glibenclamide) C Dystonia Zoloft (Sertraline Speech Disorder Hydrochloride) C Synthroid (Levothyroxine Sodium) C Peri-Colace C Trazodone C Date:02/01/00ISR Number: 3449755-3Report Type:Expedited (15-DaCompany Report #USA/00/00098/LEX Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Consumer Clozaril (Clozapine) PS ORAL 150 MG, ORAL Medication Error Zyprexa (Olanzapine) C Nasopharyngitis Neurontin Overdose (Gabapentin) C Rhinitis Date:02/01/00ISR Number: 3449757-7Report Type:Expedited (15-DaCompany Report #USA/00/00099/LEX Age:22 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiomegaly Consumer Clozaril (Clozapine) PS ORAL ORAL Cardiomyopathy Lasix (Furosemide) C Cardiovascular Disorder Lanoxin (Digoxin) C Aldactone (Spironolactone) C Capoten (Captopril) C Flonase (Fluticasone Propionate) C Prozac (Fluoxetine Hydrochlordie) C Lithium C 22-Feb-2006 08:30 AM Page: 608 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/01/00ISR Number: 3449759-0Report Type:Expedited (15-DaCompany Report #USA/99/03077/LEX Age:31 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abortion Induced Health Clozaril (Clozapine) PS ORAL 30 MG, ONCE A Required Diabetes Mellitus Professional DAY, ORAL Intervention to Ectopic Pregnancy Zoloft (Sertraline Prevent Permanent Fluid Retention Hydrochloride) C Impairment/Damage Oedema Date:02/02/00ISR Number: 3449754-1Report Type:Expedited (15-DaCompany Report #USA/00/00097/LEX Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aggression Consumer Clozaril (Clozapine) PS ORAL 25 MG, ORAL Cardiovascular Disorder Seroquel C Psychotic Disorder Flomax (Morniflumate) C Prozac (Fluoxetine Hydrochloride) C Date:02/02/00ISR Number: 3450960-0Report Type:Expedited (15-DaCompany Report #GB/99/01192/LEX Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Albuminuria Foreign Clozaril (Clozapine) PS ORAL 250 MG ORAL Coma Health Confusional State Professional Disorientation Eye Movement Disorder Haematuria Hallucination Leukocytosis Nephritis Proteinuria Pyrexia Sedation Speech Disorder White Blood Cell Count Increased Date:02/03/00ISR Number: 3450679-6Report Type:Expedited (15-DaCompany Report #99-12-0447 Age:78 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dehydration Health Clozapine - Zenith Leukocytosis Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm ORAL 100-200 MG ORAL Date:02/03/00ISR Number: 3450680-2Report Type:Expedited (15-DaCompany Report #00-01-0004 Age:51 YR Gender:Male I/FU:I Outcome PT Death Biopsy Liver Abnormal Jaundice Leukocytosis 22-Feb-2006 08:30 AM Page: 609 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Metastases To Liver Small Cell Lung Cancer Stage Unspecified Report Source Product Role Manufacturer Route Dose Duration Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 425MG ORAL Date:02/03/00ISR Number: 3450681-4Report Type:Expedited (15-DaCompany Report #00-01-0021 Age:86 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Leukocytosis Health Clozapine - Zenith Leukopenia Professional Goldline Pharm. Renal Failure Acute Tablets PS Zenith Goldline Pharm. ORAL 25-50MG ORAL Date:02/03/00ISR Number: 3451118-1Report Type:Expedited (15-DaCompany Report #99-12-0455 Age:50 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL ORAL Date:02/03/00ISR Number: 3451120-XReport Type:Expedited (15-DaCompany Report #00-01-0020 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Leukocytosis Health Clozapine - Zenith Professional Goldine Pharm. Tablets PS Zenith Goldline Pharm. ORAL 300-600/MG ORAL Date:02/03/00ISR Number: 3451122-3Report Type:Expedited (15-DaCompany Report #00-01-0017 Age:84 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Leukocytosis Health Clozapine - Zenith Leukopenia Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. Tablets ORAL 50-87.5MG ORAL Date:02/03/00ISR Number: 3451124-7Report Type:Expedited (15-DaCompany Report #00-01-0016 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Injury Asphyxiation Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. Tablets ORAL 75-150MG ORAL 22-Feb-2006 08:30 AM Page: 610 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/03/00ISR Number: 3451135-1Report Type:Expedited (15-DaCompany Report #00-01-0008 Age:88 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. Tablets ORAL 12.5MG ORAL Date:02/03/00ISR Number: 3451137-5Report Type:Expedited (15-DaCompany Report #99-12-0449 Age:81 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Choking Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. Tablets ORAL 100MG ORAL Date:02/03/00ISR Number: 3451140-5Report Type:Expedited (15-DaCompany Report #00-01-0022 Age:81 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. Tablets ORAL 6.2MG-12.5MG ORAL Date:02/04/00ISR Number: 3452535-6Report Type:Expedited (15-DaCompany Report #D/96/01945/LEX Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aggression Foreign Leponex (Clozapine) PS ORAL 500 MG, ORAL Agitation Health Diazepam SS ORAL 2 MG, ORAL Cyanosis Professional Sudden Death Other Date:02/04/00ISR Number: 3452612-XReport Type:Expedited (15-DaCompany Report #GB/99/00875/LEX Age:54 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Colon Cancer Foreign Clozaril (Clozapine) PS 350 MG Intestinal Obstruction Health Professional Date:02/04/00ISR Number: 3453009-9Report Type:Expedited (15-DaCompany Report #AUS/99/01625/LEX Age:66 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Foreign Clozaril (Clozapine) PS ORAL 350 MG, ORAL Initial or Prolonged Escherichia Sepsis Health Aspirin C Required Malaise Professional Intervention to Renal Failure Acute Prevent Permanent Impairment/Damage 22-Feb-2006 08:30 AM Page: 611 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/04/00ISR Number: 3453013-0Report Type:Expedited (15-DaCompany Report #GB/00/00108/LEX Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Constipation Foreign Clozaril (Clozapine) PS ORAL ORAL Faecaloma Health Amitriptyline C Intestinal Obstruction Professional Date:02/04/00ISR Number: 3453016-6Report Type:Expedited (15-DaCompany Report #GB/00/00120/LEX Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril (Clozapine) PS ORAL 300 MG ORAL Health Professional Date:02/04/00ISR Number: 3453076-2Report Type:Expedited (15-DaCompany Report #AUS/99/00202/LEX Age:23 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Alkaline Foreign Clozaril (Clozapine) PS ORAL 225 MG, ORAL Initial or Prolonged Phosphatase Increased Health Losec (Omeprazole) C Required Diabetes Mellitus Professional Intervention to Fatigue Prevent Permanent Glycosylated Haemoglobin Impairment/Damage Increased Hyperglycaemia Increased Appetite Weight Decreased Weight Increased Date:02/04/00ISR Number: 3453108-1Report Type:Expedited (15-DaCompany Report #USA/00/00175/LEX Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Health Clozaril (Clozapine) PS ORAL 400 MG, ORAL, Initial or Prolonged Suicide Attempt Professional 2 YEARS APPROX Date:02/07/00ISR Number: 3453287-6Report Type:Expedited (15-DaCompany Report #USA/00/00256/LEX Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukocytosis Health Clozaril (Clozapine) PS ORAL 450 MG, ORAL Initial or Prolonged Pneumothorax Professional Primaxin C Date:02/07/00ISR Number: 3453472-3Report Type:Expedited (15-DaCompany Report #CDN/00/00013/LEX Age:24 YR Gender:Male I/FU:I Outcome PT Life-Threatening Blood Creatine Hospitalization - Phosphokinase Increased Initial or Prolonged Cardiogenic Shock Disability Cardiomyopathy Dyspnoea Ejection Fraction Abnormal 22-Feb-2006 08:30 AM Page: 612 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Fatigue Left Ventricular Failure Myocarditis Report Source Product Role Manufacturer Route Dose Duration Pulmonary Oedema Foreign Clozaril (Clozapine) PS ORAL 425 MG Renal Failure Acute Study UNKNOWN ORAL Health Professional Date:02/07/00ISR Number: 3453540-6Report Type:Expedited (15-DaCompany Report #GB/00/00055/LEX Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Foreign Clozaril (Clozapine) PS ORAL 300 MG, ONCE Cardiomegaly Study A DAY, ORAL; Coronary Artery Health Atherosclerosis Professional Hepatic Steatosis Lung Disorder Sudden Death Date:02/07/00ISR Number: 3453542-XReport Type:Expedited (15-DaCompany Report #GB/99/01184/LEX Age:35 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abortion Spontaneous Foreign Clozaril (Clozapine) PS ORAL 400 MG, ONCE Vaginal Haemorrhage Health A DAY, ORAL; Professional Sertraline (Sertraline) C Senna (Senna) C Lactulose (Lactulose) C Date:02/07/00ISR Number: 3453551-0Report Type:Expedited (15-DaCompany Report #USA/00/00252/LEX Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozaril (Clozapine) PS 400 MG Professional Date:02/07/00ISR Number: 3453559-5Report Type:Expedited (15-DaCompany Report #CDN/99/01211/LEX Age:49 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Clozaril (Clozapine) PS ORAL 350 MG, ORAL Hospitalization - Coronary Artery Disease Study Initial or Prolonged Dyspnoea Health Fall Professional Date:02/09/00ISR Number: 3455530-6Report Type:Expedited (15-DaCompany Report #00P-167-0086333-00(1) Age:38 YR Gender:Female I/FU:F Outcome PT Required Confusional State Intervention to Coordination Abnormal Prevent Permanent Drug Interaction Impairment/Damage Drug Level Above 22-Feb-2006 08:30 AM Page: 613 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Therapeutic Dysarthria Dysphagia Enuresis Report Source Product Role Manufacturer Route Dose Duration Grand Mal Convulsion Foreign Valproate Sodium Hemiparesis Health (Sodium Valproate) Muscle Twitching Professional (Sodium Valproate) PS ORAL 2 IN 1 D, PER ORAL Clozapine (Clozapine) SS ORAL 1 IN 1 D, PER ORAL Fluoxetine (Fluoxetine) SS ORAL 60 MG, 1 IN 1 D, PER ORAL Hyoscine (Hyoscine) C Date:02/10/00ISR Number: 3456148-1Report Type:Expedited (15-DaCompany Report #00P-056-0086712-00(0) Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Foreign Tranxene (Tranxene) Initial or Prolonged Hallucination, Visual Health (Clorazepate Professional Dipotassium) PS ORAL 100 MG, 1 IN 1 D, PER ORAL Clonazepam (Clonazepam) SS ORAL PER ORAL Ferrous Sulfate (Ferrous Sulfate) SS ORAL PER ORAL Clozapine (Clozapine) SS ORAL 600 MG, 1 IN 1 D, PER ORAL Omeprazole (Omeprazole) SS ORAL PER ORAL Gabapentin (Gabapentin) SS ORAL 200 MG, 1 IN 1 D, PER ORAL Date:02/10/00ISR Number: 3456201-2Report Type:Expedited (15-DaCompany Report #USA/00/00292/LEX Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozaril (Clozapine) PS ORAL 300MG, ORAL Hospitalization - Cardiomyopathy Professional Initial or Prolonged Influenza Like Illness Date:02/10/00ISR Number: 3456204-8Report Type:Expedited (15-DaCompany Report #USA/00/00094/LEX Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abnormal Behaviour Health Clozaril (Clozapine) PS ORAL 750 MG, Cardiac Failure Professional OTHER, ORAL Eating Disorder Symptom Klonopin Myocardial Infarction (Clonazepam) C Weight Increased Imdur (Isosorbide Mononitrate) C Nitro Plus (Glyceryl Trinitrate) C Asa (Acetylsalicylic Acid) C 22-Feb-2006 08:30 AM Page: 614 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prilosec (Omeprazole) C Digoxin C Reglan (Metoclopramide) C Colace (Docusate Sodium) C Date:02/10/00ISR Number: 3456206-1Report Type:Expedited (15-DaCompany Report #USA/00/00049/LEX Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accident Health Clozaril (Clozapine) PS ORAL 500 MG, ORAL Professional Date:02/10/00ISR Number: 3456208-5Report Type:Expedited (15-DaCompany Report #USA/99/03165/LEX Age:50 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coma Health Clozaril (Clozapine) PS ORAL 400 MG, ORAL, Hospitalization - Medication Error Professional 450 MG Initial or Prolonged Overdose ,OTHER, ORAL Disability Sedation Lithium C Required Multivitamins C Intervention to Prevent Permanent Impairment/Damage Date:02/10/00ISR Number: 3456211-5Report Type:Expedited (15-DaCompany Report #GB/99/00930/LEX Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Level Above Foreign Clozaril (Clozapine) PS ORAL ORAL Required Therapeutic Health Intervention to Drug Toxicity Professional Prevent Permanent Ecchymosis Impairment/Damage Excoriation Eyelid Vascular Disorder Fall Hepatic Steatosis Laceration Purpura Skin Discolouration Skin Disorder Sudden Death Date:02/10/00ISR Number: 3456213-9Report Type:Expedited (15-DaCompany Report #N/99/00138/LEX Age:52 YR Gender:Female I/FU:F Outcome PT Hospitalization - Agranulocytosis Initial or Prolonged Amnesia Other Difficulty In Walking Required Gait Disturbance Intervention to Glycosuria Prevent Permanent Immunosuppression Impairment/Damage Infection 22-Feb-2006 08:30 AM Page: 615 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pneumonia Suicidal Ideation Report Source Product Role Manufacturer Route Dose Duration Foreign Leponex (Clozapine) PS ORAL SEE IMAGE Health Glucofag (Metformin Professional Hydrochloride) C Daonil (Glibenclamide) C Furosemid (Furosemide) C Renitec (Enalapril Maleate) C Fenergan (Promethazine) C Vidal (Diazepam) C Cisordinol (Clopenthixol Hydrochloride) C Date:02/10/00ISR Number: 3456216-4Report Type:Expedited (15-DaCompany Report #GB/00/00133/LEX Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Pain Foreign Clozaril (Clozapine) PS ORAL 400 MG , ORAL Hospitalization - Cardiac Arrest Health Initial or Prolonged Circulatory Collapse Professional Diarrhoea Malaise Pulmonary Embolism Date:02/10/00ISR Number: 3456220-6Report Type:Expedited (15-DaCompany Report #AUS/99/01567/LEX Age:60 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Foreign Clozaril (Clozapine) PS ORAL 250 MG, ORAL Initial or Prolonged Blood Albumin Decreased Study Valproate (Valproate Delirium Health Sodium) C Hypoproteinaemia Professional Hypotension Hypoxia Myocarditis Tachycardia Date:02/11/00ISR Number: 3455857-8Report Type:Expedited (15-DaCompany Report #00-01-0028 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Leukocytosis Health Clozapine-Zenith Professional Goldline Pharm. Tablets PS ORAL 900 MG ORAL Date:02/11/00ISR Number: 3456735-0Report Type:Direct Company Report # Age:85 YR Gender:Female I/FU:I Outcome Required Intervention to 22-Feb-2006 08:30 AM Page: 616 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Cellulitis Clozapine PS ORAL 25MG PO QHS White Blood Cell Count (CHRONIC Decreased USE;START DATE?) Lithium C Multivitamin C Aricept C Date:02/11/00ISR Number: 3456831-8Report Type:Expedited (15-DaCompany Report #AUS/00/00105/LEX Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Foreign Clozaril (Clozapine) PS ORAL 400 MG, ORAL Initial or Prolonged Congestive Health Warfarin (Warfarin) C Required Dyspnoea Professional Keflex (Cefalexin Intervention to Hypertension Monohydrate) C Prevent Permanent Influenza Like Illness Bricanyl Impairment/Damage Malaise (Terbutaline Myocarditis Sulfate) C Renal Failure Acute Respiratory Rate Increased Right Ventricular Failure Tachycardia Venous Pressure Jugular Increased Vomiting Date:02/11/00ISR Number: 3456834-3Report Type:Expedited (15-DaCompany Report #AUS/99/01695/LEX Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril (Clozapine) PS ORAL 475 MG, ORAL Required Ketoacidosis Health Intervention to Professional Prevent Permanent Impairment/Damage Date:02/11/00ISR Number: 3456836-7Report Type:Expedited (15-DaCompany Report #AUS/99/01696/LEX Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril (Clozapine) PS ORAL 400 MG, ORAL Required Weight Decreased Health Intervention to Professional Prevent Permanent Impairment/Damage Date:02/11/00ISR Number: 3456838-0Report Type:Expedited (15-DaCompany Report #SF/99/04740/LEX Age:38 YR Gender:Female I/FU:F Outcome Hospitalization - Initial or Prolonged 22-Feb-2006 08:30 AM Page: 617 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Required Intervention to Prevent Permanent PT Report Source Product Role Manufacturer Route Dose Duration Impairment/Damage Abdominal Pain Upper Foreign Leponex (Clozapine) PS ORAL 200 MG, ORAL C-Reactive Protein Health Lito (Lithium Increased Professional Carbonate) C Cough Other Diapam (Diazepam) C Eosinophilia Expigen (Expigen) C Gastroenteritis Laxoberon (Sodium Influenza Picosulfate) C Iritis Doximycin Red Blood Cell (Doxycycline Sedimentation Rate Hydrochloride) C Increased Oftan (Oftan) C Urticaria Ultracortrenol White Blood Cell Count (Prednisolone Increased Pivalate) C Date:02/11/00ISR Number: 3456842-2Report Type:Expedited (15-DaCompany Report #GB/00/00002/LEX Age:74 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Disorder Foreign Clozaril (Clozapine) PS ORAL 75 MG, ORAL Dysphagia Health Rectal Haemorrhage Professional Toxicologic Test Abnormal Date:02/11/00ISR Number: 3456855-0Report Type:Expedited (15-DaCompany Report #GB/00/00116/LEX Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril (Clozapine) PS ORAL ORAL Required Pruritus Health Intervention to Professional Prevent Permanent Impairment/Damage Date:02/11/00ISR Number: 3456857-4Report Type:Expedited (15-DaCompany Report #GB/00/00050/LEX Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Foreign Clozaril (Clozapine) PS ORAL 125 MG, ORAL Initial or Prolonged Hyperglycaemia Health Citalopram Ketoacidosis Professional (Citalopram) C Ketonuria Losec (Omeprazole) C Tachycardia Procyclidine Weight Increased (Procyclidine) C Date:02/11/00ISR Number: 3456983-XReport Type:Expedited (15-DaCompany Report #LIT/00/00088/LEX Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neurosis Foreign Clozapine Required Social Phobia Literature (Clozapine) PS ORAL 250 MG, ORAL 4 MON Intervention to Health Prevent Permanent Professional Impairment/Damage 22-Feb-2006 08:30 AM Page: 618 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/11/00ISR Number: 3456986-5Report Type:Expedited (15-DaCompany Report #GB/00/00051/LEX Age:20 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Iron Deficiency Anaemia Foreign Clozaril PS ORAL 200 MG, TWICE Initial or Prolonged Iron Metabolism Disorder Health A DAY, ORAL Required Professional Sulpiride Intervention to (Sulpiride) C Prevent Permanent Ferrous Sulphate Impairment/Damage (Ferrous Sulfate) C Date:02/11/00ISR Number: 3456987-7Report Type:Expedited (15-DaCompany Report #GB/00/00055/LEX Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Foreign Clozaril (Clozapine) PS ORAL 300 MG, ONCE Cardiomegaly Study A DAY, ORAL Coronary Artery Health Atherosclerosis Professional Hepatic Steatosis Lung Disorder Date:02/11/00ISR Number: 3457281-0Report Type:Expedited (15-DaCompany Report #A000521 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Dysphoria Health Zoloft Tablets PS ORAL 50.00 MG Intervention to Nervousness Professional TOTAL:DAILY:O Prevent Permanent Sedation RAL Impairment/Damage Clozapine SS ORAL 300.00 MG TOTAL:DAILY:O RAL Date:02/14/00ISR Number: 3457859-4Report Type:Expedited (15-DaCompany Report #LIT/00/00061/LEX Age:49 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asthma Foreign Clozapine Bronchospasm Literature (Clozapine) PS 200 MG, Circulatory Collapse Health UNKNOWN,; 500 Constipation Professional MG, UNKNOWN Cyanosis Ventolin Depression (Salbutamol) C Dyspnoea Becotide Faecaloma (Beclometasone Foreign Body Aspiration Dipropionate) C Oesophagitis Epilim (Valproate Pneumonia Sodium) C Pneumonia Aspiration Pulmicort Pulmonary Oedema (Budesonide) C Pulse Absent Shock Vomiting 22-Feb-2006 08:30 AM Page: 619 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/14/00ISR Number: 3457861-2Report Type:Expedited (15-DaCompany Report #AUS/00/00111/LEX Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiomyopathy Foreign Clozaril (Clozapine) PS ORAL 400 MG, Initial or Prolonged Coma Health UNKNOWN, ORAL Loss Of Consciousness Professional Pyrexia Date:02/14/00ISR Number: 3457865-XReport Type:Expedited (15-DaCompany Report #AUS/00/00111/LEX Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiomyopathy Foreign Clozaril (Clozapine) PS ORAL 400 MG, Initial or Prolonged Coma Health UNKNOWN, ORAL Loss Of Consciousness Professional Pyrexia Date:02/14/00ISR Number: 3457867-3Report Type:Expedited (15-DaCompany Report #GB/00/00115/LEX Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cerebrovascular Disorder Foreign Clozaril (Clozapine) PS Health Professional Date:02/14/00ISR Number: 3457870-3Report Type:Expedited (15-DaCompany Report #USA/99/03378/LEX Age:81 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Clozaril (Clozapine) PS ORAL 25 MG, Congestive Professional UNKNOWN, ORAL Date:02/14/00ISR Number: 3457872-7Report Type:Expedited (15-DaCompany Report #USA/99/02613/LEX Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coma Health Clozaril (Clozapine) PS ORAL UNSPECIFIED, Life-Threatening Death Professional UNKNOWN, ORAL Hyperglycaemia Haldol (Haloperidol) C Ketoacidosis Toxicologic Test Abnormal Date:02/14/00ISR Number: 3457873-9Report Type:Expedited (15-DaCompany Report #AUS/99/01688/LEX Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Constipation Foreign Clozaril (Clozapine) PS ORAL 750 MG, Required Gastrointestinal Necrosis Study UNKNOWN; ORAL Intervention to Hepatic Failure Health Prevent Permanent Intestinal Obstruction Professional Impairment/Damage Multi-Organ Failure Post Procedural Complication Sepsis Vomiting 22-Feb-2006 08:30 AM Page: 620 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/14/00ISR Number: 3457894-6Report Type:Expedited (15-DaCompany Report #AUS/99/01637/LEX Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Nephrolithiasis Foreign Clozaril (Clozapine) PS ORAL 225 MG, ORAL Initial or Prolonged Study Required Health Intervention to Professional Prevent Permanent Impairment/Damage Date:02/14/00ISR Number: 3457897-1Report Type:Expedited (15-DaCompany Report #GB/00/00133/LEX Age:31 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Pain Foreign Clozaril (Clozapine) PS ORAL 400 MG, ORAL Appendicitis Health Cardiac Arrest Professional Circulatory Collapse Diarrhoea Malaise Peritonitis Pulmonary Embolism Date:02/15/00ISR Number: 3457412-2Report Type:Direct Company Report # Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Catatonia Clozapine PS ORAL 100 MG PO Initial or Prolonged Drug Withdrawal Syndrome SEVERAL YEARS Disability Muscle Rigidity Lorazepam C Mutism Digoxin C Tremor Date:02/15/00ISR Number: 3457869-7Report Type:Expedited (15-DaCompany Report #LIT/00/00062/LEX Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Foreign Clozapine Colonic Obstruction Literature (Clozapine) PS 400 MG, Constipation Health UNKNOWN 22 DAY Vomiting Professional Date:02/15/00ISR Number: 3459158-3Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Clozapine 100 Mg PS Zenith ORAL TWICE PO Q Psychotic Disorder AM, 4 TIMES Q HS Date:02/16/00ISR Number: 3458638-4Report Type:Expedited (15-DaCompany Report #USA/99/03199/LEX Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetes Mellitus Health Clozaril (Clozapine) PS ORAL 400 MG, ORAL Myocardial Infarction Professional Depakote (Valproate 22-Feb-2006 08:30 AM Page: 621 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Semisodium) C Prozac (Fluoxetine Hydrochloride) C Date:02/16/00ISR Number: 3458641-4Report Type:Expedited (15-DaCompany Report #USA/00/00053/LEX Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Health Clozaril (Clozapine) PS ORAL 550 MG, OTHER Required Hyperglycaemia Professional ORAL Intervention to Paxil (Paroxetine Prevent Permanent Hydrochloride) C Impairment/Damage Depakote (Valproate Semisodium) C Zyprexa (Olanzapine) C Ativan (Lorazepam) C Pepcid (Famotidine) C Date:02/16/00ISR Number: 3458916-9Report Type:Expedited (15-DaCompany Report #AUS/00/00091/LEX Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Disorder Foreign Clozaril (Clozapine) PS ORAL 550 MG, ONCE Initial or Prolonged Convulsion Health A DAY; ORAL Disability Electroencephalogram Professional Lithium (Lithium) C Required Abnormal Intervention to Encephalopathy Prevent Permanent Labile Blood Pressure Impairment/Damage Malaise Transient Ischaemic Attack Date:02/17/00ISR Number: 3458506-8Report Type:Expedited (15-DaCompany Report #00-01-0040 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Leukopenia Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS ORAL ORAL 1 MON Date:02/17/00ISR Number: 3458507-XReport Type:Expedited (15-DaCompany Report #00-02-0043 Age:78 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine -Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 75-125MG ORAL Date:02/17/00ISR Number: 3458509-3Report Type:Expedited (15-DaCompany Report #00-02-0045 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death White Blood Cell Count Health Clozapine - Zenith Increased Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 400MG ORAL 22-Feb-2006 08:30 AM Page: 622 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/17/00ISR Number: 3458510-XReport Type:Expedited (15-DaCompany Report #00-01-0004 Age:51 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Jaundice Health Clozapine - Zenith Leukocytosis Professional Goldline Pharm. Metastases To Liver Tablets PS Zenith Goldline Small Cell Lung Cancer Pharm. ORAL 425MG ORAL Stage Unspecified Date:02/17/00ISR Number: 3458511-1Report Type:Expedited (15-DaCompany Report #00-01-0003 Age:74 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Condition Aggravated Health Clozapine - Zenith Mental Disorder Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 125-325MG ORAL Date:02/17/00ISR Number: 3458697-9Report Type:Expedited (15-DaCompany Report #99-11-0399 Age:58 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Health Clozapine PS Zenith Goldline Drug Interaction Professional Pharm. ORAL 500-600MG Drug Toxicity ORAL Leukocytosis Ativan 3mg C Humibid - Slow Realease 2 Tabs C Vitamins C Lactulose C Artane 10mg C Myocholine "Glenwood" C Urecholine C Theodur G 50mg Bid C Hytrin C Oscal 500 C Procardia C Capoten 50mg C Bactrin C Albuterol C Combivent C Denorex C Prilosec C Date:02/17/00ISR Number: 3458699-2Report Type:Expedited (15-DaCompany Report #99-09-0318 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Pain Health Clozapine PS Zenith Goldline Hospitalization - Respiratory Arrest Professional Pharm. 275MG-500MG Initial or Prolonged White Blood Cell Count Decreased 22-Feb-2006 08:30 AM Page: 623 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/17/00ISR Number: 3459151-0Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Clozapine 100mg PS Zenith ORAL 3 TIMES, PO Psychotic Disorder BID ... C Date:02/17/00ISR Number: 3459154-6Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Clozapine 25 Mg PS Zenith ORAL ONCE PO BID Psychotic Disorder ... C Date:02/17/00ISR Number: 3459156-XReport Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Clozapine 100mg PS Zenith ORAL 100MG FIVE Psychotic Disorder TIMES PO BID Date:02/17/00ISR Number: 3459160-1Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Clozapine 100 Mg PS Zenith ORAL TWICE Q AM, 3 Psychotic Disorder X Q PM, 4 X Q HS ... C Date:02/17/00ISR Number: 3459162-5Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Clozapine 100mg PS Zenith ORAL TWICE PO BID Psychotic Disorder ... C Date:02/17/00ISR Number: 3459164-9Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Clozapine 100 Mg PS Zenith ORAL TWICE Q AM & Psychotic Disorder HS P.O. ... C Date:02/17/00ISR Number: 3459165-0Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Clozapine 100 Mg PS Zenith ORAL ONE BID P.O. Psychotic Disorder ... C 22-Feb-2006 08:30 AM Page: 624 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/17/00ISR Number: 3459167-4Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Clozapine 100 Mg PS Zenith ORAL 100 MG TWICE Psychotic Disorder Q AM & MIDDAY; THRICE HS PO ... C Date:02/17/00ISR Number: 3459170-4Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Clozapine 100mg PS Zenith ORAL 100MG, TWICE Psychotic Disorder PO BID; THRICE HS PO ... C THREE Q HS Date:02/17/00ISR Number: 3459171-6Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Clozapine 100 Mg PS Zenith ORAL THREE PO BID Psychotic Disorder ... C Date:02/17/00ISR Number: 3459172-8Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Clozapine 100 Mg PS Zenith ORAL TWO PO BID, Psychotic Disorder FIVE P.O. Q HS ... C Date:02/17/00ISR Number: 3459174-1Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Clozapine 100mg PS Zenith THREE BID Psychotic Disorder ... C Date:02/17/00ISR Number: 3459176-5Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Clozapine 100mg PS Zenith ORAL TWICE P.O. Q Psychotic Disorder AM, 3X PO Q HS ... C 22-Feb-2006 08:30 AM Page: 625 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/17/00ISR Number: 3459178-9Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Clozapine 100 Mg PS Zenith ORAL 3X PO BID Psychotic Disorder ... C Date:02/17/00ISR Number: 3459179-0Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Clozapine 100mg PS Zenith ORAL 3X PO BID Psychotic Disorder ... C Date:02/18/00ISR Number: 3459215-1Report Type:Direct Company Report # Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Confusional State Consumer Clozaril PS Novartis Decreased Appetite Pharmaceuticals Gastric Cancer Insomnia Retching Date:02/22/00ISR Number: 3460592-6Report Type:Expedited (15-DaCompany Report #LIT/00/00062/LEX Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Foreign Clozapine Intestinal Obstruction Literature (Clozapine) PS 400 MG, Health UNKNOWN 36 DAY Professional Date:02/22/00ISR Number: 3460665-8Report Type:Expedited (15-DaCompany Report #GB/00/00133/LEX Age:32 YR Gender:Male I/FU:F Outcome PT Death Acidosis Appendicitis Blood Amylase Increased Blood Bilirubin Increased Blood Creatine Phosphokinase Increased Cardiac Arrest Chest X-Ray Abnormal Circulatory Collapse Coma Diarrhoea Dyspepsia Electrocardiogram T Wave Inversion Heart Rate Increased Hepatic Function Abnormal Hypertension Hyponatraemia Hypotension Hypoxia Leukocytosis 22-Feb-2006 08:30 AM Page: 626 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Liver Function Test Abnormal Malaise Report Source Product Role Manufacturer Route Dose Duration Oxygen Saturation Foreign Clozaril (Clozapine) PS ORAL 400 MG, Decreased Health UNKNOWN, ORAL Pain Professional Venlafaxine Peritonitis (Venlafaxine) C Pulmonary Embolism Hyoscine (Hyoscine) C Pyrexia Sinus Tachycardia Vomiting White Blood Cell Count Increased Date:02/22/00ISR Number: 3460670-1Report Type:Expedited (15-DaCompany Report #GB/00/00171/LEX Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Foreign Clozaril (Clozapine) PS ORAL ORAL Initial or Prolonged Diabetic Coma Health Professional Date:02/22/00ISR Number: 3460674-9Report Type:Expedited (15-DaCompany Report #USA/00/00344/LEX Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cough Health Clozaril (Clozapine) PS ORAL 150 MG, Initial or Prolonged Dehydration Professional UNKNOWN, ORAL Hyperkalaemia Depakote (Valproate Lethargy Semisodium) C Sedation Lithium C White Blood Cell Count Lasix (Furosemide) C Decreased Proventil (Salbutamol) C Atrovent (Ipratropium Bromide) C Date:02/22/00ISR Number: 3460753-6Report Type:Expedited (15-DaCompany Report #00USA10198 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Level Above Health Anafranil Capsule Therapeutic Professional (Clomipramine Drug Toxicity Hydrochloride) PS ORAL 150 MG DAILY Hepatic Congestion ORAL Pulmonary Congestion Clozaril Tablet Spleen Disorder (Clozapine) SS ORAL ORAL Buspar Tablet (Buspirone Hydrochloride) SS ORAL ORAL Luvox Tablet (Fluvoxamine Maleate) SS ORAL ORAL Insulin Solution For Injec C 22-Feb-2006 08:30 AM Page: 627 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/22/00ISR Number: 3461172-9Report Type:Expedited (15-DaCompany Report #USA/99/02389/LEX Age:51 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Brain Neoplasm Malignant Health Clozaril (Clozapine) PS ORAL 350 MG , ORAL Required Leukocytosis Professional Intervention to Lung Neoplasm Malignant Prevent Permanent Impairment/Damage Date:02/22/00ISR Number: 3461233-4Report Type:Expedited (15-DaCompany Report #USA/00/00358/LEX Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Health Clozaril (Clozapine) PS ORAL 200 MG, ORAL Initial or Prolonged Back Pain Professional Lithobid SS 600 MG Bronchitis Depakote C Dehydration Ativan C Drug Level Above Prolixin C Therapeutic Gait Disturbance Leukocytosis Myalgia Pyrexia Renal Failure Acute Vomiting Date:02/22/00ISR Number: 3461250-4Report Type:Expedited (15-DaCompany Report #LEX/ABA451/X/128/1/1/USA Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aortic Atherosclerosis Study Clozaril (Clozapine) PS ORAL 350 MG ORAL Required Cardiomegaly Health Intervention to Electrocardiogram Professional Prevent Permanent Abnormal Impairment/Damage Fatigue Pneumonia Rales Ventricular Extrasystoles Date:02/22/00ISR Number: 3463802-4Report Type:Periodic Company Report #JRFUSA1999003039 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Health Risperdal (3 Mg Initial or Prolonged Phosphokinase Increased Professional Tablet) Required Convulsion (Risperidone) PS ORAL 3 MG, 2 IN 1 Intervention to Hyponatraemia DAY(S), ORAL Prevent Permanent Pyrexia Clozaril (Clozapine) SS ORAL ORAL Impairment/Damage Date:02/23/00ISR Number: 3461418-7Report Type:Direct Company Report # Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abnormal Behaviour Clozapine Mfd By Affective Disorder Zenith PS Zenith 22-Feb-2006 08:30 AM Page: 628 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/23/00ISR Number: 3461537-5Report Type:Expedited (15-DaCompany Report #00-02-0050 Age:81 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. Tablets ORAL 6.2MG-625MG ORAL Date:02/23/00ISR Number: 3461538-7Report Type:Expedited (15-DaCompany Report #00-02-0051 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Health Clozapine - Zenith Initial or Prolonged Leukocytosis Professional Goldline Pharm. Tablets PS ORAL 800MG ORAL Date:02/23/00ISR Number: 3461704-0Report Type:Expedited (15-DaCompany Report #D/99/01665/LEX Age:46 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arteriosclerosis Foreign Leponex (Clozapine) PS ORAL 600 MG, ORAL Cerebral Infarction Health Tavor (Lorazepam) C Cerebral Ischaemia Professional Coma Haemorrhagic Stroke Loss Of Consciousness Precerebral Artery Occlusion Vasculitis Vasculitis Cerebral Date:02/23/00ISR Number: 3461705-2Report Type:Expedited (15-DaCompany Report #D/00/00169/LEX Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatic Neoplasm Foreign Leponex (Clozapine) PS ORAL UNSPECIFIED, Hepatocellular Damage Health ORAL; Metastases To Liver Professional Date:02/23/00ISR Number: 3461802-1Report Type:Expedited (15-DaCompany Report #20000200475 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Distension Prilosec PS ORAL 20 MG QD PO Constipation Clozapine SS Hypotension Valproate Sodium SS Intestinal Obstruction Pneumonia Thrombocytopenia Vomiting 22-Feb-2006 08:30 AM Page: 629 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/23/00ISR Number: 3462026-4Report Type:Expedited (15-DaCompany Report #HQ1114317FEB2000 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Health Atenolol PS ORAL 50 MG 2X PER Arthralgia Professional 1 DAY, ORAL Asthenia Clozapine SS ORAL ORAL Back Pain Clomipramine Chest Pain Hydrochloride C Dehydration Divalproex Sodium C Dyspnoea Quetiapine Fumarate C Haemoglobin Decreased Headache Hypotension Leukocytosis Neutrophilia Date:02/25/00ISR Number: 3463297-0Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Liver Function Test Clozaril 50mg Am PS 50 MG Intervention to Abnormal Clozaril 100mg H.L. SS 100MG Prevent Permanent Impairment/Damage Date:02/25/00ISR Number: 3463968-6Report Type:Expedited (15-DaCompany Report #USA/00/00388/LEX Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Toxicity Health Clozaril (Clozapine) PS ORAL ORAL Hepatic Congestion Professional Anafranil Hepatocellular Damage (Clomipramine Obesity Hydrochloride) SS ORAL 150 MG, ORAL Pulmonary Congestion Buspar (Buspirone Splenomegaly Hydrochloride) SS Luvox (Fluvoxamine Maleate) SS Insulin C Date:02/25/00ISR Number: 3463969-8Report Type:Expedited (15-DaCompany Report #DK/99/00044/LEX Age:66 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiomyopathy Foreign Leponex (Clozapine) PS ORAL 75 MG; ORAL 5 YR Initial or Prolonged Health Required Professional Intervention to Other Prevent Permanent Impairment/Damage Date:02/25/00ISR Number: 3463970-4Report Type:Expedited (15-DaCompany Report #DK/99/00012/LEX Age:65 YR Gender:Male I/FU:F Outcome Hospitalization - Initial or Prolonged Required 22-Feb-2006 08:30 AM Page: 630 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Intervention to Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Cardiomyopathy Foreign Leponex (Clozapine) PS ORAL 75 MG; ORAL 5 YR Other Date:02/25/00ISR Number: 3463975-3Report Type:Expedited (15-DaCompany Report #GB/99/00478/LEX Age:44 YR Gender:Female I/FU:F Outcome PT Death Abscess Hospitalization - Acidosis Initial or Prolonged Anaemia Required Antiphospholipid Syndrome Intervention to Aortic Thrombosis Prevent Permanent Atrial Fibrillation Impairment/Damage Circulatory Collapse Coagulation Factor Increased Coagulation Time Shortened Deep Vein Thrombosis Dehydration Diabetes Mellitus Gastroenteritis Hypernatraemia Hypertension Leg Amputation Lipid Metabolism Disorder Malaise Mesenteric Artery Embolism Muscle Necrosis Nephrogenic Diabetes Insipidus Nephrotic Syndrome Pain In Extremity Pancreatitis Paraesthesia Pericarditis Peripheral Ischaemia Phlebitis Pleural Effusion Pneumonia Postoperative Infection Pulmonary Embolism Pulmonary Oedema Pyrexia Rash Maculo-Papular Red Blood Cell Sedimentation Rate Increased Renal Failure Acute Rhabdomyolysis Sepsis Shock Sinus Tachycardia Systemic Candida Thrombocytopenia Vena Cava Thrombosis 22-Feb-2006 08:30 AM Page: 631 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Vomiting Report Source Product Role Manufacturer Route Dose Duration Foreign Clozaril (Clozapine) PS ORAL 700 MG ORAL Health Amiodarone Professional (Amiodarone) C Erythromycin (Erythromycin) C Lithium (Lithium) C Haloperidol (Haloperidol) C Procyclidine (Procyclidine) C Date:02/25/00ISR Number: 3463976-5Report Type:Expedited (15-DaCompany Report #D/99/01676/LEX Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Leponex (Clozapine) PS ORAL 500 MG ORAL Initial or Prolonged Drug Ineffective Health Rifampicin Drug Interaction Professional (Rifampicin) SS ORAL 600 MG ORAL Drug Level Below Therapeutic Psychotic Disorder Pulmonary Tuberculosis Date:02/25/00ISR Number: 3463977-7Report Type:Expedited (15-DaCompany Report #AUS/00/00144/LEX Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Foreign Clozaril (Clozapine) PS ORAL 600 MG, ONCE Study A DAY, ORAL Health Professional Date:02/25/00ISR Number: 3463978-9Report Type:Expedited (15-DaCompany Report #GB/00/00181/LEX Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril (Clozapine) PS ORAL 450 MG ORAL Health Professional Date:02/25/00ISR Number: 3463991-1Report Type:Expedited (15-DaCompany Report #USA/00/00371/LEX Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Heat Exposure Injury Consumer Clozaril (Clozapine) PS ORAL 300 MG, ORAL Life-Threatening Hyperpyrexia Date:02/25/00ISR Number: 3463992-3Report Type:Expedited (15-DaCompany Report #USA/00/00393/LEX Age:51 YR Gender:Male I/FU:I Outcome PT Other Enuresis Renal Cell Carcinoma 22-Feb-2006 08:30 AM Page: 632 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Stage Unspecified Urinary Incontinence Report Source Product Role Manufacturer Route Dose Duration Health Clozaril (Clozapine) PS ORAL 400 MG, ORAL Professional Tofranil (Imipramine Hydrochloride) C Ativan (Lorazepam) C Trazodone (Trazodone) C Procardia (Nifedipine) C Depakote (Valproate Semisodium) C Date:02/25/00ISR Number: 3464306-5Report Type:Expedited (15-DaCompany Report #AUS/00/00177/LEX Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatic Neoplasm Foreign Clozaril (Clozapine) PS ORAL XX, ORAL Malignant Study Health Professional Date:02/28/00ISR Number: 3463883-8Report Type:Direct Company Report # Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Clozapine 100mg & Initial or Prolonged Irritability 25mg - Zenith PS Zenith 100MG AM & Medication Error 150MG HS Date:02/28/00ISR Number: 3463886-3Report Type:Direct Company Report # Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Clozapine 100 Mg. Mania Zenith PS Zenith CLOZARIL Pregnancy 100MG AM & Psychotic Disorder 400MG HS Date:02/28/00ISR Number: 3463889-9Report Type:Direct Company Report # Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Clozapine 100mg PS Zenith CLOZARIL Initial or Prolonged Unevaluable Event 300MG AM , 50MG HS Date:02/28/00ISR Number: 3463891-7Report Type:Direct Company Report # Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Clozapine 25mg Initial or Prolonged Pyromania Zenith PS Zenith CLOZARIL 75MG Soliloquy BID 22-Feb-2006 08:30 AM Page: 633 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/28/00ISR Number: 3463893-0Report Type:Direct Company Report # Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucination, Auditory Clozapine 100mg Initial or Prolonged Suicidal Ideation Zentih PS Zenith CLOZARIL 225MG BID Date:02/28/00ISR Number: 3464476-9Report Type:Expedited (15-DaCompany Report #JACGER2000000222 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutropenia Foreign Risperdal (Tablet) Initial or Prolonged Health (Risperidone) PS ORAL SEE IMAGE Professional Haldol (Tablet) (Haloperidol) SS ORAL SEE IMAGE Leponex (Clozapine) SS ORAL SEE IMAGE Ciatyl-Z (Zuclopenthixol Hydrochloride) SS ORAL MG, ORAL Taxilan (Perazine) SS MG, DAILY; MG, DAILY Tavor (Lorazepam) SS SEE IMAGE Sulp (Sulpiride) SS ORAL SEE IMAGE Akineton (Biperiden Hydrochloride) C Date:02/28/00ISR Number: 3464825-1Report Type:Expedited (15-DaCompany Report #USA/00/00421/LEX Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Health Clozaril (Clozapine) PS ORAL 75 MG, TWICE Electrocardiogram Qrs Professional A DAY, ORAL Complex Prolonged Glipizide C Hypothyroidism Depakote (Valproate Semisodium) C Paxil (Paroxetine Hydrochloride) C Klonopin (Clonazepam) C Cogentin (Benzatropine Mesilate) C Date:02/28/00ISR Number: 3464826-3Report Type:Expedited (15-DaCompany Report #USA/00/00103/LEX Age:52 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coma Health Clozaril (Clozapine) PS ORAL 275 MG, Hospitalization - Drooling Professional OTHER, ORAL Initial or Prolonged Fall Neurontin Leukocytosis (Gabapentin) C Parkinsonism Paxil (Paroxetine Salivary Hypersecretion Hydrochloride) C Sedation Lithobid (Lithium Carbonate) C Klonopin (Clonazepam) C Dilantin (Phenytoin 22-Feb-2006 08:30 AM Page: 634 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sodium) C Lithotab (Lithium Carbonate) C Date:02/28/00ISR Number: 3464827-5Report Type:Expedited (15-DaCompany Report #USA/00/00252/LEX Age:61 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozaril (Clozapine) PS ORAL 400 MG, ORAL Professional Date:02/28/00ISR Number: 3464836-6Report Type:Expedited (15-DaCompany Report #D/99/01645/LEX Age:22 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Asthenia Foreign Leponex (Clozapine) PS ORAL 600 MG, ORAL Hospitalization - Bronchopneumonia Health Initial or Prolonged Cardiac Disorder Professional Required Cardiac Failure Intervention to Cardiac Murmur Prevent Permanent Cardiomyopathy Impairment/Damage Condition Aggravated Congestive Cardiomyopathy Cough Dyspnoea Hypersomnia Palpitations Sleep Disorder Tachycardia Viral Infection Date:02/28/00ISR Number: 3464837-8Report Type:Expedited (15-DaCompany Report #GB/99/00841/LEX Age:53 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Foreign Clozaril (Clozapine) PS ORAL 400 MG, ORAL Coordination Abnormal Health Broperidol Hypersensitivity Professional (Droperidol) C Leukocytosis Lymphopenia Myocardial Infarction Myocarditis Nervousness Neutrophilia Salivary Hypersecretion Sudden Death Date:02/28/00ISR Number: 3464838-XReport Type:Expedited (15-DaCompany Report #AUS/99/01698/LEX Age:29 YR Gender:Male I/FU:F Outcome PT Hospitalization - Alanine Aminotransferase Initial or Prolonged Increased Required Aspartate Intervention to Aminotransferase Prevent Permanent Increased Impairment/Damage Asthenia Blood Creatine 22-Feb-2006 08:30 AM Page: 635 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Phosphokinase Increased Blood Creatine Phosphokinase Mb Increased Report Source Product Role Manufacturer Route Dose Duration Blood Creatinine Foreign Clozaril (Clozapine) PS ORAL 1900 MG, ONCE Increased Health A DAY, ORAL;, Compartment Syndrome Professional 800MG, ORAL Flight Of Ideas Guillain-Barre Syndrome Haemodialysis Hepatic Function Abnormal Infection Leukocytosis Malaise Muscle Necrosis Overdose Red Blood Cell Sedimentation Rate Increased Renal Failure Acute Rhabdomyolysis Tremor Date:02/28/00ISR Number: 3464839-1Report Type:Expedited (15-DaCompany Report #DK/00/00009/LEX Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Lymphocytic Leukaemia Foreign Leponex (Clozapine) PS ORAL 250 MG, ORAL Initial or Prolonged Health Melleril Professional (Thioridazine Other Hydrochloride) C Alopam (Axazepam) C Date:02/28/00ISR Number: 3464840-8Report Type:Expedited (15-DaCompany Report #AUS/00/00189/LEX Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Congestive Cardiomyopathy Foreign Clozaril (Clozapine) PS UNSPECIFIED Health Professional Date:02/28/00ISR Number: 3465672-7Report Type:Periodic Company Report #C2000-0045.01 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Consumer Clozapine 25mg Mylan PS Mylan ORAL 125MG, QD, Disturbance In Attention ORAL Fatigue Depakote 250mg Irritability Abbott SS Abbott ORAL 1G QD THEN Oedema 750MG QD THEN Weight Increased 500MG QD, ORAL Paxil 10mg Smithkline Beecham SS Smithkline Beecham ORAL 40MG QD THEN 20MG QD THEN 10MG QD, ORAL 22-Feb-2006 08:30 AM Page: 636 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/28/00ISR Number: 3465673-9Report Type:Periodic Company Report #990965.01 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Psychotic Disorder Consumer Clozaril Tablets 100 Other Mg Novartis PS Novartis ORAL 300MG, ORAL Clozapine Tablets 100 Mg SS ORAL 300MG, ORAL Ativan C Date:02/29/00ISR Number: 3464601-XReport Type:Expedited (15-DaCompany Report #C2000-0132.01 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozaril Novartis PS Novartis ORAL 600MG, ORAL Other Professional Doxycycline SS Required Other Intervention to Prevent Permanent Impairment/Damage Date:02/29/00ISR Number: 3465479-0Report Type:Expedited (15-DaCompany Report #USA/99/03378/LEX Age:81 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Clozaril (Clozapine) PS ORAL 25 MG, ORAL Congestive Professional Date:02/29/00ISR Number: 3465483-2Report Type:Expedited (15-DaCompany Report #CDN/99/00489/LEX Age:53 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Foreign Clozaril (Clozapine) PS ORAL 450 MG, ORAL Asphyxia Study Moditen Aspiration Health (Fluphenazine Cardiac Disorder Professional Hydrochloride) C Cardiovascular Disorder Kemadrub Circulatory Collapse (Procyclidine Coma Hydrochloride) C Facial Bones Fracture Largactil Haemorrhage (Chlorpromazine Hypotension Hydrochloride) C Loss Of Consciousness Modecate Salivary Hypersecretion (Fluphenazine Shock Decanoate) C Subdural Haematoma Date:02/29/00ISR Number: 3465485-6Report Type:Expedited (15-DaCompany Report #USA/00/00442/LEX Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Health Clozaril (Clozapine) PS ORAL ORAL Professional 22-Feb-2006 08:30 AM Page: 637 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/29/00ISR Number: 3465607-7Report Type:Expedited (15-DaCompany Report #GB/00/00213/LEX Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Clozaril (Clozapine) PS ORAL ORAL Diarrhoea Health Pyrexia Professional Date:02/29/00ISR Number: 3465609-0Report Type:Expedited (15-DaCompany Report #JR/00/00063/LEX Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Foreign Leponex (Clozapine) PS ORAL 800 MG, ORAL Required Cardio-Respiratory Arrest Health Haldol (Haloperidol) C Intervention to Confusional State Professional Akineton (Biperiden Prevent Permanent Hypoventilation Hydrochloride) C Impairment/Damage Pyrexia Buspiron (Buspiron) C Restlessness Apranax (Naproxen Tachycardia Sodium) C Fluoxetine (Fluoxetine) C Biperiden (Biperiden) C Date:02/29/00ISR Number: 3465611-9Report Type:Expedited (15-DaCompany Report #D/99/01619/LEX Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Chronic Myeloid Leukaemia Foreign Leponex (Clozapine) PS ORAL 250 MG, ORAL Hospitalization - Leukaemia Granulocytic Health Initial or Prolonged Leukocytosis Professional Date:02/29/00ISR Number: 3465634-XReport Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Medication Error Clozaril 400mg PS X 1 Hospitalization - Pneumonia Aspiration Initial or Prolonged Salivary Hypersecretion Sedation Date:02/29/00ISR Number: 3465869-6Report Type:Expedited (15-DaCompany Report #HQ1152922FEB2000 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutropenia Study Tavor (Lorazepam) PS ORAL "2 MG, 8 MG, Initial or Prolonged Health 0.5 MG" ORAL 62 DAY Other Professional Ciatyl (Clopenthixol Hydrochloride) SS 600 MG 1X PER 1 DAY 1 DAY Clozapine (Clozapine0 SS 100 MG-250 MG DAILY 15 DAY Haldol (Haloperidol) SS 5 MG - 50 MG DAILY 26 DAY Risperdal (Risperidone) SS 2MG - 4 MG DAILY 5 DAY 22-Feb-2006 08:30 AM Page: 638 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sulpiride (Sulpiride) SS 100 MG - 200 MG DAILY 5 DAY Taxilan (Perazine) C 100 MG - 200 MG DAILY Akineton C Date:02/29/00ISR Number: 3465897-0Report Type:Expedited (15-DaCompany Report #JACGER2000000222 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutropenia Foreign Haldol (Tablet) Initial or Prolonged Health (Haloperidol) PS ORAL SEE IMAGE Professional Leponex (Clozapine) SS ORAL SEE IMAGE Ciatyl-Z (Zuclopenthixol Hydrochloride) SS MG, DAILY Taxilan (Perazine) SS ORAL SEE IMAGE Tavor (Lorazepam) SS SEE IMAGE Sulp (Sulpiride) SS ORAL SEE IMAGE Risperidal (Tablet) (Risperidone) SS ORAL SEE IMAGE Akineton (Biperiden Hydrochloride) C Date:03/01/00ISR Number: 3466704-2Report Type:Expedited (15-DaCompany Report #USA/00/00489/LEX Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Disorder Health Clozaril (Clozapine) PS ORAL 400 MG; ORAL Professional Date:03/01/00ISR Number: 3466705-4Report Type:Expedited (15-DaCompany Report #USA/00/00053/LEX Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Health Clozaril (Clozapine) PS ORAL 550 MG, ORAL Required Professional Paxil C Intervention to Depakote C Prevent Permanent Zyprexa C Impairment/Damage Ativan C Pepcid C Date:03/01/00ISR Number: 3466992-2Report Type:Expedited (15-DaCompany Report #S/94/00004/LEX Age:57 YR Gender:Male I/FU:F Outcome PT Life-Threatening Atrial Fibrillation Required Cardiac Failure Intervention to Chest Pain Prevent Permanent Congestive Cardiomyopathy Impairment/Damage Dyspnoea Fatigue Hypotension Nodal Arrhythmia Pneumonia Respiratory Disorder 22-Feb-2006 08:30 AM Page: 639 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tachycardia Report Source Product Role Manufacturer Route Dose Duration Foreign Leponex PS ORAL 100 MG, ONCE Health A DAY, ORAL Professional Insulin C Tavegyl C Disipal C Lactulose C Furosemide C K-Mic C Modikate C Stesolid C Date:03/01/00ISR Number: 3466994-6Report Type:Expedited (15-DaCompany Report #S/94/01276/LEX Age:56 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Atrial Fibrillation Foreign Leponex PS Cardiac Failure Other Cardiomyopathy Chest Pain Congestive Cardiomyopathy Dyspnoea Fatigue Hypotension Nodal Arrhythmia Pneumonia Respiratory Disorder Tachycardia Date:03/01/00ISR Number: 3466995-8Report Type:Expedited (15-DaCompany Report #GB/00/00204/LEX Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Duodenal Ulcer Foreign Clozaril (Clozapine) PS ORAL 500 MGK, ORAL Initial or Prolonged Haematemesis Health Lorazepam Leukocytosis Professional (Lorazepam) C Oesophagitis Droperidol (Droperidol) C Date:03/01/00ISR Number: 3467064-3Report Type:Expedited (15-DaCompany Report #FLUV00399000044 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bite Foreign Fevarin PS ORAL 50 MG DAILY Depressed Level Of Health PO Consciousness Professional Leponex SS 700 MG DAILY Fall Other UNK, 725 MG Grand Mal Convulsion DAILY UNK, Joint Dislocation 800 MG DAILY UNK, 600 MG Hypnorex - Slow Release SS 800 MG DAILY UNK, 1000 MG DAILY UNK, 1200 MG DAILY UNK 22-Feb-2006 08:30 AM Page: 640 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Gastrozepin C Date:03/02/00ISR Number: 3467581-6Report Type:Expedited (15-DaCompany Report #00-02-0060 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Chronic Obstructive Health Clozapine - Zenith Pulmonary Disease Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 450MG ORAL Date:03/02/00ISR Number: 3467583-XReport Type:Expedited (15-DaCompany Report #00-01-0075 Age:81 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bronchitis Acute Health Clozapine - Zenith Genital Neoplasm Professional Goldline Pharm - Malignant Female Tablets PS Zenith Goldline Haematuria Pharm. ORAL 50-150MG ORAL White Blood Cell Count Increased Date:03/02/00ISR Number: 3467585-3Report Type:Expedited (15-DaCompany Report #00-02-0057 Age:79 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 50-100MG ORAL Date:03/02/00ISR Number: 3467593-2Report Type:Expedited (15-DaCompany Report #00-02-0066 Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 300MG ORAL Date:03/02/00ISR Number: 3468080-8Report Type:Expedited (15-DaCompany Report #FLUV00200000844 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Toxicity Health Luvox PS ORAL DAILY, PO Hepatic Congestion Professional Anafranil SS ORAL 150 MG DAILY Pulmonary Congestion PO Spleen Disorder Clozaril SS ORAL DAILY PO Buspar C Insulin C 22-Feb-2006 08:30 AM Page: 641 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/02/00ISR Number: 3469844-7Report Type:Expedited (15-DaCompany Report #USA/00/00229/LEX Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Cancer Stage Iv Health Clozaril (Clozapine) PS ORAL 425 MG, ORAL Leukocytosis Professional Neurontin (Gabapentin) C Lovenox (Heparin-Fraction, Sodium Salt) C Tamoxifen C Prinivil (Lisinopril) C Ventolin (Salbutamol) C Atrovent Inhaler (Ipratropium Bromide) C K-Dur (Potassium Chloride) C Ranitidine C Date:03/02/00ISR Number: 3469846-0Report Type:Expedited (15-DaCompany Report #GB/00/00220/LEX Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril (Clozapine) PS ORAL 300 MG, ORAL Glycosuria Health Urinary Incontinence Professional Date:03/02/00ISR Number: 3469849-6Report Type:Expedited (15-DaCompany Report #AUS/99/01692/LEX Age:30 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Level Below Foreign Clozaril (Clozapine) PS ORAL 600 MG, ORAL Initial or Prolonged Therapeutic Health Schizophrenia Professional Date:03/02/00ISR Number: 3469854-XReport Type:Expedited (15-DaCompany Report #AUS/00/00002/LEX Age:61 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Balance Disorder Foreign Clozaril (Clozapine) PS ORAL 100 MG, ORAL Cardiac Failure Health Coordination Abnormal Professional Coronary Artery Disease Dizziness Hypertension Influenza Like Illness Lethargy Malaise Myocarditis Neutrophil Count Decreased Sedation White Blood Cell Count Decreased 22-Feb-2006 08:30 AM Page: 642 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/02/00ISR Number: 3473364-3Report Type:Expedited (15-DaCompany Report #LBID00200000843 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bronchitis Health Lithobid PS ORAL 600 MG DAILY Initial or Prolonged Dehydration Professional PO Drug Toxicity Clozaril SS ORAL 200 MG DAILY Gait Disturbance PO Leukocytosis Depakote C Myalgia Ativan C Pyrexia Prolixin C Renal Failure Acute Vomiting Date:03/03/00ISR Number: 3470201-8Report Type:Expedited (15-DaCompany Report #AUS/00/00217/LEX Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Clozaril (Clozapine) PS 75 MG Health Professional Date:03/03/00ISR Number: 3470204-3Report Type:Expedited (15-DaCompany Report #GB/00/00171/LEX Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depressed Level Of Foreign Clozaril (Clozapine) PS ORAL 225 MG, ORAL Initial or Prolonged Consciousness Health Paroxetine C Required Diabetic Coma Professional Clopixol C Intervention to Hyperglycaemia Prevent Permanent Impairment/Damage Date:03/06/00ISR Number: 3469150-0Report Type:Direct Company Report # Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Clozaril PS 450 AM AM Initial or Prolonged 500MG EVENING Prolixin SS INTRAMUSCULAR 50MG IM WEEKLY Klonopin C Cogentin C Date:03/06/00ISR Number: 3470323-1Report Type:Expedited (15-DaCompany Report #A006862 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Acne Health Vibramycin Capsules PS ORAL ORAL Intervention to Agranulocytosis Professional Clozapine SS 600.00 MG Prevent Permanent TOTAL Impairment/Damage 22-Feb-2006 08:30 AM Page: 643 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/06/00ISR Number: 3470429-7Report Type:Direct Company Report # Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukocytosis Clozaril PS 25 MG BID AND Neutrophilia 200 MD Q HS Glucotrol Xl C Lipitor C Wellbutrin Sr C Depakote C Doxepin C Oyster Shell Calcium C ... C Tylenol C Date:03/06/00ISR Number: 3470504-7Report Type:Expedited (15-DaCompany Report #AUS/00/00225/LEX Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Foreign Clozaril (Clozapine) PS 300 MG Initial or Prolonged Blood Bicarbonate Health Prednisolone Required Decreased Professional (Prednisolone) SS ORAL 50 MG, ONCE A Intervention to Blood Creatinine DAY, ORAL Prevent Permanent Increased Famotidine Impairment/Damage Blood Urea Increased (Famotidine) C Haemoglobin Decreased Folic Acid (Folic Hepatic Enzyme Increased Acid) C Hypercalcaemia Allopurinol Hyperuricaemia (Allopurinol) C Lymphoma Ferrogradumet Red Blood Cell Count (Ferrous Sulfate) C Decreased Sodibic (Sodium Bicarbonate) C Date:03/06/00ISR Number: 3470506-0Report Type:Expedited (15-DaCompany Report #AUS/00/00177/LEX Age:24 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Hepatic Neoplasm Foreign Clozaril (Clozapine) PS ORAL 300 MG, ORAL Required Malignant Study Intervention to Health Prevent Permanent Professional Impairment/Damage Date:03/06/00ISR Number: 3470507-2Report Type:Expedited (15-DaCompany Report #GB/99/00891/LEX Age:52 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Ovarian Cyst Foreign Clozaril (Clozapine) PS ORAL 200 MG, ORAL Required Weight Increased Health Clomipramine Intervention to Professional (Clomipramine) C Prevent Permanent Impairment/Damage 22-Feb-2006 08:30 AM Page: 644 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/06/00ISR Number: 3471023-4Report Type:Expedited (15-DaCompany Report #GB/00/00133/LEX Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Pain Foreign Clozaril (Clozapine) PS ORAL 400 MG, ORAL Acidosis Health Venlavfaxine Appendicitis Professional (Venlafaxine) C Blood Amylase Increased Hyoscine (Hyoscine) C Blood Bilirubin Increased Blood Creatine Phosphokinase Increased Cardio-Respiratory Arrest Chest X-Ray Abnormal Circulatory Collapse Coma Diarrhoea Drug Level Above Therapeutic Dyspepsia Electrocardiogram T Wave Inversion Hepatic Function Abnormal Hypertension Hyponatraemia Hypotension Hypoxia Intestinal Gangrene Leukocytosis Liver Function Test Abnormal Malaise Oxygen Saturation Decreased Pain Peritonitis Pulmonary Embolism Pyrexia Vomiting Date:03/07/00ISR Number: 3471210-5Report Type:Expedited (15-DaCompany Report #USA/00/00107/LEX Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Aspiration Health Clozaril (Clozapine) PS ORAL 400 MG, ORAL Hospitalization - Fatigue Professional Oxybutynin Initial or Prolonged Medication Error (Oxybutynin) SS ORAL 5 MG, ORAL Required Overdose Navane (Tiotixene) SS ORAL 10 MG, ORAL Intervention to Pneumonia Aspiration Propranolol SS ORAL 40 MG, ORAL Prevent Permanent Respiratory Arrest Colace (Docusate Impairment/Damage Respiratory Depression Sodium) SS Salivary Hypersecretion Vitamin E SS Sedation Lescol (Fluvastatin Sodium) SS Lithium C Olanzapine C 22-Feb-2006 08:30 AM Page: 645 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/07/00ISR Number: 3471427-XReport Type:Expedited (15-DaCompany Report #GB/99/01038/LEX Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Adrenal Neoplasm Foreign Clozaril (Clozapine) PS ORAL 100 MG, ORAL Required Cerebrovascular Accident Health Amisulpride Intervention to Endocrine Disorder Professional (Amisulpride) C Prevent Permanent Hypertension Salbutamol Impairment/Damage Transient Ischaemic (Salbutamol) C Attack Potassium Chloride C Procyclidine (Procyclidine) C Date:03/07/00ISR Number: 3471620-6Report Type:Expedited (15-DaCompany Report #USA/99/03382/LEX Age:65 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Clozaril (Clozapine) PS ORAL ORAL Professional Date:03/07/00ISR Number: 3471621-8Report Type:Expedited (15-DaCompany Report #NL/00/00398/LEX Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Foreign Leponex (Clozapine) PS ORAL 100 MG, THREE Health TIMES A DAY, Professional ORAL; Other Akineton (Biperiden Hydrochloride) C Amitryptilinum (Amitriptyline) C Sodium Valproate (Valproate Sodium) C Date:03/07/00ISR Number: 3471622-XReport Type:Expedited (15-DaCompany Report #NL/00/00401/LEX Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocarditis Foreign Leponex (Clozapine) PS ORAL 200 MG, ORAL Health Frenactil Professional (Benperidol) C Other Dipiperon (Pipamperone) C Date:03/07/00ISR Number: 3471624-3Report Type:Expedited (15-DaCompany Report #DW/92/00455/LEX Age:86 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Foreign Clozaril (Clozapine) PS ORAL 200 MG, ORAL Pneumonia Digimerck (Digitoxin) C Ferlixit C 22-Feb-2006 08:30 AM Page: 646 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/07/00ISR Number: 3471626-7Report Type:Expedited (15-DaCompany Report #DW/91/00455/LEX Age:86 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Foreign Leponex PS ORAL 200 MG, Pneumonia Health UNKOWN, ORAL Professional Digimerck C Ferlecit C Date:03/07/00ISR Number: 3471678-4Report Type:Expedited (15-DaCompany Report #HQ1357503MAR2000 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coma Health Ativan Injection PS INTRAMUSCULAR 1 MG, Hospitalization - Convulsion Professional INTRAMUSCULAR Initial or Prolonged Drug Interaction Clozaril SS ORAL 500 MG, ORAL Other Loss Of Consciousness Haldol SS Psychotic Disorder Respiratory Distress Syncope White Blood Cell Count Decreased Date:03/08/00ISR Number: 3472125-9Report Type:Expedited (15-DaCompany Report #00-02-0070 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delirium Health Clozapine -Zenith Initial or Prolonged Hyponatraemia Professional Goldline PS ORAL 125MG ORAL Leukocytosis Seroquel Tablets SS Lower Limb Fracture Risperdal Tablets SS ORAL ORAL Pneumonia Aspiration Respiratory Distress Date:03/08/00ISR Number: 3472126-0Report Type:Expedited (15-DaCompany Report #99-11-0422 Age:70 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Health Clozapine-Zenith Cerebrovascular Accident Professional Goldline Pharm. Dementia Tablets PS ORAL 100MG ORAL Depakote Sprinkle SS ORAL 725MG ORAL Lorazepam C Levoxyl C Novolin L C Date:03/08/00ISR Number: 3472128-4Report Type:Expedited (15-DaCompany Report #00-02-0074 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hallucination, Auditory Health Clozapine - Zenith Suicidal Ideation Professional Goldline Pharm. Inhalation Solution PS ORAL 300-450MG ORAL 22-Feb-2006 08:30 AM Page: 647 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/08/00ISR Number: 3472387-8Report Type:Expedited (15-DaCompany Report #USA/ 00/ 00544 / LEX Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Health Clozaril Required Leukopenia Professional (Clozapine) PS ORAL 900 MG, Intervention to Weight Increased OTHER, ORAL Prevent Permanent Cogentin C Impairment/Damage Paxil C Date:03/08/00ISR Number: 3472389-1Report Type:Expedited (15-DaCompany Report #USA/00/00542/ LEX Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accident Health Clozaril (Clozapine) PS ORAL 400 MG, Life-Threatening Injury Professional UNKNOWN, ORAL Road Traffic Accident Date:03/09/00ISR Number: 3472127-2Report Type:Expedited (15-DaCompany Report #00-02-0067 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine - Zenith Professional Goldline Pharm. Inhalation Solution PS Zenith Goldline Pharm. ORAL ORAL Date:03/09/00ISR Number: 3472553-1Report Type:Expedited (15-DaCompany Report #200000530BWH (1) Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Interaction Health Cipro Tablet PS ORAL PO Drug Level Above Professional Clozapine SS Therapeutic Other Date:03/09/00ISR Number: 3474296-7Report Type:Expedited (15-DaCompany Report #HQ1403806MAR2000 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Accidental Overdose Health Inderal Tablet PS ORAL 40 M,G 1 X Hospitalization - Fatigue Professional PER 1 DOS, Initial or Prolonged Respiratory Depression ORAL Other Salivary Hypersecretion Clozapine SS ORAL 400 MG 1X PER Sedation 1 DOS, ORAL Docusate Sodium SS ORAL UNSPECIFIED DOSE, ORAL Fluvastatin Sodium SS ORAL UNSPECIFIED DOSE, ORAL Oxybutynin SS ORAL 5 MG 1 X PER 1 DOS, ORAL Tiotixene SS ORAL 10 MG 1 X PER 1 DOS, ORAL Vitamin E SS ORAL UNSPECIFIED DOSE, ORAL Lithium C Olanzapine C 22-Feb-2006 08:30 AM Page: 648 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/09/00ISR Number: 3474570-4Report Type:Expedited (15-DaCompany Report #HQ1114317FEB2000 Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Health Atenolol PS ORAL 50 MG 2XPER 1 Arthralgia Professional DAY, ORAL Asthenia Clozapine SS ORAL 100 MG 1XPER Back Pain 1 DAY, ORAL Chest Pain Clomipramine Dehydration Hydrochloride C Dyspnoea Divalproex Sodium C Haemoglobin Decreased Quetiapine Fumarate C Headache Hypotension Leukocytosis Neutrophilia Date:03/10/00ISR Number: 3474105-6Report Type:Expedited (15-DaCompany Report #PRIUSA2000000054 Age:23 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Colitis Consumer Topamax (Tablet) Initial or Prolonged Dialysis Health (Topiramate) PS ORAL 400 MG, Haematocrit Decreased Professional DAILY, ORAL; Haemoglobin Decreased 375 MG, Iron Deficiency Anaemia DAILY, ORAL Renal Failure Lamictal Renal Impairment (Lamotrigine) SS ORAL ORAL 2 YR Sepsis Clozaril (Clozapine) SS ORAL ORAL 4 YR Thrombocytopenia Neurontin Vasculitis (Gabapentin) C Synthroid (Levothyroxine Sodium) C Prednisone (Prednisone) C Risperdal (Risperidone) C Atarax (Hydroxyzine Hydrochloride) C Prilosec (Omeprazole) C Date:03/10/00ISR Number: 3474376-6Report Type:Expedited (15-DaCompany Report #USA/00/00621/LEX Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Clozaril (Clozapine) PS ORAL ORAL Life-Threatening Date:03/10/00ISR Number: 3474379-1Report Type:Expedited (15-DaCompany Report #D/99/01619/LEX Age:28 YR Gender:Male I/FU:F Outcome Life-Threatening Hospitalization - Initial or Prolonged Required Intervention to 22-Feb-2006 08:30 AM Page: 649 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Chronic Myeloid Leukaemia Foreign Leponex (Clozapine) PS ORAL 250 MG,ORAL Leukocytosis Health Litalir Thrombocythaemia Professional (Hydroxycarbamide) C Cotrim Forte (Bactrim) C Date:03/10/00ISR Number: 3474382-1Report Type:Expedited (15-DaCompany Report #D/99/01728/LEX Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chronic Myeloid Leukaemia Foreign Leponex (Clozapine) PS ORAL 100 MG, ORAL Initial or Prolonged Health Professional Date:03/10/00ISR Number: 3474384-5Report Type:Expedited (15-DaCompany Report #USA/00/00188/LEX Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asthma Health Clozaril (Clozapine) PS ORAL 600 MG, ORAL Hospitalization - Influenza Professional Initial or Prolonged Leukocytosis Required Leukopenia Intervention to Necrosis Prevent Permanent Neutropenia Impairment/Damage Pneumonia Staphylococcal Pyrexia Respiratory Failure Staphylococcal Infection Date:03/10/00ISR Number: 3474386-9Report Type:Expedited (15-DaCompany Report #USA/00/00577/LEX Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Overdose Health Clozaril (Clozapine) PS ORAL 500 MG, ORAL Initial or Prolonged Suicide Attempt Professional Date:03/10/00ISR Number: 3474551-0Report Type:Expedited (15-DaCompany Report #BR/00/00478/LEX Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Leponex (Clozapine) PS ORAL 600 MG, ORAL Cardio-Respiratory Arrest Health Joint Contracture Professional Other Date:03/10/00ISR Number: 3474552-2Report Type:Expedited (15-DaCompany Report #USA/00/00615/LEX Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Health Clozaril (Clozapine) PS ORAL 450 MG, ORAL Throat Cancer Professional 22-Feb-2006 08:30 AM Page: 650 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/10/00ISR Number: 3474553-4Report Type:Expedited (15-DaCompany Report #BG/00/00213/LEX Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Clozaril (Clozapine) PS ORAL 300 MG, ORAL Diarrhoea Health Procyclidine Hypotension Professional (Procyclidine) C Pyrexia Other Chlorpromazine C Date:03/10/00ISR Number: 3474554-6Report Type:Expedited (15-DaCompany Report #USA/00/00421/LEX Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Health Clozaril (Clozapine) PS ORAL 75 MG, TWICE Electrocardiogram Qrs Professional A DAY, ORAL Complex Prolonged Glipizide C Hypothyroidism Depakote (Valproate Semisodium) C Paxil (Paroxetine Hydrochloride) C Klonopin (Clonazepam) C Cogentin (Benzatropine Mesilate) C Date:03/13/00ISR Number: 3473919-6Report Type:Expedited (15-DaCompany Report #00-01-0040 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Leukocytosis Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS ORAL ORAL 1 MON Date:03/13/00ISR Number: 3473927-5Report Type:Expedited (15-DaCompany Report #C2000-0132.01 Age:33 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozaril Novartis PS ORAL 600MG, ORAL Other Professional Doxycycline SS Required Other Intervention to Prevent Permanent Impairment/Damage Date:03/14/00ISR Number: 3475625-0Report Type:Expedited (15-DaCompany Report #USA/99/03397/LEX Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozaril (Clozapine) PS ORAL 500 MG, Hospitalization - Cardio-Respiratory Arrest Professional OTHER, ORAL Initial or Prolonged Convulsion Peri-Colace C Respiratory Depression Cogentin Sleep Apnoea Syndrome (Benzatropine Mesilate) C Deseril (Methysergide) C 22-Feb-2006 08:30 AM Page: 651 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/14/00ISR Number: 3475626-2Report Type:Expedited (15-DaCompany Report #USA/00/00344/LEX Age:64 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cough Health Clozaril (Clozapine) PS ORAL 150 MG, Initial or Prolonged Dehydration Professional OTHER, ORAL Hyperkalaemia Depakote (Valproate Lethargy Semisodium) C Leukopenia Lithium C Sedation Lasix (Furosemide) C White Blood Cell Disorder Proventil (Salutamol) C Atrovent (Ipratropium Bromide) C Date:03/14/00ISR Number: 3475630-4Report Type:Expedited (15-DaCompany Report #BR/00/00478/LEX Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Foreign Leponex (Clozapine) PS ORAL 500 MG, ORAL Chest Pain Health Joint Contracture Professional Myocardial Infarction Date:03/14/00ISR Number: 3475639-0Report Type:Expedited (15-DaCompany Report #GB/99/01038/LEX Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cerebrovascular Accident Foreign Clozaril (Clozapine) PS ORAL 100 MG, ORAL Required Cerebrovascular Disorder Health Amisulpride Intervention to Endocrine Disorder Professional (Amisulpride) C Prevent Permanent Primary Salbutamol Impairment/Damage Hyperaldosteronism (Salbutamol) C Transient Ischaemic Potassium Chloride C Attack Procyclidine (Procyclidine) C Date:03/14/00ISR Number: 3475648-1Report Type:Expedited (15-DaCompany Report #USA/00/00522/LEX Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozaril (Clozapine) PS ORAL 900 MG, ORAL Hospitalization - Blood Pressure Decreased Professional Haldol Decanoate Initial or Prolonged Hypotension (Haloperidol) C Required Leukocytosis Paxil (Paroxetine Intervention to Lobar Pneumonia Hydrochloride) C Prevent Permanent Sepsis Benztropeine Impairment/Damage Shock (Benztropeine) C Haldol (Haloperidol) C Date:03/14/00ISR Number: 3475649-3Report Type:Expedited (15-DaCompany Report #USA/00/00393/LEX Age:51 YR Gender:Male I/FU:F Outcome PT Other Enuresis Renal Cell Carcinoma Stage Unspecified 22-Feb-2006 08:30 AM Page: 652 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Urinary Incontinence Report Source Product Role Manufacturer Route Dose Duration Health Clozaril (Clozapine) PS ORAL 400 MG, ORAL Professional Tofranil (Imipramine Hydrochloride) C Ativan (Lorazepam) C Trazodone (Trazodone) C Procardia (Nifedipine) C Depakote (Valproate Semisodium) C Date:03/15/00ISR Number: 3475871-6Report Type:Expedited (15-DaCompany Report #20000200475 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Distension Foreign Prilosec Cap PS ORAL 20 MG QD PO Constipation Health Clozapine SS Hypotension Professional Intestinal Obstruction Pneumonia Thrombocytopenia Vomiting Date:03/15/00ISR Number: 3475918-7Report Type:Expedited (15-DaCompany Report #JRFUSA2000001604 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Thrombocytopenia Health Risperdal (Tablet) Professional (Risperidone) PS ORAL ORAL Clozapine (Clozapine) SS Date:03/15/00ISR Number: 3476410-6Report Type:Direct Company Report # Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutropenia Health Clozapine PS ORAL 300 PO Q AM Initial or Prolonged Sepsis Professional 600MG PO Q PM Date:03/16/00ISR Number: 3476129-1Report Type:Expedited (15-DaCompany Report #00-01-0002 Age:77 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dementia Alzheimer'S Type Clozapine-Zenith Leukocytosis Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 50MG ORAL Lorazepam C 22-Feb-2006 08:30 AM Page: 653 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/16/00ISR Number: 3476131-XReport Type:Expedited (15-DaCompany Report #00-01-0021 Age:86 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Renal Failure Acute Health Clozapine Tablets - White Blood Cell Disorder Professional Zenith Goldline Pharm. PS Zenith Goldline Pharm. ORAL 25MG ORAL Humulin S C Date:03/16/00ISR Number: 3476133-3Report Type:Expedited (15-DaCompany Report #00-02-0094 Age:87 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine -Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 12.5MG ORAL Date:03/16/00ISR Number: 3476136-9Report Type:Expedited (15-DaCompany Report #00-03-0100 Age:92 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine -Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 12.5-25MG ORAL Date:03/16/00ISR Number: 3476140-0Report Type:Expedited (15-DaCompany Report #00-02-0096 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Choking Other Clozapine -Zenith Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 150MG ORAL Date:03/16/00ISR Number: 3476145-XReport Type:Expedited (15-DaCompany Report #00-02-0095 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chronic Obstructive Health Clozapine-Zenith Initial or Prolonged Pulmonary Disease Professional Goldline Pharm. Leukocytosis Tablets PS Zenith Goldline Respiratory Failure Pharm. ORAL 350-450MG ORAL Date:03/16/00ISR Number: 3476447-7Report Type:Direct Company Report # Age: Gender: I/FU:I Outcome PT Hospitalization - Communication Disorder Initial or Prolonged Diarrhoea Other Disturbance In Attention Hallucination, Auditory Road Traffic Accident 22-Feb-2006 08:30 AM Page: 654 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Schizophrenia Social Avoidant Behaviour Report Source Product Role Manufacturer Route Dose Duration Clozapine, Both Strengths Mfd By Zenith PS Zenith Date:03/16/00ISR Number: 3477300-5Report Type:Expedited (15-DaCompany Report #USA/99/02117/LEX Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agranulocytosis Health Clozaril (Clozapine) PS ORAL 700 MG, ORAL Life-Threatening Aortic Atherosclerosis Professional Colace (Docusate Hospitalization - Atrial Septal Defect Sodium) C Initial or Prolonged Condition Aggravated Depakote (Valproate Coronary Artery Semisodium) C Atherosclerosis Seroquel C Leukopenia Artane Mania (Trihexyphenidyl Pleural Effusion Hydrochloride) C Pneumonia Klonopin Psychotic Disorder (Clonazepam) C Thrombocytopenia Date:03/16/00ISR Number: 3477301-7Report Type:Expedited (15-DaCompany Report #GB/00/00279/LEX Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Circulatory Collapse Foreign Clozaril (Cloazpine) PS ORAL 100 MG, ORAL Constipation Study Quetiapine Diaphragmatic Hernia Health (Quetiapine) C Dyspnoea Professional Intestinal Obstruction Date:03/16/00ISR Number: 3477302-9Report Type:Expedited (15-DaCompany Report #GB/00/00273/LEX Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril (Clozapine) PS ORAL 425 MG, ORAL Weight Increased Health Citalopram Professional (Citalopram) C Gaviscon (Gaviscon) C Gamolenic Acid C Date:03/16/00ISR Number: 3477303-0Report Type:Expedited (15-DaCompany Report #IRL/00/00271/LEX Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intestinal Perforation Foreign Clozaril (Clozapine) PS ORAL 500 MG, ORAL Initial or Prolonged Health Professional 22-Feb-2006 08:30 AM Page: 655 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/17/00ISR Number: 3477404-7Report Type:Expedited (15-DaCompany Report #USA/99/03220/LEX Age:16 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Health Clozaril (Clozapine) PS ORAL 200 MG, TWICE Initial or Prolonged Electrocardiogram Qt Professional A DAY, ORAL Other Prolonged Multivitamins C Required Hepatic Function Abnormal Flu Vaccine Intervention to Liver Function Test (Influenza Virus Prevent Permanent Abnormal Vaccine Polyvalent) C Impairment/Damage Urinary Tract Infection Vaginal Candidiasis Weight Increased Date:03/17/00ISR Number: 3477405-9Report Type:Expedited (15-DaCompany Report #USA/00/00442/LEX Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Aggression Health Clozaril (Clozapine) PS ORAL 350 MG, Hospitalization - Diabetes Mellitus Professional OTHER, ORAL 1 YR Initial or Prolonged Insulin-Dependent Risperdal Required Hyperglycaemia (Risperidone) SS Intervention to Psychotic Disorder Reglan Prevent Permanent (Metoclopramide) C Impairment/Damage Vitamin B6 (Pyridoxine Hydrochloride) C Paxil (Paroxetine Hydrochloride) C Isoniazid C Date:03/17/00ISR Number: 3477549-1Report Type:Expedited (15-DaCompany Report #GB/00/00282/LEX Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril (Clozapine) PS ORAL 200 MG, ORAL Health Professional Date:03/17/00ISR Number: 3477550-8Report Type:Expedited (15-DaCompany Report #GB/00/00283/LEX Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Foreign Clozaril (Clozapine) PS ORAL 100 MG, ORAL; Initial or Prolonged Health ORAL; Professional Date:03/20/00ISR Number: 3477722-2Report Type:Expedited (15-DaCompany Report #A008941 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Aspiration Health Navane Capsules PS 10.00 MG Hospitalization - Fatigue Professional TOTAL Initial or Prolonged Medication Error Clozapine SS 400.00 MG Respiratory Failure TOTAL Salivary Hypersecretion Oxybutynin SS 5.00 MG TOTAL Propranolol SS 40.00 MG TOTAL 22-Feb-2006 08:30 AM Page: 656 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Colace C Vitamin E C Lithium C Olanzapine C Date:03/20/00ISR Number: 3477743-XReport Type:Expedited (15-DaCompany Report #AUS/00/00111/LEX Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Clozaril (Clozapine) PS ORAL 400 MG, ORAL Initial or Prolonged Phosphokinase Increased Health Aspirine Required Cardiomyopathy Professional (Acetylsalicylic Intervention to Coma Acid) C Prevent Permanent Electrocardiogram T Wave Pravastatin Impairment/Damage Inversion (Pravastatin) C Pyrexia Metoprolol (Metoprolol) C Sodium Valproate (Valproate Sodium) C Thyroxine (Levothyroxine Sodium) C Date:03/20/00ISR Number: 3477746-5Report Type:Expedited (15-DaCompany Report #GB/00/00213/LEX Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Clozaril (Clozapine) PS ORAL 150 MG, TWICE Diarrhoea Health A DAY, ORAL Hypotension Professional Procyclidine Pyrexia (Procyclidine) C Viral Myocarditis Chlorpromazine C Date:03/20/00ISR Number: 3478096-3Report Type:Expedited (15-DaCompany Report #AUS/00/00378/LEX Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiac Disorder Foreign Clozaril (Clozapine) PS ORAL 600 MG, ONCE Cardiomyopathy Health A DAY, ORAL Neutropenia Professional Other Date:03/20/00ISR Number: 3478097-5Report Type:Expedited (15-DaCompany Report #AUS/00/00380/LEX Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dystonia Foreign Clozaril (Clozapine) PS 450 MG, ONCE Required Oculogyration Health A DAY, Intervention to Trismus Professional Prevent Permanent Other Impairment/Damage 22-Feb-2006 08:30 AM Page: 657 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/20/00ISR Number: 3478100-2Report Type:Expedited (15-DaCompany Report #AUS/00/00382/LEX Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiomyopathy Foreign Clozaril (Clozapine) PS ORAL 375 MG, ORAL Health Oroxine Professional (Levothyroxine Other Sodium) C Premia (Provella-14) C Quinine Bisulphate (Quinine Bisulfate) C Date:03/20/00ISR Number: 3478104-XReport Type:Expedited (15-DaCompany Report #CH/00/00018/LEX Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatinine Foreign Leponex (Clozapine) PS ORAL 250 MG, ORAL 20 YR Initial or Prolonged Increased Health Blood Urea Increased Professional C-Reactive Protein Increased Dehydration Hypernatraemia Hyperuricaemia Leukocytosis Weight Decreased Date:03/20/00ISR Number: 3478107-5Report Type:Expedited (15-DaCompany Report #D/00/00169/LEX Age:42 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Foreign Leponex (Clozapine) PS ORAL 50 MG, FOUR Dizziness Health TIMES A DAY, Ear Disorder Professional ORAL Hepatic Neoplasm Ximovan (Zopiclone) C Hepatocellular Damage Menorrhagia Metastases To Liver Date:03/20/00ISR Number: 3478109-9Report Type:Expedited (15-DaCompany Report #GB/00/00294/LEX Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Pain Foreign Clozaril (Clozapine) PS ORAL 450 MG, ONCE Hospitalization - Agitation Health A DAY, ORAL Initial or Prolonged Arrhythmia Professional Droperidol Cardiac Disorder (Droperidol) SS 5 MG, FOUR Conduction Disorder TIMES A DAY, Constipation 5 MG, THREE Drug Interaction TIMES A DAY, Gastrointestinal Disorder Cefuroxime Intestinal Obstruction (Cefuroxine) C Vomiting Metronidazole (Metronidazole) C Heparin (Heparin) C Calcium (Calcium) C 22-Feb-2006 08:30 AM Page: 658 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/20/00ISR Number: 3478132-4Report Type:Expedited (15-DaCompany Report #USA/00/00657/LEX Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Health Clozaril (Clozapine) PS ORAL 800 MG,ORAL Hospitalization - Binge Eating Professional Depakote (Valproate Initial or Prolonged Cardio-Respiratory Arrest Semisodium) C Cardiovascular Disorder Cogentin Intestinal Obstruction (Benzatropine Vomiting Mesilate) C Celexa (Citalopram Hydrobromide) C Risperdal (Risperidone) C Prevacid (Lansoprazole) C Peri-Colace (Peri-Colace) C Celebrex (Celecoxib) C Allegra (Fexofenadine Hydrochloride) C Ddavp (Desmopressin) C Date:03/20/00ISR Number: 3478136-1Report Type:Expedited (15-DaCompany Report #USA/99/03164/LEX Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Clozaril (Clozapine) PS ORAL 400 MG, ONCE Life-Threatening Cardiomegaly Professional A DAY,ORAL Dyspnoea Navane (Tiotixene) C Hepatic Congestion Cogentin Hypertension (Benzatropine Hypertensive Heart Mesilate) C Disease Atenolol C Influenza Nasopharyngitis Obesity Pulmonary Oedema Respiratory Failure Spleen Disorder Tachycardia Viral Infection Weight Increased Date:03/20/00ISR Number: 3478139-7Report Type:Expedited (15-DaCompany Report #USA/00/00621/LEX Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozaril (Clozapine) PS ORAL 300 MG, ORAL Life-Threatening Professional Klonopin (Clonazepam) C Topimax (Topiramate) C 22-Feb-2006 08:30 AM Page: 659 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/20/00ISR Number: 3478154-3Report Type:Expedited (15-DaCompany Report #AUS/00/00358/LEX Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiomyopathy Foreign Clozaril (Clozapine) PS Required Health Intervention to Professional Prevent Permanent Impairment/Damage Date:03/21/00ISR Number: 3477224-3Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Health Clozaril PS 500 MG / DAY Decreased Professional Date:03/21/00ISR Number: 3477240-1Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Clozaril PS 450 MG/ DAY 1 YR Date:03/21/00ISR Number: 3477242-5Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Pressure Increased Clozaril PS 250 MG QD Body Temperature Increased Heart Rate Increased Date:03/21/00ISR Number: 3477728-3Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Upper Clozapine PS Initial or Prolonged Blood Creatine Trifluperazine SS Phosphokinase Increased Ritalin SS Confusional State Lopid (Gemfibrozol) C Dyskinesia Docusate Sodium C Loss Of Consciousness Metamucil C Neuroleptic Malignant Multivitamin C Syndrome Pallor Refusal Of Treatment By Patient Respiratory Rate Increased Speech Disorder Urinary Incontinence Weight Gain Poor 22-Feb-2006 08:30 AM Page: 660 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/21/00ISR Number: 3478591-7Report Type:Expedited (15-DaCompany Report #225690 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Foreign Rivotril Initial or Prolonged Hallucination Other (Clonazepam) PS ORAL ORAL Tardyferon (Ferrous Sulfate) SS ORAL ORAL Tranxene (Clorazepate Dipotassium) SS ORAL 100 MG 1 PER 1 DAY ORAL Leponex (Clozapine) SS ORAL 600 MG 1 PER 1 DAY ORAL Mopral (Omeprazole) SS ORAL ORAL Neurontin (Gabapentin) SS ORAL 200 MG 1 PER 1 DAY ORAL Date:03/22/00ISR Number: 3478799-0Report Type:Expedited (15-DaCompany Report #GB/00/00290/LEX Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril (Clozapine) PS ORAL ORAL Health Professional Date:03/22/00ISR Number: 3478804-1Report Type:Expedited (15-DaCompany Report #AUS/00/00418/LEX Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiac Disorder Foreign Clozaril (Clozapine) PS ORAL 500 MG, ONCE Cardiomyopathy Study A DAY, ORAL Myocardial Ischaemia Health Paroxetine C Professional Date:03/22/00ISR Number: 3478806-5Report Type:Expedited (15-DaCompany Report #USA/00/00711/LEX Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Ovarian Cancer Health Clozaril (Clozapine) PS ORAL 350 MG , Hospitalization - Professional OTHER, ORAL Initial or Prolonged Haldol Deconoate C Depakote C Paxil C Date:03/23/00ISR Number: 3478925-3Report Type:Expedited (15-DaCompany Report #99-12-0437 Age:74 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aortic Aneurysm Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm ORAL 100-125MG ORAL 22-Feb-2006 08:30 AM Page: 661 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/23/00ISR Number: 3478926-5Report Type:Expedited (15-DaCompany Report #00-03-0104 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm ORAL 100MG ORAL Heroin SS Date:03/23/00ISR Number: 3478928-9Report Type:Expedited (15-DaCompany Report #00-03-0101 Age:78 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebral Haemorrhage Health Clozapine - Zenith Traumatic Professional Goldline Pharm. Fall Tablets PS Zenith Goldline Pharm. ORAL 25-37.5MG ORAL Date:03/23/00ISR Number: 3478930-7Report Type:Expedited (15-DaCompany Report #00-03-0103 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bone Neoplasm Malignant Health Clozapine - Zenith Brain Neoplasm Professional Goldline Pharm. Lung Neoplasm Malignant Tablets PS Zenith Goldline Pharm. ORAL 150-500 MG ORAL Date:03/23/00ISR Number: 3479096-XReport Type:Expedited (15-DaCompany Report #GB/00/00295/LEX Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Foreign Clozaril (Clozapine) PS ORAL 300MG, ORAL; Drug Interaction Health ORAL Professional Venlafaxine (Venlafaxine) SS Valproate Sodium C Date:03/23/00ISR Number: 3479401-4Report Type:Expedited (15-DaCompany Report #AUS/00/00177/LEX Age:25 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Hepatic Neoplasm Foreign Clozaril (Clozapine) PS ORAL 300 MG, TWICE Required Malignant Health A DAY; ORAL Intervention to Leukopenia Professional Prevent Permanent Impairment/Damage Date:03/23/00ISR Number: 3479402-6Report Type:Expedited (15-DaCompany Report #GB/00/00116/LEX Age:47 YR Gender:Female I/FU:F Outcome Other Required Intervention to 22-Feb-2006 08:30 AM Page: 662 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Diabetes Mellitus Foreign Clozaril (Clozapine) PS ORAL 350 MG, ONCE Pruritus Health A DAY; ORAL Professional Metformin (Metformin) C Vallergan (Alimemazine Tartrate) C Date:03/23/00ISR Number: 3518461-9Report Type:Periodic Company Report #00-03-0112 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Psychotic Disorder Health Clozapine PS Zenith Goldline ORAL 400 MG ORAL Professional Date:03/23/00ISR Number: 3518487-5Report Type:Periodic Company Report #00-03-0122 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Psychotic Disorder Health Clozapine PS Zenith Goldline ORAL 700 MG ORAL Professional Date:03/23/00ISR Number: 3518489-9Report Type:Periodic Company Report #00-03-0123 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Psychotic Disorder Health Clozapine PS Zenith Goldline ORAL 1000 MG ORAL Professional Date:03/24/00ISR Number: 3479713-4Report Type:Expedited (15-DaCompany Report #AUS/00/00217/LEX Age:24 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Clozaril (Clozapine) PS ORAL 75 MG, Health UNKNOWN, ORAL Professional Clomipramine (Clomipramine) C Date:03/24/00ISR Number: 3479765-1Report Type:Expedited (15-DaCompany Report #USA/00/00529/LEX Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Medication Error Health Clozaril (Clozapine) PS ORAL 225 MG, ORAL Life-Threatening Overdose Professional Tylenol (Paracetamol) SS Benadryl (Dephenhydramine Hydrochloride) SS Buspar (Buspirone Hydrochloride) C Serzone (Nefazodone Hydrochloride) C Depakote (Valproate 22-Feb-2006 08:30 AM Page: 663 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Semisodium) C Klonopin (Clonazepam) C Date:03/24/00ISR Number: 3480256-2Report Type:Expedited (15-DaCompany Report #GB/00/00312/LEX Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril (Clozapine) PS ORAL 150 MG, ORAL; Health 150 MG Professional Date:03/24/00ISR Number: 3480258-6Report Type:Expedited (15-DaCompany Report #AUS/00/00444/LEX Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiomyopathy Foreign Clozaril (Clozapine) PS ORAL 750 MG, ORAL Dyspnoea Health Lithium (Lithium) C Obesity Professional Vitamin B.C.Zinc (Vitamins) C Aporex (Aporex) C Diazepam (Diazepam) C Date:03/24/00ISR Number: 3480691-2Report Type:Expedited (15-DaCompany Report #JRFUSA2000002001 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delirium Health Risperdal (Tablet) Initial or Prolonged Hyponatraemia Professional (Risperidone) PS ORAL ORAL Required Leukocytosis Clozapine Intervention to Lower Limb Fracture (Clozapine) SS ORAL ORAL Prevent Permanent Pneumonia Aspiration Seroquel (Seroquel) SS ORAL ORAL Impairment/Damage Respiratory Distress Respiratory Failure Date:03/27/00ISR Number: 3480461-5Report Type:Expedited (15-DaCompany Report #A006862 Age:33 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Agranulocytosis Health Vibramycin Capsules PS ORAL ORAL Intervention to Professional Clozapine SS 600.00 MG Prevent Permanent TOTAL Impairment/Damage Date:03/28/00ISR Number: 3480287-2Report Type:Direct Company Report # Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Hepatitis C Consumer Lithium Carbonate Hospitalization - Hepatocellular Damage Tab Cr 900 M PS ORAL 900M, PO BID, Initial or Prolonged TAB Disability Clozapine Tab 300m SS ORAL 300 M PO BID Other TAB Required Intervention to Prevent Permanent Impairment/Damage 22-Feb-2006 08:30 AM Page: 664 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/28/00ISR Number: 3480785-1Report Type:Expedited (15-DaCompany Report #USA/00/00695/LEX Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Arrhythmia Health Clozaril (Clozapine) PS ORAL 150 MG, Cardiomyopathy Professional OTHER, ORAL Weight Increased Lanoxin (Digoxin) C Date:03/28/00ISR Number: 3480787-5Report Type:Expedited (15-DaCompany Report #USA/00/00728/LEX Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Metastases To Lymph Nodes Health Clozaril (Clozapine) PS ORAL 300 MG, ORAL Required Oesophageal Professional Paxil (Paroxetine Intervention to Adenocarcinoma Hydrochloride) C Prevent Permanent Compazine C Impairment/Damage Lorazepam C Vicodin (Vicodin) C Date:03/28/00ISR Number: 3480861-3Report Type:Expedited (15-DaCompany Report #6147 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Aspiration Health Oxybutynin Generic Hospitalization - Fatigue Professional (Oxybutynin Initial or Prolonged Medication Error Other Chloride) PS 5 MG Respiratory Distress Clozaril SS 400MG Salivary Hypersecretion Navane SS 10 MG Propranolol SS 40 MG Lithium C Olanzapine C Date:03/28/00ISR Number: 3480986-2Report Type:Expedited (15-DaCompany Report #USA/00/00059/LEX Age:2.4 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Health Clozaril (Clozapine) PS ORAL 100 MG, ORAL Initial or Prolonged Coordination Abnormal Professional Moban (Molindone) SS ORAL ORAL Medication Error Sedation Sinus Tachycardia Date:03/28/00ISR Number: 3480988-6Report Type:Expedited (15-DaCompany Report #MOBAN2000-00113 Age:2 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Exposure Health Moban PS Endo ORAL 1 TAB ONCE PO Initial or Prolonged Coma Professional Clozaril SS Endo ORAL 100 MG ONCE Coordination Abnormal PO Medication Error Sedation Sinus Tachycardia 22-Feb-2006 08:30 AM Page: 665 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/28/00ISR Number: 3481071-6Report Type:Expedited (15-DaCompany Report #USA/00/00522/LEX Age:56 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozaril (Clozapine) PS ORAL 900 MG, Hospitalization - Hypotension Professional UNKNOWN, ORAL Initial or Prolonged Leukocytosis Haldol Decanoate Required Lobar Pneumonia (Haloperidol) C Intervention to Lung Infiltration Paxil (Paroxetine Prevent Permanent Sepsis Hydrochloride) C Impairment/Damage Shock Benztropeine (Benztropeine) C Haldol (Haloperidol) C Date:03/28/00ISR Number: 3481218-1Report Type:Expedited (15-DaCompany Report #AUS/00/00299/LEX Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocarditis Foreign Clozaril (Clozapine) PS Study Health Professional Date:03/28/00ISR Number: 3481220-XReport Type:Expedited (15-DaCompany Report #USA/00/00767/LEX Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Seminoma Health Clozaril (Clozapine) PS ORAL 550 MG, ORAL Hospitalization - Professional Initial or Prolonged Disability Other Required Intervention to Prevent Permanent Impairment/Damage Date:03/28/00ISR Number: 3481238-7Report Type:Expedited (15-DaCompany Report #GB/99/01173/LEX Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Neoplasm Malignant Foreign Clozaril (Clozapine) PS ORAL 500 MG, Pneumonia Health UNKNOWN, Professional ORAL; Date:03/28/00ISR Number: 3481239-9Report Type:Expedited (15-DaCompany Report #USA/00/00778/LEX Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Abdominal Distension Health Clozaril (Clozapine) PS ORAL 100 MG, TWICE Other Ascites Professional A DAY, ORAL Required Diabetes Mellitus Lithium C Intervention to Hepatic Cirrhosis Lipitor Prevent Permanent (Atorvastatin) C Impairment/Damage Aldactone (Spironolactone) C Depo-Provera (Medroxyprogesterone 22-Feb-2006 08:30 AM Page: 666 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Acetate) C Folic Acid C Dulcolax (Bisacodyl) C Rhinocort Nasal Spray (Budesonide) C Date:03/28/00ISR Number: 3481240-5Report Type:Expedited (15-DaCompany Report #USA/99/03201/LEX Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Colon Cancer Health Clozaril (Clozapine) PS ORAL 200 MG, ONCE Initial or Prolonged Vomiting Professional A DAY; ORAL Required Serzone (Nefazodone Intervention to Hydrochloride) C Prevent Permanent Zantac (Ranitidine Impairment/Damage Hydrochloride) C Valium (Diazepam) C Date:03/29/00ISR Number: 3480879-0Report Type:Expedited (15-DaCompany Report #00-03-0129 Age:18 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Road Traffic Accident Health Clozapine - Zenith Professional Goldline Pharm Tablets PS Zenith Goldline Pharm. ORAL 125-450MG ORAL Date:03/29/00ISR Number: 3480884-4Report Type:Expedited (15-DaCompany Report #00-03-0132 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. 325MG ORAL Date:03/29/00ISR Number: 3480907-2Report Type:Expedited (15-DaCompany Report #00-03-0126 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 300MG ORAL Date:03/29/00ISR Number: 3481392-7Report Type:Direct Company Report # Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Influenza Like Illness Clozapine 100 Mg PS 2 AM & 2.5 HS Hospitalization - Leukopenia Flu Shot C Initial or Prolonged Neutropenia Pseudoephedrine C Doxycycline C 22-Feb-2006 08:30 AM Page: 667 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/29/00ISR Number: 3481472-6Report Type:Direct Company Report # Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Dystonia Paxil PS ORAL 20 MG 1 QD PO Intervention to Clozaril SS 100 MG 2 QAM Prevent Permanent 1 QHS PRN Impairment/Damage Lorazepam C Trazodone C Inderal C Date:03/30/00ISR Number: 3482344-3Report Type:Expedited (15-DaCompany Report #D/00/00358/LEX Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocarditis Foreign Leponex (Clozapine) PS Health Professional Date:03/30/00ISR Number: 3482379-0Report Type:Expedited (15-DaCompany Report #GB/00/00213/LEX Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Clozaril (Clozapine) PS ORAL 150 MG, TWICE Hospitalization - Diarrhoea Health A DAY, ORAL Initial or Prolonged Gastroenteritis Professional Procyclidine Hypotension (Procyclidine) C Necrosis Chlorpromazine C Pyrexia Viral Myocarditis Date:03/30/00ISR Number: 3482382-0Report Type:Expedited (15-DaCompany Report #AUS/00/00480/LEX Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Clozaril (Clozapine) PS ORAL 500 MG, ORAL Study Health Professional Date:03/30/00ISR Number: 3482389-3Report Type:Expedited (15-DaCompany Report #AUS/99/01688/LEX Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Colonic Obstruction Foreign Clozaril (Clozapine) PS ORAL 750 MG, ORAL Required Constipation Study Sodium Valporate Intervention to Faecaloma Health (Valproic Acid) C Prevent Permanent Hepatic Failure Professional Omeprazole Impairment/Damage Intestinal Obstruction (Omeprazole) C Megacolon Metamucil (Psyllium Multi-Organ Failure Hydrophilic Nausea Mucilloid) C Necrosis Ischaemic Oesophagitis Post Procedural Complication Sepsis Vomiting 22-Feb-2006 08:30 AM Page: 668 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/30/00ISR Number: 3482417-5Report Type:Expedited (15-DaCompany Report #GB/00/00343/LEX Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril (Clozapine) PS 300 MG, Other Valproate Sodium C Thyroxine (Levothyroxine Sodium) C Olanzapine (Olanzapine) C ... C Date:03/31/00ISR Number: 3482900-2Report Type:Expedited (15-DaCompany Report #GB/00/00350/LEX Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiac Failure Foreign Clozaril (Clozapine) PS ORAL ORAL Drug Interaction Health Venlafaxine Drug Level Above Professional (Venlafaxine) SS ORAL 100 MG ORAL; Therapeutic 200 MG ORAL Oedema Tachycardia Date:03/31/00ISR Number: 3482902-6Report Type:Expedited (15-DaCompany Report #GB/00/00351/LEX Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Foreign Clozaril (Clozapine) PS ORAL ORAL Initial or Prolonged Drug Level Above Health Venlafaxine Therapeutic Professional (Venlafaxine) SS Ileus Paralytic Lethargy Sedation Date:03/31/00ISR Number: 3482908-7Report Type:Expedited (15-DaCompany Report #AUS/00/00521/LEX Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bacterial Infection Foreign Clozaril (Clozapine) PS ORAL 100 MG, ORAL Initial or Prolonged Cellulitis Health Epilim (Valproate Required Staphylococcal Infection Professional Sodium) C Intervention to Subcutaneous Abscess Aropax (Paroxetine Prevent Permanent Hydrochloride) C Impairment/Damage Date:03/31/00ISR Number: 3482911-7Report Type:Expedited (15-DaCompany Report #IRL/00/00207/LEX Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Circulatory Collapse Foreign Clozaril (Clozapine) PS ORAL ORAL Dyskinesia Study Shock Health Professional 22-Feb-2006 08:30 AM Page: 669 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/31/00ISR Number: 3482913-0Report Type:Expedited (15-DaCompany Report #AUS/00/00177/LEX Age:25 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Drug Level Below Foreign Clozaril (Clozapine) PS ORAL 150 MG, TWICE Required Therapeutic Health A DAY, ORAL; Intervention to Hepatic Neoplasm Professional Prevent Permanent Malignant Impairment/Damage Leukopenia Malaise Date:03/31/00ISR Number: 3482915-4Report Type:Expedited (15-DaCompany Report #AUS/94/00075/LEX Age:58 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Clozaril PS ORAL 200 MG, ORAL Myocardial Infarction Study Frusemide - Cardiac Health Failure C Professional Thyroxine Sodium - Hypothyroidism C Date:04/03/00ISR Number: 3482954-3Report Type:Direct Company Report # Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Leukopenia Clozapine 100mg Zenith/Goldline PS Zenith/Goldline ORAL 100MG AM 200MG HS PO Lithium C Diphenhydramine C Lorazepam C Date:04/03/00ISR Number: 3483192-0Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Dyspnoea Clozaril 100mg PS 2 QHS Hospitalization - Pulmonary Embolism Clozaril SS 2 Q AM & 2 Q Initial or Prolonged 5PM Premarin C Zocor C Artane C Prevacid C Levothyroxine C Loxapine C Vioxx C Serzone C K-Dur C Acetaminophen C Neurontin C Senokot C Klonopin C 22-Feb-2006 08:30 AM Page: 670 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/03/00ISR Number: 3483420-1Report Type:Expedited (15-DaCompany Report #D/00/00358/LEX Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Atherosclerosis Foreign Leponex (Clozapine) PS Croup Infectious Health Myocarditis Professional Viral Infection Date:04/03/00ISR Number: 3483711-4Report Type:Expedited (15-DaCompany Report #USA/00/00877/LEX Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Clozaril (Clozapine) PS ORAL UNSPECIFIED, Professional ORAL Date:04/03/00ISR Number: 3483734-5Report Type:Expedited (15-DaCompany Report #D/99/01660/LEX Age:46 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Left Ventricular Failure Foreign Leponex (Clozapine) PS ORAL 600 MG, ORAL Megacolon Health Neurocil Pulmonary Oedema Professional (Levomepromazine Sepsis Maleate) SS ORAL 150 MG, ORAL Shock Haldol Decanoate (Haloperidol Decanoate) SS 50 MG, EVERY THREE WEEKS, UNKNOWN Sostril (Ranitidine Hydrochloride) - Chronic Gastritis C Akineton Retard (Biperiden Hydrochloride)- Epms C Bifetiral (Lactulose)- Obstipation C Ferro "Sanol" (Ferro "Sanol") - Hypoferric Anaemia C Date:04/03/00ISR Number: 3483883-1Report Type:Expedited (15-DaCompany Report #200000530BWH (2) Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bronchitis Health Cipro Tablet PS ORAL PO Drug Interaction Professional Clozapine Tablet SS ORAL PO Drug Level Above Other Therapeutic Sedation Urinary Tract Infection 22-Feb-2006 08:30 AM Page: 671 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/06/00ISR Number: 3484232-5Report Type:Expedited (15-DaCompany Report #00-03-0139 Age:67 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 125MG ORAL Date:04/06/00ISR Number: 3484235-0Report Type:Expedited (15-DaCompany Report #00-03-0133 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 6-25MG ORAL Date:04/06/00ISR Number: 3484291-XReport Type:Periodic Company Report #99-12-0444 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukocytosis Health Clozapine - Zenith Pharyngitis Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 400MG ORAL Tylenol C Paxil C Zyprexa C Date:04/06/00ISR Number: 3484292-1Report Type:Periodic Company Report #99-12-0452 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Parotid Gland Enlargement Health Clozapine - Zenith Salivary Hypersecretion Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 500MG ORAL Ativan C Lorazepam C Date:04/06/00ISR Number: 3484293-3Report Type:Periodic Company Report #99-12-0464 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Insomnia Health Clozapine - Zenith Logorrhoea Professional Goldline Pharm. Mania Tablets PS Zenith Goldline Restlessness Pharm. ORAL 100-300MG ORAL Clonazepam C Mellaril C 22-Feb-2006 08:30 AM Page: 672 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/06/00ISR Number: 3484294-5Report Type:Periodic Company Report #00-01-0005 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dermatitis Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 125-225MG ORAL Date:04/06/00ISR Number: 3484295-7Report Type:Periodic Company Report #00-01-0007 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Delusion Health Clozapine - Zenith Drooling Professional Goldline Pharm. Hallucination Tablets PS Zenith Goldline Pharm. ORAL 150-600MG ORAL Date:04/06/00ISR Number: 3484296-9Report Type:Periodic Company Report #00-01-0007 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Delusion Health Clozapine - Zenith Drooling Professional Goldline Pharm. Hallucination Tablets PS Zenith Goldline Pharm. ORAL 150-600MG ORAL Date:04/06/00ISR Number: 3484297-0Report Type:Periodic Company Report #00-01-0012 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatitis Infectious Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 350-650MG ORAL Metoclopramide C Peri-Colace C Allegra D C Glyburide C Omeprazole C Mesoridazine Besilate C Multivitamins C Date:04/06/00ISR Number: 3484298-2Report Type:Periodic Company Report #00-01-0018 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hormone Level Abnormal Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 900MG ORAL Hormonal Contraceptive For 22-Feb-2006 08:30 AM Page: 673 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Systemic Use C Date:04/06/00ISR Number: 3484299-4Report Type:Periodic Company Report #06-01-0019 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Health Clozapine - Zenith Emotional Disorder Professional Goldline Pharm. Suspiciousness Tablets PS Zenith Goldline Pharm. ORAL 550MG ORAL Zoloft C Depakote C Date:04/06/00ISR Number: 3484300-8Report Type:Periodic Company Report #00-01-0030 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Face Oedema Health Clozapine - Zenith Oedema Peripheral Professional Goldline Pharm. Weight Increased Tablets PS Zenith Goldline Pharm. ORAL 200MG ORAL Lotensin C Date:04/06/00ISR Number: 3484301-XReport Type:Periodic Company Report #00-01-0032 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dermatitis Health Clozapine - Zenith Psychotic Disorder Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 75-400MG ORAL Date:04/06/00ISR Number: 3484302-1Report Type:Periodic Company Report #00-01-0034 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Health Clozapine - Zenith Drug Level Above Professional Goldline Pharm. Therapeutic Tablets PS Zenith Goldline Pharm. Cipro Tablets SS Date:04/06/00ISR Number: 3484303-3Report Type:Periodic Company Report #00-01-0035 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 25MG ORAL 22-Feb-2006 08:30 AM Page: 674 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/06/00ISR Number: 3484304-5Report Type:Periodic Company Report #00-01-0042 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amnesia Health Clozapine - Zenith Fatigue Professional Goldline Pharm. Movement Disorder Tablets PS Zenith Goldline Weight Increased Pharm. ORAL 350MG ORAL Clozaril SS ORAL ORAL Prozac C Lamictal C Date:04/06/00ISR Number: 3484305-7Report Type:Periodic Company Report #00-02-0046 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypotension Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 600-650MG ORAL Glyburide C Metformin C Haldol C Atenolol C Date:04/06/00ISR Number: 3484306-9Report Type:Periodic Company Report #00-02-0048 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eye Movement Disorder Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 800-900MG ORAL Clozaril SS ORAL 900MG ORAL Cogentin C Date:04/06/00ISR Number: 3484307-0Report Type:Periodic Company Report #00-02-0052 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pyrexia Health Clozapine - Zenith Thrombocythaemia Professional Goldline Pharm. White Blood Cell Count Tablets PS Zenith Goldline Increased Pharm. ORAL 25-50MG ORAL Date:04/06/00ISR Number: 3484308-2Report Type:Periodic Company Report #00-02-0063 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pain In Extremity Health Clozapine - Zenith Weight Increased Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 150-300MG ORAL 22-Feb-2006 08:30 AM Page: 675 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/06/00ISR Number: 3484309-4Report Type:Periodic Company Report #00-02-0068 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sedation Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 250MG ORAL Thorazine C Klonopin C Propranolol C Glyburide C Paxil C Lescol C Ferrous Sulfate C Depakote C Date:04/06/00ISR Number: 3484310-0Report Type:Periodic Company Report #00-02-0069 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Mania Clozapine - Zenith Goldline Pharm. Tablets PS ORAL 500-600MG ORAL Date:04/06/00ISR Number: 3484311-2Report Type:Periodic Company Report #00-02-0061 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 475MG ORAL Date:04/06/00ISR Number: 3484967-4Report Type:Periodic Company Report #00-02-0064 Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bronchitis Health Clozapine - Zenith Pneumonia Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 100MG ORAL Date:04/06/00ISR Number: 3484968-6Report Type:Periodic Company Report #00-02-0072 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Clozapine - Zenith Confusional State Goldline Pharm. Schizophrenia Tablets PS Zenith Goldline Pharm. ORAL 700MG ORAL 22-Feb-2006 08:30 AM Page: 676 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/06/00ISR Number: 3484969-8Report Type:Periodic Company Report #99-09-0310 Age:81 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Health Clozapine - Zenith Cardiac Failure Professional Goldline Pharm. Congestive Tablets PS Zenith Goldline Parkinson'S Disease Pharm. ORAL 6.2 - 18.7/MG ORAL Amantadine C Sinemet C Lanoxin C Norvasc C Sorbitol C Sinemet Cr C Neurontin C Date:04/06/00ISR Number: 3484970-4Report Type:Periodic Company Report #99-09-0322 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 450-475MG ORAL Zoloft C Celex C Date:04/06/00ISR Number: 3484971-6Report Type:Periodic Company Report #99-09-0337 Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pulmonary Embolism Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm ORAL 400-500MG ORAL 1 YR Buspar C Zoloft C Date:04/06/00ISR Number: 3484972-8Report Type:Periodic Company Report #99-10-0352 Age:56 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Pneumonia Health Clozapine - Zenith Hospitalization - Professional Goldline Pharm. Initial or Prolonged Tablets PS Zenith Goldline Pharm ORAL 500MG-ORAL Lithium C Vitamin E C Artane C 22-Feb-2006 08:30 AM Page: 677 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/06/00ISR Number: 3484973-XReport Type:Periodic Company Report #99-10-0372 Age:89 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm ORAL 12.5MG ORAL Sinemet 25/100 C Date:04/06/00ISR Number: 3484974-1Report Type:Periodic Company Report #99-11-0395 Age:56 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozapine - Zenith Hospitalization - Pneumonia Professional Goldline Pharm. Initial or Prolonged Sepsis Tablets PS Zenith Goldline Required Pharm ORAL 50-400MG ORAL Intervention to Anafranil C Prevent Permanent Risperdal C Impairment/Damage Paxil C Haldol C Buspar C Neupogen C Depakote C Date:04/06/00ISR Number: 3484976-5Report Type:Periodic Company Report #99-11-0411 Age:71 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pulmonary Embolism Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm ORAL 300-350MG ORAL Date:04/06/00ISR Number: 3484977-7Report Type:Periodic Company Report #99-11-0415 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiac Failure Health Clozapine - Zenith Hospitalization - Leukopenia Professional Goldline Pharm. Initial or Prolonged Pneumonia Tablets PS Zenith Goldline Pharm ORAL 600-700MG ORAL Serax C Eskalith C Date:04/06/00ISR Number: 3484978-9Report Type:Periodic Company Report #99-11-0416 Age:47 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pulmonary Embolism Health Clozapine - Zenith Initial or Prolonged Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 400-500MG ORAL Paxil C 22-Feb-2006 08:30 AM Page: 678 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Depakote C Insulin C Date:04/06/00ISR Number: 3484979-0Report Type:Periodic Company Report #99-11-0418 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 700MG ORAL Depakote C Klonopin C Date:04/06/00ISR Number: 3484980-7Report Type:Periodic Company Report #99-11-0421 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 400MG ORAL Tegretol C Date:04/06/00ISR Number: 3484981-9Report Type:Periodic Company Report #99-12-0448 Age:69 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS ORAL 500MG ORAL Date:04/06/00ISR Number: 3484982-0Report Type:Periodic Company Report #00-01-0003 Age:74 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 125-325MG ORAL Date:04/06/00ISR Number: 3484983-2Report Type:Periodic Company Report #99-11-0425 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Psychotic Disorder Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 75MG/DAY ORAL 22-Feb-2006 08:30 AM Page: 679 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/06/00ISR Number: 3484984-4Report Type:Periodic Company Report #99-12-0432 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukocytosis Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 350-375MG ORAL Date:04/06/00ISR Number: 3484985-6Report Type:Periodic Company Report #99-12-0442 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Irritable Bowel Syndrome Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 400MG ORAL Date:04/06/00ISR Number: 3484986-8Report Type:Periodic Company Report #99-12-0443 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Coordination Abnormal Health Clozapine Tablets - Lethargy Professional Zenith Goldline Speech Disorder Pharm. PS Zenith Goldline Pharm. ORAL 25MG ORAL Clozaril Tablets SS ORAL 100MG ORAL Prolixin Capsules C Efexor C Artane C Depakote C Ativan C Buspar C Date:04/06/00ISR Number: 3487117-3Report Type:Periodic Company Report #00-01-0011 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozapine - Zenith Hospitalization - Pyrexia Professional Goldline Pharm. Initial or Prolonged Tablets PS Zenith Goldline Pharm. ORAL 200-350 MG, ORAL Date:04/06/00ISR Number: 3487118-5Report Type:Periodic Company Report #00-01-0014 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Activated Partial Health Clozapine - Zenith Initial or Prolonged Thromboplastin Time Professional Goldline Pharm. Prolonged Tablets PS Zenith Goldline Pneumonia Pharm. ORAL 500-775MG Thrombocytopenia ORAL Vistaril C 22-Feb-2006 08:30 AM Page: 680 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/06/00ISR Number: 3487119-7Report Type:Periodic Company Report #00-01-0017 Age:84 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine Tablets - Professional Zenith Goldline Pharm. PS Zenith Goldline Pharm. ORAL 25MG, ORAL Date:04/06/00ISR Number: 3487120-3Report Type:Periodic Company Report #00-01-0023 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Health Clozapine - Zenith Initial or Prolonged Professional Goldline Pharm. Tablets PS Goldline Pharm. ORAL 350MG, ORAL Date:04/06/00ISR Number: 3487121-5Report Type:Periodic Company Report #00-01-0026 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozapine Tablets - Professional Zenith Goldline Pharm. PS Goldline Pharm. ORAL 175 MG, ORAL Risperdal C Depakote C Vancenase Nasal Spray C Albuterol Inhalation C Reglan C Lasix C Ferrous Sulfate C Colace C Azmacort C Date:04/06/00ISR Number: 3487122-7Report Type:Periodic Company Report #00-01-0027 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 25-600MG ORAL Depakote C Dilantin C Date:04/06/00ISR Number: 3487123-9Report Type:Periodic Company Report #00-01-0029 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 25-500MG ORAL 22-Feb-2006 08:30 AM Page: 681 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/06/00ISR Number: 3487126-4Report Type:Periodic Company Report #00-01-0031 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pericardial Effusion Health Clozapine - Zenith Initial or Prolonged Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 200-600MG ORAL Date:04/06/00ISR Number: 3487128-8Report Type:Periodic Company Report #00-01-0037 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Clozapine - Zenith Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 500-650MG ORAL Date:04/06/00ISR Number: 3487131-8Report Type:Periodic Company Report #00-01-0038 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Clozapine - Zenith Congestive Professional Goldline Pharm. Leukocytosis Tablets PS Zenith Goldline Staphylococcal Sepsis Pharm. ORAL 12.5-200MG ORAL Metronidazone C Vancomycin C Coumadin C Date:04/06/00ISR Number: 3487135-5Report Type:Periodic Company Report #00-01-0039 Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Clozapine - Zenith Congestive Professional Goldline Pharm. Pneumonia Tablets PS Zenith Goldline Pharm. ORAL 6.2-12.5MG ORAL Date:04/06/00ISR Number: 3487136-7Report Type:Periodic Company Report #00-01-0041 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 225MG ORAL 22-Feb-2006 08:30 AM Page: 682 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/06/00ISR Number: 3487138-0Report Type:Periodic Company Report #00-02-0044 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Clozapine - Zenith Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL ORAL Date:04/06/00ISR Number: 3487141-0Report Type:Periodic Company Report #00-02-0047 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pulmonary Embolism Health Clozapine - Zenith Initial or Prolonged Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 400MG ORAL Coumadin C Lovenox C Date:04/06/00ISR Number: 3487142-2Report Type:Periodic Company Report #00-02-0053 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Phlebitis Health Clozapine - Zenith Initial or Prolonged Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 400MG ORAL Ortho Cyclen C Date:04/06/00ISR Number: 3487143-4Report Type:Periodic Company Report #00-02-0054 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Vomiting Health Clozapine - Zenith Initial or Prolonged Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 500-800MG ORAL Date:04/06/00ISR Number: 3487145-8Report Type:Periodic Company Report #00-02-0055 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Angina Pectoris Clozapine Tablets - Initial or Prolonged Chest Pain Zenith Goldline Electrocardiogram Pharm. PS Zenith Goldline Abnormal Pharm. ORAL 25-50MG ORAL Date:04/06/00ISR Number: 3487146-XReport Type:Periodic Company Report #00-02-0056 Age:69 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Parkinson'S Disease Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 25MG ORAL 22-Feb-2006 08:30 AM Page: 683 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/06/00ISR Number: 3487147-1Report Type:Periodic Company Report #00-02-0058 Age:78 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Clozapine - Zenith Initial or Prolonged Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 25MG ORAL Parlodel C Cogentin C Miacalcin C Date:04/06/00ISR Number: 3487149-5Report Type:Periodic Company Report #00-02-0059 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Health Clozapine - Zenith Initial or Prolonged Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL ORAL Date:04/06/00ISR Number: 3487157-4Report Type:Periodic Company Report #99-09-0313 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Urinary Incontinence Health Clozapine - Zenith Initial or Prolonged Professional Goldline Pharm. Tablets PS ORAL 125MG ORAL Date:04/06/00ISR Number: 3487159-8Report Type:Periodic Company Report #99-11-0420 Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bronchitis Health Clozapine-Zenith Initial or Prolonged Professional Goldline Pharm Tablets PS ORAL 050-150MG ORAL Date:04/06/00ISR Number: 3487162-8Report Type:Periodic Company Report #99-11-0427 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Health Clozapine-Zenith Initial or Prolonged Hallucination, Visual Professional Goldline Pharm. Tardive Dyskinesia Tablets PS ORAL 300 MG ORAL Thinking Abnormal Lithium C Date:04/06/00ISR Number: 3487163-XReport Type:Periodic Company Report #99-11-0429 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Haematocrit Decreased Health Clozapine-Zenith Initial or Prolonged Haemoglobin Decreased Professional Goldline Pharm. Platelet Count Decreased Tablets PS ORAL 600 MG ORAL White Blood Cell Count Increased 22-Feb-2006 08:30 AM Page: 684 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/06/00ISR Number: 3487165-3Report Type:Periodic Company Report #99-12-0433 Age:88 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozapine -Zenith Parkinsonism Professional Goldline Pharm Tablets PS Zenith Goldline Pharm ORAL 12.5 MG ORAL Sinemet Cr C Tamoxifen C Requip 25mg C Date:04/06/00ISR Number: 3487166-5Report Type:Periodic Company Report #99-12-0434 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intestinal Obstruction Health Clozapine-Zenith Initial or Prolonged Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm ORAL 375 MG ORAL Date:04/06/00ISR Number: 3487168-9Report Type:Periodic Company Report #99-12-0435 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozapine-Zenith Professional Goldline Pharm PS Zenith Goldline Pharm ORAL 325-700 MG ORAL Neupogen C Date:04/06/00ISR Number: 3487170-7Report Type:Periodic Company Report #99-12-0438 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Health Clozapine -Zenith Initial or Prolonged Suicide Attempt Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm ORAL 500 MG ORAL Buspar C Date:04/06/00ISR Number: 3487172-0Report Type:Periodic Company Report #99-12-0439 Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Respiratory Failure Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm ORAL 450 MG ORAL Depakote C Furosemide C 22-Feb-2006 08:30 AM Page: 685 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/06/00ISR Number: 3487176-8Report Type:Periodic Company Report #99-12-0440 Age:99 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine Tablets - Professional Zenith Goldline Pharm. PS Zenith Goldline Pharm ORAL 75 MG ORAL Date:04/06/00ISR Number: 3487200-2Report Type:Periodic Company Report #99-12-0451 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozapine Tablets - Hospitalization - Cardiac Failure Professional Zenith Goldline Initial or Prolonged Congestive Pharm. PS Zenith Goldline Myocardial Infarction Pharm ORAL 600 MG ORAL Date:04/06/00ISR Number: 3487203-8Report Type:Periodic Company Report #99-12-0453 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Dyspnoea Health Clozapine - Zenith Hospitalization - Pulmonary Embolism Professional Goldline Pharm. Initial or Prolonged Pulmonary Infarction Tablets PS Zenith Goldline Pyrexia Pharm ORAL 600 MG ORAL Rhabdomyolysis Risperdal C Cogentin C Depakote C Date:04/06/00ISR Number: 3487206-3Report Type:Periodic Company Report #99-12-0458 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozapine Tablets - Constipation Professional Zenith Goldline Hallucination Pharm. PS Zenith Goldline Listless Pharm ORAL 100-300 MG Sedation ORAL Seroquel C Date:04/06/00ISR Number: 3487207-5Report Type:Periodic Company Report #99-12-0462 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drooling Health Clozapine Tablets - Initial or Prolonged Tremor Professional Zenith Goldline Urinary Incontinence Pharm. PS Zenith Goldline Pharm ORAL 700-800 MG /DAY ORAL Cogentin C Depakote C Neurontin C 22-Feb-2006 08:30 AM Page: 686 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/06/00ISR Number: 3487209-9Report Type:Periodic Company Report #99-12-0463 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Clozapine Tablets - Initial or Prolonged Congestive Zenith Goldline Pharm. PS ORAL 450 -600 MG ORAL Date:04/06/00ISR Number: 3487210-5Report Type:Periodic Company Report #99-12-0465 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Health Clozapine Tablets - Initial or Prolonged White Blood Cell Count Professional Zenith Goldline Decreased Pharm. PS Zenith Goldline Pharm ORAL 150 MG ORAL Seroquel C Date:04/06/00ISR Number: 3487214-2Report Type:Periodic Company Report #99-12-0466 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozapine-Zenith Professional Goldline Pharm. Tablets PS ORAL 25-175 MG ORAL Date:04/06/00ISR Number: 3487216-6Report Type:Periodic Company Report #00-01-0001 Age:81 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Clozapine Tablets - Initial or Prolonged Delusion Professional Zenith Goldline Hallucination Pharm. PS Zenith Goldline Pharm ORAL 25-75MG ORAL Amantadine C Furosemide C Date:04/06/00ISR Number: 3487219-1Report Type:Periodic Company Report #00-01-0006 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine Tablets - Professional Zenith Goldline Pharm. PS Zenith Goldline Pharm ORAL 350MG ORAL Date:04/06/00ISR Number: 3487220-8Report Type:Periodic Company Report #00-01-0009 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Health Clozapine Tablets - Initial or Prolonged Phosphokinase Increased Professional Zenith Goldline Delirium Pharm. PS Zenith Goldline Hypertonia Pharm ORAL 400 MG ORAL Pyrexia Depakote C 22-Feb-2006 08:30 AM Page: 687 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/06/00ISR Number: 3487276-2Report Type:Periodic Company Report #00-02-0071 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Health Clozapine-Zenith Paranoia Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 175-200MG ORAL Date:04/06/00ISR Number: 3487278-6Report Type:Periodic Company Report #00-02-0073 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperlipidaemia Health Clozapine - Zenith Schizophrenia Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 900MG ORAL Loxitane C Neurontin C Date:04/06/00ISR Number: 3487279-8Report Type:Periodic Company Report #99-08-0263 Age:39 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Parotid Gland Enlargement Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 100-125MG / QD ORAL Depakote C Paxil C Date:04/06/00ISR Number: 3487280-4Report Type:Periodic Company Report #99-08-0270 Age:46 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Health Clozapine - Zenith Confusional State Professional Goldline Pharm. Constipation Tablets PS Zenith Goldline Coordination Abnormal Pharm. ORAL 200MG / QD Drug Level Above ORAL Therapeutic Effexor C Lethargy Desyrel C Migraine Ambien C Muscular Weakness Clonidine C Myalgia Vicodin C Nausea Senokot C Pharyngolaryngeal Pain Photophobia Pyrexia Salivary Hypersecretion 22-Feb-2006 08:30 AM Page: 688 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/06/00ISR Number: 3487282-8Report Type:Periodic Company Report #99-08-0278 Age:84 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Psychotic Disorder Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL ORAL Neurontin C Date:04/06/00ISR Number: 3487284-1Report Type:Periodic Company Report #99-09-0319 Age:64 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tremor Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 12.5MG ORAL Risperdal C Zestril C Aricept C Date:04/06/00ISR Number: 3487286-5Report Type:Periodic Company Report #99-10-0353 Age:37 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Salivary Hypersecretion Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 600MG ORAL Date:04/06/00ISR Number: 3487290-7Report Type:Periodic Company Report #99-10-0356 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Corneal Oedema Health Clozapine - Zenith Eye Irritation Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 300-400MG ORAL Date:04/06/00ISR Number: 3487291-9Report Type:Periodic Company Report #99-10-0377 Age:36 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukocytosis Health Clozapine - Zenith Tooth Abscess Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 375MG ORAL Depakote C Lithium C 22-Feb-2006 08:30 AM Page: 689 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/06/00ISR Number: 3487293-2Report Type:Periodic Company Report #99-11-0386 Age:38 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Clozapine - Zenith Sinus Tachycardia Professional Goldline Pharm. Syncope Tablets PS Zenith Goldline Pharm. ORAL 2500-300MG ORAL Promethazine C Date:04/06/00ISR Number: 3487315-9Report Type:Periodic Company Report #99-11-0389 Age:27 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diarrhoea Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 150MG ORAL Date:04/06/00ISR Number: 3487319-6Report Type:Periodic Company Report #99-11-0396 Age:77 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pain Health Clozapine - Zenith Psychotic Disorder Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 12.5-18MG ORAL Date:04/06/00ISR Number: 3487322-6Report Type:Periodic Company Report #99-11-0401 Age:54 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypotension Health Clozapine - Zenith Leukopenia Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 12.5-175MG ORAL Simethicone C Sorbitol C Docusate C Date:04/06/00ISR Number: 3487325-1Report Type:Periodic Company Report #99-11-0406 Age:23 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 100-400MG ORAL Lithium C 22-Feb-2006 08:30 AM Page: 690 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/07/00ISR Number: 3485453-8Report Type:Expedited (15-DaCompany Report #N/00/00562/LEX Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Polyneuropathy Foreign Leponex (Clozapine) PS ORAL 800 MG, ORAL; Health Haldol (Haloperidol) C Professional Cisordinol Other (Clopenthixol Hydrochloride) C Largactil (Chlorpromazine Hydrochloride) C Glucophage (Metformin Hydrochloride) C Tegretol (Carbamazepine) C Efexor (Venlafaxine Hydrochloride) C Akineton (Biperiden Hydrochloride) C Amaryl (Glimepiride) C Flunipam (Flunitrazepam) C Sobril (Oxazepam) C Rivotril (Clonazepam) C Flux (Sodium Fluoride) C B 12 (Cyanocobalamin) C Cosylan Mix (Cosylan) C Paracet (Paracetamol) C Date:04/07/00ISR Number: 3485800-7Report Type:Expedited (15-DaCompany Report #USA/00/00922/LEX Age:89 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Health Clozaril (Clozapine) PS ORAL 500 MG, Initial or Prolonged Hypotension Professional OTHER, ORAL Required Medication Error Intervention to Overdose Prevent Permanent Renal Failure Acute Impairment/Damage Date:04/07/00ISR Number: 3485801-9Report Type:Expedited (15-DaCompany Report #RA/00/00910/LEX Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hiccups Foreign Lapenax (Clozapine) PS ORAL 25 MG, ORAL Initial or Prolonged Health Required Professional Intervention to Prevent Permanent Impairment/Damage 22-Feb-2006 08:30 AM Page: 691 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/07/00ISR Number: 3485810-XReport Type:Expedited (15-DaCompany Report #USA/00/00084/LEX Age:50 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lymphoma Health Clozaril (Clozapine) PS ORAL 825 MG, ORAL Life-Threatening White Blood Cell Disorder Professional Hospitalization - Initial or Prolonged Disability Date:04/07/00ISR Number: 3485812-3Report Type:Expedited (15-DaCompany Report #GB/00/00276/LEX Age:56 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bronchopneumonia Foreign Clozaril (Clozapine) PS ORAL 300 MG, ORAL Hospitalization - Coma Study Senna C Initial or Prolonged Dizziness Health Flomax C Required Headache Professional Intervention to Hyperhidrosis Prevent Permanent Hypotension Impairment/Damage Left Ventricular Failure Malaise Nausea Pain Pneumonia Pulmonary Oedema Pyrexia Respiratory Disorder Respiratory Rate Increased Sedation Date:04/07/00ISR Number: 3485813-5Report Type:Expedited (15-DaCompany Report #IRL/00/00271/LEX Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Circulatory Collapse Foreign Clozaril (Clozapine) PS ORAL 500 MG, ORAL Initial or Prolonged Constipation Health Faecaloma Professional Intestinal Perforation Respiratory Arrest Shock Date:04/07/00ISR Number: 3485814-7Report Type:Expedited (15-DaCompany Report #USA/00/00292/LEX Age:43 YR Gender:Male I/FU:F Outcome PT Death Abdominal Pain Life-Threatening Agitation Hospitalization - Bradycardia Initial or Prolonged Cardiac Arrest Cardiomyopathy Coma Coronary Artery Disease Drug Level Above Therapeutic Dyspnoea Hepatic Congestion Hyperventilation 22-Feb-2006 08:30 AM Page: 692 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Influenza Like Illness Loss Of Consciousness Overdose Report Source Product Role Manufacturer Route Dose Duration Pulmonary Oedema Health Clozaril (Clozapine) PS ORAL 300 MG, OTHER Respiratory Depression Professional , ORAL Vomiting Date:04/07/00ISR Number: 3485977-3Report Type:Expedited (15-DaCompany Report #AUS/00/00105/LEX Age:44 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Foreign Clozaril (Clozapine) PS 400 MG, Initial or Prolonged Congestive Health UNKNOWN, Required Dyspnoea Professional Warfarin (Warfarin) C Intervention to Hypertension Keflex (Cefalexin Prevent Permanent Influenza Like Illness Monohydrate) C Impairment/Damage Malaise Bricanyl Medication Error (Terbutaline Myocarditis Sulfate) C Renal Failure Acute Respiratory Rate Increased Right Ventricular Failure Tachycardia Vomiting Date:04/07/00ISR Number: 3485979-7Report Type:Expedited (15-DaCompany Report #D/00/00122/LEX Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Test Abnormal Foreign Leponex (Clozapine) PS 550 MG, Leukocytosis Health OTHER, Lymphoma Professional Diazepam (Diazepam) C Date:04/07/00ISR Number: 3485980-3Report Type:Expedited (15-DaCompany Report #GB/00/00294/LEX Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Pain Foreign Clozaril (Clozapine) PS ORAL 450 MG, ONCE Hospitalization - Agitation Health A DAY ORAL Initial or Prolonged Arrhythmia Professional Droperidol Conduction Disorder (Droperidol) SS ORAL 5 MG, FOUR Constipation TIMES A DAY, Drug Interaction UNKNOWN, 5 Gastrointestinal Disorder MG, THREE Intestinal Obstruction TIMES A DAY, Vomiting Cefuroxime (Cefuroxime) C Metronidazole (Metronidazole) C Heparin (Heparin) C Calcium (Calcium) C 22-Feb-2006 08:30 AM Page: 693 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/07/00ISR Number: 3485982-7Report Type:Expedited (15-DaCompany Report #GB/00/00279/LEX Age:61 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Circulatory Collapse Foreign Clozaril (Clozapine) PS ORAL 100 MG, Constipation Study UNKNOWN, Diaphragmatic Hernia Health ORAL Dyspnoea Professional Quetiapine Intestinal Obstruction (Quetiapine) C Date:04/07/00ISR Number: 3485987-6Report Type:Expedited (15-DaCompany Report #AUS/00/00600/LEX Age:67 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Fall Foreign Clozaril (Clozapine) PS ORAL 50 MG, ONCE A Hypotension Health DAY, ORAL Professional Date:04/07/00ISR Number: 3486162-1Report Type:Expedited (15-DaCompany Report #AUS/00/00294/LEX Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Condition Aggravated Foreign Clozaril (Clozapine) PS ORAL ORAL Convulsion Study Epilepsy Health Ganglioneuroma Professional Schizophrenia Date:04/07/00ISR Number: 3486163-3Report Type:Expedited (15-DaCompany Report #GB/00/00383/LEX Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Haematemesis Foreign Clozaril (Clozapine) PS ORAL 300 MG, ORAL Initial or Prolonged Oesophagitis Health Gaviscon (Gaviscon) C Professional Lansoprazole (Lansoprazole) C Cyclizine (Cyclizine) C Date:04/07/00ISR Number: 3486164-5Report Type:Expedited (15-DaCompany Report #GB/00/00369/LEX Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arthritis Bacterial Foreign Clozaril (Clozapine) PS ORAL 750 MG, ORAL Initial or Prolonged Cellulitis Health Required Sepsis Professional Intervention to Prevent Permanent Impairment/Damage Date:04/10/00ISR Number: 3486059-7Report Type:Expedited (15-DaCompany Report #USA/00/00950/LEX Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukaemia Health Clozaril (Clozapine) PS ORAL 400 MG, ORAL Leukocytosis Professional Zoloft C Trazodone C 22-Feb-2006 08:30 AM Page: 694 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Seroquel C Date:04/10/00ISR Number: 3486062-7Report Type:Expedited (15-DaCompany Report #USA/00/00951/LEX Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozaril (Clozapine) PS ORAL 300 MG, ORAL Professional Date:04/10/00ISR Number: 3486064-0Report Type:Expedited (15-DaCompany Report #SF/00/00019/LEX Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Toxicity Foreign Leponex (Clozapine) PS ORAL 300 MG, ORAL Liver Disorder Health Chlorpromazine C Myocardial Fibrosis Professional Zopiclon C Overdose Other Trazodon C Sleep Disorder Weight Decreased Date:04/11/00ISR Number: 3486634-XReport Type:Expedited (15-DaCompany Report #S/91/00292/LEX Age:59 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arteriosclerosis Foreign Leponex (Clozapine) PS 300 MG, Atelectasis Health OTHER, Benign Prostatic Professional Cisordinol Hyperplasia Other (Clopenthixol Cardiomegaly Hydrochloride) C Cystitis Dyspnoea Fatigue Haemorrhage Hepatosplenomegaly Myocardial Infarction Pulmonary Embolism Pulmonary Oedema Pyrexia Salivary Hypersecretion Tachycardia Date:04/11/00ISR Number: 3486637-5Report Type:Expedited (15-DaCompany Report #USA/00/00980/LEX Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Health Clozaril (Clozapine) PS ORAL 100 MG, ONCE Initial or Prolonged Insulin-Dependent Professional A DAY ORAL Required Diabetic Ketoacidosis Fluphenazine Intervention to Haemoglobinaemia Decanoate Prevent Permanent Hyperglycaemia (Fluphenazine Impairment/Damage Decanoate) C Ranitidine (Ranitidine) C Atenolol C Olanzapine C 22-Feb-2006 08:30 AM Page: 695 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/12/00ISR Number: 3487333-0Report Type:Expedited (15-DaCompany Report #10336519 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Level Above Health Buspar Tabs Therapeutic Professional (Buspirone Hcl) PS ORAL ORAL Drug Toxicity Anafranil Hepatic Congestion (Clomipramine) SS ORAL 150 Pulmonary Congestion MILLIGRAM, Spleen Disorder 1/1 DAY ORAL Clozaril (Clozapine) SS ORAL ORAL Luvox (Fluvoxamine) SS ORAL ORAL Date:04/12/00ISR Number: 3487569-9Report Type:Expedited (15-DaCompany Report #HQ2540110APR2000 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Health Ativan Tablet PS ORAL ORAL Initial or Prolonged Convulsion Professional Clozaril SS ORAL ORAL Drug Withdrawal Syndrome Cardura C Luvox C Vasotec C Zantac C Date:04/12/00ISR Number: 3487599-7Report Type:Expedited (15-DaCompany Report #S/98/00042/LEX Age:37 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diarrhoea Foreign Leponex (Clozapine) PS ORAL 300 MG; ORAL Initial or Prolonged Face Oedema Health Imovane (Zopiclone) C Required Gastroenteritis Professional Intervention to Jugular Vein Thrombosis Other Prevent Permanent Lymphadenopathy Impairment/Damage Neuroleptic Malignant Syndrome Oedema Pyrexia Sepsis Vomiting Date:04/12/00ISR Number: 3487601-2Report Type:Expedited (15-DaCompany Report #USA/00/00922/LEX Age:89 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Health Clozaril (Clozapine) PS ORAL 500 MG, Initial or Prolonged Hypotension Professional OTHER, ORAL Required Medication Error Intervention to Overdose Prevent Permanent Renal Failure Acute Impairment/Damage Date:04/12/00ISR Number: 3487602-4Report Type:Expedited (15-DaCompany Report #GB/00/00391/LEX Age:34 YR Gender:Male I/FU:I Outcome Hospitalization - Initial or Prolonged Required 22-Feb-2006 08:30 AM Page: 696 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Intervention to Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Lymphoma Foreign Clozaril (Clozapine) PS ORAL 200 MG, ORAL Health Professional Other Date:04/13/00ISR Number: 3487551-1Report Type:Expedited (15-DaCompany Report #00-02-0095 Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chronic Obstructive Health Clozapine - Zenith Initial or Prolonged Pulmonary Disease Professional Goldline Pharm. Leukocytosis Tablets PS Zenith Goldline Pneumonia Pharm. ORAL 450 MG ORAL Respiratory Failure Haldol C Wellbutrin C Cogentin C Date:04/13/00ISR Number: 3487554-7Report Type:Expedited (15-DaCompany Report #00-02-0094 Age:87 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 12.5MG ORAL Ditropan C Prilosec C Lactulose C Dilantin C Arthrotec C Permax C Sinemet Cr C Date:04/13/00ISR Number: 3487626-7Report Type:Direct Company Report # Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Neutrophil Count Clozapine 100 Mg + Intervention to Decreased 25 Mg Tablets PS ORAL 100 MG Q AM Prevent Permanent White Blood Cell Count PO 250 Q HS Impairment/Damage Decreased PO Stelazine C Paxil C Depakote C Klonopin C Mvi C Dss C Pepcid C Atenolol C 22-Feb-2006 08:30 AM Page: 697 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/13/00ISR Number: 3487630-9Report Type:Direct Company Report # Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutrophil Count Clozapine 100 Mg & Initial or Prolonged Decreased 25mg Tablets PS ORAL 100 MG Q AM & Pyrexia 150MG PO HS White Blood Cell Count Stelazine C Decreased Cogentin C Date:04/13/00ISR Number: 3487633-4Report Type:Direct Company Report # Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Leukopenia Clozapine 100 Mg PS ORAL 200 MG BID PO Intervention to Neutropenia Paroxetine C Prevent Permanent Depokate C Impairment/Damage Mvi C Dss C Metamucil C Date:04/13/00ISR Number: 3487634-6Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Leukopenia Clozapine 100mg 3 Intervention to Neutropenia Bid PS ORAL 300 MG BID PO Prevent Permanent Mvi C Impairment/Damage Calcium Carbonate C Date:04/13/00ISR Number: 3487637-1Report Type:Direct Company Report # Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Leukopenia Clozapine 100 Mg Intervention to Neutropenia Tablets & 25 Mg Tabs PS ORAL 150 MG Q AM Prevent Permanent PO 550 MG Q Impairment/Damage HS PO Haldol C Depokate C Synthroid C Ephedrine C Cogentin C Calcium Carbonate C Ditropan C Ddavp C Dss C Date:04/13/00ISR Number: 3487919-3Report Type:Direct Company Report # Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diarrhoea Clozaril 100mg + Initial or Prolonged Intestinal Obstruction 25mg Tablets PS ORAL 375 MG PO QD Vomiting 22-Feb-2006 08:30 AM Page: 698 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/13/00ISR Number: 3488046-1Report Type:Expedited (15-DaCompany Report #GB/91/90484/LEX Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiomyopathy Foreign Clozaril (Clozapine) PS ORAL 250 MG, Sudden Death OTHER, ORAL Carbamazepine C Benzhexol C Date:04/13/00ISR Number: 3488071-0Report Type:Expedited (15-DaCompany Report #GB/00/00298/LEX Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Alkaline Foreign Clozaril (Clozapine) PS ORAL 125 MG, TWICE Required Phosphatase Increased Health A DAY ORAL; Intervention to C-Reactive Protein Professional 25 MG UNKNOWN Prevent Permanent Increased ORAL Impairment/Damage Cardiac Arrest Trifluoperazine Colitis (Trifluoperazine)- Diarrhoea Acne C Drug Hypersensitivity Paracetamol Eosinophilia (Paracetamol) C Extrasystoles Cefalexin Leukocytosis (Cefalexin) C Pyrexia Red Blood Cell Sedimentation Rate Increased Sinus Tachycardia Thrombocythaemia Vomiting Date:04/13/00ISR Number: 3488109-0Report Type:Expedited (15-DaCompany Report #AUS/00/00645/LEX Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Gas Gangrene Foreign Clozaril (Clozapine) PS ORAL ORAL Lower Respiratory Tract Study Infection Health Professional Date:04/13/00ISR Number: 3488125-9Report Type:Expedited (15-DaCompany Report #GB/90/00806/LEX Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiomyopathy Foreign Leponex (Clozapine) PS ORAL 250 MG, ORAL Health Benzhexol Professional (Trihexyphenidyl) SS 5 MG Carbamazepine (Carbamazepine) SS 1200 MG Date:04/13/00ISR Number: 3488151-XReport Type:Expedited (15-DaCompany Report #USA/00/00995/LEX Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Cancer Female Consumer Clozaril (Clozapine) PS ORAL 400 MG, ONCE Leukopenia A DAY, ORAL 22-Feb-2006 08:30 AM Page: 699 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/13/00ISR Number: 3488200-9Report Type:Expedited (15-DaCompany Report #USA/99/00331/LEX Age:56 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Delusion Health Clozaril (Clozapine) PS ORAL 2500 MG, ORAL Hospitalization - Differential White Blood Professional Zyprexa (Olanzapine) C Initial or Prolonged Cell Count Abnormal Klonopin Required Dysphagia (Clonazepam) C Intervention to Electrocardiogram Nembutal Prevent Permanent Abnormal (Pentobarbital Impairment/Damage Hallucination Sodium) C Hypertension Cognetin Leukocytosis (Benzatropine Neutrophilia Mesilate) C Overdose Stupor Suicide Attempt Tachycardia Date:04/13/00ISR Number: 3488224-1Report Type:Expedited (15-DaCompany Report #000201001 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Pain Foreign Droperidol PS 15 MG, DAILY Arrhythmia Health Droleptan SS Cardiac Disorder Professional Clozaril SS Constipation Cefuroxime C Drug Interaction Metronidazole C Intestinal Dilatation Heparin C Intestinal Obstruction Calcium C Sudden Death Vomiting Date:04/14/00ISR Number: 3488465-3Report Type:Direct Company Report # Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depressed Level Of Clozaril 25 Mg Initial or Prolonged Consciousness Novartis PS Novartis ORAL TITRATION Neuroleptic Malignant ORAL Syndrome Naltrexone C Pyrexia Tmp-Smx C Sedation Divalproate C Chlorpromazine C Date:04/14/00ISR Number: 3488699-8Report Type:Expedited (15-DaCompany Report #D/00/00448/LEX Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Foreign Leponex (Clozapine) PS ORAL 12.5 MG, ORAL Required Headache Health Fluanxol Depot Intervention to Hypertensive Crisis Professional (Flupentixol Prevent Permanent Dihydrochloride) C Impairment/Damage Risperdal (Risperidone) C 22-Feb-2006 08:30 AM Page: 700 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/14/00ISR Number: 3488703-7Report Type:Expedited (15-DaCompany Report #AUS/00/00114/LEX Age:33 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arteritis Foreign Clozaril (Clozapine) PS ORAL 775 MG, ORAL Initial or Prolonged Coordination Abnormal Health Sodium Valproate Dysarthria Professional (Valproate Sodium) C Neurological Symptom Pulmicort Nuclear Magnetic (Budesonide) C Resonance Imaging Citalopram Abnormal (Citalopram) C Aspirin (Acetylsalicylic Acid) C Date:04/14/00ISR Number: 3488707-4Report Type:Expedited (15-DaCompany Report #GB/00/00386/LEX Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Loss Of Consciousness Foreign Clozaril (Clozapine) PS ORAL ORAL Initial or Prolonged Health Haloperidol Professional (Haloperidol) C Procyclidine (Procyclidine) C Amiloride (Amiloride) C Frusemide (Frusemide) C Ramipril (Ramipril) C Date:04/14/00ISR Number: 3488709-8Report Type:Expedited (15-DaCompany Report #GB/00/00407/LEX Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Foreign Clozaril (Clozapine) PS ORAL 725MG, ORAL Initial or Prolonged Glycosuria Health Atenolol (Atenolol) C Ketoacidosis Professional Ketonuria Other Porphyria Non-Acute Thirst Date:04/17/00ISR Number: 3489096-1Report Type:Expedited (15-DaCompany Report #00-03-0124 Age:55 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anoxia Health Clozapine - Zenith Escherichia Sepsis Professional Goldline Pharm. Pneumonia Tablets PS ORAL 400MG ORAL Urinary Tract Infection Date:04/17/00ISR Number: 3489098-5Report Type:Expedited (15-DaCompany Report #00-01-0029 Age:52 YR Gender:Male I/FU:F Outcome PT Death Cardiac Arrest Coronary Artery Disease Cough Dyspnoea 22-Feb-2006 08:30 AM Page: 701 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Ecchymosis Endocardial Fibrosis Injury Report Source Product Role Manufacturer Route Dose Duration Leukocytosis Health Clozapine - Zenith Obesity Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 25-500MG ORAL Seroquel C Date:04/17/00ISR Number: 3489101-2Report Type:Expedited (15-DaCompany Report #00-02-0091 Age:73 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Distension Health Clozapine - Zenith Hospitalization - Abdominal Pain Professional Goldline Pharm. Initial or Prolonged Anaemia Tablets PS Zenith Goldline Constipation Pharm. ORAL 50MG ORAL Gastrointestinal Haemorrhage Gastrointestinal Ulcer Haemorrhage Ruptured Diverticulum Of Colon Sepsis Date:04/17/00ISR Number: 3489104-8Report Type:Expedited (15-DaCompany Report #00-03-0141 Age:79 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dementia Alzheimer'S Type Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 6.2-375MG ORAL Date:04/17/00ISR Number: 3489106-1Report Type:Expedited (15-DaCompany Report #00-03-0126 Age:68 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 300MG ORAL Lasix C Synthroid C Apap C Depakote C Risperdal C Date:04/17/00ISR Number: 3489108-5Report Type:Expedited (15-DaCompany Report #00-03-0129 Age:18 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Road Traffic Accident Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 125-450MG 22-Feb-2006 08:30 AM Page: 702 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL Date:04/17/00ISR Number: 3489109-7Report Type:Expedited (15-DaCompany Report #00-02-0070 Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Clozapine - Zenith Initial or Prolonged Convulsion Professional Goldline Pharm. Delirium Tablets PS Zenith Goldline Hyponatraemia Pharm. ORAL 125MG ORAL Leukocytosis Seroquel Tablets SS ORAL ORAL Lower Limb Fracture Risperdal Tablets SS ORAL ORAL Oxygen Saturation Prozac C Decreased Pneumonia Aspiration Psychotic Disorder Respiratory Distress Respiratory Failure Respiratory Rate Increased Date:04/17/00ISR Number: 3489110-3Report Type:Expedited (15-DaCompany Report #00-04-0160 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Huntington'S Chorea Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 600-750MG ORAL Date:04/17/00ISR Number: 3489112-7Report Type:Expedited (15-DaCompany Report #00-03-0103 Age:56 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 150-500MG ORAL Date:04/17/00ISR Number: 3489330-8Report Type:Expedited (15-DaCompany Report #2000UW01269 Age:41 YR Gender:Male I/FU:I Outcome PT Required Abdominal Pain Intervention to Anaemia Prevent Permanent Arthralgia Impairment/Damage Asthenia Back Pain Chest Pain Dehydration Dyspnoea Haemoglobin Decreased Headache Hypotension Leukocytosis Muscle Spasms 22-Feb-2006 08:30 AM Page: 703 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Neutrophilia Report Source Product Role Manufacturer Route Dose Duration Health Atenolol PS ORAL 50 MG BID PO Professional Clozaril SS ORAL 200 MG PO Seroquel C Depakote C Anafranil C Date:04/18/00ISR Number: 3489543-5Report Type:Expedited (15-DaCompany Report #GB/99/01051/LEX Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Catecholamines Urine Foreign Clozaril (Clozapine) PS ORAL 450 MG TWICE Initial or Prolonged Increased Health A DAY ORAL Diabetes Mellitus Professional Venlafaxine Hyperglycaemia (Venlafaxine) C Hyperhidrosis Sulpiride Hypertension (Sulpiride) C Tachycardia Date:04/18/00ISR Number: 3489604-0Report Type:Expedited (15-DaCompany Report #USA/00/00403/LEX Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abdominal Distension Health Clozaril (Clozapine) PS ORAL 250 MG, OTHER Hospitalization - Hepatic Function Abnormal Professional , ORAL Initial or Prolonged Hepatocellular Damage Docusate C Hepatotoxicity Metoclopramide C Hyperammonaemia Prilosec Liver Function Test (Omeprozole) C Abnormal Trazodone C Date:04/18/00ISR Number: 3489606-4Report Type:Expedited (15-DaCompany Report #USA/00/00821/LEX Age:48 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Oesophageal Carcinoma Health Clozaril (Clozapine) PS Professional Date:04/18/00ISR Number: 3489617-9Report Type:Expedited (15-DaCompany Report #AUS/00/00444/LEX Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alcoholism Foreign Clozaril (Clozapine) PS ORAL 750 MG ORAL Initial or Prolonged Cardiomyopathy Health Lithium (Lithium) C Dyspnoea Professional Vitamin B.C. Zinc Obesity (Vitamins) C Viral Infection Aporex (Aporex) C Diazepam (Diazepam) C Zoton (Lansoprazole) C 22-Feb-2006 08:30 AM Page: 704 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/18/00ISR Number: 3489619-2Report Type:Expedited (15-DaCompany Report #USA/00/00995/LEX Age:53 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Cancer Female Health Clozaril (Clozapine) PS ORAL 400 MG, ONCE Leukopenia Professional A DAY, ORAL Date:04/18/00ISR Number: 3489623-4Report Type:Expedited (15-DaCompany Report #AUS/00/00658/LEX Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Gastrointestinal Disorder Foreign Clozaril (Clozapine) PS ORAL 200 MG, ORAL Initial or Prolonged Leukocytosis Study Neutrophilia Health Surgery Professional Date:04/18/00ISR Number: 3489626-XReport Type:Expedited (15-DaCompany Report #USA/00/01023/LEX Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozaril (Clozapine) PS ORAL 300 MG, ORAL Hospitalization - Leukopenia Professional Tegretol C Initial or Prolonged Lung Neoplasm Malignant Disability Required Intervention to Prevent Permanent Impairment/Damage Date:04/18/00ISR Number: 3489628-3Report Type:Expedited (15-DaCompany Report #CDN/99/00064/LEX Age:38 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Complications Of Maternal Foreign Clozaril (Clozapine) PS ORAL 350 MG, ORAL 3 YR Initial or Prolonged Exposure To Therapeutic Health Syntocinon C Required Drugs Professional Intervention to Foetal Distress Syndrome Prevent Permanent Impairment/Damage Date:04/18/00ISR Number: 3489630-1Report Type:Expedited (15-DaCompany Report #USA/99/02392/LEX Age:59 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Multiple Myeloma Health Clozaril (Clozapine) PS ORAL 200 MG, TWICE Disability Professional A DAY, ORAL Paxil C Olanzapine C Chemotherapy C Date:04/19/00ISR Number: 3489782-3Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome Death Hospitalization - Initial or Prolonged 22-Feb-2006 08:30 AM Page: 705 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Required Intervention to Prevent Permanent PT Report Source Product Role Manufacturer Route Dose Duration Impairment/Damage Aspiration Clozapine 25mg & Cardio-Respiratory Arrest 100mg Novartis PS Novartis ORAL 450 MG DAILY Condition Aggravated ORAL Convulsion Valproic Acid Drug Ineffective Capsules 250mg Schein SS Schein ORAL 2250MG DAILY ORAL Synthroid C Risperidone C Calcium Carbonate C Vitamin D C Lactulose C Diphenhydramine C Cisapride C Citalopram C Prampro C Multivitamins C Date:04/19/00ISR Number: 3490489-7Report Type:Expedited (15-DaCompany Report #D/00/00477/LEX Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Atrioventricular Block Foreign Leponex (Clozapine) PS ORAL Cardiomyopathy Health Extrasystoles Professional Date:04/19/00ISR Number: 3490490-3Report Type:Expedited (15-DaCompany Report #S/00/00221/LEX Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pulmonary Embolism Foreign Leponex (Clozapine) PS 400 MG, Health Buspar (Buspirone Professional Hydrochloride) C Efexor (Venlafaxine Hydrochloride0 C Nozinan (Levomepromazine) C Alcohol C Date:04/19/00ISR Number: 3490492-7Report Type:Expedited (15-DaCompany Report #S/94/00007/LEX Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asthenia Foreign Leponex (Clozapine) PS 500 MG Required Cyanosis Health Androcur 900 Mg SS 900 MG Intervention to Fatigue Professional Hibernal Prevent Permanent Gastrointestinal Disorder (Chlorpromazine Impairment/Damage Myocarditis Hydrochloride) C Nasopharyngitis Haldol (Halperidol) C Pulmonary Embolism Disipal Pulmonary Thrombosis (Orphenadrine Respiratory Arrest Hydrochloride) C Sudden Death 22-Feb-2006 08:30 AM Page: 706 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/19/00ISR Number: 3490513-1Report Type:Expedited (15-DaCompany Report #00-03-0124 Age:55 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anoxia Health Clozapine-Zenith Escherichia Sepsis Professional Goldline Pharm. Pneumonia Tablets PS Zenith Goldline Urinary Tract Infection Pharm. ORAL 400 MG ORAL Premarin C Biaxin C Atrovent Ud C Proventil Solution C Ativan C Depakote C Date:04/19/00ISR Number: 3490516-7Report Type:Expedited (15-DaCompany Report #00-04-0162 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Gastrointestinal Health Clozapine-Zenith Other Haemorrhage Professional Goldline Pharm. Overdose Tablets PS Goldline Pharm. ORAL 700 MG ORAL Motrin Tablets SS ORAL ORAL Date:04/21/00ISR Number: 3490995-5Report Type:Expedited (15-DaCompany Report #USA/00/00778/LEX Age:42 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Abdominal Distension Health Clozaril (Clozapine) PS ORAL 100 MG, TWICE Other Ascites Professional A DAY, ORAL Required Diabetes Mellitus Lithium C Intervention to Hepatic Cirrhosis Lipitor C Prevent Permanent Aldactone C Impairment/Damage Depo-Provera C Folic Acid C Dulcolax C Rhinocort Nasal Spray C Date:04/21/00ISR Number: 3490996-7Report Type:Expedited (15-DaCompany Report #USA/00/01045/LEX Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Alcohol Poisoning Health Clozaril (Clozapine) PS ORAL 300 MG, Hospitalization - Coma Professional OTHER,ORAL Initial or Prolonged Dyspnoea Alcohol (Ethanol) SS ORAL UNKNOWN, ORAL Hypoventilation Loss Of Consciousness Respiratory Distress Date:04/21/00ISR Number: 3490997-9Report Type:Expedited (15-DaCompany Report #USA/00/00695/LEX Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Arrhythmia Health Clozaril (Clozapine) PS ORAL 125 MG, Other Cardiomyopathy Professional OTHER,ORAL; Weight Increased Lanoxin C 22-Feb-2006 08:30 AM Page: 707 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/21/00ISR Number: 3490998-0Report Type:Expedited (15-DaCompany Report #USA/00/00358/LEX Age:31 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Iron Decreased Health Clozaril (Clozapine) PS ORAL 200 MG, Hospitalization - Bronchitis Professional UNKNOWN; ORAL Initial or Prolonged Dehydration Lithobid (Lithium Drug Toxicity Carbonate) SS 600 MG, Eosinophil Count UNKNOWN Increased Depakote C Eosinophilia Ativan C Gait Disturbance Prolixin C Hypersensitivity Iron Metabolism Disorder Leukocytosis Myalgia Nausea Nephritis Interstitial Neuroleptic Malignant Syndrome Pyrexia Renal Failure Acute Vomiting Date:04/21/00ISR Number: 3491011-1Report Type:Expedited (15-DaCompany Report #D/00/00358/LEX Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Atherosclerosis Foreign Leponex (Clozapine) PS UNSPECIFIED Croup Infectious Health Inflammation Professional Myocarditis Pyrexia Viral Infection Date:04/21/00ISR Number: 3491031-7Report Type:Expedited (15-DaCompany Report #AUS/00/00248/LEX Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiomegaly Foreign Clozaril (Clozapine) PS ORAL 450 MG ORAL Ejection Fraction Health Abnormal Professional Electrocardiogram Abnormal Left Ventricular Failure Date:04/21/00ISR Number: 3491032-9Report Type:Expedited (15-DaCompany Report #AUS/00/00715/LEX Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypertrophic Obstructive Foreign Clozaril (Clozapine) PS ORAL 500 MG, TWICE Cardiomyopathy Health A DAY, ORAL; 2 DAY Professional Amitriptyline (Amitriptyline) C Diazepam (Diazepam) C 22-Feb-2006 08:30 AM Page: 708 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/21/00ISR Number: 3491033-0Report Type:Expedited (15-DaCompany Report #GB/00/00448/LEX Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiac Disorder Foreign Clozaril (Clozapine) PS ORAL 400 MG, ORAL; Cardiomegaly Health Cardiomyopathy Professional Electrocardiogram St Segment Elevation Electrocardiogram T Wave Inversion Fall Hypertrophic Obstructive Cardiomyopathy Syncope Ventricular Hypertrophy Date:04/21/00ISR Number: 3491380-2Report Type:Expedited (15-DaCompany Report #AUS/00/00189/LEX Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiomyopathy Foreign Clozaril (Clozapine) PS ORAL 400 MG, ORAL; Required Health Zoloft (Sertraline Intervention to Professional Hydrochloride) C Prevent Permanent Thyroxine Impairment/Damage (Levothyroxine Sodium) C Date:04/24/00ISR Number: 3491562-XReport Type:Expedited (15-DaCompany Report #USA/99/02577/LEX Age:31 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other No Adverse Drug Effect Health Clozaril (Clozapine) PS ORAL ORAL Professional Clozapine SS 650 MG, Peri-Colace C Allegra-D (Fexofenadine Hydrochloride) C Glyburide (Glibenclamide) C Metoclopramide (Metoclopramide C Milti-Vitamins (Multivitains) C Omeprazole C Mesoridazine Besilate (Mesoridazine Besilate) C Date:04/24/00ISR Number: 3491569-2Report Type:Expedited (15-DaCompany Report #AUS / 00 / 00521 / LEX Age:44 YR Gender:Female I/FU:F Outcome Hospitalization - Initial or Prolonged Required Intervention to Prevent Permanent 22-Feb-2006 08:30 AM Page: 709 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Cellulitis Foreign Clozaril (Clozapine) PS ORAL 550 MG, ORAL Staphylococcal Infection Health Epilim (Valproate Subcutaneous Abscess Professional Sodium) C Aropax (Paroxetine Hydrochloride) C Date:04/24/00ISR Number: 3491781-2Report Type:Expedited (15-DaCompany Report #USA/00/01128/LEX Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coma Health Clozaril (Clozapine) PS ORAL 200 MG, ONCE Hospitalization - Drug Abuser Professional A DAY ORAL Initial or Prolonged Overdose Cocaine SS UNSPECIFIED Stupor Valium (Diazepam) SS UNSPECIFIED Date:04/24/00ISR Number: 3491804-0Report Type:Expedited (15-DaCompany Report #GB/00/00204/LEX Age:30 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Duodenal Ulcer Foreign Clozaril (Clozapine) PS ORAL 500 MG, ONCE Initial or Prolonged Gastric Ulcer Perforation Health A DAY, ORAL Haematemesis Professional Lorazepam Leukocytosis (Lorazepam) C Oesophagitis Droperidol (Droperidol) C Date:04/24/00ISR Number: 3491805-2Report Type:Expedited (15-DaCompany Report #GB/00/00115/LEX Age:65 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amnesia Foreign Clozaril (Clozapine) PS Arrhythmia Health Blood Creatine Professional Phosphokinase Increased Cerebral Infarction Cerebrovascular Accident Coma Condition Aggravated Confusional State Depression Dysarthria Infarction Loss Of Consciousness Nervous System Disorder Refusal Of Treatment By Patient Sedation Date:04/24/00ISR Number: 3491818-0Report Type:Expedited (15-DaCompany Report #GB/00/00448/LEX Age:29 YR Gender:Male I/FU:F Outcome PT Other Cardiomegaly Cardiomyopathy 22-Feb-2006 08:30 AM Page: 710 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Electrocardiogram St Segment Elevation Electrocardiogram T Wave Report Source Product Role Manufacturer Route Dose Duration Inversion Foreign Clozaril (Clozapine) PS ORAL 400 MG, ORAL Fall Health Syncope Professional Date:04/24/00ISR Number: 3491819-2Report Type:Expedited (15-DaCompany Report #GB/00/00463/LEX Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril (Clozapine) PS ORAL 275 MG , ORAL Hyperglycaemia Health Professional Date:04/24/00ISR Number: 3491820-9Report Type:Expedited (15-DaCompany Report #CDN/00/00379/LEX Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiomyopathy Foreign Clozaril (Clozapine) PS ORAL ORAL Health Professional Date:04/24/00ISR Number: 3491821-0Report Type:Expedited (15-DaCompany Report #D/00/00375/LEX Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Rigidity Foreign Leponex (Clozapine) PS ORAL SEE IMAGE Hospitalization - Aspiration Health Truxal Initial or Prolonged Bronchopneumonia Professional (Chlorprothixene Required Cardiac Failure Hydrochloride) SS ORAL 100, 50 MG Intervention to Ileus Paralytic ORAL Prevent Permanent Respiratory Failure Gastrozepin Impairment/Damage (Pirenzepine Dihydrochloride) SS ORAL 50 MG, ORAL Delix (Ramipril) C Dytide H (Dyazide) C Amoxypen (Amoxicillin Trihydrate) C Date:04/26/00ISR Number: 3492337-8Report Type:Expedited (15-DaCompany Report #00-04-0163 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets - Professional Zenith Goldline Pharm. PS ORAL 550-600MG ORAL Date:04/26/00ISR Number: 3492338-XReport Type:Expedited (15-DaCompany Report #00-01-0028 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Leukocytosis Health Clozapine Tablets - Professional Zenith Goldline 22-Feb-2006 08:30 AM Page: 711 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pharm. PS ORAL 900MG ORAL Date:04/26/00ISR Number: 3492549-3Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Grand Mal Convulsion Clozaril 25 Mg Initial or Prolonged (Sandoz) PS Sandoz ORAL 25 MG PO QD Loxitane C Ativan C Seroquel C Date:04/27/00ISR Number: 3493805-5Report Type:Expedited (15-DaCompany Report #S00-USA-00553-01 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Embolism Health Celexa (Citalopram) PS Hospitalization - Pulmonary Thrombosis Professional Clozaril (Clozapine) SS ORAL 500 MG PO Initial or Prolonged Birth Control Pills (Oral Contraceptive Nos) SS Imipramine C Prolixin Decanoate C Amitriptyline C Prilosec C Azmacort C Albuterol Mdi C Date:04/28/00ISR Number: 3494020-1Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypotension Health Clozapine 25 Mg Tabs PS ORAL 75MG BID, PO Initial or Prolonged Syncope Professional Date:04/28/00ISR Number: 3494382-5Report Type:Expedited (15-DaCompany Report #00P-163-0089162-00(0) Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Overdose Health Depakote (Depakote) Initial or Prolonged Psychotic Disorder Professional (Divalproex Sodium) PS ORAL PER ORAL Suicide Attempt Other Clozapine (Clozapine) SS ORAL 500 MG, 1 IN 1 D, PER ORAL Buspirone Hydrochloride (Buspirone Hydrochloride) SS ORAL PER ORAL Clozapine (Clozapaine) SS Date:05/01/00ISR Number: 3494657-XReport Type:Expedited (15-DaCompany Report #AUS/00/00790/LEX Age:40 YR Gender:Male I/FU:I Outcome PT Other Cardiomyopathy Echocardiogram Abnormal 22-Feb-2006 08:30 AM Page: 712 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Left Ventricular Failure Myocardial Ischaemia Report Source Product Role Manufacturer Route Dose Duration Foreign Clozaril (Clozapine) PS ORAL UNSPECIFIED, Health UNKNOWN, ORAL Professional Date:05/01/00ISR Number: 3494659-3Report Type:Expedited (15-DaCompany Report #AUS/00/00781/LEX Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthma Foreign Clozaril (Clozapine) PS ORAL UNSPECIFIED, Bronchospasm Health UNKNOWN, ORAL Respiratory Disorder Professional Date:05/01/00ISR Number: 3494661-1Report Type:Expedited (15-DaCompany Report #USA/00/01177/LEX Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aneurysm Health Clozaril (Clozapine) PS ORAL 150 MG, ONCE Professional A DAY; ORAL Seroquel C Zoloft (Sertraline Hydrochloride) C Klonopin (Clonazepam) C Accupril (Quinapril Hydrochloride) C Potassium Supplement (Potassium) C Aldactazide (Aldactazide A) C Senokot (Senna Fruit) C Date:05/01/00ISR Number: 3494682-9Report Type:Expedited (15-DaCompany Report #USA/00/00615/LEX Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozaril (Clozapine) PS ORAL 450 MG, Life-Threatening Sudden Death Professional OTHER, ORAL Throat Cancer Depakote (Valproate Semisodium) C Risperidone C Atenolol C Date:05/01/00ISR Number: 3494683-0Report Type:Expedited (15-DaCompany Report #USA/00/01168/LEX Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Respiratory Failure Health Clozaril (Clozapine) PS ORAL 350 MG, ONCE Professional A DAY, ORAL; Celexa (Citalopram Hydrobromide) C Neurontin (Gabapentin) C Seroquel C 22-Feb-2006 08:30 AM Page: 713 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Eskalith Sr (Lithium Carbonate) C Remeron (Mirtazapine) C Verapamil C Augmentin (Clavulin) C Prilosec (Omeprazole) C Albuteral (Salbutamol) C Date:05/01/00ISR Number: 3494685-4Report Type:Expedited (15-DaCompany Report #USA/00/01163/LEX Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Health Clozaril (Clozapine) PS ORAL 500 MG, ORAL Non-Insulin-Dependent Professional Clonazepam C Lymphopenia Glipizide C Rheumatoid Arthritis Date:05/01/00ISR Number: 3494688-XReport Type:Expedited (15-DaCompany Report #USA/00/00951/LEX Age:58 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Health Clozaril (Clozapine) PS ORAL 300 MG, Life-Threatening Myocardial Infarction Professional OTHER, ORAL Throat Cancer Date:05/01/00ISR Number: 3494692-1Report Type:Expedited (15-DaCompany Report #USA/00/00995/LEX Age:53 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Cancer Female Health Clozaril (Clozapine) PS ORAL 400 MG, ONCE Required Leukopenia Professional A DAY, ORAL Intervention to Prevent Permanent Impairment/Damage Date:05/01/00ISR Number: 3495537-6Report Type:Expedited (15-DaCompany Report #00USA10520 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Level Above Health Anafranil Capsule Therapeutic Professional (Clomipramine Drug Toxicity Other Hydrochloride) PS ORAL DAILY ORAL Dyspnoea Clozapine Tablet Leukocytosis (Clozapine) SS ORAL 750 MG DAILY ORAL Co-Medication Nos C Date:05/02/00ISR Number: 3495222-0Report Type:Expedited (15-DaCompany Report #00-03-0101 Age:78 YR Gender:Male I/FU:F Outcome PT Death Cerebral Haemorrhage Traumatic 22-Feb-2006 08:30 AM Page: 714 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Coma Fall Report Source Product Role Manufacturer Route Dose Duration Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharmaceuticals ORAL 25-37.5MG ORAL Lisinopril C Digoxin C Furosemide C Date:05/03/00ISR Number: 3495419-XReport Type:Expedited (15-DaCompany Report #00-04-0191 Age:71 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Clozapine - Zenith Congestive Professional Goldline Pharm. Neoplasm Malignant Tablets PS ORAL 12.5 MG ORAL Pneumonia Date:05/03/00ISR Number: 3495421-8Report Type:Expedited (15-DaCompany Report #00-04-0192 Age:86 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Gastrointestinal Health Clozapine - Zenith Haemorrhage Professional Goldline Pharm. Rectal Haemorrhage Tablets PS ORAL 225 MG ORAL Date:05/03/00ISR Number: 3495423-1Report Type:Expedited (15-DaCompany Report #00-02-0096 Age:49 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Choking Health Clozapine - Zenith Professional Goldline Pharm. Other Tablets PS ORAL 150MG ORAL 18 DAY Navane C Paxil C Date:05/04/00ISR Number: 3496658-4Report Type:Expedited (15-DaCompany Report #JRFUSA2000002933 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Thrombocytopenia Health Risperdal (Tablet) Professional (Risperidone) PS ORAL 3 MG, 2 IN 1 DAY(S), ORAL Clozaril (Clozapine) SS ORAL ORAL Risperdal (Tablet) (Risperidone) SS ORAL 2 MG, 2 IN 1 DAY(S), ORAL Haldol (Tablet) Haloperidol) C 22-Feb-2006 08:30 AM Page: 715 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/04/00ISR Number: 3496781-4Report Type:Expedited (15-DaCompany Report #HQ2540110APR2000 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Health Ativan Tablet PS ORAL ORAL Initial or Prolonged Convulsion Professional Clozaril SS ORAL ORAL Other Drug Withdrawal Syndrome Cardura C Luvox C Vasotec C Zantac C Date:05/05/00ISR Number: 3497263-6Report Type:Expedited (15-DaCompany Report #GB/00/00448/LEX Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram St Foreign Clozaril (Clozapine) PS ORAL 800 MG, ORAL; Segment Elevation Health Lithium (Lithium) C Electrocardiogram T Wave Professional Hyoscine (Hyoscine) C Inversion Omeprazole Fall (Omeprazole) C Hypertrophic Obstructive Cardiomyopathy Syncope Date:05/05/00ISR Number: 3497264-8Report Type:Expedited (15-DaCompany Report #USA/99/01841/LEX Age:73 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bone Marrow Depression Health Clozaril (Clozapine) PS ORAL 400 MG, ORAL; Disability Leukopenia Professional Zocor (Simvastatin) C Lung Neoplasm Malignant Hydroxyzine C Lopressor (Metoprolol Tartrate) C Gemfibrozil C Date:05/05/00ISR Number: 3497289-2Report Type:Expedited (15-DaCompany Report #234644 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bradycardia Foreign Diazepam (Diazepam) PS 40 MG DAILY Circulatory Collapse Literature Clozapine Drug Interaction Health (Clozapine) SS 12. 5MG DAILY Electrocardiogram Professional Abnormal Electrocardiogram St Segment Abnormal Electrocardiogram T Wave Inversion Hypotension Loss Of Consciousness Respiratory Rate Increased Sinus Bradycardia Syncope 22-Feb-2006 08:30 AM Page: 716 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/05/00ISR Number: 3497309-5Report Type:Expedited (15-DaCompany Report #LIT/99/00052/LEX Age:31 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Ketone Body Absent Foreign Clozapine Initial or Prolonged Blood Urea Increased Literature (Clozapine) PS ORAL 200 MG, ORAL Required Dehydration Health Intervention to Depressed Level Of Professional Prevent Permanent Consciousness Impairment/Damage Diabetic Ketoacidosis Hyperglycaemia Hypernatraemia Hypokalaemia Ketonuria Sedation Weight Increased Date:05/08/00ISR Number: 3497221-1Report Type:Expedited (15-DaCompany Report #00-04-0205 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine-Zenith Professional Goldline Pharm. Tablets PS ORAL 500 MG ORAL Date:05/08/00ISR Number: 3497222-3Report Type:Expedited (15-DaCompany Report #00-04-0196 Age:74 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine- Zenith Professional Goldline Pharm. Tablets PS ORAL 12.5 - 75MG ORAL Date:05/08/00ISR Number: 3497223-5Report Type:Expedited (15-DaCompany Report #00-04-0197 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Encephalopathy Health Clozapine-Zenith Myocardial Infarction Professional Goldline Pharm. Tablets PS ORAL 200-450 MG ORAL Date:05/08/00ISR Number: 3497225-9Report Type:Expedited (15-DaCompany Report #00-04-0198 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets PS ORAL 150MG ORAL Professional Date:05/08/00ISR Number: 3497227-2Report Type:Expedited (15-DaCompany Report #00-04-0199 Age:49 YR Gender:Male I/FU:I Outcome Required Intervention to Prevent Permanent 22-Feb-2006 08:30 AM Page: 717 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Chronic Lymphocytic Health Clozapine - Zenith Leukaemia Professional Goldline Pharm. White Blood Cell Count Tablets PS ORAL 200-600MG Increased ORAL Date:05/08/00ISR Number: 3497228-4Report Type:Expedited (15-DaCompany Report #00-01-0075 Age:81 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Pain Lower Health Clozapine - Zenith Bronchitis Acute Professional Goldline Pharm Haematuria Tablets. PS ORAL 50-150MG ORAL Leukocytosis Buspar C Male Reproductive Tract Norpace C Carcinoma In Situ Synthroid C Pelvic Pain Urinary Retention Date:05/08/00ISR Number: 3497230-2Report Type:Expedited (15-DaCompany Report #00-02-0091 Age:73 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Distension Health Clozapine - Zenith Hospitalization - Abdominal Pain Professional Goldline Pharm PS ORAL 50 MG ORAL Initial or Prolonged Anaemia Depakote C Constipation Axid C Diverticular Perforation Vasotec C Gastrointestinal Haemorrhage Sepsis Date:05/08/00ISR Number: 3497231-4Report Type:Expedited (15-DaCompany Report #00-03-0143 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Acute Respiratory Health Clozapine - Zenith Hospitalization - Distress Syndrome Professional Goldline Pharm. Initial or Prolonged Pneumonia Tablets PS ORAL 300MG ORAL Effexor Xr C Levoxyl C Cogentin C Trilafon C Date:05/08/00ISR Number: 3497665-8Report Type:Expedited (15-DaCompany Report #AUS/94/00092/LEX Age:49 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Foreign Clozaril PS Novartis Required Sudden Death Health Pharmaceuticals Corp ORAL 250 MG, Intervention to Professional UNKNOWN, ORAL Prevent Permanent Benzotropine C Impairment/Damage Nifedipine C Theophylline C Clonazepam C 22-Feb-2006 08:30 AM Page: 718 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Diazepam C Amitriptyline C Date:05/08/00ISR Number: 3497666-XReport Type:Expedited (15-DaCompany Report #AUS/00/00324/LEX Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Atelectasis Foreign Clozaril PS Novartis Required Blood Creatine Health Pharmaceuticals Corp ORAL 125 MG, ONCE Intervention to Phosphokinase Increased Professional A DAY, ORAL Prevent Permanent Breath Sounds Abnormal Omeprazole C Impairment/Damage Crepitations Efexor C Dyspnoea Diazepam C Hypoxia Neuroleptic Malignant Syndrome Pulmonary Embolism Pulmonary Oedema Date:05/08/00ISR Number: 3497667-1Report Type:Expedited (15-DaCompany Report #GB/00/00477/LEX Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril PS Novartis Tachycardia Health Pharmaceuticals Corp ORAL 300 MG, Ventricular Hypertrophy Professional UNKNOWN, ORAL Date:05/08/00ISR Number: 3497732-9Report Type:Expedited (15-DaCompany Report #USA/00/00950/LEX Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Leukaemia Granulocytic Health Clozaril (Clozapine) PS ORAL 400 MG, Disability Leukocytosis Professional OTHER, ORAL Zoloft (Sertraline Hydrochloride) C Trazodone (Trazodone) C Seroquel C Date:05/08/00ISR Number: 3497734-2Report Type:Expedited (15-DaCompany Report #AUS/96/00082/LEX Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Albuminuria Foreign Clozaril (Clozapine) PS ORAL 300 MG, ONCE Hospitalization - Blood Creatine Health A DAY, ORAL Initial or Prolonged Phosphokinase Increased Professional Required Blood Urea Increased Intervention to Cardiac Arrest Prevent Permanent Delirium Impairment/Damage Myocarditis Proteinuria Pyrexia Renal Failure Acute Respiratory Disorder Tachycardia Tachypnoea Urinary Casts 22-Feb-2006 08:30 AM Page: 719 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/08/00ISR Number: 3497735-4Report Type:Expedited (15-DaCompany Report #AUS/00/00272/LEX Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Intestinal Ischaemia Foreign Clozaril (Clozapine) PS ORAL 650 MG, ORAL Intestinal Obstruction Study Omeprazole Health (Omerprazole) C Professional Sodium Valproate (Valproate Sodium) C Dothiepin (Dosulepin) C Date:05/08/00ISR Number: 3497905-5Report Type:Expedited (15-DaCompany Report #USA/00/01280/LEX Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Respiratory Failure Health Clozaril (Clozapine) PS ORAL 200 MG, ONCE Professional A DAY, ORAL Risperdal (Risperidone) C Lithium C Celebrex (Celecoxib) C Hyzaar-50 (Hyzaar) C Inhaler (Non-Drug: Respiratory System Therapy) C Date:05/08/00ISR Number: 3497910-9Report Type:Expedited (15-DaCompany Report #GB/00/00487/LEX Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril (Clozapine) PS ORAL 400 MG, ORAL Health Professional Date:05/08/00ISR Number: 3497993-6Report Type:Expedited (15-DaCompany Report #RA/00/01135/LEX Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Toxicity Foreign Clozaril PS Novartis Hospitalization - Gastrointestinal Disorder Study Pharmaceuticals Corp ORAL 100 MG, ORAL Initial or Prolonged Haemolysis Health Lorazepam C Required Hepatic Function Abnormal Professional Carbamazepine C Intervention to Jaundice Non Benzodiazepinic Prevent Permanent Leukopenia Hypnotic C Impairment/Damage Lung Infiltration Neutropenia Oedema Polyuria Pyrexia Urinary Tract Infection Date:05/08/00ISR Number: 3498335-2Report Type:Expedited (15-DaCompany Report #AUS/00/00804/LEX Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Other Eosinophilic Pneumonia Foreign Health 22-Feb-2006 08:30 AM Page: 720 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Product Role Manufacturer Route Dose Duration Clozaril (Clozapine) PS 3 YR Date:05/09/00ISR Number: 3497849-9Report Type:Direct Company Report # Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Differential White Blood Clozapine PS ORAL 450MG DAILY Initial or Prolonged Cell Count Abnormal ORAL Leukopenia Lymphocytosis Neutropenia Pneumonitis Date:05/09/00ISR Number: 3497981-XReport Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Clonic Convulsion Clozapine 100mg Initial or Prolonged Grand Mal Convulsion Zenith-Goldline PS Zenith-Goldline ORAL 250 MG AM/HS Other ORAL Required Clozapine 25 Mg Intervention to Zenith-Goldline SS Zenith-Goldline ORAL 300 MG AN/HS Prevent Permanent ORAL Impairment/Damage Valproic Acid C Date:05/11/00ISR Number: 3498724-6Report Type:Direct Company Report # Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Leukopenia Clozaril PS ORAL 500MG QD PO Hospitalization - Initial or Prolonged Date:05/11/00ISR Number: 3498766-0Report Type:Expedited (15-DaCompany Report #00-05-0209 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other No Adverse Drug Effect Health Clozaril Tablets PS ORAL ORAL Professional Clozapine SS Zenith Goldline ORAL 650 MG ORAL Peri-Colace C Allegra D C Glyburide C Metoclopramide C Multivitamins C Omeprazole C Mesoridazine Besilate C 22-Feb-2006 08:30 AM Page: 721 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/11/00ISR Number: 3498767-2Report Type:Expedited (15-DaCompany Report #99-12-0450 Age:66 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death White Blood Cell Count Health Clozapine PS Zenith Goldline Increased Professional Pharm. ORAL 425-450MG ORAL Date:05/11/00ISR Number: 3498768-4Report Type:Expedited (15-DaCompany Report #00-03-0142 Age:84 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coronary Artery Disease Health Clozapine PS Zenith Goldline Dementia Professional Pharm ORAL 25 MG ORAL Parkinson'S Disease Date:05/11/00ISR Number: 3499570-XReport Type:Expedited (15-DaCompany Report #2000UW01557 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Apnoea Health Seroquel PS Astrazeneca Uk Ltd Hospitalization - Delirium Professional Risperdal SS Initial or Prolonged Fracture Clozapine SS Required Hyponatraemia Intervention to Leukocytosis Prevent Permanent Pneumonia Aspiration Impairment/Damage Respiratory Failure Date:05/12/00ISR Number: 3499772-2Report Type:Expedited (15-DaCompany Report #GB/00/00489/LEX Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril PS Novartis Drug Withdrawal Syndrome Health Pharmaceuticals Corp 450 MG Vomiting Professional Date:05/12/00ISR Number: 3499775-8Report Type:Expedited (15-DaCompany Report #GB/00/00486/LEX Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening C-Reactive Protein Foreign Clozaril PS Novartis Hospitalization - Increased Health Pharmaceuticals Corp ORAL 275 MG, ORAL Initial or Prolonged Cardiac Arrest Professional Procyclidine Required Coma (Procyclidine) C Intervention to Convulsion Prevent Permanent Diarrhoea Impairment/Damage Gastroenteritis Viral Hypotension Loss Of Consciousness Neutropenia Pyrexia Red Blood Cell Sedimentation Rate Increased White Blood Cell Count Increased 22-Feb-2006 08:30 AM Page: 722 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/12/00ISR Number: 3499777-1Report Type:Expedited (15-DaCompany Report #AUS/00/00418/LEX Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiomyopathy Foreign Clozaril PS Novartis Myocardial Ischaemia Study Pharmaceuticals Corp ORAL 500 MG, ONCE Health A DAY, ORAL Professional Paroxetine (Paroxetine) C Date:05/12/00ISR Number: 3499785-0Report Type:Expedited (15-DaCompany Report #D/00/00042/LEX Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril PS Novartis Hyperglycaemia Health Pharmaceuticals Corp ORAL 300 MG, 400 Professional MG, ORAL Solian (Amisulpride) C Date:05/12/00ISR Number: 3499788-6Report Type:Expedited (15-DaCompany Report #D/00/00122/LEX Age:53 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other B-Cell Small Lymphocytic Foreign Clozaril PS Novartis Lymphoma Health Pharmaceuticals Corp ORAL 550 MG, Biopsy Bone Marrow Professional OTHER, ORAL Abnormal Diazepam (Diazapam) C Leukocytosis Date:05/12/00ISR Number: 3500009-6Report Type:Expedited (15-DaCompany Report #00USA10520 Age:41 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Interaction Health Anafranil Capsule Drug Toxicity Professional (Clomipramine Dyspnoea Other Hydrochloride) PS Novartis Leukocytosis Pharmaceuticals Corp ORAL 150 MG, Mental Disorder DAILY, ORAL Clozapine Tablet (Clozapine) SS ORAL 450 MG, DAILY, ORAL Neurontin Capsule C Risperdal Tablet C Artane C Moban C Date:05/15/00ISR Number: 3499992-7Report Type:Direct Company Report # Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Clozapine 100mg Hypotension (Novartis) PS Novartis ORAL 100MG BID PO Neuroleptic Malignant Haloperidol 10mg Syndrome (Geneva) SS Geneva ORAL 10MG BID PO Pain Olanzapine C Pyrexia Divalproex C Sepsis Benztropine C Tachycardia Asa (Ec) C 22-Feb-2006 08:30 AM Page: 723 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lorazepam C Docusate C Date:05/15/00ISR Number: 3500490-2Report Type:Expedited (15-DaCompany Report #AUS/00/00790/LEX Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiomyopathy Foreign Clozaril PS Novartis Initial or Prolonged Left Ventricular Failure Health Pharmaceuticals Corp ORAL ORAL Other Myocardial Ischaemia Professional Date:05/15/00ISR Number: 3500496-3Report Type:Expedited (15-DaCompany Report #GB/00/00511/LEX Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Foreign Clozaril PS Novartis Required Respiratory Arrest Health Pharmaceuticals Corp ORAL 800 MG, ORAL; Intervention to Respiratory Depression Professional Prevent Permanent Impairment/Damage Date:05/15/00ISR Number: 3500627-5Report Type:Expedited (15-DaCompany Report #GB/00/00386/LEX Age:56 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Circulatory Collapse Foreign Clozaril PS Novartis Initial or Prolonged Loss Of Consciousness Health Pharmaceuticals Corp ORAL 600 MG, Professional UNKNOWN, ORAL Haloperidol (Haloperidol) C Procyclidine (Procyclidine) C Amiloride (Amiloride) C Frusemide (Furosemide) C Ramipril (Ramipril) C Hyoscine (Hyoscine) C Insulin (Insulin) C Atenolol (Atenolol) C Amlodipine (Amlodipine) C Date:05/15/00ISR Number: 3500630-5Report Type:Expedited (15-DaCompany Report #TR/00/00193/LEX Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Foreign Clozaril PS Novartis Initial or Prolonged Health Pharmaceuticals Corp ORAL 300 MG, Required Professional UNKNOWN, ORAL Intervention to Horse Bean SS UNKNOWN, Prevent Permanent UNKNOWN, Impairment/Damage UNKNOWN Clomiprmin (Clomipramine) C 22-Feb-2006 08:30 AM Page: 724 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/15/00ISR Number: 3500632-9Report Type:Expedited (15-DaCompany Report #GB/00/00504/LEX Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril PS Novartis Required Non-Insulin-Dependent Health Pharmaceuticals Corp ORAL 225 MG, Intervention to Professional UNKNOWN, ORAL Prevent Permanent Impairment/Damage Date:05/15/00ISR Number: 3500694-9Report Type:Expedited (15-DaCompany Report #S/00/00236/LEX Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aggression Foreign Clozaril PS Novartis Agitation Health Pharmaceuticals Corp ORAL 25 MG, ORAL; Apnoea Professional Glucophage Arteriosclerosis Other (Metformin Cardiac Arrest Hydrochloride) C Coronary Artery Disease Spironolacton Nh Cyanosis (Spironolactone) C Dyspnoea Madopar (Madopar) C Encephalopathy Amaryl (Glimepiride) C Hallucination Cabaser Hypotension (Cabergoline) C Hypoxic Encephalopathy Shock Date:05/15/00ISR Number: 3500695-0Report Type:Expedited (15-DaCompany Report #NL/00/01008/LEX Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Complications Of Maternal Foreign Clozaril PS Novartis Hospitalization - Exposure To Therapeutic Health Pharmaceuticals Corp ORAL 25 MG, ONCE A Initial or Prolonged Drugs Professional DAY, ORAL; 8 WK Foetal Disorder Other Lithii Carbonas Hepatic Haemorrhage (Lithium Carbonate) SS 400 MG, ONCE Hepatic Steatosis A DAY, Intra-Uterine Death Date:05/15/00ISR Number: 3500696-2Report Type:Expedited (15-DaCompany Report #USA/00/00615/LEX Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozaril PS Novartis Life-Threatening Throat Cancer Professional Pharmaceuticals Corp ORAL 450 MG, OTHER, ORAL; Depakote (Valproate Semisodium) C Resperidone C Atenolol C Date:05/15/00ISR Number: 3500980-2Report Type:Expedited (15-DaCompany Report #DK/96/00006/LEX Age:33 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pulmonary Embolism Foreign Clozaril PS Novartis Other Pharmaceuticals Corp ORAL 300 MG, ORAL 22-Feb-2006 08:30 AM Page: 725 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Trilafon C Fontex C Date:05/15/00ISR Number: 3500981-4Report Type:Expedited (15-DaCompany Report #DK/96/00800/LEX Age:33 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dyspnoea Foreign Clozaril PS Novartis Pulmonary Embolism Health Pharmaceuticals Corp ORAL 300 MG, ORAL Professional Perphenazine C Fluoxetin C Flunitrazepam C Date:05/19/00ISR Number: 3502043-9Report Type:Expedited (15-DaCompany Report #AUS/00/00600/LEX Age:67 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asphyxia Foreign Clozaril PS Novartis Balance Disorder Health Pharmaceuticals Corp ORAL 50 MG, ONCE A Cyanosis Professional DAY, ORAL Fall Hypotension Obstructive Airways Disorder Date:05/19/00ISR Number: 3502045-2Report Type:Expedited (15-DaCompany Report #TR/00/00193/LEX Age:37 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Foreign Clozaril PS Novartis Initial or Prolonged Health Pharmaceuticals Corp ORAL 300 MG , ORAL Required Professional Broad Bean SS Intervention to Clomiprmin C Prevent Permanent Impairment/Damage Date:05/19/00ISR Number: 3502097-XReport Type:Expedited (15-DaCompany Report #GB/00/00368/LEX Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Foreign Clozaril PS Novartis Leukopenia Study Pharmaceuticals Corp ORAL 600 MG, ORAL Metastasis Health Radiotherapy SS Rectal Cancer Professional Chemotherapy SS Seminoma Bleomycin C Date:05/19/00ISR Number: 3502272-4Report Type:Expedited (15-DaCompany Report #00-05-0211 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Health Clozapine PS Zenith Goldline ORAL 150 MG ORAL Professional 22-Feb-2006 08:30 AM Page: 726 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/19/00ISR Number: 3502286-4Report Type:Expedited (15-DaCompany Report #00-05-0219 Age:73 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Health Clozapine PS Zenith Goldline ORAL 25MG ORAL Professional Date:05/19/00ISR Number: 3502510-8Report Type:Expedited (15-DaCompany Report #AUS/99/01692/LEX Age:30 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Clozaril PS Novartis Initial or Prolonged Drug Level Below Health Pharmaceuticals Corp ORAL 600 MG ORAL Therapeutic Professional Psychotic Disorder Date:05/19/00ISR Number: 3502513-3Report Type:Expedited (15-DaCompany Report #GB/00/00525/LEX Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cerebrovascular Accident Foreign Clozaril PS Novartis Convulsion Health Pharmaceuticals Corp ORAL 400 MG ORAL Professional Date:05/19/00ISR Number: 3502516-9Report Type:Expedited (15-DaCompany Report #USA/00/01044/LEX Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Extrapyramidal Disorder Health Clozaril PS Novartis Parkinson'S Disease Professional Pharmaceuticals Corp ORAL ORAL Pneumonia Date:05/19/00ISR Number: 3502517-0Report Type:Expedited (15-DaCompany Report #AUS/00/00858/LEX Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Ineffective Foreign Clozaril PS Novartis Suicide Attempt Study Pharmaceuticals Corp ORAL ORAL Health Professional Date:05/19/00ISR Number: 3502520-0Report Type:Expedited (15-DaCompany Report #AUS/00/00857/LEX Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypertrophic Obstructive Foreign Clozaril PS Novartis Cardiomyopathy Health Pharmaceuticals Corp ORAL 450 MG ORAL Professional Sodium Valproate (Valproate Sodium) C Date:05/19/00ISR Number: 3502523-6Report Type:Expedited (15-DaCompany Report #AUS/00/00843/LEX Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Death Cardiac Arrest Foreign Hypoglycaemia Health 22-Feb-2006 08:30 AM Page: 727 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Product Role Manufacturer Route Dose Duration Clozaril PS Novartis Pharmaceuticals Corp ORAL 400 MG, ONCE A DAY, ORAL Serenace (Haloperidol) C Metformin (Metforin) C Date:05/19/00ISR Number: 3502526-1Report Type:Expedited (15-DaCompany Report #D/00/00592/LEX Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cervical Dysplasia Foreign Clozaril PS Novartis Health Pharmaceuticals Corp ORAL 250 MG, ORAL 18 MON Professional Date:05/23/00ISR Number: 3503607-9Report Type:Expedited (15-DaCompany Report #RA/00/01471/LEX Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatinine Foreign Clozaril PS Novartis Increased Health Pharmaceuticals Corp ORAL 300 MG, ORAL; 25 DAY Renal Failure Acute Professional Lotrial (Enalapril) SS ORAL 5 MG, TWICE A DAY, ORAL; Date:05/23/00ISR Number: 3503721-8Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Pain Health Clozaril 600 Mg Qd PS ORAL 600 MG QD PO 3 YR Atelectasis Professional Zocor C Cardio-Respiratory Arrest Diazepam C Constipation Effexor Xr C Drug Toxicity Gastrointestinal Disorder Gastrointestinal Necrosis Hepatic Steatosis Hypotension Intestinal Ischaemia Megacolon Peritoneal Disorder Peritonitis Renal Failure Acute Respiratory Acidosis Respiratory Arrest Sepsis Vomiting Date:05/24/00ISR Number: 3503397-XReport Type:Expedited (15-DaCompany Report #00-05-0210 Age:86 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arteriosclerosis Health Clozapine PS Zenith Goldline ORAL 25-250 MG Cerebrovascular Accident Professional ORAL 22-Feb-2006 08:30 AM Page: 728 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/24/00ISR Number: 3503400-7Report Type:Expedited (15-DaCompany Report #00-05-0229 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 400 MG ORAL Professional Date:05/24/00ISR Number: 3503403-2Report Type:Expedited (15-DaCompany Report #00-05-0229 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 25-125 MG Professional ORAL Date:05/24/00ISR Number: 3503406-8Report Type:Expedited (15-DaCompany Report #00-05-0230 Age:82 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 25 MG ORAL Professional Date:05/24/00ISR Number: 3503702-4Report Type:Expedited (15-DaCompany Report #00-05-0214 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 50-112.5 MG Professional ORAL Date:05/24/00ISR Number: 3503947-3Report Type:Direct Company Report # Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Constipation Health Clozaril - 25 Mg + Intervention to Faecaloma Professional 100 Mg (Novartis) PS Novartis 100MG AM + HS Prevent Permanent Clozaril - 25mg Impairment/Damage +100mg Novartis SS Novartis 25MG 2 HS Norpramin C Lithium Co3 C Premarin C Feso4 C Date:05/24/00ISR Number: 3503965-5Report Type:Direct Company Report # Age:74 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Status Epilepticus Health Clozaril (Novartis) Initial or Prolonged Professional 100 Mg PS Novartis 100 MG HS Required Paxil C Intervention to Haldol C Prevent Permanent Ativan C Impairment/Damage 22-Feb-2006 08:30 AM Page: 729 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/24/00ISR Number: 3503966-7Report Type:Direct Company Report # Age:71 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Health Clozapine 25 Mg Initial or Prolonged Leukopenia Professional (Zenith-Goldline) PS Zenith-Goldline ORAL 6.25 MG PO AM Other Neutropenia +HS Required Clozapine 25mg Intervention to Zenith-Goldline SS Zenith-Goldline OPHTHALMIC 12.5 PO AM + Prevent Permanent HS Impairment/Damage Clozapine 25mg Zenith-Goldline SS Zenith-Goldline ORAL 50MG AM + HS Haldol C Prilosec C Olanzapine C Tylenol C Nifedipine Xl C Glipizide C Vistaril C Date:05/24/00ISR Number: 3504459-3Report Type:Expedited (15-DaCompany Report #USA/00/00711/LEX Age:42 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abdominal Discomfort Health Clozaril PS Novartis Hospitalization - Abdominal Mass Professional Pharmaceuticals Corp ORAL 350 MG, Initial or Prolonged Gastrointestinal Disorder OTHER, ORAL Required Leukocytosis Haldol Deconoate Intervention to Ovarian Cancer (Haloperidol Prevent Permanent Decanoate) C Impairment/Damage Depakote (Valproate Semisodium) C Paxil (Paroxetine Hydrochloride) C Date:05/24/00ISR Number: 3504460-XReport Type:Expedited (15-DaCompany Report #USA/00/01459/LEX Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Cancer Female Health Clozaril PS Novartis Neutropenia Professional Pharmaceuticals Corp ORAL 175 MG, ORAL Cytoxan (Cyclophosphamide) C Doxorubicin C Chemotherapy (Chemotherapeutics, Other) C Date:05/24/00ISR Number: 3504512-4Report Type:Expedited (15-DaCompany Report #AUS/00/00177/LEX Age:25 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Hepatic Neoplasm Foreign Clozaril PS Novartis Required Leukopenia Health Pharmaceuticals Corp 150 MG , Intervention to Mental Disorder Professional TWICE A Prevent Permanent Impairment/Damage 22-Feb-2006 08:30 AM Page: 730 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/24/00ISR Number: 3504514-8Report Type:Expedited (15-DaCompany Report #D/00/00375/LEX Age:61 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Rigidity Foreign Clozaril PS Novartis Required Aspiration Health Pharmaceuticals Corp ORAL 200 MG; 300 Intervention to Bronchopneumonia Professional MG; 400 MG, Prevent Permanent Cardiac Arrest 450 MG; Impairment/Damage Cardiac Failure (ORAL) Ileus Paralytic Truxal Respiratory Failure (Chlorprothixene Shock Hydrochloride) SS ORAL 100 MG, ORAL Vomiting Gastrozepin SS ORAL 50 MG, ORAL Date:05/24/00ISR Number: 3504589-6Report Type:Direct Company Report # Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Asthenia Health Clozapine 100mg PS ORAL 100MG BID Hospitalization - Neutropenia Professional ORAL Initial or Prolonged Pharyngolaryngeal Pain Required Pyrexia Intervention to White Blood Cell Count Prevent Permanent Decreased Impairment/Damage Date:05/25/00ISR Number: 3504465-9Report Type:Expedited (15-DaCompany Report #GB/99/01107/LEX Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Alcoholism Foreign Clozaril PS Novartis Hospitalization - Aortic Valve Replacement Health Pharmaceuticals Corp ORAL 350 MG, ONCE Initial or Prolonged Cardiac Failure Professional A DAY, ORAL Cardiomegaly Valium (Diazepam) C Haemorrhagic Stroke Amitriptyline Left Ventricular Failure (Amitriptyline) C Myocarditis Date:05/25/00ISR Number: 3504667-1Report Type:Expedited (15-DaCompany Report #D/96/03180/LEX Age:22 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Creatine Foreign Clozaril PS Novartis Other Phosphokinase Increased Consumer Pharmaceuticals Corp ORAL 400 MG, Cardiac Arrest Health UNKNOWN, Cardiac Failure Professional ORAL; 75 MG, Catatonia UNKNOWN, ORAL Drug Interaction Praxiten Forte Hepatic Steatosis (Oxazepam) SS ORAL 100 MG, ONCE Neuroleptic Malignant A DAY, ORAL Syndrome Tavor (Lorazepam) SS ORAL ORAL Overdose Rohypnol Pulmonary Oedema (Flunitrazepam) SS ORAL ORAL Pyrexia Atosil Renal Disorder (Isopromethazine Respiratory Depression Hydrochloride) SS 100 MG Sudden Death Ximovan (Zopiclone) SS ORAL ORAL Toxicologic Test Abnormal Ciatyl (Clopenthixol Hydrochloride) SS INTRAMUSCULAR INTRAMUSCULAR 22-Feb-2006 08:30 AM Page: 731 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dapotum Depot (Fluphenazine Decanoate) SS Valium (Diazepam) SS ORAL 30 MG, ORAL Date:05/25/00ISR Number: 3504669-5Report Type:Expedited (15-DaCompany Report #USA/00/01476/LEX Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Arthropathy Health Clozaril PS Novartis Asthenia Professional Pharmaceuticals Corp ORAL 750 MG, ORAL Clonic Convulsion Glipizide C Diabetes Mellitus Naproxen C Muscle Contractions Involuntary Date:05/25/00ISR Number: 3504670-1Report Type:Expedited (15-DaCompany Report #USA/00/01458/LEX Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Intestinal Obstruction Health Clozaril PS Novartis Post Procedural Professional Pharmaceuticals Corp ORAL 25 MG, ONCE A Complication DAY, ORAL Postoperative Adhesion Morphine C Duragesic Patch (Fentanyl) C Date:05/25/00ISR Number: 3504671-3Report Type:Expedited (15-DaCompany Report #USA/00/00820/LEX Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Extrapyramidal Disorder Health Clozaril PS Novartis Parkinson'S Disease Professional Pharmaceuticals Corp ORAL ORAL Date:05/25/00ISR Number: 3504675-0Report Type:Expedited (15-DaCompany Report #00USA10520 Age:41 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Collapse Of Lung Health Anafranil PS Novartis Coma Professional Pharmaceuticals Corp ORAL 150 MG, Cough Other DAILY, ORAL Dizziness Clozapine Tablet Drug Interaction (Clozapine) SS ORAL 450 MG, Drug Toxicity DAILY, ORAL Dyspnoea Neurontin Capsule C Toxicologic Test Abnormal Risperdal Tablet C White Blood Cell Count Zyprexa Tablet C Increased Loestrin Tablet C Artane C Moban C 22-Feb-2006 08:30 AM Page: 732 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/26/00ISR Number: 3504741-XReport Type:Expedited (15-DaCompany Report #00-05-0247 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiomyopathy Health Clozapine PS Zenith Goldline ORAL 750MG ORAL Professional Coumadin C Cordarone C Demadex C Accupril C Lanoxin C Date:05/26/00ISR Number: 3504744-5Report Type:Expedited (15-DaCompany Report #00-05-0231 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL ORAL Professional Date:05/26/00ISR Number: 3504745-7Report Type:Expedited (15-DaCompany Report #00-05-0246 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 200MG ORAL Professional Date:05/26/00ISR Number: 3504746-9Report Type:Expedited (15-DaCompany Report #00-04-0197 Age:61 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Clozapine PS Zenith Goldline ORAL 200-450 MG Hypoxic Encephalopathy ORAL Myocardial Infarction Date:05/26/00ISR Number: 3504747-0Report Type:Expedited (15-DaCompany Report #00-04-0163 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 550-600MG Professional ORAL Date:05/26/00ISR Number: 3504748-2Report Type:Expedited (15-DaCompany Report #00-01-0020 Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Leukocytosis Health Clozapine PS Zenith Goldline ORAL 300-600/MG Professional ORAL Date:05/26/00ISR Number: 3504749-4Report Type:Expedited (15-DaCompany Report #00-04-0192 Age:86 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Condition Aggravated Health Clozapine PS Zenith Goldline ORAL 225 MG ORAL Gastrointestinal Professional Trilisate C Haemorrhage Prevacid C Rectal Haemorrhage 22-Feb-2006 08:30 AM Page: 733 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/26/00ISR Number: 3505460-6Report Type:Expedited (15-DaCompany Report #AUS/00/00715/LEX Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypertrophic Obstructive Foreign Clozaril PS Novartis Cardiomyopathy Health Pharmaceuticals Corp ORAL 500 MG, ONCE Professional A DAY,ORAL Amitriptyline C Diazepam C Date:05/26/00ISR Number: 3505465-5Report Type:Expedited (15-DaCompany Report #AUS/00/00924/LEX Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiac Disorder Foreign Clozaril PS Novartis Study Pharmaceuticals Corp ORAL 300 MG, ORAL Health Professional Date:05/26/00ISR Number: 3505470-9Report Type:Expedited (15-DaCompany Report #GB/00/00548/LEX Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril PS Novartis Health Pharmaceuticals Corp ORAL 450 MG, ORAL Professional Lithium (Lithium) C Lansoprazole (Lansoprazole) C Metformin (Metformin) C Date:05/26/00ISR Number: 3505474-6Report Type:Expedited (15-DaCompany Report #GB/00/00551/LEX Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Constipation Foreign Clozaril PS Novartis Initial or Prolonged Diabetes Mellitus Health Pharmaceuticals Corp ORAL 500 MG, ORAL Required Diarrhoea Professional Intervention to Ketoacidosis Prevent Permanent Sedation Impairment/Damage Vomiting Date:05/26/00ISR Number: 3507089-2Report Type:Expedited (15-DaCompany Report #RA/00/01471/LEX Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypertension Foreign Clozaril PS Novartis Initial or Prolonged Hyperuricaemia Health Pharmaceuticals Corp ORAL 200 MG, ORAL Required Hypotension Professional Lotrial (Enalapril) SS ORAL 5 MG, TWICE A Intervention to Pyogenic Granuloma DAY, ORAL Prevent Permanent Pyrexia Clonazepam C Impairment/Damage Renal Failure Acute Akineton (Biperiden Tachycardia Hydrochloride) C Vomiting Risperidone C Atenolol C 22-Feb-2006 08:30 AM Page: 734 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/30/00ISR Number: 3505319-4Report Type:Direct Company Report # Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Anticholinergic Syndrome Clozapine Zenith Diarrhoea Goldline PS Zenith Goldline ORAL 150MG BID Hypotension ORAL Thrombocytopenia Paroxetine C Vomiting Haloperidol C White Blood Cell Count Paxil C Decreased Haldol C Date:05/30/00ISR Number: 3505743-XReport Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abdominal Distension Valproic Acid Liquid Hospitalization - Abdominal Pain / 250mg/5ml/Morton Initial or Prolonged Ascites Grove Required Bowel Sounds Abnormal Pharmaceuticals PS Morton Grove Intervention to Dialysis Pharmaceuticals 3750 MG DAY Prevent Permanent Disseminated Clozapine 100mg Impairment/Damage Intravascular Coagulation Zenith/Goldline SS Zenith/Goldline 500 MG/DAY Heart Rate Increased Fluoxetine C Hypertension Lorazepam C Lipase Urine Increased Docusate C Nausea Omeprazole C Pancreatitis Terazosin C Pancreatitis Haemorrhagic Renal Failure Acute Date:05/30/00ISR Number: 3505888-4Report Type:Expedited (15-DaCompany Report #AUS/00/00340/LEX Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abortion Spontaneous Foreign Clozaril PS Novartis Initial or Prolonged Anaemia Health Pharmaceuticals Corp 625 MG Required Complications Of Maternal Professional Stelazine Intervention to Exposure To Therapeutic (Trifluoperazine Prevent Permanent Drugs Hydrochloride) SS 25 MG Impairment/Damage Haemorrhage Medication Error Date:05/30/00ISR Number: 3505896-3Report Type:Expedited (15-DaCompany Report #AUS/00/00941/LEX Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiomegaly Foreign Clozaril PS Novartis Cardiomyopathy Health Pharmaceuticals Corp ORAL 550 MG ORAL Ejection Fraction Professional Abnormal Electrocardiogram Abnormal 22-Feb-2006 08:30 AM Page: 735 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/30/00ISR Number: 3506357-8Report Type:Expedited (15-DaCompany Report #USA/00/01489/LEX Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Health Clozaril PS Novartis Hospitalization - Cerebrovascular Disorder Professional Pharmaceuticals Corp 200 MG Initial or Prolonged Date:05/30/00ISR Number: 3506361-XReport Type:Expedited (15-DaCompany Report #GB/00/00563/LEX Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Breast Cancer Female Foreign Clozaril PS Novartis Metastasis Health Pharmaceuticals Corp 175 MG Professional Date:06/01/00ISR Number: 3507086-7Report Type:Expedited (15-DaCompany Report #USA/00/00621/LEX Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozaril PS Novartis Life-Threatening Professional Pharmaceuticals Corp ORAL 300 MG, ORAL Klonopin (Clonazepam) C Topimax C Date:06/01/00ISR Number: 3507088-0Report Type:Expedited (15-DaCompany Report #USA/00/01063/LEX Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozaril PS Novartis Hospitalization - Professional Pharmaceuticals Corp ORAL 300 MG, ORAL Initial or Prolonged Date:06/01/00ISR Number: 3507092-2Report Type:Expedited (15-DaCompany Report #GB/00/00536/LEX Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Deep Vein Thrombosis Foreign Clozaril PS Novartis Initial or Prolonged Diabetes Mellitus Health Pharmaceuticals Corp ORAL 375 MG, ORAL Other Non-Insulin-Dependent Professional Warfarin (Warfarin) C Required Hyperglycaemia Gliclazide Intervention to Oedema Peripheral (Gliclazide) C Prevent Permanent Pain In Extremity Impairment/Damage Date:06/01/00ISR Number: 3507097-1Report Type:Expedited (15-DaCompany Report #GB/00/00312/LEX Age:30 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril PS Novartis Required Insulin-Dependent Health Pharmaceuticals Corp ORAL 150 MG, Intervention to Pregnancy Professional UNKNOWN,ORAL; Prevent Permanent UNKN'UNKN;UNK Impairment/Damage N; 22-Feb-2006 08:30 AM Page: 736 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/01/00ISR Number: 3507127-7Report Type:Expedited (15-DaCompany Report #AUS/00/00444/LEX Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiomyopathy Foreign Clozaril PS Novartis Initial or Prolonged Dyspnoea Health Pharmaceuticals Corp ORAL 750 MG, ORAL Obesity Professional Lithium (Lithium) C Vitamin B.C. Zinc (Vitamins) C Aporex (Aporex) C Diazepam (Diazepam) C Zoton (Lansoprazole) C Date:06/01/00ISR Number: 3507426-9Report Type:Direct Company Report # Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Clozapine 100mg Hallucination, Auditory (Zenith Goldline) PS Zenith Goldline ORAL 375MG HS /PO Clozapine 25mg (Zenith Goldline) SS Zenith Goldline Date:06/01/00ISR Number: 3507429-4Report Type:Direct Company Report # Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Clozapine 100mg Hallucination, Auditory (Zenith Goldline) PS Zenith Goldline ORAL 100MG QAM PO Clozapine 25mg (Zenith Goldline) SS Zenith Goldline ORAL 25MG QID PO Date:06/02/00ISR Number: 3507621-9Report Type:Expedited (15-DaCompany Report #F/00/01269/LEX Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hodgkin'S Disease Foreign Clozaril PS Novartis Initial or Prolonged Health Pharmaceuticals Corp 350 MG Required Professional Intervention to Prevent Permanent Impairment/Damage Date:06/02/00ISR Number: 3507735-3Report Type:Expedited (15-DaCompany Report #GB/00/00580/LEX Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Foreign Clozaril PS Novartis Health Pharmaceuticals Corp ORAL 725 MG, ORAL; Professional Date:06/02/00ISR Number: 3507869-3Report Type:Expedited (15-DaCompany Report #AUS/00/00843/LEX Age:28 YR Gender:Female I/FU:F Outcome PT Report Source Death Cardiac Arrest Foreign Hypoglycaemia Study Health 22-Feb-2006 08:30 AM Page: 737 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Product Role Manufacturer Route Dose Duration Clozaril PS Novartis Pharmaceuticals Corp ORAL 400 MG, ONCE A DAY, ORAL Serenace C Metformin C Date:06/02/00ISR Number: 3507872-3Report Type:Expedited (15-DaCompany Report #A008941 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Aspiration Health Navane PS Roerig Div Pfizer Hospitalization - Fatigue Professional Inc ORAL 10.00 MG Initial or Prolonged Pneumonia Aspiration TOTAL; DAILY; Respiratory Failure ORAL Salivary Hypersecretion Clozapine SS 400.00 MG Sedation TOTAL Oxybutynin SS 5.00 MG TOTAL Propranolol SS 40.00 MG TOTAL Colace C Vitamin E C Lithium C Olanzapine C Date:06/02/00ISR Number: 3507907-8Report Type:Expedited (15-DaCompany Report #GB/00/00486/LEX Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening C-Reactive Protein Foreign Clozaril PS Novartis Hospitalization - Increased Study Pharmaceuticals Corp ORAL 275 MG, ORAL Initial or Prolonged Cardiac Arrest Health Procyclidine C Coma Professional Convulsion Diarrhoea Gastroenteritis Hypokalaemia Hypotension Hypoxia Loss Of Consciousness Neutropenia Pyrexia Red Blood Cell Sedimentation Rate Increased Date:06/02/00ISR Number: 3507908-XReport Type:Expedited (15-DaCompany Report #GB/00/00543/LEX Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Circulatory Collapse Foreign Clozaril PS Novartis Drug Interaction Study Pharmaceuticals Corp ORAL 600 MG, ORAL Shock Health Clomipramine SS ORAL ORAL Sudden Death Professional Thioridazine C 22-Feb-2006 08:30 AM Page: 738 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/02/00ISR Number: 3507910-8Report Type:Expedited (15-DaCompany Report #D/00/00656/LEX Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dermatitis Foreign Clozaril PS Novartis Vasculitis Health Pharmaceuticals Corp ORAL 12.5 MG, ORAL Professional Verapamil C Madopar C Antiparkin C Adumbran C Date:06/02/00ISR Number: 3507915-7Report Type:Expedited (15-DaCompany Report #GB/00/00511/LEX Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Encephalitis Foreign Clozaril PS Novartis Required Encephalopathy Health Pharmaceuticals Corp ORAL 800 MG, ORAL Intervention to Grand Mal Convulsion Professional Diazepam C Prevent Permanent Herpes Zoster Valproate Sodium C Impairment/Damage Respiratory Depression Date:06/02/00ISR Number: 3508112-1Report Type:Expedited (15-DaCompany Report #AUS/00/00521/LEX Age:44 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abscess Foreign Clozaril PS Novartis Initial or Prolonged Cellulitis Health Pharmaceuticals Corp 550 MG Required Staphylococcal Infection Professional Epilim (Valproate Intervention to Sodium) C Prevent Permanent Aropax (Paroxetine Impairment/Damage Hydrochloride) C Date:06/02/00ISR Number: 3508113-3Report Type:Expedited (15-DaCompany Report #GB/00/00572/LEX Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril PS Novartis Health Pharmaceuticals Corp 250 MG Professional Date:06/05/00ISR Number: 3508164-9Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Upper Clozaril( Novartis) PS Novartis ORAL 100MG AM & Initial or Prolonged Pancreatitis Acute 150MG PO HS 2 WK Valproic Acid -Schein SS Schein ORAL 1000MG AM & HS PO 4 MON Date:06/05/00ISR Number: 3508385-5Report Type:Expedited (15-DaCompany Report #D/00/00592/LEX Age:31 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cervical Dysplasia Foreign Clozaril PS Novartis Health Pharmaceuticals Corp ORAL 225 MG, ORAL Professional Clozapin (Clozapine) SS 300 MG 22-Feb-2006 08:30 AM Page: 739 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/05/00ISR Number: 3508387-9Report Type:Expedited (15-DaCompany Report #AUS/99/01567/LEX Age:60 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Foreign Clozaril PS Novartis Initial or Prolonged Blood Albumin Decreased Study Pharmaceuticals Corp ORAL 250 MG, ORAL Delirium Health Risperidone Hypoproteinaemia Professional (Risperidone) SS Hypotension Valproate (Valproate Hypoxia Sodium) C Myocarditis Tachycardia Date:06/05/00ISR Number: 3508389-2Report Type:Expedited (15-DaCompany Report #S/00/00254/LEX Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Clozaril PS Novartis Health Pharmaceuticals Corp Professional Other Date:06/05/00ISR Number: 3508394-6Report Type:Expedited (15-DaCompany Report #D/00/00593/LEX Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Caesarean Section Foreign Clozaril PS Novartis Required Foetal Distress Syndrome Health Pharmaceuticals Corp ORAL 300 MG, ORAL Intervention to Labour Complication Professional Clozapine-Neurax Prevent Permanent Placental Insufficiency (Clozapine) SS 150 MG Impairment/Damage Date:06/05/00ISR Number: 3508750-6Report Type:Expedited (15-DaCompany Report #LIT/99/00052/LEX Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Urea Increased Foreign Clozaril PS Novartis Initial or Prolonged Dehydration Literature Pharmaceuticals Corp 200 MG Required Depressed Level Of Health Intervention to Consciousness Professional Prevent Permanent Electrolyte Imbalance Impairment/Damage Hyperglycaemia Hypernatraemia Hypokalaemia Ketoacidosis Ketonuria Sedation Weight Increased Date:06/05/00ISR Number: 3508772-5Report Type:Expedited (15-DaCompany Report #AUS/00/00230/LEX Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiomyopathy Foreign Clozaril PS Novartis Initial or Prolonged Laboratory Test Abnormal Health Pharmaceuticals Corp ORAL 950 MG, ORAL Professional Clonazepam SS 2 MG, TWICE A DAY Lithium SS 500 MG, ONCE 22-Feb-2006 08:30 AM Page: 740 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report A DAY, 750 MG, ONCE A DAY Sodium Valproate C Benztropine C Amlodipine C Date:06/06/00ISR Number: 3508696-3Report Type:Direct Company Report # Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Small Intestinal Clozaril 100mg Initial or Prolonged Obstruction Novartis PS Novartis ORAL 300MG QAM Other ORAL / 500MG QPM ORAL Date:06/06/00ISR Number: 3508779-8Report Type:Expedited (15-DaCompany Report #00-04-0199 Age:49 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Chronic Lymphocytic Health Clozapine PS Zenith Goldline ORAL 200-600MG Intervention to Leukaemia Professional ORAL Prevent Permanent White Blood Cell Count Impairment/Damage Increased Date:06/06/00ISR Number: 3508784-1Report Type:Expedited (15-DaCompany Report #00-02-0043 Age:78 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Brain Hypoxia Health Clozapine PS Zenith Goldline ORAL 75-125MG ORAL Cardiac Failure Professional Trazodone C Cardiovascular Disorder Clonazepam C Hypertension Pepcid C Cardura C Requip C Lanoxin Tablets C Lanoxin Tablets C Lorazepam C Bisacodyl C Rocephin C Ceftin C Broncholate C Lidocaine C Levodopa-Carbidopa Er C Date:06/06/00ISR Number: 3508786-5Report Type:Expedited (15-DaCompany Report #00-05-0268 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL ORAL Professional 22-Feb-2006 08:30 AM Page: 741 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/06/00ISR Number: 3508790-7Report Type:Expedited (15-DaCompany Report #00-05-0267 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL ORAL Professional Date:06/06/00ISR Number: 3508792-0Report Type:Expedited (15-DaCompany Report #00-05-0265 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 900MG ORAL Professional Date:06/06/00ISR Number: 3508794-4Report Type:Expedited (15-DaCompany Report #00-05-0266 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alcoholism Health Clozapine PS Zenith Goldline ORAL 550MG ORAL Initial or Prolonged Professional Date:06/06/00ISR Number: 3508796-8Report Type:Expedited (15-DaCompany Report #00-05-0269 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 450MG ORAL Professional Date:06/08/00ISR Number: 3509814-3Report Type:Direct Company Report # Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Creatine Clozaril 500mg Qhs Hospitalization - Phosphokinase Increased Po PS ORAL 500MG QHS PO Initial or Prolonged Circulatory Collapse Lithium 600mg Bid Po SS ORAL 600MG BID PO Required Coma Neurontin C Intervention to Pyrexia Bowel Regimen C Prevent Permanent Tachycardia Impairment/Damage Date:06/08/00ISR Number: 3510657-5Report Type:Expedited (15-DaCompany Report #USA/96/02866/LEX Age:24 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Constipation Health Clozaril PS Novartis Fatigue Professional Pharmaceuticals Corp ORAL 300 MG, TWICE Respiratory Arrest A DAY, ORAL; Probanthine (Propantheline Bromide) C Prozac (Flouxetine Hydrochloride) C Trazodone C Depakote ( Valproate Semisodium) C Bactrim C 22-Feb-2006 08:30 AM Page: 742 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/08/00ISR Number: 3510661-7Report Type:Expedited (15-DaCompany Report #USA/96/01440/LEX Age:25 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Condition Aggravated Health Clozaril PS Novartis Other Constipation Professional Pharmaceuticals Corp 300 MG, TWICE Drug Level Above A DAY, ORAL Therapeutic Prozac (Fluoxetine Drug Toxicity Hydrochoride) SS ORAL 80 MG Fatigue Bactrim C Hepatic Steatosis Propantheline C Leukocytosis Trazodone C Oesophageal Ulcer Divalproex Overdose (Valproate Pneumonitis Semisodium) C Respiratory Arrest Date:06/08/00ISR Number: 3510664-2Report Type:Expedited (15-DaCompany Report #RA/00/01135/LEX Age:52 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Bilirubin Increased Foreign Clozaril PS Novartis Hospitalization - Drug Toxicity Study Pharmaceuticals Corp ORAL 100 MG, ORAL Initial or Prolonged Embolism Health Lorazepam C Required Haemolysis Professional Carbamazepine C Intervention to Jaundice Non Benzodiazepinic Prevent Permanent Leukopenia Hypnotic C Impairment/Damage Lung Infiltration Neutropenia Oedema Oliguria Pulmonary Embolism Pyrexia Urinary Tract Infection Date:06/08/00ISR Number: 3510665-4Report Type:Expedited (15-DaCompany Report #USA/99/02014/LEX Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiomegaly Health Clozaril PS Novartis Condition Aggravated Professional Pharmaceuticals Corp ORAL 300 MG, ONCE Confusional State A DAY, ORAL; Delusion Levoxyl Depressed Level Of (Levothyroxine Consciousness Sodium) C Disorientation Pravachol Gait Disturbance (Pravastatin Sodium) C Leukocytosis Imipramine C Liver Function Test Risperdal Abnormal (Risperidone) C Nausea Loxapine C Timoptic (Timolol Maleate) C Verapamil C Alprazolam C Terizidone C 22-Feb-2006 08:30 AM Page: 743 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/08/00ISR Number: 3510687-3Report Type:Expedited (15-DaCompany Report #2000UW01557 Age:51 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Apnoea Health Seroquel PS Astrazeneca Uk Ltd Hospitalization - Convulsion Professional Risperdal SS 4 MG QD Initial or Prolonged Delirium Clozapine SS ORAL 125 MG QD Required Hyponatraemia Intervention to Leukocytosis Prevent Permanent Lower Limb Fracture Impairment/Damage Pneumonia Aspiration Po2 Decreased Respiratory Failure Date:06/09/00ISR Number: 3512674-8Report Type:Expedited (15-DaCompany Report #D/98/02955/LEX Age:46 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Foreign Clozaril PS Novartis Hospitalization - Asthenia Health Pharmaceuticals Corp ORAL 300 MG ORAL Initial or Prolonged Cough Professional Amaryl (Glimepiride) C Required Fatigue Acerbon (Lisinopril) C Intervention to Influenza Like Illness Prevent Permanent Leukopenia Impairment/Damage Neutropenia Pancytopenia Pharyngitis Platelet Count Decreased Pyrexia Thrombocytopenia Date:06/12/00ISR Number: 3511802-8Report Type:Expedited (15-DaCompany Report #GB/00/00504/LEX Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril PS Novartis Required Non-Insulin-Dependent Health Pharmaceuticals Corp ORAL 225 MG Intervention to Professional Prevent Permanent Impairment/Damage Date:06/12/00ISR Number: 3511803-XReport Type:Expedited (15-DaCompany Report #AUS/00/00521/LEX Age:44 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abscess Foreign Clozaril PS Novartis Initial or Prolonged Cellulitis Health Pharmaceuticals Corp ORAL 550 MG Required Staphylococcal Infection Professional Epilim (Valproate Intervention to Sodium) C Prevent Permanent Aropax (Paroxetine Impairment/Damage Hydrochloride) C Date:06/12/00ISR Number: 3511804-1Report Type:Expedited (15-DaCompany Report #AUS/00/01069/LEX Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Death Cardiac Arrest Foreign Health 22-Feb-2006 08:30 AM Page: 744 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Product Role Manufacturer Route Dose Duration Clozaril PS Novartis Pharmaceuticals Corp ORAL 500 MG Date:06/12/00ISR Number: 3511805-3Report Type:Expedited (15-DaCompany Report #GB/00/00108/LEX Age:57 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Constipation Foreign Clozaril PS Novartis Faecaloma Health Pharmaceuticals Corp ORAL 400 MG Intestinal Obstruction Professional Amitriptyline C Date:06/12/00ISR Number: 3511812-0Report Type:Expedited (15-DaCompany Report #AUS/00/00912/LEX Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Foreign Clozaril PS Novartis Initial or Prolonged Demyelinating Health Pharmaceuticals Corp ORAL 300 MG, ORAL; Polyneuropathy Professional Fatigue Neuropathy Peripheral Visual Disturbance Date:06/12/00ISR Number: 3511813-2Report Type:Expedited (15-DaCompany Report #AUS/00/00804/LEX Age:42 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bronchoscopy Abnormal Foreign Clozaril PS Novartis Chest Pain Health Pharmaceuticals Corp ORAL 450 MG, ORAL; 3 YR Eosinophilic Pneumonia Professional Isoptin-Sr Lung Disorder (Verapamil Lung Infiltration Hydrochloride) C Myocarditis Vitamin C (Ascorbic Pneumonia Acid) C Ferro-Gradument (Ferrous Sulfate) C Date:06/12/00ISR Number: 3511814-4Report Type:Expedited (15-DaCompany Report #AUS/00/00299/LEX Age:39 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocarditis Foreign Clozaril PS Novartis Required Study Pharmaceuticals Corp ORAL 100 MG, ORAL; Intervention to Health Efexor (Venlafaxine Prevent Permanent Professional Hydrochloride) C Impairment/Damage Date:06/12/00ISR Number: 3511815-6Report Type:Expedited (15-DaCompany Report #NL/00/01177/LEX Age:23 YR Gender:Male I/FU:I Outcome Life-Threatening Required Intervention to 22-Feb-2006 08:30 AM Page: 745 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Cardiac Valve Disease Foreign Clozaril PS Novartis Congestive Cardiomyopathy Health Pharmaceuticals Corp ORAL 100 MG, TIWCE Dyspnoea Professional A DAY, ORAL; Ejection Fraction Other Augmentin (Clavulin) C Abnormal Clomipramine Pyrexia (Clomipramine) C Furosemide (Furosemide) C Date:06/12/00ISR Number: 3511816-8Report Type:Expedited (15-DaCompany Report #USA/00/01626/LEX Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Testis Cancer Health Clozaril PS Novartis Required White Blood Cell Count Professional Pharmaceuticals Corp ORAL 400 MG, TWICE Intervention to Decreased A DAY, ORAL; Prevent Permanent Loxitane (Loxapine Impairment/Damage Succinate) C Artane (Trihexyphenidyl Hydrochloride) C Date:06/12/00ISR Number: 3511817-XReport Type:Expedited (15-DaCompany Report #AUS/00/00645/LEX Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Gas Gangrene Foreign Clozaril PS Novartis Lower Respiratory Tract Study Pharmaceuticals Corp ORAL 600 MG, ORAL; Infection Health Omeprazole Professional (Omeprazole) C Date:06/12/00ISR Number: 3512048-XReport Type:Expedited (15-DaCompany Report #USA/00/01503/LEX Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Nervous System Disorder Health Clozaril PS Novartis Required Systemic Lupus Professional Pharmaceuticals Corp ORAL 300 MG, ONCE Intervention to Erythematosus A DAY, ORAL Prevent Permanent Impairment/Damage Date:06/12/00ISR Number: 3512243-XReport Type:Expedited (15-DaCompany Report #00-05-0210 Age:86 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebral Atherosclerosis Health Clozapine PS Zenith Goldline ORAL 25-250MG ORAL Cerebrovascular Accident Professional Atenolol C Dysphagia Accupril C Sepsis Synthroid C Urinary Tract Infection 22-Feb-2006 08:30 AM Page: 746 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/12/00ISR Number: 3512256-8Report Type:Expedited (15-DaCompany Report #00-04-0197 Age:61 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozapine PS Zenith Goldline ORAL 200-450 MG Cerebral Ischaemia Professional ORAL Encephalopathy Myocardial Infarction Date:06/12/00ISR Number: 3512260-XReport Type:Expedited (15-DaCompany Report #00-04-0198 Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anxiety Health Clozapine PS Zenith Goldline ORAL 150 MG ORAL Depression Professional Depakote C Benadryl C Date:06/12/00ISR Number: 3512262-3Report Type:Expedited (15-DaCompany Report #00-04-0196 Age:74 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 12.5-75MG Professional ORAL Date:06/12/00ISR Number: 3512265-9Report Type:Expedited (15-DaCompany Report #00-03-0142 Age:84 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coronary Artery Disease Health Clozapine PS Zenith Goldline ORAL 25MG ORAL Dementia Professional Parkinson'S Disease Date:06/12/00ISR Number: 3512267-2Report Type:Expedited (15-DaCompany Report #00-05-0275 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 550-800MG Professional ORAL Date:06/15/00ISR Number: 3514329-2Report Type:Expedited (15-DaCompany Report #D/99/01619/LEX Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Biopsy Bone Marrow Foreign Clozaril PS Novartis Hospitalization - Abnormal Health Pharmaceuticals Corp ORAL 250 MG, ORAL Initial or Prolonged Chronic Myeloid Leukaemia Professional Cotrim Forte Required Leukaemia Granulocytic Other (Bactrim) C Intervention to Leukocytosis Prevent Permanent Thrombocythaemia Impairment/Damage 22-Feb-2006 08:30 AM Page: 747 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/15/00ISR Number: 3515511-0Report Type:Expedited (15-DaCompany Report #USA/00/01664/LEX Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozaril PS Novartis Professional Pharmaceuticals Corp TITRATION Date:06/15/00ISR Number: 3515512-2Report Type:Expedited (15-DaCompany Report #GB/00/00603/LEX Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril PS Novartis Health Pharmaceuticals Corp 500MG Professional Date:06/15/00ISR Number: 3515513-4Report Type:Expedited (15-DaCompany Report #USA/00/01678/LEX Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Other Clozaril PS Novartis Leukopenia Pharmaceuticals Corp ORAL 400 MG OTHER Neoplasm ORAL Humulin(Insulin) C Chemothrapy (Chemotherapeutics, Other) C Date:06/15/00ISR Number: 3515514-6Report Type:Expedited (15-DaCompany Report #GB/00/00477/LEX Age:33 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril PS Novartis Required Hyperglycaemia Health Pharmaceuticals Corp 300 MG, Intervention to Tachycardia Professional Metformin C Prevent Permanent Ventricular Hypertrophy Other Gliclazide Impairment/Damage (Gliclazide) C Date:06/19/00ISR Number: 3516054-0Report Type:Expedited (15-DaCompany Report #D/00/00748/LEX Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Bundle Branch Block Foreign Clozaril PS Novartis Hospitalization - Cardiomyopathy Health Pharmaceuticals Corp ORAL ORAL Initial or Prolonged Dyspnoea Professional Elcrit SS Required Hypertension Intervention to Hypotension Prevent Permanent Left Ventricular Failure Impairment/Damage Obstructive Airways Disorder Tachycardia Date:06/19/00ISR Number: 3516062-XReport Type:Expedited (15-DaCompany Report #GB/00/00614/LEX Age:46 YR Gender:Male I/FU:I Outcome PT Death Chest Pain Gastrointestinal 22-Feb-2006 08:30 AM Page: 748 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Haemorrhage Report Source Product Role Manufacturer Route Dose Duration Foreign Clozaril PS Novartis Study Pharmaceuticals Corp ORAL 350 MG, ORAL Health Professional Date:06/19/00ISR Number: 3516065-5Report Type:Expedited (15-DaCompany Report #AUS/00/01123/LEX Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Clozaril PS Novartis Ventricular Fibrillation Health Pharmaceuticals Corp ORAL 300 MG, ORAL Professional Date:06/19/00ISR Number: 3516180-6Report Type:Expedited (15-DaCompany Report #AUS/00/01132/LEX Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Clozaril PS Novartis Health Pharmaceuticals Corp ORAL 100 MG, ORAL Professional Date:06/19/00ISR Number: 3516181-8Report Type:Expedited (15-DaCompany Report #AUS/00/00953/LEX Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pyelonephritis Foreign Clozaril PS Novartis Initial or Prolonged Sepsis Study Pharmaceuticals Corp ORAL UNSPECIFIED, Health UNKNOWN ,ORAL Professional Date:06/19/00ISR Number: 3516183-1Report Type:Expedited (15-DaCompany Report #AUS/00/01092/LEX Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Malaise Foreign Clozaril PS Novartis Initial or Prolonged Neoplasm Malignant Study Pharmaceuticals Corp ORAL UNSPECIFIED,U Pneumonia Health NKNOWN, ORAL Professional Date:06/19/00ISR Number: 3516186-7Report Type:Expedited (15-DaCompany Report #GB/00/00120/LEX Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Angina Pectoris Foreign Clozaril PS Novartis Required Chest Pain Health Pharmaceuticals Corp ORAL 300 MG, Intervention to Coma Professional UNKNOWN,ORAL Prevent Permanent Diabetes Mellitus Impairment/Damage Dyspnoea Glycosylated Haemoglobin Increased Hyperglycaemia Metabolic Acidosis Tachycardia 22-Feb-2006 08:30 AM Page: 749 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/19/00ISR Number: 3516188-0Report Type:Expedited (15-DaCompany Report #AUS/00/00942/LEX Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Clonic Convulsion Foreign Clozaril PS Novartis Muscle Contractions Study Pharmaceuticals Corp ORAL UNSPECIFIED,U Involuntary Health NKNOWN; ORAL Pituitary Tumour Professional Date:06/19/00ISR Number: 3516190-9Report Type:Expedited (15-DaCompany Report #USA/00/01665/LEX Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Optic Atrophy Health Clozaril PS Novartis Professional Pharmaceuticals Corp ORAL UNSPECIFIED, UNKNOWN, ORAL Depakote C Lithium C Date:06/19/00ISR Number: 3516192-2Report Type:Expedited (15-DaCompany Report #CDN/00/00229/LEX Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agranulocytosis Foreign Clozaril PS Novartis Life-Threatening Bronchospasm Study Pharmaceuticals Corp Hospitalization - Lung Infection Health Initial or Prolonged Pseudomonal Professional Required Pseudomonal Sepsis Intervention to Pyrexia Prevent Permanent Respiratory Arrest Impairment/Damage Date:06/19/00ISR Number: 3516195-8Report Type:Expedited (15-DaCompany Report #AUS/00/01133/LEX Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Clozaril PS Novartis Suicide Attempt Health Pharmaceuticals Corp ORAL 400 MG, Professional UNKNOWN, ORAL; Date:06/19/00ISR Number: 3516215-0Report Type:Expedited (15-DaCompany Report #USA/00/01692/LEX Age:79 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril PS Novartis Professional Pharmaceuticals Corp ORAL 12.5 MG, ORAL Date:06/19/00ISR Number: 3516216-2Report Type:Expedited (15-DaCompany Report #USA/00/00980/LEX Age:51 YR Gender:Male I/FU:F Outcome Life-Threatening Hospitalization - Initial or Prolonged Required Intervention to 22-Feb-2006 08:30 AM Page: 750 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Diabetes Mellitus Health Clozaril PS Novartis Insulin-Dependent Professional Pharmaceuticals Corp ORAL 200 MG, ONCE Diabetic Ketoacidosis A DAY , ORAL Haemoglobinaemia Fluphenazine Hyperglycaemia Decanoate (Fluphenazine Decanoate) C Ranitidine (Ranitidine) C Atenolol C Olanzapine C Date:06/21/00ISR Number: 3516384-2Report Type:Expedited (15-DaCompany Report #00-05-0219 Age:73 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Health Clozapine PS Zenith Goldline ORAL 25 MG ORAL Professional Cipro C Neurontin C Buspar C Lanoxin C Date:06/21/00ISR Number: 3516386-6Report Type:Expedited (15-DaCompany Report #00-06-0279 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 12.5 MG ORAL Professional Date:06/21/00ISR Number: 3516388-XReport Type:Expedited (15-DaCompany Report #00-06-0280 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 262.5 - 462.5 Professional MG ORAL Date:06/21/00ISR Number: 3516389-1Report Type:Expedited (15-DaCompany Report #00-06-0278 Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiovascular Disorder Health Clozapine PS Zenith Goldline ORAL 30-300MG ORAL Professional Date:06/21/00ISR Number: 3517226-1Report Type:Expedited (15-DaCompany Report #GB/00/00642/LEX Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Haemodialysis Foreign Clozaril PS Novartis Initial or Prolonged Renal Failure Health Pharmaceuticals Corp ORAL 200 MG, ORAL; Required Renal Failure Chronic Professional 25 MG, ORAL, Intervention to Other 50 MG, ORAL Prevent Permanent Thyroxine Impairment/Damage (Levothyroxine 22-Feb-2006 08:30 AM Page: 751 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sodium) C Alfacalcidol (Alfacalcidol) C Iron Sulphate (Ferrous Sulfate) C Sodium Bicarbonate (Sodium Bicarbonate) C Perindopril (Perindopril) C Date:06/21/00ISR Number: 3517294-7Report Type:Expedited (15-DaCompany Report #USA/00/01503/LEX Age:36 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Systemic Lupus Health Clozaril PS Novartis Required Erythematosus Professional Pharmaceuticals Corp ORAL 300 MG, ONCE Intervention to A DAY; ORAL Prevent Permanent Impairment/Damage Date:06/21/00ISR Number: 3517296-0Report Type:Expedited (15-DaCompany Report #USA/00/01741/LEX Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dehydration Health Clozaril PS Novartis Initial or Prolonged Leukopenia Professional Pharmaceuticals Corp ORAL 350 MG, ORAL Other Small Cell Lung Cancer Zyrtec (Cetirizine Required Stage Unspecified Hydrochloride) C Intervention to Allopurinol C Prevent Permanent Florinef Impairment/Damage (Fludrocortisone Acetate) C Depakote (Valproate Semisodium) C Combivent Inhaler (Combivent) C Oxycontin (Oxycodone Hydrochloride) C Date:06/21/00ISR Number: 3517297-2Report Type:Expedited (15-DaCompany Report #GB/00/00626/LEX Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cerebrovascular Accident Foreign Clozaril PS Novartis Cerebrovascular Disorder Health Pharmaceuticals Corp ORAL 450 MG, ONCE Professional A DAY, ORAL, 500 MG, ONCE A DAY, ORAL Date:06/21/00ISR Number: 3517495-8Report Type:Expedited (15-DaCompany Report #AUS/00/00248/LEX Age:49 YR Gender:Female I/FU:F Outcome PT Disability Cardiac Failure Required Cardiomegaly Intervention to Cardiomyopathy Prevent Permanent Ejection Fraction Impairment/Damage Abnormal 22-Feb-2006 08:30 AM Page: 752 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Electrocardiogram Abnormal Left Ventricular Failure Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Foreign Clozaril PS Novartis Venous Pressure Jugular Health Pharmaceuticals Corp ORAL 500 MG, Increased Professional UNKNOWN, ORAL; Epilim (Valproate Sodium) C Fluoxetine (Fluoxetine) C Ephedrine (Ephedrine) C Date:06/21/00ISR Number: 3517496-XReport Type:Expedited (15-DaCompany Report #GB/00/00612/LEX Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Foreign Clozaril PS Novartis Initial or Prolonged Cardiomegaly Health Pharmaceuticals Corp ORAL 325 MG, Pleural Effusion Professional UNKNONW, ORAL Date:06/21/00ISR Number: 3517499-5Report Type:Expedited (15-DaCompany Report #USA/00/01045/LEX Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Alcohol Poisoning Health Clozaril PS Novartis Hospitalization - Blood Alcohol Increased Professional Pharmaceuticals Corp ORAL 300 MG, Initial or Prolonged Coma OTHER, ORAL; Dyspnoea Alcohol (Ethanol) SS ORAL UNSPECIFIED, Hypoventilation UNKNOWN, Respiratory Distress ORAL; Date:06/22/00ISR Number: 3517752-5Report Type:Expedited (15-DaCompany Report #USA/00/01627/LEX Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Health Clozaril PS Novartis Life-Threatening Cardiac Failure Professional Pharmaceuticals Corp 600 MG, Cardiomyopathy UNKNOWN Confusional State Zyprexa C Hypoxia Eldepryl C Pneumonia Ativan C Pneumonia Aspiration Vasotec C Lanoxin C Diuretic C Lipitor C Lactulose C Plavix C Prevacid C Date:06/22/00ISR Number: 3517793-8Report Type:Expedited (15-DaCompany Report #USA/00/01597/LEX Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozaril PS Novartis Professional Pharmaceuticals Corp 300 MG 22-Feb-2006 08:30 AM Page: 753 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/22/00ISR Number: 3517797-5Report Type:Expedited (15-DaCompany Report #AUS/00/00941/LEX Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiomegaly Foreign Clozaril PS Novartis Cardiomyopathy Health Pharmaceuticals Corp ORAL 550 MG, ORAL Ejection Fraction Professional Abnormal Electrocardiogram Abnormal Date:06/22/00ISR Number: 3517868-3Report Type:Expedited (15-DaCompany Report #AUS/00/00924/LEX Age:58 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiac Disorder Foreign Clozaril PS Novartis Study Pharmaceuticals Corp ORAL 300 MG, ORAL Health Prepulsid Professional (Cisapride) C Lasix (Furosemide) C Zantac (Ranitidine Hydrochloride) C Ferro-Gradumet (Ferrous Sulfate) C Perindopril (Perindopril) C Date:06/22/00ISR Number: 3517872-5Report Type:Expedited (15-DaCompany Report #AUS/00/01153/LEX Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Brain Damage Foreign Clozaril PS Novartis Initial or Prolonged Cardiac Disorder Health Pharmaceuticals Corp ORAL ORAL Encephalopathy Professional Date:06/22/00ISR Number: 3517873-7Report Type:Expedited (15-DaCompany Report #AUS/00/01152/LEX Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Clozaril PS Novartis Health Pharmaceuticals Corp ORAL 300 MG, ORAL Professional Date:06/23/00ISR Number: 3518264-5Report Type:Periodic Company Report #00-02-0089 Age:29 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Health Clozapine PS Zenith Goldline ORAL 100-300MG Initial or Prolonged Professional ORAL Lithium Citrate C Lithium Citrate C Diphenhydramine C Lorazepam C 22-Feb-2006 08:30 AM Page: 754 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/23/00ISR Number: 3518267-0Report Type:Expedited (15-DaCompany Report #00-02-0094 Age:87 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Clozapine PS Zenith Goldline ORAL 12.5 MG ORAL Ditropan Xl C Prilosec C Lactulose C Dilantin C Arthrotec C Permax C Sinemet C Asa C Centrum C Date:06/23/00ISR Number: 3518268-2Report Type:Periodic Company Report #00-03-0097 Age:91 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Health Clozapine PS Zenith Goldline ORAL 12.5 - 25 MG Other Professional ORAL Date:06/23/00ISR Number: 3518281-5Report Type:Periodic Company Report #00-03-0102 Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Respiratory Arrest Health Clozapine PS Zenith Goldline ORAL 750-850 MG Professional ORAL Date:06/23/00ISR Number: 3518282-7Report Type:Periodic Company Report #00-03-0105 Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine PS Zenith Goldline ORAL 900 MG ORAL Sepsis Professional Date:06/23/00ISR Number: 3518283-9Report Type:Periodic Company Report #00-03-0127 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine PS Zenith Goldline ORAL 600 MG ORAL Professional Wellbutrin C Date:06/23/00ISR Number: 3518286-4Report Type:Periodic Company Report #00-03-0128 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine PS Zenith Goldline ORAL 300-500MG Pulmonary Embolism Professional ORAL Date:06/23/00ISR Number: 3518287-6Report Type:Periodic Company Report #00-03-0130 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neutropenia Health Clozapine PS Zenith Goldline ORAL 300 MG ORAL Professional 22-Feb-2006 08:30 AM Page: 755 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/23/00ISR Number: 3518288-8Report Type:Periodic Company Report #00-03-0131 Age:71 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozapine PS Zenith Goldline ORAL 37.5-125MG Professional ORAL Valproic Acid C Ranitidine C Milk Of Magnesia C Tylenol C Roxanol C Dulcolax C Date:06/23/00ISR Number: 3518289-XReport Type:Expedited (15-DaCompany Report #00-03-0132 Age:46 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine PS Zenith Goldline ORAL 325 MG ORAL Professional Date:06/23/00ISR Number: 3518291-8Report Type:Expedited (15-DaCompany Report #00-03-0133 Age:69 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Clozapine PS Zenith Goldline ORAL 6-25MG ORAL Congestive Professional Date:06/23/00ISR Number: 3518292-XReport Type:Periodic Company Report #00-03-0134 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Chest Pain Health Clozapine PS Zenith Goldline ORAL 25 MG ORAL Myocardial Infarction Professional Skin Discolouration Date:06/23/00ISR Number: 3518293-1Report Type:Periodic Company Report #00-03-0135 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Pneumonia Health Clozapine PS Zenith Goldline ORAL 12.5-500 MG Hospitalization - Professional ORAL Initial or Prolonged Buspar C Deapkote C Ativan C Date:06/23/00ISR Number: 3518295-5Report Type:Periodic Company Report #00-03-0136 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neutropenia Health Clozapine PS Zenith Goldline ORAL 25-400 MG Professional ORAL Vaproic Acid C 22-Feb-2006 08:30 AM Page: 756 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/23/00ISR Number: 3518296-7Report Type:Periodic Company Report #00-03-0137 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Clozapine PS Zenith Goldline ORAL 600 MG ORAL Myocardial Infarction Professional Depakote C Haldol C Naproxen C Librium C Trazodone C Ambien C Date:06/23/00ISR Number: 3518297-9Report Type:Expedited (15-DaCompany Report #00-03-0139 Age:67 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Parkinson'S Disease Health Clozapine PS Zenith Goldline ORAL 125 MG ORAL Professional Date:06/23/00ISR Number: 3518299-2Report Type:Periodic Company Report #00-03-0145 Age:71 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dementia Health Clozapine PS Zenith Goldline ORAL 50 MG ORAL Pneumonia Aspiration Professional Date:06/23/00ISR Number: 3518300-6Report Type:Periodic Company Report #00-03-0146 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Health Clozapine PS Zenith Goldline ORAL 25-150 MG Cardiac Arrest Professional ORAL Parkinson'S Disease Date:06/23/00ISR Number: 3518301-8Report Type:Periodic Company Report #00-03-0147 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neutropenia Clozapine PS Zenith Goldline ORAL 175-350MG ORAL Clonazepam C Date:06/23/00ISR Number: 3518303-1Report Type:Periodic Company Report #00-03-0148 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Sepsis Health Clozapine PS Zenith Goldline ORAL 100 MG ORAL Initial or Prolonged Professional Date:06/23/00ISR Number: 3518305-5Report Type:Periodic Company Report #00-03-0149 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Health Clozapine PS Zenith Goldline ORAL 50-500MG ORAL Initial or Prolonged Professional 22-Feb-2006 08:30 AM Page: 757 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/23/00ISR Number: 3518307-9Report Type:Periodic Company Report #00-03-0151 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozapine PS Zenith Goldline ORAL ORAL Professional Date:06/23/00ISR Number: 3518309-2Report Type:Periodic Company Report #00-03-0152 Age:71 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine PS Zenith Goldline ORAL 150MG ORAL Professional Depakote C Dilantin C Phenobarbital C Risperdal C Trazodone C Ntg C Ntg C Calcium Carbonate Tablets C Date:06/23/00ISR Number: 3518311-0Report Type:Periodic Company Report #00-03-0154 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozapine PS Zenith Goldline ORAL 150-400MG Professional ORAL Prozac C Date:06/23/00ISR Number: 3518314-6Report Type:Periodic Company Report #00-03-0155 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozapine PS Zenith Goldline ORAL 100-250MG Hospitalization - Professional ORAL Initial or Prolonged Trifluoperazine C Cogentin C Date:06/23/00ISR Number: 3518316-XReport Type:Periodic Company Report #00-03-0156 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neutropenia Clozapine PS Zenith Goldline ORAL 200MG ORAL Mvi C Calcium Carbonate C Date:06/23/00ISR Number: 3518317-1Report Type:Periodic Company Report #00-04-0157 Age:71 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Health Clozapine PS Zenith Goldline ORAL 50-100MG ORAL Initial or Prolonged Professional Haldol C Olanzapine C Prilosec C Nifedipine Xl C Tylenol Prn C 22-Feb-2006 08:30 AM Page: 758 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Glipizide C Synthroid C Vistaril C Date:06/23/00ISR Number: 3518319-5Report Type:Periodic Company Report #00-04-0158 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozapine PS Zenith Goldline ORAL 200MG ORAL Professional Paxil C Date:06/23/00ISR Number: 3518320-1Report Type:Periodic Company Report #00-04-0161 Age:84 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine PS Zenith Goldline ORAL 25-27.5MG Professional ORAL Date:06/23/00ISR Number: 3518322-5Report Type:Periodic Company Report #00-04-0165 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Consumer Clozapine PS Zenith Goldline ORAL 100-150MG Initial or Prolonged ORAL Date:06/23/00ISR Number: 3518323-7Report Type:Periodic Company Report #00-04-0167 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine PS Zenith Goldline ORAL 150MG ORAL Pneumonia Professional Propulsid C Reglan C Luvox C Date:06/23/00ISR Number: 3518325-0Report Type:Periodic Company Report #00-04-0173 Age:82 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Clozapine PS Zenith Goldline ORAL 75MG ORAL Congestive Professional Date:06/23/00ISR Number: 3518326-2Report Type:Periodic Company Report #00-04-0174 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neutropenia Health Clozapine PS Zenith Goldline ORAL 388-500MG Professional ORAL Seroquel C 22-Feb-2006 08:30 AM Page: 759 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/23/00ISR Number: 3518328-6Report Type:Periodic Company Report #00-04-0178 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Parkinson'S Disease Health Clozapine PS Zenith Goldline ORAL 32.5-100MG Professional ORAL Permax C Levodopa-Carbidopa Tablets C Date:06/23/00ISR Number: 3518329-8Report Type:Periodic Company Report #00-04-0179 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Grand Mal Convulsion Health Clozapine PS Zenith Goldline ORAL 50-550MG ORAL Initial or Prolonged Professional Cogentin C Haldol Decanoate C Date:06/23/00ISR Number: 3518331-6Report Type:Periodic Company Report #00-04-0181 Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozapine PS Zenith Goldline ORAL 400MG ORAL Professional Prolixin C Cogentin C Glucophage C Ambien C Azmacort C Date:06/23/00ISR Number: 3518332-8Report Type:Periodic Company Report #00-04-0184 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Health Clozapine PS Zenith Goldline ORAL 300- 400 MG Initial or Prolonged Professional ORAL Date:06/23/00ISR Number: 3518333-XReport Type:Periodic Company Report #00-04-0185 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delirium Health Clozapine PS Zenith Goldline ORAL ORAL Initial or Prolonged Disorientation Professional Zyprexa Discontinued C Other Pyrexia Date:06/23/00ISR Number: 3518334-1Report Type:Periodic Company Report #00-03-0186 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Deep Vein Thrombosis Health Clozapine PS Zenith Goldline ORAL 300-400 MG Hospitalization - Dyspnoea Professional ORAL Initial or Prolonged Pulmonary Embolism Clozaril Tablets SS ORAL 800MG ORAL Proventil C Elavil C 22-Feb-2006 08:30 AM Page: 760 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/23/00ISR Number: 3518335-3Report Type:Periodic Company Report #00-04-0187 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Health Clozapine PS Zenith Goldline ORAL 50MG ORAL Initial or Prolonged Professional Date:06/23/00ISR Number: 3518340-7Report Type:Periodic Company Report #00-04-0190 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine PS Zenith Goldline ORAL 300-700MG Professional ORAL Date:06/23/00ISR Number: 3518341-9Report Type:Expedited (15-DaCompany Report #00-04-0191 Age:71 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Clozapine PS Zenith Goldline ORAL 12.5 MG ORAL Congestive Neoplasm Malignant Pneumonia Date:06/23/00ISR Number: 3518343-2Report Type:Periodic Company Report #00-04-0193 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Health Clozapine PS Zenith Goldline ORAL 400 MG ORAL Initial or Prolonged Professional Other Date:06/23/00ISR Number: 3518345-6Report Type:Periodic Company Report #00-04-0194 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neutropenia Health Clozapine PS Zenith Goldline ORAL 175 MG ORAL Professional Depakote C Depakote C Haldol C Haldol C Congentin C Lithium C Date:06/23/00ISR Number: 3518346-8Report Type:Periodic Company Report #00-04-0200 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine PS Zenith Goldline ORAL 400-500 MG Professional ORAL Date:06/23/00ISR Number: 3518348-1Report Type:Periodic Company Report #00-04-0201 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozapine PS Zenith Goldline ORAL 400-700 MG Professional ORAL 22-Feb-2006 08:30 AM Page: 761 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/23/00ISR Number: 3518349-3Report Type:Periodic Company Report #00-04-0202 Age:85 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine PS Zenith Goldline P.O. 75 MG Hospitalization - Professional Atenolol C Initial or Prolonged Isosorbide Monintrate C Aricept C Sinemet C Date:06/23/00ISR Number: 3518351-1Report Type:Periodic Company Report #00-04-0203 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophrenia Health Clozapine PS Zenith Goldline P.O. Initial or Prolonged Professional 200-300MG Date:06/23/00ISR Number: 3518353-5Report Type:Periodic Company Report #00-04-0204 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophrenia Health Clozapine PS Zenith Goldline P.O. 250-450 Initial or Prolonged Professional MG Date:06/23/00ISR Number: 3518354-7Report Type:Periodic Company Report #00-04-0206 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Leukopenia Health Clozapine PS Zenith Goldline ORAL 300 MG ORAL Professional Date:06/23/00ISR Number: 3518355-9Report Type:Periodic Company Report #00-04-0207 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Clozapine PS Zenith Goldline ORAL 300-325MG Professional ORAL Date:06/23/00ISR Number: 3518356-0Report Type:Periodic Company Report #00-04-0208 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neutropenia Clozapine PS Zenith Goldline ORAL 250 MG ORAL Date:06/23/00ISR Number: 3518358-4Report Type:Periodic Company Report #00-04-0213 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Overdose Health Clozapine PS Zenith Goldline ORAL 600 MG ORAL Other Professional Ultram Tablets SS ORAL 50 MG ORAL 22-Feb-2006 08:30 AM Page: 762 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/23/00ISR Number: 3518360-2Report Type:Expedited (15-DaCompany Report #00-05-0214 Age:70 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dementia Health Clozapine PS Zenith Goldline ORAL 50-112.5MG Parkinson'S Disease Professional ORAL Pneumonia Aspiration Levodopa-Carbidopa C Date:06/23/00ISR Number: 3518361-4Report Type:Periodic Company Report #00-05-0217 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Leukopenia Health Clozapine PS Zenith Goldline OPHTHALMIC 150-800 MG Professional ORAL Date:06/23/00ISR Number: 3518362-6Report Type:Periodic Company Report #00-05-0218 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neutropenia Health Clozapine PS Zenith Goldline ORAL 150-425 MG Professional ORAL Date:06/23/00ISR Number: 3518364-XReport Type:Periodic Company Report #00-05-0220 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Health Clozapine PS Zenith Goldline ORAL 900 MG ORAL Professional Dilantin C Lithium C Clonazepam C Cogentin C Date:06/23/00ISR Number: 3518365-1Report Type:Periodic Company Report #00-05-0225 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine PS Zenith Goldline ORAL 175-275 MG Professional ORAL Ranitidine C Paxil C Lorazepam C Peri-Colace C Beandryl C Ibuprofen C Date:06/23/00ISR Number: 3518368-7Report Type:Periodic Company Report #00-05-0236 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neutropenia Health Clozapine PS Zenith Goldline ORAL ORAL Hospitalization - Professional Initial or Prolonged 22-Feb-2006 08:30 AM Page: 763 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/23/00ISR Number: 3518371-7Report Type:Periodic Company Report #00-05-0238 Age:74 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Sepsis Health Clozapine PS Zenith Goldline ORAL 25 MG ORAL Initial or Prolonged Professional Date:06/23/00ISR Number: 3518379-1Report Type:Periodic Company Report #00-05-0242 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Gastroenteritis Health Clozapine PS Zenith Goldline ORAL 300 MG ORAL Initial or Prolonged Pancreatitis Professional Lithium C Date:06/23/00ISR Number: 3518380-8Report Type:Expedited (15-DaCompany Report #0124P Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Health Valproic Acid PS Rp Scherer North Initial or Prolonged Pancreatitis Acute Professional America ORAL 1000 MG AM & HS PO 4 MON Clozaril SS 100 MG AM & 150MG 2 WK Clozaril SS Date:06/23/00ISR Number: 3518382-1Report Type:Periodic Company Report #00-05-0249 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozapine PS Zenith Goldline ORAL 500 MG ORAL Professional Date:06/23/00ISR Number: 3518384-5Report Type:Periodic Company Report #00-05-0251 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophrenia Clozapine PS Zenith Goldline ORAL 25-450 MG Initial or Prolonged ORAL Date:06/23/00ISR Number: 3518386-9Report Type:Periodic Company Report #00-05-0252 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Platelet Count Decreased Health Clozapine PS Zenith Goldline ORAL 200 MG ORAL Professional Date:06/23/00ISR Number: 3518388-2Report Type:Periodic Company Report #00-05-0254 Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Respiratory Arrest Health Clozapine PS Zenith Goldline ORAL 150-400 MG Respiratory Failure Professional ORAL 22-Feb-2006 08:30 AM Page: 764 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/23/00ISR Number: 3518391-2Report Type:Periodic Company Report #00-05-0255 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Leukocytosis Health Clozapine PS Zenith Goldline ORAL 425-625 MG Professional ORAL Date:06/23/00ISR Number: 3518392-4Report Type:Periodic Company Report #00-04-0258 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Health Clozapine PS Zenith Goldline ORAL 900 MG ORAL Professional Date:06/23/00ISR Number: 3518393-6Report Type:Periodic Company Report #00-05-0259 Age:66 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Convulsion Health Clozapine PS Zenith Goldline ORAL 125 MG ORAL Professional Date:06/23/00ISR Number: 3518394-8Report Type:Periodic Company Report #00-05-0260 Age:78 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine PS Zenith Goldline ORAL 25 MG ORAL Professional Date:06/23/00ISR Number: 3518396-1Report Type:Periodic Company Report #00-05-0261 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Anaemia Health Clozapine PS Zenith Goldline ORAL 50-200 MG Leukopenia Professional ORAL Date:06/23/00ISR Number: 3518400-0Report Type:Periodic Company Report #00-05-0262 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine PS Zenith Goldline ORAL ORAL Professional Date:06/23/00ISR Number: 3518405-XReport Type:Periodic Company Report #00-05-0263 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Myocardial Infarction Health Clozapine PS Zenith Goldline ORAL 550 MG ORAL Initial or Prolonged Professional Date:06/23/00ISR Number: 3518407-3Report Type:Periodic Company Report #00-05-0264 Age:88 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine PS Zenith Goldline ORAL ORAL Respiratory Failure Professional 22-Feb-2006 08:30 AM Page: 765 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/23/00ISR Number: 3518408-5Report Type:Periodic Company Report #00-05-0270 Age:89 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Aspiration Health Clozapine PS Zenith Goldline ORAL 125 MG ORAL Professional Date:06/23/00ISR Number: 3518409-7Report Type:Periodic Company Report #00-05-0271 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neutropenia Health Clozapine PS Zenith Goldline ORAL 350 MG ORAL Professional Date:06/23/00ISR Number: 3518410-3Report Type:Expedited (15-DaCompany Report #99-09-0318 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Pain Health Clozapine PS Zenith Goldline ORAL 275MG-500MG Hospitalization - Abnormal Behaviour Professional ORAL Initial or Prolonged Anoxia Tagamet C Apnoea Zyprexa C Blood Creatine Darvocet-N C Phosphokinase Increased Risperdal C Bradycardia Benzatropine C Cardio-Respiratory Arrest Cerebral Ischaemia Chest X-Ray Abnormal Disseminated Intravascular Coagulation Dysarthria Dyspnoea Electroencephalogram Abnormal Encephalopathy Gastric Ulcer Leukocytosis Leukopenia Lung Infiltration Myocardial Infarction Myocardial Ischaemia Pneumonia Pulse Absent Renal Failure Acute Respiratory Arrest Respiratory Disorder Sepsis Speech Disorder Staphylococcal Infection Streptococcal Sepsis Date:06/23/00ISR Number: 3518411-5Report Type:Periodic Company Report #99-11-0389 Age:27 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diarrhoea Health Clozapine PS Zenith Goldline ORAL 150 MG ORAL Initial or Prolonged Professional 22-Feb-2006 08:30 AM Page: 766 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/23/00ISR Number: 3518412-7Report Type:Expedited (15-DaCompany Report #99-11-0426 Age:41 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Level Above Health Clozapine PS Zenith Goldline ORAL 450MG ORAL Therapeutic Professional Anafranil Capsules SS ORAL 150MG ORAL 9 YR Drug Toxicity Moban C Dyspnoea Neurontin C Leukocytosis Risperdal C Respiratory Disorder Date:06/23/00ISR Number: 3518413-9Report Type:Expedited (15-DaCompany Report #99-12-0448 Age:69 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozapine PS Zenith Goldline ORAL 500MG ORAL Dysphagia Professional Leukocytosis Pneumonia Date:06/23/00ISR Number: 3518415-2Report Type:Expedited (15-DaCompany Report #99-12-0456 Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Leukocytosis Health Clozapine PS Zenith Goldline ORAL 25MG ORAL Parkinson'S Disease Professional Pneumonia Date:06/23/00ISR Number: 3518434-6Report Type:Expedited (15-DaCompany Report #00-01-0003 Age:74 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Condition Aggravated Health Clozapine PS Zenith Goldline ORAL 125-325MG Mental Disorder Professional ORAL Pneumonia Date:06/23/00ISR Number: 3518435-8Report Type:Periodic Company Report #00-01-0011 Age:19 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozapine PS Zenith Goldline ORAL 325 MG ORAL Hospitalization - Pyrexia Professional Initial or Prolonged Date:06/23/00ISR Number: 3518437-1Report Type:Periodic Company Report #00-01-0027 Age:25 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Clozapine PS Zenith Goldline ORAL 100MG ORAL Depakote C Dilantin C Pepcid "Ovacon" C 22-Feb-2006 08:30 AM Page: 767 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/23/00ISR Number: 3518440-1Report Type:Expedited (15-DaCompany Report #00-01-0028 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coma Health Clozapine PS Zenith Goldline ORAL 900MG ORAL Cyanosis Professional Leukocytosis Sudden Death Date:06/23/00ISR Number: 3518441-3Report Type:Periodic Company Report #00-01-0031 Age:46 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pericardial Effusion Health Clozapine PS Zenith Goldline ORAL 200-600MG Initial or Prolonged Professional ORAL Depakene C Cogentin C Zestril C Date:06/23/00ISR Number: 3518444-9Report Type:Periodic Company Report #00-01-0037 Age:52 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine PS Zenith Goldline ORAL 500-650MG Hospitalization - Professional ORAL Initial or Prolonged Fluphenazine Decanoate C Hydrochlorothiazide C Relafen C Skelaxin C Cogentin C Inderal C Amitriptyline C Prilosec C Propranolol C Docusate C Date:06/23/00ISR Number: 3518446-2Report Type:Periodic Company Report #00-02-0047 Age:25 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pulmonary Embolism Health Clozapine PS Zenith Goldline ORAL 400MG ORAL Initial or Prolonged Professional Coumadin C Lovenox C Date:06/23/00ISR Number: 3518448-6Report Type:Periodic Company Report #00-02-0053 Age:31 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Phlebitis Health Clozapine PS Zenith Goldline ORAL 400MG ORAL Initial or Prolonged Pulmonary Embolism Professional Ortho Cyclen Tablets SS ORAL QD ORAL Trazodone C Atenolol C 22-Feb-2006 08:30 AM Page: 768 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/23/00ISR Number: 3518449-8Report Type:Periodic Company Report #00-02-0056 Age:69 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Parkinson'S Disease Health Clozapine PS Zenith Goldline ORAL 12.5MG ORAL Professional Date:06/23/00ISR Number: 3518450-4Report Type:Periodic Company Report #00-02-0058 Age:78 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Clozapine PS Zenith Goldline ORAL 25MG ORAL Initial or Prolonged Professional Parlodel Tablets SS ORAL 7.5MG ORAL Cogentin C Mysoline C Date:06/23/00ISR Number: 3518451-6Report Type:Periodic Company Report #00-02-0059 Age:43 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Health Clozapine PS Zenith Goldline ORAL ORAL Initial or Prolonged Professional Zyprexa C Date:06/23/00ISR Number: 3518452-8Report Type:Periodic Company Report #00-02-0061 Age:29 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aneurysm Health Clozapine PS Zenith Goldline ORAL 475MG ORAL Myocardial Infarction Professional Paxil C Ranitidine C Triamcinolone Ointment C Lo/Ovral C Date:06/23/00ISR Number: 3518453-XReport Type:Expedited (15-DaCompany Report #00-02-0066 Age:64 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine PS Zenith Goldline ORAL 300MG ORAL Professional Date:06/23/00ISR Number: 3518454-1Report Type:Expedited (15-DaCompany Report #00-02-0067 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Balance Disorder Health Clozapine PS Zenith Goldline ORAL ORAL Circulatory Collapse Professional Adalat Cc C Dizziness Lisinopril C Gastrointestinal Ulcer Ferrous Sulfate C Haemorrhage Axid C Obstructive Airways Prolixin C Disorder Benztropeine C Respiratory Arrest Vomiting 22-Feb-2006 08:30 AM Page: 769 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/23/00ISR Number: 3518455-3Report Type:Expedited (15-DaCompany Report #00-02-0074 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arterial Thrombosis Health Clozapine PS Zenith Goldline ORAL 300-450MG Cardiac Arrest Professional ORAL Coronary Artery Occlusion Prozac C Fibrosis Lorazepam C Hallucination, Auditory Myocardial Ischaemia Date:06/23/00ISR Number: 3518456-5Report Type:Periodic Company Report #00-02-0093 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Confusional State Health Clozapine PS Zenith Goldline ORAL 400MG ORAL Drug Interaction Professional Augmentin Tablets SS ORAL 500MG ORAL Other Date:06/23/00ISR Number: 3518457-7Report Type:Periodic Company Report #00-03-0108 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Health Clozapine PS Zenith Goldline ORAL 400MG ORAL Psychotic Disorder Professional Date:06/23/00ISR Number: 3518458-9Report Type:Periodic Company Report #00-03-0109 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Health Clozapine PS Zenith Goldline ORAL 600MG ORAL Psychotic Disorder Professional Date:06/23/00ISR Number: 3518459-0Report Type:Periodic Company Report #00-03-0110 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Psychotic Disorder Health Clozapine PS Zenith Goldline ORAL 50MG ORAL Professional Date:06/23/00ISR Number: 3518460-7Report Type:Periodic Company Report #00-03-0111 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Psychotic Disorder Health Clozapine PS Zenith Goldline ORAL 200MG ORAL Professional Date:06/23/00ISR Number: 3518462-0Report Type:Periodic Company Report #00-03-0113 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Psychotic Disorder Health Clozapine PS Zenith Goldline ORAL 400 MG ORAL Professional 22-Feb-2006 08:30 AM Page: 770 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/23/00ISR Number: 3518463-2Report Type:Periodic Company Report #00-03-0114 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Health Clozapine PS Zenith Goldline ORAL 900 MG ORAL Psychotic Disorder Professional Date:06/23/00ISR Number: 3518464-4Report Type:Periodic Company Report #00-03-0115 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Psychotic Disorder Health Clozapine PS Zenith Goldline ORAL 600 MG ORAL Professional Date:06/23/00ISR Number: 3518475-9Report Type:Periodic Company Report #00-03-0116 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Psychotic Disorder Health Clozapine PS Zenith Goldline ORAL 600 MG ORAL Professional Date:06/23/00ISR Number: 3518477-2Report Type:Periodic Company Report #00-03-0117 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Psychotic Disorder Health Clozapine PS Zenith Goldline ORAL 500 MG ORAL Professional Date:06/23/00ISR Number: 3518479-6Report Type:Periodic Company Report #00-03-0118 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Psychotic Disorder Health Clozapine PS Zenith Goldline ORAL 600 MG ORAL Professional Date:06/23/00ISR Number: 3518481-4Report Type:Periodic Company Report #00-03-0119 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Psychotic Disorder Health Clozapine PS Zenith Goldline ORAL 700 MG ORAL Professional Date:06/23/00ISR Number: 3518483-8Report Type:Periodic Company Report #00-03-0120 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Psychotic Disorder Health Clozapine PS Zenith Goldline ORAL 600 MG ORAL Professional Date:06/23/00ISR Number: 3518485-1Report Type:Periodic Company Report #00-03-0121 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Health Clozapine PS Zenith Goldline ORAL 700 MG ORAL Psychotic Disorder Professional 22-Feb-2006 08:30 AM Page: 771 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/23/00ISR Number: 3518491-7Report Type:Periodic Company Report #00-03-0125 Age:47 MON Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Clozapine PS Zenith Goldline ORAL 300 MG ORAL Professional Norvasc C Colace C Inderal C Date:06/23/00ISR Number: 3518493-0Report Type:Periodic Company Report #00-03-0138 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Parkinsonian Gait Health Clozapine PS Zenith Goldline ORAL 12.5 - 25 MG Sedation Professional ORAL Speech Disorder Date:06/23/00ISR Number: 3518495-4Report Type:Periodic Company Report #00-03-0153 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Heart Rate Increased Health Clozapine PS Zenith Goldline ORAL 500 - 550 MG Tremor Professional ORAL Urinary Incontinence Buspar C Wellbutrin C Depakote C Klonopin C Vitamin E C Date:06/23/00ISR Number: 3518496-6Report Type:Periodic Company Report #00-04-0164 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Health Clozapine PS Zenith Goldline ORAL 200 - 600 MG Weight Increased Professional ORAL Prozac C Date:06/23/00ISR Number: 3518497-8Report Type:Periodic Company Report #00-04-0215 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Health Clozapine PS Zenith Goldline ORAL 800 MG ORAL Professional Date:06/23/00ISR Number: 3518498-XReport Type:Periodic Company Report #00-04-0171 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dermatitis Health Clozapine PS Zenith Goldline ORAL 50 MG ORAL Professional 22-Feb-2006 08:30 AM Page: 772 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/23/00ISR Number: 3518499-1Report Type:Periodic Company Report #00-04-0216 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Ineffective Health Clozapine PS Zenith Goldline ORAL 100-700MG Professional ORAL Date:06/23/00ISR Number: 3518500-5Report Type:Periodic Company Report #00-04-0172 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Constipation Health Clozapine PS Zenith Goldline ORAL 25 - 200 MG Professional ORAL Depakote C Tegretol C Date:06/23/00ISR Number: 3518501-7Report Type:Periodic Company Report #00-05-0224 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abnormal Behaviour Health Clozapine PS Zenith Goldline ORAL 500MG ORAL Anxiety Professional Mental Impairment Paranoia Suspiciousness Date:06/23/00ISR Number: 3518502-9Report Type:Periodic Company Report #00-04-0182 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sedation Health Clozapine PS Zenith Goldline ORAL 550 - 600 MG Professional ORAL Clonidine C Date:06/23/00ISR Number: 3518503-0Report Type:Periodic Company Report #00-05-0227 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Health Clozapine PS Zenith Goldline ORAL ORAL Professional Date:06/23/00ISR Number: 3518504-2Report Type:Periodic Company Report #00-04-0183 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sedation Health Clozapine PS Zenith Goldline ORAL 400 MG ORAL Professional Risperdal C Effexor Xr C Prolixin C Date:06/23/00ISR Number: 3518505-4Report Type:Periodic Company Report #00-05-0232 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Health Clozapine - Zenith Professional Goldline Pharm. 22-Feb-2006 08:30 AM Page: 773 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tablets PS ORAL 400-700 MG ORAL Risperdal C Date:06/23/00ISR Number: 3518506-6Report Type:Periodic Company Report #00-05-0233 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Depression Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS ORAL ORAL Zoloft C Date:06/23/00ISR Number: 3518507-8Report Type:Periodic Company Report #00-05-0234 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Schizophrenia Health Clozapine PS Zenith Goldline ORAL 250-750MG Professional ORAL Date:06/23/00ISR Number: 3518508-XReport Type:Periodic Company Report #00-05-0237 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Nausea Health Clozapine PS Zenith Goldline ORAL 75MG ORAL Professional Date:06/23/00ISR Number: 3518509-1Report Type:Periodic Company Report #00-05-0243 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Priapism Health Clozapine PS Zenith Goldline ORAL 35-350MG ORAL Professional Depakote C Klonopin C Paxil C Pepcid C Claritin C Colace C Multivitamins C Atropine Drops C Date:06/23/00ISR Number: 3518510-8Report Type:Periodic Company Report #00-05-0244 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dysphagia Health Clozapine PS Zenith Goldline ORAL 12.5-350MG Salivary Hypersecretion Professional ORAL Sedation Zoloft C Weight Increased Nimodipine C Klonopin C 22-Feb-2006 08:30 AM Page: 774 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/23/00ISR Number: 3518511-XReport Type:Periodic Company Report #00-05-0250 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Enuresis Health Clozapine PS Zenith Goldline ORAL 300MG ORAL Urinary Incontinence Professional Prinivil C Maxair C Albuterol C Procardia Xl C Vistaril C Date:06/23/00ISR Number: 3518512-1Report Type:Periodic Company Report #00-05-0253 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dermatitis Health Clozapine PS Zenith Goldline ORAL ORAL Professional Date:06/23/00ISR Number: 3518513-3Report Type:Periodic Company Report #00-05-0256 Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dysphagia Health Clozapine PS Zenith Goldline ORAL 200-800MG Professional ORAL Date:06/23/00ISR Number: 3518514-5Report Type:Periodic Company Report #00-05-0257 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Salivary Hypersecretion Health Clozapine PS Zenith Goldline ORAL 800MG ORAL Professional Lamictal C Depakote C Neurontin C Thorazine C Date:06/23/00ISR Number: 3518516-9Report Type:Periodic Company Report #00-04-0274 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Health Clozapine PS Zenith Goldline ORAL 450MG ORAL Muscle Tightness Professional Sedation Tremor Date:06/23/00ISR Number: 3518517-0Report Type:Periodic Company Report #00-01-0034 Age:51 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Health Clozapine PS Zenith Goldline ORAL ORAL Drug Level Above Professional Cipro Tablets SS Therapeutic 22-Feb-2006 08:30 AM Page: 775 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/23/00ISR Number: 3518518-2Report Type:Periodic Company Report #00-01-0042 Age:27 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amnesia Health Clozapine PS Zenith Goldline ORAL 350MG ORAL Cognitive Disorder Professional Clozaril Tablets SS ORAL ORAL Fatigue Prozac C Movement Disorder Lamictal C Speech Disorder Weight Increased Date:06/23/00ISR Number: 3518519-4Report Type:Periodic Company Report #00-02-0048 Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eye Movement Disorder Health Clozapine PS Zenith Goldline ORAL 900MG ORAL Professional Clozaril Tablets SS ORAL 900MG ORAL Cogentin C Date:06/23/00ISR Number: 3518520-0Report Type:Periodic Company Report #00-02-0063 Age:17 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pain In Extremity Health Clozapine PS Zenith Goldline ORAL 150-300MG Weight Increased Professional ORAL Effexor C Date:06/23/00ISR Number: 3518717-XReport Type:Expedited (15-DaCompany Report #USA/00/00822/LEX Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril PS Novartis Professional Pharmaceuticals Corp ORAL ORAL Date:06/23/00ISR Number: 3518719-3Report Type:Expedited (15-DaCompany Report #USA/00/01745/LEX Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Medication Error Health Clozaril PS Novartis Initial or Prolonged Suicide Attempt Professional Pharmaceuticals Corp ORAL 400 MG, OTHER, ORAL Prozac C Cogentin C Lipitor C Vasotec C Norvasc C Colace C Date:06/23/00ISR Number: 3518721-1Report Type:Expedited (15-DaCompany Report #USA/00/01177/LEX Age:54 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aneurysm Health Clozaril PS Novartis Professional Pharmaceuticals Corp ORAL 150 MG, ONCE A DAY, ORAL Seroquel C Zoloft C 22-Feb-2006 08:30 AM Page: 776 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Klonopin C Accupril C Potassium Suplement C Aldactazide C Senokot C Date:06/23/00ISR Number: 3518723-5Report Type:Expedited (15-DaCompany Report #AUS/00/00947/LEX Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Foreign Clozaril PS Novartis Initial or Prolonged Study Pharmaceuticals Corp Health Temazepam Professional (Temazepam) SS Date:06/26/00ISR Number: 3519562-1Report Type:Expedited (15-DaCompany Report #S/00/00264/LEX Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dermatitis Exfoliative Foreign Clozaril PS Novartis Initial or Prolonged Exfoliative Rash Health Pharmaceuticals Corp ORAL 350 MG, ORAL Required Psoriasis Professional Theralen Intervention to Rash Erythematous Other (Alimemazine Prevent Permanent Rash Psoriaform Tartrate) C Impairment/Damage Skin Disorder Stesolid (Diazepam) C Staphylococcal Infection Tegretol Streptococcal Infection (Carbamazepine) C Date:06/26/00ISR Number: 3519563-3Report Type:Expedited (15-DaCompany Report #LIT/00/00290/LEX Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Level Above Foreign Clozaril PS Novartis Therapeutic Literature Pharmaceuticals Corp 400 MG; 600 Hepatic Failure Health MG Metastasis Professional Chlordiazepoxide Neoplasm Malignant (Chlordiazepoxide) C Pneumonia Paracetamol Sepsis (Paracetamol) C Amoxicillin (Amoxicillin) C Date:06/26/00ISR Number: 3519775-9Report Type:Expedited (15-DaCompany Report #GB/00/00498/LEX Age:43 YR Gender:Male I/FU:I Outcome PT Death Blood Creatine Phosphokinase Increased Brain Hypoxia C-Reactive Protein Increased Cardiac Arrest Diarrhoea Dizziness Drug Level Below Therapeutic Hyperhidrosis 22-Feb-2006 08:30 AM Page: 777 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hypotension Hypoxia Malaise Report Source Product Role Manufacturer Route Dose Duration Orthostatic Hypotension Foreign Clozaril PS Novartis Pallor Health Pharmaceuticals Corp 150 MG ORAL; Pyrexia Professional 300 MG ORAL Salivary Hypersecretion Hyoscine C Sedation Senna C Shock Lactulose C Tachycardia Upper Respiratory Tract Infection Vomiting Weight Decreased Date:06/26/00ISR Number: 3519807-8Report Type:Expedited (15-DaCompany Report #USA/00/00820/LEX Age:64 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Extrapyramidal Disorder Health Clozaril PS Novartis Parkinson'S Disease Professional Pharmaceuticals Corp ORAL UNSPECIFIED, ORAL Date:06/27/00ISR Number: 3520233-6Report Type:Direct Company Report # Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Clozapine 100mg (Zenith Goldline) PS Zenith Goldine ORAL 375MG HS/PO Clozapine 25mg (Zenith Goldine) SS Zenith Goldine Date:06/27/00ISR Number: 3520237-3Report Type:Direct Company Report # Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Clozapine 100mg (Zenith Goldline) PS Zenith Goldine ORAL 100MG QAM PO Clozapine 25mg (Zenith Goldine) SS Zenith Goldine ORAL 25MG QID PO Date:06/27/00ISR Number: 3520429-3Report Type:Expedited (15-DaCompany Report #IRL/00/00271/LEX Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Circulatory Collapse Foreign Clozaril PS Novartis Initial or Prolonged Constipation Health Pharmaceuticals Corp ORAL 500 MG, ORAL Required Faecaloma Professional Intervention to Intestinal Perforation Prevent Permanent Postoperative Infection Impairment/Damage Respiratory Arrest Shock Staphylococcal Infection 22-Feb-2006 08:30 AM Page: 778 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/29/00ISR Number: 3521523-3Report Type:Expedited (15-DaCompany Report #00-06-0296 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 900MG ORAL Professional Date:06/29/00ISR Number: 3521527-0Report Type:Expedited (15-DaCompany Report #00-06-0294 Age:78 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 12.55-12MG Professional ORAL Date:06/29/00ISR Number: 3522313-8Report Type:Expedited (15-DaCompany Report #GB/00/00115/LEX Age:65 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abnormal Behaviour Foreign Clozaril PS Novartis Amnesia Health Pharmaceuticals Corp ORAL ORAL Arrhythmia Professional Blood Creatine Phosphokinase Increased Cerebrovascular Disorder Coma Confusional State Depression Dysarthria Haemorrhagic Stroke Heart Rate Irregular Loss Of Consciousness Sedation Speech Disorder Date:06/29/00ISR Number: 3522314-XReport Type:Expedited (15-DaCompany Report #AUS/00/00857/LEX Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypertrophic Obstructive Foreign Clozaril PS Novartis Cardiomyopathy Health Pharmaceuticals Corp ORAL 450 MG, ORAL; Ventricular Hypertrophy Professional Sodium Valproate (Valproate Sodium) C Date:06/29/00ISR Number: 3522315-1Report Type:Expedited (15-DaCompany Report #AUS/00/00294/LEX Age:24 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Foreign Clozaril PS Novartis Epilepsy Study Pharmaceuticals Corp ORAL 600 MG, ORAL; Neuroma Health UNKNOWN, Schizophrenia Professional UNKNOWN, ORAL; 22-Feb-2006 08:30 AM Page: 779 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/30/00ISR Number: 3522865-8Report Type:Direct Company Report # Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Neutropenia Quetiapine 250 Mg PS ORAL 250 MG BID Intervention to ORAL Prevent Permanent Clozapine 100 Mg SS ORAL 400 ONCE A Impairment/Damage DAY ORAL Lorazepan C Date:06/30/00ISR Number: 3523012-9Report Type:Expedited (15-DaCompany Report #8-99247-014A Age:66 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - C-Reactive Protein Study Effexor Xr PS Wyeth Ayerst Initial or Prolonged Increased Laboratories Inc ORAL 75 MG 1X PER Other Extrapyramidal Disorder 1 DAY ORAL, Hallucination 150 MG 1X PER Red Blood Cell 1 DAY, 225 MG Sedimentation Rate 1X PER 1 DAY, 16 DAY Increased Leponex SS 200 MG DAILY Orfiril (Valproate Sodium) C Pirenzepine C Date:06/30/00ISR Number: 3523102-0Report Type:Expedited (15-DaCompany Report #USA/00/01163/LEX Age:58 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Lymphopenia Health Clozaril PS Novartis Professional Pharmaceuticals Corp ORAL 500 MG, ORAL Clonazepam C Glipizide C Date:07/03/00ISR Number: 3523781-8Report Type:Expedited (15-DaCompany Report #GB/00/00663/LEX Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiac Disorder Foreign Clozaril PS Novartis Complications Of Maternal Health Pharmaceuticals Corp ORAL 50 MG, ONCE A Exposure To Therapeutic Professional DAY, ORAL Drugs Fluoxetine C Congenital Genital Malformation Date:07/03/00ISR Number: 3523782-XReport Type:Expedited (15-DaCompany Report #GB/00/00255/LEX Age:53 YR Gender:Male I/FU:I Outcome PT Hospitalization - Abdominal Pain Initial or Prolonged Blood Ph Increased Required Cardiac Failure Intervention to Cardiomegaly Prevent Permanent Chest Pain Impairment/Damage Chest X-Ray Abnormal Confusional State Constipation Coxsackie Viral Infection 22-Feb-2006 08:30 AM Page: 780 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Crepitations Dyspnoea Electrocardiogram Report Source Product Role Manufacturer Route Dose Duration Abnormal Foreign Clozaril PS Novartis Enterovirus Infection Health Pharmaceuticals Corp ORAL 100 MG, TWICE Eosinophilia Professional A DAY, ORAL Extrasystoles Quetiapine Hypotension (Quetiapine) C Hypoxia Gaviscon (Gaviscon) C Left Ventricular Failure Cyproterone Lower Respiratory Tract (Cyproterone) C Infection Malaise Nausea Neck Pain Neutropenia Nosocomial Infection Pain Pneumonia Po2 Decreased Pyrexia Supraventricular Extrasystoles Tachyarrhythmia Tachycardia Vomiting Date:07/03/00ISR Number: 3523783-1Report Type:Expedited (15-DaCompany Report #GB/00/00614/LEX Age:46 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Chest Pain Foreign Clozaril PS Novartis Collapse Of Lung Study Pharmaceuticals Corp ORAL 350 MG, ORAL Duodenitis Health Cisapride Gastrointestinal Professional (Cisapride) C Haemorrhage Omeprazole Oesophageal Perforation (Omeprazole) C Oesophageal Ulcer Haemorrhage Date:07/03/00ISR Number: 3582103-7Report Type:Periodic Company Report #2000-04-1234 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Haemoglobinaemia Health Rebetol PS Schering Plough Polycythaemia Professional Research Institute ORAL ORAL 48 WK Intron A (Interferon Alfa-2b Recombinant) Injectable Solution SS 48 WK Clozaril SS Date:07/05/00ISR Number: 3523819-8Report Type:Expedited (15-DaCompany Report #00-06-0309 Age:88 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 25 MG ORAL Professional 22-Feb-2006 08:30 AM Page: 781 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/05/00ISR Number: 3523822-8Report Type:Expedited (15-DaCompany Report #00-06-0308 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Clozapine PS Zenith Goldline ORAL 25- 225MG ORAL Date:07/05/00ISR Number: 3523824-1Report Type:Expedited (15-DaCompany Report #00-06-0310 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 300- 500MG Professional ORAL Date:07/05/00ISR Number: 3523827-7Report Type:Expedited (15-DaCompany Report #00-06-0295 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asthenia Health Clozapine PS Zenith Goldline ORAL 800-900MG Lethargy Professional ORAL Multi-Organ Failure Pain Date:07/05/00ISR Number: 3523830-7Report Type:Expedited (15-DaCompany Report #00-05-0275 Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 550-800MG Professional ORAL Date:07/05/00ISR Number: 3523834-4Report Type:Expedited (15-DaCompany Report #00-05-0228 Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 400 MG ORAL Professional Date:07/05/00ISR Number: 3523838-1Report Type:Expedited (15-DaCompany Report #00-04-0160 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Huntington'S Chorea Health Clozapine PS Zenith Goldline ORAL 600-750MG Professional ORAL Date:07/05/00ISR Number: 3523861-7Report Type:Expedited (15-DaCompany Report #00-05-0211 Age:70 YR Gender:Female I/FU:F Outcome PT Death Cerebrovascular Accident Hospitalization - Dehydration Initial or Prolonged Delusion Hallucination Leukocytosis Mental Disorder Pyrexia Sepsis 22-Feb-2006 08:30 AM Page: 782 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Speech Disorder Tremor Urinary Tract Infection Report Source Product Role Manufacturer Route Dose Duration Urine Analysis Abnormal Health Clozapine PS Zenith Goldline ORAL 150MG ORAL Professional Neurontin C Verapamil C Lithium C Date:07/06/00ISR Number: 3525212-0Report Type:Direct Company Report # Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Asthenia Clozaril 100mg U/D Intervention to Chills (Sandoz) PS Sandoz ORAL 200MG PO Prevent Permanent Feeling Cold HS(9PM) Impairment/Damage Headache Lopid C Pyrexia Tylenol C Tachycardia Visteril C Tachypnoea Analgasic Balm C Tremor Tinactin Powder C Urinary Incontinence Date:07/10/00ISR Number: 3526613-7Report Type:Expedited (15-DaCompany Report #00-05-0228 Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 400 MG ORAL Professional Restoril C Date:07/10/00ISR Number: 3526614-9Report Type:Expedited (15-DaCompany Report #00-05-0219 Age:73 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Health Clozapine PS Zenith Goldline ORAL 25 MG ORAL Cardiac Failure Professional Cipro C Congestive Neurontin C Cerebrovascular Accident Buspar C Chronic Obstructive Lanoxin C Pulmonary Disease Condition Aggravated Depression Pneumonia Pulmonary Congestion Pulmonary Oedema Date:07/10/00ISR Number: 3526615-0Report Type:Expedited (15-DaCompany Report #00-05-0230 Age:82 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 25MG ORAL Professional 22-Feb-2006 08:30 AM Page: 783 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/10/00ISR Number: 3526616-2Report Type:Expedited (15-DaCompany Report #00-06-0312 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Health Clozapine PS Zenith Goldline ORAL 500 MG ORAL Professional Date:07/10/00ISR Number: 3526619-8Report Type:Expedited (15-DaCompany Report #00-06-0311 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Neoplasm Malignant Health Clozapine PS Zenith Goldline ORAL 225-450MG Professional ORAL Date:07/10/00ISR Number: 3526620-4Report Type:Expedited (15-DaCompany Report #00-06-0313 Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aneurysm Health Clozapine PS Zenith Goldline ORAL 600 MG ORAL Professional Date:07/10/00ISR Number: 3526621-6Report Type:Expedited (15-DaCompany Report #00-05-0321 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Health Clozapine PS Zenith Goldline ORAL 50MG ORAL Initial or Prolonged Professional Date:07/10/00ISR Number: 3526622-8Report Type:Expedited (15-DaCompany Report #00-03-0320 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Surgery Health Clozapine PS Zenith Goldline ORAL 25-175MG ORAL Initial or Prolonged Professional Date:07/10/00ISR Number: 3526623-XReport Type:Expedited (15-DaCompany Report #00-04-0174 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Leukaemia Health Clozapine PS Zenith Goldline ORAL 388-500 MG Hospitalization - Leukopenia Professional ORAL Initial or Prolonged Neutropenia Seroquel C Date:07/10/00ISR Number: 3526624-1Report Type:Expedited (15-DaCompany Report #00-06-0295 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asthenia Health Clozapine PS Zenith Goldline ORAL 800-900MG Lethargy Professional ORAL Multi-Organ Failure Pain Renal Failure 22-Feb-2006 08:30 AM Page: 784 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/10/00ISR Number: 3526773-8Report Type:Expedited (15-DaCompany Report #D/00/00800/LEX Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Foreign Clozaril PS Novartis Initial or Prolonged Blood Fibrinogen Study Pharmaceuticals Corp ORAL 125 MG, ORAL; Increased Health 200 MG, Blood Urea Increased Professional UNKNOWN, Coagulation Time ORAL;, 250 MG Prolonged , UNKNOWN, Diarrhoea Orfiril (Valproate Drug Level Above Soidum) C Therapeutic Truxal Eosinophilia (Chlorpothixene Eosinophilic Pneumonia Hydrochloride) C Haemoglobin Decreased Hepatosplenomegaly Hypersensitivity Hyponatraemia Leukocytosis Liver Function Test Abnormal Lung Infiltration Oliguria Pericardial Effusion Pleural Effusion Date:07/10/00ISR Number: 3526860-4Report Type:Expedited (15-DaCompany Report #AUS/00/00858/LEX Age:22 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asphyxia Foreign Clozaril PS Novartis Aspiration Study Pharmaceuticals Corp Coma Health Completed Suicide Professional Drug Toxicity Date:07/10/00ISR Number: 3526863-XReport Type:Expedited (15-DaCompany Report #AUS/00/00942/LEX Age:35 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Clonic Convulsion Foreign Clozaril PS Novartis Muscle Contractions Study Pharmaceuticals Corp ORAL 600 MG ORAL Involuntary Health Sodium Valproate Pituitary Tumour Benign Professional (Valproate Sodium) C Date:07/10/00ISR Number: 3526865-3Report Type:Expedited (15-DaCompany Report #AUS/00/01152/LEX Age:20 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Suicide Attempt Foreign Clozaril PS Novartis Health Pharmaceuticals Corp 300 MG Professional 22-Feb-2006 08:30 AM Page: 785 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/10/00ISR Number: 3526871-9Report Type:Expedited (15-DaCompany Report #GB/00/00551/LEX Age:19 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Constipation Foreign Clozaril PS Novartis Initial or Prolonged Diabetes Mellitus Health Pharmaceuticals Corp 500 MG Required Diarrhoea Professional Intervention to Ketoacidosis Prevent Permanent Polydipsia Impairment/Damage Sedation Thirst Vomiting Date:07/10/00ISR Number: 3526872-0Report Type:Expedited (15-DaCompany Report #RA/00/01886/LEX Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Haematocrit Decreased Foreign Clozaril PS Novartis Initial or Prolonged Haemoglobin Decreased Health Pharmaceuticals Corp Leukaemia Granulocytic Professional Leukopenia Lower Respiratory Tract Infection Lymphopenia Neutropenia Red Blood Cell Count Decreased Date:07/10/00ISR Number: 3526885-9Report Type:Expedited (15-DaCompany Report #GB/98/00184/LEX Age:38 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Foreign Clozaril PS Novartis Hospitalization - Cardiomyopathy Health Pharmaceuticals Corp ORAL 100 MG TWICE Initial or Prolonged Chronic Obstructive Professional A DAY, ORAL; Required Pulmonary Disease 200 MG TWICE Intervention to Congestive Cardiomyopathy A DAY, ORAL Prevent Permanent Cough Co-Amilofruse Impairment/Damage Cryptogenic Organizing (Frumil) C Pneumonia Aerolin (Salbutamol Dyspnoea Sulfate) C Ejection Fraction Aerobic Forte C Abnormal Ferrous Sulphate Haemorrhage Intracranial (Ferrous Sulfate) C Hypokinesia Prednisolone Lower Respiratory Tract (Prednisolone) C Infection Lactulose Mental Impairment (Lactulose) C Myocarditis Pneumonia Pneumonia Klebsiella Respiratory Arrest Respiratory Depression Subdural Haematoma Thrombocytopenia 22-Feb-2006 08:30 AM Page: 786 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/10/00ISR Number: 3526886-0Report Type:Expedited (15-DaCompany Report #GB/98/00666/LEX Age:37 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Congestive Cardiomyopathy Foreign Clozaril PS Novartis Initial or Prolonged Hypokinesia Other Pharmaceuticals Corp ORAL OTH, ORAL Required Left Ventricular Failure Prednisolone Intervention to Malaise (Prednisolone) C Prevent Permanent Tachycardia Lactulose Impairment/Damage (Lactulose) C Ventolin (Salbutamol) C Co-Amilofruse (Frumil) C Date:07/10/00ISR Number: 3527224-XReport Type:Expedited (15-DaCompany Report #USA/00/01874/LEX Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozaril PS Novartis Metastases To Lung Professional Pharmaceuticals Corp Sarcoma Date:07/10/00ISR Number: 3527226-3Report Type:Expedited (15-DaCompany Report #NZ/00/00082/LEX Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Clozaril PS Novartis Initial or Prolonged Haematemesis Health Pharmaceuticals Corp ORAL 375 MG ORAL Hiatus Hernia Professional Oesophageal Ulcer Other Oesophagitis Date:07/10/00ISR Number: 3527229-9Report Type:Expedited (15-DaCompany Report #GB/00/00612/LEX Age:27 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Foreign Clozaril PS Novartis Initial or Prolonged Cardiomegaly Health Pharmaceuticals Corp ORAL 325 MG, ORAL Required Congestive Cardiomyopathy Professional Intervention to Dyspnoea Prevent Permanent Haemoptysis Impairment/Damage Pleural Effusion Date:07/10/00ISR Number: 3527233-0Report Type:Expedited (15-DaCompany Report #AUS/00/00912/LEX Age:24 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Foreign Clozaril PS Novartis Initial or Prolonged Diabetes Mellitus Health Pharmaceuticals Corp ORAL 300 MG, ORAL Required Fatigue Professional Intervention to Hyperglycaemia Prevent Permanent Neuropathy Peripheral Impairment/Damage Vision Blurred Visual Disturbance Weight Increased 22-Feb-2006 08:30 AM Page: 787 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/10/00ISR Number: 3527264-0Report Type:Expedited (15-DaCompany Report #00D--10829 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Arthralgia Foreign Ludiomil PS Novartis Deep Vein Thrombosis Health Pharmaceuticals Corp 50 MG DAILY Oedema Peripheral Professional Leponex (Clozapine) SS Pain In Extremity Other Tavor C Heparin C Date:07/10/00ISR Number: 3527438-9Report Type:Expedited (15-DaCompany Report #RA/00/01875/LEX Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Apnoea Foreign Clozaril PS Novartis Hospitalization - Cardio-Respiratory Arrest Company Pharmaceuticals Corp ORAL 300 MG ORAL 90 DAY Initial or Prolonged Hyperhidrosis Representative Tegretol SS 1200 MG 90 DAY Required Tonic Convulsion Intervention to Prevent Permanent Impairment/Damage Date:07/10/00ISR Number: 3527445-6Report Type:Expedited (15-DaCompany Report #AUS/00/00953/LEX Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Foreign Clozaril PS Novartis Initial or Prolonged Syndrome Study Pharmaceuticals Corp ORAL 350 MG, ORAL Required Pyelonephritis Health Lithium C Intervention to Sepsis Professional Prevent Permanent Impairment/Damage Date:07/10/00ISR Number: 3527447-XReport Type:Expedited (15-DaCompany Report #GB/00/00713/LEX Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Foreign Clozaril PS Novartis Initial or Prolonged Shock Health Pharmaceuticals Corp ORAL ORAL Professional Date:07/10/00ISR Number: 3527448-1Report Type:Expedited (15-DaCompany Report #AUS/00/00941/LEX Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiomyopathy Foreign Clozaril PS Novartis Dyspnoea Health Pharmaceuticals Corp ORAL 450 MG, ORAL Ejection Fraction Professional Abnormal Electrocardiogram Abnormal 22-Feb-2006 08:30 AM Page: 788 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/11/00ISR Number: 3527108-7Report Type:Expedited (15-DaCompany Report #C2000-0831.01 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cholecystectomy Health Clozapine PS Mylan Initial or Prolonged Small Intestinal Professional Pharmaceuticals Inc ORAL 300 MG Q AM, Other Obstruction Other 500MG Q PM, ORAL Accupril C Metamucil C Date:07/11/00ISR Number: 3527179-8Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Clozaril 400mg Hs (Novartis)>5yr PS Navane 10mg Hs (Generic) SS Atenolol 100mg Hs (Generic)>6mo SS Cogentin C Date:07/11/00ISR Number: 3527734-5Report Type:Expedited (15-DaCompany Report #JACGER2000001030 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Haldol PS Rw Johnson Initial or Prolonged Phosphokinase Increased Health Pharmaceutical Gait Disturbance Professional Research Institute Hyperhidrosis Div Ortho Pharm ORAL MG, DAILY, Muscle Rigidity ORAL Parkinsonism Leponex (Clozapine) SS ORAL MG, DAILY, Sinus Tachycardia ORAL Tremor Fluanxol (Flupentixol Dihydrochloride) SS ORAL MG, DAILY, ORAL Tavor (Lorazepam) C Akineton (Biperiden Hydrochloride) C Zyprexa (Olanzapine) C Date:07/12/00ISR Number: 3527582-6Report Type:Direct Company Report # Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coma Clozaril 400mg PS ORAL 200MG PO BID Hyperglycaemia Hypotension Ketoacidosis Pancreatitis Chronic 22-Feb-2006 08:30 AM Page: 789 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/12/00ISR Number: 3528311-2Report Type:Expedited (15-DaCompany Report #00RA-10005 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Apnoea Foreign Tegretol-Xr PS Novartis Hospitalization - Cardio-Respiratory Arrest Company Pharmaceuticals Corp ORAL 1200 MG, Initial or Prolonged Hyperhidrosis Representative DAILY, ORAL 90 DAY Required Tonic Convulsion Lapenax (Clozapine) SS ORAL 300 MG DAILY, Intervention to ORAL 90 DAY Prevent Permanent Impairment/Damage Date:07/13/00ISR Number: 3528300-8Report Type:Expedited (15-DaCompany Report #00-07-0323 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Neoplasm Malignant Health Clozapine PS Zenith Goldline ORAL 700-900MG Professional ORAL Date:07/13/00ISR Number: 3528304-5Report Type:Expedited (15-DaCompany Report #00-05-0268 Age:54 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Vaginal Cancer Health Clozapine PS Zenith Goldline ORAL ORAL Professional Date:07/13/00ISR Number: 3528305-7Report Type:Expedited (15-DaCompany Report #00-07-0322 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 200-300MG Professional ORAL Date:07/13/00ISR Number: 3528306-9Report Type:Expedited (15-DaCompany Report #00-06-0324 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 500MG ORAL Professional Date:07/13/00ISR Number: 3528308-2Report Type:Expedited (15-DaCompany Report #00-06-0325 Age:71 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 25MG ORAL Professional Date:07/13/00ISR Number: 3528990-XReport Type:Expedited (15-DaCompany Report #JRFUSA2000002001 Age:51 YR Gender:Female I/FU:F Outcome Hospitalization - Initial or Prolonged Required Intervention to Prevent Permanent 22-Feb-2006 08:30 AM Page: 790 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Convulsion Health Risperdal PS Janssen Research Fdn Delirium Professional Div Johnson And Fibula Fracture Johnson ORAL 9 MG, DAILY, Hyponatraemia ORAL Leukocytosis Clozapine Lower Limb Fracture (Clozapine) SS ORAL ORAL Pneumonia Aspiration Seroquel (Seroquel) SS ORAL ORAL Respiratory Distress Respiratory Failure Tibia Fracture Date:07/13/00ISR Number: 3529250-3Report Type:Expedited (15-DaCompany Report #GB/00/00603/LEX Age:28 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Foreign Clozaril PS Novartis Initial or Prolonged Diabetes Mellitus Health Pharmaceuticals Corp ORAL 500 MG ORAL Required Urinary Tract Infection Professional Valproate Sodium C Intervention to Vomiting Lithium Carbonate C Prevent Permanent Impairment/Damage Date:07/13/00ISR Number: 3529251-5Report Type:Expedited (15-DaCompany Report #AUS/00/01133/LEX Age:29 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Clozaril PS Novartis Overdose Health Pharmaceuticals Corp ORAL 400 MG, ORAL Pulmonary Embolism Professional Tricyclics SS Weight Increased Luvox C Largactil C Leulen C Date:07/14/00ISR Number: 3529899-8Report Type:Expedited (15-DaCompany Report #S00-GER-00980-01 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Foreign Celexa PS Forest Laboratories Initial or Prolonged Biopsy Bone Marrow Health Inc ORAL 20 MG QD PO Abnormal Professional Cipramil (Citalopram Bone Marrow Depression Hydrobromide) SS ORAL 30 MG QD PO Leukocytosis Leponex "Novartis" Neutrophilia (Clozapine) SS ORAL 25 MG QD PO Pyrexia Leponex "Novartis" Red Blood Cell Count (Clozapine) SS ORAL 50 MG QD PO Decreased Leponex "Novartis" Suicide Attempt (Clozapine) SS ORAL 100 MG QD PO Leponex "Novartis" (Clozapine) SS ORAL 250 MG QD PO Leponex "Novartis" (Clozapine) SS ORAL 350 MG QD PO Elobact (Cefuroxime Axetil) SS ORAL 500 MG QD PO Leponex "Novartis" (Clozapine) SS ORAL 300 MG QD PO 22-Feb-2006 08:30 AM Page: 791 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Leponex "Novartis" (Clozapine) SS ORAL 175 MG QD PO Leponex "Novartis" (Clozapine) SS ORAL 75 MG QD PO Sonata (Zaleplon) C Acc Long (Acetylcysteine) C Navisinetten (Oxymetazoline Hydrochloride) C Date:07/14/00ISR Number: 3529996-7Report Type:Expedited (15-DaCompany Report #DW/93/00283/LEX Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Bundle Branch Block Foreign Clozaril PS Novartis Disability Cardiomegaly Health Pharmaceuticals Corp ORAL 250 MG Required Congestive Cardiomyopathy Professional UNKNOWN ORAL Intervention to Weight Increased Tavor C Prevent Permanent Neurocil C Impairment/Damage Atosil (Isopromethazine Hydrochloride) C Date:07/14/00ISR Number: 3529999-2Report Type:Expedited (15-DaCompany Report #DW/94/00429/LEX Age:39 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Bundle Branch Block Left Foreign Clozaril PS Novartis Required Congestive Cardiomyopathy Health Pharmaceuticals Corp ORAL 250 MG Intervention to Professional UNKNOWN ORAL Prevent Permanent Atosil C Impairment/Damage Date:07/14/00ISR Number: 3530001-7Report Type:Expedited (15-DaCompany Report #PHBS2000BR04069 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatic Enzyme Increased Foreign Clozaril PS Novartis Initial or Prolonged Hepatitis Viral Health Pharmaceuticals Corp ORAL 100 MG BID Jaundice Professional ORAL 2 YR Other Date:07/14/00ISR Number: 3530069-8Report Type:Expedited (15-DaCompany Report #PHFR2000GB00451 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Foreign Clozaril PS Novartis Initial or Prolonged Transient Ischaemic Health Pharmaceuticals Corp ORAL ORAL Attack Professional Other 22-Feb-2006 08:30 AM Page: 792 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/18/00ISR Number: 3531136-5Report Type:Expedited (15-DaCompany Report #00-0934 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Foreign Loxitane PS Watson Laboratories Initial or Prolonged Biopsy Bone Marrow Health Inc ORAL 100 MG ONCE Other Abnormal Professional DAILY ORAL Leponex (Clozapine) SS ORAL 250 MG DAILY ORAL .... C Hept-A-Myl (Heotaminol) C Daflon (Bioblavins) C Depo-Provera (Medroxyprogesterone ) C Date:07/20/00ISR Number: 3532041-0Report Type:Expedited (15-DaCompany Report #00-07-0334 Age:67 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetic Coma Health Clozapine PS Zenith Goldline ORAL 75MG-500MG Professional ORAL Date:07/20/00ISR Number: 3532530-9Report Type:Expedited (15-DaCompany Report #PHFR2000GB00457 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Foreign Clozaril PS Novartis Initial or Prolonged Hyperglycaemia Health Pharmaceuticals Corp ORAL 400 MG/DAY, Professional ORAL Other Date:07/20/00ISR Number: 3532645-5Report Type:Expedited (15-DaCompany Report #PHBS2000CA04064 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Foreign Clozaril PS Novartis Increased Literature Pharmaceuticals Corp ORAL ORAL 16 DAY Anorexia Health Lithium (Lithium) SS 12 DAY Aspartate Professional Aminotransferase Other Increased Asthenia Blood Alkaline Phosphatase Increased Blood Creatinine Increased Eosinophilia Fatigue Influenza Like Illness Leukocytosis Nausea Pyrexia Sinus Tachycardia Vomiting 22-Feb-2006 08:30 AM Page: 793 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/20/00ISR Number: 3532646-7Report Type:Expedited (15-DaCompany Report #PHBS2000AU04123 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Gastrointestinal Necrosis Foreign Clozaril PS Novartis Initial or Prolonged Study Pharmaceuticals Corp ORAL 175 MG/DAY, Required Health ORAL Intervention to Professional Prevent Permanent Other Impairment/Damage Date:07/20/00ISR Number: 3532647-9Report Type:Expedited (15-DaCompany Report #PHBS2000NZ04134 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Neoplasm Malignant Foreign Clozaril PS Novartis White Blood Cell Count Health Pharmaceuticals Corp ORAL 450 MG/DAY, Increased Professional ORAL Other Cyproterone (Cyproterone) C Chemotherapeutics (Chemotherapeutic, Other) C Date:07/20/00ISR Number: 3532696-0Report Type:Expedited (15-DaCompany Report #PHEH2000US02479 Age:79 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Health Clozaril PS Novartis Prostate Cancer Professional Pharmaceuticals Corp ORAL 12.5 MG/DAY, ORAL Tasmar (Tolcapone) C Proamatine (Midodrine Hydrochloride) C Plavix (Clopidogrel Sulfate) C Sinemet (Levodopa, Carbidopa) C Amantadine (Amantadine) C Detrol (Tolterodine L-Tartrate) C Date:07/20/00ISR Number: 3532698-4Report Type:Expedited (15-DaCompany Report #PHEH1999US03439 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Clozaril PS Novartis Loss Of Consciousness Professional Pharmaceuticals Corp ORAL 300 MG, TID, Pulmonary Congestion ORAL Ativan C Inderal C 22-Feb-2006 08:30 AM Page: 794 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/20/00ISR Number: 3532699-6Report Type:Expedited (15-DaCompany Report #PHEH2000US02825 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Respiratory Arrest Health Clozaril PS Novartis Professional Pharmaceuticals Corp ORAL 600 MG, ORAL Date:07/21/00ISR Number: 3532705-9Report Type:Expedited (15-DaCompany Report #00-05-0231 Age:52 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL ORAL Professional Date:07/21/00ISR Number: 3532707-2Report Type:Expedited (15-DaCompany Report #00-07-0338 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 600MG ORAL Professional Date:07/21/00ISR Number: 3532708-4Report Type:Expedited (15-DaCompany Report #00-07-0335 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ankle Fracture Health Clozapine PS Zenith Goldline ORAL 350-500MG Initial or Prolonged Professional ORAL Date:07/21/00ISR Number: 3533464-6Report Type:Expedited (15-DaCompany Report #A024029 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anhedonia Foreign Zoloft PS Pfizer Initial or Prolonged Circulatory Collapse Literature Pharmaceuticals Inc ORAL 150.00 MG Dizziness Health TOTAL: BID: Dyspnoea Professional ORAL Hyperhidrosis Clozapine SS ORAL 400.00 MG Poverty Of Speech TOTAL: BID: Pulmonary Embolism ORAL Social Avoidant Behaviour Tachycardia Thinking Abnormal Weight Decreased Date:07/21/00ISR Number: 3533594-9Report Type:Expedited (15-DaCompany Report #2000AP03226 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Foreign Seroquel PS Astrazeneca Uk Ltd ORAL 75 MG DAILY Initial or Prolonged Health PO Required Professional Leponex SS Novartis Intervention to Other Pharmaceuticals ORAL 100 MG DAILY Prevent Permanent PO Impairment/Damage Aspirin C Bayer Sorbidilat C Diamicron C Seropram C 22-Feb-2006 08:30 AM Page: 795 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/21/00ISR Number: 3533999-6Report Type:Expedited (15-DaCompany Report #240429 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Foreign Clonopin PS Hoffmann La Roche Anaemia Other Inc ORAL 30 DROP 1 PER Aplasia DAY ORAL Delirium Depakine (Valproate Haemoglobin Decreased Sodium) SS ORAL 4 DOSE FORM Leukopenia DAILY ORAL Myeloid Maturation Arrest Imovane (Zopiclone) Neutropenia 7.5 Mg SS ORAL 7.5 MG 1 PER Persecutory Delusion DAY ORAL Weight Decreased Leponex (Clozapine) SS ORAL 550 MG 1 PER DAY ORAL Ditropan (Oxybutynin Chloride) 5 Mg SS ORAL 2.5 MG 3 PER DAY ORAL Date:07/24/00ISR Number: 3534469-1Report Type:Expedited (15-DaCompany Report #PHBS2000AU04068 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiomyopathy Foreign Clozaril PS Novartis Leukopenia Study Pharmaceuticals Corp ORAL ORAL Neutropenia Health Professional Other Date:07/24/00ISR Number: 3534473-3Report Type:Expedited (15-DaCompany Report #PHHO2000AU02747 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Neoplasm Malignant Foreign Clozaril PS Novartis Hospitalization - Pneumonia Study Pharmaceuticals Corp ORAL ORAL Initial or Prolonged Health Professional Other Date:07/24/00ISR Number: 3534478-2Report Type:Expedited (15-DaCompany Report #PHBS1999GB05568 Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Catecholamines Foreign Clozaril PS Novartis Initial or Prolonged Abnormal Health Pharmaceuticals Corp ORAL 450 MG, BID, Diabetes Mellitus Professional ORAL Hyperhidrosis Other Venlafaxine Hypertension (Venlafaxine) C Phaeochromocytoma Sulpiride Tachycardia (Sulpiride) C Date:07/24/00ISR Number: 3534479-4Report Type:Expedited (15-DaCompany Report #PHHO2000AU00569 Age:30 YR Gender:Male I/FU:F Outcome PT Death Circulatory Collapse Cor Pulmonale Myocardial Infarction 22-Feb-2006 08:30 AM Page: 796 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sleep Apnoea Syndrome Report Source Product Role Manufacturer Route Dose Duration Foreign Clozaril PS Novartis Study Pharmaceuticals Corp ORAL 600 MG, QD, Health ORAL Professional Other Date:07/25/00ISR Number: 3535262-6Report Type:Expedited (15-DaCompany Report #S00-GER-00980-01 Age:20 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Foreign Celexa PS Forest Laboratories Initial or Prolonged Bone Marrow Depression Health Inc ORAL 20 MG QD PO Depression Professional Cipramil (Citalopram Erythropenia Other Hydrobromide) SS ORAL 30 MG QD PO Headache Leponex (Clozapine) SS ORAL 25 MG QD PO Leukopenia Leponex (Clozapine) SS ORAL 50 MG QD PO Myelodysplastic Syndrome Leponex (Clozapine) SS ORAL 75 MG QD PO Neutropenia Leponex (Clozapine) SS ORAL 100 MG QD PO Pyrexia Leponex (Clozapine) SS ORAL 175 MG QD PO Suicide Attempt Leponex (Clozapine) SS ORAL 250 MG QD PO Leponex (Clozapine) SS ORAL 300 MG QD PO Leponex (Clozapine) SS ORAL 350 MG QD PO Elobact (Cefuroxime Axetil) SS ORAL 500 MG QD PO Sonata (Zaleplon) C Acc Long(Acetylcysteine) C Navisinetten (Oxymetazoline Hydrochloride) C Date:07/25/00ISR Number: 3535274-2Report Type:Expedited (15-DaCompany Report #PHHO2000GB01966 Age:43 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Circulatory Collapse Foreign Clozaril PS Novartis Drug Interaction Study Pharmaceuticals Corp ORAL 600 MG/DAY, Drug Level Above Health ORAL Therapeutic Professional Clomipramine Respiratory Failure (Clomipramine Sudden Death Hydrochloride) SS ORAL ORAL Thioridazine C Date:07/25/00ISR Number: 3535275-4Report Type:Expedited (15-DaCompany Report #PHHO2000AU01991 Age:58 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiac Disorder Foreign Clozaril PS Novartis Cardiomegaly Study Pharmaceuticals Corp ORAL 300 MG, ORAL Echocardiogram Abnormal Health Prepulsid C Professional Lasix C Other Zantac C Ferro-Gradumet C Perindopril C 22-Feb-2006 08:30 AM Page: 797 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/25/00ISR Number: 3535279-1Report Type:Expedited (15-DaCompany Report #PHBS2000DE01876 Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Atrioventricular Block Foreign Clozaril PS Novartis First Degree Health Pharmaceuticals Corp ORAL 250 MG, QD , Cardiomyopathy Professional ORAL Echocardiogram Abnormal Other Electrocardiogram Abnormal Ventricular Extrasystoles Date:07/25/00ISR Number: 3535280-8Report Type:Expedited (15-DaCompany Report #PHBS2000FR03434 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Asthenia Foreign Clozaril PS Novartis Hospitalization - Cardiac Failure Health Pharmaceuticals Corp ORAL 400 MG/DAY, Initial or Prolonged Congestive Professional ORAL Disability Cardiomyopathy Other Teralithe (Lithium Myocarditis Carbonate) (Lithium Pyrexia Carbonate) SS ORAL 600 MG/DAY, ORAL 1 YR Depakine C Largactil C Tranxene C Kaleroid C Date:07/25/00ISR Number: 3535282-1Report Type:Expedited (15-DaCompany Report #PHBS2000GB01207 Age:32 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril PS Novartis Non-Insulin-Dependent Health Pharmaceuticals Corp ORAL 425 MG, ORAL 1820 DAY Weight Increased Professional Citalopram C Other Gaviscon C Gamolenic Acid C Metformin C Date:07/26/00ISR Number: 3535537-0Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pneumonia Clozapine 100mg-Zenith/Goldlin e PS Zenith/Goldline ORAL PO 200MG VID 400MG HS Dulcolax C Surfak C Klonopin C Synthroid C Depakote C Lactulose C 22-Feb-2006 08:30 AM Page: 798 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/26/00ISR Number: 3535585-0Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pneumonia Clozapine 100mg - Zenith /Goldline PS Zenith/ Goldline ORAL 200MG BID HS PO Ativan C Mom C Metamucil C Date:07/26/00ISR Number: 3535589-8Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pneumonia Clozapine 100 Mg Zenith/Goldline PS Zenith/Goldline 200 MG BID HS Vancenase C Depakote C Lactulose C Claritin C Prilosec C Ativan C Nacl C Date:07/26/00ISR Number: 3535592-8Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Lobar Pneumonia Clozapine 25mg - Zenith/Goldline PS Zenith/Goldline ORAL 112.5MG PO Ecasa C Mov C Glipizide C Haldol C Isosorbide C Lopressor C Procardia C Topamax C Date:07/26/00ISR Number: 3535595-3Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pneumonia Clozapine 100 Mg - Zenith/Goldline PS Zenith/Goldline ORAL 200 MG AM PO 400 MG HS Prolixin C Ativan C Metformin C Oxybutynin C Zoloft C Mom C Metamucil C 22-Feb-2006 08:30 AM Page: 799 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/27/00ISR Number: 3536250-6Report Type:Expedited (15-DaCompany Report #00-07-0339 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 300-337.5 MG Professional ORAL Date:07/27/00ISR Number: 3536252-XReport Type:Expedited (15-DaCompany Report #00-07-0340 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 525MG ORAL Professional Date:07/27/00ISR Number: 3536254-3Report Type:Expedited (15-DaCompany Report #00-07-0336 Age:67 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Other Clozapine PS Zenith Goldline ORAL 50-250MG ORAL Date:07/27/00ISR Number: 3536321-4Report Type:Expedited (15-DaCompany Report #00-06-0312 Age:39 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Health Clozapine PS Zenith Goldline ORAL 500MG ORAL Professional Depakote Ec C Date:07/27/00ISR Number: 3536322-6Report Type:Expedited (15-DaCompany Report #00-05-0321 Age:51 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Health Clozapine PS Zenith Goldline ORAL 50MG ORAL Initial or Prolonged Professional Date:07/27/00ISR Number: 3536323-8Report Type:Expedited (15-DaCompany Report #00-03-0320 Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arthropathy Health Clozapine PS Zenith Goldline ORAL 25-175MG ORAL Initial or Prolonged Surgery Professional Date:07/27/00ISR Number: 3536325-1Report Type:Expedited (15-DaCompany Report #00-06-0294 Age:78 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 12.5-125MG Professional ORAL Date:07/27/00ISR Number: 3536327-5Report Type:Expedited (15-DaCompany Report #00-06-0308 Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 25-225MG ORAL Professional Glucophage C Lasix C 22-Feb-2006 08:30 AM Page: 800 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Catapres C Haldol C Elavil C Altace C Zocor C Novolin C Date:07/27/00ISR Number: 3536329-9Report Type:Expedited (15-DaCompany Report #00-07-0337 Age:66 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Peritonitis Health Clozapine PS Zenith Goldline ORAL 50-700MG ORAL Professional Date:07/27/00ISR Number: 3536417-7Report Type:Expedited (15-DaCompany Report #PHBS2000AU04204 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Foreign Clozaril PS Novartis Initial or Prolonged Abnormal Health Pharmaceuticals Corp ORAL 500 MG/DAY, Overdose Professional ORAL Restrictive Other Alcohol (Ethanol) SS Cardiomyopathy Benzodiazepine (No Ingredients/Substanc es) SS Date:07/27/00ISR Number: 3536533-XReport Type:Expedited (15-DaCompany Report #PHHO2000AU01100 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Injury Asphyxiation Foreign Clozaril PS Novartis Study Pharmaceuticals Corp ORAL 50 MG, BID, Health ORAL Professional Paroxetine Other (Paroxetine) C Diazepam C Date:07/27/00ISR Number: 3536534-1Report Type:Expedited (15-DaCompany Report #PHBS2000CA04131 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthma Foreign Clozaril PS Novartis Dyspnoea Health Pharmaceuticals Corp ORAL ORAL Laryngeal Disorder Professional Pneumonia Other Respiratory Disorder Date:07/27/00ISR Number: 3536536-5Report Type:Expedited (15-DaCompany Report #PHHO1998AU01752 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Clozaril PS Novartis Other Insomnia Study Pharmaceuticals Corp ORAL 300 MG/DAY, Leukopenia Health ORAL Neutropenia Professional Other 22-Feb-2006 08:30 AM Page: 801 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/27/00ISR Number: 3536537-7Report Type:Expedited (15-DaCompany Report #PHBS2000AU02080 Age:38 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthma Foreign Clozaril PS Novartis Dyspnoea Health Pharmaceuticals Corp ORAL UNSPECIFIED, Hyperhidrosis Professional ORAL Movement Disorder Other Respiratory Disorder Date:07/27/00ISR Number: 3536580-8Report Type:Expedited (15-DaCompany Report #00P-056-0095331-00(0) Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Foreign Depakene PS Abbott Laboratories Hospitalization - Aplasia Health Pharmaceutical Initial or Prolonged Haemoglobin Decreased Professional Products Div ORAL 4 DOSAGE FORMS, 1 IN 1 D, PER ORAL Zopiclone (Zopiclone) SS ORAL 7.5 MG, 1 IN 1 D, PER ORAL Clozapine (Clozapine) SS ORAL 550 MG, 1 IN 1 D, PER ORAL Oxybutynin (Oxybutynin) SS ORAL 2.5 MG, 3 IN 1 D, PER ORAL Clonazepam (Clonazepam) SS ORAL 3 MG, 1 IN 1 D, PER ORAL Date:07/27/00ISR Number: 3536619-XReport Type:Expedited (15-DaCompany Report #PHBS2000AU04205 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bone Marrow Depression Foreign Clozaril PS Novartis Initial or Prolonged Dialysis Health Pharmaceuticals Corp Required Leukopenia Professional Intervention to Malaise Other Prevent Permanent Neutropenia Impairment/Damage Pancytopenia Renal Failure Sepsis Date:07/27/00ISR Number: 3536624-3Report Type:Expedited (15-DaCompany Report #PHBS2000GB03360 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Clonic Convulsion Foreign Clozaril PS Novartis Diabetes Mellitus Health Pharmaceuticals Corp ORAL 700 MG DAILY, Diabetic Ketoacidosis Professional ORAL Polyuria Other Simvastatin C Thirst Lamotrigine C Fluoxetine C Domperidone C Ranitidine C Diclofenac C Fybogel C 22-Feb-2006 08:30 AM Page: 802 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Clonazepam C Lithium C Date:07/27/00ISR Number: 3536625-5Report Type:Expedited (15-DaCompany Report #PHH02000GB01815 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril PS Novartis Non-Insulin-Dependent Study Pharmaceuticals Corp ORAL 650 MG, ORAL Fatigue Health Sulpiride C Hyperglycaemia Professional Lansoprazole C Polyuria Other Thirst Date:07/27/00ISR Number: 3536626-7Report Type:Expedited (15-DaCompany Report #PHBS2000CA04195 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Grand Mal Convulsion Foreign Clozaril PS Novartis Initial or Prolonged Hypernatraemia Health Pharmaceuticals Corp ORAL SEE IMAGE Other Influenza Professional Olanzapine C Other Venlafaxine C Antibiotics C Oxazepam C Pantoprazole C Date:07/27/00ISR Number: 3536627-9Report Type:Expedited (15-DaCompany Report #PHFR2000GB00478 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Neoplasm Malignant Foreign Clozaril PS Novartis Study Pharmaceuticals Corp ORAL 275 MG/DAY, Health PO Professional Other Date:07/27/00ISR Number: 3536628-0Report Type:Expedited (15-DaCompany Report #PHBS2000CA04247 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Brain Neoplasm Foreign Clozaril PS Novartis Initial or Prolonged Study Pharmaceuticals Corp ORAL PO Other Other Date:07/27/00ISR Number: 3536639-5Report Type:Expedited (15-DaCompany Report #PHH01998AU01752 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Clozaril PS Novartis Other Insomnia Study Pharmaceuticals Corp ORAL 300 MG/DAY; Neutropenia Health ORAL Professional Other 22-Feb-2006 08:30 AM Page: 803 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/28/00ISR Number: 3537735-9Report Type:Expedited (15-DaCompany Report #PHEH2000US02980 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Health Clozaril PS Novartis Professional Pharmaceuticals Corp Date:07/28/00ISR Number: 3537787-6Report Type:Expedited (15-DaCompany Report #PHBS1999AU04725 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiomyopathy Foreign Clozaril PS Novartis Initial or Prolonged Left Ventricular Failure Health Pharmaceuticals Corp ORAL 75 MG MANE & Mental Impairment Professional 100 MG Orthostatic Hypotension Other NOCTE/DAY, Psychotic Disorder ORAL Pyrexia Olanzapine Tachycardia (Olanzapine) SS 5 MG, QD Sodium Valproate (Valproate Sodium) C Ranitidine (Ranitidine) C Date:07/28/00ISR Number: 3537790-6Report Type:Expedited (15-DaCompany Report #PHHO2000AU03028 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Balance Disorder Foreign Clozaril PS Novartis Initial or Prolonged Dizziness Study Pharmaceuticals Corp ORAL 100MG/DAY, Dysarthria Health ORAL Dyskinesia Professional Prozac (Fluoxetine Eyelid Ptosis Other Hydrochloride) SS 20 MG/DAY Face Oedema Flushing Guillain-Barre Syndrome Headache Muscle Rigidity Musculoskeletal Stiffness Paraesthesia Speech Disorder Developmental Vision Blurred Date:07/31/00ISR Number: 3538198-XReport Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Lobar Pneumonia Clozapine 100mg/25mg-Zenith/Go ldine PS Zenith/Goldine ORAL PO 100MG AM PO & 175MG HS Risperdal C Nacl C Valproic Acid C 22-Feb-2006 08:30 AM Page: 804 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/31/00ISR Number: 3538830-0Report Type:Expedited (15-DaCompany Report #JRFUSA2000002933 Age:50 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Health Risperdal PS Janssen Research Fdn Initial or Prolonged Anticholinergic Syndrome Professional Div Johnson And Diarrhoea Johnson ORAL 3 MG, 2 IN Erythropenia DAY(S), ORAL Hypotension SEE IMAGE Leukopenia Clozaril SS ORAL ORAL Thrombocytopenia Paroxetine SS ORAL ORAL Vomiting Haldol (Tablet) Loperidol C Date:07/31/00ISR Number: 3538934-2Report Type:Expedited (15-DaCompany Report #PHBS2000KP04287 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Foreign Clozaril PS Novartis Abnormal Literature Pharmaceuticals Corp 200 MG/DAY 21 DAY Myocardial Ischaemia Health Ventricular Hypertrophy Professional Other Date:07/31/00ISR Number: 3538936-6Report Type:Expedited (15-DaCompany Report #PHBS2000KP04286 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiomegaly Foreign Clozaril PS Novartis Literature Pharmaceuticals Corp 68.75 MG/DAY Other Date:07/31/00ISR Number: 3539006-3Report Type:Expedited (15-DaCompany Report #PHBS2000KP04290 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Foreign Clozaril PS Novartis Prolonged Literature Pharmaceuticals Corp 137.MG 39 DAY Health Professional Date:07/31/00ISR Number: 3539010-5Report Type:Expedited (15-DaCompany Report #PHBS2000AU04208 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiac Enzymes Increased Foreign Clozaril PS Novartis Chest Pain Health Pharmaceuticals Corp ORAL 400 MG QD, Cough Professional ORAL Electrocardiogram T Wave Other Amplitude Decreased Myocarditis Neutrophil Count Increased Oral Candidiasis Pharyngolaryngeal Pain 22-Feb-2006 08:30 AM Page: 805 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/31/00ISR Number: 3539013-0Report Type:Expedited (15-DaCompany Report #PHFR2000GB00487 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abdominal Distension Foreign Clozaril PS Novartis Acidosis Health Pharmaceuticals Corp ORAL 600 MG/DAY, Cardiac Arrest Professional ORAL 49 DAY Cardiomyopathy Other Dehydration Heart Rate Increased Hypotension Myocarditis Date:07/31/00ISR Number: 3539015-4Report Type:Expedited (15-DaCompany Report #PHBS2000KP04293 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram St Foreign Clozaril PS Novartis Segment Elevation Literature Pharmaceuticals Corp ORAL 500 MG/DAY, Ventricular Hypertrophy Health ORAL Professional Other Date:08/01/00ISR Number: 3539287-6Report Type:Expedited (15-DaCompany Report #PHEH2000US03013 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Burkitt'S Lymphoma Health Clozaril PS Novartis Initial or Prolonged Professional Pharmaceuticals Corp ORAL 25 MG, BID, ORAL Paxil C Clozaril (Clozapine) C Date:08/02/00ISR Number: 3539823-XReport Type:Expedited (15-DaCompany Report #00-06-0310 Age:62 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Small Cell Lung Cancer Health Clozapine PS Zenith Goldline ORAL 300-500MG Stage Unspecified Professional ORAL Lopressor C Aspirin C Pepcid C Multivitamins 1qd C Thiamine C Folvite C Serevent C Lomotil C Psorcon Cream Bid C Dilantin C Roxicet C Duragesic C Roxanol C 22-Feb-2006 08:30 AM Page: 806 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/02/00ISR Number: 3539825-3Report Type:Expedited (15-DaCompany Report #00-06-0309 Age:88 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 25MG ORAL Professional Date:08/02/00ISR Number: 3539827-7Report Type:Expedited (15-DaCompany Report #00-05-0246 Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 200MG ORAL Professional Furosemide C Date:08/02/00ISR Number: 3539833-2Report Type:Expedited (15-DaCompany Report #00-06-0311 Age:72 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Atherosclerosis Health Clozapine PS Zenith Goldline ORAL 225-450MG Lung Neoplasm Malignant Professional ORAL Date:08/02/00ISR Number: 3539835-6Report Type:Expedited (15-DaCompany Report #00-07-0323 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Neoplasm Malignant Health Clozapine PS Zenith Goldline ORAL 700-900MG Professional ORAL Date:08/02/00ISR Number: 3539838-1Report Type:Expedited (15-DaCompany Report #00-07-0357 Age:66 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Hip Fracture Health Clozapine PS Zenith Goldline ORAL UNK ORAL Hospitalization - Leukopenia Professional Initial or Prolonged Date:08/02/00ISR Number: 3539840-XReport Type:Expedited (15-DaCompany Report #00-07-0358 Age:67 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 150MG ORAL Professional Date:08/02/00ISR Number: 3539842-3Report Type:Expedited (15-DaCompany Report #00-07-0356 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hepatic Steatosis Health Clozapine PS Zenith Goldline ORAL 50-150MG ORAL Professional Company Representative 22-Feb-2006 08:30 AM Page: 807 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/02/00ISR Number: 3540456-XReport Type:Expedited (15-DaCompany Report #S00-GER-00980-01 Age:20 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Foreign Citalopram PS Forest Laboratories Initial or Prolonged Bone Marrow Depression Health Inc ORAL 20 MG QD PO Depression Professional Cipramil (Citalopram Headache Other Hydrobromide) SS ORAL 30 MG QD PO Leukopenia Leponex (Clozapine) SS ORAL 25 MG QD PO Pyrexia Leponex (Clozapine) SS ORAL 50 MG QD PO Suicide Attempt Leponex (Clozapine) SS ORAL 250 MG QD PO Elobact (Cefuroxime Axetil) SS ORAL 500 MG QD PO Leponex (Clozapine) SS ORAL 300 MG QD PO Leponex (Clozapine) SS ORAL 350 MG QD PO Leponex (Clozapine) SS ORAL 75 MG QD PO Leponex (Clozapine) SS ORAL 100 MG QD PO Leponex (Clozapine) C ORAL 175 MG QD PO Sonata (Zaleplon) C Acc Long (Acetylcysteine) C Navisinetten (Oxymetazikine Hydrochloride) C Date:08/03/00ISR Number: 3540410-8Report Type:Expedited (15-DaCompany Report #00-07-0339 Age:66 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 300-337, 5MG Professional ORAL Date:08/03/00ISR Number: 3540411-XReport Type:Expedited (15-DaCompany Report #00-07-0334 Age:67 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetic Coma Health Clozapine PS Zenith Goldline ORAL 75MG-500MG Professional ORAL Date:08/03/00ISR Number: 3540412-1Report Type:Expedited (15-DaCompany Report #00-06-0278 Age:71 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiovascular Disorder Health Clozapine PS Zenith Goldline ORAL 30-300MG ORAL Professional Xanax C Ditropan C Date:08/03/00ISR Number: 3540413-3Report Type:Expedited (15-DaCompany Report #00-07-0367 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Road Traffic Accident Health Clozapine PS Zenith Goldline ORAL 250-500MG PO Professional ORAL 22-Feb-2006 08:30 AM Page: 808 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/03/00ISR Number: 3540414-5Report Type:Expedited (15-DaCompany Report #00-07-0364 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Road Traffic Accident Health Clozapine PS Zenith Goldline ORAL 300MG ORAL Initial or Prolonged Professional Date:08/07/00ISR Number: 3543513-7Report Type:Direct Company Report # Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Glucose Increased Clozaril 25mg & Glycosuria 100mg Tabs PS 300MG QD 18 MON Weight Increased Date:08/07/00ISR Number: 3544063-4Report Type:Expedited (15-DaCompany Report #PHEH2000US03098 Age:79 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hip Arthroplasty Health Clozaril PS Novartis Initial or Prolonged Pneumonia Professional Pharmaceuticals Corp ORAL 150 MG, QHS,ORAL Prolixin (Fluphenazine Hydrochloride) C Cogentin (Benzatropine Mesilate) C Date:08/07/00ISR Number: 3544066-XReport Type:Expedited (15-DaCompany Report #PHFR2000GB00533 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril PS Novartis Health Pharmaceuticals Corp ORAL 450 MG/DAY, Professional ORAL Other Date:08/07/00ISR Number: 3544070-1Report Type:Expedited (15-DaCompany Report #PHBS2000DE02032 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Allergic Granulomatous Foreign Clozaril PS Novartis Initial or Prolonged Angiitis Health Pharmaceuticals Corp ORAL 150 MG, UNK, Eosinophilia Professional ORAL Hepatosplenomegaly Other Antibiotics (No Lower Respiratory Tract Ingredients/Substanc Infection es) C Pleural Effusion Pulmonary Congestion Red Blood Cell Sedimentation Rate Increased 22-Feb-2006 08:30 AM Page: 809 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/07/00ISR Number: 3544074-9Report Type:Expedited (15-DaCompany Report #PHFR2000GB00515 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatomegaly Foreign Clozaril PS Novartis Liver Function Test Health Pharmaceuticals Corp ORAL 100 MG/DAY, Abnormal Professional ORAL Other Date:08/07/00ISR Number: 3544203-7Report Type:Expedited (15-DaCompany Report #PHFR2000GB00510 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiomyopathy Foreign Clozaril PS Novartis Initial or Prolonged Health Pharmaceuticals Corp ORAL 375 MG DAY Professional ORAL Other Date:08/07/00ISR Number: 3544205-0Report Type:Expedited (15-DaCompany Report #PHHO1998AU01752 Age:54 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Clozaril PS Novartis Other Insomnia Study Pharmaceuticals Corp ORAL 300 MG DAY Neutropenia Health ORAL Professional Other Date:08/07/00ISR Number: 3544206-2Report Type:Expedited (15-DaCompany Report #PHBS2000NZ04325 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Clonic Convulsion Foreign Clozaril PS Novartis Coordination Abnormal Health Pharmaceuticals Corp ORAL ORAL Encephalopathy Professional Cortisol Extensor Plantar Response Other (Hydrocortisone) SS Neurological Symptom Tremor Urinary Incontinence Visual Field Defect Date:08/07/00ISR Number: 3544252-9Report Type:Expedited (15-DaCompany Report #PHEH2000US03010 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Nausea Health Clozaril PS Novartis Initial or Prolonged Suicide Attempt Professional Pharmaceuticals Corp ORAL 600MG QID, ORAL Zyprexa (Olanzapine) C Remeron (Mirtazapine) C Trazodone (Trazodone) C Prevacid C Effexor (Venlafaxine Hydrochloride) C 22-Feb-2006 08:30 AM Page: 810 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/07/00ISR Number: 3544253-0Report Type:Expedited (15-DaCompany Report #PHBS2000US04431 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Literature Clozaril PS Novartis Weight Increased Health Pharmaceuticals Corp ORAL 800 MG/D, Professional ORAL Docusate (Docusate) C Naproxen C Diazepam C Metoprolol (Metoprolol) C Simvastatin C Psyllium (Psyllium) C Nitroglycerin "David Bull" C Levofloxaci N (Levofloxacin) C Fludrocortisone (Fludrocortisone) C Lisinopril (Lisinopril) C Date:08/07/00ISR Number: 3544254-2Report Type:Expedited (15-DaCompany Report #PHBS2000US04429 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Literature Clozaril PS Novartis Weight Increased Health Pharmaceuticals Corp ORAL 900 MG/D, Professional ORAL Magnesium Hydroxide C Ranitidine (Ranitidine) C Prazosin (Prazosin) C Docusate (Docusate) C Famotidine C Albuterol C Ipratropium (Ipratropium) C Ferrous Sulfate C Pseudoephedrine (Pseudoephedrine) C Amoxicillin (Amoxicillin) C Guaifenesin W/Dextromethorphan Syrup C Prednisone C Date:08/07/00ISR Number: 3548271-8Report Type:Expedited (15-DaCompany Report #00-07-0322 Age:70 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 200-300 MG Professional ORAL 22-Feb-2006 08:30 AM Page: 811 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/09/00ISR Number: 3546619-1Report Type:Expedited (15-DaCompany Report #00-05-0321 Age:51 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Health Clozapine PS Zenith Goldline ORAL 50 MG ORAL Initial or Prolonged Professional Lithium Carbonate C Date:08/09/00ISR Number: 3546672-5Report Type:Expedited (15-DaCompany Report #00-07-0377 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 400-550MG Professional ORAL Date:08/09/00ISR Number: 3546673-7Report Type:Expedited (15-DaCompany Report #00-08-0375 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Thyroid Gland Cancer Health Clozapine PS Zenith Goldline ORAL 600 MG ORAL Professional Date:08/10/00ISR Number: 3546671-3Report Type:Expedited (15-DaCompany Report #00-07-0378 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Empyema Health Clozapine PS Zenith Goldline ORAL 250 MG ORAL Lung Abscess Professional Date:08/10/00ISR Number: 3548291-3Report Type:Expedited (15-DaCompany Report #00D--10829 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Arthralgia Foreign Ludiomil PS Novartis Deep Vein Thrombosis Health Pharmaceuticals Corp 50 MG DAILY Oedema Peripheral Professional Leponex Unknown Pain In Extremity Other (Clozapine) SS Tavor C Heparin C Date:08/10/00ISR Number: 3548384-0Report Type:Expedited (15-DaCompany Report #00RA-10005 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Apnoea Foreign Tegretol-Xr PS Novartis Hospitalization - Cardio-Respiratory Arrest Health Pharmaceuticals Corp ORAL 600 MG DAILY, Initial or Prolonged Epilepsy Professional ORAL 90 DAY Required Excitability Company Lapenax Unknown Intervention to Hyperhidrosis Representative (Clozapine) SS ORAL 300 MG, Prevent Permanent Injury Other DAILY, ORAL 90 DAY Impairment/Damage Tonic Convulsion 22-Feb-2006 08:30 AM Page: 812 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/11/00ISR Number: 3548281-0Report Type:Expedited (15-DaCompany Report #00-07-0336 Age:67 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Fall Health Clozapine PS Zenith Goldline ORAL 50-250 MG Hospitalization - Hip Fracture Professional ORAL Initial or Prolonged Hypotension Other Pulmonary Embolism Date:08/11/00ISR Number: 3549219-2Report Type:Expedited (15-DaCompany Report #PHEH2000US03235 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Health Clozaril PS Novartis Drug Level Below Professional Pharmaceuticals Corp ORAL 200MG AM + Therapeutic 650MG HS, Fall ORAL Medication Error Depakote(Valproate Syncope Semisodium) SS Seroquel (Quetiapine) C Docusate (Docusate) C Desmopressin (Desmopressin) C Date:08/11/00ISR Number: 3549227-1Report Type:Expedited (15-DaCompany Report #PHEH2000US03127 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hodgkin'S Disease Health Clozaril PS Novartis Professional Pharmaceuticals Corp ORAL 500 MG, ORAL Date:08/14/00ISR Number: 3549028-4Report Type:Direct Company Report # Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Eosinophilia Health Clozapine PS Zenith-Goldline ORAL 600 MG QHS PO Intervention to Professional Buspirone C Prevent Permanent Cogentin C Impairment/Damage Clonidine C Date:08/14/00ISR Number: 3550012-5Report Type:Expedited (15-DaCompany Report #PHBS2000F104505 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiomyopathy Foreign Clozaril PS Novartis Health Pharmaceuticals Corp ORAL ORAL Professional Other Date:08/14/00ISR Number: 3550014-9Report Type:Expedited (15-DaCompany Report #PHFR2000GB00586 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Hospitalization - Condition Aggravated Foreign Initial or Prolonged Diabetes Mellitus Health Other Pancreatitis Professional 22-Feb-2006 08:30 AM Page: 813 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Product Role Manufacturer Route Dose Duration Clozaril PS Novartis Pharmaceuticals Corp ORAL 300 MG/DAY, ORAL Date:08/14/00ISR Number: 3550134-9Report Type:Expedited (15-DaCompany Report #PHEH2000US03264 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pelvic Mass Health Clozaril PS Novartis Weight Increased Professional Pharmaceuticals Corp ORAL 100MG AM + 600MGHS, ORAL Paxil C Date:08/14/00ISR Number: 3550141-6Report Type:Expedited (15-DaCompany Report #PHNU2000DE00526 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Amylase Increased Foreign Clozaril PS Novartis Initial or Prolonged Colitis Health Pharmaceuticals Corp ORAL UNK, UNK, Diarrhoea Professional ORAL Lipase Increased Valproic Acid C Pancreatitis Acute Dipiperon (Pipamperone) C Date:08/14/00ISR Number: 3550166-0Report Type:Expedited (15-DaCompany Report #PHHO2000CA02483 Age:81 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Condition Aggravated Foreign Clozaril PS Novartis Drug Level Above Study Pharmaceuticals Corp ORAL 150 MG/DAY Therapeutic Health ORAL Haemoglobin Decreased Professional Temazepam C Heart Rate Irregular Insulin Humulin Neutropenia 70/30 (Insulin Oedema Human, Insulin Human Pneumonia Klebsiella Injection) C Psychotic Disorder Synthroid C Red Blood Cell Tylenol C Sedimentation Rate Furosemide C Increased Arthrotec Urinary Tract Infection (Misoprostol) C Micro K C Lorazepam C Lasix C Date:08/14/00ISR Number: 3550169-6Report Type:Expedited (15-DaCompany Report #PHBS2000GB02329 Age:51 YR Gender:Male I/FU:I Outcome PT Other Chronic Lymphocytic Leukaemia Lymphocyte Count Increased White Blood Cell Count 22-Feb-2006 08:30 AM Page: 814 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Increased Report Source Product Role Manufacturer Route Dose Duration Foreign Clozaril PS Novartis Health Pharmaceuticals Corp ORAL 400 MG/DAY Professional ORAL Amitriptyline (Amitriptyline) C Procyclidine (Procyclidine) C Valproate Sodium C Date:08/14/00ISR Number: 3550172-6Report Type:Expedited (15-DaCompany Report #PHBS2000AU04603 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abscess Oral Foreign Clozaril PS Novartis Cardiac Failure Consumer Pharmaceuticals Corp ORAL 200 MG/DAY ORAL Date:08/14/00ISR Number: 3550175-1Report Type:Expedited (15-DaCompany Report #PHFR2000GB00569 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cerebrovascular Accident Foreign Clozaril PS Novartis Diabetes Mellitus Health Pharmaceuticals Corp ORAL 400MG/DAY Professional ORAL Date:08/14/00ISR Number: 3550195-7Report Type:Expedited (15-DaCompany Report #PHHO2000AU02931 Age:22 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Foreign Clozaril PS Novartis Initial or Prolonged Study Pharmaceuticals Corp ORAL UNSPECIFIED, Health ORAL Professional Temazepam (Temazepam) (Temazepam) SS Date:08/14/00ISR Number: 3550481-0Report Type:Expedited (15-DaCompany Report #PHBS2000US04620 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Literature Clozaril PS Novartis Depression Health Pharmaceuticals Corp 300 MG/DAY 45 DAY Fatigue Professional Sertraline Glycosuria (Sertraline) SS 45 DAY Hyperglycaemia Hyponatraemia Polydipsia Polyuria 22-Feb-2006 08:30 AM Page: 815 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/14/00ISR Number: 3550513-XReport Type:Expedited (15-DaCompany Report #PHBS2000GB01694 Age:47 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arthritis Bacterial Foreign Clozaril PS Novartis Initial or Prolonged Cellulitis Health Pharmaceuticals Corp ORAL 750MG/DAY, Feeling Hot Professional ORAL Leukocytosis Other Acarbose (Acarbose) C Oedema Peripheral Thyroxine C Risperidone (Risperidone) C Lactulose C Zopiclone C Date:08/14/00ISR Number: 3550527-XReport Type:Expedited (15-DaCompany Report #PHHO2000AU01923 Age:28 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Clozaril PS Novartis Eosinophilic Myocarditis Health Pharmaceuticals Corp ORAL 400 MG, QD, Hypoglycaemia Professional ORAL Other Serenase C Metformin C Midazolam C Haloperidol C Actrapid Human C Gentamicin C Date:08/14/00ISR Number: 3550640-7Report Type:Expedited (15-DaCompany Report #PHBS2000AU04068 Age:31 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Foreign Clozaril PS Novartis Cardiomyopathy Study Pharmaceuticals Corp ORAL 750 MG/DAY, Leukopenia Health ORAL Neutropenia Professional Lithium Carbonate C Other Date:08/14/00ISR Number: 3550643-2Report Type:Expedited (15-DaCompany Report #PHBS2000GB02540 Age:33 YR Gender:Female I/FU:I Outcome PT Other Abdominal Distension Anxiety Blood Creatine Phosphokinase Increased Blood Creatine Phosphokinase Mb Increased Blood Folate Decreased C-Reactive Protein Increased Eosinophilia Haemoglobin Decreased Haemolysis Haemolytic Anaemia Hereditary Spherocytosis Hypersensitivity Neutropenia 22-Feb-2006 08:30 AM Page: 816 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Palpitations Polychromasia Pyrexia Report Source Product Role Manufacturer Route Dose Duration Red Blood Cell Foreign Clozaril PS Novartis Schistocytes Present Health Pharmaceuticals Corp ORAL 400MG/DAY, Reticulocyte Count Professional ORAL Increased Other Fybogel (Ispaghula) C Sinus Tachycardia Vomiting Date:08/14/00ISR Number: 3550644-4Report Type:Expedited (15-DaCompany Report #PHFR2000GB00451 Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Balance Disorder Foreign Clozaril PS Novartis Initial or Prolonged Cerebrovascular Accident Health Pharmaceuticals Corp ORAL 150 MG, BID, Transient Ischaemic Professional ORAL Attack Other Ramipril (Ramipril) C Atenolol C Simvastatin C Nitrazepam C Date:08/14/00ISR Number: 3550645-6Report Type:Expedited (15-DaCompany Report #PHFR2000GB00451 Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Balance Disorder Foreign Clozaril PS Novartis Initial or Prolonged Cerebrovascular Accident Health Pharmaceuticals Corp ORAL 150 MG, BID, Transient Ischaemic Professional ORAL Attack Other Ramipril (Ramipril) C Atenolol C Simvastatin C Nitrazepam C Date:08/14/00ISR Number: 3550646-8Report Type:Expedited (15-DaCompany Report #PHHO2000GB03272 Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Foreign Clozaril PS Novartis Increased Study Pharmaceuticals Corp ORAL 6.25 MG/DAY, Asthenia Health ORAL 56 DAY Blood Glucose Increased Professional Diabetes Mellitus Other Non-Insulin-Dependent Glycosuria Liver Function Test Abnormal Muscular Weakness Ventricular Extrasystoles Weight Increased Date:08/14/00ISR Number: 3550695-XReport Type:Expedited (15-DaCompany Report #PHEH2000US03260 Age:42 YR Gender:Male I/FU:I Outcome PT Other Dizziness Haemoglobin Decreased 22-Feb-2006 08:30 AM Page: 817 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hyperhidrosis Lymphoma Muscular Weakness Report Source Product Role Manufacturer Route Dose Duration Pyrexia Health Clozaril PS Novartis Subcutaneous Nodule Professional Pharmaceuticals Corp ORAL 100 MG AM + 350 MG HS ORAL Ativan C Date:08/15/00ISR Number: 3550958-8Report Type:Expedited (15-DaCompany Report #00-08-0387 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Malaise Health Clozapine PS Zenith Goldline ORAL 400 MG ORAL Professional Date:08/15/00ISR Number: 3550959-XReport Type:Expedited (15-DaCompany Report #00-06-0310 Age:62 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arterial Rupture Health Clozapine PS Zenith Goldline ORAL 300-500MG Refusal Of Treatment By Professional ORAL Patient Lopressor C Small Cell Lung Cancer Aspirin C Stage Unspecified Pepcid C Multivitamins C Thiamine C Folvite C Serevent C Lomotil C Psorcon Cream C Dilantin C Roxicet C Duragesic C Roxanol C Date:08/18/00ISR Number: 3553783-7Report Type:Expedited (15-DaCompany Report #PHBS1999AU00497 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coronary Artery Foreign Clozaril PS Novartis Other Atherosclerosis Health Pharmaceuticals Corp ORAL 300MG/DAY, Drug Level Above Professional ORAL Therapeutic Other Amitriptyline (Amitriptyline) SS Date:08/18/00ISR Number: 3553785-0Report Type:Expedited (15-DaCompany Report #PHBS2000GB02530 Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril PS Novartis Non-Insulin-Dependent Health Pharmaceuticals Corp ORAL 450MG/DAY; Professional ORAL Other Lithium (Lithium) C Lansoprazole (Lansoprazole) C 22-Feb-2006 08:30 AM Page: 818 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/18/00ISR Number: 3553816-8Report Type:Expedited (15-DaCompany Report #PHFR2000GB00601 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiomyopathy Foreign Clozaril PS Novartis Initial or Prolonged Left Ventricular Failure Health Pharmaceuticals Corp ORAL 250 MG/AM, Supraventricular Professional 350 MG/PM Tachycardia Other ORAL Gaviscon (Sodium Alginate) C Kwells Junior C Paroxetine (Paroxetine) C Date:08/18/00ISR Number: 3553929-0Report Type:Expedited (15-DaCompany Report #00-06-0294 Age:78 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Atrial Fibrillation Health Clozapine PS Zenith Goldline ORAL 12.5-125MG Squamous Cell Carcinoma Professional ORAL Sinemet Cr 50/200 C Lanoxin 0.25mg Qd C Coumadin 1 Mg C Date:08/18/00ISR Number: 3553931-9Report Type:Expedited (15-DaCompany Report #00-07-0334 Age:67 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetic Coma Health Clozapine PS Zenith Goldline ORAL 75MG-500MG Professional ORAL Date:08/18/00ISR Number: 3553933-2Report Type:Expedited (15-DaCompany Report #00-06-0313 Age:61 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aneurysm Health Clozapine PS Zenith Goldline ORAL 600MG ORAL Professional Date:08/18/00ISR Number: 3588967-5Report Type:Periodic Company Report #S99-USA-01985-01 Age:20 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Interaction Health Celexa PS Forest Laboratories Urinary Incontinence Professional Inc ORAL 10 MG QD PO Celexa (Citalopram Hydrobromide) SS ORAL 20 MG QD PO Clozaril (Clozapine) SS Lithium C Synthroid (Levothyroxine Sodium) C Coumadin (Warfarin Sodium) C Klonopin (Clonazepam) C Wellbutrin (Amfebutamone Hydrochloride) C 22-Feb-2006 08:30 AM Page: 819 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/21/00ISR Number: 3554479-8Report Type:Expedited (15-DaCompany Report #PHFR2000GB00595 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Sodium Decreased Foreign Clozaril PS Novartis Initial or Prolonged Cardiac Murmur Health Pharmaceuticals Corp ORAL 200MG/DAY Dyspnoea Professional ORAL Inappropriate Other Antidiuretic Hormone Secretion Pericardial Effusion Date:08/21/00ISR Number: 3554951-0Report Type:Expedited (15-DaCompany Report #PHBS2000NZ04624 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Foreign Clozaril PS Novartis Initial or Prolonged Health Pharmaceuticals Corp ORAL 175 MG DAY Professional ORAL Other Date:08/22/00ISR Number: 3557890-4Report Type:Expedited (15-DaCompany Report #PHH01999AU05481 Age:21 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Injury Foreign Clozaril PS Novartis Neutrophil Count Study Pharmaceuticals Corp ORAL 650 MG, QD, Increased Health ORAL Pulmonary Embolism Professional Effexor C White Blood Cell Count Doxycycline C Increased Date:08/23/00ISR Number: 3555459-9Report Type:Expedited (15-DaCompany Report #00-08-0390 Age:77 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Progressive Supranuclear Health Clozapine PS Zenith Goldline ORAL 12.5-125MG Palsy Professional ORAL Date:08/23/00ISR Number: 3555465-4Report Type:Expedited (15-DaCompany Report #00-08-0389 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Foot Fracture Health Clozapine PS Zenith Goldline ORAL 50-500MG ORAL Initial or Prolonged Respiratory Disorder Professional Date:08/23/00ISR Number: 3555467-8Report Type:Expedited (15-DaCompany Report #00-08-0391 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Health Clozapine PS Zenith Goldline ORAL 150-600MG Initial or Prolonged Transient Ischaemic Professional ORAL Attack Lithium C 22-Feb-2006 08:30 AM Page: 820 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/23/00ISR Number: 3555471-XReport Type:Expedited (15-DaCompany Report #00-08-0392 Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neoplasm Malignant Health Clozapine PS Zenith Goldline ORAL 200MG ORAL Professional Date:08/23/00ISR Number: 3555485-XReport Type:Expedited (15-DaCompany Report #00-07-0357 Age:66 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Hip Fracture Health Clozapine PS Zenith Goldline ORAL ORAL Hospitalization - Infection Professional Nethotrexate 17.5mg C Initial or Prolonged Leukopenia Levodopa-Carbidopa Orthostatic Hypotension 25/100mg C Date:08/23/00ISR Number: 3555490-3Report Type:Expedited (15-DaCompany Report #00-07-0356 Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hepatic Steatosis Health Clozapine PS Zenith Goldline ORAL 50-150MG ORAL Professional Prozac 10 Mg C Zu[Rexa 75mg C Lorazepam 1mg C Date:08/23/00ISR Number: 3556493-5Report Type:Expedited (15-DaCompany Report #PHBS2000AU04628 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acute Lymphocytic Foreign Clozaril PS Novartis Initial or Prolonged Leukaemia Health Pharmaceuticals Corp ORAL 300 MG, QD, Other Laboratory Test Abnormal Professional ORAL Other Zoloft (Sertraline Hydrochloride) C Date:08/24/00ISR Number: 3557680-2Report Type:Expedited (15-DaCompany Report #PHHO2000DE03168 Age:33 YR Gender:Female I/FU:F Outcome PT Hospitalization - Autoantibody Positive Initial or Prolonged Blood Creatinine Increased Blood Fibrinogen Increased Diarrhoea Drug Hypersensitivity Drug Level Above Therapeutic Eosinophilia Haemoglobin Decreased Hepatic Enzyme Increased Hepatosplenomegaly Hyponatraemia Leukopenia Liver Function Test Lung Infiltration Pericardial Effusion Pleural Effusion 22-Feb-2006 08:30 AM Page: 821 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Vasculitis Report Source Product Role Manufacturer Route Dose Duration Foreign Clozaril PS Novartis Study Pharmaceuticals Corp ORAL 125 MG, ORAL Health Leponex/Clozaril Professional (Clozapine) SS ORAL 250 MG, ORAL Other Leponex/Clozaril (Clozapine) SS ORAL 300 MG, ORAL Leponex/Clozaril (Clozapine) SS ORAL 200 MG, ORAL Leponex/Clozaril (Clozapine) SS ORAL 175 MG, ORAL Orfiril (Valproate Sodium) C Truxal (Chlorprothixene Hydrochloride) C Date:08/24/00ISR Number: 3557694-2Report Type:Expedited (15-DaCompany Report #PHBS2000NZ07796 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aphasia Foreign Clozaril PS Novartis Initial or Prolonged Catatonia Health Pharmaceuticals Corp ORAL 500 MG/D, Coma Professional ORAL Developmental Other Coordination Disorder Diabetes Mellitus Non-Insulin-Dependent Hyperglycaemia Micturition Urgency Pallor Restlessness Staring Date:08/25/00ISR Number: 3558701-3Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Rash Macular Clozapine PS 350MG/D-DIVID Skin Hyperpigmentation ED Lithium SS ORAL 300MG PO TID Cogentin C Neurontin C Lithium C Prevacid C Date:08/25/00ISR Number: 3558705-0Report Type:Direct Company Report # Age:45 YR Gender:Male I/FU:I Outcome PT Other Body Temperature Required Increased Intervention to Confusional State Prevent Permanent Lethargy Impairment/Damage Mental Impairment Neuroleptic Malignant 22-Feb-2006 08:30 AM Page: 822 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Syndrome Respiratory Rate Increased Report Source Product Role Manufacturer Route Dose Duration Clozapine PS ORAL 300MG QD PO Date:08/25/00ISR Number: 3559033-XReport Type:Expedited (15-DaCompany Report #PHEH2000US07561 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arthralgia Health Clozaril PS Novartis Coronary Artery Occlusion Professional Pharmaceuticals Corp ORAL ORAL Tardive Dyskinesia Zyprexa (Olanzapine) C Zoloft (Sertraline Hydrochloride) C Date:08/25/00ISR Number: 3559040-7Report Type:Expedited (15-DaCompany Report #PHEH2000US02040 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Health Clozaril PS Novartis Initial or Prolonged Depression Professional Pharmaceuticals Corp ORAL 350 MG, ORAL 224 DAY Other Diabetes Mellitus Hidroxizin Dyspnoea (Hydroxyzine Hallucination Hydrochloride) C Psychiatric Symptom Pulmonary Embolism Tachycardia Date:08/25/00ISR Number: 3559097-3Report Type:Expedited (15-DaCompany Report #PHBS2000DE03454 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asthenia Foreign Clozaril PS Novartis Life-Threatening Cardiac Failure Health Pharmaceuticals Corp ORAL ORAL Hospitalization - Cardiomegaly Professional Elcrit (Clozapine) Initial or Prolonged Congestive Cardiomyopathy Other (Clozapine) SS ORAL 200 MG, ORAL Dyspnoea Coaprovel Electrocardiogram (Irbesartan) C Abnormal Ass "Hexal" C Hypotension Tranxilium Influenza Like Illness (Clorazepate Tachycardia Dipotassium) C Vertigo Doxepin (Doxepin) C Lithium (Lithium) C Date:08/25/00ISR Number: 3559114-0Report Type:Expedited (15-DaCompany Report #PHBS2000CA04065 Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Creatinine Foreign Clozaril PS Novartis Increased Study Pharmaceuticals Corp ORAL 1) 6000 MG, Blood Urea Increased Health ORAL; 2) Delirium Professional 300MG/DAY, Overdose Other ORAL Renal Failure Acute Alcohol (Ethanol) SS 1175 DAY Vomiting 22-Feb-2006 08:30 AM Page: 823 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/25/00ISR Number: 3559118-8Report Type:Expedited (15-DaCompany Report #PHBS2000CA04065 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Overdose Foreign Clozaril PS Novartis Renal Failure Study Pharmaceuticals Corp ORAL 1) 6000MG, Health ONCE/SINGLE, Professional ORAL; 2) Other 300MG/DAY, ORAL Alcohol (Ethanol) SS Date:08/25/00ISR Number: 3559148-6Report Type:Expedited (15-DaCompany Report #PHBS2000NZ03893 Age:76 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lymphoma Foreign Clozaril PS Novartis Lymphopenia Health Pharmaceuticals Corp ORAL 20 MG/DAY PO Professional Allopurinol C Other Omeprazole C Norfloxacin C Date:08/25/00ISR Number: 3559165-6Report Type:Expedited (15-DaCompany Report #PHFR2000GB01224 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asphyxia Foreign Clozaril PS Novartis Convulsion Study Pharmaceuticals Corp ORAL 25 MG/DAY PO Health Professional Other Date:08/25/00ISR Number: 3559245-5Report Type:Expedited (15-DaCompany Report #PHBS2000NZ07796 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aphasia Foreign Clozaril PS Novartis Initial or Prolonged Catatonia Health Pharmaceuticals Corp ORAL 500 MG/D, Diabetes Mellitus Professional ORAL Non-Insulin-Dependent Other Hyperglycaemia Micturition Urgency Motor Dysfunction Mutism Pallor Restlessness Staring Date:08/25/00ISR Number: 3559250-9Report Type:Expedited (15-DaCompany Report #JRFBEL2000002066 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Foreign Risperdal PS Janssen Research Fdn Biopsy Bone Marrow Literature Div Johnson And Abnormal Health Johnson MG, DAILY Leukopenia Professional Clozapine Neutropenia (Clozapine) SS 22-Feb-2006 08:30 AM Page: 824 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/25/00ISR Number: 3559261-3Report Type:Expedited (15-DaCompany Report #PHBS2000AU04068 Age:31 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Foreign Clozaril PS Novartis Initial or Prolonged Cardiomyopathy Study Pharmaceuticals Corp ORAL ORAL Other Leukopenia Health Lithium Carbonate C Neutropenia Professional Other Date:08/25/00ISR Number: 3559263-7Report Type:Expedited (15-DaCompany Report #PHBS2000FI04505 Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Foreign Clozaril PS Novartis Initial or Prolonged Cardiomegaly Health Pharmaceuticals Corp ORAL 400 MG/DAY, Other Cardiomyopathy Professional ORAL Cough Other Temesta C Dyspnoea Tenox C Hypertension Tachycardia Date:08/25/00ISR Number: 3559264-9Report Type:Expedited (15-DaCompany Report #JACGBR2000000339 Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Foreign Risperdal PS Janssen Research Fdn Required Cardio-Respiratory Arrest Health Div Johnson And Intervention to Respiratory Arrest Professional Johnson ORAL SEE IMAGE Prevent Permanent Respiratory Failure Sulpiride Impairment/Damage Sudden Death (Sulpiride) SS ORAL 2400 MG, DAILY, ORAL Clozapine (Clozapine) SS ORAL 700, DAILY,ORAL Procyclidine (Procyclidine) SS ORAL 15 MG, ORAL Droleptan (Unspecified) (Droperidol) C Lorazepam (Lorazepam) C Date:08/28/00ISR Number: 3560245-XReport Type:Expedited (15-DaCompany Report #PHHO2000CA02483 Age:81 YR Gender:Female I/FU:F Outcome PT Death Condition Aggravated Drug Level Above Therapeutic Haemoglobin Decreased Heart Rate Irregular Neutropenia Oedema Pneumonia Klebsiella Psychotic Disorder Red Blood Cell Sedimentation Rate Increased 22-Feb-2006 08:30 AM Page: 825 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Urinary Tract Infection Report Source Product Role Manufacturer Route Dose Duration Foreign Clozaril PS Novartis Study Pharmaceuticals Corp ORAL 150 MG/DAY, Health PO Professional Temazepam C Other Insulin Humulin 70/30 C Synthroid C Tylenol C Furosemide C Arthrotec C Micro K C Lorazepam C Lasix C Date:08/28/00ISR Number: 3560306-5Report Type:Expedited (15-DaCompany Report #FRA002194 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Enuresis Foreign Akineton PS Knoll Pharmaceutical Initial or Prolonged Hallucination, Auditory Health Co Professional Xanax SS Leponex SS Date:08/28/00ISR Number: 3560338-7Report Type:Expedited (15-DaCompany Report #PHFR2000GB00623 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril PS Novartis Hyperglycaemia Health Pharmaceuticals Corp ORAL ORAL Professional Other Date:08/28/00ISR Number: 3560342-9Report Type:Expedited (15-DaCompany Report #PHFR2000GB00550 Age:24 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Distension Foreign Clozaril PS Novartis Initial or Prolonged Abdominal Pain Health Pharmaceuticals Corp ORAL 700MG, Other Abdominal Tenderness Professional 600MG/DAY, Blood Bilirubin Increased Other ORAL C-Reactive Protein Reboxetine Increased (Reboxetine) C Clostridium Colitis Diarrhoea Haematochezia Hepatic Function Abnormal Hepatitis Infection Inflammation Liver Function Test Abnormal Malaise Nausea Rectal Tenesmus 22-Feb-2006 08:30 AM Page: 826 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/28/00ISR Number: 3560350-8Report Type:Expedited (15-DaCompany Report #PHBS2000CA08210 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bundle Branch Block Foreign Clozaril PS Novartis Health Pharmaceuticals Corp ORAL 800 MG/DAY Professional ORAL Other Paroxetine (Paroxetine) C Date:08/28/00ISR Number: 3560352-1Report Type:Expedited (15-DaCompany Report #PHFR2000GB01227 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Coma Foreign Clozaril PS Novartis Initial or Prolonged Health Pharmaceuticals Corp ORAL 275 MG DAY Other Professional ORAL Other Quetiapine (Quetiapine) C Oral Antidiabetics (No Ingredients/Substanc es) C Date:08/28/00ISR Number: 3560363-6Report Type:Expedited (15-DaCompany Report #PHBS2000AU07823 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiomyopathy Foreign Clozaril PS Novartis Chest Pain Health Pharmaceuticals Corp ORAL 150 MG/DAY Hypertension Professional ORAL Left Ventricular Failure Other Ventricular Hypertrophy Date:08/28/00ISR Number: 3560365-XReport Type:Expedited (15-DaCompany Report #PHBS2000AU07793 Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatinine Foreign Clozaril PS Novartis Initial or Prolonged Increased Health Pharmaceuticals Corp ORAL 300 MG/DAY Blood Urea Increased Professional ORAL Other Senokot(Senna Fruit) SS Trimethoprim C Omeprazole (Omeprazole) C Panadol (Paracetamol) C Date:08/28/00ISR Number: 3560369-7Report Type:Expedited (15-DaCompany Report #PHBS2000CA04091 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Foreign Clozaril PS Novartis Initial or Prolonged Pneumonia Study Pharmaceuticals Corp ORAL 300 MG, QD, Health ORAL Professional Effexor C Other Diazepam C 22-Feb-2006 08:30 AM Page: 827 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/28/00ISR Number: 3560502-7Report Type:Expedited (15-DaCompany Report #PHEH2000US01611 Age:69 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Health Clozaril PS Novartis Initial or Prolonged Haematocrit Decreased Professional Pharmaceuticals Corp ORAL 25 MG, QHS, Leukopenia ORAL Osteomyelitis Dyazide C Pseudomonas Infection Sinemet C Radius Fracture Pepcid (Famotidine) C Refractory Anaemia Flomax (Morniflumate) C Vicodin C Comptan (Bromhexine, Glycyrrhiza Extract, Senega Extract, Amoxicillin, Belladonna Tincture, C Detrol (Tolterodine-Tartrat e) C Surfax (Zinc, Ascorbic Acid, Pantothenic Acid, Vitamin B Nos) C Requip (Ropinirole Hydrochloride) C Date:08/28/00ISR Number: 3560504-0Report Type:Expedited (15-DaCompany Report #PHEH2000US02553 Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Clozaril PS Novartis Initial or Prolonged Depression Professional Pharmaceuticals Corp ORAL 100MG AM + Insomnia 300MG HS ORAL Medication Error Prozac (Fluoxetine Paranoia Hydrochloride) C Psychotic Disorder Cogentin Suicide Attempt (Benzatropine Mesilate) C Lipitor (Atorvastatin) C Vasotec (Enalapril Maleate) C Norvasc (Amlodipine Besilate) C Colace (Docusate Sodium) C Aspirin C Folic Acid C Cozaar (Losartan Potassium) C Date:08/28/00ISR Number: 3560510-6Report Type:Expedited (15-DaCompany Report #PHBS2000AU04394 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Other Diabetes Mellitus Foreign Hyperglycaemia Health Professional 22-Feb-2006 08:30 AM Page: 828 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Product Role Manufacturer Route Dose Duration Clozaril PS Novartis Pharmaceuticals Corp ORAL 400 MG/DAY, ORAL Date:08/28/00ISR Number: 3560512-XReport Type:Expedited (15-DaCompany Report #PHBS2000GB01774 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Constipation Foreign Clozaril PS Novartis Initial or Prolonged Orchidectomy Health Pharmaceuticals Corp ORAL 650MG/DAY, Testicular Pain Professional ORAL Urinary Incontinence Other Stelazine Urinary Retention (Trifluoperazine Hydrochloride) C Date:08/28/00ISR Number: 3560514-3Report Type:Expedited (15-DaCompany Report #PHBS2000AU04068 Age:31 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Foreign Clozaril PS Novartis Initial or Prolonged Cardiomyopathy Study Pharmaceuticals Corp ORAL ORAL Other Leukopenia Health Lithium Carbonate C Neutropenia Professional Other Date:08/28/00ISR Number: 3561712-5Report Type:Periodic Company Report #USA/00/01056/PLO Age:78 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Parlodel PS Novartis Initial or Prolonged Professional Pharmaceuticals Corp Clozapine SS OTHER 25 MG, OTHER, UNKNOWN Cogentin (Benzatropine Mesilate) C Mysoline (Primidone) C Date:08/29/00ISR Number: 3560428-9Report Type:Expedited (15-DaCompany Report #00-08-0399 Age:78 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Health Clozapine PS Zenith Goldline ORAL ORAL Lung Neoplasm Malignant Professional Date:08/29/00ISR Number: 3560430-7Report Type:Expedited (15-DaCompany Report #00-05-0273 Age:63 YR Gender:Female I/FU:I Outcome PT Life-Threatening Cough Hospitalization - Deep Vein Thrombosis Initial or Prolonged Leukocytosis Leukopenia 22-Feb-2006 08:30 AM Page: 829 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pharyngolaryngeal Pain Pyrexia Staphylococcal Infection Report Source Product Role Manufacturer Route Dose Duration Upper Respiratory Tract Health Clozapine PS Zenith Goldline ORAL 37.5MG-200MG Infection Professional ORAL Florinef 0.1mg Qd C Date:08/29/00ISR Number: 3560431-9Report Type:Expedited (15-DaCompany Report #00-07-0335 Age:57 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ankle Fracture Health Clozapine PS Zenith Goldline ORAL 350-500MG Initial or Prolonged Surgery Professional ORAL Date:08/29/00ISR Number: 3560432-0Report Type:Expedited (15-DaCompany Report #00-07-0367 Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Restlessness Health Clozapine PS Zenith Goldline ORAL 250-500MG PO Road Traffic Accident Professional ORAL Klonopin C Date:08/29/00ISR Number: 3560441-1Report Type:Expedited (15-DaCompany Report #00-07-0337 Age:66 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Intestinal Perforation Health Clozapine PS Zenith Goldline ORAL 50-700MG ORAL Peritonitis Professional Depakote C Sepsis Haldol C Seroquel C Congentin C Chloral Hydrate C Date:08/29/00ISR Number: 3560444-7Report Type:Expedited (15-DaCompany Report #00-08-0400 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Injury Asphyxiation Health Clozapine PS Zenith Goldline ORAL 500MG ORAL Professional Date:08/29/00ISR Number: 3560484-8Report Type:Expedited (15-DaCompany Report #00-08-0401 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Urinary Tract Infection Health Clozapine PS Zenith Goldline ORAL 375MG ORAL Initial or Prolonged Professional Date:08/29/00ISR Number: 3560488-5Report Type:Expedited (15-DaCompany Report #00-08-0402 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 25-450MG ORAL Professional 22-Feb-2006 08:30 AM Page: 830 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/29/00ISR Number: 3560489-7Report Type:Expedited (15-DaCompany Report #00-08-0403 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Health Clozapine PS Zenith Goldline ORAL 25-250MG ORAL Initial or Prolonged Congestive Professional Chronic Obstructive Pulmonary Disease Condition Aggravated Peripheral Vascular Disorder Date:08/29/00ISR Number: 3560491-5Report Type:Expedited (15-DaCompany Report #00-08-0408 Age:80 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Nephrotic Syndrome Health Clozapine PS Zenith Goldline ORAL 25MG ORAL Pneumonia Professional Date:08/29/00ISR Number: 3561691-0Report Type:Expedited (15-DaCompany Report #PHEH2000US07911 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cervix Carcinoma Health Clozaril PS Novartis Leukopenia Professional Pharmaceuticals Corp ORAL 200 MG, BID, ORAL Cytoxan (Cyclophosphamide) SS 3380 DAY Date:08/29/00ISR Number: 3561693-4Report Type:Expedited (15-DaCompany Report #PHEH2000US07911 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cervix Carcinoma Health Clozaril PS Novartis Leukopenia Professional Pharmaceuticals Corp ORAL 200 MG, BID, ORAL Cytoxan (Cyclophophamide) SS 3380 DAY Date:08/30/00ISR Number: 3561900-8Report Type:Direct Company Report # Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Leukopenia Health Clozapine 100mg Neutrophilia Professional Tablet (Mylan/Udl) PS Mylan/Udl 100MG AT 4PM + HS Clozapine 25mg Tablet (Mylan/Udl) SS Mylan/Udl 50 MG Q AM Date:08/30/00ISR Number: 3562226-9Report Type:Expedited (15-DaCompany Report #HQ0130422AUG2000 Age:17 YR Gender:Male I/FU:I Outcome PT Hospitalization - Athetosis Initial or Prolonged Cerebellar Syndrome Coma Coordination Abnormal 22-Feb-2006 08:30 AM Page: 831 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dysarthria Dysphagia Dystonia Report Source Product Role Manufacturer Route Dose Duration Electroencephalogram Literature Artane PS Lederle Laboratories Abnormal Div American Encephalopathy Cyanamid Co ORAL 2 MG FOUR Enuresis TIMES DAILY Fall ORAL Grand Mal Convulsion Chlorpromazine SS 50 MG AS Hypotension NEEDED Hypotonia Clozapine SS ORAL 25 MG DAILY Lethargy INCREASED TO Movement Disorder 100 MG TWICE Neuroleptic Malignant DAILY Syndrome DECREASED TO Orthostatic Hypotension Lithium SS ORAL 300 MG FOUR Pyrexia TIMES DAILY Sedation ORAL Tachycardia Aspirin "Bayer" C Tremor Ceftriaxone C Vomiting Haloperidol C Date:08/31/00ISR Number: 3562972-7Report Type:Expedited (15-DaCompany Report #10507333 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Ventricular Tachycardia Foreign Pravachol PS Bristol Myers Squibb ORAL 20 MILLIGRAM, Health 1 DAY ORAL Professional Seloken SS ORAL 100 Other MILLIGRAM, 2/1 DAY ORAL Aspegic SS ORAL 250 MILLIGRAM, 1 DAY ORAL Leponex SS ORAL 100 MILLIGRAM, 3/1 DAY ORAL Renitec SS ORAL 5 MILLIGRAM, 1/1 DAY ORAL Valium C Depamide C Largactil C Haldol C Moditen C Date:08/31/00ISR Number: 3565755-7Report Type:Expedited (15-DaCompany Report #PHNU2000DE01619 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Congestive Cardiomyopathy Foreign Clozaril PS Novartis Ventricular Extrasystoles Health Pharmaceuticals Corp ORAL ORAL Professional Decentan Other (Perphenazine) C Fluctin (Fluoxetine Hydrochloride) C 22-Feb-2006 08:30 AM Page: 832 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/01/00ISR Number: 3562906-5Report Type:Direct Company Report # Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening White Blood Cell Count Clozapine 100 Mg Required Increased Tablet (Mylan/Udl) PS 300 MG BID Intervention to Metamucil C Prevent Permanent Ditropan Xl C Impairment/Damage Selenium Sulfide Lotion C Retin A C Zyprexa C Clindamycin 1% Topical Solution C Phenytoin Sodium C Valproic Acid C Docusate C Chlorpromazine C Levothyroxine C Benztropine C Date:09/01/00ISR Number: 3562951-XReport Type:Expedited (15-DaCompany Report #00-08-0410 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Road Traffic Accident Health Clozapine PS Zenith Goldline ORAL 800MG ORAL Professional Date:09/01/00ISR Number: 3562952-1Report Type:Expedited (15-DaCompany Report #00-08-0409 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetic Coma Health Clozapine PS Zenith Goldline ORAL 200MG ORAL Hospitalization - Professional Initial or Prolonged Date:09/01/00ISR Number: 3563895-XReport Type:Expedited (15-DaCompany Report #PHEH2000US07888 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Respiratory Other Clozaril PS Novartis Distress Syndrome Pharmaceuticals Corp ORAL LESS THAN 5MG Dysphagia ORAL Foreign Body Aspiration Pneumonia Date:09/01/00ISR Number: 3563901-2Report Type:Expedited (15-DaCompany Report #PHEH2000US07902 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Cancer Female Health Clozaril PS Novartis Professional Pharmaceuticals Corp ORAL 75 MG AM + 250MG HS, ORAL 22-Feb-2006 08:30 AM Page: 833 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/01/00ISR Number: 3563905-XReport Type:Expedited (15-DaCompany Report #PHEH2000US07924 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukocytosis Health Clozaril PS Novartis Testis Cancer Professional Pharmaceuticals Corp ORAL 350MG, ORAL Date:09/01/00ISR Number: 3563915-2Report Type:Expedited (15-DaCompany Report #PHEH2000US02389 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozaril (Clozapine) Testis Cancer Professional (Clozapine) Tablet PS ORAL 400 MG, BID, ORAL 3094 DAY Chemotherpay (Chemotherapeutics,O ther)(Chemotherapeut ics, Other) SS 102 MON Loxitane (Loxapine Succinate) C Artane (Trihexyphenidyl Hydrochloride) C Date:09/01/00ISR Number: 3563921-8Report Type:Expedited (15-DaCompany Report #PHEH2000US07983 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hodgkin'S Disease Health Clozaril PS Novartis Leukopenia Professional Pharmaceuticals Corp ORAL ORAL Neutropenia Clozapine(Clozapine) SS ORAL ORAL Date:09/01/00ISR Number: 3563954-1Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Leukocytosis Clozapine 100mg Tabs Intervention to (Zenith-Gold) PS Zenith-Gold ORAL 200MG PO AM Prevent Permanent Clozapine 250mg Tabs Impairment/Damage (Zenith-Gold) SS Zenith-Gold ORAL 250MG PO HS Date:09/01/00ISR Number: 3564086-9Report Type:Expedited (15-DaCompany Report #PHBS2000AU07884 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril PS Novartis Hyperglycaemia Health Pharmaceuticals Corp ORAL 175 MG/DAY, Professional ORAL Other Moclobemide (Moclobemide) C Date:09/05/00ISR Number: 3565379-1Report Type:Expedited (15-DaCompany Report #PHEH2000US02389 Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozaril PS Novartis Testis Cancer Professional Pharmaceuticals Corp ORAL 400 MG, BID, 22-Feb-2006 08:30 AM Page: 834 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report PO 3094 DAY Chemotherapy (Chemotherapeutics, Other) (Chemotherapeutics, Other) SS 9 YR Loxitane C Artane C Date:09/05/00ISR Number: 3565568-6Report Type:Expedited (15-DaCompany Report #PHBS2000AU07882 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril PS Novartis Hyperglycaemia Health Pharmaceuticals Corp ORAL 600 MG/DAY Professional ,ORAL Other Date:09/05/00ISR Number: 3565843-5Report Type:Expedited (15-DaCompany Report #PHHO1999AU05481 Age:21 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Deep Vein Thrombosis Foreign Clozaril PS Novartis Ecchymosis Study Pharmaceuticals Corp ORAL 650 MG QD Haemorrhage Health ORAL Physical Assault Professional Efexor (Venlafaxine Pulmonary Embolism Other Hydrochloride) C Pulmonary Infarction Doxycycline (Doxycycline) C Oral Contraceptive Nos (Oral Contraceptive Nos) C Date:09/05/00ISR Number: 3567038-8Report Type:Periodic Company Report #PRIUSA2000006776 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Deep Vein Thrombosis Health Ortho Tri-Cyclen PS Rw Johnson Hospitalization - Obesity Professional Pharmaceutical Initial or Prolonged Pulmonary Embolism Research Institute Div Ortho Pharm ORAL 1 TABLE, DAILY, PO Clozaril (Clozapine) SS ORAL 325 MG, 1 IN 1 DAILY, PO Lithium C Synthroid C Wellbutrin C Klonopin C Date:09/06/00ISR Number: 3566533-5Report Type:Expedited (15-DaCompany Report #JACGBR2000000339 Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Foreign Risperdal PS Janssen Research Fdn Required Cardio-Respiratory Arrest Health Div Johnson And Intervention to Circulatory Collapse Professional Johnson Prevent Permanent Loss Of Consciousness Sulpiride Impairment/Damage Respiratory Failure (Sulpiride) SS ORAL 2400 MG, 22-Feb-2006 08:30 AM Page: 835 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report DAILY, ORAL Clozapine (Clozapine SS ORAL 700 , DAILY, ORAL Procyclidine (Procyclidine) SS ORAL 15 MG, ORAL Droleptan (Droperidol) C Lorazepam (Lorazepam) C Date:09/06/00ISR Number: 3566819-4Report Type:Expedited (15-DaCompany Report #00P-163-0096825-00 (0) Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Depakote PS Abbott Laboratories ORAL 1500 MG 1 IN Initial or Prolonged Psychotic Disorder Professional 1 D PER ORAL Schizoaffective Disorder Clozapine(Clozapine) SS ORAL 350 MG 1 IN 1D PER ORAL Glipizide (Glipizide) C Detrol C Metformin Hydrochloride (Metformin Hydrochloride) C Date:09/06/00ISR Number: 3569469-9Report Type:Expedited (15-DaCompany Report #00-09-0422 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 200 MG ORAL Professional Date:09/06/00ISR Number: 3569471-7Report Type:Expedited (15-DaCompany Report #00-08-0421 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neoplasm Malignant Health Clozapine PS Zenith Goldline ORAL 400 MG ORAL Professional Date:09/06/00ISR Number: 3569472-9Report Type:Expedited (15-DaCompany Report #00-08-0424 Age:89 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Clozapine PS Zenith Goldline ORAL ORAL Date:09/06/00ISR Number: 3569474-2Report Type:Expedited (15-DaCompany Report #00-08-0399 Age:78 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Health Clozapine PS Zenith Goldline ORAL ORAL Lung Neoplasm Malignant Professional Metastases To Central Nervous System 22-Feb-2006 08:30 AM Page: 836 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/06/00ISR Number: 3569476-6Report Type:Expedited (15-DaCompany Report #00-08-0392 Age:84 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neoplasm Malignant Health Clozapine PS Zenith Goldline ORAL 200 MG ORAL Professional Date:09/06/00ISR Number: 3569479-1Report Type:Expedited (15-DaCompany Report #00-08-0402 Age:72 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 25-450MG ORAL Professional Valproic Acid C Lithium Carbonaate C Zoloft C Date:09/06/00ISR Number: 3569481-XReport Type:Expedited (15-DaCompany Report #00-07-0364 Age:39 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Road Traffic Accident Health Clozapine PS Zenith Goldline ORAL 300 MG ORAL Initial or Prolonged Professional Effexor 225 Mg Qd C Zyprexa 20 Mg C Stelazine C .. C Date:09/06/00ISR Number: 3569483-3Report Type:Expedited (15-DaCompany Report #00-08-0400 Age:58 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Foreign Body Aspiration Health Clozapine PS Zenith Goldline ORAL 500 MG ORAL Professional Propraanolol 20 Mg Tid C Buspar 10 Mg Tid C Risperdal 1mg Bid C Zoloft C Trazodone C Date:09/06/00ISR Number: 3569990-3Report Type:Expedited (15-DaCompany Report #00-09-0423 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 200MG ORAL Professional Date:09/06/00ISR Number: 3569993-9Report Type:Expedited (15-DaCompany Report #00-09-0419 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Intestinal Perforation Health Clozapine PS Zenith Goldline ORAL 300MG ORAL Peritonitis Professional 22-Feb-2006 08:30 AM Page: 837 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/07/00ISR Number: 3566488-3Report Type:Direct Company Report # Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperglycaemia Clozapine 25mg Tab (Zenith Goldline) PS Zenith Goldline Normodyne C Haloperidol C Diflucan C Flagyl C Chronulac C Motrin C Hydralazine C Unasyn C Catapres C Neurontin C Adalat Cc C Date:09/07/00ISR Number: 3567535-5Report Type:Expedited (15-DaCompany Report #PHHO2000GB01831 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Anoxia Foreign Clozaril PS Novartis Hospitalization - C-Reactive Protein Study Pharmaceuticals Corp ORAL 100 MANE/175 Initial or Prolonged Increased Health NOCTE, ORAL Cardiac Arrest Professional Procyclidine Convulsion Other (Procyclidine) C Diarrhoea Flupentixol Gastroenteritis Viral (Flupentixol) C Hypokalaemia Hypotension Loss Of Consciousness Neutropenia Pyrexia Date:09/07/00ISR Number: 3569372-4Report Type:Expedited (15-DaCompany Report #PHBS2000CA08210 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bundle Branch Block Foreign Clozaril PS Novartis Electrocardiogram Health Pharmaceuticals Corp ORAL 800 MG/DAY, Abnormal Professional ORAL Other Paroxetine (Paroxetine) C Divalproex Sodium (Valproate Semisodium) C Nova C Date:09/07/00ISR Number: 3569375-XReport Type:Expedited (15-DaCompany Report #PHFR2000GB00569 Age:56 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cerebrovascular Accident Foreign Clozaril PS Novartis Diabetes Mellitus Health Pharmaceuticals Corp ORAL 400MG/DAY, Non-Insulin-Dependent Professional ORAL Other 22-Feb-2006 08:30 AM Page: 838 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/07/00ISR Number: 3569637-6Report Type:Expedited (15-DaCompany Report #PHEH2000US08052 Age:80 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Parkinson'S Disease Health Clozaril PS Novartis Professional Pharmaceuticals Corp ORAL 12.5MGUNK, ORAL Date:09/08/00ISR Number: 3568079-7Report Type:Expedited (15-DaCompany Report #00-08-0416 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 300MG ORAL Professional Date:09/08/00ISR Number: 3568334-0Report Type:Direct Company Report # Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Clozapine (Zenith) PS Zenith ORAL 100MG Initial or Prolonged Disorientation AM/300MG Dyskinesia PM-PO Dyspnoea Citalopram C Loss Of Consciousness Atorvastatin C Tongue Disorder Valproic Acid C Date:09/08/00ISR Number: 3569568-1Report Type:Expedited (15-DaCompany Report #PHBS2000AU04208 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiac Enzymes Increased Foreign Clozaril PS Novartis Chest Pain Health Pharmaceuticals Corp ORAL 400 MG, QD, Cough Professional ORAL Electrocardiogram T Wave Other Amplitude Decreased Myocarditis Neutrophil Count Increased Oral Candidiasis Pharyngolaryngeal Pain Date:09/11/00ISR Number: 3569145-2Report Type:Expedited (15-DaCompany Report #PHEH2000US07928 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukocytosis Health Clozaril PS Novartis Initial or Prolonged Lung Abscess Professional Pharmaceuticals Corp ORAL ORAL Pneumonia Date:09/11/00ISR Number: 3570078-6Report Type:Expedited (15-DaCompany Report #PHBS2000FR04042 Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hodgkin'S Disease Foreign Clozaril PS Novartis Initial or Prolonged Health Pharmaceuticals Corp ORAL ORAL Professional Seropram (Citalopram Other Hydrobromide) SS 40 MG DAILY 22-Feb-2006 08:30 AM Page: 839 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Leponex (Clozapine) SS ORAL 400 MG DAILY ORAL Xanax (Alprazolam) SS ORAL 3MG DAILY, ORAL Date:09/12/00ISR Number: 3570407-3Report Type:Direct Company Report # Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coma Clozapine PS 150 MG AM 350 Pallor PM Pyrexia Propanolol C Topamax C Date:09/12/00ISR Number: 3570458-9Report Type:Expedited (15-DaCompany Report #001-0981-M0006541 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Health Lipitor PS Warner Lambert Initial or Prolonged Myositis Professional Export Ltd Clozaril (Clozapine) SS Date:09/12/00ISR Number: 3570555-8Report Type:Expedited (15-DaCompany Report #PHEH2000US08088 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Health Clozaril PS ORAL ORAL Weight Increased Professional Date:09/12/00ISR Number: 3570556-XReport Type:Expedited (15-DaCompany Report #PHEH2000US08089 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Health Clozaril PS ORAL ORAL Professional Date:09/12/00ISR Number: 3570557-1Report Type:Expedited (15-DaCompany Report #PHEH2000US08090 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Health Clozaril PS ORAL ORAL Professional Date:09/12/00ISR Number: 3570614-XReport Type:Expedited (15-DaCompany Report #20000800798 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Arteritis Foreign Pulmicort PS Astrazeneca Coordination Abnormal Health Pharmaceuticals Lp Dysarthria Professional Clozaril SS Valproate Sodium SS Citalopram SS 22-Feb-2006 08:30 AM Page: 840 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/13/00ISR Number: 3571049-6Report Type:Expedited (15-DaCompany Report #PHBS2000GB04038 Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Circulatory Collapse Foreign Clozaril PS Novartis Loss Of Consciousness Health Pharmaceuticals Corp ORAL 725 MG/DAY, Professional ORAL Other Date:09/13/00ISR Number: 3571239-2Report Type:Expedited (15-DaCompany Report #PHFR2000GB00623 Age:49 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril PS Novartis Fatigue Health Pharmaceuticals Corp ORAL 125 MG MANE, Flushing Professional 150 MG NOCTE, Hyperglycaemia Other ORAL Nausea Premiquie (Estrogens Sedation Conjugated) C Vomiting Gliclazide (Gliclazide0 C Fluoxetine (Fluoclazide) C ... C Date:09/14/00ISR Number: 3570932-5Report Type:Expedited (15-DaCompany Report #244329 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Xenical PS Roche Initial or Prolonged Condition Aggravated Leponex SS 365 DAY Delirium Drug Interaction Hallucination Persecutory Delusion Schizophrenia Date:09/14/00ISR Number: 3571617-1Report Type:Expedited (15-DaCompany Report #PHBS2000AU08555 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyspnoea Foreign Clozaril PS Novartis Initial or Prolonged Face Oedema Health Pharmaceuticals Corp ORAL 300 MG/D, Pallor Professional ORAL Tongue Oedema Other Sertraline (Sertraline) SS 50 MG/D 18 DAY Date:09/14/00ISR Number: 3571620-1Report Type:Expedited (15-DaCompany Report #PHBS2000NZ08646 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Foreign Clozaril PS Novartis Diarrhoea Health Pharmaceuticals Corp ORAL ORAL Drug Toxicity Professional Temazepam C Electrolyte Imbalance Other Vomiting 22-Feb-2006 08:30 AM Page: 841 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/14/00ISR Number: 3571621-3Report Type:Expedited (15-DaCompany Report #PHBS2000AU08574 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiomyopathy Foreign Clozaril PS Novartis Echocardiogram Abnormal Health Pharmaceuticals Corp ORAL 700 MG/D, Professional ORAL Other Sodium Valproate C Date:09/14/00ISR Number: 3571675-4Report Type:Direct Company Report # Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Parotitis Clozaril 100mg Intervention to Novartis PS Novartis ORAL 325 MG PO HS Prevent Permanent Clozaril 25mg Impairment/Damage Novartis SS Novartis ORAL 325 MG PO HS Serzone C Neurontin C Axid C Ativan C Date:09/14/00ISR Number: 3571690-0Report Type:Expedited (15-DaCompany Report #PHBS2000GB03927 Age:55 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Foreign Clozaril PS Novartis Initial or Prolonged Health Pharmaceuticals Corp ORAL ORAL Professional Date:09/15/00ISR Number: 3571938-2Report Type:Expedited (15-DaCompany Report #00-08-0390 Age:77 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Paralysis Health Clozapine PS Zenith Goldline ORAL 12.5-125MG Professional ORAL Date:09/15/00ISR Number: 3571939-4Report Type:Expedited (15-DaCompany Report #00-08-0390 Age:77 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Paralysis Health Clozapine PS Zenith Goldline ORAL 12.5-125MG Professional ORAL Date:09/15/00ISR Number: 3571940-0Report Type:Expedited (15-DaCompany Report #00-08-0387 Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozapine PS Zenith Goldline ORAL 400MG ORAL Cardiac Failure Professional Congestive Cardiomyopathy Viral Infection 22-Feb-2006 08:30 AM Page: 842 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/15/00ISR Number: 3571941-2Report Type:Expedited (15-DaCompany Report #00-08-0410 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Head Injury Health Clozapine PS Zenith Goldline ORAL 800MG ORAL Road Traffic Accident Professional Imipramine C Date:09/18/00ISR Number: 3572869-4Report Type:Expedited (15-DaCompany Report #00-08-0390 Age:77 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Progressive Supranuclear Health Clozapine PS Zenith Goldline ORAL 12.54-125MG Palsy Professional ORAL Date:09/18/00ISR Number: 3572870-0Report Type:Expedited (15-DaCompany Report #00-09-0473 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Road Traffic Accident Health Clozapine PS Zenith Goldline ORAL 300MG ORAL Professional Date:09/18/00ISR Number: 3572871-2Report Type:Expedited (15-DaCompany Report #00-09-0467 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Clozapine PS Zenith Goldline ORAL 50-200MG ORAL Congestive Professional Coronary Artery Disease Date:09/18/00ISR Number: 3573099-2Report Type:Direct Company Report # Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drooling Clozapine PS Sedation Weight Increased Date:09/18/00ISR Number: 3573704-0Report Type:Periodic Company Report #00-09-0472 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Lymphoma Health Clozapine PS Zenith Goldline ORAL 200-700MG White Blood Cell Count Professional ORAL White Blood Cell Count Increased Date:09/18/00ISR Number: 3574504-8Report Type:Expedited (15-DaCompany Report #244329 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Foreign Xenical PS Hlr Technology ORAL ORAL Initial or Prolonged Delirium Other Leponex (Clozapine) Drug Interaction 100 Mg SS ORAL 100 MG DAILY Hallucination ORAL 365 DAY Schizophrenia 22-Feb-2006 08:30 AM Page: 843 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/18/00ISR Number: 3574559-0Report Type:Expedited (15-DaCompany Report #PHNU2000DE01667 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Antibody Test Abnormal Foreign Clozaril PS Novartis Initial or Prolonged Blood Immunoglobulin A Health Pharmaceuticals Corp ORAL ORAL Decreased Professional Blood Immunoglobulin E Other Decreased Blood Immunoglobulin M Decreased Immunodeficiency Lymphopenia Date:09/18/00ISR Number: 3574576-0Report Type:Expedited (15-DaCompany Report #PHFR2000GB00533 Age:46 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril PS Novartis Non-Insulin-Dependent Health Pharmaceuticals Corp ORAL 450 MG/DAY, Hyperglycaemia Professional ORAL Polyuria Other Thirst Date:09/19/00ISR Number: 3573343-1Report Type:Direct Company Report # Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Clozapine 100 Mg Tab PS ORAL PO 400 MG Q Initial or Prolonged PM, 100 MG Q Required AM Intervention to Ranitidine C Prevent Permanent Pramipexole C Impairment/Damage Oxybutynin C Aspirin C Docusate C Lisinopril C Digoxin C Citalopram C Heparin Inj C Sinemet 50/200 C Sinemet 25/100 C Timentin C Ciprofloxacin C Date:09/19/00ISR Number: 3574686-8Report Type:Direct Company Report # Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Prostate Cancer Clozaril (For 8 Prostatic Specific Years) 475 Mg/D In 3 Antigen Increased Divided Doses PS SEE ABOVE 8 YR Clozapine (For 10 Mos) 475 Mg/D In 3 Divided Doses SS AS ABOVE 10 MON Buspar C 22-Feb-2006 08:30 AM Page: 844 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/19/00ISR Number: 3574937-XReport Type:Expedited (15-DaCompany Report #00-09-0479 Age:86 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 50-75MG ORAL 2 YR Professional Date:09/20/00ISR Number: 3575655-4Report Type:Expedited (15-DaCompany Report #PHBS2000IT08714 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Foreign Clozaril PS Novartis Initial or Prolonged Diabetic Hyperglycaemic Literature Pharmaceuticals Corp 400 MG/DAY Coma Health Valproic Acid C Diabetic Ketoacidosis Professional Glycosuria Other Hyperglycaemia Ketonuria Vomiting Date:09/20/00ISR Number: 3575665-7Report Type:Expedited (15-DaCompany Report #PHBS2000CH08668 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Foreign Clozaril PS Novartis Initial or Prolonged Drug Interaction Health Pharmaceuticals Corp ORAL 100 MG/D, Hallucination Professional ORAL; 200 Mania Other MG/D, ORAL Xenical (Orlistat) SS Date:09/20/00ISR Number: 3575668-2Report Type:Expedited (15-DaCompany Report #PHBS2000NL08716 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril PS Novartis Hyperglycaemia Literature Pharmaceuticals Corp 100 MG/DAY 1 WK Hypertension Health Perphenazine Malaise Professional (Perphenazine) C Other Date:09/20/00ISR Number: 3575671-2Report Type:Expedited (15-DaCompany Report #PHBS2000AU04327 Age:66 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Neoplasm Malignant Foreign Clozaril PS Novartis Study Pharmaceuticals Corp ORAL 75 MG/DAY, Health ORAL Professional Other Date:09/20/00ISR Number: 3578209-9Report Type:Periodic Company Report #CDN/99/00547/LEX Age:55 YR Gender:Male I/FU:I Outcome Life-Threatening Hospitalization - Initial or Prolonged 22-Feb-2006 08:30 AM Page: 845 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Required Intervention to Prevent Permanent PT Report Source Product Role Manufacturer Route Dose Duration Impairment/Damage Agranulocytosis Foreign Clozaril (Clozapine) PS ORAL 200 MG, THREE Leukopenia Study TIMES A DAY, Mouth Ulceration Health ORAL Professional Glyburide (Glibenclamide) SS UNKNOWN Lescol (Fluvastatin Sodium) C Metformin (Metformin) C Colace (Docusate Sodium) C Norvasc (Amlodipine Besilate) C Seunosides (Sennoside A) C Date:09/21/00ISR Number: 3575759-6Report Type:Expedited (15-DaCompany Report #00-09-0480 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 300-325MG, Professional ORAL Date:09/21/00ISR Number: 3575760-2Report Type:Expedited (15-DaCompany Report #00-09-0481 Age:71 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 100 MG, ORAL Professional Date:09/21/00ISR Number: 3575761-4Report Type:Expedited (15-DaCompany Report #00-08-0401 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Urinary Tract Infection Health Clozapine PS Zenith Goldline ORAL 375 MG, ORAL Initial or Prolonged Professional Date:09/21/00ISR Number: 3575777-8Report Type:Expedited (15-DaCompany Report #00-06-0325 Age:71 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 25 MG, ORAL Professional Prevacid C Carfate C Acetaminophen C Ensure Supplement C Date:09/21/00ISR Number: 3575781-XReport Type:Expedited (15-DaCompany Report #00-08-0389 Age:60 YR Gender:Female I/FU:F Outcome PT Hospitalization - Fall Initial or Prolonged Foot Fracture 22-Feb-2006 08:30 AM Page: 846 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Respiratory Disorder Report Source Product Role Manufacturer Route Dose Duration Health Clozapine PS Zenith Goldline ORAL 50-50MG, ORAL Professional Date:09/21/00ISR Number: 3576907-4Report Type:Expedited (15-DaCompany Report #PHBS2000DE03993 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Immunoglobulin E Foreign Clozaril PS Novartis Initial or Prolonged Increased Health Pharmaceuticals Corp ORAL 250 MG, ORAL Eosinophilia Professional Haldol (Haloperidol) C Joint Effusion Other Melperone Pericardial Effusion (Melperone) C Pleural Effusion Pneumonia Polyserositis Date:09/21/00ISR Number: 3576908-6Report Type:Expedited (15-DaCompany Report #PHBS2000AU08777 Age:81 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiovascular Disorder Foreign Clozaril PS Novartis Health Pharmaceuticals Corp ORAL 19 MG/D, ORAL Professional Other Date:09/21/00ISR Number: 3577105-0Report Type:Expedited (15-DaCompany Report #200020716GDC Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiac Failure Foreign Bricanyl PS Aventis Dyspnoea Other Pharmaceuticals Inc ORAL PO Hypertension Clozapine (Clozaril) SS 1044 DAY Malaise Cefalexin Myocarditis Monohydrate (Keflex) SS Neutrophil Count Warfarin C Increased Renal Failure Acute Right Ventricular Failure Tachycardia Vomiting Date:09/22/00ISR Number: 3578402-5Report Type:Expedited (15-DaCompany Report #PHHO2000AU00957 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiomyopathy Foreign Clozaril PS Novartis Dyspnoea Study Pharmaceuticals Corp ORAL 500 MG QD Weight Increased Health ORAL Professional Amitriptyline Other (Amitriptyline) C 22-Feb-2006 08:30 AM Page: 847 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/22/00ISR Number: 3578427-XReport Type:Expedited (15-DaCompany Report #PHBS2000AU09078 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiomyopathy Foreign Clozaril PS Novartis Health Pharmaceuticals Corp ORAL 40 MG/D, ORAL Professional Other Date:09/22/00ISR Number: 3578432-3Report Type:Expedited (15-DaCompany Report #PHBS2000CA04131 Age:49 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthma Foreign Clozaril PS Novartis Dyspnoea Health Pharmaceuticals Corp ORAL ORAL Laryngeal Disorder Professional Oedema Other Pneumonia Respiratory Disorder Date:09/22/00ISR Number: 3578446-3Report Type:Expedited (15-DaCompany Report #PHBS2000CA07713 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bundle Branch Block Foreign Clozaril PS Novartis Conduction Disorder Study Pharmaceuticals Corp ORAL ORAL Pyrexia Health Congentin Professional (Benzatropine Other Mesilate) C Haldol C Isig Modecate C Date:09/22/00ISR Number: 3578732-7Report Type:Expedited (15-DaCompany Report #PHEH2000US08192 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Clozaril PS Novartis Initial or Prolonged Cardiac Arrest Professional Pharmaceuticals Corp ORAL 850MG, ORAL Cardiomyopathy Anafranil (Clomipramine Hydrochloride,Clomip ramine Hydrochloride) C Date:09/22/00ISR Number: 3578893-XReport Type:Expedited (15-DaCompany Report #PHBS2000AU08893 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiac Disorder Foreign Clozaril PS Novartis Cardiomyopathy Health Pharmaceuticals Corp ORAL ORAL Hypokinesia Professional Left Ventricular Failure Other 22-Feb-2006 08:30 AM Page: 848 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/22/00ISR Number: 3578896-5Report Type:Expedited (15-DaCompany Report #PHBS2000F108870 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - C-Reactive Protein Foreign Clozaril PS Novartis Initial or Prolonged Increased Health Pharmaceuticals Corp ORAL ORAL Pneumonitis Professional Other Date:09/22/00ISR Number: 3578903-XReport Type:Expedited (15-DaCompany Report #PHBS2000AU08833 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Atrial Fibrillation Foreign Clozaril PS Novartis Brain Stem Infarction Health Pharmaceuticals Corp ORAL 12 MG/D, ORAL Professional Other Date:09/22/00ISR Number: 3578904-1Report Type:Expedited (15-DaCompany Report #PHBS2000AU08847 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eosinophilic Pneumonia Foreign Clozaril PS Novartis Lung Infiltration Health Pharmaceuticals Corp ORAL ORAL Psychotic Disorder Professional Other Date:09/22/00ISR Number: 3578907-7Report Type:Expedited (15-DaCompany Report #PHBS2000AU09075 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Complications Of Maternal Foreign Clozaril PS Novartis Exposure To Therapeutic Health Pharmaceuticals Corp ORAL 400 MG/D, Drugs Professional ORAL Drug Interaction Other Ursofalk Foetal Distress Syndrome (Ursodeoxycholic Foetal Movements Acid) SS 1.5 G/D Decreased Date:09/22/00ISR Number: 3578908-9Report Type:Expedited (15-DaCompany Report #PHBS2000AU09081 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiomyopathy Foreign Clozaril PS Novartis Health Pharmaceuticals Corp Professional Other Date:09/25/00ISR Number: 3578734-0Report Type:Expedited (15-DaCompany Report #PHEH2000US0875 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Parkinson'S Disease Health Clozaril PS Novartis Professional Pharmaceuticals Corp ORAL 75MG, ORAL 22-Feb-2006 08:30 AM Page: 849 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/25/00ISR Number: 3579549-XReport Type:Expedited (15-DaCompany Report #PHFR2000GB01416 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Foreign Clozaril PS Novartis Initial or Prolonged Blood Creatine Health Pharmaceuticals Corp ORAL 300MG/DAY, Other Phosphokinase Increased Professional ORAL Blood Pressure Other Librium Fluctuation (Chlordiazepoxide Hyperhidrosis Hydrochloride) C Infection Leukocytosis Neuroleptic Malignant Syndrome Neutrophilia Pyrexia Tachycardia Thrombocythaemia Date:09/25/00ISR Number: 3579557-9Report Type:Expedited (15-DaCompany Report #PHNU2000DE01760 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alveolitis Foreign Clozaril PS Novartis Initial or Prolonged Body Temperature Health Pharmaceuticals Corp ORAL ORAL Increased Professional Antibiotics C Cough Other Drug Level Above Therapeutic Eosinophilia Eosinophilic Pneumonia Leukocytosis Neutrophilia Pneumonia Date:09/25/00ISR Number: 3579638-XReport Type:Expedited (15-DaCompany Report #PHEH2000US08712 Age:74 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozaril (Clozapine) Professional (Clozapine) Tablet PS Novartis Pharmaceuticals Corp ORAL 650MG ,ORAL Clozapine Zenith Goldline) (Clozapine) SS Zenith Goldline Date:09/25/00ISR Number: 3579644-5Report Type:Expedited (15-DaCompany Report #PHEH2000US08711 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Respiratory Failure Health Clozaril (Clozapine) Hospitalization - Professional (Clozapine) Tablet PS Novartis Initial or Prolonged Pharmaceuticals Corp ORAL 600 MG, ORAL 22-Feb-2006 08:30 AM Page: 850 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/25/00ISR Number: 3579657-3Report Type:Expedited (15-DaCompany Report #PHBS2000AU08574 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiac Disorder Foreign Clozaril PS Novartis Cardiomyopathy Health Pharmaceuticals Corp ORAL 700 MG/D, Echocardiogram Abnormal Professional ORAL Other Date:09/25/00ISR Number: 3579658-5Report Type:Expedited (15-DaCompany Report #PHBS2000AU00621 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Difficulty In Walking Foreign Clozaril PS Novartis Initial or Prolonged Dyspnoea Health Pharmaceuticals Corp ORAL 75 MG + 300 Fatigue Professional MG, ORAL Nausea Other Brevinor (Normensal) C Palpitations Tegretol Tricuspid Valve (Carbamazepine) C Incompetence Zantac C Date:09/26/00ISR Number: 3580939-XReport Type:Periodic Company Report #00-05-0456 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eosinophil Count Health Clozapine PS Zenith Goldline ORAL UNKNOWN ORAL Decreased Professional Date:09/26/00ISR Number: 3580940-6Report Type:Periodic Company Report #00-05-0457 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eosinophil Count Health Clozapine PS Zenith Goldline ORAL UNKNOWN ORAL Decreased Professional Date:09/26/00ISR Number: 3580941-8Report Type:Periodic Company Report #00-05-0458 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eosinophil Count Health Clozapine PS Zenith Goldline ORAL UNKNOWN ORAL Decreased Professional Date:09/26/00ISR Number: 3580942-XReport Type:Periodic Company Report #00-05-0459 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eosinophil Count Health Clozapine PS Zenith Goldline ORAL UNKNOWN ORAL Decreased Professional Date:09/26/00ISR Number: 3580943-1Report Type:Periodic Company Report #00-05-0460 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eosinophil Count Health Clozapine PS Zenith Goldline ORAL UNKNOWN ORAL Decreased Professional 22-Feb-2006 08:30 AM Page: 851 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/26/00ISR Number: 3580944-3Report Type:Periodic Company Report #00-05-0461 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eosinophil Count Health Clozapine PS Zenith Goldline ORAL 500MG ORAL Decreased Professional Date:09/26/00ISR Number: 3580945-5Report Type:Periodic Company Report #00-05-0462 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eosinophil Count Health Clozapine PS Zenith Goldline ORAL UNKNOWN ORAL Decreased Professional Date:09/26/00ISR Number: 3580946-7Report Type:Periodic Company Report #00-05-0463 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eosinophil Count Health Clozapine PS Zenith Goldline ORAL UNKNOWN ORAL Decreased Professional Date:09/26/00ISR Number: 3580947-9Report Type:Periodic Company Report #00-05-0464 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eosinophil Count Health Clozapine PS Zenith Goldline ORAL UNKNOWN ORAL Decreased Professional Date:09/26/00ISR Number: 3580949-2Report Type:Periodic Company Report #00-05-0465 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eosinophil Count Health Clozapine PS Zenith Goldline ORAL UNKNOWN ORAL Decreased Professional Date:09/26/00ISR Number: 3580950-9Report Type:Periodic Company Report #00-03-0109 Age:60 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Psychotic Disorder Health Clozapine PS Zenith Goldline ORAL 600MG ORAL Professional Date:09/26/00ISR Number: 3580951-0Report Type:Periodic Company Report #00-05-0224 Age:44 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Ineffective Health Clozapine PS Zenith Goldline ORAL 500MG ORAL Professional Date:09/26/00ISR Number: 3580952-2Report Type:Periodic Company Report #00-05-0227 Age:47 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Ineffective Health Clozapine PS Zenith Goldline ORAL ORAL Professional 22-Feb-2006 08:30 AM Page: 852 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/26/00ISR Number: 3580953-4Report Type:Periodic Company Report #00-05-0232 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Health Clozapine PS Zenith Goldline Professional Pharm. ORAL 400 - 700MG ORAL Date:09/26/00ISR Number: 3580954-6Report Type:Periodic Company Report #00-05-0233 Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Depression Health Clozapine PS Zenith Goldline Professional Pharm. ORAL ORAL Zoloft C Date:09/26/00ISR Number: 3580956-XReport Type:Periodic Company Report #00-05-0234 Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Schizophrenia Health Clozapine PS Zenith Goldline ORAL 250-750MG Professional ORAL Date:09/26/00ISR Number: 3580958-3Report Type:Periodic Company Report #00-05-0237 Age:31 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Nausea Health Clozapine PS Zenith Goldline ORAL 75MG ORAL Professional Date:09/26/00ISR Number: 3580960-1Report Type:Periodic Company Report #00-05-0243 Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Priapism Health Clozapine PS Zenith Goldline ORAL 35-350MG ORAL Professional Depakote C Paxil C Pepcid C Claritin C Colace C Multivitamins C Atropine Drops C Date:09/26/00ISR Number: 3580961-3Report Type:Periodic Company Report #00-05-0250 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Enuresis Health Clozapine PS Zenith Goldline ORAL 300MG ORAL Urinary Incontinence Professional Prinivil C Maxair C Albuterol C Procardia Xl C Vistaril C Verapamil Sr C Hydroxyzine C 22-Feb-2006 08:30 AM Page: 853 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/26/00ISR Number: 3580963-7Report Type:Periodic Company Report #00-05-0253 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dermatitis Health Clozapine PS Zenith Goldline ORAL N/A ORAL Professional Clozaril SS ORAL ORAL Date:09/26/00ISR Number: 3581174-1Report Type:Periodic Company Report #00-04-0258 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Health Clozapine PS Zenith Goldline ORAL 900MG ORAL Condition Aggravated Professional Hallucination, Auditory Restlessness Date:09/26/00ISR Number: 3581176-5Report Type:Periodic Company Report #00-05-0436 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eosinophil Count Health Clozapine PS Zenith Goldline ORAL 300MG ORAL Decreased Professional Date:09/26/00ISR Number: 3581177-7Report Type:Periodic Company Report #00-05-0437 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eosinophil Count Health Clozapine PS Zenith Goldline ORAL ORAL Decreased Professional Date:09/26/00ISR Number: 3581178-9Report Type:Periodic Company Report #00-05-0438 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eosinophil Count Health Clozapine PS Zenith Goldline ORAL 525MG ORAL Decreased Professional Date:09/26/00ISR Number: 3581180-7Report Type:Periodic Company Report #00-05-0439 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eosinophil Count Health Clozapine PS Zenith Goldline ORAL ORAL Decreased Professional Date:09/26/00ISR Number: 3581181-9Report Type:Periodic Company Report #00-05-0440 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eosinophil Count Health Clozapine PS Zenith Goldline ORAL ORAL Decreased Professional 22-Feb-2006 08:30 AM Page: 854 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/26/00ISR Number: 3581183-2Report Type:Periodic Company Report #00-05-0441 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eosinophil Count Health Clozapine PS Zenith Goldline ORAL ORAL Decreased Professional Date:09/26/00ISR Number: 3581190-XReport Type:Periodic Company Report #00-05-0442 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eosinophil Count Health Clozapine PS Zenith Goldline ORAL ORAL Decreased Professional Date:09/26/00ISR Number: 3581192-3Report Type:Periodic Company Report #00-05-0443 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eosinophil Count Health Clozapine PS Zenith Goldline ORAL ORAL Decreased Professional Date:09/26/00ISR Number: 3581193-5Report Type:Periodic Company Report #00-05-0444 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eosinophil Count Health Clozapine PS Zenith Goldline ORAL ORAL Decreased Professional Date:09/26/00ISR Number: 3581194-7Report Type:Periodic Company Report #00-05-0445 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eosinophil Count Health Clozapine PS Zenith Goldline ORAL 500-700MG Decreased Professional ORAL Date:09/26/00ISR Number: 3581195-9Report Type:Periodic Company Report #00-05-0446 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eosinophil Count Health Clozapine PS Zenith Goldline ORAL ORAL Decreased Professional Date:09/26/00ISR Number: 3581196-0Report Type:Periodic Company Report #00-05-0447 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eosinophil Count Health Clozapine PS Zenith Goldline ORAL ORAL Decreased Professional Date:09/26/00ISR Number: 3581197-2Report Type:Periodic Company Report #00-05-0448 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eosinophil Count Health Clozapine PS Zenith Goldline ORAL ORAL Decreased Professional 22-Feb-2006 08:30 AM Page: 855 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/26/00ISR Number: 3581198-4Report Type:Periodic Company Report #00-05-0449 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eosinophil Count Health Clozapine PS Zenith Goldline ORAL ORAL Decreased Professional Date:09/26/00ISR Number: 3581199-6Report Type:Periodic Company Report #00-05-0450 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eosinophil Count Health Clozapine PS Zenith Goldline ORAL ORAL Decreased Professional Date:09/26/00ISR Number: 3581200-XReport Type:Periodic Company Report #00-05-0451 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eosinophil Count Health Clozapine PS Zenith Goldline ORAL ORAL Decreased Professional Date:09/26/00ISR Number: 3581201-1Report Type:Periodic Company Report #00-05-0452 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eosinophil Count Health Clozapine PS Zenith Goldline ORAL ORAL Decreased Professional Date:09/26/00ISR Number: 3581202-3Report Type:Periodic Company Report #00-05-0453 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eosinophil Count Health Clozapine PS Zenith Goldline ORAL ORAL Decreased Professional Date:09/26/00ISR Number: 3581203-5Report Type:Periodic Company Report #00-05-0454 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eosinophil Count Health Clozapine PS Zenith Goldline ORAL ORAL Decreased Professional Date:09/26/00ISR Number: 3581204-7Report Type:Periodic Company Report #00-05-0455 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eosinophil Count Health Clozapine PS Zenith Goldline ORAL ORAL Decreased Professional Date:09/26/00ISR Number: 3581210-2Report Type:Periodic Company Report #00-06-0300 Age:45 YR Gender:Male I/FU:I Outcome PT Other Clonic Convulsion Mental Disorder 22-Feb-2006 08:30 AM Page: 856 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Muscular Weakness Report Source Product Role Manufacturer Route Dose Duration Health Clozapine PS Zenith Goldline ORAL 300-700MG Professional ORAL Depakote C Prolixin C Date:09/26/00ISR Number: 3581214-XReport Type:Periodic Company Report #00-06-0301 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Health Clozapine PS Zenith Goldline ORAL 300MG ORAL Cognitive Disorder Professional Disorientation Drug Ineffective Date:09/26/00ISR Number: 3581216-3Report Type:Periodic Company Report #00-06-0315 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Muscle Rigidity Health Clozapine PS Zenith Goldline ORAL 100-200MG Professional ORAL Depakote C Prozac C Klonopin C Date:09/26/00ISR Number: 3581218-7Report Type:Periodic Company Report #00-06-0317 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Weight Increased Health Clozapine PS Zenith Goldline ORAL 500MG ORAL Professional Clozapine - Zenith Goldline Pharm. Tablets SS ORAL 500MG ORAL Cogentin C Paxil C Risperdal C Date:09/26/00ISR Number: 3581221-7Report Type:Periodic Company Report #00-07-0347 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Unevaluable Event Health Clozapine PS Zenith Goldline ORAL 100-275MG Professional ORAL Date:09/26/00ISR Number: 3581222-9Report Type:Periodic Company Report #00-07-0351 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Enuresis Health Clozapine PS Zenith Goldline ORAL 25-400MG ORAL Micturition Urgency Professional Haldol Decanoate C Salivary Hypersecretion Zyprexa C Sedation Lithium Carbonate C Neurontin C Cogentin C 22-Feb-2006 08:30 AM Page: 857 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/26/00ISR Number: 3581224-2Report Type:Periodic Company Report #00-07-0353 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypersensitivity Health Clozapine PS Zenith Goldline ORAL 250MG ORAL Professional Date:09/26/00ISR Number: 3581225-4Report Type:Periodic Company Report #00-07-0355 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Health Clozapine PS Zenith Goldline ORAL ORAL Delusion Professional Drug Ineffective Obsessive-Compulsive Disorder Date:09/26/00ISR Number: 3581226-6Report Type:Periodic Company Report #00-07-0361 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diarrhoea Health Clozapine PS Zenith Goldline ORAL 400-500MG Professional ORAL Date:09/26/00ISR Number: 3581227-8Report Type:Periodic Company Report #00-07-0362 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Faecal Incontinence Health Clozapine PS Zenith Goldline ORAL 400-600MG Urinary Incontinence Professional ORAL Date:09/26/00ISR Number: 3581228-XReport Type:Periodic Company Report #00-07-0369 Age:79 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sedation Health Clozapine PS Zenith Goldline ORAL 25MG PO ORAL Speech Disorder Professional Proscar C Pepcid C Date:09/26/00ISR Number: 3581230-8Report Type:Periodic Company Report #00-08-0383 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Health Clozapine PS Zenith Goldline ORAL 600MG ORAL Professional Date:09/26/00ISR Number: 3581232-1Report Type:Periodic Company Report #00-08-0384 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Tolerance Decreased Health Clozapine PS Zenith Goldline ORAL ORAL Professional 22-Feb-2006 08:30 AM Page: 858 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/26/00ISR Number: 3581234-5Report Type:Periodic Company Report #00-04-0393 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Mental Disorder Health Clozapine PS Zenith Goldline ORAL 200-725MG Professional ORAL Date:09/26/00ISR Number: 3581238-2Report Type:Periodic Company Report #00-08-0397 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukocytosis Health Clozapine PS Zenith Goldline ORAL 900MG ORAL Professional Date:09/26/00ISR Number: 3581239-4Report Type:Periodic Company Report #00-08-0398 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Parotid Gland Enlargement Health Clozapine PS Zenith Goldline ORAL 150-350MG Salivary Hypersecretion Professional ORAL Depakote C Docusate C Levoxyl C Ferrous Sulfate C Zocor C Date:09/26/00ISR Number: 3581240-0Report Type:Periodic Company Report #00-08-0406 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Salivary Hypersecretion Consumer Clozapine PS Zenith Goldline ORAL 50-100MG ORAL Sedation Weight Decreased Date:09/26/00ISR Number: 3581242-4Report Type:Periodic Company Report #00-05-0433 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eosinophil Count Health Clozapine PS Zenith Goldline ORAL ORAL Decreased Professional Date:09/26/00ISR Number: 3581244-8Report Type:Periodic Company Report #00-05-0434 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eosinophil Count Health Clozapine PS Zenith Goldline ORAL ORAL Decreased Professional Date:09/26/00ISR Number: 3581245-XReport Type:Periodic Company Report #00-05-0435 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eosinophil Count Clozapine PS Zenith Goldline ORAL ORAL Decreased 22-Feb-2006 08:30 AM Page: 859 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/26/00ISR Number: 3581247-3Report Type:Periodic Company Report #00-05-0225 Age:57 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine PS Zenith Goldline ORAL 175-275MG Professional ORAL Ranitidine C Paxil C Lorazepam C Peri-Colace C Benadryl C Ibuprofen C Date:09/26/00ISR Number: 3581249-7Report Type:Periodic Company Report #00-05-0229 Age:76 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Pain Lower Health Clozapine PS Zenith Goldline ORAL 25-125 MG Hospitalization - Myocardial Infarction Professional ORAL Initial or Prolonged Norvasc C Ntg Patch C Metoprolol C Prozac C Date:09/26/00ISR Number: 3581250-3Report Type:Periodic Company Report #00-05-0236 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neutropenia Health Clozapine PS Zenith Goldline ORAL ORAL Hospitalization - Professional Depakote C Initial or Prolonged Ecotrin C Date:09/26/00ISR Number: 3581252-7Report Type:Periodic Company Report #00-05-0249 Age:49 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine PS Zenith Goldline ORAL 500MG ORAL Professional Paxil C Date:09/26/00ISR Number: 3581253-9Report Type:Periodic Company Report #00-05-0252 Age:51 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Platelet Count Decreased Health Clozapine PS Zenith Goldline ORAL 200MG ORAL Professional Date:09/26/00ISR Number: 3581256-4Report Type:Periodic Company Report #00-05-0255 Age:52 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Leukocytosis Health Clozapine PS Zenith Goldline ORAL 425-625MG Professional ORAL 22-Feb-2006 08:30 AM Page: 860 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/26/00ISR Number: 3581257-6Report Type:Periodic Company Report #00-05-0256 Age:84 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dysphagia Health Clozapine PS Zenith Goldline ORAL 200-800 MG Initial or Prolonged Pneumonia Aspiration Professional ORAL Divalproex Sodium C Trazodone C Date:09/26/00ISR Number: 3581258-8Report Type:Periodic Company Report #00-05-0260 Age:78 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine PS Zenith Goldline ORAL 25MG ORAL Professional Date:09/26/00ISR Number: 3581260-6Report Type:Periodic Company Report #00-05-0262 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine PS Zenith Goldline ORAL ORAL Professional Date:09/26/00ISR Number: 3581261-8Report Type:Periodic Company Report #00-05-0263 Age:57 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperhidrosis Health Clozapine PS Zenith Goldline ORAL 550 MG ORAL Initial or Prolonged Myocardial Infarction Professional Propulsid C Pallor Lactulose Syrup C Prevacid C Date:09/26/00ISR Number: 3581262-XReport Type:Periodic Company Report #00-05-0265 Age:27 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Health Clozapine PS Zenith Goldline ORAL 900 MG ORAL Professional Date:09/26/00ISR Number: 3581265-5Report Type:Periodic Company Report #00-05-0267 Age:51 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Clozapine PS Zenith Goldline ORAL ORAL Professional Date:09/26/00ISR Number: 3581266-7Report Type:Periodic Company Report #00-05-0270 Age:89 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Aspiration Health Clozapine PS Zenith Goldline ORAL 125MG ORAL Professional Ranitidine C Cogentin C Digoxin Elixir C 22-Feb-2006 08:30 AM Page: 861 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/26/00ISR Number: 3581269-2Report Type:Periodic Company Report #00-05-0271 Age:42 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neutropenia Health Clozapine PS Zenith Goldline ORAL 350 MG ORAL Professional Date:09/26/00ISR Number: 3581271-0Report Type:Periodic Company Report #00-06-0285 Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Ineffective Health Clozapine PS Zenith Goldline ORAL 150 MG ORAL Urinary Incontinence Professional Thorazine C Risperdal C Depakote C Date:09/26/00ISR Number: 3581273-4Report Type:Periodic Company Report #00-06-0288 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sedation Health Clozapine PS Zenith Goldline ORAL 50-100 MG Professional ORAL Date:09/26/00ISR Number: 3581274-6Report Type:Periodic Company Report #00-06-0289 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Health Clozapine PS Zenith Goldline ORAL 550 MG ORAL Professional Date:09/26/00ISR Number: 3581275-8Report Type:Periodic Company Report #00-06-0292 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Health Clozapine PS Zenith Goldline ORAL 300 MG ORAL Professional Date:09/26/00ISR Number: 3581277-1Report Type:Periodic Company Report #00-06-0297 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Psychotic Disorder Health Clozapine PS Zenith Goldline ORAL 500-550MG Professional ORAL Date:09/26/00ISR Number: 3581279-5Report Type:Periodic Company Report #00-06-0298 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Psychotic Disorder Health Clozapine PS Zenith Goldline ORAL 500-600MG Professional ORAL 22-Feb-2006 08:30 AM Page: 862 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/26/00ISR Number: 3581280-1Report Type:Periodic Company Report #00-08-0407 Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine PS Zenith Goldline ORAL ORAL Professional Date:09/26/00ISR Number: 3581282-5Report Type:Periodic Company Report #00-08-0411 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pulmonary Embolism Health Clozapine PS Zenith Goldline ORAL 50 MG ORAL Professional Date:09/26/00ISR Number: 3581283-7Report Type:Periodic Company Report #00-08-0412 Age:80 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine PS Zenith Goldline ORAL ORAL Professional Date:09/26/00ISR Number: 3581285-0Report Type:Periodic Company Report #00-08-0413 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine PS Zenith Goldline ORAL 25-250 MG Professional ORAL Date:09/26/00ISR Number: 3581287-4Report Type:Periodic Company Report #00-08-0414 Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dementia Health Clozapine PS Zenith Goldline ORAL 25-250MG ORAL Professional Date:09/26/00ISR Number: 3581288-6Report Type:Periodic Company Report #00-08-0417 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozapine PS Zenith Goldline ORAL 250-275MG Professional ORAL Date:09/26/00ISR Number: 3581290-4Report Type:Periodic Company Report #00-03-0097 Age:91 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Health Clozapine PS Zenith Goldline ORAL 12.5 - 25 MG Professional ORAL Ranitidine C Lorazepam C 22-Feb-2006 08:30 AM Page: 863 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/26/00ISR Number: 3581292-8Report Type:Periodic Company Report #00-03-0134 Age:75 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Chest Pain Health Clozapine PS Zenith Goldline ORAL 25 MG ORAL Cyanosis Professional Myocardial Infarction Date:09/26/00ISR Number: 3581294-1Report Type:Periodic Company Report #00-03-0146 Age:75 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Health Clozapine PS Zenith Goldline ORAL 25-150MG ORAL Cardiac Arrest Professional Aspirin C Parkinson'S Disease Colace C Pneumonia Synthroid C Sinemet 50/200 Qid C Tylenol 500mg Q8hr C Date:09/26/00ISR Number: 3581296-5Report Type:Periodic Company Report #00-03-0154 Age:50 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozapine PS Zenith Goldline ORAL 150-400 MG Myocardial Infarction Professional ORAL Prozac C Date:09/26/00ISR Number: 3581298-9Report Type:Periodic Company Report #00-03-0155 Age:52 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozapine PS Zenith Goldline ORAL 100-250MG Hospitalization - Pyrexia Professional ORAL Initial or Prolonged Trifluoperazine 20 Mg Qam C Trifluoperazine 15 Mg Qam C Sterozine 15 Mg Bid C Date:09/26/00ISR Number: 3581299-0Report Type:Periodic Company Report #00-04-0165 Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Consumer Clozapine PS Zenith Goldline ORAL 100-150MG Initial or Prolonged Asthenia ORAL Chest Pain Mellaril 100 Mg C Cold Sweat Lithium 300 Mg C Pallor Wellbutrin 150 Mg C Date:09/26/00ISR Number: 3581302-8Report Type:Periodic Company Report #00-04-0173 Age:82 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Clozapine PS Zenith Goldline ORAL 75MG ORAL Congestive Professional Acetaminophen 325 Qid C Allopurinol 100 Mg 22-Feb-2006 08:30 AM Page: 864 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Bid C Date:09/26/00ISR Number: 3581304-1Report Type:Periodic Company Report #00-04-0187 Age:78 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Health Clozapine PS Zenith Goldline ORAL 50MG ORAL Initial or Prolonged Professional Date:09/26/00ISR Number: 3581306-5Report Type:Periodic Company Report #00-04-0201 Age:50 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozapine PS Zenith Goldline ORAL 400-700 MG Hospitalization - Pyrexia Professional ORAL Initial or Prolonged Benztropine Mesylate 1mg Bid C Sinemet 100mg Qd Bid C Amantadine C Date:09/26/00ISR Number: 3581309-0Report Type:Periodic Company Report #00-04-0206 Age:49 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Body Temperature Health Clozapine PS Zenith Goldline ORAL 300MG ORAL Hospitalization - Increased Professional Kemadrin 5mg Qid C Initial or Prolonged Decreased Appetite Trifluoperazine 10mg Drooling Qid C Hyperhidrosis Leukopenia Neuroleptic Malignant Syndrome Oedema Peripheral Pharyngolaryngeal Pain Tremor Date:09/26/00ISR Number: 3581311-9Report Type:Periodic Company Report #00-04-0208 Age:62 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neutropenia Health Clozapine PS Zenith Goldline ORAL 250MG ORAL Professional Carbamazepine 200mg Tid C Serzone 100mg Bid C Date:09/26/00ISR Number: 3581312-0Report Type:Periodic Company Report #00-04-0213 Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Overdose Health Clozapine PS Zenith Goldline ORAL 600MG ORAL Other Professional Ultram Tablets SS ORAL 50MG ORAL 22-Feb-2006 08:30 AM Page: 865 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/26/00ISR Number: 3581314-4Report Type:Periodic Company Report #0-05-0217 Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Leukopenia Health Clozapine PS Zenith Goldline ORAL 150-800MG Professional ORAL Prolixin 12.5mg Q3wi C Zyprexa 30mg Qhs C Wellbutrin Sr 150mg Bid C Date:09/26/00ISR Number: 3581316-8Report Type:Periodic Company Report #00-05-0218 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neutropenia Health Clozapine PS Zenith Goldline ORAL 150-425MG Hospitalization - Professional ORAL Initial or Prolonged Divalproex Sodium 100mg Bid C Date:09/26/00ISR Number: 3582070-6Report Type:Periodic Company Report #00-03-0330 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophrenia Health Clozapine PS Zenith Goldline ORAL 500MG-600MG Initial or Prolonged Professional ORAL Date:09/26/00ISR Number: 3582071-8Report Type:Periodic Company Report #00-07-0340 Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozapine PS Zenith Goldline ORAL 525MG ORAL Hospitalization - Pneumonia Professional Initial or Prolonged Date:09/26/00ISR Number: 3582072-XReport Type:Periodic Company Report #00-07-0341 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Health Clozapine PS Zenith Goldline ORAL 450MG-700MG Professional ORAL Phenobarbital C Dilantin C Zyprexa C Navane C Cogentin C Niferex C Date:09/26/00ISR Number: 3582073-1Report Type:Periodic Company Report #00-07-0342 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Accidental Overdose Health Clozapine PS Zenith Goldline ORAL 150-300MG Lethargy Professional ORAL Depakote C 22-Feb-2006 08:30 AM Page: 866 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/26/00ISR Number: 3582074-3Report Type:Periodic Company Report #00-07-0349 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pharyngolaryngeal Pain Health Clozapine PS Zenith Goldline ORAL 25-200MG ORAL Initial or Prolonged Pyrexia Professional Lithium C White Blood Cell Count Zyprexa C Decreased Benadryl C Date:09/26/00ISR Number: 3582075-5Report Type:Periodic Company Report #00-07-0350 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Eosinophilia Health Clozapine PS Zenith Goldline ORAL 100-600MG Professional ORAL Buspar C Vitamin E C Clonidine C Metformin C Aspirin C Maalox C Cogentin C Date:09/26/00ISR Number: 3582076-7Report Type:Periodic Company Report #00-07-0352 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Disorientation Health Clozapine PS Zenith Goldline ORAL ORAL Initial or Prolonged Professional Date:09/26/00ISR Number: 3582077-9Report Type:Periodic Company Report #00-07-0354 Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Clozapine PS Zenith Goldline ORAL 250 MG ORAL Professional Date:09/26/00ISR Number: 3582078-0Report Type:Periodic Company Report #00-07-0360 Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Parkinsonism Health Clozapine PS Zenith Goldline ORAL 50 MG ORAL Professional Date:09/26/00ISR Number: 3582079-2Report Type:Periodic Company Report #00-07-0363 Age:66 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Parkinsonism Health Clozapine PS Zenith Goldline ORAL 12.5-500MG Professional ORAL 22-Feb-2006 08:30 AM Page: 867 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/26/00ISR Number: 3582080-9Report Type:Periodic Company Report #00-08-0371 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Eosinophilia Health Clozapine PS Zenith Goldline ORAL 12.5-175 MG Professional ORAL Date:09/26/00ISR Number: 3582081-0Report Type:Periodic Company Report #00-08-0372 Age:79 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Parkinson'S Disease Health Clozapine PS Zenith Goldline ORAL 25-75MG ORAL Professional Date:09/26/00ISR Number: 3582082-2Report Type:Periodic Company Report #00-08-0373 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cholelithiasis Health Clozapine PS Zenith Goldline ORAL ORAL Leukopenia Professional Date:09/26/00ISR Number: 3582083-4Report Type:Periodic Company Report #00-08-0376 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Thrombocythaemia Health Clozapine PS Zenith Goldline ORAL 200-300MG Professional ORAL Darvocet-N C Date:09/26/00ISR Number: 3582084-6Report Type:Periodic Company Report #00-07-0379 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine PS Zenith Goldline ORAL 62.5 MG ORAL Professional Date:09/26/00ISR Number: 3582085-8Report Type:Periodic Company Report #00-08-0380 Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozapine PS Zenith Goldline ORAL 12.5 MG ORAL Professional Date:09/26/00ISR Number: 3582086-XReport Type:Periodic Company Report #00-08-0382 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Clozapine PS Zenith Goldline ORAL 250MG ORAL Initial or Prolonged Professional 22-Feb-2006 08:30 AM Page: 868 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/26/00ISR Number: 3582087-1Report Type:Periodic Company Report #00-08-0385 Age:55 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neutropenia Health Clozapine PS Zenith Goldline ORAL ORAL Professional Date:09/26/00ISR Number: 3582088-3Report Type:Periodic Company Report #00-08-0404 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Clozapine PS Zenith Goldline ORAL 50-400 MG Initial or Prolonged Mental Disorder Professional ORAL Date:09/26/00ISR Number: 3582089-5Report Type:Periodic Company Report #00-08-0405 Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Respiratory Arrest Health Clozapine PS Zenith Goldline ORAL 200-450MG Professional ORAL Date:09/26/00ISR Number: 3582090-1Report Type:Periodic Company Report #00-05-0273 Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozapine PS Zenith Goldline ORAL 37.5 MG-200MG Hospitalization - Cough Professional ORAL Initial or Prolonged Deep Vein Thrombosis Florinef C Pharyngolaryngeal Pain Pyrexia Staphylococcal Infection Upper Respiratory Tract Infection Date:09/26/00ISR Number: 3582092-5Report Type:Periodic Company Report #00-05-0276 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Health Clozapine PS Zenith Goldline ORAL 400-700MG Professional ORAL Date:09/26/00ISR Number: 3582093-7Report Type:Periodic Company Report #00-05-0277 Age:94 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Parkinson'S Disease Health Clozapine PS Zenith Goldline ORAL 12.5 - 125MG Pneumonia Aspiration Professional ORAL Date:09/26/00ISR Number: 3582096-2Report Type:Periodic Company Report #00-06-0279 Age:76 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozapine PS Zenith Goldline ORAL 12.5 MG ORAL Professional 22-Feb-2006 08:30 AM Page: 869 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/26/00ISR Number: 3582097-4Report Type:Periodic Company Report #00-06-0281 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozapine PS Zenith Goldline ORAL 300MG ORAL Hospitalization - Infectious Mononucleosis Professional Initial or Prolonged Pharyngolaryngeal Pain Date:09/26/00ISR Number: 3582100-1Report Type:Periodic Company Report #00-06-0284 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neutropenia Health Clozapine PS Zenith Goldline ORAL 12.5-600MG Hospitalization - Professional ORAL Initial or Prolonged Olanzapine C Date:09/26/00ISR Number: 3582102-5Report Type:Periodic Company Report #00-06-0286 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophrenia Health Clozapine PS Zenith Goldline ORAL 30-800MG ORAL Initial or Prolonged Professional Date:09/26/00ISR Number: 3582104-9Report Type:Periodic Company Report #00-06-0287 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Small Intestinal Health Clozapine PS Zenith Goldline ORAL 800MG ORAL Initial or Prolonged Obstruction Professional Accupril C Metamucil C Date:09/26/00ISR Number: 3582106-2Report Type:Periodic Company Report #00-06-0290 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neutropenia Health Clozapine PS Zenith Goldline ORAL 50MG ORAL Professional Date:09/26/00ISR Number: 3582108-6Report Type:Periodic Company Report #00-06-0291 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine PS Zenith Goldline ORAL 600MG ORAL Professional Date:09/26/00ISR Number: 3582109-8Report Type:Periodic Company Report #00-06-0299 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Convulsion Health Clozapine PS Zenith Goldline ORAL 900MG ORAL Professional 22-Feb-2006 08:30 AM Page: 870 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/26/00ISR Number: 3582111-6Report Type:Periodic Company Report #00-06-0306 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Intestinal Obstruction Health Clozapine PS Zenith Goldline ORAL 350MG ORAL Pneumonia Professional Sepsis Staphylococcal Infection Date:09/26/00ISR Number: 3582113-XReport Type:Periodic Company Report #00-06-0307 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Convulsion Health Clozapine PS Zenith Goldline ORAL 650-700MG Professional ORAL Glyburide C Valproate Sodium C Benztropine Mesylate C Lopid C Synthroid C Docusate Sodium C Metamucil C Vitamin C C Multivitamins C Date:09/26/00ISR Number: 3582115-3Report Type:Periodic Company Report #00-06-0314 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine PS Zenith Goldline ORAL 300MG ORAL Professional Date:09/26/00ISR Number: 3582116-5Report Type:Periodic Company Report #00-06-0318 Age:71 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Respiratory Distress Health Clozapine PS Zenith Goldline ORAL 12.5-25MG Professional ORAL Date:09/26/00ISR Number: 3582119-0Report Type:Periodic Company Report #00-06-0319 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Anticholinergic Syndrome Health Clozapine PS Zenith Goldline ORAL 25-300 MG Hospitalization - Diarrhoea Professional ORAL Initial or Prolonged Hyponatraemia Risperdal Tablets SS ORAL 4MG ORAL Hypotension Risperidone C Nausea Paroxetine C Thrombocytopenia Haloperidol C Vomiting Date:09/26/00ISR Number: 3582120-7Report Type:Periodic Company Report #00-03-0326 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pericardial Effusion Health Clozapine PS Zenith Goldline ORAL 200-300MG Initial or Prolonged Professional ORAL 22-Feb-2006 08:30 AM Page: 871 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/26/00ISR Number: 3582122-0Report Type:Periodic Company Report #00-02-0327 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mental Disorder Health Clozapine PS Zenith Goldline ORAL 500MG ORAL Initial or Prolonged Professional Date:09/26/00ISR Number: 3582124-4Report Type:Periodic Company Report #00-07-0328 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Convulsion Health Clozapine PS Zenith Goldline ORAL ORAL Drooling Professional Risperdal C Dysarthria Benztropine Mesylate C Oral Pain Diphenhydramine C Pain In Jaw Lithium C Speech Disorder Tylenol Prn C Tremor Maalox Prn C Haldol Prn C Ativan Prn Subcu-Inj C Date:09/26/00ISR Number: 3582126-8Report Type:Periodic Company Report #00-03-0329 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Clozapine PS Zenith Goldline ORAL 150MG ORAL Initial or Prolonged Convulsion Professional Depakote Tablets SS ORAL 1500MG ORAL Psychotic Disorder Glucotrol Xl C Glucophage C Date:09/27/00ISR Number: 3581512-XReport Type:Expedited (15-DaCompany Report #PHBS2000AU03578 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Clozaril PS Novartis Initial or Prolonged Phosphokinase Increased Health Pharmaceuticals Corp ORAL 250 MG, ORAL Disability Cardiac Enzymes Increased Professional Haloperidol Cardiac Failure Other (Haloperidol) C Cardiomyopathy Complan (Ascorobic Heart Rate Increased Acid, Pyridoxine, Hyperpyrexia Retinol, Pantothenic Hypotension Acid, Phosphorus) C Myocarditis ... C Neuroleptic Malignant Syndrome Neutrophilia Pneumonia Bacterial Date:09/27/00ISR Number: 3581513-1Report Type:Expedited (15-DaCompany Report #PHBS2000AU08893 Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiomyopathy Foreign Clozaril PS Novartis Echocardiogram Abnormal Health Pharmaceuticals Corp ORAL ORAL Left Ventricular Failure Professional Sertraline Other (Sertraline) C Benztropeine (Benztropeine) C 22-Feb-2006 08:30 AM Page: 872 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/27/00ISR Number: 3581673-2Report Type:Expedited (15-DaCompany Report #PHBS2000NZ07796 Age:35 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aphasia Foreign Clozaril PS Novartis Initial or Prolonged Catatonia Health Pharmaceuticals Corp ORAL 500 MG/D, Diabetes Mellitus Professional ORAL Non-Insulin-Dependent Other Hyperglycaemia Micturition Urgency Pallor Psychomotor Retardation Restlessness Staring Date:09/27/00ISR Number: 3581678-1Report Type:Expedited (15-DaCompany Report #PHBS2000AU09122 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Completed Suicide Foreign Clozaril PS Novartis Drug Withdrawal Syndrome Health Pharmaceuticals Corp ORAL 300 MG/D, Insomnia Professional ORAL Other Normison (Temazepam) SS 10 MG/D, Date:09/27/00ISR Number: 3581680-XReport Type:Expedited (15-DaCompany Report #PHBS2000AU09082 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiomyopathy Foreign Clozaril PS Novartis Initial or Prolonged Myocarditis Health Pharmaceuticals Corp Pyrexia Professional Valproate Sodium C Other Date:09/28/00ISR Number: 3581780-4Report Type:Periodic Company Report #C2000-0617.01 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Health Clozapine PS Mylan Professional Pharmaceuticals Inc ORAL 700MG QD Other TITRATED DOWN TO 400MG QD, ORAL Clozaril Tablets Novartis SS Novartis ORAL 700MG QD, ORAL Risperdal C Date:09/28/00ISR Number: 3581781-6Report Type:Periodic Company Report #C2000-0650.01 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Clozapine PS Mylan Initial or Prolonged Professional Pharmaceuticals Inc ORAL TITRATION BY Other Other 25MG Q DAY, ORAL Buspar C Risperdal C Lithium C 22-Feb-2006 08:30 AM Page: 873 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Trilafon C Date:09/28/00ISR Number: 3581782-8Report Type:Periodic Company Report #C2000-0891.01 Age:6 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozapine PS Mylan Professional Pharmaceuticals Inc ORAL GRADUALLY TO 300MG QD, THEN 250 MG QD ORAL Ritalin C Clonidine C Date:09/28/00ISR Number: 3581783-XReport Type:Periodic Company Report #C2000-0926.01 Age:12 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Consumer Clozapine PS Mylan Neutropenia Pharmaceuticals Inc ORAL 150MG BID, ORAL Depakote C Clonidine C Lithium C Date:09/28/00ISR Number: 3581784-1Report Type:Periodic Company Report #C2000-0616.01 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozapine PS Mylan Professional Pharmaceuticals Inc ORAL 300MG QD, Other ORAL Clozaril Novartis SS Novartis ORAL 300MG QD, ORAL Prozac C Glyburide C Lopid C Tylenol C Metamucil C Date:09/28/00ISR Number: 3581785-3Report Type:Periodic Company Report #C2000-0623.01 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Platelet Count Decreased Health Clozapine PS Mylan Initial or Prolonged Professional Pharmaceuticals Inc ORAL 100MG Q NOON Other Other & 350MG Q HS TITRATED DOWN, ORAL Effexor C 22-Feb-2006 08:30 AM Page: 874 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/28/00ISR Number: 3581786-5Report Type:Periodic Company Report #C2000-0827.01 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Health Clozapine PS Mylan Nausea Professional Pharmaceuticals Inc ORAL 250MG QD, ORAL Claritin C Flonase C Date:09/28/00ISR Number: 3581788-9Report Type:Periodic Company Report #C2000-0902.01 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thyroid Disorder Health Clozapine PS Mylan Professional Pharmaceuticals Inc ORAL 500MG/DAY, ORAL Chlortrimeton C Paxil C Zantac C Date:09/28/00ISR Number: 3581789-0Report Type:Periodic Company Report #C2000-0969.01 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Other Clozapine PS Mylan Pharmaceuticals Inc ORAL 200MG Q HS, ORAL Depakote C Claritin C Flonase C Date:09/28/00ISR Number: 3583092-1Report Type:Expedited (15-DaCompany Report #PHFR2000GB01261 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Delusion Foreign Clozaril PS Novartis Diarrhoea Health Pharmaceuticals Corp ORAL 375 MG/DAY, Dyspnoea Professional ORAL Haemoglobin Decreased Other Aspirine C Hepatosplenomegaly Sertraline C Lobar Pneumonia Irbesartan C Lymphocyte Count Oxybutynin C Decreased Evorel Sequi C Monocyte Count Decreased Neutrophil Toxic Granulation Present Pulmonary Congestion Pulmonary Oedema Red Blood Cell Sedimentation Rate Increased Ventricular Hypertrophy 22-Feb-2006 08:30 AM Page: 875 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/28/00ISR Number: 3583185-9Report Type:Expedited (15-DaCompany Report #PHFR2000IE01464 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Obstruction Foreign Clozaril PS Novartis Prostatic Disorder Health Pharmaceuticals Corp ORAL 200 MG /DAY, Renal Failure Acute Professional ORAL Urinary Retention Date:09/29/00ISR Number: 3584585-3Report Type:Expedited (15-DaCompany Report #PHBS000AU08376 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Congestive Cardiomyopathy Foreign Clozaril PS Novartis Echocardiogram Abnormal Health Pharmaceuticals Corp ORAL 650 MG/D, Professional ORAL Other Date:09/29/00ISR Number: 3584593-2Report Type:Expedited (15-DaCompany Report #PHNU2000DE01759 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Distension Foreign Clozaril PS Novartis Initial or Prolonged Cardiac Enzymes Increased Health Pharmaceuticals Corp ORAL ORAL Leukocytosis Professional Pancreatitis Other Pleural Effusion Polyserositis Pyrexia Date:09/29/00ISR Number: 3584596-8Report Type:Expedited (15-DaCompany Report #PHBS2000FI08399 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Foreign Clozaril PS Novartis Drug Level Below Health Pharmaceuticals Corp ORAL 600 MG/D, Therapeutic Professional ORAL Drug Toxicity Other Neuroleptic Malignant Syndrome Date:09/29/00ISR Number: 3585342-4Report Type:Expedited (15-DaCompany Report #PHBS2000AU09236 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Clozaril PS Novartis Intentional Overdose Other Pharmaceuticals Corp ORAL 200 MG/D, ORAL Heroin (Diamorphine) SS 9 MON Date:09/29/00ISR Number: 3585343-6Report Type:Expedited (15-DaCompany Report #PHNU2000DE01785 Age: Gender:Unknown I/FU:I Outcome PT Report Source Other Peritonitis Foreign Health Professional 22-Feb-2006 08:30 AM Page: 876 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Product Role Manufacturer Route Dose Duration Clozaril PS Novartis Pharmaceuticals Corp ORAL ORAL Date:09/29/00ISR Number: 3585344-8Report Type:Expedited (15-DaCompany Report #PHBS2000BRO4069 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cytomegalovirus Hepatitis Foreign Clozaril PS Novartis Initial or Prolonged Hepatic Enzyme Increased Health Pharmaceuticals Corp ORAL 100 MG, BID, Jaundice Professional ORAL 2 YR Other Date:09/29/00ISR Number: 3585348-5Report Type:Expedited (15-DaCompany Report #PHFR2000GB00575 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Biopsy Liver Abnormal Foreign Clozaril PS Novartis Initial or Prolonged Blood Bilirubin Increased Health Pharmaceuticals Corp ORAL 300 MG/DAY, Other Cholelithiasis Professional ORAL Cholestasis Other Clozaril (Clozapine) Hepatic Steatosis (Clozapine) Tablet SS ORAL 300 MG/DAY, Hyperglycaemia ORAL Jaundice Gliclazide Liver Function Test (Gliclazide) C Abnormal Diazepam C Droperidol (Droperidol) C Gliclazide (Gliclazide) C Diazepam C Date:10/02/00ISR Number: 3585128-0Report Type:Expedited (15-DaCompany Report #00-08-0403 Age:51 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Health Clozapine PS Zenith Goldline ORAL 25-250MG ORAL Initial or Prolonged Congestive Professional Captopril C Chronic Obstructive Atenolol C Pulmonary Disease Potassium Chloride C Condition Aggravated Peripheral Vascular Disorder Date:10/02/00ISR Number: 3585129-2Report Type:Expedited (15-DaCompany Report #00-09-0485 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Haemorrhagic Ovarian Cyst Health Clozapine PS Zenith Goldline ORAL 100-150MG Professional ORAL 22-Feb-2006 08:30 AM Page: 877 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/02/00ISR Number: 3585130-9Report Type:Expedited (15-DaCompany Report #00-08-0416 Age:31 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 300 MG ORAL Professional Date:10/02/00ISR Number: 3585131-0Report Type:Expedited (15-DaCompany Report #00-09-0423 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 200 MG ORAL Professional Buspar 15mg Tid C Seroquel 100 Mg Hs C Depakote 1000mg Hs C Date:10/02/00ISR Number: 3585478-8Report Type:Expedited (15-DaCompany Report #PHEH2000US08708 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Clozaril PS Novartis Professional Pharmaceuticals Corp SEE IMAGE Cogentin C Date:10/02/00ISR Number: 3585507-1Report Type:Expedited (15-DaCompany Report #PHEH2000US02445 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Health Clozaril PS Novartis Dehydration Professional Pharmaceuticals Corp ORAL 300 MG, BID, Eyes Sunken ORAL Gastrointestinal Disorder Musculoskeletal Disorder Pseudomonas Infection Scar Soft Tissue Disorder Streptococcal Sepsis Date:10/02/00ISR Number: 3585508-3Report Type:Expedited (15-DaCompany Report #PHEH2000US08564 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Caesarean Section Health Clozaril PS Novartis Initial or Prolonged Complications Of Maternal Professional Pharmaceuticals Corp TRANSPLACENTAL 350 MG/DAY, Exposure To Therapeutic TRANSPLACENTA Drugs L Convulsion Neonatal Hypoglycaemia Neonatal Neonatal Disorder Neonatal Respiratory Depression Tachypnoea 22-Feb-2006 08:30 AM Page: 878 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/02/00ISR Number: 3585617-9Report Type:Expedited (15-DaCompany Report #PHEH2000US08783 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Colitis Health Clozaril PS Novartis Hospitalization - Diabetic Ketoacidosis Professional Pharmaceuticals Corp ORAL 100MG AM + Initial or Prolonged Gastrointestinal 400MG HS, Haemorrhage ORAL Leukopenia Zoloft (Sertraline Neutropenia Hydrochloride) C Pancytopenia Trazodone Pharyngolaryngeal Pain (Trazodone) C Renal Failure Dilantin C Thrombocytopenia Benadryl C Vomiting Ditropan (Oxybutynin) C Haldol C Date:10/02/00ISR Number: 3585619-2Report Type:Expedited (15-DaCompany Report #PHEH2000US08710 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pharyngitis Health Clozaril PS Novartis Initial or Prolonged Professional Pharmaceuticals Corp ORAL 400MG, ORAL Antibiotics (No Ingredients/Substanc es) C Date:10/02/00ISR Number: 3585645-3Report Type:Expedited (15-DaCompany Report #PHHO2000AU01090 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Clozaril PS Novartis Study Pharmaceuticals Corp ORAL 500 MG, QD, Health ORAL Professional Panadeine Forte SS 60 MG/D 3 MON Other Sodium Valproate (Valproate Sodium) C Clonazepam C Omeprazole C Keflex (Cefalexin Monohydrate) C Benztropine C Amitriptyline C Beconase (Beclometasone Dipropionate) C Chloral Hydrate C Zerfazadine C Date:10/02/00ISR Number: 3585647-7Report Type:Expedited (15-DaCompany Report #PHBS2000NZ09194 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Foreign Clozaril PS Novartis Initial or Prolonged Drug Interaction Health Pharmaceuticals Corp ORAL 300 MG/D, Hypotension Professional ORAL Miosis Other Clonazepam(Clonazepa Pyrexia m) SS ORAL 2 MG/D, ORAL 22-Feb-2006 08:30 AM Page: 879 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/02/00ISR Number: 3585660-XReport Type:Expedited (15-DaCompany Report #PHFR2000GB00595 Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Murmur Foreign Clozaril PS Novartis Initial or Prolonged Dyspnoea Health Pharmaceuticals Corp ORAL 200 MG/DAY, Hyponatraemia Professional ORAL Inappropriate Other Antidiuretic Hormone Secretion Inflammation Pericardial Effusion Pericarditis Pneumonia Date:10/02/00ISR Number: 3585662-3Report Type:Expedited (15-DaCompany Report #PHBS2000AU09082 Age:22 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiomyopathy Foreign Clozaril PS Novartis Initial or Prolonged Myocarditis Health Pharmaceuticals Corp ORAL UNK, UNK, Pyrexia Professional ORAL Other Valproate Sodium C Date:10/02/00ISR Number: 3585835-XReport Type:Expedited (15-DaCompany Report #PHBS2000F108399 Age:25 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Foreign Clozaril PS Novartis Drug Level Above Health Pharmaceuticals Corp ORAL 600 MG/D, Therapeutic Professional ORAL Fall Other Zyprexa (Olanzapine) C Neuroleptic Malignant Triptyl Syndrome (Amotriptyline Pallor Hydrochloride) C Pollakiuria Depakine C Pulse Pressure Decreased Levozin Pyrexia (Levomepromazine Rhinorrhoea Maleate) C Thirst Cisordinol-Acutard Tremor (Zuclopenthixol Vomiting Acetate) C Diazepam C Date:10/03/00ISR Number: 3586763-6Report Type:Expedited (15-DaCompany Report #10543064 Age:75 YR Gender:Female I/FU:I Outcome PT Life-Threatening Atelectasis Hospitalization - Atrial Fibrillation Initial or Prolonged Attention Other Deficit/Hyperactivity Disorder Cardiac Arrest Coma Decreased Activity Ejection Fraction Abnormal Electrocardiogram Qrs 22-Feb-2006 08:30 AM Page: 880 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Complex Abnormal Electrocardiogram Qt Prolonged Hypokalaemia Report Source Product Role Manufacturer Route Dose Duration Pleural Effusion Health Tequin PS Bristol Myers Squibb Sinus Tachycardia Professional Co Pharmaceutical Torsade De Pointes Research Institute ORAL 400 MILIGRAM, Ventricular Extrasystoles 1/1 DAY ORAL Ventricular Tachycardia Digoxin SS .13 MILLIGRAM, 1 DAY Clozaril (Clozapine) SS 75 MILLIGRAM, 2/1 DAY Prozac (Fluoxetine Hcl) SS 10 MILLIGRAM, 1 DAY Nortriptyline (Nortriptyline Hcl) SS 40 MILLIGRAM, 1/1 DAY Metoprolol C Ativan C Aspirin C Lisinopril C Date:10/04/00ISR Number: 3587523-2Report Type:Direct Company Report # Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthma Propranolol (Major Pharm/Sidmak Labs. PS Major Pharm/Sidmak Labs. ORAL 10 MG PO BID Clozapine Zenith-Goldline SS Zenith-Goldline ORAL 100 MG PO H.S. Date:10/04/00ISR Number: 3587537-2Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required White Blood Cell Count Clozapine PS 400 MG DAILY Intervention to Decreased Prevent Permanent Impairment/Damage Date:10/04/00ISR Number: 3587538-4Report Type:Direct Company Report # Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tachycardia Clozapine 100mg Zenith Goldline PS Zenith Goldline ORAL 100MG PO HS Date:10/05/00ISR Number: 3587758-9Report Type:Expedited (15-DaCompany Report #00-09-0495 Age:81 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 12.5-125MG Professional ORAL 22-Feb-2006 08:30 AM Page: 881 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/05/00ISR Number: 3587760-7Report Type:Expedited (15-DaCompany Report #00-09-0494 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL ORAL Professional Date:10/05/00ISR Number: 3587762-0Report Type:Expedited (15-DaCompany Report #00-09-0419 Age:38 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Infection Health Clozapine PS Zenith Goldline ORAL 300MG ORAL Inguinal Hernia, Professional Periactin C Obstructive Intestinal Perforation Peritonitis Sepsis Date:10/05/00ISR Number: 3588501-XReport Type:Direct Company Report # Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Heart Rate Irregular Clozapine (Clozaril) PS 500MG Ventricular Tachycardia Date:10/05/00ISR Number: 3588761-5Report Type:Direct Company Report # Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neuroleptic Malignant Clozapine PS ORAL 275MG, 275MG Hospitalization - Syndrome QD, ORAL Initial or Prolonged Risperidone C Divalproex Ec C Date:10/06/00ISR Number: 3589226-7Report Type:Expedited (15-DaCompany Report #00-09-0502 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 300MG ORAL Professional Date:10/06/00ISR Number: 3589228-0Report Type:Expedited (15-DaCompany Report #00-09-0501 Age:92 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 25-150MG ORAL Professional Date:10/06/00ISR Number: 3590797-5Report Type:Expedited (15-DaCompany Report #PHBS2000NZ09588 Age:48 YR Gender:Male I/FU:I Outcome PT Hospitalization - Cardiac Enzymes Increased Initial or Prolonged Hyperhidrosis Leukocytosis Pyrexia 22-Feb-2006 08:30 AM Page: 882 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Red Blood Cell Sedimentation Rate Increased Report Source Product Role Manufacturer Route Dose Duration Tachycardia Foreign Clozaril PS Novartis Health Pharmaceuticals Corp ORAL 200 MG/D ORAL Professional Risperidone Other (Risperidone) C Date:10/06/00ISR Number: 3590799-9Report Type:Expedited (15-DaCompany Report #PHFR2000GB01486 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril PS Novartis Liver Function Test Health Pharmaceuticals Corp ORAL 500MG/DAY Abnormal Professional ORAL , Other 450MG/DAY, ORAL Gliclazide(Gliclazid e) SS 240 MG/DAY Metformin(Metformin) C Lithium (Lithium) C Date:10/06/00ISR Number: 3590840-3Report Type:Expedited (15-DaCompany Report #PHFR2000GB01416 Age:53 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Foreign Clozaril PS Novartis Initial or Prolonged Blood Creatine Health Pharmaceuticals Corp ORAL 300MG/DAY, Other Phosphokinase Increased Professional ORAL Blood Pressure Other Librium Fluctuation (Chlordiazepoxide Heart Rate Increased Hydrochloride) C Hyperhidrosis Infection Labile Blood Pressure Leukocytosis Medication Error Neuroleptic Malignant Syndrome Neutrophilia Pyrexia Tachycardia Thrombocythaemia Date:10/06/00ISR Number: 3590842-7Report Type:Expedited (15-DaCompany Report #PHBS2000NZ09611 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bronchospasm Foreign Clozaril PS Novartis Initial or Prolonged Pyrexia Health Pharmaceuticals Corp ORAL 225 MG/D, Respiratory Failure Professional ORAL Other Olanzapine (Olanzapine) C Valproate Sodium C Salbutamol C Beclomethasone Dipropionate (Beclometasone 22-Feb-2006 08:30 AM Page: 883 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dipropionate) C Date:10/06/00ISR Number: 3590851-8Report Type:Expedited (15-DaCompany Report #PHBS2000CA09652 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiomegaly Foreign Clozaril PS Novartis Cardiomyopathy Health Pharmaceuticals Corp ORAL 300 MG/DAY, Hypertension Professional ORAL Tachycardia Other Date:10/10/00ISR Number: 3591942-8Report Type:Expedited (15-DaCompany Report #PHEH2000US09015 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Metastases To Lung Health Clozaril PS Novartis Testis Cancer Professional Pharmaceuticals Corp ORAL 450MG ORAL Date:10/10/00ISR Number: 3592217-3Report Type:Expedited (15-DaCompany Report #PHBS2000AU07793 Age:77 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatinine Foreign Clozaril PS Novartis Initial or Prolonged Increased Health Pharmaceuticals Corp ORAL 300 MG/DAY, Blood Urea Increased Professional ORAL Other Senokot SS Trimethoprim C Omeprazole C Panadol C Date:10/10/00ISR Number: 3592303-8Report Type:Expedited (15-DaCompany Report #200020716GDDC Age:44 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiac Failure Foreign Bricanyl PS Aventis Congestive Other Pharmaceuticals Inc ORAL PO Drug Level Above Clozapine (Clozaril) SS 2 YR Therapeutic Cefalexin Dyspnoea Monohydrate (Keflex) SS Hypertension Warfarin C Malaise Myocarditis Neutrophilia Renal Failure Acute Right Ventricular Failure Tachycardia Tachypnoea Vomiting Date:10/11/00ISR Number: 3591973-8Report Type:Expedited (15-DaCompany Report #00-08-0401 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dysuria Health Clozapine PS Zenith Goldline ORAL 375MG ORAL Initial or Prolonged Hyperglycaemia Professional Tenderness Urinary Tract Infection 22-Feb-2006 08:30 AM Page: 884 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/11/00ISR Number: 3591984-2Report Type:Expedited (15-DaCompany Report #00-07-0378 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Empyema Health Clozapine PS Zenith Goldline ORAL 250MG ORAL Fall Professional Depakote C Leukocytosis Zoloft C Lung Abscess Malaise Date:10/11/00ISR Number: 3591988-XReport Type:Expedited (15-DaCompany Report #00-08-0375 Age:46 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Hodgkin'S Disease Health Clozapine PS Zenith Goldline ORAL 600MG ORAL Swelling Professional Albuterol C Azmacort C Date:10/11/00ISR Number: 3591989-1Report Type:Expedited (15-DaCompany Report #00-09-0510 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 25MG ORAL Professional Date:10/11/00ISR Number: 3591991-XReport Type:Expedited (15-DaCompany Report #00-09-0503 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 200MG ORAL Professional Methotrexate C Date:10/11/00ISR Number: 3592852-2Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required White Blood Cell Count Clozapine PS 400 MG DAILY Intervention to Decreased Prevent Permanent Impairment/Damage Date:10/11/00ISR Number: 3592875-3Report Type:Direct Company Report # Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Priapism Clozapine 25 Mg + Initial or Prolonged 100 Mg Po Tabs PS ORAL 12.5 MG PO BID TITRATED TO 200MG BID 30 DAY Date:10/12/00ISR Number: 3595696-0Report Type:Expedited (15-DaCompany Report #PHEH2000US03356 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Health Clozaril PS Novartis Fall Professional Pharmaceuticals Corp ORAL 300MG AM + 22-Feb-2006 08:30 AM Page: 885 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report 400MG HS, ORAL Wellbutrin (Amfebutamone Hydrochloride) C Zestril (Lisinopril) C Date:10/12/00ISR Number: 3595710-2Report Type:Expedited (15-DaCompany Report #PHEH2000US09171 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bone Marrow Depression Health Clozaril PS Novartis Neoplasm Malignant Professional Pharmaceuticals Corp Platelet Disorder Depakote (Valproate White Blood Cell Count Semisodium) SS Decreased Chemotherapy () SS Date:10/12/00ISR Number: 3595712-6Report Type:Expedited (15-DaCompany Report #PHEH2000US09161 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Cancer Female Health Clozaril PS Novartis Professional Pharmaceuticals Corp ORAL 900 MG , ORAL Zyprexa (Olanzapine) C Cogentin (Benzatropine Mesilate) C Date:10/13/00ISR Number: 3594803-3Report Type:Expedited (15-DaCompany Report #2000AP04388 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Cardiac Arrest Foreign Diprivan PS Astrazeneca Uk Ltd Intervention to Drug Interaction Health Clozaril SS Prevent Permanent Professional Fentanyl SS Impairment/Damage Other Atropine SS Hyoscine SS Date:10/13/00ISR Number: 3594874-4Report Type:Expedited (15-DaCompany Report #PHBS2000AU09831 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Disorder Foreign Clozaril PS Novartis Initial or Prolonged Health Pharmaceuticals Corp ORAL ORAL Professional Other Date:10/13/00ISR Number: 3594876-8Report Type:Expedited (15-DaCompany Report #PHBS2000BE09820 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Blindness Foreign Clozaril PS Novartis Retinal Detachment Health Pharmaceuticals Corp ORAL 200 MG/DAY, Professional ORAL Other Zyprexa (Olanzapine) C 22-Feb-2006 08:30 AM Page: 886 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/13/00ISR Number: 3594893-8Report Type:Expedited (15-DaCompany Report #PHBS2000CA09103 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coma Foreign Clozaril PS Novartis Hospitalization - Diabetes Mellitus Study Pharmaceuticals Corp ORAL ORAL Initial or Prolonged Pancreatic Disorder Health Other Professional Other Date:10/13/00ISR Number: 3594895-1Report Type:Expedited (15-DaCompany Report #PHBS2000AU09236 Age:24 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Clozaril PS Novartis Intentional Overdose Health Pharmaceuticals Corp ORAL 200 MG, QD, Professional ORAL Other Heroin(Diamorphine) SS 9 MON Date:10/13/00ISR Number: 3595478-XReport Type:Expedited (15-DaCompany Report #PHNU2000DE01888 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril PS Novartis Insulin-Dependent Health Pharmaceuticals Corp ORAL ORAL Professional Other Date:10/13/00ISR Number: 3595485-7Report Type:Expedited (15-DaCompany Report #PHBS2000AU09764 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Triglycerides Foreign Clozaril PS Novartis Increased Health Pharmaceuticals Corp ORAL 400 MG, BID, Diabetes Mellitus Professional ORAL Liver Function Test Other Metformin Abnormal (Metformin) C Oesophageal Ulcer Zoton (Lansoprazole) C Zoloft (Sertraline Hydrochloride) C Date:10/16/00ISR Number: 3594906-3Report Type:Expedited (15-DaCompany Report #00-10-0511 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 400 MG; ORAL Professional Date:10/16/00ISR Number: 3594907-5Report Type:Expedited (15-DaCompany Report #00-10-0512 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Health Clozapine PS Zenith Goldline ORAL 800 MG; ORAL Initial or Prolonged Professional 22-Feb-2006 08:30 AM Page: 887 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/16/00ISR Number: 3594908-7Report Type:Expedited (15-DaCompany Report #00-07-0357 Age:66 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Fall Health Clozapine PS Zenith Goldline ORAL ORAL Hospitalization - Gait Disturbance Professional Methotrexate C Initial or Prolonged Hip Fracture Levodopa-Carbidopa C Infection Prednisone C Leukopenia Methotrexate C Orthostatic Hypotension Date:10/16/00ISR Number: 3594909-9Report Type:Expedited (15-DaCompany Report #00-09-0480 Age:41 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sedation Health Clozapine PS Zenith Goldline ORAL 300-325 MG; Professional ORAL Depakote C Date:10/16/00ISR Number: 3594910-5Report Type:Expedited (15-DaCompany Report #00-09-0423 Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Weight Increased Health Clozapine PS Zenith Goldline ORAL ORAL Professional Buspar C Seroquel C Depakote C Prozac C Date:10/16/00ISR Number: 3595901-0Report Type:Expedited (15-DaCompany Report #00P-163-0098357-00(0) Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Decreased Health Depakote PS Abbott Laboratories ORAL 1000 MG, 1 IN Initial or Prolonged Cardiovascular Disorder Professional 1 D, PER ORAL Required Dizziness Clozapine Intervention to Drug Interaction (Clozapine) SS ORAL 400 MG, 1 IN Prevent Permanent Eczema 1 D, PER ORAL Impairment/Damage Neoplasm Malignant Purulent Discharge White Blood Cell Count Decreased Date:10/16/00ISR Number: 3596022-3Report Type:Expedited (15-DaCompany Report #PHBS2000NL08716 Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril PS Novartis Hyperglycaemia Literature Pharmaceuticals Corp 100 MG/DAY Hypertension Health Perphenazine Malaise Professional (Perphenazine) C Tachycardia Other 22-Feb-2006 08:30 AM Page: 888 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/19/00ISR Number: 3598957-4Report Type:Expedited (15-DaCompany Report #00-10-0523 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ankle Fracture Health Clozapine PS Zenith Goldline ORAL 350MG ORAL Initial or Prolonged Professional Date:10/19/00ISR Number: 3598958-6Report Type:Expedited (15-DaCompany Report #00-09-0503 Age:42 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetes Mellitus Health Clozapine PS Zenith Goldline ORAL 200MG ORAL Inadequate Control Professional Methotrexate C Date:10/19/00ISR Number: 3598960-4Report Type:Expedited (15-DaCompany Report #00-10-0526 Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozapine PS Zenith Goldline ORAL 50-150MG ORAL 4 DAY Convulsion Professional Zyprexa C Haldol C Date:10/19/00ISR Number: 3598962-8Report Type:Expedited (15-DaCompany Report #00-10-0525 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Multiple Sclerosis Health Clozapine PS Zenith Goldline ORAL 300-500MG Professional ORAL Date:10/19/00ISR Number: 3599021-0Report Type:Expedited (15-DaCompany Report #00-10-0520 Age:73 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 75MG ORAL Professional Date:10/20/00ISR Number: 3599253-1Report Type:Expedited (15-DaCompany Report #PHEH2000US09372 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neoplasm Malignant Health Clozaril PS Novartis Professional Pharmaceuticals Corp Clozapine (Clozapine) SS 3302 DAY Clozapine (Clozapine) SS Date:10/23/00ISR Number: 3600380-0Report Type:Expedited (15-DaCompany Report #PHEH2000US00410 Age:50 YR Gender:Male I/FU:F Outcome PT Other Aortic Atherosclerosis Atrioventricular Block Cardiomegaly Electrocardiogram Abnormal 22-Feb-2006 08:30 AM Page: 889 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Fatigue Pneumonia Rales Report Source Product Role Manufacturer Route Dose Duration Ventricular Extrasystoles Study Clozaril PS Novartis Health Pharmaceuticals Corp ORAL 350 MG, ORAL Professional Date:10/23/00ISR Number: 3600410-6Report Type:Expedited (15-DaCompany Report #PHFR2000GB00586 Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abdominal Pain Foreign Clozaril PS Novartis Hospitalization - Diabetes Mellitus Health Pharmaceuticals Corp ORAL 250MG/DAY, Initial or Prolonged Non-Insulin-Dependent Professional ORAL Other Pancreatitis Acute Other Metformin (Metformin) C Lactulose C Date:10/23/00ISR Number: 3600513-6Report Type:Expedited (15-DaCompany Report #PHBS2000AU04362 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiomegaly Foreign Clozaril PS Novartis Cardiomyopathy Health Pharmaceuticals Corp ORAL 600 MG DAY Echocardiogram Abnormal Professional ORAL Left Ventricular Failure Other Pimozide (Pimozide) C Sertraline (Sertraline) C Valium C Endone (Oxycodone Hydrochloride) C Date:10/23/00ISR Number: 3600515-XReport Type:Expedited (15-DaCompany Report #PHBS2000AU07742 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Foreign Clozaril PS Novartis Initial or Prolonged Insulin-Dependent Study Pharmaceuticals Corp ORAL 350 MG QD Other Electrocardiogram T Wave Health ORAL Inversion Professional Eosinophilia Other Influenza Like Illness Pericarditis Sinus Tachycardia Date:10/23/00ISR Number: 3600629-4Report Type:Expedited (15-DaCompany Report #PHBS2000CA04195 Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Grand Mal Convulsion Foreign Clozaril PS Novartis Initial or Prolonged Hypernatraemia Health Pharmaceuticals Corp ORAL 450 MG, QD, Other Professional ORAL Other Ect SS Olanzapine C Venlafaxine C Antibiotics C Oxazepam C 22-Feb-2006 08:30 AM Page: 890 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pantoprazole C Date:10/23/00ISR Number: 3600632-4Report Type:Expedited (15-DaCompany Report #PHBS2000BE09820 Age:76 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Blindness Foreign Clozaril PS Novartis Retinal Detachment Health Pharmaceuticals Corp ORAL 10 MG, BID, Visual Disturbance Professional ORAL Other Zyprexa C Losferron C Sorbitol C Ditropan C Lasix C Augmentin C Date:10/23/00ISR Number: 3600634-8Report Type:Expedited (15-DaCompany Report #PHBS2000AU03578 Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Clozaril PS Novartis Initial or Prolonged Phosphokinase Increased Health Pharmaceuticals Corp ORAL 250 MG, ORAL Disability Cardiac Failure Professional Haloperidol C Cardiomyopathy Other Complan C Enzyme Abnormality Pantothenic Acid, Heart Rate Increased Phosphorus C Hypotension Myocarditis Neutrophilia Pneumonia Pyrexia Date:10/23/00ISR Number: 3600691-9Report Type:Expedited (15-DaCompany Report #PHBS2000GB03477 Age:39 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Foreign Clozaril PS Novartis Initial or Prolonged Dysarthria Health Pharmaceuticals Corp ORAL 500MG/DAY, Transient Ischaemic Professional ORAL Attack Other Venlafaxine C Date:10/23/00ISR Number: 3600697-XReport Type:Expedited (15-DaCompany Report #PHFR2000IE01622 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril PS Novartis Non-Insulin-Dependent Health Pharmaceuticals Corp ORAL 550MG/DAY, Professional ORAL Other Steroids Nos C Date:10/24/00ISR Number: 3601352-2Report Type:Expedited (15-DaCompany Report #00-10-0535 Age:84 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 12.5-225MG Professional ORAL 22-Feb-2006 08:30 AM Page: 891 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/24/00ISR Number: 3601354-6Report Type:Expedited (15-DaCompany Report #00-10-0534 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Clozapine PS Zenith Goldline ORAL 150MG ORAL Date:10/24/00ISR Number: 3601486-2Report Type:Expedited (15-DaCompany Report #PHEH2000US01690 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coma Health Clozaril PS Novartis Hospitalization - Hypoventilation Professional Pharmaceuticals Corp ORAL 300 MG, QD, Initial or Prolonged Loss Of Consciousness ORAL Medication Error Alcohol (Ethanol) C Overdose Respiratory Distress Date:10/26/00ISR Number: 3602215-9Report Type:Expedited (15-DaCompany Report #PHBS2000CA09780 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Clozaril PS Novartis Initial or Prolonged Phosphokinase Increased Study Pharmaceuticals Corp ORAL ORAL Blood Creatinine Health Antibiotics (No Increased Professional Ingredients / Cardiomyopathy Other Substances) C Lethargy Dopamine Hcl In 5% Pyrexia Dextrose Inj Renal Failure (Dopamine Shock Hypoglycaemic Hydrochloride) C Norepinephrine (Norepinephrine) C Celexa (Citalopram Hydrobromide) C Glyburide C Date:10/27/00ISR Number: 3603063-6Report Type:Expedited (15-DaCompany Report #10543064 Age:75 YR Gender:Female I/FU:F Outcome PT Life-Threatening Atelectasis Hospitalization - Atrial Fibrillation Initial or Prolonged Cardiac Arrest Other Cardiac Disorder Cardio-Respiratory Arrest Coma Ejection Fraction Abnormal Electrocardiogram Qrs Complex Abnormal Electrocardiogram Qt Corrected Interval Prolonged Electrocardiogram Qt Prolonged Electrocardiogram St Segment Depression Hypokalaemia Hypokinesia 22-Feb-2006 08:30 AM Page: 892 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Myocardial Ischaemia Pleural Effusion Sinus Tachycardia Report Source Product Role Manufacturer Route Dose Duration Torsade De Pointes Health Tequin PS Bristol Myers Squibb Ventricular Extrasystoles Professional Co Pharmaceutical Ventricular Tachycardia Research Institute ORAL 400 MILLIGRAM, 1/1 DAY ORAL Digoxin SS .13 MILLIGRAM, 1 DAY Clozaril (Clozapine) SS 75 MILLIGRAM, 2/1 DAY Prozac (Fluoxetine Hcl) SS 10 MILLIGRAM, 1 DAY Nortriptyline (Nortriptyline Hcl) SS 40 MILLIGRAM, 1/1 DAY Metoprolol C Ativan C Aspirin C Lisinopril C Date:10/27/00ISR Number: 3621500-8Report Type:Periodic Company Report #PHEH2000US03125 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril PS Novartis Professional Pharmaceuticals Corp 650MG Date:10/30/00ISR Number: 3603899-1Report Type:Expedited (15-DaCompany Report #PHNU2000DE01989 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Loss Of Consciousness Foreign Clozaril PS Novartis Thermal Burn Other Pharmaceuticals Corp Date:10/30/00ISR Number: 3604471-XReport Type:Expedited (15-DaCompany Report #PHBS2000AU10100 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiomegaly Foreign Clozaril PS Novartis Initial or Prolonged Drug Level Below Health Pharmaceuticals Corp 300 MG MANE Therapeutic Professional +400 MG Other NOCTE, UNKNOWN Valproate Sodium(Valproate Sodium) SS 1000 MANE, 500 LUNCH, 1000 NOCTE, UNKNOWN 1646 DAY Benztropeine (Benztropeine) C Gemfibrozil (Gemfibrozil) C Atorvastatin 22-Feb-2006 08:30 AM Page: 893 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Atorvastatin) C Metformin (Metformin) C Mixtard (Insulin, Insulin Injection, Isophane) C Diazepam C Haloperidol C Provera C Date:10/30/00ISR Number: 3604486-1Report Type:Expedited (15-DaCompany Report #PHBS2000AU10241 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Abuser Foreign Clozaril PS Novartis Overdose Health Pharmaceuticals Corp 100 MG, QD, Professional UNK Other Date:10/31/00ISR Number: 3604166-2Report Type:Expedited (15-DaCompany Report #00-09-0485 Age:41 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Lower Health Clozapine PS Zenith Goldline ORAL 100-150MG Initial or Prolonged Decreased Activity Professional ORAL Fatigue Zoloft C Haemorrhage Ritalin C Nausea Ovarian Cyst Date:10/31/00ISR Number: 3604172-8Report Type:Expedited (15-DaCompany Report #00-10-0542 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 125MG ORAL Professional Date:10/31/00ISR Number: 3604174-1Report Type:Expedited (15-DaCompany Report #00-10-0543 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 37.5-40MG Professional ORAL Date:10/31/00ISR Number: 3604178-9Report Type:Expedited (15-DaCompany Report #00-09-0494 Age:75 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL ORAL Professional Sinemet C 22-Feb-2006 08:30 AM Page: 894 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/31/00ISR Number: 3604819-6Report Type:Expedited (15-DaCompany Report #PHFR2000GB01654 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatinine Foreign Clozaril PS Novartis Initial or Prolonged Increased Health Pharmaceuticals Corp ORAL 100 MG DAY Liver Function Test Professional ORAL Abnormal Other Citalopram Pyrexia (Citalopram) C Red Blood Cell Aspirine C Sedimentation Rate Quetiapine Increased (Quetiapine) C Date:10/31/00ISR Number: 3604820-2Report Type:Expedited (15-DaCompany Report #PHBS2000AU07821 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bronchopneumonia Foreign Clozaril PS Novartis Other Cardiomegaly Study Pharmaceuticals Corp ORAL 575 MG DAY Drug Interaction Health ORAL Drug Level Above Professional Sertraline Therapeutic Other (Sertraline) SS 835 DAY Hepatic Cirrhosis Mesasal (Mesalazine) C Hepatic Steatosis Caltrate C Ranitidine (Ranitidine) C Nitrazepam C Prednisone C Ostelin C Kapanol C Date:10/31/00ISR Number: 3604821-4Report Type:Expedited (15-DaCompany Report #PHFR2000GB01660 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Subarachnoid Haemorrhage Foreign Clozaril PS Novartis Health Pharmaceuticals Corp ORAL 300MG DAY Professional ORAL Other Date:10/31/00ISR Number: 3604822-6Report Type:Expedited (15-DaCompany Report #PHBS2000AU10099 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiomyopathy Foreign Clozaril PS Novartis Initial or Prolonged Ventricular Hypertrophy Health Pharmaceuticals Corp 100 MG MANE Professional 450 MG NOCTE Other Paroxetine (Paroxetine) SS 40 MG QD 214 DAY Date:10/31/00ISR Number: 3604823-8Report Type:Expedited (15-DaCompany Report #PHFR2000GB01679 Age:45 YR Gender:Male I/FU:I Outcome PT Life-Threatening Cardio-Respiratory Arrest Coma Drug Level Above Therapeutic 22-Feb-2006 08:30 AM Page: 895 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Gastric Haemorrhage Haematemesis Overdose Report Source Product Role Manufacturer Route Dose Duration Vomiting Foreign Clozaril PS Novartis Health Pharmaceuticals Corp ORAL 700 MG/DAY Professional ORAL Other Midazolam (Midazolam) C Opioids (No Ingredients/Substanc es) C Date:10/31/00ISR Number: 3605246-8Report Type:Expedited (15-DaCompany Report #PHFR2000GB01360 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Epilepsy Foreign Clozaril PS Novartis Study Pharmaceuticals Corp ORAL 300 MG/DAY, Health ORAL Professional Valproate Sodium C Other Date:10/31/00ISR Number: 3605249-3Report Type:Expedited (15-DaCompany Report #PHBS2000NZ04325 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Clonic Convulsion Foreign Clozaril PS Novartis Coordination Abnormal Health Pharmaceuticals Corp ORAL ORAL Encephalopathy Professional Cortisol Extensor Plantar Response Other (Hydrocortisone) SS Meningitis Neurological Symptom Tremor Urinary Incontinence Visual Field Defect Date:11/02/00ISR Number: 3605958-6Report Type:Expedited (15-DaCompany Report #PHEH2000US09171 Age:45 YR Gender:Female I/FU:F Outcome PT Hospitalization - Adrenocortical Initial or Prolonged Insufficiency Acute Other Aplastic Anaemia Body Temperature Increased Dehydration Dermatitis Dizziness Fall Haematocrit Decreased Leukopenia Nausea Neoplasm Malignant Orthostatic Hypotension Pancytopenia Pseudomonal Sepsis Red Blood Cell Count Decreased 22-Feb-2006 08:30 AM Page: 896 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Staphylococcal Sepsis Thrombocytopenia Report Source Product Role Manufacturer Route Dose Duration Health Clozaril PS Novartis Professional Pharmaceuticals Corp ORAL 150 MG AM, ORAL Depakote (Valproate Semisodium) C Vp-16 C Cisplatin (Cisplatin) C Allopurinol C Zyrtec (Cetirizine Hydrochloride) C Date:11/02/00ISR Number: 3605959-8Report Type:Expedited (15-DaCompany Report #PHEH2000US08090 Age:41 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Health Clozaril PS Novartis Glycosylated Haemoglobin Professional Pharmaceuticals Corp ORAL 150MG DAILY, Increased ORAL Depakote (Valproate Semisodium) C Cogentin (Benzatropine Mesilate) C Synthroid C Date:11/02/00ISR Number: 3605960-4Report Type:Expedited (15-DaCompany Report #PHEH2000US08088 Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Glucose Increased Health Clozaril PS Novartis Diabetes Mellitus Professional Pharmaceuticals Corp ORAL 150 MG, QHS, Weight Increased ORAL Vitamin E C Multivitamins (Panthenol, Retinol, Ascorbic Acid) C Artane (Thihexyphenidyl Hydrochloride) C Date:11/02/00ISR Number: 3605961-6Report Type:Expedited (15-DaCompany Report #PHEH2000US07902 Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Cancer Female Health Clozaril PS Novartis Professional Pharmaceuticals Corp ORAL 75MG AM + 250 MG HS, ORAL 22-Feb-2006 08:30 AM Page: 897 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/02/00ISR Number: 3606214-2Report Type:Expedited (15-DaCompany Report #PHBS2000AU09684 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Nasal Congestion Foreign Clozaril PS Novartis Sinusitis Health Pharmaceuticals Corp ORAL 450 MG, QD, Sleep Apnoea Syndrome Professional ORAL Other Lithium (Lithium) C Vibramycin (Doxycycline Hyclate) C Date:11/02/00ISR Number: 3606220-8Report Type:Expedited (15-DaCompany Report #PHFR2000GB01686 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril PS Novartis Health Pharmaceuticals Corp ORAL 400MG/DAY, Professional ORAL Other Date:11/03/00ISR Number: 3606884-9Report Type:Expedited (15-DaCompany Report #00-10-0546 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 350-700MG Professional ORAL Date:11/03/00ISR Number: 3606886-2Report Type:Expedited (15-DaCompany Report #00-09-0473 Age:49 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Road Traffic Accident Health Clozapine PS Zenith Goldline ORAL 300 MG ORAL Professional Date:11/03/00ISR Number: 3606891-6Report Type:Expedited (15-DaCompany Report #PHEH2000US02825 Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozaril PS Novartis Respiratory Arrest Professional Pharmaceuticals Corp ORAL 600 MG, ORAL Date:11/03/00ISR Number: 3606989-2Report Type:Expedited (15-DaCompany Report #PHBS2000AU01327 Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiac Disorder Foreign Clozaril PS Novartis Cardiomyopathy Health Pharmaceuticals Corp ORAL 500 MG, QD, Myocardial Ischaemia Professional ORAL Other Paroxetine C 22-Feb-2006 08:30 AM Page: 898 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/00ISR Number: 3607040-0Report Type:Expedited (15-DaCompany Report #PHHO2000GB01831 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anoxia Foreign Clozaril PS Novartis Life-Threatening Blood Potassium Decreased Study Pharmaceuticals Corp ORAL 100MANE/175NO Hospitalization - Brain Hypoxia Health CTE, ORAL Initial or Prolonged Bronchopneumonia Professional Procyclidine C-Reactive Protein Other (Procyclidine) C Increased Flupentixol Cardiac Arrest (Flupentixol) C Convulsion Croup Infectious Diarrhoea Gastroenteritis Hypokalaemia Hypotension Hypoxic Encephalopathy Loss Of Consciousness Myocardial Ischaemia Pyrexia Ventricular Fibrillation Vomiting White Blood Cell Count Increased Date:11/06/00ISR Number: 3607562-2Report Type:Expedited (15-DaCompany Report #PHBS2000AU10479 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agranulocytosis Foreign Clozaril PS Novartis Other Leukaemia Health Pharmaceuticals Corp ORAL 400 MG/D, Neutropenia Professional ORAL Other Date:11/06/00ISR Number: 3607563-4Report Type:Expedited (15-DaCompany Report #PHBS2000AU09082 Age:22 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiomegaly Foreign Clozaril PS Novartis Initial or Prolonged Cardiomyopathy Health Pharmaceuticals Corp ORAL 300 MG/D, Echocardiogram Abnormal Professional ORAL Myocarditis Other Valproate Sodium C Pyrexia Date:11/06/00ISR Number: 3607564-6Report Type:Expedited (15-DaCompany Report #PHBS2000AU09236 Age:24 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Clozaril PS Novartis Intentional Overdose Health Pharmaceuticals Corp ORAL 200 MG, QD, Professional ORAL Other Heroin (Diamorphine) SS 9 MON 22-Feb-2006 08:30 AM Page: 899 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/06/00ISR Number: 3607565-8Report Type:Expedited (15-DaCompany Report #PHBS2000CA09780 Age:49 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Creatine Foreign Clozaril PS Novartis Hospitalization - Phosphokinase Increased Study Pharmaceuticals Corp ORAL ORAL Initial or Prolonged Blood Creatinine Health Antibiotics (No Increased Professional Ingredients/Substanc Cardiomyopathy Other es) C Lethargy Dopamine Hcl In 5% Neuroleptic Malignant Dextrose Inj Syndrome (Dopamine Pneumonia Hydrochloride) C Pyrexia Norepinephrine Renal Failure (Norepinephrine) C Shock Hypoglycaemic Celexa (Citalopram Hydrochloride) C Glyburide C Date:11/06/00ISR Number: 3607566-XReport Type:Expedited (15-DaCompany Report #PHNU2000DE01667 Age:50 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Antibody Test Abnormal Foreign Clozaril PS Novartis Initial or Prolonged Blood Immunoglobulin A Health Pharmaceuticals Corp ORAL ORAL Decreased Professional Blood Immunoglobulin E Other Decreased Blood Immunoglobulin M Decreased Hypogammaglobulinaemia Immune System Disorder Lymphopenia Date:11/06/00ISR Number: 3607567-1Report Type:Expedited (15-DaCompany Report #PHBS2000NZ10535 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Foreign Clozaril PS Novartis Health Pharmaceuticals Corp ORAL 500 MG/D, Professional ORAL Other Epilim C Date:11/06/00ISR Number: 3608079-1Report Type:Expedited (15-DaCompany Report #PHEH2000US09015 Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Germ Cell Cancer Health Clozaril PS Novartis Metastases To Lung Professional Pharmaceuticals Corp ORAL 450MG, ORAL Remeron (Mirtazapine) C Depakote (Valproate Semisodium) C Multivitamins (Panthenol, Retinol, Ascorbic Acid) C 22-Feb-2006 08:30 AM Page: 900 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/06/00ISR Number: 3608194-2Report Type:Expedited (15-DaCompany Report #PHBS1998GB01916 Age:50 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Pain Foreign Clozaril PS Novartis Other Drug Level Above Health Pharmaceuticals Corp ORAL 900 MG, ORAL Therapeutic Professional Metformin Dyspepsia (Metformin) C Megacolon Aspirine C Myocardial Infarction Glipizide Myocardial Ischaemia (Glipizide) C Thioridazine (Thioridazine) C Date:11/06/00ISR Number: 3608328-XReport Type:Expedited (15-DaCompany Report #PHEH2000US09372 Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Neoplasm Malignant Health Clozaril PS Novartis Professional Pharmaceuticals Corp 3302 DAY Clozapine(Clozapine) Tablet SS ORAL 300MG AM + 500MG HS, ORAL Date:11/07/00ISR Number: 3608318-7Report Type:Expedited (15-DaCompany Report #2000SIN0155 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Confusional State Health Sinemet PS Dupont Hospitalization - Dementia Professional Pharmaceuticals Co ORAL 25/100 MG 1.5 Initial or Prolonged Disorientation TABS TID PO Mirapex (Pramipexole Dihydrochloride) SS UNKNOWN 0.25 MG 3 TABS TID UNK Clozaril (Clozapine) SS UNKNOWN 25 MG 5 TABS DLY UNK Date:11/07/00ISR Number: 3609169-XReport Type:Expedited (15-DaCompany Report #PHEH2000US09161 Age:47 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Cancer Female Health Clozaril PS Novartis Inflammation Professional Pharmaceuticals Corp ORAL 300 MG, TID, Metastases To Bone ORAL Zyprexa (Olanzapine) C Cogentin (Benzatropine Mesilate) C Date:11/09/00ISR Number: 3609184-6Report Type:Expedited (15-DaCompany Report #00-09-0503 Age:42 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 200MG ORAL Professional Methotrexate C Insulin C 22-Feb-2006 08:30 AM Page: 901 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/09/00ISR Number: 3609185-8Report Type:Expedited (15-DaCompany Report #00-10-0526 Age:15 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Health Clozapine PS Zenith Goldline ORAL 50-150MG ORAL 4 DAY Convulsion Professional Zyprexa C Haldol C Date:11/09/00ISR Number: 3609186-XReport Type:Expedited (15-DaCompany Report #00-10-0525 Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 300-500MG Professional ORAL Loperamide 2 Mg C Date:11/09/00ISR Number: 3609187-1Report Type:Expedited (15-DaCompany Report #00-10-0558 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 12.5-50MG Professional ORAL Date:11/09/00ISR Number: 3609188-3Report Type:Expedited (15-DaCompany Report #00-10-0554 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Ovarian Cancer Health Clozapine PS Zenith Goldline ORAL 200MG ORAL Professional Date:11/09/00ISR Number: 3609189-5Report Type:Expedited (15-DaCompany Report #00-10-0553 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abscess Health Clozapine PS Zenith Goldline ORAL 37.5MG ORAL Diverticulitis Professional Respiratory Disorder Date:11/09/00ISR Number: 3609190-1Report Type:Expedited (15-DaCompany Report #00-10-0551 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Neoplasm Malignant Health Clozapine PS Zenith Goldline ORAL 400-850MH Life-Threatening Metastases To Central Professional ORAL Nervous System Metastases To Liver Weight Decreased Date:11/09/00ISR Number: 3609191-3Report Type:Expedited (15-DaCompany Report #00-10-0550 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Chronic Lymphocytic Health Clozapine PS Zenith Goldline ORAL 200 MG ORAL Leukaemia Professional 22-Feb-2006 08:30 AM Page: 902 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/13/00ISR Number: 3614246-3Report Type:Periodic Company Report #FLUV00299001195 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Literature Luvox PS Solvay Initial or Prolonged Drug Interaction Pharmaceuticals ORAL 200 MG DAILY Drug Level Above PO, 100 MG Therapeutic DAILY PO, 50 Drug Level Below MG DAILY PO, Therapeutic 25 MG DAILY Hostility Risperdal SS ORAL 10 MG DAILY Psychotic Disorder PO Mellaril SS ORAL 300 MG DAILY PO, 500 MG DAILY PO, 300 MG DAILY PO, 200 MG DAILY Tegretol SS ORAL 1000 MG DAILY PO, 800 MG DAILY PO, 200 MG DAILY PO Clozapine SS ORAL SEE IMAGE Depakote C Cogentin C Mysoline C Date:11/14/00ISR Number: 3611172-0Report Type:Expedited (15-DaCompany Report #C2000-1645.01 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Neoplasm Malignant Health Clozapine PS Mylan Professional Pharmaceuticals Inc ORAL 800MG QD, Other ORAL Date:11/14/00ISR Number: 3611379-2Report Type:Expedited (15-DaCompany Report #PHEH2000US10196 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Haemolytic Anaemia Health Clozaril PS Novartis Professional Pharmaceuticals Corp ORAL 50 MG, QD, ORAL Norvasc C Zestril (Lisinopril) C Catapres (Clonidine) C Fosamax (Alendronate Sodium) C Metoprolol Succinate (Metoprolol Succinate) C Milk Of Magnesia C Date:11/14/00ISR Number: 3611392-5Report Type:Expedited (15-DaCompany Report #PHEH2000US08192 Age:35 YR Gender:Male I/FU:F Outcome PT Life-Threatening Agitation Hospitalization - Cardiac Arrest Initial or Prolonged Cardiomyopathy Confusional State 22-Feb-2006 08:30 AM Page: 903 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Cyanosis Hyperhidrosis Pulse Absent Report Source Product Role Manufacturer Route Dose Duration Pulse Pressure Decreased Health Clozaril PS Novartis Respiratory Arrest Professional Pharmaceuticals Corp ORAL 850 MG, ORAL Tachycardia Anafranil (Clomipramine Hydrochloride, Clomipramine Hydrochloride) C Depakote (Valproate Semisodium) C Tranxene (Clorazepate Dipotassium) C Date:11/14/00ISR Number: 3611393-7Report Type:Expedited (15-DaCompany Report #PHEH2000US07561 Age:51 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coronary Artery Disease Health Clozaril PS Novartis Myocardial Ischaemia Professional Pharmaceuticals Corp ORAL 200 MG, BID, ORAL Zyprexa (Olanzapine) C Zoloft (Sertraline Hydrochloride) C Date:11/14/00ISR Number: 3611552-3Report Type:Expedited (15-DaCompany Report #PHBS2000AU07678 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Foreign Clozaril PS Novartis Hospitalization - Depressed Level Of Health Pharmaceuticals Corp ORAL 100 & 300 Initial or Prolonged Consciousness Professional MG/DAY, ORAL Eating Disorder Symptom Other Folic Acid C Epilepsy Thiamine C Fall Salbutamol C Hypotension Valproate Sodium C Intestinal Obstruction Omeprazole Pneumonia Aspiration (Omeprazole) C Respiratory Distress Lamotrigine C Shock Chlorsig C Vomiting Sorbitrol C Ceftotaxime C Metronidazole (Metronidazole) C Vitamin K C Vitamin C (Ascorbic Acid) C Date:11/14/00ISR Number: 3611583-3Report Type:Expedited (15-DaCompany Report #PHEH2000US10197 Age:93 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dehydration Health Clozaril PS Novartis Hospitalization - Prostate Cancer Professional Pharmaceuticals Corp ORAL ORAL Initial or Prolonged 22-Feb-2006 08:30 AM Page: 904 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/14/00ISR Number: 3611939-9Report Type:Expedited (15-DaCompany Report #PHNU2000DE01945 Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - C-Reactive Protein Foreign Clozaril PS Novartis Initial or Prolonged Increased Health Pharmaceuticals Corp ORAL MAX. 200 Diarrhoea Professional MG/DAY, ORAL Fatigue Other Ergenyl Chrono C Headache Sortis "Godecke" Leukocytosis (Atorvastatin Malaise Calcium) C Nausea Tavor C Pleural Effusion Zyprexa (Olanzapine) C Pleural Infection Beloc-Zoc Mite Pyrexia (Metoprolol Red Blood Cell Succinate) C Sedimentation Rate Augmentin Oral Increased (Clavulanate Viral Infection Potassium) C Date:11/14/00ISR Number: 3611961-2Report Type:Expedited (15-DaCompany Report #PHRM2000FR01595 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electroencephalogram Foreign Clozaril PS Novartis Initial or Prolonged Abnormal Health Pharmaceuticals Corp ORAL UNK, UNK, Enuresis Professional ORAL Malaise Other Date:11/14/00ISR Number: 3612303-9Report Type:Expedited (15-DaCompany Report #2000AP04800 Age:31 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Tenormin PS Astrazeneca Overdose Health Pharmaceuticals Lp Professional Diltiazem SS Clozapine SS Date:11/15/00ISR Number: 3611864-3Report Type:Direct Company Report # Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Confusional State Clozaril PS ORAL 150 MG PO BID 3 WK Pyrexia Risperdal C Amoxicillin C Date:11/15/00ISR Number: 3612134-XReport Type:Expedited (15-DaCompany Report #PHBS2000AU09745 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Muscle Atrophy Foreign Clozaril PS Novartis Health Pharmaceuticals Corp ORAL 250 MG, BID Professional ORAL Cogentin (Benzatropine Mesilate) C 22-Feb-2006 08:30 AM Page: 905 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/15/00ISR Number: 3612137-5Report Type:Expedited (15-DaCompany Report #PHBS2000AU07678 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Intestinal Obstruction Foreign Clozaril PS Novartis Hospitalization - Pneumonia Health Pharmaceuticals Corp ORAL ORAL Initial or Prolonged Professional Date:11/15/00ISR Number: 3612141-7Report Type:Expedited (15-DaCompany Report #PHFR2000GB01790 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Foreign Clozaril PS Novartis Circulatory Collapse Health Pharmaceuticals Corp ORAL SEE IMAGE Drug Interaction Professional Venlafaxine Drug Level Above Other (Venlafaxine) SS ORAL 150 MG/DAY, Therapeutic ORAL Dyspnoea Gliclazide Emotional Disorder (Gliclazide) C Emotional Distress Metformin Hypoventilation (Metformin) C Malaise Omeprazole Pallor (Omeprazole) C Pyrexia Simple Linctus Restlessness (Anise Water, Chloroform Spirit, Citric Acid Monohydrate, C Procyclidine (Procyclidine) C Becotide (Beclometasone Dipropionate) C Date:11/15/00ISR Number: 3612143-0Report Type:Expedited (15-DaCompany Report #PHBS2000AU09764 Age:26 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Upper Foreign Clozaril PS Novartis Blood Triglycerides Health Pharmaceuticals Corp ORAL 100 MG MANE, Increased Professional 300 MG NOCTE, Diabetes Mellitus Other ORAL Gastrooesophageal Reflux Metformin Disease (Metformin) C Hepatic Enzyme Increased Zoton (Lansoprazole) C High Density Lipoprotein Zoloft (Sertraline Decreased Hydrochloride) C Oesophageal Ulcer Rash Papular Rash Pustular Date:11/15/00ISR Number: 3612144-2Report Type:Expedited (15-DaCompany Report #PHFR2000IE01622 Age:39 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril PS Novartis Non-Insulin-Dependent Health Pharmaceuticals Corp ORAL 450 MG/DAY, Hyperglycaemia Professional ORAL Other Steroids Nos (No 22-Feb-2006 08:30 AM Page: 906 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Ingredients/Substanc es) C Lofepramine (Lofepramine) C Date:11/15/00ISR Number: 3612471-9Report Type:Expedited (15-DaCompany Report #PHNU2000DE02113 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril PS Novartis Health Pharmaceuticals Corp ORAL ORAL Professional Other Date:11/15/00ISR Number: 3612496-3Report Type:Expedited (15-DaCompany Report #PHBS2000CL10911 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiac Failure Foreign Clozaril PS Novartis Hospitalization - Cardiomyopathy Health Pharmaceuticals Corp ORAL 300 MG/DAY, Initial or Prolonged Dyspnoea Professional ORAL Pyrexia Rivotril C Sedation Date:11/15/00ISR Number: 3612502-6Report Type:Expedited (15-DaCompany Report #PHFR2000GB01557 Age:67 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Foreign Clozaril PS Novartis Phosphokinase Increased Health Pharmaceuticals Corp ORAL 50 MG, BID, Cerebrovascular Accident Professional ORAL Gait Disturbance Other Risperidone Hyperglycaemia (Risperidone) C Malaise Paroxetine Movement Disorder (Paroxetine) C Temazepam C Lactulose C Paracetamol (Paracetamol) C Date:11/15/00ISR Number: 3612669-XReport Type:Expedited (15-DaCompany Report #S00-USA-01731-01 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Celexa PS Forest Laboratories Initial or Prolonged Drug Interaction Professional Inc Tardive Dyskinesia Clozapine SS Date:11/15/00ISR Number: 3613174-7Report Type:Expedited (15-DaCompany Report #HQ3206403NOV2000 Age:54 YR Gender:Female I/FU:I Outcome PT Hospitalization - Abdominal Pain Upper Initial or Prolonged Acute Abdomen Other Bowel Sounds Abnormal Constipation Dyskinesia 22-Feb-2006 08:30 AM Page: 907 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Gastrointestinal Disorder Gastrointestinal Motility Disorder Report Source Product Role Manufacturer Route Dose Duration Nausea Study Effexor PS Wyeth Ayerst Vomiting Laboratories ORAL 150MG PER DAY/75 MG PER DAY 34 DAY Lepnex "Wander" (Clozapine) SS ORAL SEE IMAGE 4 DAY Saroten (Amitriptyline Hydrochloride) SS SEE IMAGE 1 DAY Date:11/16/00ISR Number: 3612226-5Report Type:Expedited (15-DaCompany Report #00-11-0567 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 200-300MG Professional ORAL Date:11/16/00ISR Number: 3612227-7Report Type:Expedited (15-DaCompany Report #00-11-0560 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Appendicitis Health Clozapine PS Zenith Goldline ORAL 150-275MG Initial or Prolonged Professional ORAL Date:11/16/00ISR Number: 3613081-XReport Type:Expedited (15-DaCompany Report #PHBS2000AU10100 Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiomegaly Foreign Clozaril PS Novartis Initial or Prolonged Drug Level Below Health Pharmaceuticals Corp ORAL 300 MG MANE + Therapeutic Professional 400 MG NOCTE, Other ORAL Valproate Sodium (Valproate Sodium) SS 1000 MANE, 500 LUNCH, 1000 NOCTE 1646 DAY Benztropeine (Benztropeine) C Gemfibrozil (Gemfibrozil) C Atorvastatin (Atorvastatin) C Metformin (Metformin) C Mixtard (Insulin, Insulin Injection, Isophane) C Diazepam C Haloperidol C Provera C 22-Feb-2006 08:30 AM Page: 908 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/16/00ISR Number: 3613082-1Report Type:Expedited (15-DaCompany Report #PHNU2000DE02101 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Level Above Foreign Clozaril PS Novartis Initial or Prolonged Therapeutic Study Pharmaceuticals Corp ORAL ORAL Fall Health Hypnorex - Slow Hypotonia Professional Release (Lithium Other Carbonate) SS ORAL ORAL Saroten SS ORAL ORAL Torem (Torasemide) SS ORAL ORAL Allopurinol C Date:11/16/00ISR Number: 3613084-5Report Type:Expedited (15-DaCompany Report #PHNU2000DE02098 Age:69 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrioventricular Block Foreign Clozaril PS Novartis Initial or Prolonged First Degree Study Pharmaceuticals Corp ORAL ORAL Cold Sweat Health Hypnorex (Lithium Electrocardiogram Qt Professional Carbonate) SS ORAL ORAL Prolonged Other Akineton(Biperiden Heart Rate Decreased Hydrochloride) SS ORAL ORAL Sick Sinus Syndrome Haldol (Haloperidol) SS ORAL ORAL Sinoatrial Block Saroten SS ORAL ORAL Sinus Bradycardia Date:11/16/00ISR Number: 3613087-0Report Type:Expedited (15-DaCompany Report #PHBS1998GB01916 Age:50 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Pain Foreign Clozaril PS Novartis Other Cholinergic Syndrome Health Pharmaceuticals Corp ORAL 900 MG, ORAL Coronary Artery Disease Professional Metformin Drug Level Above Other (Metformin) C Therapeutic Aspirine C Dyspepsia Glipizide Megacolon (Glipizide) C Myocardial Infarction Thioridazine Myocardial Ischaemia (Thioridazine) C Date:11/17/00ISR Number: 3613556-3Report Type:Expedited (15-DaCompany Report #JACGER2000001716 Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arrhythmia Foreign Haldol PS Rw Johnson Initial or Prolonged Atrioventricular Block Health Pharmaceutical Bradycardia Professional Research Institute Bundle Branch Block Right Div Ortho Pharm ORAL MG, DAILY, Cold Sweat ORAL Electrocardiogram Qt Hypnorex (Lithium Prolonged Carbonate) SS ORAL MG, DAILY, Sick Sinus Syndrome ORAL Sinus Bradycardia Akineton (Biperiden Hydrochloride) SS ORAL MG, DAILY, ORAL Leponex (Clozapine) SS ORAL MG, DAILY, ORAL Saroten 22-Feb-2006 08:30 AM Page: 909 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Amitriptyline Hydrochloride) SS ORAL MG, DAILY, ORAL Fluanxol (Flupentixol) C Date:11/17/00ISR Number: 3613561-7Report Type:Expedited (15-DaCompany Report #JACGER2000001707 Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bladder Disorder Foreign Haldol PS Rw Johnson Initial or Prolonged Blood Folate Decreased Health Pharmaceutical Pneumonia Professional Research Institute ORAL MG, Polyneuropathy DAILY,ORAL Pulmonary Congestion Leponex (Clozapine) SS ORAL MG, DAILY, Pyrexia ORAL Rales Seroxat (Paroxetine Urinary Retention Hydrochloride) SS ORAL MG, DAILY, ORAL Noveril (Dibenzepin Hydrochloride) C ORAL MG,DAILY, ORAL Tavor (Lorazepam) C Staurodorm (Staurodorm) C Chloraldurat Red (Chloral Hydrate) C Chloraldurat Blue(Chloral Hydrate) C Date:11/20/00ISR Number: 3614676-XReport Type:Expedited (15-DaCompany Report #PHBS2000AU10935 Age:40 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiomyopathy Foreign Clozaril PS Novartis Health Pharmaceuticals Corp ORAL ORAL Professional Other Date:11/20/00ISR Number: 3614679-5Report Type:Expedited (15-DaCompany Report #PHFR2000GB01828 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril PS Novartis Hyperglycaemia Health Pharmaceuticals Corp ORAL ORAL Weight Decreased Professional Amlodipine C Other Date:11/20/00ISR Number: 3614790-9Report Type:Expedited (15-DaCompany Report #PHBS2000SE11027 Age:47 YR Gender:Male I/FU:I Outcome PT Hospitalization - Abdominal Pain Initial or Prolonged Constipation Gastric Ulcer Perforation Gastrointestinal Disorder Haematemesis 22-Feb-2006 08:30 AM Page: 910 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hypotension Nausea Report Source Product Role Manufacturer Route Dose Duration Foreign Clozaril PS Novartis Health Pharmaceuticals Corp ORAL 300 MG/DAY, Professional ORAL Other Zantac(Ranitidine Hydrochloride) Tablet SS ORAL 150 MG/DAY, ORAL; 300 MG Alvedon(Paracetamol) C Date:11/20/00ISR Number: 3614828-9Report Type:Expedited (15-DaCompany Report #PHBS2000BR10774 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agranulocytosis Foreign Clozaril PS Novartis Life-Threatening Pneumonia Aspiration Health Pharmaceuticals Corp ORAL 100 MG, TID, Pyrexia Professional ORAL Other Date:11/20/00ISR Number: 3614833-2Report Type:Expedited (15-DaCompany Report #PHBS2000AU10058 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiomyopathy Foreign Clozaril PS Novartis Echocardiogram Abnormal Study Pharmaceuticals Corp ORAL 350 MG/ DAY, Leukocytosis Health ORAL Neutrophilia Professional Other Date:11/20/00ISR Number: 3614891-5Report Type:Expedited (15-DaCompany Report #PHBS2000AU09831 Age:54 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Disorder Foreign Clozaril PS Novartis Initial or Prolonged Study Pharmaceuticals Corp ORAL 200 MG/D, Health ORAL Professional Other Date:11/20/00ISR Number: 3615186-6Report Type:Expedited (15-DaCompany Report #PHBS2000CA10688 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Foreign Clozaril PS Novartis Other Haematuria Study Pharmaceuticals Corp ORAL 500 MG/D, Nephrolithiasis Health ORAL Professional Ativan C Other 22-Feb-2006 08:30 AM Page: 911 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/20/00ISR Number: 3615297-5Report Type:Expedited (15-DaCompany Report #PHBS2000CH10977 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - C-Reactive Protein Foreign Clozaril PS Novartis Initial or Prolonged Increased Health Pharmaceuticals Corp ORAL 150 MG/D, Normochromic Normocytic Professional ORAL Anaemia Akineton (Biperiden Pneumonia Hydrochloride) C Tegretol C Depakine C Tiatral C Zocor C Rocaltrol (Calcitroil) C Calcium C Mucilar (Psyllium) C Haldol C Motilium "Sanofi Winthrop" (Domperidone Maleate) C Date:11/20/00ISR Number: 3615460-3Report Type:Expedited (15-DaCompany Report #JRFUSA2000009257 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Health Risperdal PS Janssen Research Fdn Professional Div Johnson And Johnson ORAL 2 MG, 1 IN 1 DAY(S), ORAL Clozaril SS ORAL ORAL Zyprexa SS ORAL ORAL Lorazepam C Benztropine C Date:11/20/00ISR Number: 3618497-3Report Type:Periodic Company Report #990861.01 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Health Clozapine PS Mylan Professional Pharmaceuticals Inc ORAL 300 MG QHS, ORAL Prozac C Date:11/21/00ISR Number: 3614700-4Report Type:Expedited (15-DaCompany Report #00-10-0521 Age:33 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Health Clozapine PS Zenith Goldline ORAL ORAL Initial or Prolonged Insulin-Dependent Professional Zerzone C Hypercholesterolaemia Lithium Carbonate C Hyperglycaemia Inderal C Hyperlipidaemia Humulin Nph C Hypertriglyceridaemia Humulin R C Insulin Resistance Paxil C 22-Feb-2006 08:30 AM Page: 912 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/21/00ISR Number: 3614701-6Report Type:Expedited (15-DaCompany Report #00-09-0502 Age:72 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 300 MG, ORAL Professional Lasix C Albuterol C Epogen C Potassium Chloride C Heparin C Artane C Date:11/21/00ISR Number: 3614703-XReport Type:Expedited (15-DaCompany Report #00-10-0523 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ankle Fracture Health Clozapine PS Zenith Goldline ORAL 350 MG, ORAL Initial or Prolonged Professional Phenytoin C Ibuprofen C Haloperidol C Date:11/21/00ISR Number: 3614705-3Report Type:Expedited (15-DaCompany Report #00-10-0521 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Health Clozapine PS Zenith Goldline ORAL ORAL Initial or Prolonged Inadequate Control Professional Serzone C Diabetes Mellitus Lithium Carbonate C Insulin-Dependent Inderal C Hyperglycaemia Humulin Nph C Humulin R C Date:11/21/00ISR Number: 3615431-7Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drooling Clozapine PS ORAL 750 MG Q HS PO Haloperidol Decanoate 100mg Q 4 Weeks SS INTRAMUSCULAR 100MG Q MONTHLY IM Trihexyphenidyl C Maalox C Date:11/22/00ISR Number: 3615412-3Report Type:Direct Company Report # Age:48 YR Gender:Male I/FU:I Outcome PT Death Agitation Blood Creatine Phosphokinase Increased Blood Creatine Phosphokinase Mb Increased Bradycardia Cardiac Arrest Cardiac Failure 22-Feb-2006 08:30 AM Page: 913 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Congestive Chest Discomfort Chest Pain Coma Report Source Product Role Manufacturer Route Dose Duration Ejection Fraction Clozapine (Zenith) PS Zenith 75 MG Q AM & Abnormal 125 MG Q HS Electroencephalogram Abnormal Feeling Abnormal Hyperhidrosis Hypertension Pain Pyrexia Ventricular Hypertrophy Vomiting Date:11/22/00ISR Number: 3615455-XReport Type:Expedited (15-DaCompany Report #00-10-0520 Age:73 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 75MG ORAL Professional Date:11/22/00ISR Number: 3615457-3Report Type:Expedited (15-DaCompany Report #00-10-0526 Age:15 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coma Health Clozapine PS Zenith Goldline ORAL 50-150MG ORAL Professional Zyprexa C Haldol C Date:11/22/00ISR Number: 3615461-5Report Type:Expedited (15-DaCompany Report #00-11-0570 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Small Cell Lung Cancer Health Clozapine PS Zenith Goldline ORAL ORAL Stage Unspecified Professional Date:11/22/00ISR Number: 3615463-9Report Type:Expedited (15-DaCompany Report #00-11-0569 Age:81 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 25-50 MG ORAL Professional Date:11/22/00ISR Number: 3615465-2Report Type:Expedited (15-DaCompany Report #00-11-0564 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Road Traffic Accident Health Clozapine PS Zenith Goldline ORAL 576-700MG Initial or Prolonged Professional ORAL 22-Feb-2006 08:30 AM Page: 914 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/22/00ISR Number: 3615466-4Report Type:Expedited (15-DaCompany Report #00-11-0574 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 50-400MG ORAL Professional Date:11/22/00ISR Number: 3615467-6Report Type:Expedited (15-DaCompany Report #99-12-0456 Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Leukocytosis Health Clozapine PS Zenith Goldline ORAL 25MG ORAL Professional Date:11/22/00ISR Number: 3617778-7Report Type:Expedited (15-DaCompany Report #A036863 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Hypotension Health Vistaril PS Pfizer Laboratories Intervention to Tachycardia Professional Div Pfizer Inc Prevent Permanent Clozapine SS Impairment/Damage Date:11/24/00ISR Number: 3616339-3Report Type:Expedited (15-DaCompany Report #10607646 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Study Taxol PS Bristol Myers Squibb Drug Ineffective Health Co Pharmaceutical Full Blood Count Professional Research Institute INTRAVENOUS IV Decreased Capecitabine SS ORAL 2/1 DAY ORAL Leukopenia Clozapine SS Date:11/24/00ISR Number: 3621585-9Report Type:Periodic Company Report #PHEH2000US01485 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Clozaril PS Novartis Professional Pharmaceuticals Corp ORAL ORAL Tegretol C Date:11/27/00ISR Number: 3616992-4Report Type:Expedited (15-DaCompany Report #00P-163-0098357-00(1) Age:44 YR Gender:Female I/FU:F Outcome PT Hospitalization - Alopecia Initial or Prolonged Anorexia Required Aplastic Anaemia Intervention to Asthenia Prevent Permanent Blood Pressure Decreased Impairment/Damage Blood Urea Increased Cellulitis Chills Conjunctivitis Dehydration Dermatitis Dizziness 22-Feb-2006 08:30 AM Page: 915 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Drug Interaction Eczema Endocarditis Report Source Product Role Manufacturer Route Dose Duration Eye Irritation Health Depakote PS Abbott Laboratories ORAL 250 MG, 4 IN Face Oedema Professional 1 D, PER ORAL Fatigue Clozapine SS ORAL 400 MG, 1 IN Hyperglycaemia 1 D, PER ORAL Hypokalaemia Combivent C Lung Infiltration Ondansetron Lymphocyte Count Hydrochloride C Increased Prochlorperazine Monocyte Count Decreased Edisylate C Mouth Ulceration Cetirizine Nausea Hydrochloride C Necrotising Fasciitis Famotidine C Neoplasm Malignant Lorazepam C Neutrophil Count Fludrocortisone Decreased Acetate C Oral Pain Olanzapine C Pain In Extremity Naphazoline C Pancytopenia Petechiae Pneumonia Pseudomonas Infection Pyrexia Rash Erythematous Rhonchi Scar Sepsis Sinusitis Skin Lesion Small Cell Lung Cancer Stage Unspecified Staphylococcal Abscess Subcutaneous Abscess Superior Vena Caval Occlusion Swelling Tachycardia Tenderness White Blood Cell Count Decreased Date:11/27/00ISR Number: 3617069-4Report Type:Expedited (15-DaCompany Report #PHEH2000US10197 Age:93 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dehydration Health Clozaril PS Novartis Hospitalization - Prostate Cancer Professional Pharmaceuticals Corp ORAL 25 MG, BID, Initial or Prolonged ORAL Sinemet (Levodopa, Carbidopa) C Proamatine (Midodrine Hydrochloride) C Lasix C Glyburide C 22-Feb-2006 08:30 AM Page: 916 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/27/00ISR Number: 3617079-7Report Type:Expedited (15-DaCompany Report #PHEH2000US07924 Age:31 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozaril PS Novartis Testis Cancer Professional Pharmaceuticals Corp ORAL 350MG; ORAL Date:11/27/00ISR Number: 3617081-5Report Type:Expedited (15-DaCompany Report #PHEH2000US10584 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hypoglycaemia Health Clozaril PS Novartis Professional Pharmaceuticals Corp ORAL ORAL Date:11/27/00ISR Number: 3617082-7Report Type:Expedited (15-DaCompany Report #PHEH2000US10583 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Lung Neoplasm Malignant Health Clozaril PS Novartis Professional Pharmaceuticals Corp ORAL 350 MG, QHS; ORAL Chemotherapy C Date:11/27/00ISR Number: 3617083-9Report Type:Expedited (15-DaCompany Report #PHEH2000US03127 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other No Adverse Drug Effect Health Clozaril PS Novartis Professional Pharmaceuticals Corp ORAL 500MG; ORAL Date:11/27/00ISR Number: 3617084-0Report Type:Expedited (15-DaCompany Report #PHEH2000US10640 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Embolism Health Clozaril PS Novartis Pneumonia Professional Pharmaceuticals Corp ORAL 200MG; ORAL Date:11/27/00ISR Number: 3617338-8Report Type:Expedited (15-DaCompany Report #PHBS2000AU10479 Age:32 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agranulocytosis Foreign Clozaril PS Novartis Hospitalization - Condition Aggravated Health Pharmaceuticals Corp ORAL 400 MG/D, Initial or Prolonged Leukaemia Professional ORAL Neutropenia Other Date:11/27/00ISR Number: 3617340-6Report Type:Expedited (15-DaCompany Report #PHBS2000SE11075 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Foreign Clozaril PS Novartis Initial or Prolonged Cardiomyopathy Health Pharmaceuticals Corp ORAL 500 MG/D, Professional ORAL Other Heminevrin (Clomethiazole Edisilate) C 22-Feb-2006 08:30 AM Page: 917 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lanacrist Tablet C Iktorivil Drops C Furix Tablet C Trombyl Tablet C Silnoct (Zolpidem Tartrate) Tablet C Cozaar (Losartan Potassium) Tablet C Date:11/27/00ISR Number: 3617439-4Report Type:Expedited (15-DaCompany Report #PHFR2000GB01840 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Foreign Clozaril PS Novartis Phosphokinase Increased Health Pharmaceuticals Corp ORAL ORAL Blood Creatine Professional Phosphokinase Mb Other Increased Diarrhoea Lung Consolidation Pleural Effusion Date:11/27/00ISR Number: 3617449-7Report Type:Expedited (15-DaCompany Report #PHBS2000AU10829 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Interaction Foreign Clozaril PS Novartis Other Haemorrhage Health Pharmaceuticals Corp ORAL 75 MG/D, ORAL Professional Methadone(Methadone) SS 3 DAY Other Heroin(Diamorphine) C Date:11/27/00ISR Number: 3617577-6Report Type:Expedited (15-DaCompany Report #PHBS2000AU11102 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neoplasm Malignant Foreign Clozaril PS Novartis Health Pharmaceuticals Corp ORAL 300 MG/D, Professional ORAL Other Date:11/27/00ISR Number: 3621502-1Report Type:Periodic Company Report #PHEH2000US03147 Age:89 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril PS Novartis Professional Pharmaceuticals Corp ORAL 25 MG, QHS, ORAL Date:11/27/00ISR Number: 3621503-3Report Type:Periodic Company Report #PHEH2000US03179 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dizziness Health Clozaril PS Novartis Initial or Prolonged Hypotension Professional Pharmaceuticals Corp 100MG AM + Injury 250MG NOON + Syncope 300MG HS 22-Feb-2006 08:30 AM Page: 918 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Buspar C Asa C Date:11/27/00ISR Number: 3621506-9Report Type:Periodic Company Report #PHEH2000US03266 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Grand Mal Convulsion Health Clozaril PS Novartis Initial or Prolonged Leukocytosis Professional Pharmaceuticals Corp ORAL 200 MG, BID, ORAL Date:11/27/00ISR Number: 3621509-4Report Type:Periodic Company Report #PHEH2000US03269 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hypotension Health Clozaril PS Novartis Professional Pharmaceuticals Corp ORAL ORAL (SEE IMAGE) 2190 DAY Cogentin C Lasix C Isoptin C Premarin C Date:11/27/00ISR Number: 3621511-2Report Type:Periodic Company Report #PHEH2000US07519 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril PS Novartis Professional Pharmaceuticals Corp ORAL 700MG ORAL Date:11/27/00ISR Number: 3621514-8Report Type:Periodic Company Report #PHEH2000US07890 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Health Clozaril PS Novartis Hospitalization - Sudden Death Professional Pharmaceuticals Corp ORAL 200 MG, TID, Initial or Prolonged ORAL M.V.I. C Depakote C Paxil C Pepcid C Peri-Colace C Thiamine C Vitamin C C Insulin C Humalog C Date:11/27/00ISR Number: 3621517-3Report Type:Periodic Company Report #PHEH2000US07929 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Clozaril PS Novartis Professional Pharmaceuticals Corp ORAL ORAL 22-Feb-2006 08:30 AM Page: 919 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/27/00ISR Number: 3621520-3Report Type:Periodic Company Report #PHEH2000US08094 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agranulocytosis Health Clozaril PS Novartis Life-Threatening Cellulitis Professional Pharmaceuticals Corp 400 MG, QHS Other Herpes Simplex Depakote C Leukopenia Mirapex C Date:11/27/00ISR Number: 3621524-0Report Type:Periodic Company Report #PHEH2000US08113 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Level Above Health Clozaril PS Novartis Therapeutic Professional Pharmaceuticals Corp ORAL 200MG AM + Overdose 200MG NOON + 300MG HS, ORAL Zoloft C Klonopin C Zantac C Combivent C Adalate C Date:11/27/00ISR Number: 3621590-2Report Type:Periodic Company Report #PHEH2000US01487 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Clozaril PS Novartis Initial or Prolonged Delusion Professional Pharmaceuticals Corp ORAL 500 MG, ORAL 2912 DAY Hallucination Cogentin C Leukocytosis Haldol C Pruritus Celexa C Rectal Haemorrhage Date:11/27/00ISR Number: 3621593-8Report Type:Periodic Company Report #PHEH2000US01517 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pancreatitis Health Clozaril PS Novartis Professional Pharmaceuticals Corp ORAL 500 MG, OT, ORAL Valproic C Ativan C Tylenol C Prilosec C Hytrin C Date:11/27/00ISR Number: 3621595-1Report Type:Periodic Company Report #PHEH2000US01524 Age:26 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Grand Mal Convulsion Health Clozaril PS Novartis Professional Pharmaceuticals Corp ORAL 500 MG, OT, ORAL Depakote (Valproate Semisodium) Valproate 22-Feb-2006 08:30 AM Page: 920 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Semisodium) SS Date:11/27/00ISR Number: 3621596-3Report Type:Periodic Company Report #PHEH2000US08114 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Grand Mal Convulsion Health Clozaril PS Novartis Initial or Prolonged Professional Pharmaceuticals Corp ORAL 100 MG AM + 300 MG HS, ORAL Zoloft (Sertraline Hydrochloride) C Ddavp (Desmopressin) C Depakote (Valproate Semisodium ) C Colace C Date:11/27/00ISR Number: 3621597-5Report Type:Periodic Company Report #PHEH2000US01612 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Health Clozaril PS Novartis Life-Threatening Professional Pharmaceuticals Corp ORAL 2500 MG, ORAL Clozapine(Clozapine) SS ORAL ORAL Date:11/27/00ISR Number: 3621598-7Report Type:Periodic Company Report #PHEH2000US08145 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril PS Novartis Hospitalization - Professional Pharmaceuticals Corp ORAL 700 MG, ORAL Initial or Prolonged Date:11/27/00ISR Number: 3621599-9Report Type:Periodic Company Report #PHEH2000US01692 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Convulsion Health Clozaril PS Novartis Other Fall Professional Pharmaceuticals Corp ORAL 300 MG, BID, Weight Decreased ORAL Luvox C Anafranil C Vitamin E C Ambien C Klonopin C Maalox C Tylenol C Date:11/27/00ISR Number: 3621600-2Report Type:Periodic Company Report #PHEH2000US01754 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukocytosis Health Clozaril PS Novartis Initial or Prolonged Professional Pharmaceuticals Corp ORAL 800 MG, QD, ORAL Haldol Decanoate C Cogentin C 22-Feb-2006 08:30 AM Page: 921 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/27/00ISR Number: 3621601-4Report Type:Periodic Company Report #PHEH2000US08146 Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Pain Health Clozaril PS Novartis Other Death Professional Pharmaceuticals Corp ORAL 100 MG, BID, Gastroenteritis ORAL Daypro (Oxaprozin) C Norvasc C Cogentin (Benzatropine Mesilate) C Colace C M.V.I (Dexpanthenol, Retinol, Ascorbic Acid) C Date:11/27/00ISR Number: 3621602-6Report Type:Periodic Company Report #PHEH2000US08164 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Health Clozaril PS Novartis Initial or Prolonged Leukopenia Professional Pharmaceuticals Corp ORAL 300 MG, QHS, Pyrexia ORAL Risperdal (Risperidone) SS 35 DAY Trazodone (Trazodone) C Vancenase (Beclometasone Dipropionate) C Atrovent (Ipratropium Bromide) C Nitroglycerin C Aspirin C Vitamin E C Metamucil (Psyllium Hydrophilic Mucilloid) C Dss C Date:11/27/00ISR Number: 3621603-8Report Type:Periodic Company Report #PHEH2000US01824 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Health Clozaril PS Novartis Initial or Prolonged Neutropenia Professional Pharmaceuticals Corp ORAL OT, ORAL Prozac C Buspar C Robinul C Date:11/27/00ISR Number: 3621604-XReport Type:Periodic Company Report #PHEH2000US01903 Age:50 YR Gender:Male I/FU:I Outcome Life-Threatening Hospitalization - Initial or Prolonged 22-Feb-2006 08:30 AM Page: 922 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Disability PT Report Source Product Role Manufacturer Route Dose Duration Agranulocytosis Health Clozaril PS Novartis Pyrexia Professional Pharmaceuticals Corp ORAL OT, ORAL Clozapine (Clozapine)(Clozapin e) SS ORAL OT, ORAL 42 DAY Benzotropine C Amantadine C Sinemet C Date:11/27/00ISR Number: 3621605-1Report Type:Periodic Company Report #PHEH2000US01926 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombocytopenia Health Clozaril PS Novartis Professional Pharmaceuticals Corp ORAL ORAL Risperdal (Risperidone) (Risperidone) SS ORAL 3 MG, BID, ORAL Haldol C Date:11/27/00ISR Number: 3621606-3Report Type:Periodic Company Report #PHEH2000US01189 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fracture Health Clozaril PS Novartis Initial or Prolonged Hyperlipidaemia Professional Pharmaceuticals Corp ORAL 800 MG ORAL; Leukopenia 1000MG ORAL Overdose Pneumonia Date:11/27/00ISR Number: 3621607-5Report Type:Periodic Company Report #PHEH2000US01190 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozaril PS Novartis Hospitalization - Anorexia Professional Pharmaceuticals Corp ORAL 400 MG QD Initial or Prolonged Hyperhidrosis ORAL Weight Decreased Seroquel C Klonopin (Clonazepam) C Neurontin (Gabapentin) C Cogentin (Benzatropine Mesilate) C Date:11/27/00ISR Number: 3621608-7Report Type:Periodic Company Report #PHEH2000US08228 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Clozaril PS Novartis Initial or Prolonged Leukopenia Professional Pharmaceuticals Corp ORAL 125 MG, QHS, Psychotic Disorder ORAL 22-Feb-2006 08:30 AM Page: 923 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Resperdal (Risperidone) C Seroquel (Quetiapine) C Date:11/27/00ISR Number: 3621609-9Report Type:Periodic Company Report #PHEH2000US08229 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Health Clozaril PS Novartis Initial or Prolonged Neutropenia Professional Pharmaceuticals Corp ORAL 200 MG, BID, ORAL Risperdal (Risperidone) C Prozac (Fluoxetine Hydrochloride) C Depakote (Valproate Semisodium) C Date:11/27/00ISR Number: 3621610-5Report Type:Periodic Company Report #PHEH2000US01192 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Dizziness Health Clozaril PS Novartis Hospitalization - Hypotension Professional Pharmaceuticals Corp ORAL 250 MG TID Initial or Prolonged Lethargy ORAL Salivary Hypersecretion Depakote(Valproate Semisodium) C Date:11/27/00ISR Number: 3621611-7Report Type:Periodic Company Report #PHEH2000US08244 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Health Clozaril PS Novartis Life-Threatening Professional Pharmaceuticals Corp ORAL 100 MG AM + 300 MG HS, ORAL; ORAL; 15000 MG ORAL Alcohol (Ethanol) SS 1918 DAY Zyprexa (Olanzapine) C Xanax (Alprazolam) C Prozac (Fluoxetine Hydrochloride) C Ambien (Zolpidem Tartrate) C Haldol C Dexidrine (Dexamfetamine Sulfate) C Synthroid C Premarin (Estrogens Conjugated) C 22-Feb-2006 08:30 AM Page: 924 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/27/00ISR Number: 3621612-9Report Type:Periodic Company Report #PHEH2000US08311 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Clozaril PS Novartis Initial or Prolonged Psychotic Disorder Professional Pharmaceuticals Corp ORAL 600 MG, QHS, Sedation ORAL Risperdal (Risperidone) C Cogentin (Benzatropine Mesilate) C Date:11/27/00ISR Number: 3621613-0Report Type:Periodic Company Report #PHEH2000US08320 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Health Clozaril PS Novartis Initial or Prolonged Neutropenia Professional Pharmaceuticals Corp ORAL 300 MG, ORAL Date:11/27/00ISR Number: 3621614-2Report Type:Periodic Company Report #PHEH2000US08334 Age:97 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril PS Novartis Hospitalization - Professional Pharmaceuticals Corp ORAL 38 MG, ORAL Initial or Prolonged Date:11/27/00ISR Number: 3621615-4Report Type:Periodic Company Report #PHEH2000US01207 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cerebral Artery Health Clozaril PS Novartis Hospitalization - Thrombosis Professional Pharmaceuticals Corp ORAL OT ORAL 1456 DAY Initial or Prolonged Zyprexa (Olanzapine) C Xanax (Alprazolam) C Date:11/27/00ISR Number: 3621616-6Report Type:Periodic Company Report #PHEH2000US01225 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neutropenia Health Clozaril PS Novartis Professional Pharmaceuticals Corp ORAL TITRATING TO 150 MG ORAL Lithium C Inderal (Propanolol Hydrochloride) C Valproic Acid) C Cogentin (Benzatropine Mesilate) C 22-Feb-2006 08:30 AM Page: 925 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/27/00ISR Number: 3621617-8Report Type:Periodic Company Report #PHEH2000US01263 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Deep Vein Thrombosis Health Clozaril PS Novartis Initial or Prolonged Professional Pharmaceuticals Corp ORAL OT ORAL Serzone(Nefazodone Hydrochloride) C Luvox (Fluvoxamine Maleate) C Ditropan (Oxybutynin) C Imipramine C Celexa (Citalopram Hydrobromide) C Date:11/27/00ISR Number: 3621618-XReport Type:Periodic Company Report #PHEH2000US01267 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozaril PS Novartis Hospitalization - Pyrexia Professional Pharmaceuticals Corp ORAL 200 MG QD Initial or Prolonged ORAL Depakote(Valproate Semisodium) C Prilosec (Omeprazole) C Vitamin D (Ergocalciferol) C Axid (Nizatidine) C Date:11/27/00ISR Number: 3621619-1Report Type:Periodic Company Report #PHEH2000US01268 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozaril PS Novartis Professional Pharmaceuticals Corp ORAL 100 MG BID ORAL Depakote (Valproate Semisodium) C Mirapex (Pramipexole Dihydrochloride) C Ativan (Lorazepam) C Date:11/27/00ISR Number: 3621621-XReport Type:Periodic Company Report #PHEH2000US01377 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cognitive Disorder Health Clozaril PS Novartis Initial or Prolonged Confusional State Professional Pharmaceuticals Corp ORAL 150 MG OT Delusional Disorder, ORAL Persecutory Type Verapamil C Vitamin E (Tocopherol) C Fish Oil C Prilosec (Omeprazole) C Temazepam (Temazepam) C 22-Feb-2006 08:30 AM Page: 926 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Klonopin (Clonazepam) C Date:11/27/00ISR Number: 3621623-3Report Type:Periodic Company Report #PHEH2000US01423 Age:18 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Acute Respiratory Health Clozaril PS Novartis Hospitalization - Distress Syndrome Professional Pharmaceuticals Corp ORAL 100 MG BID Initial or Prolonged Leukopenia ORAL Neutropenia Depakote (Valproate Otitis Media Semisodium) C Pneumonia Rispardal Pyrexia (Risperidone) C Cogentin (Benzatropine Mesilate) C Synthroid (Levothyroxine Sodium) C Gemfibrozil C Ddavp (Desmopressin)) C Date:11/27/00ISR Number: 3621807-4Report Type:Periodic Company Report #PHEH2000US00919 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Priapism Health Clozaril PS Novartis Initial or Prolonged Professional Pharmaceuticals Corp ORAL 200 MG BID ORAL 2002 DAY Date:11/27/00ISR Number: 3621810-4Report Type:Periodic Company Report #PHEH2000US00923 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Clozaril PS Novartis Initial or Prolonged Leukopenia Professional Pharmaceuticals Corp ORAL 500 MG ORAL Psychotic Disorder Zyprexa (Olanzapine) (Olanzapine) SS Prozac (Fluoxetine Hydrochloride) C Date:11/27/00ISR Number: 3621839-6Report Type:Periodic Company Report #PHEH2000US00948 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Health Clozaril PS Novartis Professional Pharmaceuticals Corp ORAL 700 MG ORAL Lithium C Klonopin (Clonazepam) C Depakote (Valproate Semisodium) C Congentin (Benzatropine Mesilate) C 22-Feb-2006 08:30 AM Page: 927 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/27/00ISR Number: 3621842-6Report Type:Periodic Company Report #PHEH2000US00951 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Deep Vein Thrombosis Health Clozaril PS Novartis Initial or Prolonged Professional Pharmaceuticals Corp ORAL 600 MG ORAL Luvox (Fluvoxamine Maleate) C Seroquel C Date:11/27/00ISR Number: 3621844-XReport Type:Periodic Company Report #PHEH2000US00998 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Health Clozaril PS Novartis Initial or Prolonged Drug Level Changed Professional Pharmaceuticals Corp ORAL ORAL Other Drug Withdrawal Ativan (Lorazepam) Convulsions (Lorazepam) SS 6 YR Luvox (Fluvoxamine Maleate) C Cardura (Doxazosin Mesilate) C Zantac C Vasotec (Enalapril Maleate) C Date:11/27/00ISR Number: 3621846-3Report Type:Periodic Company Report #PHEH2000US01002 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dysarthria Health Clozaril PS Novartis Initial or Prolonged Hyperglycaemia Professional Pharmaceuticals Corp ORAL 150 MG BID Salivary Hypersecretion ORAL 112 DAY Sedation Voltaren (Diclofenac Weight Increased Sodium) C Lasix (Furosemide) C Diamox (Acetazolamide) C Aldactone (Spironolactone) C Klonopin (Clonazepam) C Date:11/27/00ISR Number: 3621848-7Report Type:Periodic Company Report #PHEH2000US01126 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Convulsion Health Clozaril PS Novartis Hospitalization - Liver Function Test Professional Pharmaceuticals Corp ORAL 500 MG ORAL; Initial or Prolonged Abnormal 300 MG ORAL ; Thrombocytopenia 250 MG ORAL 7 YR Zyprexa (Olanzapine) (Olanzapine) SS 5 MG 11 DAY Trinalin (Congesteze) C Nitrostat (Glyceryl Trinitrate) C Alupent (Orciprenaline 22-Feb-2006 08:30 AM Page: 928 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sulfate) C Tagamet (Cimetidine) C Date:11/27/00ISR Number: 3621850-5Report Type:Periodic Company Report #PHEH2000US01134 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozaril PS Novartis Neutropenia Professional Pharmaceuticals Corp ORAL 125 MG OT ORAL Luvox (Fluvoxamine Maleate) C Seroquel C Lithium C Date:11/27/00ISR Number: 3621852-9Report Type:Periodic Company Report #PHEH2000US01156 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Health Clozaril PS Novartis Initial or Prolonged Hallucination Professional Pharmaceuticals Corp ORAL 500 MG ORAL ; Hypertension 700 MG ORAL 412 MON Tachycardia Clonidine C Prozac (Fluoxetine Hydrochloride) C Date:11/27/00ISR Number: 3621855-4Report Type:Periodic Company Report #PHEH2000US01159 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Clozaril PS Novartis Professional Pharmaceuticals Corp ORAL 300 MG ORAL Depakote (Valproate Semisodium) C Date:11/27/00ISR Number: 3621858-XReport Type:Periodic Company Report #PHEH2000US02858 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pleural Effusion Health Clozaril PS Novartis Initial or Prolonged Professional Pharmaceuticals Corp ORAL ORAL Date:11/27/00ISR Number: 3621860-8Report Type:Periodic Company Report #PHEH2000US02859 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Health Clozaril PS Novartis Initial or Prolonged Professional Pharmaceuticals Corp ORAL 100 MG AM = 300 MG HS. ORAL 762 DAY Depakote (Valproate Semisodium) C Lipitor (Atorvastatin) C Paxil C Reglan (Metoclopramide) C 22-Feb-2006 08:30 AM Page: 929 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Glyburide C Date:11/27/00ISR Number: 3621861-XReport Type:Periodic Company Report #PHEH2000US02873 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril PS Novartis Professional Pharmaceuticals Corp Date:11/27/00ISR Number: 3621863-3Report Type:Periodic Company Report #PHEH2000US02977 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Accidental Overdose Health Clozaril PS Novartis Convulsion Professional Pharmaceuticals Corp ORAL 400 MG UKN, ORAL Date:11/27/00ISR Number: 3621865-7Report Type:Periodic Company Report #PHEH2000US02978 Age:81 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril PS Novartis Professional Pharmaceuticals Corp OCCLUSIVE DRESSING 12.5 MG UNK. ORAL 2920 DAY Date:11/27/00ISR Number: 3621866-9Report Type:Periodic Company Report #PHEH2000US02979 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Health Clozaril PS Novartis Professional Pharmaceuticals Corp ORAL ORAL Paxil SS ORAL Date:11/27/00ISR Number: 3621868-2Report Type:Periodic Company Report #PHEH2000US03011 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril PS Novartis Professional Pharmaceuticals Corp ORAL 200 MG. TID , ORAL Depakote (Valporoateemisodium ) C Haldol Decanoate(Haloperido l Decanoate) C Norvasc C Date:11/27/00ISR Number: 3621870-0Report Type:Periodic Company Report #PHEH2000US03089 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Health Clozaril PS Novartis Initial or Prolonged Congestive Professional Pharmaceuticals Corp ORAL ORAL 22-Feb-2006 08:30 AM Page: 930 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/27/00ISR Number: 3621872-4Report Type:Periodic Company Report #PHEH2000US03091 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Consumer Clozaril PS Novartis Pharmaceuticals Corp ORAL 300 MG AM + 300 MG HS. ORAL Depakote (Valproate Semisodium) C Seroquel (Quetiapine) C Buspirone (Buspirone) C Date:11/27/00ISR Number: 3621874-8Report Type:Periodic Company Report #PHEH2000US03124 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Clozaril PS Novartis Pharmaceuticals Corp ORAL 300 MG UNK, ORAL Date:11/27/00ISR Number: 3621875-XReport Type:Periodic Company Report #PHEH2000US02467 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Dyspnoea Health Clozaril PS Novartis Hospitalization - Myocardial Infarction Professional Pharmaceuticals Corp ORAL 200 MG, OT, Initial or Prolonged Pericarditis ORAL 728 DAY Depakote C Remeron C Cogentin C Ativan C Risperdal C Date:11/27/00ISR Number: 3621876-1Report Type:Periodic Company Report #PHEH2000US02480 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pulmonary Embolism Health Clozaril PS Novartis Professional Pharmaceuticals Corp ORAL ORAL Date:11/27/00ISR Number: 3621878-5Report Type:Periodic Company Report #PHEH2000US02523 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Health Clozaril PS Novartis Initial or Prolonged Condition Aggravated Professional Pharmaceuticals Corp ORAL 25 MG, BID, Hallucination ORAL 224 DAY Liver Function Test Depakote C Abnormal Klonopin C Pancreatitis Zoloft C Psychotic Disorder Prilosec C Suicidal Ideation Magnesium Oxide C 22-Feb-2006 08:30 AM Page: 931 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/27/00ISR Number: 3621879-7Report Type:Periodic Company Report #PHEH2000US02559 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutropenia Health Clozaril PS Novartis Initial or Prolonged Professional Pharmaceuticals Corp ORAL 100 MG, QD, ORAL Haldol C Depakote C Risperdal C Gabapentin C Klonopin C Cogentin C Date:11/27/00ISR Number: 3621881-5Report Type:Periodic Company Report #PHEH2000US02698 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozaril PS Novartis Sudden Death Professional Pharmaceuticals Corp ORAL 300 MG, OT, ORAL Cardizem C Digoxin C Singulair C Cogentin C Celexa C Loxapine C Wellbutrin C Cephalexin C Date:11/27/00ISR Number: 3621882-7Report Type:Periodic Company Report #PHEH2000US02708 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Grand Mal Convulsion Health Clozaril PS Novartis Initial or Prolonged Professional Pharmaceuticals Corp ORAL TITRATION, ORAL Lithium C Buspar C Risperdal C Date:11/27/00ISR Number: 3621883-9Report Type:Periodic Company Report #PHEH2000US02717 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Grand Mal Convulsion Health Clozaril PS Novartis Professional Pharmaceuticals Corp ORAL 100 MG, OT, ORAL 2716 DAY Navane C Depakote C Klonopin C Dilantin C Amantidine C 22-Feb-2006 08:30 AM Page: 932 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/27/00ISR Number: 3621884-0Report Type:Periodic Company Report #PHEH2000US02786 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril PS Novartis Professional Pharmaceuticals Corp ORAL 700 MG, ORAL Date:11/27/00ISR Number: 3621885-2Report Type:Periodic Company Report #PHEH2000US02851 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Health Clozaril PS Novartis Initial or Prolonged Professional Pharmaceuticals Corp ORAL 300 MG, ORAL 1 DAY Zyprexa (Olanzapine) SS 1 DAY Neurontin C Cogentin C Prolixin C Date:11/27/00ISR Number: 3621886-4Report Type:Periodic Company Report #PHEH2000US02852 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril PS Novartis Professional Pharmaceuticals Corp ORAL 100 MG AM +300 MG HS, ORAL Nuerontin C Paxil C Date:11/27/00ISR Number: 3621904-3Report Type:Periodic Company Report #PHEH2000US02225 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Health Clozaril PS Novartis Urinary Tract Infection Professional Pharmaceuticals Corp ORAL 50 MG, BID, ORAL Seroquel (Quetiapine)C C Depakote (Valproate Sodium) C Gabapentin C Tenex (Guanfacine Hydrochloride) C Date:11/27/00ISR Number: 3621906-7Report Type:Periodic Company Report #PHEH2000US02247 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancreatitis Acute Health Clozaril PS Novartis Initial or Prolonged Professional Pharmaceuticals Corp ORAL 100 MG, BID, ORAL Valproic Acid (Valproic Acid) SS ORAL 1000 MG, BID, ORAL Zyprexa (Olanzapine) C Haldol (Haloperidol) C 22-Feb-2006 08:30 AM Page: 933 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/27/00ISR Number: 3621908-0Report Type:Periodic Company Report #PHEH2000US02332 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Health Clozaril PS Novartis Initial or Prolonged Neutropenia Professional Pharmaceuticals Corp ORAL 600 MG, OT, ORAL Notriptyline (Nortriptyline) C Klonopin (Clonazepam) C Navane (Tiotixene) C Ddavp (Desmopressin) C Date:11/27/00ISR Number: 3621909-2Report Type:Periodic Company Report #PHEH2000US02333 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dizziness Health Clozaril PS Novartis Initial or Prolonged Leukopenia Professional Pharmaceuticals Corp ORAL 450 MG, ORAL Malaise Zyprexa (Olanzapine) C Neutropenia Colace (Docusate Sodium) C Multivitamins C Date:11/27/00ISR Number: 3621910-9Report Type:Periodic Company Report #PHEH2000US02388 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Clozaril PS Novartis Initial or Prolonged Professional Pharmaceuticals Corp ORAL 700 MG, OT, ORAL Tegretol (Carbamazepine) C Dilantin (Phenytoin Sodium) C Depakote (Valproate Semisodium) C Klonopin (Clonazepam) C Cogentin (Benzatropine Mesilate) C Cyprogeptadine C Date:11/27/00ISR Number: 3621912-2Report Type:Periodic Company Report #PHEH2000US02398 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancreatitis Acute Health Clozaril PS Novartis Initial or Prolonged Professional Pharmaceuticals Corp ORAL 350 MG, OT, ORAL 14 DAY Valproic Acid (Valproic Acid) SS ORAL 1000 MG, BID, ORAL 112 DAY 22-Feb-2006 08:30 AM Page: 934 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/27/00ISR Number: 3621914-6Report Type:Periodic Company Report #PHEH2000US02399 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pulmonary Embolism Health Clozaril PS Novartis Initial or Prolonged Professional Pharmaceuticals Corp ORAL 50 MG BID + 75 MG HS, ORAL Ventolin Inhaler (Salbutamol) C Cholesterol Lowering Agent (Cholesterol-And-Tri glyceride Reducers) C Coumadin (Warfarin Sodium) C Haldol C Date:11/27/00ISR Number: 3621915-8Report Type:Periodic Company Report #PHEH2000US02443 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Clozaril PS Novartis Initial or Prolonged Overdose Professional Pharmaceuticals Corp ORAL 600 MG, ORAL 1 DAY Deseril (Methysergide) C Lasix (Furosemide) C Zestril (Lisinopril) C Cipro (Ciprofloxacin Hydrochloride) C Augmentin (Clavulin) C Combivent Inhaler (Combivent) C Date:11/27/00ISR Number: 3621918-3Report Type:Periodic Company Report #PHEH2000US02465 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Clozaril PS Novartis Professional Pharmaceuticals Corp ORAL 400 MG, BID, ORAL 644 DAY Lithium C Neurontin (Gabapentin) C Paxil (Paroxetine Hydrochloride) C Date:11/27/00ISR Number: 3621920-1Report Type:Periodic Company Report #PHEH2000US02466 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Clozaril PS Novartis Initial or Prolonged Convulsion Professional Pharmaceuticals Corp ORAL 350 MG, ORAL 728 DAY Psychotic Disorder Anafranil (Clomipramine Hydrochloride) C 22-Feb-2006 08:30 AM Page: 935 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/27/00ISR Number: 3621923-7Report Type:Periodic Company Report #PHEH2000US02009 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Clozaril PS Novartis Initial or Prolonged Hyponatraemia Professional Pharmaceuticals Corp ORAL 350 MG OT ORAL ; 150 MG ORAL 34 MON Paxil (Paroxetine Hydrochloride) C Cogentin (Benzatropine Mesilate) C Neurontin (Gabapentin) C Zyrtec (Cetirizine Hydrochloride) C Ativan (Lorazepam) C Colace (Docusate Sodium) C Asa (Acetylsalicylic Acid) C Proventil (Salbutamol Sulfate) C Date:11/27/00ISR Number: 3621924-9Report Type:Periodic Company Report #PHEH2000US02010 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Grand Mal Convulsion Health Clozaril PS Novartis Hospitalization - Professional Pharmaceuticals Corp ORAL 700 MG OT Initial or Prolonged ORAL Loxitane (Loxapine Succinate) C Amantadine C Colace (Docusate Sodium) C Date:11/27/00ISR Number: 3621926-2Report Type:Periodic Company Report #PHEH2000US02042 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Grand Mal Convulsion Health Clozaril PS Novartis Professional Pharmaceuticals Corp ORAL 375 MG ORAL Neurontin (Gabapentin) C Ativan (Lorazepam) C Vitamin C (Ascorbic Acid) C Oral Contraceptives (Oral Contraceptive Nos) C Date:11/27/00ISR Number: 3621927-4Report Type:Periodic Company Report #PHEH2000US02088 Age:30 YR Gender:Male I/FU:I Outcome Life-Threatening Hospitalization - 22-Feb-2006 08:30 AM Page: 936 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Initial or Prolonged PT Report Source Product Role Manufacturer Route Dose Duration Agranulocytosis Health Clozaril PS Novartis Pyrexia Professional Pharmaceuticals Corp ORAL 100 MG, 5QD, ORAL Xanax (Alprazolam) C Date:11/27/00ISR Number: 3621929-8Report Type:Periodic Company Report #PHEH2000US02093 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Health Clozaril PS Novartis Life-Threatening Professional Pharmaceuticals Corp ORAL 200 MG BID ORAL Ambien (Zolpidem Tartrate) C Effexor Xr (Venlafaxine Hydrochloride) C Artane (Triexyphenidyl Hydrochloride) C Atarax (Hydroxyzine Hydrochloride) C Vistaril (Hydroxyzine Embonate) C Date:11/27/00ISR Number: 3621931-6Report Type:Periodic Company Report #PHEH2000US02113 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Health Clozaril PS Novartis Initial or Prolonged Leukopenia Professional Pharmaceuticals Corp ORAL 300 MG, BID, ORAL Ranitidine C Metoprolol C Levothyroxine C Hydrocortisone Valerate C Date:11/27/00ISR Number: 3621932-8Report Type:Periodic Company Report #PHEH2000US02114 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bipolar Disorder Health Clozaril PS Novartis Initial or Prolonged Neutropenia Professional Pharmaceuticals Corp ORAL 150 MG QD ORAL Zoloft (Sertraline Hydrochloride) C Zyprexa (Olanzapine) C Premarin (Estrogens Conjugated) C Klonopin (Clonazepam) C Depakote (Valproate Semisodium) C 22-Feb-2006 08:30 AM Page: 937 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Ambien (Zolpidem Tartrate) C Depakote (Valproate Semisodium) C Naproxen C Date:11/27/00ISR Number: 3621934-1Report Type:Periodic Company Report #PHEH2000US02122 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Clozaril PS Novartis Professional Pharmaceuticals Corp ORAL 400 MG QD ORAL 637 DAY Depakote (Valproate Semisodium) C Atenolol C Date:11/27/00ISR Number: 3621936-5Report Type:Periodic Company Report #PHEH2000US02152 Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Grand Mal Convulsion Health Clozaril PS Novartis Initial or Prolonged Professional Pharmaceuticals Corp ORAL 300 MG ORAL Seroquel (Quetiapine) C Percocet (Tylox) C Rocephin (Ceftriaxone Sodium) C Date:11/27/00ISR Number: 3621938-9Report Type:Periodic Company Report #PHEH2000US02165 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Clozaril PS Novartis Professional Pharmaceuticals Corp ORAL 150 MG ORAL Date:11/27/00ISR Number: 3621962-6Report Type:Periodic Company Report #PHEH2000US08434 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Clozaril PS Novartis Professional Pharmaceuticals Corp ORAL 750MG/DAY, ORAL Depakote(Valproate Semisodium) C Date:11/27/00ISR Number: 3621965-1Report Type:Periodic Company Report #PHEH2000US08478 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Health Clozaril PS Novartis Initial or Prolonged Dizziness Professional Pharmaceuticals Corp ORAL ORAL Fall Effexor (Venlafxine Leukopenia Hydrochloride) C Lower Limb Fracture 22-Feb-2006 08:30 AM Page: 938 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/27/00ISR Number: 3621966-3Report Type:Periodic Company Report #PHEH2000US08565 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bradycardia Health Clozaril PS Novartis Coma Professional Pharmaceuticals Corp ORAL 200MG AM Embolism +300MG HS Fall ORAL Heart Rate Decreased Paxil C Hypertension Cogentin Malaise (Benzatropine Overdose Mesilate) C Pulmonary Embolism Trazodone (Trazodone) C Haldol C Oral Contraceptive Nos (Oral Contraceptive Nos) C Date:11/27/00ISR Number: 3621969-9Report Type:Periodic Company Report #PHEH2000US08784 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Health Clozaril PS Novartis Initial or Prolonged Confusional State Professional Pharmaceuticals Corp ORAL 100MG AM + Erythema 200MG HS, Face Oedema ORAL Date:11/27/00ISR Number: 3621971-7Report Type:Periodic Company Report #PHEH2000US08805 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Clozaril PS Novartis Professional Pharmaceuticals Corp ORAL 200 MG. BID, ORAL Cogentin (Benzatropine Mesilate) C Depakote (Valproate Semisodium C Fluphenazine (Fluphenazine) C Date:11/27/00ISR Number: 3621974-2Report Type:Periodic Company Report #PHEH2000US08813 Age:71 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril PS Novartis Professional Pharmaceuticals Corp ORAL 25 MG, ORAL Date:11/27/00ISR Number: 3621975-4Report Type:Periodic Company Report #PHEH2000US08917 Age:86 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril PS Novartis Hospitalization - Professional Pharmaceuticals Corp ORAL 37.5 MG, ORAL Initial or Prolonged 22-Feb-2006 08:30 AM Page: 939 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/27/00ISR Number: 3621977-8Report Type:Periodic Company Report #PHEH2000US09071 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Health Clozaril PS Novartis Professional Pharmaceuticals Corp ORAL 1000 MG, QD, ORAL Risperdal(Risperidon e) SS Olanzapine(Olanzapin e) C Date:11/27/00ISR Number: 3621980-8Report Type:Periodic Company Report #PHEH1996US00346 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Leukopenia Health Clozaril PS Novartis Hospitalization - Pharyngolaryngeal Pain Professional Pharmaceuticals Corp ORAL 750 MG, ORAL Initial or Prolonged Pyrexia Klonopin (Clonazepam) C Depakote (Valproate Semisodium) C Haldol (Halopendol) C Date:11/27/00ISR Number: 3622058-XReport Type:Periodic Company Report #PHEH2000US00661 Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Supraventricular Health Clozaril PS Novartis Hospitalization - Tachycardia Professional Pharmaceuticals Corp ORAL OT, ORAL Initial or Prolonged Haldol (Haloperidol) C Cardizem (Diltiazem Hydrochloride) C Ambien (Zolpidem Tartrate) C Date:11/27/00ISR Number: 3622060-8Report Type:Periodic Company Report #PHEH2000US00662 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Health Clozaril PS Novartis Initial or Prolonged Convulsion Professional Pharmaceuticals Corp ORAL OT, ORAL Other Doxycycline (Doxycycline) SS Zoloft C Date:11/27/00ISR Number: 3622062-1Report Type:Periodic Company Report #PHEH2000US00664 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Pulmonary Embolism Health Clozaril PS Novartis Hospitalization - Professional Pharmaceuticals Corp ORAL 500 MG, OT, Initial or Prolonged ORAL Celexa (Citalopram Hydrobromide) SS 4 MON Birth Control Pills (Oral Contraceptive Nos)(Oral 22-Feb-2006 08:30 AM Page: 940 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Contraceptive Nos) SS 4 MON Imipramine C Prolixin Decanoate (Fluphenazine Decanoate) C Amitriptyline C Prilosec (Omeprazole) C Azmacort (Triamcinolone Acetonide) C Albuterol Mdi (Salbutamol) C Date:11/27/00ISR Number: 3622064-5Report Type:Periodic Company Report #PHEH2000US00674 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Pulmonary Embolism Health Clozaril PS Novartis Hospitalization - Professional Pharmaceuticals Corp ORAL 400 MG, BID, Initial or Prolonged ORAL Clozapine (Clozapine) SS ORAL 400 MG, ORAL 168 DAY Proventil (Salbutamol) C Elavil (Amitriptyline Hydrochloride) C Celexa (Citalopram Hydrobromide) C Provigil (Modafinil) C Date:11/27/00ISR Number: 3622066-9Report Type:Periodic Company Report #PHEH2000US00748 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Health Clozaril PS Novartis Initial or Prolonged Professional Pharmaceuticals Corp ORAL 500 MG, ORAL 2548 DAY Ativan (Lorazepam) C Date:11/27/00ISR Number: 3622068-2Report Type:Periodic Company Report #PHEH2000US00753 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Health Clozaril PS Novartis Initial or Prolonged Neutropenia Professional Pharmaceuticals Corp ORAL 400 MG, ORAL Depakote (Valproate Semisodium) (Valproate Semisodium) SS 8 YR Apap (Paracetamol) C Bisacodyl (Bisacodyl) C Risperdal (Risperidone) C Thorazine (Chlorpromazine Hydrochloride) C Klonopin 22-Feb-2006 08:30 AM Page: 941 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Clonazepam) C Depakene (Valproate Sodium) C Date:11/27/00ISR Number: 3622070-0Report Type:Periodic Company Report #PHEH2000US00756 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Health Clozaril PS Novartis Professional Pharmaceuticals Corp ORAL 700 MG, OT, ORAL 1825 DAY Prozac (Fluoxetine Hydrochloride) C Zyprexa (Olanzapine) C Klonopin (Clonazepam) C Clomipramine C Date:11/27/00ISR Number: 3622072-4Report Type:Periodic Company Report #PHEH2000US00805 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Clozaril PS Novartis Initial or Prolonged Fall Professional Pharmaceuticals Corp ORAL SEE IMAGE, Other Fracture ORAL Orthostatic Hypotension Seroquel C Cogentin (Benzatropine Mesilate) C Ativan (Lorazepam) C Depakote (Valproate Semisodium) C Date:11/27/00ISR Number: 3622073-6Report Type:Periodic Company Report #PHEH2000US00837 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abnormal Behaviour Health Clozaril PS Novartis Hospitalization - Convulsion Professional Pharmaceuticals Corp ORAL OT, ORAL Initial or Prolonged Disorientation Lithium Carbonate C Gait Disturbance Buspar (Buspirone Perseveration Hydrochloride) C Tremor Disulfiram C Date:11/27/00ISR Number: 3622075-XReport Type:Periodic Company Report #PHEH2000US00893 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Deep Vein Thrombosis Health Clozaril PS Novartis Hospitalization - Obesity Professional Pharmaceuticals Corp ORAL 325 MG, OT, Initial or Prolonged Pulmonary Embolism ORAL Ortho-Tri-Cyclen (Cilest)(Cilest) SS Lithium C Synthroid (Levothyroxine Sodium) C Wellbutrin 22-Feb-2006 08:30 AM Page: 942 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Amfebutamone Hydrochloride) C Klonopin (Clonazepam) C Date:11/27/00ISR Number: 3622077-3Report Type:Periodic Company Report #PHEH2000US00401 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Fatigue Health Clozaril PS Novartis Hospitalization - Overdose Professional Pharmaceuticals Corp ORAL 400MG ORAL Initial or Prolonged Pneumonia Aspiration Oxybutynin Respiratory Arrest (Oxybutynin) Salivary Hypersecretion (Oxybutynin) SS ORAL ORAL Sedation Navane (Tiotixene) (Tiotixene) SS ORAL ORAL Propranolol(Proprano lol) SS ORAL ORAL Colace (Docusate Sodium) (Docusate Sodium) SS 1 DAY Vitamin E(Tocopherol) SS 1 DAY Lescol (Fluvastatin Sodium) (Fluvastatin Sodium) Unknown SS 1 DAY Lithium C Olanzapine C Date:11/27/00ISR Number: 3622080-3Report Type:Periodic Company Report #PHEH2000US00431 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Health Clozaril PS Novartis Initial or Prolonged Mania Professional Pharmaceuticals Corp ORAL 500 MG, OT, Pyrexia ORAL Klonopin C Neurontin C Date:11/27/00ISR Number: 3622082-7Report Type:Periodic Company Report #PHEH2000US00466 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anorexia Health Clozaril PS Novartis Initial or Prolonged Thrombocytopenia Professional Pharmaceuticals Corp ORAL 400 MG, OT, Weight Decreased ORAL Zoloft C Ativan C Date:11/27/00ISR Number: 3622084-0Report Type:Periodic Company Report #PHEH2000US00467 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthma Health Clozaril PS Novartis Initial or Prolonged Pneumonia Professional Pharmaceuticals Corp ORAL OT, ORAL 280 DAY Celexa (Citalopram Hydrobromide) (Citalopram 22-Feb-2006 08:30 AM Page: 943 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrobromide) SS 10 MON Doxycycline C Date:11/27/00ISR Number: 3622086-4Report Type:Periodic Company Report #PHEH2000US00548 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozaril PS Novartis Hospitalization - Fatigue Professional Pharmaceuticals Corp ORAL 300 MG, ORAL Initial or Prolonged Hypotension Lithium C Lethargy Depakote C Pneumonia Aspiration Tenormin C Pyrexia Cogentin C Respiratory Failure Synthroid C Sepsis Sinemet Cr C Urinary Tract Infection Seroquel C White Blood Cell Count Zyprexa C Thorazine C Date:11/27/00ISR Number: 3622088-8Report Type:Periodic Company Report #PHEH2000US00550 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dizziness Health Clozaril PS Novartis Initial or Prolonged Overdose Professional Pharmaceuticals Corp ORAL ORAL Date:11/27/00ISR Number: 3622089-XReport Type:Periodic Company Report #PHEH2000US00552 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Health Clozaril PS Novartis Professional Pharmaceuticals Corp ORAL 400MG, ORAL 20 DAY Date:11/27/00ISR Number: 3622090-6Report Type:Periodic Company Report #PHEH2000US00559 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Influenza Like Illness Health Clozaril PS Novartis Leukopenia Professional Pharmaceuticals Corp ORAL 300 MG, OT, Neutropenia ORAL Anafranil C Date:11/27/00ISR Number: 3622091-8Report Type:Periodic Company Report #PHEH2000US00605 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pericardial Effusion Health Clozaril PS Novartis Initial or Prolonged Pericarditis Professional Pharmaceuticals Corp ORAL 200 MG, BID, ORAL 364 DAY Paxil C Procardia Xl C Nph Insulin C Glucophage C Risperdal C Lopid C Rezulin C Synthroid C 22-Feb-2006 08:30 AM Page: 944 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/27/00ISR Number: 3622092-XReport Type:Periodic Company Report #PHEH2000US00647 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Health Clozaril PS Novartis Initial or Prolonged Hallucination, Auditory Professional Pharmaceuticals Corp ORAL 300 MG, ORAL 112 DAY Hypothyroidism Zantac C White Blood Cell Count Cogentin C Decreased Lithium C Synthroid C Date:11/27/00ISR Number: 3622096-7Report Type:Periodic Company Report #PHEH2000US00121 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Health Clozaril PS Novartis Professional Pharmaceuticals Corp ORAL 300 MG UNK ORAL Date:11/27/00ISR Number: 3622097-9Report Type:Periodic Company Report #PHEH2000US00145 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Clozaril PS Novartis Initial or Prolonged Psychotic Disorder Professional Pharmaceuticals Corp ORAL 200 MG UNK ORAL 56 DAY Glyburide C Depakote (Valproate Semisodium) C Date:11/27/00ISR Number: 3622099-2Report Type:Periodic Company Report #PHEH2000US00214 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozaril PS Novartis Hospitalization - Lymphocytosis Professional Pharmaceuticals Corp ORAL UNK OT ORAL Initial or Prolonged Depakote (Valproate Semisodium) C Date:11/27/00ISR Number: 3622100-6Report Type:Periodic Company Report #PHEH2000US00247 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Convulsion Health Clozaril PS Novartis Hospitalization - Drug Interaction Professional Pharmaceuticals Corp ORAL 500 MG OT Initial or Prolonged Loss Of Consciousness ORAL 140 DAY Psychotic Disorder Ativan (Lorazepam) Respiratory Distress (Lorazepam) SS INTRAMUSCULAR 1 MG White Blood Cell Count INTRAMUSCULAR Decreased Haldol (Haloperidol) C Date:11/27/00ISR Number: 3622101-8Report Type:Periodic Company Report #PHEH2000US00266 Age:48 YR Gender:Male I/FU:I Outcome Life-Threatening Hospitalization - 22-Feb-2006 08:30 AM Page: 945 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Initial or Prolonged PT Report Source Product Role Manufacturer Route Dose Duration Agranulocytosis Health Clozaril PS Novartis Hyponatraemia Professional Pharmaceuticals Corp ORAL 200 MG BID Lymphopenia ORAL Pneumonia Ativan (Lorazepam) C Pyrexia Zyprexa (Olanzapine) C Paxil (Paroxetine Hydrochloride) C Navane (Tiotixene) C Artane (Trihexyphenidyl Hydrochloride) C Norvasc (Amlodipine Besilate) C Depakote (Valproate Semisodium) C Date:11/27/00ISR Number: 3622103-1Report Type:Periodic Company Report #PHEH2000US00273 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Health Clozaril PS Novartis Initial or Prolonged Thrombocytopenia Professional Pharmaceuticals Corp ORAL UNK, OT, ORAL Date:11/27/00ISR Number: 3622105-5Report Type:Periodic Company Report #PHEH2000US00274 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Health Clozaril PS Novartis Initial or Prolonged Professional Pharmaceuticals Corp ORAL UNK, OT, ORAL Norvasc (Amlodipine Besilate) C Inderal (Propranolol Hydrochloride) C Mellaril (Thioridazine Hydrochloride) C Date:11/27/00ISR Number: 3622107-9Report Type:Periodic Company Report #PHEH2000US00275 Age:2 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Health Clozaril PS Novartis Initial or Prolonged Coordination Abnormal Professional Pharmaceuticals Corp ORAL 100 MG, ORAL Medication Error Moban Sedation (Molindone)(Molindon Sinus Tachycardia e) SS ORAL ORAL Date:11/27/00ISR Number: 3622108-0Report Type:Periodic Company Report #PHEH2000US00295 Age: Gender:Male I/FU:I Outcome PT Hospitalization - Liver Function Test Initial or Prolonged Abnormal Nausea 22-Feb-2006 08:30 AM Page: 946 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Vomiting Report Source Product Role Manufacturer Route Dose Duration Health Clozaril PS Novartis Professional Pharmaceuticals Corp ORAL 350 MG, ORAL Depakote (Valproate Semisodium)(Valproat e Semisodium) SS ORAL 500 MG, TID, ORAL 5 WK Luvox C Dexedrine C Date:11/27/00ISR Number: 3622110-9Report Type:Periodic Company Report #PHEH2000US00337 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozaril PS Novartis Hospitalization - Leukocytosis Professional Pharmaceuticals Corp ORAL OT, ORAL Initial or Prolonged Leukopenia Ativan C Date:11/27/00ISR Number: 3622113-4Report Type:Periodic Company Report #PHEH1999US05544 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Health Clozaril PS Novartis Initial or Prolonged Convulsion Professional Pharmaceuticals Corp ORAL 400 MG, QD, Liver Function Test ORAL 560 DAY Abnormal Depakote (Valproate Pneumonia Semisodium) C Renal Impairment Dilantin (Phenytoin Sodium) C Date:11/27/00ISR Number: 3622114-6Report Type:Periodic Company Report #PHEH1999US05550 Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Health Clozaril PS Novartis Leukopenia Professional Pharmaceuticals Corp ORAL OT, ORAL Neutropenia Levaquin Pneumonia (Levofloxacin)` SS Pyrexia Eskalith (Lithium Carbonate) C Levoxyl (Levoxythyroxine Sodium) C Sular (Nisoldipine) C Colace (Docusate Sodium) C Lactulose C Date:11/27/00ISR Number: 3622116-XReport Type:Periodic Company Report #PHEH1999US05624 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Thrombocytopenia Health Clozaril PS Novartis Professional Pharmaceuticals Corp ORAL 400 MG, ORAL Zyprexa (Olanzapine) C 22-Feb-2006 08:30 AM Page: 947 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Cogentin (Benzatropine Mesilate) C Buspar (Buspirone Hydrochloride) C Date:11/27/00ISR Number: 3622118-3Report Type:Periodic Company Report #PHEH1999US05627 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Health Clozaril PS Novartis Initial or Prolonged Professional Pharmaceuticals Corp ORAL 400 MG, QD, ORAL 112 DAY Date:11/27/00ISR Number: 3622120-1Report Type:Periodic Company Report #PHEH19999US05649 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pleural Effusion Health Clozaril PS Novartis Pneumonia Viral Professional Pharmaceuticals Corp ORAL ORAL Date:11/27/00ISR Number: 3622122-5Report Type:Periodic Company Report #PHEH1999US05653 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diarrhoea Health Clozaril PS Novartis Initial or Prolonged Professional Pharmaceuticals Corp ORAL 300 MG, ORAL 448 DAY Loperamide C Prevacid (Lansoprazole) C Verapamil C Estratest (Estrates Hs) C Feosol (Ferrous Sulfate) C Synthroid (Levothyroxine Sodium) C Flazole C Artane (Trihexyphenidyl Hydrochloride) C Cardizem (Diltiazem Hydrochloride) C Urispas (Flavoxate Hydrochloride) C Date:11/27/00ISR Number: 3622123-7Report Type:Periodic Company Report #PHEH1999US05669 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Clozaril PS Novartis Initial or Prolonged Psychotic Disorder Professional Pharmaceuticals Corp ORAL 25 MG, ORAL 22-Feb-2006 08:30 AM Page: 948 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/27/00ISR Number: 3622125-0Report Type:Periodic Company Report #PHEH1999US05671 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aspartate Health Clozaril PS Novartis Initial or Prolonged Aminotransferase Professional Pharmaceuticals Corp ORAL 150 MG, BID, Increased ORAL Blood Creatine Klonopin Phosphokinase Increased (Clonazepam) C Blood Lactate Anafranil Dehydrogenase Increased (Clomipramine Dermatitis Hydrochloride) C Synthroid (Levothyroxine Sodium) C Date:11/27/00ISR Number: 3622126-2Report Type:Periodic Company Report #PHEH1999US05675 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Health Clozaril PS Novartis Professional Pharmaceuticals Corp ORAL ORAL Date:11/27/00ISR Number: 3622128-6Report Type:Periodic Company Report #PHEH2000US00118 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Health Clozaril PS Novartis Initial or Prolonged Phosphokinase Increased Professional Pharmaceuticals Corp ORAL 400 MG, ORAL Delirium Clozapine Muscle Rigidity (Clozapine) SS ORAL 350 MG, ORAL 3 DAY Pyrexia Depakote (Valproate Semisodium) C Date:11/27/00ISR Number: 3622129-8Report Type:Periodic Company Report #PHEH1999US05353 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Cholesterol Health Clozaril PS Novartis Increased Professional Pharmaceuticals Corp ORAL ORAL Hepatitis Pancreatitis Date:11/27/00ISR Number: 3622131-6Report Type:Periodic Company Report #PHEH1999US05385 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Clozaril PS Novartis Professional Pharmaceuticals Corp ORAL ORAL Date:11/27/00ISR Number: 3622132-8Report Type:Periodic Company Report #PHEH1999US05386 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozaril PS Novartis Other Professional Pharmaceuticals Corp ORAL 250 MG ORAL Lithium Carbonate 22-Feb-2006 08:30 AM Page: 949 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Lithium Carbonate) C Date:11/27/00ISR Number: 3622134-1Report Type:Periodic Company Report #PHEH1999US05417 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pulmonary Embolism Health Clozaril PS Novartis Initial or Prolonged Professional Pharmaceuticals Corp ORAL ORAL Date:11/27/00ISR Number: 3622136-5Report Type:Periodic Company Report #PHEH1999US05430 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pulmonary Embolism Health Clozaril PS Novartis Initial or Prolonged Professional Pharmaceuticals Corp ORAL 275 MG ORAL Date:11/27/00ISR Number: 3622138-9Report Type:Periodic Company Report #PHEH1999US05431 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Health Clozaril PS Novartis Initial or Prolonged Cardiac Fibrillation Professional Pharmaceuticals Corp ORAL 300 MG ORAL Haldol (Haloperidol) C Zyprexa(Olanzapine) C Depakote (Valproate Semisodium) C Cogentin (Benzatropine Mesilate) C Date:11/27/00ISR Number: 3622139-0Report Type:Periodic Company Report #PHEH1999US05491 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukocytosis Health Clozaril PS Novartis Initial or Prolonged Professional Pharmaceuticals Corp ORAL 300 MG QD ORAL 28 DAY Date:11/27/00ISR Number: 3622140-7Report Type:Periodic Company Report #PHEH1999US05494 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Health Clozaril PS Novartis Phosphokinase Increased Professional Pharmaceuticals Corp ORAL ORAL Neuroleptic Malignant Syndrome Date:11/27/00ISR Number: 3622142-0Report Type:Periodic Company Report #PHEH1999US05521 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiac Failure Health Clozaril PS Novartis Other Congestive Professional Pharmaceuticals Corp ORAL 100 MG ORAL Sleep Apnoea Syndrome Paxil (Paroxetine Weight Increased Hydrochloride) C Wellbutrin 22-Feb-2006 08:30 AM Page: 950 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Amfebutamone Hydrochloride) C Lipitor (Atorvastatin) C Amoxicillin Trihydrate) C Lanoxin (Digoxin) C Cozaar (Losartan Potassium) C Furosemide C Glucotrol (Glipizide) C Depakote (Valproate Semisodium) C Date:11/27/00ISR Number: 3622143-2Report Type:Periodic Company Report #PHEH1999US05534 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neutropenia Health Clozaril PS Novartis White Blood Cell Count Professional Pharmaceuticals Corp ORAL 200 MG BID Decreased ORAL Depakote (Valproate Semisodium) C Prolixin (Fluphenazine Hyrdrochloride) C Paxil (Paroxetine Hydrochloride) C Congentin (Benzatropine Mesilate) C Date:11/27/00ISR Number: 3622147-XReport Type:Periodic Company Report #PHEH1999US05104 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Clozaril PS Novartis Initial or Prolonged Delusion Professional Pharmaceuticals Corp ORAL 100 MG, ORAL Delusional Disorder, Luvox (Fluvoxamine Persecutory Type Maleate) C Psychotic Disorder Serzone (Nefazodone Hydrochloride) C Haldol (Haloperidol) C Amantadine C Date:11/27/00ISR Number: 3622149-3Report Type:Periodic Company Report #PHEM1999US05147 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Fluid Retention Health Clozaril PS Novartis Gallbladder Disorder Professional Pharmaceuticals Corp ORAL 350 MG, ORAL Neuroleptic Malignant Lithium C Syndrome Pulmonary Oedema Sudden Death 22-Feb-2006 08:30 AM Page: 951 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/27/00ISR Number: 3622151-1Report Type:Periodic Company Report #PHEH1999US05166 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Psychotic Disorder Health Clozaril PS Novartis Hospitalization - Professional Pharmaceuticals Corp ORAL 1400 MG, ORAL Initial or Prolonged Depakote (Valproate Semisodium) C Date:11/27/00ISR Number: 3622152-3Report Type:Periodic Company Report #PHEH1999US05193 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Clozaril PS Novartis Initial or Prolonged Professional Pharmaceuticals Corp ORAL 300 MG, ORAL 42 DAY Date:11/27/00ISR Number: 3622154-7Report Type:Periodic Company Report #PHEH1999US05202 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukocytosis Health Clozaril PS Novartis Initial or Prolonged Neutrophilia Professional Pharmaceuticals Corp ORAL 800 MG, OT, Pancreatitis ORAL Depakote (Valproate Semisodium) C Haldol (Haloperidol) C Peri-Colace C Demerol (Pethidine Hydrochloride) C Phenergan (Promethazine Hydrochloride) C Date:11/27/00ISR Number: 3622156-0Report Type:Periodic Company Report #PHEH1999US05240 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Small Intestinal Health Clozaril PS Novartis Initial or Prolonged Obstruction Professional Pharmaceuticals Corp ORAL 100 MG, ORAL Dilantin (Phenytoin Sodium) C Lithium C Hydrochlorothiazide C Date:11/27/00ISR Number: 3622160-2Report Type:Periodic Company Report #PHEH1999US05246 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyponatraemia Health Clozaril PS Novartis Initial or Prolonged Professional Pharmaceuticals Corp ORAL UNSPECIFIED, ORAL Benzatropine C Propranolol C Clonidine C Methocarbamol C Pepcid (Famotidine) C Carafate (Sucralfate) C 22-Feb-2006 08:30 AM Page: 952 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Desmopressin Nasal Spray (Desmopressin) C Date:11/27/00ISR Number: 3622162-6Report Type:Periodic Company Report #PHEH1999US05268 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Health Clozaril PS Novartis Initial or Prolonged Professional Pharmaceuticals Corp ORAL 500 MG, ORAL 728 DAY Date:11/27/00ISR Number: 3622163-8Report Type:Periodic Company Report #PHEH1999US05273 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neutropenia Health Clozaril PS Novartis Hospitalization - Pharyngolaryngeal Pain Professional Pharmaceuticals Corp ORAL 200 MG, BID, Initial or Prolonged Tachycardia ORAL Depakote (Valproate Semisodium) C Cepacol (Cetylpyridimium Chloride) C Sudafed (Pseudoephedrine Hydrochloride) C Atenolol C Divalproex (Valproate Semisodium) C Cogentin (Benzatropine Mesilate) C Clonidine C Levaquin (Levofloxacin) C Habitrol (Nicotine) C Benzoyl Peroxide Wash (Benzoyl Peroxide) C Guaifenesin (Guaifenesin) C Date:11/27/00ISR Number: 3622165-1Report Type:Periodic Company Report #PHEH1999US05327 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bronchitis Health Clozaril PS Novartis Initial or Prolonged Overdose Professional Pharmaceuticals Corp ORAL 2000 MG, ORAL Sedation Depakote (Valproate Semisodium) C Benzotropine (Benzatropine Mesilate) C Cefuroxime C Estrogen (Estrogen Nos) C Loxapine C Prednisone C 22-Feb-2006 08:30 AM Page: 953 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Theophylline C Zyban (Bupropion Hci) C Date:11/27/00ISR Number: 3622166-3Report Type:Periodic Company Report #PHEH1999US04723 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Health Clozaril PS Novartis Initial or Prolonged Phosphokinase Increased Professional Pharmaceuticals Corp ORAL ORAL Convulsion Risperdal Hyponatraemia (Risperidone) Pyrexia (Risperidone) SS ORAL 3 MG, ORAL Date:11/27/00ISR Number: 3622167-5Report Type:Periodic Company Report #PHEH1999US04814 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Health Clozaril PS Novartis Initial or Prolonged Neutropenia Professional Pharmaceuticals Corp ORAL 300 MG, ORAL 56 DAY Pyrexia Date:11/27/00ISR Number: 3622169-9Report Type:Periodic Company Report #PHEH1999US04837 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Health Clozaril PS Novartis Initial or Prolonged Pyrexia Professional Pharmaceuticals Corp ORAL OT, ORAL Prozac (Fluoxetine Hydrochloride) C Klonopin (Clonazepam) C Date:11/27/00ISR Number: 3622184-5Report Type:Periodic Company Report #PHEH1999US04862 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Clozaril PS Novartis Initial or Prolonged Enuresis Professional Pharmaceuticals Corp ORAL 800 MG, ORAL Lithium C Paxil (Paroxetine Hydrochloride) C Moban (Molindone) C Risperdal (Risperidone) C Inderal (Propranolol Hydrochloride) C Buspar (Buspirone Hydrochloride) C Cogentin (Benzatropine Besilate) C Vitamin E (Tocoheral) C Ativan (Lorazepam) C 22-Feb-2006 08:30 AM Page: 954 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/27/00ISR Number: 3622185-7Report Type:Periodic Company Report #PHEH1999US04863 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Clozaril PS Novartis Initial or Prolonged Professional Pharmaceuticals Corp ORAL 100 MG, QD, ORAL 98 DAY Maxzide (Dyazide) C Date:11/27/00ISR Number: 3622186-9Report Type:Periodic Company Report #PHEH1999US04960 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophreniform Disorder Health Clozaril PS Novartis Initial or Prolonged Professional Pharmaceuticals Corp ORAL 200 MG, ORAL Risperdal (Risperidone) C Zoloft (Sertraline Hydrochloride) C Date:11/27/00ISR Number: 3622187-0Report Type:Periodic Company Report #PHEH1999US04981 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozaril PS Novartis Hospitalization - Professional Pharmaceuticals Corp ORAL 300 MG, ORAL Initial or Prolonged Depakote (Valproate Semisodium) C Cogentin (Benzatropine Mesilate) C Zyprexa (Olanzapine) C Date:11/27/00ISR Number: 3622188-2Report Type:Periodic Company Report #PHEH1999US05018 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abdominal Pain Health Clozaril PS Novartis Hospitalization - Intestinal Obstruction Professional Pharmaceuticals Corp ORAL 100 MG, BID, Initial or Prolonged Nausea ORAL 2912 DAY Vomiting Zoloft (Sertraline Hydrochloride) C Cogentin (Benzatropine Mesilate) C Ativan (Lorazepam) C Date:11/27/00ISR Number: 3622189-4Report Type:Periodic Company Report #PHEH1999US05071 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Health Clozaril PS Novartis Initial or Prolonged Professional Pharmaceuticals Corp ORAL UNSPECIFIED, ORAL 22-Feb-2006 08:30 AM Page: 955 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/27/00ISR Number: 3622190-0Report Type:Periodic Company Report #PHEH1999US05074 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coma Health Clozaril PS Novartis Hospitalization - Condition Aggravated Professional Pharmaceuticals Corp ORAL 850 MG, OT, Initial or Prolonged Fracture ORAL 546 DAY Grand Mal Convulsion Paxil (Paroxetine Haemorrhage Hydrochloride) C Psychotic Disorder Depakote (Valproate Sedation Semisodium) C Thrombocytopenia Klonopin (Clonazepam) C Lithium Carbonate C Date:11/27/00ISR Number: 3622191-2Report Type:Periodic Company Report #PHEH1999US04466 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pericarditis Health Clozaril PS Novartis Initial or Prolonged Professional Pharmaceuticals Corp ORAL ORAL Date:11/27/00ISR Number: 3622192-4Report Type:Periodic Company Report #PHEH1999US04504 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Health Clozaril PS Novartis Initial or Prolonged Leukopenia Professional Pharmaceuticals Corp ORAL 100 MG, BID, ORAL Lithium C Aricept (Donepezil Hydrochloride) C Date:11/27/00ISR Number: 3622193-6Report Type:Periodic Company Report #PHEH1999US04522 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozaril PS Novartis Hospitalization - Professional Pharmaceuticals Corp ORAL 100 MG, ORAL Initial or Prolonged Date:11/27/00ISR Number: 3622194-8Report Type:Periodic Company Report #PHEH1999US04533 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Constipation Health Clozaril PS Novartis Professional Pharmaceuticals Corp ORAL OT, ORAL 8 DAY Neurontin (Gabapentin) C Luvox (Fluvoxamine Maleate) C Wellbutrin (Amfebutamone Hydrochloride) C Colace (Docusate Sodium) C Metamucil (Psyllium Hydrophilic 22-Feb-2006 08:30 AM Page: 956 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Mucilloid) C Date:11/27/00ISR Number: 3622195-XReport Type:Periodic Company Report #PHEH1999US04534 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Clozaril PS Novartis Overdose Professional Pharmaceuticals Corp ORAL 400 MG, ORAL Date:11/27/00ISR Number: 3622196-1Report Type:Periodic Company Report #PHEH1999US04611 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Clonic Convulsion Health Clozaril PS Novartis Initial or Prolonged Convulsion Professional Pharmaceuticals Corp ORAL 500 MG, ORAL 2184 DAY Other Drug Interaction Luvox (Fluvoxamine Drug Level Changed Maleate)(Fluvoxamine Obsessive-Compulsive Maleate) SS ORAL 150 MG, BID, Disorder ORAL Zyprexa (Olanzapine) C Depakote (Valproate Semisodium) C Lithium C Date:11/27/00ISR Number: 3622197-3Report Type:Periodic Company Report #PHEH1999US04625 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukocytosis Health Clozaril PS Novartis Initial or Prolonged Thrombocythaemia Professional Pharmaceuticals Corp ORAL 300 MG, QD, ORAL Lithium C Seroquel C Date:11/27/00ISR Number: 3622198-5Report Type:Periodic Company Report #PHEH1999US04626 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Clozaril PS Novartis Drug Withdrawal Syndrome Professional Pharmaceuticals Corp ORAL 800 MG, ORAL 364 DAY Tegretol (Carbamazepine)(Carb amazepine) SS Haldol (Haloperidol) C Date:11/27/00ISR Number: 3622199-7Report Type:Periodic Company Report #PHEH1999US04655 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Health Clozaril PS Novartis Initial or Prolonged Professional Pharmaceuticals Corp ORAL 200 MG, BID, Other ORAL Olanzapine C Colace (Docusate Sodium) C 22-Feb-2006 08:30 AM Page: 957 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/27/00ISR Number: 3622200-0Report Type:Periodic Company Report #PHEH1999US04705 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Pancreatitis Health Clozaril PS Novartis Hospitalization - Sepsis Professional Pharmaceuticals Corp ORAL OT, ORAL Initial or Prolonged Haldol (Haloperidol) C Depakote (Valproate Semisodium) C Cogentin (Benzatropine Mesilate) C Date:11/27/00ISR Number: 3622260-7Report Type:Periodic Company Report #PHEH2000US00921 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Retinal Depigmentation Health Clozaril PS Novartis Professional Pharmaceuticals Corp ORAL 125 MG, ORAL 364 DAY Lithium C Estrace (Estradiol) C Provera (Medroxyprogesterone Acetate) C Vitamin E C Date:11/27/00ISR Number: 3622261-9Report Type:Periodic Company Report #PHEH2000US00982 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anaemia Health Clozaril PS Novartis Fall Professional Pharmaceuticals Corp ORAL 700 MG, ORAL Leukocytosis Verapamil C Normochromic Normocytic Haldol (Haloperidol) C Anaemia Multivitamins C Oesophagitis Zyprexa (Olanzapine) C Date:11/27/00ISR Number: 3622262-0Report Type:Periodic Company Report #PHEH2000US01161 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Muscular Weakness Health Clozaril PS Novartis Renal Failure Acute Professional Pharmaceuticals Corp ORAL 450 MG, ORAL 1820 DAY Cardizem Cd (Diltiazem Hydrochloride) C Hydrochlorothiazide C Depakote (Valproate Semisodium) C Lipitor (Atorvastatin) C Lactulose C Miranax (Naproxen Sodium) C 22-Feb-2006 08:30 AM Page: 958 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/27/00ISR Number: 3622263-2Report Type:Periodic Company Report #PHEH2000US01165 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Cardiovascular Disorder Health Clozaril PS Novartis Professional Pharmaceuticals Corp ORAL 150 MG, ORAL 1274 DAY Date:11/27/00ISR Number: 3622264-4Report Type:Periodic Company Report #PHEH2000US01224 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hepatitis Non-A Non-B Health Clozaril PS Novartis Leukopenia Professional Pharmaceuticals Corp ORAL 50 MG, ORAL 280 DAY Prozac (Fluoxetine Hydrochloride) C Lithium C Date:11/27/00ISR Number: 3622265-6Report Type:Periodic Company Report #PHEH2000US01233 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hepatomegaly Health Clozaril PS Novartis Liver Function Test Professional Pharmaceuticals Corp ORAL 500 MG, QD, Abnormal ORAL Pain Depakote (Valproate Psychotic Disorder Semisodium) C Provera (Medroxyprogestereon e Acetate) C Synthroid C Cogentin (Benzatropine Mesilate) C Haldol (Haloperidol) C Date:11/27/00ISR Number: 3622266-8Report Type:Periodic Company Report #PHEH2000US01381 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Depression Health Clozaril PS Novartis Fatigue Professional Pharmaceuticals Corp ORAL 600 MG, ORAL 1274 DAY Haemolytic Anaemia Ambiem (Zolpidem Tremor Tartrate) C Date:11/27/00ISR Number: 3622267-XReport Type:Periodic Company Report #PHEH2000US01429 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Biliary Cirrhosis Health Clozaril PS Novartis Professional Pharmaceuticals Corp ORAL OT, ORAL 84 DAY Date:11/27/00ISR Number: 3622268-1Report Type:Periodic Company Report #PHEH2000US01607 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Health Clozaril PS Novartis Professional Pharmaceuticals Corp ORAL 700 MG, OT, 22-Feb-2006 08:30 AM Page: 959 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL Paxil (Paroxetine Hydrochloride)(Parox etine Hydrochloride) SS ORAL 20 MG, ORAL Lorazepam C Trazodone (Trazodone) C Inderal (Propranolol Hydrochloride) C Date:11/27/00ISR Number: 3622269-3Report Type:Periodic Company Report #PHEH2000US01710 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Lymphopenia Health Clozaril PS Novartis Professional Pharmaceuticals Corp ORAL 150 MG, QD, ORAL Cogentin (Benzatropine Mesilate) C Prozac (Fluoxetine Hydrochloride) C Klonopin (Clonazepam) C Haldol (Haloperidol) C Date:11/27/00ISR Number: 3622927-0Report Type:Periodic Company Report #PHEH1999US03968 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eosinophilia Health Clozaril PS Novartis Neutropenia Professional Pharmaceuticals Corp ORAL 500 MG, OT, Pleural Effusion ORAL Colace (Docusate Sodium) C Depakote (Valproaqte Semisodium) C Ativan (Lorazepam) C Cogentin (Benzatropine Mesilate) C Risperdal (Risperidone) C Atenolol C Hydrochlorothiazide (Hydrochlorothiazide ) C Buspar (Buspirone Hydrochloride) C Date:11/27/00ISR Number: 3622929-4Report Type:Periodic Company Report #PHEH1999US04132 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Health Clozaril PS Novartis Professional Pharmaceuticals Corp ORAL 250 MG, OT, ORAL Seroquel (Seroquel) SS Prozac (Fluoxetine 22-Feb-2006 08:30 AM Page: 960 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride) C Risperdal (Risperidone) C Neurontin (Gabapentin) C Vitamin E (Tocopherol) C Ambien (Zolpidem Tartrate) C Aspirin (Acetylsalicylic Acid) C Niferex (Polysaccharide-Iron Complex) C Vitamin C (Ascorbic Acid) C Date:11/27/00ISR Number: 3622931-2Report Type:Periodic Company Report #PHEH1999US04188 Age:67 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Constipation Health Clozaril PS Novartis Hospitalization - Grand Mal Convulsion Professional Pharmaceuticals Corp ORAL 75 MG BID, Initial or Prolonged Hypokalaemia ORAL Oral Intake Reduced Ascorbic Acid C Colace (Docusate Sodium) C Prempro (Provella-14) C Sucralfate 9sucralfate) C Sodium Biphosphate Enemas C Potassium Chloride C Sorbitol C Date:11/27/00ISR Number: 3622934-8Report Type:Periodic Company Report #PHEH1999US04189 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozaril PS Novartis Hospitalization - Leukopenia Professional Pharmaceuticals Corp ORAL 300 MG, BID, Initial or Prolonged Neutropenia ORAL Date:11/27/00ISR Number: 3622936-1Report Type:Periodic Company Report #PHEH1999US04291 Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Leukopenia Health Clozaril PS Novartis Other Professional Pharmaceuticals Corp ORAL 300 MG, QD, ORAL Ceftin (Cefuroxime Axetil) C Remeron (Mirtazapine) C Augmentin (Clavulin) C Eskalith Cr (Lithium Carbonate) C 22-Feb-2006 08:30 AM Page: 961 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Levoxyl (Levothyroxine Sodium) C Date:11/27/00ISR Number: 3622938-5Report Type:Periodic Company Report #PHEH1999US04329 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Grand Mal Convulsion Health Clozaril PS Novartis Professional Pharmaceuticals Corp ORAL ORAL 196 DAY Depakote (Valproate Semisodium) C Cogentin (Benzatropine Mesilate) C Zyprexa (Olanzapine) C Effexor (Venlafaxine Hydrochloride) C Ativan (Lorazepam) C Vistaril (Hydroxyzine Embonate) C Date:11/27/00ISR Number: 3622940-3Report Type:Periodic Company Report #PHEH1999US04371 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Health Clozaril PS Novartis Initial or Prolonged Agranulocytosis Professional Pharmaceuticals Corp ORAL 125 MG, BID, Other Leukopenia ORAL Myocardial Ischaemia Magnesium C Neutropenia Synthroid Pneumonia (Levothyroxine Staphylococcal Infection Sodium) C Vomiting Colace (Docusate Sodium) C Paxil (Paroxetine Hydrochloride) C Lopressor (Metoprolol Tartrate) C Thiamine C Oscal (Calcium Carbonate) C Date:11/27/00ISR Number: 3622941-5Report Type:Periodic Company Report #PHEH1999US04374 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Lymphopenia Health Clozaril PS Novartis Initial or Prolonged Monocytosis Professional Pharmaceuticals Corp ORAL 150 MG, QD, Pneumonia ORAL 56 DAY Haldol (Haloperidol) C Klonopin (Clonazepam) C Depakote (Valproate Semisodium) C Prozac (Fluoxetine 22-Feb-2006 08:30 AM Page: 962 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride) C Cogentin (Benzatropine Mesilate) C Date:11/27/00ISR Number: 3622942-7Report Type:Periodic Company Report #PHEH1999US04392 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Clozaril PS Novartis Initial or Prolonged Sedation Professional Pharmaceuticals Corp ORAL 350 MG, QD, Other Weight Increased ORAL Depakote (Valproate Semisodium) SS ORAL 350 MG, QD, ORAL Date:11/27/00ISR Number: 3622944-0Report Type:Periodic Company Report #PHEH1999US04459 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozaril PS Novartis Hospitalization - Cardiac Failure Professional Pharmaceuticals Corp ORAL 650 MG, ORAL Initial or Prolonged Condition Aggravated Risperdal Other Leukopenia (Risperidone) SS Neutropenia Lithium C Pharyngolaryngeal Pain Cogentin Psychotic Disorder (Benzatropine Pyrexia Mesilate) C Benztropine (Benzatropine) C Date:11/27/00ISR Number: 3622947-6Report Type:Periodic Company Report #PHEH1999US01050 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Clozaril PS Novartis Initial or Prolonged Tremor Professional Pharmaceuticals Corp ORAL 125 MG ORAL Depakote (Valproate Smisodiumo C Inderal (Propranolol Hydrochloride) C Zyprexa (Olanzapine) C Date:11/27/00ISR Number: 3622950-6Report Type:Periodic Company Report #PHEH1999US02708 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Leukopenia Health Clozaril PS Novartis Neutropenia Professional Pharmaceuticals Corp ORAL 200 MG, BID, ORAL Propranolo C 22-Feb-2006 08:30 AM Page: 963 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/27/00ISR Number: 3622952-XReport Type:Periodic Company Report #PHEH1999US03296 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukocytosis Health Clozaril PS Novartis Initial or Prolonged Neuroleptic Malignant Professional Pharmaceuticals Corp ORAL OT, ORAL Syndrome Depakote (Valproate Pyrexia Semisodium) C Sepsis Cogentin (Benzatropine Mesilate) C Date:11/27/00ISR Number: 3622956-7Report Type:Periodic Company Report #PHEH1999US03338 Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Empyema Health Clozaril PS Novartis Hospitalization - Pleural Effusion Professional Pharmaceuticals Corp ORAL OT, ORAL Initial or Prolonged Pneumonia Zoloft (Sertraline Weight Increased Hydrochloride) C Tylenol With Codeine (Panadeine Co) C Streptokinase C Potassium C Date:11/27/00ISR Number: 3622961-0Report Type:Periodic Company Report #PHEH1999US03367 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozaril PS Novartis Hospitalization - Lymphopenia Professional Pharmaceuticals Corp ORAL 200 MG ORAL Initial or Prolonged Pyrexia Lipitor (Atorvastain) C Thorazine (Chlorpromazine Hydrochloride) C Artane (Trihexyphenidyl Hydrochloride) C Syntgroid (Levothyroxine Sodium) C Risperdal (Risperidone) C Inapsine (Droperidol) C Trazodone C Date:11/27/00ISR Number: 3622963-4Report Type:Periodic Company Report #PHEH1999US03382 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Convulsion Health Clozaril PS Novartis Hospitalization - Professional Pharmaceuticals Corp ORAL 500 MG ORAL 168 DAY Initial or Prolonged Depakote (Valproate Other Semisodium) C Haldol (Haloperidol) C Eskalith (Lithium Carbonate) C 22-Feb-2006 08:30 AM Page: 964 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Cogentin (Benzatropine Mesilate) C Inderal (Propranolol Hydrochloride) C Synthroid (Levothyroxine Sodium) C Date:11/27/00ISR Number: 3622964-6Report Type:Periodic Company Report #PHEH1999US03798 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Convulsion Clozaril PS Novartis Hospitalization - Coordination Abnormal Pharmaceuticals Corp ORAL 450 MG ORAL Initial or Prolonged Disorientation Lithium SS 900 MG 3 MON Fall Risperdal C Leukocytosis Effexor (Venlafaxine Sedation Hydrochloride) C Stupor Lithobid (Lithium Tachycardia Carbonate) C Tremor Depakene (Valproate Sodium) C Tavist (Clemastine Fumarate) C Ddavap (Desmopressin) C Prednisone C Date:11/27/00ISR Number: 3622965-8Report Type:Periodic Company Report #PHEH1999US03856 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Clozaril PS Novartis Initial or Prolonged Professional Pharmaceuticals Corp ORAL 50 MG ORAL Depakote (Valproate Semisodium) C Neurontin (Gabapentin) C Zyprexa (Olanzapine) C Valproic Acid C Tegretol (Carbamazepine) C Date:11/27/00ISR Number: 3622966-XReport Type:Periodic Company Report #PHEH1999US03918 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Convulsion Health Clozaril PS Novartis Hospitalization - Leukocytosis Professional Pharmaceuticals Corp ORAL OT, ORAL 140 DAY Initial or Prolonged Neuroleptic Malignant Genora (Normensal) C Syndrome Mestranol C Sepsis Depakote (Valproate Semisodium) C Cogentin (Benzatropine Mesilate) C Maalox C 22-Feb-2006 08:30 AM Page: 965 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/27/00ISR Number: 3622967-1Report Type:Periodic Company Report #PHEH1999US03940 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozaril PS Novartis Hospitalization - Leukopenia Professional Pharmaceuticals Corp ORAL 500 MG, QD Initial or Prolonged Neutropenia ORAL Date:11/27/00ISR Number: 3623216-0Report Type:Periodic Company Report #PHEH2000US01842 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Ovarian Cyst Health Clozaril PS Novartis Professional Pharmaceuticals Corp ORAL 125 MG, ORAL 392 DAY Date:11/27/00ISR Number: 3623217-2Report Type:Periodic Company Report #PHEH2000US01902 Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Electrocardiogram Qt Health Clozaril PS Novartis Prolonged Professional Pharmaceuticals Corp ORAL 125 MG, ORAL Mellaril (Thioridazine Hydrochloride)(Thior idazine Hydrochloride) SS 500 MG Risperdal (Risperidone) C Date:11/27/00ISR Number: 3623219-6Report Type:Periodic Company Report #PHEH2000US01923 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Rhinorrhoea Other Clozaril PS Novartis Swelling Pharmaceuticals Corp ORAL OT, ORAL 154 DAY Depakote (Valproate Semisodium) C Date:11/27/00ISR Number: 3623221-4Report Type:Periodic Company Report #PHEH2000US02270 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Colitis Health Clozaril PS Novartis Professional Pharmaceuticals Corp ORAL 200 MG, BID, ORAL Risperidone C Date:11/27/00ISR Number: 3623223-8Report Type:Periodic Company Report #PHEH2000US02400 Age:31 YR Gender:Male I/FU:I Outcome PT Blood Alkaline Phosphatase Increased Blood Creatinine Increased Blood Potassium Decreased Hypergammaglobulinaemia 22-Feb-2006 08:30 AM Page: 966 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pco2 Increased Report Source Product Role Manufacturer Route Dose Duration Health Clozaril PS Novartis Professional Pharmaceuticals Corp ORAL 200 MG, BID, ORAL 728 DAY Cogentin (Benzatropine Mesilate) C Date:11/27/00ISR Number: 3623224-XReport Type:Periodic Company Report #PHEH2000US02402 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hypersensitivity Health Clozaril PS Novartis Tachycardia Professional Pharmaceuticals Corp ORAL 350 MG, QD, ORAL 2366 DAY Claritin (Loratadine) C Klonopin (Clonazepam) C Date:11/27/00ISR Number: 3623226-3Report Type:Periodic Company Report #PHEH2000US02524 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tooth Disorder Health Clozaril PS Novartis Professional Pharmaceuticals Corp ORAL 700 MG, ORAL 728 DAY Risperdal (Risperidone) C Paxil (Paroxetine Hydrochloride) C Buspar (Buspirone Hydrochloride) C Date:11/27/00ISR Number: 3623228-7Report Type:Periodic Company Report #PHEH2000US02644 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Basophil Count Increased Health Clozaril PS Novartis Eosinophilia Professional Pharmaceuticals Corp ORAL 25MG AM + Leukocytosis 37.5MG QHS, ORAL Seroquel (Quetiapine) C Haldol (Haloperidol) C Cogentin (Benzatropine Mesilate) C Prinivil (Lisinopril) C Norvasc C Lobetol C 22-Feb-2006 08:30 AM Page: 967 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/27/00ISR Number: 3623229-9Report Type:Periodic Company Report #PHEH2000US02925 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Constipation Health Clozaril PS Novartis Dysgeusia Professional Pharmaceuticals Corp ORAL 12.5 MG, BID, Hyperhidrosis ORAL Aspirin "Bayer" C Date:11/27/00ISR Number: 3623230-5Report Type:Periodic Company Report #PHEH2000US03100 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Asthma Health Clozaril PS Novartis Professional Pharmaceuticals Corp ORAL ORAL Date:11/27/00ISR Number: 3623251-2Report Type:Periodic Company Report #PHEH2000US03122 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Trismus Health Clozaril PS Novartis Professional Pharmaceuticals Corp 500 MG, QHS, Zyrtec C Verapamil C Hyzaar C Date:11/27/00ISR Number: 3623252-4Report Type:Periodic Company Report #PHEH2000US03123 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Gingival Infection Health Clozaril PS Novartis Professional Pharmaceuticals Corp ORAL 700 MG, QHS, ORAL Paxil C Buspar C Risperdal C Date:11/27/00ISR Number: 3623253-6Report Type:Periodic Company Report #PHEH2000US03176 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Differential White Blood Health Clozaril PS Novartis Cell Count Abnormal Professional Pharmaceuticals Corp ORAL 75 MG, QHS, ORAL Doxepin C Tranxene C Ativan C Vicodin C Prilosec C Vioxx C Date:11/27/00ISR Number: 3623254-8Report Type:Periodic Company Report #PHEH2000US03177 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Gait Disturbance Health Clozaril PS Novartis Speech Disorder Professional Pharmaceuticals Corp ORAL 200 MG AM + 22-Feb-2006 08:30 AM Page: 968 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report 300 MG HS, ORAL Dilantin C Atenolol C Lithobid C Hydrochlorothiazide C Date:11/27/00ISR Number: 3623255-XReport Type:Periodic Company Report #PHEH2000US03261 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Glycosuria Health Clozaril PS Novartis Hyperglycaemia Professional Pharmaceuticals Corp ORAL 600 MG, QHS, ORAL Date:11/27/00ISR Number: 3623256-1Report Type:Periodic Company Report #PHEH2000US03265 Age:76 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Prothrombin Time Health Clozaril PS Novartis Shortened Professional Pharmaceuticals Corp ORAL 100 MG, ORAL Coumadine C Date:11/27/00ISR Number: 3623257-3Report Type:Periodic Company Report #PHEH2000US03358 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Accidental Exposure Health Clozaril PS Novartis Professional Pharmaceuticals Corp ORAL 200 MG, ORAL Prolixin C Date:11/27/00ISR Number: 3623258-5Report Type:Periodic Company Report #PHEH2000US03361 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hepatitis C Health Clozaril PS Novartis Salivary Hypersecretion Professional Pharmaceuticals Corp ORAL 200 MG AM + Sedation 300 MG HS, ORAL Neurontin C Lithium C Date:11/27/00ISR Number: 3623259-7Report Type:Periodic Company Report #PHEH2000US08087 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hepatitis C Health Clozaril PS Novartis Professional Pharmaceuticals Corp ORAL 200 MG AM + 100 MG NOON + 300 MG HS, ORAL Prozac C Glipizide C 22-Feb-2006 08:30 AM Page: 969 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/27/00ISR Number: 3623260-3Report Type:Periodic Company Report #PHEH2000US08118 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hepatomegaly Health Clozaril PS Novartis Liver Function Test Professional Pharmaceuticals Corp ORAL 800 MG/DAY, Abnormal ORAL Date:11/27/00ISR Number: 3631224-9Report Type:Periodic Company Report #PHEH2000US00143 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Cataract Health Clozaril PS Novartis Professional Pharmaceuticals Corp ORAL 375 MG QD ORAL Date:11/27/00ISR Number: 3631225-0Report Type:Periodic Company Report #PHEH2000US00301 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Fatigue Health Clozaril PS Novartis Hypoglycaemia Professional Pharmaceuticals Corp ORAL 50 MG QD ORAL Seroquel C Sinemet C Date:11/27/00ISR Number: 3631226-2Report Type:Periodic Company Report #PHEH2000US00501 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Libido Decreased Health Clozaril PS Novartis Professional Pharmaceuticals Corp ORAL ORAL Date:11/27/00ISR Number: 3631227-4Report Type:Periodic Company Report #PHEH2000US00503 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Porphyria Non-Acute Health Clozaril PS Novartis Professional Pharmaceuticals Corp ORAL ORAL Date:11/27/00ISR Number: 3631228-6Report Type:Periodic Company Report #PHEH2000US00549 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Cardiomyopathy Health Clozaril PS Novartis Professional Pharmaceuticals Corp ORAL 300 MG OT ORAL Lithium C Zoloft (Sertraline Hydrochloride) C Date:11/27/00ISR Number: 3631229-8Report Type:Periodic Company Report #PHEH2000US00602 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tooth Disorder Health Clozaril PS Novartis Professional Pharmaceuticals Corp ORAL 400 MG ORAL 2548 DAY 22-Feb-2006 08:30 AM Page: 970 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/27/00ISR Number: 3631230-4Report Type:Periodic Company Report #PHEH2000US00640 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hiatus Hernia Health Clozaril PS Novartis Pregnancy Professional Pharmaceuticals Corp ORAL 500 MG ORAL 1092 DAY Prozac (Fluoxetine Hydrochloride) C Date:11/27/00ISR Number: 3631231-6Report Type:Periodic Company Report #PHEH2000US00641 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hypertension Health Clozaril PS Novartis Oculogyration Professional Pharmaceuticals Corp ORAL OT , ORAL Clozapine (Clozapine) SS ORAL OT, ORAL 56 DAY Atenolol C Date:11/27/00ISR Number: 3631232-8Report Type:Periodic Company Report #PHEH2000US00644 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alopecia Health Clozaril PS Novartis Professional Pharmaceuticals Corp ORAL 400 MG QD ORAL Mellaril (Thioridazine Hydrochloride) (Thioridazine Hydrochloride) C Date:11/27/00ISR Number: 3631233-XReport Type:Periodic Company Report #PHEH2000US00657 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disturbance In Attention Health Clozaril PS Novartis Muscle Contractions Professional Pharmaceuticals Corp ORAL UNSPECIFIED , Involuntary ORAL Date:11/27/00ISR Number: 3631277-8Report Type:Periodic Company Report #PHEH1999US04894 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Asthenia Health Clozaril PS Novartis Leukocytosis Professional Pharmaceuticals Corp ORAL 300 MG, BID, ORAL Lithium C Hytrin C Date:11/27/00ISR Number: 3631278-XReport Type:Periodic Company Report #PHEH1999US04958 Age:17 YR Gender:Male I/FU:I Outcome PT Drooling Hypertension Orthostatic Hypotension 22-Feb-2006 08:30 AM Page: 971 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sedation Sinusitis Tachycardia Report Source Product Role Manufacturer Route Dose Duration Weight Increased Health Clozaril PS Novartis Professional Pharmaceuticals Corp ORAL SEE IMAGE 19 DAY Risperidal C Prozac C Artane C Date:11/27/00ISR Number: 3631279-1Report Type:Periodic Company Report #PHEH1999US04983 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anorexia Health Clozaril PS Novartis Hepatic Steatosis Professional Pharmaceuticals Corp ORAL 50 MG, QD, Hyperglycaemia ORAL Nausea Norvasc C Vomiting Effexor C Weight Decreased Date:11/27/00ISR Number: 3631280-8Report Type:Periodic Company Report #PHEH1999US05065 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Condition Aggravated Health Clozaril PS Novartis Drug Level Below Professional Pharmaceuticals Corp ORAL UNK, OT, ORAL 28 DAY Therapeutic Celexa C Hyperthyroidism Topiramate C Liver Function Test Depakote C Abnormal Doxycycline C Neutropenia Omeprazole C Psychotic Disorder Date:11/27/00ISR Number: 3631281-XReport Type:Periodic Company Report #PHEH1999US05099 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Haematuria Health Clozaril PS Novartis Urinary Tract Infection Professional Pharmaceuticals Corp ORAL 500 MG, UNK, ORAL Date:11/27/00ISR Number: 3631282-1Report Type:Periodic Company Report #PHEH1999US05105 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tooth Discolouration Health Clozaril PS Novartis Professional Pharmaceuticals Corp ORAL 500 MG, UNK, ORAL Date:11/27/00ISR Number: 3631283-3Report Type:Periodic Company Report #PHEH1999US05109 Age:37 YR Gender:Female I/FU:I Outcome PT Arthralgia Dysphagia Otitis Media 22-Feb-2006 08:30 AM Page: 972 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pain Pharyngolaryngeal Pain Salivary Hypersecretion Report Source Product Role Manufacturer Route Dose Duration Health Clozaril PS Novartis Professional Pharmaceuticals Corp ORAL 150 MG, QD, ORAL Date:11/27/00ISR Number: 3631285-7Report Type:Periodic Company Report #PHEH1999US05149 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alcoholism Health Clozaril PS Novartis Professional Pharmaceuticals Corp ORAL 500 MG, UNK, ORAL Wellbutrin C Date:11/27/00ISR Number: 3631286-9Report Type:Periodic Company Report #PHEH1999US05165 Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alopecia Health Clozaril PS Novartis Professional Pharmaceuticals Corp ORAL 50 MG, UNK, ORAL Lipitor C Vitaplex C Humulin C Nasacort C Vitamin E C Arthrotec C Glucophage C Prinivil C Lanoxin C Transderm Nitro C Chlorhexidine C Coumadin C Docusate Sodium C Date:11/27/00ISR Number: 3631288-2Report Type:Periodic Company Report #PHEH1999US05238 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Health Clozaril PS Novartis Anxiety Professional Pharmaceuticals Corp ORAL 650 MG, UNK, Drug Level Changed ORAL 546 DAY Serax C Cogentin C Date:11/27/00ISR Number: 3631295-XReport Type:Periodic Company Report #PHEH1999US01246 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration White Blood Cell Disorder Health Clozaril PS Novartis Professional Pharmaceuticals Corp ORAL 450 MG ORL 22-Feb-2006 08:30 AM Page: 973 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/27/00ISR Number: 3631297-3Report Type:Periodic Company Report #PHEH1999US04458 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anaemia Health Clozaril PS Novartis Drug Level Changed Professional Pharmaceuticals Corp ORAL 450 MG BID Hypotension ORAL Muscular Weakness Depakote (Valproate Tachycardia Semisodium) C Propulsid (Cisapride) C Prevacid (Lansoprazole) C Date:11/27/00ISR Number: 3631299-7Report Type:Periodic Company Report #PHEH1999US04462 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anaemia Health Clozaril PS Novartis Hepatitis Non-A Non-B Professional Pharmaceuticals Corp ORAL 325 MG ORAL Leukopenia Depakote (Valproate Malaise Semisodium) C Neutropenia Luvox (Fluvoxamine Maleate) C Artane (Trihexyphenidyl Hydrochloride) C Intron (Interferon) C Rebatrol C Date:11/27/00ISR Number: 3631300-0Report Type:Periodic Company Report #PHEH1999US04517 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abnormal Behaviour Health Clozaril PS Novartis Anaemia Professional Pharmaceuticals Corp ORAL 600 MG ORAL Drug Level Changed Depakote (Valproate Galactorrhoea Semisodium) C Neurontin (Gabapentin) C Date:11/27/00ISR Number: 3631301-2Report Type:Periodic Company Report #PHEH1999US04537 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Lymphopenia Health Clozaril PS Novartis Professional Pharmaceuticals Corp ORAL ORAL Date:11/27/00ISR Number: 3631302-4Report Type:Periodic Company Report #PHEH1999US04549 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Condition Aggravated Health Clozaril PS Novartis Delusion Professional Pharmaceuticals Corp OT ORAL Dental Caries Ditropan Psychotic Disorder (Oxybutynin) C Sedation Urinary Incontinence 22-Feb-2006 08:30 AM Page: 974 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/27/00ISR Number: 3631303-6Report Type:Periodic Company Report #PHEH1999US04709 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hyperglycaemia Health Clozaril PS Novartis Hypertriglyceridaemia Professional Pharmaceuticals Corp ORAL 400 MG ORAL 1820 DAY Wellbutrin (Amfebutamone Hydrochloride) C Depakote (Valproate Semisodium) C Klonopin (Clorazepam) C Date:11/27/00ISR Number: 3631304-8Report Type:Periodic Company Report #PHEH1999US04771 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hypoglycaemia Health Clozaril PS Novartis Professional Pharmaceuticals Corp ORAL ORAL 2 WK Insulin C Date:11/27/00ISR Number: 3631306-1Report Type:Periodic Company Report #PHEH1999US04805 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Cholesterol Health Clozaril PS Novartis Increased Professional Pharmaceuticals Corp ORAL OT, ORAL Blood Glucose Increased Blood Triglycerides Increased Date:11/27/00ISR Number: 3631308-5Report Type:Periodic Company Report #PHEH1999US04816 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukocytosis Health Clozaril PS Novartis Red Blood Cell Professional Pharmaceuticals Corp ORAL 350 MG ORAL Abnormality Depakote (Valproate Thrombocythaemia Semisodium) C Date:11/27/00ISR Number: 3631309-7Report Type:Periodic Company Report #PHEH2000US08150 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pyrexia Health Clozaril PS Novartis Professional Pharmaceuticals Corp 350 MG, QHS Risperdal (Resperidone) C Inderal C Clozaril (Clozapine) Tablet C 22-Feb-2006 08:30 AM Page: 975 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/27/00ISR Number: 3631312-7Report Type:Periodic Company Report #PHEH2000US08188 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Interaction Health Clozaril PS Novartis Parotid Gland Enlargement Professional Pharmaceuticals Corp ORAL 100 MG AM+300 MG HS, ORAL 730 DAY Lithium(Lithium) SS 751 DAY Zoloft SS 751 DAY Date:11/27/00ISR Number: 3631314-0Report Type:Periodic Company Report #PHEH2000US08316 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Eye Infection Health Clozaril PS Novartis Neutropenia Professional Pharmaceuticals Corp ORAL ORAL Phenobarbital C Prilosec (Omeprazole) C Prozac (Fluoxetine Hydrochloride) C Depakote (Valproate Semisodium) C Date:11/27/00ISR Number: 3631317-6Report Type:Periodic Company Report #PHEH2000US08333 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Unevaluable Event Health Clozaril PS Novartis Professional Pharmaceuticals Corp ORAL ORAL Date:11/27/00ISR Number: 3631318-8Report Type:Periodic Company Report #PHEH2000US08441 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Parotid Gland Enlargement Health Clozaril PS Novartis Professional Pharmaceuticals Corp ORAL 700MG, ORAL Seroquel (Quetiapine) C Wellbutrin (Amfebutamone Hydrochloride) C Depakote (Valproate Semisodium) C Klonopin C Prevacid (Lansoprazole) C Reglan (Metoclopramide) C Zantac C Date:11/27/00ISR Number: 3631319-XReport Type:Periodic Company Report #PHEH2000US08577 Age:29 YR Gender:Male I/FU:I Outcome PT Anorexia Chills Confusional State 22-Feb-2006 08:30 AM Page: 976 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Muscle Rigidity Pyrexia Report Source Product Role Manufacturer Route Dose Duration Health Clozaril PS Novartis Professional Pharmaceuticals Corp ORAL 100MG AM + 200MG HS, ORAL Zoloft (Sertraline Hydrochloride) C Cogentin (Benzatropine Mesilate) C Symmetrel C Zyprexa(Olanzapine) C Date:11/27/00ISR Number: 3631357-7Report Type:Periodic Company Report #PHEH1999US05303 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drooling Health Clozaril PS Novartis Hypercholesterolaemia Professional Pharmaceuticals Corp ORAL 350 MG, UNK, Hypertriglyceridaemia ORAL Sedation Paxil (Paroxetine Hydrochloride) C Haldol (Haloperidol) C Artane (Trihexyphenidyl Hydrochloride) C Risperdal (Risperidone) C Date:11/27/00ISR Number: 3631362-0Report Type:Periodic Company Report #PHEH1999US05445 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abnormal Behaviour Health Clozaril PS Novartis Tremor Professional Pharmaceuticals Corp ORAL 275 MG, OT, ORAL 140 DAY Date:11/27/00ISR Number: 3631363-2Report Type:Periodic Company Report #PHEH1999US05461 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Vaginal Haemorrhage Health Clozaril PS Novartis Professional Pharmaceuticals Corp ORAL 200 MG, UNK, ORAL 84 DAY Prozac (Fluoxetine Hydrochloride) C Date:11/27/00ISR Number: 3631364-4Report Type:Periodic Company Report #PHEH1999US05488 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Mood Swings Health Clozaril PS Novartis Professional Pharmaceuticals Corp ORAL 200 MG, UNK, ORAL 238 DAY 22-Feb-2006 08:30 AM Page: 977 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/27/00ISR Number: 3631365-6Report Type:Periodic Company Report #PHEH1999US05495 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Otitis Media Health Clozaril PS Novartis Professional Pharmaceuticals Corp ORAL UNSPECIFIED, ORAL Ativan (Lorazepam) C Cepastat (Phenol) C Date:11/27/00ISR Number: 3631366-8Report Type:Periodic Company Report #PHEH1999US05542 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Triglycerides Health Clozaril PS Novartis Increased Professional Pharmaceuticals Corp ORAL UNSPECIFIED, ORAL Date:11/27/00ISR Number: 3631367-XReport Type:Periodic Company Report #PHEH1999US05600 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hypercholesterolaemia Health Clozaril PS Novartis Hypertriglyceridaemia Professional Pharmaceuticals Corp ORAL 200 MG, BID, ORAL Lipitor (Atorvastatin) C Lopid (Gemfibrozil) C Benadryl (Diphenhydramine Hydrochloride) C Vasotec (Enalapril Maleate) C Procardia Xl (Nifedipine) C Klonopin (Clonazepam) C Depakene (Valproate Sodium) C Date:11/27/00ISR Number: 3631369-3Report Type:Periodic Company Report #PHEH1999US05632 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alopecia Consumer Clozaril PS Novartis Pharmaceuticals Corp ORAL UNSPECIFIED, ORAL Date:11/27/00ISR Number: 3631371-1Report Type:Periodic Company Report #PHEH1999US05634 Age:80 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Cardiovascular Disorder Health Clozaril PS Novartis Parkinsonism Professional Pharmaceuticals Corp ORAL 32.5 MG, UNK, Renal Failure Acute ORAL 910 DAY 22-Feb-2006 08:30 AM Page: 978 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/27/00ISR Number: 3631376-0Report Type:Periodic Company Report #PHEH1999US05680 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Gastrointestinal Disorder Health Clozaril PS Novartis Professional Pharmaceuticals Corp ORAL 200 MG, UNK, ORAL 112 DAY Neurontin (Gabapentin) C Prozac (Fluoxetine Hydrochloride) C Buspar (Buspirone Hydrochloride) C Prilosec (Omeprazole) C Date:11/28/00ISR Number: 3617971-3Report Type:Expedited (15-DaCompany Report #00-10-0550 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Chronic Lymphocytic Health Clozapine PS Zenith Goldline ORAL 200 MG ORAL Leukaemia Professional Laboratory Test Abnormal Date:11/28/00ISR Number: 3617973-7Report Type:Expedited (15-DaCompany Report #00-09-0467 Age:51 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Clozapine PS Zenith Goldline ORAL 50-200 MG Congestive Professional ORAL Condition Aggravated Tenormin C Coronary Artery Disease Verapamil C Risperdal C Effexor C Hydrochlorothiazide C Date:11/28/00ISR Number: 3617974-9Report Type:Expedited (15-DaCompany Report #00-11-0578 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aneurysm Health Clozapine PS Zenith Goldline ORAL 600 MG ORAL Professional Date:11/28/00ISR Number: 3617976-2Report Type:Expedited (15-DaCompany Report #00-11-0580 Age:79 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 25MG ORAL Professional Date:11/28/00ISR Number: 3618027-6Report Type:Direct Company Report # Age:47 YR Gender:Male I/FU:I Outcome Death Life-Threatening Hospitalization - 22-Feb-2006 08:30 AM Page: 979 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Initial or Prolonged Other PT Report Source Product Role Manufacturer Route Dose Duration Blood Creatine Clozapine 275 Mg/Day PS Phosphokinase Increased Coma Confusional State Neuroleptic Malignant Syndrome Pyrexia Date:11/29/00ISR Number: 3618944-7Report Type:Expedited (15-DaCompany Report #PHFR2000GB01660 Age:34 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Aneurysm Foreign Clozaril PS Novartis Subarachnoid Haemorrhage Health Pharmaceuticals Corp ORAL 300 MG/DAY, Professional ORAL Date:11/29/00ISR Number: 3619021-1Report Type:Expedited (15-DaCompany Report #PHFR2000GB01876 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiac Arrest Foreign Clozaril PS Novartis Hospitalization - Renal Failure Health Pharmaceuticals Corp ORAL ORAL Initial or Prolonged Respiratory Arrest Professional Sepsis Other Date:11/29/00ISR Number: 3620125-8Report Type:Expedited (15-DaCompany Report #PHFR2000GB01715 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Triglycerides Foreign Clozaril PS Novartis Abnormal Health Pharmaceuticals Corp ORAL 150 MG/DAY, Blood Triglycerides Professional ORAL Increased Other Simvastatin C Diabetes Mellitus Metformin Glycosylated Haemoglobin (Metformin) C Increased Hyperglycaemia Date:12/01/00ISR Number: 3620767-XReport Type:Expedited (15-DaCompany Report #PHBS2000NO11327 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Upper Foreign Clozaril PS Novartis Initial or Prolonged Ascites Health Pharmaceuticals Corp ORAL 100 MG, BID, Blood Albumin Abnormal Professional ORAL Hepatic Function Abnormal Other Liver Function Test Abnormal Nephrotic Syndrome Oedema Pericardial Disease Pericardial Effusion Pyrexia Sepsis 22-Feb-2006 08:30 AM Page: 980 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/01/00ISR Number: 3620821-2Report Type:Expedited (15-DaCompany Report #PHEH2000US10809 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asthma Health Clozaril PS Novartis Injury Asphyxiation Professional Pharmaceuticals Corp ORAL 300 MG, QD, Medication Error ORAL Diazepam C Vistaril (Hydroxyzine Embonate) C Date:12/01/00ISR Number: 3620866-2Report Type:Expedited (15-DaCompany Report #PHFR2000GB01714 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril PS Novartis Health Pharmaceuticals Corp ORAL 200 MG/MANE & Professional 400 MG/NOCTE, Other ORAL Metformin C Gliclazide C Senna C Sertraline C Human Mixtard C Date:12/01/00ISR Number: 3620920-5Report Type:Expedited (15-DaCompany Report #PHBS2000AU11427 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Endocarditis Bacterial Foreign Clozaril PS Novartis Study Pharmaceuticals Corp ORAL 300 MG/D ORAL Health Professional Other Date:12/01/00ISR Number: 3621429-5Report Type:Expedited (15-DaCompany Report #PHBS2000AU10935 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Cardiomegaly Foreign Clozaril PS Novartis Cardiomyopathy Health Pharmaceuticals Corp ORAL 300 MG QD Mitral Valve Incompetence Professional ORAL Pericardial Effusion Other Lithium Carbonate C Date:12/01/00ISR Number: 3621466-0Report Type:Expedited (15-DaCompany Report #PHBS2000AU01938 Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hypertrophic Obstructive Foreign Clozaril PS Novartis Cardiomyopathy Health Pharmaceuticals Corp ORAL 500 MG/D, Professional ORAL Other Amtriptyline (Amitriptyline) C Diazepam (Diazepam) C 22-Feb-2006 08:30 AM Page: 981 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/01/00ISR Number: 3621495-7Report Type:Expedited (15-DaCompany Report #PHBS2000AU11221 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiomyopathy Foreign Clozaril PS Novartis Initial or Prolonged Catatonia Health Pharmaceuticals Corp ORAL 300 MG/D, Ejection Fraction Professional ORAL Abnormal Other Myocarditis Paranoia Date:12/04/00ISR Number: 3621626-9Report Type:Expedited (15-DaCompany Report #PHEH2000US10928 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Clozaril PS Novartis Congestive Professional Pharmaceuticals Corp ORAL 800MG, ORAL Date:12/04/00ISR Number: 3621628-2Report Type:Expedited (15-DaCompany Report #PHEH2000US10792 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Ejection Fraction Health Clozaril PS Novartis Abnormal Professional Pharmaceuticals Corp ORAL 250 MG, BID, ORAL Date:12/04/00ISR Number: 3621638-5Report Type:Expedited (15-DaCompany Report #PHEH2000US10877 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Haemolytic Anaemia Health Clozaril PS Novartis Initial or Prolonged Professional Pharmaceuticals Corp ORAL 12.5 MG, BID, ORAL Sinemet (Levodopa, Carbidopa) C Nifedipine C Ecotrin C Sorbitol C Tylenol (Paracetamol) C Date:12/04/00ISR Number: 3621873-6Report Type:Expedited (15-DaCompany Report #PHEH2000US09161 Age:47 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Cancer Stage Iv Health Clozaril PS Novartis Leukopenia Professional Pharmaceuticals Corp ORAL 300 MG, TID, Metastases To Bone ORAL Zyprexa (Olanzapine) C Cogentin (Benzatropine Mesilate) C Clozaril C 22-Feb-2006 08:30 AM Page: 982 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/04/00ISR Number: 3621970-5Report Type:Expedited (15-DaCompany Report #PHBS2000CA10282 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Foreign Clozaril PS Novartis Initial or Prolonged Influenza Like Illness Study Pharmaceuticals Corp ORAL 350 MG/DAY, Ketoacidosis Health ORAL Professional Fluoxetine Other (Fluoxetine) C Date:12/04/00ISR Number: 3622404-7Report Type:Expedited (15-DaCompany Report #WAES 00115577 Age:69 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dyspnoea Foreign Stromectol PS Merck Research Hospitalization - Electroencephalogram Health Laboratories Div Initial or Prolonged Abnormal Professional Merck Co Inc ORAL 1 DAY Medication Error Clozapine SS 100 MG 1 DAY Myocardial Infarction Date:12/05/00ISR Number: 3621762-7Report Type:Direct Company Report # Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Constipation Clozapine PS ORAL 500MG PO BID Decreased Appetite Metamucil C Dyspepsia Maalox C Hyperglycaemia Inderal C Nausea Multivitamin C Date:12/05/00ISR Number: 3621769-XReport Type:Direct Company Report # Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperglycaemia Clozaril PS ORAL 550 MG PO Antibuse C Depakote C Prozac C Lithium Carbonate C ... C Revia C Tagamet C Date:12/05/00ISR Number: 3621776-7Report Type:Direct Company Report # Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Clozapine PS 300MG HS Confusional State Seroquel SS 10MG HS Dysarthria Depakote C Gait Disturbance Lamocatil C Hyperglycaemia Lipitor C Memory Impairment Norvase C Tremor Inderal C Urinary Incontinence Vistaril C Vomiting Zoloft C Vasotec C 22-Feb-2006 08:30 AM Page: 983 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/05/00ISR Number: 3622648-4Report Type:Expedited (15-DaCompany Report #PHFR2000GB01966 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril PS Novartis Health Pharmaceuticals Corp ORAL 200 MG, BID, Professional ORAL Other Nitrazepam C Date:12/05/00ISR Number: 3622778-7Report Type:Expedited (15-DaCompany Report #PHBS2000AU11423 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiomyopathy Foreign Clozaril PS Novartis Health Pharmaceuticals Corp ORAL 600 MG, QD, Professional ORAL Other Paroxetine (Paroxetine) C Clonazepam C Date:12/06/00ISR Number: 3622701-5Report Type:Expedited (15-DaCompany Report #00-11-0596 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 100-350 MG, Professional QD, ORAL Date:12/06/00ISR Number: 3622702-7Report Type:Expedited (15-DaCompany Report #00-11-0597 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 100 MG, QD, Professional ORAL Date:12/06/00ISR Number: 3622704-0Report Type:Expedited (15-DaCompany Report #00-11-0598 Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 200-500 MG, Professional QD, ORAL Date:12/06/00ISR Number: 3622705-2Report Type:Expedited (15-DaCompany Report #00-11-0591 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Health Clozapine PS Zenith Goldline ORAL 350-450 MG, Professional QD, ORAL Date:12/06/00ISR Number: 3622707-6Report Type:Expedited (15-DaCompany Report #00-11-0588 Age:76 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 12.5 MG-300 Professional MG, ORAL 22-Feb-2006 08:30 AM Page: 984 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/06/00ISR Number: 3622709-XReport Type:Expedited (15-DaCompany Report #00-11-0589 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 250-325 MG, Professional QD, ORAL Date:12/06/00ISR Number: 3622712-XReport Type:Expedited (15-DaCompany Report #00-11-0583 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neoplasm Malignant Health Clozapine PS Zenith Goldline ORAL 100-400 MG, Professional QD, ORAL Date:12/06/00ISR Number: 3622725-8Report Type:Expedited (15-DaCompany Report #00-11-0587 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Lung Neoplasm Malignant Health Clozapine PS Zenith Goldline ORAL 500 MG QD Professional ORAL Date:12/06/00ISR Number: 3622726-XReport Type:Expedited (15-DaCompany Report #00-10-0551 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Carcinoma Cell Type Health Clozapine PS Zenith Goldline ORAL 400-850MG Life-Threatening Unspecified Stage Iv Professional ORAL Metastases To Central Nervous System Metastases To Liver Weight Decreased White Blood Cell Count Increased Date:12/06/00ISR Number: 3622728-3Report Type:Expedited (15-DaCompany Report #00-10-0551 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Weight Decreased Health Clozapine PS Zenith Goldline ORAL 400-850MG Life-Threatening White Blood Cell Count Professional ORAL Increased Effexor Xr C Effexor Xr C Guaifenesin La C Morphine C Promethazine C Ultram C Tobramycin Opth Soln C Prevacid C Allegra C Zithromax 2-Pak C Albuterol C Flonase Nasal Spray C Ambien C Pseudoephedrine C Acetaminophen C Metamucil C Depakote C Docusate Calcium C 22-Feb-2006 08:30 AM Page: 985 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Multivitamins And Iron C Ranitidine C Date:12/06/00ISR Number: 3622729-5Report Type:Expedited (15-DaCompany Report #00-11-0560 Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Appendicitis Perforated Health Clozapine PS Zenith Goldline ORAL 150-275MG Initial or Prolonged Professional ORAL Lithium C Zyprexa C Prozac C Vistaril C Ativan C Date:12/07/00ISR Number: 3624746-8Report Type:Expedited (15-DaCompany Report #PHBS2000BR11474 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonitis Foreign Clozaril PS Novartis Initial or Prolonged Renal Failure Acute Health Pharmaceuticals Corp ORAL 100 MG, TID, Viral Infection Professional ORAL Other Date:12/07/00ISR Number: 3624748-1Report Type:Expedited (15-DaCompany Report #PHBS2000CA10783 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Distension Foreign Clozaril PS Novartis Initial or Prolonged Constipation Study Pharmaceuticals Corp ORAL SEE IMAGE 358 DAY Decreased Appetite Health Epival C Dyspepsia Professional Metamucil C Gastrointestinal Injury Other Ileus Paralytic Intestinal Obstruction Megacolon Date:12/07/00ISR Number: 3625071-1Report Type:Expedited (15-DaCompany Report #PHFR2000GB01993 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abdominal Abscess Foreign Clozaril PS Novartis Hospitalization - Appendicitis Perforated Health Pharmaceuticals Corp ORAL 650 MG /DAY, Initial or Prolonged Peritonitis Professional ORAL Other Lithium Carbonate C Citalopram (Citalopram) C Date:12/08/00ISR Number: 3625585-4Report Type:Expedited (15-DaCompany Report #PHBS2000AU10761 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Other Condition Aggravated Foreign Obsessive-Compulsive Health Disorder Professional 22-Feb-2006 08:30 AM Page: 986 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Product Role Manufacturer Route Dose Duration Clozaril PS Novartis Pharmaceuticals Corp ORAL ORAL Date:12/11/00ISR Number: 3626816-7Report Type:Expedited (15-DaCompany Report #PHEH2000US03356 Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Health Clozaril PS Novartis Life-Threatening Fall Professional Pharmaceuticals Corp ORAL 600 MG, ORAL Hospitalization - Hepatic Failure Wellbutrin (Amfebut Initial or Prolonged Intestinal Ischaemia Hydrochloride) C Zestril (Lisinopril) C Colace C Norvas C Date:12/11/00ISR Number: 3626817-9Report Type:Expedited (15-DaCompany Report #PHEH2000US10583 Age:52 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Lung Neoplasm Malignant Clozaril PS Novartis Other White Blood Cell Count Pharmaceuticals Corp ORAL 350 MG, QHS, Decreased ORAL Chemotherapy C Ddavp (Demopressin) C Risperdal (Risperidone) C Trazodone (Trazodone) C Topamax (Topiramaate) C Date:12/11/00ISR Number: 3626898-2Report Type:Expedited (15-DaCompany Report #PHFR2000IE01990 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Ventricular Extrasystoles Foreign Clozaril PS Novartis Health Pharmaceuticals Corp ORAL 25 MG/DAY Professional ORAL Other Date:12/12/00ISR Number: 3627515-8Report Type:Expedited (15-DaCompany Report #PHEH2000US07983 Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hodgkin'S Disease Health Clozaril PS Novartis Leukopenia Professional Pharmaceuticals Corp ORAL ORAL Neutropenia Clozapine SS ORAL ORAL 22-Feb-2006 08:30 AM Page: 987 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/13/00ISR Number: 3627802-3Report Type:Direct Company Report # Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eye Irritation Clozapine Tabs Po Face Oedema 25mg & 100mg PS 150MG AM & Pruritus 200MG HS Rash Maculo-Papular Date:12/13/00ISR Number: 3628960-7Report Type:Expedited (15-DaCompany Report #PHBS2000GB01774 Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Constipation Foreign Clozaril PS Novartis Initial or Prolonged Dysuria Health Pharmaceuticals Corp ORAL UP TO Orchidectomy Professional 700MG/DAY, Testicular Pain Other ORAL Urinary Incontinence Stelazine Urinary Retention (Trifluoperazine Hydrochloride) C Date:12/13/00ISR Number: 3629509-5Report Type:Expedited (15-DaCompany Report #PHFR2000GB01729 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Arrhythmia Foreign Clozaril PS Novartis Hospitalization - Coma Health Pharmaceuticals Corp ORAL 600MG/DAY Initial or Prolonged Convulsion Professional ORAL Hypokalaemia Other Alcohol (Ethanol) SS 769 DAY Hypotension Procyclidine(Procycl Overdose idine) SS 769 DAY Date:12/13/00ISR Number: 3629511-3Report Type:Expedited (15-DaCompany Report #PHFR2000GB02023 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiomyopathy Foreign Clozaril PS Novartis Initial or Prolonged Health Pharmaceuticals Corp ORAL 500MG/DAY Professional ORAL Other Date:12/13/00ISR Number: 3629512-5Report Type:Expedited (15-DaCompany Report #PHFR2000GB02027 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiomegaly Foreign Clozaril PS Novartis Initial or Prolonged Cardiomyopathy Health Pharmaceuticals Corp ORAL 500MG/DAY Professional ORAL Other Date:12/13/00ISR Number: 3629514-9Report Type:Expedited (15-DaCompany Report #PHNU2000DE02294 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Other Diabetes Mellitus Foreign Tachycardia Health Weight Increased Professional 22-Feb-2006 08:30 AM Page: 988 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Company Representative Product Role Manufacturer Route Dose Duration Clozaril PS Novartis Pharmaceuticals Corp ORAL ORAL Tavor C Beloc Mite C Date:12/13/00ISR Number: 3629520-4Report Type:Expedited (15-DaCompany Report #PHNU2000DE02291 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Foreign Clozaril PS Novartis Initial or Prolonged Congestive Health Pharmaceuticals Corp ORAL ORAL Congestive Cardiomyopathy Professional Other Date:12/14/00ISR Number: 3630233-3Report Type:Expedited (15-DaCompany Report #PHFR2000GB01686 Age:33 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Foreign Clozaril PS Novartis Initial or Prolonged Health Pharmaceuticals Corp ORAL ORAL Other Professional Metformin C Other Date:12/14/00ISR Number: 3630235-7Report Type:Expedited (15-DaCompany Report #PHBS2000AU11020 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Clozaril PS Novartis Initial or Prolonged Phosphokinase Increased Health Pharmaceuticals Corp ORAL 250 MG/ DAY, Cardiomegaly Professional ORAL Leukocytosis Other Medication Error Mitral Valve Disease Date:12/14/00ISR Number: 3630238-2Report Type:Expedited (15-DaCompany Report #PHNU2000DE01760 Age:34 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alveolitis Foreign Clozaril PS Novartis Initial or Prolonged Body Temperature Health Pharmaceuticals Corp ORAL ORAL Increased Professional Antibiotics C Drug Level Changed Other Eosinophilia Leukocytosis Neutrophilia Pneumonia Date:12/14/00ISR Number: 3630286-2Report Type:Expedited (15-DaCompany Report #C2000-1851.01 Age:91 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Other Clozapine PS Mylan Pharmaceuticals Inc 22-Feb-2006 08:30 AM Page: 989 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/14/00ISR Number: 3630294-1Report Type:Expedited (15-DaCompany Report #C2000-1850.01 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Other Clozapine PS Mylan Pharmaceuticals Inc Date:12/14/00ISR Number: 3630402-2Report Type:Expedited (15-DaCompany Report #PHBS2000AR11875 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Distension Foreign Clozaril PS Novartis Abdominal Tenderness Consumer Pharmaceuticals Corp ORAL Agranulocytosis Other Cardio-Respiratory Arrest Coma Confusional State Depressed Level Of Consciousness Hepatic Failure Hyperglycaemia Overdose Renal Failure Tachycardia Upper Respiratory Tract Infection Date:12/15/00ISR Number: 3631697-1Report Type:Expedited (15-DaCompany Report #PHEH2000US11197 Age:84 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hypertension Health Clozaril PS Novartis Professional Pharmaceuticals Corp ORAL 75 MG, ORAL Date:12/15/00ISR Number: 3631716-2Report Type:Expedited (15-DaCompany Report #PHBS2000DE03970 Age:79 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dermatitis Foreign Clozaril PS Novartis Health Pharmaceuticals Corp ORAL 12.5 MG, ORAL Professional Verapamil (Verapamil) C Madopar (Madopar) C Antiparkin (Selegiline Hydrochloride) C Adumbran (Oxazepam) C Date:12/15/00ISR Number: 3631718-6Report Type:Expedited (15-DaCompany Report #PHFR2000GB01306 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acute Abdomen Foreign Clozaril PS Novartis Initial or Prolonged Appendicitis Health Pharmaceuticals Corp ORAL 350 MG/DAY, Other Convulsion Professional ORAL Megacolon 22-Feb-2006 08:30 AM Page: 990 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/18/00ISR Number: 3632953-3Report Type:Expedited (15-DaCompany Report #NSADSS2000002064 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutrophil Count Health Risperdal(2 Mg Decreased Professional Tablet) (Risperidone) PS Janssen Research Fdn Div Johnson And Johnson ORAL 2 MG, 2 IN 2 DAY(S), ORAL Clozapine(Clozapine) SS ORAL ORAL Depakote(Valproate Semisodium) SS ORAL ORAL Date:12/18/00ISR Number: 3633019-9Report Type:Expedited (15-DaCompany Report #A036863 Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypotension Health Vistaril PS Pfizer Laboratories Initial or Prolonged Tachycardia Professional Div Pfizer Inc ORAL 75.00 MG Required TOTAL: TID: Intervention to ORAL Prevent Permanent Clozapine SS ORAL 500.00 MG Impairment/Damage TOTAL: BID: ORAL Imipramine SS ORAL 50.00 MG TOTAL: DAILY: ORAL Depakote SS 1750.00 MG TOTAL: TID Date:12/18/00ISR Number: 3633040-0Report Type:Expedited (15-DaCompany Report #PHEH2000US09071 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozaril PS Novartis Electrocardiogram Qt Professional Pharmaceuticals Corp ORAL 1000 MG, QD, Prolonged ORAL Overdose Serentil (Mesoridazine) SS Risperdal (Risperidone) SS Olanzapine (Olanzapine) SS Date:12/18/00ISR Number: 3633045-XReport Type:Expedited (15-DaCompany Report #PHBS2000US11770 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Literature Clozaril PS Novartis Initial or Prolonged Aggression Health Pharmaceuticals Corp 125 MG, BID; Agitation Professional 150 MG, BID; Delusion 325 MG/D Hypervigilance Insomnia Logorrhoea Male Sexual Dysfunction Pneumonia 22-Feb-2006 08:30 AM Page: 991 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/18/00ISR Number: 3633264-2Report Type:Expedited (15-DaCompany Report #PHBS2000AU10241 Age:21 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Foreign Clozaril PS Novartis Health Pharmaceuticals Corp UNKNOWN 100 MG QD Professional UNKNOWN Other Heroin (Diamorphine) SS UNKNOWN UNKNOWN Date:12/18/00ISR Number: 3633334-9Report Type:Expedited (15-DaCompany Report #PHBS2000AU09171 Age:38 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril PS Novartis Non-Insulin-Dependent Health Pharmaceuticals Corp ORAL ORAL Hepatic Steatosis Professional Efexor Er Hypertriglyceridaemia Other (Venlafaxine Liver Function Test Hydrochloride) C Desipramine (Desipramine) C Date:12/18/00ISR Number: 3633466-5Report Type:Expedited (15-DaCompany Report #PHFR2000GB01804 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alcohol Poisoning Foreign Clozaril PS Novartis Initial or Prolonged Circulatory Collapse Health Pharmaceuticals Corp ORAL 375 MG/DAY, Diabetes Mellitus Professional ORAL Fall Other Propranolol C Cipramil C Date:12/18/00ISR Number: 3633491-4Report Type:Expedited (15-DaCompany Report #PHBS2000CA10688 Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Foreign Clozaril PS Novartis Haematuria Study Pharmaceuticals Corp ORAL 500 MG/D, Health ORAL Professional Ativan C Other Date:12/19/00ISR Number: 3633871-7Report Type:Expedited (15-DaCompany Report #00-10-0558 Age:76 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine PS Zenith Goldline ORAL 12.5-50MG Renal Failure Professional ORAL Permax C Date:12/19/00ISR Number: 3633873-0Report Type:Expedited (15-DaCompany Report #00-03-0320 Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - No Adverse Drug Effect Health Clozapine PS Zenith Goldline ORAL 25-175 MG Initial or Prolonged Professional ORAL 22-Feb-2006 08:30 AM Page: 992 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/19/00ISR Number: 3633875-4Report Type:Expedited (15-DaCompany Report #00-10-0542 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anxiety Health Clozapine PS Zenith Goldline ORAL 125MG ORAL Asthma Professional Aerobid C Albuterol C Clonazepam C Date:12/19/00ISR Number: 3633890-0Report Type:Expedited (15-DaCompany Report #00-11-0588 Age:76 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 12.5 Professional MG-300MG, ORAL Date:12/19/00ISR Number: 3633891-2Report Type:Expedited (15-DaCompany Report #00-11-0587 Age:42 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Lung Neoplasm Malignant Health Clozapine PS Zenith Goldline ORAL 500 MG QD Professional ORAL Risperdal C Atenolol C Timoptic-Xe C Axid C Erythromycin Ophthalmic Ointment C Date:12/19/00ISR Number: 3633892-4Report Type:Expedited (15-DaCompany Report #00-11-0588 Age:76 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neoplasm Malignant Health Clozapine PS Zenith Goldline ORAL 12.5 MG - 300 Hospitalization - Vomiting Professional MG, ORAL Initial or Prolonged Weight Decreased Synthroid C Lithium Carbonate C Pepcid C Date:12/19/00ISR Number: 3633893-6Report Type:Expedited (15-DaCompany Report #00-12-0620 Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 75-150MG, Professional ORAL Date:12/19/00ISR Number: 3633895-XReport Type:Expedited (15-DaCompany Report #00-12-0622 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 100-700MG QD Professional ORAL 22-Feb-2006 08:30 AM Page: 993 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/19/00ISR Number: 3633896-1Report Type:Expedited (15-DaCompany Report #00-12-0619 Age:78 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Prostate Cancer Health Clozapine PS Zenith Goldline ORAL 25-50MG QD Professional ORAL Date:12/19/00ISR Number: 3633897-3Report Type:Expedited (15-DaCompany Report #00-12-0623 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Renal Failure Health Clozapine PS Zenith Goldline ORAL 225-525MG QD Professional ORAL Depakote C Zoloft C Date:12/19/00ISR Number: 3634388-6Report Type:Expedited (15-DaCompany Report #PHBS2000AR03205 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Foreign Clozaril PS Novartis Hospitalization - Cardio-Respiratory Arrest Health Pharmaceuticals Corp ORAL 300 MG, ORAL Initial or Prolonged Hyperhidrosis Professional Tegretol 400 Lc Injury Company (Carbamazepine)(Carb Tonic Convulsion Representative amazepine) SS ORAL 600 MG/DAY, Other ORAL 90 DAY Diazepam C Date:12/19/00ISR Number: 3634389-8Report Type:Expedited (15-DaCompany Report #PHFR2000GB00487 Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abdominal Distension Foreign Clozaril PS Novartis Other Acidosis Health Pharmaceuticals Corp ORAL 600 MG/DAY, Atrioventricular Block Professional ORAL 49 DAY Complete Other Cardiac Arrest Constipation Dehydration Heart Rate Increased Hypotension Lower Respiratory Tract Infection Date:12/20/00ISR Number: 3634726-4Report Type:Expedited (15-DaCompany Report #00-11-0591 Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Health Clozapine PS Zenith Goldline ORAL 350-450MG QD Professional ORAL Synthroid C Eskalith - Slow Release C Atenolol C 22-Feb-2006 08:30 AM Page: 994 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/20/00ISR Number: 3634728-8Report Type:Expedited (15-DaCompany Report #00-12-0626 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 25-62.5MG Professional ORAL Date:12/21/00ISR Number: 3634641-6Report Type:Direct Company Report # Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Pain Clozapine 100mg PS ORAL PO 100MG PO Anxiety 300MG Cardiomyopathy Sucralfate C Genital Pain Clonazepam C Hallucination, Auditory Haloperidol C Headache Trazodone C Sudden Death Prednisone C Multivitamin C Albuterol Inhaler C Impratopium Inhaler C Date:12/21/00ISR Number: 3635677-1Report Type:Expedited (15-DaCompany Report #PHEH2000US10809 Age:44 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asthma Health Clozaril PS Novartis Injury Asphyxiation Professional Pharmaceuticals Corp ORAL 300 MG, QD, Medication Error ORAL Diazepam C Vistaril (Hydroxyzine Embonate) C Date:12/21/00ISR Number: 3635687-4Report Type:Expedited (15-DaCompany Report #PHBS2000AU09831 Age:54 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Body Temperature Foreign Clozaril PS Novartis Initial or Prolonged Increased Study Pharmaceuticals Corp ORAL 200 MG/D, Cardiomyopathy Health ORAL Circulatory Collapse Professional Confusional State Other Cough Date:12/21/00ISR Number: 3635724-7Report Type:Expedited (15-DaCompany Report #PHRM2000FR01831 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Foreign Clozaril PS Novartis Initial or Prolonged Intentional Overdose Health Pharmaceuticals Corp ORAL ORAL, 1800 Suicide Attempt Professional MG, Other ONCE/SINGLE, ORAL Zyprexa (Olanzapine) Tablet SS ORAL 200 MG, ONCE/SINGLE, ORAL 22-Feb-2006 08:30 AM Page: 995 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/21/00ISR Number: 3635758-2Report Type:Expedited (15-DaCompany Report #PHNU2000DE02340 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperthermia Malignant Foreign Clozaril PS Novartis Initial or Prolonged Health Pharmaceuticals Corp ORAL ORAL Professional Seroquel Company (Quetiapine) C Representative Other Date:12/21/00ISR Number: 3635761-2Report Type:Expedited (15-DaCompany Report #PHBS2000AU03259 Age:63 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Clozaril PS Novartis Circulatory Collapse Health Pharmaceuticals Corp ORAL 450 MG/DAY, Professional ORAL Luvox (Fluvoxamine Maleate C Date:12/21/00ISR Number: 3635784-3Report Type:Expedited (15-DaCompany Report #PHBS2000CA12055 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Renal Failure Foreign Clozaril PS Novartis Health Pharmaceuticals Corp Professional Other Date:12/21/00ISR Number: 3635787-9Report Type:Expedited (15-DaCompany Report #PHFR2000GB01966 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril PS Novartis Non-Insulin-Dependent Health Pharmaceuticals Corp ORAL 150 MG, BID, Professional ORAL Other Nitrazepam C Date:12/21/00ISR Number: 3635790-9Report Type:Expedited (15-DaCompany Report #PHBS2000AU04205 Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dialysis Foreign Clozaril PS Novartis Initial or Prolonged Malaise Health Pharmaceuticals Corp ORAL 700 MG/D, Required Pancytopenia Professional ORAL Intervention to Renal Failure Other Amitriptyline Prevent Permanent Sepsis (Amitriptyline) C Impairment/Damage Clonazepam C Date:12/21/00ISR Number: 3635844-7Report Type:Expedited (15-DaCompany Report #PHEH2000US11326 Age:8 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Health Clozaril PS Novartis Initial or Prolonged Intracranial Aneurysm Professional Pharmaceuticals Corp 22-Feb-2006 08:30 AM Page: 996 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/22/00ISR Number: 3635546-7Report Type:Direct Company Report # Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Hepatic Failure Clozaril PS ORAL ORAL Hepatitis Prevacid C Prozac C Date:12/26/00ISR Number: 3635877-0Report Type:Direct Company Report # Age:76 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutrophil Count Clozapine-(100mg Tab Initial or Prolonged Decreased Zenith Goldline) PS Zenith Goldline ORAL 100MG BID PO White Blood Cell Count Decreased Date:12/26/00ISR Number: 3637982-1Report Type:Expedited (15-DaCompany Report #PHBS2000AU03422 Age:29 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Foreign Clozaril PS Novartis Completed Suicide Health Pharmaceuticals Corp ORAL 400 MG/D, Overdose Professional ORAL Pulmonary Embolism Other Tricyclics Weight Increased (Tricyclic Antidepressants) SS 3 YR Luvox (Fluovoxamine Maleate) C Largactil (Chlorpromazine Hydrochloride) C Luelen C Date:12/26/00ISR Number: 3638134-1Report Type:Expedited (15-DaCompany Report #PHEH2000US03098 Age:79 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hip Arthroplasty Health Clozaril PS Novartis Initial or Prolonged Pneumonia Professional Pharmaceuticals Corp ORAL 150 MG, QHS, Post Procedural ORAL Complication Prolixin (Fluphenazine Hydrochloride) C Cogentin (Benzatropine Mesilate) C Date:12/26/00ISR Number: 3638135-3Report Type:Expedited (15-DaCompany Report #PHEH2000US11460 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Clozaril PS Novartis Professional Pharmaceuticals Corp ORAL 25 MG, ORAL 22-Feb-2006 08:30 AM Page: 997 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/26/00ISR Number: 3638415-1Report Type:Expedited (15-DaCompany Report #PHEH2000US11584 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Non-Hodgkin'S Lymphoma Health Clozaril PS Novartis Professional Pharmaceuticals Corp ORAL 900MG UNK, ORAL Date:12/26/00ISR Number: 3638416-3Report Type:Expedited (15-DaCompany Report #PHEH2000US10877 Age:80 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Health Clozaril PS Novartis Initial or Prolonged Condition Aggravated Professional Pharmaceuticals Corp ORAL 12.5 MG, BID, Haemolytic Anaemia ORAL Sinemet (Levodopa, Carbidopa) C Nifedipine C Estrace C Ecotrin C Sorbitol C Tylenol (Paracetamol) C Date:12/26/00ISR Number: 3638419-9Report Type:Expedited (15-DaCompany Report #PHEH2000US03098 Age:79 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Health Clozaril PS Novartis Initial or Prolonged Post Procedural Professional Pharmaceuticals Corp ORAL 150 MG, QHS, Complication ORAL Prolixin (Fluphenazine Hydrochloride) C Cogentin (Benzatropine Mesilate) C Date:12/26/00ISR Number: 3639222-6Report Type:Expedited (15-DaCompany Report #PHFR2000GB02159 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Foreign Clozaril PS Novartis Initial or Prolonged Insulin-Dependent Health Pharmaceuticals Corp ORAL 375MG/DAY,ORA Professional L Date:12/26/00ISR Number: 3639223-8Report Type:Expedited (15-DaCompany Report #PHRM2000FR01889 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chronic Lymphocytic Foreign Clozaril PS Novartis Leukaemia Health Pharmaceuticals Corp ORAL 900 Professional MG/DAY,ORAL Tercian(Cyamemazine) C 22-Feb-2006 08:30 AM Page: 998 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/26/00ISR Number: 3639318-9Report Type:Expedited (15-DaCompany Report #PHBS2000IL12012 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Foreign Clozaril PS Novartis Initial or Prolonged Agitation Literature Pharmaceuticals Corp 600 MG DAY 3 MON Confusional State Health Drug Effect Decreased Professional Drug Withdrawal Syndrome Other Psychotic Disorder Salivary Hypersecretion Sedation Suicidal Ideation Date:12/26/00ISR Number: 3639320-7Report Type:Expedited (15-DaCompany Report #PHBS2000IL12011 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Foreign Clozaril PS Novartis Initial or Prolonged Cholinergic Syndrome Literature Pharmaceuticals Corp 425 MG DAY 4 MON Condition Aggravated Health Haloperidol C Drug Withdrawal Syndrome Professional Intentional Self-Injury Medication Error Psychotic Disorder Suicidal Ideation Tachycardia Date:12/26/00ISR Number: 3639387-6Report Type:Expedited (15-DaCompany Report #PHBS2000NZ04263 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Circulatory Collapse Foreign Clozaril PS Novartis Conjunctival Haemorrhage Health Pharmaceuticals Corp ORAL 150 MG/DAY, Diarrhoea Professional ORAL Drug Level Below Other Temazepam SS 876 DAY Therapeutic Haemorrhage Polydipsia Polyuria Vomiting Date:12/26/00ISR Number: 3639421-3Report Type:Expedited (15-DaCompany Report #PHBS2000GB12019 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agoraphobia Foreign Clozaril PS Novartis Anxiety Literature Pharmaceuticals Corp 400 MG/D, 20 WK Chest Discomfort Health Dizziness Professional Fear Other Panic Disorder Sinus Tachycardia 22-Feb-2006 08:30 AM Page: 999 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/26/00ISR Number: 3640133-0Report Type:Expedited (15-DaCompany Report #PHBS2000CA11972 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Foreign Clozaril PS Novartis Clonic Convulsion Health Pharmaceuticals Corp Muscle Rigidity Professional Pyrexia Other Self Mutilation Date:12/26/00ISR Number: 3640136-6Report Type:Expedited (15-DaCompany Report #PHFR1997GB00440 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiac Failure Foreign Clozaril PS Novartis Drug Interaction Health Pharmaceuticals Corp ORAL ORAL Drug Level Above Professional Venlafaxine Therapeutic Other (Venlafaxine) SS 100 - 200 MG Oedema DAILY, UNK Tachycardia Date:12/26/00ISR Number: 3643220-6Report Type:Periodic Company Report #WAES 00100858 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Level Above Health Vioxx PS Merck Research Therapeutic Professional Laboratories Div Merck Co Inc ORAL PO Clozapine SS Date:12/28/00ISR Number: 3638064-5Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Clozaril 25 Mg Initial or Prolonged Phosphokinase Increased Novartis PS Novartis ORAL 75 MG BID Blood Pressure Increased ORAL Body Temperature Wellbutrin Sr C Increased Cyproheptadine C Delirium Remeron C Heart Rate Increased Cogentin C Hypotension Claritin C White Blood Cell Count Haldol C Increased Lorazepam C Date:12/28/00ISR Number: 3638075-XReport Type:Direct Company Report # Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Neutrophil Count Clozaril Novartis PS Novartis ORAL 300 MG PO Q Intervention to Decreased 12 HR Prevent Permanent White Blood Cell Count Levothyroxine C Impairment/Damage Decreased Ranitidine C Metoprolol C 22-Feb-2006 08:30 AM Page: 1000 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/29/00ISR Number: 3638995-6Report Type:Expedited (15-DaCompany Report #C2000-1906.01 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Ruptured Cerebral Other Clozapine PS Mylan Aneurysm Pharmaceuticals Inc Date:12/29/00ISR Number: 3639461-4Report Type:Periodic Company Report #00-08-0415 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Health Clozapine PS Zenith Goldline ORAL ORAL Initial or Prolonged Fatigue Professional Seroquel C Hypotension Haldol C Tachycardia Date:12/29/00ISR Number: 3639462-6Report Type:Periodic Company Report #00-08-0420 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozapine PS Zenith Goldline ORAL 600-800 MG Professional ORAL Taxotere Injectable SS INTRAVENOUS Q WEEK INTRAVENOUS Neurontin C Senokot C Docusate C Date:12/29/00ISR Number: 3639465-1Report Type:Periodic Company Report #00-08-0425 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Clozapine PS ORAL 200-500 MG Initial or Prolonged Hyponatraemia Professional ORAL Pneumonia Zoloft C Buspar C Cogentin C Date:12/29/00ISR Number: 3639467-5Report Type:Periodic Company Report #00-08-0428 Age:97 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine PS Zenith Goldline ORAL 12.5 MG ORAL Professional Date:12/29/00ISR Number: 3639469-9Report Type:Periodic Company Report #00-09-0427 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cystitis Health Clozapine PS Zenith Goldline ORAL ORAL Initial or Prolonged Kidney Infection Professional Leukocytosis 22-Feb-2006 08:30 AM Page: 1001 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/29/00ISR Number: 3639470-5Report Type:Periodic Company Report #00-09-0429 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Embolism Health Clozapine PS Zenith Goldline ORAL 350-500 MG Professional ORAL Docusate Sodium C Luvox C Milk Of Magnesia C Bactroban Ointment C Effexor C Etodolac C Benztropine Mesylate C Risperdal C Acetaminophen W/Hydrocodone Bitartrate C Beepen-Vk C Date:12/29/00ISR Number: 3639472-9Report Type:Periodic Company Report #00-09-0468 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Health Clozapine PS Zenith Goldline ORAL ORAL Initial or Prolonged Professional Date:12/29/00ISR Number: 3639474-2Report Type:Periodic Company Report #00-09-0470 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Health Clozapine PS Zenith Goldline ORAL 25-350 MG Initial or Prolonged Professional ORAL Cyclophosphamide SS Doxorubicin SS Vincristine SS Prednisone SS Date:12/29/00ISR Number: 3639476-6Report Type:Periodic Company Report #00-09-0476 Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Parkinson'S Disease Health Clozapine PS Zenith Goldline ORAL 12.5 MG ORAL Professional Date:12/29/00ISR Number: 3639477-8Report Type:Periodic Company Report #00-09-0477 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Acute Respiratory Health Clozapine PS Zenith Goldline ORAL 25-400 MG Required Distress Syndrome Professional ORAL Intervention to Agranulocytosis Haldol C Prevent Permanent Sepsis Seroquel C Impairment/Damage Small Intestinal Vitamin E C Obstruction Tylenol C Maalox C Milk Of Magnesia C 22-Feb-2006 08:30 AM Page: 1002 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/29/00ISR Number: 3639478-XReport Type:Periodic Company Report #00-09-0482 Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Respiratory Health Clozapine PS Zenith Goldline ORAL 50 MG ORAL Distress Syndrome Professional Wellbutrin Sr C Myocardial Infarction Neurontin C Guaifenesin C Asa C Combivent C Hydroxyzine C Date:12/29/00ISR Number: 3639479-1Report Type:Periodic Company Report #00-09-0483 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Thrombocytopenia Health Clozapine PS Zenith Goldline ORAL 400MG ORAL Professional Date:12/29/00ISR Number: 3639480-8Report Type:Periodic Company Report #00-09-0484 Age:74 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dementia Health Clozapine PS Zenith Goldline ORAL 12.5-250MG Professional ORAL Sinemet Cr C Coumadin C Dilantin C Date:12/29/00ISR Number: 3639482-1Report Type:Periodic Company Report #00-08-0487 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozapine PS Zenith Goldline ORAL 150-200MG Hospitalization - Ecchymosis Professional ORAL Initial or Prolonged Pyrexia Mitoxantrone SS Sepsis Etoposide No Dose Staphylococcal Infection Form SS INTRAVENOUS INTRAVENOUS Thrombocytopenia Date:12/29/00ISR Number: 3639483-3Report Type:Periodic Company Report #00-09-0488 Age:74 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Eosinophilia Health Clozapine PS Zenith Goldline ORAL 50MG ORAL 6 MON Professional Acetaminophen C Bisacodyl C Levodopa-Carbidopa C Cyanocobalamin C Depakote C Dovonex Cream C Lorazepam C Prevacid C Promethazine C Darvocet-N 1-2 Q C Prozac C Risperdal C Vitamin C C 22-Feb-2006 08:30 AM Page: 1003 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Zyrtec C Date:12/29/00ISR Number: 3639485-7Report Type:Periodic Company Report #00-09-0492 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine PS Zenith Goldline 500 MG Professional Date:12/29/00ISR Number: 3639487-0Report Type:Periodic Company Report #00-09-0500 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intestinal Obstruction Health Clozapine PS Zenith Goldline ORAL 700MG ORAL Initial or Prolonged Professional Docusate Sodium C Date:12/29/00ISR Number: 3639488-2Report Type:Periodic Company Report #00-09-0504 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucination Health Clozapine PS Zenith Goldline ORAL 200MG ORAL Initial or Prolonged Professional Ativan C Risperdal C Depakote C Atenolol C Cogentin C Zyprexa C Date:12/29/00ISR Number: 3639489-4Report Type:Periodic Company Report #00-09-0505 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Condition Aggravated Health Clozapine PS Zenith Goldline ORAL 400MG ORAL Hospitalization - Psychotic Disorder Professional Seroquel C Initial or Prolonged White Blood Cell Count Pepcid C Decreased Date:12/29/00ISR Number: 3639490-0Report Type:Periodic Company Report #00-10-0507 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pulmonary Embolism Health Clozapine PS Zenith Goldline ORAL 600MG ORAL Professional Asprin C Vitamin C C Depakote C Sorbitol C Nasacort C Ditropan C Tums C Haldol C Ativan C Lorazepam C Lisinopril C Cipro C Milk Of Magnesia C Dulcolax C 22-Feb-2006 08:30 AM Page: 1004 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/29/00ISR Number: 3639491-2Report Type:Periodic Company Report #00-10-0508 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Health Clozapine PS Zenith Goldline ORAL 400-500 MG Initial or Prolonged Professional ORAL Date:12/29/00ISR Number: 3639492-4Report Type:Periodic Company Report #00-10-0514 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Aspiration Health Clozapine PS Zenith Goldline ORAL 50-200MG ORAL Professional Date:12/29/00ISR Number: 3639493-6Report Type:Periodic Company Report #00-10-0517 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Gastrointestinal Ulcer Health Clozapine PS Zenith Goldline ORAL 100MG ORAL Professional Date:12/29/00ISR Number: 3639494-8Report Type:Periodic Company Report #00-10-0518 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Peptic Ulcer Perforation Health Clozapine PS Zenith Goldline ORAL 100-150 MG Professional ORAL Date:12/29/00ISR Number: 3639505-XReport Type:Periodic Company Report #00-10-0519 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Urticaria Health Clozapine PS Zenith Goldline ORAL 350-700MG Initial or Prolonged Professional ORAL Celexa C Clonazepam C Date:12/29/00ISR Number: 3639507-3Report Type:Periodic Company Report #00-10-0524 Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Parkinson'S Disease Health Clozapine PS Zenith Goldline ORAL 150 MG ORAL Professional Date:12/29/00ISR Number: 3639508-5Report Type:Periodic Company Report #00-10-0528 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Epilepsy Health Clozapine PS Zenith Goldline ORAL ORAL Professional Neurontin C Trileptal C 22-Feb-2006 08:30 AM Page: 1005 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/29/00ISR Number: 3639510-3Report Type:Periodic Company Report #00-10-0529 Age:91 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine PS Zenith Goldline ORAL ORAL Professional Date:12/29/00ISR Number: 3639511-5Report Type:Periodic Company Report #00-10-0538 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Tardive Dyskinesia Clozapine PS Zenith Goldline ORAL ORAL Initial or Prolonged Celexa Tablets SS ORAL ORAL Date:12/29/00ISR Number: 3639513-9Report Type:Periodic Company Report #00-10-0541 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Health Clozapine PS Zenith Goldline ORAL 600MG ORAL Initial or Prolonged Sepsis Professional Zyprexa C Cogentin C Date:12/29/00ISR Number: 3639516-4Report Type:Periodic Company Report #00-10-0544 Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Extrapyramidal Disorder Health Clozapine PS Zenith Goldline ORAL 100 MG ORAL Malnutrition Professional Date:12/29/00ISR Number: 3639517-6Report Type:Periodic Company Report #00-10-0552 Age:76 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Health Clozapine PS Zenith Goldline ORAL 100-200 MG Initial or Prolonged Professional ORAL Prilosec C Lanoxin C Zoloft C Synthroid C K-Dur C Lasix C Valproic Acid C Cytomel C Aspirin C Date:12/29/00ISR Number: 3639518-8Report Type:Periodic Company Report #00-10-0555 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Parkinson'S Disease Health Clozapine PS Zenith Goldline ORAL 25 MG ORAL Professional 22-Feb-2006 08:30 AM Page: 1006 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/29/00ISR Number: 3639520-6Report Type:Periodic Company Report #00-11-0556 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine PS Zenith Goldline ORAL 100-400MG Professional ORAL Date:12/29/00ISR Number: 3639521-8Report Type:Periodic Company Report #00-10-0557 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dementia Health Clozapine PS Zenith Goldline ORAL 18.7-50MG Professional ORAL Date:12/29/00ISR Number: 3639523-1Report Type:Periodic Company Report #00-11-0561 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Respiratory Distress Health Clozapine PS Zenith Goldline ORAL ORAL Professional Date:12/29/00ISR Number: 3639525-5Report Type:Periodic Company Report #00-11-0563 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Parkinson'S Disease Health Clozapine PS Zenith Goldline ORAL 75MG ORAL Professional Date:12/29/00ISR Number: 3639526-7Report Type:Periodic Company Report #00-11-0566 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Aspiration Health Clozapine PS Zenith Goldline ORAL 12.5-250MG Professional ORAL Date:12/29/00ISR Number: 3639527-9Report Type:Periodic Company Report #00-11-0575 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Parkinson'S Disease Health Clozapine PS Zenith Goldline ORAL 50MG ORAL Professional Date:12/29/00ISR Number: 3639528-0Report Type:Periodic Company Report #00-11-0576 Age:83 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine PS Zenith Goldline ORAL 75MG ORAL Professional Date:12/29/00ISR Number: 3639531-0Report Type:Periodic Company Report #00-11-0590 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Unevaluable Event Health Clozapine PS Zenith Goldline ORAL 600 MG QD Initial or Prolonged Professional ORAL 22-Feb-2006 08:30 AM Page: 1007 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/29/00ISR Number: 3639533-4Report Type:Periodic Company Report #00-11-0621 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Health Clozapine PS Zenith Goldline ORAL 500 MG QD Professional ORAL Date:12/29/00ISR Number: 3639535-8Report Type:Periodic Company Report #00-10-0633 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Infection Health Clozapine - Zenith Initial or Prolonged Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 600 MG ORAL Date:12/29/00ISR Number: 3639536-XReport Type:Periodic Company Report #98-11-0287 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agranulocytosis Health Clozapine PS Zenith Goldline ORAL 25-400 MG Professional ORAL Date:12/29/00ISR Number: 3639538-3Report Type:Periodic Company Report #98-12-0288 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozapine PS Zenith Goldline ORAL 500 MG ORAL Professional Date:12/29/00ISR Number: 3639540-1Report Type:Periodic Company Report #99-02-0468 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozapine PS Zenith Goldline ORAL 100-200 MG Professional ORAL Date:12/29/00ISR Number: 3639542-5Report Type:Periodic Company Report #99-03-0467 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozapine PS Zenith Goldline ORAL 100-350 MG Professional ORAL Date:12/29/00ISR Number: 3639544-9Report Type:Periodic Company Report #00-05-0264 Age:88 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine PS Zenith Goldline ORAL ORAL Respiratory Failure Professional Z-Bec C Lasix C Uni-Dur C Miacalcin C Ferrous Sulfate C Celluvisc C Zantac C 22-Feb-2006 08:30 AM Page: 1008 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Docusate Sodium C Albuterol C Atrovent C Chloraseptic C Tegretol C Nitrostat C Milk Of Amnesia C Maalox Plus C Acetaminophen C Date:12/29/00ISR Number: 3639545-0Report Type:Periodic Company Report #00-05-0277 Age:94 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Parkinsonism Health Clozapine PS Zenith Goldline ORAL 12.5 - 125 Pneumonia Aspiration Professional MG ORAL Date:12/29/00ISR Number: 3639547-4Report Type:Periodic Company Report #00-06-0318 Age:71 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Respiratory Distress Health Clozapine PS Zenith Goldline ORAL 12.5-25 MG Professional ORAL Ditropan C Prednisone C Zestril C Sinemet C Coumadin C Heparin C Dulcolax Suppositories C Milk Of Magnesia C Date:12/29/00ISR Number: 3639550-4Report Type:Periodic Company Report #00-08-0371 Age:46 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Eosinophilia Health Clozapine PS Zenith Goldline ORAL 12.5-175MG White Blood Cell Count Professional ORAL 1 MON Increased Oscal C Lopressor C Date:12/29/00ISR Number: 3639553-XReport Type:Periodic Company Report #00-07-0379 Age:79 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine PS Zenith Goldline ORAL 62.5MG ORAL Professional Date:12/29/00ISR Number: 3639555-3Report Type:Periodic Company Report #00-08-0382 Age:74 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Clozapine PS Zenith Goldline ORAL 250MG ORAL Initial or Prolonged Professional 22-Feb-2006 08:30 AM Page: 1009 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/29/00ISR Number: 3639557-7Report Type:Periodic Company Report #00-08-0385 Age:55 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neutropenia Health Clozapine PS Zenith Goldline ORAL 350MG QD ORAL Professional Zyprexa C Depakote Sprinkle C Cogentin C Lorazepam C Docusate Sodium C Date:12/29/00ISR Number: 3639559-0Report Type:Periodic Company Report #00-08-0404 Age:79 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Health Clozapine PS Zenith Goldline ORAL 50-400MG ORAL Initial or Prolonged Professional Date:12/29/00ISR Number: 3639560-7Report Type:Periodic Company Report #00-08-0405 Age:64 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Respiratory Arrest Health Clozapine PS Zenith Goldline ORAL 200-450MG Professional ORAL Carafate Susp C Clonazepam C Metoclopramide C Prevacid C Promethazine C Transderm-Scop Patch C Valproic Acid C Nitroglycerin Patch C Date:12/29/00ISR Number: 3639561-9Report Type:Periodic Company Report #00-08-0412 Age:80 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine PS Zenith Goldline ORAL ORAL Professional Synthroid C Zestril C Furosemide C Catapres Tts Patch C Florinef C Ferrous Sulfate C Prilosec C Potassium Chloride C Sinemet C Trazodone C Nifedipine C Acetaminophen Suppositories C Osmolite Plain C 22-Feb-2006 08:30 AM Page: 1010 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/29/00ISR Number: 3639564-4Report Type:Periodic Company Report #00-08-0413 Age:78 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Decreased Appetite Health Clozapine PS Zenith Goldline ORAL 25-250MG ORAL Pneumonia Professional Depakote C Pepcid C Ferrous Sulfate C Lovenox C Dilantin C Date:12/29/00ISR Number: 3639567-XReport Type:Periodic Company Report #00-08-0417 Age:52 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozapine PS Zenith Goldline ORAL 250-275MG Professional ORAL Taxol SS INTRAVENOUS WEEKLY INTRAVENOUS Date:12/29/00ISR Number: 3639570-XReport Type:Periodic Company Report #00-09-0422 Age:35 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Health Clozapine PS Zenith Goldline ORAL 200MG ORAL Professional Zoloft C Date:12/29/00ISR Number: 3639578-4Report Type:Expedited (15-DaCompany Report #00-09-0479 Age:81 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Foreign Body Aspiration Health Clozapine PS Zenith Goldline ORAL 50-75 MG ORAL 2 YR Professional Zantac C Sinemet C Date:12/29/00ISR Number: 3639584-XReport Type:Expedited (15-DaCompany Report #00-09-0495 Age:80 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 12.5 -125 MG Professional ORAL Date:12/29/00ISR Number: 3639588-7Report Type:Expedited (15-DaCompany Report #00-09-0501 Age:92 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine PS Zenith Goldline ORAL 25-150 MG Professional ORAL Date:12/29/00ISR Number: 3639590-5Report Type:Periodic Company Report #00-09-0426 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypotension Health Clozapine PS Zenith Goldline ORAL 300-450 MG Tachycardia Professional ORAL Vistaril C 22-Feb-2006 08:30 AM Page: 1011 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Depakote C ... C Imipramine C Date:12/29/00ISR Number: 3639594-2Report Type:Periodic Company Report #00-09-0486 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Unevaluable Event Health Clozapine PS Zenith Goldline ORAL 225 MG ORAL Professional Motrin C Zithromax C Date:12/29/00ISR Number: 3639599-1Report Type:Periodic Company Report #00-09-0489 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Unevaluable Event Health Clozapine PS Zenith Goldline ORAL 400 MG ORAL Professional Date:12/29/00ISR Number: 3639603-0Report Type:Periodic Company Report #00-09-0490 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Unevaluable Event Health Clozapine PS Zenith Goldline ORAL 150 MG ORAL Professional Date:12/29/00ISR Number: 3639608-XReport Type:Periodic Company Report #00-09-0493 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sedation Health Clozapine PS Zenith Goldline ORAL 12.5 -300 MG Professional ORAL Date:12/29/00ISR Number: 3639616-9Report Type:Periodic Company Report #00-09-0496 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Vith Nerve Paralysis Health Clozapine PS Zenith Goldline ORAL 37.5-300 MG Professional ORAL Date:12/29/00ISR Number: 3639623-6Report Type:Periodic Company Report #00-09-0498 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Infection Health Clozapine PS Zenith Goldline ORAL 700 MG ORAL Professional Date:12/29/00ISR Number: 3639628-5Report Type:Periodic Company Report #00-10-0506 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Platelet Count Decreased Health Clozapine PS Zenith Goldline ORAL 50-500MG ORAL Professional Depakote Tablets SS ORAL 1000 MG HS ORAL 22-Feb-2006 08:30 AM Page: 1012 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Mellaril C Cogentin C Date:12/29/00ISR Number: 3639629-7Report Type:Periodic Company Report #00-10-0509 Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Infection Health Clozapine PS Zenith Goldline ORAL 150-200MG Professional ORAL Date:12/29/00ISR Number: 3639630-3Report Type:Periodic Company Report #00-10-0515 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eosinophilia Health Clozapine PS Zenith Goldline ORAL 500MG QD ORAL Professional Lithium C Date:12/29/00ISR Number: 3639631-5Report Type:Periodic Company Report #00-10-0530 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Distension Health Clozapine PS Zenith Goldline ORAL 400MG ORAL Constipation Professional Eskalith C Orthostatic Hypotension Urinary Retention Date:12/29/00ISR Number: 3639632-7Report Type:Periodic Company Report #00-10-0533 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dermatitis Health Clozapine PS Zenith Goldline ORAL 100MG ORAL Professional Doxycycline C Date:12/29/00ISR Number: 3639633-9Report Type:Periodic Company Report #00-10-0536 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Unevaluable Event Health Clozapine PS Zenith Goldline ORAL 100MG ORAL Professional Date:12/29/00ISR Number: 3639634-0Report Type:Periodic Company Report #00-10-0537 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sedation Health Clozapine PS Zenith Goldline ORAL ORAL Professional Date:12/29/00ISR Number: 3639635-2Report Type:Periodic Company Report #00-10-0539 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Polyserositis Health Clozapine PS Zenith Goldline ORAL 50-900MG ORAL Professional Ascorbic Acid C Colace C 22-Feb-2006 08:30 AM Page: 1013 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Valproic Acid C Date:12/29/00ISR Number: 3639636-4Report Type:Periodic Company Report #00-10-0548 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Erectile Dysfunction Health Clozapine PS Zenith Goldline ORAL 200-500MG Professional ORAL Date:12/29/00ISR Number: 3639637-6Report Type:Periodic Company Report #00-11-0568 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Thyroid Stimulating Health Clozapine PS Zenith Goldline ORAL 200-300MG Hormone Increased Professional ORAL Liver Function Test Eskalith C Abnormal Date:12/29/00ISR Number: 3639752-7Report Type:Periodic Company Report #00-11-0571 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Ineffective Health Clozapine PS Zenith Goldline ORAL 150-700 MG Professional ORAL Date:12/29/00ISR Number: 3639755-2Report Type:Periodic Company Report #00-11-0572 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Ineffective Health Clozapine PS Zenith Goldline ORAL 50MG ORAL Professional Date:12/29/00ISR Number: 3639756-4Report Type:Periodic Company Report #00-11-0573 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Health Clozapine PS Zenith Goldline ORAL 25-75 MG ORAL Dizziness Professional Date:12/29/00ISR Number: 3639757-6Report Type:Periodic Company Report #00-11-0579 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Triglycerides Health Clozapine PS Zenith Goldline ORAL 175-400 MG Increased Professional ORAL Date:12/29/00ISR Number: 3639760-6Report Type:Periodic Company Report #00-11-0584 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Health Clozapine PS Zenith Goldline ORAL 300 MG QD Psychotic Disorder Professional ORAL 22-Feb-2006 08:30 AM Page: 1014 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/29/00ISR Number: 3639762-XReport Type:Periodic Company Report #00-11-0586 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drooling Health Clozapine PS Zenith Goldline ORAL 12.5-175MG QD Professional ORAL Prolixin C Atenolol C Date:12/29/00ISR Number: 3639764-3Report Type:Periodic Company Report #00-04-0274 Age:31 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Health Clozapine PS Zenith Goldline ORAL 450MG ORAL Abdominal Pain Upper Professional Monopril C Chest Discomfort Depakote C Sedation Tremor Date:12/29/00ISR Number: 3639767-9Report Type:Periodic Company Report #00-07-0353 Age:46 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypersensitivity Health Clozapine PS Zenith Goldline ORAL 250MG ORAL Professional Date:12/29/00ISR Number: 3639768-0Report Type:Periodic Company Report #00-07-0355 Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Health Clozapine PS Zenith Goldline ORAL ORAL Delusion Professional Anafranil C Obsessive-Compulsive Disorder Psychotic Disorder Date:12/29/00ISR Number: 3639770-9Report Type:Periodic Company Report #00-08-0383 Age:46 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Feeling Abnormal Health Clozapine PS Zenith Goldline ORAL 600 MG ORAL Professional Depakote C Date:12/29/00ISR Number: 3639822-3Report Type:Expedited (15-DaCompany Report #PHEH2000US02718 Age:47 YR Gender:Male I/FU:F Outcome PT Death Arthralgia Hospitalization - Bronchitis Initial or Prolonged Cardiac Failure Cellulitis Constipation Deep Vein Thrombosis Dyspnoea Lethargy Lymphadenopathy Metastases To Lung 22-Feb-2006 08:30 AM Page: 1015 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Oedema Peripheral Oliguria Pleural Effusion Report Source Product Role Manufacturer Route Dose Duration Sarcoma Health Clozaril PS Novartis Vomiting Professional Pharmaceuticals Corp ORAL 200MG AM + 500MG HS, ORAL Lorazepam C Zoloft C Metoprolol C Lasix C Senna C Bisacodyl C Date:12/29/00ISR Number: 3639880-6Report Type:Periodic Company Report #00-08-0397 Age:53 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukocytosis Health Clozapine PS Zenith Goldline ORAL 900MG ORAL Professional Valproic Acid C Oxazepam C Lovastatin C Fluphenazine C Haloperidol C Betamethasone C Fluocinonide C Date:12/29/00ISR Number: 3639882-XReport Type:Periodic Company Report #00-08-0398 Age:42 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Parotid Gland Enlargement Health Clozapine PS Zenith Goldline ORAL 150-350MG Salivary Hypersecretion Professional ORAL Depakote C Docusate C Levoxyl C Ferrous Sulfate C Zocor C Date:01/02/01ISR Number: 3640942-8Report Type:Expedited (15-DaCompany Report #PHFR2000GB02027 Age:35 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiomegaly Foreign Clozaril PS Novartis Initial or Prolonged Congestive Cardiomyopathy Health Pharmaceuticals Corp ORAL 500 MG/DAY, Drug Level Above Professional ORAL Therapeutic Other Sertraline C Docusate Sodium C Isogel (Ispaghula) C Bisacodyl C Ponstan (Mefenamic Acid) C 22-Feb-2006 08:30 AM Page: 1016 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/02/01ISR Number: 3640943-XReport Type:Expedited (15-DaCompany Report #PHFR2000GB01993 Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abdominal Abscess Foreign Clozaril PS Novartis Hospitalization - Appendicitis Perforated Health Pharmaceuticals Corp ORAL 650MG/DAY, Initial or Prolonged Loss Of Consciousness Professional ORAL Other Peritonitis Other Lithium Carbonate C Renal Failure Acute Citalopram C Date:01/02/01ISR Number: 3641086-1Report Type:Expedited (15-DaCompany Report #PHEH2000US08712 Age:74 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozaril PS Novartis Professional Pharmaceuticals Corp ORAL 650 MG, ORAL Clozapine Zenith Goldline)(Clozapine) SS Date:01/02/01ISR Number: 3659258-9Report Type:Expedited (15-DaCompany Report #PHBS2001CA00805 Age:47 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cerebral Infarction Foreign Clozaril PS Novartis Hospitalization - Cerebrovascular Accident Health Pharmaceuticals Corp ORAL 475 MG/D, Initial or Prolonged Computerised Tomogram Professional ORAL Abnormal Other Synthroid C Dysarthria Lorazepam C Facial Palsy Fall Headache Hemiplegia Injury Sinus Tachycardia Date:01/03/01ISR Number: 3641156-8Report Type:Expedited (15-DaCompany Report #PHEH2000US11609 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Nephrogenic Diabetes Health Clozaril PS Novartis Insipidus Professional Pharmaceuticals Corp ORAL 350 MG/DAY, Company ORAL Representative Clonazepam C Atenolol C Lorazepam C Date:01/03/01ISR Number: 3641157-XReport Type:Expedited (15-DaCompany Report #PHEH2000US07911 Age:49 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cervix Carcinoma Health Clozaril PS Novartis White Blood Cell Count Professional Pharmaceuticals Corp ORAL 200 MG, BID, Decreased ORAL Cytoxan (Cyclophosphamide) SS 3380 DAY 22-Feb-2006 08:30 AM Page: 1017 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/03/01ISR Number: 3641466-4Report Type:Expedited (15-DaCompany Report #PHBS2000CA12349 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Immune System Disorder Foreign Clozaril PS Novartis Pulmonary Tuberculosis Literature Pharmaceuticals Corp 300 MG/DAY 9 MON Health Valproic Acid C Professional Haloperidol C Other Date:01/03/01ISR Number: 3641467-6Report Type:Expedited (15-DaCompany Report #PHBS2000AU11427 Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Foreign Clozaril PS Novartis Congestive Study Pharmaceuticals Corp ORAL 300 MG/D, Cardiomyopathy Health ORAL Dialysis Professional Valproate Sodium C Dyspnoea Other Frusemide C Fatigue Slow-K C Malaise Nausea Date:01/03/01ISR Number: 3641468-8Report Type:Expedited (15-DaCompany Report #PHBS2000AU03419 Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Clozaril PS Novartis Eosinophilia Health Pharmaceuticals Corp ORAL 300 MG, ORAL Myocarditis Professional Ventricular Fibrillation Other Date:01/03/01ISR Number: 3641540-2Report Type:Expedited (15-DaCompany Report #PHBS2000CA11972 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Foreign Clozaril PS Novartis Initial or Prolonged Apnoea Study Pharmaceuticals Corp ORAL 500 MG/D, Blood Creatine Health ORAL Phosphokinase Increased Professional Clonic Convulsion Other Confusional State Convulsion Muscle Rigidity Pyrexia Self Mutilation Date:01/04/01ISR Number: 3641198-2Report Type:Expedited (15-DaCompany Report #00-11-0591 Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Health Clozapine PS Zenith Goldline ORAL 340-450MG QD Professional ORAL Synthroid C Eskalith - Slow Release C Atenolol C 22-Feb-2006 08:30 AM Page: 1018 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/04/01ISR Number: 3641201-XReport Type:Expedited (15-DaCompany Report #00-11-0595 Age:55 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cellulitis Health Clozapine PS Zenith Goldline ORAL 225MG QD ORAL Initial or Prolonged Diabetes Mellitus Professional Date:01/04/01ISR Number: 3641204-5Report Type:Expedited (15-DaCompany Report #00-11-0595 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Health Clozapine PS Zenith Goldline ORAL 225MG QD ORAL Initial or Prolonged Professional Date:01/04/01ISR Number: 3641206-9Report Type:Expedited (15-DaCompany Report #00-11-0597 Age:83 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coma Health Clozapine PS Zenith Goldline ORAL 100MG QD ORAL Other Professional Date:01/04/01ISR Number: 3641209-4Report Type:Expedited (15-DaCompany Report #00-11-0596 Age:74 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 100-350MG QD Professional ORAL Date:01/04/01ISR Number: 3641211-2Report Type:Expedited (15-DaCompany Report #00-11-0598 Age:82 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 200-500MG QD Professional ORAL Date:01/04/01ISR Number: 3641213-6Report Type:Expedited (15-DaCompany Report #00-12-0639 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coronary Artery Disease Health Clozapine PS Zenith Goldline ORAL 25-75MG QD Professional ORAL Date:01/04/01ISR Number: 3641214-8Report Type:Expedited (15-DaCompany Report #00-12-0631 Age:92 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozapine PS Zenith Goldline ORAL 100MG QD ORAL Cerebrovascular Accident Professional Date:01/04/01ISR Number: 3641216-1Report Type:Expedited (15-DaCompany Report #00-12-0626 Age:75 YR Gender:Male I/FU:F Outcome Death Hospitalization - 22-Feb-2006 08:30 AM Page: 1019 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Initial or Prolonged PT Report Source Product Role Manufacturer Route Dose Duration Cardiac Failure Health Clozapine PS Zenith Goldline ORAL 25-62.5MG Congestive Professional ORAL Pneumonia Aspiration Renal Failure Acute Date:01/04/01ISR Number: 3641218-5Report Type:Expedited (15-DaCompany Report #00-12-0612 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 200-900MG QD Professional ORAL Date:01/04/01ISR Number: 3641219-7Report Type:Expedited (15-DaCompany Report #00-12-0611 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bone Graft Health Clozapine PS Zenith Goldline ORAL 25-750MG QD Initial or Prolonged Surgery Professional ORAL Date:01/04/01ISR Number: 3641220-3Report Type:Expedited (15-DaCompany Report #00-12-0611 Age:59 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bone Graft Health Clozapine PS Zenith Goldline ORAL 25-750MG QD Initial or Prolonged Fall Professional ORAL Surgery Date:01/04/01ISR Number: 3641222-7Report Type:Expedited (15-DaCompany Report #00-12-0610 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accident Health Clozapine PS Zenith Goldline ORAL 100-175MG QD Initial or Prolonged Lower Limb Fracture Professional ORAL Date:01/04/01ISR Number: 3641223-9Report Type:Expedited (15-DaCompany Report #00-11-0603 Age:49 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Myeloid Leukaemia Health Clozapine PS Zenith Goldline ORAL 150-300MG QD Hospitalization - Agranulocytosis Professional ORAL Initial or Prolonged Condition Aggravated Olanzapine C Pancytopenia Lorazepam C Sepsis Perphenazine C Desmopressin C Date:01/04/01ISR Number: 3641225-2Report Type:Expedited (15-DaCompany Report #00-11-0603 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agranulocytosis Health Clozapine PS Zenith Goldline ORAL 150-300MG QD Breast Cancer Female Professional ORAL 22-Feb-2006 08:30 AM Page: 1020 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/04/01ISR Number: 3641226-4Report Type:Expedited (15-DaCompany Report #00-11-0602 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 225-400MG QD Professional ORAL Date:01/04/01ISR Number: 3641228-8Report Type:Expedited (15-DaCompany Report #00-12-0645 Age:80 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Surgery Health Clozapine PS Zenith Goldline ORAL 100MG QD ORAL Professional Date:01/04/01ISR Number: 3641229-XReport Type:Expedited (15-DaCompany Report #00-12-0646 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 50-200MG QD Professional ORAL Date:01/04/01ISR Number: 3641230-6Report Type:Expedited (15-DaCompany Report #00-12-0649 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 25MG QD ORAL Professional Date:01/04/01ISR Number: 3641232-XReport Type:Expedited (15-DaCompany Report #00-10-0554 Age:83 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Adenocarcinoma Health Clozapine PS Zenith Goldline ORAL 200MG ORAL Ovarian Cancer Professional Levothyroxine C Vitamin E C Date:01/04/01ISR Number: 3641234-3Report Type:Expedited (15-DaCompany Report #00-10-0553 Age:80 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abscess Health Clozapine PS Zenith Goldline ORAL 37.5MG ORAL Condition Aggravated Professional Diverticulitis Respiratory Disorder Date:01/04/01ISR Number: 3641235-5Report Type:Expedited (15-DaCompany Report #00-11-0564 Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Road Traffic Accident Health Clozapine PS Zenith Goldline ORAL 576-700MG Initial or Prolonged Professional ORAL 22-Feb-2006 08:30 AM Page: 1021 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/04/01ISR Number: 3641237-9Report Type:Expedited (15-DaCompany Report #00-11-0569 Age:81 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 25-50MG ORAL Professional Date:01/04/01ISR Number: 3641239-2Report Type:Expedited (15-DaCompany Report #00-11-0583 Age:61 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neoplasm Malignant Health Clozapine PS Zenith Goldline ORAL 100-400MG QD Professional ORAL Date:01/04/01ISR Number: 3641241-0Report Type:Expedited (15-DaCompany Report #00-11-0602 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 225-400MG QD Professional ORAL Date:01/04/01ISR Number: 3641242-2Report Type:Expedited (15-DaCompany Report #00-11-0602 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 225-400MG QD Professional ORAL .... C Depakote C Ativan C Inderal C Artane C Date:01/04/01ISR Number: 3641244-6Report Type:Expedited (15-DaCompany Report #00-11-0601 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 200-300MG QD Professional ORAL Date:01/04/01ISR Number: 3641891-1Report Type:Direct Company Report # Age:42 YR Gender:Male I/FU:I Outcome PT Death Convulsion Hospitalization - Diabetes Mellitus Initial or Prolonged Drug Interaction Ecchymosis Fall Haemorrhage Head Injury Hepatic Failure Hypertension Intestinal Ischaemia Loss Of Consciousness Medication Error Mental Retardation 22-Feb-2006 08:30 AM Page: 1022 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Severity Unspecified Obesity Schizoaffective Disorder Sudden Death Report Source Product Role Manufacturer Route Dose Duration Wellbutrin Sr (Glaxo Wellcome) PS Glaxo Wellcome 100MG 2 TABS AM /PM Clozaril (Novartis Pharmaceutical) SS Novartis Pharmaceutical 100MG 3 BID Norvasc C Zestril C Colace C Date:01/04/01ISR Number: 3848234-9Report Type:Periodic Company Report #01-04-0228 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neutropenia Health Clozapine-Ivax Hospitalization - Overdose Professional Pharmaceuticals, Initial or Prolonged Inc. Tablets PS ORAL 450MG QD ORAL Paxil Tablets SS ORAL 20 MG QD ORAL Haldol C Risperdal C Cogentin C Date:01/08/01ISR Number: 3642823-2Report Type:Expedited (15-DaCompany Report #00-11-0556 Age:51 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Alkaline Health Clozapine PS Zenith Goldline ORAL 100-400 MG Phosphatase Increased Professional ORAL Blood Cholesterol Atrovent C Increased Ventolin C Blood Sodium Decreased Dilantin C Low Density Lipoprotein Ultram C Increased Darvocet-N C Mood Altered Advil C Pneumonia Pulmonary Haemorrhage Schizophrenia Date:01/08/01ISR Number: 3642825-6Report Type:Expedited (15-DaCompany Report #00-12-0654 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 350 MG QD Professional ORAL Date:01/08/01ISR Number: 3642826-8Report Type:Expedited (15-DaCompany Report #00-12-0623 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drooling Health Clozapine PS Zenith Goldline ORAL 225-550MD QD Ovarian Neoplasm Professional ORAL Renal Failure Risperdal Tablets SS ORAL 1MG PO QD Sedation Depakote C Zoloft C 22-Feb-2006 08:30 AM Page: 1023 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Ibuprofen C Amiloride C Date:01/08/01ISR Number: 3643609-5Report Type:Expedited (15-DaCompany Report #PHBS2000AU09684 Age:27 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Hidradenitis Foreign Clozaril PS Novartis Other Nasal Congestion Health Pharmaceuticals Corp ORAL 450 MG, QD, Sinusitis Professional ORAL Sleep Apnoea Syndrome Other Lithium (Lithium) C Vibramycin (Doxycycline Hyclate) C Date:01/08/01ISR Number: 3643646-0Report Type:Expedited (15-DaCompany Report #PHBS2000AU12379 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiomegaly Foreign Clozaril PS Novartis Initial or Prolonged Dehydration Health Pharmaceuticals Corp ORAL ORAL Delirium Professional Diarrhoea Other Full Blood Count Abnormal Hypotension Infection Mental Impairment Pyrexia Tachycardia Date:01/08/01ISR Number: 3643647-2Report Type:Expedited (15-DaCompany Report #PHFR2000GB02235 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hiatus Hernia Foreign Clozaril PS Novartis Initial or Prolonged Health Pharmaceuticals Corp ORAL 50 MG, QD, Professional ORAL Other Date:01/08/01ISR Number: 3643650-2Report Type:Expedited (15-DaCompany Report #PHBS2000AU12499 Age:47 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Foreign Clozaril PS Novartis Initial or Prolonged Laboratory Test Abnormal Study Pharmaceuticals Corp 200 MG/D White Blood Cell Count Health Increased Professional Other Date:01/08/01ISR Number: 3643653-8Report Type:Expedited (15-DaCompany Report #PHRM2000FR01831 Age:34 YR Gender:Female I/FU:F Outcome PT Hospitalization - Agitation Initial or Prolonged Clonic Convulsion Intentional Overdose 22-Feb-2006 08:30 AM Page: 1024 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Microcytic Anaemia Suicide Attempt Report Source Product Role Manufacturer Route Dose Duration Foreign Clozaril PS Novartis Health Pharmaceuticals Corp ORAL ORAL Professional Zyprexa (Olanzapine) SS ORAL 200 MG, Other ONCE/SINGLE , ORAL Artane (Trihexyphenidyl Hydrochloride) SS Date:01/08/01ISR Number: 3643658-7Report Type:Expedited (15-DaCompany Report #PHBS2000AU10829 Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Interaction Foreign Clozaril PS Novartis Haemorrhage Health Pharmaceuticals Corp ORAL 75 MG/D, ORAL Professional Methadone Other (Methadone) SS 3 DAY Heroin C Date:01/08/01ISR Number: 3643782-9Report Type:Expedited (15-DaCompany Report #PHFR2000GB02225 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diverticulitis Foreign Clozaril PS Novartis Initial or Prolonged Health Pharmaceuticals Corp ORAL 250MG/DAY, Professional ORAL Other Date:01/08/01ISR Number: 3643835-5Report Type:Expedited (15-DaCompany Report #PHEH2000US02980 Age: Gender:Unknown I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other No Adverse Drug Effect Health Clozaril PS Novartis Professional Pharmaceuticals Corp Date:01/09/01ISR Number: 3643644-7Report Type:Expedited (15-DaCompany Report #PHNU2000DE02400 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Foreign Clozaril PS Novartis Initial or Prolonged Excitability Health Pharmaceuticals Corp ORAL ORAL Haemorrhagic Stroke Professional Intracranial Venous Sinus Other Thrombosis Status Epilepticus Vasculitis Cerebral Date:01/09/01ISR Number: 3644379-7Report Type:Expedited (15-DaCompany Report #00-12-0651 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Health Clozapine PS Zenith Goldline ORAL 500MG QD ORAL Professional 22-Feb-2006 08:30 AM Page: 1025 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/09/01ISR Number: 3644380-3Report Type:Expedited (15-DaCompany Report #00-10-0554 Age:83 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Ascites Health Clozapine PS Zenith Goldline ORAL 200MG ORAL Ovarian Cancer Professional Levothyroxine C Pulmonary Embolism Acetaminophen C Compazine C Loperamide C Milk Of Magnesia C Ranitidine C Hydrochlorothiazide With Triamterene C Vitamin E C Levoxyl C Date:01/09/01ISR Number: 3644381-5Report Type:Expedited (15-DaCompany Report #00-11-0621 Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Health Clozapine PS Zenith Goldline ORAL 500MG QD ORAL Myocardial Ischaemia Professional Sudden Death Date:01/10/01ISR Number: 3644735-7Report Type:Expedited (15-DaCompany Report #A0135841A Age:19 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Health Lamictal PS Glaxo Wellcome ORAL 100MG See Hospitalization - Completed Suicide Professional text 1 YR Initial or Prolonged Condition Aggravated Clozapine SS ORAL 300MG See Overdose text Schizoaffective Disorder Cogentin SS ORAL 20MG See text No Concurrent Medications C Date:01/11/01ISR Number: 3646100-5Report Type:Periodic Company Report #C2000-1170.01 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozapine PS Mylan Neutropenia Professional Pharmaceuticals Inc ORAL 25MG, BID, ORAL Benztropine C Chlorpromazine C Diphenhydramine C Divalproex Sodium C Fluphenazine C Risperidone C Date:01/11/01ISR Number: 3646101-7Report Type:Periodic Company Report #C2000-1394.01 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Health Clozapine PS Mylan Initial or Prolonged Professional Pharmaceuticals Inc Other Other Clozapine Tablets 100mg Mylan SS Mylan 22-Feb-2006 08:30 AM Page: 1026 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/11/01ISR Number: 3646103-0Report Type:Periodic Company Report #C2000-1395.01 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozapine PS Mylan Hospitalization - Professional Pharmaceuticals Inc ORAL 75 MG, QD, Initial or Prolonged Other THEN 200MG Other QD, ORAL Olanzapine C Fluphenazine C Quetiapine C Date:01/11/01ISR Number: 3646108-XReport Type:Periodic Company Report #C2000-1562.01 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Weight Increased Consumer Clozapine PS Mylan Pharmaceuticals Inc Clozapine Tablets SS Atorvastatin C Sertraline C Date:01/11/01ISR Number: 3646109-1Report Type:Periodic Company Report #C2000-1155.01 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Consumer Clozapine PS Mylan Pharmaceuticals Inc ORAL 150 MG Q HS ORAL ONE DOSE ONLY Date:01/11/01ISR Number: 3646110-8Report Type:Periodic Company Report #C2000-1177.01 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozapine PS Mylan Neutropenia Professional Pharmaceuticals Inc ORAL 50MG Q AM, Other ORAL Clozapine Tablets 100mg Mylan SS ORAL 100MG BID, ORAL Olanzapine C Gemfibrozil C Ranitidine C Sertraline C Multivitamin C Date:01/11/01ISR Number: 3646111-XReport Type:Periodic Company Report #C2000-1190.01 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombocytopenia Health Clozapine PS Mylan Professional Pharmaceuticals Inc ORAL 300MG, QD, ORAL Sertraline C 22-Feb-2006 08:30 AM Page: 1027 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/11/01ISR Number: 3646113-3Report Type:Periodic Company Report #C2000-1201.01 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozapine PS Mylan Neutropenia Professional Pharmaceuticals Inc ORAL GRADUALLY Other INCREASED DOSE FROM 25MG QD TO MAINTENANCE Gabapentin C Nefazadone C Phenytoin C Trifluoperazine C Tolterodine C Terazosin C Clonazepam C Fluvoxamine C Quetiapine C Date:01/11/01ISR Number: 3646116-9Report Type:Periodic Company Report #C2000-1423.01 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tic Consumer Clozapine PS Mylan Pharmaceuticals Inc ORAL 150MG QAM, 100MG Q NOON, 150MG QHS, ORAL Clozapine Tablets 100 Mg Mylan SS Mylan ORAL 150MG QAM, 100MG Q NOON, 150MG QHS, ORAL Bentropine Mesylate C Lorazepam C Trazodone C Date:01/11/01ISR Number: 3646117-0Report Type:Periodic Company Report #C2000-1628.01 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Health Clozapine PS Mylan Professional Pharmaceuticals Inc ORAL 500MG, QD, Other ORAL Clonazepam C Levothyroxine C Lithium C Phenytoin C Valproic Acid C Date:01/11/01ISR Number: 3646333-8Report Type:Direct Company Report # Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Clozapine 100mg Initial or Prolonged Diabetic Ketoacidosis Sandoz PS Sandoz ORAL 100MG QAM, 225M QHS ORAL 22-Feb-2006 08:30 AM Page: 1028 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Megace C Date:01/11/01ISR Number: 3646450-2Report Type:Expedited (15-DaCompany Report #PHEH2000US08320 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Health Clozaril PS Novartis Initial or Prolonged Myelodysplastic Syndrome Professional Pharmaceuticals Corp ORAL 300 MG, ORAL Neutropenia Zoloft (Sertraline Hydrochloride) C Prol C Date:01/11/01ISR Number: 3646451-4Report Type:Expedited (15-DaCompany Report #PHEH2000US11283 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Lethargy Health Clozaril PS Novartis Initial or Prolonged Poor Peripheral Professional Pharmaceuticals Corp ORAL 700 MG, QHS, Circulation ORAL Depakote (Valproate Semisodium) C Seroquel (Quetiapine) C Date:01/11/01ISR Number: 3646460-5Report Type:Expedited (15-DaCompany Report #PHEH2000US11694 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neoplasm Malignant Health Clozaril PS Novartis Professional Pharmaceuticals Corp ORAL 250MG , ORAL Date:01/11/01ISR Number: 3646461-7Report Type:Expedited (15-DaCompany Report #PHEH2000US11458 Age:88 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozaril PS Novartis Professional Pharmaceuticals Corp ORAL ORAL Date:01/11/01ISR Number: 3646504-0Report Type:Expedited (15-DaCompany Report #PHBS2000AU11661 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthma Foreign Clozaril PS Novartis Initial or Prolonged Blood Creatine Health Pharmaceuticals Corp ORAL 250 MG/D, Phosphokinase Increased Professional ORAL Bronchitis Other Solone C Cardiac Enzymes Increased Euhypnos C Drug Hypersensitivity Zactin (Fluoxetine Myocarditis Hydrochloride) C Pyrexia Paxam (Piroxicam) C 22-Feb-2006 08:30 AM Page: 1029 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/11/01ISR Number: 3646505-2Report Type:Expedited (15-DaCompany Report #PHRM2000FR01952 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypertonia Foreign Clozaril PS Novartis Initial or Prolonged Intentional Overdose Health Pharmaceuticals Corp ORAL SEE IMAGE Suicide Attempt Professional Loxapac (Loxapine Other Succinate) Tablet SS ORAL 20 DF, ONCE/SINGLE, ORAL Date:01/11/01ISR Number: 3646688-4Report Type:Expedited (15-DaCompany Report #PHBS2000CA12350 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pleural Effusion Foreign Clozaril PS Novartis Pulmonary Tuberculosis Literature Pharmaceuticals Corp 600 MG/DAY Health Haloperidol C Professional Procyclidine C Other Clonazepam C Divalproex Sodium C Date:01/11/01ISR Number: 3646745-2Report Type:Expedited (15-DaCompany Report #PHBS2001US00467 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abdominal Pain Literature Clozaril PS Novartis Hospitalization - Cerebrovascular Accident Health Pharmaceuticals Corp ORAL 200 MG, BID, Initial or Prolonged Condition Aggravated Professional ORAL 6 WK Constipation Lorazepam C Intestinal Perforation Peritonitis Sepsis Date:01/12/01ISR Number: 3646552-0Report Type:Direct Company Report # Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Clozapine (Novaris) PS Novaris 50 MG AM 100, Initial or Prolonged Anxiety HS Dizziness Risperidone C Orthostatic Hypotension Lithium C Amlodipine C Date:01/12/01ISR Number: 3646738-5Report Type:Expedited (15-DaCompany Report #00-12-0655 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lymphoma Health Clozapine PS Zenith Goldline ORAL 350MG QD ORAL Professional Date:01/12/01ISR Number: 3646739-7Report Type:Expedited (15-DaCompany Report #00-12-0646 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 50-200MG QD Professional ORAL 22-Feb-2006 08:30 AM Page: 1030 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/12/01ISR Number: 3646880-9Report Type:Direct Company Report # Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Clozapine PS ORAL 500MG PO QD Initial or Prolonged Confusional State Ibuprofen C Drooling Levothyroxine C Divalproex Na C Bupropion(Wellbutrin Sr) C Ranitidine C Temazepam C Sumatriptan Succinate C Date:01/12/01ISR Number: 3647206-7Report Type:Expedited (15-DaCompany Report #PHEH2000US07911 Age:49 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Cancer Female Health Clozaril PS Novartis White Blood Cell Count Professional Pharmaceuticals Corp ORAL 200 MG BID Decreased ORAL Cytoxan (Cyclophosphamide) SS 3419 DAY Date:01/12/01ISR Number: 3647273-0Report Type:Expedited (15-DaCompany Report #PHEH2000US11584 Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Liver Function Test Health Clozaril PS Novartis Abnormal Professional Pharmaceuticals Corp ORAL 900 MG, QID, Non-Hodgkin'S Lymphoma ORAL Lorazepam C Date:01/12/01ISR Number: 3647274-2Report Type:Expedited (15-DaCompany Report #PHEH2000US08827 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Health Clozaril PS Novartis Initial or Prolonged Balance Disorder Professional Pharmaceuticals Corp ORAL 500 MG, ORAL Blood Pressure Depakote (Valproate Fluctuation Semisodium) SS ORAL 2000 MG, ORAL Clonic Convulsion Lithium Carbonate C Drug Interaction Artane (Trihexyphenidyl Hydrochloride) C Risperdal (Risperidone) C Trilafon (Perphenazine) C Date:01/16/01ISR Number: 3648294-4Report Type:Direct Company Report # Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Colazal PS Clozaril SS 22-Feb-2006 08:30 AM Page: 1031 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/16/01ISR Number: 3648764-9Report Type:Expedited (15-DaCompany Report #PHFR2001GB00463 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intestinal Perforation Foreign Clozaril PS Novartis Initial or Prolonged Peritonitis Health Pharmaceuticals Corp ORAL 200 MG/DAY, Professional ORAL (SEE Other IMAGE) Droperidol C Date:01/16/01ISR Number: 3651609-4Report Type:Expedited (15-DaCompany Report #PHBS2000AU01327 Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiomyopathy Foreign Clozaril PS Novartis Initial or Prolonged Health Pharmaceuticals Corp ORAL 500 MG, QD, Professional ORAL Other Paroxetine (Paroxetine) C Date:01/17/01ISR Number: 3648103-3Report Type:Direct Company Report # Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Clozaril PS UNKNOWN Initial or Prolonged Syndrome Required Intervention to Prevent Permanent Impairment/Damage Date:01/17/01ISR Number: 3648188-4Report Type:Expedited (15-DaCompany Report #01-01-0025 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Health Clozapine PS Zenith Goldline ORAL ORAL Professional Date:01/17/01ISR Number: 3648191-4Report Type:Expedited (15-DaCompany Report #01-01-0016 Age:80 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Health Clozapine PS Zenith Goldline ORAL 25 MG QD ORAL Professional Date:01/17/01ISR Number: 3648197-5Report Type:Expedited (15-DaCompany Report #01-01-0014 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 400-600 MG QD Professional ORAL 22-Feb-2006 08:30 AM Page: 1032 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/17/01ISR Number: 3648200-2Report Type:Expedited (15-DaCompany Report #01-01-0013 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL ORAL Professional Date:01/17/01ISR Number: 3648203-8Report Type:Expedited (15-DaCompany Report #01-01-0010 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Neoplasm Malignant Health Clozapine PS Zenith Goldline ORAL 800 MG QD Metastases To Central Professional ORAL Nervous System Date:01/17/01ISR Number: 3648205-1Report Type:Expedited (15-DaCompany Report #01-01-0007 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL ORAL Professional Date:01/17/01ISR Number: 3648209-9Report Type:Expedited (15-DaCompany Report #01-01-0006 Age:69 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Joint Dislocation Health Clozapine PS Zenith Goldline ORAL 25-62 MG QD Professional ORAL Date:01/17/01ISR Number: 3648751-0Report Type:Expedited (15-DaCompany Report #00-12-0610 Age:49 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Health Clozapine PS Zenith Goldline ORAL 100-175MG QD Initial or Prolonged Lower Limb Fracture Professional ORAL Benzatropine C Prozac C Valproic Acid C Date:01/17/01ISR Number: 3648752-2Report Type:Expedited (15-DaCompany Report #00-10-5046 Age:57 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Haemorrhage Health Clozapine PS Zenith Goldline ORAL 350-700MG Hospitalization - Professional ORAL Initial or Prolonged Date:01/17/01ISR Number: 3648753-4Report Type:Expedited (15-DaCompany Report #00-12-0626 Age:75 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Clozapine PS Zenith Goldline ORAL 25-62.5MG Congestive Professional ORAL Pneumonia Aspiration Renal Failure Acute 22-Feb-2006 08:30 AM Page: 1033 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/17/01ISR Number: 3648755-8Report Type:Expedited (15-DaCompany Report #01-01-0027 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 550MG QD ORAL Professional Date:01/17/01ISR Number: 3648756-XReport Type:Expedited (15-DaCompany Report #01-01-0022 Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL UNKNOWN ORAL Professional Date:01/17/01ISR Number: 3649292-7Report Type:Expedited (15-DaCompany Report #PHEH2001US00489 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Metastasis Health Clozaril PS Novartis Ovarian Cancer Professional Pharmaceuticals Corp ORAL 275 MG UNK ORAL Chemotherapeutics C Date:01/17/01ISR Number: 3649642-1Report Type:Expedited (15-DaCompany Report #PHFR2001GB00446 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril PS Novartis Health Pharmaceuticals Corp ORAL 600MG/DAY, Professional ORAL Other Trifluoperazine (Trifluoperazine) C Chlorpromazine (Chlorpromazine) C Dothiepin (Dosulepin) C Quetiapine (Quetiapine) C Date:01/17/01ISR Number: 3649644-5Report Type:Expedited (15-DaCompany Report #PHFR2001GB00451 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Gingival Bleeding Foreign Clozaril PS Novartis Initial or Prolonged Haemorrhage Health Pharmaceuticals Corp ORAL 350MG/DAY, Lip Disorder Professional ORAL Other Date:01/17/01ISR Number: 3649645-7Report Type:Expedited (15-DaCompany Report #PHRM2001FR00449 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Foreign Clozaril PS Novartis Hospitalization - Diabetes Mellitus Health Pharmaceuticals Corp ORAL 200 MG PER Initial or Prolonged Non-Insulin-Dependent Professional DAY, ORAL Infection Other 22-Feb-2006 08:30 AM Page: 1034 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/17/01ISR Number: 3649679-2Report Type:Expedited (15-DaCompany Report #PHBS2001CH00597 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Foreign Clozaril PS Novartis Hospitalization - Dyspnoea Health Pharmaceuticals Corp ORAL 6.25 TO 12.5 Initial or Prolonged Hepatic Enzyme Increased Professional MG/D, ORAL Hepatocellular Damage Other Reniten Mite Rpd Pancreatitis (Enalapril Maleate) SS ORAL 20 MG/D, ORAL Renal Impairment Zocor (Simvastatin) Tablet SS ORAL 20MG/D, ORAL Sortis (Artovastatin) SS 17 DAY Fragmin (Heparin-Fraction, Sodium Salt) C Marcoumar (Phenprocoumon) C Digoxine Tablet C Dipperon (Pipamperone) Tablet C Torem (Torasemide) Tablet C Captopril Tablet C Noroxin (Norfloxacin) Tablet C Date:01/18/01ISR Number: 3653008-8Report Type:Periodic Company Report #PRIUSA2000004500 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Deep Vein Thrombosis Health Ortho Cyclen-21 PS Rw Johnson Initial or Prolonged Embolism Professional Pharmaceutical Research Institute Div Ortho Pharm ORAL 1 TABLET, DAILY, ORAL Clozapine SS ORAL 400 MG, 1 IN 1 DAILY, ORAL Date:01/19/01ISR Number: 3651390-9Report Type:Expedited (15-DaCompany Report #WAES 01010657 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Health Cogentin PS Merck And Co Inc ORAL 20 MG/HS/PO Professional Clozapine SS ORAL 300 Other MG/DAILY/PO Lamictal SS ORAL 100 MG/BID/PO Date:01/19/01ISR Number: 3651542-8Report Type:Expedited (15-DaCompany Report #PHEH2001US00626 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neoplasm Malignant Health Clozaril PS Novartis Professional Pharmaceuticals Corp ORAL 450 MG, ORAL 22-Feb-2006 08:30 AM Page: 1035 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/19/01ISR Number: 3651546-5Report Type:Expedited (15-DaCompany Report #PHEH2001US00636 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozaril PS Novartis Pharyngeal Cancer Stage Professional Pharmaceuticals Corp ORAL ORAL Unspecified Clozapine (Clozapine) SS ORAL 200 MG, ORAL Date:01/19/01ISR Number: 3651645-8Report Type:Expedited (15-DaCompany Report #01-01-0032 Age:96 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Chronic Obstructive Health Clozapine PS Zenith Goldline ORAL 12.5-75MG QD Hospitalization - Pulmonary Disease Professional ORAL Initial or Prolonged Dehydration Electrolyte Imbalance Hypoxia Pneumonia Renal Failure Respiratory Failure Date:01/19/01ISR Number: 3651646-XReport Type:Expedited (15-DaCompany Report #00-12-0620 Age:72 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 75-150MG ORAL Professional Date:01/19/01ISR Number: 3651651-3Report Type:Expedited (15-DaCompany Report #PHBS2001AU00529 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Basal Cell Carcinoma Foreign Clozaril PS Novartis Health Pharmaceuticals Corp ORAL 400 MG/DAY, Professional ORAL Other Date:01/19/01ISR Number: 3652712-5Report Type:Expedited (15-DaCompany Report #PHFR2000GB01659 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril PS Novartis Health Pharmaceuticals Corp ORAL 450 MG, QD, Professional ORAL Other Chlorpromazine (Chlorpromazine) C Amisulpride (Amisulpride) C Date:01/19/01ISR Number: 3652713-7Report Type:Expedited (15-DaCompany Report #PHFR2001GB00507 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Other Diabetes Mellitus Foreign Hypothyroidism Health Sedation Professional 22-Feb-2006 08:30 AM Page: 1036 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Product Role Manufacturer Route Dose Duration Clozaril PS Novartis Pharmaceuticals Corp ORAL 800 MG/DAY, ORAL Date:01/19/01ISR Number: 3652714-9Report Type:Expedited (15-DaCompany Report #PHFR2001GB00506 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Ketoacidosis Foreign Clozaril PS Novartis Initial or Prolonged Health Pharmaceuticals Corp Professional Lansoprazole Other (Lansoprazole) C Date:01/22/01ISR Number: 3652805-2Report Type:Expedited (15-DaCompany Report #PHRM2001FR00461 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ankle Fracture Foreign Clozaril PS Novartis Initial or Prolonged Blood Creatine Health Pharmaceuticals Corp ORAL 500 MG DAILY, Phosphokinase Increased Professional ORAL Confusional State Other Seresta (Oxazepam) SS ORAL 25 MG, QID, Dermatitis Bullous ORAL Fall Rash Erythematous Sedation Date:01/22/01ISR Number: 3652815-5Report Type:Expedited (15-DaCompany Report #PHHO2000ZA01405 Age:25 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pyelonephritis Foreign Clozaril PS Novartis Initial or Prolonged Study Pharmaceuticals Corp ORAL 100 MG, ORAL Health Professional Other Date:01/22/01ISR Number: 3652840-4Report Type:Expedited (15-DaCompany Report #PHNU2000DE02400 Age:39 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Foreign Clozaril PS Novartis Initial or Prolonged Grand Mal Convulsion Health Pharmaceuticals Corp ORAL 50 MG/DAY Haemorrhagic Stroke Professional ORAL Intracranial Haemangioma Intracranial Venous Sinus Thrombosis Paresis Status Epilepticus 22-Feb-2006 08:30 AM Page: 1037 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/22/01ISR Number: 3652963-XReport Type:Expedited (15-DaCompany Report #10543064 Age:75 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Atelectasis Health Tequin PS Bristol Myers Squibb Hospitalization - Cardiac Arrest Professional Co Pharmaceutical Initial or Prolonged Cardiac Disorder Research Institute ORAL 400 Other Coma MILLIGRAM, Ejection Fraction 1/1 DAY ORAL Abnormal Digoxin SS .13 Electrocardiogram Qrs MILLIGRAM, 1 Complex Abnormal DAY Electrocardiogram St Clozaril (Clozapine) SS 75 MILLIGRAM, Segment Depression 2/1 DAY Hypokalaemia Prozac (Fluoxetine Hypokinesia Hc1) SS 10 MILLIGRAM, Myocardial Ischaemia 1 DAY Pleural Effusion Nortriptyline Ventricular Extrasystoles (Nortriptyline Hc1) SS 40 MILLIGRAM, Ventricular Fibrillation 1/1 DAY Metoprolol C Ativan C Aspirin C Lisionopril C Date:01/23/01ISR Number: 3653360-3Report Type:Expedited (15-DaCompany Report #PHFR1997GB00440 Age:41 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiac Failure Foreign Clozaril PS Novartis Drug Interaction Health Pharmaceuticals Corp ORAL ORAL Drug Level Above Professional Venlafaxine Therapeutic Other (Venlafaxine) SS 100 - 200 MG Oedema DAILY, Tachycardia Date:01/23/01ISR Number: 3653779-0Report Type:Expedited (15-DaCompany Report #PHBS2001AU00819 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Ketoacidosis Foreign Clozaril PS Baxter Healthcare Initial or Prolonged Hyperventilation Health Corp ORAL 400 MG /D Malaise Professional ORAL Thirst Other Weight Increased Date:01/23/01ISR Number: 3653861-8Report Type:Expedited (15-DaCompany Report #PHBS2001CA00805 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cerebrovascular Accident Foreign Clozaril PS Novartis Health Pharmaceuticals Corp ORAL ORAL Professional Other 22-Feb-2006 08:30 AM Page: 1038 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/23/01ISR Number: 3653864-3Report Type:Expedited (15-DaCompany Report #PHRM2001FR00500 Age:66 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Accidental Exposure Foreign Clozaril PS Novartis Coma Health Pharmaceuticals Corp ORAL ORAL Drug Interaction Professional Tercian Flatulence Other (Cyamemazine) Hypotension Solution SS ORAL ORAL Spironolactone C Furosemide C Lepticur (Tropatepine Hydrochloride) C Avlocardyl C Seresta (Oxazepam) C Noroxin (Norfloxacin) C Duphalac C Date:01/23/01ISR Number: 3653866-7Report Type:Expedited (15-DaCompany Report #PHFR2000GB02202 Age:21 YR Gender:Male I/FU:U Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradycardia Foreign Clozaril PS Novartis Initial or Prolonged Dizziness Health Pharmaceuticals Corp ORAL ORAL Hepatitis Viral Professional Hypotension Other Vomiting Date:01/23/01ISR Number: 3653867-9Report Type:Expedited (15-DaCompany Report #PHBS2001GR00745 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Face Oedema Foreign Clozaril PS Novartis Health Pharmaceuticals Corp ORAL 300 MG/D, Professional ORAL; 400 Other MG/D, ORAL Rivotril C Legofer (Ferriprotinate) C Date:01/23/01ISR Number: 3654143-0Report Type:Expedited (15-DaCompany Report #PHBS2000GB01572 Age:41 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiac Failure Foreign Clozaril PS Novartis Drug Interaction Health Pharmaceuticals Corp ORAL ORAL Drug Level Above Professional Venlafaxine Therapeutic Other (Venlafaxine) Oedema (Venlafaxine) SS ORAL SEE IMAGE Tachycardia 22-Feb-2006 08:30 AM Page: 1039 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/24/01ISR Number: 3653397-4Report Type:Expedited (15-DaCompany Report #C2001-0049.01 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Health Clozapine PS Mylan Initial or Prolonged Glycosuria Professional Pharmaceuticals Inc ORAL 150MG QD, Other Mania Other ORAL Date:01/24/01ISR Number: 3653405-0Report Type:Expedited (15-DaCompany Report #01-01-0022 Age:68 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 300MG QD ORAL Professional Date:01/24/01ISR Number: 3653416-5Report Type:Expedited (15-DaCompany Report #01-01-0007 Age:49 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 350MG QD ORAL Professional Date:01/24/01ISR Number: 3653424-4Report Type:Expedited (15-DaCompany Report #01-01-0006 Age:69 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hip Fracture Health Clozapine PS Zenith Goldline ORAL 25-62.5MG QD Professional ORAL Date:01/24/01ISR Number: 3653426-8Report Type:Expedited (15-DaCompany Report #01-01-0037 Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Renal Failure Health Clozapine PS Zenith Goldline ORAL 50-200MG QD Professional ORAL Date:01/24/01ISR Number: 3653946-6Report Type:Direct Company Report # Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Amnesia Clozapine (Clozaril) PS Initial or Prolonged Asthenia Required Convulsion Intervention to Fall Prevent Permanent Gait Disturbance Impairment/Damage Speech Disorder Date:01/25/01ISR Number: 3653895-3Report Type:Direct Company Report # Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neutrophil Count Clozaril 25 Mg Decreased Novartis PS Novartis ORAL 50 MG BID ORAL Clonazepam C Divalproex C 22-Feb-2006 08:30 AM Page: 1040 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Fluphenazine C Ranitidine C Trihexyphenidyl C Date:01/25/01ISR Number: 3654608-1Report Type:Periodic Company Report #00-10-0545 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chest Pain Consumer Clozapine PS Zenith Goldline OTHER Q4H Dyspnoea AERO-INHALATI Palpitations ON Date:01/25/01ISR Number: 3655184-XReport Type:Expedited (15-DaCompany Report #NSADSS2001001367 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Benign Ovarian Tumour Consumer Risperdal PS Janssen Research Fdn Drooling Health Div Johnson And Renal Failure Professional Johnson ORAL ORAL Sedation Topamax SS ORAL ORAL Clozapine SS ORAL 550 MG, DAILY, ORAL Depakote C Amiloride C Ibuprofen C Zoloft C Lisinopril C Date:01/25/01ISR Number: 3655798-7Report Type:Expedited (15-DaCompany Report #WAES 01018212 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Foreign Vasotec PS Merck Research Hospitalization - Coronary Artery Disease Health Laboratories Div Initial or Prolonged Hepatocellular Damage Professional Merck Co Inc ORAL 10 MG 21 DAY Pancreatitis Other Tab Clozapine SS ORAL 6.25 / 12.5 Renal Impairment MG 3 DAY Pipamperone Hydrochloride SS ORAL 80 MG 157 DAY Furosemide SS ORAL 40 MG Phenprocoumon SS ORAL Atorvastatin Calcium SS ORAL 10 MG Zocor C Acetaminophen C Captopril C Codeine C Dalteparin Sodium C Digoxin C Isosorbide Dinitrate C Moclobemide C Norfloxacin C Piperacillin C Torsemide C 22-Feb-2006 08:30 AM Page: 1041 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/25/01ISR Number: 3656046-4Report Type:Expedited (15-DaCompany Report #S01-UKI-00103-01 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Foreign Celexa PS Forest Laboratories Initial or Prolonged Grand Mal Convulsion Health Inc 60 MG QD Professional Cipramil SS Other Clozapine SS ORAL 400 MG QD PO Clozapine SS Date:01/25/01ISR Number: 3656366-3Report Type:Expedited (15-DaCompany Report #PHFR2001GB00561 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Foreign Clozaril PS Novartis Initial or Prolonged Cerebrovascular Accident Health Pharmaceuticals Corp ORAL 850 MG/DAY Professional ORAL Valproate Sodium C Orphenadrine (Orphenadrine) C Ranitidine (Ranitidine) C Date:01/25/01ISR Number: 3656368-7Report Type:Expedited (15-DaCompany Report #PHBS2001CL00894 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Nephritis Interstitial Foreign Clozaril PS Novartis Disability Renal Failure Chronic Health Pharmaceuticals Corp ORAL 250 MG/D ORAL Professional Lithium C Date:01/25/01ISR Number: 3656386-9Report Type:Expedited (15-DaCompany Report #PHFR2000GB01936 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abortion Spontaneous Foreign Clozaril PS Novartis Complications Of Maternal Health Pharmaceuticals Corp ORAL 275 MG/DAY, Exposure To Therapeutic Professional ORAL Drugs Pregnancy Date:01/26/01ISR Number: 3655923-8Report Type:Expedited (15-DaCompany Report #PHEH2001US00878 Age:67 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Breast Cancer Stage Ii Health Clozaril PS Novartis Initial or Prolonged Leukopenia Professional Pharmaceuticals Corp ORAL 400 MG, QD, ORAL Date:01/26/01ISR Number: 3655924-XReport Type:Expedited (15-DaCompany Report #PHEH2001US00799 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiomyopathy Health Clozaril PS Novartis Initial or Prolonged Professional Pharmaceuticals Corp ORAL 300 MG, QID, ORAL 22-Feb-2006 08:30 AM Page: 1042 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/29/01ISR Number: 3656417-6Report Type:Direct Company Report # Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Clozaril PS 75 MG QD 3 WK Initial or Prolonged Cardiac Enzymes Increased Effexor C Myocarditis Haldol C Vomiting Zyprexa C Date:01/29/01ISR Number: 3656903-9Report Type:Expedited (15-DaCompany Report #PHEH2000US11734 Age:69 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dementia Health Clozaril PS Novartis Other Pneumonia Professional Pharmaceuticals Corp ORAL 63 MG ORAL Date:01/29/01ISR Number: 3658403-9Report Type:Expedited (15-DaCompany Report #PHRM2001FR00539 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Foreign Clozaril PS Novartis Initial or Prolonged Diabetes Mellitus Health Pharmaceuticals Corp ORAL 100 MG QD Ketonuria Professional ORAL Polydipsia Other Deroxat (Paroxetine Polyuria Hydrochloride) Weight Decreased Tablet SS ORAL 20 MG QD ORAL Vitamin B12 (Cyancobalamin ) Solution For Injection SS INTRAMUSCULAR 100 UG QMO INTRAMUSCULAR Date:01/30/01ISR Number: 3656738-7Report Type:Expedited (15-DaCompany Report #00-12-0655 Age:60 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lymphoma Health Clozapine PS Zenith Goldline ORAL 350MG QD ORAL Neoplasm Malignant Professional Date:01/30/01ISR Number: 3656739-9Report Type:Expedited (15-DaCompany Report #01-01-0025 Age:60 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Health Clozapine PS Zenith Goldline ORAL 150MG HS ORAL Professional Date:01/30/01ISR Number: 3656740-5Report Type:Expedited (15-DaCompany Report #01-01-0013 Age:36 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL ORAL Professional Levaquin C Proventil Ud C Atrovent C 22-Feb-2006 08:30 AM Page: 1043 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/30/01ISR Number: 3656741-7Report Type:Expedited (15-DaCompany Report #01-01-0050 Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Nasopharyngeal Disorder Health Clozapine PS Zenith Goldline ORAL 25-100MG QD Paralysis Professional ORAL Vocal Cord Paralysis Date:01/30/01ISR Number: 3656742-9Report Type:Expedited (15-DaCompany Report #01-01-0048 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Gastrointestinal Health Clozapine PS Zenith Goldline ORAL ORAL Haemorrhage Professional Date:01/30/01ISR Number: 3656744-2Report Type:Expedited (15-DaCompany Report #01-01-0049 Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 25-250 MG QD Professional ORAL Date:01/30/01ISR Number: 3656746-6Report Type:Expedited (15-DaCompany Report #01-01-0046 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 100-300MG QD Professional ORAL Date:01/30/01ISR Number: 3656749-1Report Type:Expedited (15-DaCompany Report #01-01-0039 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Gastrointestinal Health Clozapine PS Zenith Goldline ORAL 400MG QD ORAL Initial or Prolonged Infection Professional Date:01/30/01ISR Number: 3656751-XReport Type:Expedited (15-DaCompany Report #01-01-0038 Age:73 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Health Clozapine PS Zenith Goldline ORAL 12.5-150MG QD Hospitalization - Coma Professional ORAL Initial or Prolonged Dehydration Lorazepam C Dementia Alzheimer'S Type Movement Disorder Date:01/30/01ISR Number: 3658729-9Report Type:Expedited (15-DaCompany Report #WAES 01010657 Age:19 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Cogentin PS Merck And Co Inc ORAL 20 MG/HS/ PO Overdose Professional Clozapine Unk SS ORAL 300 MG/DAILY/ Other PO Lamictal Unk SS ORAL 100 MG/ BID/ PO 22-Feb-2006 08:30 AM Page: 1044 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/31/01ISR Number: 3658131-XReport Type:Periodic Company Report #A0122448A Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pulmonary Embolism Health Wellbutrin PS Glaxo Wellcome Inc ORAL ORAL Initial or Prolonged Professional Clozapine Other (Formulation Unknown) (Clozapine) SS Oral Contraceptive C Lithium Salt C Clonazepam C Thyroxine Sodium C Date:01/31/01ISR Number: 3658713-5Report Type:Expedited (15-DaCompany Report #C2000-1906.01 Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Ruptured Cerebral Health Clozapine PS Mylan Aneurysm Professional Pharmaceuticals Inc Other Date:02/01/01ISR Number: 3657981-3Report Type:Expedited (15-DaCompany Report #01-01-0055 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 300-500 MG QD Professional ORAL Date:02/01/01ISR Number: 3657982-5Report Type:Expedited (15-DaCompany Report #01-01-0052 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 25-50 MG QD Professional ORAL Date:02/01/01ISR Number: 3657983-7Report Type:Expedited (15-DaCompany Report #01-01-0057 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Health Clozapine PS Zenith Goldline ORAL ORAL Professional Date:02/01/01ISR Number: 3657984-9Report Type:Expedited (15-DaCompany Report #01-01-0054 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 25 MG QD ORAL Professional Date:02/01/01ISR Number: 3657985-0Report Type:Expedited (15-DaCompany Report #00-10-0557 Age:66 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Failure To Thrive Health Clozapine PS Zenith Goldline ORAL 18.7-50 MG Professional ORAL 22-Feb-2006 08:30 AM Page: 1045 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/01/01ISR Number: 3657986-2Report Type:Expedited (15-DaCompany Report #00-10-0557 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 18.7-50 MG, Professional ORAL Date:02/01/01ISR Number: 3657987-4Report Type:Expedited (15-DaCompany Report #00-05-0214 Age:70 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dementia Health Clozapine PS Zenith Goldline ORAL 50-112.5 MG, Parkinson'S Disease Professional ORAL Pneumonia Aspiration Date:02/01/01ISR Number: 3657988-6Report Type:Expedited (15-DaCompany Report #00-05-0214 Age:70 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dementia Health Clozapine PS Zenith Goldline ORAL 50-112.5 MG, Parkinson'S Disease Professional ORAL Pneumonia Aspiration Levodopa-Carbidopa C Date:02/01/01ISR Number: 3657990-4Report Type:Expedited (15-DaCompany Report #00-11-0570 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Small Cell Lung Cancer Health Clozapine PS Zenith Goldline ORAL ORAL Stage Unspecified Professional Date:02/01/01ISR Number: 3657991-6Report Type:Expedited (15-DaCompany Report #00-12-0631 Age:92 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 100 MG QD Professional ORAL Date:02/01/01ISR Number: 3657992-8Report Type:Expedited (15-DaCompany Report #01-01-0056 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 25-150 MG, Professional QD, ORAL Date:02/01/01ISR Number: 3657993-XReport Type:Expedited (15-DaCompany Report #00-08-0414 Age:77 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dementia Health Clozapine PS Zenith Goldline ORAL 25-50MG, ORAL Professional 22-Feb-2006 08:30 AM Page: 1046 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/01/01ISR Number: 3657998-9Report Type:Expedited (15-DaCompany Report #00-08-0414 Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dementia Health Clozapine PS Zenith Goldline ORAL 25-250MG ORAL Professional Date:02/01/01ISR Number: 3657999-0Report Type:Expedited (15-DaCompany Report #00-09-0484 Age:74 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dementia Health Clozapine PS Zenith Goldline ORAL 12.5-250MG Professional ORAL Date:02/01/01ISR Number: 3658000-5Report Type:Expedited (15-DaCompany Report #00-09-0484 Age:74 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dementia Health Clozapine PS Zenith Goldline ORAL 12.5-250MG, Professional ORAL Sinemet-Cr C Coumadin C Dilantin C Date:02/01/01ISR Number: 3659251-6Report Type:Expedited (15-DaCompany Report #PHFR2000GB02134 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Confusional State Foreign Clozaril PS Novartis Convulsion Health Pharmaceuticals Corp ORAL 475 MG/DAY, Extensor Plantar Response Professional ORAL Sedation Other Amitriptyline C Ranitidine C Haloperidol C Gaviscon (Sodium Alginate) C Date:02/01/01ISR Number: 3659252-8Report Type:Expedited (15-DaCompany Report #PHBS2001AU01070 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiomyopathy Foreign Clozaril PS Novartis Health Pharmaceuticals Corp 500 MG/D Professional Other Date:02/01/01ISR Number: 3659254-1Report Type:Expedited (15-DaCompany Report #PHFR2001GB00563 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Foreign Clozaril PS Novartis Initial or Prolonged Haematemesis Health Pharmaceuticals Corp ORAL 200 MG Haematuria Professional TID/100 MG Influenza Like Illness Other NOCTE, ORAL Proteinuria Ulcer 22-Feb-2006 08:30 AM Page: 1047 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/01/01ISR Number: 3660235-2Report Type:Expedited (15-DaCompany Report #PHEH2001US00489 Age:56 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Metastasis Health Clozaril PS Novartis Ovarian Cancer Professional Pharmaceuticals Corp ORAL 275 MG, ORAL Cogentin (Benzatropine Mesilate) C Klonopin C Florinef (Fludrocortisone Acetate) C Chemotherapeutics, Other C Date:02/01/01ISR Number: 3660238-8Report Type:Expedited (15-DaCompany Report #PHEH2001US00909 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Health Clozaril PS Novartis Initial or Prolonged Testis Cancer Professional Pharmaceuticals Corp ORAL 150 MG AM Other +300MG HS, ORAL Clozapine SS Cogentin (Benzatropine Mesilate) C Nortriptyline (Nortriptyline) C Date:02/01/01ISR Number: 3660292-3Report Type:Expedited (15-DaCompany Report #97001553 Age:31 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Atrioventricular Block Literature Cardizem Sr PS Aventis Hospitalization - Blood Creatinine Health Pharmaceuticals Inc ORAL PO Initial or Prolonged Increased Professional Atenolol SS Other Blood Glucose Increased Clozapine SS Bradycardia Cardiac Arrest Hypotension Intentional Overdose Lethargy Suicide Attempt Ventricular Fibrillation Date:02/01/01ISR Number: 3660529-0Report Type:Expedited (15-DaCompany Report # PHNU2001DE00559 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Deep Vein Thrombosis Foreign Clozaril PS Novartis Pelvic Venous Thrombosis Health Pharmaceuticals Corp Post Thrombotic Syndrome Professional Skin Ulcer Other 22-Feb-2006 08:30 AM Page: 1048 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/01/01ISR Number: 3660532-0Report Type:Expedited (15-DaCompany Report #PHFR2001GB00475 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ecchymosis Foreign Clozaril PS Novartis Initial or Prolonged Fall Health Pharmaceuticals Corp ORAL ORAL Other Hypotonia Professional Other Date:02/01/01ISR Number: 3660785-9Report Type:Expedited (15-DaCompany Report #HQ6458626JAN2001 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Foreign Ativan PS Wyeth Ayerst Initial or Prolonged Cerebral Atrophy Health Laboratories 2.5 - 10 MG Other Confusional State Professional DAILY Delusion Other Leponex (Clozapine) SS Novartis ORAL 125MG 1 DAY Depersonalisation Leponex (Clozapine) SS Novartis ORAL 75MG 1 X/ 1 Depression DAY Disorientation Zoloft (Sertraline Fear Hydrochloride) C Sedation Noroxin Sleep Disorder (Norfloxacin) C Thinking Abnormal Tranxilium (Clorazepate Dipotassium) C Date:02/01/01ISR Number: 3660814-2Report Type:Expedited (15-DaCompany Report #PHRM2000FR01889 Age:50 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chronic Lymphocytic Foreign Clozaril PS Novartis Leukaemia Pharmaceuticals Corp ORAL 900 MG/DAY, ORAL Tercian (Cyamemazine) Tablet C Glucophage "Merck" Tablet C Hemi-Daonil Tablet C Lipanthyl "Fournier" (Fenofibrate) Capsule C Rohypnol (Flunitrazepan) Tablet C Stablon (Tianeptine) Tablet C Date:02/02/01ISR Number: 3660116-4Report Type:Periodic Company Report #FLUV00200000386 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Clonic Convulsion Health Luvox PS Solvay Initial or Prolonged Drug Level Above Professional Pharmaceuticals 150 MG BID Therapeutic UNK, 50 MG Muscle Twitching BID UNK Clozaril (Clozapine) SS 500 MG DAILY PO, UNK DAILY 22-Feb-2006 08:30 AM Page: 1049 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report UNK, UNK DAILY Lithium (Lithium Carbonate) SS UNK DAILY UNK Zyprexa (Olanzapine) C Depakote (Valproate Semisodium) C Loxapine (Loxapine) C Date:02/02/01ISR Number: 3660255-8Report Type:Expedited (15-DaCompany Report #PHFR2000GB02235 Age:38 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Strangulated Foreign Clozaril PS Novartis Initial or Prolonged Hernia Health Pharmaceuticals Corp ORAL 50 MG, QD, Condition Aggravated Professional ORAL Other Date:02/02/01ISR Number: 3660343-6Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypotonia Health Clozaril PS . Initial or Prolonged Loss Of Consciousness Professional Depakote SS Sedation Neurontin SS Ativan SS Date:02/05/01ISR Number: 3659733-7Report Type:Direct Company Report # Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutropenia Clozaril PS 50MG QAM, Initial or Prolonged 150MG Q HS STABILIZED X SEVERAL YEARS Neurontin C Zocor C Date:02/05/01ISR Number: 3661089-0Report Type:Expedited (15-DaCompany Report #PHEH2001US01171 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Toxicity Consumer Clozaril PS Novartis Pharmaceuticals Corp ORAL UNK, UNK, ORAL Date:02/05/01ISR Number: 3661650-3Report Type:Expedited (15-DaCompany Report #PHEH2001US01171 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Toxicity Consumer Clozaril PS Novartis Pharmaceuticals Corp ORAL ORAL 22-Feb-2006 08:30 AM Page: 1050 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/05/01ISR Number: 3661780-6Report Type:Expedited (15-DaCompany Report #PHEH2000US09312 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatitis C Health Clozaril PS Novartis Leukopenia Professional Pharmaceuticals Corp ORAL 200 MG AM Neutropenia +350MG HS, ORAL Cogentin (Benzatropine Mesilate ) C Zyprexa (Olanzapine) C Zantac C Ativan C Date:02/05/01ISR Number: 3662462-7Report Type:Expedited (15-DaCompany Report #PHBS2000NL08716 Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril PS Novartis Insulin-Dependent Literature Pharmaceuticals Corp 100 MG/DAY Hypertension Health Perphenazine Malaise Professional (Perphenazine) C Tachycardia Other Date:02/05/01ISR Number: 3662786-3Report Type:Expedited (15-DaCompany Report #PHFR2001GB00632 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Foreign Clozaril PS Novartis Initial or Prolonged Health Pharmaceuticals Corp ORAL 550MG/DAY, Other Professional ORAL Other Lithium (Lithium) C Aspirine C Tamoxifen C Date:02/05/01ISR Number: 3662795-4Report Type:Expedited (15-DaCompany Report #PHBS2000AU03421 Age:55 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Clozaril PS Novartis Health Pharmaceuticals Corp ORAL 100 MG, ORAL Professional Other Date:02/05/01ISR Number: 3662802-9Report Type:Expedited (15-DaCompany Report #PHBS2001GR00745 Age:38 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Erythema Foreign Clozaril PS Novartis Other Face Oedema Health Pharmaceuticals Corp ORAL 300,450,250,3 Skin Discolouration Professional 00 MG/D Other Rivotril C Legofer (Ferriprotinate) C 22-Feb-2006 08:30 AM Page: 1051 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/06/01ISR Number: 3660373-4Report Type:Direct Company Report #USP 53676 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Colazal PS Salix Pharmaceuticals Clozaril (Clozapine) SS Novartis Date:02/06/01ISR Number: 3662536-0Report Type:Expedited (15-DaCompany Report #PHBS2001CA00454 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Foreign Clozaril PS Novartis Body Temperature Study Pharmaceuticals Corp ORAL ORAL Increased Health Heart Rate Increased Professional Respiratory Depression Date:02/08/01ISR Number: 3662740-1Report Type:Expedited (15-DaCompany Report #PHBS2000CA10783 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Distension Foreign Clozaril PS Novartis Initial or Prolonged Constipation Study Pharmaceuticals Corp ORAL 400 MG, Decreased Appetite Health 300MG, QD, Dyspepsia Professional ORAL 358 DAY Gastrointestinal Injury Other Epival (Valproate Ileus Paralytic Semisodium) C Intestinal Obstruction Metamucil (Psyllium Megacolon Hydrophilic Mucilloid) C Date:02/08/01ISR Number: 3662742-5Report Type:Expedited (15-DaCompany Report #PHRM2001FR00612 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Lung Disorder Foreign Clozaril PS Novartis Initial or Prolonged Neutropenia Health Pharmaceuticals Corp ORAL 900 MG DAILY, Pulmonary Oedema Professional ORAL Other Depakine C Largactil (Chlorpromazine Hydrochloride) C Mopral (Omeprazole) C Date:02/08/01ISR Number: 3662746-2Report Type:Expedited (15-DaCompany Report #PHRM2000FR01952 Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypertonia Foreign Clozaril PS Novartis Initial or Prolonged Intentional Overdose Health Pharmaceuticals Corp ORAL 600 MG DAILY, Sedation Professional ORAL Suicide Attempt Other Loxapac (Loxapine Succinate) SS ORAL 1 G, ONCE/SINGLE, ORAL 22-Feb-2006 08:30 AM Page: 1052 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/09/01ISR Number: 3663115-1Report Type:Expedited (15-DaCompany Report #01-01-0032 Age:96 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Chronic Obstructive Health Clozapine PS Zenith Goldline ORAL 12.5 MG-75 MG Hospitalization - Pulmonary Disease Professional QD ORAL Initial or Prolonged Dehydration Megace C Electrolyte Imbalance Dilantin C Pneumonia Lanoxin C Renal Failure Respiratory Failure Date:02/09/01ISR Number: 3663117-5Report Type:Expedited (15-DaCompany Report #01-01-0062 Age:67 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Gastrointestinal Health Clozapine PS Zenith Goldline ORAL 6.2-37.5 MG Hospitalization - Haemorrhage Professional QD ORAL Initial or Prolonged Date:02/12/01ISR Number: 3663693-2Report Type:Direct Company Report # Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Clozapine Clozaril Anxiety 700 Mg PS ORAL 700 MG ONCE A Asthma DAY ORAL Convulsion Lorazepan Ativan 2 Cyst Mg Po SS ORAL 2 MG PRN ORAL Drug Interaction Morphine C Dyspnoea Percocet C Hallucination, Auditory Localised Infection Overdose Respiratory Depression Weight Increased Date:02/12/01ISR Number: 3664110-9Report Type:Periodic Company Report #HQ298862OCT1999 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Interaction Health Effexor PS Wyeth Ayerst Overdose Professional Laboratories ORAL 75 MG 2X PER 1 DAY, ORAL Caffeine (Caffeine) SS Carbamazepine (Carbamazepine) SS ORAL ORAL Clozapine (Clozapine) SS Methadone (Methadone) SS ORAL 40 MG INCREASED 10 MG DAILY TO 80 MG DAILY, ORAL 22-Feb-2006 08:30 AM Page: 1053 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/12/01ISR Number: 3664242-5Report Type:Expedited (15-DaCompany Report #01-01-0030 Age:55 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozapine PS Zenith Goldline ORAL 60 MG QD ORAL Respiratory Disorder Professional Olanzapine Tablets SS ORAL 30MG QD ORAL White Blood Cell Count Lorazepam 2 Mg Tid C Decreased Date:02/12/01ISR Number: 3664243-7Report Type:Expedited (15-DaCompany Report #01-01-0070 Age:90 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 6-2-12MG QD Professional ORAL Date:02/12/01ISR Number: 3664244-9Report Type:Expedited (15-DaCompany Report #01-01-0048 Age:75 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Upper Gastrointestinal Health Clozapine PS Zenith Goldline ORAL ORAL Haemorrhage Professional Sinemet C Estradiol 1 Mg C Levoxyl C Nortriptyline 100 Mg C Pindolol 5 Mg C Trazodone 50 Mg C Date:02/12/01ISR Number: 3664245-0Report Type:Expedited (15-DaCompany Report #01-01-0014 Age:53 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Breast Cancer Stage Iv Health Clozapine PS Zenith Goldline ORAL 400 MG-600 MG Professional QD ORAL Date:02/12/01ISR Number: 3664435-7Report Type:Expedited (15-DaCompany Report #C2001-0049.01 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Health Clozapine PS Mylan Initial or Prolonged Glycosuria Professional Pharmaceuticals Inc ORAL 150MG QD, Other Mania Other ORAL Date:02/13/01ISR Number: 3664949-XReport Type:Expedited (15-DaCompany Report #PHFR2001GB00632 Age:53 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebral Infarction Foreign Clozaril PS Novartis Initial or Prolonged Cerebrovascular Accident Health Pharmaceuticals Corp ORAL 550 MG/DAY, Disability Professional ORAL Other Other Lithium (Lithium) C Aspirine C Tamoxifen C Valproate Semisodium (Valproate Semisodium) C 22-Feb-2006 08:30 AM Page: 1054 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/13/01ISR Number: 3665024-0Report Type:Expedited (15-DaCompany Report #PHFR2001GB00674 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Crohn'S Disease Foreign Clozaril PS ORAL 500 MG,DAY, Hypertension Health ORAL Professional Prednisolone C Date:02/13/01ISR Number: 3665026-4Report Type:Expedited (15-DaCompany Report #PHBS2001CA00454 Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agranulocytosis Foreign Clozaril (Clozapine) Body Temperature Study (Clozapine) PS ORAL ORAL Increased Health Heart Rate Decreased Professional Heart Rate Increased Hepatic Failure Respiratory Depression Date:02/13/01ISR Number: 3665109-9Report Type:Expedited (15-DaCompany Report #PHBS2000AU11221 Age:49 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiomyopathy Foreign Clozaril (Clozapine) Initial or Prolonged Catatonia Health Tablet PS ORAL 300 MG/D, Mutism Professional ORAL Myocarditis Other Paranoia Date:02/13/01ISR Number: 3665117-8Report Type:Expedited (15-DaCompany Report #PHBS2001ID01499 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cyanosis Foreign Clozaril PS Novartis Hospitalization - Ileus Paralytic Health Pharmaceuticals Corp ORAL SEE IMAGE 18 DAY Initial or Prolonged Professional Alinamin F Other (Fursultiamine) C Domperidone (Domperidone) C Date:02/13/01ISR Number: 3665169-5Report Type:Expedited (15-DaCompany Report #PHBS2001CA00519 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cough Foreign Clozaril PS Novartis Initial or Prolonged Depressed Level Of Study Pharmaceuticals Corp ORAL ORAL Consciousness Health Dyspnoea Professional Renal Failure Respiratory Distress Respiratory Failure Sepsis Tachycardia Tachypnoea Urinary Tract Infection 22-Feb-2006 08:30 AM Page: 1055 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/13/01ISR Number: 3665448-1Report Type:Expedited (15-DaCompany Report #PHFR2001GB00683 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Distension Foreign Clozaril PS Novartis Initial or Prolonged Abdominal Pain Health Pharmaceuticals Corp ORAL 350MG/DAY, Appendicitis Professional ORAL Constipation Other Amitriptyline Peritonitis Hydrochloride (Amitriptyline Hydrochloride) C Date:02/14/01ISR Number: 3664756-8Report Type:Direct Company Report # Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Convulsion Clozapine (Clozaril) PS Date:02/14/01ISR Number: 3664927-0Report Type:Expedited (15-DaCompany Report #01-01-0046 Age:72 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 100-300MG QD Professional ORAL Ranitidine C Benztropine C Date:02/14/01ISR Number: 3664928-2Report Type:Expedited (15-DaCompany Report #01-01-0038 Age:73 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coma Health Clozapine PS Zenith Goldline ORAL 12.5 -150MG Hospitalization - Dehydration Professional QD ORAL Initial or Prolonged Lorazepam 0.5mg C Morphine 2mg C Date:02/14/01ISR Number: 3664929-4Report Type:Expedited (15-DaCompany Report #01-01-0046 Age:72 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 100-300MG QD Professional ORAL Ranitidine 150 Mg C Benztropine Mesylate C Date:02/14/01ISR Number: 3664931-2Report Type:Expedited (15-DaCompany Report #01-01-0006 Age:69 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hip Fracture Health Clozapine PS Zenith Goldline ORAL 25-62.5MG QD Professional ORAL Ativan C Permax C Sinemet-Cr C Dulcolax Supositories C Phenegran C 22-Feb-2006 08:30 AM Page: 1056 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Timoptic C Granulex Spray C Date:02/14/01ISR Number: 3664939-7Report Type:Expedited (15-DaCompany Report #01-02-0073 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 575-600MG QD Professional ORAL Date:02/14/01ISR Number: 3664940-3Report Type:Expedited (15-DaCompany Report #01-02-0074 Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neoplasm Malignant Health Clozapine PS Zenith Goldline ORAL 50-75MG QD Professional ORAL Date:02/15/01ISR Number: 3666626-8Report Type:Expedited (15-DaCompany Report #PHBS2000AU12379 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiomegaly Foreign Clozaril Dehydration Health (Clozapine)(Clozapin Delirium Professional e) PS ORAL 200 MG/D, Diarrhoea Other ORAL Hypotension Epilim C Laboratory Test Abnormal Venlafaxine Mental Impairment (Venlafaxine) C Pneumonia Sepsis Tachycardia Date:02/15/01ISR Number: 3666676-1Report Type:Expedited (15-DaCompany Report #PHFR2000GB01824 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Basal Ganglion Foreign Clozaril Degeneration Health (Clozapine)Tablet PS ORAL 900MG/DAY, Grand Mal Convulsion Professional ORAL Diazepam C Lactulose Solution Bp C Keto-Sugars C Galactose C Tagatose C Lactose C Valproate Sodium C Date:02/15/01ISR Number: 3667111-XReport Type:Expedited (15-DaCompany Report #PHEH2000US11734 Age:69 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Oral Intake Reduced Health Clozaril (Clozapine) PS Novartis Pharm ORAL 12.5 MG, BID, Pyrexia Professional ORAL Sepsis Urinary Tract Infection 22-Feb-2006 08:30 AM Page: 1057 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/16/01ISR Number: 3667342-9Report Type:Expedited (15-DaCompany Report #PHEH2000US10928 Age:62 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Clozaril (Clozapine) Life-Threatening Congestive Professional (Clozapine) PS ORAL 800MG, ORAL Congestive Cardiomyopathy Ativan C Haldol C Lasix C Lanoxin C Coreg (Carvedilol) C Date:02/16/01ISR Number: 3667345-4Report Type:Expedited (15-DaCompany Report #PHEH2000US10584 Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hypoglycaemia Health Clozaril (Clozapine) Professional (Clozapine) Tablet PS ORAL 300 MG, ORAL Amantadine (Amantadine) C Lescol C Nitroglycerin Transdermal System C Humulin (Insulin Human, Insulin Isophane, Human Biosynthetic) C Date:02/16/01ISR Number: 3667347-8Report Type:Expedited (15-DaCompany Report #PHEH2001US01171 Age: Gender:Unknown I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Potassium Decreased Consumer Clozaril (Clozapine) PS ORAL 900 MG DAILY, Hospitalization - Confusional State ORAL Initial or Prolonged Drug Toxicity Clozaril Regimen # SS ORAL 300 MG DAILY, Fall ORAL Hypotension Leukocytosis Pneumonia Tachycardia Date:02/16/01ISR Number: 3667401-0Report Type:Expedited (15-DaCompany Report #PHEH2000US11733 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) PS ORAL 25MG, ORAL Professional Date:02/16/01ISR Number: 3667533-7Report Type:Expedited (15-DaCompany Report #PHFR2001IE00562 Age:53 YR Gender:Female I/FU:I Outcome PT Hospitalization - Blood Pressure Decreased Initial or Prolonged Diabetes Mellitus Hyperglycaemia Hyperglycaemic Hyperosmolar Nonketotic Syndrome 22-Feb-2006 08:30 AM Page: 1058 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pneumonia Sedation Report Source Product Role Manufacturer Route Dose Duration Foreign Clozaril Health (Clozapine)(Clozapin Professional e) PS ORAL ORAL; 200 MG, Other QD, ORAL Epanutin C Demospray (Desmopressin) C Date:02/16/01ISR Number: 3667797-XReport Type:Expedited (15-DaCompany Report #PHEH2000US11197 Age:84 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hypertension Health Clozaril (Clozapine) Professional Tablet PS ORAL 25 MG, ORAL Date:02/16/01ISR Number: 3668003-2Report Type:Expedited (15-DaCompany Report #PHFR2001GB00729 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pyrexia Foreign Clozaril(Clozapine) PS Temporal Arteritis Health Professional Other Date:02/16/01ISR Number: 3668012-3Report Type:Expedited (15-DaCompany Report #PHBS2000CA09287 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Myocardial Infarction Foreign Clozaril Hospitalization - Nephritis Interstitial Study (Clozapine)(Clozapin Initial or Prolonged Pneumonia Health e) PS ORAL ORAL Renal Failure Acute Professional Other Date:02/16/01ISR Number: 3668021-4Report Type:Expedited (15-DaCompany Report #PHHO2000GB01831 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anoxia Foreign Clozaril Life-Threatening Bronchopneumonia Study (Clozapine)(Clozapin Hospitalization - Cardiac Arrest Health e)Tablet PS ORAL 100MANE/175NO Initial or Prolonged Convulsion Professional CTE, ORAL Coronary Artery Disease Other Procyclidine Croup Infectious (Procyclidine) C Gastroenteritis Flupentixol Hypokalaemia (Flupentixol) C Hypotension Hypoxic Encephalopathy Loss Of Consciousness Overdose Ventricular Fibrillation Vomiting 22-Feb-2006 08:30 AM Page: 1059 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/16/01ISR Number: 3668348-6Report Type:Expedited (15-DaCompany Report #PHBS2001AU01675 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bacterial Sepsis Foreign Clozaril PS Novartis Pyrexia Study Pharmaceuticals Corp ORAL 275 MG/D, Health ORAL Professional Other Date:02/20/01ISR Number: 3666798-5Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Constipation Clozapine (100 Mg Hospitalization - Megacolon Tab) PS SEE IMAGE Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage Date:02/20/01ISR Number: 3667273-4Report Type:Direct Company Report # Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Clozapine 100 Mg Ud Hospitalization - - Zenith Goldline PS Zenith Goldline ORAL AMHS Initial or Prolonged (100MG)PO ;HS (50 MG ) PO Lactulose C Ativan C Nifedipine Xl C Vasotec C Kci C Zoloft C Date:02/21/01ISR Number: 3667631-8Report Type:Expedited (15-DaCompany Report #01-01-0037 Age:72 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Renal Failure Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 50-200MG QD ORAL Aspirin (E.C.) C Furosemide C Trihexyphenidyl C Metoprolol C Nasacort Aq C Novolin R C Triazolam C Novolin N C Enulose C Comtan C Lanoxin C Thermazene Cream 1% C Enalapril C 22-Feb-2006 08:30 AM Page: 1060 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Mag-Ox C Requip C Santyl C Nizoral 2% C Lorazepam C Sinemet C Date:02/21/01ISR Number: 3667632-XReport Type:Expedited (15-DaCompany Report #01-01-0027 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 550MG QD ORAL Detrol C Pravachol C Prevacid C Remeron C Date:02/21/01ISR Number: 3667633-1Report Type:Expedited (15-DaCompany Report #01-02-0079 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 225MG QD ORAL Date:02/21/01ISR Number: 3667636-7Report Type:Expedited (15-DaCompany Report #01-02-0082 Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 25-200MG QD ORAL Date:02/21/01ISR Number: 3667639-2Report Type:Expedited (15-DaCompany Report #01-02-0088 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL ORAL Date:02/21/01ISR Number: 3667641-0Report Type:Expedited (15-DaCompany Report #01-02-0083 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 150-300MG QD 22-Feb-2006 08:30 AM Page: 1061 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL Date:02/21/01ISR Number: 3667888-3Report Type:Direct Company Report # Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abnormal Behaviour Clozaril PS Hospitalization - Confusional State Initial or Prolonged Pallor Required Speech Disorder Intervention to Prevent Permanent Impairment/Damage Date:02/21/01ISR Number: 3668687-9Report Type:Expedited (15-DaCompany Report #PHBS2000SE11027 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acute Abdomen Foreign Clozaril PS Novartis Initial or Prolonged Constipation Health Pharmaceuticals Corp ORAL 300 MG/DAY, Gastric Ulcer Perforation Professional ORAL Haematemesis Other Zantac(Ranitidine Hypotension Hydrochloride) Nausea Tablet SS ORAL 150 MG/DAY,ORAL; 300 MG Alvedon (Paracetamol) C Date:02/21/01ISR Number: 3668691-0Report Type:Expedited (15-DaCompany Report #PHBS1996SE02492 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiomyopathy Foreign Clozaril PS Novartis Initial or Prolonged Diarrhoea Health Pharmaceuticals Corp ORAL 300 MG, ORAL Eosinophilia Professional Lithium(Lithium) SS Headache Other Truxal C Hepatic Function Abnormal Neutropenia Pyrexia Date:02/21/01ISR Number: 3668708-3Report Type:Expedited (15-DaCompany Report #PHBS2001BE01172 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Foreign Clozaril PS Novartis Initial or Prolonged C-Reactive Protein Health Pharmaceuticals Corp ORAL 200 MG/D, Increased Professional ORAL Infection Other Pyrexia White Blood Cell Count Increased 22-Feb-2006 08:30 AM Page: 1062 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/21/01ISR Number: 3668731-9Report Type:Expedited (15-DaCompany Report #PHBS2001CA01561 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Nausea Foreign Clozaril PS Novartis Weight Decreased Health Pharmaceuticals Corp ORAL 400 MG/D, Professional ORAL Other Date:02/21/01ISR Number: 3669546-8Report Type:Expedited (15-DaCompany Report #PHNU2001DE00696 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril PS Novartis Health Pharmaceuticals Corp ORAL ORAL Professional Alcohol (Ethanol) SS UNKNOWN Date:02/21/01ISR Number: 3669552-3Report Type:Expedited (15-DaCompany Report #PHRM2001FR00698 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aphasia Foreign Clozaril PS Novartis Initial or Prolonged Convulsion Health Pharmaceuticals Corp ORAL 400 MG DAILY Other Extensor Plantar Response Professional ORAL; 300 MG Motor Dysfunction Other DAILY ORAL Neuritis Hept-A-Myl Partial Seizures (Heptaminol Sensory Disturbance Hydrochloride) C Date:02/21/01ISR Number: 3669866-7Report Type:Expedited (15-DaCompany Report #PHFR2001GB00738 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Coma Foreign Clozaril PS Novartis Initial or Prolonged Health Pharmaceuticals Corp ORAL ORAL Professional Other Date:02/22/01ISR Number: 3668752-6Report Type:Expedited (15-DaCompany Report #S01-FRA-00291-01 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Amnesia Foreign Celexa PS Forest Laboratories Initial or Prolonged Blood Pressure Decreased Health Inc ORAL 20 MG QD PO Confusional State Professional Leponex (Clozapine) SS ORAL 100 MG QID PO Delirium Other Tranxene Epilepsy (Clorazepate Fall Dipotassium) SS ORAL 25 MG QD PO Nausea Syncope Vertigo Vomiting 22-Feb-2006 08:30 AM Page: 1063 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/22/01ISR Number: 3669932-6Report Type:Expedited (15-DaCompany Report #PHBS2000AU12499 Age:47 YR Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Diabetes Mellitus Foreign Clozaril PS Novartis White Blood Cell Count Health Pharmaceuticals Corp 200 MG/D Increased Professional Gliclazide Other (Gliclazide) C Date:02/26/01ISR Number: 3670033-1Report Type:Direct Company Report # Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Fall Clozapine PS 150MG QAM, Hospitalization - Lower Limb Fracture 300MG QHS Initial or Prolonged Neuroleptic Malignant Paxil SS 40MG QD Syndrome Oliguria Pyrexia Respiratory Distress Serotonin Syndrome Vasopressin Challenge Test Normal Date:02/26/01ISR Number: 3670505-XReport Type:Expedited (15-DaCompany Report #PHEH2001US00909 Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Health Clozaril PS Novartis Initial or Prolonged Testis Cancer Professional Pharmaceuticals Corp ORAL 150 MG AM + Other 300 HS ORAL Clozapine (Clozapine) SS Cogentin (Benzatropine Mesilate) C Nortriptyline (Nortriptyline) C Date:02/26/01ISR Number: 3670506-1Report Type:Expedited (15-DaCompany Report #PHEH2000US11326 Age:53 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Health Clozaril PS Novartis Initial or Prolonged Ruptured Cerebral Professional Pharmaceuticals Corp ORAL 675 MG QD Aneurysm ORAL Depakote (Valproate Semisodium) C Ativan C Ditropan (Oxybutynin) C Colace C 22-Feb-2006 08:30 AM Page: 1064 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/01ISR Number: 3670507-3Report Type:Expedited (15-DaCompany Report #PHEH2000US08113 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Atherosclerosis Health Clozaril PS Novartis Cardio-Respiratory Arrest Professional Pharmaceuticals Corp ORAL 700 MG QD Cardiomyopathy ORAL Drug Toxicity Klonopin Hiatus Hernia (Clonazepam) SS ORAL 0.25 MG QD Hypertension ORAL Restlessness Zoloft (Sertraline Hydrochloride) C Zantac C Combivent (Ipratropium Bromide, Salbutamol Sulfate) C Adalate C Date:02/26/01ISR Number: 3670710-2Report Type:Expedited (15-DaCompany Report #PHHO2000AU01923 Age:28 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Clozaril PS Novartis Cardiomegaly Study Pharmaceuticals Corp ORAL 400 MG, QD, Coma Health ORAL Confusional State Professional Serenace Diabetes Mellitus Other (Haloperidol) C Inadequate Control Metformin Dyspnoea (Metformin) C Eosinophilic Myocarditis Midazolam Hepatic Steatosis (Midazolam) C Influenza Like Illness Haloperidol C Ketonuria Actrapid Human Lymphadenopathy (Insulin Human) C Obesity Gentamicin Sedation (Gentamicin) C Tachycardia Date:02/26/01ISR Number: 3670729-1Report Type:Expedited (15-DaCompany Report #PHBS2001BR01203 Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Arrhythmia Foreign Clozaril PS Novartis Supraventricular Health Pharmaceuticals Corp ORAL 500; 400 Blood Cholesterol Professional MG/D, ORAL Increased Other Blood Triglycerides Increased Hypertension Date:02/26/01ISR Number: 3670738-2Report Type:Expedited (15-DaCompany Report #PHBS2001BR01886 Age:37 YR Gender:Male I/FU:I Outcome PT Hospitalization - Apathy Initial or Prolonged Confusional State Disorientation Drug Interaction 22-Feb-2006 08:30 AM Page: 1065 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hypomania Polyuria Report Source Product Role Manufacturer Route Dose Duration Foreign Clozaril PS Novartis Health Pharmaceuticals Corp ORAL 600 MG/D, Professional ORAL Other Leponex Regimen #2 SS ORAL 400 MG/D, ORAL Haloperidol C Biperiden (Biperiden) C Date:02/26/01ISR Number: 3670872-7Report Type:Expedited (15-DaCompany Report #PHFR2000GB02159 Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Diabetes Mellitus Foreign Clozaril PS Novartis Hospitalization - Insulin-Dependent Health Pharmaceuticals Corp ORAL 400 MG/DAY, Initial or Prolonged Diabetic Ketoacidosis Professional ORAL Thirst Other Benztropene (Benztropene) C Date:02/26/01ISR Number: 3671343-4Report Type:Expedited (15-DaCompany Report #PHFR2001GB00787 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Foreign Clozaril PS Novartis Initial or Prolonged Weight Increased Health Pharmaceuticals Corp ORAL 400 MG/DAY, Professional ORAL Other Amoxicillin (Amoxicillin) C Date:02/27/01ISR Number: 3670416-XReport Type:Direct Company Report # Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutrophil Count Health Clozapine (425 Mg / Initial or Prolonged Decreased Professional Daily) (Made By White Blood Cell Count Zenith) PS Zenith 7/21/00 Decreased STARTED AT 125 MG INCREASED TO 425 MG Date:02/27/01ISR Number: 3670428-6Report Type:Expedited (15-DaCompany Report #01-02-0101 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Chronic Myeloid Leukaemia Health Clozapine PS Zenith Goldline ORAL 250 MG ORAL Professional 22-Feb-2006 08:30 AM Page: 1066 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/27/01ISR Number: 3670429-8Report Type:Expedited (15-DaCompany Report #01-02-0094 Age:85 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 12.5MG QD Professional ORAL Date:02/27/01ISR Number: 3670630-3Report Type:Expedited (15-DaCompany Report #01-02-0093 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Breast Cancer Female Health Clozapine PS Zenith Goldline ORAL 150-200MG QD Professional ORAL Adriamycin C Cytoxan C Date:02/27/01ISR Number: 3670631-5Report Type:Expedited (15-DaCompany Report #01-02-0089 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Chronic Obstructive Health Clozapine PS Zenith Goldline ORAL 200 MG QD Pulmonary Disease Professional ORAL Date:02/27/01ISR Number: 3670634-0Report Type:Expedited (15-DaCompany Report #00-12-0654 Age:37 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 350 MG QD Professional ORAL Risperdal C Date:02/27/01ISR Number: 3671290-8Report Type:Direct Company Report # Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Haldol (Haloperidol) PS 5 MG IM / PO Life-Threatening Dyspnoea Q 4 HRS PRN Hospitalization - Muscle Rigidity Clozaril SS ORAL 25 MG PO Q Initial or Prolonged Neuroleptic Malignant PM / DC'D Syndrome AFTER ONE Oxygen Saturation DOSE Decreased Sinemet C Pneumonia Effexor C Pyrexia Lipitor C Inderal C Asa C Exelon C Depakote C Date:02/28/01ISR Number: 3671628-1Report Type:Direct Company Report # Age:26 YR Gender:Male I/FU:I Outcome Life-Threatening Hospitalization - Initial or Prolonged Required 22-Feb-2006 08:30 AM Page: 1067 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Intervention to Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Body Temperature Risperidal PS 8MG Q D / Increased APPROX. 4-6 Dysuria WEEKS 4 WK Fall Clozapine SS 450 QHS Hyperhidrosis Pyrexia Tachycardia Tachypnoea Date:02/28/01ISR Number: 3672710-5Report Type:Periodic Company Report #C2000-0126.01 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Health Atenolol PS Mylan Asthenia Professional Pharmaceuticals Inc ORAL 50 MG BID, Back Pain Other ORAL Chest Pain Clozaril Novartis SS Novartis ORAL 200 MG , ORAL Dehydration Seroquel C Dyspnoea Depakote C Headache Anafranil C Hypotension Muscle Spasms Date:02/28/01ISR Number: 3676933-0Report Type:Periodic Company Report #A019726 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Health Zoloft PS Pfizer Delusion Professional Pharmaceuticals Inc ORAL 100.00 MG Dermatitis TOTAL:DAILY:O Infection RAL Leukocytosis Clozapine SS ORAL 400.00 MG Paranoia TOTAL:BID:ORA Pruritus L Schizophreniform Disorder Clonazepam SS ORAL 2.00 MG Speech Disorder TOTAL:DAILY:O RAL Olanzapine SS ORAL 10.00 MG TOTAL:DAILY:O RAL Herbal Supplement C Date:03/01/01ISR Number: 3672053-XReport Type:Expedited (15-DaCompany Report #PHEH2001US01811 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozaril PS Novartis Life-Threatening Professional Pharmaceuticals Corp ORAL 600 MG, ORAL Hospitalization - Initial or Prolonged 22-Feb-2006 08:30 AM Page: 1068 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/01/01ISR Number: 3672068-1Report Type:Expedited (15-DaCompany Report #PHEH2001US01801 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hepatic Neoplasm Health Clozaril PS Novartis Malignant Professional Pharmaceuticals Corp ORAL 350 MG, ORAL Lung Neoplasm Malignant Company Representative Date:03/01/01ISR Number: 3672305-3Report Type:Expedited (15-DaCompany Report #PHBS2001AU02069 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril PS Novartis Non-Insulin-Dependent Study Pharmaceuticals Corp ORAL ORAL Health Professional Other Date:03/01/01ISR Number: 3672308-9Report Type:Expedited (15-DaCompany Report #PHBS2001AU02053 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril PS Novartis Non-Insulin-Dependent Study Pharmaceuticals Corp ORAL ORAL Health Professional Other Date:03/01/01ISR Number: 3672310-7Report Type:Expedited (15-DaCompany Report #PHFR20011E00630 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Clozaril PS Novartis Initial or Prolonged Increased Health Pharmaceuticals Corp ORAL 275 MG/DAY, Aspartate Professional ORAL Aminotransferase Other Valproate Sodium C Increased Diazepam C Blood Bilirubin Increased Lorazepam C Clostridium Colitis Gamma-Glutamyltransferase Increased Date:03/01/01ISR Number: 3672311-9Report Type:Expedited (15-DaCompany Report #PHBS2001CA00755 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accident Foreign Clozaril PS Novartis Initial or Prolonged Accidental Overdose Study Pharmaceuticals Corp ORAL 75 MG/D, Disability Burns Second Degree Health ORAL; 50 MG Other Confusional State Professional MANE, 100 MG Disorientation Other NOCTE, ORAL; Dizziness 450 MG/D, UNK Face Oedema Ativan C Sedation Epival (Valproate Swelling Semisodium) C Ditropan (Oxybutynin) C 22-Feb-2006 08:30 AM Page: 1069 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Seroquel (Quetiapine) C Lithium (Lithium) C L-Thyroxin C Date:03/01/01ISR Number: 3672326-0Report Type:Expedited (15-DaCompany Report #PHBS2001CA02001 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abnormal Behaviour Foreign Anafranil PS Novartis Agitation Literature Pharmaceuticals Corp 150 MG/DAY Chills Health Clozapine Compulsions Professional (Clozapine) SS Condition Aggravated Other Confusional State Constipation Drug Withdrawal Syndrome Hyperhidrosis Nervousness Serotonin Syndrome Date:03/01/01ISR Number: 3672331-4Report Type:Expedited (15-DaCompany Report #PHBS2001AU02054 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril PS Novartis Non-Insulin-Dependent Study Pharmaceuticals Corp ORAL ORAL Health Professional Other Date:03/01/01ISR Number: 3672332-6Report Type:Expedited (15-DaCompany Report #PHFR2001GB00793 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Foreign Clozaril PS Novartis Initial or Prolonged Convulsion Health Pharmaceuticals Corp ORAL 500MG/DAY, Overdose Professional ORAL Other Lithium (Lithium) C Citalopram (Citalopram) C Procyclidine (Procyclidine) C Zopiclone C Date:03/01/01ISR Number: 3672333-8Report Type:Expedited (15-DaCompany Report #PHBS2001AU02070 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril PS Novartis Non-Insulin-Dependent Study Pharmaceuticals Corp ORAL ORAL Health Professional Other 22-Feb-2006 08:30 AM Page: 1070 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/01/01ISR Number: 3672513-1Report Type:Expedited (15-DaCompany Report #PHBS2001AU01357 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Discomfort Foreign Clozaril (Clozapine) Initial or Prolonged Chest Pain Health (Clozapine) PS Novartis Melaena Professional Pharmaceuticals Corp ORAL 200 MG/DAY, Pain In Extremity ORAL Epilim C Olanzapine (Olanzapine) C Date:03/01/01ISR Number: 3673228-6Report Type:Expedited (15-DaCompany Report #PHBS2000AU08981 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anorexia Foreign Clozaril (Clozapine) Hospitalization - Cerebrovascular Accident Study (Clozapine) PS Novartis Initial or Prolonged Circulatory Collapse Health Pharmaceuticals Corp ORAL 400 MG/D, Disability Constipation Professional ORAL Convulsion Becloforte "Glaxo" Decubitus Ulcer (Beclometasone Drug Level Changed Dipropionate) C Electrolyte Imbalance Paracetamol Ileus Paralytic (Paracetamol) C Meningitis Viral Salbutamol C Pubic Rami Fracture Rib Fracture Sedation Urinary Tract Infection Date:03/02/01ISR Number: 3673509-6Report Type:Expedited (15-DaCompany Report #PHBS2001AU02133 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Embolism Foreign Clozaril PS Novartis Gastrointestinal Necrosis Health Pharmaceuticals Corp ORAL 175 MG, QD, Professional ORAL Other Date:03/05/01ISR Number: 3673254-7Report Type:Expedited (15-DaCompany Report #01-02-0104 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Health Clozapine PS Zenith Goldline ORAL 25-625MG QD Professional ORAL Date:03/05/01ISR Number: 3673262-6Report Type:Expedited (15-DaCompany Report #01-02-0096 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 150MG QD ORAL Professional 22-Feb-2006 08:30 AM Page: 1071 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/05/01ISR Number: 3673263-8Report Type:Expedited (15-DaCompany Report #01-02-0074 Age:64 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neoplasm Malignant Health Clozapine PS Zenith Goldline ORAL 50-725MG QD Professional ORAL Date:03/05/01ISR Number: 3673266-3Report Type:Expedited (15-DaCompany Report #01-01-0056 Age:80 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dementia Alzheimer'S Type Health Clozapine PS Zenith Goldline ORAL 25-150MG QD Professional ORAL Date:03/05/01ISR Number: 3673270-5Report Type:Expedited (15-DaCompany Report #01-01-0030 Age:55 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozapine PS Zenith Goldline ORAL 600MG QD ORAL Respiratory Disorder Professional Olanzapine Tablets SS ORAL 30MG QD ORAL Lorazepam C Date:03/05/01ISR Number: 3673273-0Report Type:Expedited (15-DaCompany Report #01-01-0025 Age:60 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Health Clozapine PS Zenith Goldline ORAL 150MG HS ORAL Professional Date:03/05/01ISR Number: 3673276-6Report Type:Expedited (15-DaCompany Report #01-01-0022 Age:68 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 300MG QD ORAL Professional Date:03/05/01ISR Number: 3673278-XReport Type:Expedited (15-DaCompany Report #01-01-0014 Age:53 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Breast Cancer Stage Iv Health Clozapine PS Zenith Goldline ORAL 400-600MG QD Professional ORAL Date:03/05/01ISR Number: 3673540-0Report Type:Expedited (15-DaCompany Report #00-03-0105 Age:63 YR Gender:Male I/FU:F Outcome PT Death Cardiac Failure Congestive Chronic Obstructive Pulmonary Disease Confusional State Dyskinesia Gait Disturbance Pneumonia Renal Failure Acute 22-Feb-2006 08:30 AM Page: 1072 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sepsis Shock Report Source Product Role Manufacturer Route Dose Duration Health Clozapine PS Zenith Goldline ORAL 900 MG ORAL Professional Lithium C Donepezil C Albuterol C Ipratropium C Levothyroxine C Prednisone C Prednisone C Date:03/05/01ISR Number: 3673886-6Report Type:Expedited (15-DaCompany Report #001-0184-M0100005 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Benadryl Hcl PS Parke Davis Div Initial or Prolonged Blood Pressure Increased Professional Warner Lambert Co Coordination Abnormal Clozapine SS Mania Clozapine SS 500 MG Movement Disorder (DAILY) Speech Disorder Zocor (Simvastatin) C Date:03/05/01ISR Number: 3673931-8Report Type:Expedited (15-DaCompany Report #PHEH2000US10292 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dehydration Health Clozaril PS Novartis Initial or Prolonged Drug Interaction Professional Pharmaceuticals Corp ORAL 600 MG, ORAL Drug Level Above Azithromycin Therapeutic (Azithromycin) SS ORAL 250 MG, QD, Grand Mal Convulsion ORAL Pneumonia Colace C Glucophag C Seroquel (Quetiapine) C Paxil C M.V.I. (Dexpanthenol, Retinol, Ascorbic Acid) C Date:03/05/01ISR Number: 3673934-3Report Type:Expedited (15-DaCompany Report #EMADSS2001000862 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Foreign Risperdal PS Janssen Research Fdn ORAL 6 MG, DAILY, Drug Ineffective Health ORAL Neutrophil Count Professional Leponex (Clozapine) SS ORAL 100 MG, Decreased DAILY, ORAL Psychotic Disorder Zyprexa (Olanzapine) SS ORAL 10 MG, DAILY, White Blood Cell Count ORAL Decreased Disipal (Orphenadrine Hydrochloride) C Propavan (Propiomazine Maleate) C 22-Feb-2006 08:30 AM Page: 1073 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Zolfot (Sertraline Hydrochloride) C Date:03/05/01ISR Number: 3674032-5Report Type:Expedited (15-DaCompany Report #PHEH2001US01040 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Infection Health Clozaril PS Novartis Hospitalization - Pneumonia Professional Pharmaceuticals Corp ORAL 500 MG, QD, Initial or Prolonged ORAL Klonopin C Artane C Prolixin (Fluphenazine Hydrochloride) C Prozac (Fluoxetine Hydrochloride) C Zantac C Date:03/05/01ISR Number: 3674038-6Report Type:Expedited (15-DaCompany Report #PHEH2001US01826 Age:92 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Exposure Health Clozaril PS Novartis Drug Level Above Professional Pharmaceuticals Corp ORAL 400 MG, QHS, Therapeutic ORAL Loss Of Consciousness Vistaril Pulmonary Oedema (Hydroxyzine Respiratory Arrest Embonate) C Risperdal (Risperidone) C Digoxin C Glucotrol (Glipizide) C Lasix C Date:03/05/01ISR Number: 3674040-4Report Type:Expedited (15-DaCompany Report #PHEH2001US01835 Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dysarthria Health Clozaril PS Novartis Hemiparesis Professional Pharmaceuticals Corp ORAL 450MG DAILY, Lethargy ORAL Transient Ischaemic Tamiflu Attack (Oseltamivir) C Asa C Prinivil (Lisinopril) C Fosamax (Alendronate Sodium) C Milk Of Magnesia C Colace C Norvasc C Haloperidol C 22-Feb-2006 08:30 AM Page: 1074 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/05/01ISR Number: 3674151-3Report Type:Expedited (15-DaCompany Report #PHFR2000GB00478 Age:63 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Neoplasm Malignant Foreign Clozaril PS Novartis Study Pharmaceuticals Corp ORAL 275 MG/DAY, Health ORAL, TABLET Professional Other Date:03/05/01ISR Number: 3674155-0Report Type:Expedited (15-DaCompany Report #PHFR2000GB01227 Age:59 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Foreign Clozaril PS Novartis Initial or Prolonged Blood Pressure Increased Health Pharmaceuticals Corp ORAL 12.5 MG/DAY, Other Circulatory Collapse Professional ORAL; 125 Diabetes Mellitus Other MG, BID, ORAL Diabetic Hyperglycaemic Quetiapine Coma (Quetiapine) C Oral Antidiabetics (No Ingredients/Substanc es) C Clonazepam C Sulpiride (Sulpiride) C Perindopril (Perindopril) C Theophylline C Amlodipine C Date:03/05/01ISR Number: 3674158-6Report Type:Expedited (15-DaCompany Report #PHBS1999GB06076 Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Pressure Systolic Foreign Clozaril PS Novartis Hospitalization - Inspiratory Decreased Health Pharmaceuticals Corp ORAL 600 MG, QD, Initial or Prolonged C-Reactive Protein Professional ORAL Increased Other Salbutamol Cardiac Tamponade (Salbutamol) C Cardiomegaly Dyspnoea Electrocardiogram Abnormal Hypotension Hypoxia Malaise Mediastinal Disorder Pericardial Effusion Pericarditis Pleural Effusion Tachycardia Venous Pressure Jugular Increased 22-Feb-2006 08:30 AM Page: 1075 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/05/01ISR Number: 3674159-8Report Type:Expedited (15-DaCompany Report #PHBS2000CA04247 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Glioblastoma Foreign Clozaril PS Novartis Hospitalization - Study Pharmaceuticals Corp ORAL 75 MG, BID, Initial or Prolonged Health ORAL Professional Morphine (Morphine) C Other Decadron C Date:03/05/01ISR Number: 3674160-4Report Type:Expedited (15-DaCompany Report #PHBS2000GB04048 Age:57 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril PS Novartis Diabetes Mellitus Health Pharmaceuticals Corp ORAL 250 MG, ORAL Inadequate Control Professional Aspirine C Weight Increased Other Amlodipine C Hyoscine Hydrobromide C Gliclazide (Gliclazide) C Metformin (Metformin) C Date:03/05/01ISR Number: 3674483-9Report Type:Expedited (15-DaCompany Report #PHNU2000DE00499 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Complications Of Maternal Foreign Clozaril PS Novartis Exposure To Therapeutic Health Pharmaceuticals Corp TRANSPLACENTAL TRANSPLACENTA Drugs Professional L Convulsion Neonatal Other Premature Baby Date:03/06/01ISR Number: 3674651-6Report Type:Direct Company Report # Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Drug Level Above Clozaril PS 525MG PER DAY Intervention to Therapeutic > 90 DAYS Prevent Permanent Hypotension SINCE Impairment/Damage 6/22/2000 Valproic Acid C Date:03/06/01ISR Number: 3674657-7Report Type:Direct Company Report # Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Myositis Atorvastatin PS 20MG PER DAY 1 YR Intervention to Clozapine SS 250MG BID 3 YR Prevent Permanent Nph Insulin C Impairment/Damage Glucophage C Depakote C Depo-Provera C Dulcolax C Colace C 22-Feb-2006 08:30 AM Page: 1076 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/06/01ISR Number: 3674958-2Report Type:Expedited (15-DaCompany Report #01P-163-0103666-00 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Neutrophil Count Health Depakote PS Abbott Laboratories ORAL PER ORAL Intervention to Decreased Professional Risperidone Prevent Permanent (Risperidone) SS ORAL 2 MG, 1 IN 1 Impairment/Damage D, PER ORAL Clozapine (Clozapine) SS ORAL PER ORAL Date:03/07/01ISR Number: 3675653-6Report Type:Expedited (15-DaCompany Report #01P-056-0103802-00 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Amnesia Foreign Tranxene PS Abbott Laboratories Initial or Prolonged Blood Pressure Systolic Health Pharmaceutical Decreased Professional Products Div ORAL 25 MG, 1 IN 1 Confusional State D, PER ORAL Convulsion Citalopram Delirium Hydrobromide Loss Of Consciousness (Citalopram Malaise Hydrobromide) SS ORAL 20 MG, 1 IN 1 Nausea D, PER ORAL Vomiting Clozapine (Clozapine) SS ORAL 400 MG, 1 IN 1 D, PER ORAL Date:03/08/01ISR Number: 3676342-4Report Type:Direct Company Report # Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delusion Clozaril PS ORAL 100MG 8:30 AM Initial or Prolonged Hallucination PO; 200MG Other Neutrophil Count 8:30 PM PO Decreased Lith Carbonate C White Blood Cell Count Decreased Date:03/08/01ISR Number: 3677030-0Report Type:Expedited (15-DaCompany Report #C2000-1645.01 Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Neoplasm Malignant Health Clozapine PS Mylan Professional Pharmaceuticals Inc ORAL 800MG QD, Other ORAL Alprazolam C Desipramine C Hydroxyzine Pamoate C Date:03/12/01ISR Number: 3679642-7Report Type:Direct Company Report # Age:74 YR Gender:Female I/FU:I Outcome PT Death Body Temperature Life-Threatening Increased Hospitalization - Full Blood Count Initial or Prolonged Decreased 22-Feb-2006 08:30 AM Page: 1077 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Upper Respiratory Tract Infection Report Source Product Role Manufacturer Route Dose Duration Clozapine (Zenith-Goldine) (400mg Qd) PS Zenith-Goldine 100 MG AM + 300MG HS Lasix SS ORAL PO - ONGOING Zestril SS ORAL P.O. - ONGOING Verapamil SS ORAL P.O. - ONGOING Furosemide C Date:03/12/01ISR Number: 3680207-1Report Type:Expedited (15-DaCompany Report #PHEH2001US01801 Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hepatic Neoplasm Health Clozaril PS Novartis Malignant Professional Pharmaceuticals Corp ORAL 350 MG, ORAL Lung Neoplasm Malignant Company Representative Date:03/12/01ISR Number: 3680530-0Report Type:Expedited (15-DaCompany Report #PHEH2000US10293 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Catatonia Health Clozaril PS Novartis Initial or Prolonged Clonic Convulsion Professional Pharmaceuticals Corp ORAL 550 MG, ORAL Other Convulsion Azithromycin Delirium (Azithromycin) SS ORAL 250 MG, QD, Drug Interaction ORAL Drug Level Above Klonopin C Therapeutic Depakote (Valproate Pneumonia Semisodium) C Haldol C Impramine (Imipramine) C Date:03/12/01ISR Number: 3680550-6Report Type:Expedited (15-DaCompany Report #PHEH2000US10809 Age:44 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asthma Health Clozaril PS Novartis Injury Asphyxiation Professional Pharmaceuticals Corp ORAL 300 MG, QD, ORAL Diazepam C Vistaril (Hydroxyzine Embonate) C Date:03/12/01ISR Number: 3681464-8Report Type:Expedited (15-DaCompany Report #PHFR2001GB00866 Age: Gender:Female I/FU:I Outcome PT Hospitalization - Cardiomegaly Initial or Prolonged Cardiomyopathy 22-Feb-2006 08:30 AM Page: 1078 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pulmonary Oedema Report Source Product Role Manufacturer Route Dose Duration Foreign Clozaril PS Novartis Health Pharmaceuticals Corp ORAL 200 MG, QD, Professional ORAL Other Date:03/12/01ISR Number: 3681467-3Report Type:Expedited (15-DaCompany Report #PHNU2001DE00770 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Foreign Clozaril PS Novartis Initial or Prolonged Diabetes Mellitus Health Pharmaceuticals Corp ORAL ORAL Other Insulin-Dependent Professional Other Date:03/12/01ISR Number: 3681515-0Report Type:Expedited (15-DaCompany Report #PHFR2001GB00865 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Foreign Clozaril PS Novartis Diarrhoea Health Pharmaceuticals Corp ORAL 300 MG, QD, Facial Palsy Professional ORAL Other Date:03/12/01ISR Number: 3681518-6Report Type:Expedited (15-DaCompany Report #PHFR2001GB00876 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Glucose Increased Foreign Clozaril PS Novartis Diabetes Mellitus Health Pharmaceuticals Corp ORAL 450MG/DAY, Diabetic Ketoacidosis Professional ORAL Malaise Other Sertraline Polydipsia (Sertraline) C Polyuria Valproate Sodium C Date:03/12/01ISR Number: 3681519-8Report Type:Expedited (15-DaCompany Report #PHBS2001AU02331 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Sleep Apnoea Syndrome Foreign Clozaril PS Novartis Initial or Prolonged Study Pharmaceuticals Corp 400 MG/D, Health Professional Other Date:03/12/01ISR Number: 3681522-8Report Type:Expedited (15-DaCompany Report #PHNU2001DE00768 Age: Gender:Female I/FU:I Outcome PT Hospitalization - Granuloma Initial or Prolonged Neuroleptic Malignant Syndrome Polyserositis Systemic Lupus 22-Feb-2006 08:30 AM Page: 1079 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Erythematosus Report Source Product Role Manufacturer Route Dose Duration Foreign Clozaril PS Novartis Health Pharmaceuticals Corp Professional Other Date:03/13/01ISR Number: 3680482-3Report Type:Expedited (15-DaCompany Report #PHFR2001GB00860 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Ketoacidosis Foreign Clozaril PS Novartis Initial or Prolonged Health Pharmaceuticals Corp Professional Other Date:03/13/01ISR Number: 3680483-5Report Type:Expedited (15-DaCompany Report #PHFR2001GB00850 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril PS Novartis Health Pharmaceuticals Corp ORAL 400 MG/DAY, Professional ORAL Other Hyoscine (Hyoscine) C Thioridazine (Thioridazine) C Gliclazide (Gliclazide) C Date:03/13/01ISR Number: 3681021-3Report Type:Expedited (15-DaCompany Report #PHBS2001BR01886 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Foreign Clozaril PS Novartis Initial or Prolonged Apathy Health Pharmaceuticals Corp ORAL 600 MG/D, Confusional State Professional ORAL; 400 Disorientation MG/D,ORAL Drug Interaction Haloperidol C Hypomania Biperiden Polyuria (Biperidon) C Schizophrenia Date:03/13/01ISR Number: 3681027-4Report Type:Expedited (15-DaCompany Report #PHBS2001AU02515 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiomyopathy Foreign Clozaril PS Novartis Gastritis Health Pharmaceuticals Corp ORAL 400 MG/D ORAL Orthostatic Hypotension Professional Haloperidol C Tachycardia Other 22-Feb-2006 08:30 AM Page: 1080 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/13/01ISR Number: 3681790-2Report Type:Expedited (15-DaCompany Report #PHFR2001GB00849 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Body Temperature Foreign Clozaril PS Novartis Initial or Prolonged Decreased Health Pharmaceuticals Corp ORAL 150MG/DAY, Other Cerebrovascular Accident Professional ORAL Circulatory Collapse Other Propranolol C Fatigue Aspirine C Gait Disturbance Tamsulosin Hyperhidrosis (Tamsulosin) C Ranitidine (Ranitidine) C Lactulose C Date:03/14/01ISR Number: 3680347-7Report Type:Expedited (15-DaCompany Report #01-01-0067 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Loss Of Consciousness Health Clozapine PS Zenith Goldline ORAL 400MG QD ORAL Initial or Prolonged Malaise Professional Lithium C Mania Date:03/14/01ISR Number: 3680349-0Report Type:Expedited (15-DaCompany Report #01-02-0104 Age:80 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Health Clozapine PS Zenith Goldline ORAL 25-625MG QD Professional ORAL Date:03/14/01ISR Number: 3680350-7Report Type:Expedited (15-DaCompany Report #01-03-0116 Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Multi-Organ Failure Health Clozapine PS Zenith Goldline ORAL 87.5MG QD Life-Threatening Parkinsonism Professional ORAL Pneumonia Date:03/14/01ISR Number: 3680351-9Report Type:Expedited (15-DaCompany Report #00-05-0228 Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiomegaly Health Clozapine PS Zenith Goldline ORAL 400MG ORAL Drug Toxicity Professional Restoril C Pulmonary Congestion Pulmonary Oedema Date:03/14/01ISR Number: 3680352-0Report Type:Expedited (15-DaCompany Report #01-01-0032 Age:96 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dehydration Health Clozapine PS Zenith Goldline ORAL 12.5-75MG QD Hospitalization - Electrolyte Imbalance Professional ORAL Initial or Prolonged Hypoxia Megace C Pneumonia Dilantin C Renal Failure Lanoxin C Respiratory Failure 22-Feb-2006 08:30 AM Page: 1081 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/14/01ISR Number: 3680353-2Report Type:Expedited (15-DaCompany Report #01-02-0093 Age:46 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening No Adverse Drug Effect Health Clozapine PS Zenith Goldline ORAL 150-200MG QD Professional ORAL Adriamycin C Cytoxan C Lithium Carbonate C Lorazepam C Date:03/14/01ISR Number: 3680354-4Report Type:Expedited (15-DaCompany Report #01-02-0096 Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 150MG QD ORAL Professional Date:03/14/01ISR Number: 3680355-6Report Type:Expedited (15-DaCompany Report #01-03-0122 Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 350-425MG QD Professional ORAL Date:03/14/01ISR Number: 3680931-0Report Type:Expedited (15-DaCompany Report #PHEH2001US02181 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozaril PS Novartis Professional Pharmaceuticals Corp ORAL 400 MG UNK ORAL Date:03/14/01ISR Number: 3680960-7Report Type:Expedited (15-DaCompany Report #PHEH2000US07545 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Study Clozaril PS Novartis Initial or Prolonged Blood Glucose Increased Health Pharmaceuticals Corp ORAL 150 MG, ORAL Confusional State Professional Pepcid C Dehydration Cogentin Diabetic Ketoacidosis (Benzatropine Disorientation Mesilate) C Dyspnoea Kussmaul Respiration Metabolic Acidosis Restlessness Thirst Date:03/14/01ISR Number: 3681735-5Report Type:Expedited (15-DaCompany Report #PHFR2001GB00463 Age:48 YR Gender:Male I/FU:F Outcome PT Hospitalization - Abdominal Distension Initial or Prolonged Abdominal Pain Appendicitis Constipation 22-Feb-2006 08:30 AM Page: 1082 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Intestinal Perforation Peritonitis Report Source Product Role Manufacturer Route Dose Duration Foreign Clozaril PS Novartis Health Pharmaceuticals Corp ORAL 350MG/DAY, Professional ORAL ORAL Other Droperidol (Droperidol) C Amitriptyline (Amitriptyline) C Date:03/14/01ISR Number: 3682584-4Report Type:Expedited (15-DaCompany Report #01-03-0121 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Circulatory Collapse Health Clozapine PS Zenith Goldline ORAL 100-300 MG QD Professional ORAL Date:03/14/01ISR Number: 3682586-8Report Type:Expedited (15-DaCompany Report #01-03-0127 Age:80 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 12.5-87.5 MG Professional ORAL Date:03/14/01ISR Number: 3682589-3Report Type:Expedited (15-DaCompany Report #01-02-0079 Age:74 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 225MG QD ORAL Professional Date:03/16/01ISR Number: 3681924-XReport Type:Direct Company Report # Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Clozaril Po PS ORAL 300MG DAILY Initial or Prolonged Prilosec C Prozac C Zantac C Docusate C Xanax C Date:03/19/01ISR Number: 3682871-XReport Type:Expedited (15-DaCompany Report #256502 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Dyspnoea Valium PS Roche Clozaril SS 22-Feb-2006 08:30 AM Page: 1083 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/19/01ISR Number: 3684020-0Report Type:Expedited (15-DaCompany Report #PHBS2000GB02329 Age:51 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chronic Lymphocytic Foreign Clozaril PS Novartis Leukaemia Literature Pharmaceuticals Corp ORAL 400 MG/DAY, Lymphocyte Count Health ORAL Increased Professional Amitriptyline White Blood Cell Count Other (Amitriptyline) C Increased Procyclidine (Procyclidine) C Valproate Sodium C Date:03/19/01ISR Number: 3684201-6Report Type:Expedited (15-DaCompany Report #001-0073-M0100097 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Dilantin PS Parke Davis Div Drug Ineffective Professional Warner Lambert Co ORAL 400 MG (DAILY), PER ORAL Neurontin (Gabapentin) SS ORAL 1100 MG (DAILY), PER ORAL Clozapine (Clozapine) SS 450 MG Levothyroxine (Levothyroxine) C Lorazepam C Zolpidem C Celecoxib (Celecoxib) C Date:03/19/01ISR Number: 3684292-2Report Type:Expedited (15-DaCompany Report #PHEH2001US02268 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Health Clozaril PS Novartis Convulsion Professional Pharmaceuticals Corp ORAL 100 MG, ORAL Date:03/19/01ISR Number: 3684570-7Report Type:Expedited (15-DaCompany Report #PHBS2001CA02655 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Bronchospasm Foreign Clozaril PS Novartis Study Pharmaceuticals Corp ORAL ORAL Health Professional Other Date:03/19/01ISR Number: 3684578-1Report Type:Expedited (15-DaCompany Report #PHNU2001DE00848 Age:64 YR Gender:Male I/FU:I Outcome PT Other Ascites Gamma-Glutamyltransferase Increased 22-Feb-2006 08:30 AM Page: 1084 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hepatic Cirrhosis Hypoproteinaemia Report Source Product Role Manufacturer Route Dose Duration Foreign Clozaril PS Novartis Health Pharmaceuticals Corp ORAL 400 MG/DAY Professional ORAL Other Date:03/19/01ISR Number: 3684590-2Report Type:Expedited (15-DaCompany Report #PHBS2000AU04204 Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Electrocardiogram Foreign Clozaril PS Novartis Abnormal Health Pharmaceuticals Corp ORAL 1500 MG /DAY Overdose Professional ORAL Restrictive Other Alcohol(Ethanol) SS Cardiomyopathy Benzodiazepines SS Date:03/19/01ISR Number: 3684594-XReport Type:Expedited (15-DaCompany Report #PHBS2000AU07823 Age:25 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Cardiac Disorder Foreign Clozaril PS Novartis Cardiomyopathy Health Pharmaceuticals Corp ORAL 150 MG/DAY, Chest Pain Professional ORAL Hypertension Other Hypokinesia Psychotic Disorder Ventricular Hypertrophy Date:03/19/01ISR Number: 3684598-7Report Type:Expedited (15-DaCompany Report #PHFR2001GB00926 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril PS Novartis Health Pharmaceuticals Corp ORAL 400MG/DAY, Professional ORAL Other Hyoscine C Thioridazine C Date:03/19/01ISR Number: 3684611-7Report Type:Expedited (15-DaCompany Report #PHBS2001AU02178 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Obsessive-Compulsive Foreign Clozaril PS Novartis Disorder Health Pharmaceuticals Corp ORAL 400 MG/D, Professional ORAL Other Date:03/19/01ISR Number: 3684615-4Report Type:Expedited (15-DaCompany Report #PHBS2001AU02564 Age: Gender:Male I/FU:I Outcome PT Report Source Other Cardiomyopathy Foreign Health Professional 22-Feb-2006 08:30 AM Page: 1085 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Product Role Manufacturer Route Dose Duration Clozaril PS Novartis Pharmaceuticals Corp ORAL 400 MG/DAY, ORAL Date:03/19/01ISR Number: 3684616-6Report Type:Expedited (15-DaCompany Report #PHNU2001DE00828 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril PS Novartis Health Pharmaceuticals Corp ORAL UNK, UNK, Professional ORAL Company Representative Other Date:03/19/01ISR Number: 3684696-8Report Type:Expedited (15-DaCompany Report #2000AP05561 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Seroquel PS Astrazeneca Uk Ltd ORAL 250 MG BID PO Health Clozapine SS ORAL 175 MG PO Professional Thyroxin C Other Date:03/19/01ISR Number: 3684699-3Report Type:Expedited (15-DaCompany Report #2000AP05619 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Agranulocytosis Foreign Seroquel PS Astrazeneca Uk Ltd ORAL 600 MG DAILY Intervention to Body Temperature Health PO Prevent Permanent Increased Professional Leponex *Novartis* SS Novartis ORAL 100 MG TID PO Impairment/Damage Drug Level Below Other Zyprexa C Therapeutic Cisordinol C Leukopenia Lorazepam C Neuroleptic Malignant Syndrome Neutropenia Date:03/19/01ISR Number: 3684901-8Report Type:Expedited (15-DaCompany Report #PHFR2001GB00729 Age:70 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pyrexia Foreign Clozaril PS Novartis Initial or Prolonged Temporal Arteritis Health Pharmaceuticals Corp ORAL 200 MG/DAY, Other Professional ORAL Other Date:03/19/01ISR Number: 3684908-0Report Type:Expedited (15-DaCompany Report #PHBS2001AU02564 Age:49 YR Gender:Male I/FU:F Outcome PT Report Source Other Cardiomyopathy Foreign Health 22-Feb-2006 08:30 AM Page: 1086 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Other Product Role Manufacturer Route Dose Duration Clozaril PS Novartis Pharmaceuticals Corp ORAL 400 MG/DAY, ORAL Date:03/19/01ISR Number: 3685596-XReport Type:Direct Company Report # Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Clozapine PS 300MG Q HS Initial or Prolonged Dehydration Ceftriaxone C Required Hypoxia Zithromax C Intervention to Pyrexia Clindamycin C Prevent Permanent Respiratory Alkalosis Flonase C Impairment/Damage Tachycardia Claritin C Tachypnoea Protonix C Cogentin C Depakote C Tylenol C Albuterol C Lovenox C Atrovent C Date:03/20/01ISR Number: 3685315-7Report Type:Direct Company Report # Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Clozaril PS 600 MG PER Cough DAY Drug Level Above Therapeutic Drug Toxicity Influenza Myalgia Date:03/20/01ISR Number: 3686055-0Report Type:Expedited (15-DaCompany Report #C2000-1851.01 Age:91 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Aspiration Health Clozapine PS Mylan Sedation Professional Pharmaceuticals Inc ORAL 6.25 BID, Other ORAL Amantadine C Gabapentin C Buspirone C Date:03/21/01ISR Number: 3685794-5Report Type:Expedited (15-DaCompany Report #01-01-0070 Age:90 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 6.2-12MG QD Professional ORAL 22-Feb-2006 08:30 AM Page: 1087 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/21/01ISR Number: 3685797-0Report Type:Expedited (15-DaCompany Report #01-02-0093 Age:46 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neutropenia Health Clozapine PS Zenith Goldline ORAL 150-200MG QD White Blood Cell Count Professional ORAL Decreased Adriamycinc Injectable SS INTRAVENOUS 110MG INTRAVENOUS Cytoxan Injectables SS INTRAVENOUS 1104MG INTRAVENOUS Lithium Carbonate C Lorazepam C Zofran C Ativan C Decadron C Date:03/21/01ISR Number: 3685798-2Report Type:Expedited (15-DaCompany Report #01-03-0130 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Aspiration Health Clozapine PS Zenith Goldline ORAL 25-100 MG QD Senile Dementia Professional ORAL Date:03/21/01ISR Number: 3685800-8Report Type:Expedited (15-DaCompany Report #01-03-0131 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neoplasm Malignant Health Clozapine PS Zenith Goldline ORAL 25-60MG QD Professional ORAL Date:03/21/01ISR Number: 3685803-3Report Type:Expedited (15-DaCompany Report #01-03-0132 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Neoplasm Malignant Health Clozapine PS Zenith Goldline ORAL 475MG QD ORAL Hospitalization - Metastasis Professional Initial or Prolonged Pneumonia Date:03/21/01ISR Number: 3685805-7Report Type:Expedited (15-DaCompany Report #01-03-0137 Age:80 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neoplasm Malignant Health Clozapine PS Zenith Goldline ORAL 75 MG QD ORAL Professional Date:03/21/01ISR Number: 3685807-0Report Type:Expedited (15-DaCompany Report #01-03-0136 Age:76 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Respiratory Disorder Health Clozapine PS Zenith Goldline ORAL 100-40MG QD Hospitalization - Professional ORAL Initial or Prolonged 22-Feb-2006 08:30 AM Page: 1088 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/21/01ISR Number: 3685809-4Report Type:Expedited (15-DaCompany Report #00-11-0574 Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Condition Aggravated Health Clozapine PS Zenith Goldline ORAL 50-400MG ORAL Medication Error Professional Celexa C Schizophrenia, Paranoid Type Date:03/21/01ISR Number: 3685810-0Report Type:Expedited (15-DaCompany Report #01-03-0140 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Chronic Obstructive Health Clozapine PS Zenith Goldline ORAL 150-350MG QD Hospitalization - Pulmonary Disease Professional ORAL Initial or Prolonged Infection Respiratory Disorder Date:03/21/01ISR Number: 3685812-4Report Type:Expedited (15-DaCompany Report #01-03-0138 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Metastasis Health Clozapine PS Zenith Goldline ORAL 800MG QD ORAL Throat Cancer Professional Date:03/21/01ISR Number: 3685813-6Report Type:Expedited (15-DaCompany Report #01-03-0139 Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Chronic Obstructive Health Clozapine PS Zenith Goldline ORAL 225-250MG QD Hospitalization - Pulmonary Disease Professional ORAL Initial or Prolonged Pneumonia Date:03/21/01ISR Number: 3687339-2Report Type:Expedited (15-DaCompany Report #001-0073-M0100097 Age:58 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Dilantin PS Parke Davis Div Drug Ineffective Professional Warner Lambert Co ORAL 400 MG DAILY Medication Error PER ORAL Neurontin (Gabapentin) SS ORAL 1100 MG DAILY PER ORAL Clozapine (Clozapine) SS 450 MG Levothyroxine (Levothyroxine) C Lorazepam C (Zolpidem) C Celecoxib (Celecoxib) C 22-Feb-2006 08:30 AM Page: 1089 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/22/01ISR Number: 3688172-8Report Type:Expedited (15-DaCompany Report #PHFR2001GB00793 Age:54 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Foreign Clozaril PS Novartis Initial or Prolonged Convulsion Health Pharmaceuticals Corp ORAL 500MG/DAY, Overdose Professional ORAL Other Lithium (Lithium) C Citalopram (Citalopram) C Zopiclone C Procyclidine (Procyclidine) C Date:03/22/01ISR Number: 3688227-8Report Type:Expedited (15-DaCompany Report #PHFR2001GB01004 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Pressure Increased Foreign Clozaril PS Novartis Catatonia Health Pharmaceuticals Corp ORAL ORAL Heart Rate Increased Professional Stupor Other Date:03/23/01ISR Number: 3688179-0Report Type:Expedited (15-DaCompany Report #256652 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Rivotril PS Roche Initial or Prolonged Increased Preterax SS Aspartate Leponex SS Aminotransferase Prozac SS Increased Chronadalate C Pulmonary Embolism Date:03/23/01ISR Number: 3689437-6Report Type:Expedited (15-DaCompany Report #PHNU2000DE01989 Age:71 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Clozaril PS Novartis Health Pharmaceuticals Corp Professional Other Date:03/26/01ISR Number: 3689742-3Report Type:Expedited (15-DaCompany Report #PHEH2001US02482 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Testis Cancer Health Clozaril PS Novartis White Blood Cell Count Professional Pharmaceuticals Corp ORAL ORAL 1825 DAY Decreased Company Representative 22-Feb-2006 08:30 AM Page: 1090 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/26/01ISR Number: 3689744-7Report Type:Expedited (15-DaCompany Report #PHEH2001US02487 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Foreign Body Aspiration Health Clozaril PS Novartis Hospitalization - Professional Pharmaceuticals Corp ORAL ORAL Initial or Prolonged Date:03/26/01ISR Number: 3689751-4Report Type:Expedited (15-DaCompany Report #01-03-0145 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 250-500MG QD Professional ORAL Date:03/26/01ISR Number: 3689753-8Report Type:Expedited (15-DaCompany Report #01-03-0153 Age:81 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 12.5-37.5MG Professional ORAL Date:03/26/01ISR Number: 3689754-XReport Type:Expedited (15-DaCompany Report #01-03-0146 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 50MG QD ORAL Professional Date:03/26/01ISR Number: 3689777-0Report Type:Expedited (15-DaCompany Report #01-02-0074 Age:64 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neoplasm Malignant Health Clozapine PS Zenith Goldline ORAL 50-725 MG QD Professional ORAL Date:03/26/01ISR Number: 3689779-4Report Type:Expedited (15-DaCompany Report #PHEH2001US02490 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Lung Neoplasm Malignant Health Clozaril PS Novartis White Blood Cell Count Professional Pharmaceuticals Corp ORAL 125 MG, ORAL Decreased Verapamil C Artane (Trihexyphenidyl Hydrochloride) C Prolixin (Fluphenazine Hydrochloride) C Zantac C Allegra (Fexofenadine Hydrochloride) C Combivent (Ipratropium Bromide, Salbutamol Sulfate) C 22-Feb-2006 08:30 AM Page: 1091 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/26/01ISR Number: 3689782-4Report Type:Expedited (15-DaCompany Report #01-02-0089 Age:64 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Chronic Obstructive Health Clozapine PS Zenith Goldline ORAL 200MG QD ORAL Pulmonary Disease Professional Diabetes Mellitus Hypertension Sepsis Date:03/26/01ISR Number: 3689784-8Report Type:Expedited (15-DaCompany Report #01-03-0122 Age:77 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 350-425MG QD Professional ORAL Date:03/26/01ISR Number: 3689786-1Report Type:Expedited (15-DaCompany Report #01-02-0088 Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL ORAL Professional Date:03/26/01ISR Number: 3689788-5Report Type:Expedited (15-DaCompany Report #01-01-0057 Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL ORAL Professional Date:03/26/01ISR Number: 3689791-5Report Type:Expedited (15-DaCompany Report #00-12-0619 Age:78 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 25-50 MG QD Professional ORAL Sinemet C Ambien C Date:03/26/01ISR Number: 3690151-1Report Type:Expedited (15-DaCompany Report #PHFR2001GB01014 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Gastric Outlet Foreign Clozaril PS Novartis Initial or Prolonged Obstruction Health Pharmaceuticals Corp ORAL 775 MG/DAY Professional ORAL Other Senna (Senna) C Amisulpride (Amisulpride) C Valproate Sodium C Venlafaxine (Venlafaxine) C Lansoprazole (Lansoprazole) C 22-Feb-2006 08:30 AM Page: 1092 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/26/01ISR Number: 3690201-2Report Type:Expedited (15-DaCompany Report #PHFR2001GB01005 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Confusional State Foreign Clozaril PS Dupont Electroencephalogram Health Pharmaceuticals Co ORAL 400 MG/DAY, Abnormal Professional ORAL Encephalopathy Other Date:03/26/01ISR Number: 3690203-6Report Type:Expedited (15-DaCompany Report #PHFR2001GB00865 Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Foreign Clozaril PS Novartis Diarrhoea Health Pharmaceuticals Corp ORAL 300 MG, QD, Facial Palsy Professional ORAL Other Atenolol C Fluoxetine (Fluoxetine) C Date:03/26/01ISR Number: 3690204-8Report Type:Expedited (15-DaCompany Report #PHFR2001GB00800 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abortion Spontaneous Foreign Clozaril PS Novartis Complications Of Maternal Health Pharmaceuticals Corp ORAL ORAL Exposure To Therapeutic Professional Drugs Other Date:03/26/01ISR Number: 3690216-4Report Type:Expedited (15-DaCompany Report #PHBS2001AU01056 Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiomyopathy Foreign Clozaril PS Novartis Health Pharmaceuticals Corp ORAL 200 MG/D, Professional ORAL Other Haloperidol C Benztropine C Clonazepam C Paroxetine (Paroxetine) C Date:03/26/01ISR Number: 3690225-5Report Type:Expedited (15-DaCompany Report #PHBS2001AU01053 Age:27 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiomyopathy Foreign Clozaril PS Novartis Sinus Tachycardia Health Pharmaceuticals Corp ORAL 500 MG, QD, Professional ORAL Other Clonazepam C Date:03/26/01ISR Number: 3690228-0Report Type:Expedited (15-DaCompany Report #PHNU2001DE00696 Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Other Diabetes Mellitus Foreign Health 22-Feb-2006 08:30 AM Page: 1093 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Other Product Role Manufacturer Route Dose Duration Clozaril PS Novartis Pharmaceuticals Corp ORAL 100 MG, TID, ORAL Date:03/26/01ISR Number: 3690253-XReport Type:Expedited (15-DaCompany Report #PHFR2001GB01017 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Abnormal Behaviour Foreign Clozaril PS Novartis Other Aggression Health Pharmaceuticals Corp ORAL 500 MG/DAY, Agitation Professional ORAL Disinhibition Other Amisulpride Impulsive Behaviour (Amisulpride) C Hyoscine Hydrobromide C Valproate Sodium C Droperidol (Droperidol) C Date:03/26/01ISR Number: 3690255-3Report Type:Expedited (15-DaCompany Report #PHBS2001AU01070 Age:21 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiomyopathy Foreign Clozaril PS Novartis Health Pharmaceuticals Corp ORAL 500 MG/DAY, Professional ORAL Other Date:03/26/01ISR Number: 3690256-5Report Type:Expedited (15-DaCompany Report #PHFR2001GB00451 Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coagulopathy Foreign Clozaril PS Novartis Initial or Prolonged Gingival Bleeding Health Pharmaceuticals Corp ORAL 350 MG/DAY, Other Haemorrhage Professional ORAL Other Date:03/26/01ISR Number: 3690264-4Report Type:Expedited (15-DaCompany Report #PHBS2001AU02736 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Foreign Clozaril PS Novartis Initial or Prolonged Fracture Health Pharmaceuticals Corp ORAL ORAL Professional Valproate Sodium C Other Clexane (Heparin-Fraction, Sodium Salt) C Voltaren "Novartis" C Amitriptyline (Amitriptyline) C 22-Feb-2006 08:30 AM Page: 1094 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/26/01ISR Number: 3690306-6Report Type:Expedited (15-DaCompany Report #256652 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Clonopin PS Hoffmann La Roche Initial or Prolonged Increased Other Inc ORAL ORAL Aspartate Preterax (Indapamide Aminotransferase / Perindopril) SS ORAL ORAL Increased Leponex (Clozapine) SS ORAL ORAL Dyspnoea Prozac (Fluoxetine Haemoglobin Decreased Hydrochloride) SS ORAL ORAL Hepatocellular Damage Chronadalate Jugular Vein Thrombosis (Nifedipine) C Platelet Count Decreased Pleural Effusion Proteus Infection Pulmonary Embolism Pyrexia Urinary Tract Infection Date:03/27/01ISR Number: 3690624-1Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dizziness Clozaril 100mg Initial or Prolonged Orthostatic Hypotension Novartis PS Novartis ORAL 200MG BID ORAL Aspirin C Lansoprazole C Risperidone C Date:03/27/01ISR Number: 3691057-4Report Type:Expedited (15-DaCompany Report #PHBS2000IE01220 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abdominal Distension Foreign Clozaril Hospitalization - Circulatory Collapse Health (Clozapine)(Clozapin Initial or Prolonged Constipation Professional e)Tablet PS ORAL 500MG/DAY, Faecaloma Other ORAL Ileus Paralytic Intestinal Perforation Respiratory Arrest Staphylococcal Infection Date:03/27/01ISR Number: 3691064-1Report Type:Expedited (15-DaCompany Report #PHBS2000NZ03893 Age:76 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lymphoma Foreign Clozaril PS Novartis Lymphopenia Health Pharmaceuticals Corp ORAL 200 MG/DAY, Professional ORAL Other Allopurinol C Omeprazole (Omeprazole) C Norfloxacin (Norfloxacin) C 22-Feb-2006 08:30 AM Page: 1095 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/27/01ISR Number: 3691082-3Report Type:Expedited (15-DaCompany Report #PHBS2001AU01950 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Accidental Overdose Foreign Clozaril PS Novartis Medication Error Health Pharmaceuticals Corp ORAL 999 MG, QD, Panic Disorder Professional ORAL Sedation Other Cannabis (Cannabis) C Alcohol (Ethanol) C Date:03/27/01ISR Number: 3691112-9Report Type:Expedited (15-DaCompany Report #PHBS2000IE01220 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abdominal Distension Foreign Clozaril (Clozapine) Hospitalization - Circulatory Collapse Health Tablet PS ORAL 500MG/DAY, Initial or Prolonged Constipation Professional ORAL Faecaloma Other Ileus Paralytic Intestinal Perforation Respiratory Arrest Date:03/27/01ISR Number: 3691654-6Report Type:Expedited (15-DaCompany Report #PHEH2001US02446 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Lung Neoplasm Malignant Health Clozaril PS Novartis Initial or Prolonged Neutrophil Count Professional Pharmaceuticals Corp ORAL ORAL Decreased Clozapine(Clozapine) SS ORAL ORAL Date:03/27/01ISR Number: 3691675-3Report Type:Expedited (15-DaCompany Report #PHEH2000US09312 Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatitis C Health Clozaril PS Novartis Leukopenia Professional Pharmaceuticals Corp ORAL 200MG AM + Neutropenia 350MG HS, ORAL Interferon(Interfero n) SS THEE TIMES A WEEK 1604 DAY Zantac C Ativan C Cogentin (Benzatropine Mesilate) C Zyprexa (Olanzapine) C Date:03/27/01ISR Number: 3691680-7Report Type:Expedited (15-DaCompany Report #PHEH2001US01811 Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiogenic Shock Health Clozaril PS Novartis Life-Threatening Myocardial Infarction Professional Pharmaceuticals Corp ORAL 200 MG AM + Hospitalization - 400MG HS, Initial or Prolonged ORAL Depakote (Valproate Semisodium) C 22-Feb-2006 08:30 AM Page: 1096 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Amantadine (Amantadine) C Date:03/29/01ISR Number: 3691300-1Report Type:Direct Company Report # Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blood Pressure Increased Clozapine / Mylan PS Mylan ORAL 150MG QHS Intervention to ORAL Prevent Permanent Trilfluoperazine C Impairment/Damage Date:03/29/01ISR Number: 3692306-9Report Type:Expedited (15-DaCompany Report #01P-163-0104529-00 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ammonia Increased Literature Depakote PS Abbott Laboratories ORAL SEE IMAGE Initial or Prolonged Ascites Health Clozapine Drug Ineffective Professional (Clozapine) SS 175 MG,1 IN 1 Drug Interaction D Drug Level Above Lithium Carbonate Therapeutic (Lithium Carbonate) C Encephalopathy Perphenazine Hepatic Failure (Perphenazine) C Hepatomegaly Selegiline Hypertension (Selegiline) C Mania Lorazepam Pyrexia (Lorazepam) C Sedation Propranolol Tachycardia (Propranolol) C Tardive Dyskinesia Biperiden Tremor (Biperiden) C Salbutamol (Salbutamol) C Date:03/29/01ISR Number: 3692348-3Report Type:Expedited (15-DaCompany Report #PHNU2001DE00559 Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Deep Vein Thrombosis Foreign Clozaril PS Novartis Initial or Prolonged Hepatitis C Health Pharmaceuticals Corp 500MG/DAY Pelvic Venous Thrombosis Professional Post Thrombotic Syndrome Other Skin Ulcer Date:03/29/01ISR Number: 3692370-7Report Type:Expedited (15-DaCompany Report #PHBS2000NZ04134 Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Neoplasm Malignant Foreign Clozaril PS Novartis Neutropenia Health Pharmaceuticals Corp ORAL 500 MG/DAY, Professional ORAL Other Cyproterone (Cyproterone) C Chemotherapeutics, Other (Chemotherapeutics, 22-Feb-2006 08:30 AM Page: 1097 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other) C Omeprazole (Omeprazole) C Metoclopramide (Metoclopramide) C Morphine (Morphine) C Date:03/29/01ISR Number: 3692389-6Report Type:Expedited (15-DaCompany Report #PHFR2001GB01080 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Body Temperature Foreign Clozaril PS Novartis Initial or Prolonged Increased Health Pharmaceuticals Corp ORAL 200MG/DAY, Oesophageal Stenosis Professional ORAL Vomiting Other Weight Decreased White Blood Cell Count Increased Date:03/29/01ISR Number: 3692391-4Report Type:Expedited (15-DaCompany Report #PHNU2001DE00768 Age:42 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - C-Reactive Protein Foreign Clozaril PS Novartis Initial or Prolonged Increased Health Pharmaceuticals Corp ORAL ORAL Convulsion Professional Tavor C Dermatitis Other Pantozol Granuloma (Pantoprazole Hypervigilance Sodium) C Neuroleptic Malignant Beloc-Zoc Mite Syndrome (Metoprolol Pericardial Effusion Succinate) C Pleural Effusion Polyserositis Pyrexia Systemic Lupus Erythematosus Date:03/29/01ISR Number: 3692404-XReport Type:Expedited (15-DaCompany Report #PHBS2001AU02515 Age:21 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiomyopathy Clozaril PS Novartis Ejection Fraction Pharmaceuticals Corp ORAL 400 MG/D, Abnormal ORAL Orthostatic Hypotension Haloperidol C Tachycardia Date:03/31/01ISR Number: 3693559-3Report Type:Expedited (15-DaCompany Report #PHBS2000AU10099 Age:27 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Cardiac Disorder Foreign Clozaril (Clozapine) Cardiomyopathy Health (Clozapine) PS Novartis Dyskinesia Professional Pharmaceuticals Corp 100 MG MANE, Ventricular Hypertrophy 450 MG NOCTE Paroxetine (Paroxetine) SS 40 MG, QD 214 DAY 22-Feb-2006 08:30 AM Page: 1098 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/31/01ISR Number: 3693569-6Report Type:Expedited (15-DaCompany Report #PHBS2000GB01365 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Foreign Clozaril (Clozapine) Initial or Prolonged Fluctuation Health (Clozapine) PS Novartis Cardiac Disorder Professional Pharmaceuticals Corp ORAL ORAL Cardiac Murmur Diarrhoea Hypoventilation Jaundice Labile Blood Pressure Pneumonia Pyrexia Tachycardia Date:04/02/01ISR Number: 3694213-4Report Type:Expedited (15-DaCompany Report #01-03-0159 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Hiv Test Positive Health Clozapine PS Zenith Goldline ORAL 400 MG QD Professional ORAL Date:04/02/01ISR Number: 3694214-6Report Type:Expedited (15-DaCompany Report #01-03-0163 Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 600 MG QD Professional ORAL Date:04/02/01ISR Number: 3694217-1Report Type:Expedited (15-DaCompany Report #01-03-0164 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 25-800MG QD Professional ORAL Date:04/02/01ISR Number: 3694219-5Report Type:Expedited (15-DaCompany Report #01-02-0096 Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 150MG QD ORAL Professional Docusate C Zyprexa C Vitamin E C Paxil C Depakote C Depakote C Allegra C Benztropine Mesylate C Haloperidol C Topamax C 22-Feb-2006 08:30 AM Page: 1099 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/02/01ISR Number: 3694220-1Report Type:Expedited (15-DaCompany Report #01-03-0121 Age:24 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Circulatory Collapse Health Clozapine PS Zenith Goldline ORAL 100-300MG QD Sudden Death Professional ORAL Prozac C Date:04/02/01ISR Number: 3694221-3Report Type:Expedited (15-DaCompany Report #01-03-0132 Age:49 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Gastrointestinal Health Clozapine PS Zenith Goldline ORAL 475MG QD ORAL Hospitalization - Haemorrhage Professional Theophylline C Initial or Prolonged Lung Neoplasm Malignant Celebrex C Metastases To Lymph Nodes Depakote C Myocardial Infarction Pneumonia Date:04/02/01ISR Number: 3694397-8Report Type:Direct Company Report # Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Clozaril PS ORAL 200MG QAM & Initial or Prolonged 400MG QPM ORAL Nortriptyline C Clonazepam C Desmopressin C Thiothixene C Date:04/02/01ISR Number: 3694435-2Report Type:Expedited (15-DaCompany Report #PHNU2001DE00925 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Ventricular Extrasystoles Foreign Clozaril PS Novartis Health Pharmaceuticals Corp ORAL 150 MG DAILY, Professional ORAL Other Fevarin (Fluvoxamine Maleate) C Date:04/02/01ISR Number: 3694448-0Report Type:Expedited (15-DaCompany Report #PHFR2001GB00475 Age:27 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ecchymosis Foreign Clozaril PS Novartis Initial or Prolonged Fall Health Pharmaceuticals Corp ORAL 400 MG DAY Other Hypotonia Professional ORAL; 350 MG Other DAY ORAL Date:04/02/01ISR Number: 3694457-1Report Type:Expedited (15-DaCompany Report #PHBS2001AU01675 Age:29 YR Gender:Male I/FU:F Outcome PT Other Bacterial Sepsis Bronchitis C-Reactive Protein 22-Feb-2006 08:30 AM Page: 1100 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Increased Chest Pain Neck Pain Pyrexia Report Source Product Role Manufacturer Route Dose Duration Staphylococcal Sepsis Foreign Clozaril PS Novartis White Blood Cell Count Study Pharmaceuticals Corp ORAL 275 MG/D ORAL Increased Health Olanzapine Professional (Olanzapine) C Other Sertraline (Sertraline) C Date:04/02/01ISR Number: 3694554-0Report Type:Expedited (15-DaCompany Report #PHBS2000NZ03255 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eosinophilia Foreign Clozaril PS Novartis Infection Parasitic Health Pharmaceuticals Corp ORAL ORAL Professional Sodium Valproate Other (Valproate Sodimu) C Date:04/02/01ISR Number: 3694556-4Report Type:Expedited (15-DaCompany Report #PHRM2001FR00655 Age:81 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Foreign Clozaril PS Novartis Hospitalization - Anaemia Health Pharmaceuticals Corp ORAL 25 MG, QD, Initial or Prolonged C-Reactive Protein Professional ORAL Increased Other Sinemet (Levodopa, Pyrexia Carbidopa) Tablet C Renal Impairment Zyloric "Glaxo Wellcome" Tablet C Lexomil (Bromazepam) Tablet C Kaleorid Slow Release Tablet C Lasilix Tablet C Lovenox (Heparin-Fraction, Sodium Salt) C Date:04/02/01ISR Number: 3694585-0Report Type:Expedited (15-DaCompany Report #PHEH2001US02706 Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Health Clozaril PS Novartis Initial or Prolonged Professional Pharmaceuticals Corp ORAL 300 MG, ORAL Micronase C Avandia (Rosiglitazone Maleate) C Antihypertensive Drugs (No Ingredients / Substances) C 22-Feb-2006 08:30 AM Page: 1101 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/02/01ISR Number: 3694631-4Report Type:Expedited (15-DaCompany Report #PHBS2000AR09975 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetes Mellitus Foreign Clozaril PS Novartis Other Myocardial Infarction Health Pharmaceuticals Corp ORAL 50 MG/D, ORAL Professional Date:04/02/01ISR Number: 3694668-5Report Type:Expedited (15-DaCompany Report #PHFR2001GB00674 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Crohn'S Disease Foreign Clozaril PS Novartis Hypertension Health Pharmaceuticals Corp ORAL 500 MG/DAY, Professional ORAL Other Prednisolone C Date:04/02/01ISR Number: 3694669-7Report Type:Expedited (15-DaCompany Report #PHBS2001AU01057 Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiomyopathy Foreign Clozaril PS Novartis Health Pharmaceuticals Corp ORAL 500 MG, QD, Professional ORAL Other Epilim C Clonazepam C Date:04/02/01ISR Number: 3694676-4Report Type:Expedited (15-DaCompany Report #PHBS1996BR01793 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiogenic Shock Foreign Clozaril PS Novartis Cyanosis Pharmaceuticals Corp ORAL 200 MG, ORAL Dizziness Promethazine C Hypotension Tachycardia Vomiting Date:04/03/01ISR Number: 3696150-8Report Type:Expedited (15-DaCompany Report #PHEH2001US01741 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozaril PS Novartis Sepsis Professional Pharmaceuticals Corp ORAL 300 MG, UNK, White Blood Cell Count ORAL Increased Date:04/04/01ISR Number: 3697065-1Report Type:Expedited (15-DaCompany Report #PHBS2000NZ04624 Age:59 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Foreign Clozaril PS Novartis Initial or Prolonged Health Pharmaceuticals Corp ORAL 175 MG/DAY, Professional ORAL Other 22-Feb-2006 08:30 AM Page: 1102 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/04/01ISR Number: 3697068-7Report Type:Expedited (15-DaCompany Report #PHBS2000DE01471 Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Atherosclerosis Foreign Clozaril PS Novartis Hospitalization - Croup Infectious Study Pharmaceuticals Corp ORAL 6.25 MG/DAY, Initial or Prolonged Influenza Health ORAL (SEE Myocarditis Professional IMAGE) Pericardial Effusion Other Haldol Decanoate Pericarditis (Haloperidol Pyrexia Decanoate) C Scar Viral Infection Date:04/04/01ISR Number: 3697093-6Report Type:Expedited (15-DaCompany Report #PHBS1999CN01849 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Upper Foreign Clozaril PS Novartis Initial or Prolonged Asthenia Literature Pharmaceuticals Corp 50 MG/D, (SEE Bulimia Nervosa Health IMAGE) 14 DAY Hyperglycaemia Professional Hyperlipidaemia Other Hypersomnia Irritability Paralysis Paralysis Flaccid Sedation Tachycardia Vomiting Weight Increased Date:04/04/01ISR Number: 3697960-3Report Type:Expedited (15-DaCompany Report #2001AP01558 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Seroquel PS Astrazeneca Uk Ltd Health Seroquel "Zeneca" SS Professional Clozapine SS 1 WK Other Date:04/04/01ISR Number: 3698000-2Report Type:Expedited (15-DaCompany Report #PHBS2000AU01327 Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiomyopathy Foreign Clozaril PS Novartis Initial or Prolonged Health Pharmaceuticals Corp ORAL 500 MG, QD, Professional ORAL Other Paroxetine C Date:04/04/01ISR Number: 3698092-0Report Type:Expedited (15-DaCompany Report #001-0184-M0100005 Age:57 YR Gender:Male I/FU:F Outcome PT Hospitalization - Agitation Initial or Prolonged Blood Pressure Increased Coordination Abnormal Dyskinesia 22-Feb-2006 08:30 AM Page: 1103 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hypertension Mania Speech Disorder Report Source Product Role Manufacturer Route Dose Duration Tachycardia Health Benadryl Hcl PS Parke Davis Div Professional Warner Lambert Co (Clozapine) SS Zocor (Simvastatin) C Date:04/04/01ISR Number: 3698097-XReport Type:Expedited (15-DaCompany Report #001-0184-M0100005 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Benadryl Hcl PS Parke Davis Div Initial or Prolonged Blood Pressure Increased Professional Warner Lambert Co Coordination Abnormal Clozapine SS 500 MG Dyskinesia (DAILY) Hypertension Zocor C Mania Speech Disorder Date:04/04/01ISR Number: 3700037-1Report Type:Expedited (15-DaCompany Report #01-03-0144 Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Parkinson'S Disease Health Clozapine PS Zenith Goldline ORAL 87.5MG QD Professional ORAL Date:04/04/01ISR Number: 3700038-3Report Type:Expedited (15-DaCompany Report #01-03-0176 Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 12.5-50MG QD Professional ORAL Date:04/05/01ISR Number: 3699706-1Report Type:Expedited (15-DaCompany Report #PHBS2001AU03265 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Foreign Clozaril PS Novartis Dysuria Study Pharmaceuticals Corp ORAL 600 MG/D ORAL Hepatosplenomegaly Health Professional Other Date:04/05/01ISR Number: 3699709-7Report Type:Expedited (15-DaCompany Report #PHBS2001AU03315 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Multiple Sclerosis Foreign Clozaril PS Novartis Health Pharmaceuticals Corp Professional Other 22-Feb-2006 08:30 AM Page: 1104 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/05/01ISR Number: 3699717-6Report Type:Expedited (15-DaCompany Report #PHNU2001DE00828 Age:35 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Diabetes Mellitus Foreign Clozaril PS Novartis Insulin-Dependent Health Pharmaceuticals Corp ORAL 475 MG/DAY, Professional ORAL Other Zantic C Calcium Effervescent C Date:04/05/01ISR Number: 3699719-XReport Type:Expedited (15-DaCompany Report #PHBS2001NL03148 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiomyopathy Foreign Clozaril PS Novartis Initial or Prolonged Ejection Fraction Health Pharmaceuticals Corp ORAL 25 MG, QD, Abnormal Professional ORAL Other Glimepiride (Glimepiride) C Algeldrate C Magnesium Oxide C Furosemide C Insulin Mixtard C Metformin (Metformin) C Fosinofril (Fosinofril) C Simvastatin C Date:04/05/01ISR Number: 3699721-8Report Type:Expedited (15-DaCompany Report #PHBS2001SE03247 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asthenia Foreign Clozaril PS Novartis Blood Pressure Increased Health Pharmaceuticals Corp ORAL 12.5 MG, QHS, Confusional State Professional ORAL Dizziness Other Imovane C Loss Of Consciousness Effortil Prolongatum C Malaise Duodopa C Myocardial Infarction Nightmare Orthostatic Hypotension Pulmonary Embolism Syncope Date:04/05/01ISR Number: 3699730-9Report Type:Expedited (15-DaCompany Report #PHFR2001GB01143 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Coagulation Time Abnormal Foreign Clozaril PS Novartis Complications Of Maternal Health Pharmaceuticals Corp TRANSPLACENTAL TRANSPLACENTA Exposure To Therapeutic Professional L Drugs Other Ferrous Sulphate C Convulsion Neonatal Folic Acid C Neonatal Disorder 22-Feb-2006 08:30 AM Page: 1105 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/06/01ISR Number: 3700141-8Report Type:Direct Company Report # Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Clozaril 25mg Hospitalization - Novartis PS Novartis ORAL 25 MG PO Q HS Initial or Prolonged Haldol C Cogentin C Trazodone C Tyelenol C Ativan C Date:04/09/01ISR Number: 3700249-7Report Type:Expedited (15-DaCompany Report #01-03-0168 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Road Traffic Accident Health Clozapine PS Zenith Goldline ORAL 900MG QD ORAL Professional Date:04/09/01ISR Number: 3700250-3Report Type:Expedited (15-DaCompany Report #01-03-0170 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine- Zenth Professional Goldline Pharm. Tablets PS ORAL 300 MG QD ORAL Date:04/09/01ISR Number: 3700251-5Report Type:Expedited (15-DaCompany Report #01-03-0171 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine- Zenith Professional Goldline Pharm. Tablets PS ORAL 100-500MG QD ORAL Date:04/09/01ISR Number: 3700252-7Report Type:Expedited (15-DaCompany Report #01-03-0172 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Appendicitis Perforated Health Clozapine- Zentith Professional Goldline Pharm. Tablets PS ORAL ORAL Date:04/09/01ISR Number: 3700253-9Report Type:Expedited (15-DaCompany Report #01-03-0173 Age:92 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Chronic Obstructive Health Clozapine PS Zenith Goldline Pulmonary Disease Professional Pharm ORAL 12.5. TO 37.5MG Q ORAL 22-Feb-2006 08:30 AM Page: 1106 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/09/01ISR Number: 3700949-9Report Type:Expedited (15-DaCompany Report #PHBS2001AU02070 Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril PS Novartis Non-Insulin-Dependent Study Pharmaceuticals Corp ORAL 600 MG/D, Hyperglycaemia Health ORAL Professional Date:04/09/01ISR Number: 3701000-7Report Type:Expedited (15-DaCompany Report #PHNU2001DE00948 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dehydration Foreign Leponex / Clozaril Initial or Prolonged Diabetes Mellitus Health (Clozapine) Insulin-Dependent Professional (Clozapine) Tablet PS Novartis Other Pharmaceuticals Corp ORAL ORAL Date:04/09/01ISR Number: 3701003-2Report Type:Expedited (15-DaCompany Report #PHFR2001GB00531 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Glucose Increased Foreign Clozaril (Clozapine) Hospitalization - Blood Sodium Increased Health (Clozapine) PS Novartis Initial or Prolonged Confusional State Professional Pharmaceuticals Corp ORAL 200 MG/DAY, Diabetes Mellitus Other ORAL Non-Insulin-Dependent Glibenclamide Disorientation (Glibenclamide) SS Hyperglycaemic Ramipril (Ramipril) C Hyperosmolar Nonketotic Amitriptyline Syndrome (Amitriptyline) C Nervousness Senna C Polydipsia Multivitamins C Polyuria Thiamine C Red Blood Cell Sedimentation Rate Increased Renal Failure Sedation Tachycardia Thirst Weight Decreased Date:04/09/01ISR Number: 3701499-6Report Type:Expedited (15-DaCompany Report #PHEH2001US02267 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aneurysm Health Clozaril PS Novartis Life-Threatening Professional Pharmaceuticals Corp ORAL 600 MG, ORAL Cogentin (Benzatropine Mesilate) C Prozac (Fluoxetine Hydrochloride) C Inderal C 22-Feb-2006 08:30 AM Page: 1107 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/09/01ISR Number: 3701596-5Report Type:Expedited (15-DaCompany Report #01P-083-0104854-00 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Creatine Foreign Depakene PS Abbott Laboratories Phosphokinase Increased Health Pharmaceutical Drug Interaction Professional Products Div ORAL 1000 MG, 1 IN Myoglobin Blood Increased 1 D, PER ORAL Myoglobinuria Clozapine (Clozapine) SS ORAL 100 MG, 1 IN 1 D, PER ORAL Date:04/09/01ISR Number: 3701636-3Report Type:Expedited (15-DaCompany Report #PHFR2001GB01150 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aspartate Foreign Clozaril PS Novartis Initial or Prolonged Aminotransferase Health Pharmaceuticals Corp ORAL 75MG/DAY, Increased Professional ORAL Blood Creatine Other Phosphokinase Increased Dehydration Disorientation Muscle Twitching Date:04/09/01ISR Number: 3701651-XReport Type:Expedited (15-DaCompany Report #PHFR2001IE00951 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Foreign Clozaril PS Novartis Initial or Prolonged Blood Amylase Increased Health Pharmaceuticals Corp ORAL 400 MG/DAY, Cholelithiasis Professional ORAL Constipation Other Aspirine C Pancreatitis Acute Diazepam C Date:04/09/01ISR Number: 3701652-1Report Type:Expedited (15-DaCompany Report #PHBS2001AU03268 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delirium Foreign Clozaril PS Novartis Initial or Prolonged Drug Interaction Health Pharmaceuticals Corp ORAL 450 MG, QD, Drug Level Above Professional ORAL Therapeutic Other Aropax(Paroxetine Hydrochloride) SS ORAL 40 MG, QD, ORAL Date:04/09/01ISR Number: 3701668-5Report Type:Expedited (15-DaCompany Report #PHBS2001AU01950 Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Accidental Overdose Foreign Clozaril PS Novartis Medication Error Health Pharmaceuticals Corp ORAL 999 MG, QD, Panic Disorder Professional ORAL Sedation Other Cannabis C Alcohol (Ethanol) C 22-Feb-2006 08:30 AM Page: 1108 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/10/01ISR Number: 3702707-8Report Type:Expedited (15-DaCompany Report #PHBS2001CA02001 Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abnormal Behaviour Foreign Anafranil PS Novartis Agitation Literature Pharmaceuticals Corp ORAL ORAL Anxiety Health Clozapine Blood Creatinine Professional (Clozapine) Tablet SS ORAL 500 MG/D, Increased Other ORAL 1825 DAY Chills Clonazepam C Cold Sweat Confusional State Constipation Drug Withdrawal Syndrome Feeling Jittery Hyperhidrosis Nervousness Serotonin Syndrome Tension White Blood Cell Count Increased Date:04/10/01ISR Number: 3702779-0Report Type:Expedited (15-DaCompany Report #EMADSS2001001747 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Foreign Haldol PS Rw Johnson Initial or Prolonged Enuresis Health Pharmaceutical Urinary Incontinence Professional Research Institute Div Ortho Pharm INTRAVENOUS 25 MG, DAILY, IV Valium (Diazepam) SS INTRAVENOUS SEE IMAGE Benperidol (Benperidol) SS Clozapine (Clozapine) SS Date:04/11/01ISR Number: 3702711-XReport Type:Expedited (15-DaCompany Report #01-03-0178 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 800MG QD ORAL Professional Date:04/11/01ISR Number: 3702712-1Report Type:Expedited (15-DaCompany Report #01-03-0181 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Disorder Health Clozapine PS ORAL 600MG QD ORAL Professional Date:04/11/01ISR Number: 3702714-5Report Type:Expedited (15-DaCompany Report #01-03-0182 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS ORAL 12.5-25 MG QD Professional ORAL 22-Feb-2006 08:30 AM Page: 1109 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/11/01ISR Number: 3702716-9Report Type:Expedited (15-DaCompany Report #01-04-0185 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Breast Cancer Female Health Clozapine PS ORAL 100-200MG QD Professional ORAL Date:04/11/01ISR Number: 3702717-0Report Type:Expedited (15-DaCompany Report #01-04-0183 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Brain Neoplasm Health Clozapine PS ORAL 400MG QD ORAL Initial or Prolonged Professional Date:04/11/01ISR Number: 3702718-2Report Type:Expedited (15-DaCompany Report #01-03-0145 Age:65 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 250-500 MG QD Professional ORAL Valium C Date:04/11/01ISR Number: 3702719-4Report Type:Expedited (15-DaCompany Report #01-03-0139 Age:68 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Chronic Obstructive Health Clozapine PS Zenith Goldline ORAL 225-250 MG QD Hospitalization - Pulmonary Disease Professional ORAL Initial or Prolonged Depression Synthroid C Libido Increased Diamox C Pneumonia Akineton C Postmenopausal Haemorrhage Rectal Haemorrhage Urethral Disorder Date:04/11/01ISR Number: 3702720-0Report Type:Expedited (15-DaCompany Report #01-03-0136 Age:76 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Respiratory Disorder Health Clozapine PS ORAL 100-400 MG QD Hospitalization - Professional ORAL Initial or Prolonged Date:04/11/01ISR Number: 3702723-6Report Type:Expedited (15-DaCompany Report #01-01-0027 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 550 MG ORAL Professional Detrol C Pravachol C Prevacid C Remeron C Restoril C 22-Feb-2006 08:30 AM Page: 1110 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/11/01ISR Number: 3702726-1Report Type:Expedited (15-DaCompany Report #01-03-0137 Age:80 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Oesophageal Carcinoma Health Clozapine PS Zenith Goldline ORAL 75 MG QD ORAL Professional Sinemet C Wellbutrin C Zocor C Date:04/11/01ISR Number: 3702728-5Report Type:Expedited (15-DaCompany Report #01-02-0104 Age:80 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Health Clozapine PS Zenith Goldline ORAL 26-625 MG QD Dysphagia Professional ORAL Date:04/11/01ISR Number: 3702732-7Report Type:Expedited (15-DaCompany Report #01-03-0130 Age:78 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Aspiration Health Clozapine PS Zenith Goldline ORAL 25-100 MG QD Professional ORAL Aspirin C Calcium With Vitamin D C Celexa C Oxycodone C Multivitamins Qd C Lactulose C Miacalcin C Date:04/12/01ISR Number: 3703582-8Report Type:Expedited (15-DaCompany Report #01-03-0117 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Decreased Health Clozapine PS Zenith Goldline ORAL 125MG QD ORAL Initial or Prolonged Blood Sodium Increased Professional Depakote C Body Temperature Neurontin C Increased Ferrous Sulfate C Diabetes Mellitus Haemoglobin Decreased Heart Rate Increased Lethargy Pneumonia Pulmonary Congestion Pyrexia Renal Failure Acute Respiratory Rate Increased White Blood Cell Count Increased Date:04/12/01ISR Number: 3703584-1Report Type:Expedited (15-DaCompany Report #01-04-0191 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 700 MG QD Professional ORAL 22-Feb-2006 08:30 AM Page: 1111 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/12/01ISR Number: 3703585-3Report Type:Expedited (15-DaCompany Report #01-04-0190 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 100-400 MG QD Professional ORAL Date:04/12/01ISR Number: 3703586-5Report Type:Expedited (15-DaCompany Report #01-03-0188 Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 12.5-37MG QD Professional ORAL Date:04/12/01ISR Number: 3704103-6Report Type:Expedited (15-DaCompany Report #PHEH2001US02487 Age:53 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Delirium Health Clozaril PS Novartis Life-Threatening Foreign Body Aspiration Professional Pharmaceuticals Corp ORAL 250 MG, ORAL Hospitalization - Obstructive Airways Nardil (Phenelzine Initial or Prolonged Disorder Sulfate) C Other Depakote (Valproate Semisodium) C Resperidone (Risperidone) C Propranolol C Trazodone (Trazodone) C Lorazepam C Date:04/12/01ISR Number: 3704104-8Report Type:Expedited (15-DaCompany Report #PHEH2001US02939 Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Parkinson'S Disease Health Clozaril PS Novartis Professional Pharmaceuticals Corp ORAL 25 MG, ORAL Date:04/13/01ISR Number: 3704556-3Report Type:Expedited (15-DaCompany Report #PHRM2001FR01019 Age:59 YR Gender:Male I/FU:I Outcome PT Hospitalization - Alanine Aminotransferase Initial or Prolonged Increased Aspartate Aminotransferase Increased Blood Creatine Phosphokinase Increased Blood Lactate Dehydrogenase Increased Blood Pressure Increased Cardiomegaly Dyspnoea Jugular Vein Thrombosis Lung Disorder Lymphadenopathy Pleural Effusion 22-Feb-2006 08:30 AM Page: 1112 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pulmonary Embolism Pulmonary Infarction Urinary Tract Infection Report Source Product Role Manufacturer Route Dose Duration Foreign Clozaril PS Novartis Health Pharmaceuticals Corp ORAL ORAL 1 YR Professional Preterax Other (Indapamide, Perindopril Erbumine) SS ORAL ORAL 1 YR Rivotril (Clonazepam) SS ORAL ORAL 1 YR Prozac (Fluoxetine Hydrochloride) SS ORAL ORAL 1 YR Chronadalate C Date:04/13/01ISR Number: 3704558-7Report Type:Expedited (15-DaCompany Report #PHRM2001FR00698 Age:52 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aphasia Foreign Clozaril PS Novartis Initial or Prolonged Convulsion Health Pharmaceuticals Corp ORAL 400 MG DAILY, Other Extensor Plantar Response Professional ORAL; 300 MG Neuritis Other DAILY, ORAL Partial Seizures Hept-A-Myl Polyneuropathy (Heptaminol Hydrochloride) C Date:04/13/01ISR Number: 3704560-5Report Type:Expedited (15-DaCompany Report #PHNU2001DE00848 Age:65 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Ascites Foreign Clozaril PS Novartis Hepatic Cirrhosis Health Pharmaceuticals Corp ORAL 500 MG/DAY, Hypoproteinaemia Professional ORAL Metastasis Other Glianimon Metastatic Neoplasm (Benperidol) SS Neoplasm Malignant Truxal(Chlorprothixe Pancreatic Carcinoma ne Hydrochloride) SS Peritoneal Disorder Haldol(Haloperidol) SS Renal Disorder Pantozol C Lactulose C Lefax C Date:04/13/01ISR Number: 3704565-4Report Type:Expedited (15-DaCompany Report #PHBS2000CA09287 Age:59 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Myocardial Infarction Foreign Clozaril PS Novartis Hospitalization - Nephritis Interstitial Study Pharmaceuticals Corp ORAL ORAL Initial or Prolonged Pneumonia Health Renal Failure Professional Other 22-Feb-2006 08:30 AM Page: 1113 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/13/01ISR Number: 3704616-7Report Type:Expedited (15-DaCompany Report #PHBS2001AU03456 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Overdose Foreign Clozaril PS Novartis Initial or Prolonged Compartment Syndrome Study Pharmaceuticals Corp ORAL SEE IMAGE Oedema Peripheral Health Alcohol (Ethanol) SS 1194 DAY Professional Other Date:04/16/01ISR Number: 3705477-2Report Type:Expedited (15-DaCompany Report #2001AP01558 Age:24 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Seroquel PS Astrazeneca Uk Ltd 300 MG DAILY Study Seroquel *Zeneca* SS Astrazeneca Health Clozapine SS 1 WK Professional Other Date:04/16/01ISR Number: 3705558-3Report Type:Expedited (15-DaCompany Report #PHEH2001US03069 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Health Clozaril PS Novartis Breast Cancer Female Professional Pharmaceuticals Corp ORAL 375 MG, ORAL Clozaril (Clozapine) SS ORAL 375 MG, ORAL Buspar (Buspirone Hhdrochloride) C Celexa (Citalopram Hydrobromide) C Colace C Klonopin C Prilosec (Omeprazole) C Cleocin (Clindamycin Hydrochloride) C Date:04/16/01ISR Number: 3705991-XReport Type:Expedited (15-DaCompany Report #PHBS2001GR00745 Age:42 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Condition Aggravated Foreign Clozaril PS Novartis Eyelid Oedema Health Pharmaceuticals Corp ORAL SEE IMAGE 39 DAY Face Oedema Professional Rivotril C Psychotic Disorder Other Ferofolic C Skin Discolouration Date:04/16/01ISR Number: 3706000-9Report Type:Expedited (15-DaCompany Report #PHBS2001CA03567 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiac Tamponade Foreign Clozaril PS Novartis Endocarditis Health Pharmaceuticals Corp Professional 22-Feb-2006 08:30 AM Page: 1114 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/16/01ISR Number: 3706025-3Report Type:Expedited (15-DaCompany Report #PHFR2001GB01080 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Body Temperature Foreign Clozaril PS Novartis Initial or Prolonged Increased Health Pharmaceuticals Corp ORAL 225 MG, QD, Nausea Professional ORAL Oesophageal Stenosis Other Cogentin Oral Intake Reduced (Benzatropine Vomiting Mesilate) C Weight Decreased Lactulose C White Blood Cell Count Increased Date:04/16/01ISR Number: 3706160-XReport Type:Expedited (15-DaCompany Report #PHBS2000AU04208 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiac Enzymes Increased Foreign Clozaril PS Novartis Chest Pain Study Pharmaceuticals Corp ORAL 350 MG, QD, Cough Health ORAL Electrocardiogram T Wave Professional Amplitude Decreased Other Myocarditis Neutrophil Count Increased Oral Candidiasis Pharyngolaryngeal Pain Date:04/17/01ISR Number: 3706031-9Report Type:Expedited (15-DaCompany Report #C2001-0026.01 Age:20 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diarrhoea Health Clozapine PS Mylan Other Drug Toxicity Professional Pharmaceuticals Inc ORAL 300 MG Q HS Nausea ORAL Vomiting Lorazepam C Date:04/17/01ISR Number: 3706922-9Report Type:Expedited (15-DaCompany Report #PHBS2001AU02331 Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sleep Apnoea Syndrome Foreign Clozaril PS Novartis Study Pharmaceuticals Corp ORAL 400 Health MG,QD,ORAL Professional Other Date:04/17/01ISR Number: 3707076-5Report Type:Expedited (15-DaCompany Report #PHBS2001AU03748 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiomyopathy Foreign Clozaril PS Novartis Health Pharmaceuticals Corp 300 MG/DAY, Professional Other 22-Feb-2006 08:30 AM Page: 1115 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/17/01ISR Number: 3707081-9Report Type:Expedited (15-DaCompany Report #PHBS2001AU02897 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiomyopathy Foreign Clozaril PS Novartis Ejection Fraction Health Pharmaceuticals Corp ORAL 300 MG/DAY, Abnormal Professional ORAL Other Date:04/17/01ISR Number: 3707082-0Report Type:Expedited (15-DaCompany Report #PHBS2000FI11686 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Clozaril PS Novartis Drug Toxicity Health Pharmaceuticals Corp ORAL SEE IMAGE Intentional Overdose Professional Oxazepam (Oxazepam) C Other Temazepam C Date:04/17/01ISR Number: 3707083-2Report Type:Expedited (15-DaCompany Report #PHFR2000GB02202 Age:21 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Bradycardia Foreign Clozaril PS Novartis Hospitalization - Dizziness Health Pharmaceuticals Corp ORAL 2 DOSESX 12.5 Initial or Prolonged Hepatic Failure Professional MG, ORAL Hepatitis Other Risperidone Hypotension (Risperidone) C Ill-Defined Disorder Lethargy Nausea Vomiting Date:04/17/01ISR Number: 3707101-1Report Type:Expedited (15-DaCompany Report #PHBS2001AU00819 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Decreased Foreign Clozaril PS Novartis Initial or Prolonged Diabetic Ketoacidosis Health Pharmaceuticals Corp ORAL 200 MG MANE + Hyperventilation Professional 300 MG NOCTE, Thirst Other ORAL Weight Increased Date:04/17/01ISR Number: 3707238-7Report Type:Expedited (15-DaCompany Report #PHEH2001US02706 Age:71 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Health Clozaril PS Novartis Initial or Prolonged Professional Pharmaceuticals Corp ORAL 300 MG, ORAL Micronase C Avandia (Rosiglitazone Maleate) C Antihypertensive Drugs (No Ingredients/Substanc es) C 22-Feb-2006 08:30 AM Page: 1116 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/17/01ISR Number: 3708091-8Report Type:Expedited (15-DaCompany Report #PHEH2001US03154 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Chronic Obstructive Health Clozaril PS Novartis Hospitalization - Pulmonary Disease Professional Pharmaceuticals Corp ORAL 300 MG, ORAL Initial or Prolonged Hypercalcaemia Date:04/17/01ISR Number: 3708093-1Report Type:Expedited (15-DaCompany Report #PHEH2001US03133 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Cholesterol Other Clozaril PS Novartis Increased Pharmaceuticals Corp ORAL 100 MG, BID, Blood Glucose Abnormal ORAL Blood Triglycerides Monopril (Fosinopril Increased Sodium) C Diabetes Mellitus Atenolol C Hypertension Celexa (Citalopram Hydrobromide) C Depakote (Valproate Semisodium) C Anafranil C Date:04/17/01ISR Number: 3708095-5Report Type:Expedited (15-DaCompany Report #PHEH2001US03070 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatic Steatosis Health Clozaril PS Novartis Initial or Prolonged Pancreatitis Professional Pharmaceuticals Corp ORAL 300 MG, ORAL Depakote (Valproate Semisodium) C Colace C Artane (Trihexyphenidyl Hydrochloride) C Glucophage "Aron" C Date:04/20/01ISR Number: 3708727-1Report Type:Expedited (15-DaCompany Report #PHBS2001SE03690 Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other C-Reactive Protein Foreign Clozaril PS Novartis Increased Health Pharmaceuticals Corp ORAL 175 MG/D, Leukocytosis Professional ORAL Other Nozinan C Date:04/20/01ISR Number: 3708731-3Report Type:Expedited (15-DaCompany Report #01-04-0200 Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Breast Cancer Female Health Clozapine PS Zenith Goldline ORAL 75-87, 5MG QD Intestinal Obstruction Professional ORAL Lung Neoplasm Malignant 22-Feb-2006 08:30 AM Page: 1117 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/20/01ISR Number: 3708732-5Report Type:Expedited (15-DaCompany Report #01-04-0199 Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 100MG QD ORAL Professional Date:04/20/01ISR Number: 3708734-9Report Type:Expedited (15-DaCompany Report #01-04-0198 Age:76 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 50 MG QD ORAL Professional Date:04/20/01ISR Number: 3708735-0Report Type:Expedited (15-DaCompany Report #01-04-0196 Age:95 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dementia Health Clozapine PS Zenith Goldline ORAL 37.5-100MG QD Professional ORAL Date:04/20/01ISR Number: 3708742-8Report Type:Expedited (15-DaCompany Report #01-04-0210 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Road Traffic Accident Health Clozapine PS Zenith Goldline ORAL 75-450MG ORAL Professional Date:04/20/01ISR Number: 3708743-XReport Type:Expedited (15-DaCompany Report #01-03-0168 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Road Traffic Accident Health Clozapine PS Zenith Goldline ORAL 900MG QD ORAL Professional Date:04/20/01ISR Number: 3708745-3Report Type:Expedited (15-DaCompany Report #01-04-0213 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Unevaluable Event Health Clozapine PS Zenith Goldline ORAL 300MG QD ORAL Professional Date:04/20/01ISR Number: 3708747-7Report Type:Expedited (15-DaCompany Report #01-04-0212 Age:67 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 400MG QD ORAL Professional Date:04/20/01ISR Number: 3708748-9Report Type:Expedited (15-DaCompany Report #01-03-0137 Age:80 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 75MG QD Professional ORAL 22-Feb-2006 08:30 AM Page: 1118 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sinemet C Wellbutrin C Zocor C Date:04/20/01ISR Number: 3708750-7Report Type:Expedited (15-DaCompany Report #01-03-0163 Age:72 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 600 MG QD Professional ORAL Date:04/20/01ISR Number: 3708752-0Report Type:Expedited (15-DaCompany Report #01-04-0203 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 300-400MG QD Professional ORAL Topamax C Depakote C Ditropan C Zyprexa C Date:04/20/01ISR Number: 3708753-2Report Type:Expedited (15-DaCompany Report #01-04-0201 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Medication Error Health Clozapine PS Zenith Goldline ORAL 600-662.5MG Initial or Prolonged Professional ORAL Date:04/23/01ISR Number: 3709069-0Report Type:Direct Company Report # Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Liver Function Test Clozapine Tabs PS 225 MG/DAY Abnormal Date:04/24/01ISR Number: 3710101-9Report Type:Expedited (15-DaCompany Report #PHEH2001US02268 Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Health Clozaril PS Novartis Life-Threatening Cardiac Arrest Professional Pharmaceuticals Corp ORAL 100 MG, ORAL Convulsion Date:04/24/01ISR Number: 3710104-4Report Type:Expedited (15-DaCompany Report #PHEH2001US03285 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Oesophageal Perforation Health Clozaril PS Novartis Initial or Prolonged Pneumonia Aspiration Professional Pharmaceuticals Corp ORAL 375 MG, ORAL Pneumothorax Prilosec C 22-Feb-2006 08:30 AM Page: 1119 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/24/01ISR Number: 3710125-1Report Type:Expedited (15-DaCompany Report #PHEH2001US03284 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Metastases To Bone Health Clozaril PS Novartis Initial or Prolonged Professional Pharmaceuticals Corp ORAL 550 MG ORAL Nortriptyline (Nortriptyline ) C Remeron (Mirtazipine) C Prevacid (Lansoprazole) C Pepcid C Clonazepam C Date:04/24/01ISR Number: 3710228-1Report Type:Expedited (15-DaCompany Report #01P-062-0105745-00 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Diabetes Mellitus Foreign Depakene PS Abbott Laboratories Intervention to Health Pharmaceutical Prevent Permanent Professional Products Div ORAL PER ORAL Impairment/Damage Clozapine (Clozapine) SS Date:04/24/01ISR Number: 3710582-0Report Type:Expedited (15-DaCompany Report #PHFR2001GB01284 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Aggression Foreign Clozaril PS Novartis Hospitalization - Bronchopneumonia Health Pharmaceuticals Corp ORAL 525 MG/DAY, Initial or Prolonged Cerebrovascular Accident Professional ORAL Convulsion Other Encephalitis Hypotension Loss Of Consciousness Meningitis Sedation Sepsis Date:04/24/01ISR Number: 3710799-5Report Type:Expedited (15-DaCompany Report #PHFR2001GB01258 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril PS Novartis Health Pharmaceuticals Corp ORAL 700 MG/DAY, Professional ORAL Other Date:04/25/01ISR Number: 3710736-3Report Type:Direct Company Report # Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Convulsion Clozapine PS CLOZAPINE X Intervention to Psychotic Disorder 50 BID 6 MON Prevent Permanent Levofloxacin SS LEVOFLOXACIN Impairment/Damage 500 MG Depakote C 22-Feb-2006 08:30 AM Page: 1120 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Gemfibrozil C Depo Provera C Date:04/25/01ISR Number: 3710737-5Report Type:Direct Company Report # Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Aspiration Clozapine (Tablets) PS 200 Initial or Prolonged Salivary Hypersecretion MG/150MG/250M G 790 DAY Omeprazole C Doccusate C Atropine C Date:04/25/01ISR Number: 3711202-1Report Type:Expedited (15-DaCompany Report #PHFR2001GB00779 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Disorder Foreign Clozaril PS Novartis Initial or Prolonged Coronary Artery Occlusion Health Pharmaceuticals Corp ORAL 350 MG/DAY Malaise Professional ORAL Ventricular Extrasystoles Other Date:04/25/01ISR Number: 3711203-3Report Type:Expedited (15-DaCompany Report #PHNU2001DE01106 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril PS Novartis Health Pharmaceuticals Corp 400MG/DAY Professional Other Date:04/26/01ISR Number: 3711788-7Report Type:Expedited (15-DaCompany Report #PHEH2001US01170 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Calcium Deficiency Health Clozaril PS Novartis Fall Professional Pharmaceuticals Corp ORAL 600 MG, QD, Grand Mal Convulsion ORAL Muscle Spasms Effexor (Venlafaxine Hydrochloride) C Seroquel (Quetiapine) C Klonopin C Date:04/27/01ISR Number: 3713074-8Report Type:Expedited (15-DaCompany Report #PHBS2001AU02192 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Creatine Foreign Clozaril PS Novartis Hospitalization - Phosphokinase Increased Health Pharmaceuticals Corp ORAL 475 MG/D, Initial or Prolonged Circulatory Collapse Professional ORAL Coma Other Haloperidol C Encephalitis Pyrexia 22-Feb-2006 08:30 AM Page: 1121 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/27/01ISR Number: 3713075-XReport Type:Expedited (15-DaCompany Report #PHFR2000GB01251 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiomyopathy Foreign Clozaril PS Novartis Initial or Prolonged Health Pharmaceuticals Corp ORAL 200 MG/DAY, Professional ORAL Other Valproate Sodium C Hyoscine (Hyoscine) C Date:04/27/01ISR Number: 3713110-9Report Type:Expedited (15-DaCompany Report #PHBS2000FI08467 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Foreign Clozaril PS Novartis Initial or Prolonged Blood Creatinine Health Pharmaceuticals Corp ORAL 350MG/D, ORAL Increased Professional Zyprexa(Olanzapine) SS 47 DAY Blood Lactate Other Haloperin C Dehydrogenase Increased Opamox (Oxazepam) C C-Reactive Protein Imovane C Increased Burana C Coombs Direct Test Positive Haemolysis Infection Leukopenia Neutropenia Pyrexia Renal Impairment Date:04/27/01ISR Number: 3713111-0Report Type:Expedited (15-DaCompany Report #PHBS2001CA02655 Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Bronchospasm Foreign Clozaril PS Novartis Study Pharmaceuticals Corp ORAL 300 MG/D, Health ORAL Professional Levaquin Other (Levofloxacin) C Acetaminophen (Paracetamol) C Pantoloc "Solvay" (Pantoprazole Sodium) C Date:04/27/01ISR Number: 3713112-2Report Type:Expedited (15-DaCompany Report #PHFR2001GB01360 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Pressure Increased Foreign Clozaril PS Novartis Norepinephrine Increased Health Pharmaceuticals Corp ORAL 600MG/DAY,ORA Phaeochromocytoma Professional L 91 DAY Other Sulpiride C Paroxetine C 22-Feb-2006 08:30 AM Page: 1122 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/27/01ISR Number: 3713550-8Report Type:Expedited (15-DaCompany Report #PHEH2001US01223 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Health Clozaril PS Novartis Initial or Prolonged Confusional State Professional Pharmaceuticals Corp ORAL 50 MG UNK Dysarthria ORAL Parkinsonian Gait Tegretol C Suicidal Ideation Trilafon (Perphenazine) C Klonopin C Date:04/27/01ISR Number: 3715733-XReport Type:Periodic Company Report #001-0376-M0100044 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Consumer Femhrt PS Parke Davis Pharmaceuticals Ltd Clozaril (Clozapine) SS Date:04/30/01ISR Number: 3713825-2Report Type:Expedited (15-DaCompany Report #PHEH2001US03028 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Health Clozaril PS Novartis Initial or Prolonged Bulimia Nervosa Professional Pharmaceuticals Corp ORAL 1000 MG, QHS, Cholinergic Syndrome ORAL Drug Withdrawal Syndrome Dyskinesia Dystonia Lethargy Overdose Polydipsia White Blood Cell Count Decreased Date:04/30/01ISR Number: 3714198-1Report Type:Expedited (15-DaCompany Report #PHEH2001US01379 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozaril PS Novartis Professional Pharmaceuticals Corp ORAL ORAL Date:04/30/01ISR Number: 3714211-1Report Type:Expedited (15-DaCompany Report #PHEH2001US03498 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Choking Health Clozaril PS Novartis Professional Pharmaceuticals Corp ORAL 825 MG, ORAL Date:04/30/01ISR Number: 3714212-3Report Type:Expedited (15-DaCompany Report #PHEH2001US03495 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Health Clozaril PS Novartis Myocardial Infarction Professional Pharmaceuticals Corp ORAL 200 MG, ORAL 22-Feb-2006 08:30 AM Page: 1123 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/30/01ISR Number: 3714377-3Report Type:Expedited (15-DaCompany Report #PHFR2001GB01342 Age:67 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Foreign Clozaril PS Novartis Initial or Prolonged Health Pharmaceuticals Corp ORAL 300MG/DAY, Professional ORAL Other Date:04/30/01ISR Number: 3714380-3Report Type:Expedited (15-DaCompany Report #PHRM2001FR00655 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Foreign Clozaril PS Novartis Hospitalization - Anaemia Health Pharmaceuticals Corp ORAL 25 MG, QD, Initial or Prolonged Aphasia Professional ORAL C-Reactive Protein Other Sinemet (Levodopa, Increased Carbidopa) Tablet C Haemoglobinaemia Zyloric "Glaxo Inflammation Wellcome" Tablet C Pulmonary Oedema Lexomil (Bromazepam) Pyrexia Tablet C Renal Impairment Kaleorid Slow White Blood Cell Count Release Tablet C Decreased Lasilix Tablet C Lovenox (Heparin-Fraction, Sodium Salt) Solution For Injection C Date:04/30/01ISR Number: 3715055-7Report Type:Expedited (15-DaCompany Report #PHNU2001DE01114 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Circulatory Collapse Foreign Clozaril PS Novartis Coordination Abnormal Health Pharmaceuticals Corp ORAL 200 MG DAY Dyspnoea Professional ORAL Pancreatitis Other Orfiril "Desitin" Sinus Tachycardia (Valproate Sodium) SS ORAL ORAL 12 DAY Transient Ischaemic Attack Date:04/30/01ISR Number: 3715056-9Report Type:Expedited (15-DaCompany Report #PHBS2001CA01915 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cellulitis Foreign Clozaril PS Novartis Health Pharmaceuticals Corp 325 MG/DAY Professional Isopto-Atropin C Other Loxapac (Loxapine Succinate) C Celexa (Citalopram Hydrobromide) C 22-Feb-2006 08:30 AM Page: 1124 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/02/01ISR Number: 3714609-1Report Type:Expedited (15-DaCompany Report #01-03-0121 Age:24 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Circulatory Collapse Health Clozapine PS Zenith Goldline ORAL 100-300MG QD Professional ORAL Prozac C Methylphenidate Sr C Date:05/02/01ISR Number: 3714610-8Report Type:Expedited (15-DaCompany Report #01-04-0233 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL ORAL Professional Date:05/02/01ISR Number: 3714615-7Report Type:Expedited (15-DaCompany Report #01-04-0232 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Limb Injury Health Clozapine PS Zenith Goldline ORAL 100-250MG QD Initial or Prolonged Professional ORAL Date:05/02/01ISR Number: 3714621-2Report Type:Expedited (15-DaCompany Report #01-04-0183 Age:46 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Brain Neoplasm Health Clozapine PS Zenith Goldline ORAL 400 MG QD Professional ORAL Eskalith C Prozac C Zyprexa C Date:05/02/01ISR Number: 3714626-1Report Type:Expedited (15-DaCompany Report #01-03-0182 Age:72 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Renal Failure Health Clozapine PS Zenith Goldline ORAL 12.5-25 MG QD Professional ORAL Date:05/02/01ISR Number: 3714629-7Report Type:Expedited (15-DaCompany Report #01-04-0230 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 600MG QD ORAL Professional Date:05/02/01ISR Number: 3714631-5Report Type:Expedited (15-DaCompany Report #01-04-0227 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 300-600MG QD Professional ORAL 22-Feb-2006 08:30 AM Page: 1125 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/02/01ISR Number: 3714633-9Report Type:Expedited (15-DaCompany Report #01-04-0226 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aneurysm Health Clozapine PS Zenith Goldline ORAL 12.5MG QD Arterial Disorder Professional ORAL Date:05/02/01ISR Number: 3714634-0Report Type:Expedited (15-DaCompany Report #01-04-0225 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Clozapine PS Zenith Goldline ORAL 125-400MG QD Injury Professional ORAL Date:05/02/01ISR Number: 3714636-4Report Type:Expedited (15-DaCompany Report #01-04-0224 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Abuser Health Clozapine PS Zenith Goldline ORAL 100-200MG QD Murder Professional ORAL Topamax C Wellbutrin C Trazodone C Date:05/02/01ISR Number: 3715712-2Report Type:Expedited (15-DaCompany Report #2001AP01969 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Seroquel PS Astrazeneca Lp ORAL 200 MG BID PO 1 WK Literature Quetiapine SS ORAL 250 MG BID PO 4 WK Health Clozapine SS 400 MG DAILY 1 YR Professional Other Date:05/03/01ISR Number: 3716966-9Report Type:Expedited (15-DaCompany Report #PHFR2001GB01258 Age:31 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Glucose Increased Foreign Clozaril PS Novartis Diabetes Mellitus Health Pharmaceuticals Corp ORAL 700 MG/DAY, Enuresis Professional ORAL Ketonuria Other Paroxetine Lethargy (Paroxetine) C Nocturia Hyoscine Polydipsia Hydrobromide C Polyuria Date:05/03/01ISR Number: 3717211-0Report Type:Expedited (15-DaCompany Report #PHFR2001GB01385 Age:81 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arrhythmia Foreign Clozaril PS Novartis Initial or Prolonged Hypotension Health Pharmaceuticals Corp ORAL 37.5 MG/DAY, Loss Of Consciousness Professional ORAL Peripheral Circulatory Other Failure 22-Feb-2006 08:30 AM Page: 1126 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/03/01ISR Number: 3717213-4Report Type:Expedited (15-DaCompany Report #PHBS2001AU03078 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Choking Foreign Clozaril PS Novartis Constipation Consumer Pharmaceuticals Corp ORAL 300 MG, QD, Enuresis Other ORAL; 1200 Loss Of Consciousness MG/D, ORAL Restlessness Aropax C Salivary Hypersecretion Risperidone(Risperid Sedation one) C Sleep Walking Vomiting Date:05/03/01ISR Number: 3717448-0Report Type:Expedited (15-DaCompany Report #PHBS2001US04040 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Literature Clozaril PS Novartis Weight Increased Health Pharmaceuticals Corp 450 MG/D 305 DAY Professional Date:05/04/01ISR Number: 3718650-4Report Type:Expedited (15-DaCompany Report #PHEH2001US03607 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Exposure Health Clozaril PS Novartis Initial or Prolonged Arrhythmia Professional Pharmaceuticals Corp ORAL 250 MG, ORAL Blood Potassium Decreased Ranitidine Coma (Ranitidine) SS 1 DAY Dysarthria Dyspnoea Fatigue Hypotension Sedation Tachycardia Ventricular Extrasystoles Vomiting Date:05/07/01ISR Number: 3719233-2Report Type:Expedited (15-DaCompany Report #PHBS2001NZ04156 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Clozaril PS Novartis Initial or Prolonged Phosphokinase Increased Health Pharmaceuticals Corp ORAL 375 MG/D, Other Cardiomyopathy Professional ORAL Chest Pain Other Dyspnoea Hypertension Pulmonary Congestion Date:05/08/01ISR Number: 3719759-1Report Type:Expedited (15-DaCompany Report #PHEH2001US03695 Age:42 YR Gender:Male I/FU:I Outcome PT Death Diabetes Mellitus Hospitalization - Insulin-Dependent Initial or Prolonged Dizziness 22-Feb-2006 08:30 AM Page: 1127 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Foreign Body Aspiration Leukocytosis Pneumonia Report Source Product Role Manufacturer Route Dose Duration Health Clozaril PS Novartis Professional Pharmaceuticals Corp ORAL 300 MG, BID, ORAL Insulin (Insulin) C Date:05/08/01ISR Number: 3719779-7Report Type:Expedited (15-DaCompany Report #PHEH2001US03850 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Fall Health Clozaril (Clozapine) Vomiting Professional Tablet PS Novartis Company Pharmaceuticals Corp ORAL 25 MG, ORAL Representative Haldol C Date:05/08/01ISR Number: 3719781-5Report Type:Expedited (15-DaCompany Report #PHEH2001US03069 Age:53 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozaril (Clozapine) Hospitalization - Breast Cancer Stage Iv Professional Tablet PS Novartis Initial or Prolonged Neutropenia Pharmaceuticals Corp ORAL 150 MG AM + Pyrexia 200 MG HS, White Blood Cell Count ORAL Decreased Clozapine SS ORAL 150 MG + 200 MG HS, ORAL Buspar (Buspirone Hydrochloride) C Celexa (Citalopram Hydrobromide) C Colace C Klonopin C Prilosec (Omeprazole) C Cleocin (Clindamycin Hydrochloride) C Date:05/09/01ISR Number: 3719647-0Report Type:Expedited (15-DaCompany Report #C2001-0026.01 Age:20 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diarrhoea Health Clozapine PS Mylan Other Drug Toxicity Professional Pharmaceuticals Inc ORAL 300MG Q HS, Nausea Other ORAL Vomiting Lorazepam (1 Mg Bid) C Date:05/09/01ISR Number: 3719648-2Report Type:Expedited (15-DaCompany Report #C2001-1070.01 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Clozapine PS Mylan Initial or Prolonged Condition Aggravated Pharmaceuticals Inc ORAL 600MG/DAY/ORA Other Hallucination, Auditory L Clozapine Tablets 22-Feb-2006 08:30 AM Page: 1128 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report 100 Mg Mylan SS ORAL UNK, ORAL Date:05/09/01ISR Number: 3720744-4Report Type:Expedited (15-DaCompany Report #PHBS2001AU03315 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration No Adverse Drug Effect Foreign Clozaril PS Novartis Health Pharmaceuticals Corp Professional Other Date:05/09/01ISR Number: 3720745-6Report Type:Expedited (15-DaCompany Report #PHNU2001DE00778 Age:30 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Foreign Clozaril PS Novartis Cardiac Failure Health Pharmaceuticals Corp ORAL 100MG/DAY, Cor Pulmonale Professional ORAL Cyanosis Other Anafranil Dyspnoea Exertional (Clomipramine Electrocardiogram T Wave Hydrochloride) C Inversion Saroten Retard Sinus Tachycardia (Amitriptyline Ventricular Hypertrophy Hydrochloride) C Weight Increased Diazepam C Magnesium Verla Dragees (Magnesium Citrate, Magnesium Nicotinate, Magnesium Glutamate) C Arelix (Piretanide) C Date:05/09/01ISR Number: 3720747-XReport Type:Expedited (15-DaCompany Report #PHBS2001AU04343 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Overdose Foreign Clozaril PS Novartis Initial or Prolonged Neutropenia Study Pharmaceuticals Corp ORAL 300 MG/D, Health ORAL Professional Opiat (Opium Other Alkaloids Total) SS 120 DAY Date:05/09/01ISR Number: 3720748-1Report Type:Expedited (15-DaCompany Report #PHRM2001FR01204 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperplasia Foreign Clozaril PS Novartis Initial or Prolonged Liver Disorder Health Pharmaceuticals Corp ORAL ORAL Professional Rivotril C Other Date:05/09/01ISR Number: 3720758-4Report Type:Expedited (15-DaCompany Report #PHFR2001GB01395 Age:49 YR Gender:Male I/FU:I Outcome PT Other Atrioventricular Block First Degree 22-Feb-2006 08:30 AM Page: 1129 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Bradycardia Loss Of Consciousness Pallor Report Source Product Role Manufacturer Route Dose Duration Pulse Absent Foreign Clozaril PS Novartis Health Pharmaceuticals Corp ORAL ORAL Professional Flupentixol Other (Flupentixol) C Procyclidine (Procyclidine) C Date:05/09/01ISR Number: 3720760-2Report Type:Expedited (15-DaCompany Report #PHNU2001DE00948 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dehydration Foreign Clozaril PS Novartis Initial or Prolonged Diabetes Mellitus Health Pharmaceuticals Corp ORAL 400 MG/DAY, Disability Insulin-Dependent Professional ORAL Other Date:05/09/01ISR Number: 3720762-6Report Type:Expedited (15-DaCompany Report #PHBS2001AU04309 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Level Above Foreign Clozaril PS Novartis Therapeutic Health Pharmaceuticals Corp ORAL 600 MG/D, Palpitations Professional ORAL Tachycardia Other Sertraline Ventricular Hypertrophy (Sertraline) C Omeprazole (Omeprazole) C Ventolin C Nitrofurantoin (Nitrofurantoin) C Date:05/10/01ISR Number: 3720166-6Report Type:Direct Company Report # Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Clozapine PS Initial or Prolonged Diabetic Ketoacidosis Date:05/10/01ISR Number: 3720168-XReport Type:Direct Company Report # Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chills Clozaril PS Initial or Prolonged Heart Rate Increased Pyrexia Pyuria Urine Odour Abnormal 22-Feb-2006 08:30 AM Page: 1130 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/10/01ISR Number: 3720423-3Report Type:Expedited (15-DaCompany Report #01-04-0213 Age:54 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Leukaemia Health Clozapine PS Zenith Goldline ORAL 300 MG QD Professional ORAL Nifedipine C K-Dur C Ranitidine C Cipro C Date:05/10/01ISR Number: 3720424-5Report Type:Expedited (15-DaCompany Report #01-03-0127 Age:80 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 12.5-87.5 MG Professional ORAL Date:05/10/01ISR Number: 3720425-7Report Type:Expedited (15-DaCompany Report #01-04-0196 Age:95 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dehydration Health Clozapine PS Zenith Goldline ORAL 37.5-100MG QD Dementia Professional ORAL Date:05/10/01ISR Number: 3720426-9Report Type:Expedited (15-DaCompany Report #01-04-0200 Age:68 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Breast Cancer Female Health Clozapine PS Zenith Goldline ORAL 75-87.5MG QD Intestinal Obstruction Professional ORAL Lung Neoplasm Malignant Catapres C Haloperidol C Tamoxifen C Effexor Xr C Zestril C Labetalol C Sodium Chloride C Date:05/10/01ISR Number: 3720427-0Report Type:Expedited (15-DaCompany Report #01-04-0185 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Breast Cancer Male Health Clozapine PS Zenith Goldline ORAL 100-200MG QD Professional ORAL Date:05/10/01ISR Number: 3720428-2Report Type:Expedited (15-DaCompany Report #01-04-0239 Age:78 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 25MG QD ORAL Professional 22-Feb-2006 08:30 AM Page: 1131 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/10/01ISR Number: 3720429-4Report Type:Expedited (15-DaCompany Report #01-04-0238 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Breast Cancer Female Health Clozapine PS Zenith Goldline ORAL 250MG QD ORAL Professional Date:05/10/01ISR Number: 3720430-0Report Type:Expedited (15-DaCompany Report #01-04-0234 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Colitis Health Clozapine PS Zenith Goldline ORAL 125-175MG QD Coronary Artery Disease Professional ORAL Myocardial Infarction Pneumonia Date:05/10/01ISR Number: 3720431-2Report Type:Expedited (15-DaCompany Report #01-05-0243 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Lung Carcinoma Cell Type Health Clozapine PS Zenith Goldline ORAL 100MG BID Initial or Prolonged Unspecified Stage Iv Professional ORAL Date:05/10/01ISR Number: 3720721-3Report Type:Expedited (15-DaCompany Report #PHEH2001US01835 Age:73 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Dysarthria Health Clozaril PS Novartis Hospitalization - Hemiparesis Professional Pharmaceuticals Corp ORAL 125MG AM + Initial or Prolonged Lethargy 325MG HS, Transient Ischaemic ORAL Attack Tamiflu Urinary Tract Infection (Oseltamivir) SS Asa C Prinivil (Lisinopril) C Fosamax (Alendronate Sodium) C Milk Of Magnesia C Colace C Norvasc C Haloperidol C Valproic Acid C Oyster Shell Calcium C Date:05/10/01ISR Number: 3720722-5Report Type:Expedited (15-DaCompany Report #PHEH2001US03285 Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Oesophageal Perforation Health Clozaril PS Novartis Hospitalization - Pneumonia Aspiration Professional Pharmaceuticals Corp ORAL 125MG AM + Initial or Prolonged Pneumothorax 250MG HS, ORAL Clozapine (Clozapine) SS 125MG AM + 250MG HS, Prilosec (Omeprazole) C 22-Feb-2006 08:30 AM Page: 1132 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/10/01ISR Number: 3721480-0Report Type:Expedited (15-DaCompany Report #PHBS2001AU04376 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ovarian Cancer Foreign Clozaril PS Novartis Initial or Prolonged Health Pharmaceuticals Corp ORAL 200 MG/D, Professional ORAL Other Date:05/10/01ISR Number: 3721507-6Report Type:Expedited (15-DaCompany Report #PHBS2001NZ04304 Age:74 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiomegaly Foreign Clozaril PS Novartis Initial or Prolonged Malaise Health Pharmaceuticals Corp ORAL 37.5 MG/DAY, Neoplasm Professional ORAL Pericardial Effusion Other Valproate Sodium C Pleural Effusion Date:05/10/01ISR Number: 3721509-XReport Type:Expedited (15-DaCompany Report #PHFR2001GB01467 Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Circulatory Collapse Foreign Clozaril PS Novartis Dehydration Health Pharmaceuticals Corp ORAL 225MG/DAY, Diarrhoea Professional ORAL Irritable Bowel Syndrome Other Lomotil Rectal Haemorrhage (Diphenoxylate Vomiting Hydrochloride) C Dioraltye C Tylex (Carbinoxamine Maleate, Paracetamol) C Date:05/11/01ISR Number: 3722404-2Report Type:Expedited (15-DaCompany Report #PHBS2001AU03748 Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiomyopathy Foreign Clozaril PS Novartis Study Pharmaceuticals Corp ORAL 300 MG/DAY, Health ORAL Professional Other Date:05/11/01ISR Number: 3722405-4Report Type:Expedited (15-DaCompany Report #PHBS2000AU11427 Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Endocarditis Foreign Clozaril PS Novartis Cardiac Failure Study Pharmaceuticals Corp ORAL 300 MG/D, Congestive Health ORAL Cardiomyopathy Professional Frusemide SS Dialysis Other Valproate Sodium C Dyspnoea Slow-K C Fatigue Malaise Nausea 22-Feb-2006 08:30 AM Page: 1133 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/11/01ISR Number: 3722407-8Report Type:Expedited (15-DaCompany Report #PHBS2001AU04475 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Brain Damage Foreign Clozaril PS Novartis Initial or Prolonged Cardiac Arrest Study Pharmaceuticals Corp ORAL 600 MG/D, Cerebrovascular Accident Health ORAL Circulatory Collapse Professional Embolism Other Loss Of Consciousness Date:05/14/01ISR Number: 3723723-6Report Type:Expedited (15-DaCompany Report #PHEH1990US01495 Age:17 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Accident Health Clozaril PS Novartis Hospitalization - Coma Professional Pharmaceuticals Corp ORAL SEE IMAGE Initial or Prolonged Convulsion Lithium(Lithium) SS Coordination Abnormal Haldol (Haloperidol) Dermatitis (Haloperidol) SS Encephalopathy Artane Fall (Trihexypenidyl Head Injury Hydrochloride SS "HIGH DOSE" Hypotension Thorazine SS HIGH DOSE Loss Of Consciousness UNK Nephropathy Toxic Orthostatic Hypotension Pyrexia Simple Partial Seizures Syncope Tachycardia White Blood Cell Count Increased Date:05/14/01ISR Number: 3723724-8Report Type:Expedited (15-DaCompany Report #PHEH2001US02939 Age:77 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hallucination Health Clozaril PS Novartis Parkinson'S Disease Professional Pharmaceuticals Corp ORAL 25 MG, ORAL Date:05/14/01ISR Number: 3723793-5Report Type:Expedited (15-DaCompany Report #PHEH2001US03962 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Tolerance Decreased Health Clozaril PS Novartis Pneumonia Professional Pharmaceuticals Corp ORAL ORAL Company Representative Date:05/14/01ISR Number: 3723821-7Report Type:Expedited (15-DaCompany Report #PHEH2001US03155 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Transient Ischaemic Health Clozaril PS Novartis Attack Professional Pharmaceuticals Corp ORAL 37.5 MG DAILY, ORAL Lithium (Lithium) C 22-Feb-2006 08:30 AM Page: 1134 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Zyprexa (Olanzapine) C Paxil C Klonopin C Date:05/14/01ISR Number: 3723831-XReport Type:Expedited (15-DaCompany Report #PHEH2001US03246 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Health Clozaril PS Novartis Hepatitis C Professional Pharmaceuticals Corp ORAL 300 MG, ORAL Salivary Hypersecretion Prilosec (Omeprazole) C Date:05/14/01ISR Number: 3723832-1Report Type:Expedited (15-DaCompany Report #PHEH2001US03245 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hysterectomy Health Clozaril PS Novartis Initial or Prolonged Leukopenia Professional Pharmaceuticals Corp ORAL 300 MG, ORAL Uterine Cancer Date:05/14/01ISR Number: 3724101-6Report Type:Expedited (15-DaCompany Report #PHBS2001AU02897 Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiac Disorder Foreign Clozaril PS Novartis Cardiomegaly Health Pharmaceuticals Corp ORAL 300 MG/DAY, Cardiomyopathy Professional ORAL Ejection Fraction Abnormal Date:05/14/01ISR Number: 3724102-8Report Type:Expedited (15-DaCompany Report #PHBS2001AU04376 Age:78 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ovarian Cancer Foreign Clozaril PS Novartis Initial or Prolonged Health Pharmaceuticals Corp ORAL 200 MG/D, Professional ORAL Date:05/15/01ISR Number: 3723208-7Report Type:Expedited (15-DaCompany Report #01-03-0138 Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diarrhoea Health Clozapine PS Zenith Goldline ORAL 800MG QD ORAL Metastasis Professional Depakote C Throat Cancer Anafranil C Weight Decreased Wellbutrin Sr C Wellbutrin C Date:05/15/01ISR Number: 3723212-9Report Type:Expedited (15-DaCompany Report #01-03-0170 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 300MG QD ORAL Professional 22-Feb-2006 08:30 AM Page: 1135 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/15/01ISR Number: 3723214-2Report Type:Expedited (15-DaCompany Report #01-03-0153 Age:81 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 12.5-37.5MG Professional ORAL Date:05/15/01ISR Number: 3723218-XReport Type:Expedited (15-DaCompany Report #01-04-0206 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine PS Zenith Goldline ORAL 50-900MG QD Professional ORAL Date:05/15/01ISR Number: 3723219-1Report Type:Expedited (15-DaCompany Report #01-05-0249 Age:89 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Eating Disorder Health Clozapine PS Zenith Goldline ORAL 25-100MG QD Professional ORAL Date:05/15/01ISR Number: 3723221-XReport Type:Expedited (15-DaCompany Report #01-04-0246 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL ORAL Professional Date:05/15/01ISR Number: 3723224-5Report Type:Expedited (15-DaCompany Report #01-05-0248 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 50-75MG QD Hospitalization - Professional ORAL Initial or Prolonged Date:05/15/01ISR Number: 3723225-7Report Type:Expedited (15-DaCompany Report #01-05-0247 Age:73 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Multiple Myeloma Health Clozapine PS Zenith Goldline ORAL 50-100MG QD Professional ORAL Date:05/15/01ISR Number: 3723569-9Report Type:Expedited (15-DaCompany Report #PHRM2001FR01230 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypertensive Crisis Foreign Clozaril PS Novartis Health Pharmaceuticals Corp ORAL ORAL Professional Company Representative Other 22-Feb-2006 08:30 AM Page: 1136 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/15/01ISR Number: 3723571-7Report Type:Expedited (15-DaCompany Report #PHRM2001FR01228 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypertensive Crisis Foreign Clozaril PS Novartis Health Pharmaceuticals Corp ORAL ORAL Professional Distributor Other Date:05/15/01ISR Number: 3723583-3Report Type:Expedited (15-DaCompany Report #PHBS2001AU03268 Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delirium Foreign Clozaril PS Novartis Initial or Prolonged Drug Level Changed Health Pharmaceuticals Corp ORAL 450 MG, QD, Professional ORAL Other Aropax C Alprazolam (Alprazolam) C Date:05/15/01ISR Number: 3723585-7Report Type:Expedited (15-DaCompany Report #PHBS2001AU04550 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Squamous Cell Carcinoma Foreign Clozaril PS Novartis Health Pharmaceuticals Corp ORAL 350 MG/D, Professional ORAL Other Date:05/15/01ISR Number: 3727548-7Report Type:Expedited (15-DaCompany Report #01-03-0140 Age:53 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Chronic Obstructive Health Clozapine PS Zenith Goldline ORAL 150-350 MG QD Hospitalization - Pulmonary Disease Professional ORAL Initial or Prolonged Upper Respiratory Tract Infection Date:05/15/01ISR Number: 3727552-9Report Type:Expedited (15-DaCompany Report #01-04-0191 Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 700MG QD ORAL Professional Docusate C Date:05/16/01ISR Number: 3725051-1Report Type:Expedited (15-DaCompany Report #PHBS2001AU02648 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eosinophil Count Foreign Clozaril PS Novartis Increased Study Pharmaceuticals Corp ORAL 400 MG/DAY, Ventricular Hypertrophy Health ORAL Professional Warfarin C Other 22-Feb-2006 08:30 AM Page: 1137 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/18/01ISR Number: 3725665-9Report Type:Expedited (15-DaCompany Report #PHEH2001US03155 Age:54 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Transient Ischaemic Health Clozaril PS Novartis Initial or Prolonged Attack Professional Pharmaceuticals Corp ORAL 25 MG, DAILY, ORAL Lithium C Zyprexa (Olanzapine) C Paxil C Klonopin C Synthroid C Atenolol C Date:05/18/01ISR Number: 3725885-3Report Type:Periodic Company Report #C2000-1800.01 Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypotonia Health Clozapine PS Mylan Professional Pharmaceuticals Inc ORAL 25 MG BID (ONE DOSE ONLY), ORAL Alprazolam C Risperidone C Date:05/18/01ISR Number: 3725886-5Report Type:Periodic Company Report #C2001-0149.01 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Lethargy Consumer Clozapine PS Mylan Sedation Pharmaceuticals Inc ORAL 125 MG Q AM, 150 MG Q NOON, 150 MG Q HS ORAL Clozapine Tablets 100 Mg Mylan SS Mylan ORAL 125 MG Q AM, 150MG Q NOON, 150 MG QHS ORAL Amphetamine Mixtures C Benztropine C Guanfacine C Sertraline C Date:05/18/01ISR Number: 3725887-7Report Type:Periodic Company Report #C2001-0168.01 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozapine PS Mylan Hospitalization - Professional Pharmaceuticals Inc ORAL 50 MG Q AM, Initial or Prolonged Other 225 MG Q H, Other ORAL Gabapentin C Trazodone C Haloperidol C Venlafaxine Xr C Olanzapine C 22-Feb-2006 08:30 AM Page: 1138 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/18/01ISR Number: 3725889-0Report Type:Periodic Company Report #C2000-1615.02 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Health Clozapine PS Mylan Professional Pharmaceuticals Inc ORAL 500 MG QD, ORAL Date:05/18/01ISR Number: 3725891-9Report Type:Periodic Company Report #C2000-1615.03 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozapine PS Mylan Professional Pharmaceuticals Inc ORAL 300M G QD, ORAL Bupropion C Citalopram C Topiramate C Loxapine C Date:05/18/01ISR Number: 3725894-4Report Type:Periodic Company Report #C2000-1615.04 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Health Clozapine PS Mylan Professional Pharmaceuticals Inc ORAL 400 MG QD, ORAL Fluphenazine C Date:05/18/01ISR Number: 3725896-8Report Type:Periodic Company Report #C2000-1615.05 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Health Clozapine PS Mylan Professional Pharmaceuticals Inc ORAL 600MG QD, ORAL Thiodazine C Clomipramine C Benztropine C Date:05/18/01ISR Number: 3725899-3Report Type:Periodic Company Report #C2000-1615.06 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Ineffective Health Clozapine PS Mylan Professional Pharmaceuticals Inc ORAL 300 MG QD, ORAL Divalproex Sodium C Benztropine C Date:05/18/01ISR Number: 3725900-7Report Type:Periodic Company Report #C2000-1615.07 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozapine PS Mylan Other Neutropenia Professional Pharmaceuticals Inc ORAL 400 MG/DAY, ORAL 22-Feb-2006 08:30 AM Page: 1139 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Paroxetine C Fluphenazine C Date:05/18/01ISR Number: 3725902-0Report Type:Periodic Company Report #C2000-1805.01 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tachycardia Health Clozapine PS Mylan Professional Pharmaceuticals Inc ORAL 300M G, QD, ORAL Divalproex Sodium Sprinkle C Albuterol Inhaler C Olanzapine C Date:05/18/01ISR Number: 3725904-4Report Type:Periodic Company Report #C2000-1826.01 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Other Clozapine PS Mylan Leukopenia Pharmaceuticals Inc ORAL 175MG Q AM, 200 MG Q HS, ORAL Citalopram C Date:05/18/01ISR Number: 3725906-8Report Type:Periodic Company Report #C2000-1950.01 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Leukopenia Other Clozapine PS Mylan Other Neutropenia Pharmaceuticals Inc ORAL 150MG Q AM, 300MG Q HS, ORAL Lithium C Gabapentin C Clonazepam C Trilafon C Date:05/18/01ISR Number: 3725908-1Report Type:Periodic Company Report #C2000-1989.01 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Health Clozapine PS Mylan Professional Pharmaceuticals Inc ORAL 150MG/DAY Other THEN 200MG Q AM, 200MG Q PM ORAL Divalproex Sodium C Olanzapine C Date:05/18/01ISR Number: 3725909-3Report Type:Periodic Company Report #C2001-0026.01 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Vomiting Health Clozapine PS Mylan Professional Pharmaceuticals Inc ORAL 300MG Q HS, 22-Feb-2006 08:30 AM Page: 1140 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL Lorazepam C Date:05/18/01ISR Number: 3725913-5Report Type:Periodic Company Report #C2001-0073.01 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Leukopenia Health Clozapine PS Mylan Other Professional Pharmaceuticals Inc ORAL 200MG QD, Other ORAL Date:05/18/01ISR Number: 3725916-0Report Type:Periodic Company Report #C2001-0126.01 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Clozapine PS Mylan Professional Pharmaceuticals Inc ORAL 100MG Q AM, 100MG Q 4 PM, 250MG Q HS ORAL Neurontin Parke-Davis SS Parke-Davis ORAL 300MG Q AM, 800MG Q HS, ORAL Dilantin Parke-Davis SS Parke-Davis ORAL 200MG Q AM, 200MG Q PM, ORAL Celecoxib C Levothyroxine C Lorazepam C Zolpidem C Date:05/18/01ISR Number: 3725918-4Report Type:Periodic Company Report #C2001-0149.01 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Lethargy Consumer Clozapine PS Mylan Sedation Pharmaceuticals Inc ORAL 125MG Q AM, 150MG Q NOON, 150MG Q HS ORAL Clozapine Tablets 100 Mg Mylan SS Mylan ORAL 125MG Q AM, 150MG Q NOON, 150MG Q HS ORAL Amphetamine Mixtures C Benztropine C Guanfacine C Sertraline C Date:05/18/01ISR Number: 3725921-4Report Type:Periodic Company Report #C2001-0196.01 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozapine PS Mylan Other Tardive Dyskinesia Professional Pharmaceuticals Inc ORAL 100MG QID, Other ORAL 22-Feb-2006 08:30 AM Page: 1141 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Valproex Sodium C Insulin Nph C Calcium Carbonate C Nifedipine C Date:05/18/01ISR Number: 3725923-8Report Type:Periodic Company Report #C2001-0244.01 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chest Pain Consumer Clozapine PS Mylan Conduction Disorder Health Pharmaceuticals Inc ORAL 200MG QD, Professional THEN 150MG QD, ORAL Gaviscon C Divalproex Sodium C Enalapril C Glyburide C Ibuprofen C Lorazepam C Niacin C Omeprazole C Paroxetine C Simethicone C Temazepam C Vitamins C Date:05/18/01ISR Number: 3725925-1Report Type:Periodic Company Report #C2000-1155.01 Age:31 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Insomnia Consumer Clozapine PS Mylan Pharmaceuticals Inc ORAL 150MG Q HS, ORAL (ONE DOSE ONLY) Date:05/21/01ISR Number: 3725761-6Report Type:Expedited (15-DaCompany Report #01-03-0171 Age:50 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 100-600MG QD Professional ORAL Date:05/21/01ISR Number: 3725763-XReport Type:Expedited (15-DaCompany Report #01-04-0199 Age:77 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Potassium Increased Health Clozapine PS Zenith Goldline ORAL 100MG QD ORAL Hospitalization - Dementia Professional Phenobarbital C Initial or Prolonged Dizziness Cardizem C Haematocrit Decreased Colace C Haemoglobin Decreased Buspar C Inappropriate Depakote C Antidiuretic Hormone Dilantin C Secretion Oscal C Lung Disorder Haldol C Neoplasm Tylenol C Sodium Chloride C 22-Feb-2006 08:30 AM Page: 1142 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/21/01ISR Number: 3725765-3Report Type:Expedited (15-DaCompany Report #01-03-0164 Age:24 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Clozapine PS Zenith Goldline ORAL 25-800MG QD Professional ORAL Date:05/21/01ISR Number: 3725767-7Report Type:Expedited (15-DaCompany Report #01-03-0188 Age:82 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 12.5-37MG QD Professional ORAL Sinemet C Lanoxin C Megace C Date:05/21/01ISR Number: 3725769-0Report Type:Expedited (15-DaCompany Report #01-03-0188 Age:82 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 12.5-37MG QD Professional ORAL Sinemet C Lanoxin C Megace C Date:05/21/01ISR Number: 3725771-9Report Type:Expedited (15-DaCompany Report #01-05-0256 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 150-600MG QD Professional ORAL Date:05/21/01ISR Number: 3726910-6Report Type:Expedited (15-DaCompany Report #PHNU2001DE00962 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Enuresis Foreign Tegretol PS Novartis Initial or Prolonged Urinary Incontinence Study Pharmaceuticals Corp ORAL 800 MG DAILY, Health ORAL Professional Leponex (Clozapine) SS ORAL 25, 300, 355 Other MG DAILY, ORAL Glianimon(Benperidol ) SS INTRAVENOUS 16, 24, 32, 12 MG DAILY, INTRAVENOUS Diazepam(Diazepam) SS INTRAVENOUS 30, 40, 30, 20, 5 MG, DAILY, INTRAVENOUS 22-Feb-2006 08:30 AM Page: 1143 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/21/01ISR Number: 3726959-3Report Type:Expedited (15-DaCompany Report #PHFR2001GB00866 Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiomegaly Foreign Clozaril PS Novartis Initial or Prolonged Cardiomyopathy Health Pharmaceuticals Corp ORAL 100 MG, BID, Pulmonary Oedema Professional ORAL Other Fluoxetine (Fluoxetine) C Date:05/21/01ISR Number: 3727001-0Report Type:Expedited (15-DaCompany Report #PHBS2001AU02331 Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Oxygen Saturation Foreign Clozaril PS Novartis Decreased Study Pharmaceuticals Corp ORAL 400 MG, QD, Sleep Apnoea Syndrome Health ORAL Sleep Disorder Professional Snoring Other Date:05/22/01ISR Number: 3727206-9Report Type:Expedited (15-DaCompany Report #PHEH2001US02939 Age:77 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hallucination Health Clozaril PS Novartis Parkinson'S Disease Professional Pharmaceuticals Corp ORAL 25 MG, UNK, ORAL Date:05/23/01ISR Number: 3727327-0Report Type:Expedited (15-DaCompany Report #01-05-0262 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 38MG QD ORAL Professional Date:05/23/01ISR Number: 3727328-2Report Type:Expedited (15-DaCompany Report #01-05-0258 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Road Traffic Accident Health Clozapine PS Zenith Goldline ORAL 400MG QD ORAL Professional Date:05/23/01ISR Number: 3727330-0Report Type:Expedited (15-DaCompany Report #01-03-0147 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Viral Infection Health Clozapine PS Zenith Goldline ORAL 500MG QD ORAL Professional Glucophage C Date:05/23/01ISR Number: 3727338-5Report Type:Expedited (15-DaCompany Report #01-04-0238 Age:61 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 250MG QD ORAL Professional 22-Feb-2006 08:30 AM Page: 1144 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/23/01ISR Number: 3727339-7Report Type:Expedited (15-DaCompany Report #01-03-0172 Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Appendicitis Health Clozapine PS Zenith Goldline ORAL 550MG QD ORAL Professional Luvox C Date:05/23/01ISR Number: 3727340-3Report Type:Expedited (15-DaCompany Report #01-04-0246 Age:55 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 200MG BID Professional ORAL Date:05/23/01ISR Number: 3727341-5Report Type:Expedited (15-DaCompany Report #01-04-0226 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aneurysm Health Clozapine PS Zenith Goldline ORAL 12.5MG QD Arterial Rupture Professional ORAL Date:05/23/01ISR Number: 3727343-9Report Type:Expedited (15-DaCompany Report #01-04-0225 Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Clozapine PS Zenith Goldline ORAL 125-400MG QD Professional ORAL Date:05/23/01ISR Number: 3727344-0Report Type:Expedited (15-DaCompany Report #01-03-0170 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coronary Artery Disease Health Clozapine PS Zenith Goldline ORAL 300 MG QD Professional ORAL Date:05/23/01ISR Number: 3731836-8Report Type:Direct Company Report # Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pyrexia Clozaril PS White Blood Cell Count Decreased Date:05/24/01ISR Number: 3728493-3Report Type:Expedited (15-DaCompany Report #PHEH2001US03246 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Health Clozaril PS Novartis Salivary Hypersecretion Professional Pharmaceuticals Corp ORAL 300 MG, ORAL Prilosec (Omeprazole) C 22-Feb-2006 08:30 AM Page: 1145 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/24/01ISR Number: 3728494-5Report Type:Expedited (15-DaCompany Report #PHEH2001US00878 Age:67 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Breast Cancer Stage Ii Health Clozaril PS Novartis Hospitalization - Leukopenia Professional Pharmaceuticals Corp ORAL 400 MG, QD, Initial or Prolonged ORAL Date:05/24/01ISR Number: 3728495-7Report Type:Expedited (15-DaCompany Report #PHEH2001US04247 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Chronic Obstructive Health Clozaril PS Novartis Hospitalization - Pulmonary Disease Professional Pharmaceuticals Corp ORAL 400 MG, ORAL Initial or Prolonged Date:05/24/01ISR Number: 3728542-2Report Type:Expedited (15-DaCompany Report #FLUV00301002243 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Eyelid Oedema Foreign Luvox PS Solvay Initial or Prolonged Oedema Health Pharmaceuticals ORAL 50 MG DAILY Weight Increased Professional PO Other Leponex (Clozapine) SS ORAL 12.5 MG DAILY PO, 25 MG DAILY PO, 50 MG DAILY PO, 100 MG DAILY Date:05/24/01ISR Number: 3728686-5Report Type:Expedited (15-DaCompany Report #PHNU2001DE01269 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Foreign Clozaril PS Novartis Initial or Prolonged Health Pharmaceuticals Corp ORAL ORAL Professional Other Date:05/24/01ISR Number: 3728692-0Report Type:Expedited (15-DaCompany Report #PHFR2001GB01143 Age:11 HR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Coagulation Time Abnormal Foreign Clozaril PS Novartis Complications Of Maternal Health Pharmaceuticals Corp Exposure To Therapeutic Professional Ferrous Sulfate C Drugs Other Folic Acid C Convulsion Nitrazepam C Cyanosis Date:05/24/01ISR Number: 3728693-2Report Type:Expedited (15-DaCompany Report #PHBS2001DE04940 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Other Binge Eating Foreign Hunger Literature Hyperphagia Health Weight Increased Professional 22-Feb-2006 08:30 AM Page: 1146 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Product Role Manufacturer Route Dose Duration Clozaril PS Novartis Pharmaceuticals Corp 450 MG/D Haloperidol SS Chlorprothixene SS Clopenthixol SS Date:05/24/01ISR Number: 3728698-1Report Type:Expedited (15-DaCompany Report #PHBS2001DE04939 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Binge Eating Foreign Clozaril PS Novartis Hunger Literature Pharmaceuticals Corp 500 MG/D Weight Increased Health Risperidone(Risperid Professional one) SS Other Date:05/25/01ISR Number: 3729135-3Report Type:Expedited (15-DaCompany Report #PHBS2001BR03799 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Leukopenia Foreign Clozaril PS Novartis Oropharyngeal Cancer Health Pharmaceuticals Corp ORAL 300 MG/D, Stage Unspecified Professional ORAL Company Representative Other Date:05/25/01ISR Number: 3729140-7Report Type:Expedited (15-DaCompany Report #PHFR2000GB01225 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Foreign Clozaril PS Novartis Study Pharmaceuticals Corp ORAL 500MG/DAY, Health ORAL Professional Paroxetine C Other Date:05/29/01ISR Number: 3729723-4Report Type:Expedited (15-DaCompany Report #PHNU2001DE00828 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril PS Novartis Insulin-Dependent Health Pharmaceuticals Corp ORAL 475 MG/DAY, Professional ORAL Other Zantac C Calcium Effervescent Tablet C 22-Feb-2006 08:30 AM Page: 1147 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/29/01ISR Number: 3729726-XReport Type:Expedited (15-DaCompany Report #PHFR2001GB00738 Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Diabetes Mellitus Foreign Clozaril PS Novartis Hospitalization - Insulin-Dependent Health Pharmaceuticals Corp ORAL 450MG/DAY, Initial or Prolonged Diabetic Coma Professional ORAL Diabetic Ketoacidosis Other Sertraline Influenza Like Illness (Sertraline) C Valproate Sodium C Date:05/29/01ISR Number: 3729751-9Report Type:Expedited (15-DaCompany Report #PHFR2001GB00463 Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Distension Foreign Clozaril PS Novartis Initial or Prolonged Appendicitis Health Pharmaceuticals Corp ORAL 350MG/DAY, Constipation Professional ORAL Intestinal Perforation Other Droperidol C Peritoneal Adhesions Amitriptyline C Peritonitis Date:05/29/01ISR Number: 3729900-2Report Type:Expedited (15-DaCompany Report #01-05-0248 Age:78 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 50-100 QD Hospitalization - Professional ORAL Initial or Prolonged Clonazepam SS Megace C Premarin C Magnesium C Nifedipine C Date:05/29/01ISR Number: 3729902-6Report Type:Expedited (15-DaCompany Report #01-05-0247 Age:73 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Multiple Myeloma Health Clozapine PS Zenith Goldline ORAL 50-100MG QD Professional ORAL Aricept C Arthrotec C Lithium C Date:05/29/01ISR Number: 3729904-XReport Type:Expedited (15-DaCompany Report #01-05-0266 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Platelet Aggregation Health Clozapine PS Zenith Goldline ORAL 100-600MG QD Initial or Prolonged Abnormal Professional ORAL White Blood Cell Count Increased 22-Feb-2006 08:30 AM Page: 1148 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/29/01ISR Number: 3729906-3Report Type:Expedited (15-DaCompany Report #01-05-0267 Age:78 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Gastric Ulcer Haemorrhage Health Clozapine PS Zenith Goldline ORAL UNKNOWN ORAL Professional Date:05/29/01ISR Number: 3729908-7Report Type:Expedited (15-DaCompany Report #01-05-0265 Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 12.5 MG QD Professional ORAL Date:05/29/01ISR Number: 3729910-5Report Type:Expedited (15-DaCompany Report #01-05-0263 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 300-400MG QD Professional ORAL Date:05/29/01ISR Number: 3729921-XReport Type:Expedited (15-DaCompany Report #PHEH2001US03962 Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Brain Oedema Health Clozaril PS Novartis Bronchitis Professional Pharmaceuticals Corp ORAL 600MG DAILY, Bronchopneumonia Company ORAL Circulatory Collapse Representative Buspar (Buspirone Renal Cyst Hydrochloride) C Sinusitis Trazodone (Trazodone) C Date:05/29/01ISR Number: 3729923-3Report Type:Expedited (15-DaCompany Report #PHEH2001US04325 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Health Clozaril PS Novartis Professional Pharmaceuticals Corp ORAL 400 MG, BID, ORAL Zoloft (Sertraline Hydrochloride) C Allopurinol C Date:05/29/01ISR Number: 3729926-9Report Type:Expedited (15-DaCompany Report #PHEH2001US04303 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatitis C Health Clozaril PS Novartis Professional Pharmaceuticals Corp ORAL 800MG DAILY, ORAL 22-Feb-2006 08:30 AM Page: 1149 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/29/01ISR Number: 3730112-7Report Type:Expedited (15-DaCompany Report #PHFR2001GB01467 Age:64 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Foreign Clozaril PS Novartis Initial or Prolonged Circulatory Collapse Health Pharmaceuticals Corp ORAL 225 MG/DAY, Other Dehydration Professional ORAL Hypotension Other Lomotil Irritable Bowel Syndrome (Diphenoxylate Pallor Hydrochloride) C Rectal Haemorrhage Dioralyte C Vomiting Tylex (Carbinoxamine Weight Decreased Maleate, Paracetamol) C Co-Dydramol (Dihydrocodeine Bitartrate, Paracetamol) C Date:05/29/01ISR Number: 3730114-0Report Type:Expedited (15-DaCompany Report #PHBS2001AU04475 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Brain Damage Foreign Clozaril PS Novartis Initial or Prolonged Cardiac Arrest Study Pharmaceuticals Corp ORAL 600 MG/D, Cerebrovascular Accident Health ORAL Circulatory Collapse Professional Warfarin (Warfarin) C Embolism Other Loss Of Consciousness Date:05/29/01ISR Number: 3730799-9Report Type:Expedited (15-DaCompany Report #PHNU2001DE01306 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Lymphoma Foreign Clozaril PS Novartis Health Pharmaceuticals Corp ORAL 300 MG/DAY, Professional ORAL Company Amitriptyline Representative (Amitriptyline) C Other Date:05/29/01ISR Number: 3730802-6Report Type:Expedited (15-DaCompany Report #PHBS2000NZ09588 Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Enzymes Increased Foreign Clozaril PS Novartis Initial or Prolonged Hyperhidrosis Health Pharmaceuticals Corp ORAL 200 MG/D, Leukocytosis Professional ORAL Pyrexia Other Risperidone Red Blood Cell (Risperidone) C Sedimentation Rate Increased Tachycardia 22-Feb-2006 08:30 AM Page: 1150 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/31/01ISR Number: 3731411-5Report Type:Expedited (15-DaCompany Report #PHBS2000NZ10535 Age:55 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Foreign Clozaril PS Novartis Health Pharmaceuticals Corp ORAL 500 MG/D, Professional ORAL Other Epilim C Date:05/31/01ISR Number: 3731608-4Report Type:Expedited (15-DaCompany Report #2001AP02279 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Seroquel PS Astrazeneca Lp 1 MON Health Clozapine SS 8 MON Professional Other Date:05/31/01ISR Number: 3731666-7Report Type:Expedited (15-DaCompany Report #PHBS2000AU11423 Age:27 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiomyopathy Foreign Clozaril PS Novartis Condition Aggravated Health Pharmaceuticals Corp ORAL 600 MG, QD, Professional ORAL Other Paroxetine (Parexetine) C Clonazepam C Date:06/01/01ISR Number: 3732242-2Report Type:Expedited (15-DaCompany Report #PHBS2001NZ05056 Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Foreign Clozaril PS Novartis Initial or Prolonged Congestive Cardiomyopathy Health Pharmaceuticals Corp ORAL 700 MG/D, Myocardial Infarction Professional ORAL Other Date:06/01/01ISR Number: 3732243-4Report Type:Expedited (15-DaCompany Report #PHFR2001GB01544 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Pneumonia Aspiration Foreign Clozaril PS Novartis Health Pharmaceuticals Corp ORAL 500 MG/DAY, Professional ORAL Other Date:06/01/01ISR Number: 3732246-XReport Type:Expedited (15-DaCompany Report #PHFR2001GB01525 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Gastric Haemorrhage Foreign Clozaril PS Novartis Gastrointestinal Health Pharmaceuticals Corp ORAL ORAL Haemorrhage Professional Other 22-Feb-2006 08:30 AM Page: 1151 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/01/01ISR Number: 3732247-1Report Type:Expedited (15-DaCompany Report #PHFR2001GB01405 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Autonomic Nervous System Foreign Clozaril PS Novartis Initial or Prolonged Imbalance Health Pharmaceuticals Corp ORAL 300 MG/DAY, Body Temperature Professional ORAL; 350 Increased Other MG/DAY, ORAL Hyperhidrosis Paroxetine Hypertension (Paroxetine) C Joint Stiffness Zopiclone C Neuroleptic Malignant Clonazepam C Syndrome Kwells C Respiratory Rate Increased Tachycardia Date:06/01/01ISR Number: 3732250-1Report Type:Expedited (15-DaCompany Report #PHFR2001GB01541 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiac Failure Foreign Clozaril PS Novartis Hospitalization - Cardiomyopathy Health Pharmaceuticals Corp ORAL 100 MG, BID, Initial or Prolonged Dyspnoea Professional ORAL Disability Ejection Fraction Other Fluoxetine Abnormal (Fluoxetine) C Prempak (Medrogestone, Estrogens Conjugated) C Iron Sulfate C Date:06/04/01ISR Number: 3732967-9Report Type:Expedited (15-DaCompany Report #PHEH2001US04421 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Cancer Female Health Clozaril PS Novartis Professional Pharmaceuticals Corp ORAL ORAL Date:06/04/01ISR Number: 3733107-2Report Type:Expedited (15-DaCompany Report #PHEH2001US04393 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Increased Health Clozaril PS Novartis Initial or Prolonged Blood Urea Increased Professional Pharmaceuticals Corp ORAL 500MG DAILY, Intestinal Obstruction ORAL Date:06/04/01ISR Number: 3733111-4Report Type:Expedited (15-DaCompany Report #PHEH2001US04415 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Health Clozaril PS Novartis Initial or Prolonged Cough Professional Pharmaceuticals Corp ORAL 300 MG, ORAL Gastritis Haldol C Mouth Ulceration Depakote (Valproate Semisodium) C Cogentin (Benzatropine 22-Feb-2006 08:30 AM Page: 1152 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Mesilate) C Buspar (Buspirone Hydrochloride) C Date:06/04/01ISR Number: 3733115-1Report Type:Expedited (15-DaCompany Report #01-05-0273 Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neoplasm Malignant Health Clozapine PS Zenith Goldline ORAL 200-350MG QD Professional ORAL Date:06/04/01ISR Number: 3733118-7Report Type:Expedited (15-DaCompany Report #01-05-0256 Age:59 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldine Pharm ORAL 150-600MG QD Professional ORAL Singulair C Prilosec C Feostat C Depakene C Date:06/04/01ISR Number: 3733121-7Report Type:Expedited (15-DaCompany Report #01-04-0201 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Health Clozapine PS Zenith Goldline ORAL 600-662.5MG Initial or Prolonged Anger Professional ORAL Condition Aggravated Decreased Appetite Delusion Disorientation Hallucinations, Mixed Insomnia Schizophrenia, Paranoid Type Weight Decreased Date:06/04/01ISR Number: 3733123-0Report Type:Expedited (15-DaCompany Report #01-04-0234 Age:78 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Colitis Health Clozapine PS Zenith Goldline ORAL 125-175MG QD Coronary Artery Disease Professional ORAL Failure To Thrive Accupril C Myocardial Infarction Acetaminophen C Pneumonia Cipro C Magnesium Citrate C Cyanocobalamin C Cyproheptadine C Diflucan C Diocto Syrup C Ambien C Amoxicillin C Antacid Liquid Plus Simethicone C Atenolol C Augmentin C 22-Feb-2006 08:30 AM Page: 1153 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Bisacodyl C Furosemide C Levodopa-Carbidopa C Cepacol C Casanthranol W/Docusate Sodium C Effexor C Glucotrol Xl C Guaifenesin Dm Syrup C Glucophage C Ibuprofen C Jevity Plus C K-Dur C Ketoconazole Cream C Lactulose C Levaquin C Metronidazole C Milk Of Magnesia C Multivitamins W/ Minerals C Norvasc C Triamcinolone Acetonide W/Nysatatin Ointment C Prevacid C Prochlorperazine C Prochlorperazine C Propoxyphene Napsylate W/Acetaminophen C Robitussin C Santyl Ointment C Synthroid C Vitamin A+D Ointment/ Zinc Oxide C Date:06/04/01ISR Number: 3733313-7Report Type:Expedited (15-DaCompany Report #PHFR2001GB01622 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chorea Foreign Clozaril PS Novartis Dyskinesia Health Pharmaceuticals Corp ORAL 750 MG/DAY, Professional ORAL Other Date:06/04/01ISR Number: 3733321-6Report Type:Expedited (15-DaCompany Report #PHFR2001GB01606 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Constipation Foreign Clozaril PS Novartis Haemorrhage Study Pharmaceuticals Corp ORAL 300 MG, DAY, Vomiting Health ORAL Professional Other 22-Feb-2006 08:30 AM Page: 1154 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/05/01ISR Number: 3733810-4Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardio-Respiratory Arrest Clozapine 25mg/100mg Hospitalization - Hyperhidrosis Zenith Goldline PS Zenith Goldline ORAL 250/BID/PO Initial or Prolonged Labile Blood Pressure Clozapine 25mg Required Lethargy Zenith Goldline SS Zenith Goldline ORAL 37.5 /BID/PO Intervention to Myalgia Olanzapine C Prevent Permanent Pain Lorazepam C Impairment/Damage Pyrexia Valproic Acid C Virus Culture Positive Diphenhydramine C Date:06/05/01ISR Number: 3733903-1Report Type:Expedited (15-DaCompany Report #HQ6458626JAN2001 Age:56 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Ativan PS Wyeth Ayerst Initial or Prolonged Cerebral Atrophy Professional Laboratories 2.5 - 10 MG Other Confusional State DAILY Delirium Leponex (Clozapine) SS Novartis ORAL 125 MG 1X PER Delusion 1 DAY / 75 MG Depersonalisation 1X PER 1 DAY 1 DAY Depression Zoloft (Sertraline Disorientation Hydrochloride) C Fear Noroxin Sedation (Norfloxacin) C Sleep Disorder Tranxilium Thinking Abnormal (Clorazepate Dipotassium) C Date:06/05/01ISR Number: 3734841-0Report Type:Expedited (15-DaCompany Report #PHEH2001US04458 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Consumer Clozaril PS Novartis Pharmaceuticals Corp ORAL ORAL 610 DAY Date:06/05/01ISR Number: 3734847-1Report Type:Expedited (15-DaCompany Report #PHEH2001US04066 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Nasopharyngitis Health Clozaril PS Novartis Hospitalization - Pneumonia Professional Pharmaceuticals Corp ORAL ORAL Initial or Prolonged Respiratory Failure Company Haldol Decanoate Representative (Haloperidol Decanoate) C Cogentin (Benzatropine Mesilate) C Efexor - Slow Release (Venlafaxine Hydrochloride) C Neurontin (Gabapentin) C 22-Feb-2006 08:30 AM Page: 1155 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/06/01ISR Number: 3734931-2Report Type:Expedited (15-DaCompany Report #PHEH2001US04240 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Clozaril PS Novartis Professional Pharmaceuticals Corp ORAL 200 MG, ORAL Date:06/06/01ISR Number: 3734932-4Report Type:Expedited (15-DaCompany Report #PHEH2001US04543 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Health Clozaril PS Novartis Initial or Prolonged Electrocardiogram Professional Pharmaceuticals Corp ORAL 3200 MG, BID, Abnormal ORAL Enzyme Abnormality Claritine (Loratadine) C Lorazepam C Date:06/06/01ISR Number: 3734934-8Report Type:Expedited (15-DaCompany Report #PHEH2001US04590 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Lung Neoplasm Malignant Health Clozaril PS Novartis Professional Pharmaceuticals Corp ORAL 800 MG, ORAL Date:06/06/01ISR Number: 3735466-3Report Type:Expedited (15-DaCompany Report #PHFR2001GB01579 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Foreign Clozapine PS Novartis Respiratory Failure Study Pharmaceuticals Corp ORAL 150 MG, BID, Health ORAL Professional Chlorpromazine C Date:06/06/01ISR Number: 3735472-9Report Type:Expedited (15-DaCompany Report #PHBS1999GB02939 Age:28 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Phaeochromocytoma Foreign Clozaril PS Novartis Literature Pharmaceuticals Corp Health Bendrofluazide C Professional Atrovent Other (Ipratropium Bromide) C Date:06/06/01ISR Number: 3735473-0Report Type:Expedited (15-DaCompany Report #PHBS1999GB05568 Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Foreign Clozaril PS Novartis Initial or Prolonged Non-Insulin-Dependent Literature Pharmaceuticals Corp ORAL 450 MG, BID, Phaeochromocytoma Health ORAL Professional Venlafaxine Other (Venlafaxine) C Sulpiride (Sulpiride) C 22-Feb-2006 08:30 AM Page: 1156 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/06/01ISR Number: 3735474-2Report Type:Expedited (15-DaCompany Report #PHNU2001DE00925 Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Ventricular Extrasystoles Foreign Clozaril PS Novartis Health Pharmaceuticals Corp ORAL 150 MG DAILY, Professional ORAL Other Fevarin (Fluvoxamine Maleate) C Date:06/06/01ISR Number: 3736002-8Report Type:Expedited (15-DaCompany Report #PHEH2001US04240 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Clozaril PS Novartis Professional Pharmaceuticals Corp ORAL 200 MG, ORAL Date:06/07/01ISR Number: 3735736-9Report Type:Expedited (15-DaCompany Report #PHFR2001GB01360 Age:22 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Pressure Increased Foreign Clozaril PS Novartis Catecholamines Urine Literature Pharmaceuticals Corp ORAL 600MG/DAY, Increased Health ORAL 91 DAY Professional Sulpiride Other (Sulpiride) C Paroxetine (Paroxetine) C Date:06/07/01ISR Number: 3735770-9Report Type:Expedited (15-DaCompany Report #PHBS1999GB02828 Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Phaeochromocytoma Foreign Clozaril PS Novartis Literature Pharmaceuticals Corp ORAL 400 MG, ORAL Health Fluoxetine Professional (Fluoxetine) C Other Date:06/07/01ISR Number: 3735771-0Report Type:Expedited (15-DaCompany Report #PHBS2001AU05548 Age:71 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Gastrointestinal Foreign Clozaril PS Novartis Haemorrhage Health Pharmaceuticals Corp ORAL 25 MG/D,ORAL Professional Other Date:06/07/01ISR Number: 3735772-2Report Type:Expedited (15-DaCompany Report #PHBS2001AU03456 Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Overdose Foreign Clozaril PS Novartis Hospitalization - Compartment Syndrome Study Pharmaceuticals Corp ORAL 800 MG/D, Initial or Prolonged Completed Suicide Health ORAL (SEE Oedema Peripheral Professional IMAGE) Other Alcohol (Ethanol) SS 1194 DAY 22-Feb-2006 08:30 AM Page: 1157 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/07/01ISR Number: 3735773-4Report Type:Expedited (15-DaCompany Report #PHFR2001GB01004 Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Increased Foreign Clozaril PS Novartis Initial or Prolonged Catatonia Health Pharmaceuticals Corp ORAL 25 MG, BID, Heart Rate Increased Professional ORAL (SEE Stupor Other IMAGE) Zopiclone C Lorazepam C Co-Codamol (Paracetamol) C Ditropan (Oxybutynin) C Date:06/08/01ISR Number: 3736461-0Report Type:Expedited (15-DaCompany Report #PHBS2001AU05622 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Clozaril PS Novartis Hospitalization - Poor Peripheral Consumer Pharmaceuticals Corp ORAL 250 MG/D, Initial or Prolonged Circulation Other ORAL Skin Disorder Date:06/11/01ISR Number: 3737092-9Report Type:Periodic Company Report #2001-03-1507 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Interaction Health Claritin Drug Level Changed Professional (Loratadine) PS Schering Corp Sub Schering Plough Corp ORAL 10 MG ORAL Clozaril SS Date:06/11/01ISR Number: 3737498-8Report Type:Expedited (15-DaCompany Report #01-05-0276 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neoplasm Malignant Health Clozapine PS Zenith Goldline ORAL 300-450 MG Professional ORAL Date:06/11/01ISR Number: 3737499-XReport Type:Expedited (15-DaCompany Report #01-06-0277 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 750MG QD ORAL Professional Date:06/11/01ISR Number: 3737500-3Report Type:Expedited (15-DaCompany Report #01-05-0285 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 50-300MG QD Professional ORAL 22-Feb-2006 08:30 AM Page: 1158 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/11/01ISR Number: 3737501-5Report Type:Expedited (15-DaCompany Report #01-06-0287 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 600-850MG QD Professional ORAL Date:06/11/01ISR Number: 3737503-9Report Type:Expedited (15-DaCompany Report #01-04-0198 Age:76 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Metastasis Health Clozapine PS Zenith Goldline ORAL 50MG QD ORAL Professional Date:06/11/01ISR Number: 3737505-2Report Type:Expedited (15-DaCompany Report #01-04-0209 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abnormal Behaviour Health Clozapine PS Zenith Goldline ORAL 25MG BID ORAL Hospitalization - Condition Aggravated Professional Atenolol C Initial or Prolonged Hallucination, Auditory Benadryl C Neutropenia Colace C Tremor Prolixin Decanoate C White Blood Cell Count Decreased Date:06/11/01ISR Number: 3737507-6Report Type:Expedited (15-DaCompany Report #C2001-1070.01 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Clozapine PS Mylan Initial or Prolonged Schizophrenia, Paranoid Professional Pharmaceuticals Inc ORAL 100 MG Q AM Other Type Other ORAL Clozapine Tablets SS Zenith Goldline ORAL 100 MG Q AM ORAL Date:06/11/01ISR Number: 3737803-2Report Type:Expedited (15-DaCompany Report #PHBS2001AU03456 Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Overdose Foreign Clozaril PS Novartis Hospitalization - Compartment Syndrome Study Pharmaceuticals Corp ORAL 800 MG/D, Initial or Prolonged Completed Suicide Health ORAL Oedema Peripheral Professional Alcohol (Ethanol) SS 1194 DAY Other Date:06/11/01ISR Number: 3737818-4Report Type:Expedited (15-DaCompany Report #PHBS2001DE04882 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Withdrawal Syndrome Foreign Clozaril PS Novartis Initial or Prolonged Muscle Spasms Literature Pharmaceuticals Corp UNKNOWN 350 MG/D, UNK Nasopharyngeal Disorder Health Amisulpride(Amisulpr Tongue Paralysis Professional ide) SS UNKNOWN 600 MG/D, UNK Other 22-Feb-2006 08:30 AM Page: 1159 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/11/01ISR Number: 3738146-3Report Type:Expedited (15-DaCompany Report #2001013629-1 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Grand Mal Convulsion Health Eskalith PS Smithkline Beecham Initial or Prolonged White Blood Cell Count Professional Pharmaceuticals Increased Clozapine SS Navane (Tiotixene) C Date:06/12/01ISR Number: 3738750-2Report Type:Expedited (15-DaCompany Report #S01-DEN-00800-01 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Autoimmune Disorder Foreign Celexa PS Forest Laboratories Initial or Prolonged Epistaxis Health Inc Other Haemolysis Professional Cipramil (Citalopram Malignant Histiocytosis Other Hydrobromide) SS ORAL 20 MG QD PO Medication Error Clozapine SS ORAL 100 MG QD PO Thrombocytopenia Clozapine SS Cisordinol (Clopenthixol Hydrochloride) SS Date:06/12/01ISR Number: 3738781-2Report Type:Expedited (15-DaCompany Report #PHFR2001GB01005 Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amnesia Foreign Clozaril PS Novartis Encephalopathy Health Pharmaceuticals Corp ORAL 400 MG/DAY, Professional ORAL Other Date:06/12/01ISR Number: 3738807-6Report Type:Expedited (15-DaCompany Report #PHBS2001AU05785 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiomegaly Foreign Clozaril PS Novartis Dizziness Literature Pharmaceuticals Corp 12.5 MG TO Dyspnoea Health 200 MG Electrocardiogram Professional Abnormal Other Electrocardiogram St Segment Depression Electrocardiogram T Wave Inversion Myocarditis Salivary Hypersecretion Sedation Date:06/12/01ISR Number: 3738809-XReport Type:Expedited (15-DaCompany Report #PHBS2000AU11423 Age:27 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiomyopathy Foreign Clozaril PS Novartis Left Ventricular Failure Health Pharmaceuticals Corp ORAL 600 MG/D, Professional ORAL Other Paroxetine (Paroxetine) C 22-Feb-2006 08:30 AM Page: 1160 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Clonazepam C Olanzapine (Olanzapine) C Date:06/13/01ISR Number: 3739064-7Report Type:Expedited (15-DaCompany Report #01-03-0173 Age:92 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Chronic Obstructive Health Clozapine PS Zenith Goldline ORAL 12.5-37.5MG Q Pulmonary Disease Professional ORAL Date:06/13/01ISR Number: 3739067-2Report Type:Expedited (15-DaCompany Report #01-04-0233 Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL ORAL Professional Date:06/13/01ISR Number: 3739068-4Report Type:Expedited (15-DaCompany Report #01-04-0239 Age:78 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 25MG QD ORAL Professional Date:06/13/01ISR Number: 3739071-4Report Type:Expedited (15-DaCompany Report #01-06-0295 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Haematocrit Increased Health Clozapine PS Zenith Goldline ORAL 150-350MG QD Initial or Prolonged Haemoglobin Increased Professional ORAL Hypoxia Premarin C Pneumonia Depakote C Theo-Dur C Zoloft C Zyrtec C Singulair C Flovent C Serevent C Date:06/13/01ISR Number: 3739073-8Report Type:Expedited (15-DaCompany Report #01-06-0293 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Surgery Health Clozapine PS Zenith Goldline ORAL 25-600MG QD Initial or Prolonged Professional ORAL Date:06/13/01ISR Number: 3739076-3Report Type:Expedited (15-DaCompany Report #01-06-0286 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 550MG QD ORAL Professional 22-Feb-2006 08:30 AM Page: 1161 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/14/01ISR Number: 3740066-5Report Type:Expedited (15-DaCompany Report #PHEH2001US03498 Age:57 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Foreign Body Aspiration Health Clozaril PS Novartis Professional Pharmaceuticals Corp ORAL 825 MG, ORAL Date:06/15/01ISR Number: 3740611-XReport Type:Expedited (15-DaCompany Report #PHEH2001US01737 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozaril PS Novartis Professional Pharmaceuticals Corp ORAL 300 MG, DAILY, ORAL Wellbutrin (Amfebutamone Hydrochloride) C Clozaril (Clozapine) C Date:06/15/01ISR Number: 3740652-2Report Type:Expedited (15-DaCompany Report #PHEH2001US04727 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pyrexia Health Clozaril PS Novartis Initial or Prolonged Tuberculosis Professional Pharmaceuticals Corp ORAL 350 MG, ORAL Ditropan (Oxybutynin) C Gabapentin (Gabapentin) C Risperdal (Risperidone) C Zoloft (Sertraline Hydrochloride) C Date:06/15/01ISR Number: 3740667-4Report Type:Expedited (15-DaCompany Report #PHEH2001US04493 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Health Clozaril PS Novartis Initial or Prolonged Blood Pressure Increased Professional Pharmaceuticals Corp ORAL 200 MG AM + Constipation 250 MG PM, Diarrhoea ORAL Eosinophil Count Zocor C Increased Neurontin Pancreatic Disorder (Gabapentin) C Pyrexia Klonopin C Swelling Motrin C Depakote (Valproate Semisodium) C Amarel (Glimepiride) C Glucophage "Merck" C Norvas C 22-Feb-2006 08:30 AM Page: 1162 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/15/01ISR Number: 3740701-1Report Type:Expedited (15-DaCompany Report #PHEH2001US04746 Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Alkaline Health Clozaril PS Novartis Required Phosphatase Increased Professional Pharmaceuticals Corp ORAL 25 MG, BID, Intervention to Blood Creatine Company ORAL Prevent Permanent Phosphokinase Increased Representative Navan (Tiotixene) C Impairment/Damage Blood Electrolytes Decreased Leukocytosis Red Blood Cell Sedimentation Rate Increased Date:06/15/01ISR Number: 3740756-4Report Type:Expedited (15-DaCompany Report #PHBS2001AU05909 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiomyopathy Foreign Clozaril PS Novartis Health Pharmaceuticals Corp ORAL ORAL Professional Date:06/15/01ISR Number: 3740758-8Report Type:Expedited (15-DaCompany Report #PHFR2001GB01711 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Foreign Clozaril PS Novartis Prolonged Health Pharmaceuticals Corp ORAL ORAL Tachycardia Professional Date:06/15/01ISR Number: 3740759-XReport Type:Expedited (15-DaCompany Report #PHFR2001GB01709 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Foreign Clozaril PS Novartis Drug Interaction Health Pharmaceuticals Corp ORAL 700MG/DAY, Professional ORAL Other Bendrofluazide (Bendroflumethiazide SS Lithium C Chlorpromazine C Ibuprofen C Omeprazole C Priadel C Date:06/15/01ISR Number: 3740763-1Report Type:Expedited (15-DaCompany Report #PHBS2001AU04550 Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Squamous Cell Carcinoma Foreign Clozaril PS Novartis Health Pharmaceuticals Corp ORAL 350 MG/D ORAL 5 YR Professional Dilantin C Other Phenobarbitone C Clonazepam C Cipramil C Haloperidol C Lamotrigine C 22-Feb-2006 08:30 AM Page: 1163 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/15/01ISR Number: 3741079-XReport Type:Expedited (15-DaCompany Report #PHNU2001DE01306 Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Non-Hodgkin'S Lymphoma Foreign Clozaril PS Novartis Health Pharmaceuticals Corp ORAL 300 MG/DAY, Professional ORAL Other Amitriptyline (Amitriptyline) C Lithium Carabonate C Carbamazepine C Date:06/15/01ISR Number: 3741117-4Report Type:Expedited (15-DaCompany Report #PHFR2000GB01851 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Intestinal Obstruction Foreign Clozaril PS Novartis Hospitalization - Neoplasm Malignant Health Pharmaceuticals Corp ORAL ORAL Initial or Prolonged Professional Other Date:06/18/01ISR Number: 3741532-9Report Type:Expedited (15-DaCompany Report #PHFR2001GB01710 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Glucose Increased Foreign Clozaril PS Novartis Hospitalization - Coma Health Pharmaceuticals Corp ORAL 300MG/DAY, Initial or Prolonged Dehydration Professional ORAL Diabetic Ketoacidosis Other Detrusitol Heart Rate Increased (Tolterodine Malaise L-Tartrate) C Vomiting Oxazepam (Oxazepam) C Diazepam C Cinnarizine (Cinnarizine) C Zoton (Lansoprazole) C Gaviscon (Sodium Alginate) C Date:06/18/01ISR Number: 3741668-2Report Type:Expedited (15-DaCompany Report #PHFR2001GB01741 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Foreign Clozaril PS Novartis Electrocardiogram Qt Health Pharmaceuticals Corp ORAL 500MG/DAY; Corrected Interval Professional ORAL Prolonged Other Lithium C Vomiting Domperidone C Amoxicillin C Date:06/18/01ISR Number: 3741669-4Report Type:Expedited (15-DaCompany Report #PHNU2001DE01406 Age:48 YR Gender:Female I/FU:I Outcome PT Other Anaemia C-Reactive Protein Increased Eosinophilia 22-Feb-2006 08:30 AM Page: 1164 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Leukocytosis Lipase Increased Lymphopenia Report Source Product Role Manufacturer Route Dose Duration Monocytosis Foreign Clozaril PS Novartis Neutropenia Health Pharmaceuticals Corp ORAL 125MG/DAY; Pericardial Effusion Professional ORAL Pleural Effusion Other Tavor C Pyrexia Glianimon Red Blood Cell (Benperidol) C Sedimentation Rate Orfiril "Desitin" C Increased Date:06/18/01ISR Number: 3741736-5Report Type:Expedited (15-DaCompany Report #2001UW06627 Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Agranulocytosis Seroquel "Zeneca" PS Astrazeneca Lp Intervention to Neutropenia Clozapil SS Prevent Permanent Impairment/Damage Date:06/18/01ISR Number: 3741756-0Report Type:Expedited (15-DaCompany Report #2001013931-1 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutropenia Health Paxil PS Smithkline Beecham Initial or Prolonged Overdose Professional Pharmaceuticals ORAL 20 MILLIGRAMS Platelet Count Decreased Other 1.0 DAILY ORAL Clozapine SS ORAL 450 MILLIGRAMS, 1.0 DAILY ORAL 151 DAY Haldol (Haloperidol) C Risperdal (Risperidone) C Cogentin (Benztropine Mesylate) C Lithium C Date:06/18/01ISR Number: 3742498-8Report Type:Periodic Company Report #LBID00201001077 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombocytopenia Health Lithobid PS Solvay Professional Pharmaceuticals ORAL 900 MG DAILY PO Clozapine (Clozapine) SS ORAL 25 MG DAILY PO, 300 MG DAILY PO Dilantin (Phenytoin Sodium) C (Propranolol) C Aricept (Donepezil Hydrochloride) C 22-Feb-2006 08:30 AM Page: 1165 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/19/01ISR Number: 3742591-XReport Type:Expedited (15-DaCompany Report #PHBS2001AR06072 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Neoplasm Malignant Foreign Clozaril PS Novartis Health Pharmaceuticals Corp ORAL 300 MG/D, Professional ORAL Other Date:06/19/01ISR Number: 3742807-XReport Type:Expedited (15-DaCompany Report #PHFR2001GB01742 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Constipation Foreign Clozaril PS Novartis Initial or Prolonged Megacolon Health Pharmaceuticals Corp ORAL 300 MG/DAY, Other Professional ORAL Date:06/19/01ISR Number: 3742959-1Report Type:Expedited (15-DaCompany Report #PHNU2001DE01106 Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril PS Novartis Health Pharmaceuticals Corp ORAL ORAL Professional Haldol Solution For Other Injection C Date:06/19/01ISR Number: 3742962-1Report Type:Expedited (15-DaCompany Report #PHFR2001GB00561 Age:53 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Foreign Clozaril PS Novartis Initial or Prolonged Cerebrovascular Accident Health Pharmaceuticals Corp ORAL 850MG/DAY, Circulatory Collapse Professional ORAL Convulsion Other Valproate Sodium C Orphenadrine C Ranitidine C Date:06/20/01ISR Number: 3742137-6Report Type:Direct Company Report # Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Petechiae Clozapine 25 Mg Hospitalization - Platelet Count Decreased Zenith Goldline PS Zenith Goldline 25 MG AM Initial or Prolonged Clozapine 100 Mg Required Zenith Goldline SS Zentih Goldline 100 MG PM Intervention to Zithromax C Prevent Permanent Depakote C Impairment/Damage Date:06/20/01ISR Number: 3743093-7Report Type:Expedited (15-DaCompany Report #01-06-0304 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 300-900MG QD Professional ORAL 22-Feb-2006 08:30 AM Page: 1166 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/20/01ISR Number: 3743096-2Report Type:Expedited (15-DaCompany Report #01-06-0310 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 50-200MG QD Professional ORAL Date:06/20/01ISR Number: 3743098-6Report Type:Expedited (15-DaCompany Report #01-06-0308 Age:93 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 100MG QD ORAL Professional Date:06/20/01ISR Number: 3743100-1Report Type:Expedited (15-DaCompany Report #01-06-0311 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Clozapine PS Zenith Goldline ORAL 400-600MG QD Professional ORAL Date:06/20/01ISR Number: 3743102-5Report Type:Expedited (15-DaCompany Report #01-06-0309 Age:82 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 25-150MG QD Professional ORAL Date:06/20/01ISR Number: 3743103-7Report Type:Expedited (15-DaCompany Report #01-06-0301 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Unevaluable Event Health Clozapine PS Zenith Goldline ORAL ORAL Initial or Prolonged Professional Date:06/20/01ISR Number: 3743106-2Report Type:Expedited (15-DaCompany Report #01-04-0227 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asthma Health Clozapine PS Zenith Goldline ORAL 300-600MG QD Cardiomegaly Professional ORAL Chronic Obstructive Prozac C Pulmonary Disease Dyspnoea Pneumonia Spinal Fracture Tooth Abscess Weight Increased Date:06/20/01ISR Number: 3743107-4Report Type:Expedited (15-DaCompany Report #01-05-0267 Age:78 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Gastrointestinal Health Clozapine PS Zenith Goldline ORAL ORAL Hospitalization - Haemorrhage Professional Zyprexa C Initial or Prolonged Prozac C 22-Feb-2006 08:30 AM Page: 1167 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lopressor C Date:06/20/01ISR Number: 3743122-0Report Type:Expedited (15-DaCompany Report #01-06-0314 Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 125-250MG QD Professional ORAL Date:06/21/01ISR Number: 3744427-XReport Type:Expedited (15-DaCompany Report #00-11-0564 Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fracture Health Clozapine PS Zenith Goldline ORAL 576-700 MG Initial or Prolonged Road Traffic Accident Professional ORAL Depakote C Date:06/21/01ISR Number: 3744430-XReport Type:Expedited (15-DaCompany Report #01-05-0285 Age:79 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 50-300MG QD Professional ORAL Adalat C Altace C Cimetidine C Remeron C Lorazepam C Date:06/21/01ISR Number: 3744433-5Report Type:Expedited (15-DaCompany Report #01-06-0293 Age:55 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Surgery Health Clozapine PS Zenith Goldline ORAL 25-600MG QD Initial or Prolonged Professional ORAL Date:06/21/01ISR Number: 3744435-9Report Type:Expedited (15-DaCompany Report #01-06-0321 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 125-600MG QD Professional ORAL Date:06/21/01ISR Number: 3744439-6Report Type:Expedited (15-DaCompany Report #01-06-0316 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 31.2-37.5MG Q Professional ORAL 22-Feb-2006 08:30 AM Page: 1168 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/21/01ISR Number: 3744442-6Report Type:Expedited (15-DaCompany Report #01-06-0315 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arterial Occlusive Clozapine PS Zenith Goldline 300-900MG QD Disease Coma Hepatic Failure Date:06/21/01ISR Number: 3744447-5Report Type:Expedited (15-DaCompany Report #PHBS1999NL00795 Age:67 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cyanosis Foreign Clozaril PS Novartis Initial or Prolonged Delirium Literature Pharmaceuticals Corp ORAL 350 MG, ORAL Drug Level Above Health Temesta (Lorazepam) C Therapeutic Professional Oxazepam (Oxazepam) C Pyrexia Tachypnoea Upper Respiratory Tract Infection Date:06/21/01ISR Number: 3744504-3Report Type:Expedited (15-DaCompany Report #PHNU2001DE01443 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Fall Foreign Clozaril PS Novartis Femoral Neck Fracture Health Pharmaceuticals Corp ORAL 75 Professional MG/DAY,ORAL Date:06/21/01ISR Number: 3744508-0Report Type:Expedited (15-DaCompany Report #PHBS2001AU06139 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiomyopathy Foreign Clozaril PS Novartis Study Pharmaceuticals Corp ORAL 200 MG/D, Health ORAL Professional Other Date:06/21/01ISR Number: 3744576-6Report Type:Expedited (15-DaCompany Report #PHFR2001GB01074 Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Foreign Clozaril PS Novartis Life-Threatening Coronary Artery Disease Study Pharmaceuticals Corp ORAL 50MG/DAY, Myocardial Infarction Health ORAL Myocardial Ischaemia Professional Frusemide C Other Enalapril (Enalapril) C Spironolactone C Digoxin C Amisulpride (Amisulpride) C 22-Feb-2006 08:30 AM Page: 1169 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/21/01ISR Number: 3744582-1Report Type:Expedited (15-DaCompany Report #PHBS2001NL06018 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Level Above Foreign Clozaril PS Novartis Initial or Prolonged Therapeutic Literature Pharmaceuticals Corp ORAL 200 TO 400 Pyrexia Health MG/D, ORAL Self Mutilation Professional (SEE IMAGE) Wound Infection Other Flucloxacillin (Flucloxacillin) SS Dehydrobenzperidol (Droperidol) C Insulin (Insulin) C Lorazepam C Lormetazepam (Lormetazepam) C Alprazolam (Alprazolam) C Omeprazole (Omeprazole) C Cisapride (Cisapride) C Oxybutynin "Nm Pharma" (Oxybutynin Hydrochloride) C Paroxetine (Paroxetine) C Date:06/21/01ISR Number: 3744586-9Report Type:Expedited (15-DaCompany Report #PHBS2001DE05997 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Condition Aggravated Foreign Clozaril PS Novartis Drug Withdrawal Syndrome Literature Pharmaceuticals Corp 400 MG/D, Murder Health (SEE IMAGE) Psychotic Disorder Professional Sedation Other Sexual Dysfunction Date:06/21/01ISR Number: 3744703-0Report Type:Expedited (15-DaCompany Report #PHBS2001AU06140 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiomyopathy Foreign Clozaril PS Novartis Health Pharmaceuticals Corp ORAL 300 MG/D, Professional ORAL Other Date:06/21/01ISR Number: 3744707-8Report Type:Expedited (15-DaCompany Report #PHBS2001AU01551 Age:47 YR Gender:Male I/FU:I Outcome PT Hospitalization - Anaemia Initial or Prolonged Eating Disorder Empyema Gastrointestinal Disorder Haemorrhage Lymphopenia Pneumonia 22-Feb-2006 08:30 AM Page: 1170 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Weight Decreased Report Source Product Role Manufacturer Route Dose Duration Foreign Clozaril PS Novartis Study Pharmaceuticals Corp ORAL 200 MG/D, Health ORAL Professional Omeprazole Other (Omeprazole) C Clonazepam C Flucloxacillin (Flucloxacillin) C Date:06/21/01ISR Number: 3744709-1Report Type:Expedited (15-DaCompany Report #PHBS2001DK06193 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Megacolon Foreign Clozaril PS Novartis Health Pharmaceuticals Corp ORAL 350 MG/D, Professional ORAL Other Congentin (Benzatropine Mesilate) SS ORAL 2 MG/D, ORAL Rivotril C Trilafon (Perphenazine) C Date:06/21/01ISR Number: 3744788-1Report Type:Expedited (15-DaCompany Report #PHBS2001AU06163 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiac Enzymes Increased Foreign Clozaril PS Novartis Study Pharmaceuticals Corp ORAL 500MG/D, ORAL Health Professional Other Date:06/21/01ISR Number: 3744890-4Report Type:Expedited (15-DaCompany Report #PHBS2001NL06015 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Appendicitis Foreign Clozaril PS Novartis Initial or Prolonged Delirium Literature Pharmaceuticals Corp ORAL 600 MG/D, Drug Level Above Health ORAL Therapeutic Professional Lorazepam C Infection Other Pyrexia Date:06/22/01ISR Number: 3745285-XReport Type:Expedited (15-DaCompany Report #PHFR2001GB01579 Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bronchopneumonia Foreign Clozaril PS Novartis Cardiac Failure Study Pharmaceuticals Corp ORAL 150 MG, BID, Diarrhoea Health ORAL Respiratory Failure Professional Chlorpromazine C Other Lithium Carbonate C Lorazepam C 22-Feb-2006 08:30 AM Page: 1171 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Zopiclone C Dioralyte C Date:06/22/01ISR Number: 3745308-8Report Type:Expedited (15-DaCompany Report #PHFR2001GB01809 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril PS Novartis Health Pharmaceuticals Corp ORAL 350 MG/DAY, Professional ORAL Other Date:06/22/01ISR Number: 3745309-XReport Type:Expedited (15-DaCompany Report #PHFR2001GB01783 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril PS Novartis Sedation Health Pharmaceuticals Corp ORAL 250MG/DAY, Professional ORAL Other Date:06/22/01ISR Number: 3745589-0Report Type:Expedited (15-DaCompany Report #PHEH2001US04325 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Health Clozaril PS Novartis Hypertension Professional Pharmaceuticals Corp ORAL 400 MG, BID, ORAL Zoloft C Allopurinol C Toproxl Xl C Date:06/22/01ISR Number: 3745592-0Report Type:Expedited (15-DaCompany Report #PHEH2001US04590 Age:47 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Lung Neoplasm Malignant Health Clozaril PS Novartis Hospitalization - Professional Pharmaceuticals Corp ORAL 200MG AM + Initial or Prolonged 600MG PM, ORAL Risperdal C Synthroid C Klonopin C Prozac C Date:06/22/01ISR Number: 3745629-9Report Type:Expedited (15-DaCompany Report #PHEH2001US04240 Age:49 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Clozaril PS Novartis Professional Pharmaceuticals Corp ORAL 200MG DAILY, ORAL Luvox C 22-Feb-2006 08:30 AM Page: 1172 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/22/01ISR Number: 3745633-0Report Type:Expedited (15-DaCompany Report #PHEH2001US05150 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Neoplasm Malignant Health Clozaril PS Novartis Professional Pharmaceuticals Corp ORAL 425MG, ORAL Date:06/22/01ISR Number: 3745712-8Report Type:Expedited (15-DaCompany Report #2001UW06625 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocarditis Other Seroquel PS Astrazeneca Lp Clozaril SS Date:06/22/01ISR Number: 3746081-XReport Type:Expedited (15-DaCompany Report #PHBS2001AU03748 Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiomyopathy Foreign Clozaril PS Novartis Drug Withdrawal Syndrome Study Pharmaceuticals Corp ORAL 300 MG/DAY, Psychotic Disorder Health ORAL Professional Other Date:06/25/01ISR Number: 3746144-9Report Type:Expedited (15-DaCompany Report #PHEH2001US03028 Age:37 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Health Clozaril PS Novartis Initial or Prolonged Bulimia Nervosa Professional Pharmaceuticals Corp ORAL 1) 1000 MG, Cholinergic Syndrome QHS, ORAL; Lethargy 2) 400MG Overdose DAILY, ORAL Polydipsia Klonopin C White Blood Cell Count Risperdal Decreased (Risperidone) C Paxil C Date:06/25/01ISR Number: 3746161-9Report Type:Expedited (15-DaCompany Report #PHEH2001US05243 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Health Clozaril PS Novartis Initial or Prolonged Gastrointestinal Professional Pharmaceuticals Corp ORAL 350 MG, ORAL Haemorrhage Atenolol C Ileus Paralytic Mental Impairment Pyrexia Date:06/25/01ISR Number: 3746164-4Report Type:Expedited (15-DaCompany Report #PHEH2001US05224 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Study Clozaril PS Novartis Health Pharmaceuticals Corp ORAL 900 MG, ORAL Professional 22-Feb-2006 08:30 AM Page: 1173 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/25/01ISR Number: 3746506-XReport Type:Expedited (15-DaCompany Report #PHRM2001FR01497 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Fall Foreign Clozaril PS Novartis Hospitalization - Hepatitis Health Pharmaceuticals Corp ORAL ORAL Initial or Prolonged Hypothermia Professional Lung Disorder Other Lymphopenia Neutropenia Thrombocytopenia Date:06/25/01ISR Number: 3747254-2Report Type:Expedited (15-DaCompany Report #PHEH2001US04201 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bronchitis Health Clozaril PS Novartis Chills Professional Pharmaceuticals Corp ORAL 650 MG, ORAL Drug Interaction Zyprexa (Olanzapine) SS SEE IMAGE 2907 DAY Leukopenia Seroquel Neutropenia (Quetiapine) C Pharyngolaryngeal Pain Synthroid C Pneumonia Inderal C Buspar (Buspirone Hydrochloride) C Efexor Er (Venlafaxine Hydrochloride) C Artane (Trihexyphenidyl Hydrochloride) C Ddavp (Desmopressin) C Date:06/25/01ISR Number: 3747410-3Report Type:Expedited (15-DaCompany Report #PHFR2001IE01798 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drowning Foreign Clozaril PS Novartis Study Pharmaceuticals Corp ORAL 500MG/DAY, Health ORAL Professional Other Date:06/26/01ISR Number: 3748084-8Report Type:Expedited (15-DaCompany Report #A110238 Age:41 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neuroleptic Malignant Health Geodon PS Pfizer Central Hospitalization - Syndrome Professional Research ORAL BID PO Initial or Prolonged Psychotic Disorder Company Clozapine SS DAILY Required Urinary Tract Infection Representative Lithium SS Intervention to Lipitor C Prevent Permanent Depakote Er C Impairment/Damage Zyprexa C 22-Feb-2006 08:30 AM Page: 1174 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/26/01ISR Number: 3748170-2Report Type:Expedited (15-DaCompany Report #PHBS2001CA06268 Age:73 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Aspiration Foreign Clozaril PS Novartis Study Pharmaceuticals Corp ORAL ORAL Health Professional Other Date:06/26/01ISR Number: 3748173-8Report Type:Expedited (15-DaCompany Report #PHBS2001AU06212 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Foreign Clozaril PS Novartis Initial or Prolonged B-Cell Lymphoma Literature Pharmaceuticals Corp Bone Pain Health Hypercalcaemia Professional Hyperphosphataemia Other Neutropenia Pyrexia Date:06/26/01ISR Number: 3748208-2Report Type:Expedited (15-DaCompany Report #PHFR2000GB01224 Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asphyxia Foreign Clozaril PS Novartis Convulsion Study Pharmaceuticals Corp ORAL 25MG/DAY, Health ORAL Professional Other Date:06/26/01ISR Number: 3748211-2Report Type:Expedited (15-DaCompany Report #PHBS2001AU05548 Age:71 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Mass Foreign Clozaril PS Novartis Disorientation Health Pharmaceuticals Corp ORAL 25 MG/D, ORAL Gastrointestinal Professional Fluvax (Influenza Haemorrhage Other Virus Vaccine Pallor Polyvalent) C Rectal Haemorrhage Zantac C Aspirine C Kinson (Carbidopa, Levodopa) C Senokot C Ferrograd (Ferrous Sulfate Exsiccated) C Date:06/27/01ISR Number: 3748973-4Report Type:Expedited (15-DaCompany Report #01-06-0324 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Health Clozapine PS Zenith Goldline ORAL 150-825MG QD Initial or Prolonged Professional ORAL 22-Feb-2006 08:30 AM Page: 1175 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/27/01ISR Number: 3748987-4Report Type:Expedited (15-DaCompany Report #01-06-0326 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 400MG QD ORAL Professional Date:06/27/01ISR Number: 3748989-8Report Type:Expedited (15-DaCompany Report #01-06-0327 Age:83 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozapine PS Zenith Goldline ORAL 25MG QD ORAL Dementia Professional Pneumonia Date:06/27/01ISR Number: 3748991-6Report Type:Expedited (15-DaCompany Report #01-06-0328 Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 50-62.5MG QD Professional ORAL Date:06/27/01ISR Number: 3748992-8Report Type:Expedited (15-DaCompany Report #01-06-0329 Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Chronic Obstructive Health Clozapine PS Zenith Goldline ORAL 100-200MG QD Pulmonary Disease Professional ORAL Colitis Ischaemic Date:06/27/01ISR Number: 3748994-1Report Type:Expedited (15-DaCompany Report #01-05-0263 Age:49 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coma Health Clozapine PS Zenith Goldline ORAL 300-400MG QD Respiratory Failure Professional ORAL Klonopin C Seroquel C Ativan C Date:06/27/01ISR Number: 3748995-3Report Type:Expedited (15-DaCompany Report #01-06-0286 Age:51 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebral Ischaemia Health Clozapine PS Zenith Goldline ORAL 550MG QD ORAL Coronary Artery Disease Professional Cogentin C Encephalopathy Prozac C Ventricular Arrhythmia Vistaril C Date:06/27/01ISR Number: 3748997-7Report Type:Expedited (15-DaCompany Report #01-06-0287 Age:49 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Chronic Obstructive Health Clozapine PS Zenith Goldline ORAL 600-850 MG QD Pulmonary Disease Professional ORAL Emphysema Paxil C 22-Feb-2006 08:30 AM Page: 1176 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Zyprexa C Date:06/27/01ISR Number: 3749681-6Report Type:Expedited (15-DaCompany Report #WAES 01066519 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Distension Foreign Cogentin PS Merck And Co Inc ORAL 2 MG/DAILY PO Megacolon Company Tab Leponex Representative (Clozapine) SS ORAL 350 MG/DAILY PO Rivotril C Trilafon C Date:06/28/01ISR Number: 3748697-3Report Type:Direct Company Report # Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Clozapine 25 Hospitalization - Zenith-Goldline PS Zenith-Goldline 125 AM Initial or Prolonged Clozapine 100 Required Zenith-Goldline SS Zenith-Goldline 175MG HS Intervention to Lithium C Prevent Permanent Impairment/Damage Date:06/28/01ISR Number: 3750109-0Report Type:Expedited (15-DaCompany Report #PHBS2001CA02548 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Adrenal Adenoma Foreign Clozaril PS Novartis Blood Creatine Study Pharmaceuticals Corp ORAL 700 MG/D, Phosphokinase Increased Health ORAL Cardiac Arrest Professional Vasotec C Cardiomegaly Other Trazodone C Foreign Body Aspiration Dalmane (Flurazepam Gastritis Erosive Hydrochloride) C Granuloma Diazepam C Hepatic Congestion Atropine Nasal Injury Asphyxiation Solution (Atropine) C Memory Impairment Salivary Hypersecretion Date:06/29/01ISR Number: 3750325-8Report Type:Direct Company Report # Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Clozapine PS Initial or Prolonged Date:06/29/01ISR Number: 3750501-4Report Type:Expedited (15-DaCompany Report #C2001-1749.01 Age:82 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death White Blood Cell Count Health Clozapine PS Mylan Abnormal Professional Pharmaceuticals Inc Other 22-Feb-2006 08:30 AM Page: 1177 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/29/01ISR Number: 3750502-6Report Type:Expedited (15-DaCompany Report #C2001-1747.01 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Mylan Professional Pharmaceuticals Inc ORAL 100 MG Q AM & Other 150 MG Q HS; ORAL Date:06/29/01ISR Number: 3750503-8Report Type:Expedited (15-DaCompany Report #C2001-1746.01 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death White Blood Cell Count Health Clozapine PS Mylan Abnormal Professional Pharmaceuticals Inc ORAL 125MG Q AM & Other 150MG Q PM; ORAL Amlodipine C Benztropine C Fluxetine C Haloperidol C Multivitamin C Date:06/29/01ISR Number: 3750504-XReport Type:Expedited (15-DaCompany Report #C2001-1744.01 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Health Clozapine PS Mylan Myocardial Infarction Professional Pharmaceuticals Inc ORAL 600 White Blood Cell Count Other MG/DAY;ORAL Abnormal Date:06/29/01ISR Number: 3750505-1Report Type:Expedited (15-DaCompany Report #C2001-1743.01 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death White Blood Cell Count Health Clozapine PS Mylan Abnormal Professional Pharmaceuticals Inc ORAL 200 MG QD; Other ORAL Acetaminophen C Albuterol Inhalation Solution C Ceftriaxone Injection C Clonazepam C Dorzolamide C Quaifenesin C Lamotrigine C Sorbitol C Venlafaxine C Date:06/29/01ISR Number: 3750506-3Report Type:Expedited (15-DaCompany Report #C2001-1747.01 Age:95 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death White Blood Cell Count Health Clozapine PS Mylan Abnormal Professional Pharmaceuticals Inc Other 22-Feb-2006 08:30 AM Page: 1178 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/29/01ISR Number: 3750507-5Report Type:Expedited (15-DaCompany Report #C2001-1740.01 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death White Blood Cell Count Health Clozapine PS Mylan Abnormal Professional Pharmaceuticals Inc Other Date:06/29/01ISR Number: 3750509-9Report Type:Expedited (15-DaCompany Report #C2001-1748-01 Age:73 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine PS Mylan Professional Pharmaceuticals Inc ORAL 450MG QD, Other ORAL Date:06/29/01ISR Number: 3750510-5Report Type:Expedited (15-DaCompany Report #C2001-1739.01 Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death White Blood Cell Count Health Clozapine PS Mylan Abnormal Professional Pharmaceuticals Inc UNKNOWN UNK Other Date:06/29/01ISR Number: 3750511-7Report Type:Expedited (15-DaCompany Report #C2001-1738.01 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Unevaluable Event Health Clozapine PS Mylan Professional Pharmaceuticals Inc ORAL 300MG BID Other ORAL Benztropine C Conjugated Estrogens/Medroxypro gesterone C Divalproex C Doxepin C Ferrous Sulfate C Meclizine C Trihexyphenidyl C Date:06/29/01ISR Number: 3750512-9Report Type:Expedited (15-DaCompany Report #C2001-1737.01 Age:81 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death White Blood Cell Count Health Clozapine PS Mylan Abnormal Professional Pharmaceuticals Inc ORAL 25MG/DAY ORAL Other Date:06/29/01ISR Number: 3750513-0Report Type:Expedited (15-DaCompany Report #C2001-1736.01 Age:91 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death White Blood Cell Count Health Clozapine PS Mylan Other Abnormal Professional Pharmaceuticals Inc UNKNOWN UNK Other 22-Feb-2006 08:30 AM Page: 1179 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/29/01ISR Number: 3750514-2Report Type:Expedited (15-DaCompany Report #C2001-1734.01 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death White Blood Cell Count Health Clozapine PS Mylan Abnormal Professional Pharmaceuticals Inc ORAL 425 MG/DAY Other ORAL Date:06/29/01ISR Number: 3750515-4Report Type:Expedited (15-DaCompany Report #C2001-1733.01 Age:92 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Mylan Professional Pharmaceuticals Inc UNKNOWN UNK Other Date:06/29/01ISR Number: 3750516-6Report Type:Expedited (15-DaCompany Report #C2001-1732.01 Age:83 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death White Blood Cell Count Health Clozapine PS Mylan Abnormal Professional Pharmaceuticals Inc UNKNOWN UNK Other Date:06/29/01ISR Number: 3750517-8Report Type:Expedited (15-DaCompany Report #C2001-1731.01 Age:82 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death White Blood Cell Count Health Clozapine PS Mylan Abnormal Professional Pharmaceuticals Inc ORAL 12.5 MG Q AM, Other 2 PM & 25 MG Q HS, ORAL Doxepin C Timolol Ophthalmic C Humulin R C Multivitamin C Date:07/02/01ISR Number: 3751034-1Report Type:Expedited (15-DaCompany Report #PHEH2001US05296 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozaril PS Novartis Lymphoma Professional Pharmaceuticals Corp ORAL 550 MG DAILY, ORAL Paxil C Lorazepam C Date:07/02/01ISR Number: 3751035-3Report Type:Expedited (15-DaCompany Report #PHEH2001US05342 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Health Clozaril PS Novartis Pneumonia Professional Pharmaceuticals Corp ORAL 25 MG DAILY, Company ORAL Representative 22-Feb-2006 08:30 AM Page: 1180 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/02/01ISR Number: 3751363-1Report Type:Expedited (15-DaCompany Report #PHNU2001DE01499 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Foreign Clozaril PS Novartis Drug Interaction Health Pharmaceuticals Corp ORAL 300 TO 500 Drug Level Above Professional MG/DAY, ORAL Therapeutic Other Stediril Electroencephalogram (Levonorgestrel) Abnormal Sugar-Coated Tablet SS ORAL ORAL Sedation Date:07/02/01ISR Number: 3751379-5Report Type:Expedited (15-DaCompany Report #01-06-0332 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Colon Cancer Health Clozapine PS Zenith Goldline ORAL 400-600MG QD Professional ORAL Date:07/02/01ISR Number: 3751382-5Report Type:Expedited (15-DaCompany Report #01-06-0331 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 125-200MG QD Professional ORAL Date:07/02/01ISR Number: 3751383-7Report Type:Expedited (15-DaCompany Report #01-06-0335 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dehydration Health Clozapine PS Zenith Goldline ORAL ORAL Professional Date:07/02/01ISR Number: 3751766-5Report Type:Expedited (15-DaCompany Report #PHBS2001AU01070 Age:21 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiomyopathy Foreign Clozaril PS Novartis Obesity Health Pharmaceuticals Corp ORAL 500 MG/DAY, Salivary Hypersecretion Professional ORAL Sedation Other Date:07/02/01ISR Number: 3751767-7Report Type:Expedited (15-DaCompany Report #PHRM2001FR01524 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukocytosis Foreign Clozaril PS Novartis Initial or Prolonged Health Pharmaceuticals Corp ORAL 600 MG DAILY, Professional ORAL Company Representative Other 22-Feb-2006 08:30 AM Page: 1181 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/02/01ISR Number: 3751877-4Report Type:Expedited (15-DaCompany Report #PHRM2001FR01512 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiomegaly Foreign Clozaril PS Novartis Drug Level Above Health Pharmaceuticals Corp ORAL 700 MG Therapeutic Professional DAILY, ORAL Hypertrophic Obstructive Other Mogadon(Nitrazepam) Cardiomyopathy Tablet SS ORAL 10 MG DAILY, Pulmonary Congestion ORAL Pulmonary Oedema Tranxene Sudden Death (Clorazepate Dipotassium) Lyophilisate In Ampoule C INTRAVENOUS 300 MG DAILY, INTRAVENOUS Date:07/02/01ISR Number: 3751878-6Report Type:Expedited (15-DaCompany Report #PHBS2001BE05918 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Insipidus Foreign Clozaril PS Novartis Initial or Prolonged Hypernatraemia Health Pharmaceuticals Corp ORAL 100 MG, TID, Professional ORAL Other Cipramil (Citalopram Hydrobromide) C Date:07/03/01ISR Number: 3752449-8Report Type:Expedited (15-DaCompany Report #PHBS2001FR06331 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Foreign Clozaril PS Novartis Cardio-Respiratory Arrest Literature Pharmaceuticals Corp 150 MG/D Drug Interaction Health Oxazepam (Oxazepam) SS 200 MG/D Orthostatic Hypotension Professional Other Date:07/03/01ISR Number: 3752451-6Report Type:Expedited (15-DaCompany Report #PHBS2001FR06332 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Foreign Clozaril PS Novartis Initial or Prolonged Agitation Literature Pharmaceuticals Corp Bundle Branch Block Right Health Clonazepam Delirium Professional (Clonazepam) SS Drug Effect Decreased Other Drug Interaction Shock Syncope Thinking Abnormal Date:07/04/01ISR Number: 3751856-7Report Type:Periodic Company Report #01-06-0338 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 100MG QD ORAL Professional 22-Feb-2006 08:30 AM Page: 1182 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/05/01ISR Number: 3752632-1Report Type:Direct Company Report # Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diarrhoea Clozaril (50mg Bid) PS ORAL 50MG BID PO Required Intervention to Prevent Permanent Impairment/Damage Date:07/05/01ISR Number: 3752646-1Report Type:Direct Company Report # Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Clozaril Initial or Prolonged (300mg)(100mg 3ttt Tab ? PS ORAL 100MG 3TTT TAB PO QHS Vistaril 50mg SS 25MG 2TT CAPSULES Date:07/05/01ISR Number: 3753018-6Report Type:Expedited (15-DaCompany Report #PHFR2001GB01742 Age:28 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Crohn'S Disease Foreign Clozaril PS Novartis Health Pharmaceuticals Corp ORAL 300 MG/DAY, Professional ORAL Other Date:07/05/01ISR Number: 3753071-XReport Type:Expedited (15-DaCompany Report #PHBS2001AU04376 Age:78 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Ovarian Cancer Foreign Clozaril PS Novartis Hospitalization - Health Pharmaceuticals Corp ORAL 200 MG/D, Initial or Prolonged Professional ORAL Other Date:07/05/01ISR Number: 3753072-1Report Type:Expedited (15-DaCompany Report #PHBS2001NZ06125 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Foreign Clozaril PS Novartis Initial or Prolonged Drug Interaction Health Pharmaceuticals Corp ORAL 650 MG/D, Medication Error Professional ORAL Other Xenical (Orlistat) SS 183 DAY Chlorpromazine (Chlorpromazine) C Valproate Sodium C Date:07/05/01ISR Number: 3753578-5Report Type:Expedited (15-DaCompany Report #PHEH2001US04458 Age:48 YR Gender:Male I/FU:F Outcome Life-Threatening Hospitalization - 22-Feb-2006 08:30 AM Page: 1183 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Initial or Prolonged Other PT Report Source Product Role Manufacturer Route Dose Duration Alcoholism Health Clozaril PS Novartis Diabetes Mellitus Professional Pharmaceuticals Corp ORAL 300 MG, QHS, Insulin-Dependent ORAL Diabetic Coma Drug Interaction Insulin Resistance Medication Error Date:07/05/01ISR Number: 3753603-1Report Type:Expedited (15-DaCompany Report #PHEH2001US04429 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Diabetes Mellitus Health Clozaril PS Novartis Hospitalization - Hyperglycaemia Professional Pharmaceuticals Corp ORAL 100MG AM + Initial or Prolonged Weight Increased 300MG HS, ORAL Date:07/05/01ISR Number: 3753605-5Report Type:Expedited (15-DaCompany Report #PHEH2001US03245 Age:43 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Health Clozaril PS Novartis Initial or Prolonged Uterine Cancer Professional Pharmaceuticals Corp ORAL 300 MG, ORAL Lithium Carbonate C Date:07/09/01ISR Number: 3755376-5Report Type:Expedited (15-DaCompany Report #PHRM2001FR01577 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrial Tachycardia Foreign Clozaril PS Novartis Initial or Prolonged Health Pharmaceuticals Corp ORAL 600 MG DAILY, Professional ORAL Other Depakine C Zocor C Leponex(Clozapine) C Date:07/09/01ISR Number: 3756114-2Report Type:Expedited (15-DaCompany Report #PHNU2001DE01097 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiac Arrest Foreign Clozaril PS Novartis Coma Health Pharmaceuticals Corp ORAL ORAL Loss Of Consciousness Professional Ovestin (Estriol) SS 1 MG, BID Pulmonary Embolism Other Tachycardia Date:07/09/01ISR Number: 3756115-4Report Type:Expedited (15-DaCompany Report #PHFR2001GB01918 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Hospitalization - Appendicitis Foreign Initial or Prolonged Health Professional 22-Feb-2006 08:30 AM Page: 1184 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Product Role Manufacturer Route Dose Duration Clozaril PS Novartis Pharmaceuticals Corp ORAL 700MG/DAY, ORAL Date:07/09/01ISR Number: 3756116-6Report Type:Expedited (15-DaCompany Report #PHFR2001GB01923 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Deep Vein Thrombosis Foreign Clozaril PS Novartis Study Pharmaceuticals Corp ORAL 400MG/DAY, Health ORAL Professional Other Date:07/09/01ISR Number: 3756117-8Report Type:Expedited (15-DaCompany Report #PHBS2000SE11075 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Foreign Clozaril PS Novartis Hospitalization - Cardiomyopathy Health Pharmaceuticals Corp ORAL 500 MG/D, Initial or Prolonged Condition Aggravated Professional ORAL Mental Disorder Other Heminevrin Myocardial Infarction (Clomethiazole Pneumonia Edisilate) C Renal Failure Acute Lanacrist C Shock Iktorivil C Furix C Trombyl C Stilnoct (Zolpidem Tartrate) C Cozaar (Losartan Potassium) C Truxal (Chlorprothixene Hydrochloride) C Lithionit - Slow Release (Lithium Sulfate) C Date:07/10/01ISR Number: 3755965-8Report Type:Expedited (15-DaCompany Report #PHBS2001SE01201 Age:34 YR Gender:Male I/FU:I Outcome PT Hospitalization - Abdominal Pain Initial or Prolonged Anuria Other Blood Creatine Phosphokinase Increased Chills Clostridium Colitis Condition Aggravated Confusional State Creatine Urine Increased Dermatitis Dialysis Disorientation 22-Feb-2006 08:30 AM Page: 1185 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Liver Function Test Abnormal Lung Infiltration Report Source Product Role Manufacturer Route Dose Duration Neuroleptic Malignant Foreign Clozaril PS Novartis Syndrome Health Pharmaceuticals Corp ORAL 300 MG/D, Pneumonia Professional ORAL Psychotic Disorder Other Zinacef (Cefuroxime) SS Pyrexia Allopurinol Renal Failure (Allopurinol) SS Renal Tubular Necrosis Temesta C Rhabdomyolysis Sepsis Vomiting Date:07/11/01ISR Number: 3755490-4Report Type:Expedited (15-DaCompany Report #01-06-0347 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neoplasm Malignant Health Clozapine PS Zenith Goldline ORAL 150-350MG QD Professional ORAL Date:07/11/01ISR Number: 3755491-6Report Type:Expedited (15-DaCompany Report #01-06-0342 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Surgery Health Clozapine PS Zenith Goldline ORAL ORAL Professional Date:07/11/01ISR Number: 3755492-8Report Type:Expedited (15-DaCompany Report #01-07-0344 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 500-900MG QD Professional ORAL Date:07/11/01ISR Number: 3755493-XReport Type:Expedited (15-DaCompany Report #01-07-0348 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening White Blood Cell Count Health Clozapine PS Zenith Goldline ORAL 200MG QD ORAL Decreased Professional Date:07/11/01ISR Number: 3755495-3Report Type:Expedited (15-DaCompany Report #01-06-0315 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arterial Occlusive Health Clozapine PS Zenith Goldline 300-900MGQD Disease Professional Seroquel C Coma Zoloft C Hepatic Failure Flurazepam C Liver Disorder 22-Feb-2006 08:30 AM Page: 1186 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/11/01ISR Number: 3755499-0Report Type:Expedited (15-DaCompany Report #01-06-0316 Age:76 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 31.2-37.5MG Q Professional ORAL Date:07/11/01ISR Number: 3756586-3Report Type:Expedited (15-DaCompany Report #01-06-0321 Age:54 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neoplasm Malignant Health Clozapine PS Zenith Goldline ORAL 125-600MG QD Professional ORAL Date:07/11/01ISR Number: 3756587-5Report Type:Expedited (15-DaCompany Report #01-06-0311 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Clozapine PS Zenith Goldline ORAL 400-600MG QD Professional ORAL Neurontin C Klonopin C Serzone C Date:07/11/01ISR Number: 3756588-7Report Type:Expedited (15-DaCompany Report #01-06-0310 Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 50-200 MG QD Professional ORAL Date:07/11/01ISR Number: 3756590-5Report Type:Expedited (15-DaCompany Report #01-06-0329 Age:77 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Chronic Obstructive Health Clozapine PS Zenith Goldline ORAL 100-200 MG QD Hospitalization - Pulmonary Disease Professional ORAL Initial or Prolonged Colitis Ischaemic Date:07/11/01ISR Number: 3756592-9Report Type:Expedited (15-DaCompany Report #01-06-0327 Age:83 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozapine PS Zenith Goldline ORAL 25 MG QD ORAL Multi-Organ Failure Professional Date:07/11/01ISR Number: 3756606-6Report Type:Expedited (15-DaCompany Report #01-05-0263 Age:49 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coma Health Clozapine PS Zenith Goldline ORAL 300-400MG QD Hypertrophic Obstructive Professional ORAL Cardiomyopathy Klonopin C Respiratory Failure Ativan C Seroquel C 22-Feb-2006 08:30 AM Page: 1187 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/11/01ISR Number: 3756611-XReport Type:Expedited (15-DaCompany Report #01-05-0285 Age:79 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 50-300MG QD Professional ORAL Adalat C Altace C Cimetidine C Remeron C Lorazepam C Colace C Vitamin E C Date:07/11/01ISR Number: 3756613-3Report Type:Expedited (15-DaCompany Report #01-07-0360 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bladder Cancer Health Clozapine PS Zenith Goldline ORAL 300MG QD ORAL Renal Failure Professional Date:07/11/01ISR Number: 3756760-6Report Type:Expedited (15-DaCompany Report #2001AP03274 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Seroquel PS Astrazeneca Lp 200 MG BID 1 WK Literature Quetiapine SS 250 MG BID 4 WK Health Clozapine SS 1 YR Professional Other Date:07/11/01ISR Number: 3756770-9Report Type:Expedited (15-DaCompany Report #PHBS2001AU05547 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Clozaril PS Novartis Initial or Prolonged Diabetes Mellitus Study Pharmaceuticals Corp ORAL ORAL Hypoaesthesia Health Aspirine C Psychotic Disorder Professional Clonidine Other (Clonidine) C Date:07/11/01ISR Number: 3756777-1Report Type:Expedited (15-DaCompany Report #01P-056-0108465-00 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Congestive Cardiomyopathy Foreign Tranxene PS Abbott Laboratories Pulmonary Congestion Health Pharmaceutical Pulmonary Oedema Professional Products Div ORAL 300 MG, 1 IN Sudden Death Other 1 D, PER ORAL Nitrazepam SS ORAL 10 MG, 1 IN 1 D, PER ORAL Clozapine SS ORAL 700 MNG, 1 IN 1 D, PER ORAL 22-Feb-2006 08:30 AM Page: 1188 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/11/01ISR Number: 3756819-3Report Type:Expedited (15-DaCompany Report #PHBS2001AU06784 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chronic Lymphocytic Foreign Clozaril PS Novartis Leukaemia Study Pharmaceuticals Corp ORAL ORAL Fatigue Health Lymphoma Professional Other Date:07/11/01ISR Number: 3756820-XReport Type:Expedited (15-DaCompany Report #PHBS2001AU06733 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaphylactic Reaction Foreign Clozaril PS Novartis Initial or Prolonged Bradycardia Health Pharmaceuticals Corp ORAL ORAL Circulatory Collapse Professional Hypotension Other Date:07/11/01ISR Number: 3756821-1Report Type:Expedited (15-DaCompany Report #PHBS2000AU08376 Age:46 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiomyopathy Foreign Clozaril PS Novartis Echocardiogram Abnormal Health Pharmaceuticals Corp ORAL 650 MG/D, Professional ORAL Other Glibenclamide C Metformin (Metformin) C Date:07/11/01ISR Number: 3756822-3Report Type:Expedited (15-DaCompany Report #PHBS2001AU05292 Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Pressure Decreased Foreign Clozaril PS Novartis Confusional State Health Pharmaceuticals Corp ORAL 12.5 MG, QD, Delirium Professional ORAL Disorientation Other Tranylcypromine Drug Interaction (Tranylcypromine) SS 1 DAY Metformin (Metformin) C Oxybutynin (Oxybutynine) C Date:07/11/01ISR Number: 3756823-5Report Type:Expedited (15-DaCompany Report #PHFR2001IE01792 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arrhythmia Foreign Clozaril PS Novartis Initial or Prolonged Circulatory Collapse Health Pharmaceuticals Corp ORAL 350 MG/DAY, Heart Rate Irregular Professional ORAL Loss Of Consciousness Other Olanzapine Pulse Absent (Olanzapine) C Ventricular Extrasystoles Ventricular Tachycardia 22-Feb-2006 08:30 AM Page: 1189 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/11/01ISR Number: 3756863-6Report Type:Expedited (15-DaCompany Report #01P-062-0105745-00 Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Diabetes Mellitus Foreign Depakene PS Abbott Laboratories Intervention to Hyperglycaemia Health Pharmaceutical Prevent Permanent Professional Products Div ORAL 2.5 TABLET, 1 Impairment/Damage Other IN 1 D, PER ORAL Clozapine SS Date:07/12/01ISR Number: 3757219-2Report Type:Expedited (15-DaCompany Report #C2001-1734.01 Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death White Blood Cell Count Health Clozapine PS Mylan Abnormal Professional Pharmaceuticals Inc ORAL 25 MG Q AM, Other ORAL Clozapine Tablets 100 Mg SS ORAL 200 MG BID, ORAL Atenolol C Ethinyl Estradiol/Levonorges trel C Levothyroxine C Date:07/12/01ISR Number: 3757220-9Report Type:Expedited (15-DaCompany Report #C2001-1736.01 Age:91 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death White Blood Cell Count Health Clozapine PS Mylan Other Abnormal Professional Pharmaceuticals Inc ORAL 100 MG BID, Other ORAL Novolin R C Atenolol C Furosemide C Glipizide C Lorazepam C Nitroglycerin Transdermal System Patches C Potassium Chloride C Trazodone C Date:07/12/01ISR Number: 3757222-2Report Type:Expedited (15-DaCompany Report #C2001-1733.01 Age:92 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dementia Health Clozapine PS Mylan Discomfort Professional Pharmaceuticals Inc ORAL 37.5 MG QD, Upper Respiratory Tract Other ORAL Infection Albuterol Inhalation Solution C Aspirin C Ceftriazone Injection C Fluoxetine C Guaifenesin/Propanol 22-Feb-2006 08:30 AM Page: 1190 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report amine/Phenylephrine C Morphine Sulfate Injection C Morphine Suppositories C Multivitamin C Potassium Chloride C Date:07/12/01ISR Number: 3757223-4Report Type:Expedited (15-DaCompany Report #C2001-1732.01 Age:83 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Clozapine PS Mylan Congestive Professional Pharmaceuticals Inc White Blood Cell Count Other Abnormal Date:07/12/01ISR Number: 3757442-7Report Type:Expedited (15-DaCompany Report #PHBS2001FR06332 Age:27 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bundle Branch Block Right Foreign Clozaril PS Novartis Initial or Prolonged Drug Interaction Literature Pharmaceuticals Corp Electrocardiogram Health Clonazepam Abnormal Professional (Clonazepam) SS Shock Other Haloperidol Syncope Decanoate C Chlorpromazine C Date:07/12/01ISR Number: 3757443-9Report Type:Expedited (15-DaCompany Report #PHBS2001FR06331 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Foreign Clozaril PS Novartis Cardio-Respiratory Arrest Literature Pharmaceuticals Corp 150 MG/D Drug Interaction Health Oxazepam SS 200 MG/D Orthostatic Hypotension Professional Other Date:07/12/01ISR Number: 3757453-1Report Type:Expedited (15-DaCompany Report #PHBS2001CA03982 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Foreign Clozaril PS Novartis Other Chronic Obstructive Study Pharmaceuticals Corp ORAL 200 MG/D, Pulmonary Disease Health ORAL Encephalitis Professional Ativan(Lorazepam) SS 373 DAY Epilepsy Other Manerix Hypothyroidism (Moclobemide) C Neuroleptic Malignant Carbolith C Syndrome Depakene C Folvite C Synthroid C 22-Feb-2006 08:30 AM Page: 1191 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/13/01ISR Number: 3758442-3Report Type:Expedited (15-DaCompany Report #PHFR2001GB01979 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril PS Novartis Health Pharmaceuticals Corp ORAL ORAL Professional Other Date:07/13/01ISR Number: 3758452-6Report Type:Expedited (15-DaCompany Report #PHBS2001AU06413 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bacterial Infection Foreign Clozaril PS Novartis Initial or Prolonged Bronchopneumonia Study Pharmaceuticals Corp ORAL 25 MG/DAY, Malaise Health ORAL Sedation Professional Viral Upper Respiratory Other Tract Infection Date:07/13/01ISR Number: 3758453-8Report Type:Expedited (15-DaCompany Report #PHBS2001AU04567 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Enzymes Increased Foreign Clozaril PS Novartis Initial or Prolonged Mental Impairment Study Pharmaceuticals Corp ORAL 250 MG/D, Platelet Count Decreased Health ORAL Professional Mixtard (Insulin, Other Insulin Injection, Isophane) C Date:07/13/01ISR Number: 3758494-0Report Type:Expedited (15-DaCompany Report #PHBS2001AU06733 Age:29 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradycardia Foreign Clozaril PS Novartis Initial or Prolonged Circulatory Collapse Health Pharmaceuticals Corp ORAL ORAL Hypotension Professional Other Date:07/13/01ISR Number: 3758826-3Report Type:Expedited (15-DaCompany Report #PHEH2001US03133 Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Cholesterol Health Clozaril (Clozapine) Increased Professional Tablet PS Novartis Blood Glucose Abnormal Pharmaceuticals Corp ORAL 100 MG, Blood Triglycerides BID,ORAL Increased Monopril (Fosinopril Diabetes Mellitus Sodium) C Hypertension Atenolol C Celexa (Citalopram Hydrobromide) C Depakote (Valproate Semisodium) C Anafranil C Prozac (Fluoxetine Hydrochloride) C 22-Feb-2006 08:30 AM Page: 1192 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Clonidine (Clonidine) C Date:07/13/01ISR Number: 3758827-5Report Type:Expedited (15-DaCompany Report #PHEH2001US04727 Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pyrexia Health Clozaril PS Novartis Initial or Prolonged Tuberculosis Professional Pharmaceuticals Corp ORAL 350 MG, ORAL Ditropan (Oxybutynin) C Gabapentin (Gabapentin) C Risperdal (Risperidone) C Zoloft (Sertraline Hydrochloride) C Date:07/13/01ISR Number: 3758828-7Report Type:Expedited (15-DaCompany Report #PHEH2001US05296 Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Leukopenia Health Clozaril PS Novartis Other Lymphoma Professional Pharmaceuticals Corp ORAL 550MG DAILY, ORAL Paxil C Lorazepam C Ativan C Date:07/13/01ISR Number: 3758865-2Report Type:Expedited (15-DaCompany Report #PHEH2001US05557 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accident Health Clozaril PS Novartis Fall Professional Pharmaceuticals Corp ORAL 500MG, ORAL Head Injury Date:07/13/01ISR Number: 3758868-8Report Type:Expedited (15-DaCompany Report #PHEH2001US05658 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Parkinson'S Disease Health Clozaril PS Novartis Professional Pharmaceuticals Corp ORAL 25 MG, ORAL Date:07/13/01ISR Number: 3758872-XReport Type:Expedited (15-DaCompany Report #PHEH2001US05150 Age:38 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Neoplasm Malignant Health Clozaril PS Novartis Life-Threatening Professional Pharmaceuticals Corp ORAL 350 MG, ORAL 1825 DAY 22-Feb-2006 08:30 AM Page: 1193 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/16/01ISR Number: 3759452-2Report Type:Expedited (15-DaCompany Report #PHFR2001GB01998 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Foreign Clozaril PS Novartis Brain Neoplasm Health Pharmaceuticals Corp ORAL ORAL Professional Dexamethasone C Date:07/16/01ISR Number: 3759453-4Report Type:Expedited (15-DaCompany Report #PHFR2001GB01923 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetes Mellitus Foreign Clozaril PS Novartis Other Pulmonary Embolism Study Pharmaceuticals Corp ORAL 400 MG DAY Health ORAL Professional Warfarin (Warfarin) C Other Date:07/16/01ISR Number: 3759547-3Report Type:Expedited (15-DaCompany Report #PHBS2001US06911 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Literature Clozaril PS Novartis Drug Interaction Health Pharmaceuticals Corp 300 MG/D; 200 Drug Level Above Professional MG/D Therapeutic Lisinopril Hypertension (Lisinopril) SS 5 MG/D; 10 Irritability MG/D 183 DAY Middle Insomnia Glipizide C Nightmare Diltiazem C Salivary Hypersecretion Sleep Disorder Date:07/16/01ISR Number: 3759836-2Report Type:Expedited (15-DaCompany Report #PHBS2000AU01327 Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiomyopathy Foreign Clozaril PS Novartis Initial or Prolonged Myocardial Ischaemia Health Pharmaceuticals Corp ORAL 500 MG, QD, Professional ORAL Other Paroxetine C Date:07/16/01ISR Number: 3759844-1Report Type:Expedited (15-DaCompany Report #PHBS2000AU01327 Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiomyopathy Foreign Clozaril PS Novartis Initial or Prolonged Myocardial Ischaemia Health Pharmaceuticals Corp ORAL 500 MG, QD, Professional ORAL Other Paroxetine C Date:07/16/01ISR Number: 3760056-6Report Type:Expedited (15-DaCompany Report #PHBS2001CA07012 Age:43 YR Gender:Male I/FU:I Outcome PT Other Convulsion Electrocardiogram Qrs 22-Feb-2006 08:30 AM Page: 1194 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Complex Palpitations Report Source Product Role Manufacturer Route Dose Duration Foreign Clozaril PS Novartis Study Pharmaceuticals Corp ORAL ORAL Health Professional Other Date:07/16/01ISR Number: 3760059-1Report Type:Expedited (15-DaCompany Report #PHRM2001FR01204 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Foreign Clozaril PS Novartis Initial or Prolonged Blood Alkaline Health Pharmaceuticals Corp ORAL 450 MG/DAY, Disability Phosphatase Increased Professional ORAL Dermatitis Other Rivotril C Hepatic Cirrhosis Hept-A-Myl Hyperplasia (Heptaminol Liver Disorder Hydrochloride) C Date:07/17/01ISR Number: 3759270-5Report Type:Expedited (15-DaCompany Report #B0113350A Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Clostridium Colitis Cefuroxime Sodium PS Glaxo Wellcome UNKNOWN 10 DAY Initial or Prolonged Dermatitis Allopurinol SS Glaxo Wellcome UNKNOWN Clozapine SS UNKNOWN YR Date:07/17/01ISR Number: 3759447-9Report Type:Expedited (15-DaCompany Report #PHBS2001AU05785 Age:23 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiomegaly Foreign Clozaril PS Novartis Dizziness Literature Pharmaceuticals Corp UNKNOWN 12.5 MG TO Dyspnoea Health 200 MG Electrocardiogram Professional Abnormal Other Electrocardiogram St Segment Depression Electrocardiogram T Wave Inversion Myocarditis Pain Pain In Extremity Salivary Hypersecretion Sedation Date:07/17/01ISR Number: 3759449-2Report Type:Expedited (15-DaCompany Report #PHFR2001GB02029 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dystonia Foreign Clozaril PS Novartis Oculogyration Health Pharmaceuticals Corp ORAL 300MG DAY Salivary Hypersecretion Professional ORAL Other 22-Feb-2006 08:30 AM Page: 1195 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/17/01ISR Number: 3759450-9Report Type:Expedited (15-DaCompany Report #PHFR2001GB01785 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Constipation Foreign Clozaril PS Novartis Initial or Prolonged Dysphagia Health Pharmaceuticals Corp ORAL 50MG MANE & Oesophagitis Professional 425 MG NOCTE, Vomiting Other ORAL; 50MG & 375 NOCTE, ORAL Sulpiride (Sulpiride) C Ranitidine (Ranitidine) C Date:07/17/01ISR Number: 3760158-4Report Type:Expedited (15-DaCompany Report #01-06-0306 Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dehydration Health Clozapine PS Zenith Goldline ORAL 400-100MG QD Initial or Prolonged Diabetes Mellitus Professional ORAL Electrolyte Imbalance Ativan 1 Mg C Medication Error Haldol 0.5mg Qd C Haldol 1 Mg Qd C Zoloft 100 Mg C Date:07/17/01ISR Number: 3760175-4Report Type:Expedited (15-DaCompany Report #01-06-0329 Age:77 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Chronic Obstructive Health Clozapine PS Zenith Goldline ORAL 100-200MG QD Hospitalization - Pulmonary Disease Professional ORAL Initial or Prolonged Colitis Ischaemic Iron Deficiency Anaemia Date:07/17/01ISR Number: 3760195-XReport Type:Expedited (15-DaCompany Report #01-07-0361 Age:87 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Leukaemia Health Clozapine PS Zenith Goldline ORAL 25-50MG QD Hospitalization - Professional ORAL Initial or Prolonged Date:07/17/01ISR Number: 3760197-3Report Type:Expedited (15-DaCompany Report #01-07-0362 Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 25-75MG QD Professional ORAL Date:07/17/01ISR Number: 3760201-2Report Type:Expedited (15-DaCompany Report #01-07-0365 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 25-50MG QD Professional ORAL 22-Feb-2006 08:30 AM Page: 1196 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/17/01ISR Number: 3760204-8Report Type:Expedited (15-DaCompany Report #01-07-0363 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiomyopathy Health Clozapine PS Zenith Goldline ORAL 500 -600 QD Myocardial Ischaemia Professional ORAL Date:07/17/01ISR Number: 3760207-3Report Type:Expedited (15-DaCompany Report #01-07-0367 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 300 MG QD Professional ORAL Date:07/17/01ISR Number: 3760460-6Report Type:Expedited (15-DaCompany Report #ENT00152 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akinesia Other Comtess Entacapone PS ORAL 1000 MG P.O. Sleep Attacks Madopar Levodopa W/ Benserazide SS ORAL 1100 MG P.O. Cabaseril Cabergoline SS ORAL 8 MG P.O. Parkinsan Budipine SS ORAL 50 MG P.O. Clozapin Clozapine SS ORAL 25 MG P.O. Digitoxin C Furesemid C Date:07/19/01ISR Number: 3761678-9Report Type:Expedited (15-DaCompany Report #PHEH2001US03070 Age:34 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Health Clozaril PS Novartis Initial or Prolonged Phosphokinase Increased Professional Pharmaceuticals Corp ORAL 300 MG, QD, Hepatic Steatosis ORAL Hypertriglyceridaemia Depakote (Valproate Pancreatitis Sodium) SS 1750 MG Colace C Artane (Trihexyphenidyl Hydrochloride) C Glucophage "Aron" C Date:07/19/01ISR Number: 3761754-0Report Type:Expedited (15-DaCompany Report #PHBS2001AU03078 Age:32 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Choking Foreign Clozaril PS Novartis Constipation Consumer Pharmaceuticals Corp ORAL 300 MG, QD, Enuresis Other ORAL (SEE Loss Of Consciousness IMAGE) Medication Error Aropax C Overdose Risperidone Restlessness (Risperidone) C Salivary Hypersecretion Sedation Sleep Walking Vomiting 22-Feb-2006 08:30 AM Page: 1197 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/19/01ISR Number: 3761853-3Report Type:Expedited (15-DaCompany Report #B0113350A Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Foreign Zinacef PS Glaxo Wellcome Inc UNKNOWN Initial or Prolonged Anuria Allopurinol Chills (Formulation Clostridium Colitis Unknown)(Allopurinol Dermatitis ) SS UNKNOWN Haemodialysis Clozapine Neuroleptic Malignant (Formulation Syndrome Unknown)(Clozapine) SS UNKNOWN Pneumonia Psychotic Disorder Renal Tubular Necrosis Rhabdomyolysis Sepsis Vomiting Date:07/19/01ISR Number: 3762393-8Report Type:Expedited (15-DaCompany Report #PHBS2001US06947 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Literature Clozaril PS Novartis Cardiomyopathy Health Pharmaceuticals Corp 100 MG, BID 1460 DAY Coronary Artery Disease Professional Sertraline C 200 MG, QD Hepatic Steatosis Risperidone C Sudden Death Atenolol C Toxicologic Test Abnormal Lorazepam C Date:07/19/01ISR Number: 3763018-8Report Type:Expedited (15-DaCompany Report #PHBS2001SE07077 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Foreign Clozaril PS Novartis Other Cardiomyopathy Health Pharmaceuticals Corp Myocardial Infarction Professional Cozaar (Losartan Shock Other Potassium) C Date:07/19/01ISR Number: 3763019-XReport Type:Expedited (15-DaCompany Report #PHBS2001AU04319 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Foreign Clozaril PS Novartis Initial or Prolonged Leukaemia Health Pharmaceuticals Corp ORAL 600 MG/D, Other Neutropenia Professional ORAL 2555 DAY White Blood Cell Count Other Decreased Date:07/19/01ISR Number: 3763020-6Report Type:Expedited (15-DaCompany Report #PHNU2000DE02431 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abortion Spontaneous Foreign Clozaril PS Novartis Complications Of Maternal Health Pharmaceuticals Corp ORAL 0.5 DF, TID, Exposure To Therapeutic Professional ORAL Drugs Other Impromen Pregnancy (Bromperidol) C 22-Feb-2006 08:30 AM Page: 1198 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Timonil-Slow Release Tablet C Date:07/19/01ISR Number: 3763021-8Report Type:Expedited (15-DaCompany Report #PHBS2001AU06733 Age:29 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaphylactic Reaction Foreign Clozaril PS Novartis Initial or Prolonged Bradycardia Health Pharmaceuticals Corp ORAL 475 MG/D, Circulatory Collapse Professional ORAL Hypotension Other Date:07/19/01ISR Number: 3763080-2Report Type:Expedited (15-DaCompany Report #PHFR2001GB02031 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hydronephrosis Foreign Clozaril PS Novartis Nephritis Health Pharmaceuticals Corp ORAL ORAL Renal Impairment Professional Risperidone Urinary Incontinence Other (Risperidone) C Urinary Retention Date:07/20/01ISR Number: 3761752-7Report Type:Direct Company Report # Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coma Clozaril (3000mg Q Feeling Cold Am , 600mg Po Qhs) PS 300MG PO QAM, 600MG Q HS PT MAINTAINED AT LEAST ONE YEAR Depakote Er(1500mg Po) SS ORAL 1000MG PO QAM Vistaril C Cozaar C Cogentin C Folic Acid C Colace C Pyridoxine C Vit E C Lico3 C Date:07/20/01ISR Number: 3762786-9Report Type:Expedited (15-DaCompany Report #PHBS2001NL06015 Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Appendicitis Foreign Clozaril PS Novartis Initial or Prolonged Delirium Literature Pharmaceuticals Corp ORAL 600 MG/D, Disturbance In Attention Health ORAL Drug Level Above Professional Lorazepam C Therapeutic Other Infection Pyrexia 22-Feb-2006 08:30 AM Page: 1199 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/20/01ISR Number: 3762812-7Report Type:Expedited (15-DaCompany Report #PHBS1999NL00795 Age:67 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cyanosis Foreign Clozaril PS Novartis Initial or Prolonged Delirium Literature Pharmaceuticals Corp ORAL SEE IMAGE Depressed Level Of Health Temesta (Lorazepam) C Consciousness Professional Oxazepam (Oxazezpam) C Disorientation Other Drug Level Above Therapeutic Tachypnoea Upper Respiratory Tract Infection Date:07/20/01ISR Number: 3762818-8Report Type:Expedited (15-DaCompany Report #PHBS2001NL06018 Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Level Changed Foreign Clozaril PS Novartis Initial or Prolonged Pyrexia Literature Pharmaceuticals Corp ORAL 200 TO 600 MG Self Mutilation Health Flucloxacillin Wound Infection Professional (Flucloxacillin) SS Other Dehydrobenzperidol (Droperidol) C Isophane Insulin (Isophane Insulin) C Lorazepam C Lormetazepam (Lormetazepam) C Alprazolam (Alprazolam) C Omeprazole (Omeprazole) C Cisapride (Cisapride) C Oxybutynin "Nm Pharma" (Oxybutinin Hydrochloride) C Paroxetine (Paroxetine) C Date:07/20/01ISR Number: 3762897-8Report Type:Expedited (15-DaCompany Report #PHEH2001US05224 Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Study Clozaril PS Novartis Life-Threatening Health Pharmaceuticals Corp ORAL 1000 MG, ORAL Professional Citalopram C Date:07/20/01ISR Number: 3762904-2Report Type:Expedited (15-DaCompany Report #PHEH2001US05989 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Health Clozaril PS Novartis Initial or Prolonged Ovarian Cancer Professional Pharmaceuticals Corp OPHTHALMIC 400MG HS, Other ORAL Chemotherapeutics,Ot her C 22-Feb-2006 08:30 AM Page: 1200 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/20/01ISR Number: 3762921-2Report Type:Expedited (15-DaCompany Report #PHEH2001US04393 Age:54 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatinine Health Clozaril PS Novartis Initial or Prolonged Increased Professional Pharmaceuticals Corp ORAL 500 MG DAILY Blood Urea Increased ORAL Intestinal Obstruction Date:07/23/01ISR Number: 3762642-6Report Type:Expedited (15-DaCompany Report #C2001-1984.01 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Health Clozapine PS Mylan Professional Pharmaceuticals Inc ORAL 500 MG QD, Other ORAL Amlodipine C Clonazepam C Folic Acid C Metaproterenol Inhalation C Multivitamin C Montelukast C Thiothixene C Date:07/23/01ISR Number: 3762647-5Report Type:Expedited (15-DaCompany Report #01-07-0370 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Health Clozapine PS Zenith Goldline ORAL 450MG QD ORAL Hospitalization - Post Procedural Professional Initial or Prolonged Complication Date:07/23/01ISR Number: 3762648-7Report Type:Expedited (15-DaCompany Report #01-07-0371 Age:88 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL ORAL Professional Date:07/23/01ISR Number: 3762649-9Report Type:Expedited (15-DaCompany Report #01-07-0375 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Health Clozapine PS Zenith Goldline ORAL ORAL Hospitalization - Professional Initial or Prolonged Date:07/23/01ISR Number: 3762650-5Report Type:Expedited (15-DaCompany Report #01-07-0376 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 350-400MG QD Professional ORAL 22-Feb-2006 08:30 AM Page: 1201 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/23/01ISR Number: 3762652-9Report Type:Expedited (15-DaCompany Report #01-07-0377 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL ORAL Professional Date:07/23/01ISR Number: 3762653-0Report Type:Expedited (15-DaCompany Report #01-07-0372 Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Oesophageal Carcinoma Health Clozapine PS Zenith Goldline ORAL 25MG QD ORAL Professional Date:07/23/01ISR Number: 3762654-2Report Type:Expedited (15-DaCompany Report #01-06-0324 Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Health Clozapine PS Zenith Goldline ORAL 150-825MG QD Initial or Prolonged Professional ORAL Seroquel C Depakote C Klonopin C Date:07/23/01ISR Number: 3762655-4Report Type:Expedited (15-DaCompany Report #01-07-0344 Age:39 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 500-900MG QD Professional ORAL Synthroid C Lotensin C Coumadin C Ultram C K-Dur C Neurontin C Phenobarbital C Atrovent C Ventolin C Cogentin C Haldol C Effexor Xr C Dulcolax C Vicodin C Phenergan C Multivitamins C Tylenol C Oxygen C Date:07/23/01ISR Number: 3762657-8Report Type:Expedited (15-DaCompany Report #01-06-0338 Age:76 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 100MG QD ORAL Professional Depakote C Sinemet C 22-Feb-2006 08:30 AM Page: 1202 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/23/01ISR Number: 3762659-1Report Type:Expedited (15-DaCompany Report #01-06-0295 Age:49 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Haematocrit Increased Health Clozapine PS Zenith Goldline ORAL 150-350MG QD Initial or Prolonged Haemoglobin Increased Professional ORAL Hypoxia Premarin C Pneumonia Depakote C Theo-Dur C Zoloft C Zyrtec C Singulair C Flovent C Serevent C Vioxx C Bactroban C Levoxyl C Acetylcysteine C Xopenex C Ipratropium C Furosemide C Prevacid C Folic Acid C K-Dur C Accolate C Zoloft C Omnicef C Amibid-Dm "Amide" C Docusate C Propoxyphene Napsylate W/Acetaminophene C Bisacodyl Suppostories C Aspirin (E.C.) C Cephalexin C Date:07/23/01ISR Number: 3762669-4Report Type:Expedited (15-DaCompany Report #01-07-0368 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 750 MG QD Professional ORAL Date:07/23/01ISR Number: 3762671-2Report Type:Expedited (15-DaCompany Report #01-07-0379 Age:81 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 12.5-50MG QD Professional ORAL Date:07/23/01ISR Number: 3762673-6Report Type:Expedited (15-DaCompany Report #01-06-0297 Age:79 YR Gender:Male I/FU:I Outcome PT Death Anaemia Hospitalization - Cardiac Arrest Initial or Prolonged Hypoxia Myocardial Infarction 22-Feb-2006 08:30 AM Page: 1203 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pneumonia Renal Failure Respiratory Arrest Report Source Product Role Manufacturer Route Dose Duration Health Clozapine PS Zenith Goldline ORAL 37.5 MG QD Professional ORAL Date:07/23/01ISR Number: 3762676-1Report Type:Expedited (15-DaCompany Report #01-06-0306 Age:72 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Electrolytes Health Clozapine PS Zenith Goldline ORAL 400-100 MG QD Initial or Prolonged Abnormal Professional ORAL Confusional State Ativan C Dehydration Haldol C Diabetes Mellitus Zoloft C Drug Effect Decreased Pneumonia Date:07/23/01ISR Number: 3762677-3Report Type:Expedited (15-DaCompany Report #01-06-0347 Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Metastases To Central Health Clozapine PS Zenith Goldline ORAL 150-350 MG QD Nervous System Professional ORAL Date:07/23/01ISR Number: 3763600-8Report Type:Expedited (15-DaCompany Report #ENT 2000-0152 (1) Age:62 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chorea Literature Comtess (Entacapone) PS ORAL 1000 MG Initial or Prolonged Iron Deficiency Anaemia Madopar (Levodopa, Motor Dysfunction Benserazide Parkinsonism Hydrochloride) SS ORAL 625 MG Sedation (DAILY) Sleep Attacks Cabaseril (Cabergoline) SS ORAL 8 MG (DAILY) Parkinsan (Budipine) SS ORAL 50 MG (DAILY) Clozapine (Clozapine) SS ORAL 25 MG (25, 1 IN 1 D) Slow-Release Levodopa-Carbidopa SS 100 MG Digitoxin (Digitoxin) C Furesemid (Furosemide) C Date:07/23/01ISR Number: 3763768-3Report Type:Expedited (15-DaCompany Report #S01-USA-01397-01 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Interaction Health Celexa PS Forest Laboratories Sudden Death Professional Inc ORAL 20 MG QD PO Company Clozapine SS Representative Effexor (Venlafaxine Hydrochloride) C 22-Feb-2006 08:30 AM Page: 1204 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/23/01ISR Number: 3763859-7Report Type:Expedited (15-DaCompany Report #PHEH2001US06049 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Head Injury Health Clozaril PS Novartis Myocardial Infarction Professional Pharmaceuticals Corp ORAL 25 MG, ORAL Company Representative Date:07/25/01ISR Number: 3765128-8Report Type:Expedited (15-DaCompany Report #C2001-1739.01 Age:68 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Mylan Professional Pharmaceuticals Inc Other Date:07/25/01ISR Number: 3765272-5Report Type:Expedited (15-DaCompany Report #PHBS2001AU07225 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neuropathy Peripheral Foreign Clozaril PS Novartis Health Pharmaceuticals Corp ORAL 400 MG/D, Professional ORAL Other Date:07/25/01ISR Number: 3765636-XReport Type:Expedited (15-DaCompany Report #PHBS1999NL00782 Age:45 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Appendicectomy Foreign Clozaril PS Novartis Initial or Prolonged Appendicitis Perforated Literature Pharmaceuticals Corp ORAL 275 MG, ORAL Diarrhoea Health Lorazepam Drug Interaction Professional (Lorazepam) C Drug Level Above Other Oxazepam (Oxazepam) C Therapeutic Perfenazine (Enoximone) (Perphenazine) C Date:07/26/01ISR Number: 3765795-9Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutrophil Count Clozaril PS ORAL 625MG/D PO Initial or Prolonged Decreased Neurontin? SS Psychotic Disorder Synthroid C White Blood Cell Count Lotensin C Decreased Ditropan C Neurontin C Date:07/26/01ISR Number: 3766171-5Report Type:Expedited (15-DaCompany Report #PHBS2001CA06182 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Life-Threatening Drug Interaction Foreign Neutropenia Study Health 22-Feb-2006 08:30 AM Page: 1205 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Other Product Role Manufacturer Route Dose Duration Clozaril PS Novartis Pharmaceuticals Corp 550 MG/D Risperdal(Risperidon e) SS 2 MG, QD Epival (Valproate Semisodium) C Haldol C Nozinan C Date:07/26/01ISR Number: 3766172-7Report Type:Expedited (15-DaCompany Report #PHRM2001FR01010 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Qt Foreign Clozaril PS Novartis Initial or Prolonged Prolonged Health Pharmaceuticals Corp ORAL 400 MG DAILY, Extensor Plantar Response Professional ORAL; 10 G Hyperreflexia Other ORAL, ORAL 1209 DAY Intentional Overdose Loss Of Consciousness Restlessness Suicide Attempt Tachycardia Date:07/26/01ISR Number: 3766234-4Report Type:Expedited (15-DaCompany Report #A117290 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blindness Unilateral Health Geodon PS Pfizer Central Intervention to Vision Blurred Professional Research 12.00 MG Prevent Permanent Company TOTAL:BID Impairment/Damage Representative Clozapine SS 700.00 MG TOTAL:BID Remeron SS Celexa SS Klonopin C Date:07/26/01ISR Number: 3766310-6Report Type:Expedited (15-DaCompany Report #PHEH2001US04303 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatitis C Health Clozaril PS Novartis Jaundice Cholestatic Professional Pharmaceuticals Corp ORAL 800 MG DAILY, ORAL Date:07/26/01ISR Number: 3766381-7Report Type:Expedited (15-DaCompany Report #PHBS2001CH07352 Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Congestive Cardiomyopathy Foreign Clozaril PS Novartis Initial or Prolonged Pleural Effusion Health Pharmaceuticals Corp ORAL 125 MG/D, Other Rheumatoid Factor Professional ORAL Positive Other Eltroxin C Marcoumar (Phenprocoumon) C 22-Feb-2006 08:30 AM Page: 1206 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lisinopril W/Hydrochlorothiazid e C Prednisone C Date:07/26/01ISR Number: 3766397-0Report Type:Expedited (15-DaCompany Report #PHFR2001GB02044 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Circulatory Collapse Foreign Clozaril PS Novartis Clonic Convulsion Health Pharmaceuticals Corp ORAL 650 MG/DAY, Electrocardiogram Qt Professional ORAL Prolonged Other Date:07/26/01ISR Number: 3766423-9Report Type:Expedited (15-DaCompany Report #ENT 2000-0152 (1) Age:62 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akinesia Literature Comtess (Entacapone) PS ORAL 1000 MG ORAL Initial or Prolonged Chorea Madopar (Levodopa, Fatigue Benserazide Motor Dysfunction Hydrochloride) SS ORAL 625 MG Sleep Attacks (DAILY) ORAL Cabaseril (Cabergoline) SS ORAL 8 MG (DAILY) ORAL Parkinsan (Budipine) SS ORAL 50 MG (DAILY) ORAL Slow-Release Levodopa-Carbidopa SS 100 MG Clozapine (Clozapine) SS ORAL 25 MG (25, 1 IN 1 D), ORAL Digitoxin (Digitoxin) C Furesemid (Furosemide) C Date:07/27/01ISR Number: 3766914-0Report Type:Expedited (15-DaCompany Report #01-07-0383 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS ORAL 75-100MG QD ORAL Date:07/27/01ISR Number: 3766915-2Report Type:Expedited (15-DaCompany Report #01-07-0385 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Neoplasm Malignant Health Clozapine PS ORAL 200-600 MG QD Professional ORAL 22-Feb-2006 08:30 AM Page: 1207 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/27/01ISR Number: 3766923-1Report Type:Expedited (15-DaCompany Report #PHBS2001CA07012 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Foreign Clozaril PS Novartis Convulsion Study Pharmaceuticals Corp ORAL ORAL Electrocardiogram Qrs Health Risperidone Complex Prolonged Professional (Risperidone) C Palpitations Other Olanzapine (Olanzapine) C Clozaril (Clozapine) C Date:07/27/01ISR Number: 3767248-0Report Type:Expedited (15-DaCompany Report #PHFR2001GB01278 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Angiopathy Foreign Clozaril PS Novartis Other Cardiomyopathy Study Pharmaceuticals Corp ORAL ORAL Drug Level Above Health Lithium Carbonate C Therapeutic Professional Nitrazepam C Drug Toxicity Other Valproic Acid C Myocardial Fibrosis Pulmonary Oedema Date:07/30/01ISR Number: 3768267-0Report Type:Expedited (15-DaCompany Report #C2001-1985.01 Age:91 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Mylan Professional Pharmaceuticals Inc ORAL 100 MG QD, Other ORAL Date:07/30/01ISR Number: 3768740-5Report Type:Expedited (15-DaCompany Report #PHBS2001AU06139 Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiomyopathy Foreign Clozaril PS Novartis Study Pharmaceuticals Corp ORAL 200 MG/D, Health ORAL Professional Other Date:07/30/01ISR Number: 3768756-9Report Type:Expedited (15-DaCompany Report #PHFR2001GB01998 Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Foreign Clozaril PS Novartis Hemiparesis Health Pharmaceuticals Corp ORAL 550MG/DAY, Lethargy Professional ORAL Meningioma Other Dexamethasone C Muscular Weakness Cyproterone Acetate (Cyproterone Acetate) C Risperidone (Risperidone) C 22-Feb-2006 08:30 AM Page: 1208 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/30/01ISR Number: 3768757-0Report Type:Expedited (15-DaCompany Report #PHFR2001GB02082 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diarrhoea Foreign Clozaril PS Novartis Headache Health Pharmaceuticals Corp ORAL 100 MG, QD, Hyperhidrosis Professional ORAL Neck Pain Other Visual Disturbance Visual Field Defect Vomiting Date:07/30/01ISR Number: 3768758-2Report Type:Expedited (15-DaCompany Report #PHFR2001GB02084 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Foreign Clozaril PS Novartis Initial or Prolonged Health Pharmaceuticals Corp ORAL 150MG/DAY, Professional ORAL Other Date:07/30/01ISR Number: 3768977-5Report Type:Expedited (15-DaCompany Report #PHBS1999NL00782 Age:45 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Foreign Clozaril PS Novartis Initial or Prolonged Appendicitis Literature Pharmaceuticals Corp ORAL 275 MG, ORAL Diarrhoea Health Lorazepam Drug Interaction Professional (Lorazepam) C Drug Level Above Other Oxazepam (Oxazepam) C Therapeutic Perfenazine Pyrexia (Enoxamine) Vomiting (Perphenazine) C Date:07/31/01ISR Number: 3768454-1Report Type:Expedited (15-DaCompany Report #PHEH2001US06234 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Health Clozaril PS Novartis Initial or Prolonged Diabetes Mellitus Professional Pharmaceuticals Corp ORAL 300 MG, ORAL Hyponatraemia Lipitor (Atorvastatin) C Synthroid C Date:07/31/01ISR Number: 3768464-4Report Type:Expedited (15-DaCompany Report #PHEH2001US04996 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Dehydration Health Clozaril PS Novartis Other Demyelination Professional Pharmaceuticals Corp ORAL 350 MG, ORAL Medication Error Lasix (Furosemide) SS 1861 DAY 22-Feb-2006 08:30 AM Page: 1209 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/31/01ISR Number: 3768496-6Report Type:Expedited (15-DaCompany Report #PHEH2001US05412 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Embolism Health Clozaril PS Novartis Professional Pharmaceuticals Corp ORAL 650MG DAILY, ORAL 2920 DAY Date:07/31/01ISR Number: 3768558-3Report Type:Expedited (15-DaCompany Report #PHRM2001FR01737 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other C-Reactive Protein Foreign Clozaril PS Novartis Increased Health Pharmaceuticals Corp ORAL 800 MG DAILY; Gastrooesophageal Reflux Professional ORAL Disease Other Risperdal Hepatic Steatosis (Risperidone) C Microcytic Anaemia Date:07/31/01ISR Number: 3768559-5Report Type:Expedited (15-DaCompany Report #PHFR2001GB02135 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Foreign Clozaril PS Novartis Renal Impairment Health Pharmaceuticals Corp ORAL 600 MG, QD; Professional ORAL Other Date:07/31/01ISR Number: 3768592-3Report Type:Expedited (15-DaCompany Report #01-06-0297 Age:79 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anaemia Health Clozapine PS Zenith Goldline ORAL 37 5MG QD Hospitalization - Cardiac Arrest Professional ORAL Initial or Prolonged Dyspnoea Fall Hypoxia Myocardial Infarction Pneumonia Pulmonary Congestion Renal Failure Respiratory Arrest Date:07/31/01ISR Number: 3768596-0Report Type:Expedited (15-DaCompany Report #01-06-0295 Age:49 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Haematocrit Increased Health Clozapine PS Zenith Goldline ORAL 150-500MG QD Initial or Prolonged Haemoglobin Increased Professional ORAL Hypoxia Premarin C Lobar Pneumonia Depakote C Theo-Dur C Zoloft C Zyrtec C Singulair C Flovent C Serevent C Vioxx 12.5 Mg C 22-Feb-2006 08:30 AM Page: 1210 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Bactroban Oimtment 2% C Levoxyl 50mcg C Acetylcysteine 10% C Xopenex 1.25mg/3ml C Ipratropium C Furosemide 40mg C Prevacid 30 Mg C Folic Acid C K-Dur 20meq C Accolate 20mg C Zoloft 100mg C Omnicef 300 Mg C Amibid-Dm "Amide" C Docusate 100mg C Propoxyphene Napsylate W/Acetaminophene C Bisacodyl Suppositories 10mg C Aspirin (E.C.) 325mg C Cephalexin 500mg C Date:07/31/01ISR Number: 3768601-1Report Type:Expedited (15-DaCompany Report #01-06-0315 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arterial Occlusive Health Clozapine PS Zenith Goldline 300-900MGQD Disease Professional Seroquel 200mg Bid C Coma Zoloft 150 Mg C Hepatic Failure Flurazepam 30 Mg C Date:07/31/01ISR Number: 3768606-0Report Type:Expedited (15-DaCompany Report #01-07-0371 Age:88 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Effect Decreased Health Clozapine PS Zenith Goldline ORAL ORAL Professional Date:07/31/01ISR Number: 3768610-2Report Type:Expedited (15-DaCompany Report #01-07-0348 Age:79 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Leukopenia Health Clozapine PS Zenith Goldline ORAL 200 MG QD Pelvic Mass Professional ORAL Date:07/31/01ISR Number: 3768612-6Report Type:Expedited (15-DaCompany Report #01-07-0362 Age:68 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 25-75MG QD Professional ORAL 22-Feb-2006 08:30 AM Page: 1211 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/31/01ISR Number: 3768614-XReport Type:Expedited (15-DaCompany Report #01-07-0386 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypothyroidism Health Clozapine PS Zenith Goldline ORAL 25-650MG QD Professional ORAL Neurontin 300mg Tid C Date:07/31/01ISR Number: 3768634-5Report Type:Expedited (15-DaCompany Report #PHFR2001GB02110 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Transient Ischaemic Foreign Clozaril PS Novartis Attack Health Pharmaceuticals Corp ORAL 400 MG/DAY, Professional ORAL Other Date:07/31/01ISR Number: 3768637-0Report Type:Expedited (15-DaCompany Report #PHBS2001AU07298 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Foreign Clozaril PS Novartis Phosphokinase Increased Study Pharmaceuticals Corp ORAL 12.5 MG/D, Cardiac Enzymes Increased Health ORAL (SEE Dermatitis Professional IMAGE) Neutropenia Other Neutrophil Count Decreased Pharyngolaryngeal Pain Pyrexia Tachycardia Thrombocythaemia White Blood Cell Count Decreased Date:08/01/01ISR Number: 3769187-8Report Type:Expedited (15-DaCompany Report #PHEH2001US06305 Age:77 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Lymphocytic Health Clozaril PS Novartis Leukaemia Professional Pharmaceuticals Corp ORAL 300 TO 350MG Leukocytosis DAILY, ORAL Date:08/01/01ISR Number: 3769579-7Report Type:Expedited (15-DaCompany Report #PHBS2001FI06547 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agranulocytosis Foreign Clozaril PS Novartis Hospitalization - Multi-Organ Failure Health Pharmaceuticals Corp ORAL 200 MG/D, Initial or Prolonged Neutrophil Count Professional ORAL Decreased Other Depakine C Pneumonia Zyprexa (Olazapine) C Sepsis White Blood Cell Count Decreased 22-Feb-2006 08:30 AM Page: 1212 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/01/01ISR Number: 3769581-5Report Type:Expedited (15-DaCompany Report #PHBS2001AU06139 Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiomyopathy Foreign Clozaril PS Novartis Study Pharmaceuticals Corp ORAL 200 MG/D, Health ORAL Professional Other Date:08/01/01ISR Number: 3769585-2Report Type:Expedited (15-DaCompany Report #PHFR2001GB02044 Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Circulatory Collapse Foreign Clozaril PS Novartis Clonic Convulsion Health Pharmaceuticals Corp ORAL SEE IMAGE 10 YR Dizziness Professional Electrocardiogram Qt Other Prolonged Date:08/01/01ISR Number: 3769588-8Report Type:Expedited (15-DaCompany Report #PHBS2001IT07607 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Catatonia Foreign Clozaril PS Novartis Intermittent Explosive Literature Pharmaceuticals Corp SEE IMAGE Disorder Health Muscle Rigidity Professional Other Date:08/01/01ISR Number: 3769589-XReport Type:Expedited (15-DaCompany Report #PHNU2001DE01706 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Biopsy Bone Marrow Foreign Clozaril PS Novartis Abnormal Health Pharmaceuticals Corp 125 MG/DAY Drug Toxicity Professional L-Thyroxin Tablet C Leukocytosis Other Date:08/01/01ISR Number: 3769598-0Report Type:Expedited (15-DaCompany Report #PHFR2001GB02121 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Transient Ischaemic Foreign Clozaril PS Novartis Attack Health Pharmaceuticals Corp ORAL ORAL Professional Other Date:08/01/01ISR Number: 3769599-2Report Type:Expedited (15-DaCompany Report #PHBS2000CA08470 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Appendicitis Perforated Foreign Clozaril PS Novartis Initial or Prolonged Constipation Health Pharmaceuticals Corp ORAL 400 MG/D, Intestinal Obstruction Professional ORAL Vomiting Other Glyburide C 22-Feb-2006 08:30 AM Page: 1213 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/02/01ISR Number: 3770312-3Report Type:Expedited (15-DaCompany Report #PHFR2001GB02143 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Embolism Foreign Clozaril PS Novartis Health Pharmaceuticals Corp ORAL 350 MG QD Professional ORAL Other Anticoagulants (Anticoagulants) C Date:08/02/01ISR Number: 3770313-5Report Type:Expedited (15-DaCompany Report #PHBS2001CH07661 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Foreign Clozaril PS Novartis Biliary Tract Disorder Health Pharmaceuticals Corp ORAL 525 MG/D, Hepatitis Cholestatic Professional ORAL Jaundice Cholestatic Other Solian (Amisulpride) C Nozinan C Melleril C Dalmadorm (Flurazepam Hydrochloride) C Urispas (Flavoxate Hydrochloride) C Date:08/02/01ISR Number: 3770766-2Report Type:Expedited (15-DaCompany Report #C2001-1732.01 Age:83 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Clozapine PS Mylan Congestive Professional Pharmaceuticals Inc ORAL 12.5 MG Q Pneumonia Other 6PM, ORAL Date:08/02/01ISR Number: 3770767-4Report Type:Expedited (15-DaCompany Report #C2001-1740.01 Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Brain Neoplasm Malignant Health Clozapine PS Mylan Professional Pharmaceuticals Inc ORAL ORAL Other Date:08/03/01ISR Number: 3770990-9Report Type:Expedited (15-DaCompany Report #PHBS2000DE03439 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akinesia Foreign Clozaril PS Novartis Initial or Prolonged Chorea Literature Pharmaceuticals Corp ORAL 1000 MG ORAL Hallucination Health Madopar Sleep Attacks Professional (Madopar)(Madopar) SS ORAL 625 MG D ORAL Other Cabaseril (Cabergoline) SS ORAL 8MG D ORAL Parkinsan (Budipine) (Budipine) SS ORAL 50 MG ORAL Clozapine (Clozapine) SS ORAL 25 MG QD ORAL Levodopa-Carbidopa (Levodopa, 22-Feb-2006 08:30 AM Page: 1214 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Carbidopa) SS UNKNOWN 100 MG UNKNOWN Digitoxin (Digitoxin) C Furosemide (Furosemide) C Date:08/03/01ISR Number: 3771078-3Report Type:Expedited (15-DaCompany Report #PHFR2001GB02146 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Rhabdomyosarcoma Foreign Clozaril PS Novartis Health Pharmaceuticals Corp 450 MG, QD Professional Other Date:08/03/01ISR Number: 3771093-XReport Type:Expedited (15-DaCompany Report #PHBS2001AU04309 Age:44 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Effect Increased Foreign Clozaril PS Novartis Palpitations Health Pharmaceuticals Corp ORAL 600 MG/D, Tachycardia Professional ORAL Ventricular Hypertrophy Other Sertraline (Sertraline) C Omeprazole (Omeprazole) C Ventolin C Nitrofuranton (Nitrofurantoin) C Date:08/06/01ISR Number: 3771578-6Report Type:Expedited (15-DaCompany Report #01-07-0393 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Urinary Tract Infection Health Clozapine PS Zenith Goldline ORAL 300MG QD ORAL Initial or Prolonged White Blood Cell Count Professional Increased Date:08/06/01ISR Number: 3771580-4Report Type:Expedited (15-DaCompany Report #01-07-0398 Age:79 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dementia Health Clozapine PS Zenith Goldline ORAL 12.5MG QD Professional ORAL Date:08/06/01ISR Number: 3771582-8Report Type:Expedited (15-DaCompany Report #01-07-0399 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hiv Test Positive Health Clozapine PS Zenith Goldline ORAL 200-400MG QD Professional ORAL 22-Feb-2006 08:30 AM Page: 1215 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/06/01ISR Number: 3771584-1Report Type:Expedited (15-DaCompany Report #01-07-0400 Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine PS Zenith Goldline ORAL 25MG QD ORAL Professional Date:08/06/01ISR Number: 3771587-7Report Type:Expedited (15-DaCompany Report #01-07-0401 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neoplasm Malignant Health Clozapine PS Zenith Goldline ORAL 550MG QD ORAL Professional Date:08/06/01ISR Number: 3771589-0Report Type:Expedited (15-DaCompany Report #01-07-0402 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Neoplasm Malignant Health Clozapine PS Zenith Goldline ORAL 100-500MG QD Professional ORAL Date:08/06/01ISR Number: 3771590-7Report Type:Expedited (15-DaCompany Report #01-07-0362 Age:68 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Neoplasm Malignant Health Clozapine PS Zenith Goldline ORAL 25-75MG QD Neoplasm Malignant Professional ORAL Date:08/06/01ISR Number: 3771591-9Report Type:Expedited (15-DaCompany Report #01-07-0377 Age:53 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 600MG QD ORAL Professional Date:08/06/01ISR Number: 3772096-1Report Type:Expedited (15-DaCompany Report #PHFR2001GB02145 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Medication Error Foreign Clozaril PS Novartis Initial or Prolonged Overdose Health Pharmaceuticals Corp ORAL SEE IMAGE Transient Ischaemic Professional Alcohol (Ethanol) SS Attack Other Date:08/06/01ISR Number: 3772237-6Report Type:Expedited (15-DaCompany Report #PHBS2001US07677 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Enuresis Literature Clozaril PS Novartis Initial or Prolonged Health Pharmaceuticals Corp 300 MG, BID, Professional UNK 3 MON Carbamzepine C Gabapentin (Gabapentin) C Olanzapine (Olanzapine) C 22-Feb-2006 08:30 AM Page: 1216 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Loxapine (Loxapine) C Date:08/08/01ISR Number: 3772902-0Report Type:Expedited (15-DaCompany Report #PHBS2001CH07668 Age:18 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Appendicitis Foreign Clozaril PS Novartis Initial or Prolonged Diarrhoea Health Pharmaceuticals Corp ORAL 100 MG/D, Eosinophilia Professional ORAL Myocarditis Other Orfiril C Poulenc Pericarditis Date:08/08/01ISR Number: 3773047-6Report Type:Expedited (15-DaCompany Report #PHEH2001US06438 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Health Clozaril PS Novartis Leukopenia Professional Pharmaceuticals Corp ORAL 400 MG, ORAL Neutropenia (SEE IMAGE) Depakote (Valproate Semisodium) C Haldol C Cogentin (Benzatropine Mesilate) C Ativan C Dilantin C Ddavp (Desmopressin) C Asa C Allegra (Fexofenadine Hydrochloride) C Ranitidine (Ranitidine) C Metamucil (Psycllium Hydrophilic Mucilloid) C Lactulose C Date:08/08/01ISR Number: 3773284-0Report Type:Expedited (15-DaCompany Report #01-07-0418 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Level Above Health Clozapine PS Zenith Goldline ORAL 500MG QD ORAL Other Therapeutic Professional Zyprexa C Eskalith C Dostinex C Clomipramine C Parlodel C Date:08/08/01ISR Number: 3773285-2Report Type:Expedited (15-DaCompany Report #01-05-0273 Age:68 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Metastasis Health Clozapine PS Zenith Goldline ORAL 200-350MG Professional ORAL 22-Feb-2006 08:30 AM Page: 1217 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/08/01ISR Number: 3773286-4Report Type:Expedited (15-DaCompany Report #01-07-0379 Age:81 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 12.5-50MG QD Professional ORAL Lorazepam C Date:08/08/01ISR Number: 3773287-6Report Type:Expedited (15-DaCompany Report #01-03-0178 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Unevaluable Event Health Clozapine PS Zenith Goldline ORAL 800MG QD ORAL Professional Date:08/08/01ISR Number: 3773289-XReport Type:Expedited (15-DaCompany Report #01-06-0329 Age:77 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Pain Health Clozapine PS Zenith Goldline ORAL 100-200MG QD Hospitalization - Hypoxia Professional ORAL Initial or Prolonged Date:08/08/01ISR Number: 3773290-6Report Type:Expedited (15-DaCompany Report #01-07-0405 Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Neoplasm Malignant Health Clozapine PS Zenith Goldline ORAL 25-700MG QD Professional ORAL Date:08/08/01ISR Number: 3773291-8Report Type:Expedited (15-DaCompany Report #01-07-0406 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 25-50MG ORAL Professional Date:08/08/01ISR Number: 3773292-XReport Type:Expedited (15-DaCompany Report #01-07-0416 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine PS Zenith Goldline ORAL UNKNOWN ORAL Professional Date:08/08/01ISR Number: 3773444-9Report Type:Expedited (15-DaCompany Report #PHBS2001AU07788 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaphylactic Shock Foreign Clozaril PS Novartis Study Pharmaceuticals Corp ORAL ORAL Health Professional Other 22-Feb-2006 08:30 AM Page: 1218 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/08/01ISR Number: 3773446-2Report Type:Expedited (15-DaCompany Report #PHFR2001GB00780 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Amenorrhoea Foreign Clozaril PS Novartis Other Ascites Health Pharmaceuticals Corp ORAL SEE IMAGE Dyspnoea Professional Gabapentin Enuresis Other (Gabapentin) C Oedema Peripheral Urinary Incontinence Date:08/08/01ISR Number: 3773451-6Report Type:Expedited (15-DaCompany Report #PHEH2001US06102 Age:81 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebral Atherosclerosis Health Clozaril PS Novartis Parkinson'S Disease Professional Pharmaceuticals Corp ORAL SEE IMAGE Urinary Tract Infection Date:08/08/01ISR Number: 3773454-1Report Type:Expedited (15-DaCompany Report #PHEH2001US06436 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Clozaril PS Novartis Initial or Prolonged Overdose Professional Pharmaceuticals Corp ORAL 400 MG, ORAL Suicide Attempt Date:08/08/01ISR Number: 3773482-6Report Type:Expedited (15-DaCompany Report #PHEH2001US04415 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Health Clozaril PS Novartis Initial or Prolonged Cough Professional Pharmaceuticals Corp ORAL 250 MG, ORAL Gastritis Haldol C Mouth Ulceration Depakote (Valproate Semisodium) C Cogentin (Benzatropine Mesilate) C Buspar (Buspirone Hydrochloride) C Date:08/09/01ISR Number: 3775076-5Report Type:Expedited (15-DaCompany Report #PHFR2001GB02195 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Foreign Clozaril PS Novartis Blood Prolactin Increased Health Pharmaceuticals Corp ORAL 125 MG/DAY, Professional ORAL Other Date:08/09/01ISR Number: 3775078-9Report Type:Expedited (15-DaCompany Report #PHBS2001AU07750 Age:32 YR Gender:Male I/FU:I Outcome PT Hospitalization - Aggression Initial or Prolonged Arrhythmia 22-Feb-2006 08:30 AM Page: 1219 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Liver Function Test Abnormal Overdose Report Source Product Role Manufacturer Route Dose Duration Sedation Foreign Clozaril PS Novartis Vomiting Health Pharmaceuticals Corp ORAL 225 MG/D, Professional ORAL; 2000 TO Other 3000 MG/D Date:08/09/01ISR Number: 3775079-0Report Type:Expedited (15-DaCompany Report #PHFR2001GB02183 Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cerebrovascular Accident Foreign Clozaril PS Novartis Health Pharmaceuticals Corp ORAL 800MG/DAY, Professional ORAL Other Date:08/09/01ISR Number: 3775109-6Report Type:Expedited (15-DaCompany Report #PHNU2001DE01724 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Coma Foreign Clozaril PS Novartis Extensor Plantar Response Health Pharmaceuticals Corp ORAL 12.5 MG , Professional ONCE/SINGLE, Other ORAL Date:08/09/01ISR Number: 3775117-5Report Type:Expedited (15-DaCompany Report #PHFR2001GB02029 Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dystonia Foreign Clozaril PS Novartis Oculogyration Health Pharmaceuticals Corp ORAL 300 MG/DAY, Salivary Hypersecretion Professional ORAL Other Sotalol (Sotalol) C Date:08/09/01ISR Number: 3775119-9Report Type:Expedited (15-DaCompany Report #PHFR2001GB02152 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Clozaril PS Novartis Other Electrocardiogram Qt Study Pharmaceuticals Corp ORAL 900 MG/DAY; Prolonged Health 800 MG/DAY, Sudden Death Professional ORAL Other Date:08/09/01ISR Number: 3775121-7Report Type:Expedited (15-DaCompany Report #PHFR2001GB01711 Age:54 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiomyopathy Foreign Clozaril PS Novartis Electrocardiogram Qt Health Pharmaceuticals Corp ORAL ORAL Prolonged Professional Myocarditis Other Phaeochromocytoma 22-Feb-2006 08:30 AM Page: 1220 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/09/01ISR Number: 3775221-1Report Type:Expedited (15-DaCompany Report #PHBS2001AU07225 Age:18 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neuropathy Peripheral Foreign Clozaril PS Novartis Health Pharmaceuticals Corp ORAL 400 MG/D, Professional ORAL Other Date:08/09/01ISR Number: 3775223-5Report Type:Expedited (15-DaCompany Report #PHBS2000CA08470 Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Appendicitis Perforated Foreign Clozaril PS Novartis Initial or Prolonged Constipation Health Pharmaceuticals Corp ORAL 400 MG/D; Intestinal Obstruction Professional ORAL Other Glyburide C Date:08/09/01ISR Number: 3775320-4Report Type:Expedited (15-DaCompany Report #C2001-1743.01 Age:83 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine Tablets PS Mylan Professional Pharmaceuticals Inc ORAL 100MG Q 9AM Other AND 5PM ORAL Acetaminophen C Albuterol Inhalation Solution C Ceftriaxone Injection C Clonazepam C Dorzolamide C Guaifenesin C Lamotrigine C Sorbitol C Venlafaxine C Levothyroxine C Date:08/09/01ISR Number: 3775323-XReport Type:Expedited (15-DaCompany Report #C2001-1736.01 Age:91 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Clozapine PS Mylan Other Respiratory Failure Professional Pharmaceuticals Inc ORAL 100MG BID, White Blood Cell Count Other ORAL Abnormal Novolin R C Atenolol C Furosemide C Glipizide Xl C Lorazepam C Nitroglycerin Transdermal System Patches C Potassium Chloride C Trazodone C 22-Feb-2006 08:30 AM Page: 1221 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/09/01ISR Number: 3775324-1Report Type:Expedited (15-DaCompany Report #C2001-1733.01 Age:92 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Upper Respiratory Tract Health Clozapine PS Mylan Infection Professional Pharmaceuticals Inc ORAL 12.5 MG TID, Other ORAL Albuterol Inhalation Solution C Fluoxetine C Morphine Sulfate Injection C Multivitamin C Ceftriazone Injection C Potassium Chloride C Morphine Suppositories C Guaifenesin/Phenylpr opanolamine/Phenylep hrine C Aspirin I Date:08/09/01ISR Number: 3776728-3Report Type:Expedited (15-DaCompany Report #C2001-1746.01 Age:57 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death White Blood Cell Count Health Clozapine PS Mylan Abnormal Professional Pharmaceuticals Inc ORAL 125MG Q AM & Other 150 MG Q PRN, ORAL Amlodipine C Benztropine C Fluoxetine C Haloperidol C Multivitamin C Date:08/13/01ISR Number: 3776008-6Report Type:Expedited (15-DaCompany Report #PHEH2001US06677 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Clozaril PS Novartis Initial or Prolonged Hepatic Failure Professional Pharmaceuticals Corp ORAL 375 MG, BID, ORAL Haldol C Ditropan (Oxyutynin) C Date:08/13/01ISR Number: 3776015-3Report Type:Expedited (15-DaCompany Report #A118469 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Literature Zoloft PS Pfizer Cardiomegaly Health Pharmaceuticals Inc 200.00 MG Cardiomyopathy Professional TOTAL:DAILY Coronary Artery Occlusion Clozapine SS 200.00 MG Hepatic Steatosis TOTAL:BID Sudden Death Risperidone C Atenolol C Lorazepam C 22-Feb-2006 08:30 AM Page: 1222 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pseudoephedrine C Date:08/13/01ISR Number: 3776132-8Report Type:Expedited (15-DaCompany Report #PHEH2001USA06234 Age:51 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Anaemia Health Clozaril PS Novartis Hospitalization - Diabetes Mellitus Professional Pharmaceuticals Corp ORAL 300 MG, ORAL Initial or Prolonged Hyponatraemia Lithium Carbonate Renal Disorder (Lithium Carbonate) SS Renal Failure Lipitor (Atorvastatin) C Synthroid C Prandin "Kuhn" (Defglazacort) C Acupril (Quinapril) C Boestrol C Date:08/13/01ISR Number: 3776532-6Report Type:Expedited (15-DaCompany Report #PHBS2001AU07750 Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Foreign Clozaril PS Novartis Initial or Prolonged Blood Creatine Health Pharmaceuticals Corp ORAL SEE IMAGE Phosphokinase Increased Professional Confusional State Other Disorientation Electrocardiogram St Segment Elevation Electrocardiogram T Wave Inversion Hepatic Function Abnormal Overdose Sedation Vomiting Date:08/13/01ISR Number: 3776913-0Report Type:Expedited (15-DaCompany Report #C2001-1738.01 Age:56 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Mylan Professional Pharmaceuticals Inc ORAL 650 MG DAILY, Other ORAL Conjugated Estrogens/Medroxypro gesterone C Divalproex C Doxepin C Ferrous Sulfate C Meclizine C Trihexyphenidyl C Benztropine C 22-Feb-2006 08:30 AM Page: 1223 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/13/01ISR Number: 3777099-9Report Type:Expedited (15-DaCompany Report #PHBS2000CA04592 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Appendicitis Foreign Clozaril PS Novartis Initial or Prolonged Study Pharmaceuticals Corp ORAL 600 MG/D, Health ORAL Professional Topiramate C Other Lamotrigine C Zoloft (Sertraline Hydrochloride) C Cogentin (Benzatropine Mesilate) C Dilantin C Date:08/13/01ISR Number: 3777111-7Report Type:Expedited (15-DaCompany Report #PHFR2001GB01821 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Foreign Clozaril PS Novartis Initial or Prolonged Dyspnoea Health Pharmaceuticals Corp ORAL 100 MG, BID, Hyperglycaemia Professional ORAL Polyuria Other Amisulpride C Sedation Clomipramine C Tachycardia Date:08/13/01ISR Number: 3777117-8Report Type:Expedited (15-DaCompany Report #PHFR2001GB02217 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cholelithiasis Foreign Clozaril PS Novartis Initial or Prolonged Health Pharmaceuticals Corp ORAL 300MG/DAY, Professional ORAL Other Date:08/13/01ISR Number: 3777131-2Report Type:Expedited (15-DaCompany Report #PHRM2001FR01779 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Foreign Clozaril PS Novartis Initial or Prolonged Drug Level Above Health Pharmaceuticals Corp ORAL 1.2 G, Therapeutic Professional ONCE/SINGLE, Electrocardiogram Other ORAL Abnormal Intentional Overdose Suicide Attempt Tachycardia Upper Motor Neurone Lesion Date:08/15/01ISR Number: 3778547-0Report Type:Expedited (15-DaCompany Report #01-08-0425 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Health Clozapine PS Zenith Goldline ORAL 400MG ORAL Professional 22-Feb-2006 08:30 AM Page: 1224 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/15/01ISR Number: 3778548-2Report Type:Expedited (15-DaCompany Report #01-08-0422 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Health Clozapine PS Zenith Goldline ORAL 100-450MG QD Dehydration Professional ORAL Date:08/15/01ISR Number: 3778549-4Report Type:Expedited (15-DaCompany Report #01-08-0423 Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Foreign Body Aspiration Health Clozapine PS Zenith Goldline ORAL 25-77MG QD Professional ORAL Date:08/15/01ISR Number: 3778550-0Report Type:Expedited (15-DaCompany Report #01-08-0424 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Eye Operation Health Clozapine PS Zenith Goldline ORAL 150MG ORAL Initial or Prolonged Professional Date:08/15/01ISR Number: 3778559-7Report Type:Expedited (15-DaCompany Report #01-06-0342 Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ecchymosis Health Clozapine PS Zenith Goldline ORAL 325-600MG QD Initial or Prolonged Fall Professional ORAL Hip Fracture Seroquel C Oedema Peripheral Date:08/15/01ISR Number: 3778560-3Report Type:Expedited (15-DaCompany Report #01-07-0411 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Clozapine PS Zenith Goldline ORAL 12.5MG QD Hypotonia Professional ORAL Lethargy Depakote C Loss Of Consciousness Haldol C Platelet Count Decreased Trileptal C Cogentin C Date:08/15/01ISR Number: 3778561-5Report Type:Expedited (15-DaCompany Report #01-06-0308 Age:93 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Body Temperature Health Clozapine PS Zenith Goldline ORAL 50MG BID ORAL Increased Professional Tequin C Date:08/15/01ISR Number: 3778562-7Report Type:Expedited (15-DaCompany Report #01-06-0311 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Clozapine PS Zenith Goldline ORAL 400-600MG QD Professional ORAL Neurontin C Klonopin C 22-Feb-2006 08:30 AM Page: 1225 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Serzone C Docusate Sodium C Dulcolax C Metamucil C Plendil C Date:08/16/01ISR Number: 3778469-5Report Type:Direct Company Report # Age:45 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Confusional State Clozaril PS Drooling Zoloft SS Gait Disturbance Risperdone SS Lethargy Serotonin Syndrome Date:08/16/01ISR Number: 3778970-4Report Type:Expedited (15-DaCompany Report #PHBS2001AU08151 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Appendicitis Foreign Clozaril PS Novartis Initial or Prolonged Study Pharmaceuticals Corp ORAL 225 MG/DAY, Health ORAL Professional Other Date:08/17/01ISR Number: 3779667-7Report Type:Expedited (15-DaCompany Report #PHEH2001US06685 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asthma Health Clozaril PS Novartis Professional Pharmaceuticals Corp ORAL 500 MG Company DAILY, ORAL Representative Lorazepam C Topamax (Topiramate) C Zoloft (Sertraline Hydrochloride) C Risperdal (Risperidone) C Prempro (Estrogens Conjugated) C Combivent (Ipratropium Bromide, Salbutamol Sulfate) C Date:08/17/01ISR Number: 3779669-0Report Type:Expedited (15-DaCompany Report #PHEH2001US06718 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypoproteinaemia Health Clozaril PS Novartis Initial or Prolonged Leukocytosis Professional Pharmaceuticals Corp ORAL 700 MG, ORAL Pneumonia 22-Feb-2006 08:30 AM Page: 1226 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/17/01ISR Number: 3779672-0Report Type:Expedited (15-DaCompany Report #PHEH2001US06737 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Health Clozaril PS Novartis Neutropenia Professional Pharmaceuticals Corp ORAL 300 MG, BID, ORAL Colace C Milk Of Magnesia C Insulin (Insulin) C Date:08/17/01ISR Number: 3779675-6Report Type:Expedited (15-DaCompany Report #PHEH2001US06305 Age:77 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Lymphocytic Health Clozaril PS Novartis Leukaemia Professional Pharmaceuticals Corp ORAL 100 MG AM + Leukocytosis 250 MG HS, ORAL ; 300 MG DAIL Y ORAL Acetaminophen (Paracetamol) C Celebrex (Celecoxib) C Prinivil (Lisinopril) C Zestril (Lisinopril) C Peri-Colace (Casanthranol) C Date:08/17/01ISR Number: 3779850-0Report Type:Expedited (15-DaCompany Report #PHEH2001US06679 Age:44 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Triglycerides Health Clozaril PS Novartis Increased Professional Pharmaceuticals Corp ORAL 600 MG, ORAL Gastrooesophageal Reflux Metoprolol Disease (Metoprolol) C Hepatitis C Tricor (Fenofibrate) C Liver Function Test Prevacid Abnormal (Lansoprazole) C Vomiting Weight Increased Date:08/17/01ISR Number: 3780161-8Report Type:Expedited (15-DaCompany Report #01-08-0430 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Gastrointestinal Health Clozapine PS Zenith Goldline ORAL 750MG ORAL Carcinoma Professional Hepatic Failure Ovarian Cancer 22-Feb-2006 08:30 AM Page: 1227 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/17/01ISR Number: 3780174-6Report Type:Expedited (15-DaCompany Report #01-08-0431 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Oesophageal Varices Health Clozapine PS Zenith Goldline ORAL 350MG ORAL Haemorrhage Professional Water Intoxication Date:08/17/01ISR Number: 3780176-XReport Type:Expedited (15-DaCompany Report #01-08-0429 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 200-350MG Professional ORAL Date:08/17/01ISR Number: 3780183-7Report Type:Expedited (15-DaCompany Report #01-08-0428 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 12.5 - 375MG Professional ORAL Date:08/17/01ISR Number: 3780184-9Report Type:Expedited (15-DaCompany Report #01-08-0437 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL ORAL Professional Date:08/17/01ISR Number: 3780185-0Report Type:Expedited (15-DaCompany Report #01-08-0438 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 200MG ORAL Professional Date:08/17/01ISR Number: 3780188-6Report Type:Expedited (15-DaCompany Report #01-08-0439 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL ORAL Professional Date:08/17/01ISR Number: 3780190-4Report Type:Expedited (15-DaCompany Report #01-08-0440 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiomyopathy Health Clozapine PS Zenith Goldline ORAL 100-300MG Professional ORAL Prozac C 22-Feb-2006 08:30 AM Page: 1228 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/17/01ISR Number: 3780192-8Report Type:Expedited (15-DaCompany Report #01-08-0441 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Malaise Health Clozapine PS Zenith Goldline ORAL 500MG ORAL Initial or Prolonged Post Procedural Professional Complication Date:08/17/01ISR Number: 3780194-1Report Type:Expedited (15-DaCompany Report #01-08-0442 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Fall Health Clozapine PS Zenith Goldline ORAL 150-300MG Head Injury Professional ORAL Injury Asphyxiation Date:08/17/01ISR Number: 3780195-3Report Type:Expedited (15-DaCompany Report #01-08-0445 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hiv Test Positive Health Clozapine PS Zenith Goldline ORAL 100MG ORAL Professional Date:08/17/01ISR Number: 3780199-0Report Type:Expedited (15-DaCompany Report #01-08-0450 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 25-50MG ORAL Professional Date:08/17/01ISR Number: 3780341-1Report Type:Expedited (15-DaCompany Report #PHBS2001AU06140 Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiomyopathy Foreign Clozaril PS Novartis Health Pharmaceuticals Corp ORAL 300 MG/D, Professional ORAL Other Thiamine C Multivitamins (Panthenol, Retinol, Asocrbic Acid) C Diazepam C Efexor - Slow Release (Venlafaxine Hydrochloride) C Date:08/17/01ISR Number: 3780373-3Report Type:Expedited (15-DaCompany Report #01-07-0372 Age:64 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 25MG QHS ORAL Professional 22-Feb-2006 08:30 AM Page: 1229 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/17/01ISR Number: 3780374-5Report Type:Expedited (15-DaCompany Report #01-07-0360 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Renal Failure Health Clozapine PS Zenith Goldline ORAL 300MG QD ORAL Professional Date:08/17/01ISR Number: 3780376-9Report Type:Expedited (15-DaCompany Report #01-06-0316 Age:76 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline ORAL 31.2-37.5MG Q Professional ORAL Date:08/17/01ISR Number: 3781224-3Report Type:Expedited (15-DaCompany Report #PHBS2001CA03982 Age:53 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Foreign Clozaril PS Novartis Hospitalization - Encephalitis Study Pharmaceuticals Corp ORAL 200 MG/D, Initial or Prolonged Epilepsy Health ORAL Professional Ativan (Lorazepam) SS Other Manerix (Moclobemide) C Carbolith C Depakene C Folvite C Synthroid C Date:08/20/01ISR Number: 3780608-7Report Type:Expedited (15-DaCompany Report #PHFR2000GB00586 Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abscess Foreign Clozaril PS Novartis Hospitalization - Diabetes Mellitus Health Pharmaceuticals Corp ORAL 250 MG/DAY , Initial or Prolonged Non-Insulin-Dependent Professional ORAL Pancreatic Disorder Other Metformin Pancreatitis Acute (Metformin) C Lactulose C Clozaril (Clozapine) (Clozapine) C Date:08/20/01ISR Number: 3780615-4Report Type:Expedited (15-DaCompany Report #PHBS2001CH08233 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiomyopathy Foreign Clozaril PS Novartis Initial or Prolonged Ejection Fraction Health Pharmaceuticals Corp ORAL 550 MG/DAY, Abnormal Professional ORAL Other Tegretol C Date:08/22/01ISR Number: 3782015-XReport Type:Expedited (15-DaCompany Report #PHFR2001GB02009 Age:22 YR Gender:Female I/FU:I Outcome PT Other Abortion Induced Complications Of Maternal 22-Feb-2006 08:30 AM Page: 1230 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Exposure To Therapeutic Drugs Report Source Product Role Manufacturer Route Dose Duration Foreign Clozaril (Clozapine) Health Tablet PS ORAL ORAL Professional Other Date:08/22/01ISR Number: 3782017-3Report Type:Expedited (15-DaCompany Report #PHBS2001AU08110 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiac Failure Foreign Clozaril (Clozapine Cardiomyopathy Study )Tablet PS ORAL 550MG/D, ORAL Myocarditis Health Professional Other Date:08/22/01ISR Number: 3782018-5Report Type:Expedited (15-DaCompany Report #PHFR2001GB02152 Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Atrioventricular Block Foreign Clozaril (Clozapine) Other Cardiac Arrest Study Tablet PS ORAL 900 MG DAY, Circulatory Collapse Health ORAL Coronary Artery Disease Professional Electrocardiogram Qt Other Prolonged Sudden Death Thrombosis Date:08/23/01ISR Number: 3782460-2Report Type:Expedited (15-DaCompany Report #2001UW05683 Age:39 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Condition Aggravated Health Seroquel "Zeneca" PS "Zeneca" ORAL 25 MG BID PO Intervention to Leukopenia Professional Seroquel "Zeneca" SS "Zeneca" 400 MG HS Prevent Permanent Schizophrenia Seroquel "Zeneca" SS "Zeneca" ORAL 500 MG HS PO Impairment/Damage Weight Increased Clozaril SS 300 MG DAILY Zyprexa C Iron Supplement C Klonopin C Date:08/23/01ISR Number: 3782535-8Report Type:Expedited (15-DaCompany Report #PHFR2001GB02084 Age:59 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Foreign Clozaril(Clozapine)T Initial or Prolonged Atrophy Health ablet PS ORAL 150MG/DAY, Cerebrovascular Accident Professional ORAL Nervous System Disorder Other Sertraline(Sertralin e) C 22-Feb-2006 08:30 AM Page: 1231 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/23/01ISR Number: 3782537-1Report Type:Expedited (15-DaCompany Report #PHFR2001GB02328 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozapine(Clozapine) Non-Insulin-Dependent Health Tablet PS ORAL 700MG/DAY, Professional ORAL Other Haloperidol C Lorazepam C Date:08/23/01ISR Number: 3782577-2Report Type:Expedited (15-DaCompany Report #PHEH2001US05412 Age:41 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Ankle Fracture Health Clozaril (Clozapine) Other Cardiac Disorder Professional Tablet PS ORAL 650MG DAILY Embolism ORAL Date:08/23/01ISR Number: 3783033-8Report Type:Expedited (15-DaCompany Report #C2001-2299.01 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 900 MG QD, Other ORAL Date:08/24/01ISR Number: 3782830-2Report Type:Expedited (15-DaCompany Report #PHBS2001SE08369 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Foreign Clozapine Initial or Prolonged Confusional State Literature (Clozapine) PS 150 MG/DAY 18 DAY Dermatitis Other Risperidone Influenza Like Illness (Risperidone0 C Left Ventricular Failure Buspirone Tachycardia (Buspirone) C Thrombosis Sertraline Vomiting (Sertraline) C Alimemazine (Alimemazine) C Chlorprothixene (Chlorprothiaxene) C Date:08/24/01ISR Number: 3782838-7Report Type:Expedited (15-DaCompany Report #PHBS2001SE08368 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrioventricular Block Foreign Clozapine Initial or Prolonged Second Degree Literature (Clozapine) PS 300 MG/DAY 14 DAY Dyspnoea Other Hypoxia Influenza Like Illness Left Ventricular Failure Pericardial Effusion 22-Feb-2006 08:30 AM Page: 1232 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/24/01ISR Number: 3783024-7Report Type:Expedited (15-DaCompany Report #PHFR2001GB02329 Age:80 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Overdose Foreign Clozaril (Clozapine) PS ORAL 350MG/ONCE/SI Agitation Health NGLE/ORAL Bronchopneumonia Professional Dorzolamide Coronary Artery Disease Other (Dorzolamide) C Emphysema Betoptic (Betaxolol Loss Of Consciousness Hydrochloride) C Medication Error Citalopram Oxygen Saturation (Citalopram) C Decreased Senna (Senna) C Restlessness Aspirine C Sedation Temazepam C Tachycardia Date:08/24/01ISR Number: 3783025-9Report Type:Expedited (15-DaCompany Report #PHBS2001SE08370 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocarditis Foreign Clozapine Vomiting Literature (Clozapine) PS 600 MG/DAY 183 DAY Other Date:08/27/01ISR Number: 3783514-7Report Type:Expedited (15-DaCompany Report #PHFR2001GB02347 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Foreign Clozaril (Clozapine) Phosphokinase Increased Health Unknown PS ORAL ORAL Blood Creatinine Professional Increased Other Blood Potassium Decreased Blood Sodium Decreased Blood Urea Increased C-Reactive Protein Increased Diarrhoea Electrolyte Imbalance Vomiting Date:08/27/01ISR Number: 3783517-2Report Type:Expedited (15-DaCompany Report #PHNU2001DE01721 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cholecystitis Foreign Leponex/Clozaril Liver Function Test Health (Clozapine) Tablet PS ORAL SEE IMAGE Abnormal Professional Pyrexia Other Tachycardia Weight Increased 22-Feb-2006 08:30 AM Page: 1233 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/27/01ISR Number: 3783521-4Report Type:Expedited (15-DaCompany Report #PHRM2001FR01882 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Brain Abscess Foreign Leponex (Clozapine) Consumer Tablet PS ORAL 100 MG/DAY Other ORAL 1460 DAY Date:08/27/01ISR Number: 3783531-7Report Type:Expedited (15-DaCompany Report #PHHO2001JP06538 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Clex Initial or Prolonged Obsessive-Compulsive Study (Leponex/Clozaril Disorder Health (Clozapine) Lex+) PS 250 MG PER Professional DAY Other Date:08/27/01ISR Number: 3783561-5Report Type:Expedited (15-DaCompany Report #PHFR2001GB02143 Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Embolism Foreign Clozaril (Clozapine) Initial or Prolonged Haemoptysis Health Tablet PS ORAL 350 MG, QD, Pulmonary Embolism Professional ORAL Other Anticoagulants (Anticoagulants) C Fluoxetine (Fluoxetine) C Benzatropine (Benzatropine) C Omeprazole (Omeprazole) C Date:08/27/01ISR Number: 3783580-9Report Type:Expedited (15-DaCompany Report #PHFR2001GB02041 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Foreign Clozaril (Clozapine) Initial or Prolonged Enuresis Health Tablet PS ORAL 400 MG/DAY, Hyperglycaemia Professional ORAL Ketonuria Other Quetiapine Obesity (Quetiapine) C Paroxetine (Paroxetine) C Valproate Sodium C Procyclidine (Procyclidine) C Date:08/27/01ISR Number: 3783582-2Report Type:Expedited (15-DaCompany Report #PHNU2001DE00768 Age:42 YR Gender:Female I/FU:F Outcome PT Hospitalization - Acute Febrile Initial or Prolonged Neutrophilic Dermatosis Bundle Branch Block Right Convulsion Dermatitis 22-Feb-2006 08:30 AM Page: 1234 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Disturbance In Attention Duodenitis Enteritis Report Source Product Role Manufacturer Route Dose Duration Gastritis Foreign Leponex/Clozaril Granuloma Health (Clozapine) Hepatic Steatosis Professional (Clozapine) Tablet PS ORAL ORAL Hepatitis Other Tavor C Hepatomegaly Pantozol Hypervigilance (Pantoprazole Lymphadenopathy Sodium) Tablet C Mental Disorder Beloc-Zoc Mite Neuroleptic Malignant (Metoprolol Syndrome Succinate) Slow Paresis Release Tablet C Polyserositis Truxal Pyrexia (Chlorprothixene Splenomegaly Hydrochloride) C Systemic Lupus Voltaren (Diclofenac Erythematosus Sodium) Suppository C Thrombocythaemia Date:08/27/01ISR Number: 3783585-8Report Type:Expedited (15-DaCompany Report #PHRM2001FR01873 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Chronic Lymphocytic Foreign Leponex (Clozapine) Leukaemia Health Tablet PS ORAL 600 MG/DAY, Professional ORAL Other Anafranil (Clomipramine Hydrochloride) Tablet SS ORAL 10 MG/DAY, ORAL Ephynal (Tocopheryl Acetate) Tablet SS ORAL 300 MG/DAY, ORAL Rivotril (Clonazepam) Tablet SS ORAL 2 MG/DAY, ORAL Xanax (Alprazolam) Tablet SS ORAL 0.75 MG/DAY, ORAL Athymil Tablet (Mianserin Hydrochloride) Tablet SS ORAL 60 MG/DAY, ORAL Date:08/27/01ISR Number: 3783586-XReport Type:Expedited (15-DaCompany Report #PHFR2001GB02145 Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Decreased Foreign Clozaril (Clozapine) Initial or Prolonged Circulatory Collapse Health Tablet PS ORAL 700 MG/DAY, Confusional State Professional ORAL (SEE Dysarthria Other IMAGE) 1483 DAY Overdose Alcohol (Ethanol) SS 1483 DAY Transient Ischaemic Bendrofluazide Attack (Bendroflumethiazide 22-Feb-2006 08:30 AM Page: 1235 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ) C Date:08/27/01ISR Number: 3783848-6Report Type:Expedited (15-DaCompany Report #PHFR2001GB02344 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Increased Foreign Clozaril (Clozapine) Initial or Prolonged Cold Sweat Health Tablet PS ORAL 75 MG/DAY, Dyspnoea Professional ORAL Hyperhidrosis Other Halopidol C Respiratory Depression Lorazepam C Respiratory Rate Hyoscine (Hyoscine) C Increased Date:08/28/01ISR Number: 3784129-7Report Type:Expedited (15-DaCompany Report #01-08-0452 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neoplasm Malignant Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 150-250 MG ORAL Date:08/28/01ISR Number: 3784130-3Report Type:Expedited (15-DaCompany Report #01-08-0455 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Medication Error Health Clozapine - Zenith Neoplasm Malignant Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 700-800 MG ORAL Date:08/28/01ISR Number: 3784131-5Report Type:Expedited (15-DaCompany Report #01-08-0454 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Leukopenia Health Clozapine - Zenith Other Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 900 MG ORAL Date:08/28/01ISR Number: 3784132-7Report Type:Expedited (15-DaCompany Report #01-08-0453 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Heat Stroke Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 600 MG ORAL 22-Feb-2006 08:30 AM Page: 1236 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/28/01ISR Number: 3784983-9Report Type:Direct Company Report # Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutropenia Clozapine PS Initial or Prolonged Date:08/29/01ISR Number: 3785068-8Report Type:Expedited (15-DaCompany Report #PHEH2001US07032 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Breast Cancer Female Health Clozaril (Clozapine) Initial or Prolonged White Blood Cell Count Professional Tablet PS ORAL 100 MG AM + Decreased 200 MG HS, ORAL Chemotherapeutics, Other (Chemotherapeutics, Other) SS Risperdal (Risperidone) C Paxil C Benadryl C Klonopin C Ddavp (Desmopressin) C Calcium C Colace C Date:08/29/01ISR Number: 3785358-9Report Type:Expedited (15-DaCompany Report #2001069191FR Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Lymphocytic Leukaemia Foreign Xanax (Alprazolam) Hospitalization - Health Tablet, 0.25 Mg PS ORAL ORAL Initial or Prolonged Professional Leponex "Novartis" (Clozapine) 100 Mg SS ORAL ORAL Ephynal (Tocopheryl Acetate) SS ORAL ORAL 1038 DAY Rivotril (Clonazepam) 2 Mg SS ORAL ORAL Anafranil (Clomipramine Hydrochloride) 10mg SS ORAL ORAL 1038 DAY Athymil Mianserin Hydrochloride) 60 Mg SS ORAL ORAL 1038 DAY Date:08/29/01ISR Number: 3785627-2Report Type:Expedited (15-DaCompany Report #01-08-0425 Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Heat Stroke Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS ORAL 400 MG HS ORAL Celexa Tablets SS ORAL 20MG QD ORAL Benztropine Mesylate C 22-Feb-2006 08:30 AM Page: 1237 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/29/01ISR Number: 3785629-6Report Type:Expedited (15-DaCompany Report #01-07-0400 Age:71 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS ORAL 25 MG QD ORAL Date:08/29/01ISR Number: 3785631-4Report Type:Expedited (15-DaCompany Report #01-07-0399 Age:22 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Health Clozapine - Zenith Decreased Professional Goldline Pharm. Tablets PS ORAL 200-400 MG QD ORAL Combivir C Date:08/29/01ISR Number: 3785632-6Report Type:Expedited (15-DaCompany Report #01-07-0402 Age:43 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Neoplasm Malignant Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS ORAL 100-500MG QD ORAL Lorazepam C Risperdal C Remeron C Date:08/29/01ISR Number: 3785633-8Report Type:Expedited (15-DaCompany Report #01-07-0376 Age:46 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS ORAL 350-400MG QD ORAL Paxil C Wellbutrin C Date:08/29/01ISR Number: 3785635-1Report Type:Expedited (15-DaCompany Report #01-07-0371 Age:88 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS ORAL 6.25MG HS ORAL Synthroid C Dyazide C Adalat Sa C Digoxin C Amantadine C Xanax C Vitamin B12 C Ferrous Sulfate C 22-Feb-2006 08:30 AM Page: 1238 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/29/01ISR Number: 3785636-3Report Type:Expedited (15-DaCompany Report #01-03-0121 Age:24 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiomyopathy Health Clozapine - Zenith Circulatory Collapse Professional Goldline Pharm. Sudden Death Tablets PS ORAL 100-300MG QD ORAL Prozac C Prozac C Methylphenidate Sr C Methylphenidate Sr C Date:08/29/01ISR Number: 3785714-9Report Type:Expedited (15-DaCompany Report #PHFR2001GB00642 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Anxiety Foreign Clozaril (Clozapine) Panic Attack Health Tablet PS ORAL 225 Professional MG/DAY,ORAL Other Date:08/29/01ISR Number: 3786186-0Report Type:Expedited (15-DaCompany Report #C2001-2545.01 Age:77 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 75 MG QD, Other ORAL Carbidopa/Levodopa C Cefazolin Injection C Ceftriazone Injection C Gemtamicin Injection C Hyoscyamine C Lorazepam C Morphine Injection C Ropinirole C Date:08/31/01ISR Number: 3786128-8Report Type:Expedited (15-DaCompany Report #266414 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Chronic Lymphocytic Rivotril PS Roche Leukaemia Ephynal SS Roche Leponex SS 1038 DAY Xanax SS Anafranil SS Athymil SS Date:08/31/01ISR Number: 3786757-1Report Type:Expedited (15-DaCompany Report #LACT00301003614 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Foreign Duphalac (3 Bags/ Initial or Prolonged Drug Ineffective Other Twice A Week) (Lactulose) PS ORAL DAILY PO Leponex (Clonzapine) SS ORAL 400 MG DAILY 22-Feb-2006 08:30 AM Page: 1239 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report PO, 300 MG DAILY PO Nozinan (Levomepromazine) SS ORAL 100 GT DAILY PO Loxapac (Loxapine Succinate) SS INTRAMUSCULAR 6 DF DAILY IM Date:08/31/01ISR Number: 3786776-5Report Type:Expedited (15-DaCompany Report #A001-002-004850 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Aricept (Donepezil) PS ORAL PER ORAL Life-Threatening Cerebrovascular Accident Health Clozapine Coma Professional (Clozapine) SS ORAL PER ORAL Dysphagia Amitriptyline Hypotension (Amitriptyline) C Pneumonia Aspiration Atropine (Atropine) C Gabapentin (Gabapentin) C Date:08/31/01ISR Number: 3787006-0Report Type:Expedited (15-DaCompany Report #01-06-0331 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine - Zenit Professional Goldline Pharm. Tablets PS ORAL 125-200 MG QD ORAL Buspar C Date:08/31/01ISR Number: 3787007-2Report Type:Expedited (15-DaCompany Report #00-10-0539 Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ascites Health Clozapine - Zenit Initial or Prolonged Cardiac Tamponade Professional Coldline Pharm. Other Haemorrhage Tablets PS ORAL 50-900MG ORAL Required Left Ventricular Failure Ascorbic Acid C Intervention to Pericarditis Colace C Prevent Permanent Pleural Effusion Valproic Acid C Impairment/Damage Polyserositis Paxil C Vitamin E C Date:08/31/01ISR Number: 3787008-4Report Type:Expedited (15-DaCompany Report #01-08-0459 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Renal Impairment Health Clozapine-Zenith Other Professional Goldline Pharm. Tablets PS ORAL 700-500MG QD ORAL 22-Feb-2006 08:30 AM Page: 1240 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/31/01ISR Number: 3787161-2Report Type:Periodic Company Report #A116965 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Health Ziprasidone Po PS ORAL 160.00 MG Leukopenia Professional TOTAL:BID:ORA L Clozaril SS ORAL 150.00 MG TOTAL:DAILY:O RAL Loxitane SS Date:08/31/01ISR Number: 3787172-7Report Type:Periodic Company Report #A111235 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Health Ziprasidone Po PS Psychotic Disorder Professional Zyprexa SS Clozaril SS Date:08/31/01ISR Number: 3787228-9Report Type:Periodic Company Report #A116067 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Health Ziprasidone Po PS Insomnia Professional Clozaril SS Unevaluable Event Company Representative Date:08/31/01ISR Number: 3787697-4Report Type:Periodic Company Report #A110619 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Consumer Ziprasidone Po PS ORAL 40.00 MG Cough TOTAL:BID:ORA Depersonalisation L Drug Ineffective Zithromax Facial Palsy (Azithromycin) SS ORAL 500.00 MG Flushing TOTAL:DAILY:O Influenza Like Illness RAL Laboratory Test Abnormal Clozapine SS 100.00 MG Malaise TOTAL:BID Nausea Valium C Pharyngitis Prilosec Respiratory Disorder (Omeprazole) C Weight Decreased Vitamins C Date:08/31/01ISR Number: 3787724-4Report Type:Periodic Company Report #A110491 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Ineffective Consumer Ziprasidone Po PS ORAL ORAL Emotional Disorder Clozaril SS ORAL ORAL Hostility Schizophreniform Disorder 22-Feb-2006 08:30 AM Page: 1241 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/03/01ISR Number: 3787694-9Report Type:Expedited (15-DaCompany Report #01P-114-0110041-00 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acute Respiratory Foreign Valproic Acid Initial or Prolonged Distress Syndrome Literature (Depakene) (Valproic Ammonia Increased Health Acid) (Valproic Blood Creatinine Professional Acid) PS ORAL 500 MG, 2 IN Increased Other 1 D, PER ORAL Blood Glucose Increased Clozapine SS ORAL 450 MG, 1 IN Blood Ph Decreased 1 D , PER Blood Potassium Increased ORAL Blood Pressure Decreased Blood Sodium Decreased Blood Urea Increased Body Temperature Increased Carnitine Decreased Coma Diabetic Ketoacidosis Disseminated Intravascular Coagulation Drug Level Below Therapeutic Drug Toxicity Hyperammonaemia Ketonuria Tachycardia Tachypnoea Date:09/04/01ISR Number: 3787932-2Report Type:Expedited (15-DaCompany Report #C2001-1743.01 Age:83 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine Tablets Professional 100mg Mylan PS ORAL 100 MG Q 9AM Other AND 5 PM, ORAL Acetaminophen C Albutrol Inhalation Solution C Ceftriaxone Injection C Clnazepam C Dorzolamideq C Guaifenesin C Lamotrigine 25 Mg C Sorbitol C Venlafaxine C Levothyroxine C Mild Of Magnesia C Lorazepam C Mirtazapine C Date:09/04/01ISR Number: 3787937-1Report Type:Expedited (15-DaCompany Report #C2001-2477.01 Age:67 YR Gender:Male I/FU:I Outcome PT Report Source Death Death Health Professional 22-Feb-2006 08:30 AM Page: 1242 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Product Role Manufacturer Route Dose Duration Clozapine Tablets 100 Mg Mylan PS Mylan ORAL 100 MG, QD, ORAL Acetaminophen/Codein e C Albuterol Nebulizer C Albuterol/Ipratropiu m Inhalation C Ibuprofen C Lorazepam C Senna C Trihexyphenidyl C Vitamin C C Zinc C Date:09/04/01ISR Number: 3787938-3Report Type:Expedited (15-DaCompany Report #C2001-2465.01 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional 100 Mg Mylan PS ORAL 500 MG, QD, Other ORAL (POSSIBLE) Captopril C Digoxin C Risperidone C Date:09/04/01ISR Number: 3787939-5Report Type:Expedited (15-DaCompany Report #C2001-2466.01 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional Mylan PS ORAL 50MG, QD, Other ORAL Date:09/05/01ISR Number: 3788148-6Report Type:Expedited (15-DaCompany Report #PHBS2001CA08624 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Embolism Foreign Clozaril (Clozapine) Study Unknown PS Health Professional Other Date:09/05/01ISR Number: 3788560-5Report Type:Expedited (15-DaCompany Report #PHFR2001GB02414 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Breast Cancer Female Foreign Clozaril (Clozapine) Initial or Prolonged Health Tablet PS ORAL 300 MG/DAY, Professional ORAL Other 22-Feb-2006 08:30 AM Page: 1243 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/05/01ISR Number: 3788561-7Report Type:Expedited (15-DaCompany Report #PHFR2001GB00850 Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril (Clozapine) Health Tablet PS ORAL 400 MG/DAY, Professional ORAL Other Hyoscine (Hyoscine) C Thioridazine (Thioridazine) C Gliclazide (Gliclazide) C Pirenzepine (Pirenzepine) C Date:09/05/01ISR Number: 3788562-9Report Type:Expedited (15-DaCompany Report #PHBS2001AU07298 Age:23 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Foreign Clozaril (Clozapine) Phosphokinase Increased Study Tablet PS ORAL SEE IMAGE Dermatitis Health Neutrophil Count Professional Decreased Other Pharyngolaryngeal Pain Platelet Count Decreased Pyrexia Tachycardia Thrombocythaemia Thrombocytopenia White Blood Cell Count Decreased Date:09/05/01ISR Number: 3788571-XReport Type:Expedited (15-DaCompany Report #PHBS2001AU06735 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiomyopathy Foreign Clozaril (Clozapine) Chest Pain Health Tablet PS ORAL 550 MG, QD, Dyspnoea Professional ORAL Mental Impairment Other Suicidal Ideation Ventricular Hypertrophy Date:09/05/01ISR Number: 3788575-7Report Type:Expedited (15-DaCompany Report #PHRM2001FR01921 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Oesophagitis Foreign Leponex (Clozapine) Initial or Prolonged Ulcer Health Tablet PS ORAL 12.5 MG, QD, Professional ORAL Other Sinemet (Levodopa, Carbidopa) Tablet C Trandate (Labetalol Hydrochloride) Tablet C Sandocal "Novartis" (Sodium) C Laroxyl 22-Feb-2006 08:30 AM Page: 1244 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Amitriptyline Hydrochloride) Solution C Date:09/05/01ISR Number: 3788577-0Report Type:Expedited (15-DaCompany Report #PHFR2001GB02442 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Depression Foreign Leponex / Clozaril Sedation Health (Clozapine) PS ORAL 250 MG/NOCTE, Suicidal Ideation Professional ORAL Other Lamotrigine C Haldol C Date:09/05/01ISR Number: 3788588-5Report Type:Expedited (15-DaCompany Report #PHBS2001TR08656 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coma Foreign Clozapine (Clozapine PS 25 MG/D/400 Completed Suicide Literature MG/D 28 DAY Haemorrhage Health Loss Of Consciousness Professional Polytraumatism Other Salivary Hypersecretion Date:09/05/01ISR Number: 3788593-9Report Type:Expedited (15-DaCompany Report #PHFR2001GB02429 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril (Clozapine) Consumer Tablet PS ORAL ORAL Health Professional Other Date:09/05/01ISR Number: 3788646-5Report Type:Expedited (15-DaCompany Report #PHRM2001FR01882 Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Brain Abscess Foreign Leponex (Clozapine) Pneumococcal Infection Health Tablet PS ORAL 100 MG/DAY, Professional ORAL 1460 DAY Other Depamide (Valpromide) C Xanax (Alprazolam) C Date:09/05/01ISR Number: 3788652-0Report Type:Expedited (15-DaCompany Report #266414 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Chronic Lymphocytic Foreign Rivotril Leukaemia Other (Clonazepam) 2 Mg PS ORAL 2 MG DAILY ORAL Leponex (Clozapine) SS ORAL 600 MG DAILY ORAL Ephynal (Vitamin E) SS ORAL 3 DOSE FORM DAILY ORAL 22-Feb-2006 08:30 AM Page: 1245 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Xanax (Alprazolam) 0.25 Mg SS ORAL 0.75 MG DAILY ORAL Anafranil (Clomipramine Hydrochloride) 10 Mg SS ORAL 10 MG DAILY ORAL Athymil (Mianserin Hydrochloride) 60 Mg SS ORAL 60 MG DAILY ORAL Date:09/05/01ISR Number: 3788757-4Report Type:Expedited (15-DaCompany Report #01-08-0467 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets PS Zenith Goldline Professional Pharm. ORAL 400-500MG QD ORAL Date:09/05/01ISR Number: 3788771-9Report Type:Expedited (15-DaCompany Report #01-08-0465 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets PS Zenith Goldline Professional Pharm. ORAL 375-400MG QD ORAL Date:09/05/01ISR Number: 3788773-2Report Type:Expedited (15-DaCompany Report #01-08-0466 Age:82 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Condition Aggravated Health Clozapine Tablets PS Zenith Goldline Dementia Alzheimer'S Type Professional Pharm. ORAL ORAL Date:09/05/01ISR Number: 3788776-8Report Type:Expedited (15-DaCompany Report #01-08-0464 Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Brain Neoplasm Health Clozapine Tablets PS Zenith Goldline Professional Pharm. ORAL 275-375MG QD ORAL Date:09/05/01ISR Number: 3788779-3Report Type:Expedited (15-DaCompany Report #01-08-0468 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets PS Zenith Goldline Professional Pharm. ORAL 350-775 MG QD ORAL 22-Feb-2006 08:30 AM Page: 1246 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/05/01ISR Number: 3788783-5Report Type:Expedited (15-DaCompany Report #01-07-0361 Age:87 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cellulitis Health Clozapine Tablet PS Zenith Goldline Hospitalization - Chronic Lymphocytic Professional Pharm. ORAL 25-50MG QD Initial or Prolonged Leukaemia ORAL Condition Aggravated Levodopa-Carbidopa C Oedema Peripheral Lasix C Rash Generalised Prednisone C Date:09/05/01ISR Number: 3788788-4Report Type:Expedited (15-DaCompany Report #01-08-0441 Age:58 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coronary Artery Surgery Health Clozapine Tablets PS Zenith Goldline Initial or Prolonged Lower Respiratory Tract Professional Pharm. ORAL 500MG ORAL Infection Myocardial Infarction Date:09/05/01ISR Number: 3788791-4Report Type:Expedited (15-DaCompany Report #01-08-0422 Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dehydration Health Clozapine Tablets PS Zenith Goldline Heat Stroke Professional Pharm. ORAL 100-450MG QD ORAL Date:09/05/01ISR Number: 3788794-XReport Type:Expedited (15-DaCompany Report #01-08-0439 Age:60 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Heat Stroke Health Clozapine PS Zenith Goldline Professional Pharm. ORAL ORAL Date:09/05/01ISR Number: 3788797-5Report Type:Expedited (15-DaCompany Report #01-06-0326 Age:42 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Fall Health Clozapine PS Zenith Coldline Professional Pharm. ORAL 200-400MG QD ORAL Fluphenazine C Date:09/05/01ISR Number: 3788801-4Report Type:Expedited (15-DaCompany Report #01-07-0402 Age:43 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Neoplasm Malignant Health Clozapine PS Zenith Goldline Professional Pharm. ORAL 100-500MG QD ORAL Lorazepam C Risperdal C Remeron C 22-Feb-2006 08:30 AM Page: 1247 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/06/01ISR Number: 3788194-2Report Type:Direct Company Report # Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Urinary Incontinence Clozapine PS ORAL 450MG/DAY PO 2 YR Urinary Retention Depakote C Lithium Sr C Gemfibrozil C Fibercon C Calcium Carbonate C Date:09/06/01ISR Number: 3788847-6Report Type:Expedited (15-DaCompany Report #PHEH2001US06718 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Drooling Health Clozaril (Clozapine) Hospitalization - Hypoproteinaemia Professional Tablet 100 Mg PS ORAL SEE IMAGE 3194 DAY Initial or Prolonged Leukocytosis Prozac (Fluoxetine Pneumonia Hydrochloride) C Red Blood Cell Count Valium C Decreased Serax (Oxazepam) C Date:09/06/01ISR Number: 3788887-7Report Type:Expedited (15-DaCompany Report #PHEH2001US07273 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neoplasm Malignant Health Clozaril (Clozapine) Professional Tablet PS ORAL 900 MG, UNK, Company ORAL Representative Date:09/06/01ISR Number: 3789017-8Report Type:Expedited (15-DaCompany Report #PHEH2001US07245 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Road Traffic Accident Health Clozaril(Clozapine) Professional Tablet PS ORAL 700 MG, ORAL Date:09/06/01ISR Number: 3789027-0Report Type:Expedited (15-DaCompany Report #PHEH2001US05658 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) Professional Tablet PS ORAL 25 MG, ORAL Date:09/06/01ISR Number: 3789096-8Report Type:Expedited (15-DaCompany Report #PHEH2001US07261 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Fall Health Clozaril Head Injury Professional (Clozapine)Tablet PS ORAL 550MG, ORAL 22-Feb-2006 08:30 AM Page: 1248 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/06/01ISR Number: 3789393-6Report Type:Expedited (15-DaCompany Report #S01-FRA-01200-01 Age:31 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Clonic Convulsion Foreign Citalopram Initial or Prolonged Epilepsy Health (Citalopram Professional Hydrobromide) PS ORAL 20 MG QD PO Other Leponex (Clozapine) SS ORAL 400 MG QD PO Leponex (Clozapine) SS ORAL 400 MG QD PO Leponex (Clozapine) SS ORAL 300 MG QD PO Date:09/07/01ISR Number: 3789336-5Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Clozapine Zenith Initial or Prolonged Goldline PS Zenith Goldline ORAL 100 MG/TID/ORAL Zyprexa Eli Lilly SS Eli Lilly ORAL 20MG HS ORAL Date:09/07/01ISR Number: 3789488-7Report Type:Expedited (15-DaCompany Report #PHEH2001US05989 Age:52 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Health Clozaril (Clozapine) Initial or Prolonged Ovarian Cancer Professional Tablet PS ORAL 400MG HS, Other ORAL Chemotherapeutics,Ot her(Chemotherapeutic s,Other) SS Date:09/07/01ISR Number: 3789490-5Report Type:Expedited (15-DaCompany Report #PHEH2001US05977 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Health Clozaril (Clozapine Red Blood Cell Count Professional ) Tablet PS ORAL 350 MG, QD, Decreased ORAL:250 MG, Thrombocytopenia QD Ditropan (Oxybutynin) C Wellbutrin (Amfebutamone Hydrochloride) C Colace C Glucophage "Merck" C Glucotrol (Glipizide) C Humulin (Insulin Human) C Geodon (Ziprasidone Hydrochloride) C 22-Feb-2006 08:30 AM Page: 1249 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/07/01ISR Number: 3789806-XReport Type:Expedited (15-DaCompany Report #PHFR2000GB02023 Age:35 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Arrest Foreign Clozaril (Clozapine) Initial or Prolonged Cardiomegaly Health (Clozapine) Tablet PS ORAL 500 MG /DAY, Cardiomyopathy Professional ORAL Torsade De Pointes Other Ventricular Arrhythmia Date:09/11/01ISR Number: 3791011-8Report Type:Expedited (15-DaCompany Report #01-08-0471 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm ORAL 100-200MG QD ORAL Date:09/11/01ISR Number: 3791013-1Report Type:Expedited (15-DaCompany Report #01-08-0470 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm ORAL 400MG QD ORAL Date:09/11/01ISR Number: 3791016-7Report Type:Expedited (15-DaCompany Report #01-08-0480 Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Chronic Obstructive Health Clozapine - Zenith Hospitalization - Pulmonary Disease Professional Goldline Pharm. Initial or Prolonged Emphysema Tablets PS Zenith Goldline Pharm ORAL 75-300MG QD ORAL Date:09/11/01ISR Number: 3791018-0Report Type:Expedited (15-DaCompany Report #01-08-0469 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm ORAL 25 MG QD ORAL Date:09/11/01ISR Number: 3791020-9Report Type:Expedited (15-DaCompany Report #01-07-0409 Age:49 YR Gender:Female I/FU:I Outcome PT Required Confusional State Intervention to Disorientation Prevent Permanent Gait Disturbance Impairment/Damage Haematoma Haemorrhage 22-Feb-2006 08:30 AM Page: 1250 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hypertension Sedation Report Source Product Role Manufacturer Route Dose Duration Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 50 - 300MG ORAL Thorazine Tablets SS ORAL 200 MG HS ORAL, MONTHS Sinequan Capsules SS ORAL 100MG HS ORAL, MONTHS Bacitracin C Neomycin C Polymyxin B C Date:09/11/01ISR Number: 3791023-4Report Type:Expedited (15-DaCompany Report #C2001-2477.01 Age:67 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Aspiration Health Clozapine Tablets Professional 100 Mg Mylan PS ORAL 100 MG QD, Other ORAL Acetaminophen/Codein e C Albuterol Nebulizer C Albuterol/Pratropium Inhalation C Ibuprofen C Lorazepam C Senna C Trihexyphenidyl C Vitamin C C Zinc C Date:09/11/01ISR Number: 3791026-XReport Type:Expedited (15-DaCompany Report #C2001-2481.01 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg Mylan PS ORAL 50 MG QD, Other ORAL Clozapine Tablets 100mg Mylan SS ORAL 100 MG Q AM, 200 MG Q PM, THEN 100MG QD ORAL Albuterol Nebulizer C Alendronate C Chloral Hydrate C Docusate Sodium/Casanthranol C Ferrous Sulfate C Fluticasone Nasal Spray C Ipratropium Inhalation C Lansoprazole C Lorazepam C 22-Feb-2006 08:30 AM Page: 1251 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Methocarbamol C Prednisone C Propoxyphene Napsylate/Apap C Theophylline Er C Trazodone C Date:09/11/01ISR Number: 3791028-3Report Type:Expedited (15-DaCompany Report #C2001-2544.01 Age:78 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 25MG QD, ORAL Other Clozapine Tablets 100 Mg Mylan SS ORAL 100MG, QD, ORAL Date:09/11/01ISR Number: 3791033-7Report Type:Expedited (15-DaCompany Report #01-03-0121 Age:24 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiomyopathy Health Clozapine - Zenith Circulatory Collapse Professional Goldline Pharm. Toxicologic Test Abnormal Tablets PS ORAL 100-300 MG QD ORAL Prozac 10mg Qd C Prozac 20mg Qam C Methylphenidate Sr 10mg Qam C Methylphenidate Sr 10mg Qnoon C Date:09/11/01ISR Number: 3791034-9Report Type:Expedited (15-DaCompany Report #01-08-0438 Age:60 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS ORAL 200MG ORAL Date:09/11/01ISR Number: 3791035-0Report Type:Expedited (15-DaCompany Report #01-07-0401 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Neoplasm Malignant Health Clozapine- Zenith Metastases To Bone Professional Goldline Pharm. Tablets PS ORAL 550MG QD ORAL Benztropine Mesylate C Valproic Acid C Date:09/11/01ISR Number: 3791036-2Report Type:Expedited (15-DaCompany Report #01-08-0422 Age:28 YR Gender:Male I/FU:F Outcome PT Death Cardiac Arrest Dehydration 22-Feb-2006 08:30 AM Page: 1252 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Heat Stroke Report Source Product Role Manufacturer Route Dose Duration Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS ORAL 100-450MG QD ORAL Date:09/11/01ISR Number: 3791037-4Report Type:Expedited (15-DaCompany Report #01-08-0455 Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Lung Neoplasm Malignant Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Goldline Pharm. ORAL 700-800 MG ORAL Date:09/11/01ISR Number: 3791038-6Report Type:Expedited (15-DaCompany Report #01-09-0482 Age:71 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dementia Alzheimer'S Type Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Goldline Pharm. ORAL 62.5 - 150 MG ORAL Date:09/11/01ISR Number: 3791039-8Report Type:Expedited (15-DaCompany Report #01-08-0483 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Goldline Pharm ORAL ORAL Date:09/11/01ISR Number: 3791081-7Report Type:Expedited (15-DaCompany Report #C2001-1738.01 Age:56 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Health Clozapine Tablets Professional 100mg Mylan PS ORAL 650 MG DAILY, Other ORAL Benztropine C Conjugated Estrogens/Medroxypro gesterone C Divalproex C Doxepin C Ferrous Sulfate C Meclizine C Trihexyphenidyl C 22-Feb-2006 08:30 AM Page: 1253 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/11/01ISR Number: 3791086-6Report Type:Expedited (15-DaCompany Report #C2001-2483.01 Age:73 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Parkinson'S Disease Health Clozapine Tablets Professional Mylan PS ORAL 50 MG QD, Other ORAL Date:09/11/01ISR Number: 3791087-8Report Type:Expedited (15-DaCompany Report #C2001-1736.01 Age:91 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Clozapine Tablets Other Respiratory Failure Professional 100 Mg Mylan PS ORAL 100 MG BID, Other ORAL Novolin R C Atenolol C Furosemide C Glipizide Xl C Lorazepam C Nitroglycerin Transdermal System Patches C Potassium Chloride C Trazodone C Date:09/11/01ISR Number: 3791153-7Report Type:Expedited (15-DaCompany Report #01P-028-0110494-00 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Foreign Biaxin Initial or Prolonged Pericardial Effusion Health (Clarithromycin) PS ORAL 1 IN 1 D, PER Pericarditis Professional ORAL Clozapine SS Haloperidol C Date:09/11/01ISR Number: 3791220-8Report Type:Expedited (15-DaCompany Report #PHHO02001JP06538 Age:21 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Foreign Clex (Leponex / Initial or Prolonged Condition Aggravated Study Clozaril (Clozapine) Crying Health Lex +) Clex(Clex) Obsessive-Compulsive Professional Unknown PS 250 MG PER Disorder Other DAY Rohypnol (Flunitrazepam) C Date:09/11/01ISR Number: 3791446-3Report Type:Expedited (15-DaCompany Report #PHFR2001GB02438 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Foreign Clozaril(Clozapine) Grand Mal Convulsion Health Tablet PS ORAL 262.5MG/DAY, Obsessive-Compulsive Professional ORAL Disorder Other Tic 22-Feb-2006 08:30 AM Page: 1254 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/11/01ISR Number: 3791452-9Report Type:Expedited (15-DaCompany Report #PHBS2001AU08110 Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiac Failure Foreign Clozaril (Clozapine) Cardiomyopathy Study Tablet PS ORAL 550 MG/D, Mental Impairment Health ORAL Professional Other Date:09/11/01ISR Number: 3791467-0Report Type:Expedited (15-DaCompany Report #PHFR2001GB02152 Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Atrioventricular Block Foreign Clozaril (Clozapine) Cardiac Arrest Study Tablet PS ORAL 900 MG DAY/ Circulatory Collapse Health ORAL Coronary Artery Disease Professional Clozaril SS ORAL 800 MG DAY/ Electrocardiogram Qt Other ORAL Prolonged Sudden Death Thrombosis Date:09/11/01ISR Number: 3791534-1Report Type:Expedited (15-DaCompany Report #PHFR2001GB02009 Age:22 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abortion Induced Foreign Clozaril (Clozapine) Complications Of Maternal Health Tablet PS ORAL ORAL Exposure To Therapeutic Professional Drugs Other Date:09/12/01ISR Number: 3790922-7Report Type:Direct Company Report # Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abnormal Behaviour Clozaril PS ORAL CLOZARIL/ Hospitalization - Blood Creatine Increased DAILY/ ORAL Initial or Prolonged Blood Electrolytes Required Increased Intervention to Blood Glucose Increased Prevent Permanent Blood Sodium Increased Impairment/Damage Confusional State Drug Toxicity Mental Disorder Pyrexia Tremor Date:09/12/01ISR Number: 3791941-7Report Type:Direct Company Report # Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Clozapine 100 Mg Initial or Prolonged Zenith Goldline PS Zenith Goldline ORAL 100 MG PO BID + 300 QHS Buspirone C Lithium C 22-Feb-2006 08:30 AM Page: 1255 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/12/01ISR Number: 3792206-XReport Type:Expedited (15-DaCompany Report #PHBS2001AU07298 Age:23 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Foreign Clozaril (Clozapine) Phosphokinase Increased Study Tablet PS ORAL SEE IMAGE Cardiac Enzymes Increased Health Dermatitis Professional Neutrophil Count Other Decreased Pharyngolaryngeal Pain Pyrexia Tachycardia Thrombocythaemia Thrombocytopenia Upper Respiratory Tract Infection White Blood Cell Count Decreased Date:09/12/01ISR Number: 3792439-2Report Type:Expedited (15-DaCompany Report #PHFR2001GB02347 Age:62 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Clozaril (Clozapine) PS ORAL ORAL Initial or Prolonged Phosphokinase Increased Health Other Blood Creatinine Professional Increased Other Blood Potassium Decreased Blood Sodium Decreased Blood Urea Increased C-Reactive Protein Increased Diarrhoea Hepatitis Renal Impairment Vomiting Date:09/12/01ISR Number: 3792493-8Report Type:Expedited (15-DaCompany Report #PHBS2001CH08916 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Foreign Leponex (Clozapine) Bronchitis Health Unknown PS Cardiac Arrest Professional Entumin (Clotiapine) Respiratory Failure Other Unknown SS Lorazepam (Lorazepam) SS Promazine (Promazine) SS Midazolam (Midazolam) SS Olanzapine (Olanzapine) SS Seretide (Salmeterol, Fluticasone Propionate) C Serevent (Salmeterol Xinafoate) C 22-Feb-2006 08:30 AM Page: 1256 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Amoxicillin (Amoxicillin) C Clavulanic Acid (Clavulanic Acid) C Clarithromycin (Clarithromycin) C Prednisolone C Tienam (Imipenem, Cilastatin) C Morphine (Morhpine) C Haloperidol C Date:09/12/01ISR Number: 3792495-1Report Type:Expedited (15-DaCompany Report #PHBS2001ZA08871 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Phlebitis Foreign Leponex (Clozapine) Splenomegaly Health Tablet PS ORAL 37.5 MG, ORAL White Blood Cell Count Professional Efexor (Venlafaxine Decreased Other Hydrochloride) C Epilim C Date:09/13/01ISR Number: 3792745-1Report Type:Expedited (15-DaCompany Report #HQ5788410SEP2001 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Foreign Temesta (Lorazepam, Constipation Health Unspec) PS 2.5-5 MG Ileus Paralytic Professional DAILY Other Haldol (Haloperidol, ) SS 10 MG 10 DAY Haldol (Haloperidol, ) SS 15 MG 76 DAY Haldol (Haloperidol, ) SS 5 MG 3 DAY Haldol (Haloperidol, ) SS 20 MG 5 DAY Leponex "Novartis" (Clozapine, ) SS 200 MG 10 DAY Leponex "Novartis" (Clozapine, ) SS 250 MG 10 DAY Leponex "Novartis" (Clozapine, ) SS 125 MG 7 DAY Leponex "Novartis" (Clozapine, ) SS 150 MG 3 DAY Haldol (Haloperidol, ) SS 12.5 MG 6 DAY .. C ... C Duphalac (Lactulose) C Clopixol (Zuclophenthixol Decanoate) C Augmentin (Amoxicillin Sodium/Clavulanate Potassium) C Vioxx (Rofecoxib) C Risperdal 22-Feb-2006 08:30 AM Page: 1257 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Risperidone) C Zyprexa (Olanzapine) C ... C .. C ... C Date:09/13/01ISR Number: 3793063-8Report Type:Expedited (15-DaCompany Report #C2001-2632.01 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Health Clozapine Tablets Depressed Mood Professional 100 Mg Mylan PS Mylan ORAL 600 MG QD, Dizziness Other ORAL Fall Possibly Diltiazem C Vomiting Date:09/13/01ISR Number: 3793065-1Report Type:Expedited (15-DaCompany Report #C2001-2633.01 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 450 MG QD, Other ORAL Bupropion Sr C Benztropine C Metformin C Glipizide Xl C Hctz C Date:09/13/01ISR Number: 3793066-3Report Type:Expedited (15-DaCompany Report #C2001-1747.01 Age:74 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 100 MG Q AM & Other 150 MG Q HS, ORAL Clonazepam C Date:09/14/01ISR Number: 3793342-4Report Type:Expedited (15-DaCompany Report #01-08-0452 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Laryngeal Cancer Health Clozapine - Zenith Metastases To Lymph Nodes Professional Goldline Phar. Tablets PS Zenith Goldline Pharm. ORAL 150-250MG ORAL Date:09/14/01ISR Number: 3793343-6Report Type:Expedited (15-DaCompany Report #01-08-0441 Age:58 YR Gender:Male I/FU:F Outcome PT Hospitalization - Lower Respiratory Tract Initial or Prolonged Infection Myocardial Infarction Post Procedural 22-Feb-2006 08:30 AM Page: 1258 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Complication Report Source Product Role Manufacturer Route Dose Duration Health Clozapine - PS Zenith Goldline Professional Phaarm ORAL 500MG ORAL B-Plex C Loperamide Hydrochloride C Acetaminophen C Penicillin V-K C Berocca C Acetaminophen W/Codeine C Cimetidine C Benztropine Mesylate C Depakote C Clozaril C Date:09/14/01ISR Number: 3793344-8Report Type:Expedited (15-DaCompany Report #01-08-0454 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Leukopenia Health Clozapine - Zenith Intervention to Professional Goldline Phar. Prevent Permanent Tablets PS ORAL 900MG ORAL Impairment/Damage Gleevec Capsules SS ORAL 2 CAPSULES QD ORAL Cogentin 1mg Qd C Restorial 30mg Hs Prn For Sleep C Neurontin 400mg Hs C Zyprexa 20mg C Prevacid 30mg C Zoloft 50mg Qd C Date:09/14/01ISR Number: 3793345-XReport Type:Expedited (15-DaCompany Report #01-08-0454 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Leukopenia Health Clozapine PS Zenith Goldline Intervention to Professional Pharm. ORAL 900MG ORAL Prevent Permanent Cogentin 1mg Qd C Impairment/Damage Restorial 30mg Hs Prn C Neurontin 400mg C Zyprexa 20mg C Prevacid 30mg C Zoloft 100mg C Date:09/14/01ISR Number: 3793347-3Report Type:Expedited (15-DaCompany Report #01-08-0485 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline Professional Pharm ORAL 225MG QD ORAL 22-Feb-2006 08:30 AM Page: 1259 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/14/01ISR Number: 3793760-4Report Type:Expedited (15-DaCompany Report #HQ5787410SEP2001 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Health Temesta (Lorazepam, Increased Professional Tablet) PS UP TO 5 MG Aspartate DAILY 48 DAY Aminotransferase Leponex "Novartis" Increased (Clozapine) SS Novartis 25 MG 19 DAY Blood Alkaline Lithiofor (Potassium Phosphatase Increased Sulfate) C Blood Creatine Doryl (Carbachol) C Phosphokinase Increased Lithium (Lithium) C Blood Creatinine Zyprexa (Olanzapine) C Increased Tenormin (Atenolol) C C-Reactive Protein Imovane (Zopiclone) C Increased Gamma-Glutamyltransferase Increased Urinary Retention Date:09/14/01ISR Number: 3793780-XReport Type:Expedited (15-DaCompany Report #PHBS2001FI08995 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiomyopathy Foreign Leponex (Clozapine) Initial or Prolonged Health Tablet PS ORAL 175 MG/D, Professional ORAL Other Date:09/14/01ISR Number: 3793865-8Report Type:Expedited (15-DaCompany Report #PHBS2001CH08915 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Depression Foreign Clozaril Drug Interaction Health (Clozapine)Tablet PS ORAL 100 MG/D, Obsessive-Compulsive Professional ORAL Disorder Other Risperdal (Risperidone) SS ORAL 8 MG/D, ORAL Date:09/14/01ISR Number: 3793867-1Report Type:Expedited (15-DaCompany Report #PHBS2001AU08936 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Lymphoma Foreign Clozaril Health (Clozapine)Tablet PS ORAL ORAL Professional Other Date:09/14/01ISR Number: 3794140-8Report Type:Expedited (15-DaCompany Report #PHFR2001GB02195 Age:33 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Foreign Clozaril (Clozapine) Blood Prolactin Increased Health Tablet PS ORAL 125 MG/DAY, Professional ORAL Gaviscon (Sodium Alginate) C 22-Feb-2006 08:30 AM Page: 1260 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Chlordiazepoxide (Chlordiazepoxide) C Valproate Sodium C Dothiepin (Dosulepin) C Amitriptyline (Amitriptyline) C Date:09/14/01ISR Number: 3794142-1Report Type:Expedited (15-DaCompany Report #PHBS2001CA08203 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Lung Abscess Foreign Clozaril (Clozapine) Initial or Prolonged Pneumonia Health Tablet PS ORAL ORAL Respiratory Distress Professional Clonazepam C White Blood Cell Count Increased Date:09/14/01ISR Number: 3794258-XReport Type:Expedited (15-DaCompany Report #PHEH2000US09015 Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Germ Cell Cancer Health Clozaril (Clozapine) Metastases To Lung Professional Tablet PS ORAL 450 MG, QD, ORAL Remeron (Mirtazapine) C Depakote (Valproate Semisodium) C Multivitamins (Panthenol, Retionl, Ascorbic Acid) C Date:09/14/01ISR Number: 3794263-3Report Type:Expedited (15-DaCompany Report #PHEH2001US07418 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozaril(Clozapine) Professional Tablet PS ORAL 900 MG, ORAL Date:09/17/01ISR Number: 3794046-4Report Type:Direct Company Report # Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Distension Clozaril 100 Mg Initial or Prolonged Novartis PS Novartis ORAL 200 MG BID ORAL Clozaril 100 Mg Novartis SS ORAL 200 MG HS ORAL Ranitidine C Sertraline C Phenytoin C Olanzapine C Gabapentin C Clonazepam C 22-Feb-2006 08:30 AM Page: 1261 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/17/01ISR Number: 3794118-4Report Type:Direct Company Report # Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Loss Of Consciousness Clozapine PS ORAL 550 MG PO HS Initial or Prolonged Mental Impairment CHRONIC Sedation Citalopram C Date:09/17/01ISR Number: 3794151-2Report Type:Expedited (15-DaCompany Report #PHEH2001US06438 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Health Clozaril (Clozapine) Neutropenia Professional Tablet PS ORAL 400MG /300MG/200MG/ DAILY, ORAL 1457 DAY Depakote (Valproate Semisodium) C Haldol C Cogentin (Benzatropine Mesilate) C Ativan C Dilantin C Ddavp (Desmopressin) C Asa C Allegra (Fexofenadine Hydrochloride) C Ranitidine (Ranitidine) C Metamucil (Psyllium Hydrophilic Mucilloid) C Lactulose C Date:09/17/01ISR Number: 3794154-8Report Type:Expedited (15-DaCompany Report #PHEH2001US07518 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozaril (Clozapine) Professional Tablet PS ORAL ORAL Date:09/17/01ISR Number: 3794246-3Report Type:Expedited (15-DaCompany Report #S01-USA-01744-01 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Heat Stroke Health Celexa (Citalopram Professional Hydrobromide) PS ORAL 20 MG QD PO Clozapine SS ORAL 400 MG QD PO Benztropine (Benztropine Mesylate) C 22-Feb-2006 08:30 AM Page: 1262 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/17/01ISR Number: 3794503-0Report Type:Expedited (15-DaCompany Report #PHFR2001GB02217 Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cholelithiasis Foreign Clozaril(Clozapine) Initial or Prolonged Health Tablet PS ORAL 275 MG/DAY, Professional ORAL Other Date:09/17/01ISR Number: 3794837-XReport Type:Expedited (15-DaCompany Report #C2001-2714.01 Age:83 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 25MG, QD, Other THEN 12.5MG QD, ORAL Bisacodyl Supopositories (Pm) C Cetrizine C Hydrocortisone Ointment (Prn) C Date:09/17/01ISR Number: 3795685-7Report Type:Expedited (15-DaCompany Report #PHBS2001AU08969 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chest Pain Foreign Clozaril (Clozapine) Neutrophil Count Health Tablet PS ORAL 150 MG/D, Decreased Professional ORAL Oesophagitis Other Orthostatic Hypotension Tachycardia Date:09/17/01ISR Number: 3795688-2Report Type:Expedited (15-DaCompany Report #PHBS2001AU09100 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypertrophic Obstructive Foreign Clozaril (Clozapine) PS ORAL 500 MG/D ORAL Cardiomyopathy Study Caltrate C Psychotic Disorder Health Kliogest "Novo Rebound Effect Professional Industri" C Other Date:09/18/01ISR Number: 3795253-7Report Type:Expedited (15-DaCompany Report #01-09-0492 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Clozapine - Zenith Congestive Professional Goldiline Pharm. Chronic Obstructive Tablets PS Zentih Goldline Pulmonary Disease Pharm. ORAL 300-700MG QD Condition Aggravated ORAL 22-Feb-2006 08:30 AM Page: 1263 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/18/01ISR Number: 3795254-9Report Type:Expedited (15-DaCompany Report #01-09-0493 Age:77 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine - Zenith Professional Goldine Pharm. Tablets PS Zenith Goldline Pharm. ORAL 75-100MG QD ORAL Date:09/18/01ISR Number: 3795255-0Report Type:Expedited (15-DaCompany Report #01-09-0494 Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine - Zenith Hospitalization - Professional Goldline Pharm. Initial or Prolonged Tablets PS Zenith Goldline Pharm. ORAL 50 MG QD ORAL Date:09/18/01ISR Number: 3795256-2Report Type:Expedited (15-DaCompany Report #01-09-0496 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine - Zenith Hospitalization - Professional Goldline Pharm. Initial or Prolonged Tablets PS Zenith Goldline Pharm. ORAL 400-900MG QD ORAL Date:09/18/01ISR Number: 3795257-4Report Type:Expedited (15-DaCompany Report #01-09-0495 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 500-600MG ORAL Date:09/18/01ISR Number: 3795258-6Report Type:Expedited (15-DaCompany Report #01-08-0429 Age:62 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Health Clozapine - Zenith Malnutrition Professional Goldline Pharm. Oral Intake Reduced Tablets PS Zenith Goldline Pharm. ORAL 200-350 MG ORAL Date:09/18/01ISR Number: 3795259-8Report Type:Expedited (15-DaCompany Report #01-09-0491 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Loss Of Consciousness Health Clozapine - Zenith Hospitalization - Pyrexia Professional Goldline Pharm. Initial or Prolonged Vomiting Tablets PS Zenith Goldline Pharm. ORAL 300-700MG QD 22-Feb-2006 08:30 AM Page: 1264 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL Date:09/18/01ISR Number: 3795284-7Report Type:Expedited (15-DaCompany Report #EMADSS2001005240 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Foreign Haldol (Unspecified) Liver Function Test Health (Haloperidol) PS ORAL 10 MG DAILY, Abnormal Professional ORAL Metabolic Acidosis Eritumine Pyrexia (Clotiapine) SS ORAL SEE IMAGE Respiratory Failure Leponex (Clozapine) SS STANDARD DAILY DOSE (PRIOR TO HOSPITALISATI ON ): 400 MG/ Temesta (Lorazepam) SS INTRAVENOUS SEE IMAGE Promazine (Promazine) SS 150 MG Midazolam (Midazolam) SS 9 MG Olanzapine (Olanzapine) SS 5 MG Fraxiparine (Heparin Fraction, Calcium Salt) C Morphine (Morphine) C Seretide (Salmeterol Xinafoate) C Date:09/18/01ISR Number: 3795417-2Report Type:Expedited (15-DaCompany Report #LACT00301003614 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Foreign Duphalac (3 Initial or Prolonged Neutropenia Other Bags/Twice A Week) White Blood Cell Count (Lactulose) PS ORAL DAILY PO Decreased Leponex (Clozapine) SS ORAL 400 MG DAILY PO: 300 MG DAILY PO Nozinan (Levomepromazine) SS ORAL 100 GTT DAILY PO Loxapac (Loxapine Succinate) SS INTRAMUSCULAR 6 DF DAILY IM Date:09/18/01ISR Number: 3795572-4Report Type:Expedited (15-DaCompany Report #PHBS2001AU09142 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Metastasis Foreign Clozaril (Clozapine) Testis Cancer Study Tablet PS 600 MG/D Health Professional Other 22-Feb-2006 08:30 AM Page: 1265 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/18/01ISR Number: 3795577-3Report Type:Expedited (15-DaCompany Report #PHBS2001CA09027 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Intentional Overdose Foreign Clozaril(Clozapine) PS Pneumonia Aspiration Study Suicide Attempt Health Professional Other Date:09/18/01ISR Number: 3795580-3Report Type:Expedited (15-DaCompany Report #PHFR2001GB02547 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Clozaril (Clozapine) Study Tablet PS ORAL 350MG/DAY, Health ORAL Professional Other Date:09/18/01ISR Number: 3795582-7Report Type:Expedited (15-DaCompany Report #PHBS2001CA09161 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiomegaly Foreign Clozaril (Clozapine) Tachycardia Study Tablet PS ORAL ORAL Health Professional Other Date:09/18/01ISR Number: 3796514-8Report Type:Expedited (15-DaCompany Report #01-09-0497 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine-Zenith Professional Goldline Pharm. Tablets PS ORAL 25-850MG QD ORAL Date:09/20/01ISR Number: 3796397-6Report Type:Expedited (15-DaCompany Report #PHFR2001GB02414 Age:47 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Breast Cancer Female Foreign Clozaril (Clozapine) Initial or Prolonged Health Tablet PS ORAL 300 MG/DAY, Professional ORAL Other Date:09/20/01ISR Number: 3796955-9Report Type:Expedited (15-DaCompany Report #PHFR2001GB02564 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bradycardia Foreign Clozaril Drug Interaction Health (Clozapine)Tablet PS ORAL 225 MG/DAY, Professional ORAL Other Thiopentone(Thiopent al) SS UNKNOWN 40 MG, 22-Feb-2006 08:30 AM Page: 1266 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ONCE/SINGLE Suxamethonium (Suxamethonium) SS UNKNOWN 225 MG, ONCE/SINGLE Date:09/21/01ISR Number: 3797406-0Report Type:Expedited (15-DaCompany Report #PHEH2001US07573 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Health Clozaril PS ORAL 300 MG, ORAL Initial or Prolonged Neutropenia Professional Cyclophosphamide Non-Hodgkin'S Lymphoma (Cyclophosphamide) C Vincristine (Vincristine) C Doxorubicin (Doxorubicin) C Prednisone C Date:09/21/01ISR Number: 3797430-8Report Type:Expedited (15-DaCompany Report #PHEH2001US07658 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neoplasm Malignant Health Clozaril (Clozapine) PS Novartis Professional Pharmaceuticals Corp. ORAL 600MG, ORAL Date:09/21/01ISR Number: 3797438-2Report Type:Expedited (15-DaCompany Report #PHEH2001US07657 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Clozaril (Clozapine) Professional Tablet PS ORAL 250MG, ORAL Date:09/21/01ISR Number: 3797547-8Report Type:Expedited (15-DaCompany Report #PHFR2001GB02561 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ankle Fracture Foreign Clozaril(Clozapine)T Initial or Prolonged Deep Vein Thrombosis Health ablet PS ORAL 300MG/DAY, Professional ORAL Other Date:09/21/01ISR Number: 3797630-7Report Type:Expedited (15-DaCompany Report #PHBS2001BE08199 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Lymphopenia Foreign Clozaril (Clozapine) Pneumonia Klebsiella Health Tablet PS ORAL ORAL Professional Clozaril SS ORAL 100 MG/ DAY Other ORAL Trazolan (Trazodone Hydrochloride) C Cipramil (Citalopram Hydrobromide) C Dipiperon (Pipamperone) C Entumin C 22-Feb-2006 08:30 AM Page: 1267 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/21/01ISR Number: 3797760-XReport Type:Expedited (15-DaCompany Report #PHBS2001CA08249 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dehydration Foreign Clozaril (Clozapine) Initial or Prolonged Eosinophilia Study Tablet PS ORAL 200 MG/D, Hepatitis Health ORAL Pneumonitis Professional Lithium (Lithium) C White Blood Cell Count Other Amitriptyline Increased (Amitriptyline) C Celexa (Citalopram Hydrobromide) C Date:09/21/01ISR Number: 3797765-9Report Type:Expedited (15-DaCompany Report #PHBS2001FI08995 Age:55 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiomyopathy Foreign Leponex (Clozapine) Initial or Prolonged Mitral Valve Incompetence Health Tablet PS ORAL 175 MG/D, Professional ORAL Other Antipsychotics (No Ingredients/Substanc es) SS Date:09/21/01ISR Number: 3797766-0Report Type:Expedited (15-DaCompany Report #PHBS2001AU08936 Age:49 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Lymphoma Foreign Clozaril (Clozapine) Neutropenia Study Tablet PS ORAL ORAL Health Professional Other Date:09/21/01ISR Number: 3797768-4Report Type:Expedited (15-DaCompany Report #PHBS2001MY09315 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Electrocardiogram Qt Foreign Clozapine Prolonged Health (Clozapine) Tablet PS ORAL 100 MG, BID, Heart Rate Increased Professional ORAL Palpitations Other Amitriptyline Salivary Hypersecretion (Amitriptyline) C Date:09/21/01ISR Number: 3797770-2Report Type:Expedited (15-DaCompany Report #PHBS2001AU09100 Age:44 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypertrophic Obstructive Foreign Clozaril (Clozapine) Cardiomyopathy Study Tablet PS ORAL 500 MG/D, Psychotic Disorder Health ORAL Rebound Effect Professional Caltrate C Other Kliogest "Novo Industri" C 22-Feb-2006 08:30 AM Page: 1268 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/24/01ISR Number: 3798407-9Report Type:Expedited (15-DaCompany Report #PHBS2001NL09017 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Clozapine(Clozapine) PS 450 MG/D Initial or Prolonged Phosphokinase Increased Literature Valproate Sodium Blood Lactate Health (Valproate Sodium) C Dehydrogenase Decreased Professional Coma Other Diabetic Ketoacidosis Disseminated Intravascular Coagulation Heart Rate Increased Hyperammonaemia Hyperglycaemia Hypotension Loss Of Consciousness Poisoning Deliberate Pyrexia Respiratory Distress Sedation Tachypnoea Therapeutic Agent Toxicity Date:09/24/01ISR Number: 3798408-0Report Type:Expedited (15-DaCompany Report #PHBS2001AU04319 Age:53 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Leukaemia Foreign Clozaril(Clozapine) Hospitalization - Agranulocytosis Health Tablet PS Novartis Initial or Prolonged Professional Pharmaceuticals Other Corp. ORAL 600 MG/D, ORAL Diazepam C Date:09/24/01ISR Number: 3798410-9Report Type:Expedited (15-DaCompany Report #PHBS2001CA09027 Age:47 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Intentional Overdose Foreign Clozaril (Clozapine) Hospitalization - Pneumonia Aspiration Study Tablet PS Novartis Initial or Prolonged Suicide Attempt Health Pharmaceuticals Professional Corp. ORAL 900 MG/D, Other ORAL Motilium "Byk Gulden" (Domperidone) C Pantoloc "Solvay" (Pantoprazole Sodium) C Date:09/24/01ISR Number: 3798712-6Report Type:Expedited (15-DaCompany Report #PHFR2001GB02201 Age:38 YR Gender:Male I/FU:I Outcome PT Life-Threatening Blood Creatine Hospitalization - Phosphokinase Increased Initial or Prolonged Cardiomegaly 22-Feb-2006 08:30 AM Page: 1269 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Communication Disorder Dyspnoea Electrocardiogram St Report Source Product Role Manufacturer Route Dose Duration Segment Elevation Foreign Clozaril (Clozapine) Electrocardiogram T Wave Health Tablet PS ORAL ORAL Amplitude Decreased Professional Valproate Sodium C Fluid Overload Other Haloperidol C Left Ventricular Failure Clonazepam C Lower Respiratory Tract Infection Pericardial Effusion Renal Impairment Tachycardia Viral Myocarditis White Blood Cell Count Increased Date:09/24/01ISR Number: 3798713-8Report Type:Expedited (15-DaCompany Report #PHBS2001AU09399 Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Adrenal Carcinoma Foreign Clozaril (Clozapine) Hospitalization - Lung Carcinoma Cell Type Health Tablet PS ORAL 12.5 MG, BID, Initial or Prolonged Unspecified Stage Iv Professional ORAL Other Date:09/25/01ISR Number: 3798356-6Report Type:Expedited (15-DaCompany Report #PHEH2001US05989 Age:52 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozaril(Clozapine) Ovarian Cancer Professional Tablet PS ORAL 300 MG, ORAL Carboplatin(Carbopla tin) SS INTRAVENOUS 614 INTRAVENOUS Taxol(Paclitaxel) SS INTRAVENOUS 290 INTRAVENOUS Date:09/25/01ISR Number: 3798371-2Report Type:Expedited (15-DaCompany Report #PHEH2001US07676 Age:85 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Fall Health Clozaril (Clozapine) Professional Tablet PS ORAL 25 MG, ORAL Company Representative Date:09/25/01ISR Number: 3798373-6Report Type:Expedited (15-DaCompany Report #PHEH2001US07245 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Road Traffic Accident Health Clozaril (Clozapine) Professional Tablet PS ORAL 700 MG, ORAL 22-Feb-2006 08:30 AM Page: 1270 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/25/01ISR Number: 3798605-4Report Type:Expedited (15-DaCompany Report #01-08-0442 Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dyspnoea Health Clozapine - Zenith Fall Professional Goldline Pharm. Head Injury Tablets PS ORAL 150-300 MG Injury Asphyxiation ORAL Obesity Date:09/25/01ISR Number: 3798606-6Report Type:Expedited (15-DaCompany Report #01-08-0464 Age:71 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Brain Neoplasm Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS ORAL 275-375MG QD ORAL Date:09/25/01ISR Number: 3798607-8Report Type:Expedited (15-DaCompany Report #01-07-0399 Age:22 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Health Clozapine- Zenith Decreased Professional Goldline Pharm. Tablets PS ORAL 200-400MG QD ORAL Combivir Bid For Hiv C Nevirapine 200 Mg Bid C Date:09/25/01ISR Number: 3798608-XReport Type:Expedited (15-DaCompany Report #01-09-0513 Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine-Zenith Professional Goldline Pharm. Tablets PS ORAL 50 MG ORAL Date:09/25/01ISR Number: 3798609-1Report Type:Expedited (15-DaCompany Report #01-09-0512 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Colectomy Health Clozapine - Zenith Ileostomy Professional Goldline Pharm. Tablets PS ORAL 600 MG ORAL Date:09/25/01ISR Number: 3798610-8Report Type:Expedited (15-DaCompany Report #01-09-0511 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS ORAL 400-450MG QD ORAL 22-Feb-2006 08:30 AM Page: 1271 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/25/01ISR Number: 3798612-1Report Type:Expedited (15-DaCompany Report #01-09-0509 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hypersensitivity Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS ORAL 50-400MG QD ORAL Cipro Tablets SS ORAL ORAL Date:09/25/01ISR Number: 3798614-5Report Type:Expedited (15-DaCompany Report #01-08-0483 Age:59 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Health Clozapine - Zenith Respiratory Disorder Professional Goldline Pharm. Sudden Death Tablets PS ORAL ORAL Date:09/25/01ISR Number: 3798616-9Report Type:Expedited (15-DaCompany Report #01-09-0514 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS ORAL 400-550MG QD ORAL Date:09/25/01ISR Number: 3799971-6Report Type:Expedited (15-DaCompany Report #PHEH2001US07656 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Body Temperature Health Clozaril (Clozapine) PS ORAL 450 MG, BID, Initial or Prolonged Increased Professional ORAL Heat Stroke Lithium (Lithium) C Paxil C Date:09/25/01ISR Number: 3801202-5Report Type:Expedited (15-DaCompany Report #PHBS2001MX09279 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Foreign Leponex (Clozapine) Dysuria Health Tablet PS ORAL 400 MG/D, Enuresis Professional ORAL Hydronephrosis Other Haldol C Pyrexia Sinogan C Renal Failure Valium C Urinary Retention Date:09/25/01ISR Number: 3801215-3Report Type:Expedited (15-DaCompany Report #PHFR2001GB02567 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Clonic Convulsion Foreign Clozaril (Clozapine) PS ORAL 375 MG/DAY, Drug Interaction Health ORAL Drug Level Above Professional Citalopram Therapeutic Other (Citalopram) SS Salivary Hypersecretion 22-Feb-2006 08:30 AM Page: 1272 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/25/01ISR Number: 3801296-7Report Type:Expedited (15-DaCompany Report #PHEH2001US07789 Age:81 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozaril(Clozapine) Professional Tablet PS ORAL 50MG, ORAL Date:09/25/01ISR Number: 3801298-0Report Type:Expedited (15-DaCompany Report #PHEH2001US07782 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anaesthetic Complication Health Clozaril(Clozapine) Professional Tablet PS ORAL 100 MG, QID, ORAL Anaesthetics(No Ingredients/Substatn ces) SS 1487 DAY Seroquel (Quetiapine) C Paxil C Date:09/25/01ISR Number: 3801301-8Report Type:Expedited (15-DaCompany Report #PHEH2001US07720 Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatinine Health Clozaril(Clozapine) Initial or Prolonged Increased Professional Tablet PS ORAL 200 MG, ORAL Drug Level Above Lithium(Lithium) SS 900 MG 13 DAY Therapeutic Geodon (Ziprasidone Leukocytosis Hydrochloride) C Pyrexia Depakote (Valproate Red Blood Cell Semisodium) C Sedimentation Rate Acetaminophen Increased (Paracetamol) C Ibuprofen C Chloral Hydrate C Date:09/25/01ISR Number: 3801508-XReport Type:Expedited (15-DaCompany Report #PHEH2001US07783 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anaesthesia Health Clozaril (Clozapine) Lung Neoplasm Malignant Professional Tablet PS ORAL 300 MG, Surgery DAILY, ORAL Clozapine (Clozapine) SS Anaesthetics (No Ingredients/Substanc es) SS Mellaril (Thioridazine Hydrochloride) C 22-Feb-2006 08:30 AM Page: 1273 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/25/01ISR Number: 3801586-8Report Type:Expedited (15-DaCompany Report #PHEH2001US07032 Age:56 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Breast Cancer Female Health Clozaril(Clozapine)T Initial or Prolonged White Blood Cell Count Professional ablet PS ORAL 100MG AM + Decreased 200MG HS, ORAL Cytoxan(Cyclophospha mide) SS Adriamycin(Doxorubic in) SS Risperdal (Risperidone) C Paxil C Benadryl C Klonopin C Ddavp(Desmopressin) C Calcium C Colace C Date:09/26/01ISR Number: 3798902-2Report Type:Direct Company Report # Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Urinary Incontinence Clozapine (100mg) PS ORAL 400 MG PO QHS Depakote C Fluphenazine Decanoate C Fluphenazine C Benztropine C Imipramine C Benztropine C Vit E C Clonazepam C Date:09/26/01ISR Number: 3799899-1Report Type:Direct Company Report # Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eye Disorder (Clozapine-Gen) Neoplasm Malignant *Clozaril PS 100MG Q AM,200MG AT 12NOON, 100MG Q 4P AND 100 MG Q 7P (AT 5 YR Date:09/26/01ISR Number: 3799900-5Report Type:Expedited (15-DaCompany Report #01-09-0504 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets - Professional Zenith Goldline Pharm PS Zenith Goldline Pharm ORAL 25MG ORAL 22-Feb-2006 08:30 AM Page: 1274 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/26/01ISR Number: 3799902-9Report Type:Expedited (15-DaCompany Report #01-09-0500 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets- Professional Zenith Goldline Pharm PS Zenith Goldline Pharm ORAL 500MG ORAL Date:09/26/01ISR Number: 3799904-2Report Type:Expedited (15-DaCompany Report #01-09-0499 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Gastric Cancer Health Clozapine Tablets - Metastases To Liver Professional Zenith Goldline Pharm. PS Zenith Goldline Pharm ORAL 400MG ORAL Date:09/26/01ISR Number: 3799906-6Report Type:Expedited (15-DaCompany Report #01-09-0498 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Angiosarcoma Health Clozapine Tablets - Initial or Prolonged White Blood Cell Count Professional Zenith Goldline Decreased Pharm PS Zenith Goldline Pharm ORAL 350MG QD ORAL Clozaril C Date:09/26/01ISR Number: 3799908-XReport Type:Expedited (15-DaCompany Report #01-09-0505 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Throat Tightness Health Clozapine Tablets - Professional Zenith Goldline Pharm. PS Zenith Goldline Pharm ORAL 300-600MG ORAL Date:09/26/01ISR Number: 3799910-8Report Type:Expedited (15-DaCompany Report #01-09-0502 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Clozapine Tablets - Professional Zenith Goldline Pharm PS Zenith Goldline Pharm ORAL 300-700MG QD ORAL Date:09/26/01ISR Number: 3799912-1Report Type:Expedited (15-DaCompany Report #01-09-0507 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets - Professional Zenith Goldline Pharm PS Zenith Goldline Pharm ORAL 800-900MG ORAL 22-Feb-2006 08:30 AM Page: 1275 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/27/01ISR Number: 3800407-7Report Type:Expedited (15-DaCompany Report #PHBS2001CO09343 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cystitis Escherichia Foreign Leponex Dysuria Other (Clozapine)Tablet PS ORAL 100 MG, BID, Leukocytosis ORAL Nasal Congestion Sinogan C Neutrophilia Valproic Acid C Odynophagia Pain Pollakiuria Pyrexia Urinary Incontinence Date:09/27/01ISR Number: 3800409-0Report Type:Expedited (15-DaCompany Report #PHFR2001GB01709 Age:54 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Foreign Clozaril (Clozapine) Drug Interaction Health Tablet PS ORAL 700MG/DAY, Hyponatraemia Professional ORAL Polydipsia Other Bendrofluazide (Bendroflumethiazide ) C Lithium (Lithium) C Chlopromazine (Chlorpromazine) C Ibuprofen C Omeprazole (Omeprazole) C Priadel C Date:09/27/01ISR Number: 3800410-7Report Type:Expedited (15-DaCompany Report #PHFR2001GB02578 Age:67 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alveolitis Fibrosing Foreign Clozaril (Clozapine) PS ORAL 150MG/DAY, Health ORAL Professional Other Date:09/27/01ISR Number: 3800458-2Report Type:Expedited (15-DaCompany Report #PHBS2001AU09474 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Clozaril (Clozapine) Health Tablet PS ORAL 12.5 MG/DAY, Professional ORAL 75 Other MG/DAY, ORAL 100 MG/DAY, ORAL 200 22-Feb-2006 08:30 AM Page: 1276 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/27/01ISR Number: 3800463-6Report Type:Expedited (15-DaCompany Report #1PHBS2001AU08482 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death C-Reactive Protein Foreign Clozaril (Clozapine) Other Increased Study Tablet PS ORAL 300 MG/DAY, Leukocytosis Health ORAL Neutrophilia Professional Ventricular Hypertrophy Other Date:09/27/01ISR Number: 3800600-3Report Type:Expedited (15-DaCompany Report #PHFR2001GB02581 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neoplasm Malignant Foreign Clozaril (Clozapine) Pelvic Mass Health Tablet PS ORAL ORAL Professional Other Date:09/27/01ISR Number: 3800602-7Report Type:Expedited (15-DaCompany Report #PHBS2000AU04068 Age:31 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Foreign Clozaril (Clozapine) Initial or Prolonged Cardiac Disorder Study (Clozapine) Tablet PS ORAL 750 MG/DAY , Other Cardiomyopathy Health ORAL Congestive Cardiomyopathy Professional Lithium Carbonate C Hypokinesia Other Olanzapine Leukopenia (Olanzapine) C Neutropenia Date:09/28/01ISR Number: 3802108-8Report Type:Expedited (15-DaCompany Report #C2001-2466.01 Age:81 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional Mylan PS ORAL 50MG QD, ORAL Other Date:09/28/01ISR Number: 3802109-XReport Type:Expedited (15-DaCompany Report #C2001-2545.01 Age:77 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sepsis Health Clozapine Tablets 25 Urinary Tract Infection Professional Mg Mylan PS Mylan Other Pharmaceuticals Inc. ORAL 75 MG QD, ORAL Carbidopa/Levodopa C Cefazolin Injection C Ceftriazone Injection C Gentamicin Injection C Hyoscyamine C Lorazepam C Morphine Injection C Ropinirole C 22-Feb-2006 08:30 AM Page: 1277 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/28/01ISR Number: 3802190-8Report Type:Expedited (15-DaCompany Report #PHBS2001CH09512 Age:82 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenopia Foreign Leponex (Clozapine) Initial or Prolonged Drug Interaction Health Tablet PS ORAL 25 MG/D, ORAL Haemorrhagic Stroke Professional Cordarone Hemiparesis Other (Amiodarone Lower Respiratory Tract Hydrochloride) SS ORAL 200 MG/D, Infection ORAL Sedation Madopar (Levodopa, Urinary Incontinence Benserazide Hydrchloride) C Aspirine C Pravastatin (Pravastatin) C Norvasc C Augmentin (Clavulanate Potassium) C Fraxiparine (Heparin-Fraction, Calcium Salt) C Laxatives (No Ingredients/Substanc es) C Date:10/01/01ISR Number: 3802562-1Report Type:Expedited (15-DaCompany Report #PHBS2001CO09420 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Distension Foreign Leponex (Clozapine) Initial or Prolonged Abdominal Pain Health Tablet PS ORAL 300 MG/D, Acute Abdomen Professional ORAL Asthenia Other Haloperidol Drops C Dehydration Levomepromazine C Disorientation Clonazepam C Faecaloma Gastrointestinal Necrosis Haematemesis Intestinal Obstruction Peristalsis Visible Proctitis Sedation Sepsis Urinary Retention Vomiting Date:10/01/01ISR Number: 3802564-5Report Type:Expedited (15-DaCompany Report #PHFR2001GB02646 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram St Foreign Clozaril (Clozapine) Segment Elevation Health Tablet PS ORAL 375 MG/DAY Extrasystoles Professional (175MG & Face Oedema Other 200MG), ORAL Psoriasis Diazepam C Supraventricular Tachycardia Vomiting 22-Feb-2006 08:30 AM Page: 1278 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/01/01ISR Number: 3802645-6Report Type:Expedited (15-DaCompany Report #PHBS2001NZ08935 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Abuser Foreign Clozaril (Clozapine) Medication Error Health Tablet PS ORAL 300 MG/D, Social Avoidant Behaviour Professional ORAL; 325 Thought Withdrawal Other MG/D, ORAL Weight Increased Cannabis (Cannabis) SS Date:10/01/01ISR Number: 3803117-5Report Type:Expedited (15-DaCompany Report #PHRM2001FR01882 Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Brain Abscess Foreign Leponex(Clozapine) Brain Herniation Health Tablet PS ORAL 600 MG/DAY, Meningism Professional ORAL 1460 DAY Pneumococcal Infection Other Depamide White Blood Cell Count (Valpromide) C Increased Xanax (Alprazolam) C Date:10/01/01ISR Number: 3803194-1Report Type:Expedited (15-DaCompany Report #PHBS2001AU06733 Age:29 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaphylactic Reaction Foreign Clozaril (Clozapine) Initial or Prolonged Anaphylactic Shock Study Tablet PS ORAL 475 MG/DAY, Bradycardia Health ORAL Circulatory Collapse Professional Convulsion Other Hypotension Date:10/01/01ISR Number: 3803199-0Report Type:Expedited (15-DaCompany Report #PHRM2001FR01921 Age:64 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dysphagia Foreign Leponex (Clozapine) Hospitalization - Oesophageal Ulcer Health Tablet PS ORAL 12.5 MG , QD, Initial or Prolonged Oesophagitis Professional ORAL Sepsis Other Sinemet (Levodopa Urinary Tract Infection Carbidopa) C Trandate (Labetalol Hydrochloride) C Sandocal "Novartis" (Sodium) C Laroxyl (Amitriptyline Hydrochloride) C Date:10/02/01ISR Number: 3803810-4Report Type:Expedited (15-DaCompany Report #01-08-0452 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 250MG QD ORAL Digoxin C 22-Feb-2006 08:30 AM Page: 1279 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Atenolol C Synthroid C Valproic Acid C Lasix C Ativan C Date:10/02/01ISR Number: 3803813-XReport Type:Expedited (15-DaCompany Report #01-06-0347 Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Mass Health Clozapine -Zenith Metastases To Central Professional Goldline Pharm. Nervous System Tablets PS Zenith Goldline Neoplasm Malignant Pharm. ORAL 150-350MG QD ORAL Date:10/02/01ISR Number: 3803815-3Report Type:Expedited (15-DaCompany Report #01-08-0466 Age:82 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 25MG BID ORAL Klonopin C Date:10/02/01ISR Number: 3803818-9Report Type:Expedited (15-DaCompany Report #01-07-0398 Age:79 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dementia Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 12.5MG QD ORAL Date:10/02/01ISR Number: 3803820-7Report Type:Expedited (15-DaCompany Report #01-07-0418 Age:42 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine - Zenith Other Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 500MG QD ORAL Zyprexa C Eskalith C Dostinex C Clomipramine C Parlodel C Depakote C 22-Feb-2006 08:30 AM Page: 1280 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/02/01ISR Number: 3803822-0Report Type:Expedited (15-DaCompany Report #01-08-0468 Age:53 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Chronic Obstructive Health Clozapine - Zenith Pulmonary Disease Professional Goldline Pharm. Respiratory Failure Tablets PS Zenith Goldline Pharm. ORAL 350-775MG QD ORAL Date:10/02/01ISR Number: 3803823-2Report Type:Expedited (15-DaCompany Report #01-08-0450 Age:54 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine -Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 50MG QHS ORAL Date:10/02/01ISR Number: 3803826-8Report Type:Expedited (15-DaCompany Report #01-08-0466 Age:82 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dementia Alzheimer'S Type Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 25MG BID ORAL Date:10/02/01ISR Number: 3803852-9Report Type:Expedited (15-DaCompany Report #01-09-0525 Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine-Zenith Professional Goldline Phar. Tablets PS ORAL 50 MG QD ORAL Date:10/02/01ISR Number: 3803859-1Report Type:Expedited (15-DaCompany Report #01-07-0370 Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Confusional State Health Clozapine- Tablets PS Zenith Goldline Hospitalization - Foreign Body Aspiration Professional Pharm. ORAL 450 MG QHS Initial or Prolonged Lung Neoplasm Malignant ORAL Post Procedural Ranitidine 150 Mg Complication Bid C Prolixin Decanoate 0.25 Mg Im C Pamelor 35mg Qhs C Depakote 250mg Qid C Date:10/02/01ISR Number: 3803861-XReport Type:Expedited (15-DaCompany Report #01-07-0385 Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Neoplasm Malignant Health Clozapine Tablets PS Zenith Goldline Professional Pharm. ORAL 200-600 MG QD ORAL 22-Feb-2006 08:30 AM Page: 1281 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/02/01ISR Number: 3803863-3Report Type:Expedited (15-DaCompany Report #01-08-0485 Age:58 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets PS Zenith Goldline Professional Pharm ORAL 225 MG QD ORAL Albuterol C Atrovent C Vanceril C Date:10/02/01ISR Number: 3803864-5Report Type:Expedited (15-DaCompany Report #01-08-0453 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Heat Stroke Health Clozapine Tablets PS Zenith Goldline Professional Pharm. ORAL 600 MG HS ORAL Amitriptyline 10 Mg Hs C Benztropine Mesylate 1 Mg Bid C Prilosec 20 Mg Bid C Date:10/02/01ISR Number: 3803865-7Report Type:Expedited (15-DaCompany Report #01-08-0423 Age:63 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coma Health Clozapine Tablets PS Zenith Goldline Cyanosis Professional Pharm. ORAL 25-77 MG QD Foreign Body Aspiration ORAL Loss Of Consciousness Zestril 5 Mg Qd C Myocardial Infarction Zantac 150 Mg Bid C Depakote 500 Mg Bid C Vistaril 100 Mg Hs C Date:10/02/01ISR Number: 3803866-9Report Type:Expedited (15-DaCompany Report #01-09-0527 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets PS Zenith Goldline Professional Pharm. ORAL ORAL Date:10/02/01ISR Number: 3803867-0Report Type:Expedited (15-DaCompany Report #01-09-0526 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets PS Zenith Goldline Professional Pharm. ORAL 300-500MG QD ORAL Date:10/02/01ISR Number: 3803868-2Report Type:Expedited (15-DaCompany Report #01-09-0523 Age:71 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets PS Zenith Goldline Professional Pharm. ORAL 12.5 25MG QD 22-Feb-2006 08:30 AM Page: 1282 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL Date:10/03/01ISR Number: 3803280-6Report Type:Expedited (15-DaCompany Report #268760 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Tamiflu PS Roche 5 DAY Neutropenia Clozapine SS 407 DAY Date:10/04/01ISR Number: 3804563-6Report Type:Expedited (15-DaCompany Report #01P-028-0110494-00 Age:19 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Tamponade Foreign Biaxin Initial or Prolonged Cardiomegaly Health (Clarithromycin) Required Chest X-Ray Abnormal Professional (Clarithromycin) PS ORAL 250 MG, 2 IN Intervention to Drug Interaction 1 D, PER ORAL Prevent Permanent Electrocardiogram Clozapine SS ORAL 150 MG, 1 IN Impairment/Damage Abnormal 1 D, PER ORAL Heart Sounds Abnormal Haloperidol C Hypotension Risperidone C Myocarditis Clonazepam C Pericardial Effusion Topiramate C Pericarditis Venlafaxine C Syncope Chlorpromazine C Peri-Colace C Meningococcal Polysaccharide C Date:10/04/01ISR Number: 3804644-7Report Type:Expedited (15-DaCompany Report #PHFR2001GB01579 Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bronchopneumonia Foreign Clozapine Cardiac Failure Study (Clozapine) Unknown PS ORAL 150 MG BID, Diarrhoea Health ORAL Respiratory Failure Professional Chlorpromazine Other (Chlorpromazine) C Lithium Carbonate C Lorazepam C Zopiclone C Dioralyte C Date:10/04/01ISR Number: 3804825-2Report Type:Expedited (15-DaCompany Report #PHFR2001GB01923 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Deep Vein Thrombosis Foreign Clozaril (Clozapine) Other Diabetes Mellitus Study Tablet PS ORAL 400MG/DAY, Pulmonary Embolism Health ORAL Professional Warfarin (Warfarin) C Other Gliclazide (Gliclazide) C 22-Feb-2006 08:30 AM Page: 1283 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/04/01ISR Number: 3804826-4Report Type:Expedited (15-DaCompany Report #PHFR2001GB02442 Age:56 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anxiety Foreign Leponex / Clozaril Depression Health (Clozapine) Salivary Hypersecretion Professional (Clozapine) PS ORAL 250MG/NOCTE, Sedation Other ORAL Suicidal Ideation Lamotrigine C Haldol C Carbamazepine C Date:10/04/01ISR Number: 3804827-6Report Type:Expedited (15-DaCompany Report #PHBS2001AU06163 Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Laboratory Test Abnormal Foreign Clozaril (Clozapine) PS ORAL 500 MG/D, Study ORAL Health Professional Other Date:10/04/01ISR Number: 3805164-6Report Type:Expedited (15-DaCompany Report #01-09-0496 Age:53 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Death Health Clozapine - Zenith Initial or Prolonged Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm ORAL 400-900MG QD ORAL Date:10/04/01ISR Number: 3805166-XReport Type:Expedited (15-DaCompany Report #01-08-0470 Age:56 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetes Mellitus Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 400MG QD ORAL Date:10/04/01ISR Number: 3805168-3Report Type:Expedited (15-DaCompany Report #0-09-0538 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 200-450MG QD ORAL Date:10/04/01ISR Number: 3805172-5Report Type:Expedited (15-DaCompany Report #01-09-0537 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine - Zenith Professional Goldline Pharm. 22-Feb-2006 08:30 AM Page: 1284 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tablets PS Zenith Goldline Pharm. ORAL 100- 300MG QD ORAL Date:10/04/01ISR Number: 3805349-9Report Type:Expedited (15-DaCompany Report #2001UW12218 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blindness Other Seroquel "Zeneca" PS 15 DAY Intervention to Cardiac Failure Clozaril SS 15 DAY Prevent Permanent Congestive Impairment/Damage Cardiomyopathy Leukocytosis Oedema Peripheral Phlebitis Date:10/04/01ISR Number: 3805377-3Report Type:Expedited (15-DaCompany Report #PHEH2001US06703 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hepatitis A Health Clozaril(Clozapine)T Hepatitis B Professional ablet PS ORAL 200MG DAILY, Hepatitis C ORAL Date:10/05/01ISR Number: 3805586-3Report Type:Expedited (15-DaCompany Report #01-08-0437 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 600 MG QD ORAL Synthroid C Klonopin C Asendin C Date:10/05/01ISR Number: 3805602-9Report Type:Expedited (15-DaCompany Report #01-09-0498 Age:62 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Angiosarcoma Health Clozapine - Zenith Initial or Prolonged White Blood Cell Count Professional Goldline Pharm. Decreased Tablets PS Zenith Goldline Pharm. ORAL 350 MG QD ORAL Clozaril C Acetaminophen Xs C Fenesin L.A. C Hydrochlorothiazide/ Triameterene C Zoloft C Levoxyl C Buspirone C Multivatimins And Iron C Potassium C Acular Ophthalmic 22-Feb-2006 08:30 AM Page: 1285 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Solution C Vioxx C Prevacid Dr C Tums C Allegra C Zyprexa C Tears Naturale C Date:10/05/01ISR Number: 3805604-2Report Type:Expedited (15-DaCompany Report #01-08-0471 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Parkinsonism Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 100-200 MG QD ORAL Date:10/05/01ISR Number: 3805607-8Report Type:Expedited (15-DaCompany Report #01-09-0505 Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Drooling Health Clozapine - Zenith Intervention to Dysphagia Professional Goldline Pharm. Prevent Permanent Throat Tightness Tablets PS Zenith Goldline Impairment/Damage Pharm. ORAL 300 MG QD ORAL Risperdal C Serzone C Cogentin C Date:10/05/01ISR Number: 3805611-XReport Type:Expedited (15-DaCompany Report #C2001-2812.01 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Metastatic Neoplasm Health Clozapine Tablets Professional 100 Mg Mylan PS ORAL 400 MG BID, Other THEN 100 MG BID, ORAL Date:10/05/01ISR Number: 3806006-5Report Type:Expedited (15-DaCompany Report #01-08-0424 Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Surgery Health Clozapine - Zenith Initial or Prolonged Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 150MG ORAL Date:10/05/01ISR Number: 3806008-9Report Type:Expedited (15-DaCompany Report #01-09-0497 Age:43 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 25-850MG QD 22-Feb-2006 08:30 AM Page: 1286 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL Synthroid C Lactulose Syrup C Ditropan C Zantac C Topamax C Risperdal C Ativan C Date:10/05/01ISR Number: 3806010-7Report Type:Expedited (15-DaCompany Report #01-07-0400 Age:71 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Clostridium Colitis Health Clozapine - Zenith Hospitalization - Pneumonia Professional Goldline Pharm. Initial or Prolonged Pyrexia Tablets PS Zenith Goldline Pharm. ORAL 25MG QD ORAL Sinemet C Metoprolol C Digoxin C Paxil C Coumadin C Date:10/05/01ISR Number: 3806015-6Report Type:Expedited (15-DaCompany Report #01-09-0541 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 100MG QD ORAL Date:10/05/01ISR Number: 3806016-8Report Type:Expedited (15-DaCompany Report #01-09-0540 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 50-800MG QD ORAL Date:10/05/01ISR Number: 3806018-1Report Type:Expedited (15-DaCompany Report #C2001-2545.01 Age:77 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sepsis Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 75MG QD, ORAL Other Carbidopa/ Levodopa C Cefazolin C Ceftriazone C Gentamicin C Hyoscyamine C Lorazepam C Morphine C Ropinirole C 22-Feb-2006 08:30 AM Page: 1287 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/05/01ISR Number: 3806019-3Report Type:Expedited (15-DaCompany Report #C2001-2465.01 Age:59 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 500MG QD, Other ORAL (POSSIBLE) Captopri C Digoxin C Risperidone C Phenazopyridine C Date:10/05/01ISR Number: 3806983-2Report Type:Expedited (15-DaCompany Report #PHBS2001CA06268 Age:73 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Aspiration Foreign Clozaril(Clozapine) Study Tablet PS ORAL ORAL Health Antibiotics C Professional Fluid/Electrolyte Other Replacement Therapy(Fluid/Electr olyte Replacement Therapy) C Date:10/05/01ISR Number: 3807413-7Report Type:Expedited (15-DaCompany Report #268760 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Tamiflu Neutropenia Health (Oseltamivir) 75 Mg PS ORAL 75 MG 2 PER Professional 1 DAY ORAL Clozapine (Clozapine) SS ORAL 600 MG DAILY ORAL Date:10/05/01ISR Number: 3807481-2Report Type:Expedited (15-DaCompany Report #PHHO2001JP06538 Age:21 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Clex(Leponex / Initial or Prolonged Drug Ineffective Study Clozaril (Clozapine) Obsessive-Compulsive Health Lex+ ) PS 250 MG PER Disorder Professional DAY Other Rohypnol (Flunitrazepam) C Date:10/05/01ISR Number: 3807482-4Report Type:Expedited (15-DaCompany Report #PHNU2001DE02136 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Oculogyration Foreign Leponex/Clozaril Health (Clozapine) Professional (Clozapine) Tablet PS ORAL 500 MG/DAY, Other ORAL Akineton Retard (Biperiden 22-Feb-2006 08:30 AM Page: 1288 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride) C Date:10/05/01ISR Number: 3807533-7Report Type:Expedited (15-DaCompany Report #PHBS2001CA09627 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Alkaline Foreign Clozaril(Clozapine) Phosphatase Increased Health Tablet PS ORAL ORAL Drooling Professional Neurontin Erythema Other (Gabapentin) C Leukocytosis Nozinan C Rectal Haemorrhage Kemadrin Rectal Prolapse (Procyclidine Weight Decreased Hydrochloride) C Losec (Omeprazole) C Fesofor C Colace C Loxapac (Loxapine Succinate) C Ativan C Date:10/05/01ISR Number: 3807546-5Report Type:Expedited (15-DaCompany Report #PHBS2001AU09721 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiomyopathy Foreign Clozaril(Clozapine) PS ORAL ORAL Health Valium C Professional Efexor (Venlafaxine Other Hydrochloride) C Date:10/05/01ISR Number: 3807568-4Report Type:Expedited (15-DaCompany Report #PHBS2001AU09474 Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Clozaril(Clozapine) Study Tablet PS ORAL 12.5 MG/DAY, Health ORAL; 75 Professional MG/DAY, ORAL; Other 100 MG/DAY, ORAL; 200 Date:10/05/01ISR Number: 3808885-4Report Type:Expedited (15-DaCompany Report #PHFR2001GB02564 Age:53 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bradycardia Foreign Clozaril (Clozapine) Drug Interaction Health Tablet PS ORAL 225MG/DAY, Professional ORAL Other Thiopentone (Thiopental) SS INTRAVENOUS 225 MG, ONCE/SINGLE, INTRAVNEOUS Suxamethonium (Suxamethonium) SS INTRAVENOUS 40 MG, ONCE/SINGLE, INTRAVENOUS Non-Drug: Electrotherapy (No 22-Feb-2006 08:30 AM Page: 1289 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Ingredients/Substanc es) SS 1 DAY Latanoprost (Latanoprost) C Date:10/05/01ISR Number: 3808888-XReport Type:Expedited (15-DaCompany Report #PHFR2001GB02678 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Colitis Ulcerative Foreign Clozaril (Clozapine) Initial or Prolonged Health Tablet PS ORAL 200 MG, QID, Professional ORAL Other Date:10/05/01ISR Number: 3808892-1Report Type:Expedited (15-DaCompany Report #PHBS2001AU09547 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Multiple Myeloma Foreign Clozaril (Clozapine) Neutropenia Study Tablet PS 300 MG/D Health Chemotherapeutics, Professional Other Other (Chemotherapeutics, Other) SS Date:10/05/01ISR Number: 3808896-9Report Type:Expedited (15-DaCompany Report #PHRM2001FR02144 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypercholesterolaemia Foreign Leponex (Clozapine) Initial or Prolonged Hypertriglyceridaemia Health Tablet PS ORAL 600 MG DAILY, Professional ORAL Other Date:10/05/01ISR Number: 3808900-8Report Type:Expedited (15-DaCompany Report #PHNU2001DE02198 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Haemoglobin Increased Foreign Leponex (Clozapine) Polycythaemia Vera Health Tablet PS ORAL 300 MG, Professional DAILY, ORAL Other Lyogen (Fluphenazine) C Date:10/05/01ISR Number: 3808904-5Report Type:Expedited (15-DaCompany Report #PHFR2001GB02681 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dermatitis Foreign Clozaril (Clozapine) Initial or Prolonged Hypotension Health Tablet PS ORAL 150 MG, BID, Other Liver Function Test Professional ORAL Abnormal Other Procyclidine Myocarditis (Procyclidine) C Tachycardia Haloperidol C Upper Respiratory Tract Infection 22-Feb-2006 08:30 AM Page: 1290 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/05/01ISR Number: 3808918-5Report Type:Expedited (15-DaCompany Report #PHBS2001AU02897 Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiomegaly Foreign Clozaril Cardiomyopathy Health (Clozapine)Tablet PS ORAL 300 MG/DAY, Ejection Fraction Professional ORAL Abnormal Other Date:10/05/01ISR Number: 3808921-5Report Type:Expedited (15-DaCompany Report #PHBS2001AU09723 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Breast Cancer Female Foreign Clozaril(Clozapine) PS 425 MG/D Health Microgynon Professional (Levonorgestrel) SS 883 DAY Other Date:10/05/01ISR Number: 3808923-9Report Type:Expedited (15-DaCompany Report #PHBS2001AU09475 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiomyopathy Foreign Clozaril(Clozapine) PS 525 MG/D Health Professional Other Date:10/05/01ISR Number: 3808939-2Report Type:Expedited (15-DaCompany Report #PHBS2001CL09695 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Non-Hodgkin'S Lymphoma Foreign Clozaril (Clozapine) Disability Consumer Tablet PS ORAL 800 MG/D, Other ORAL Date:10/08/01ISR Number: 3806261-1Report Type:Expedited (15-DaCompany Report #HQ6442326SEP2001 Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Foreign Cordarone Initial or Prolonged Lower Respiratory Tract Health (Amiodarone) PS Wyeth ORAL 200 MG 1X PER Infection Professional 1 DAY ORAL Neurological Symptom Other Leponex (Clozapine, Overdose ) SS Novartis ORAL 25 MG 1X PER Psychiatric Symptom 1 DAY ORAL 2 DAY Sedation Madopar (Benserazide Urinary Incontinence Hydrochloride/Levodo pa) C Aspirine (Acetylsalicylic Acid) C Pravastatin (Pravastatin) C Norvasc (Amlodipine Besilate) C Augmentin (Amoxicillin Sodium/Clavulanate 22-Feb-2006 08:30 AM Page: 1291 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Potassium) C Fraxiparine (Heparin-Fraction, Calcium Salt) C Ped-El (Electrolytes Nos/Sorbitol) C Date:10/08/01ISR Number: 3806620-7Report Type:Expedited (15-DaCompany Report #PHBS2001AU02515 Age:21 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiomyopathy Foreign Clozaril(Clozapine) Echocardiogram Abnormal Health Tablet PS ORAL 400 MG/D, Gastritis Professional ORAL Orthostatic Hypotension Other Haloperidol C Tachycardia Date:10/08/01ISR Number: 3806622-0Report Type:Expedited (15-DaCompany Report #PHRM2001FR01882 Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Brain Abscess Foreign Leponex(Clozapine) Hospitalization - Brain Herniation Health Tablet PS ORAL 600 MG, QD, Initial or Prolonged Brain Oedema Professional ORAL Depressed Level Of Other Depamide(Valpromide) Consciousness Tablet SS ORAL 900 MG, QD, Electroencephalogram ORAL Abnormal Xanax(Alprazolam)Tab Leukocytosis let SS ORAL 2 MG, QD, Meningism ORAL Pneumococcal Infection Pyrexia Date:10/08/01ISR Number: 3806624-4Report Type:Expedited (15-DaCompany Report #PHBS2001AU07225 Age:18 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Fall Foreign Clozaril (Clozapine) Neuropathy Peripheral Health Tablet PS ORAL 400 MG/D, Professional ORAL Other Date:10/08/01ISR Number: 3806626-8Report Type:Expedited (15-DaCompany Report #PHBS2000AU11661 Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthma Foreign Clozaril Initial or Prolonged Bronchitis Health (Clozapine)(Clozapin Hypersensitivity Professional e) Tablet PS ORAL 250 MG/D, Myocarditis Other ORAL Pyrexia Solone C Euhypnos C Zactin (Fluoxetine Hydrochloride) C Paxam (Piroxicam) C 22-Feb-2006 08:30 AM Page: 1292 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/08/01ISR Number: 3806692-XReport Type:Expedited (15-DaCompany Report #PHBS2001CA09927 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anxiety Foreign Clozaril (Clozapine) Other Arrhythmia Study Tablet PS ORAL 75 MG/D, ORAL Delusion Health Cogentin Drug Level Changed Professional (Benzatropine Psychotic Disorder Other Mesilate) C Risperidone (Risperidone) C Clonazepam C Stelazine (Trifluoperazine Hydrochloride) C Valproate Sodium C Tegretol (Carbamazepine) C Date:10/08/01ISR Number: 3806693-1Report Type:Expedited (15-DaCompany Report #PHBS2001CA09591 Age:80 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coma Foreign Clozaril Study (Clozapine)Tablet PS ORAL 12.5 MG, QHS, Health ORAL Professional Sinemet (Levodopa, Other Carbidopa) C Date:10/08/01ISR Number: 3806726-2Report Type:Expedited (15-DaCompany Report #PHBS2001AU03265 Age:31 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Foreign Clozaril (Clozapine) Dysuria Study Tablet PS ORAL 600 MG/D, Hepatosplenomegaly Health ORAL Professional Other Date:10/08/01ISR Number: 3806729-8Report Type:Expedited (15-DaCompany Report #PHBS2000AU09745 Age:37 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Alkaline Foreign Clozaril (Clozapine) Phosphatase Increased Health (Clozapine) Tablet PS ORAL 250 MG, BID, Gamma-Glutamyltransferase Professional ORAL Increased Other Cogentin Muscle Atrophy (Benzatropine Mesilate) C Date:10/08/01ISR Number: 3806740-7Report Type:Expedited (15-DaCompany Report #PHBS2001AU01551 Age:47 YR Gender:Male I/FU:F Outcome PT Hospitalization - Anaemia Initial or Prolonged Eating Disorder Empyema Gastrointestinal Disorder 22-Feb-2006 08:30 AM Page: 1293 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Haemorrhage Lymphopenia Pneumonia Report Source Product Role Manufacturer Route Dose Duration Weight Decreased Foreign Clozaril (Clozapine) Study Tablet PS ORAL 200 MG/D, Health ORAL Professional Omeprazole Other (Omeprazole) C Clonazepam C Flucloxacillin (Flucloxacillin) C Date:10/08/01ISR Number: 3806741-9Report Type:Expedited (15-DaCompany Report #PHBS2001AU04475 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Circulatory Collapse Foreign Clozaril (Clozapine) Initial or Prolonged Loss Of Consciousness Study Tablet PS ORAL 600 MG/D, Disability Health ORAL Professional Warfarin (Warfarin) C Other Date:10/08/01ISR Number: 3806742-0Report Type:Expedited (15-DaCompany Report #PHBS2001AU02564 Age:49 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiomyopathy Foreign Clozaril (Clozapine) Condition Aggravated Health Tablet PS ORAL 400 MG, ORAL Professional Other Date:10/08/01ISR Number: 3806781-XReport Type:Expedited (15-DaCompany Report #2001UW12243 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Convulsion Foreign Seroquel "Zeneca" PS Intervention to Neutropenia Other Clonazepam SS Prevent Permanent Clozaril SS 148 DAY Impairment/Damage Estrogen SS Levothyroxine SS Singulair SS Date:10/08/01ISR Number: 3807636-7Report Type:Expedited (15-DaCompany Report #NSADSS2001029538 Age:38 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Literature Haldol (Unspecified) Health (Haloperidol) PS ORAL ORAL Professional Benztropine (Benztropine) SS Clozapine (Clozapine) SS 22-Feb-2006 08:30 AM Page: 1294 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/09/01ISR Number: 3806618-9Report Type:Expedited (15-DaCompany Report #PHBS2001AU01070 Age:21 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiomyopathy Foreign Clozaril (Clozapine) PS ORAL 500 MG/DAY, Obesity Health ORAL Salivary Hypersecretion Professional Olanzapine Sedation Other (Olanzapine) C Date:10/10/01ISR Number: 3807152-2Report Type:Expedited (15-DaCompany Report #PHFR2001GB02691 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chest Discomfort Foreign Clozaril (Clozapine) Hyperhidrosis Health Tablet PS ORAL 250MG/DAY, Tachycardia Professional ORAL Other Date:10/10/01ISR Number: 3807153-4Report Type:Expedited (15-DaCompany Report #PHFR2001GB02715 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Oculogyration Foreign Clozaril (Clozapine) Health Tablet PS ORAL 625MG/DAY, Professional ORAL Other Amitriptyline (Amitriptyline) C Date:10/10/01ISR Number: 3807154-6Report Type:Expedited (15-DaCompany Report #PHFR2001GB02718 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Lower Respiratory Tract Foreign Clozaril (Clozapine) Infection Health Tablet PS ORAL 350 MG/DAY, Petit Mal Epilepsy Professional ORAL Urinary Tract Infection Other Lamotrigine C Date:10/10/01ISR Number: 3807155-8Report Type:Expedited (15-DaCompany Report #PHBS2001AU09762 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Ketoacidosis Foreign Clozaril (Clozapine) Initial or Prolonged Health Tablet PS ORAL 200 MG, QD, Professional ORAL Other Date:10/10/01ISR Number: 3807156-XReport Type:Expedited (15-DaCompany Report #PHNU2001DE01807 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Thyrotoxic Crisis Health Leponex (Clozaril) Initial or Prolonged Professional (Clozapine) Other (Clozaril) Tablet PS ORAL ORAL Dipiperon (Pipamperone) C 22-Feb-2006 08:30 AM Page: 1295 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/10/01ISR Number: 3807909-8Report Type:Expedited (15-DaCompany Report #PHBS2001AU09873 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiomyopathy Foreign Clozaril(Clozapine)T Initial or Prolonged Study ablet PS ORAL 450 MG/D, Health ORAL Professional Other Date:10/10/01ISR Number: 3807910-4Report Type:Expedited (15-DaCompany Report #PHFR2001GB02685 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dehydration Foreign Clozaril (Clozapine) Initial or Prolonged Diarrhoea Health (Clozapine)Tablet PS ORAL 300MG/DAY, Dizziness Professional ORAL Hyponatraemia Other Renal Impairment Tachycardia Date:10/10/01ISR Number: 3807912-8Report Type:Expedited (15-DaCompany Report #PHBS2001NZ09761 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Level Above Foreign Clozaril(Clozapine) Therapeutic Health Tablet PS ORAL 250 MG/D, Dyspnoea Professional ORAL Malaise Other Atenolol C Orphenadrine (Orphenadrine) C Atorvastatin (Atorvastatin) C Clonazepam C Temazepam C Desmopressin (Desmopressin) C Mylanta (Aluminum Hydroxide Gel, Dried, Simeticone) C Date:10/10/01ISR Number: 3807937-2Report Type:Expedited (15-DaCompany Report #PHBS2001AU09597 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neoplasm Malignant Foreign Clozaril(Clozapine)T Study ablet PS ORAL 600 MG/D, Health ORAL Professional Other Date:10/10/01ISR Number: 3807941-4Report Type:Expedited (15-DaCompany Report #PHBS2001AU09474 Age:38 YR Gender:Male I/FU:F Outcome PT Death Alcoholism Completed Suicide Emotional Distress 22-Feb-2006 08:30 AM Page: 1296 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Intentional Overdose Report Source Product Role Manufacturer Route Dose Duration Foreign Clozaril(Clozapine) Study Tablet PS ORAL 12.5 MG/DAY, Health ORAL Professional Clozaril SS ORAL 75 MG/DAY, Other ORAL Clozaril SS ORAL 100 MG/DAY, ORAL Clozaril SS ORAL 200 MG/DAY, ORAL Clozaril SS ORAL 250 MG/DAY, ORAL Date:10/10/01ISR Number: 3807950-5Report Type:Expedited (15-DaCompany Report #PHFR2001GB02262 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril(Clozapine) Health Tablet PS ORAL 400MG/DAY, Professional ORAL Other Glipizide (Glipizide) C Date:10/11/01ISR Number: 3807649-5Report Type:Direct Company Report # Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Clozapine PS Prolonged Fluvoxamine SS Date:10/11/01ISR Number: 3808040-8Report Type:Expedited (15-DaCompany Report #01-10-0550 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neoplasm Malignant Health Clozapine PS Zenith Goldline Parkinson'S Disease Professional Pharm ORAL 37.5MG QD ORAL Dilantin C Remeron C Symmetrel C Ambien C Prozac C Singulair C Date:10/11/01ISR Number: 3808041-XReport Type:Expedited (15-DaCompany Report #01-10-0549 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hepatic Neoplasm Health Clozapine - Zenith Malignant Professional Goldline Pharm. Tablets PS ORAL 300MG QD ORAL 22-Feb-2006 08:30 AM Page: 1297 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/11/01ISR Number: 3808042-1Report Type:Expedited (15-DaCompany Report #01-09-0491 Age:42 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Appendicitis Perforated Health Clozapine PS Zenith Goldline Hospitalization - Hypertonia Professional Pharm. ORAL 300-700MG QD Initial or Prolonged Nausea ORAL Pyrexia Depakote C Vomiting Zyprexa C Mylanta C Peri-Colace C Risperdal C Clonazepam C Singulair C Augmentin C Date:10/12/01ISR Number: 3807814-7Report Type:Expedited (15-DaCompany Report #B0122642A Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bradycardia Suxamethonium PS Glaxo Wellcome INTRAVENOUS 40MG Single Drug Interaction dose 1 DAY Hypertension Clozapine SS ORAL 225MG Per day Thiopentone SS INTRAVENOUS 225MG Single dose 1 DAY Latanoprost C OPHTHALMIC Date:10/12/01ISR Number: 3809741-8Report Type:Expedited (15-DaCompany Report #A123176 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Ziprasidone Po PS 160.00 MG Professional TOTAL Company Clozaril SS 250.00 MG Representative TOTAL Date:10/12/01ISR Number: 3809835-7Report Type:Expedited (15-DaCompany Report #A123221 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Confusional State Health Sinequan Capsules PS 100.00 MG Intervention to Disorientation Professional TOTAL:DAILY Prevent Permanent Dyskinesia Clozapine SS Impairment/Damage Gait Disturbance Thorazine SS 200.00 MG Haematoma TOTAL:DAILY Movement Disorder Orthostatic Hypotension Pain Sedation Speech Disorder Date:10/15/01ISR Number: 3809411-6Report Type:Expedited (15-DaCompany Report #01/07/0409 Age:49 YR Gender:Female I/FU:F Outcome Required Intervention to Prevent Permanent 22-Feb-2006 08:30 AM Page: 1298 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Confusional State Health Clozapine PS Zenith Goldline Disorientation Professional Pharm. ORAL 150MG BID Fall ORAL Gait Disturbance Thorazine Tablets SS ORAL 200MG HS ORAL MON Haematoma Sinequan Capsules SS ORAL 100MG HS ORAL MON Haemorrhage Bacitracin C Movement Disorder Bacitracin/Neomycin/ Orthostatic Hypotension Polymyxin B C Sedation Lithium C Skin Injury Date:10/15/01ISR Number: 3809412-8Report Type:Expedited (15-DaCompany Report #01-10-0551 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neoplasm Malignant Health Clozapine Tablets PS Zenith Goldline Professional Pharm. ORAL 350MG QD ORAL Date:10/15/01ISR Number: 3809413-XReport Type:Expedited (15-DaCompany Report #01-10-0552 Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Health Clozapine Tablets PS Zenith Goldline Professional Pharm. ORAL 50MG QD ORAL Vitamin C C Centrum C Lorazepam C Fosfree C Hydrochlorothiazide C Lortab Elixir C Lopressor Nitrostat C Morphihne Sulfate C Duragesic Patch C Zoloft C Date:10/15/01ISR Number: 3809414-1Report Type:Expedited (15-DaCompany Report #01-09-0493 Age:76 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Depressed Level Of Health Clozapine Tablets PS Zenith Goldline Consciousness Professional Pharm. ORAL 75-100MG QD Sepsis ORAL Urinary Tract Disorder Paxil C White Blood Cell Count Sinemet C Increased Metamucil Wafers C Peri-Colace 1hr C Miacalcin Spay C Benadryl Elixir C Dyazide C 22-Feb-2006 08:30 AM Page: 1299 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/15/01ISR Number: 3809415-3Report Type:Expedited (15-DaCompany Report #01-09-0513 Age:72 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Intestinal Infarction Health Clozapine Tablets PS Zenith Goldline Sepsis Professional Pharm. ORAL 75MG BID ORAL Date:10/15/01ISR Number: 3809416-5Report Type:Expedited (15-DaCompany Report #01-09-0537 Age:62 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Respiratory Arrest Health Clozapine Tablets PS Zenith Goldline Professional Pharm. ORAL 100-300MG QD ORAL Date:10/15/01ISR Number: 3809418-9Report Type:Expedited (15-DaCompany Report #01-09-0507 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Clozapine Tablets PS Zenith Goldline Congestive Professional Pharm. ORAL 800MG QD ORAL Condition Aggravated Depakote C Respiratory Disorder Mevacor C Loxapine C Seroquel C Date:10/15/01ISR Number: 3809420-7Report Type:Expedited (15-DaCompany Report #C2001-2477.01 Age:67 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Aspiration Health Clozapine PS Mylan ORAL 100MG Q HS, Professional ORAL Other Acetaminophen/Codein e C Albuterol Nebulizer C Albuterol/Pratropium Inhalation C Ibuprofen C Lorazepam C Senna C Trihexyphenidyl C Vitamin C C Znic C Potassium Chloride Er C Fludrocortisone C Ranitidine C Date:10/15/01ISR Number: 3809421-9Report Type:Expedited (15-DaCompany Report #C2001-2936.01 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 50MG QD, ORAL Other Carbidopa/Levodopa C Captopril C Sertraline C Clopidogrel C 22-Feb-2006 08:30 AM Page: 1300 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Aspirin C Multivitamin C Calcium Citrate C Alendronate C Olanzapine C Pergolide C Polysaccharide Iron Complex C Date:10/15/01ISR Number: 3809423-2Report Type:Expedited (15-DaCompany Report #C2001-2935.01 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Post Procedural Health Clozapine PS Mylan ORAL 37.5 MG QD, Complication Professional ORAL Other Carbidopa/Levodopa C Lorazepam C Trazodone C Date:10/16/01ISR Number: 3809852-7Report Type:Direct Company Report # Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Leukocytosis Lithobid (600 Mg) Intervention to (Solvay Prevent Permanent Pharmaceuticals) PS Solvay Impairment/Damage Pharmaceuticals ORAL 600 MG QHS PO Clozapine (400mg) SS ORAL (400 MG) BID PO Klonopin C Clonidine C Cogentin C Date:10/16/01ISR Number: 3810160-9Report Type:Expedited (15-DaCompany Report #PHFR2001GB02082 Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diarrhoea Foreign Clozaril (Clozapine) Headache Health Tablet PS ORAL 100 MG, QD, Hyperhidrosis Professional ORAL Neck Pain Other Paracetamol Visual Disturbance (Paracetamol) C Visual Field Defect Vomiting Date:10/16/01ISR Number: 3810163-4Report Type:Expedited (15-DaCompany Report #PHBS2001AU02331 Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sleep Apnoea Syndrome Foreign Clozaril (Clozapine) Sleep Disorder Study Tablet PS ORAL 400 MG, QD, Snoring Health ORAL Professional Other 22-Feb-2006 08:30 AM Page: 1301 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/16/01ISR Number: 3810164-6Report Type:Expedited (15-DaCompany Report #PHBS2001AU09597 Age:23 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Testis Cancer Foreign Clozaril (Clozapine) Study Tablet PS ORAL 600 MG/D, Health ORAL Professional Other Date:10/16/01ISR Number: 3810170-1Report Type:Expedited (15-DaCompany Report #PHHO2000GB00343 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Toxicity Foreign Clozaril (Clozapine) Hepatic Steatosis Study Tablet PS ORAL 600MG/DAY, Overdose Health ORAL 2548 DAY Professional Other Date:10/16/01ISR Number: 3810171-3Report Type:Expedited (15-DaCompany Report #PHFR2001GB02719 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cerebrovascular Accident Foreign Clozaril (Clozapine) Health Tablet PS ORAL 300MG/DAY, Professional ORAL Other Date:10/16/01ISR Number: 3810293-7Report Type:Expedited (15-DaCompany Report #PHBS2001CA09027 Age:47 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Intentional Overdose Foreign Clozaril (Clozapine) Hospitalization - Neutrophil Count Study Tablet PS ORAL 900 MG/D, 18 Initial or Prolonged Increased Health TABLETS/D Pneumonia Aspiration Professional ORAL Suicide Attempt Other Motilium "Byk Gulden" (Domperidone) C Pantoloc "Solvay" (Pantoprazole Sodium) C Date:10/16/01ISR Number: 3810488-2Report Type:Expedited (15-DaCompany Report #PHEH2001US08062 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Mass Health Clozaril (Clozapine) Lymphoma Professional Tablet PS ORAL 550 MG, ORAL Oedema Peripheral Zyprexa (Olanzapine) C Prolixin (Fluphenazine Hydrochloride) C 22-Feb-2006 08:30 AM Page: 1302 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/16/01ISR Number: 3810491-2Report Type:Expedited (15-DaCompany Report #PHEH2001US08128 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Health Clozaril (Clozapine) Initial or Prolonged Delirium Professional Tablet PS ORAL 350 MG, BID, Drug Level Changed ORAL Movement Disorder Tremor Date:10/16/01ISR Number: 3810493-6Report Type:Expedited (15-DaCompany Report #PHEH2001US08218 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lymphoma Health Clozaril (Clozapine) Other Professional Tablet PS ORAL ORAL Date:10/16/01ISR Number: 3810494-8Report Type:Expedited (15-DaCompany Report #PHEH2001US08135 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Health Clozaril(Clozapine)T Initial or Prolonged Drug Level Above Professional ablet PS ORAL SEE IMAGE Therapeutic Lithium (Lithium) C Fall Synthroid C Leukocytosis Zoloft (Sertraline Pleural Effusion Hydrochloride) C Date:10/17/01ISR Number: 3810559-0Report Type:Expedited (15-DaCompany Report #01-10-0559 Age:42 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Unevaluable Event Health Clozapine - Zenith Initial or Prolonged Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 100-500MG QD ORAL Date:10/17/01ISR Number: 3810566-8Report Type:Expedited (15-DaCompany Report #01-10-0555 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 100-750MG QD ORAL Date:10/17/01ISR Number: 3810568-1Report Type:Expedited (15-DaCompany Report #01-10-0553 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Gastrointestinal Health Clozapine - Zenith Obstruction Professional Goldline Pharm. Neoplasm Malignant Tablets PS Zenith Goldline Pharm. ORAL 12.5-25MG QD ORAL 22-Feb-2006 08:30 AM Page: 1303 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sinemet C Vitamin E C Oscal C Amantadine C Multivitamins And Iron C Date:10/17/01ISR Number: 3810584-XReport Type:Expedited (15-DaCompany Report #C2001-2465-01 Age:59 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Health Clozapine Tablets Professional 100 Mg Mylan PS 500 MG Q HS Other ORAL (POSSIBLE) Captopri C Digoxin C Risperidone C Phenazopyridine C Date:10/17/01ISR Number: 3810779-5Report Type:Expedited (15-DaCompany Report #EMADSS2001005883 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ileus Paralytic Foreign Haldol (Unspecified) Initial or Prolonged Study (Haloperidol) PS ORAL 10MG, DAILY, Health ORAL; 20MG Professional DAILY, ORAL; 15MG, DAILY, ORAL; 10MG, Leponex (Clozapine) SS ORAL 300 MG,DAILY,ORAL ; 900 MG, DAILY,ORAL ; 800 Glianimon (Benperidol) SS ORAL 10 MG, DAILY, ORAL Melleril Ret (Thioridazine Hydrochloride) SS ORAL 400 MG, DAILY, ORAL ; 600 MG, DAILY, ORAL Akineton Ret (Biperiden Hydrochloride) SS ORAL 4 MG, DAILY, ORAL Gastrozepin (Pirenzepine Dihydrochloride) SS ORAL 100 MG, DAILY, ORAL ; 150 MG, DAILY, ORAL 22-Feb-2006 08:30 AM Page: 1304 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/18/01ISR Number: 3811362-8Report Type:Expedited (15-DaCompany Report #PHNU2001DE02293 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Leponex/Clozaril Overdose Health (Clozapine) Professional (Clozapine) Tablet PS Other Date:10/18/01ISR Number: 3811363-XReport Type:Expedited (15-DaCompany Report #PHFR2001GB02788 Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril (Clozapine) Health Tablet PS ORAL 325 MG/DAY, Professional ORAL Other Date:10/18/01ISR Number: 3811364-1Report Type:Expedited (15-DaCompany Report #PHBS2001CA09927 Age:46 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anxiety Foreign Clozaril (Clozapine) Other Arrhythmia Study Tablet PS ORAL 75 MG/D, ORAL Delusion Health Clonazepam C Drug Level Below Professional Tegretol Therapeutic Other (Carbamazepine) C Drug Level Changed Cogentin Psychotic Disorder (Benzatropine Mesilate) C Risperidone (Risperidone) C Stelazine (Trifluoperazine Hydrochloride) C Valproate Sodium C Date:10/18/01ISR Number: 3811368-9Report Type:Expedited (15-DaCompany Report #PHRM2001FR01577 Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Atrial Tachycardia Foreign Leponex (Clozapine) Health Tablet PS ORAL 200 MG, TID, Professional ORAL ; 600 MG Other PER DAY, ORAL Depakine Chrono C Zocor C Imovane C Mopral (Omeprazole) C Peristaltine (Cascara Dry Extract) C 22-Feb-2006 08:30 AM Page: 1305 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/18/01ISR Number: 3811396-3Report Type:Expedited (15-DaCompany Report #PHNU2001DE00828 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Foreign Leponex (Clozapine) Initial or Prolonged Diabetes Mellitus Health Tablet PS ORAL SEE IMAGE Insulin-Dependent Professional Zantic C Leukopenia Other Calcium C Lymphopenia Date:10/18/01ISR Number: 3811427-0Report Type:Expedited (15-DaCompany Report #B0122642A Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bradycardia Foreign Anectine Hypertension (Formulation Unknown) (Succinylcholine Chloride) PS INTRAVENOUS 40 MG / SINGLE DOSE / INTRAVENOUS Clozapine (Formulation Unknown) (Clozapine) SS ORAL 225 MG / PER DAY / ORAL Thiopentone Sodium (Formulation Unknown) (Thiopental Sodium) SS INTRAVENOUS 225 MG / SINGLE DOSE / INTRAVENOUS Latanoprost C Date:10/18/01ISR Number: 3811587-1Report Type:Expedited (15-DaCompany Report #PHEH2001US07520 Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozaril (Clozapine) Cardiac Failure Professional Tablet PS ORAL 125 MG, ORAL Congestive Obesity Date:10/18/01ISR Number: 3811589-5Report Type:Expedited (15-DaCompany Report #PHEH2001US07244 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Fall Health Clozaril (Clozapine) Professional Tablet PS ORAL 50 MG, ORAL Date:10/18/01ISR Number: 3811592-5Report Type:Expedited (15-DaCompany Report #PHEH2001US06677 Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Convulsion Health Clozaril (Clozapine) Hospitalization - Hepatic Failure Professional Tablet PS ORAL 375 MG, BID, Initial or Prolonged Hepatic Necrosis ORAL Haldol C Ditropan 22-Feb-2006 08:30 AM Page: 1306 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Oxybutynin) C Date:10/18/01ISR Number: 3811608-6Report Type:Expedited (15-DaCompany Report #PHEH2001US08258 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agranulocytosis Health Clozaril (Clozapine) Hospitalization - Asthma Professional Tablet PS ORAL 50 MG, TID, Initial or Prolonged Obesity ORAL Osteoarthritis Cogentin Renal Failure (Benzatropine Mesilate) C Trileptal "Novartis" C Date:10/18/01ISR Number: 3811635-9Report Type:Expedited (15-DaCompany Report #PHBS2001US09909 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Literature Clozapine Mania Health (Clozapine) Unknown PS Weight Decreased Professional Thyroxine C Weight Increased Valproic Acid C Gabapentin (Gabapentin) C Date:10/18/01ISR Number: 3811713-4Report Type:Expedited (15-DaCompany Report #PHEH2001US08284 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Lymphoma Health Clozaril (Clozapine) PS ORAL ORAL Professional Date:10/18/01ISR Number: 3811777-8Report Type:Expedited (15-DaCompany Report #A122356 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abnormal Behaviour Consumer Ziprasidone Po PS ORAL 120.00 MG Hospitalization - Catatonia Health TOTAL: BID: Initial or Prolonged Condition Aggravated Professional ORAL Endocardial Fibrosis Clozaril SS 400.00 MG Eye Rolling TOTAL: DAILY Hallucination, Auditory Clozapine C Mitral Valve Prolapse Lamictal Orthostatic Hypotension (Lamotrigine) C Sudden Death Ativan (Lorazepam) C Casanthranol/Docsuat e Sodium C Metamucil (Psyllium) C Celexa (Citalopram) C Inderal (Propranolol) C Cogentin C Lamictal C 22-Feb-2006 08:30 AM Page: 1307 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/18/01ISR Number: 3811829-2Report Type:Expedited (15-DaCompany Report #PHEH2001US08329 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Level Above Health Clozaril(Clozapine) Therapeutic Professional Tablet PS ORAL 750 MG/DAY, Drug Level Changed ORAL Paxil C Prevacid (Lansoprazole) C Neurontin (Gabapentin) C Depakote (Valproate Semisodium) C Cogentin (Benzatopine Mesilate) C Atenolol C Haldol C Lipitor (Atorvastatin) C Synthroid C Date:10/18/01ISR Number: 3812188-1Report Type:Expedited (15-DaCompany Report #PHFR2001GB02777 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chest Pain Foreign Clozaril(Clozapine) Respiratory Disorder Health Tablet PS ORAL 125MG/DAY, Professional ORAL Date:10/18/01ISR Number: 3812194-7Report Type:Expedited (15-DaCompany Report #PHBS2001AU08969 Age:18 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Chest Pain Foreign Clozaril(Clozapine) Neutrophil Count Health Tablet PS ORAL 150 MG/D, Decreased Professional ORAL Oesophagitis Orthostatic Hypotension Tachycardia Date:10/19/01ISR Number: 3811481-6Report Type:Direct Company Report # Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancreatitis Acute Clozapine(200mg Am Initial or Prolonged And 300mg Q Hs) PS 200MG AM AND 300MG Q HS Date:10/19/01ISR Number: 3811736-5Report Type:Expedited (15-DaCompany Report #01-09-0504 Age:59 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Refusal Of Treatment By Health Clozapine - Zenith Hospitalization - Patient Professional Goldline Pharm. Initial or Prolonged Tablets PS Zenith Goldline Pharm. ORAL 25MG ORAL 22-Feb-2006 08:30 AM Page: 1308 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/19/01ISR Number: 3811737-7Report Type:Expedited (15-DaCompany Report #01-09-0492 Age:58 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Chronic Obstructive Health Clozapine - Zenith Pulmonary Disease Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 300-700MG QD ORAL Date:10/19/01ISR Number: 3811738-9Report Type:Expedited (15-DaCompany Report #01-10-0556 Age:66 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Brain Neoplasm Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 100-575MG QD ORAL Date:10/19/01ISR Number: 3811739-0Report Type:Expedited (15-DaCompany Report #01-10-0560 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neoplasm Malignant Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 350-900MG QD ORAL Date:10/19/01ISR Number: 3811740-7Report Type:Expedited (15-DaCompany Report #C2001-2940.01 Age:92 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Aspiration Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 100MG, QD, Other ORAL Date:10/19/01ISR Number: 3811742-0Report Type:Expedited (15-DaCompany Report #C2001-2466.01 Age:81 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Health Clozapine Tablets Hospitalization - Professional Mylan PS Mylan ORAL 50MG QD, ORAL Initial or Prolonged Other Date:10/19/01ISR Number: 3812835-4Report Type:Expedited (15-DaCompany Report #DEU004542 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ileus Paralytic Foreign Akineton Retard PS ORAL 4 MG OD PO Initial or Prolonged Health Leponex "Novartis" SS Novartis ORAL 100 MG TID PO Professional Leponex "Novartis" SS Novartis ORAL 300 MG TID PO Other Leponex "Novartis" SS Novartis ORAL 800 MG DAILY PO Haldol SS ORAL 10 MG DAILY PO 22-Feb-2006 08:30 AM Page: 1309 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Haldol SS ORAL 15 MG DAILY PO Glianimon SS ORAL 10 MG DAILY PO Melleril - Slow Release "Novartis" SS Novartis ORAL 200 MG TID PO Gastrozepin SS ORAL 50 MG TID PO Gastrozepin SS ORAL 50 MG BID PO Melleril - Slow Release "Novartis" SS Novartis ORAL 200 MG BID PO Haldol SS ORAL 10 MG DAILY PO Haldol SS ORAL 20 MG DAILY PO Leponex "Novartis" SS Novartis ORAL 700 MG DAILY PO Euglucon N C Glucobay C Date:10/23/01ISR Number: 3812728-2Report Type:Expedited (15-DaCompany Report #IRL/99/01193/LEX Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril (Clozapine) Gamma-Glutamyltransferase Health (Clozapine) Tablet PS ORAL ORAL Increased Professional Other Date:10/23/01ISR Number: 3812729-4Report Type:Expedited (15-DaCompany Report #PHBS2001CO09420 Age:31 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Distension Foreign Leponex (Clozapine) Initial or Prolonged Acute Abdomen Health Tablet PS ORAL 300 MG/DAY, Asthenia Professional ORAL Constipation Other Haloperidol C Dehydration Clonazepam C Disorientation Fluconazole Faecaloma (Fluconazole) C Gastrointestinal Necrosis Imopenem C Haematemesis Levomepromazine C Hyperaemia Intestinal Obstruction Multi-Organ Failure Pain Peristalsis Visible Proctitis Sedation Sepsis Urinary Retention Vomiting Date:10/23/01ISR Number: 3812733-6Report Type:Expedited (15-DaCompany Report #PHRM2001FR02233 Age:50 YR Gender:Female I/FU:I Outcome PT Hospitalization - Erythema Nodosum Initial or Prolonged Pyrexia 22-Feb-2006 08:30 AM Page: 1310 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Red Blood Cell Sedimentation Rate Increased Report Source Product Role Manufacturer Route Dose Duration Skin Lesion Foreign Leponex (Clozapine) Thrombocythaemia Health Tablet PS ORAL 75 MG PER Professional DAY, ORAL Other Date:10/23/01ISR Number: 3812735-XReport Type:Expedited (15-DaCompany Report #PHBS2001SE10034 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bundle Branch Block Left Foreign Leponex (Clozapine) Initial or Prolonged Cardiac Failure Consumer Tablet PS ORAL 125 MG/DAY, Cardiac Murmur Health ORAL Cardiomegaly Professional Nitrazepam "Recip" C Cardiomyopathy Other Echocardiogram Abnormal Electrocardiogram T Wave Inversion Date:10/23/01ISR Number: 3812790-7Report Type:Expedited (15-DaCompany Report #PHRM2001FR01737 Age:25 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other C-Reactive Protein Foreign Leponex (Clozapine) Increased Health Tablet PS ORAL 800 MG DAILY, Hepatic Steatosis Professional ORAL Microcytic Anaemia Other Risperdal (Risperidone) C Date:10/23/01ISR Number: 3812810-XReport Type:Expedited (15-DaCompany Report #PHFR2001GB02691 Age:38 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Discomfort Foreign Clozaril(Clozapine) Initial or Prolonged Chest Pain Health Tablet PS ORAL 250MG/DAY, Dizziness Professional ORAL Electrocardiogram Other Abnormal Fatigue Heart Rate Decreased Hyperhidrosis Myocarditis Tachycardia Date:10/23/01ISR Number: 3813317-6Report Type:Direct Company Report # Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Amylase Increased Clozapine (100mg Lipase Increased Tab) PS ORAL 100MG/DAY ORAL Fluphenazine C Lorazepam C Benztropine C 22-Feb-2006 08:30 AM Page: 1311 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/23/01ISR Number: 3813578-3Report Type:Expedited (15-DaCompany Report #PHBS2001AU10052 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiomyopathy Foreign Clozaril(Clozapine) Initial or Prolonged Study Tablet PS ORAL 500 MG/DAY, Health ORAL Professional Other Date:10/23/01ISR Number: 3813617-XReport Type:Expedited (15-DaCompany Report #PHFR2001GB02681 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - C-Reactive Protein Foreign Clozaril (Clozapine) Initial or Prolonged Increased Health Tablet PS ORAL 100 MG, BID, Other Condition Aggravated Professional ORAL Dermatitis Haloperidol C Extrasystoles Procyclidine Hypertension (Procyclidine) C Hypotension Lorazepam C Influenza Like Illness Liver Function Test Abnormal Myocarditis Palpitations Red Blood Cell Sedimentation Rate Increased Supraventricular Tachycardia Tachycardia Upper Respiratory Tract Infection Date:10/23/01ISR Number: 3813620-XReport Type:Expedited (15-DaCompany Report #PHBS2001AU09475 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiomyopathy Foreign Clozaril (Clozapine) PS 525 MG/D Dyspnoea Study Lithium (Lithium) C Extrasystoles Health Valproate Sodium C Fibrosis Professional Thyroxine C Scar Calcitriol (Calcitriol) C Norvasc C Enalapril (Enalapril) C Date:10/23/01ISR Number: 3813709-5Report Type:Expedited (15-DaCompany Report #PHBS2001AU09597 Age:23 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Testis Cancer Foreign Clozaril(Clozapine)T Study ablet PS ORAL 600 MG/D, Health ORAL Professional Haldol C Other Serenace C Cogentin 22-Feb-2006 08:30 AM Page: 1312 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Benzatropine Mesilate) C Naprosyn C Pepcidin C Date:10/23/01ISR Number: 3813729-0Report Type:Expedited (15-DaCompany Report #PHBS2001CA10287 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Clozaril(Clozapine)T Study ablet PS ORAL ORAL Health Professional Other Date:10/23/01ISR Number: 3813784-8Report Type:Expedited (15-DaCompany Report #PHBS2001AU10083 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiomyopathy Foreign Clozaril (Clozapine) Health Tablet PS ORAL 300 MG/DAY, Professional ORAL Other Date:10/23/01ISR Number: 3813938-0Report Type:Expedited (15-DaCompany Report #PHBS2001AU00533 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coma Foreign Clozaril (Clozapine) Convulsion Study Tablet PS ORAL 450 MG, QD, Cough Health ORAL Depressed Level Of Professional Amitriptyline Consciousness Other (Amitriptyline) SS Dyspnoea Intentional Overdose Date:10/23/01ISR Number: 3813954-9Report Type:Expedited (15-DaCompany Report #PHFR2001GB02438 Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Foreign Clozaril (Clozapine) PS SEE IMAGE Grand Mal Convulsion Health Clomipramine Obsessive-Compulsive Professional (Clomipramine) C Disorder Other Sedation Tachycardia Tic Date:10/23/01ISR Number: 3814212-9Report Type:Expedited (15-DaCompany Report #A123176 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Consumer Ziprasidone Po PS 160.00 MG Health TOTAL: BID: Professional Clozapine SS 300.00 MG Company TOTAL:DAILY: Representative Lipitor 22-Feb-2006 08:30 AM Page: 1313 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Atorvastatin) C Ambien (Zolpidem) C Unspecified Antihypertensive Medication C Date:10/24/01ISR Number: 3814866-7Report Type:Expedited (15-DaCompany Report #PHBS2001CA10287 Age:59 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Clozaril (Clozapine) PS ORAL ORAL Study Health Professional Other Date:10/24/01ISR Number: 3814887-4Report Type:Expedited (15-DaCompany Report #PHEH2001US06442 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Health Clozaril (Clozapine) Hospitalization - Professional Tablet PS ORAL 900 MG, ORAL Initial or Prolonged Date:10/24/01ISR Number: 3814888-6Report Type:Expedited (15-DaCompany Report #PHEH2001US07418 Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozaril (Clozapine) Professional Tablet PS ORAL 900 MG/DAY ORAL Eskalith C Lithium (Lithium) C Cogentin (Benzatropine Mesilate) C Atenolol C Depakote (Valproate Semisodium) C Vitamin E C Date:10/24/01ISR Number: 3814923-5Report Type:Expedited (15-DaCompany Report #PHBS2001CA10078 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Haemolytic Anaemia Foreign Clozaril (Clozapine) PS ORAL ORAL Initial or Prolonged Jaundice Study Platelet Count Decreased Health Professional Other Date:10/24/01ISR Number: 3815024-2Report Type:Expedited (15-DaCompany Report #PHEH2001US08128 Age:25 YR Gender:Male I/FU:F Outcome Life-Threatening Hospitalization - 22-Feb-2006 08:30 AM Page: 1314 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Initial or Prolonged PT Report Source Product Role Manufacturer Route Dose Duration Accidental Overdose Health Clozaril (Clozapine) Coma Professional Tablet PS ORAL 350 MG/DAY, Confusional State ORAL Delirium Delusion Drug Level Changed Movement Disorder Tremor Date:10/24/01ISR Number: 3815380-5Report Type:Expedited (15-DaCompany Report #PHEH2001US08462 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neoplasm Malignant Health Clozaril (Clozapine) Hospitalization - Professional Tablet PS ORAL 100 MG, ORAL Initial or Prolonged Date:10/24/01ISR Number: 3815384-2Report Type:Expedited (15-DaCompany Report #PHEH2001US08135 Age:49 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Health Clozaril (Clozapine) Initial or Prolonged Drug Level Above Professional Tablet PS ORAL SEE IMAGE Therapeutic Lithium (Lithium) C Empyema Synthroid C Fall Zoloft (Sertraline Leukocytosis Hydrochloride) C Pleural Effusion Zyprexa (Olanzapine) C Betoptic (Betaxolol Hydrochloride) C Vioxx (Rofecoxib) C Colace C Dulcolax C Triamcinolone (Triamcinolone) C Date:10/25/01ISR Number: 3813994-XReport Type:Expedited (15-DaCompany Report #WAES 01107284 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arteriosclerosis Cogentin PS Merck & Co., Inc ORAL Cardiac Arrest Clozapine SS ORAL Cardiomegaly Loss Of Consciousness Myocardial Infarction Shock Viral Upper Respiratory Tract Infection 22-Feb-2006 08:30 AM Page: 1315 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/25/01ISR Number: 3815564-6Report Type:Expedited (15-DaCompany Report #01-08-0467 Age:51 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Haematemesis Health Clozapine PS Zenith Goldline Upper Gastrointestinal Professional Pharm ORAL 400-500 MG QD Haemorrhage ORAL Date:10/25/01ISR Number: 3815566-XReport Type:Expedited (15-DaCompany Report #01-07-0375 Age:70 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Health Clozapine PS Zenith Goldline Hospitalization - Myocardial Infarction Professional Pharm. ORAL ORAL Initial or Prolonged Date:10/25/01ISR Number: 3815567-1Report Type:Expedited (15-DaCompany Report #01-08-0425 Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Heat Exhaustion Health Clozapine PS Zenith Goldline Heat Stroke Professional Pharm. ORAL 400 MG HS ORAL Celexa Tablets SS ORAL 200 MG QD ORAL Benztropine Mesylate C Date:10/25/01ISR Number: 3815569-5Report Type:Expedited (15-DaCompany Report #01-09-0540 Age:57 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine- Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 400 MG HS ORAL Date:10/25/01ISR Number: 3815571-3Report Type:Expedited (15-DaCompany Report #01-10-0565 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine -Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 50-175 MG QD ORAL Date:10/25/01ISR Number: 3815573-7Report Type:Expedited (15-DaCompany Report #01-10-0564 Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Zenith Goldline Professional Pharm ORAL 125-400 MG QD ORAL 22-Feb-2006 08:30 AM Page: 1316 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/25/01ISR Number: 3815574-9Report Type:Expedited (15-DaCompany Report #01-10-0557 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Haemorrhagic Stroke Health Clozapine PS Zenith Goldline Professional Pharm ORAL 300-400 QD ORAL Date:10/25/01ISR Number: 3815590-7Report Type:Expedited (15-DaCompany Report #01-09-0538 Age:46 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Clozapine - Zenith Stress Professional Goldline Pharm. Tablets PS Zenith Goldline ORAL 100MG ORAL Prolixin Decanoate C Date:10/25/01ISR Number: 3815592-0Report Type:Expedited (15-DaCompany Report #01-10-0570 Age:83 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline ORAL UNKNOWN ORAL Date:10/26/01ISR Number: 3815736-0Report Type:Expedited (15-DaCompany Report #01-10-0570 Age:83 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Volvulus Of Bowel Health Clozapine-Zenith Professional Goldline Pharm. Tablets PS ORAL ORAL Date:10/26/01ISR Number: 3815737-2Report Type:Expedited (15-DaCompany Report #01-10-0572 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neoplasm Malignant Health Clozapine-Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm ORAL 400MG QD ORAL Date:10/26/01ISR Number: 3815738-4Report Type:Expedited (15-DaCompany Report #01-10-0566 Age:67 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine-Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm ORAL 500MG QD ORAL 22-Feb-2006 08:30 AM Page: 1317 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/26/01ISR Number: 3815739-6Report Type:Expedited (15-DaCompany Report #01-10-0573 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Health Clozapine-Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm ORAL 100-450MG QD ORAL Date:10/26/01ISR Number: 3815740-2Report Type:Expedited (15-DaCompany Report #01-10-0580 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Health Clozapine-Zenith Weight Increased Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm ORAL 50-450MG QD ORAL Date:10/26/01ISR Number: 3815741-4Report Type:Expedited (15-DaCompany Report #01-10-0583 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine-Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm ORAL ORAL Date:10/26/01ISR Number: 3815742-6Report Type:Expedited (15-DaCompany Report #C2001-3034.01 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aneurysm Health Clozapine Tablets Arterial Rupture Professional 100 Mg Mylan PS Mylan ORAL 500MG Q AM, Other 400 MG Q PRN, ORAL Date:10/26/01ISR Number: 3816124-3Report Type:Expedited (15-DaCompany Report #PHFR2001GB02685 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arrhythmia Foreign Clozaril (Clozapine) Initial or Prolonged Bradycardia Health (Clozapine)Tablet PS ORAL 300 MG/DAY, Dehydration Professional ORAL Diarrhoea Other Dizziness Haemoglobin Decreased Hyponatraemia Renal Impairment Tachycardia 22-Feb-2006 08:30 AM Page: 1318 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/26/01ISR Number: 3816143-7Report Type:Expedited (15-DaCompany Report #PHBS2001CA10078 Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Haemolytic Anaemia Foreign Clozaril Initial or Prolonged Jaundice Study (Clozapine) Tablet PS ORAL ORAL Platelet Count Decreased Health Professional Other Date:10/26/01ISR Number: 3816145-0Report Type:Expedited (15-DaCompany Report #PHFR2001GB02849 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Ketoacidosis Foreign Clozaril (Clozapine) Initial or Prolonged Health Tablet PS ORAL 350 MG, BID, Professional ORAL Other Valproate Sodium C Thyroxine C Lithium (Lithium) C Atorvastatin (Atrorvastatin) C Date:10/26/01ISR Number: 3816146-2Report Type:Expedited (15-DaCompany Report #PHBS2001AU10497 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Foreign Clozaril (Clozapine) Initial or Prolonged Head Injury Study Tablet PS ORAL 400 MG/DAY, Muscle Atrophy Health ORAL Nervous System Disorder Professional Vomiting Other Date:10/26/01ISR Number: 3816181-4Report Type:Expedited (15-DaCompany Report #PHFR2001GB02833 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bronchopneumonia Foreign Clozaril (Clozapine) Health Tablet PS ORAL 750MG/DAY, Professional ORAL Other Date:10/26/01ISR Number: 3816212-1Report Type:Expedited (15-DaCompany Report #PHBS2001AU09100 Age:44 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypertrophic Obstructive Foreign Clozaril (Clozapine) Cardiomyopathy Study Tablet PS ORAL 500 MG/D, Psychotic Disorder Health ORAL Rebound Effect Professional Caltrate C Other Kliogest "Novo Industri" C 22-Feb-2006 08:30 AM Page: 1319 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/29/01ISR Number: 3817144-5Report Type:Expedited (15-DaCompany Report #2001PK00879 Age:33 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Foreign Seroquel "Zeneca" PS Astrazeneca Hospitalization - Drug Toxicity Study Pharmaceuticals 50 MG DAILY Initial or Prolonged Leukopenia Health Seroquel "Zeneca" SS 75 MG DAILY Professional Seroquel "Zeneca" SS 100 MG DAILY Other Seroquel "Zeneca" SS 200 MG DAILY Seroquel "Zeneca" SS 400 MG DAILY Seroquel "Zeneca" SS 1000 MG DAILY Leponex "Sandoz" SS Leponex "Sandoz" SS 162.5 MG DAILY Leponex "Sandoz" SS 200 MG DAILY Leponex "Sandoz" SS 150 MG DAILY Leponex "Sandoz" SS 100 MG DAILY Lyogen C Akineton C Truxal C Date:10/30/01ISR Number: 3817344-4Report Type:Direct Company Report # Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Clozapine 100mg Initial or Prolonged Fall Zenith-Goldline PS Zenith-Goldline ORAL 600MG DAY Laceration ORAL Clozapine 25 Mg Zenith-Goldline SS Zenith-Goldline ORAL 50MG QAMS AND QHS ORAL Celebrex C Docusate Sodium C Luvox C Oxybutynin C Acetaminophen C Maalox C Mom/Cascara C Date:10/31/01ISR Number: 3818196-9Report Type:Expedited (15-DaCompany Report #PHFR2001GB01967 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril (Clozapine) Non-Insulin-Dependent Health Tablet PS ORAL 400MG/DAY, Professional ORAL Other Lactulose C Bendrofluazide (Bendroflumethiazide ) C Atenolol C Date:10/31/01ISR Number: 3818215-XReport Type:Expedited (15-DaCompany Report #PHNU2001DE01871 Age:39 YR Gender:Male I/FU:I Outcome PT Hospitalization - Asthenia Initial or Prolonged Bundle Branch Block Right Cardiac Failure 22-Feb-2006 08:30 AM Page: 1320 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Congestive Cardiomyopathy Dyspnoea Electrocardiogram T Wave Report Source Product Role Manufacturer Route Dose Duration Inversion Foreign Leponex / Clozaril Eosinophilia Health (Clozapine) PS ORAL 100 MG, TID , Fatigue Professional ORAL Myocarditis Other SEE IMAGE Pleural Effusion Trevilor Tachycardia (Venlafaxine Hydrochloride) C Lopirin "Bristol-Myers Squibb" C Furosemide C Metoprolol (Metoprolol) C Marcumar (Phenprocoumon) C Date:10/31/01ISR Number: 3818234-3Report Type:Expedited (15-DaCompany Report #PHBS2001AU09555 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Leukocytosis Foreign Clozaril(Clozapine) Hospitalization - Neutrophilia Health Tablet PS ORAL 750 MG/D, Initial or Prolonged Pharyngitis Streptococcal Professional ORAL Tonsillitis Other Date:10/31/01ISR Number: 3818545-1Report Type:Expedited (15-DaCompany Report #PHEH2001US08700 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Neoplasm Malignant Health Clozaril(Clozapine) Professional Tablet PS ORAL 400 MG, QHS, ORAL Synthroid C Glucophage "Merck" C Avandia (Rosiglitazone Maleate) C Glyburide C Cogentin (Benzatropine Mesilate) C Date:10/31/01ISR Number: 3818752-8Report Type:Expedited (15-DaCompany Report #PHFR2001GB02685 Age:43 YR Gender:Male I/FU:F Outcome PT Hospitalization - Arrhythmia Initial or Prolonged Blood Creatinine Increased Bradycardia Dehydration Diarrhoea Dizziness Haemoglobin Decreased Hyponatraemia 22-Feb-2006 08:30 AM Page: 1321 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Renal Impairment Tachycardia Vomiting Report Source Product Role Manufacturer Route Dose Duration Foreign Clozaril (Clozapine) Health (Clozapine) Tablet PS ORAL 300 MG/DAY, Professional ORAL Other Date:10/31/01ISR Number: 3818891-1Report Type:Expedited (15-DaCompany Report #WAES 01107284 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arteriosclerosis Foreign Tab Congentin Brain Oedema Other (Benztropine C-Reactive Protein Mesylate) PS ORAL 4 MG/DAILY Increased Tab Clozapine SS ORAL 350 MG/DAILY Cardiac Arrest Cardiomegaly Heart Rate Increased Loss Of Consciousness Lung Disorder Myocardial Infarction Nausea Pulmonary Oedema Rales Shock Upper Respiratory Tract Infection Viral Infection White Blood Cell Count Increased Date:10/31/01ISR Number: 3819123-0Report Type:Expedited (15-DaCompany Report #PHEH2001US08569 Age:81 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenopia Health Clozaril Initial or Prolonged Fall Professional (Clozapine)Tablet PS ORAL 25 MG/DAY, Loss Of Consciousness ORAL Speech Disorder Sinemet (Levodopa, Carbidopa) C Periactin (Cyproheptadine Hydrochloride) C Haldol C Date:10/31/01ISR Number: 3819127-8Report Type:Expedited (15-DaCompany Report #A123176 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Consumer Ziprasidone Po PS 160.00 MG Psychotic Disorder Health TOTAL:BID Professional Clozaril SS 300.00 MG Company TOTAL:DAILY Representative Lipitor (Atorvastatin) C Ambien (Zolpidem) C Antihypertensive 22-Feb-2006 08:30 AM Page: 1322 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Medication C Date:11/02/01ISR Number: 3819671-3Report Type:Expedited (15-DaCompany Report #PHEH2001US08718 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukocytosis Health Clozaril (Clozapine) Initial or Prolonged Psoriasis Professional Tablet PS ORAL 400MG DAILY, Pyrexia ORAL Date:11/02/01ISR Number: 3819673-7Report Type:Expedited (15-DaCompany Report #PHEH2001US08807 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Murmur Health Clozaril (Clozapine) Initial or Prolonged Professional Tablet PS ORAL 100 MG/DAY, ORAL Date:11/02/01ISR Number: 3819937-7Report Type:Expedited (15-DaCompany Report #C2001-3113.01 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 50 MG Q HS, Other ORAL Date:11/02/01ISR Number: 3819940-7Report Type:Expedited (15-DaCompany Report #C2001-2632.01 Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Health Clozapine Tablets Depressed Mood Professional 100 Mg Dylan PS Mylan ORAL 600 MG QD, Dizziness Other ORAL Fall Ibuprofen C Head Injury Fluticasone C Vomiting Lansoprazole C Diltiazem C Docusate Sodium C Psyllium C Lisinopril C Pravastatin C Chlorpromazine C Lithium C Divalproex Sodium C Date:11/02/01ISR Number: 3819941-9Report Type:Expedited (15-DaCompany Report #C2001-3116.01 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 100 MG Q AM, Other 200MG Q HS, ORAL Benztropine C Divalproex C 22-Feb-2006 08:30 AM Page: 1323 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/02/01ISR Number: 3819959-6Report Type:Expedited (15-DaCompany Report #GB/00/00105/LEX Age:50 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hepatic Steatosis Foreign Clozaril Overdose Study (Clozapine)Tablet PS ORAL 600MG/DAY, Health ORAL 2548 DAY Professional Other Date:11/02/01ISR Number: 3820149-1Report Type:Expedited (15-DaCompany Report #PHBS2001CA10613 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Foreign Clozaril (Clozapine) Hospitalization - Aplastic Anaemia Study Tablet PS ORAL ORAL Initial or Prolonged Haemoglobin Decreased Health Amoxicillin Lower Respiratory Tract Professional (Amoxicillin) C Infection Other Lamotrigine C Nasopharyngitis Risperidone Neutropenia (Risperidone) C Pyrexia Thrombocytopenia Date:11/02/01ISR Number: 3820196-XReport Type:Expedited (15-DaCompany Report #PHBS2001A10613 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Foreign Clozaril (Clozapine) Hospitalization - Aplastic Anaemia Study Tablet PS ORAL ORAL Initial or Prolonged Haemoglobin Decreased Health Amoxicillin Lower Respiratory Tract Professional (Amoxicillin) C Infection Other Lamotrigine C Nasopharyngitis Risperidone Neutropenia (Risperidone) C Pyrexia Thrombocytopenia Date:11/05/01ISR Number: 3820403-3Report Type:Expedited (15-DaCompany Report #2001078254US Age:40 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Micronase Health (Glyburide) Tablet, Professional 1.25-5 Mg PS ORAL ORAL Clozapine (Clozapine) SS Thioridazine (Thioridazine) SS Date:11/05/01ISR Number: 3820672-XReport Type:Expedited (15-DaCompany Report #02667 Age:45 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Medication Error Literature Lorazepam PS Other Overdose Clozapine SS Morphine SS 22-Feb-2006 08:30 AM Page: 1324 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/05/01ISR Number: 3821827-0Report Type:Expedited (15-DaCompany Report #PHFR2001GB02833 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bronchopneumonia Foreign Clozaril (Clozapine) Health Tablet PS ORAL 650MG/DAY, Professional ORAL Other Valproate Sodium C Sertraline (Sertraline) C Date:11/05/01ISR Number: 3821847-6Report Type:Expedited (15-DaCompany Report #PHFR2001GB02939 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril (Clozapine) Health Tablet PS ORAL 400MG/DAY, Professional ORAL Other Olanzapine (Olanzapine) C Date:11/05/01ISR Number: 3821867-1Report Type:Expedited (15-DaCompany Report #PHNU2001DE02054 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Eosinophilia Foreign Leponex / Clozaril Initial or Prolonged Neutrophilia Health (Clozapine) Pancreatitis Professional (Clozapine) Tablet PS ORAL SEE IMAGE Other Xanef C Dipiperon (Pipamperone) C Amaryl (Glimepiride) C Date:11/05/01ISR Number: 3821938-XReport Type:Expedited (15-DaCompany Report #PHBS2001AU10666 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Circulatory Collapse Foreign Clozaril (Clozapine) Initial or Prolonged Infection Study Tablet PS ORAL 250 MG/DAY, Leukocytosis Health ORAL Professional Other Date:11/06/01ISR Number: 3820779-7Report Type:Expedited (15-DaCompany Report #PHEH2001US08891 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Electrocardiogram Health Clozaril (Clozapine) Abnormal Professional Tablet PS ORAL 800MG, DAILY, Haematemesis ORAL Seroquel (Quetiapine) C Effexor (Venlafaxine Hydrochloride) C Depakote (Valproate Semisodium) C Lipitor (Atorvastatin) C 22-Feb-2006 08:30 AM Page: 1325 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Cozaar (Losartan Potassium) C Date:11/06/01ISR Number: 3820781-5Report Type:Expedited (15-DaCompany Report #PHEH2001US08427 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cyst Health Clozaril (Clozapine) Initial or Prolonged Leukocytosis Professional Tablet PS ORAL 375 MG/DAY, Neutrophil Count ORAL Increased Pneumonia Thrombocythaemia Date:11/06/01ISR Number: 3821024-9Report Type:Expedited (15-DaCompany Report #PHFR2001GB03010 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Cholesterol Foreign Clozaril (Clozapine) Increased Health Tablet PS ORAL 300MG/DAY, Chest Pain Professional ORAL Constipation Other Haematochezia Date:11/06/01ISR Number: 3821025-0Report Type:Expedited (15-DaCompany Report #PHBS2001AU10949 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatic Neoplasm Foreign Clozaril (Clozapine) Initial or Prolonged Malignant Study Tablet PS ORAL 300 MG/DAY, Leukopenia Health ORAL Neutropenia Professional Surgery Other Date:11/06/01ISR Number: 3821027-4Report Type:Expedited (15-DaCompany Report #PHBS2001AU10947 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Infection Foreign Clozaril (Clozapine) Initial or Prolonged Leukocytosis Study Tablet PS ORAL 200 MG/DAY, Neutrophilia Health ORAL Professional Other Date:11/06/01ISR Number: 3821028-6Report Type:Expedited (15-DaCompany Report #PHFR2001GB02719 Age:53 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cerebrovascular Accident Foreign Clozaril (Clozapine) Health Tablet PS ORAL 250 MG/DAY, Professional ORAL Other Temazepam C 22-Feb-2006 08:30 AM Page: 1326 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/06/01ISR Number: 3821029-8Report Type:Expedited (15-DaCompany Report #PHFR2001GB03010 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Cholesterol Foreign Clozaril (Clozapine) Increased Health Tablet PS ORAL 300 MG/DAY, Chest Pain Professional ORAL Constipation Other Haematochezia Date:11/06/01ISR Number: 3821543-5Report Type:Expedited (15-DaCompany Report #01-08-0445 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutrophil Count Health Clozapine - Zenith Decreased Professional Goldline Pharm. White Blood Cell Count Tablets PS ORAL 100MG QD ORAL Decreased Bactrim Ds Tablets SS ORAL 1 HS ORAL Neurontin C Zyprexa C Depakote C Date:11/06/01ISR Number: 3821544-7Report Type:Expedited (15-DaCompany Report #C2001-2633.01 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 450 MG Q HS, Other ORAL Bupropion Sr C Benztropine C Metformin C Glipizide Xl C Hctz C Fluoxetine C Fosinopril C Date:11/06/01ISR Number: 3821545-9Report Type:Expedited (15-DaCompany Report #C2001-2812.01 Age:53 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 400MG BID, Other THEN 100MG BID, ORAL Date:11/06/01ISR Number: 3821548-4Report Type:Expedited (15-DaCompany Report #C2001-3191.01 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 25MG TID, Other ORAL 22-Feb-2006 08:30 AM Page: 1327 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/06/01ISR Number: 3821552-6Report Type:Expedited (15-DaCompany Report #01-10-0551 Age:53 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Neoplasm Malignant Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS ORAL 325MG HS ORAL Albuterol C Ipratroprium C Procrit C Prednisone C Cipro C Nifedipine C Roxicodone C Ibuprofen C Zoloft C Date:11/06/01ISR Number: 3821555-1Report Type:Expedited (15-DaCompany Report #01-10-0559 Age:42 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Surgery Health Clozapine-Zenith Initial or Prolonged Professional Goldline Pharm. Tablets PS ORAL 500MG HS ORAL Date:11/06/01ISR Number: 3821559-9Report Type:Expedited (15-DaCompany Report #01-09-0500 Age:56 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS ORAL 500MG ORAL Date:11/06/01ISR Number: 3821560-5Report Type:Expedited (15-DaCompany Report #01-10-0587 Age:88 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS ORAL 25-137 .5MG QD ORAL Date:11/06/01ISR Number: 3821563-0Report Type:Expedited (15-DaCompany Report #01-10-0588 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine - Zenith Hospitalization - Professional Goldline Pharm. Initial or Prolonged Tablets PS ORAL 800 MG QD ORAL Insulin Humulin 70/30 C Albuterol C Azmacort C Iron C 22-Feb-2006 08:30 AM Page: 1328 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/06/01ISR Number: 3821566-6Report Type:Expedited (15-DaCompany Report #01-10-0586 Age:91 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dehydration Health Clozapine - Zenith Pyrexia Professional Goldline Pharm. Upper Respiratory Tract Tablets PS ORAL 50-75MG QD Infection ORAL Date:11/06/01ISR Number: 3821568-XReport Type:Expedited (15-DaCompany Report #01-10-0585 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bronchitis Health Clozapine - Zenith Hospitalization - Professional Goldline Pharm. Initial or Prolonged Tablets PS ORAL 300-350MG QHS ORAL Zithromax C Date:11/07/01ISR Number: 3822313-4Report Type:Expedited (15-DaCompany Report #98HQ-10118 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Acute Psychosis Foreign Rifampicin Drug Interaction Literature (Rifampicin) PS MG Drug Level Below Health Clozapine Therapeutic Professional (Clozapine) SS Drug Withdrawal Syndrome Other Isoniazid Insomnia (Isoniazid) C Restlessness Pyrazinamide (Pyrazinamide) C Date:11/07/01ISR Number: 3823161-1Report Type:Expedited (15-DaCompany Report #PHBS2001IT10874 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiomyopathy Foreign Leponex (Clozapine) Health Tablet PS ORAL 250 MG/DAY, Professional ORAL Other Depakine C Date:11/07/01ISR Number: 3823163-5Report Type:Expedited (15-DaCompany Report #PHBS2001AU10666 Age:28 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Circulatory Collapse Foreign Clozaril (Clozapine) Initial or Prolonged Infection Study Tablet PS ORAL 250 MG/DAY, Leukocytosis Health ORAL Professional Other Date:11/07/01ISR Number: 3823165-9Report Type:Expedited (15-DaCompany Report #PHBS2001CA10613 Age:54 YR Gender:Male I/FU:F Outcome Life-Threatening Hospitalization - 22-Feb-2006 08:30 AM Page: 1329 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Initial or Prolonged PT Report Source Product Role Manufacturer Route Dose Duration Agranulocytosis Foreign Clozaril (Clozapine) Aplastic Anaemia Study Tablet PS ORAL ORAL Haemoglobin Decreased Health Amoxicillin Lower Respiratory Tract Professional (Amoxicillin) C Infection Other Lamotrigine C Nasopharyngitis Risperidone Neutropenia (Risperidone) C Thrombocytopenia Date:11/07/01ISR Number: 3823173-8Report Type:Expedited (15-DaCompany Report #PHBS2001IT10882 Age:90 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Atrial Tachycardia Foreign Leponex (Clozapine) Atrioventricular Block Health Tablet PS ORAL SEE IMAGE Complete Professional Lanoxin (Digoxin) SS ORAL 0.0625 Supraventricular Other MG/DAY, ORAL Tachycardia Aldactone C Lasix C Ascriptin C Sinemet (Carbidopa, Levodopa) C Madopar (Levodopa, Benserazide Hydrochloride) C Date:11/07/01ISR Number: 3823183-0Report Type:Expedited (15-DaCompany Report #PHFR2001GB02925 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Foreign Clozaril (Clozapine) Drug Withdrawal Health Tablet PS ORAL 650MG/DAY, Convulsions Professional ORAL Other Lorazepam (Lorazepam) SS Lamotrigine C Docusate (Docusate) C Date:11/07/01ISR Number: 3823590-6Report Type:Expedited (15-DaCompany Report #PHFR2001GB02785 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Foreign Clozaril (Clozapine) Initial or Prolonged Diabetes Mellitus Health Tablet PS ORAL 100 MG, BID, Insulin-Dependent Professional ORAL Dizziness Other Olanzapine Hyperhidrosis (Olanzapine) C Hypertension Lithium Citrate C Influenza Like Illness Diazepam C Malaise Paroxetine Tachycardia (Paroxetine) C Vision Blurred 22-Feb-2006 08:30 AM Page: 1330 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/07/01ISR Number: 3823595-5Report Type:Expedited (15-DaCompany Report #PHFR2001IE02952 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril (Clozapine) Health Tablet PS ORAL 100MG/NOCTE, Professional ORAL Other Fenofibrate (Fenofibrate) C Diazepam C Sertraline (Sertraline) C Date:11/07/01ISR Number: 3823598-0Report Type:Expedited (15-DaCompany Report #PHFR2001GB02928 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Foreign Clozaril (Clozapine) Initial or Prolonged Dysphagia Health Tablet PS ORAL 50MG/DAY ; Gastritis Professional 200 X 25MG Haematemesis Other OVERDOSE : Nausea ORAL Neuralgia Overdose Salivary Hypersecretion Date:11/07/01ISR Number: 3823599-2Report Type:Expedited (15-DaCompany Report #PHFR2001GB02777 Age:65 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Angina Pectoris Foreign Clozaril (Clozapine) Initial or Prolonged Respiratory Disorder Health Tablet PS ORAL 125MG/DAY ; Professional 150MG/DAY : Other ORAL Fluoxetine (Fluoxetine) C Epilim Chrono C Date:11/07/01ISR Number: 3823652-3Report Type:Expedited (15-DaCompany Report #PHFR2001GB02849 Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Ketoacidosis Foreign Clozaril (Clozapine) Initial or Prolonged Health Tablet PS ORAL 800MG/DAY, Professional ORAL Other Valproate Sodium C Lithium (Lithium) C Date:11/07/01ISR Number: 3823653-5Report Type:Expedited (15-DaCompany Report #PHBS2001CA10289 Age:44 YR Gender:Male I/FU:I Outcome PT Hospitalization - Blood Creatine Initial or Prolonged Phosphokinase Increased Confusional State Cough Depressed Level Of Consciousness 22-Feb-2006 08:30 AM Page: 1331 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Diarrhoea Dyspnoea Lung Infiltration Report Source Product Role Manufacturer Route Dose Duration Pyrexia Foreign Clozaril (Clozapine) Respiratory Disorder Study Tablet PS ORAL 200 MG/DAY, Sepsis Health ORAL Sputum Discoloured Professional Quetiapine Thrombocytopenia Other (Quetiapine) C Divalproxe Sodium (Valproate Semisodium) C Disulfiram (Disulfiram) C Date:11/07/01ISR Number: 3823799-1Report Type:Expedited (15-DaCompany Report #PHFR2001GB02646 Age:25 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram St Foreign Clozaril (Clozapine) Segment Elevation Health Tablet PS ORAL 375MG/DAY Extrasystoles Professional (175MG & 200 Face Oedema Other MG), ORAL Psoriasis Diazepam C Supraventricular Tachycardia Vomiting Date:11/07/01ISR Number: 3824301-0Report Type:Expedited (15-DaCompany Report #2001UW12243 Age:55 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Convulsion Foreign Seroquel "Zeneca" PS Zeneca Intervention to Neutropenia Other Clonazepam SS Prevent Permanent Clozaril SS Impairment/Damage Estrogen SS Levothyroxine C Singulair C Date:11/07/01ISR Number: 3824411-8Report Type:Expedited (15-DaCompany Report #PHBS2000AU04068 Age:31 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiomegaly Foreign Clozaril (Clozapine) Initial or Prolonged Congestive Cardiomyopathy Study (Clozapine) Tablet PS ORAL 750 MG/DAY, Echocardiogram Abnormal Health ORAL Professional Olanzapine Other (Olazapine) C Lithium Carbonate C Date:11/07/01ISR Number: 3824413-1Report Type:Expedited (15-DaCompany Report #PHNU2001DE02198 Age:52 YR Gender:Male I/FU:F Outcome PT Hospitalization - Haemoglobin Increased Initial or Prolonged Lymphocyte Count Increased Polycythaemia Vera 22-Feb-2006 08:30 AM Page: 1332 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report White Blood Cell Count Increased Report Source Product Role Manufacturer Route Dose Duration Foreign Leponex (Clozapine) Health Tablet PS ORAL 300MG/DAY, Professional ORAL Other Lyogen (Fluphenazine) C Date:11/08/01ISR Number: 3822474-7Report Type:Direct Company Report # Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Salivary Hypersecretion Clozaril PS 100MG TID Date:11/08/01ISR Number: 3822509-1Report Type:Direct Company Report # Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Colazal Capsules; Mfd By Salix Pharmaceuticals PS Salix Pharmaceuticals Clozaril (Clozapine) Tables; Mfd By Novartis SS Novartis Date:11/08/01ISR Number: 3822827-7Report Type:Expedited (15-DaCompany Report #S01-USA-01744-01 Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Heat Stroke Health Celexa (Citalopram Professional Hydrobromide) PS ORAL 20 MG QD PO Clozapine SS ORAL 400 MG QD PO Benztropine (Benztropine Mesylate) C Date:11/08/01ISR Number: 3822914-3Report Type:Expedited (15-DaCompany Report #PHBS2001AU10666 Age:26 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Circulatory Collapse Foreign Clozaril (Clozapine) Initial or Prolonged Convulsion Study Tablet PS ORAL 400 MG/DAY, Hyponatraemia Health ORAL Infection Professional Leukocytosis Other Date:11/08/01ISR Number: 3824085-6Report Type:Expedited (15-DaCompany Report #PHEH2001US08920 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Upper Health Clozaril (Clozapine) Barrett'S Oesophagus Professional Tablet PS ORAL 400MG/DAY, ORAL Nadolol (Nadolol) C 22-Feb-2006 08:30 AM Page: 1333 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Nexium (Esomeprazole)F C Zonegran (Zonisamide) C Klonopin C Date:11/08/01ISR Number: 3824381-2Report Type:Expedited (15-DaCompany Report #PHFR2001GB03017 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperglycaemia Foreign Clozaril Initial or Prolonged Hyperlipidaemia Health (Clozapine)Tablet PS ORAL 300MG/DAY, Professional ORAL Other Date:11/09/01ISR Number: 3822973-8Report Type:Direct Company Report # Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyskinesia Clozapine PS Initial or Prolonged Tardive Dyskinesia Required Intervention to Prevent Permanent Impairment/Damage Date:11/12/01ISR Number: 3823727-9Report Type:Expedited (15-DaCompany Report #01-08-0483 Age:59 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Health Clozapine - Zenith Other Lung Disorder Professional Goldline Phar. Sudden Death Tablets PS Zenith Goldline Pharm. ORAL ORAL Singulair C Remeron C Metoprolol C Lorazepam C Levothyroxine C Albuterol C Atrovent C Flovent C Diphenhydramine C Combivent C Clonazepam C Amantadine C Date:11/12/01ISR Number: 3823730-9Report Type:Expedited (15-DaCompany Report #01-11-0594 Age:71 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine - Zenith Professional Goldline Pharm Tablets PS Zenith Goldline ORAL 125-275MG QD ORAL 22-Feb-2006 08:30 AM Page: 1334 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/12/01ISR Number: 3823732-2Report Type:Expedited (15-DaCompany Report #01-11-0598 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline ORAL 200-450MG QD ORAL Date:11/12/01ISR Number: 3823733-4Report Type:Expedited (15-DaCompany Report #01-11-0599 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Renal Failure Chronic Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline ORAL 300-600MG QD ORAL Date:11/12/01ISR Number: 3823734-6Report Type:Expedited (15-DaCompany Report #01-11-0593 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline ORAL 200-500MG QD ORAL Date:11/13/01ISR Number: 3824409-XReport Type:Expedited (15-DaCompany Report #PHFR2001GB02925 Age:24 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Foreign Clozaril (Clozapine) Drug Withdrawal Health Tablet PS ORAL 650MG/DAY, Convulsions Professional ORAL Nuclear Magnetic Other Lorazepam(Lorazepam) SS ORAL 2 MG, PRN, Resonance Imaging Brain ORAL 42 DAY Abnormal Lamotrigine C Propranolol C Pirenzepine (Pirenzepine) C Docusate (Docusate) C Date:11/13/01ISR Number: 3824412-XReport Type:Expedited (15-DaCompany Report #PHRM2001FR02144 Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypercholesterolaemia Foreign Leponex (Clozapine) Initial or Prolonged Hypertriglyceridaemia Health Tablet PS ORAL 600 MG DAILY, Professional ORAL Other Zyloric "Glax Wellcome" C 22-Feb-2006 08:30 AM Page: 1335 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/13/01ISR Number: 3824521-5Report Type:Expedited (15-DaCompany Report #PHBS2001CA11172 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Colitis Foreign Clozaril(Clozapine) Dermatitis Health Tablet PS ORAL ORAL Weight Decreased Professional Other Date:11/13/01ISR Number: 3824525-2Report Type:Expedited (15-DaCompany Report #PHBS2001AU08067 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril(Clozapine) Health Tablet PS ORAL ORAL; 175 MG, Professional QD, ORAL Other Date:11/13/01ISR Number: 3824526-4Report Type:Expedited (15-DaCompany Report #PHFR2001GB01124 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Condition Aggravated Foreign Clozaril(Clozapine) Hospitalization - Cyst Health Tablet PS ORAL 275 MG/DAY, Initial or Prolonged Pancreatitis Acute Professional ORAL Other Paraxotene (Paroxetene) C Hyoscine (Hyoscine) C Date:11/13/01ISR Number: 3824809-8Report Type:Expedited (15-DaCompany Report #PHEH2001US08992 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozaril (Clozapine) Professional Tablet PS ORAL ORAL Date:11/13/01ISR Number: 3824811-6Report Type:Expedited (15-DaCompany Report #PHEH2001US08996 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozaril (Clozapine) Professional Tablet PS ORAL 400 MG/DAY, ORAL Date:11/13/01ISR Number: 3825773-8Report Type:Expedited (15-DaCompany Report #PHFR2001GB02677 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Foreign Clozaril (Clozapine) Initial or Prolonged Bile Duct Obstruction Health Tablet PS ORAL 425 MG/DAY, Other Jaundice Professional ORAL Liver Function Test Other Olanzapine Abnormal (Olanzapine) C Nausea Quetiapine Neoplasm Malignant (Quetiapine) C Salivary Hypersecretion 22-Feb-2006 08:30 AM Page: 1336 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/13/01ISR Number: 3826199-3Report Type:Expedited (15-DaCompany Report #PHBS2001CA10078 Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Haemolytic Foreign Clozaril(Clozapine) Initial or Prolonged Autoimmune Study Tablet PS ORAL ORAL Jaundice Health Olanzapine Platelet Count Decreased Professional (Olanzapine) C Splenomegaly Other Benzotropine (Benzatropine Mesilate) C Insulin (Insulin) C Date:11/13/01ISR Number: 3826200-7Report Type:Expedited (15-DaCompany Report #PHFR2001GB02904 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Choking Sensation Foreign Clozaril(Clozapine) PS ORAL 400MG/DAY, Constipation Health ORAL Dysphagia Professional Risperidone Melaena Other (Risperidone) C Polydipsia Polyuria Thirst Weight Decreased Date:11/13/01ISR Number: 3826212-3Report Type:Expedited (15-DaCompany Report #PHBS2001CA05195 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Foreign Clozaril(Clozapine) PS ORAL 250 MG/D, Hospitalization - Infection Study ORAL Initial or Prolonged Neutropenia Health Pharyngitis Professional Pharyngolaryngeal Pain Other Pyrexia Renal Impairment Skin Lesion Date:11/13/01ISR Number: 3826215-9Report Type:Expedited (15-DaCompany Report #PHFR2001GB02788 Age:68 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril (Clozapine) Health Tablet PS ORAL 325MG/DAY, Professional ORAL Other Venlafaxine (Venlafaxine) C Zopiclone C Zoton (Lansoprazole) C Isosorbide (Isosorbide) C 22-Feb-2006 08:30 AM Page: 1337 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/13/01ISR Number: 3826246-9Report Type:Expedited (15-DaCompany Report #PHBS2001AU08936 Age:49 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Clozaril(Clozapine)T Lymphoma Study ablet PS ORAL 550 MG/DAY, Neutropenia Health ORAL Professional Chemotherapeutics, Other Other (Chemotherapeutics, Other) SS Date:11/13/01ISR Number: 3826278-0Report Type:Expedited (15-DaCompany Report #PHFR2001GB01918 Age:25 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Appendicitis Foreign Clozaril(Clozapine) Initial or Prolonged Health Tablet PS ORAL 700MG/DAY, Professional ORAL Other Date:11/13/01ISR Number: 3830225-5Report Type:Expedited (15-DaCompany Report #PHFR2001GB03138 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Foreign Clozaril (Clozapine) Cardiomyopathy Health Tablet PS ORAL 400MG/DAY, Dizziness Professional ORAL Drug Level Changed Other Fluoxetine Dyspnoea (Fluoxetine) C Electrocardiogram Abnormal Neutrophil Count Increased Palpitations Red Blood Cell Sedimentation Rate Increased Sinus Tachycardia White Blood Cell Count Increased Date:11/14/01ISR Number: 3823662-6Report Type:Periodic Company Report #C2000-1615.07 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozapine Tablets Other Neutropenia Professional 100mg Mylan PS ORAL 400 MG/DAY, ORAL Paroxetine C Fluphenazine C Divalproex Sodium C 22-Feb-2006 08:30 AM Page: 1338 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/14/01ISR Number: 3823663-8Report Type:Periodic Company Report #C2001-0879.01 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozapine Tablets Other Leukopenia Professional 100 Mg Mylan PS ORAL 500 MG QD, Other ORAL Fluoxetine C Risperidone C Olanzapine C Divalproex Sodium C Date:11/14/01ISR Number: 3823664-XReport Type:Periodic Company Report #C2001-08504 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Pressure Increased Other Clozapine Tablet Tachycardia 100mg Mylan PS ORAL 300MG QD, ORAL Date:11/14/01ISR Number: 3823665-1Report Type:Periodic Company Report #C2001-0854.01 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Leukopenia Health Clozapine Tablets Other Professional 100mg Mylan PS ORAL 100MG QD, Other ORAL Date:11/14/01ISR Number: 3823666-3Report Type:Periodic Company Report #C2001-0746.01 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Leukopenia Health Clozapine Tablets Other Thrombocytopenia Professional 100 Mg Mylan PS ORAL 250MG Q HS, Other ORAL Lithobid Solvay SS ORAL 300 MG Q AM, 600MG Q HS, ORAL Denepezil C Phenytoin C Propranolol C Date:11/14/01ISR Number: 3823667-5Report Type:Periodic Company Report #C2001-0718.01 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Eosinophilia Health Clozapine Tablets Other Leukopenia Professional 100 Mg Mylan PS ORAL TITRATE 100 Lymphocyte Count MG QD, ORAL Decreased Clonazepam C Lithium Carbonatge C Quetiapine C 22-Feb-2006 08:30 AM Page: 1339 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/14/01ISR Number: 3823668-7Report Type:Periodic Company Report #C2001-0636.01 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Leukopenia Health Clozapine Tablets Other Professional 100 Mg Mylan PS ORAL 200MG BID, Other ORAL Date:11/14/01ISR Number: 3823669-9Report Type:Periodic Company Report #C2001-0492.01 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Granulocytopenia Health Clozapine Tablets Other Leukopenia Professional 100 Mg Mylan PS ORAL 400 MG QD, Other ORAL Benztropine C Fluphenazine C Paroxetine C Date:11/14/01ISR Number: 3823671-7Report Type:Periodic Company Report #C2001-0348.01 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Leukopenia Health Clozapine Tablets Hospitalization - Professional 100 Mg Mylan PS ORAL 100 MIG, BID, Initial or Prolonged ORAL Other Olanzapine C Paroxetine C Date:11/14/01ISR Number: 3823673-0Report Type:Periodic Company Report #C2001-1063.01 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Leukopenia Health Clozapine Tablets 25 Other Neutropenia Professional Mg Mylan PS ORAL 525 MG/DAY, Other ORAL Depakote Abbott SS ORAL 1750 MG/DAY, ORAL Seroquel Astra Zeneca SS Astra Zeneca ORAL 700 MG/DAY, ORAL Levothyroxine C Lithium C Date:11/14/01ISR Number: 3823677-8Report Type:Periodic Company Report #C2001-2935.01 Age:75 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg Mylan PS ORAL 37.5MG QD, Other ORAL Carbidopa/Levodopa Cr C Lorazepam C Trazodone C 22-Feb-2006 08:30 AM Page: 1340 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/14/01ISR Number: 3823679-1Report Type:Periodic Company Report #C2001-3222.01 Age:73 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg Mylan PS ORAL 25MG QD, ORAL Other Date:11/14/01ISR Number: 3823681-XReport Type:Periodic Company Report #C2001-2940.01 Age:92 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional 100 Mg Mylan PS ORAL 100MG QD, Other ORAL Tamsulosin C Trazodone C Ceftriaxone C Carbidopa/Levodopa Cr C Propoxyphene Napsylate/Apap C Date:11/14/01ISR Number: 3824022-4Report Type:Direct Company Report # Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Back Pain Clozaril 400mg Day PS 400MG /DAY ( Initial or Prolonged Breath Sounds Abnormal HAD BEEN Collapse Of Lung 500MG PER DAY Cough UNTIL 8/6/01 Drug Level Above Zoloft C Therapeutic Lithium C Pleural Effusion Synthroid C Zyprexa C Vioxx C Date:11/14/01ISR Number: 3825174-2Report Type:Expedited (15-DaCompany Report #PHEH2001US08996 Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Clozaril (Clozapine) Tablet PS ORAL 100 MG, QID, ORAL Zyprexa (Olanzapine) C Tranxene (Clorazepate Dipotassium) C Date:11/14/01ISR Number: 3825181-XReport Type:Expedited (15-DaCompany Report #PHEH2001US08992 Age:55 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozaril Professional (Clozapine)Tablet PS ORAL 300 MG, BID, ORAL 22-Feb-2006 08:30 AM Page: 1341 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/14/01ISR Number: 3825303-0Report Type:Expedited (15-DaCompany Report #PHBS2001AU10083 Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiomyopathy Foreign Clozaril (Clozapine) Mental Disorder Health Tablet PS ORAL 300 MG/DAY, Professional ORAL Other Date:11/14/01ISR Number: 3825305-4Report Type:Expedited (15-DaCompany Report #PHNU2001DE02363 Age:28 YR Gender:Not SpecifiI/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Body Temperature Foreign Leponex/Clozaril Increased Health (Clozapine) Drug Interaction Professional (Clozapine) Tablet PS ORAL 500MG/DAY, Drug Level Above Other ORAL Therapeutic Voltaren (Diclofenac Sodium) Unknown, 50mg SS ORAL 150MG/DAY, ORAL Date:11/14/01ISR Number: 3825341-8Report Type:Expedited (15-DaCompany Report #A122356 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Consumer Ziprasidone Po PS ORAL 120.00 MG Hospitalization - Catatonia Health TOTAL: Initial or Prolonged Scar Professional BID:ORAL Sudden Death Clozaril SS 400.00 MG TOTAL DAILY Lamictal (Lamotrigine) C Ativan (Lorazepam) C Casanthranol /Docusate Sodium C Metamucil (Psyllium) C Celexa (Citalopram) C Inderal (Propanolol) C Cogentin C Date:11/16/01ISR Number: 3825370-4Report Type:Direct Company Report # Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Circulatory Collapse Clozaril (Novartis) Haematemesis 500-800 Mg/D X 6yr PS Novartis 500-800 MG/D Sudden Death X 6YR 6 YR Seroquel 800-600mg/D X 3 Years SS 800-600MG/D X 3 YEARS 3 YR Effexor Xr 300-450mg/D X 5 Mo SS 300-450MG/D X 5 MO 5 MON Depakote 1000mg Hs X 5mo SS 1000MG HS X 5MO 5 MON Lipitor C Cozaar C 22-Feb-2006 08:30 AM Page: 1342 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lung Inhaler C Date:11/16/01ISR Number: 3825619-8Report Type:Direct Company Report # Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Hyperglycaemia Clozapine 100 Mg And Hospitalization - 25 Mg Zenith Gl PS Zenith Gl ORAL 150 MG AM/ Initial or Prolonged 200 HS PO TITRATION STARTED 5/30. THIS DOSE Quetiapine C Depakote C Klonopin C Date:11/16/01ISR Number: 3825926-9Report Type:Expedited (15-DaCompany Report #NSADSS2001026744 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Chloride Increased Study Risperdal Initial or Prolonged Bradycardia Health (Risperidone) PS 1 MG, Coma Professional Topiramate Convulsion (Unspecified) Lethargy (Topiramate) SS ORAL 1000 MG, ORAL Medication Error Atenolol (Atenolol) SS 50 MG Pco2 Decreased Cogentin Sedation (Benzatropine Mesilate) SS 2 MG Clozaril (Clozapine) SS 30 MG Depakote (Valproate Semisodium) SS 200 MG Lamictal (Lamotrigine) C Dilantin (Phenytoin Sodium) C Date:11/16/01ISR Number: 3827380-XReport Type:Expedited (15-DaCompany Report #2001PK01070 Age:71 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Foreign Seroquel "Zeneca" PS ORAL 150 MG DAILY Initial or Prolonged Anxiety Health PO Confusional State Professional Seroquel "Zeneca" SS ORAL 200 MG DAILY Delirium Other PO Disorientation Seroquel "Zeneca" SS ORAL 250 MG DAILY Dizziness PO Drug Interaction Seroquel "Zeneca" SS ORAL 300 MG DAILY Drug Level Above PO Therapeutic Leponex "Novartis" SS ORAL 225 MG DAILY Drug Level Below PO Therapeutic Leponex "Novartis" SS ORAL 275 MG DAILAY Vomiting PO Leponex "Novartis" SS ORAL 300 MG DAILY PO Leponex "Novartis" SS ORAL 350 MG DAILY PO Leponex "Novartis" SS ORAL 400 MG DAILY 22-Feb-2006 08:30 AM Page: 1343 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report PO Leponex "Novartis" SS ORAL 450 MG DAILY PO Leponex "Novartis" SS ORAL 500 MG DAILY PO Leponex "Novartis" SS ORAL 550 MG DAILY PO Leponex "Novartis" SS ORAL 650 MG DAILY PO Leponex "Novartis" SS ORAL 700 MG DAILY PO Leponex "Novartis" SS ORAL 500 MG DAILY PO Leponex "Novartis" SS ORAL 400 MG DAILY PO Stilnox C Tavor C Pirenzepin C Date:11/16/01ISR Number: 3827533-0Report Type:Expedited (15-DaCompany Report #2001SIN0164 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Anuria Foreign Sinemet Hospitalization - Renal Failure Health (Carbidopa/Levodopa) PS ORAL 200/50 MG DLY Initial or Prolonged Rhabdomyolysis Professional PO Other Leponex (Clozapine) SS ORAL 25 MG DLY PO Date:11/16/01ISR Number: 3827550-0Report Type:Expedited (15-DaCompany Report #2001PK01076 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Clonic Convulsion Foreign Seroquel PS Zeneca ORAL 100 MG DAILY Initial or Prolonged Drug Interaction Health PO Hypoaesthesia Professional Seroquel SS Zeneca ORAL 200 MG DAILY PO Seroquel SS Zeneca ORAL 600 MG DAILY PO Leponex SS Novartis ORAL 200 MG DAILY PO Leponex SS Novartis ORAL 250 MG DAILY PO Leponex SS Novartis ORAL 300 MG DAILY PO Leponex SS Novartis ORAL 350 MG DAILY PO Leponex SS Novartis ORAL 400 MG DAILY PO Leponex SS Novartis ORAL 200 MG DAILY PO L-Thyroxin C Dociton C Date:11/16/01ISR Number: 3827584-6Report Type:Expedited (15-DaCompany Report #EMADSS2001006505 Age:44 YR Gender:Female I/FU:I Outcome Hospitalization - Initial or Prolonged 22-Feb-2006 08:30 AM Page: 1344 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other PT Report Source Product Role Manufacturer Route Dose Duration Condition Aggravated Foreign Haldol (10 Mg Constipation Health Tablet) Ileus Paralytic Professional (Haloperidol) PS ORAL 10 MG, ORAL; SEE IMAGE Leponex (Clozapine) SS ORAL 150 MG, ORAL; SEE IMAGE Temesta (Lorazepam) C Vioxx (Rofecoxib) C Date:11/16/01ISR Number: 3827879-6Report Type:Expedited (15-DaCompany Report #PHEH2001US09288 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Health Clozaril (Clozapine) Initial or Prolonged Pancytopenia Professional Tablet PS ORAL 400 MG/DAY, ORAL Benzotropine (Benzatropine Mesilate) C Depakote (Valproate Semisodium) C Docusate Sodium C Ranitidine (Ranitidine) C Date:11/16/01ISR Number: 3827882-6Report Type:Expedited (15-DaCompany Report #PHEH2001US09283 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatinine Health Clozaril (Clozapine) Initial or Prolonged Increased Professional Tablet PS ORAL 200 MG, BID, Blood Pressure Decreased ORAL Dehydration Lithium (Lithium) C Oedema Artane Pallor (Trihexyphenidyl Vertigo Hydrochloride) C Tetracycline (Tetracycline) C Vitamin E C Prilosec (Omeprazole) C Aspirin "Bayer" C Date:11/18/01ISR Number: 3825674-5Report Type:Direct Company Report # Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lower Respiratory Tract Geodon PS 20 MICROGRAMS Other Infection QAM & 40 MICROGRAMS QD Clozaril 300 Mg Q Hs SS 300 MG Q HS Paxil C 22-Feb-2006 08:30 AM Page: 1345 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/19/01ISR Number: 3825861-6Report Type:Expedited (15-DaCompany Report #WAES 01111658 Age:38 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Cogentin PS Merck & Co., Inc ORAL Clozapine SS Haloperidol SS Date:11/19/01ISR Number: 3827308-2Report Type:Direct Company Report # Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Clozapine 100mg Initial or Prolonged Status Epilepticus Zenith PS Zenith ORAL 300MG TID ORAL Valproic Acid C Lorazepam C Acetaminophen C Date:11/19/01ISR Number: 3827476-2Report Type:Expedited (15-DaCompany Report #2001078254US Age:40 YR Gender:Unknown I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Micronase(Glyburide) Drug Level Above Health Tablet, 1.25-5 Mg PS ORAL ORAL Therapeutic Professional Clozapine(Clozapine) SS Thioridazine SS Date:11/19/01ISR Number: 3828252-7Report Type:Expedited (15-DaCompany Report #PHBS2001US11288 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Literature Clozapine Initial or Prolonged Blood Amylase Increased Health (Clozapine) PS Other Blood Bicarbonate Professional Sertraline Increased (Sertraline) C Blood Potassium Increased Ranitidine Blood Sodium Increased (Ranitidine) C Dehydration Trihexyphenidyl Diabetic Ketoacidosis (Trihexyphenidyl) C Glucose Urine Glycosylated Haemoglobin Increased Ketonuria Lipase Increased Nausea Vomiting Weight Decreased Weight Increased Date:11/19/01ISR Number: 3828392-2Report Type:Expedited (15-DaCompany Report #PHFR2001GB03082 Age: Gender: I/FU:I Outcome PT Report Source Other Obsessive-Compulsive Foreign Disorder Health Professional Company 22-Feb-2006 08:30 AM Page: 1346 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Representative Other Product Role Manufacturer Route Dose Duration Clozaril(Clozapine)T ablet PS ORAL ORAL Date:11/19/01ISR Number: 3828418-6Report Type:Expedited (15-DaCompany Report #PHRM2001FR02478 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Foreign Leponex(Clozapine) Initial or Prolonged Dehydration Health Tablet PS ORAL 6.25 MG, QD, Difficulty In Walking Professional ORAL Disorientation Other Sinemet (Levodopa, Dyskinesia Carbidopa) C Renal Impairment Zestril (Lisinopril) C Sedation Importal C Date:11/19/01ISR Number: 3828431-9Report Type:Expedited (15-DaCompany Report #PHFR2001GB03081 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Obsessive-Compulsive Foreign Clozaril (Clozapine) Disorder Health Tablet PS Professional Other Date:11/19/01ISR Number: 3828432-0Report Type:Expedited (15-DaCompany Report #PHFR2001GB03039 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Clozaril (Clozapine) Study Tablet PS ORAL 400MG/DAY, Health ORAL Professional Other Date:11/19/01ISR Number: 3828433-2Report Type:Expedited (15-DaCompany Report #PHRM2001FR02455 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Foreign Leponex/Lx Initial or Prolonged Cardiomyopathy Health (Clozapine) Tablet PS ORAL 800 MG DAILY, Pulmonary Oedema Professional ORAL Date:11/19/01ISR Number: 3828434-4Report Type:Expedited (15-DaCompany Report #PHBS2001CA04312 Age:38 YR Gender:Male I/FU:I Outcome PT Other Dizziness Drug Level Above Therapeutic Hepatic Fibrosis Hepatitis Jaundice Malaise 22-Feb-2006 08:30 AM Page: 1347 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Salivary Hypersecretion Thrombocytopenia Vomiting Report Source Product Role Manufacturer Route Dose Duration Weight Decreased Foreign Clozaril(Clozapine)T Health ablet PS ORAL 700 MG/D, Professional ORAL Other Epival(Valproate Semisodium) SS Date:11/20/01ISR Number: 3827829-2Report Type:Expedited (15-DaCompany Report #PHFR2001GB02678 Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Colitis Ulcerative Foreign Clozaril (Clozapine) PS ORAL 200 MG, QID, Initial or Prolonged White Blood Cell Count Health ORAL 1 DAY Increased Professional Other Date:11/20/01ISR Number: 3827880-2Report Type:Expedited (15-DaCompany Report #PHFR2001GB02928 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agitation Foreign Clozaril (Clozapine) Hospitalization - Anxiety Health Tablet PS ORAL SEE IMAGE Initial or Prolonged Dysphagia Professional Other Gastritis Other Haematemesis Hypoaesthesia Muscle Twitching Nausea Neuralgia Overdose Pain In Extremity Salivary Hypersecretion Date:11/20/01ISR Number: 3827919-4Report Type:Expedited (15-DaCompany Report #PHBS2001AU06140 Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiac Disorder Foreign Clozaril (Clozapine) Cardiomyopathy Health Tablet PS ORAL 300 MG/D, Hypokinesia Professional ORAL Other Thiamine C Multivitamins (Panthenol, Retinol, Ascorbic Acid) C Diazepam C Efexor - Slow Release (Venlafaxine Hydrochloride) C Date:11/20/01ISR Number: 3827920-0Report Type:Expedited (15-DaCompany Report #PHFR2001IE01798 Age:63 YR Gender:Male I/FU:F Outcome PT Report Source Death Accident Foreign Drowning Study 22-Feb-2006 08:30 AM Page: 1348 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Health Professional Other Product Role Manufacturer Route Dose Duration Clozaril(Clozapine)T ablet PS ORAL 500 MG/DAY, ORAL Priadel C Sulpiride (Sulpiride) C Date:11/20/01ISR Number: 3827927-3Report Type:Expedited (15-DaCompany Report #DEU004629 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Clonic Convulsion Foreign Akineton PS ORAL 2 MG BID PO Study Leponex SS ORAL 50 MG DAILY Health PO Professional Leponex SS ORAL 500 MG DAILY Other PO Leponex SS Date:11/20/01ISR Number: 3827946-7Report Type:Expedited (15-DaCompany Report #01-10-0586 Age:91 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Health Clozapine-Zenith Dehydration Professional Goldline Pharm. Insomnia Tablets PS Zenith Goldline Pyrexia Pharm. ORAL 50-75MG QD Restlessness ORAL Screaming Upper Respiratory Tract Infection Date:11/20/01ISR Number: 3827947-9Report Type:Expedited (15-DaCompany Report #01-10-0585 Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bronchitis Health Clozapine Tablets PS Zenith Goldline Hospitalization - Professional Pharm. ORAL 300MG QD ORAL Initial or Prolonged Zithromax C Paxil C Geodon C Date:11/20/01ISR Number: 3827948-0Report Type:Expedited (15-DaCompany Report #01-10-0565 Age:54 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Pressure Decreased Health Clozapine - Zenith Depressed Level Of Professional Goldline Pharm. Consciousness Tablets PS Zenith Goldline Myocardial Infarction Pharm. ORAL 75MG QAM Pallor ORAL;67.5MG Tachycardia ,ORAL;100MG QHS ORAL Vitamin C C Celebrex C 22-Feb-2006 08:30 AM Page: 1349 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Premarin C Provera C Asa C Lactulose C Ambien C Ativan C Date:11/20/01ISR Number: 3827949-2Report Type:Expedited (15-DaCompany Report #01-08-0431 Age:58 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Condition Aggravated Health Clozapine Tablets PS Zenith Goldline Oesophageal Varices Professional Pharm. ORAL 50MG QD ORAL Haemorrhage Renal Failure Water Intoxication Date:11/20/01ISR Number: 3827950-9Report Type:Expedited (15-DaCompany Report #01-09-0537 Age:62 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozapine Tablets PS Zenith Goldline Coma Professional Pharm. ORAL 300 MG QD Constipation ORAL Erosive Oesophagitis Gastrointestinal Disorder Haematochezia Peritoneal Adhesions Pleural Adhesion Pneumonia Aspiration Rectal Haemorrhage Respiratory Arrest Vomiting Date:11/20/01ISR Number: 3827951-0Report Type:Expedited (15-DaCompany Report #01-11-0616 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mastectomy Health Clozapine Tablets PS Zenith Goldline Initial or Prolonged Professional Pharm. ORAL 575 MG QD ORAL Date:11/20/01ISR Number: 3827952-2Report Type:Expedited (15-DaCompany Report #01-11-0613 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiomyopathy Health Clozapine - Zenith Condition Aggravated Professional Coldline Pharm. Ejection Fraction Tablets PS Zenith Goldline Abnormal Pharm. ORAL 400 MG QD Renal Impairment ORAL Lithium C Wellbutrin C 22-Feb-2006 08:30 AM Page: 1350 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/20/01ISR Number: 3827953-4Report Type:Expedited (15-DaCompany Report #01-11-0610 Age:86 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine-Zenith Professional Goldine Pharm. Tablets PS Zenith Goldline Pharm. ORAL 50MG QD ORAL Date:11/20/01ISR Number: 3827954-6Report Type:Expedited (15-DaCompany Report #01-11-0608 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Clozapine Tablets PS Zenith Goldline Professional Pharm. ORAL ORAL Date:11/20/01ISR Number: 3827963-7Report Type:Expedited (15-DaCompany Report #C2001-3307.01 Age:82 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Oral Intake Reduced Health Clozapine Tablets 25 Other Professional Mg Mylan PS ORAL 75MG QD, ORAL Other Furosemide C Gabapentin C Glyburide C Hydroxyzine C Nicotine Patches C Potassium Chloride C Quetiapine C Spironolactone C Date:11/20/01ISR Number: 3828071-1Report Type:Expedited (15-DaCompany Report #PHBS2001BR11398 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Foreign Leponex (Clozapine) Obsessive-Compulsive Health Tablet PS ORAL ORAL 60 DAY Disorder Professional Other Date:11/20/01ISR Number: 3828076-0Report Type:Expedited (15-DaCompany Report #PHFR2001GB02847 Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Appendix Disorder Foreign Clozaril (Clozapine) Hospitalization - Constipation Health Tablet PS ORAL SEE IMAGE Initial or Prolonged Gangrene Professional Propanolol C Small Intestinal Other Oxybutynin Obstruction (Oxybutynin) C Wound Infection Lactulose C Docusate Sodium C Sodium Picosulfate (Sodium Picosulfate) C 22-Feb-2006 08:30 AM Page: 1351 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/20/01ISR Number: 3828077-2Report Type:Expedited (15-DaCompany Report #PHFR2001GB02939 Age:59 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril (Clozapine) Health Tablet PS ORAL 400 MG/DAY, Professional ORAL Other Olanzapine (Olanzapine) C Laxatives (No Ingredients/Substanc es) C Benzhexol (Trihexyphenidyl) C Date:11/20/01ISR Number: 3828080-2Report Type:Expedited (15-DaCompany Report #PHBS2001BR11397 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Obsessive-Compulsive Foreign Leponex(Clozapine) Disorder Health Tablet PS ORAL 500 MG/D,ORAL Professional Lorax (Loracarbef) C Date:11/20/01ISR Number: 3828081-4Report Type:Expedited (15-DaCompany Report #PHBS2001AU11456 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiomyopathy Foreign Clozaril (Clozapine) Health Tablet PS ORAL 200 MG/DAY, Professional ORAL Date:11/20/01ISR Number: 3828104-2Report Type:Expedited (15-DaCompany Report #PHNU2001DE02565 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Intentional Overdose Foreign Leponex/Clozaril Suicide Attempt Health (Clozapine) Professional (Clozapine) Tablet PS ORAL 250 MG, Company ONCE/SINGLE, Representative ORAL Other Date:11/20/01ISR Number: 3828142-XReport Type:Expedited (15-DaCompany Report #EMADSS2001006505 Age:44 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ileus Paralytic Foreign Haldol (10 Mg Initial or Prolonged Health Tablet) Other Professional (Haloperidol) PS ORAL 10 MG, ORAL; SEE IMAGE Leponex (Clozapine) SS ORAL 150 MG, ORAL; SEE IMAGE Temesta (Lorazepam) C Vioxx (Rofecoxib) C 22-Feb-2006 08:30 AM Page: 1352 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/20/01ISR Number: 3828178-9Report Type:Expedited (15-DaCompany Report #A126612 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Asthenia Health Sinequan Capsules PS 100.00 MG Intervention to Confusional State Professional TOTAL: DAILY Prevent Permanent Disorientation Chlorpromazine SS 200.00 MG Impairment/Damage Dysarthria TOTAL DAILY Dysphonia Clozapine SS Fall Lithium C Gait Disturbance Haematoma Movement Disorder Orthostatic Hypotension Sedation Staring Date:11/20/01ISR Number: 3828182-0Report Type:Expedited (15-DaCompany Report #PHBS2001US11287 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Cholesterol Literature Clozaril (Clozapine) Initial or Prolonged Increased Health Unknown PS 350 MG/DAY Blood Triglycerides Professional Risperidone Increased (Risperidone) SS Diabetes Mellitus Non-Insulin-Dependent Erectile Dysfunction Galactorrhoea Weight Increased Date:11/20/01ISR Number: 3828183-2Report Type:Expedited (15-DaCompany Report #PHBS2001US11286 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Literature Clozaril (Clozapine) Initial or Prolonged Blood Cholesterol Health Unknown PS Increased Professional Risperidone Blood Triglycerides (Risperidone) SS Increased Diabetes Mellitus Non-Insulin-Dependent Weight Increased Date:11/20/01ISR Number: 3830671-XReport Type:Periodic Company Report #PHEH2001US07543 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Health Clozaril (Clozapine) Initial or Prolonged Congestive Professional Tablet PS ORAL 200MG, ORAL Pneumonia Date:11/20/01ISR Number: 3830678-2Report Type:Periodic Company Report #PHEH2001US07545 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozaril (Clozapine) Professional Tablet PS ORAL 400 MG, ORAL 22-Feb-2006 08:30 AM Page: 1353 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Chemotherapeutics, Other (Chemotherapeutics, Other) SS Date:11/20/01ISR Number: 3830710-6Report Type:Periodic Company Report #PHEH2001US07866 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Difficulty In Walking Health Clozaril (Clozapine) Initial or Prolonged Tremor Professional Tablet PS ORAL 1) 225 MG, QHS, ORAL; 2) ORAL Date:11/20/01ISR Number: 3830711-8Report Type:Periodic Company Report #PHEH2001US07901 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Clozaril (Clozapine) White Blood Cell Count Professional Tablet PS ORAL ORAL Decreased Date:11/20/01ISR Number: 3830712-XReport Type:Periodic Company Report #PHEH2001US07912 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Clozaril (Clozapine) Professional Tablet PS ORAL 900 MG, ORAL Prozac (Fluoxetine Hydrochloride) C Ativan C Dilantin C Date:11/20/01ISR Number: 3830713-1Report Type:Periodic Company Report #PHEH2001US07926 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Grand Mal Convulsion Health Clozaril (Clozapine) Professional Tablet PS ORAL ORAL Neurontin (Gabapentin) C Date:11/20/01ISR Number: 3830714-3Report Type:Periodic Company Report #PHEH2001US07947 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) Professional Tablet PS ORAL ORAL Date:11/20/01ISR Number: 3830715-5Report Type:Periodic Company Report #USA/99/02850/LEX Age:57 YR Gender:Female I/FU:F Outcome Life-Threatening Hospitalization - 22-Feb-2006 08:30 AM Page: 1354 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Initial or Prolonged PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Pain Health Clozaril (Clozapine) Ileus Paralytic Professional (Clozapine) Tablet PS ORAL 100 MG, BID, Nausea ORAL 2912 DAY Vomiting Zoloft (Sertraline Hydrochloride) C Cogentin (Benzatropine Mesilate) C Ativan (Lorazepam) C Date:11/20/01ISR Number: 3830716-7Report Type:Periodic Company Report #USA/00/01427/LEX Age:63 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Grand Mal Convulsion Health Clozaril (Clozapine) Initial or Prolonged Professional (Clozapine) Tablet PS ORAL 300 MG, ORAL Seroquel (Quetiapine) C Percocet (Tylox) C Rocephin (Ceftriaxone Sodium) C Date:11/20/01ISR Number: 3830717-9Report Type:Periodic Company Report #PHEH2000US08565 Age:38 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Pressure Increased Health Clozaril (Clozapine) Coma Professional (Clozapine) Tablet PS ORAL 200MG AM + Fall 300MG HS, Heart Rate Decreased ORAL Malaise Paxil C Overdose Cogentin Pulmonary Embolism (Benzatropine Mesilate) C Trazodone (Trazodone) C Haldol C Oral Contraceptive Nos (Oral Contraceptive Nos) C Benzotropine (Benzatropine Mesilate) C Date:11/20/01ISR Number: 3830718-0Report Type:Periodic Company Report #PHEH2000US02784 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abdominal Pain Health Clozaril (Clozapine) Hospitalization - Agranulocytosis Professional (Clozapine) Tablet PS ORAL 600 MG, ORAL Initial or Prolonged Body Temperature Prozac (Fluoxetine Increased Hydrochloride) C Leukopenia Depakote (Valproate Pharyngolaryngeal Pain Semisodium) C Seroquel 22-Feb-2006 08:30 AM Page: 1355 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Quetiapine) C Remeron (Mirtazapine) C Klonopin C Cogentin (Benzatropine Mesilate) C Date:11/20/01ISR Number: 3830719-2Report Type:Periodic Company Report #PHEH2000US03359 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arrhythmia Health Clozaril (Clozaril) Initial or Prolonged Syncope Professional Tablet PS ORAL SEE IMAGE Clozapine (Clozapine) SS ORAL ORAL Trifluoperazine C Triphasal C Risperdal (Risperidone) C Zyprexa (Olanzapine) C Lithium Carbonate C Zantac C Clonazepam C Seroquel (Quetiapine) C Cogentin (Benzatropine Mesilate) C Date:11/20/01ISR Number: 3830720-9Report Type:Periodic Company Report #PHEH2000US07985 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Granulocytopenia Health Clozaril (Clozaril) Leukopenia Professional Tablet PS ORAL 100MG AM + 200MG PM, ORAL Haldol C Neurontin (Gabapentin) C Date:11/20/01ISR Number: 3830721-0Report Type:Periodic Company Report #PHEH2000US08309 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Alkaline Health Clozaril (Clozapine) Hospitalization - Phosphatase Increased Professional (Clozapine) Tablet PS ORAL 150 MG, TID, Initial or Prolonged Diarrhoea ORAL Granulocytopenia Risperdal Leukopenia (Risperidone) C Pyrexia Premarin (Estrogens Conjugated) C Zantac C Antibiotics (No Ingredients/Substanc es) C Potassium (Potassium) C 22-Feb-2006 08:30 AM Page: 1356 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/20/01ISR Number: 3830722-2Report Type:Periodic Company Report #PHEH2000US08433 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Hepatitis Clozaril (Clozapine) Hospitalization - Liver Function Test (Clozapine) Tablet PS ORAL 25 TO 600 MG, Initial or Prolonged Abnormal ORAL; 75 MG + 100 MG, ORAL Lithium (Lithium) C Date:11/20/01ISR Number: 3830723-4Report Type:Periodic Company Report #PHEH2000US08825 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Decreased Health Clozaril (Clozapine) Initial or Prolonged Clonic Convulsion Professional Tablet PS ORAL 250 MG, ORAL Depakote (Valproate Semisodium) C Seroquel (Quetiapine) C Date:11/20/01ISR Number: 3830724-6Report Type:Periodic Company Report #PHEH2000US09057 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Health Clozaril (Clozapine) Professional Tablet PS ORAL 300 MG, QD, ORAL Date:11/20/01ISR Number: 3830725-8Report Type:Periodic Company Report #PHEH2000US09164 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Granulocytopenia Health Clozaril (Clozapine) Leukopenia Professional (Clozapine) Tablet PS ORAL 200MG AM + 300MG HS, ORAL; 200MG AM + 300MG HS, ORAL Colace C Date:11/20/01ISR Number: 3830726-XReport Type:Periodic Company Report #PHEH2000US09221 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Sodium Decreased Health Clozaril (Clozapine) Hospitalization - Convulsion Professional Tablet PS ORAL 700 MG, ORAL Initial or Prolonged Delirium Ddavp (Desmopressin) SS 0.2 MG, Pollakiuria ONCE/SINGLE Polydipsia Risperdal (Risperidone) SS 4 MG 366 DAY Accupril (Quinapril Hydrochloride) SS ORAL 20 MG, ORAL 22-Feb-2006 08:30 AM Page: 1357 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/20/01ISR Number: 3830728-3Report Type:Periodic Company Report #PHEH2000US09339 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) Professional Tablet PS ORAL 800 MG, QD, ORAL Colace C Date:11/20/01ISR Number: 3830734-9Report Type:Periodic Company Report #PHEH2000US09343 Age:12 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozaril Neutropenia Professional (Clozapine)(Clozapin e) Tablet PS ORAL 450 MG, UNK, ORAL; 300 MG, BID, ORAL Claritin (Loratadine) C Axid (Nizatidine) C Cogentin (Benzatropine Mesilate) C Date:11/20/01ISR Number: 3830736-2Report Type:Periodic Company Report #PHEH2000US09383 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozaril Leukopenia Professional (Clozapine)(Clozapin e) Tablet PS ORAL 600 MG, QD, ORAL Haldol C Date:11/20/01ISR Number: 3830737-4Report Type:Periodic Company Report #PHEH2000US09448 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Health Clozaril (Clozapine) Initial or Prolonged Leukopenia Professional Tablet PS ORAL 175 MG AM + Other Pneumonia 200 MG HS, Pyrexia ORAL Urinary Tract Infection (Clozapine)(Clozapin e) SS ORAL 375 MG, QD, ORAL Celexa (Citalopram Hydrobromide) C Date:11/20/01ISR Number: 3830738-6Report Type:Periodic Company Report #PHEH2000US09451 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Health Clozaril (Clozapine) Initial or Prolonged Neutropenia Professional Tablet PS ORAL 400 MG, QD, Psychotic Disorder ORAL Paxil C Ritalin C 22-Feb-2006 08:30 AM Page: 1358 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Depakote (Valproate Semisodium) C Date:11/20/01ISR Number: 3830742-8Report Type:Periodic Company Report #PHEH2000US09452 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Contusion Health Clozaril Initial or Prolonged Convulsion Professional (Clozapine)(Clozapin Other Drug Interaction e) Tablet PS ORAL 700 MG, QD, Drug Level Above ORAL; ORAL Therapeutic Zoloft (Sertraline Hydrochloride) SS ORAL 100 MG, QD, ORAL; 150 MG, QD, ORAL; 100 MG, QD Risperdal (Risperidone) C Date:11/20/01ISR Number: 3830755-6Report Type:Periodic Company Report #PHEH2000US09657 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Clozaril Initial or Prolonged Drug Interaction Professional (Clozapine)(Clozapin Drug Level Increased e) Tablet PS ORAL 550 MG, QD, ORAL; 600 MG, UNK, ORAL Cimetidine (Cimetidine) SS ORAL 800 MG, BID, ORAL Dds C Congentin (Benzatropine Mesilate) C Colace C Date:11/20/01ISR Number: 3830758-1Report Type:Periodic Company Report #PHEH2000US09662 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Health Clozaril (Clozapine) Professional Tablet PS ORAL ORAL Prolixin (Fluphenazine Hydrochloride) C Lithium (Lithium) C Pericolace C Magonate C Depakote (Valproate Semisodium) C Seroquel (Quetiapine) C 22-Feb-2006 08:30 AM Page: 1359 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/20/01ISR Number: 3830760-XReport Type:Periodic Company Report #PHEH2000US09765 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Granulocytopenia Health Clozaril (Clozapine) White Blood Cell Count Professional Tablet PS ORAL 300 MG, BID, Decreased ORAL Date:11/20/01ISR Number: 3830761-1Report Type:Periodic Company Report #PHEH2000US09797 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Clozaril Professional (Clozapine)(Clozapin e) Tablet PS ORAL 300 MG, QD, ORAL; 200 MG, QD, ORAL Date:11/20/01ISR Number: 3830762-3Report Type:Periodic Company Report #PHEH2000US09873 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Leukocytosis Health Clozaril (Clozapine) Professional Tablet PS Date:11/20/01ISR Number: 3830763-5Report Type:Periodic Company Report #PHEH2000US09874 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Health Clozaril Initial or Prolonged Salivary Hypersecretion Professional (Clozapine)Tablet PS ORAL 300 MG , QHS, ORAL Prozac (Fluoxetine Hydrochloride) C Prevacid (Lansoprazole) C Glucotrol (Glipizide) C Date:11/20/01ISR Number: 3830764-7Report Type:Periodic Company Report #PHEH2000US09911 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tic Consumer Clozaril (Clozapine) Tablet PS ORAL 150MG AM + 100MG NOON + 150MG HS, ORAL Clozapine C Benztropine Mesylate (Benzatropine Mesilate) C Lorazepam C Trazodone (Trazodone) C 22-Feb-2006 08:30 AM Page: 1360 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/20/01ISR Number: 3830765-9Report Type:Periodic Company Report #PHEH2000US09928 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Health Clozaril (Clozapine) Initial or Prolonged Leukopenia Professional (Clozapine) Tablet PS ORAL 50MG AM + Malaise 500MG HS, Pyrexia ORAL Prozac (Fluoxetine Hydrochloride) C Date:11/20/01ISR Number: 3830766-0Report Type:Periodic Company Report #PHEH2000US10060 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Health Clozaril (Clozapine) Initial or Prolonged Professional (Clozapine) Tablet PS ORAL 500 MG, QD, ORAL Prolixin (Fluphenazine Hydrochloride) C Prozac (Fluoxetine Hydrochloride) C Ativan C Date:11/20/01ISR Number: 3830767-2Report Type:Periodic Company Report #PHEH2000US10064 Age:18 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypotension Health Clozaril (Clozapine) Initial or Prolonged Professional (Clozapine) Tablet PS ORAL 12.5MG AM + 12.5 MG HS, ORAL Lamictal C Seroquel (Quetiapine) C Claritin (Loratadine) C Ortho Tri-Cyclen (Norgestimate) C Date:11/20/01ISR Number: 3830768-4Report Type:Periodic Company Report #PHEH2000US10095 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Health Clozaril (Clozapine) Leukopenia Professional (Clozapine) Tablet PS ORAL 400 MG, QHS, ORAL Chemotherapy () Chemotherapy () SS Date:11/20/01ISR Number: 3830769-6Report Type:Periodic Company Report #PHEH2000US10101 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancreatitis Health Clozaril (Clozapine) Initial or Prolonged Vomiting Professional Tablet PS ORAL 100MG AM + 400MG HS, 22-Feb-2006 08:30 AM Page: 1361 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL Atenolol C Date:11/20/01ISR Number: 3830770-2Report Type:Periodic Company Report #PHEH2000US10318 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Lipase Increased Health Clozaril (Clozapine) Pancreatitis Professional Tablet PS ORAL 150MG AM+50MG NOON+325MG HS, ORAL Effexor (Venlafaxine Hydrochloride) C Trazodone (Trazodone) C Glucophag C Glycep C Lipitor (Atorvastatin) C Iron C Vitamin C (Ascorbic Acid) C Vitamin E C Date:11/20/01ISR Number: 3830771-4Report Type:Periodic Company Report #PHEH2000US10322 Age:80 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) Professional (Clozapine) Tablet PS ORAL 6.25MG, ORAL Date:11/20/01ISR Number: 3830772-6Report Type:Periodic Company Report #PHEH2000US10427 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Health Clozaril (Clozapine) Initial or Prolonged Professional Tablet PS ORAL 400 MG, ORAL Zyprexa (Olanzapine) C Lithium (Lithium) C Luvox (Fluvoxamine Maleate) C Date:11/20/01ISR Number: 3830773-8Report Type:Periodic Company Report #PHEH2000US10438 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) Professional (Clozapine) Tablet PS ORAL 63MG, ORAL Date:11/20/01ISR Number: 3830774-XReport Type:Periodic Company Report #PHEH2000US10447 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Health Clozaril (Clozapine) Initial or Prolonged Psychotic Disorder Professional Tablet PS Clozapine(Clozapine) SS 22-Feb-2006 08:30 AM Page: 1362 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/20/01ISR Number: 3830775-1Report Type:Periodic Company Report #PHEH2000US10643 Age:85 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril(Clozapine) Professional Tablet PS ORAL 25MG, ORAL Date:11/20/01ISR Number: 3830776-3Report Type:Periodic Company Report #PHEH2000US10810 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) Professional (Clozapine) Tablet PS ORAL 200MG AM + 700 MG HS, ORAL Depakote (Valproate Semisodium) C Seroquel (Quetiapine) C Date:11/20/01ISR Number: 3830777-5Report Type:Periodic Company Report #PHEH2000US10929 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Granulocytopenia Other Clozaril(Clozapine) Tablet PS ORAL ORAL Risperdal(Risperidon e) SS ORAL 2 MG, QD, ORAL Risperdal Regiment #2 SS ORAL 3 MG, QD, ORAL Risperdal Regiment #3 SS ORAL 2 MG, QD, ORAL Risperdal Regiment #4 SS ORAL 5 MG, QD, ORAL Risperdal Regiment #5 SS ORAL 3 MG, BID, ORAL Zyprexa(Olanzapine) SS ORAL ORAL Benztropine (Benzatropine Mesilate) C Lorazepam C Date:11/20/01ISR Number: 3830778-7Report Type:Periodic Company Report #PHEH2000US10971 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril Professional (Clozapine)(Clozapin e) Tablet PS ORAL 50MG, ORAL 22-Feb-2006 08:30 AM Page: 1363 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/20/01ISR Number: 3830779-9Report Type:Periodic Company Report #PHEH2000US11015 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozaril Hospitalization - Diarrhoea Professional (Clozapine)(Clozapin Initial or Prolonged Pyrexia Company e) Tablet PS ORAL 400 MG, ORAL Representative Date:11/20/01ISR Number: 3830780-5Report Type:Periodic Company Report #PHEH2000US11026 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Leukopenia Health Clozaril(Clozapine) Hospitalization - Professional Tablet PS ORAL 200 MG, QD, Initial or Prolonged ORAL Tegretol C Date:11/20/01ISR Number: 3830781-7Report Type:Periodic Company Report #PHEH2000US11144 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Contusion Health Clozaril(Clozapine) Initial or Prolonged Thrombocytopenia Professional Tablet PS ORAL 575 MG, ORAL Risperdal (Risperidone) C Depakote (Valproate Semisodium) C Lopressor C Ativan C Date:11/20/01ISR Number: 3830782-9Report Type:Periodic Company Report #PHEH2000US11195 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Back Pain Health Clozaril Initial or Prolonged Blood Amylase Increased Professional (Clozapine)(Clozapin Other Diarrhoea e) Tablet PS ORAL 250 MG, ORAL Lipase Increased Klonopin C Myalgia Zyprexa (Olanzapine) C Orthostatic Hypotension Pancreatitis Pyrexia Date:11/20/01ISR Number: 3830783-0Report Type:Periodic Company Report #PHEH2000US11216 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agranulocytosis Health Clozaril Hospitalization - Cardiac Arrest Professional (Clozapine)(Clozapin Initial or Prolonged Leukopenia e) Tablet PS ORAL 100 MG AM + Pyrexia 100MG, HS, Sepsis ORAL Clonazepam C 22-Feb-2006 08:30 AM Page: 1364 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/20/01ISR Number: 3830784-2Report Type:Periodic Company Report #PHEH2000US11218 Age:69 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Health Clozaril (Clozapine) Leukopenia Professional Tablet PS ORAL 25 MG AM + 50MG HS, ORAL Multivitamin (Pathenol, Retinol, Ascorbic Acid) C Rivastigmine C Klonopin C Trileptal C Dilantin C Lasix C Date:11/20/01ISR Number: 3830785-4Report Type:Periodic Company Report #PHEH2000US11282 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coordination Abnormal Health Clozaril (Clozapine) Initial or Prolonged Fall Professional Tablet PS ORAL 600 MG, QHS, Lethargy ORAL Weight Decreased Depakote (Valproate Semisodium) C Date:11/20/01ISR Number: 3830786-6Report Type:Periodic Company Report #PHEH2000US11285 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Health Clozaril (Clozapine) Leukopenia Professional Tablet PS ORAL 100 MG AM + 100MG NOON + 350MG HS, ORAL Exelon (Rivastigmine) Capsule C Trileptal (Oxcarbazepine) Tablet C Norvasc C Klonopin C Premarin (Estrogens Conjugated) C Marinol (Dronabinol) C Date:11/20/01ISR Number: 3830787-8Report Type:Periodic Company Report #PHEH2000US11337 Age:51 YR Gender:Female I/FU:I Outcome PT Life-Threatening Drug Level Above Therapeutic Electrocardiogram Qt Prolonged Eosinophilia Lethargy Leukocytosis Nausea 22-Feb-2006 08:30 AM Page: 1365 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Neutrophilia Vomiting Report Source Product Role Manufacturer Route Dose Duration Health Clozaril Professional (Clozapine)(Clozapin e) Tablet PS ORAL 100 MG, BID, ORAL Haldol (Haloperidol) SS Date:11/20/01ISR Number: 3830788-XReport Type:Periodic Company Report #PHEH2000US11344 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Clozaril (Clozapine) Professional Tablet PS ORAL 300 MG, UNK, ORAL Keflex (Cefalexin Monohydrate) C Date:11/20/01ISR Number: 3830789-1Report Type:Periodic Company Report #PHEH2000US11459 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) Professional Tablet PS ORAL 96MG UNK, ORAL Date:11/20/01ISR Number: 3830790-8Report Type:Periodic Company Report #PHEH2000US11488 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Health Clozaril (Clozapine) Atrial Tachycardia Professional Tablet PS ORAL 200 MG UNK, Blood Glucose Increased ORAL Palpitations Prevacid (Lansoprazole) C Topamax (Topiramate) C Tolinase (Tolazamide) C Valium C Depo-Provera C Lamictal C Trazon (Trazodone) C Vicodin (Paracetamol) C Riboxin (Roxithromycin) C Verpamil (Verapamil Hydrochloride) C Date:11/20/01ISR Number: 3830791-XReport Type:Periodic Company Report #PHEH2000US11489 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Health Clozaril Pyrexia Professional (Clozapine)(Clozapin e) Tablet PS 22-Feb-2006 08:30 AM Page: 1366 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/20/01ISR Number: 3830792-1Report Type:Periodic Company Report #PHEH2000US11490 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Granulocytopenia Health Clozaril Initial or Prolonged Leukopenia Professional (Clozapine)(Clozapin e) Tablet PS ORAL 175 MG, QD, ORAL; 100 MG, UNK, ORAL Seroquil (Quetiapine) C Varpamil (Verapamil Hydrochloride) C Vasotec C Proventil/Old Form/ C Asthmacort C Folic Acid C Multiple Vitamins (Vitamin B Nos, Retinol, Ascorbic Acid) C Date:11/20/01ISR Number: 3830793-3Report Type:Periodic Company Report #PHEH2000US11596 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) Professional (Clozapine) Tablet PS ORAL 75 MG, ORAL Date:11/20/01ISR Number: 3830794-5Report Type:Periodic Company Report #PHEH2000US11732 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Small Intestinal Health Clozaril (Clozapine) Initial or Prolonged Obstruction Professional Tablet PS ORAL 425 MG, QHS, ORAL Haldol C Cogentin (Benzatropine Mesilate) C Ativan C Date:11/20/01ISR Number: 3830795-7Report Type:Periodic Company Report #PHEH2001US00500 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) Professional (Clozapine) Tablet PS ORAL 600 MG, ORAL Cogent (Benzatropine Mesilate) C Seroquel (Quetiapine) C Paxil C Ddavp (Desmopressin) C Albuterol C Azmacort (Triamcinolone Acetonide) C 22-Feb-2006 08:30 AM Page: 1367 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/20/01ISR Number: 3830796-9Report Type:Periodic Company Report #PHEH2001US00550 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diarrhoea Health Clozaril (Clozapine) Initial or Prolonged Drug Withdrawal Syndrome Professional (Clozapine) Tablet PS ORAL 500 MG, QD, Headache ORAL 200MG Hyperhidrosis UKN,ORAL Nausea Navane (Tiotixene) C Tremor Trazodone C Vomiting Zoloft (Sertraline White Blood Cell Count Hydrochloride) C Increased Date:11/20/01ISR Number: 3830797-0Report Type:Periodic Company Report #PHEH2001US00608 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Eosinophilia Health Clozaril (Clozapine) Hospitalization - Leukocytosis Professional (Clozapine) Tablet PS ORAL 200 MG, QD, Initial or Prolonged ORAL Depakote (Valproate Semisodium) C Thorazine (Chlorpromazine Hydrochloride) C Date:11/20/01ISR Number: 3830798-2Report Type:Periodic Company Report #PHEH2001US00637 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Thrombocytopenia Health Clozaril (Clozapine) Initial or Prolonged Professional (Clozapine) Tablet PS ORAL 550 MG, ORAL Thorazine (Chlorpromazine Hydrochloride) C Haldol C Benadryl C Date:11/20/01ISR Number: 3830799-4Report Type:Periodic Company Report #PHEH2001US00880 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Health Clozaril (Clozapine) Initial or Prolonged Leukopenia Professional (Clozapine) Tablet PS ORAL ORAL Depakote (Valproate Semisodium) C Synthroid C Ativan C Date:11/20/01ISR Number: 3830800-8Report Type:Periodic Company Report #PHEH2001US00916 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intestinal Obstruction Health Clozaril (Clozapine) Initial or Prolonged Professional (Clozapine) Tablet PS ORAL 300 MG, QD, ORAL Depakote (Valproate 22-Feb-2006 08:30 AM Page: 1368 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Semisodium) C Date:11/20/01ISR Number: 3830801-XReport Type:Periodic Company Report #PHEH2001US00918 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Constipation Health Clozaril (Clozapine) Initial or Prolonged Intestinal Obstruction Professional Tablet PS ORAL 575 MG, ORAL Clozapine (Clozapine) SS ORAL 575 MG, ORAL 3650 DAY Date:11/20/01ISR Number: 3830802-1Report Type:Periodic Company Report #PHEH2001US00920 Age:88 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) Professional Tablet PS ORAL ORAL Date:11/20/01ISR Number: 3830803-3Report Type:Periodic Company Report #PHEH2001US01041 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Body Temperature Health Clozaril (Clozapine) Initial or Prolonged Increased Professional (Clozapine)Tablet PS ORAL 450 MG QD Cough ORAL Dyspnoea Zyprexa (Olanzapine) C Pneumonia Valium C Trilafon (Perphenazine) C Remeron (Mirtazapine) C Colace C Date:11/20/01ISR Number: 3830804-5Report Type:Periodic Company Report #PHEH2001US01114 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Health Clozaril (Clozapine) Drug Level Changed Professional (Clozapine)Tablet PS ORAL 300MG AM + 400MG HS ORAL Klonopin C Oxybutynin (Oxybutynin) C Trileptal C Date:11/20/01ISR Number: 3830805-7Report Type:Periodic Company Report #PHEH2001US01117 Age:84 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) Professional (Clozapine)Tablet PS ORAL 75 MG ORAL 22-Feb-2006 08:30 AM Page: 1369 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/20/01ISR Number: 3830806-9Report Type:Periodic Company Report #PHEH2001US01118 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) Professional (Clozapine)Tablet PS ORAL 250 MG ORAL Date:11/20/01ISR Number: 3830807-0Report Type:Periodic Company Report #PHEH2001US01119 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) Professional Tablet PS ORAL 200 MG ORAL Date:11/20/01ISR Number: 3830808-2Report Type:Periodic Company Report #PHEH2001US01120 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) Professional Tablet PS ORAL 800 MG ORAL Date:11/20/01ISR Number: 3830809-4Report Type:Periodic Company Report #PHEH2001US01221 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Health Clozaril (Clozapine) Initial or Prolonged Leukopenia Professional Tablet PS ORAL 300 MG QD ORAL Date:11/20/01ISR Number: 3830810-0Report Type:Periodic Company Report #PHEH2001US01272 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Clozaril (Clozapine) Professional Tablet PS ORAL 150 MG BID ORAL Date:11/20/01ISR Number: 3830811-2Report Type:Periodic Company Report #PHEH2001US01443 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Health Clozaril (Clozapine) Neutrophil Count Professional Tablet PS ORAL 550 MG ORAL Decreased Zoloft (Sertraline White Blood Cell Count Hydrochloride) C Decreased Colace C Oral Contraceptive Nos (Oral Contraceptive Nos) C Cough And Cold Preparations (No Ingredients/Substanc es) C 22-Feb-2006 08:30 AM Page: 1370 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/20/01ISR Number: 3830812-4Report Type:Periodic Company Report #PHEH2001US01502 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Myocardial Infarction Health Clozaril (Clozapine) Initial or Prolonged Respiratory Arrest Professional Tablet PS ORAL 300 MG ORAL Date:11/20/01ISR Number: 3830813-6Report Type:Periodic Company Report #PHEH2001US01504 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) Hospitalization - Professional (Clozapine) Tablet PS ORAL ORAL Initial or Prolonged Date:11/20/01ISR Number: 3830814-8Report Type:Periodic Company Report #PHEH2001US01636 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Health Clozaril (Clozapine) Initial or Prolonged Phosphokinase Increased Professional (Clozapine) Tablet PS Other Drooling Haemoglobin Decreased Hypotension Leukocytosis Liver Function Test Abnormal Neuroleptic Malignant Syndrome Pneumonia Respiratory Failure Sedation Tachycardia Thrombocythaemia Date:11/20/01ISR Number: 3830815-XReport Type:Periodic Company Report #PHEH2001US01687 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Health Clozaril (Clozapine) Initial or Prolonged Leukopenia Professional (Clozapine) Tablet PS ORAL 125 MG, UNK, ORAL Efexor (Venlafaxine Hydrochloride) C Neurontin (Gabapentin) C Trazodone (Trazodone) C Haldol C Date:11/20/01ISR Number: 3830816-1Report Type:Periodic Company Report #PHEH2001US01840 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Sedation Health Clozaril (Clozapine) Initial or Prolonged Professional (Clozapine) Tablet PS ORAL 125 MG, UNK, ORAL Luvox (Fluvoxamine 22-Feb-2006 08:30 AM Page: 1371 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Maleate) SS 200 MG Valium C Ambien (Zolpidem Tartrate) C Lamictal C Date:11/20/01ISR Number: 3830817-3Report Type:Periodic Company Report #PHEH2001US02366 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutrophil Count Health Clozaril (Clozapine) Initial or Prolonged Decreased Professional (Clozapine) Tablet PS ORAL 200MG AM + Pneumonia 400MG HS, White Blood Cell Count ORAL Decreased Zoloft (Sertraline Hydrochloride) C Date:11/20/01ISR Number: 3830818-5Report Type:Periodic Company Report #PHEH2001US02550 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Health Clozaril (Clozapine) Professional (Clozapine) Tablet PS ORAL 400 MG, UNK, ORAL Cogentin (Benzatropine Mesilate) C Glucophage "Aron" C Lipitor (Atorvastatin) C Date:11/20/01ISR Number: 3830819-7Report Type:Periodic Company Report #PHEH2001US02638 Age:84 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) Professional (Clozapine) Tablet PS ORAL 25MG UNK ORAL Date:11/20/01ISR Number: 3830820-3Report Type:Periodic Company Report #PHEH2001US02953 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Clozaril (Clozapine) Initial or Prolonged Professional (Clozapine) Tablet PS ORAL 650 MG, UNK, ORAL Inderal C Prolixin (Fluphenazine Hydrochloride) C Clonidine C Cogentin (Benzatropine Mesilate) C Depakote (Valproate Semisodium) C 22-Feb-2006 08:30 AM Page: 1372 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/20/01ISR Number: 3830821-5Report Type:Periodic Company Report #PHEH2001US03071 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Urinary Tract Obstruction Health Clozaril (Clozapine) Initial or Prolonged Professional (Clozapine) Tablet PS ORAL ORAL Date:11/20/01ISR Number: 3830822-7Report Type:Periodic Company Report #PHEH2001US03162 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Health Clozaril (Clozapine) Initial or Prolonged Neutropenia Professional Tablet, 100 Mg PS ORAL 100MG AM + 200MG HS, ORAL Efexor Er (Venlafaxine Hydrochloride) C Cogentin (Benzatropine Mesilate) C Prolixin Decanoate (Fluphenazine Decanoate) C Date:11/20/01ISR Number: 3830823-9Report Type:Periodic Company Report #PHEH2001US03384 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Clozaril (Clozapine) Drooling Professional Tablet PS ORAL 400 MG UNK, Dysphemia ORAL Seroquel (Quetiapine) C Paxil C Date:11/20/01ISR Number: 3830824-0Report Type:Periodic Company Report #PHEH2001US03497 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) Hospitalization - Professional Tablet, 25 Mg PS ORAL 50MG QD + Initial or Prolonged 75MG HS, ORAL Aricept (Donepezil Hydrochloride) C Date:11/20/01ISR Number: 3830825-2Report Type:Periodic Company Report #PHEH2001US03500 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Clozaril (Clozapine) Professional Tablets PS ORAL 350 MG, ORAL Neurontin (Gabapentin) C Risperdal (Risperidone) C Atenolol C Vicodin 22-Feb-2006 08:30 AM Page: 1373 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Paracetamol) C Date:11/20/01ISR Number: 3830826-4Report Type:Periodic Company Report #PHEH2001US03659 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Health Clozaril (Clozapine) Initial or Prolonged Professional Tablet PS ORAL 100 MG, TID, ORAL Tegretol (Carbamazepine, Carbamazepine) Tablet SS Risperdal (Risperidone) C Celebrex (Celecoxib) C Flonase (Fluticasone Propionate) C Glucotrol (Glipizide) C Lasix C Micro-K C Ativan C Robitussin-Dm (Ethanol) C Mom-Hot (Methyl Salicylate, Extractum Fluidum Capsici) C Ketokonazol (Ketoconazole) C Allegra (Fexofenadine Hydrochloride) C Synthroid C Date:11/20/01ISR Number: 3830827-6Report Type:Periodic Company Report #PHEH2001US03694 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Health Clozaril(Clozapine) Initial or Prolonged Professional Tablet PS ORAL 100 MG, TID, ORAL Lithium (Lithium) C Paxil C Date:11/20/01ISR Number: 3830828-8Report Type:Periodic Company Report #PHEH2001US03770 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pyrexia Health Clozaril(Clozapine) Initial or Prolonged Professional Tablet, 25 Mg PS ORAL SEE IMAGE Lorazepam C Zaleplon (Zaleplon) C 22-Feb-2006 08:30 AM Page: 1374 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/20/01ISR Number: 3830829-XReport Type:Periodic Company Report #PHEH2001US03779 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Health Clozaril (Clozapine) Initial or Prolonged Neutropenia Professional Tablet PS ORAL ORAL Overdose Haldol C Cogentin (Benzatropine Mesilate) C Lithium (Lithium) C Paxil C Risperdal (Risperidone) C Date:11/20/01ISR Number: 3830830-6Report Type:Periodic Company Report #PHEH2001US03780 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Health Clozaril (Clozapine) Initial or Prolonged Increased Professional Tablet PS ORAL 700 MG, ORAL Aspartate Haldol C Aminotransferase Cogentin Increased (Benzatropine Blood Creatine Mesilate) C Phosphokinase Increased Ativan C Date:11/20/01ISR Number: 3830831-8Report Type:Periodic Company Report #PHEH2001US03827 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pulmonary Embolism Health Clozaril(Clozapine) PS ORAL 325 MG, ORAL Initial or Prolonged Professional Eskalith C Company Depakote (Valproate Representative Semisodium) C Colace C Ortho-Novum 7/7/7-28 (Norethisterone) C Coumadin "Taro" C Lasix C Centrum (Vitamins Nos) C Date:11/20/01ISR Number: 3830832-XReport Type:Periodic Company Report #PHEH2001US03830 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) Professional Tablet PS ORAL 19 MG, QW, ORAL Date:11/20/01ISR Number: 3831552-8Report Type:Periodic Company Report #PHEH2000US08577 Age:29 YR Gender:Male I/FU:I Outcome PT Hospitalization - Anorexia Initial or Prolonged Atrial Fibrillation Blood Creatine 22-Feb-2006 08:30 AM Page: 1375 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Phosphokinase Increased Chills Confusional State Liver Function Test Report Source Product Role Manufacturer Route Dose Duration Abnormal Health Clozaril (Clozapine) Malaise Professional (Clozapine) Tablet PS ORAL 300 MG, QD, Muscle Rigidity ORAL Pyrexia Zoloft (Sertraline Hydrochloride) C Cogentin (Benzatropine Mesilate) C Symmetrel C Zyprexa (Olanzapine) C Mellaril C Date:11/20/01ISR Number: 3831553-XReport Type:Periodic Company Report #PHEH2000US08784 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Health Clozaril (Clozapine) Initial or Prolonged Confusional State Professional (Clozapine) Tablet PS ORAL 100MG AM + Erythema 200HG HS, Face Oedema ORAL Risperdal (Risperidone) C Trazodone (Trazodone) C Date:11/20/01ISR Number: 3831554-1Report Type:Periodic Company Report #PHEH2000US08813 Age:71 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) Professional Tablet PS ORAL 25 MG UNK ORAL Other Medications For Parkinson'S Disease C Date:11/20/01ISR Number: 3831555-3Report Type:Periodic Company Report #PHEH2000US08917 Age:86 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) Hospitalization - Professional (Clozapine) PS ORAL 37.5 MG, UNK, Initial or Prolonged ORAL Date:11/20/01ISR Number: 3831558-9Report Type:Periodic Company Report #PHEH2001US03968 Age:78 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) Professional Tablet PS ORAL 25 MG DAILY; Company 38 MG: ORAL Representative 22-Feb-2006 08:30 AM Page: 1376 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/20/01ISR Number: 3831560-7Report Type:Periodic Company Report #PHEH2001US04196 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Leukocytosis Health Clozaril (Clozapine) Pulmonary Embolism Professional Tablet PS ORAL 500MG DAILY, ORAL Haldol C Lithium (Lithium) C Zoloft (Sertraline Hydrochloride) C Cogentin (Benzatropine Mesilate) C Klonopin C Date:11/20/01ISR Number: 3831562-0Report Type:Periodic Company Report #PHEH2001US04200 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Leukocytosis Health Clozaril (Clozapine) Hospitalization - Pneumonia Professional Tablet PS ORAL 150 MG, BID, Initial or Prolonged ORAL Effexor (Venlafaxine Hydrochloride) C Lithobid C Synthroid C Cytomel C Provigil (Modafinil) C Depakote (Valproate Semisodium) C Remeron (Mirtazapine) C Date:11/20/01ISR Number: 3831564-4Report Type:Periodic Company Report #PHEH2001US04237 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) Professional Tablet PS ORAL ORAL Date:11/20/01ISR Number: 3831565-6Report Type:Periodic Company Report #PHEH2001US04302 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neutropenia Health Clozaril (Clozapine) Professional Tablet PS ORAL ORAL Chemotherapeutics,Ot her(Chemotherapeutic s, Other) SS Date:11/20/01ISR Number: 3831567-XReport Type:Periodic Company Report #PHEH2001US04305 Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypotension Other Clozaril (Clozapine) Initial or Prolonged Tablet PS ORAL ORAL 22-Feb-2006 08:30 AM Page: 1377 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/20/01ISR Number: 3831568-1Report Type:Periodic Company Report #PHEH2001US04306 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Leukocytosis Health Clozaril (Clozapine) Overdose Professional Tablet PS ORAL 625 MG DAILY, ORAL Date:11/20/01ISR Number: 3831569-3Report Type:Periodic Company Report #PHEH2001US04323 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Faecaloma Health Clozaril (Clozapine) Professional Tablet PS ORAL 450 MG DAILY, ORAL Date:11/20/01ISR Number: 3831570-XReport Type:Periodic Company Report #PHEH2001US04324 Age:86 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) Hospitalization - Professional Tablet PS ORAL 75 MG DAILY, Initial or Prolonged ORAL Prednisone C Depakote (Valproate Semisodium) C Trazodone (Trazodone) C Paxil C Calcium Carbonate C Vitamin B12 C Date:11/20/01ISR Number: 3831571-1Report Type:Periodic Company Report #PHEH2001US04423 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Circulatory Collapse Health Clozaril PS ORAL 400MG DAILY, Initial or Prolonged Dehydration Professional ORAL Delusion Clozapine SS Hypotension Shock Syncope Urinary Incontinence Date:11/20/01ISR Number: 3831573-5Report Type:Periodic Company Report #PHEH2001US04425 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Health Clozaril (Clozapine) Initial or Prolonged Eosinophilia Professional Tablet PS ORAL 600 MG, UNK, Haematochezia ORAL Liver Function Test Abnormal 22-Feb-2006 08:30 AM Page: 1378 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/20/01ISR Number: 3831575-9Report Type:Periodic Company Report #PHEH2001US04448 Age:67 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Petit Mal Epilepsy Health Clozaril (Clozapine) Professional Tablet PS ORAL 100 MG, UNK, ORAL Trileptal C Exelon (Rivastigmine Tartrate) C Date:11/20/01ISR Number: 3831578-4Report Type:Periodic Company Report #PHEH2001US04495 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) Professional Tablet PS ORAL 38 MG, UNK, ORAL Date:11/20/01ISR Number: 3831580-2Report Type:Periodic Company Report #PHEH2001US04496 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Amnesia Health Clozaril (Clozapine) Hospitalization - Anaemia Professional Tablet PS ORAL 200 MG, BID, Initial or Prolonged Confusional State ORAL Leukopenia Ziprasidone Neutropenia Hydrochloride Pneumonia (Ziprasidone Pyrexia Hydrochloride) SS ORAL 20 MG, AM, 40 Urinary Tract Infection MG, HS, ORAL Cogentin (Benzatropine Mesilate) C Neurontin (Gabapentin) C Haldol C Lamictal C Date:11/20/01ISR Number: 3831581-4Report Type:Periodic Company Report #PHEH2001US06214 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypothermia Health Clozaril (Clozapine) Initial or Prolonged Infection Professional Tablet PS ORAL 25 MG, UNK, ORAL Antibiotics (No Ingredients/Substanc es) C Date:11/20/01ISR Number: 3831583-8Report Type:Periodic Company Report #PHEH2001US06231 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Health Clozaril (Clozapine) Initial or Prolonged Psychotic Disorder Professional Tablet PS ORAL 625 MG, UNK, Other Company ORAL Representative Synthroid C 22-Feb-2006 08:30 AM Page: 1379 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lotensin C Ditropan (Oxybutynin) C Neurontin (Gabapentin) C Date:11/20/01ISR Number: 3831584-XReport Type:Periodic Company Report #PHEH2001US06304 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypotension Health Clozaril (Clozapine) Initial or Prolonged Professional Tablet PS ORAL 12.5 MG, BID, ORAL Quetiapine C Date:11/20/01ISR Number: 3831586-3Report Type:Periodic Company Report #PHEH2001US06306 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Clozaril (Clozapine) Initial or Prolonged Professional Tablet PS ORAL ORAL Dilantin C Lamictal C Levothyroxine C Geodon (Ziprasidone Hydrochloride) C Trazodone C Colace C Date:11/20/01ISR Number: 3831587-5Report Type:Periodic Company Report #PHEH2001US06337 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) Professional Tablet PS ORAL 750 MG, UNK, ORAL Date:11/20/01ISR Number: 3831589-9Report Type:Periodic Company Report #PHEH2001US06358 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Tetany Health Clozaril (Clozapine) Initial or Prolonged Professional Tablet PS ORAL 300 MG, BID, Company ORAL Representative Depoke C Synthroid C Bisacodyl C Date:11/20/01ISR Number: 3831592-9Report Type:Periodic Company Report #PHEH2001US06441 Age:48 YR Gender:Female I/FU:I Outcome PT Hospitalization - Clonic Convulsion Initial or Prolonged Face Oedema Muscular Weakness Oedema Peripheral 22-Feb-2006 08:30 AM Page: 1380 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sedation Weight Increased Report Source Product Role Manufacturer Route Dose Duration Health Clozaril (Clozapine) Professional Tablet PS ORAL SEE IMAGE Lithium (Lithium) C Cogentin (Benzatropine Mesilate) C Ziac C Haldol C Depakote (Valproat Semisodium) C Multivitamins And Iron (No Ingredients/Substanc es) C Date:11/20/01ISR Number: 3831594-2Report Type:Periodic Company Report #PHEH2001US06563 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Health Clozaril(Clozapine) Leukopenia Professional Tablet PS ORAL 700 MG DAILY, ORAL Date:11/20/01ISR Number: 3831595-4Report Type:Periodic Company Report #PHEH2001US06675 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozaril(Clozapine) Hospitalization - Psychotic Disorder Professional Tablet PS ORAL 300MG DAILY, Initial or Prolonged White Blood Cell Count ORAL Decreased Cogentin (Benzatropine Mesilate) C Date:11/20/01ISR Number: 3831596-6Report Type:Periodic Company Report #PHEH2001US06710 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Health Clozaril (Clozapine) Initial or Prolonged Professional Tablet PS ORAL 350MG DAILY, ORAL Date:11/20/01ISR Number: 3831597-8Report Type:Periodic Company Report #PHEH2001US06734 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) Professional Tablet PS ORAL 500MG AM+ Company 100MG HS, Representative ORAL Lorazepam C Topamax (Topiramate) C Eskalith C Geodon (Ziprasidone 22-Feb-2006 08:30 AM Page: 1381 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride0 C Wellbutrin (Amfebutamone Hydrochloride) C Date:11/20/01ISR Number: 3831599-1Report Type:Periodic Company Report #PHEH2001US06740 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukocytosis Health Clozaril(Clozapine) Initial or Prolonged Psychotic Disorder Professional Tablet PS ORAL SEE IMAGE Risperdal (Risperidone) C Neurontin (Gabapentin) C Cogentin (Benzatropine Mesilate) C Date:11/20/01ISR Number: 3831601-7Report Type:Periodic Company Report #PHEH2001US06791 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Health Clozaril (Clozapine) Initial or Prolonged Phosphokinase Increased Professional Tablet PS ORAL SEE IMAGE Convulsion Neuroleptic Malignant Syndrome Pneumonia Aspiration Rhabdomyolysis Date:11/20/01ISR Number: 3831602-9Report Type:Periodic Company Report #PHEH2001US06895 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Clozaril(Clozapine) PS ORAL 400 MG, QHS, Professional ORAL Company Neurontin Representative (Gabapentin) C Depakote (Valproate Semisodium) C Haldol C Zyprexa (Olanzapine) C Celexa (Citalopram Hydrobromide) C Inderal C Pepcid C Date:11/20/01ISR Number: 3831604-2Report Type:Periodic Company Report #PHEH2001US06896 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pneumonia Health Clozaril(Clozapine) Vomiting Projectile Professional Tablet PS ORAL 225 MG, UNK, ORAL Ceclor (Cefaclor) SS Penicillin V-K C Zyrtec (Cetirizine 22-Feb-2006 08:30 AM Page: 1382 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride) C Humibid La C Albuterol C Date:11/20/01ISR Number: 3831606-6Report Type:Periodic Company Report #PHEH2001US07000 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Health Clozaril(Clozapine) Upper Respiratory Tract Professional Tablet PS ORAL 450 MG UNK, Infection ORAL Geodon (Ziprasidone Hydrochloride) C Anafranil C Wellbutrin-Slow Release (Amfebutamone Hydrochloride) C Depakote (Valproate Semisodium) C Cogentin (Benzatropine Mesilate) C Date:11/20/01ISR Number: 3831609-1Report Type:Periodic Company Report #PHEH2001US07171 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Clozaril(Clozapine)T Initial or Prolonged Professional ablet PS ORAL 400 MG, ORAL Depakene(Valproate Sodium) SS Lithium (Lithium) C Wellbutrin (Amfebutamone Hydrochloride) C Date:11/20/01ISR Number: 3831611-XReport Type:Periodic Company Report #PHEH2001US07215 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Granulocytopenia Health Clozaril(Clozapine) Hepatitis C Professional Tablet PS ORAL 600 MG DAILY, ORAL Date:11/20/01ISR Number: 3831612-1Report Type:Periodic Company Report #PHEH2001US07242 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril(Clozapine) Professional Tablets PS ORAL 200 MG, ORAL 22-Feb-2006 08:30 AM Page: 1383 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/20/01ISR Number: 3831613-3Report Type:Periodic Company Report #PHEH2001US07243 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril(Clozapine) Professional Tablet PS ORAL 600 MG, ORAL Date:11/20/01ISR Number: 3831614-5Report Type:Periodic Company Report #PHEH2001US07262 Age:82 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril(Clozapine) Professional Tablet PS ORAL 25MG, ORAL Date:11/20/01ISR Number: 3831615-7Report Type:Periodic Company Report #PHEH2001US07263 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril(Clozapine) Professional Tablet PS ORAL 500MG, ORAL Date:11/20/01ISR Number: 3831617-0Report Type:Periodic Company Report #PHEH2001US07288 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril(Clozapine) Professional Tablet PS ORAL ORAL Date:11/20/01ISR Number: 3831618-2Report Type:Periodic Company Report #PHEH2001US07407 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukocytosis Health Clozaril(Clozapine) Initial or Prolonged Professional Tablet PS ORAL 450 MG, ORAL Celexa (Citalopram Hydrobromide) C Geodon (Ziprasidone Hydrochloride) C Cogentin (Benzaropine Mesilate) C Citalopram (Citalopram) C Ziprasidone (Ziprasidone) C Date:11/20/01ISR Number: 3831621-2Report Type:Periodic Company Report #PHEH2001US07408 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pyrexia Health Clozaril (Clozapine) Initial or Prolonged Professional Tablet PS 300 MG, QD Risperidone (Risperidone) C 22-Feb-2006 08:30 AM Page: 1384 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/20/01ISR Number: 3831623-6Report Type:Periodic Company Report #PHEH2001US07509 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozaril(Clozapine) Hospitalization - Leukopenia Professional Tablet PS ORAL 400 MG/DAY, Initial or Prolonged Psychotic Disorder Company ORAL Representative Depakote (Valproate Semisodium) C Date:11/21/01ISR Number: 3829052-4Report Type:Expedited (15-DaCompany Report #PHNU2001DE02136 Age:25 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Oculogyration Foreign Leponex / Clozaril Health (Clozapine) Professional (Clozapine) Tablet PS ORAL 500 MG/DAY, Other ORAL Ciatyl-Z (Zuclopenthixol Dihydrochloride, Zuclopenthixol Hydrochloride) SS ORAL 100 DROPS/D, ORAL Date:11/21/01ISR Number: 3829583-7Report Type:Expedited (15-DaCompany Report #PHEH2001US08462 Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Metastatic Neoplasm Health Clozaril (Clozapine) Hospitalization - Professional Tablet PS ORAL 100 MG, Initial or Prolonged DAILY, ORAL Date:11/21/01ISR Number: 3829584-9Report Type:Expedited (15-DaCompany Report #PHEH2001US09048 Age:77 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Left Ventricular Failure Health Clozaril (Clozapine) PS ORAL 500 MG, UNK, Hospitalization - Pneumonia Professional ORAL Initial or Prolonged Date:11/23/01ISR Number: 3828671-9Report Type:Expedited (15-DaCompany Report #HQ8398513NOV2001 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Alkaline Health Effexor Xr Phosphatase Increased Professional (Venlafaxine Circulatory Collapse Hydrochloride, Electrocardiogram St Capsule, Extended Segment Abnormal Release) PS 450 MG 1X PER Haematemesis 1 DAY 5 MON Influenza Like Illness Clozaril (Clozapine, Mitral Valve Incompetence ) SS 800 MG 1X PER Sudden Death 1 DAY 6 YR Ventricular Hypertrophy Depakote (Valproate White Blood Cell Count Semisodium, ) SS 1000 MG AT Increased BEDTIME 5 MON Seroquel 22-Feb-2006 08:30 AM Page: 1385 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Quetiapine) SS 600 MG 1X PER 1 DAY 3 YR Lipitor (Atorvastatin) C Cozaar (Losartan Potassium) C Unspecified Inhaler (Unspecified Inhaler) C Date:11/23/01ISR Number: 3829223-7Report Type:Expedited (15-DaCompany Report #PHNU2001DE01499 Age:26 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Foreign Leponex / Clozaril Drug Level Above Health (Clozapine) Therapeutic Professional (Clozapine) Tablet PS SEE IMAGE Electroencephalogram Other Stediril Abnormal (Levonorgestrel) Sedation Sugar-Coated Tablet SS ORAL 1 DF, QD, ORAL Euthyrox C Ximovan "Rhone-Poulenc" C Date:11/23/01ISR Number: 3829226-2Report Type:Expedited (15-DaCompany Report #PHBS2001AU10497 Age:83 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Amyotrophic Lateral Foreign Clozaril (Clozapine) Initial or Prolonged Sclerosis Study Tablet PS ORAL 400 MG/DAY, Blood Alkaline Health ORAL Phosphatase Increased Professional Zantac C Dysphagia Other Coloxyl With Senna Fall (Sennoside A+B) C Head Injury Hyperreflexia Muscle Atrophy Nervous System Disorder Pneumonia Klebsiella Sedation Urinary Tract Infection Vomiting Weight Decreased Date:11/26/01ISR Number: 3829688-0Report Type:Expedited (15-DaCompany Report #WAES 01111658 Age:38 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Literature Tab Cogentin Unk PS ORAL PO Clozapine SS Haloperidol SS 22-Feb-2006 08:30 AM Page: 1386 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/26/01ISR Number: 3829826-XReport Type:Expedited (15-DaCompany Report #PHFR2001GB03141 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Transient Ischaemic Foreign Clozaril(Clozapine)T Attack Health ablet PS ORAL 100MG Professional MANE/125MG Other NOCTE, ORAL Date:11/26/01ISR Number: 3829836-2Report Type:Expedited (15-DaCompany Report #PHFR2001GB01855 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aspartate Foreign Clozaril Aminotransferase Health (Clozapine)Tablet PS ORAL ORAL Increased Professional Blood Creatine Company Phosphokinase Increased Representative Bundle Branch Block Right Other Chest Pain Infarction Date:11/26/01ISR Number: 3829838-6Report Type:Expedited (15-DaCompany Report #PHFR2001GB02997 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Foreign Clozaril(Clozapine)T Diabetes Mellitus Health ablet PS ORAL 150 MG, BID, Non-Insulin-Dependent Professional ORAL Glucose Tolerance Other Lactulose C Impaired Urinary Incontinence Date:11/26/01ISR Number: 3830227-9Report Type:Expedited (15-DaCompany Report #PHFR2001GB03151 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril(Clozapine) PS ORAL 600MG/DAY, Health ORAL Professional Other Date:11/26/01ISR Number: 3830383-2Report Type:Expedited (15-DaCompany Report #PHFR2001GB02735 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Eczema Foreign Clozaril(Clozapine) Eczema Infected Health Tablet PS ORAL 550MG/DAY, Eczema Nummular Professional 600MG/DAY, Inflammation ORAL Lymphadenopathy Becotide Lymphangitis (Beclometasone Rash Vesicular Dipropionate) C Streptococcal Infection Ventolin C Valproate Sodium C Kwells C Hyoscine Hydrobromide C 22-Feb-2006 08:30 AM Page: 1387 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/26/01ISR Number: 3830386-8Report Type:Expedited (15-DaCompany Report #PHBS2001CA11179 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Cholesterol Foreign Clozaril(Clozapine) Increased Study Tablet PS ORAL 500 MG/DAY, Blood Triglycerides Health ORAL Increased Professional Accutane (Isotretinoin) C Date:11/27/01ISR Number: 3830573-9Report Type:Expedited (15-DaCompany Report #PHEH2001US08891 Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Electrocardiogram Health Clozaril Abnormal Professional (Clozapine)Tablet PS ORAL 800MG DAILY, Gastrointestinal ORAL Infection Seroquel Haematemesis (Quetiapine) SS Ventricular Hypertrophy Effexor(Venlafaxine Hydrochloride) SS Depakote(Valproate Semisodium) SS Lipitor (Atorvastatin) C Cozaar(Losartan Potassium) C Lung Surfactants C Date:11/27/01ISR Number: 3831045-8Report Type:Expedited (15-DaCompany Report #C2001-3319.01 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 900 MG QD, Other ORAL Calcium C Ceftriaxone C Dilitazem Er C Diphenhydramine C Epoetin C Furosemide C Heparin C Lactulose C Metoclopramide C Propranolol C Thiothixene C Trazodone C Date:11/27/01ISR Number: 3831053-7Report Type:Expedited (15-DaCompany Report #C2001-3116.01 Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 100MG Q AM, Other 200 MG Q HS, ORAL Benztropine C Divalproex Sodium C 22-Feb-2006 08:30 AM Page: 1388 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/27/01ISR Number: 3831055-0Report Type:Expedited (15-DaCompany Report #01-11-0624 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine - Zenith Professional Goldine Pharm. Tablets PS Zenith Goldine ORAL 400 MG QD ORAL Date:11/27/01ISR Number: 3831057-4Report Type:Expedited (15-DaCompany Report #01-10-0570 Age:83 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Volvulus Of Bowel Health Clozapine - Zenith Professional Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL 100MG QD ORAL Sinemet C Vitamin B12 C Flomax C Lasix C Date:11/27/01ISR Number: 3831059-8Report Type:Expedited (15-DaCompany Report #01-11-0610 Age:86 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Parkinson'S Disease Health Clozapine-Zenith Professional Goldline Pharm, Tablets PS Zenith Goldline Pharm. ORAL 50 MG QD, ORAL Date:11/27/01ISR Number: 3831061-6Report Type:Expedited (15-DaCompany Report #01-11-0632 Age:86 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine-Zenith Professional Goldline Pharm, Tablets PS Zenith Goldline Pharm. ORAL 75 MG QD ORAL Date:11/27/01ISR Number: 3831062-8Report Type:Expedited (15-DaCompany Report #01-11-0633 Age:74 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine-Zenith Professional Goldline Pharm, Tablets PS Zenith Goldline Pharm. ORAL 150 MG QD ORAL Date:11/27/01ISR Number: 3831064-1Report Type:Expedited (15-DaCompany Report #01-11-0622 Age:69 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine-Zenith Professional Goldline Pharm. 22-Feb-2006 08:30 AM Page: 1389 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tablets PS Zenith Goldline Pharm. ORAL ORAL Date:11/27/01ISR Number: 3831703-5Report Type:Expedited (15-DaCompany Report #PHFR2001GB03173 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Metastases To Central Foreign Clozaril (Clozapine) Nervous System Health Tablet PS ORAL ORAL Professional Other Date:11/28/01ISR Number: 3832133-2Report Type:Expedited (15-DaCompany Report #PHFR2001GB02344 Age:19 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Increased Foreign Clozaril (Clozapine) Initial or Prolonged Cold Sweat Health Tablet PS ORAL SEE IMAGE Dyspnoea Professional Haloperidol C Gastrooesophageal Reflux Other Lorazepam C Disease Hyoscine (Hyoscine) C Heart Rate Increased Zopiclone C Hyperhidrosis Procyclidine Respiratory Rate (Procyclidine) C Increased Date:11/29/01ISR Number: 3832042-9Report Type:Expedited (15-DaCompany Report #PHFR2001GB02974 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Choking Foreign Clozaril (Clozapine) Other Drug Level Above Study Tablet PS ORAL 400 MG/DAY, Therapeutic Health ORAL Professional Other Date:11/29/01ISR Number: 3832043-0Report Type:Expedited (15-DaCompany Report #PHFR2001GB02981 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depressed Level Of Foreign Clozaril (Clozapine) Initial or Prolonged Consciousness Health Tablet PS ORAL 900 MG/DAY, Diabetes Mellitus Professional ORAL Diabetic Coma Other Haloperidol C Diabetic Ketoacidosis Amitriptyline Hyponatraemia (Amtiriptyline) C Tremor Lorazepam C Date:11/29/01ISR Number: 3832045-4Report Type:Expedited (15-DaCompany Report #PHFR2001GB03168 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Complications Of Maternal Foreign Clozaril (Clozapine) PS TRANSPLACENTAL TRANSPLACENTA Initial or Prolonged Exposure To Therapeutic Health L Drugs Professional Grunting Other Neonatal Disorder 22-Feb-2006 08:30 AM Page: 1390 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/01ISR Number: 3832070-3Report Type:Expedited (15-DaCompany Report #PHNU2001DE02689 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Foreign Leponex / Clozaril Leukopenia Health (Clozapine)(Clozapin Pancytopenia Professional e) Tablet PS ORAL 450MG/DAY, Thrombocytopenia Other ORAL Date:11/29/01ISR Number: 3832100-9Report Type:Expedited (15-DaCompany Report #PHFR2000GB02023 Age:35 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Arrest Foreign Clozaril (Clozapine) Initial or Prolonged Cardiomegaly Health (Clozapine) Tablet PS ORAL 500 MG/DAY, Cardiomyopathy Professional ORAL Torsade De Pointes Other Sertraline Ventricular Arrhythmia (Sertraline) C Docusate Sodium C Isogel (Ispaghula) C Bisacodyl C Ponstan (Mefenamic Acid) C Date:11/29/01ISR Number: 3832125-3Report Type:Expedited (15-DaCompany Report #PHBS2001AU11757 Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lower Respiratory Tract Foreign Clozaril PS ORAL 225 MG/DAY, Infection Study ORAL Pneumonia Health Professional Other Date:11/29/01ISR Number: 3832503-2Report Type:Expedited (15-DaCompany Report #PHEH2001US09168 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Leukocytosis Health Clozaril (Clozapine) Myocardial Infarction Professional Tablet PS ORAL 350MG, ORAL Date:11/29/01ISR Number: 3832527-5Report Type:Expedited (15-DaCompany Report #PHFR2001GB02677 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Foreign Clozaril (Clozapine) Initial or Prolonged Bile Duct Obstruction Health Tablet PS ORAL 425 MG/DAY, Other Jaundice Professional ORAL Liver Function Test Other Olanzapine Abnormal (Olanzapine) C Nausea Quetiapine Pancreatic Carcinoma (Quetiapine) C Salivary Hypersecretion 22-Feb-2006 08:30 AM Page: 1391 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/01ISR Number: 3832545-7Report Type:Expedited (15-DaCompany Report #PHFR2001GB03190 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Haematemesis Foreign Clozaril (Clozapine) Hypotension Health Tablet PS ORAL ORAL Oesophagitis Professional Other Date:11/29/01ISR Number: 3832560-3Report Type:Expedited (15-DaCompany Report #PHEH2001US09488 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Clozaril (Clozapine) Professional Tablet PS ORAL 200MG, ORAL Date:11/29/01ISR Number: 3832563-9Report Type:Expedited (15-DaCompany Report #PHEH2001US09283 Age:37 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Alkaline Health Clozaril (Clozapine) Initial or Prolonged Phosphatase Increased Professional Tablet PS ORAL 200 MG, BID, Blood Creatinine ORAL Increased Lithium (Lithium) C Blood Pressure Decreased Artane Dehydration (Trihexphenidyl Liver Function Test Hydrochloride) C Liver Function Test Tetracycline Abnormal (Tetracycline) C Oedema Vitamin E C Pallor Prilosec Vertigo (Omeprazole) C Aspirin "Bayer" C Bayer Date:11/29/01ISR Number: 3832763-8Report Type:Expedited (15-DaCompany Report #PHEH2001US09361 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozaril (Clozapine) Professional Tablet PS ORAL 300MG, ORAL Date:11/29/01ISR Number: 3832764-XReport Type:Expedited (15-DaCompany Report #PHEH2001US09288 Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Health Clozaril (Clozapine) Initial or Prolonged Fall Professional Tablet PS ORAL 400 MG/DAY, Pancytopenia ORAL Benzotropine (Benzatropine Mesilate) C Depakote (Valproate Semisodium) C Docusate Sodium C Ranitidine (Ranitidine) C 22-Feb-2006 08:30 AM Page: 1392 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/30/01ISR Number: 3833154-6Report Type:Expedited (15-DaCompany Report #PHBS2001AU09399 Age:68 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Adrenal Carcinoma Foreign Clozaril (Clozapine) Life-Threatening Lung Neoplasm Malignant Health Tablet PS ORAL 12.5 MG, BID, Hospitalization - Professional ORAL Initial or Prolonged Other Date:11/30/01ISR Number: 3833155-8Report Type:Expedited (15-DaCompany Report #PHFR2001GB03039 Age:27 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Clozaril (Clozapine) Study Tablet PS ORAL 400 MG/DAY, Health ORAL Professional Zolpidem (Zolpidem) C Other Hyoscine (Hyoscine) C Salbutamol C Becotide (Beclometasone Dipropionate) C Date:12/03/01ISR Number: 3833733-6Report Type:Expedited (15-DaCompany Report #PHEH2001US09490 Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anorexia Health Clozaril Breast Cancer Female Professional (Clozapine)Tablet PS ORAL 50MG, DAILY, Cerebrovascular Disorder ORAL Dehydration Proamatine Electrolyte Imbalance (Midodrine Oral Intake Reduced Hydrochloride) C Vascular Dementia Aricept (Donepezil Hydrochloride) C Zoloft (Sertraline Hydrochloride) C Flexeril (Cyclobenzaprine Hydrochloride) C Vitamin E C Detrol (Tolterodine L-Tartrate) C Risperdal (Risperidone) C Tamoxifen C Sinemet (Levodopa, Carbidopa) C Peri-Colace (Casanthranol) C Date:12/03/01ISR Number: 3833734-8Report Type:Expedited (15-DaCompany Report #PHEH2001US09553 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozaril (Clozapine) Professional Tablet PS ORAL 300 MG/DAY, ORAL Zoloft (Sertraline 22-Feb-2006 08:30 AM Page: 1393 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride) C Vasotec C Aspirin "Bayer" C Ibuprofen C Colace C Lanoxin C Naproxen C Ultram (Tramadol Hydrochloride) C Coreg (Carvedilol) C Date:12/03/01ISR Number: 3833885-8Report Type:Expedited (15-DaCompany Report #PHFR2001GB03240 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Retinal Oedema Foreign Clozaril(Clozapine)( Retinitis Health Continued) PS ORAL 600MG/DAY, Professional ORAL Other Date:12/03/01ISR Number: 3833922-0Report Type:Expedited (15-DaCompany Report #PHFR2001GB03173 Age:57 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Metastases To Central Foreign Clozaril (Clozapine) Nervous System Health Tablet PS ORAL ORAL Metastatic Neoplasm Professional Clonazepam C Other Midazolam (Midazolam) C Date:12/03/01ISR Number: 3833939-6Report Type:Expedited (15-DaCompany Report #PHFR2001GB03238 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Clozaril (Clozapine) Intentional Overdose Study Tablet PS ORAL 425MG/DAY, Health ORAL Professional Other Date:12/03/01ISR Number: 3833945-1Report Type:Expedited (15-DaCompany Report #PHBS2001CA09161 Age:19 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Atrial Hypertrophy Foreign Clozaril (Clozapine) Chest Pain Study Tablet PS ORAL 400 MG/DAY, Tachycardia Health ORAL Professional Other Date:12/03/01ISR Number: 3834001-9Report Type:Expedited (15-DaCompany Report #PHBS2001CA11853 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Other Diabetes Mellitus Foreign Study Health 22-Feb-2006 08:30 AM Page: 1394 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Product Role Manufacturer Route Dose Duration Clozaril(Clozapine)( Continued) PS ORAL ORAL Date:12/03/01ISR Number: 3834040-8Report Type:Expedited (15-DaCompany Report #C2001-3191.01 Age:83 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 25 MG TID, Other ORAL Date:12/03/01ISR Number: 3834108-6Report Type:Expedited (15-DaCompany Report #C2001-3440.01 Age:78 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablet 100 Professional Mg Mylan PS ORAL 100 MG Q HS, Other ORAL Clozapine Tablets 25mg Mylan SS ORAL 50 MG Q HS, ORAL Date:12/04/01ISR Number: 3834845-3Report Type:Expedited (15-DaCompany Report #A122356 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abnormal Behaviour Consumer Ziprasidone Po PS ORAL 120.00 MG Hospitalization - Arrhythmia Health TOTAL:BID:ORA Initial or Prolonged Cardiomegaly Professional L Catatonia Clozaril SS 400.00 MG Condition Aggravated TOTAL:DAILY Coronary Artery Lamictal Atherosclerosis (Lamotrigine) C Coronary Artery Occlusion Ativan (Lorazepam) C Hallucination Casanthranol/Docusat Mitral Valve Prolapse e Sodium C Scar Metamucil (Psyllium) C Sudden Death Celexa (Citalopram) C Supraventricular Inderal Extrasystoles (Propranolol) C Cogentin C Date:12/04/01ISR Number: 3834867-2Report Type:Expedited (15-DaCompany Report #01P-163-01113250-00 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Haematemesis Health Depakote (Divalproex Influenza Professional Sodium) (Divalproex Sudden Death Sodium) PS 1000 MG, 1 IN 1 D Clozapine SS 800 MG, 1 IN 1 D Venlafaxine Hydrochloride SS 450 MG, 1 IN 22-Feb-2006 08:30 AM Page: 1395 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report 1 D Seroquel SS 600 MG, 1 IN 1 D Atorvastatin C Losartan Potassium C Lung Inhaler C Date:12/06/01ISR Number: 3836550-6Report Type:Expedited (15-DaCompany Report #PHEH2001US09745 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Fall Health Clozaril (Clozapine) Infection Professional Tablet PS ORAL 700 MG/DAY, ORAL Eskalith C Ativan C Fibercon (Polycarbophil Calcium) C Colace C Date:12/06/01ISR Number: 3836973-5Report Type:Expedited (15-DaCompany Report #PHNU2001DE02788 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Morphoea Foreign Leponex / Clozaril Scleroderma Health (Clozapine) Professional (Clozapine) Tablet PS ORAL ORAL Other Date:12/06/01ISR Number: 3836974-7Report Type:Expedited (15-DaCompany Report #PHBS2001AU12041 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dysphemia Foreign Clozaril (Clozapine) Study Tablet PS ORAL 300 MG/D, Health ORAL Professional Other Date:12/06/01ISR Number: 3836975-9Report Type:Expedited (15-DaCompany Report #PHFR2001GB03294 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Lung Neoplasm Malignant Foreign Clozaril (Clozapine) Metastases To Bone Health Tablet PS ORAL 250MG/DAY, Professional ORAL Other Date:12/06/01ISR Number: 3837305-9Report Type:Expedited (15-DaCompany Report #PHBS2001CA09627 Age: Gender:Male I/FU:F Outcome PT Other Blood Alkaline Phosphatase Increased Drooling Erythema 22-Feb-2006 08:30 AM Page: 1396 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Leukocytosis Rectal Haemorrhage Rectal Prolapse Report Source Product Role Manufacturer Route Dose Duration Weight Decreased Foreign Clozaril (Clozapine) Health Tablet PS ORAL 400 MG/DAY, Professional ORAL Other Neurontin (Gabapentin) C Nozinan C Kemadrin (Procyclidine Hydrochloride) C Losec (Omeprazole) C Fesofor C Colace C Loxapac (Loxapine Succinate) C Ativan C Date:12/06/01ISR Number: 3837341-2Report Type:Expedited (15-DaCompany Report #PHBS2001GB11833 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dehydration Foreign Clozapine Initial or Prolonged Diabetic Ketoacidosis Literature (Clozapine) Tablet PS 150 MG BID Hyperglycaemia Health Minocycline Hypokalaemic Syndrome Professional (Minocycline) C Hyponatraemic Syndrome Other Date:12/06/01ISR Number: 3837360-6Report Type:Expedited (15-DaCompany Report #PHBS2001IT12025 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypereosinophilic Foreign Leponex (Clozapine) Initial or Prolonged Syndrome Health Tablet PS ORAL 150 TO 200 Inflammation Professional MG/D, ORAL Pyrexia Other En Drops Vomiting (Delorazepam) C Date:12/07/01ISR Number: 3836345-3Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Level Decreased Clozapine (700mg / Day- ) (Goldline) PS Goldine ORAL 200MG Q0800 AND 1200 300MG Q 2000(PO) Docusate Sodium C Lactulose C Lansoprazole C Levothyroxine C Loratadine C Topiramate C 22-Feb-2006 08:30 AM Page: 1397 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/07/01ISR Number: 3836818-3Report Type:Expedited (15-DaCompany Report #PHNU2001DE02428 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Foreign Leponex/Clozaril Increased Health (Clozapine) Aspartate Professional (Clozapine) Tablet PS ORAL 200 MG/D, Aminotransferase Other ORAL Increased Blood Triglycerides Increased Diabetes Mellitus Hypertension Liver Disorder Metabolic Syndrome Obesity Date:12/07/01ISR Number: 3836820-1Report Type:Expedited (15-DaCompany Report #PHFR2001GB03281 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Multiple Myeloma Foreign Clozaril (Clozapine) Health Tablet PS ORAL 325 MG/DAY, Professional ORAL Other Date:12/07/01ISR Number: 3836868-7Report Type:Expedited (15-DaCompany Report #PHBS2001ZA11879 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiomyopathy Foreign Clozaril (Clozapine) Health Tablet PS ORAL ORAL Professional Other Date:12/07/01ISR Number: 3837116-4Report Type:Expedited (15-DaCompany Report #PHBS2001NZ11894 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukocytosis Foreign Clozaril (Clozapine) Neutrophil Count Health Tablet PS Increased Professional Tachycardia Other Ventricular Hypertrophy Date:12/07/01ISR Number: 3837447-8Report Type:Expedited (15-DaCompany Report #PHEH2001US09488 Age:53 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Other Clozaril (Clozapine) Tablet PS ORAL 200 MG, QHS, ORAL Zoloft (Sertraline Hydrochloride) C Topamax (Topiramate) C 22-Feb-2006 08:30 AM Page: 1398 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/11/01ISR Number: 3838084-1Report Type:Expedited (15-DaCompany Report #01-11-0633 Age:74 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neoplasm Malignant Health Clozapine-Ivax Pneumonia Professional Pharmaceuticals, Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 150 MG QD ORAL Date:12/11/01ISR Number: 3838085-3Report Type:Expedited (15-DaCompany Report #01-11-0594 Age:71 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine - Ivax Professional Pharmaceuticals, Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 50 MG BID ORAL Wellbutrin C Insulin, Regular C Ferrous Sulfate C Ipratropium C Albuterol Sulfate C Nph Insulin C Date:12/11/01ISR Number: 3838088-9Report Type:Expedited (15-DaCompany Report #01-11-0598 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pulmonary Embolism Health Clozapine - Ivax Professional Pharmaceuticals, Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 200-450 MG QD ORAL Neurontin C Propranolol C Benztropine Mesylate C Lorazepam C Depakote C Risperdal C Date:12/11/01ISR Number: 3838091-9Report Type:Expedited (15-DaCompany Report #01-11-0599 Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Renal Failure Health Clozapine - Ivax Professional Pharmaceuticals, Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 300-600 QD ORAL Benztropine Mesylate C Depakote C 22-Feb-2006 08:30 AM Page: 1399 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/11/01ISR Number: 3838094-4Report Type:Expedited (15-DaCompany Report #01-11-0616 Age:58 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Breast Cancer Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 625 MG QD ORAL Glucophage C Actos C Prevacid C Celebrex C Prempro C Zoloft C Trimox C Fluocinonide Cream C Hydroxyzine Hydrochloride C Sucralfate C Propoxyphene Napsylate C Acetaminophen C Vioxx C Benzonatate C Docusate Sodium C Clonidine C Date:12/11/01ISR Number: 3838096-8Report Type:Expedited (15-DaCompany Report #01-08-0429 Age:62 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Health Clozapine - Ivax Malnutrition Professional Pharmaceuticals, Multi-Organ Failure Inc. Tablets PS Ivax Oral Intake Reduced Pharmaceuticals, Inc. ORAL 200-350MG ORAL Date:12/11/01ISR Number: 3838098-1Report Type:Expedited (15-DaCompany Report #01-10-0583 Age:59 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neoplasm Malignant Health Clozapine - Ivax Professional Pharmaceuticals, Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 600 MG QD ORAL Date:12/11/01ISR Number: 3838099-3Report Type:Expedited (15-DaCompany Report #01-10-0570 Age:83 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Volvulus Of Bowel Health Clozapine - Ivax Professional Pharmaceuticals, Inc. Tablets PS Ivax Pharmaceuticals, 22-Feb-2006 08:30 AM Page: 1400 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Inc. ORAL 100 MG QD ORAL Sinemet C Vitamin B12 C Flomax C Lasix C Date:12/11/01ISR Number: 3838342-0Report Type:Expedited (15-DaCompany Report #PHEH2001US09913 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyspnoea Health Clozaril (Clozapine) Initial or Prolonged Gastric Mucosal Lesion Professional Tablet PS ORAL 800MG DAILY, Non-Hodgkin'S Lymphoma ORAL Zyprexa (Olanzapine) C Seroquel (Quetiapine) C Risperdal (Risperidone) C Klonopin C Cogentin (Benzatropine Mesilate) C Date:12/11/01ISR Number: 3838409-7Report Type:Expedited (15-DaCompany Report #PHFR2001GB03319 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Hodgkin'S Disease Foreign Clozaril (Clozapine) Health Tablet PS ORAL 650MG/DAY, Professional ORAL Other Date:12/11/01ISR Number: 3838416-4Report Type:Expedited (15-DaCompany Report #PHFR2001GB03293 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetic Ketoacidosis Foreign Clozaril Health (Clozapine)Tablet PS 225 MG/DAY Professional Lithium (Lithium) C Other Venlafaxine (Venlafaxine) C Diazepam C Senna (Senna) C Aspirine C Dipyridamole (Dipyridamole) C Date:12/11/01ISR Number: 3838519-4Report Type:Expedited (15-DaCompany Report #PHBS2001AU12218 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiac Disorder Foreign Clozaril (Clozapine) Chest Pain Health Tablet PS ORAL ORAL Professional Other 22-Feb-2006 08:30 AM Page: 1401 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/11/01ISR Number: 3838521-2Report Type:Expedited (15-DaCompany Report #PHFR2001GB02974 Age:28 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Choking Foreign Clozaril(Clozapine) PS ORAL 400MG/DAY, Drug Level Above Study ORAL Therapeutic Health Drug Level Below Professional Therapeutic Other Date:12/11/01ISR Number: 3838525-XReport Type:Expedited (15-DaCompany Report #PHFR2001GB03263 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Oesophagitis Foreign Clozaril (Clozapine) PS ORAL 400MG/DAY,ORA Initial or Prolonged Renal Failure Acute Health L Disability Vomiting Professional Lansoprazole Other (Lansoprazole) C Atenolol C Ferrous Sulphate C Ensure (Vitamins Nos, Amino Acids Nos) C Lactulose C Date:12/11/01ISR Number: 3838739-9Report Type:Expedited (15-DaCompany Report #C2001-3442.01 Age:69 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 150 MG QD, Other ORAL Date:12/11/01ISR Number: 3838740-5Report Type:Expedited (15-DaCompany Report #C2001-3441.01 Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death White Blood Cell Count Health Clozapine Tablets 25 Abnormal Professional Mg Mylan PS Mylan ORAL 12.5MG QD, Other ORAL Acetaminophen C Carbidopa/Levodopa C Levoththyroxine C Pramipexole C Sorbitol C Vitamins C Various Wound Dressings C Date:12/11/01ISR Number: 3838798-3Report Type:Expedited (15-DaCompany Report #PHFR2001GB03321 Age:67 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alveolitis Fibrosing Foreign Clozaril (Clozapine) Initial or Prolonged Hypotension Health Tablet PS ORAL 350 MG/DAY, Professional ORAL Other 22-Feb-2006 08:30 AM Page: 1402 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/11/01ISR Number: 3838803-4Report Type:Expedited (15-DaCompany Report #PHFR2000GB02027 Age:35 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiomegaly Foreign Clozaril (Clozapine) Initial or Prolonged Cardiomyopathy Health (Clozapine) Tablet PS ORAL 500MG/DAY, Professional ORAL Other Sertraline (Sertraline0 C Ducosate Sodium C Isogel (Ispaghula) C Bisacodyl C Ponstan (Mefenamic Acid) C Date:12/11/01ISR Number: 3838804-6Report Type:Expedited (15-DaCompany Report #PHFR2001GB02718 Age:63 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Grand Mal Convulsion Foreign Clozaril Loss Of Consciousness Health (Clozapine)Tablet PS ORAL 200 MG/DAY, Lower Respiratory Tract Professional ORAL Infection Other Temazepam C Urinary Tract Infection Frusemide C Moclobemide (Moclobemide) C Ranitidine (Ranitidine) C Lamictal C Date:12/11/01ISR Number: 3838806-XReport Type:Expedited (15-DaCompany Report #PHRM2001FR01779 Age:35 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Foreign Leponex(Clozapine) Initial or Prolonged Electrocardiogram Health Tablet PS ORAL 1.2 G Abnormal Professional ONCE/SINGLE, Intentional Overdose Other ORAL Suicide Attempt Tachycardia Upper Motor Neurone Lesion Date:12/11/01ISR Number: 3838807-1Report Type:Expedited (15-DaCompany Report #PHRM2001FR01010 Age:35 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Foreign Leponex (Clozapine) Initial or Prolonged Disorientation Health Tablet PS ORAL SEE IMAGE Electrocardiogram Qt Professional .. C Prolonged Other Hyperreflexia Intentional Overdose Restlessness Suicide Attempt Tachycardia Upper Motor Neurone Lesion 22-Feb-2006 08:30 AM Page: 1403 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/11/01ISR Number: 3838900-3Report Type:Direct Company Report # Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Electrocardiogram Clozapine 100mg Intervention to Abnormal Zenith Goldline Prevent Permanent Electrocardiogram T Wave Pharmaceuticals PS Zenith Goldline Impairment/Damage Abnormal Pharmaceuticals ORAL 300MG PO BID Myocardial Ischaemia Prolixin C Sinus Tachycardia Wellbutrin C Valproic Acid C Date:12/11/01ISR Number: 3840748-0Report Type:Expedited (15-DaCompany Report #PHFR2001GB02833 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bronchopneumonia Foreign Clozaril(Clozapine)T Drug Level Increased Health ablet PS ORAL 650MG/DAY, Professional ORAL Other Sertraline (Sertraline) C Valproate Sodium C Date:12/12/01ISR Number: 3839198-2Report Type:Expedited (15-DaCompany Report #C2001-2936.01 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 50 MG, QD, Other ORAL Carbidopa/Levodopa C Carbidopa C Captopril C Sertraline C Clopidogrel C Enteric-Coated Aspirin C Multivitamin, Calcium Citrate C Alendronate C Olanzapine C Pergolide C Polysaccharide Iron Complex C Cyproheptadine C Ferrous Gluconate C Date:12/12/01ISR Number: 3839420-2Report Type:Expedited (15-DaCompany Report #2001UW14675 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Leukopenia Foreign Seroquel PS ORAL 1400 MG DAILY Intervention to Neutrophil Count Health PO Prevent Permanent Decreased Professional Seroquel SS ORAL 1300 MG DAILY Impairment/Damage PO Clozapine SS 22-Feb-2006 08:30 AM Page: 1404 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/12/01ISR Number: 3839996-5Report Type:Expedited (15-DaCompany Report #C2001-3116.01 Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional 100 Mg Mylan PS ORAL 100 MG Q AM, Other 200 MG Q HS, ORAL Benztropine C Divalproex Sodium C Date:12/12/01ISR Number: 3840000-3Report Type:Expedited (15-DaCompany Report #C2001-3542.01 Age:87 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Clozapine Tablets 25 Mg Mylan PS ORAL 75 MG QD, ORAL Date:12/12/01ISR Number: 3840012-XReport Type:Expedited (15-DaCompany Report #C2001-3191.01 Age:83 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 25 MG TID, Other ORAL Date:12/12/01ISR Number: 3840028-3Report Type:Expedited (15-DaCompany Report #C2001-3462.01 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Myocarditis Health Clozapine Tablets Initial or Prolonged Professional 100 Mg Mylan PS Mylan ORAL 100MG, BID, Other Other ORAL Divalproex Sodium C Risperidone C Date:12/12/01ISR Number: 3844182-9Report Type:Periodic Company Report #C2001-1183.01 Age:67 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Jaundice Other Clozapine Tablets Other Liver Function Test Mylan PS Mylan ORAL 125 MG QD, Abnormal ORAL Lithium C Gabapentin C Date:12/12/01ISR Number: 3844183-0Report Type:Periodic Company Report #C2000-1826.01 Age:28 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Other Clozapine Tablets Other Leukopenia 100 Mg Mylan PS Mylan ORAL 175 MG Q AM, 200 MG Q HS, ORAL Citalopram C 22-Feb-2006 08:30 AM Page: 1405 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/12/01ISR Number: 3844184-2Report Type:Periodic Company Report #C2001-0196.01 Age:65 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozapine Tablets Other Tardive Dyskinesia Professional 100 Mg Mylan PS Mylan ORAL 100 MG QID Other ORAL Valproex Sodium C Insulin Nph C Calcium Carbonate C Nifedipine Xl C Date:12/12/01ISR Number: 3844185-4Report Type:Periodic Company Report #C2001-2217.01 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Leukopenia Health Clozapine Tablets Other Professional 100 Mg Mylan PS Mylan ORAL 200 MG QD ORAL Albuterol Inhaler C Beclomethasone Inhaler C Benztropine C Fluoxetine C Lamivudine C Loxapine C Nelfinavir C Olanzapine C Zidovudine C Nystatin Suspension C Cephalexin C Ranitidine C Benztropine C Amoxicillin C Clindamicin C Glyburide C Date:12/12/01ISR Number: 3844186-6Report Type:Periodic Company Report #C2001-2183.01 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Anorexia Health Clozapine Tablets Hospitalization - Dizziness Professional 100 Mg Mylan PS Mylan ORAL 150 MG Q AM & Initial or Prolonged Leukopenia 200 MG Q PM, Other Nausea ORAL Neutrophil Count Decreased Vomiting Weight Decreased Date:12/12/01ISR Number: 3844187-8Report Type:Periodic Company Report #C2001-2180.01 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neutrophil Count Health Clozapine Tablets Other Decreased Professional 100 Mg Mylan PS Mylan ORAL 600 MG QD TITRATED FROM 200 MG ON 5/22/01 ORAL 22-Feb-2006 08:30 AM Page: 1406 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Fluoxetine C Lorazepam C Levothyroxine C Divalproex Sodium C Medroxypregesterone Contraceptive C Date:12/12/01ISR Number: 3844188-XReport Type:Periodic Company Report #C2001-2133.01 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Leukopenia Health Clozapine Tablets Other Neutrophil Count Professional 100 Mg Mylan PS Mylan ORAL 250 MG QD Decreased ORAL Divalproex Sodium C Lithium C Levothyroxine C Famotidine C Sertraline C Oxybutynin C Psyllium C Milk Of Magnesia C Docusate Calcium C Date:12/12/01ISR Number: 3844189-1Report Type:Periodic Company Report #C2001-1697.01 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neutrophil Count Health Clozapine Tablets Other Decreased Professional 100 Mg Mylan PS Mylan ORAL 200 ,G Q AM, 400 MG Q PM, ORAL Valproic Acid C Date:12/12/01ISR Number: 3844190-8Report Type:Periodic Company Report #C2001-2065.01 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Leukopenia Health Clozapine Tablets Other Neutrophil Count Professional 100 Mg Mylan PS Mylan ORAL 100MG QD Decreased Other ORAL Divalproex Sodium C Nefazodone C Olanzapine C Date:12/12/01ISR Number: 3844191-XReport Type:Periodic Company Report #C2001-1340.01 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Leukopenia Health Clozapine Tablets Other Professional 100mg Mylan PS Mylan ORAL 200MG Q HS Other ORAL Clonazepam C Tolterodine C 22-Feb-2006 08:30 AM Page: 1407 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/12/01ISR Number: 3849702-6Report Type:Periodic Company Report #C2001-2476.01 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cough Health Clozapine Tablets PS ORAL 50MG BID, Initial or Prolonged Dyspnoea Professional ORAL Other Leukocytosis Other Pneumonia Pyrexia Date:12/12/01ISR Number: 3849703-8Report Type:Periodic Company Report #C2001-1851-01 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Leukopenia Health Clozapine Tablets Other Neutrophil Count Professional Mylan PS ORAL 12.5MG DAY 1, Decreased Other 25MG DAY 2, HEN 25MG BID ORAL Chloral Hydrate (Pm) C Clonazepam (Years - Ongoing) C Divalproex Sodium (1000 Mg Bid, Years - Ongoing) C Quetiapine Fumarate C Lorazepam C Bacitracin C Acetaminophen C Haloperidol (10 Mg Bid, 06/11/01 - Ongoing) C Fluphenazine (5mg Bid, Unk - 06/11/01) C Ziprasidone (40mg Bid, Unk - 06/11/01) C Date:12/12/01ISR Number: 3849704-XReport Type:Periodic Company Report #C2001-2067.01 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Leukopenia Health Clozapine Tablets Other Neutrophil Count Professional Mylan PS ORAL 25 MG QD X1, Decreased Other 25MG BID X2, 50MG BID X1DAY, ORAL Clozapine Tablets Mylan SS ORAL 50MG QAM, 100MG QHS, ORAL Date:12/12/01ISR Number: 3849705-1Report Type:Periodic Company Report #C2001-2182.01 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Convulsion Health Clozapine Tablets Other Leukopenia Professional Mylan PS ORAL 25MG QD (X 1 Neutrophil Count Other DAY), 25MG Decreased BID (X 1DAY), 22-Feb-2006 08:30 AM Page: 1408 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL Seroquel Astra Zeneca SS ORAL 200MG, ORAL Date:12/12/01ISR Number: 3849706-3Report Type:Periodic Company Report #C2001-1195.01 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Leukopenia Health Clozapine Tablet Other Neutrophil Count Professional Mylan PS ORAL 200MG Q 8AM, Decreased 300MG Q 8PM, Platelet Count Decreased ORAL Depakote Abbott SS ORAL 2500MG/DAY, ORAL Maalox (15mg Q 6 Hours, Pm) C Conjugated Estrogens (Qd, Years - Ongoing) C Haloperiodl (5mg Pm, Years - Ongoing) C Gabapentin C Olanzapine C Date:12/13/01ISR Number: 3839361-0Report Type:Expedited (15-DaCompany Report #PHEH2001US07676 Age:85 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Fall Health Clozaril (Clozapine) Professional Tablet PS ORAL 25MG, ORAL Date:12/13/01ISR Number: 3839362-2Report Type:Expedited (15-DaCompany Report #USA/95/00100/LEX Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Creatine Health Clozaril (Clozapine) Hospitalization - Phosphokinase Increased Professional Tablet PS ORAL 200MG, DAILY, Initial or Prolonged Cardiac Failure Other ORAL Cardiomyopathy Valproic Acid C Confusional State Lithium (Lithium) C Coordination Abnormal Inderal C Delirium Eskalith C Diarrhoea Vistaril Dysarthria (Hydroxyzine Eosinophilic Myocarditis Embonate) C Faecal Incontinence Prolixin Faeces Discoloured (Fluphenazine Gait Disturbance Hydrochloride) C Heart Rate Irregular Hypotonia Pyrexia Renal Failure Acute Respiratory Arrest Respiratory Disorder Somnolence Urinary Incontinence 22-Feb-2006 08:30 AM Page: 1409 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/13/01ISR Number: 3839928-XReport Type:Expedited (15-DaCompany Report #PHEH2001US07518 Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozaril (Clozapine) Life-Threatening Myocardial Infarction Professional Tablet PS ORAL 300 MG/DAY, ORAL Trazodone (Trazodone) C Trilafon (Perphenazine) C Symmetrel C Dds C Claritin (Loratadine) C Vioxx (Rofecoxib) C Zestril (Lisinopril) C Asa C Vitamin B12 C Date:12/14/01ISR Number: 3840461-XReport Type:Expedited (15-DaCompany Report #PHFR2001GB03143 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Balance Disorder Foreign Clozaril (Clozapine) Clonic Convulsion Health Tablet PS ORAL SEE IMAGE Dizziness Professional Salbutamol C Electrocardiogram Qt Other Prolonged Electroencephalogram Abnormal Fall Grand Mal Convulsion Syncope Date:12/14/01ISR Number: 3840464-5Report Type:Expedited (15-DaCompany Report #PHFR2001IE03315 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Decreased Appetite Foreign Clozaril (Clozapine) Infection Health Tablet PS ORAL 300 MG/DAY, Malaise Professional ORAL Splenomegaly Other Weight Decreased Date:12/14/01ISR Number: 3840467-0Report Type:Expedited (15-DaCompany Report #PHBS2001CA09929 Age:34 YR Gender:Male I/FU:I Outcome PT Hospitalization - Abdominal Pain Initial or Prolonged Abdominal Pain Upper Diarrhoea Hepatic Failure Hepatitis Viral Idiosyncratic Drug Reaction Nausea Pyrexia Renal Failure 22-Feb-2006 08:30 AM Page: 1410 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Vomiting Report Source Product Role Manufacturer Route Dose Duration Foreign Clozaril (Clozapine) Study Tablet PS ORAL 300 MG/DAY, Health ORAL Professional Epival (Valproate Other Semisodium) C Monopril (Fosinopril Sodium) C Date:12/17/01ISR Number: 3840750-9Report Type:Expedited (15-DaCompany Report #PHBS2001AU06140 Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiomyopathy Foreign Clozaril (Clozapine) Other Ventricular Hypokinesia Study Tablet PS ORAL SEE IMAGE Health Thiamine C Professional Multivitamins Other (Panthenol, Retino, Ascorbicacid) C Diazepam C Efexor - Slow Release (Venlafaxine Hydrochloride) C Date:12/17/01ISR Number: 3840753-4Report Type:Expedited (15-DaCompany Report #PHBS2001AU06139 Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiomyopathy Foreign Clozaril(Clozapine) Study Tablet PS ORAL 200 MG/D, Health ORAL Professional Other Date:12/17/01ISR Number: 3840760-1Report Type:Expedited (15-DaCompany Report #PHFR2001GB03371 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypogammaglobulinaemia Foreign Clozaril(Clozapine) Immunodeficiency Common Health Tablet PS ORAL 650MG/DAY,ORA Variable Professional L Other Date:12/17/01ISR Number: 3840762-5Report Type:Expedited (15-DaCompany Report #PHFR2001GB03240 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Retinal Vasculitis Foreign Clozaril(Clozapine) White Blood Cell Count Health Tablet PS ORAL 300 MG, BID, Increased Professional ORAL Other 22-Feb-2006 08:30 AM Page: 1411 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/17/01ISR Number: 3840763-7Report Type:Expedited (15-DaCompany Report #PHBS2001AU12219 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Circulatory Collapse Foreign Clozaril(Clozapine) Initial or Prolonged Disseminated Health Tablet PS ORAL 700 MG/D, Intravascular Coagulation Professional ORAL Hypothermia Other Valproate Sodium C Neutrophil Count Haloperidol C Increased Metformin Platelet Count Decreased (Metformin) C Sepsis Vomiting White Blood Cell Count Increased Date:12/17/01ISR Number: 3840765-0Report Type:Expedited (15-DaCompany Report #PHFR2001GB03138 Age:37 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Foreign Clozaril(Clozapine) C-Reactive Protein Health Tablet PS ORAL 400MG/DAY, Increased Professional ORAL, Cardiomyopathy Other 375MG/DAY, Chest Pain ORAL Dizziness Fluoxetine Drug Level Increased (Fluoxetine) C Dyspnoea Chlorpramazine Electrocardiogram (Chlorpromazine) C Abnormal Lactulose C Neutrophil Count Senokot C Increased Palpitations Red Blood Cell Sedimentation Rate Increased Sinus Tachycardia White Blood Cell Count Increased Date:12/17/01ISR Number: 3841200-9Report Type:Expedited (15-DaCompany Report #CDN/97/00181/LEX Age:25 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Foreign Clozaril (Clozapine) Initial or Prolonged Hodgkin'S Disease Study Tablet PS ORAL 600 MG, ORAL Other Neutropenia Health Professional Other Date:12/18/01ISR Number: 3840296-8Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-11617669 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Mesna PS Bristol-Myers Squibb Initial or Prolonged Company Other Ifosfamide SS Bristol-Myers Squibb Company Carboplatin SS Bristol-Myers Squibb 22-Feb-2006 08:30 AM Page: 1412 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Company Etoposide SS Bristol-Myers Squibb Company Clozaril SS ORAL 11 YR Date:12/18/01ISR Number: 3841678-0Report Type:Expedited (15-DaCompany Report #01-12-0684 Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Surgery Health Clozapine Tablets - Initial or Prolonged Professional Ivax Pharmaceuticals Other Inc PS Ivax Pharmaceuticals Inc ORAL UNKNOWN ORAL Date:12/18/01ISR Number: 3841680-9Report Type:Expedited (15-DaCompany Report #01-12-0683 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diarrhoea Health Clozapine Tablets - Drug Toxicity Professional Ivax Pharmaceuticals Nausea Inc PS Ivax Pharmaceuticals Vomiting Inc ORAL 300MG QHS ORAL Clozapine Tablets SS ORAL 300MG QHS ORAL Lorazepam C Date:12/18/01ISR Number: 3841681-0Report Type:Expedited (15-DaCompany Report #01-12-0681 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Surgery Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals Inc PS Ivax Pharmaceuticals Other Inc ORAL 100-200MG QD ORAL Date:12/18/01ISR Number: 3841685-8Report Type:Expedited (15-DaCompany Report #01-12-0680 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Neoplasm Malignant Health Clozapine Tablets - Professional Ivax Pharmaceuticals Other Inc PS Ivax Pharmaceuticals Inc ORAL 25-500MG QD ORAL Date:12/18/01ISR Number: 3841687-1Report Type:Expedited (15-DaCompany Report #01-12-0676 Age:26 YR Gender:Male I/FU:I Outcome PT Death Cardiomegaly Coronary Artery Disease Coronary Artery Occlusion Hepatic Steatosis Lung Disorder Obesity Sudden Cardiac Death 22-Feb-2006 08:30 AM Page: 1413 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Toxicologic Test Abnormal Report Source Product Role Manufacturer Route Dose Duration Literature Clozapine-Ivax Health Pharmaceuticals, Professional Inc. Tablets PS Ivax Pharmaceuticals Inc ORAL 100 MG BID ORAL 4 YR Sertraline Tablets "Pfizer" SS Pfizer ORAL 200MG QD ORAL 1 YR Risperidone C Atenolol C Akathisia C Lorazepam C Date:12/18/01ISR Number: 3841688-3Report Type:Expedited (15-DaCompany Report #01-12-0675 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Health Clozapine-Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals Inc ORAL 50-200 MG QD ORAL Date:12/18/01ISR Number: 3841689-5Report Type:Expedited (15-DaCompany Report #01-12-0673 Age:86 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Gangrene Health Clozapine-Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals Inc ORAL 6.2-625MGQD ORAL Date:12/18/01ISR Number: 3841690-1Report Type:Expedited (15-DaCompany Report #01-12-0671 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine-Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc ORAL 600MG QD ORAL Date:12/18/01ISR Number: 3841691-3Report Type:Expedited (15-DaCompany Report #01-12-0670 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Gastrointestinal Disorder Health Clozapine-Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc 300-600MG QD 22-Feb-2006 08:30 AM Page: 1414 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/18/01ISR Number: 3841692-5Report Type:Expedited (15-DaCompany Report #01-12-0662 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Lung Neoplasm Malignant Health Clozapine-Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals Inc ORAL 600-700MG QD ORAL Date:12/18/01ISR Number: 3841693-7Report Type:Expedited (15-DaCompany Report #01-11-0657 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Gastrointestinal Health Clozapine-Ivax Hospitalization - Haemorrhage Professional Pharmaceuticals, Initial or Prolonged Other Inc. Tablets PS Ivax Pharmaceuticals Inc ORAL 25-125 MG QD ORAL Date:12/18/01ISR Number: 3841701-3Report Type:Expedited (15-DaCompany Report #01-11-0642 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Aspiration Health Clozapine Professional Tablets-Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 350-400MG QD ORAL Date:12/18/01ISR Number: 3841702-5Report Type:Expedited (15-DaCompany Report #01-11-0610 Age:86 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Professional Tablets-Ivax Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 50MG QD ORAL Date:12/18/01ISR Number: 3841703-7Report Type:Expedited (15-DaCompany Report #01-11-0622 Age:69 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Professional Tablets-Ivax Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 25MG BID ORAL 22-Feb-2006 08:30 AM Page: 1415 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/18/01ISR Number: 3841706-2Report Type:Expedited (15-DaCompany Report #01-11-0593 Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Professional Tablets-Ivax Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 200-500MG QD ORAL Acetaminophen C Allegra C Apap Sol C Ativan Injectable C Bactroban Ointment C Benzoyl Peroxide C Betadine C ` Bisacodyl Suppositories C Cephalexin C Cerumenex C Claritin C Clindamycin Hydrochloride C Cyclobenzaprine C Diocto Syrup C Duragesic C Elocon Cream C Erythromycin C Fleet Enema C Hydrocodone W/ Acetaminophen C Kenalog C Lac-Hydrin C Lactulose C Levaquin C Lorazepam C Lotrisone Cream C Metamucil C Metoclopramide Syrup C Milk Of Magnesia C Naproxen C Phenytoin C Propoxyphene Napsylate / Acetaminophen C Pseudoephedrine C Ranitidine C Rocephin C Selenium Sulfide C Selsun Blue C Triple Antibiotic Ointment C Isosource C Zyprexa C Zinc Oxide C Bacitracin C Ibuprofen C Water For Injection C 22-Feb-2006 08:30 AM Page: 1416 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/19/01ISR Number: 3841665-2Report Type:Direct Company Report # Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Anxiety Clozapine 100mg Hospitalization - Delusion Mylan PS Mylan ORAL 200MG EVERY Initial or Prolonged Hallucination MORNIN ORAL Required Mood Altered 400MG EVERY Intervention to Psychotic Disorder EVENING ORAL Prevent Permanent White Blood Cell Count Impairment/Damage Decreased Date:12/19/01ISR Number: 3842211-XReport Type:Expedited (15-DaCompany Report #PHBS2001AU10304 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Foreign Clozaril (Clozapine) Study Tablet PS ORAL 400 MG, QD, Health ORAL Professional Chlorpromazine Other (Chlorpromazine) C Diazepam C Brufen C Benztropine Mesylate (Benzatropine Mesilate) C Pholcodine C Date:12/19/01ISR Number: 3842326-6Report Type:Expedited (15-DaCompany Report #PHBS2001AU12325 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abortion Spontaneous Foreign Clozaril (Clozapine) Drug Exposure During Study Tablet PS ORAL 350 MG/D, Pregnancy Health ORAL Pregnancy Professional Other Date:12/19/01ISR Number: 3842328-XReport Type:Expedited (15-DaCompany Report #PHFR2001GB03360 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Nephritis Foreign Clozaril (Clozapine) Initial or Prolonged Renal Failure Health Tablet PS ORAL 750 MG/DAY, Vomiting Professional ORAL Other Date:12/19/01ISR Number: 3842329-1Report Type:Expedited (15-DaCompany Report #PHFR2001GB03378 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hodgkin'S Disease Foreign Clozaril (Clozapine) Health Tablet PS ORAL 700MG/DAY, Professional ORAL Other 22-Feb-2006 08:30 AM Page: 1417 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/19/01ISR Number: 3842502-2Report Type:Expedited (15-DaCompany Report #C2001-3462.01 Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Myocarditis Health Clozapine Tablets Initial or Prolonged Professional 100 Mg Mylan PS Mylan ORAL 100MG, BID, Other Other ORAL Divalproex Sodium C Risperidone C Date:12/19/01ISR Number: 3842505-8Report Type:Expedited (15-DaCompany Report #2001UW16100 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Alkaline Health Seroquel PS 800-600 MG QD 3 YR Required Phosphatase Increased Professional Clozaril SS 500-800 MG QD 6 YR Intervention to Circulatory Collapse Effexor SS 300-450 MG Prevent Permanent Electrocardiogram QD 5 MON Impairment/Damage Abnormal Depakote SS 1000 MG HS 5 MON Gastrointestinal Lipitor C Infection Cozaar C Haematemesis Unspecified C Influenza Mitral Valve Incompetence Sudden Death Ventricular Hypertrophy White Blood Cell Count Increased Date:12/19/01ISR Number: 3842894-4Report Type:Expedited (15-DaCompany Report #PHEH2001US10039 Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hepatic Neoplasm Health Clozaril (Clozapine) Other Malignant Professional Tablet PS ORAL 75 MG AM + Thrombocytopenia 225 MG HS, ORAL Date:12/20/01ISR Number: 3843184-6Report Type:Expedited (15-DaCompany Report #C2001-3441.01 Age:82 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 12.5 MG QD, Other ORAL Acetaminophen C Carbidopa/Levodopa C Levothyroxine C Pramipexole C Sorbitol C Various Wound Dressings C Vitamins C 22-Feb-2006 08:30 AM Page: 1418 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/20/01ISR Number: 3843185-8Report Type:Expedited (15-DaCompany Report #C2001-3034.01 Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aneurysm Ruptured Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 500MG Q AM, Other 400MG Q PM, ORAL Antiepileptic Medications C Date:12/20/01ISR Number: 3843541-8Report Type:Expedited (15-DaCompany Report #PHBS2001CA02548 Age:51 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abnormal Behaviour Foreign Clozaril (Clozapine) Adenoma Benign Study (Clozapine) Tablet PS ORAL 700 MG/D, Aspiration Tracheal Health ORAL Blood Creatine Professional Atropine Nasal Phosphokinase Increased Other Solution (Atropine) SS Cardiac Arrest Vasotec C Cardiomegaly Trazodone Cardiomyopathy (Trazodone) C Convulsion Dalmane (Flurazepam Drug Level Above Hydrochloride) C Therapeutic Diazepam C Drug Level Increased Extrapyramidal Disorder Gastritis Erosive Granuloma Hepatic Congestion Hypertrophy Injury Asphyxiation Memory Impairment Muscle Spasms Muscle Twitching Normochromic Normocytic Anaemia Papillary Thyroid Cancer Renal Disorder Salivary Hypersecretion Vomiting Weight Increased Date:12/20/01ISR Number: 3843564-9Report Type:Expedited (15-DaCompany Report #PHFR2001GB02581 Age:44 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Distension Foreign Clozaril (Clozapine) Initial or Prolonged Abdominal Pain Health Tablet PS ORAL ORAL Pelvic Mass Professional Other Date:12/20/01ISR Number: 3843565-0Report Type:Expedited (15-DaCompany Report #PHFR2001GB03263 Age:40 YR Gender:Male I/FU:F Outcome Hospitalization - Initial or Prolonged 22-Feb-2006 08:30 AM Page: 1419 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Disability PT Report Source Product Role Manufacturer Route Dose Duration Oesophagitis Foreign Clozaril (Clozapine) Renal Failure Acute Health Tablet PS ORAL 400MG/DAY, Vomiting Professional ORAL Other Lansoprazole (Lansoprazole) C Atenolol C Ferrous Sulphate C Ensure (Vitamins Nos, Amino Acids Nos) C Lactulose C Date:12/20/01ISR Number: 3843566-2Report Type:Expedited (15-DaCompany Report #PHBS2000AU11102 Age:60 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neoplasm Malignant Foreign Clozaril(Clozapine) Study Tablet PS ORAL 300 MG/D, Health ORAL Professional Other Date:12/20/01ISR Number: 3843599-6Report Type:Expedited (15-DaCompany Report #PHBS2001CA12613 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Clozaril (Clozapine) Study Tablet PS ORAL ORAL Health Professional Other Date:12/21/01ISR Number: 3843718-1Report Type:Direct Company Report # Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pruritus Clozapine 100 Mg Zenith/Goldline PS Zenith/Goldline BUCCAL 100MG BID BUCCAL Paroxetin-Paxil C ... C Buspirone-Buspar C ... C Olanzepine-Zyprexa C ... C Quiatepine-Seroquel C ... C Date:12/24/01ISR Number: 3844392-0Report Type:Expedited (15-DaCompany Report #PHEH2001US07947 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Health Clozaril (Clozapine) Myocardial Ischaemia Professional Tablet PS ORAL 750MG DAILY, 22-Feb-2006 08:30 AM Page: 1420 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL Ativan C Ensure Plus (Carbohydrates Nos, Electrolytesnos, Fatty Acids Nos, Proteins Nos, C Date:12/24/01ISR Number: 3844502-5Report Type:Expedited (15-DaCompany Report #PHBS2001AU12591 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Lymphocytosis Foreign Clozaril (Clozapine) Initial or Prolonged Multiple Myeloma Study Tablet PS ORAL ORAL Neutropenia Health Chemotherapeutics, Professional Other Other (Chemotherapeutics, Other) C Date:12/24/01ISR Number: 3844504-9Report Type:Expedited (15-DaCompany Report #PHFR2001GB02833 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bronchopneumonia Foreign Clozaril(Clozapine) Drug Level Above Health Tablet PS ORAL 650MG/DAY, Therapeutic Professional ORAL Other Sertraline (Sertraline) C Valproate Sodium C Date:12/24/01ISR Number: 3844506-2Report Type:Expedited (15-DaCompany Report #PHFR2001GB02084 Age:59 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Foreign Clozaril (Clozapine) PS ORAL 425MG/DAY,ORA Initial or Prolonged Asthenia Health L; 150MG/DAY, Disability Cerebrovascular Accident Professional ORAL Hemiparesis Other Sertraline (Sertraline) C Date:12/26/01ISR Number: 3844039-3Report Type:Direct Company Report # Age:66 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Constipation Clozaril PS Hospitalization - Neutrophil Count Initial or Prolonged Decreased Date:12/26/01ISR Number: 3844982-5Report Type:Expedited (15-DaCompany Report #A129265 Age:41 YR Gender:Male I/FU:I Outcome Hospitalization - Initial or Prolonged Required Intervention to Prevent Permanent 22-Feb-2006 08:30 AM Page: 1421 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Aggression Literature Lithane Tablets PS Cushingoid Health Clozapine SS Leukocytosis Professional Thioridiazine C Paranoia Psychiatric Symptom Date:12/26/01ISR Number: 3845007-8Report Type:Expedited (15-DaCompany Report #PHFR2001GB03037 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Fibrinogen Foreign Clozaril (Clozapine) Initial or Prolonged Increased Health Tablet, 25 Mg PS ORAL 75MG/DAY, Other Coagulopathy Professional ORAL Dizziness Other Amoxicillin Dyspnoea (Amoxicillin) SS ORAL 250 MG, TID, Fibrin D Dimer Increased ORAL Hypersensitivity Gamolenic Acid Lower Respiratory Tract (Gamolenic Acid) C Infection Naproxen C Swelling Paroxetine (Paroxetine) C Acyclovir Cream C Paracetamol (Paracetamol) C Date:12/26/01ISR Number: 3845009-1Report Type:Expedited (15-DaCompany Report #PHBS2001AU12041 Age:49 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Communication Disorder Foreign Clozaril (Clozapine) Dysphemia Study Tablet PS ORAL 300 MG/D, Health ORAL Professional Other Date:12/26/01ISR Number: 3845234-XReport Type:Expedited (15-DaCompany Report #PHEH2001US10209 Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Health Clozaril(Clozapine) Leukopenia Professional Tablet PS ORAL 300MG DAILY, Sarcoma ORAL Clozapine(Clozapine) SS ORAL 300MG DAILY, ORAL Zoloft (Sertraline Hydrochloride) C Coumadin "Endo" (Warfarin Sodium) C Buspar (Buspirone Hydrochloride) C 22-Feb-2006 08:30 AM Page: 1422 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/26/01ISR Number: 3845235-1Report Type:Expedited (15-DaCompany Report #PHEH2001US10220 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bladder Operation Health Clozaril (Clozapine) Initial or Prolonged Lymphocyte Count Professional Tablet PS ORAL 600MG, ORAL Decreased Prozac (Fluoxetine Hydrochloride) C Klonopin C Haldol C Cogentin (Benzatropine Mesilate) C Date:12/26/01ISR Number: 3845350-2Report Type:Expedited (15-DaCompany Report #PHFR2001GB03360 Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Renal Failure Foreign Clozaril Initial or Prolonged Renal Tubular Necrosis Health (Clozapine)Tablet PS ORAL 750 MG/DAY, Rhabdomyolysis Professional ORAL Vomiting Other Date:12/26/01ISR Number: 3845398-8Report Type:Expedited (15-DaCompany Report #01-12-0701 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Brain Neoplasm Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 400MG QD ORAL Date:12/26/01ISR Number: 3845401-5Report Type:Expedited (15-DaCompany Report #C2001-3222.01 Age:73 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Health Clozapine Tablets 25 Fall Professional Mg Mylan PS Mylan ORAL 25MG QD, ORAL Hip Fracture Other Carbidopa/Levodopa C Date:12/28/01ISR Number: 3846472-2Report Type:Expedited (15-DaCompany Report #PHBS2001AU08936 Age:49 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Leukopenia Foreign Clozaril (Clozapine) Other Lymphoma Study Tablet PS ORAL 550 MG DAY, Neutropenia Health ORAL Professional Chemotherapeutics, Other (Chemotherapeutics, Other) SS 22-Feb-2006 08:30 AM Page: 1423 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/28/01ISR Number: 3846492-8Report Type:Expedited (15-DaCompany Report #PHBS2001CA08624 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Embolism Foreign Clozaril (Clozapine) PS ORAL 200 MG & 500 Study MG HS, ORAL Health Professional Date:12/28/01ISR Number: 3846517-XReport Type:Expedited (15-DaCompany Report #PHRM2001FR02860 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Foreign Leponex (Clozapine) Initial or Prolonged Neutropenia Health Tablet PS ORAL 600 MG DAILY, Professional ORAL Company Interferon Representative (Interferon) SS Other Date:12/28/01ISR Number: 3846518-1Report Type:Expedited (15-DaCompany Report #PHBS2001CA12728 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiomyopathy Foreign Clozaril (Clozapine) Health Tablet PS ORAL ORAL Professional Other Date:12/28/01ISR Number: 3846519-3Report Type:Expedited (15-DaCompany Report #PHFR2001GB03430 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Oesophageal Carcinoma Foreign Clozaril (Clozapine) Weight Decreased Health (Clozapine) Tablet PS ORAL 800MG/DAY, Professional ORAL Other Date:12/28/01ISR Number: 3846520-XReport Type:Expedited (15-DaCompany Report #PHBS2001AU12623 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Foreign Clozaril (Clozapine) Initial or Prolonged Study Tablet PS ORAL 350 MG, QD, Health ORAL Professional Chlorpromazine Other (Chlorpromazine) SS Date:12/28/01ISR Number: 3846969-5Report Type:Expedited (15-DaCompany Report #PHEH2001US10157 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Circulatory Collapse Health Clozaril Initial or Prolonged Coma Professional (Clozapine)Tablet PS ORAL ORAL Lipase Increased Wellbutrin (Amfebutamone Hydrochloride) C 22-Feb-2006 08:30 AM Page: 1424 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/28/01ISR Number: 3847156-7Report Type:Expedited (15-DaCompany Report #PHEH2001US10176 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Clozaril (Clozapine) Hallucination, Visual Professional Tablet PS ORAL 200 MG DAILY, ORAL Aricpet (Donepezily Hydrochloride) C Amantadine (Amantadine) C Trazodone (Trazodone) C Reglan (Metoclopramide) C Date:12/31/01ISR Number: 3847185-3Report Type:Expedited (15-DaCompany Report #01-07-0386 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Thyroid Stimulating Health Clozapine - Ivax Hormone Decreased Professional Pharmaceuticals, Hyperthyroidism Inc. Tablets PS Ivax Tri-Iodothyronine Pharmaceuticals, Increased Inc. ORAL 25-650MG QD ORAL Neurontin C Date:12/31/01ISR Number: 3847277-9Report Type:Expedited (15-DaCompany Report #PHFR2001GB03238 Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Clozaril(Clozapine) Drug Level Increased Study Tablet PS ORAL 425MG/DAY, Intentional Overdose Health ORAL Professional Other Date:01/02/02ISR Number: 3847349-9Report Type:Expedited (15-DaCompany Report #C2001-3647.01 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Consumer Clozapine Tablets Health 100 Mg Mylan PS Mylan ORAL 300 MG, Q HS, Professional ORAL Other Clozapine Tablets 25 Mg Mylan SS Mylan ORAL 25MG BID, ORAL Date:01/02/02ISR Number: 3847350-5Report Type:Expedited (15-DaCompany Report #C2001-3664.01 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 300MG, BID, Other ORAL Benztropine C Gemfibrozil C 22-Feb-2006 08:30 AM Page: 1425 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Atorvastatin C Date:01/03/02ISR Number: 3847826-0Report Type:Expedited (15-DaCompany Report #PHEH2001US00799 Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Congestive Cardiomyopathy Health Clozaril (Clozapine) Ejection Fraction Professional (Clozapine) Tablet PS ORAL 300MG DAILY, Decreased ORAL Extrasystoles Coreg (Carvedilol) C Myocardial Fibrosis Lanoxin C Ventricular Arrhythmia Altace (Ramipril) C Ventricular Hypokinesia Zyprexa (Olanzapine) C Ventricular Wall Ativan C Thickening Celebrex (Celecoxib) C Date:01/03/02ISR Number: 3847858-2Report Type:Direct Company Report #CTU 158202 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cholecystitis Acute Clozaril PS ORAL PO QD Hospitalization - Hepatocellular Damage Valproic Acid Er C Initial or Prolonged Nephritis Interstitial Dexedrine C Pain Flonase C Renal Failure Acute Cotrimazole C Date:01/03/02ISR Number: 3847869-7Report Type:Expedited (15-DaCompany Report #2001SE09514 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Foreign Seroquel PS ORAL 300 MG DAILY Asthenia Health PO Liver Function Test Professional Leponex SS ORAL 500 MG DAILY Abnormal Other PO Pyrexia Date:01/03/02ISR Number: 3847976-9Report Type:Expedited (15-DaCompany Report #C2001-3665.01 Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dysphagia Health Clozapine Tablets 25 Pneumonia Professional Mg Mylan PS Mylan ORAL 25 MG QD ORAL Other Date:01/03/02ISR Number: 3848161-7Report Type:Expedited (15-DaCompany Report #PHBS2001AU12733 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril (Clozapine) Health Tablet PS 250 MG, QD Professional Other 22-Feb-2006 08:30 AM Page: 1426 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/03/02ISR Number: 3848175-7Report Type:Expedited (15-DaCompany Report #PHFR2001GB03468 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Gastric Haemorrhage Foreign Clozaril (Clozapine) Health Unknown PS Professional Company Representative Other Date:01/04/02ISR Number: 3848071-5Report Type:Periodic Company Report #00-11-0604 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine Tablets - Professional Ivax Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 30-500MG QD; ORAL Date:01/04/02ISR Number: 3848072-7Report Type:Periodic Company Report #00-11-0606 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Infection Health Clozapine Tablets - Initial or Prolonged Professional Ivax Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 300-400MG QD; ORAL Date:01/04/02ISR Number: 3848073-9Report Type:Periodic Company Report #00-12-0613 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Thrombocytopenia Health Clozapine Tablets - Professional Ivax Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 600 MG QD; ORAL Depakote Tablets SS ORAL 500 MG BID; ORAL Effexor C Depakote C Date:01/04/02ISR Number: 3848075-2Report Type:Periodic Company Report #00-12-0616 Age:92 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Aspiration Health Clozapine Tablets - Professional Ivax Pharmaceuticals, 22-Feb-2006 08:30 AM Page: 1427 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Inc. PS Ivax Pharmaceuticals, Inc. ORAL 12.5-10MG QD; ORAL Date:01/04/02ISR Number: 3848076-4Report Type:Periodic Company Report #00-12-0628 Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Parkinson'S Disease Health Clozapine - Ivax Professional Pharmaceuticals, Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL ORAL Date:01/04/02ISR Number: 3848077-6Report Type:Periodic Company Report #00-12-0632 Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine - Ivax Pulmonary Embolism Professional Pharmaceuticals, Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 500-600MG QD; ORAL Trazodone C Klonopin C Depakote C Date:01/04/02ISR Number: 3848079-XReport Type:Periodic Company Report #00-12-0634 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozapine - Ivax Professional Pharmaceuticals, Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 600MG QD; ORAL Risperidone C Depakote C Zoloft C Ritalin C Date:01/04/02ISR Number: 3848080-6Report Type:Periodic Company Report #00-12-0635 Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Aspiration Health Clozapine - Ivax Professional Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 250-400MG QD; ORAL 22-Feb-2006 08:30 AM Page: 1428 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/04/02ISR Number: 3848082-XReport Type:Periodic Company Report #00-12-0637 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neutropenia Health Clozapine Tablets - Professional Ivax Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 25-80MG QD; ORAL Date:01/04/02ISR Number: 3848083-1Report Type:Periodic Company Report #00-12-0641 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Leukopenia Health Clozapine Tablets - Professional Ivax Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 600-900MG QD; ORAL Seroquel C Date:01/04/02ISR Number: 3848084-3Report Type:Periodic Company Report #00-12-0642 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine Tablets - Professional Ivax Pharmaceuticals, Inc PS Ivax Pharmaceuticals, Inc ORAL 300-600MG QD; ORAL Seroquel C Vistaril C Date:01/04/02ISR Number: 3848085-5Report Type:Periodic Company Report #00-12-0643 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine Tablets - Professional Ivax Pharmaceuticals, Inc PS Ivax Pharmaceuticals, Inc ORAL 650MG QD; ORAL Date:01/04/02ISR Number: 3848086-7Report Type:Periodic Company Report #00-12-0650 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Angina Unstable Health Clozapine Tablets - Initial or Prolonged Chest Pain Professional Ivax Thrombosis Pharmaceuticals, Inc PS Ivax Pharmaceuticals, Inc. ORAL 100-900MG QD; ORAL Atenolol C 22-Feb-2006 08:30 AM Page: 1429 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Mavik C Cardizem Cd C Aspirin C Pravachol C Nitroglycerin Sl C Synthroid C Glucotrol Xl C Date:01/04/02ISR Number: 3848087-9Report Type:Periodic Company Report #00-12-0653 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozapine Tablets - Professional Ivax Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 300MG QD; ORAL Date:01/04/02ISR Number: 3848088-0Report Type:Periodic Company Report #01-01-0001 Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine - Ivax Professional Pharmaceuticals, Inc. Tablets PS Ivax Pharmaceuticals, Inc ORAL 12.5-62.5 MG; ORAL Ranitidine C Prozac C Ferrous Sulfate C Colace C Date:01/04/02ISR Number: 3848089-2Report Type:Periodic Company Report #01-01-0003 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozapine Tablets - Influenza Professional Ivax Respiratory Arrest Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 50-350MG QD; ORAL Date:01/04/02ISR Number: 3848090-9Report Type:Periodic Company Report #01-01-0004 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cognitive Disorder Health Clozapine Tablets - Initial or Prolonged Eye Rolling Professional Ivax Hallucination, Auditory Pharmaceuticals, Lethargy Inc. PS Ivax Personality Change Pharmaceuticals, Inc. ORAL 500MG QD; ORAL 22-Feb-2006 08:30 AM Page: 1430 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/04/02ISR Number: 3848091-0Report Type:Periodic Company Report #01-01-0008 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine Tablets - Professional Ivax Pharmaceuticals, Inc PS Ivax Pharmaceuticals, Inc. ORAL 400MG QD; ORAL Pacil C Lorazepam C Date:01/04/02ISR Number: 3848092-2Report Type:Periodic Company Report #01-01-0009 Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Parkinson'S Disease Health Clozapine Tablets - Pneumonia Aspiration Professional Ivax Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 25-300MG QD; ORAL Date:01/04/02ISR Number: 3848093-4Report Type:Periodic Company Report #01-01-0012 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozapine - Ivax Professional Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 525 MG QD; ORAL Date:01/04/02ISR Number: 3848094-6Report Type:Periodic Company Report #01-01-0017 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozapine - Ivax Professional Pharmaceuticals, Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 400 MG QD ORAL Date:01/04/02ISR Number: 3848095-8Report Type:Periodic Company Report #01-01-0018 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine - Ivax Professional Pharmaceuticals, Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 300 MG QD ORAL Celexa C 22-Feb-2006 08:30 AM Page: 1431 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Nadolol C Valproic Acid C Allopurinol C Date:01/04/02ISR Number: 3848096-XReport Type:Periodic Company Report #01-01-0019 Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine - Ivax Professional Pharmaceuticals, Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 400 MG QD ORAL Lasix C Potassium C Aspirin C Date:01/04/02ISR Number: 3848097-1Report Type:Periodic Company Report #01-01-0021 Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine - Ivax Professional Pharmaceuticals, Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 12.5-175 MG QD ORAL Date:01/04/02ISR Number: 3848098-3Report Type:Periodic Company Report #01-01-0023 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine - Ivax Professional Pharmaceuticals, Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 25-75 MG QD ORAL Date:01/04/02ISR Number: 3848099-5Report Type:Periodic Company Report #01-01-0026 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neutropenia Health Clozapine - Ivax Hospitalization - Professional Pharmaceuticals, Initial or Prolonged Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 400 MG QD ORAL Didanosine C Mtv C Videx C Depakote C Paxil C Prenatal Qd C Vitamin C C 22-Feb-2006 08:30 AM Page: 1432 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/04/02ISR Number: 3848100-9Report Type:Periodic Company Report #01-01-0029 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 200-500 MG QD ORAL Lamictal C Fluvoxamine C Thiothixene C Date:01/04/02ISR Number: 3848101-0Report Type:Periodic Company Report #01-01-0040 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Aspiration Health Clozapine - Ivax Hospitalization - Professional Pharmaceuticals, Initial or Prolonged Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 25-100 MG QD ORAL Date:01/04/02ISR Number: 3848103-4Report Type:Periodic Company Report #01-01-0041 Age:69 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Health Clozapine - Ivax Influenza Like Illness Professional Pharmaceuticals, Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 900 MG QD ORAL Nortriptyline C Lorazepam C Loxapine C Date:01/04/02ISR Number: 3848105-8Report Type:Periodic Company Report #01-01-0042 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Grand Mal Convulsion Health Clozapine - Ivax Hospitalization - Professional Pharmaceuticals, Initial or Prolonged Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 37.5-100 MG QD ORAL Haldol C Depakote C Neurontin C Haloperidol C 22-Feb-2006 08:30 AM Page: 1433 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/04/02ISR Number: 3848106-XReport Type:Periodic Company Report #01-01-0047 Age:69 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozapine - Ivax Hospitalization - Professional Pharmaceuticals, Initial or Prolonged Inc. Tablets PS Ivax Pharmaceuticals, Inc. 75-300MG QD Hydrochlorothiazide C Glucotrol C Date:01/04/02ISR Number: 3848107-1Report Type:Periodic Company Report #01-01-0053 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozapine - Ivax Professional Pharmaceuticals, Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 175-450 MG QD ORAL Cisplatin Inj Soln-Gmp SS INTRAVENOUS INTRAVENOUS Etoposide SS Date:01/04/02ISR Number: 3848108-3Report Type:Periodic Company Report #01-01-0059 Age:81 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sepsis Health Clozapine - Ivax Professional Pharmaceuticals, Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 50 MG QD ORAL Date:01/04/02ISR Number: 3848109-5Report Type:Periodic Company Report #01-01-0063 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozapine - Ivax Hospitalization - Professional Pharmaceuticals, Initial or Prolonged Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 600MG QD ORAL Date:01/04/02ISR Number: 3848110-1Report Type:Periodic Company Report #01-01-0064 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neutropenia Health Clozapine - Ivax Hospitalization - Personality Disorder Professional Pharmaceuticals, Initial or Prolonged Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 550-700MG QD ORAL Depakote C Olanzapine C 22-Feb-2006 08:30 AM Page: 1434 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Trazodone C Date:01/04/02ISR Number: 3848112-5Report Type:Periodic Company Report #01-01-0069 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Clozapine - Ivax Initial or Prolonged Blood Pressure Increased Professional Pharmaceuticals, Coordination Abnormal Inc. Tablets PS Ivax Hypomania Pharmaceuticals, Movement Disorder Inc. ORAL 500MG QD ORAL Speech Disorder Benadryl Tablets SS ORAL 500MG QD ORAL Zocor C Date:01/04/02ISR Number: 3848114-9Report Type:Periodic Company Report #01-02-0068 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine - Ivax Professional Pharmaceuticals, Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 500-625MG QD ORAL Colace C Hydrochlorothiazide C Ibuprofen C Lithium C Date:01/04/02ISR Number: 3848116-2Report Type:Periodic Company Report #01-02-0078 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Eosinophil Count Health Clozapine - Ivax Initial or Prolonged Decreased Professional Pharmaceuticals, Neutropenia Inc. Tablets PS Ivax Red Blood Cell Count Pharmaceuticals, Decreased Inc. ORAL 800MG QD ORAL Depakote C Klonopin C Buspar C Date:01/04/02ISR Number: 3848117-4Report Type:Periodic Company Report #01-02-0081 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Respiratory Failure Health Clozapine - Ivax Professional Pharmaceuticals, Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 350MG QD ORAL 22-Feb-2006 08:30 AM Page: 1435 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/04/02ISR Number: 3848119-8Report Type:Periodic Company Report #01-02-0084 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 400-600MG QD ORAL Date:01/04/02ISR Number: 3848126-5Report Type:Periodic Company Report #01-02-0085 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine - Ivax Professional Pharmaceuticals, Inc. Tablets PS Ivax Pharmaceuticals, Inc ORAL 75MG QD ORAL Date:01/04/02ISR Number: 3848134-4Report Type:Periodic Company Report #01-02-0092 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sepsis Health Clozapine - Ivax Professional Pharmaceuticals, Inc Tablets PS Ivax Pharmaceuticals, Inc ORAL 300MG QD ORAL Celexa C Nasalcrom 4% Spray C Cromolyn Sodium Nasal C Dilantin C Sulfamethoxazole W/ Trimethoprim C Premarin C Medroxyprogesterone C Guiatuss Dm C Albuterol Sulfate Inhalation Solution C Sodium Chloride C Eucerin Creme C Calcium C Date:01/04/02ISR Number: 3848156-3Report Type:Periodic Company Report #01-02-0095 Age:89 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Aspiration Health Clozapine - Ivax Professional Pharmaceuticals, Inc. Tablets PS Ivax Pharmaceuticals, Inc ORAL 25MG QD ORAL 22-Feb-2006 08:30 AM Page: 1436 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/04/02ISR Number: 3848157-5Report Type:Periodic Company Report #01-02-0097 Age:83 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine - Ivax Professional Pharmaceuticals, Inc Tablets PS Ivax Pharmaceuticals Inc ORAL 100 MG QD ORAL Date:01/04/02ISR Number: 3848159-9Report Type:Periodic Company Report #01-02-0098 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozapine - Ivax Professional Pharmaceuticals, Inc Tablets PS Ivax Pharmaceuticals Inc ORAL 12.5 - 22.5MG QD ORAL Date:01/04/02ISR Number: 3848160-5Report Type:Periodic Company Report #01-02-0099 Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozapine - Ivax Hospitalization - Professional Pharmaceuticals, Inc Initial or Prolonged Tablet PS Ivax Pharmaceuticals, Inc ORAL 50-275MG QD ORAL Vasotec C Ativan C Zoloft C Adalat Cc C Potassium Chloride C Lactulose C Date:01/04/02ISR Number: 3848177-0Report Type:Periodic Company Report #01-02-0103 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine - Ivax Hospitalization - Professional Pharmaceuticals, Initial or Prolonged Inc. Tablets PS Ivax Pharmaceuticals, Inc ORAL 300MG QD ORAL Depakote C Paxil C Hydroxyzine C Date:01/04/02ISR Number: 3848178-2Report Type:Periodic Company Report #01-02-0105 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neutropenia Health Clozapine - Ivax Professional Pharmaceuticals, Inc Tablets PS Ivax Pharmaceuticals, Inc ORAL 50-600MG QD ORAL Aspirin C 22-Feb-2006 08:30 AM Page: 1437 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Docusate C Haloperidol C Isosorbide Mononitrate C Lithium Carbonate C Metoprolol Tartrate C Milk Of Magnesia C Oxcarbazepine C Psyllium C Quetiapine Fumarate C Ranitidine Hydrochloride C Simvastatin C Topiramate C Multivitamin And Mineral Supplement C Bisacodyl Suppositories C Calcium Carbonate C Diphenhydramine Hydrochloride C Droperidol Injectable C Guaifenesin Dm C Ibuprofen C Aluminum Hydroxide W/ Magnesium Hydroxide C Nitroglycerin C Analgesic Balm Prn C Sorbitol C Lansoprazole C Amlodipine C Clonidine C Date:01/04/02ISR Number: 3848179-4Report Type:Periodic Company Report #01-02-0107 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neutropenia Health Clozapine - Ivax Professional Pharmaceuticals, Inc. Tablets PS Ivax Pharmaceuticals Inc, ORAL 550-600MG QD ORAL Imipramine Tablets SS ORAL 35MG QHS ORAL Maalox C Date:01/04/02ISR Number: 3848181-2Report Type:Periodic Company Report #01-02-0109 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozapine - Ivax Pneumonia Professional Pharmaceuticals, Inc. Tablets PS Ivax Pharmaceuticals, Inc ORAL 350-650MG ORAL 22-Feb-2006 08:30 AM Page: 1438 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/04/02ISR Number: 3848183-6Report Type:Periodic Company Report #01-02-0110 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 800MG QD ORAL Date:01/04/02ISR Number: 3848184-8Report Type:Periodic Company Report #01-02-0113 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozapine - Ivax Professional Pharmaceuticals, Inc. Tablets PS ORAL 400-800MG QD ORAL Date:01/04/02ISR Number: 3848186-1Report Type:Periodic Company Report #01-03-0123 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozapine - Ivax Professional Pharmaceuticals, Inc. Tablets PS Ivax Pharmaceuticals ORAL 13-300MG QD ORAL Date:01/04/02ISR Number: 3848187-3Report Type:Periodic Company Report #01-03-0124 Age:86 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Respiratory Failure Health Clozapine - Ivax Professional Pharmaceuticals, Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 12.5-50MG QD ORAL Date:01/04/02ISR Number: 3848188-5Report Type:Periodic Company Report #01-03-0125 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutropenia Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 200MG QD ORAL Divalproex Sodium C Risperidone C Date:01/04/02ISR Number: 3848189-7Report Type:Periodic Company Report #01-03-0126 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, 22-Feb-2006 08:30 AM Page: 1439 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 75-87.5MG QD ORAL Date:01/04/02ISR Number: 3848190-3Report Type:Periodic Company Report #01-03-0142 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozapine - Ivax Upper Respiratory Tract Professional Pharmaceuticals, Infection Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 750 MG QD ORAL Cogentin C Date:01/04/02ISR Number: 3848191-5Report Type:Periodic Company Report #01-03-0143 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Health Clozapine - Ivax Initial or Prolonged Phosphokinase Increased Professional Pharmaceuticals, Viral Infection Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 50-750MG QD ORAL Rifampicin C Pyrazinamide C Prolixin C Date:01/04/02ISR Number: 3848192-7Report Type:Periodic Company Report #01-03-0148 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozapine - Ivax Professional Pharmaceuticals, Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 25-500MG QD ORAL Date:01/04/02ISR Number: 3848193-9Report Type:Periodic Company Report #01-03-0150 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine - Ivax Professional Pharmaceuticals, Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 600 MG QD ORAL 22-Feb-2006 08:30 AM Page: 1440 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/04/02ISR Number: 3848195-2Report Type:Periodic Company Report #01-03-0151 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Health Clozapine - Ivax Initial or Prolonged Suicidal Ideation Professional Pharmaceuticals, Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 300-400MG QD ORAL Date:01/04/02ISR Number: 3848200-3Report Type:Periodic Company Report #01-03-0152 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Clozapine - Ivax Leukopenia Professional Pharmaceuticals, Pneumonia Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 87.5-187.5MG ORAL Zyprexa C Remeron C Date:01/04/02ISR Number: 3848203-9Report Type:Periodic Company Report #01-03-0155 Age:81 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Respiratory Distress Health Clozapine - Ivax Professional Pharmaceuticals, Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL ORAL Date:01/04/02ISR Number: 3848205-2Report Type:Periodic Company Report #01-03-0157 Age:81 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine - Ivax Professional Pharmaceuticals, Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 75-100MG QD ORAL Date:01/04/02ISR Number: 3848206-4Report Type:Periodic Company Report #01-03-0160 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Convulsion Health Clozapine - Ivax Professional Pharmaceuticals, Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 700MG QD ORAL Cogentin C Robinul C Diphenhydramine C 22-Feb-2006 08:30 AM Page: 1441 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/04/02ISR Number: 3848208-8Report Type:Periodic Company Report #01-03-0161 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperglycaemia Health Clozapine - Ivax Required Professional Pharmaceuticals, Intervention to Inc. Tablets PS Ivax Prevent Permanent Pharmaceuticals, Impairment/Damage Inc. ORAL 25-375MG QD ORAL Paxil C Valproic Acid C Lescol C Glucophage C Diabeta C Insulin, Regular C Date:01/04/02ISR Number: 3848210-6Report Type:Periodic Company Report #01-03-0166 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Eosinophilia Health Clozapine - Ivax Initial or Prolonged Haematocrit Decreased Professional Pharmaceuticals, Haemoglobin Decreased Inc. Tablets PS Ivax Oedema Pharmaceuticals, Pneumonia Inc. ORAL 150-300MG QD ORAL Zyprexa C Date:01/04/02ISR Number: 3848212-XReport Type:Periodic Company Report #01-03-0177 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Myocardial Infarction Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 400-600MG QD ORAL Date:01/04/02ISR Number: 3848213-1Report Type:Periodic Company Report #01-03-0179 Age:80 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Aspiration Health Clozapine - Ivax Professional Pharmaceuticals, Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 12.5-18.7MG ORAL Amantadine C Date:01/04/02ISR Number: 3848215-5Report Type:Periodic Company Report #01-03-0180 Age:79 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Parkinsonism Health Clozapine - Ivax Professional Pharmaceuticals, 22-Feb-2006 08:30 AM Page: 1442 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 25MG QD ORAL Date:01/04/02ISR Number: 3848219-2Report Type:Periodic Company Report #01-03-0192 Age:87 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Parkinson'S Disease Health Clozapine Tablets - Professional Ivax Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 37.5 MG QD ORAL Depakote C Prevacid C Buspar C Date:01/04/02ISR Number: 3848221-0Report Type:Periodic Company Report #01-03-0689 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Health Clozapine Tablets - Professional Ivax Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 300MG QD ORAL Chemotherapy SS Date:01/04/02ISR Number: 3848223-4Report Type:Periodic Company Report #01-04-0186 Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine Tablets - Hospitalization - Professional Ivax Initial or Prolonged Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 12.5-37.5MG ORAL Trazodone C Levodopa-Carbidopa C Pepcid C Ranitidine C Ativan C Date:01/04/02ISR Number: 3848224-6Report Type:Periodic Company Report #01-04-0197 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pulmonary Embolism Health Clozapine Tablets - Professional Ivax Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 100-200MG QD 22-Feb-2006 08:30 AM Page: 1443 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL Bumex C Sinemet C Paxil C Date:01/04/02ISR Number: 3848226-XReport Type:Periodic Company Report #01-04-0202 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neutropenia Health Clozapine Tablets - Professional Ivax Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 100MG QD ORAL Date:01/04/02ISR Number: 3848227-1Report Type:Periodic Company Report #01-04-0216 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Health Clozapine - Ivax Myocardial Infarction Professional Pharmaceuticals, Inc. Tablets PS Ivax Pharmaceuticals Inc. ORAL 700MG QD ORAL Date:01/04/02ISR Number: 3848228-3Report Type:Periodic Company Report #01-04-0217 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozapine Tablets - Professional Ivax Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 400-600MG QD ORAL Cisplatin SS INTRAVENOUS INTRAVENOUS Etoposide "Bristol" SS INTRAVENOUS INTRAVENOUS Date:01/04/02ISR Number: 3848229-5Report Type:Periodic Company Report #01-04-0220 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neutropenia Health Clozapine Tablets - Hospitalization - Professional Ivax Initial or Prolonged Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 400MG QD ORAL Zyprexa C Aspirin C Klonopin C 22-Feb-2006 08:30 AM Page: 1444 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/04/02ISR Number: 3848230-1Report Type:Periodic Company Report #01-04-0221 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Grand Mal Convulsion Health Clozapine Tablets - Professional Ivax Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 900MG QD ORAL Luvox Tablets SS ORAL 150MG ORAL Lithium C Wellbutrin C Haldol C Cytomel C Ddavp C Date:01/04/02ISR Number: 3848231-3Report Type:Periodic Company Report #01-04-0222 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Deep Vein Thrombosis Health Clozapine Tablets - Hospitalization - Pulmonary Embolism Professional Ivax Initial or Prolonged Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 100-550MG QD ORAL Effexor Xl C Dexedrine C Synthroid C Ortho-Novum C Date:01/04/02ISR Number: 3848235-0Report Type:Periodic Company Report #01-04-0229 Age:77 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Aspiration Health Clozapine-Ivax Professional Pharmaceuticals, Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 50 MG QD ORAL Date:01/04/02ISR Number: 3848237-4Report Type:Periodic Company Report #01-04-0235 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Convulsion Health Clozapine-Ivax Professional Pharmaceuticals, Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 575-625 MG QD ORAL Verapamil Sa C Luvox C Multivitamins C Phenytoin Sodium C Fluvoxamine C 22-Feb-2006 08:30 AM Page: 1445 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/04/02ISR Number: 3848238-6Report Type:Periodic Company Report #01-04-0236 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Convulsion Health Clozapine-Ivax Professional Pharmaceuticals, Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 50MG QD ORAL Seroquel C Seroquel C Gabapentin C Date:01/04/02ISR Number: 3848239-8Report Type:Periodic Company Report #01-04-0240 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Upper Health Clozapine-Ivax Decreased Appetite Professional Pharmaceuticals, Eosinophil Count Inc. Tablets PS Ivax Increased Pharmaceuticals, Hypersensitivity Inc. ORAL 300-500 MG QD Ileus Paralytic ORAL Intestinal Obstruction Thrombocythaemia Ulcer Weight Decreased Date:01/04/02ISR Number: 3848240-4Report Type:Periodic Company Report #01-04-0241 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pulmonary Embolism Health Clozapine-Ivax Hospitalization - Professional Pharmaceuticals, Initial or Prolonged Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 50-200MG QD ORAL Date:01/04/02ISR Number: 3848241-6Report Type:Periodic Company Report #01-05-0250 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Thyroid Stimulating Health Clozapine-Ivax Hormone Increased Professional Pharmaceuticals, Bronchitis Inc. Tablets PS Ivax Depression Pharmaceuticals, Haemoglobin Decreased Inc. ORAL 150-250 MG QD Liver Function Test ORAL Abnormal Paxil C White Blood Cell Count Increased 22-Feb-2006 08:30 AM Page: 1446 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/04/02ISR Number: 3848243-XReport Type:Periodic Company Report #01-05-0251 Age:74 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Parkinson'S Disease Health Clozapine-Ivax Professional Pharmaceuticals, Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 75 MG QD ORAL Date:01/04/02ISR Number: 3848245-3Report Type:Periodic Company Report #01-05-0255 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Platelet Count Decreased Health Clozapine-Ivax Professional Pharmaceuticals, Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 300 MG QD ORAL Date:01/04/02ISR Number: 3848246-5Report Type:Periodic Company Report #01-05-0257 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Grand Mal Convulsion Health Clozapine Hospitalization - Professional Tablets-Ivax Initial or Prolonged Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 650MG QD ORAL Depakote Tablets SS ORAL 1000 MG QD ORAL Zyprexa Tablets SS ORAL 30MG QD ORAL Lorazepam C Date:01/04/02ISR Number: 3848248-9Report Type:Periodic Company Report #01-05-0260 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine - Ivax Professional Pharmaceuticals, Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 150-700 MG QD ORAL Date:01/04/02ISR Number: 3848250-7Report Type:Periodic Company Report #01-05-0261 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Grand Mal Convulsion Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 700 MG QD ORAL Lithium Tablets SS ORAL 900 MG QD 22-Feb-2006 08:30 AM Page: 1447 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL Navane C Date:01/04/02ISR Number: 3848252-0Report Type:Periodic Company Report #01-05-0264 Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine PS Ivax Professional Pharmaceuticals, Inc ORAL 50-725 MG QD ORAL Date:01/04/02ISR Number: 3848254-4Report Type:Periodic Company Report #01-05-0268 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukocytosis Health Clozapine PS Ivax Initial or Prolonged Professional Pharmaceuticals, Inc. ORAL 12.5-25 MG QD ORAL Date:01/04/02ISR Number: 3848255-6Report Type:Periodic Company Report #01-05-0269 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozapine PS Ivax Hospitalization - Rash Erythematous Professional Pharmaceuticals, Initial or Prolonged Sepsis Inc. ORAL 550 MG QD ORAL Septra Tablets SS ORAL ORAL Date:01/04/02ISR Number: 3848256-8Report Type:Periodic Company Report #01-05-0270 Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozapine - Ivax Professional Pharmaceuticals, Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 50 MG QD ORAL Date:01/04/02ISR Number: 3848258-1Report Type:Periodic Company Report #01-05-0271 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Clozapine - Ivax Congestive Professional Pharmaceuticals, Pneumonia Inc. Tablets PS Ivax Pharmaceutical, Respiratory Failure Inc. ORAL 300-350 MG QD ORAL Date:01/04/02ISR Number: 3848260-XReport Type:Periodic Company Report #01-05-0272 Age:30 YR Gender:Male I/FU:I Outcome Life-Threatening Hospitalization - 22-Feb-2006 08:30 AM Page: 1448 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Initial or Prolonged PT Report Source Product Role Manufacturer Route Dose Duration Neuroleptic Malignant Health Clozapine - Ivax Syndrome Professional Pharmaceuticals, Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 25-450 MG QD ORAL Lorazepam C Valproic Acid C Benadryl C Date:01/04/02ISR Number: 3848261-1Report Type:Periodic Company Report #01-05-0281 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neutropenia Health Clozapine - Ivax Professional Pharmaceuticals, Inc. Tablets PS Ivax Pharmaceuticals, Inc ORAL 300-550 MG QD ORAL Depakote C Cogentin C Prilosec C Lactulose C Date:01/04/02ISR Number: 3848263-5Report Type:Periodic Company Report #01-05-0284 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Platelet Count Decreased Health Clozapine - Ivax Professional Pharmaceuticals, Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 300MG QD ORAL Zyprexa C Date:01/04/02ISR Number: 3848265-9Report Type:Periodic Company Report #01-06-0279 Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozapine - Ivax Hospitalization - Professional Pharmaceuticals, Initial or Prolonged Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 100-500MG QD ORAL Vitamin E C Enalapril C Lithium C Olanzapine C Prevacid C 22-Feb-2006 08:30 AM Page: 1449 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/04/02ISR Number: 3848267-2Report Type:Periodic Company Report #01-06-0280 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Respiratory Failure Health Clozapine PS Ivax Professional Pharmaceuticals, Inc. ORAL 200MG QD ORAL Date:01/04/02ISR Number: 3848269-6Report Type:Periodic Company Report #01-06-0282 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Platelet Count Decreased Health Clozapine PS Ivax Hospitalization - Professional Pharmaceuticals, Initial or Prolonged Inc. ORAL 100-125MG QD ORAL Depakote C Date:01/04/02ISR Number: 3848271-4Report Type:Periodic Company Report #01-06-0288 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Health Clozapine PS Ivax Professional Pharmaceuticals, Inc ORAL 900 MG QD ORAL Date:01/04/02ISR Number: 3848272-6Report Type:Periodic Company Report #01-06-0290 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozapine - Ivax Hospitalization - Pyrexia Professional Pharmaceuticals, Initial or Prolonged Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 800-875 MG QD ORAL Theo-Dur C Valproic Acid C Date:01/04/02ISR Number: 3848274-XReport Type:Periodic Company Report #01-06-0291 Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dehydration Health Clozapine PS Ivax Initial or Prolonged Dysphagia Professional Pharmaceuticals, Pneumonia Aspiration Inc. ORAL 400-600MG QD Pyrexia ORAL White Blood Cell Count Zoloft C Increased Depakote C Ativan C Date:01/04/02ISR Number: 3848276-3Report Type:Periodic Company Report #01-06-0296 Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine - Ivax Professional Pharmaceuticals, 22-Feb-2006 08:30 AM Page: 1450 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 62.5 MG QD ORAL Coumadin C Furosemide C Digoxin C Lisinopril C Selegiline C Spironolactone C Date:01/04/02ISR Number: 3848278-7Report Type:Periodic Company Report #01-06-0298 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Clozapine - Ivax Congestive Professional Pharmaceuticals, Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL ORAL Date:01/04/02ISR Number: 3848279-9Report Type:Periodic Company Report #01-06-0299 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozapine - Ivax Professional Pharmaceuticals, Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 250-275 MG QD ORAL Gemcitabine Inj Soln-Gmp SS ORAL 250-275 MG QD ORAL ... C Date:01/04/02ISR Number: 3848281-7Report Type:Periodic Company Report #01-06-0300 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozapine - Ivax Professional Pharmaceuticals, Inc., Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 25-200MG QD ORAL Date:01/04/02ISR Number: 3848287-8Report Type:Periodic Company Report #01-06-0302 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pleural Effusion Health Clozapine Tablets - Initial or Prolonged Pneumonia Professional Ivax Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 300MG QD ORAL Benzotropine C 22-Feb-2006 08:30 AM Page: 1451 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Celexa C Oxybutynin C Clonidine C Levothyroxine C Ferrous Sulfate C Valproate Sodium C Date:01/04/02ISR Number: 3848288-XReport Type:Periodic Company Report #01-06-0305 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Clozapine Tablets - Initial or Prolonged Mental Disorder Professional Ivax Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 800MG QD ORAL Benztropine Mesylate C Ddavp C Ditropan Xl C Docusate C Haloperidol C Multivitamins C Thiothixene C Depakote 500 Mg C Date:01/04/02ISR Number: 3848289-1Report Type:Periodic Company Report #01-06-0307 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine Tablets - Professional Ivax Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 650MG QD ORAL Date:01/04/02ISR Number: 3848290-8Report Type:Periodic Company Report #01-06-0312 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Clozapine Tablets - Professional Ivax Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 300-700MG QD ORAL Date:01/04/02ISR Number: 3848292-1Report Type:Periodic Company Report #01-06-0317 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine Tablets - Professional Ivax Pharmaceuticals, Inc. PS Ivax 22-Feb-2006 08:30 AM Page: 1452 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pharmaceuticals, Inc. ORAL 400-600MG QD ORAL Date:01/04/02ISR Number: 3848294-5Report Type:Periodic Company Report #01-06-0319 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Platelet Count Decreased Health Clozapine Tablets - Initial or Prolonged Professional Ivax Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 100-125MG QD ORAL Date:01/04/02ISR Number: 3848295-7Report Type:Periodic Company Report #01-06-0322 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Neutropenia Health Clozapine Tablets - Intervention to Professional Ivax Prevent Permanent Pharmaceuticals, Impairment/Damage Inc. PS Ivax Pharmaceuticals, Inc. ORAL 25-400MG QD ORAL Benadryl C Ritalin C Pepcid C Depakote C Artane C Propranolol C Haldol C Hydrochlorothiazide C Date:01/04/02ISR Number: 3848297-0Report Type:Periodic Company Report #01-06-0323 Age:67 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Health Clozapine Tablets - Professional Ivax Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 100-350MG QD ORAL Date:01/04/02ISR Number: 3848298-2Report Type:Periodic Company Report #01-06-0325 Age:86 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Health Clozapine Tablets - Initial or Prolonged Pneumonia Professional Ivax Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 100-125MG QD 22-Feb-2006 08:30 AM Page: 1453 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL Artificial Tears C Serevent Inhalation Solution C Prilosec C Furosemide C Fosamax C Benztropine Mesylate C Enalapril C Guaifenex La C K-Dur C Docusate Calcium C Uniphyl C Vioxx C Codol Syrup Dh C Levaquin C Azmacort Inhalation Solution C Milk Of Magnesia C Date:01/04/02ISR Number: 3848301-XReport Type:Periodic Company Report #01-06-0330 Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Myocardial Health Clozapine Tablets - Infarction Professional Ivax Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 25-100MG QD ORAL Rocephin C Cephalexin C Aspirin C Lorazepam C Megestrol C Captopril C Verapamil C Lacri-Lube Ointment Ophthalmic C Premarin C Vitamin C C Keflex C Augmentin C Tylenol Suppositories C Date:01/04/02ISR Number: 3848303-3Report Type:Periodic Company Report #01-06-0333 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Deep Vein Thrombosis Health Clozapine - Ivax Professional Pharmaceuticals, Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 600 MG QD ORAL 22-Feb-2006 08:30 AM Page: 1454 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/04/02ISR Number: 3848304-5Report Type:Periodic Company Report #01-06-0337 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Convulsion Health Clozapine - Ivax Professional Pharmaceuticals, Inc. Tablets PS Ivax Pharmaceuticals ORAL 50-400 MG QD ORAL Date:01/04/02ISR Number: 3848306-9Report Type:Periodic Company Report #01-06-0343 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypertension Health Clozapine - Ivax Initial or Prolonged Syncope Professional Pharmaceuticals, Inc. Tablets PS Ivax Pharmaceuticals, Inc ORAL 600 MG QD ORAL Prozac C Klonopin C Date:01/04/02ISR Number: 3848309-4Report Type:Periodic Company Report #01-07-0346 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Unevaluable Event Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Inc. Tablets PS ORAL 600MG QD ORAL Date:01/04/02ISR Number: 3848310-0Report Type:Periodic Company Report #01-07-0351 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozapine - Ivax Hospitalization - Professional Pharmaceuticals, Initial or Prolonged Inc. Tablets PS Ivax Required Pharmaceuticals, Intervention to Inc. ORAL 37.5-275 MG Prevent Permanent QD ORAL Impairment/Damage Lithium C Date:01/04/02ISR Number: 3848901-7Report Type:Expedited (15-DaCompany Report #C2001-3441.01 Age:82 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dementia Health Clozapine Tblets 25 Parkinson'S Disease Professional Mg Mylan PS Mylan ORAL 12.5 MG QD White Blood Cell Count Other ORAL Abnormal Acetaminophen C Carbidopa/Levodopa C Levothyroxine C Pramipexole C Sorbitol C Various Wound Dressings C Multivitamin C Ferrous Sulfate C Vitamin C C 22-Feb-2006 08:30 AM Page: 1455 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Calcium Carbonate/Vitamin D C Date:01/04/02ISR Number: 3848902-9Report Type:Expedited (15-DaCompany Report #C2001-3666.01 Age:73 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg (Mylan) PS Mylan ORAL 12.5MG Q AM, Other 25 MG Q 8PM ORAL Date:01/04/02ISR Number: 3848982-0Report Type:Expedited (15-DaCompany Report #PHFR2001GB03247 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Coordination Abnormal Foreign Clozaril (Clozapine) Faecal Incontinence Health Tablet PS ORAL 100 MG X 4 Fatigue Professional STAT, ORAL Medication Error Other Chlordiazepoxide Pain (Chlordiazepoxide) C Palpitations Amitriptyline Tachycardia (Amitriptyline) C Thiamine C Temazepam C Carbamazepine C Chlorhexamide (Vinblastine) C Lithium (Lithium) C Date:01/04/02ISR Number: 3849009-7Report Type:Expedited (15-DaCompany Report #PHEH2001US00799 Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiomyopathy Health Clozaril (Clozapine) Ejection Fraction Professional (Clozapine) Tablet PS ORAL 300MG DAILY, Decreased ORAL Extrasystoles Coreg (Carvedilol) C Myocardial Fibrosis Lanoxin C Ventricular Arrhythmia Altace (Ramipril) C Ventricular Hypertrophy Zyprexa (Olazapine) C Ventricular Hypokinesia Ativan C Ventricular Wall Celebrex (Celecoxib) C Thickening Date:01/04/02ISR Number: 3849188-1Report Type:Expedited (15-DaCompany Report #PHBS2001AU12733 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril (Clozapine) Health Tablet PS 250 MG, QD Professional Other 22-Feb-2006 08:30 AM Page: 1456 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/04/02ISR Number: 3849569-6Report Type:Expedited (15-DaCompany Report #PHBS2001AU12041 Age:49 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dysphemia Foreign Clozaril (Clozapine) Study Tablet PS ORAL 300 MG/D, Health ORAL Professional Other Date:01/04/02ISR Number: 3849570-2Report Type:Expedited (15-DaCompany Report #PHFR2001GB03487 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Appendicitis Foreign Clozaril (Clozapine) PS ORAL 500 MG/DAY, Health ORAL Professional Other Date:01/04/02ISR Number: 3849571-4Report Type:Expedited (15-DaCompany Report #PHBS2001CA12937 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Level Increased Foreign Clozaril (Clozapine) Myocarditis Health Tablet PS ORAL 900 MG/DAY, Pericardial Effusion Professional ORAL Pulmonary Congestion Other Risperdal Pulmonary Oedema (Risperidone) C Clonidine (Clonidine) C Synthroid C Trazodone (Trazodone) C Valproic Acid C Psyllium (Psyllium) C Docusate Sodium C Date:01/04/02ISR Number: 3849572-6Report Type:Expedited (15-DaCompany Report #PHBS2001AU09721 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiomyopathy Foreign Clozaril (Clozapine) Dyspnoea Health Tablet PS ORAL 250 MG/D, Ejection Fraction Professional ORAL Abnormal Other Efexor (Venlafaxine Fatigue Hydrochloride) C Valium C Date:01/04/02ISR Number: 3850849-9Report Type:Expedited (15-DaCompany Report #PHFR2001GB03472 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Appendicitis Foreign Clozaril (Clozapine) Initial or Prolonged Postoperative Infection Health Tablet PS ORAL 700MG/DAY Professional ORAL Other Ceftriaxone (Ceftriaxone) C Metronidazole 22-Feb-2006 08:30 AM Page: 1457 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Metronidazole) C Date:01/07/02ISR Number: 3849401-0Report Type:Expedited (15-DaCompany Report #PHBS2001US13146 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Level Increased Literature Clozapine Pneumonia Aspiration Health (Clozapine) PS 300 MG, BID Professional Date:01/07/02ISR Number: 3849429-0Report Type:Expedited (15-DaCompany Report #PHEH2001US10350 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Health Clozaril(Clozapine) Granulocytopenia Professional Tablet PS ORAL 375 MG, ORAL Hepatitis C Interferon Leukopenia (Interferon) C Mental Disorder Zyprexa (Olanzapine) C Suicidal Ideation Nph Insulin (Insulin Injection, Isophane) C Humalog (Insulin Lispro) C Prozac (Fluoxetine Hydrochloride) C Date:01/07/02ISR Number: 3849430-7Report Type:Expedited (15-DaCompany Report #PHEH2001US10226 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coronary Artery Disease Health Clozaril(Clozapine) Myocardial Infarction Professional Tablet PS ORAL 125MG, ORAL Date:01/07/02ISR Number: 3849458-7Report Type:Expedited (15-DaCompany Report #2014817 Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coma Health Oxycodone Depression Professional Hydrochloride Drug Abuser Other (Similar To Nda Ecchymosis 20-553) PS Myocarditis Citalopram SS Quinine Sulfate SS Clozapine SS Thioridazine Hcl SS Heroin SS Date:01/07/02ISR Number: 3849484-8Report Type:Expedited (15-DaCompany Report #PHNU2001DE02988 Age:43 YR Gender:Male I/FU:I Outcome PT Other Cough Leukocytosis Lymphopenia Nasopharyngitis Neutrophilia Pyrexia 22-Feb-2006 08:30 AM Page: 1458 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Viral Infection Report Source Product Role Manufacturer Route Dose Duration Foreign Leponex / Clozaril Health (Clozapine) Professional (Clozapine) Tablet PS ORAL ORAL Truxal (Chlorprothixene Hydrochloride) C Date:01/07/02ISR Number: 3849490-3Report Type:Expedited (15-DaCompany Report #PHBS2001AU12457 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Foreign Clozaril (Clozapine) Initial or Prolonged Ketoacidosis Study Tablet PS ORAL 400 MG, QD, Weight Increased Health ORAL Professional Date:01/07/02ISR Number: 3849517-9Report Type:Expedited (15-DaCompany Report #PHNU2001DE02989 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diarrhoea Haemorrhagic Foreign Leponex(Clozapine) PS 175 MG/D Viral Infection Health Zyprexa (Olanzapine) C Professional Other Date:01/07/02ISR Number: 3849519-2Report Type:Expedited (15-DaCompany Report #PHFR2001GB03378 Age:20 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Hodgkin'S Disease Foreign Clozaril (Clozapine) PS ORAL 300 MG Hospitalization - Health MANE/400MG Initial or Prolonged Professional NOCTE, ORAL Other Other Diazepam C Date:01/07/02ISR Number: 3849521-0Report Type:Expedited (15-DaCompany Report #PHFR2001GB03319 Age:42 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Hodgkin'S Disease Foreign Clozaril (Clozapine) Other Health Tablet PS ORAL 650MG/DAY, Professional ORAL Other Sulpiride (Sulpiride) C Olanzapine(Olanzapin e) C Procyclidine (Procyclidine) C 22-Feb-2006 08:30 AM Page: 1459 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/07/02ISR Number: 3849549-0Report Type:Expedited (15-DaCompany Report #PHFR2001GB03409 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Erosive Oesophagitis Foreign Clozaril(Clozapine) Initial or Prolonged Haematemesis Health Tablet PS ORAL 400MG/DAY Other Professional ORAL Citalopram (Citalopam) C Date:01/07/02ISR Number: 3849555-6Report Type:Expedited (15-DaCompany Report #PHFR2001GB03506 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Enteritis Necroticans Foreign Clozaril (Clozapine) Hospitalization - Malaise Study Tablet PS ORAL ORAL Initial or Prolonged Health Professional Other Date:01/07/02ISR Number: 3849599-4Report Type:Expedited (15-DaCompany Report #2001SE09514 Age:22 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Foreign Seroquel PS ORAL 300 MG DAILY Health PO Professional Leponex SS ORAL 500 MG DAILY Other PO Date:01/07/02ISR Number: 3849606-9Report Type:Expedited (15-DaCompany Report #PHBS2001CA13067 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Clozaril (Clozapine) Intentional Overdose Health Unknown PS Professional Valproic Acid Other (Valproic Acid) SS Date:01/07/02ISR Number: 3849609-4Report Type:Expedited (15-DaCompany Report #PHBS2001AU13000 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neoplasm Malignant Foreign Clozaril (Clozapine) Health Tablet PS ORAL 500 MG/DAY, Professional ORAL Other Date:01/07/02ISR Number: 3849915-3Report Type:Expedited (15-DaCompany Report #PHFR2001GB03497 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neutrophil Count Foreign Clozaril (Clozapine) Increased Health Tablet PS ORAL 600 MG/DAY, Pneumocystis Jiroveci Professional ORAL Pneumonia Other 22-Feb-2006 08:30 AM Page: 1460 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/07/02ISR Number: 3850828-1Report Type:Expedited (15-DaCompany Report #C2001-3705.01 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lymphoma Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 200MG QD, Other ORAL Albuterol Sulfate Inhalation Solution C Benztropine C Ciprofloxacin C Divalproex Sodium C Risperidol C Date:01/07/02ISR Number: 3850830-XReport Type:Expedited (15-DaCompany Report #C2001-3462.01 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Myocarditis Health Clozapine Tablets Initial or Prolonged Urinary Tract Infection Professional 100 Mg Mylan PS Mylan ORAL 100MG BID, Other Other ORAL Divalproex Sodium C Risperidone C Date:01/08/02ISR Number: 3849885-8Report Type:Expedited (15-DaCompany Report #PHFR2001GB03215 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bundle Branch Block Right Foreign Clozaril (Clozapine) Condition Aggravated Health Tablet PS ORAL 200 MG, BID, Diastolic Hypertension Professional ORAL Electrocardiogram Other Paroxetine Abnormal (Paroxetine) C Sinus Tachycardia Date:01/08/02ISR Number: 3850118-7Report Type:Expedited (15-DaCompany Report #PHFR2001GB03520 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Hodgkin'S Disease Foreign Clozaril (Clozapine) Disability Health Tablet PS ORAL 700MG/DAY, Other Professional ORAL Other Diazepam C Date:01/08/02ISR Number: 3850121-7Report Type:Expedited (15-DaCompany Report #PHBS2001AU13115 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Ventricular Hypokinesia Foreign Clozaril (Clozapine) Health Tablet PS ORAL ORAL Professional Other 22-Feb-2006 08:30 AM Page: 1461 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/08/02ISR Number: 3850149-7Report Type:Expedited (15-DaCompany Report #PHFR2001GB03507 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatitis C Foreign Clozaril (Clozapine) Health Tablet PS ORAL 450 MG/DAY, Professional ORAL Other Sertraline (Sertraline) C Propranolol C Date:01/08/02ISR Number: 3850158-8Report Type:Expedited (15-DaCompany Report #PHBS2001AU04319 Age:53 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Leukaemia Foreign Clozaril(Clozapine)T Hospitalization - Agranulocytosis Health ablet PS ORAL 600 MG/D, Initial or Prolonged Neutropenia Professional ORAL Other Diazepam C Date:01/08/02ISR Number: 3850163-1Report Type:Expedited (15-DaCompany Report #PHBS2001AU13079 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Foreign Clozaril(Clozapine)T Phosphokinase Increased Health ablet PS ORAL 200 MG/D, Blood Creatinine Professional ORAL Increased Other Epilim C Blood Pressure Systolic Abnormal Dilatation Ventricular Malaise Neutrophilia Pyrexia White Blood Cell Count Increased Date:01/08/02ISR Number: 3850166-7Report Type:Expedited (15-DaCompany Report #PHBS2001AU10392 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Foreign Clozaril(Clozapine)T Initial or Prolonged Health ablet PS ORAL ORAL Professional Other Date:01/08/02ISR Number: 3850192-8Report Type:Expedited (15-DaCompany Report #PHEH2001US08807 Age:51 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Cardiac Murmur Health Clozaril (Clozapine) Professional Tablet PS ORAL 100 MG/DAY, ORAL Haldol Decanoate (Haloperidol Decanoate) C Atenolol C 22-Feb-2006 08:30 AM Page: 1462 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/08/02ISR Number: 3850663-4Report Type:Expedited (15-DaCompany Report #01-12-0732 Age:85 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dementia Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 50-62.5MG QD ORAL Date:01/08/02ISR Number: 3850665-8Report Type:Expedited (15-DaCompany Report #01-12-0735 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Unevaluable Event Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 100-450MG QD ORAL Date:01/08/02ISR Number: 3850669-5Report Type:Expedited (15-DaCompany Report #01-12-0738 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Caffeine Increased Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 200-600MG QD ORAL Date:01/08/02ISR Number: 3850672-5Report Type:Expedited (15-DaCompany Report #01-12-0740 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hysterectomy Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 600MG QD ORAL Date:01/08/02ISR Number: 3850676-2Report Type:Expedited (15-DaCompany Report #01-12-0744 Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Back Disorder Health Clozapine - Ivax Initial or Prolonged Stress Fracture Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 25-50MG QD ORAL 22-Feb-2006 08:30 AM Page: 1463 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/08/02ISR Number: 3850677-4Report Type:Expedited (15-DaCompany Report #01-11-0613 Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiomegaly Health Clozapine - Ivax Initial or Prolonged Congestive Cardiomyopathy Professional Pharmaceuticals, Disability Pulmonary Oedema Inc. Tablets PS Ivax Refusal Of Treatment By Pharmaceuticals, Patient Inc. ORAL 400MG QHS Somnolence ORAL Lithobid C Wellbutrin - Slow Release C Ranitidine C Date:01/08/02ISR Number: 3850678-6Report Type:Expedited (15-DaCompany Report #01-12-0717 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebral Haemorrhage Health Clozapine - Ivax Cerebrovascular Accident Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 250-500MG QD ORAL Date:01/08/02ISR Number: 3850679-8Report Type:Expedited (15-DaCompany Report #01-12-0722 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Parkinson'S Disease Health Clozapine - Ivak Professional Pharmaceuticals, Other Inc. Tablets PS Ivak Pharmaceuticals, Inc. ORAL 25-50MG QD ORAL Date:01/08/02ISR Number: 3850682-8Report Type:Expedited (15-DaCompany Report #01-12-0724 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pulmonary Embolism Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL ORAL Date:01/08/02ISR Number: 3850686-5Report Type:Expedited (15-DaCompany Report #01-12-0723 Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Clozapine - Ivax Pneumonia Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 75-225MG QD ORAL 22-Feb-2006 08:30 AM Page: 1464 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/08/02ISR Number: 3850688-9Report Type:Expedited (15-DaCompany Report #01-12-0729 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Health Clozapine - Ivax Initial or Prolonged Injury Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 400MG QD ORAL Date:01/08/02ISR Number: 3850690-7Report Type:Expedited (15-DaCompany Report #01-12-0730 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Unevaluable Event Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 6.2-400MG QD ORAL Date:01/08/02ISR Number: 3850692-0Report Type:Expedited (15-DaCompany Report #01-12-0731 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Operation Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 225-400MG QD ORAL Date:01/08/02ISR Number: 3850839-6Report Type:Expedited (15-DaCompany Report #PHFR2001GB03516 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Activated Partial Foreign Clozaril (Clozapine) Initial or Prolonged Thromboplastin Time Health Tablet PS ORAL 100MG/OM,150M Prolonged Professional G/ON, ORAL Anaemia Other Zuclopenthixol Blood Immunoglobulin G (Zuclopenthixol) C Increased Carbamazepine C Diarrhoea Levothyroxine Sodium C Eosinophil Count Chlorpromazine Increased (Chlorpromazine) C Liver Function Test Abnormal Lupus-Like Syndrome Lymphopenia Neutrophil Count Increased Platelet Count Increased White Blood Cell Count Increased 22-Feb-2006 08:30 AM Page: 1465 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/09/02ISR Number: 3850296-XReport Type:Expedited (15-DaCompany Report #PHBS2001AU13079 Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatinine Foreign Clozaril (Clozapine) Increased Health Tablet PS ORAL 200 MG/D, Blood Pressure Systolic Professional ORAL Abnormal Other Epilim C Dilatation Ventricular Malaise Neutrophilia Pyrexia White Blood Cell Count Increased Date:01/09/02ISR Number: 3850303-4Report Type:Expedited (15-DaCompany Report #PHBS2001AU10052 Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiomyopathy Foreign Clozaril (Clozapine) Initial or Prolonged Study Tablet PS ORAL 500 MG/DAY, Health ORAL Professional Other Date:01/09/02ISR Number: 3850471-4Report Type:Direct Company Report #CTU 158723 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Ineffective Clozaril (450gm @Hs) PS 450GM @ HS PAST 6 MONTHS 6 MON Cogentin C Prolixin C Desyrel C Multivitamins C Vit C C Senonot C Oscal C Lipitor C Dulcolax C Flonase C Ryna Tuss C Ca Mg C Depo-Provera C Nexium C Date:01/09/02ISR Number: 3850477-5Report Type:Direct Company Report #CTU 158725 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Ineffective Clozaril (250 @ Hs) Pharmaceutical Product (Generic) PS 250MG @HS Complaint /100MG 2 1/ 2 @HS Inderal C Depakote C Cogentin C Tofranil C Camg C 22-Feb-2006 08:30 AM Page: 1466 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Kenalog C Ddavp C Date:01/09/02ISR Number: 3850478-7Report Type:Direct Company Report #CTU 158726 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Ineffective Clozaril(50mg In Am Pharmaceutical Product And Noon And 275mg Complaint @Hs) PS 50MG AM AND NOON AND 275MG Q HS 6 MON Depakote C Cogentin C Accupril C Amaryl C Synthroid C Insulin C Glucophage C Reglan C Zantac C Celebrex C Lipitor C Pericolace C Camg C Date:01/09/02ISR Number: 3850480-5Report Type:Direct Company Report #CTU 158727 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Ineffective Clozaril (50gm Bid) PS ORAL 50GM PO BID Pharmaceutical Product DAILY Complaint Clozaril(500gm@Hs) SS ORAL 500MG PO @HS DAILY Depakote C Prozac C Zantac C Camg C Date:01/10/02ISR Number: 3851083-9Report Type:Expedited (15-DaCompany Report #PHEH2001US10097 Age:19 YR Gender:Male I/FU:I Outcome PT Hospitalization - Abdominal Pain Initial or Prolonged Anaemia Appendix Disorder Blood Albumin Decreased Blood Calcium Decreased Blood Potassium Decreased Blood Sodium Decreased Cholecystitis Acute Convulsion Diarrhoea Leukocytosis Lipase Increased Nausea Nephritis Interstitial Pallor 22-Feb-2006 08:30 AM Page: 1467 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pyrexia Renal Hypertrophy Vomiting Report Source Product Role Manufacturer Route Dose Duration Weight Decreased Health Clozaril (Clozapine) Professional Tablet PS ORAL 50 MG/DAY, ORAL Depakote (Valproate Semisodium) C Flonase (Fluticasone Propionate) C Nicoderm C Dextroamphetamine (Dexamfetamine) C Date:01/10/02ISR Number: 3851085-2Report Type:Expedited (15-DaCompany Report #PHEH2001US10350 Age:52 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Granulocytopenia Health Clozaril (Clozapine) Leukopenia Professional Tablet PS ORAL 375 MG, ORAL Interferon (Interferon) C Zyprexa (Olanzapine) C Nph Insulin (Insulin Injection, Isophane) C Humalog (Insulin Lispro) C Prozac (Fluoxetine Hydrochloride) C Date:01/10/02ISR Number: 3851118-3Report Type:Expedited (15-DaCompany Report #PHFR2001GB03497 Age:49 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Pressure Foreign Clozaril(Clozapine)T Fluctuation Health ablet PS ORAL 600 MG/DAY, Haemoglobin Decreased Professional ORAL Immunosuppression Other Dexamethasone C Infection Loss Of Consciousness Lung Neoplasm Malignant Lymphocyte Count Decreased Neutrophil Count Increased Platelet Count Decreased Pneumocystis Jiroveci Pneumonia Renal Failure Date:01/10/02ISR Number: 3851121-3Report Type:Expedited (15-DaCompany Report #PHBS2002DE00504 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Hospitalization - Agranulocytosis Foreign Initial or Prolonged Drug Interaction Literature Health Professional 22-Feb-2006 08:30 AM Page: 1468 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Product Role Manufacturer Route Dose Duration Clozapine(Clozapine) PS 200 MG/D Interferon(Interfero n) SS Date:01/10/02ISR Number: 3851164-XReport Type:Expedited (15-DaCompany Report #PHBS2001AU13000 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neoplasm Malignant Foreign Clozaril Health (Clozapine) PS ORAL 500 MG/DAY, Professional ORAL Other Date:01/10/02ISR Number: 3851426-6Report Type:Expedited (15-DaCompany Report #PHEH2002US00513 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cataract Health Clozaril (Clozapine) Professional Tablet PS ORAL ORAL Ativan C Trilafon (Perphenazine) C Navane (Tiotixene) C Haldol C Loxitane (Loxapine Succinate) C Date:01/11/02ISR Number: 3851962-2Report Type:Expedited (15-DaCompany Report #A123221 Age:49 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Asthenia Health Sinequan Capsules PS 100.00 MG Intervention to Confusional State Professional TOTAL; DAILY Prevent Permanent Disorientation Clozapine SS Impairment/Damage Fall Thorazine SS 200.00 MG Gait Disturbance TOTAL; DAILY Haematoma Lithium C Haemorrhage Movement Disorder Orthostatic Hypotension Somnolence Speech Disorder Date:01/11/02ISR Number: 3851964-6Report Type:Expedited (15-DaCompany Report #A200414 Age:26 YR Gender:Male I/FU:I Outcome PT Death Cardiac Disorder Hospitalization - Cardiomegaly Initial or Prolonged Cardiomyopathy Cardiovascular Disorder Coronary Artery Atherosclerosis Coronary Artery Occlusion 22-Feb-2006 08:30 AM Page: 1469 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hepatic Steatosis Sudden Cardiac Death Toxicologic Test Abnormal Report Source Product Role Manufacturer Route Dose Duration Health Zoloft Tablets PS Professional Clozapine SS Risperidone C Unspecified Medications C Date:01/11/02ISR Number: 3852049-5Report Type:Expedited (15-DaCompany Report #PHFR2002GB00457 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril (Clozapine) Localised Infection Health Tablet PS ORAL ORAL Professional Other Date:01/14/02ISR Number: 3852225-1Report Type:Expedited (15-DaCompany Report #2001SE09514 Age:22 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Foreign Seroquel PS ORAL 300 MG DAILY Asthenia Health PO Liver Function Test Professional Leponex SS ORAL 500 MG DAILY Abnormal Other PO Pyrexia Date:01/14/02ISR Number: 3852262-7Report Type:Expedited (15-DaCompany Report #PHBS2001CA11853 Age:51 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Confusional State Foreign Clozaril (Clozapine) Diabetes Mellitus Study Tablet PS ORAL SEE IMAGE Non-Insulin-Dependent Health Effexon C Influenza Like Illness Professional Metoprolol Somnolence Other (Metoprolol) C Epival (Valproate Semisodium) C Olanzapine (Olanzapine) C Date:01/14/02ISR Number: 3852263-9Report Type:Expedited (15-DaCompany Report #PHFR2002GB00464 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Lupus-Like Syndrome Foreign Clozaril (Clozapine) Rash Health Tablet PS ORAL 175 MG, BID, Professional ORAL Other Valproate Sodium (Valproate Sodium) C Isosorbide Mononitrate C Aspirine C Multivitamins (Retinol, Panthenol, Ascorbic Acid) C 22-Feb-2006 08:30 AM Page: 1470 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Senna (Senna) C Salbutamol C Becotide (Beclometasone Dipropionate) C Date:01/14/02ISR Number: 3852265-2Report Type:Expedited (15-DaCompany Report #PHBS2001CA12613 Age:46 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Clozaril (Clozapine) Study Tablet PS ORAL ORAL Health Professional Other Date:01/14/02ISR Number: 3852573-5Report Type:Expedited (15-DaCompany Report #PHEH2001US10176 Age:70 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozaril (Clozapine) Hallucination, Visual Professional Tablet PS ORAL 200 MG DAILY, ORAL Aricept (Donepezil Hydrochloride) C Amantadine (Amantadine) C Trazodone (Trazodone) C Reglan (Metoclopramide) C Prempro (Estrogens Conjugated) C Prinivil (Lisinopril) C Detrol (Tolterodine L-Tartrate) C Date:01/14/02ISR Number: 3852950-2Report Type:Expedited (15-DaCompany Report #2002UW00297 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutrophil Count Health Seroquel PS ORAL 250 MG DAILY Decreased Professional PO Clozapine SS ORAL 700 MG DAILY PO Divalproex Sodium SS ORAL 500 MG TID PO Divalproex Sodium C ORAL 1000 MG BID PO Chlorpromazine C Date:01/15/02ISR Number: 3853951-0Report Type:Expedited (15-DaCompany Report #C2001-3715.01 Age:89 YR Gender:Female I/FU:I Outcome PT Death Convulsion Laboratory Test Abnormal 22-Feb-2006 08:30 AM Page: 1471 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pyrexia Report Source Product Role Manufacturer Route Dose Duration Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 25MG BID, Other ORAL Acetaminophen C Aspirin C Furosemide C Nitroglycerin Patch C Potassium Chloride C Venlafaxine Xr C Date:01/15/02ISR Number: 3853952-2Report Type:Expedited (15-DaCompany Report #02-01-0002 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Choking Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc 300-500MG QD Date:01/15/02ISR Number: 3853953-4Report Type:Expedited (15-DaCompany Report #02-01-0008 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Clozapine - Ivax Congestive Professional Pharmaceuticals, Condition Aggravated Other Inc. Tablets PS Ivax Pharmaceuticals, Inc ORAL 400-700MG QD ORAL Date:01/15/02ISR Number: 3853954-6Report Type:Expedited (15-DaCompany Report #02-01-0015 Age:67 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc 50-600MG QD Date:01/15/02ISR Number: 3853955-8Report Type:Expedited (15-DaCompany Report #02-01-0016 Age:67 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc 12.5-25MG QD Date:01/15/02ISR Number: 3856830-8Report Type:Expedited (15-DaCompany Report #02-01-0001 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Hospitalization - Hip Fracture Health Initial or Prolonged Professional 22-Feb-2006 08:30 AM Page: 1472 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Product Role Manufacturer Route Dose Duration Clozapine PS Ivax Pharmaceuticals, Inc ORAL 450-850MG QD ORAL Date:01/16/02ISR Number: 3855125-6Report Type:Expedited (15-DaCompany Report #PHFR2001GB03319 Age:42 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Computerised Tomogram Foreign Clozaril (Clozapine) Abnormal Health Tablet PS ORAL 650MG/DAY, Hodgkin'S Disease Professional ORAL Lymphadenopathy Other Sulpiride (Sulpiride) C Olanzapine (Olanzapine) C Procyclidine (Procyclidine) C Date:01/16/02ISR Number: 3855131-1Report Type:Expedited (15-DaCompany Report #PHFR2002GB00490 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril(Clozapine)T Other ablet PS ORAL ORAL Date:01/17/02ISR Number: 3853978-9Report Type:Direct Company Report #CTU 159456 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperglycaemia Clozapine PS ORAL 200MG, 100MG Initial or Prolonged BID ORAL Date:01/17/02ISR Number: 3854994-3Report Type:Expedited (15-DaCompany Report #PHEH2002US00673 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Road Traffic Accident Other Clozaril (Clozapine) Tablet PS ORAL 350 MG DAILY, ORAL Depakote (Valproate Semisodium) C Zyprexa (Olanzapine) C Seroquel (Quetiapine) C Cogentin (Benzatropine Mesilate) C 22-Feb-2006 08:30 AM Page: 1473 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/17/02ISR Number: 3855694-6Report Type:Direct Company Report #CTU 159558 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - White Blood Cell Count Clozapine -Generic PS Initial or Prolonged Decreased Date:01/17/02ISR Number: 3855815-5Report Type:Expedited (15-DaCompany Report #02-01-0024 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine Tablets - Hospitalization - Professional Ivax Initial or Prolonged Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 600MG QD ORAL Date:01/17/02ISR Number: 3855817-9Report Type:Expedited (15-DaCompany Report #02-01-0023 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 50-125MG QD ORAL Date:01/17/02ISR Number: 3855819-2Report Type:Expedited (15-DaCompany Report #01-07-0405 Age:63 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Neoplasm Malignant Health Clozapine Tablets - Professional Ivax Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 25-700MG QD ORAL Date:01/17/02ISR Number: 3855821-0Report Type:Expedited (15-DaCompany Report #C2001-3440.01 Age:78 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Clozapine Tablets Congestive Professional 100 Mg Mylan PS Mylan ORAL 100MG Q HS, Dyspnoea Other ORAL Pulmonary Congestion Clozapine Tablets 25 Mg Mylan SS ORAL 50MG Q HS, ORAL Nifedipine Er C Warfarin C Fluoxetine C Quetiapine C 22-Feb-2006 08:30 AM Page: 1474 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/17/02ISR Number: 3855849-0Report Type:Expedited (15-DaCompany Report #PHBS2002CA00644 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Colitis Foreign Clozaril(Clozapine)T Eosinophilia Health ablet PS ORAL ORAL Professional Other Date:01/17/02ISR Number: 3855850-7Report Type:Expedited (15-DaCompany Report #PHFR2001GB01783 Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril(Clozapine)T Salivary Hypersecretion Health ablet PS ORAL SEE IMAGE Somnolence Professional Gliclazide(Gliclazid Tachycardia Other e) C Metformin (Metformin) C Date:01/18/02ISR Number: 3855721-6Report Type:Expedited (15-DaCompany Report #PHEH2002US00537 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozaril (Clozapine) Professional Tablet PS ORAL 600 MG/DAY, ORAL Date:01/18/02ISR Number: 3855722-8Report Type:Expedited (15-DaCompany Report #PHEH2001US10138 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozaril (Clozapine) Professional Tablet PS ORAL ORAL Klonopin C Ranitidine (Ranitidine) C Naprosyn C Cogentin (Benzatropine Mesilate) C Fibercon (Polycarbophil Calcium) C Date:01/18/02ISR Number: 3856050-7Report Type:Expedited (15-DaCompany Report #PHBS2001AU11499 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Gastrooesophageal Reflux Foreign Clozaril (Clozapine) Disease Health Tablet PS ORAL 600 MG/DAY, Vomiting Professional ORAL Other 22-Feb-2006 08:30 AM Page: 1475 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/18/02ISR Number: 3856766-2Report Type:Direct Company Report #CTU 159619 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Colazal , Salix Pharm PS Salix Pharm Clozaril SS Date:01/18/02ISR Number: 3856799-6Report Type:Expedited (15-DaCompany Report #PHBS2002AU00646 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiomyopathy Foreign Clozaril (Clozapine) Initial or Prolonged Health Tablet PS ORAL 150 MG, QD, Professional ORAL Other Date:01/18/02ISR Number: 3856801-1Report Type:Expedited (15-DaCompany Report #PHNU2002DE00491 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Toxicity Foreign Leponex / Clozaril Initial or Prolonged Loss Of Consciousness Health (Clozapine) Overdose Professional (Clozapine) Tablet PS ORAL 50 DF, Sedation Other ONCE/SINGLE, Suicidal Ideation ORAL Date:01/18/02ISR Number: 3856802-3Report Type:Expedited (15-DaCompany Report #PHFR2002GB00506 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Foreign Clozaril (Clozapine) Initial or Prolonged Health Tablet PS ORAL 200 MG/DAY, Professional ORAL Other Date:01/18/02ISR Number: 3856803-5Report Type:Expedited (15-DaCompany Report #PHBS2002CA00829 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Foreign Clozaril (Clozapine) Study Tablet PS ORAL ORAL Health Professional Other Date:01/22/02ISR Number: 3855992-6Report Type:Expedited (15-DaCompany Report #C2002-0076.01 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine Tablets Hospitalization - White Blood Cell Count Professional 100 Mg Mylan PS Mylan ORAL 200 MG Q AM, Initial or Prolonged Increased Other 300 MG AT NOON, 400MG Q HS ORAL Calcium C Furosemide C 22-Feb-2006 08:30 AM Page: 1476 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lisinopril C Potassium C Theophylline C Date:01/22/02ISR Number: 3855993-8Report Type:Expedited (15-DaCompany Report #02-01-0031 Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 25MG QD ORAL Date:01/22/02ISR Number: 3855995-1Report Type:Expedited (15-DaCompany Report #02-01-0032 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Foot Fracture Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 150-600MG QD ORAL Date:01/22/02ISR Number: 3855997-5Report Type:Expedited (15-DaCompany Report #01-12-0729 Age:52 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Health Clozapine - Ivax Initial or Prolonged Hip Fracture Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 400MG QD ORAL Date:01/22/02ISR Number: 3857934-6Report Type:Expedited (15-DaCompany Report #PHFR2001IE03315 Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Decreased Appetite Foreign Clozaril (Clozapine) Initial or Prolonged Infection Health Tablet PS ORAL 250MG/DAY,ORA Liver Function Test Professional L Abnormal Other Lithium (Lithium) C Malaise Solian (Amisulpride) C Nausea Splenomegaly Vomiting Weight Decreased Date:01/22/02ISR Number: 3857935-8Report Type:Expedited (15-DaCompany Report #PHBS2001IT10874 Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Other Cardiomyopathy Foreign Health Professional 22-Feb-2006 08:30 AM Page: 1477 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Product Role Manufacturer Route Dose Duration Leponex (Clozapine) Tablet PS ORAL 250 MG/DAY, ORAL Depakine C Date:01/22/02ISR Number: 3857936-XReport Type:Expedited (15-DaCompany Report #PHBS2001AU13115 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Ventricular Hypokinesia Foreign Clozaril (Clozapine) Health Tablet PS ORAL ORAL Professional Other Date:01/22/02ISR Number: 3858273-XReport Type:Expedited (15-DaCompany Report #A119456 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delusion Health Ziprasidone Po PS ORAL 160.00 MG Initial or Prolonged Grandiosity Professional TOTAL:BID:ORA Oedema Peripheral L Depakote SS ORAL ORAL Clozapine SS ORAL ORAL Colace C Clonazepam C Date:01/22/02ISR Number: 3858277-7Report Type:Expedited (15-DaCompany Report #PHEH2002US00641 Age:84 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Health Clozaril (Clozapine) Other Professional Tablet PS ORAL 100MG DAILY, ORAL Cefzil (Cefprozil) C Aspirin "Bayer" C Albuterol C Vitamin C (Ascorbic Acid) C Vitamin E C Tenormin C Thorazine (Chlorpromazine Hydochloride) C Tylenol (Paracetamol) C Milk Of Magnesia C Date:01/23/02ISR Number: 3857681-0Report Type:Expedited (15-DaCompany Report #PHBS2002AU00940 Age: Gender:Unknown I/FU:I Outcome PT Report Source Hospitalization - Malignant Melanoma Foreign Initial or Prolonged Health Professional 22-Feb-2006 08:30 AM Page: 1478 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Product Role Manufacturer Route Dose Duration Clozaril (Clozapine) Tablet PS ORAL ORAL Date:01/23/02ISR Number: 3857685-8Report Type:Expedited (15-DaCompany Report #PHFR2002GB00546 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Circulatory Collapse Foreign Clozaril (Clozapine) Dizziness Study Tablet PS Hypotension Health Diazepam (Diazepam) SS Neoplasm Malignant Professional Nefopam (Nefopam) SS Overdose Other Dihydrocodeine Weight Decreased (Dihydrocodeine) SS Alcohol (Ethanol) C Vitamin B (No Ingredients/Substanc es) C Date:01/23/02ISR Number: 3857717-7Report Type:Expedited (15-DaCompany Report #PHNU2002DE00539 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Leponex/Clozaril Weight Increased Health (Clozapine)(Clozapin Professional e) Tablet PS ORAL 100MG/D, ORAL Other Date:01/23/02ISR Number: 3857760-8Report Type:Expedited (15-DaCompany Report #PHNU2001DE02293 Age:59 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Foreign Leponex/Clozaril Hospitalization - Bradycardia Health (Clozapine)(Clozapin Initial or Prolonged Cardiac Arrest Professional e) Tablet PS 10 G, Cardiac Failure Other ONCE/SINGLE, Completed Suicide UNK Delirium Disorientation Electrocardiogram Abnormal Electrocardiogram Q Waves Electrocardiogram T Wave Inversion Intentional Overdose Oxygen Saturation Decreased Po2 Decreased Sinus Tachycardia 22-Feb-2006 08:30 AM Page: 1479 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/23/02ISR Number: 3857765-7Report Type:Expedited (15-DaCompany Report #PHNU2002DE00529 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Cholinesterase Foreign Leponex/Clozaril(Clo Decreased Health zapine) (Clozapine) Hepatic Function Abnormal Professional Tablet PS ORAL 250MG/DAY, Liver Function Test Other ORAL Abnormal Prothrombin Time Abnormal Pyrexia Urinary Tract Infection Viral Infection Date:01/23/02ISR Number: 3857800-6Report Type:Expedited (15-DaCompany Report #PHBS2002GB00916 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Foreign Clozapine(Clozapine) PS 600 MG/D 365 DAY Cardiomegaly Literature Benzodiazepnines (No Circulatory Collapse Health Ingredients/Substanc Pulmonary Oedema Professional es) SS Date:01/23/02ISR Number: 3857816-XReport Type:Expedited (15-DaCompany Report #PHBS2002CA00644 Age:35 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Colitis Foreign Clozaril (Clozapine) Initial or Prolonged Health Tablet PS ORAL ORAL Professional Xenical (Orlistat) C Other Tamiflu (Oseltamivir) C Date:01/23/02ISR Number: 3857818-3Report Type:Expedited (15-DaCompany Report #PHBS2001CA13067 Age:53 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Clozaril (Clozapine) PS Overdose Health Valproic Acid Professional (Valproic Acid) SS Other Date:01/23/02ISR Number: 3857820-1Report Type:Expedited (15-DaCompany Report #PHFR2001GB03430 Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dysphagia Foreign Clozaril (Clozapine) Initial or Prolonged Oesophageal Carcinoma Health (Clozapine) Tablet PS ORAL 800MG/DAY, Other Weight Decreased Professional ORAL Other Date:01/23/02ISR Number: 3857868-7Report Type:Expedited (15-DaCompany Report #PHBS2002CA00877 Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Life-Threatening Cardiac Arrest Foreign Cerebrovascular Accident Study 22-Feb-2006 08:30 AM Page: 1480 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Health Professional Other Product Role Manufacturer Route Dose Duration Clozaril (Clozapine) Tablet PS ORAL ORAL Date:01/23/02ISR Number: 3859462-0Report Type:Expedited (15-DaCompany Report #PHEH2002US00785 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accident Health Clozaril (Clozapine) Drug Level Increased Professional Tablet PS ORAL 500MG DAILY, Drug Toxicity ORAL Risperdal (Risperidone) C Date:01/23/02ISR Number: 3859596-0Report Type:Expedited (15-DaCompany Report #PHFR2001GB03212 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Bilirubin Increased Foreign Clozaril (Clozapine) Haematocrit Decreased Health Tablet PS ORAL ORAL Haemorrhage Professional Mean Cell Volume Other Increased Red Blood Cell Count Decreased Date:01/23/02ISR Number: 3859692-8Report Type:Expedited (15-DaCompany Report #02P-167-0115117-00 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Effect Increased Foreign Sodium Valproate Initial or Prolonged Overdose Health (Sodium Valproate) Vomiting Professional (Sodium Valproate) PS Other Clozapine SS ORAL 400 MG, 1 IN 1 D, PER ORAL Docusate SS Clopenthixol Decanoate SS Aspirin SS Zopiclone SS Levothyroxine Sodium SS Citalopram SS Date:01/24/02ISR Number: 3858324-2Report Type:Expedited (15-DaCompany Report #PHEH2002US00765 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozaril (Clozapine) Chronic Obstructive Professional Tablet PS ORAL 200MG AM + Pulmonary Disease 250MG HS, Respiratory Failure ORAL Tequin (Gatifloxacin) C Zyprexa (Olanzapine) C Lipitor 22-Feb-2006 08:30 AM Page: 1481 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Atorvastatin) C Depakote (Valproate Semisodium) C Date:01/24/02ISR Number: 3858326-6Report Type:Expedited (15-DaCompany Report #PHEH2001US10209 Age:63 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Health Clozaril (Clozapine) Leukopenia Professional Tablet PS ORAL 300MG DAILY, Sarcoma ORAL Clozapine (Clozapine) SS ORAL 300MG DAILY, ORAL Zoloft (Sertraline Hydrochloride) C Coumadin "Endo" (Warfarin Sodium) C Buspar (Buspirone Hydrochloride) C Syndthroid C Potassium (Potassium) C Maxzide C Multivitamins (Ascorbic Acid, Panthenol, Retinol) C Advair Diskus (Salmeterol Xinafoate, Fluticasone Propionate) C Humibid C Fibercon (Polycarbophil Calcium) C Date:01/24/02ISR Number: 3858769-0Report Type:Expedited (15-DaCompany Report #PHEH2002US00764 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Health Clozaril (Clozapine) Hospitalization - Coma Professional Tablet PS ORAL 600 MG/DAY, Initial or Prolonged Lung Abscess ORAL Pneumonia Topamax (Topiramate) C Zoloft (Sertraline Hydrochloride) C Remeron (Mirtazapine) C Insulin (Insulin) C Date:01/24/02ISR Number: 3858925-1Report Type:Direct Company Report #CTU 160026 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Neutrophil Count Abnormal Clozaril 300mg Bid PS ORAL 300 MG PO, Intervention to White Blood Cell Count BID Prevent Permanent Decreased Impairment/Damage 22-Feb-2006 08:30 AM Page: 1482 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/24/02ISR Number: 3858926-3Report Type:Direct Company Report #CTU 160030 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diarrhoea Clozaril PS ORAL 12.5MG PO Pyrexia BID Dilantin C Synthroid C Date:01/24/02ISR Number: 3859030-0Report Type:Expedited (15-DaCompany Report #01P-163-0113250-00 Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Circulatory Collapse Health Depakote (Divalproex Gastrointestinal Disorder Professional Sodium) (Divalproex Haematemesis Sodium) PS 1000 MG, 1 IN Influenza 1 D Sudden Death Clozapine SS 800 MG, 1 IN 1 D Venlafaxine Hydrochloride SS 450 MG, 1 IN 1 D Seroquel SS 600 MG, 1 IN 1 D Atorvastatin C Losartan Potassium C Lung Inhaler C Date:01/24/02ISR Number: 3859514-5Report Type:Expedited (15-DaCompany Report #A118469 Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Literature Zoloft Tablets PS 200.00 MG Atherosclerosis Health TOTAL:DAILY Cardiomegaly Professional Clozapine SS 200.00 MG Cardiomyopathy TOTAL:BID Coronary Artery Disease Risperidone C Coronary Artery Occlusion Atenolol C Hepatic Steatosis Lorazepam C Sudden Death Pseudophedrine C Toxicologic Test Abnormal Unspecified Medications C Date:01/24/02ISR Number: 3859525-XReport Type:Expedited (15-DaCompany Report #C2001-3664.01 Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Health Clozapine Tablets White Blood Cell Count Professional 100 Mg Mylan PS Mylan ORAL 300MG, BID, Decreased Other ORAL Benztropine C Gemfibrozil C Atorvastatin C 22-Feb-2006 08:30 AM Page: 1483 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/24/02ISR Number: 3860035-4Report Type:Direct Company Report #CTU 159934 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Vomiting Clozaril 100mg Qam PS 100MG QAM Buspar C Zyprexa C Date:01/24/02ISR Number: 3860135-9Report Type:Expedited (15-DaCompany Report #PHNU2002DE00545 Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiomegaly Foreign Leponex / Clozaril Hospitalization - Circulatory Collapse Health (Clozapine) Initial or Prolonged Right Ventricular Failure Professional (Clozapine) Tablet PS ORAL 12.5MG/D, Other ORAL; 37MG/D, ORAL Date:01/25/02ISR Number: 3860954-9Report Type:Expedited (15-DaCompany Report #PHEH2002US00767 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Health Clozaril (Clozapine) PS ORAL 400 MG, ORAL Professional Dilantin C Prozac (Fluoxetine Hydrochloride) C Seroquel (Quetiapine) C Cogentin (Benzatropine Mesilate) C Date:01/28/02ISR Number: 3859791-0Report Type:Expedited (15-DaCompany Report #A119456 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delusion Health Ziprasidone Po PS ORAL 160.00 MG Initial or Prolonged Grandiosity Professional TOTAL;BID;ORA Oedema Peripheral L Depakote SS ORAL ORAL Clozapine SS ORAL ORAL Colace C Clonazepam C Date:01/28/02ISR Number: 3861452-9Report Type:Expedited (15-DaCompany Report #PHBS2001AU11757 Age:71 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lower Respiratory Tract Foreign Clozaril(Clozapine)T Infection Study ablet PS ORAL 225 MG/DAY, Pneumonia Health ORAL Professional Oxazepam (Oxazepam) C Other Valproate Sodium C 22-Feb-2006 08:30 AM Page: 1484 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/28/02ISR Number: 3861453-0Report Type:Expedited (15-DaCompany Report #PHFR2001GB03293 Age:65 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Diabetes Mellitus Foreign Clozaril(Clozapine)T Hospitalization - Diabetic Ketoacidosis Health ablet PS 325 MG/DAY Initial or Prolonged Professional Lithium (Lithium) C Other Venlafaxine(Venlafax ine) C Diazepam C Senna (Senna) C Aspirine C Dipyridamole (Dipyridamole) C Movicol (Macrogol) C Persantin (Dipyridamole) C Date:01/29/02ISR Number: 3861193-8Report Type:Expedited (15-DaCompany Report #PHNU2002DE00574 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Lymphocytosis Foreign Leponex / Clozaril Thrombocytopenia Health (Clozapine)(Clozapin Professional e) Tablet PS ORAL ORAL; Other 500MG/DAY, ORAL Orfiril "Desitin"(Valproate Sodium) SS ORAL ORAL Tambocor (Flecainide Acetate) C Novodigal C Mevinacor C Date:01/29/02ISR Number: 3861232-4Report Type:Expedited (15-DaCompany Report #PHNU2001DE02988 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Lymphopenia Foreign Leponex / Clozaril Purulence Health (Clozapine)(Clozapin Tonsillitis Professional e) Tablet PS ORAL ORAL Viral Infection Other Truxal (Chlorprothixene Hydrochloride) Sugar-Coated Tablet C Date:01/29/02ISR Number: 3861502-XReport Type:Expedited (15-DaCompany Report #PHNU2001DE02565 Age:52 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Coma Foreign Leponex/Clozaril Intentional Overdose Health (Clozapine) Suicide Attempt Professional (Clozapine) Tablet PS ORAL 250 MG, Other ONCE/SINGLE, ORAL Metoprolol (Metoprolol) Tablet C Amantadin 22-Feb-2006 08:30 AM Page: 1485 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Film-Coated Tablet C Phenamacide (Phenamacide) C Date:01/29/02ISR Number: 3861503-1Report Type:Expedited (15-DaCompany Report #PHBS2001AU11456 Age:59 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bundle Branch Block Left Foreign Clozaril (Clozapine) Cardiomyopathy Health Tablet PS ORAL 200 MG/DAY, Left Ventricular Failure Professional ORAL Ventricular Hypokinesia Other Captopril C Date:01/29/02ISR Number: 3861505-5Report Type:Expedited (15-DaCompany Report #PHFR2001GB03017 Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Foreign Clozaril (Clozapine) Initial or Prolonged Hyperlipidaemia Health Tablet PS ORAL 300 MG/DAY, Other Professional ORAL Cipramil C Date:01/29/02ISR Number: 3861508-0Report Type:Expedited (15-DaCompany Report #PHFR2001GB02110 Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electroencephalogram Foreign Clozaril (Clozapine) Initial or Prolonged Abnormal Health Tablet PS ORAL 400 MG/DAY, Encephalopathy Professional ORAL Transient Ischaemic Other Attack Date:01/29/02ISR Number: 3861516-XReport Type:Expedited (15-DaCompany Report #PHNU2002DE00596 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Leponex / Clozaril Drowning Health (Clozapine) PS ORAL 200 MG/DAY, Professional ORAL Company Trevilor Representative (Venlafaxine Other Hydrochloride) C Pantozol (Pantoprazole Sodium) C Tavor Tablet C Bifiteral C Solvay Arznemittel Date:01/29/02ISR Number: 3861913-2Report Type:Expedited (15-DaCompany Report #PHEH2002US00871 Age:40 YR Gender:Female I/FU:I Outcome PT Death Catatonia Constipation Drug Level Above Therapeutic Mitral Valve Prolapse 22-Feb-2006 08:30 AM Page: 1486 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Salivary Hypersecretion Tremor Report Source Product Role Manufacturer Route Dose Duration Consumer Clozaril (Clozapine) Tablet PS ORAL 400MG, DAILY, ORAL Celexa C Lamictal C Ativan C Geodon (Ziprasidone Hydrochloride) C Date:01/29/02ISR Number: 3862030-8Report Type:Expedited (15-DaCompany Report #PHNU2002DE00574 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Lymphocytosis Foreign Leponex/Clozaril Thrombocytopenia Health (Clozapine_ Professional (Clozapine) Tablet PS ORAL ORAL, 500 Other MG/DAY; ORAL Orfiril "Desitin" (Valproate Sodium) SS ORAL Tambocor (Flecainide Acetate) C Novodigal C Mevinacor C Date:01/29/02ISR Number: 3862212-5Report Type:Expedited (15-DaCompany Report #PHFR2002GB00509 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dialysis Foreign Clozaril(Clozapine) PS ORAL 300MG/DAY, Haemoglobin Decreased Health ORAL Nephrotic Syndrome Professional Other Date:01/29/02ISR Number: 3862213-7Report Type:Expedited (15-DaCompany Report #PHBS2002AU00941 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiac Enzymes Increased Foreign Clozaril(Clozapine)T Health ablet PS ORAL 800 MG/D, Professional ORAL Other Clonazepam C Date:01/30/02ISR Number: 3860899-4Report Type:Direct Company Report #CTU 160381 Age:39 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Generic Clozapine Anxiety Supplied By Kincaid Confusional State Pharm. Centrailia, Drug Effect Decreased Md PS Kincaid Pharm. Hallucination, Auditory Centrailia, Md 100 MG 1 Insomnia TID & 2 HS 3 WK Pharmaceutical Product Complaint 22-Feb-2006 08:30 AM Page: 1487 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/30/02ISR Number: 3862008-4Report Type:Expedited (15-DaCompany Report #PHNU2002DE00615 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiomyopathy Foreign Leponex/Clozaril Dyspnoea Health (Clozapine) Professional (Clozapine) Tablet PS ORAL ORAL Other Date:01/30/02ISR Number: 3862009-6Report Type:Expedited (15-DaCompany Report #PHRM2002FR00589 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperglycaemia Foreign Leponex (Clozapine) Initial or Prolonged Hypertriglyceridaemia Health Tablet PS ORAL ORAL Other Professional Other Date:01/30/02ISR Number: 3862010-2Report Type:Expedited (15-DaCompany Report #PHFR2002GB00464 Age:51 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alopecia Foreign Clozaril (Clozapine) Eczema Health Tablet PS ORAL 175 MG, BID, Herpes Zoster Professional ORAL Lupus-Like Syndrome Other Valproate Sodium Rash (Valproate Sodium) C Isosorbide Mononitrate C Aspirine C Multivitamins (Retinol, Panthenol, Ascorbic Acid) C Senna (Senna) C Salbutamol C Atenolol C Mebeverine (Mebeverine) C Date:01/30/02ISR Number: 3862185-5Report Type:Expedited (15-DaCompany Report #02-01-0045 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Aneurysm Health Clozapine - Ivax Dialysis Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 300-700MG QD ORAL Date:01/30/02ISR Number: 3862186-7Report Type:Expedited (15-DaCompany Report #02-01-0043 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Lung Abscess Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, 22-Feb-2006 08:30 AM Page: 1488 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Inc. ORAL 350-650MG QD ORAL Date:01/30/02ISR Number: 3862187-9Report Type:Expedited (15-DaCompany Report #02-01-0042 Age:76 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Post Procedural Health Clozapine - Ivax Complication Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL ORAL Date:01/30/02ISR Number: 3862189-2Report Type:Expedited (15-DaCompany Report #02-01-0041 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyspnoea Other Clozapine - Ivax Initial or Prolonged Oropharyngeal Cancer Pharmaceuticals, Other Stage Unspecified Inc. Tablets PS Ivax Syncope Pharmaceuticals, Weight Decreased Inc. ORAL 500MG QD ORAL Date:01/30/02ISR Number: 3862190-9Report Type:Expedited (15-DaCompany Report #02-01-0039 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Health Clozapine - Ivax Initial or Prolonged Limb Injury Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL ORAL Date:01/30/02ISR Number: 3862192-2Report Type:Expedited (15-DaCompany Report #02-01-0037 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Chronic Obstructive Health Clozapine - Ivax Pulmonary Disease Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals Inc. ORAL ORAL Date:01/30/02ISR Number: 3862196-XReport Type:Expedited (15-DaCompany Report #C2002-0091.01 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 25MG @ 7AM, Other 25MG @ 8PM, ORAL Clozapine Tablets 100 Mg Mylan SS Mylan ORAL 100MG Q AM, 100MG Q NOON, 200MG QHS, ORAL 22-Feb-2006 08:30 AM Page: 1489 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/30/02ISR Number: 3862312-XReport Type:Expedited (15-DaCompany Report #PHFR2002GB00573 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Nervous System Disorder Foreign Clozaril (Clozapine) Health (Clozapine) Tablet PS ORAL 100MG/DAY, Professional ORAL Other Lithium (Lithium) C Olanzapine (Olanzapine) C Mirtazapine (Mirtazapine) C Date:01/30/02ISR Number: 3862433-1Report Type:Expedited (15-DaCompany Report #PHBS2002IT01283 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Clozapine Drug Level Increased Literature (Clozapine) PS Drug Toxicity Health Orphenadrine(Orphena Overdose Professional drine) SS Poisoning Other Date:01/30/02ISR Number: 3862434-3Report Type:Expedited (15-DaCompany Report #PHBS2001AU12591 Age:51 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Lymphocytosis Foreign Clozaril (Clozapine) Initial or Prolonged Multiple Myeloma Study Tablet PS ORAL 50 MG, BID, Neutropenia Health ORAL Professional Chemotherapeutics, Other Other (Chemotherapeutics, Other) C Date:01/30/02ISR Number: 3862435-5Report Type:Expedited (15-DaCompany Report #PHBS2002AU00575 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Arrhythmia Foreign Clozaril (Clozapine) Extrasystoles Study Tablet PS ORAL 125 MG, QD, Heart Rate Increased Health ORAL Palpitations Professional Supraventricular Other Tachycardia Ventricular Tachycardia Date:01/30/02ISR Number: 3862436-7Report Type:Expedited (15-DaCompany Report #PHBS2001AU12219 Age:57 YR Gender:Female I/FU:F Outcome PT Hospitalization - Circulatory Collapse Initial or Prolonged Disseminated Intravascular Coagulation Hypothermia Platelet Count Decreased Sepsis Vomiting 22-Feb-2006 08:30 AM Page: 1490 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report White Blood Cell Count Increased Report Source Product Role Manufacturer Route Dose Duration Foreign Clozaril (Clozapine) Health Tablet PS ORAL 700 MG/D, Professional ORAL Other Metformin (Metformin) C Valproate Sodium C Haloperidol C Date:01/30/02ISR Number: 3862437-9Report Type:Expedited (15-DaCompany Report #PHFR2002GB00577 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Cholesterol Foreign Clozapine Hospitalization - Increased Health (Clozapine) Tablet PS ORAL 600 MG, QD, Initial or Prolonged Blood Glucose Increased Professional ORAL Pancreatitis Other Sertraline Weight Increased (Sertraline) C Lansoprazole (Lansoprazole) C Date:01/30/02ISR Number: 3862438-0Report Type:Expedited (15-DaCompany Report #PHFR2002GB00588 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril (Clozapine) Health Tablet PS ORAL 600MG/DAY, Professional ORAL Other Date:01/30/02ISR Number: 3862550-6Report Type:Expedited (15-DaCompany Report #02P-163-0115529-00 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Albumin Decreased Health Depakote Er Initial or Prolonged Clumsiness Professional (Divalproex Sodium) Disturbance In Attention (Divalproex Sodium) PS ORAL 3000 MG, 1 IN Drug Interaction 1 D , PER Drug Level Increased ORAL 1500 MG, Dysarthria 1 IN 1 D, PER Gait Disturbance ORAL Haemoglobin Decreased Clozapine SS ORAL 475 MG, 1 IN Memory Impairment 1 D, PER ORAL Protein Total Decreased 400 MG, 1 IN 1 D, PER ORAL Lithium C Tiotixene C Salbutamol C 22-Feb-2006 08:30 AM Page: 1491 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/30/02ISR Number: 3863109-7Report Type:Expedited (15-DaCompany Report #PHRM2001FR01524 Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Metamyelocyte Count Foreign Leponex (Clozapine) Initial or Prolonged Increased Health Tablet PS ORAL 600 MG, Professional DAILY, ORAL Company Psychiatric Therapy Representative (No Ingredients/Substanc es) SS Benzodiazepines (No Ingredients/Substanc es) C Date:01/30/02ISR Number: 3863112-7Report Type:Expedited (15-DaCompany Report #PHNU2001DE02788 Age:59 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Scleroderma Foreign Leponex/Clozaril Initial or Prolonged Health (Clozapine)(Clozapin Other Professional e) Tablet PS ORAL 87.5 MG/DAY, Other ORAL Saroten Retard (Amitriptyline Hydrochloride) C Aarane (Cromoglicate Sodium) C Vioxx (Rofecoxib) C Rivotril C Valoron N (Naloxone Hydrochloride, Tilidine Hydrochloride) C Date:02/01/02ISR Number: 3862568-3Report Type:Expedited (15-DaCompany Report #02-01-0080 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Operation Health Clozapine Tablets Initial or Prolonged Professional -Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 150-100MG QD ORAL Date:02/01/02ISR Number: 3862569-5Report Type:Expedited (15-DaCompany Report #02-01-0074 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neoplasm Malignant Health Clozapine -Tablets Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc ORAL 300-900MG QD ORAL 22-Feb-2006 08:30 AM Page: 1492 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/01/02ISR Number: 3862571-3Report Type:Expedited (15-DaCompany Report #02-01-0059 Age:78 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Aspiration Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 6.2-25 MG QD ORAL Date:02/01/02ISR Number: 3862573-7Report Type:Expedited (15-DaCompany Report #02-01-0058 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Collapse Of Lung Health Clozapine Tablets- Hospitalization - Professional Ivax Initial or Prolonged Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 700 MG QD ORAL Date:02/01/02ISR Number: 3862574-9Report Type:Expedited (15-DaCompany Report #02-01-0037 Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine Tablets PS Ivax Hospitalization - Respiratory Arrest Professional Pharmaceuticals, Initial or Prolonged Other Inc. ORAL 150 MG BID ORAL Depakote C Glucophage C Glyburide C Insulin,Regular Sliding Scale C Prednisone C Albuterol Sulfate C Atrovent C C Lasix C Potassium Chloride C Date:02/01/02ISR Number: 3862576-2Report Type:Expedited (15-DaCompany Report #01-12-0724 Age:43 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pulmonary Embolism Health Clozapine Tablets PS Ivax Professional Pharmaceuticals, Inc ORAL 500 MG QD Other ORAL Date:02/01/02ISR Number: 3862580-4Report Type:Expedited (15-DaCompany Report #C2001-3715.01 Age:89 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Health Clozapine Tablets 25 Laboratory Test Abnormal Professional Mg Mylan PS ORAL 25MG BID, Pyrexia Other ORAL 22-Feb-2006 08:30 AM Page: 1493 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Acetaminophen C Aspirin C Furosemide C Nitroglycerin Patch C Potassium Chloride C Venlafaxine Xr C Venlafaxine Xr C Date:02/01/02ISR Number: 3864545-5Report Type:Expedited (15-DaCompany Report #002-0981-M0200090 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aspartate Foreign Atorvastatin Aminotransferase Consumer (Atorvastatin) PS Increased Clozapine SS ORAL 200 MG (BID), Blood Alkaline PER ORAL Phosphatase Abnormal Metformin C Diabetes Mellitus Hyperglycaemia Tachycardia Date:02/04/02ISR Number: 3863923-8Report Type:Expedited (15-DaCompany Report #PHBS2000CA09287 Age:59 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Myocardial Infarction Foreign Clozaril (Clozapine) Hospitalization - Nephritis Interstitial Study (Clozapine) Tablet PS ORAL ORAL Initial or Prolonged Pneumonia Health Renal Failure Professional Other Date:02/04/02ISR Number: 3864570-4Report Type:Expedited (15-DaCompany Report #PHBS2002NZ01393 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hepatic Failure Foreign Clozaril(Clozapine) Health Tablet PS ORAL 600 MG /D, Professional ORAL Other Date:02/04/02ISR Number: 3864572-8Report Type:Expedited (15-DaCompany Report #PHRM2002FR00593 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Epilepsy Foreign Leponex (Clozapine) Other Fall Health Tablet PS ORAL 400 MG DAILY, Haematemesis Professional ORAL Sudden Death Other Stilnox (Zolpidem) C Temesta C Date:02/04/02ISR Number: 3864577-7Report Type:Expedited (15-DaCompany Report #PHBS2002AR01396 Age:44 YR Gender:Female I/FU:I Outcome PT Death Menometrorrhagia Other Neoplasm 22-Feb-2006 08:30 AM Page: 1494 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pyrexia Report Source Product Role Manufacturer Route Dose Duration Foreign Lapenax (Clozapine) Health Tablet PS ORAL 450 MG/D, Professional ORAL Other Date:02/04/02ISR Number: 3864580-7Report Type:Expedited (15-DaCompany Report #PHNU2001DE02350 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anti-Thyroid Antibody Foreign Leponex / Clozaril Autoimmune Thyroiditis Health (Clozapine) Blood Thyroid Stimulating Professional (Clozapine) Tablet PS ORAL 300MG/DAY, Hormone Increased Other ORAL Thyroid Disorder Solian (Amisulpride) C Thyroxine Decreased Tri-Iodothyronine Decreased Date:02/04/02ISR Number: 3864585-6Report Type:Expedited (15-DaCompany Report #PHFR2001GB03487 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Appendicitis Foreign Clozaril (Clozapine) Initial or Prolonged Health Tablet PS ORAL 500 MG/DAY, Other Professional ORAL Other Date:02/04/02ISR Number: 3864588-1Report Type:Expedited (15-DaCompany Report #PHFR2001GB03321 Age:67 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alveolitis Fibrosing Foreign Clozaril (Clozapine) Initial or Prolonged Angina Pectoris Health Tablet PS ORAL 350MG/DAY, Iron Deficiency Anaemia Professional ORAL Orthostatic Hypotension Steroids Nos (No Ingredients/Substanc es) C Venlafaxine (Venlafaxine) C Prednisolone C Lansoprazole (Lansoprazole) C Nystatin (Nystatin) C Date:02/04/02ISR Number: 3864949-0Report Type:Expedited (15-DaCompany Report #PHEH2002US00537 Age:46 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozaril Professional (Clozapine) Tablet PS ORAL 600 MG/DAY, ORAL 22-Feb-2006 08:30 AM Page: 1495 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/04/02ISR Number: 3865081-2Report Type:Expedited (15-DaCompany Report #2001UW16100 Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Alkaline Health Seroquel PS 800-600 MG QD 3 YR Required Phosphatase Increased Professional Clozaril SS 500-800 MG QD 6 YR Intervention to Circulatory Collapse Effexor SS 300-450 MG QD 5 MON Prevent Permanent Electrocardiogram Depakote SS 1000 MG HS 5 MON Impairment/Damage Abnormal Lipitor C Gamma-Glutamyltransferase Cozaar C Increased Unspecified C Haematemesis Heart Rate Increased Influenza Mitral Valve Incompetence Sudden Death Ventricular Hypertrophy White Blood Cell Disorder Date:02/04/02ISR Number: 3865363-4Report Type:Expedited (15-DaCompany Report #PHBS2000CA04592 Age:21 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Appendicitis Foreign Clozaril (Clozapine) Initial or Prolonged Study Tablet PS ORAL 600 MG/D, Health ORAL Professional Topiramate Other (Topiramate) C Lamotrigine C Zoloft (Sertraline Hydrochloride) C Cogentin (Benzatropine Mesilate) C Dilantin C Date:02/04/02ISR Number: 3865367-1Report Type:Expedited (15-DaCompany Report #PHRM2001FR02860 Age:50 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Foreign Leponex(Clozapine) Initial or Prolonged Neutropenia Health Tablet PS ORAL 200 MG DAILY Professional ORAL Company Viraferon(Interferon Representative Alfa) SS Other Rebetol(Ribavirin) SS Mantadix(Amantadine Hydrochloride) SS Depakine C Doliprane (Paracetamol) C Date:02/05/02ISR Number: 3865287-2Report Type:Expedited (15-DaCompany Report #PHFR2002GB00598 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Other Cardiomegaly Foreign Health Professional 22-Feb-2006 08:30 AM Page: 1496 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Product Role Manufacturer Route Dose Duration Clozaril (Clozapine) Tablet PS ORAL 400 MG/DAY, ORAL Lithium (Lithium) C Date:02/05/02ISR Number: 3865303-8Report Type:Expedited (15-DaCompany Report #PHBS2002CO01403 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Overdose Foreign Leponex (Clozapine) Initial or Prolonged Nausea Health Tablet PS ORAL 400 MG / D, Somnolence Professional ORAL ; 40 Suicide Attempt Other TABLETS/D, Tachycardia ORAL Amitriptyline (Amitriptyline) SS 12.5 MG/D ; 20 TABLETS/D Diltiazem (Diltiazem) C Ranitidine (Ranitidine) C Date:02/05/02ISR Number: 3865695-XReport Type:Expedited (15-DaCompany Report #C2002-0242.01 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 100MG QD, Other ORAL Date:02/05/02ISR Number: 3865912-6Report Type:Expedited (15-DaCompany Report #PHFR2002GB00645 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Feeding Disorder Neonatal Foreign Clozaril (Clozapine) Maternal Drugs Affecting Health Tablet PS TRANSPLACENTAL TRANSPLACENTA Foetus Professional L Polydactyly Other Vomiting Neonatal Date:02/05/02ISR Number: 3865997-7Report Type:Expedited (15-DaCompany Report #C2002-0226.01 Age:73 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 12.5MG QD, Other THEN 12.5MG BID, THEN 12.5MG AM AND 25MG Q HS, 22-Feb-2006 08:30 AM Page: 1497 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/05/02ISR Number: 3866013-3Report Type:Expedited (15-DaCompany Report #C2001-3307.01 Age:82 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Eating Disorder Health Clozapine Tablets 25 Other Suicidal Ideation Professional Mg Mylan PS ORAL 75MG, QD, Other ORAL; END OF 09/01-UNK Furosemide C Gabapentin C Glyburide C Hydroxyzine C Nicotine Patches C Potassium Chloride C Quetiapine C Spironolactone C Fentanyl Transdermal C Ipratropium Mdi C Magnesium Sulfate C Date:02/05/02ISR Number: 3866549-5Report Type:Expedited (15-DaCompany Report #PHEH2001US08569 Age:81 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Asthenopia Health Clozaril (Clozapine) Fall Professional Tablet PS ORAL 25 MG/DAY Loss Of Consciousness ORAL Speech Disorder Sinemet (Levodopa, Syncope Carbidopa) C Periactin (Cyproheptadine Hydrochloride) C Haldol C Date:02/05/02ISR Number: 3867009-8Report Type:Expedited (15-DaCompany Report #C2001-3705.01 Age:58 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Mylan ORAL 100 MG BID, Professional ORAL Other Albuterol Sulfate C Benztropine C Ciprofloxacin C Divalproex Sodium C Risperidol C Loxapine C Date:02/06/02ISR Number: 3865732-2Report Type:Expedited (15-DaCompany Report #PHEH2002US01143 Age:37 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Health Clozaril (Clozapine) Hepatitis C Virus Professional Tablet PS ORAL SEE IMAGE Geodon (Ziprasidone Hydrochloride) C 22-Feb-2006 08:30 AM Page: 1498 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/06/02ISR Number: 3866288-0Report Type:Expedited (15-DaCompany Report #PHRM2002FR00658 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Obsessive-Compulsive Foreign Leponex (Clozapine) Disorder Health Tablet PS ORAL 450 MG PER Professional DAY, ORAL Other Date:02/06/02ISR Number: 3866318-6Report Type:Expedited (15-DaCompany Report #PHBS2001CA10613 Age:54 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Foreign Clozaril (Clozapine) PS ORAL ORAL Hospitalization - Aplastic Anaemia Study Amoxicillin Initial or Prolonged Lower Respiratory Tract Health (Amoxicillin) C Infection Professional Lamotrigine C Nasopharyngitis Other Risperidone Neutropenia (Risperidone) C Pyrexia Revia (Naltrexone) C Thrombocytopenia Pantoloc C Clotrimazole (Clotrimazole) C Amoxil Sodium (Amoxicillin Sodium) C Date:02/06/02ISR Number: 3866480-5Report Type:Expedited (15-DaCompany Report #AUS/00/01132/LEX Age:55 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Clozaril (Clozapine) Depression Health Tablet PS ORAL 100 MG ORAL 588 DAY Professional Other Date:02/06/02ISR Number: 3866482-9Report Type:Expedited (15-DaCompany Report #PHFR2001GB03497 Age:49 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Pressure Foreign Clozaril (Clozapine) Fluctuation Health Tablet PS ORAL 200MG Haemoglobin Decreased Professional MANE/400MG Immunosuppression Other NOCTE, ORAL Infection Dexamethasone(Dexame Leukopenia thasone) SS ORAL 6 MG/DAY, Loss Of Consciousness ORAL Lymphocyte Count Procyclidine Decreased (Procyclidine) C Neutrophil Count Lansoprazole Increased (Lansoprazole) C Platelet Count Decreased Diazepam C Pneumocystis Jiroveci Prothiazine C Pneumonia Renal Failure 22-Feb-2006 08:30 AM Page: 1499 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/06/02ISR Number: 3866483-0Report Type:Expedited (15-DaCompany Report #PHBS2001AU12623 Age:21 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Foreign Clozaril (Clozapine) Initial or Prolonged Study Tablet PS ORAL 350 MG, QD, Health ORAL Professional Chlorpromazine Other (Chlorpromazine) SS 16 X 100 MG, ONCE/SINGLE Marijuana (Cannabis) C Date:02/06/02ISR Number: 3866496-9Report Type:Expedited (15-DaCompany Report #PHFR2002GB00667 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril (Clozapine) Health Tablet PS ORAL 20 MG/DAY Professional ORAL Other Date:02/06/02ISR Number: 3866497-0Report Type:Expedited (15-DaCompany Report #PHBS2002CA01603 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Insipidus Foreign Clozaril (Clozapine) Health Tablet PS ORAL 300 MG/DAY Professional ORAL Other Date:02/06/02ISR Number: 3866499-4Report Type:Expedited (15-DaCompany Report #PHBS2001NZ11894 Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukocytosis Foreign Clozaril (Clozapine) Neutrophil Count Health Tablet PS ORAL 375 MG/DAY Increased Professional ORAL Tachycardia Other Omeprazole Ventricular Hypertrophy (Omeprazole) C Date:02/07/02ISR Number: 3867344-3Report Type:Expedited (15-DaCompany Report #PHBS2002BR01611 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dengue Fever Foreign Leponex (Clozapine) Initial or Prolonged Weight Increased Consumer Tablet PS ORAL 600 MG/D, Other ORAL Cipramil C Valproic Acid C Vitamins (No Ingredients/Substanc es) C 22-Feb-2006 08:30 AM Page: 1500 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/07/02ISR Number: 3867346-7Report Type:Expedited (15-DaCompany Report #PHBS2002SE01687 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiomegaly Foreign Leponex (Clozapine) Cardiomyopathy Health Tablet PS ORAL 550 MG/D, Fatigue Professional ORAL Scar Other Date:02/08/02ISR Number: 3867335-2Report Type:Expedited (15-DaCompany Report #PHRM2002FR00672 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Leponex (Clozapine) Health Tablet PS ORAL ORAL Professional Company Representative Other Date:02/08/02ISR Number: 3867435-7Report Type:Expedited (15-DaCompany Report #PHFR2002GB00672 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Clozapine Initial or Prolonged Increased Health (Clozapine) Tablet PS ORAL UP TO 300MG Blood Albumin Increased Professional DAY, ORAL Electrocardiogram Other Clopixol - Slow Abnormal Release Gamma-Glutamyltransferase (Zuclopenthixol Increased Decanoate) C Hypergammaglobulinaemia Risperidone (Risperidone) C Procyclidine (Procyclidine) C Date:02/08/02ISR Number: 3868101-4Report Type:Expedited (15-DaCompany Report #PHEH2001US09168 Age:49 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Leukocytosis Health Clozaril (Clozapine) Myocardial Infarction Professional Tablet PS ORAL 350MG, ORAL Artane (Trihxyphenidyl Hydrochloride) C Ativan C Prolixin (Fluphenazine Hydrochloride) C Date:02/08/02ISR Number: 3868104-XReport Type:Expedited (15-DaCompany Report #PHEH2002US01165 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozaril(Clozapine) Metastatic Neoplasm Professional Tablet PS ORAL 250 MG DAILY, ORAL; SEE IMAGE 22-Feb-2006 08:30 AM Page: 1501 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/08/02ISR Number: 3868113-0Report Type:Expedited (15-DaCompany Report #PHEH2002US01322 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Health Clozaril(Clozapine) Non-Insulin-Dependent Professional Tablet PS ORAL ORAL Date:02/08/02ISR Number: 3869503-2Report Type:Periodic Company Report #C2001-2982.01 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukocytosis Health Clozapine Tablets Professional Mylan PS Mylan Other Date:02/08/02ISR Number: 3869505-6Report Type:Periodic Company Report #C2001-2744.01 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozapine Tablets 25 Neutrophil Count Professional Mg Mylan PS Mylan ORAL 125 MG QD, Decreased Other ORAL Fluoxetine C Levothyoxine C Date:02/08/02ISR Number: 3869507-XReport Type:Periodic Company Report #C2001-2881.01 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutrophil Count Health Clozapine Tablets 25 Decreased Professional Mg Mylan PS Mylan ORAL 50MG QD, ORAL Other Clozapine Tablets 100 Mg Mylan SS Mylan ORAL 500MG QD, ORAL Valproate C Lamivudine C Nelfinavir C Quetiapine C Stavudine C Date:02/08/02ISR Number: 3869509-3Report Type:Periodic Company Report #C2001-3212.01 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozapine Tablets 25 Neutrophil Count Professional Mg Mylan PS Mylan ORAL 75MG QD, ORAL Decreased Other Fluphenazine Decanoate C Lansoprazole C Levothyroxine C Lorazepam C Olanzapine C Valproic Acid C 22-Feb-2006 08:30 AM Page: 1502 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/08/02ISR Number: 3869511-1Report Type:Periodic Company Report #C2001-2438.01 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dysphemia Consumer Clozaril Tablets 100 Fatigue Health Mg Novartis PS Novartis ORAL 400MG BID, Gait Disturbance Professional ORAL Muscular Weakness Clozapine Tablets Salivary Hypersecretion 100mg Mylan SS Mylan ORAL 400MG BID, Somnolence ORAL Tremor Rofecoxib C Weight Increased Terbenafine C Vitamins C Date:02/08/02ISR Number: 3869522-6Report Type:Periodic Company Report #C2001-2440.01 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 300MG, QD, ORAL Carboplatin C Citalopram C Lithium C Paclitaxel C Date:02/08/02ISR Number: 3869524-XReport Type:Periodic Company Report #C2001-2592.01 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Health Clozapine Tablets Initial or Prolonged Professional 100 Mg Mylan PS Mylan ORAL 450MG QD, Other Other ORAL Benztropine C Terazosin C Haloperidol C Divalproex C Date:02/08/02ISR Number: 3869526-3Report Type:Periodic Company Report #C2001-2595.01 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozapine Tablets Neutrophil Count Professional 100 Mg Mylan PS Mylan ORAL 600MG QD, Decreased Other ORAL Doxycycline Hyclate C Ibuprofen C Lorazepam C Methylphenidate Hcl C Divalproex Sodium C Multivitamin C Date:02/08/02ISR Number: 3869527-5Report Type:Periodic Company Report #C2001-2612.01 Age:18 YR Gender:Female I/FU:I Outcome PT Report Source Other Neutrophil Count Health Decreased Professional 22-Feb-2006 08:30 AM Page: 1503 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Product Role Manufacturer Route Dose Duration Clozapine Tablets 100 Mg Mylan PS Mylan ORAL 450MG QD, ORAL Clozapine Tablets Zenith Goldline SS Clozaril Novartis SS Novartis Date:02/08/02ISR Number: 3869528-7Report Type:Periodic Company Report #C2001-2698.01 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Haemoglobin Decreased Health Clozapine Tablets Initial or Prolonged Professional 100 Mg PS ORAL 100MG QAM AND Other QHS, ORAL Clozapine Tablets 25 Mg SS ORAL 15MG QHS, ORAL Date:02/11/02ISR Number: 3867417-5Report Type:Direct Company Report #161401 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Chest Pain Clozapine (300 Qhs) PS ORAL 300 PO CPHT Required Dizziness Intervention to Drug Effect Decreased Prevent Permanent Headache Impairment/Damage Myalgia Nausea Pharmaceutical Product Complaint Date:02/11/02ISR Number: 3867674-5Report Type:Expedited (15-DaCompany Report #02-01-0090 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hysterectomy Health Clozapine-Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 375MG QD ORAL Date:02/11/02ISR Number: 3867676-9Report Type:Expedited (15-DaCompany Report #02-01-0098 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Suicide Attempt Health Clozapine Initial or Prolonged Professional Tablets-Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 175 MG QD ORAL 22-Feb-2006 08:30 AM Page: 1504 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/11/02ISR Number: 3867679-4Report Type:Expedited (15-DaCompany Report #02-01-0085 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine Tablets- Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 800MG QD ORAL Date:02/11/02ISR Number: 3867681-2Report Type:Expedited (15-DaCompany Report #02-01-0110 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Laryngeal Cancer Other Clozapine - Ivax Initial or Prolonged Nasopharyngitis Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL ORAL Date:02/11/02ISR Number: 3867682-4Report Type:Expedited (15-DaCompany Report #02-02-0111 Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Aspiration Health Clozapine Tablets- Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 500-700MG QD ORAL Date:02/11/02ISR Number: 3868557-7Report Type:Expedited (15-DaCompany Report #PHBS2002GB01776 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bulimia Nervosa Foreign Clozapine(Clozapine) Initial or Prolonged Catatonia Literature Tablet PS ORAL ORAL Other Coma Health Drug Withdrawal Syndrome Professional Immobile Other Muscle Rigidity Muscle Twitching Mutism Psychotic Disorder Pyrexia Stupor Tardive Dyskinesia Urinary Incontinence Vomiting Date:02/11/02ISR Number: 3868559-0Report Type:Expedited (15-DaCompany Report #PHFR2002GB00450 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Death Bronchopneumonia Foreign Study 22-Feb-2006 08:30 AM Page: 1505 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Health Professional Other Product Role Manufacturer Route Dose Duration Clozaril(Clozapine) Tablet PS ORAL 600 MG/DAY, ORAL Date:02/11/02ISR Number: 3868918-6Report Type:Expedited (15-DaCompany Report #PHNU2002DE00491 Age:25 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Grand Mal Convulsion Foreign Leponex / Clozaril Initial or Prolonged Intentional Overdose Health (Clozapine) Tablet PS ORAL 5000 MG, Loss Of Consciousness Professional ONCE/SINGLE, Sedation Other ORAL Suicide Attempt Therapeutic Agent Toxicity Date:02/11/02ISR Number: 3868920-4Report Type:Expedited (15-DaCompany Report #PHBS2001AU12591 Age:51 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Lymphocytosis Foreign Clozaril (Clozapine) Initial or Prolonged Multiple Myeloma Study Tablet PS ORAL 50 MG, BID, Neutropenia Health ORAL Professional Chemotherapeutics, Other (Chemotherapeutics, Other) C Date:02/11/02ISR Number: 3869319-7Report Type:Expedited (15-DaCompany Report #PHEH2002US01271 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Valve Disease Health Clozaril (Clozapine) PS ORAL 600MG, ORAL Cardiomegaly Professional Heart Valve Replacement Pulmonary Embolism Date:02/11/02ISR Number: 3869326-4Report Type:Expedited (15-DaCompany Report #PHEH2002US01295 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Lung Neoplasm Malignant Health Clozaril (Clozapine) Professional Tablet PS ORAL 150 MG DAILY, ORAL Date:02/12/02ISR Number: 3868961-7Report Type:Direct Company Report #CTU 161507 Age:35 YR Gender:Male I/FU:I Outcome Life-Threatening Required Intervention to Prevent Permanent 22-Feb-2006 08:30 AM Page: 1506 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Neutropenia Clozaril (Novartis) PS ORAL 500 MG PO Augmentin C Alprazolam C Pseudoephedrine C Phenobarbital C Prilosec C Depakote C Metamucil C Asa C Date:02/12/02ISR Number: 3869630-XReport Type:Expedited (15-DaCompany Report #C2001-3666.01 Age:73 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 12.5MG Q AM, Other 25MG Q 8PM, ORAL Date:02/12/02ISR Number: 3869631-1Report Type:Expedited (15-DaCompany Report #C2001-3715.01 Age:89 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coma Health Clozapine Tablets 25 Convulsion Professional Mg Mylan PS Mylan ORAL 25MG, BID, Laboratory Test Abnormal Other ORAL Pyrexia Acetaminophen C Aspirin C Furosemide C Nitroglycerin Patch C Potassium Chloride C Venlafaxine Xr C Venlafaxine Xr C Date:02/12/02ISR Number: 3869632-3Report Type:Expedited (15-DaCompany Report #C2002-0297.01 Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan Other Date:02/13/02ISR Number: 3869169-1Report Type:Direct Company Report #CTU 161553 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diarrhoea Clozaxil (Clozapine) PS ORAL 25MG PO BID Initial or Prolonged Hypersensitivity (SEE IMAGE) Pyrexia Es Kalith Cr C Depakene C Aud C Ddavp C Zoloft C Topamax C 22-Feb-2006 08:30 AM Page: 1507 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Risperdal C Thyrolax C Date:02/13/02ISR Number: 3869281-7Report Type:Direct Company Report #CTU 161579 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bronchospasm Clozapine PS 100 MG 2 QPM Pharmaceutical Product Depakote C Complaint Date:02/13/02ISR Number: 3869652-9Report Type:Expedited (15-DaCompany Report #PHFR2001GB03506 Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Enteritis Necroticans Foreign Clozaril (Clozapine) Hospitalization - Intestinal Ischaemia Study Tablet PS ORAL SEE IMAGE Initial or Prolonged Intestinal Obstruction Health Diazepam C Multi-Organ Failure Professional Olanzapine Sepsis Other (Olanzapine) C Lansoprazole (Lansoprazole) C Date:02/13/02ISR Number: 3869658-XReport Type:Expedited (15-DaCompany Report #PHFR2001GB03238 Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Clozaril (Clozapine) Drug Level Increased Study Tablet PS ORAL 425MG/DAY, Intentional Overdose Health ORAL Medication Error Professional Therapeutic Agent Other Toxicity Toxicologic Test Abnormal Date:02/13/02ISR Number: 3869663-3Report Type:Expedited (15-DaCompany Report #PHFR2001GB03238 Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Level Increased Foreign Clozaril (Clozapine) Intentional Overdose Study Tablet PS ORAL 425MG DAY Medication Error Health ORAL Therapeutic Agent Professional Toxicity Date:02/13/02ISR Number: 3870277-XReport Type:Expedited (15-DaCompany Report #PHFR2001GB03321 Age:67 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Alveolitis Fibrosing Foreign Clozaril (Clozapine) Hospitalization - Angina Pectoris Health Tablet PS ORAL 350MG/DAY, Initial or Prolonged Hypotension Professional ORAL Other Iron Deficiency Anaemia Other Steroids Nos (No Orthostatic Hypotension Ingredients/Substanc Pulmonary Fibrosis es) C Venlafaxine 22-Feb-2006 08:30 AM Page: 1508 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Venlafaxine) C Prednisolone C Lansoprazole (Lansoprazole) C Nystatin (Nystatin) C Calcichew-D3 C Cloxapen (Cloxacillin Sodium) C Date:02/13/02ISR Number: 3870284-7Report Type:Expedited (15-DaCompany Report #PHFR2001GB03506 Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Enteritis Necroticans Foreign Clozaril (Clozapine) Hospitalization - Intestinal Ischaemia Study Tablet PS ORAL 1) 200MG/DAY, Initial or Prolonged Malaise Health ORAL; 2) Multi-Organ Failure Professional 12.5MG/DAY, Sepsis Other ORAL Diazepam C Olanzapine (Olanzapine) C Lansoprazole (Lansoprazole) C Date:02/13/02ISR Number: 3870363-4Report Type:Expedited (15-DaCompany Report #PHBS2001BR11397 Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Obsessive-Compulsive Foreign Leponex (Clozapine) Disorder Health Tablet PS ORAL 500 MG/D, Professional ORAL Other Lorax (Loracarbef) C Date:02/13/02ISR Number: 3870776-0Report Type:Expedited (15-DaCompany Report #PHEH2002US01176 Age:88 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Concomitant Disease Health Clozaril(Clozapine) Progression Professional Tablet PS ORAL 50 MG, ORAL Dysphagia Pneumonia Aspiration Date:02/13/02ISR Number: 3875578-7Report Type:Periodic Company Report #2012190 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Overdose Health Oxycontin Cr Tablets PS ORAL PO Professional Clozapine SS Other Date:02/13/02ISR Number: 3889597-8Report Type:Periodic Company Report #C2001-2711.01 Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dermatitis Health Clozapine Tablets Initial or Prolonged Professional 100 Mg Mylan PS Mylan ORAL 350MG QD, Other Other ORAL 22-Feb-2006 08:30 AM Page: 1509 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/13/02ISR Number: 3889601-7Report Type:Periodic Company Report #C2001-2717.01 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Consumer Clozaril Novartis PS Novartis ORAL 500 MG QD, ORAL Clozapine Tablets 100 Mg Mylan SS Mylan ORAL 500 MG QD, THEN 200MG QD, THEN 500MG QD ORAL Lorazepam C Mirtazapine C Ziprasidone C Zolpidem C Date:02/13/02ISR Number: 3889605-4Report Type:Periodic Company Report #C2001-2798.01 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Health Clozapine Tablets Leukocytosis Professional 100 Mg PS ORAL 450MG QD, Thrombocythaemia Other ORAL Date:02/13/02ISR Number: 3889607-8Report Type:Periodic Company Report #C2001-2807.01 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 350MG, THEN Other 300MG QD, ORAL Valproic Acid C Atorvastatin C Date:02/13/02ISR Number: 3889608-XReport Type:Periodic Company Report #C2001-3093.01 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukocytosis Consumer Clozaril Tablets 100 Weight Increased Mg Novartis PS Novartis ORAL 200MG QD, ORAL Clozapine Tablets 100 Mg Mylan SS Mylan ORAL 200MG QD, ORAL Simvastatin C Date:02/13/02ISR Number: 3889609-1Report Type:Periodic Company Report #C2001-0750.01 Age:17 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Haemoglobin Decreased Health Clozapine Tablets 25 Sedation Professional Mg Mylan PS Mylan ORAL 25MG Q AM, Somnolence Other ORAL White Blood Cell Count Decreased 22-Feb-2006 08:30 AM Page: 1510 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/13/02ISR Number: 3889610-8Report Type:Periodic Company Report #C2001-1063.01 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Leukopenia Health Clozapine Tablets 25 Other Neutropenia Professional Mg Mylan PS Mylan ORAL 525 MG/DAY, Other ORAL Depakote Abbott SS Abbott ORAL 1750 MG/DAY, ORAL Seroquel Astrazeneca SS Astrazeneca ORAL 700 MG/DAY, ORAL Levothyroxine C Lithium C Date:02/13/02ISR Number: 3889611-XReport Type:Periodic Company Report #C2001-1116.01 Age:71 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 50MG Q HS, Other ORAL Fludrocortisone C Ropinirole C Senna Concentrate C Sorbital C Warfarin Sodium C Date:02/13/02ISR Number: 3889612-1Report Type:Periodic Company Report #C2001-0196.01 Age:65 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozapine Tablets Other Tardive Dyskinesia Professional 100 Mg Mylan PS Mylan ORAL 100MG QID, Other ORAL Valproex Sodium C Insulin Nph C Calcium Carbonate C Nifedipine Xl C Date:02/13/02ISR Number: 3889613-3Report Type:Periodic Company Report #C2001-0244.01 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chest Pain Consumer Clozapine Tablets Conduction Disorder Health 100 Mg Mylan PS Mylan ORAL 450MG QD, Professional THEN 150MG QD, ORAL Gaviscon C Divalproex Sodium C Enalapril C Glyburide C Ibuprofen C Lorazepam C Niacin C Omeprazole C Paroxetine C Simethicone C Temazepam C Vitamins C 22-Feb-2006 08:30 AM Page: 1511 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Atorvastatin C Date:02/13/02ISR Number: 3889614-5Report Type:Periodic Company Report #C2001-2217.01 Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Leukopenia Health Clozapine Tablets Other Professional 100 Mg Mylan PS Mylan ORAL 200MG QD, Other ORAL Albuterol Inhaler C Beclomethasone Inhaler C Benztropine C Fluoxetine C Lamivudine C Loxapine C Nelfinavir C Olanzapine C Zidovudine C Nystatin Suspension C Cephalexin C Ranitidine C Benztropine C Amoxicillin C Clindamycin C Glyburide C Date:02/14/02ISR Number: 3870135-0Report Type:Expedited (15-DaCompany Report #PHRM2002GB00700 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiomyopathy Foreign Clozaril (Clozapine) Health Tablet PS ORAL 600 MG/DAY, Professional ORAL Other Date:02/14/02ISR Number: 3870137-4Report Type:Expedited (15-DaCompany Report #PHFR2001GB03531 Age:66 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Potassium Decreased Foreign Clozaril (Clozapine) Initial or Prolonged Overdose Health Tablet PS SEE IMAGE Professional Fluoxetine Other (Fluoxetine) SS SEE IMAGE Docusate Sodium (Docusate Sodium) SS ORAL SEE IMAGE Lactulose C Date:02/14/02ISR Number: 3870282-3Report Type:Expedited (15-DaCompany Report #PHNU2001DE02563 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Galactorrhoea Foreign Leponex/Clozaril PS ORAL ORAL 175 Initial or Prolonged Study MG/D , ORAL Health 250 MG/D, Professional ORAL 300 Other MG/D, ORAL 22-Feb-2006 08:30 AM Page: 1512 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pirenzepine (Pirenzepine) C Haloperidol Tablet C Date:02/15/02ISR Number: 3870983-7Report Type:Expedited (15-DaCompany Report #PHBS2002ES02006 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Suicide Attempt Foreign Leponex (Clozapine) Initial or Prolonged Health Tablet PS ORAL 125 MG/DAY, Professional ORAL Other Date:02/15/02ISR Number: 3871155-2Report Type:Expedited (15-DaCompany Report #PHNU2001DE02689 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Laboratory Test Foreign Leponex/ Clozaril Interference Health (Clozapine) Professional (Clozapine) Tablet PS ORAL 450MG/DAY, Other ORAL Date:02/15/02ISR Number: 3871358-7Report Type:Expedited (15-DaCompany Report #PHBS2002ES02028 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Leponex (Clozapine) Health Tablet PS ORAL 500 MG/DAY, Professional ORAL Other Date:02/15/02ISR Number: 3871381-2Report Type:Expedited (15-DaCompany Report #PHEH2002US01535 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Health Clozaril (Clozapine) Cardiac Arrest Professional Tablet PS ORAL 400 MG/DAY, Coma ORAL Diarrhoea Moban (Molindone) C Loss Of Consciousness Cogentin (Benzatropine Mesilate) C Paxil C Klonopin C Date:02/15/02ISR Number: 3871394-0Report Type:Expedited (15-DaCompany Report #PHBS2002ES02012 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Leponex (Clozapine) Tablet PS ORAL 100 MG/DAY, ORAL Plenur C Akineton (Biperiden Hydrochloride) C 22-Feb-2006 08:30 AM Page: 1513 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/15/02ISR Number: 3871543-4Report Type:Expedited (15-DaCompany Report #PHBS2002DE00504 Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Foreign Clozapine Initial or Prolonged Drug Interaction Literature (Clozapine) Unknown PS 200 MG/D Health Interferon Professional (Interferon) SS Other Date:02/19/02ISR Number: 3871458-1Report Type:Expedited (15-DaCompany Report #C2002-0354.01 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 100MG Q AM, Other 200MG Q HS, ORAL Date:02/19/02ISR Number: 3871459-3Report Type:Expedited (15-DaCompany Report #C2002-0359.01 Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 500MG AT 6PM, Other QD, ORAL Date:02/19/02ISR Number: 3871880-3Report Type:Expedited (15-DaCompany Report #C2002-0091.01 Age:53 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 25 MG@7AM, Other 25MG @8PM; ORAL Clozapine Tablets 100 Mg Mylan SS Mylan ORAL 100 MG Q AM, 100 MG Q NOON, 200MG QHS, ORAL Date:02/19/02ISR Number: 3871882-7Report Type:Expedited (15-DaCompany Report #C2002-0076.01 Age:62 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine Tablets Hospitalization - Professional 100 Mg Mylan PS Mylan ORAL 200MG Q AM, Initial or Prolonged Other 300MG AT NOON, 400MG Q HS; ORAL Calcium C Furosemide C Lisinopril C Potassium C Theophylline C Docusate Sodium C Aspirin C Miltivitamin C 22-Feb-2006 08:30 AM Page: 1514 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prednisone C Date:02/19/02ISR Number: 3871889-XReport Type:Expedited (15-DaCompany Report #PHFR2001GB02561 Age:25 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ankle Fracture Foreign Clozaril (Clozapine) Initial or Prolonged Deep Vein Thrombosis Health Tablet PS ORAL 300MG/DAY, Suicide Attempt Professional ORAL Other Date:02/19/02ISR Number: 3871890-6Report Type:Expedited (15-DaCompany Report #PHBS2002GB00916 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Foreign Clozapine Cardiomegaly Literature (Clozapine) Unknown PS 600 MG/D, UNK 365 DAY Pulmonary Oedema Health Benzodiazepines (No Professional Ingredients/Substanc Other es) SS Date:02/19/02ISR Number: 3871973-0Report Type:Expedited (15-DaCompany Report #PHBS2002ES02003 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ankle Fracture Foreign Leponex(Clozapine) Initial or Prolonged Dizziness Health Tablet PS ORAL SEE IMAGE Dyskinesia Professional Faecal Incontinence Other Hypotonia Leukocytosis Syncope Urinary Incontinence Date:02/19/02ISR Number: 3871974-2Report Type:Expedited (15-DaCompany Report #PHBS2002ES02084 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Leponex(Clozapine) Health Tablet PS ORAL 50 MG/D, ORAL Professional Other Date:02/19/02ISR Number: 3871991-2Report Type:Expedited (15-DaCompany Report #PHFR2002GB00588 Age:26 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Foreign Clozaril (Clozapine) Initial or Prolonged Diabetic Ketoacidosis Health Tablet PS ORAL 550 MG/DAY, Nausea Professional ORAL Vomiting Other Senna (Senna) C Depo Provera C Procyclidine (Procyclidine) C Oxcarbazepine C 22-Feb-2006 08:30 AM Page: 1515 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/19/02ISR Number: 3871994-8Report Type:Expedited (15-DaCompany Report #PHBS2001AU10052 Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiomyopathy Foreign Clozaril (Clozapine) Initial or Prolonged Dilatation Ventricular Study Tablet PS ORAL 500 MG/DAY, Sinus Tachycardia Health ORAL Professional Other Date:02/19/02ISR Number: 3872065-7Report Type:Expedited (15-DaCompany Report #PHFR2001GB02120 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Barrett'S Oesophagus Foreign Clozaril (Clozapine) PS ORAL 550MG/DAY, Initial or Prolonged Condition Aggravated Health ORAL Gastritis Professional Promethazine Haematemesis Other (Promethazine) C Date:02/19/02ISR Number: 3872517-XReport Type:Expedited (15-DaCompany Report #GB/00/00543/LEX Age:43 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Foreign Clozaril (Clozapine) Cardiomegaly Literature (Clozapine) Tablet PS ORAL 600 MG/DAY, Circulatory Collapse Health ORAL 392 DAY Drug Interaction Professional Clomipramine Pulmonary Oedema Other (Clomipramine Sudden Death Hydrochloride) Unknown SS ORAL ORAL Thioridazine (Thioridazine) C Benzodiazepines (No Ingredients/Substanc es) C Date:02/19/02ISR Number: 3872518-1Report Type:Expedited (15-DaCompany Report #PHFR2002GB00598 Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiac Failure Foreign Clozaril (Clozapine) PS ORAL 400 MG/DAY, Hospitalization - Cardiomegaly Health ORAL Initial or Prolonged Cardiomyopathy Professional Lithium Carbonate C Circulatory Collapse Other Date:02/19/02ISR Number: 3872519-3Report Type:Expedited (15-DaCompany Report #PHFR2001GB03497 Age:49 YR Gender:Male I/FU:F Outcome PT Death Anaemia Blood Pressure Fluctuation Constipation Dyspnoea Immunosuppression Infection Lethargy Leukopenia 22-Feb-2006 08:30 AM Page: 1516 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Loss Of Consciousness Lung Squamous Cell Carcinoma Stage Report Source Product Role Manufacturer Route Dose Duration Unspecified Foreign Clozaril (Clozapine) Lymphocyte Count Health Tablet PS ORAL 200 MG Decreased Professional MANE/400 MG Neutrophil Count Other NOCTE, ORAL Increased Dexamethasone Platelet Count Decreased (Dexamethasone) SS ORAL SEE IMAGE Pneumocystis Jiroveci Procyclidine Pneumonia (Procyclidine) C Renal Failure Lansoprazole Stridor (Lansoprazole) C Diazepam C Prothiazine C Date:02/19/02ISR Number: 3872738-6Report Type:Expedited (15-DaCompany Report #PHBS2002AU01743 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiomyopathy Foreign Clozaril (Clozapine) Dyspnoea Health Tablet PS ORAL ORAL Professional Date:02/20/02ISR Number: 3872182-1Report Type:Periodic Company Report #FLUV00201002624 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Luvox (Fluvoxamine Professional Maleate) PS ORAL 150 MG BID PO Clozapine (Clozapine) SS ORAL 300 MG BID PO Lithium (Lithium) C Wellbutrin - Slow Release (Amfebutamone Hydrochloride) C Haldol (Haloperidol) C Ddavp (Desmopressin) C Cytomel (Liothyronine Sodium) C Date:02/20/02ISR Number: 3872591-0Report Type:Direct Company Report #CTU 161916 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Anxiety Clozapine 100mg PS ORAL 375MG TOTAL Intervention to Condition Aggravated PO Prevent Permanent Drug Ineffective Clozapine 25mg SS ORAL Impairment/Damage Dystonia Insomnia Paranoia Pharmaceutical Product Complaint 22-Feb-2006 08:30 AM Page: 1517 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/20/02ISR Number: 3872613-7Report Type:Direct Company Report #CTU 161896 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Glucose Increased Clozapine PS ORAL 300 MG PO QHS Hospitalization - Ketoacidosis Prolixin Decanoate C Initial or Prolonged Date:02/20/02ISR Number: 3872752-0Report Type:Expedited (15-DaCompany Report #02-02-0101 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine PS Ivax Professional Pharmaceuticals, Inc ORAL 600-700MG QD Other ORAL Date:02/20/02ISR Number: 3872755-6Report Type:Expedited (15-DaCompany Report #02-02-0103 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozapine PS Ivax Professional Pharmaceuticals, Inc ORAL 250MG QHS Other ORAL Luvox C Klonopin C Hydroxyzine C Date:02/20/02ISR Number: 3872756-8Report Type:Expedited (15-DaCompany Report #02-02-0104 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Clozapine PS Ivax Professional Pharmaceuticals, Inc ORAL ORAL Other Date:02/20/02ISR Number: 3872757-XReport Type:Expedited (15-DaCompany Report #02-02-0108 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Health Clozapine PS Ivax Professional Pharmaceuticals, Inc ORAL 600MG QD ORAL Other Date:02/20/02ISR Number: 3872760-XReport Type:Expedited (15-DaCompany Report #02-02-0115 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine PS Ivax Pharmaceuticals Hospitalization - Renal Failure Professional Inc ORAL 150MD QD ORAL Initial or Prolonged Other 22-Feb-2006 08:30 AM Page: 1518 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/20/02ISR Number: 3872763-5Report Type:Expedited (15-DaCompany Report #02-02-0116 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Skin Ulcer Health Clozapine PS Iivax Initial or Prolonged Professional Pharmaceuticals, Inc ORAL 25MG AM ORAL, Other 50MG PM ORAL Date:02/20/02ISR Number: 3872765-9Report Type:Expedited (15-DaCompany Report #02-02-0118 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Health Clozapine PS Ivax Professional Pharmaceuticals, Inc ORAL 250-725MG QD Other ORAL Date:02/20/02ISR Number: 3872767-2Report Type:Expedited (15-DaCompany Report #02-02-0130 Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Gastrointestinal Health Clozapine -Ivax Hospitalization - Haemorrhage Professional Pharmaceuticals, Initial or Prolonged Gastrointestinal Ulcer Other Inc. Tablets PS Ivax Perforation Pharmaceuticals, Inc. ORAL 300-400MG QD ORAL Date:02/20/02ISR Number: 3872768-4Report Type:Expedited (15-DaCompany Report #02-02-0134 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Ketoacidosis Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 200-400MG QD ORAL Date:02/20/02ISR Number: 3872769-6Report Type:Expedited (15-DaCompany Report #02-02-0135 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Health Clozapine - Ivax Initial or Prolonged Weight Increased Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 100MG HS ORAL 6 YR Seroquel C Date:02/20/02ISR Number: 3872770-2Report Type:Expedited (15-DaCompany Report #02-02-0137 Age: Gender: I/FU:I Outcome PT Death Blood Glucose Increased Hospitalization - Cardiac Arrest Initial or Prolonged Difficulty In Walking Drooling 22-Feb-2006 08:30 AM Page: 1519 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Speech Disorder Vision Blurred Report Source Product Role Manufacturer Route Dose Duration Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 700MG QD ORAL Date:02/20/02ISR Number: 3872771-4Report Type:Expedited (15-DaCompany Report #02-02-0143 Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neoplasm Malignant Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 500MG QD ORAL Date:02/20/02ISR Number: 3872773-8Report Type:Expedited (15-DaCompany Report #02-02-0149 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Respiratory Distress Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 50 MG QD ORAL Date:02/20/02ISR Number: 3872774-XReport Type:Expedited (15-DaCompany Report #02-02-0150 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Accident Health Clozapine - Ivax Hospitalization - Thermal Burn Professional Pharmaceuticals, Initial or Prolonged Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 300MG HS ORAL Date:02/20/02ISR Number: 3872776-3Report Type:Expedited (15-DaCompany Report #02-02-0154 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dehydration Health Clozapine - Ivax Initial or Prolonged Dyspepsia Professional Pharmaceuticals, Electrolyte Imbalance Other Inc. Tablets PS Ivax Vomiting Pharmaceuticals, Inc. ORAL 600 MG HS ORAL Prilosec SS 20 MG QAM 22-Feb-2006 08:30 AM Page: 1520 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/20/02ISR Number: 3872803-3Report Type:Expedited (15-DaCompany Report #C2002-0358.01 Age:82 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional 100 Mg Mylan PS ORAL 100 MG Q AM, Other 200MG Q HS, THEN 100MG Q AM, 300MG Q HS, ORAL Date:02/20/02ISR Number: 3872804-5Report Type:Expedited (15-DaCompany Report #C2001-3705.01 Age:58 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lymphoma Health Clozapine Tablets Metastasis Professional 100 Mg Mylan PS ORAL 100 MG, BID, Other ORAL Albuterol Sulfate C Benztropine C Ciprofloxacin C Divalproex Sodium C Risperidol C Loxapine C Date:02/20/02ISR Number: 3872808-2Report Type:Expedited (15-DaCompany Report #02-02-0155 Age:88 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Respiratory Failure Health Clozapine - Ivax Hospitalization - Professional Pharmaceuticals, Initial or Prolonged Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 200MG QD ORAL Date:02/20/02ISR Number: 3872809-4Report Type:Expedited (15-DaCompany Report #02-02-0161 Age:67 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Health Clozapine - Ivax Initial or Prolonged Dementia Professional Pharmaceuticals, Other Inc. PS Ivax Pharmaceuticals, Inc. ORAL 12.5-125MG QD ORAL Date:02/20/02ISR Number: 3872810-0Report Type:Expedited (15-DaCompany Report #02-01-0059 Age:78 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Aspiration Health Clozapine- Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 6.2-25MG QD ORAL Rocephin C Augmentin C 22-Feb-2006 08:30 AM Page: 1521 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Albuterol Sulfate C Date:02/20/02ISR Number: 3872816-1Report Type:Expedited (15-DaCompany Report #C2001-3647.01 Age:42 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Myocardial Health Clozapine Tablets Infarction Professional 100mg Mylan PS Mylan ORAL 300 MG Q HS, Other ORAL Clozapine Tablets 25 Mg Mylan SS Mylan ORAL 25 MG BID, ORAL Sertraline C Topiramate C Bupropion C Date:02/20/02ISR Number: 3872821-5Report Type:Expedited (15-DaCompany Report #C2002-0379.01 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 600MG, QD, Other ORAL Trihexyphenidyl C Date:02/21/02ISR Number: 3872722-2Report Type:Direct Company Report #CTU 161985 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Effect Decreased Generic Clozaril Initial or Prolonged Pharmaceutical Product (Clozapine) 100 Mg PS SEE IMAGE Complaint Date:02/21/02ISR Number: 3872950-6Report Type:Expedited (15-DaCompany Report #PHBS2002AU02133 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sedation Foreign Clozaril (Clozapine) Sexual Assault Victim Consumer Tablet PS ORAL 250 MG/DAY, Other ORAL Valproate Sodium C Alcohol (Beer) (Ethanol) C Date:02/21/02ISR Number: 3872952-XReport Type:Expedited (15-DaCompany Report #PHBS2002ES02046 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Overdose Foreign Leponex (Clozapine) Initial or Prolonged Suicide Attempt Health Tablet PS ORAL 200 MG/D, Professional ORAL; SEE Other IMAGE 22-Feb-2006 08:30 AM Page: 1522 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/21/02ISR Number: 3872956-7Report Type:Expedited (15-DaCompany Report #PHFR2001GB03321 Age:67 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Foreign Clozaril (Clozapine) Hospitalization - Alveolitis Fibrosing Health Tablet PS ORAL 350 Initial or Prolonged Angina Pectoris Professional MG/DAY,ORAL Other Dyspnoea Other Steroids Nos (No Emotional Distress Ingredients/Substanc Hypotension es) C Iron Deficiency Anaemia Venlafaxine Myocardial Ischaemia (Venalafaxine) C Orthostatic Hypotension Prednisolone C Pulmonary Fibrosis Lansoprazole C Respiratory Distress Nystatin (Nystatin) C Calcichew-D3 C Cloxapen (Cloxacillin Sodium) C Date:02/22/02ISR Number: 3874041-7Report Type:Expedited (15-DaCompany Report #02-02-0163 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Brain Neoplasm Health Clozapine PS Ivax Pharmaceuticals Initial or Prolonged Professional Inc ORAL ORAL Other Date:02/22/02ISR Number: 3874920-0Report Type:Expedited (15-DaCompany Report #PHEH2002US01556 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Clonic Convulsion Health Clozaril (Clozapine) Convulsion Professional Tablet PS ORAL 75 MG AM + Drug Interaction 400 MG HS, Drug Level Increased ORAL Fall Haldol (Haloperidol) SS Manganese Decreased Albuterol C Muscle Twitching Atrovent (Ipratropium Bromide) C Colace C Valproic C Norvasc C Fosamax (Alendronate Sodium) C Simethicone (Simeticone) C Milk Of Magnesia C Date:02/22/02ISR Number: 3874930-3Report Type:Expedited (15-DaCompany Report #PHEH2002US00513 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cataract Health Clozaril (Clozapine) Professional Tablet, 100 Mg PS ORAL 200 MG, TID, ORAL; ORAL Ativan C Trilafon (Perphenazine) C 22-Feb-2006 08:30 AM Page: 1523 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Navane (Tiotixene) C Haldol C Loxitane (Loxapine Succinate) C Zantac C Date:02/22/02ISR Number: 3874932-7Report Type:Expedited (15-DaCompany Report #PHEH2002US01697 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Disease Progression Health Clozaril (Clozapine) Lung Neoplasm Malignant Professional Tablet PS ORAL 50 MG AM+ 50 MG PM+ 100 MG HS, ORAL Klonopin C Plaquenil (Hydroxychloroquine Phosphate) C Premarin (Estrogens Conjugated) C Naprosyn C Date:02/22/02ISR Number: 3875205-9Report Type:Expedited (15-DaCompany Report #PHFR2002GB00804 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiomyopathy Foreign Clozapine Health (Clozpaine)Tablet PS ORAL 400 MG/DAY, Professional ORAL Other Lithium Carbonate C Date:02/22/02ISR Number: 3875206-0Report Type:Expedited (15-DaCompany Report #PHBS2001CA00747 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Foreign Clozaril (Clozapine) Congestive Study (Clozapine) Tablet PS ORAL 200 MG, BID, Cardiomegaly Health ORAL Hypertension Professional Risperidone Myocardial Ischaemia Other (Risperidone) C Effexor (Venlafaxine Hydrochloride) C Kemadrin (Procyclidine Hydrochloride) C Ativan C Date:02/22/02ISR Number: 3875234-5Report Type:Expedited (15-DaCompany Report #02P-056-0187941-00 Age:65 YR Gender:Male I/FU:I Outcome PT Death Cardio-Respiratory Arrest Chest Pain Electrocardiogram Abnormal Mydriasis Pulmonary Embolism 22-Feb-2006 08:30 AM Page: 1524 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sudden Death Report Source Product Role Manufacturer Route Dose Duration Foreign Tranxene Other (Clorazepate Dipotassium) (Clorazepate Dipotassium) PS ORAL 10 MG, 1 IN 1 D, PER ORAL; 50 MG, 1 IN 1 D, PER ORAL Valpromide SS ORAL 600 MG, 1 IN 1 D, PER ORAL Madopar SS ORAL 500 MG, 1 IN 1 D, PER ORAL Leponex SS ORAL 12.5 MG, 1 IN 1 D, PER ORAL; 25 MG, 1 IN 1 D, PER ORAL; 27.5 Date:02/22/02ISR Number: 3875247-3Report Type:Expedited (15-DaCompany Report #PHFR2001GB03486 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Appendicitis Foreign Clozaril (Clozapine) Initial or Prolonged Blood Creatinine Health Tablet PS ORAL 450 MG/DAY, Increased Professional ORAL Blood Urea Increased Other Platelet Count Increased Date:02/25/02ISR Number: 3873299-8Report Type:Direct Company Report #CTU 162101 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Congestive Cardiomyopathy Clozapine (Novartis) PS ORAL 450 MG/D PO Sudden Death Date:02/25/02ISR Number: 3873939-3Report Type:Expedited (15-DaCompany Report #2002UW02223 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Leukopenia Health Seroquel PS ORAL 700 MG DAILY Liver Function Test Professional PO Abnormal Clozapine SS ORAL 525 MG QD PO Neutropenia Depakote SS ORAL 1750 MG QD PO Levothyroxine C Lithium C Interferon C Date:02/25/02ISR Number: 3874185-XReport Type:Expedited (15-DaCompany Report #02P-062-0188087-00 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Foreign Akineton (Biperiden) Initial or Prolonged Sinus Tachycardia Health (Biperiden) PS ORAL 8 MG, 1 IN 1 Professional D, PER ORAL 22-Feb-2006 08:30 AM Page: 1525 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Leponex SS ORAL (SEE IMAGE) , 1 IN 1 D, PER ORAL Date:02/25/02ISR Number: 3874322-7Report Type:Expedited (15-DaCompany Report #A200422 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cough Consumer Ziprasidone Po PS ORAL 160.00 MG Initial or Prolonged Dizziness TOTAL:BID:ORA Dyspepsia L Insomnia Clozaril SS Laryngitis Nasopharyngitis Vomiting Date:02/26/02ISR Number: 3874623-2Report Type:Expedited (15-DaCompany Report #PHBS2002AU02234 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Clozaril (Clozapine) Initial or Prolonged Phosphokinase Increased Health Tablet PS ORAL 600 MG, QD , Electrolyte Imbalance Professional ORAL Psychotic Disorder Other Date:02/26/02ISR Number: 3874626-8Report Type:Expedited (15-DaCompany Report #PHBS2002SE02251 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Insulin Increased Foreign Clozapine Other Weight Increased Health (Clozapine) Unknown PS Professional Other Date:02/26/02ISR Number: 3874640-2Report Type:Expedited (15-DaCompany Report #PHFR2002GB00836 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Empyema Foreign Clozaril (Clozapine) Initial or Prolonged Fatigue Health Tablet PS ORAL ORAL Hiatus Hernia Professional Lansoprazole Hypotension Other (Lansoprazole) C Oesophageal Carcinoma Oesophageal Stenosis Oesophageal Ulcer Weight Decreased White Blood Cell Count Increased Date:02/26/02ISR Number: 3875708-7Report Type:Expedited (15-DaCompany Report #PHEH2002US01536 Age:93 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Clozaril (Clozapine) Congestive Professional Tablet PS ORAL 100 MG, QHS, ORAL 22-Feb-2006 08:30 AM Page: 1526 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lanoxin C Parnate (Tranylcypromine Sulfate) C Furosemide C Ultram (Tramadol Hydrochloride) C Aspirin "Bayer" C Tylenol (Paracetamol) C Date:02/26/02ISR Number: 3875855-XReport Type:Expedited (15-DaCompany Report #PHFR2001GB01891 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Blood Glucose Increased Foreign Clozaril(Clozapine) PS ORAL SEE IMAGE Diabetes Mellitus Health Amitriptyline Non-Insulin-Dependent Professional (Amitriptyline) C Other Olanzapine (Olanzapine) C Date:02/26/02ISR Number: 3875868-8Report Type:Expedited (15-DaCompany Report #PHBS2002IT01283 Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Clozapine(Clozapine) PS Drug Level Increased Literature Orphenadrine Overdose Health (Orphenadrine) SS Professional Other Date:02/26/02ISR Number: 3875992-XReport Type:Expedited (15-DaCompany Report #PHBS2002SE02247 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Glucose Increased Foreign Clozapine Blood Insulin Increased Literature (Clozapine) PS Weight Increased Health Professional Other Date:02/26/02ISR Number: 3875997-9Report Type:Expedited (15-DaCompany Report #PHBS2002SE02250 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Growth Hormone Foreign Clozapine Decreased Literature (Clozapine) PS Blood Insulin Increased Health Insulin Resistance Professional Weight Increased Other 22-Feb-2006 08:30 AM Page: 1527 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/02ISR Number: 3876026-3Report Type:Expedited (15-DaCompany Report #PHBS2002SE02252 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Insulin Increased Foreign Clazapine Literature (Clozapine) PS Health Professional Other Date:02/27/02ISR Number: 3875944-XReport Type:Direct Company Report #CTU 162430 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Glucose Increased Clozapine PS ORAL 300MG PO QHS Hospitalization - Disorientation Prolixin C Initial or Prolonged Dizziness Decanoate C Ketoacidosis Polydipsia Weight Decreased Date:02/27/02ISR Number: 3877076-3Report Type:Expedited (15-DaCompany Report #02P-163-0188315-00 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Leukopenia Health Depakote (Divalproex Neutropenia Professional Sodium) Platelet Count Decreased Other (Divalproex Sodium) PS ORAL 1750 MG, 1 IN 1 D, PER ORAL Clozapine SS ORAL 525 MG, 1 IN 1 D, PER ORAL Quetiapine Fumarate SS ORAL 700 MG, 1 IN 1 D, PER ORAL Levothyroxine C Lithium C Date:02/28/02ISR Number: 3877506-7Report Type:Expedited (15-DaCompany Report #PHNU2002DE00780 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Catecholamines Urine Foreign Leponex /Clozaril Increased Health (Clozapine/Clozapine Hypertension Professional ) Tablet PS ORAL 300MG/DAY, Nosocomial Infection Other ORAL Pneumonia Fluanxol "Bayer" (Flupentixol Dihydrochloride) C Date:02/28/02ISR Number: 3877508-0Report Type:Expedited (15-DaCompany Report #PHFR2002GB00874 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Foreign Clozaril (Clozapine) Initial or Prolonged Insulin-Dependent Health Tablet PS ORAL 800 MG /DAY, Professional ORAL Other 22-Feb-2006 08:30 AM Page: 1528 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/28/02ISR Number: 3877983-1Report Type:Expedited (15-DaCompany Report #PHFR2002GB00700 Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiomyopathy Foreign Clozaril (Clozapine) Electrocardiogram T Wave Health Tablet PS ORAL 600MG/DAY, Abnormal Professional ORAL Glycosuria Other Paroxetine Ventricular Hypokinesia (Paroxetine) C Date:02/28/02ISR Number: 3878103-XReport Type:Expedited (15-DaCompany Report #PHEH2002US01734 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Health Clozaril (Clozapine) Hepatitis C Professional Tablet PS ORAL 500 MG/DAY, Leukopenia ORAL Neutropenia Glucophage "Merck" C Glynase C Ditropan (Oxybutynin) C Prilosec (Omeprazole) C Date:02/28/02ISR Number: 3878576-2Report Type:Expedited (15-DaCompany Report #GB8915225FEB2002 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Health Advil (Ibuprofen, Initial or Prolonged Dehydration Professional Tablet, 0) PS ORAL 1200 MG DAILY Diarrhoea Other ORAL Hepatitis Clozaril (Clozapine, Hyperglycaemia , 0) SS ORAL 300 MG DAILY Hypomania ORAL 30 DAY Paroxetine (Paroxetine, , 0) SS ORAL 20MG DAILY ORAL Date:03/01/02ISR Number: 3876663-6Report Type:Expedited (15-DaCompany Report #PHBS2002AU00646 Age:27 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Foreign Clozaril (Clozapine) Initial or Prolonged Cardiomyopathy Health Tablet PS ORAL 150 TO 250 Dizziness Professional MG/DAY, ORAL Dyspnoea Other Ventolin C Fatigue Sedation Tachycardia Date:03/01/02ISR Number: 3876664-8Report Type:Expedited (15-DaCompany Report #PHBS2001AU12591 Age:51 YR Gender:Female I/FU:F Outcome PT Hospitalization - Agranulocytosis Initial or Prolonged Haemoglobin Decreased Leukopenia Lymphocytosis 22-Feb-2006 08:30 AM Page: 1529 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Multiple Myeloma Report Source Product Role Manufacturer Route Dose Duration Foreign Clozaril (Clozapine) Study Tablet PS ORAL SEE IMAGE Health Chemotherapeutics, Professional Other Other (Chemotherapeutics, Other) C Date:03/01/02ISR Number: 3876667-3Report Type:Expedited (15-DaCompany Report #PHRM2002FR00658 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Obsessive-Compulsive Foreign Leponex (Clozapine) Disorder Health Tablet PS ORAL 350 MG PER Professional DAY, ORAL Other Depakin Chrono (Valproate Sodium) SS ORAL 500 MG, QD, ORAL Date:03/01/02ISR Number: 3876668-5Report Type:Expedited (15-DaCompany Report #PHFR2001GB01606 Age:53 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Constipation Foreign Clozaril(Clozapine) Coronary Artery Study Tablet PS ORAL 300 MG/DAY, Atherosclerosis Health ORAL Gastroenteritis Professional Haemorrhage Other Ventricular Hypertrophy Vomiting Date:03/01/02ISR Number: 3876787-3Report Type:Expedited (15-DaCompany Report #PHNU2002DE00812 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Balanitis Foreign Leponex / Clozaril Initial or Prolonged Hypertonic Bladder Study (Clozapine)(Clozapin Micturition Disorder Health e) Tablet PS ORAL 12.5-375 Professional MG/DAY, ORAL Other 425 MG/DAY, ORAL 375-250 Bifiteral "Phillips" C Solian (Amisulpride) C Tavor C Gastrozepin (Pirenzepine Dihydrochloride) C Date:03/01/02ISR Number: 3876788-5Report Type:Expedited (15-DaCompany Report #PHNU2002DE00827 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Hospitalization - Dystonia Foreign Initial or Prolonged Gait Disturbance Study 22-Feb-2006 08:30 AM Page: 1530 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Health Professional Other Product Role Manufacturer Route Dose Duration Clozaril (Clozapine) (Clozapine)Tablet PS ORAL 75MG/DAY, ORAL Date:03/01/02ISR Number: 3876790-3Report Type:Expedited (15-DaCompany Report #PHNU2002DE00829 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukocytosis Foreign Leponex/Clozaril Lymphocytosis Health (Clozapine) Lymphoma Professional (Clozapine) Tablet PS ORAL ORAL Neutropenia Other 300MG/DAY, ORAL Haldol C Date:03/01/02ISR Number: 3876791-5Report Type:Expedited (15-DaCompany Report #PHFR2002GB00920 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyspnoea Exertional Foreign Clozaril (Clozapine) Electrocardiogram Qt Health Tablet PS ORAL ORAL Prolonged Professional Tachycardia Other Date:03/01/02ISR Number: 3876812-XReport Type:Expedited (15-DaCompany Report #PHBS2002BE02477 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Triglycerides Foreign Leponex (Clozapine) Increased Health Tablet PS ORAL 450 MG/D, Professional ORAL Other Logastric (Omeprazole) C Date:03/01/02ISR Number: 3876815-5Report Type:Expedited (15-DaCompany Report #PHBS2002CA02694 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Clozaril (Clozapine) Study Tablet PS ORAL ORAL Health Professional Other Date:03/01/02ISR Number: 3876817-9Report Type:Expedited (15-DaCompany Report #PHNU2002DE00799 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Panic Attack Foreign Leponex /Clozaril Initial or Prolonged Sinus Tachycardia Study (Clozapine) Health (Clozapine) Tablet PS ORAL 12.5 - Professional 275MG/DAY, Other ORAL ; 300 22-Feb-2006 08:30 AM Page: 1531 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report MG/DAY ORAL ; 350MG/DAY Akineton (Biperiden Hydrochloride) Tablet SS ORAL 8MG/DAY, ORAL Date:03/01/02ISR Number: 3876819-2Report Type:Expedited (15-DaCompany Report #PHBS2002CA00707 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Foreign Clozaril (Clozapine) Initial or Prolonged Hip Fracture Study Tablet PS ORAL 500 MG/D, Intentional Overdose Health ORAL Professional Gravol(Dimenhydrinat Other e) SS Haldol C Losec (Omeprazole) C Date:03/01/02ISR Number: 3877333-0Report Type:Expedited (15-DaCompany Report #034-0945-M0200002 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Foreign Gabapentin Drug Interaction Health (Gabapentin) PS ORAL 1200 MG Neutropenia Professional (TID), PER Company ORAL Representative (Clozapine) SS ORAL PER ORAL Date:03/04/02ISR Number: 3878602-0Report Type:Expedited (15-DaCompany Report #02-02-0102 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 900MG QD ORAL Chemotherapy C Date:03/04/02ISR Number: 3878630-5Report Type:Expedited (15-DaCompany Report #C2002-0468.01 Age:84 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Chronic Obstructive Health Clozapine Tablets 25 Pulmonary Disease Professional Mg Mylan PS ORAL 75MG Q HS, Pneumonia Other ORAL Carbidopa/Levodopa C Loratadine C Morphine C Quetiapine C Date:03/04/02ISR Number: 3878654-8Report Type:Expedited (15-DaCompany Report #02-02-0181 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Hospitalization - Ankle Fracture Health Initial or Prolonged Professional 22-Feb-2006 08:30 AM Page: 1532 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Product Role Manufacturer Route Dose Duration Clozapine Tablets - Ivax Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 600-725MG QD ORAL Date:03/04/02ISR Number: 3878657-3Report Type:Expedited (15-DaCompany Report #02-02-0173 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Health Clozapine Tablets - Initial or Prolonged Hip Fracture Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 450MG QD ORAL Date:03/04/02ISR Number: 3878659-7Report Type:Expedited (15-DaCompany Report #02-02-0182 Age:66 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sepsis Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 250-300MG QD ORAL Date:03/04/02ISR Number: 3878661-5Report Type:Expedited (15-DaCompany Report #02-02-0183 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Suicide Attempt Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 50-550MG QD ORAL Date:03/04/02ISR Number: 3879063-8Report Type:Expedited (15-DaCompany Report #S02-GER-00331-01 Age:19 YR Gender:Male I/FU:I Outcome PT Hospitalization - Abdominal Pain Upper Initial or Prolonged Faecaloma Hyperhidrosis Nausea Pallor Subileus Tachycardia 22-Feb-2006 08:30 AM Page: 1533 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Vomiting Report Source Product Role Manufacturer Route Dose Duration Foreign Cipramil (Citalopram Health Hydrobromide) PS ORAL 20 MG QD PO Professional Solian (Amisulpride) SS ORAL 1200 MG QD PO Other Leponex "Novartis" (Clozapine) SS Novartis ORAL 650 MG QD PO Leponex "Novartis" (Clozapine) SS Novartis ORAL 700 MG QD PO Leponex "Novartis" (Clozapine) SS Novartis ORAL 12.5 MG QD PO Leponex "Novartis" (Clozapine) SS Novartis ORAL 600 MG QD PO Tavor (Lorazepam) C Gastrozepin (Pirenzepine Dihydrochloride) C Bifiteral (Lactulose) C Date:03/05/02ISR Number: 3879759-8Report Type:Direct Company Report #CTU 162730 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Clozapine (Ivax) PS Ivax FOR SEVERAL Decreased YEARS YR Date:03/05/02ISR Number: 3880538-6Report Type:Expedited (15-DaCompany Report #PHBS2002CL02615 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperpyrexia Foreign Leponex (Clozapine) Initial or Prolonged Health Tablet PS ORAL 200 MG/DAY, Professional ORAL Other Paroxetine C Date:03/06/02ISR Number: 3879641-6Report Type:Direct Company Report #CTU 162916 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Acute Myeloid Leukaemia Clozaril 100mg Tabs Pancytopenia Novartis PS Novartis 450MG Celexa C Tyenol C Date:03/06/02ISR Number: 3880000-0Report Type:Expedited (15-DaCompany Report #002-0981-M0200090 Age:47 YR Gender:Male I/FU:F Outcome PT Other Aspartate Aminotransferase Increased Blood Alkaline Phosphatase Increased Diabetes Mellitus Oxygen Saturation 22-Feb-2006 08:30 AM Page: 1534 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Abnormal Tachycardia Report Source Product Role Manufacturer Route Dose Duration Foreign Atorvastatin PS Consumer (Clozapine) SS ORAL 400 MG (BID), Health PER ORAL Professional (Metformin) C Other ... C Date:03/06/02ISR Number: 3880084-XReport Type:Expedited (15-DaCompany Report #02-02-0189 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional - Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 350 MG QD ORAL Date:03/06/02ISR Number: 3880085-1Report Type:Expedited (15-DaCompany Report #C2002-0359.01 Age:82 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 500 MG AT 6PM Other QD, ORAL Date:03/06/02ISR Number: 3880086-3Report Type:Expedited (15-DaCompany Report #C2002-0379.01 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Brain Neoplasm Health Clozapine Tablets Convulsion Professional 100 Mg Mylan PS Mylan ORAL 600 MG QD, Myocardial Infarction Other ORAL Trihexyphenidyl C Date:03/06/02ISR Number: 3880092-9Report Type:Expedited (15-DaCompany Report #02-02-0190 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Obsessive-Compulsive Foreign Clozapine - Ivax Disorder Literature Pharmacetuicals, Psychiatric Symptom Health Inc. Tablets PS ORAL 400-600MG QD Suicidal Ideation Professional ORAL Date:03/06/02ISR Number: 3880370-3Report Type:Expedited (15-DaCompany Report #PHBS2002HK02618 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Foreign Clozapine Obsessive-Compulsive Literature (Clozapine) PS 400 MG/DAY; Disorder Health SEE IMAGE Suicidal Ideation Professional Clomipramine Other (Clomipramine) C 22-Feb-2006 08:30 AM Page: 1535 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/06/02ISR Number: 3880377-6Report Type:Expedited (15-DaCompany Report #PHBS2002CA02865 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthma Foreign Clozaril (Clozapine) Initial or Prolonged Health Tablet PS ORAL ORAL Professional Other Date:03/06/02ISR Number: 3880378-8Report Type:Expedited (15-DaCompany Report #PHFR2002GB00995 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril (Clozapine) Health Tablet PS ORAL ORAL Professional Other Date:03/06/02ISR Number: 3880379-XReport Type:Expedited (15-DaCompany Report #PHFR2002IE00932 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Headache Foreign Clozaril (Clozapine) Myalgia Health Tablet PS ORAL 100MG/DAY, Periorbital Oedema Professional ORAL Pharyngitis Other Prothiaden (Dosulepin) C Date:03/06/02ISR Number: 3880380-6Report Type:Expedited (15-DaCompany Report #PHBS2002AU02886 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiomegaly Foreign Clozaril (Clozapine) Hospitalization - Pneumonia Health Tablet PS ORAL 550 MG/DAY, Initial or Prolonged Professional ORAL Other Date:03/06/02ISR Number: 3880424-1Report Type:Expedited (15-DaCompany Report #PHNU2002DE00780 Age:21 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Catecholamines Urine Foreign Leponex/ Clozaril Increased Health (Clozapine) Hypertension Professional (Clozapine) Tablet PS ORAL 300 MG/DAY, Pneumonia Other ORAL Fluanxol "Bayer" (Flupentixol Dihydrochloride) C Date:03/06/02ISR Number: 3880562-3Report Type:Expedited (15-DaCompany Report #PHNU2002DE00574 Age:32 YR Gender:Male I/FU:F Outcome PT Hospitalization - Acute Lymphocytic Initial or Prolonged Leukaemia Erythropenia Granulocytopenia 22-Feb-2006 08:30 AM Page: 1536 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Leukopenia Lymphocytosis Thrombocytopenia Report Source Product Role Manufacturer Route Dose Duration Foreign Leponex/Clozaril Health (Clozapine/Clozapine Professional ) Tablet PS ORAL 500MG/DAY,ORA Other L Orfiril "Desitin" (Valproate Sodium) Enteric-Film-Coated Tablet SS ORAL 1800MG/DAY/OR AL Tambocor (Flecaininde Acetate) C Novodigal Tablet C Mevinacor C Date:03/06/02ISR Number: 3880587-8Report Type:Expedited (15-DaCompany Report #PHBS2001AU12591 Age:51 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Foreign Clozaril (Clozapine) Initial or Prolonged Haemoglobin Decreased Study Tablet PS ORAL SEE IMAGE Leukopenia Health Chemotherapeutics, Multiple Myeloma Professional Other Neutropenia Other (Chemotherapeutics, Other) C Date:03/07/02ISR Number: 3880074-7Report Type:Expedited (15-DaCompany Report #PHBS2002BE02477 Age:23 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypertriglyceridaemia Foreign Leponex (Clozapine) PS ORAL 450 MG/D, Initial or Prolonged Health ORAL Professional Other Date:03/08/02ISR Number: 3880901-3Report Type:Expedited (15-DaCompany Report #C2002-0532.01 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional 100 Mg Mylan PS ORAL 500MG QD, Other ORAL Date:03/08/02ISR Number: 3880902-5Report Type:Expedited (15-DaCompany Report #C2002-0510.01 Age:69 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional 100mg Mylan PS Mylan ORAL 100MG, BID, Other ORAL 22-Feb-2006 08:30 AM Page: 1537 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/08/02ISR Number: 3880903-7Report Type:Expedited (15-DaCompany Report #C2002-0577.01 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozapine Tablets Post Procedural Professional 100 Mg Mylan PS Mylan ORAL 900MG QD, Complication Other ORAL Date:03/08/02ISR Number: 3880905-0Report Type:Expedited (15-DaCompany Report #C2002-0546.01 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Haemorrhage Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 100MG BID, Other ORAL Date:03/08/02ISR Number: 3880928-1Report Type:Expedited (15-DaCompany Report #1648393A Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Foreign Unspecified Initial or Prolonged Blood Glucose Increased Other Ibuprofen Product PS ORAL 1200 MG/DAY, Other Dehydration PO Diarrhoea Clozaril SS 300 MG/DAY 29 DAY Hepatitis Paroxetine SS 20MG/DAY Hyperglycaemia Hypomania Mania Date:03/08/02ISR Number: 3881414-5Report Type:Expedited (15-DaCompany Report #PHBS2002AU03021 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Treatment Noncompliance Foreign Clozaril (Clozapine) Initial or Prolonged Study Tablet PS ORAL 250 MG/D, Health ORAL Professional Other Date:03/08/02ISR Number: 3881415-7Report Type:Expedited (15-DaCompany Report #PHBS2002AU02971 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Multiple Myeloma Foreign Clozaril (Clozapine) Health Tablet PS ORAL ORAL Professional Other Date:03/08/02ISR Number: 3881416-9Report Type:Expedited (15-DaCompany Report #PHFR2002GB00710 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Face Oedema Foreign Clozaril (Clozapine) Hodgkin'S Disease Health Tablet PS ORAL 300 MG/DAY, Neck Mass Professional ORAL Other 22-Feb-2006 08:30 AM Page: 1538 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/08/02ISR Number: 3881668-5Report Type:Expedited (15-DaCompany Report #PHRM2002FR00793 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiac Disorder Foreign Leponex (Clozapine) Cardiomyopathy Health Tablet PS ORAL ORAL Dyspnoea Exertional Professional Hypokinesia Other Sinus Tachycardia Weight Increased Date:03/08/02ISR Number: 3881669-7Report Type:Expedited (15-DaCompany Report #PHFR2002GB00990 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Haemoglobin Decreased Foreign Clozaril Leukopenia Health (Clozapine)(Clozapin Monocyte Count Abnormal Professional e) PS ORAL 200MG/DAY, Myelofibrosis Other ORAL Thrombocytopenia Date:03/08/02ISR Number: 3881672-7Report Type:Expedited (15-DaCompany Report #PHFR2002GB00969 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dehydration Foreign Clozaril(Clozapine) Electrocardiogram Health Tablet PS ORAL 300MG/DAY, Abnormal Professional ORAL Ketonuria Other Ventricular Hypertrophy Weight Decreased Date:03/08/02ISR Number: 3881673-9Report Type:Expedited (15-DaCompany Report #PHBS2002CA02852 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Ketoacidosis Foreign Clozaril (Clozapine) PS ORAL ORAL Initial or Prolonged Ileus Paralytic Study Vomiting Health Weight Decreased Professional Other Date:03/08/02ISR Number: 3881679-XReport Type:Expedited (15-DaCompany Report #PHEH2002US01295 Age:51 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Non-Small Cell Lung Health Clozaril(Clozapine)T Cancer Professional ablet PS ORAL 150 MG DAILY,ORAL Premarin(Estrogens Conjugated) C Detrol(Tolterodine L-Tartrate) C Nexium (Esomeprazole) C Zocor "Merck" C Triamterene C Hydrochlorothiazide C 22-Feb-2006 08:30 AM Page: 1539 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Celexa C Combivent(Salbutamol Sulfate, Ipratropium Bromide) C Date:03/08/02ISR Number: 3881949-5Report Type:Expedited (15-DaCompany Report #PHFR2002GB01009 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Subarachnoid Haemorrhage Foreign Clozaril (Clozapine) Initial or Prolonged Health Tablet PS ORAL 400 MG/DAY, Professional ORAL Other Date:03/08/02ISR Number: 3881950-1Report Type:Expedited (15-DaCompany Report #PHNU2002DE00913 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Biopsy Heart Abnormal Foreign Leponex / Clozaril Cardiomyopathy Health (Clozapine) Myocarditis Professional (Clozapine) PS ORAL ORAL Ventricular Hypokinesia Other Date:03/08/02ISR Number: 3881951-3Report Type:Expedited (15-DaCompany Report #PHFR2002GB00771 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Oesophageal Carcinoma Foreign Clozaril (Clozapine) Pneumonia Study Tablet PS ORAL 800 Health MG/DAY,ORAL Professional Omeprazole Other (Omeprazole) C Date:03/08/02ISR Number: 3881953-7Report Type:Expedited (15-DaCompany Report #PHBS2002CA02270 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Pulmonary Oedema Foreign Clozaril (Clozapine) Cardiac Failure Study Tablet PS ORAL 225 MG/D, Hyperhidrosis Health ORAL Hyperpyrexia Professional Anaesthetics, Pneumonia Other General (No Salivary Hypersecretion Ingredients / Substances) SS Epival (Valproate Semisodium) C Rivotril C Empracet (Paracetamol) C Levoxine C Naprosyn C Rocephin (Ceftriaxone Sodium) C 22-Feb-2006 08:30 AM Page: 1540 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/08/02ISR Number: 3882016-7Report Type:Expedited (15-DaCompany Report #A127624 Age:17 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Conversion Disorder Foreign Ziprasidone Po PS ORAL 40.00 MG Initial or Prolonged Galactorrhoea Health TOTAL: BID: Hallucination Professional ORAL Nausea Cipramil SS ORAL ORAL Psychotic Disorder Clozapine SS Sleep Disorder Antiepileptic Drugs C Visual Acuity Reduced Lamictal C Weight Increased Date:03/08/02ISR Number: 3882063-5Report Type:Expedited (15-DaCompany Report #PHBS2002AU00646 Age:27 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Acute Foreign Clozaril (Clozapine Initial or Prolonged Cardiomyopathy Health ) Tablet PS ORAL 150 TO 250 Professional MG/DAY, ORAL Other Ventolin C Date:03/11/02ISR Number: 3882478-5Report Type:Expedited (15-DaCompany Report #PHEH2002US02279 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Cancer Health Clozaril (Clozapine) Professional Tablet PS ORAL 400 MG, ORAL Date:03/12/02ISR Number: 3882225-7Report Type:Expedited (15-DaCompany Report #PHFR2001IE02952 Age:60 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril (Clozapine) Non-Insulin-Dependent Health Tablet PS ORAL 200 MG/DAY, Glucose Tolerance Professional ORAL Impaired Other Fenofibrate (Fenofibrate) C Diazepam C Sertraline (Sertraline) C Epilim C Date:03/12/02ISR Number: 3882228-2Report Type:Expedited (15-DaCompany Report #PHFR2002IE00998 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Foreign Clozaril (Clozapine) Initial or Prolonged Diabetic Coma Health Tablet PS ORAL 300 MG/DAY, Other Professional ORAL Other 22-Feb-2006 08:30 AM Page: 1541 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/02ISR Number: 3882230-0Report Type:Expedited (15-DaCompany Report #PHFR2002GB00857 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Foreign Clozaril (Clozapine) Initial or Prolonged Blood Pressure Increased Health Tablet PS ORAL 350MG/DAY, Contusion Professional ORAL Convulsion Other Head Injury Heart Rate Increased Mental Disorder Neutrophil Count Increased Overdose Road Traffic Accident Date:03/12/02ISR Number: 3882818-7Report Type:Expedited (15-DaCompany Report #C2002-0578.01 Age:86 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death White Blood Cell Count Health Clozapine Tablets PS Mylan ORAL 25 MG QD, Abnormal Professional ORAL Other Date:03/12/02ISR Number: 3882820-5Report Type:Expedited (15-DaCompany Report #02-02-0115 Age:39 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pneumonia Health Clozapine PS Ivax Renal Failure Professional Pharmaceuticals, Other Inc. ORAL 150 MG QD ORAL Date:03/12/02ISR Number: 3882823-0Report Type:Expedited (15-DaCompany Report #02-02-0193 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine - Ivax Hospitalization - Renal Failure Professional Pharmaceuticals, Initial or Prolonged Other Inc. Tablets PS Ivax Pharmaceuticals , Inc. ORAL 50-300MG QD ORAL Date:03/12/02ISR Number: 3882824-2Report Type:Expedited (15-DaCompany Report #02-02-0194 Age:74 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine PS Ivax Professional Pharmaceuticals, Other Inc. ORAL 12.5 -250 MG QD ORAL 22-Feb-2006 08:30 AM Page: 1542 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/02ISR Number: 3882826-6Report Type:Expedited (15-DaCompany Report #02-02-0198 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Health Clozapine Talbets PS Ivax Professional Pharmaceuticals, Other Inc. ORAL 50-200MG QD ORAL Date:03/12/02ISR Number: 3882828-XReport Type:Expedited (15-DaCompany Report #02-02-0199 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Other Clozapine Tablets PS Ivax Pharmaceuticals, Inc. ORAL 200-500MG QD ORAL Date:03/12/02ISR Number: 3882830-8Report Type:Expedited (15-DaCompany Report #02-02-0203 Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Inguinal Hernia Clozapine Tablets PS Ivax Initial or Prolonged Intestinal Obstruction Pharmaceuticals, Inc. ORAL 100-200MG QD ORAL Date:03/12/02ISR Number: 3882832-1Report Type:Expedited (15-DaCompany Report #02-03-0216 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cellulitis Health Clozapine PS Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. ORAL 400 MG QD ORAL Date:03/12/02ISR Number: 3882833-3Report Type:Expedited (15-DaCompany Report #02-03-0218 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Akathisia Literature Clozapine - Ivax Blood Cholesterol Health Pharmaceuticals, Increased Professional Inc. Tablets PS Ivax Blood Triglycerides Pharmaceuticals, Increased Inc. ORAL 400 MG QD Diabetes Mellitus ORAL Non-Insulin-Dependent Fatigue Metabolic Disorder Polyuria Vision Blurred Weight Increased 22-Feb-2006 08:30 AM Page: 1543 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/02ISR Number: 3882835-7Report Type:Expedited (15-DaCompany Report #02-03-0219 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Cholesterol Literature Clozapine - Ivax Increased Health Pharmaceuticals, Blood Prolactin Increased Professional Inc. Tablets PS Ivax Blood Triglycerides Pharmaceuticals, Increased Inc. ORAL 350 MG QD Diabetes Mellitus ORAL Non-Insulin-Dependent Erectile Dysfunction Galactorrhoea Glycosylated Haemoglobin Increased High Density Lipoprotein Increased Low Density Lipoprotein Increased Weight Increased Date:03/12/02ISR Number: 3882836-9Report Type:Expedited (15-DaCompany Report #02-02-0104 Age:23 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Clozapine PS Ivax Professional Pharmaceuticals, Other Inc. ORAL ORAL Date:03/13/02ISR Number: 3881792-7Report Type:Expedited (15-DaCompany Report #308614 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Interferon Alfa-2a PS Roche Initial or Prolonged Clozapine SS 1096 DAY Date:03/13/02ISR Number: 3882623-1Report Type:Expedited (15-DaCompany Report #A122356 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abnormal Behaviour Consumer Ziprasidone Po PS ORAL 120.00 MG Hospitalization - Atherosclerosis Health TOTAL:BID:ORA Initial or Prolonged Catatonia Professional L Coronary Artery Occlusion Clozaril SS 400.00 MG Dilatation Ventricular TOTAL:DAILY Drug Level Above Lamictal Therapeutic (Lamotrigine) C Eye Rolling Ativan (Lorazepam) C Fall Casanthrandol/Docusa Hallucination, Auditory te Sodium C Mitral Valve Prolapse Metamucil (Psyllium) C Myositis Celexa (Citalopram) C Scar Inderal (Propranolol) C Cogentin C 22-Feb-2006 08:30 AM Page: 1544 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/13/02ISR Number: 3883287-3Report Type:Expedited (15-DaCompany Report #PHBS2002NO03083 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Leponex (Clozapine) PS ORAL 500 MG/ DAY, Other ORAL Zoloft (Sertraline Hydrochloride) C Buspar C Date:03/13/02ISR Number: 3883289-7Report Type:Expedited (15-DaCompany Report #PHFR2002GB01053 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Foreign Clozaril (Clozapine) Initial or Prolonged Fluctuation Health Tablet PS ORAL 880MG/ DAY, Overdose Professional ORAL Pulse Abnormal Other Paroxetine (Paroxetine) SS Date:03/13/02ISR Number: 3883316-7Report Type:Expedited (15-DaCompany Report #PHNU2002DE00958 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blast Cells Foreign Leponex /Clozaril Leukaemia Health (Clozapine) Leukocytosis Professional (Clozapine) Tablet PS ORAL 200 MG/DAY Myelocytosis Other ORAL Dipiperon (P0ipamperone) Tablet C Date:03/13/02ISR Number: 3883323-4Report Type:Expedited (15-DaCompany Report #PHBS2002AU03321 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril (Clozapine) Study Tablet PS ORAL 100 MG/D, Health ORAL Professional Other Date:03/13/02ISR Number: 3883395-7Report Type:Expedited (15-DaCompany Report #02P-062-0188087-00 Age:18 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Foreign Akineton (Biperiden) Initial or Prolonged Sinus Tachycardia Health (Biperiden) PS ORAL 8 MG, 1 IN 1 Professional D, PER ORAL Leponex SS ORAL SEE IMAGE Date:03/14/02ISR Number: 3882719-4Report Type:Direct Company Report #CTU 163417 Age: Gender:Male I/FU:I Outcome Required Intervention to 22-Feb-2006 08:30 AM Page: 1545 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration No Adverse Drug Effect Clozapine 100mg Generic PS Generic ORAL 300MG Q ORAL; 400MG Q ORAL Ativan C Paxil C Date:03/15/02ISR Number: 3883127-2Report Type:Expedited (15-DaCompany Report #221710 Age:70 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Gastrointestinal Disorder Tasmar PS Roche THE INITIAL Hospitalization - Hepatitis DOSE ON 23 Initial or Prolonged Musculoskeletal Disorder OCT 99 WAS 50 Neuroleptic Malignant MG BID AND Syndrome WAS GRADUALLY 18 DAY Parkinson'S Disease Madopar Dr SS Roche DRUG WAS Psychotic Disorder TAKEN FOR Thrombocytopenia APPROX. 20 YEARS. 7305 DAY Ditropan SS DRUG WAS TAKEN FOR YEARS. Tryptizol SS 27 DAY Motilium SS 22 DAY Leponex SS 11 DAY Celebrex SS 12 DAY Pk-Merz C Konakion Injection C Date:03/15/02ISR Number: 3884165-6Report Type:Expedited (15-DaCompany Report #02-03-0231 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Respiratory Failure Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 175MG QD ORAL Date:03/15/02ISR Number: 3884167-XReport Type:Expedited (15-DaCompany Report #02-03-0224 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Lung Neoplasm Malignant Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 800-900MG QD ORAL 22-Feb-2006 08:30 AM Page: 1546 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/15/02ISR Number: 3884176-0Report Type:Expedited (15-DaCompany Report #02-03-0225 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 300-500MG QD ORAL Date:03/15/02ISR Number: 3884179-6Report Type:Expedited (15-DaCompany Report #02-03-0226 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 25-50MG QD ORAL Date:03/15/02ISR Number: 3884181-4Report Type:Expedited (15-DaCompany Report #02-03-0229 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bone Disorder Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 425MG QD ORAL Date:03/15/02ISR Number: 3884183-8Report Type:Expedited (15-DaCompany Report #02-03-0232 Age:81 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Clozapine - Ivax Congestive Professional Pharmaceuticals, Chronic Obstructive Other Inc. Tablets PS Ivax Pulmonary Disease Pharmaceuticals, Inc. ORAL 150-300MG QD ORAL Date:03/15/02ISR Number: 3884187-5Report Type:Expedited (15-DaCompany Report #02-03-0234 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Mass Health Clozapine - Ivax Initial or Prolonged Surgery Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 50 MG QD ORAL 22-Feb-2006 08:30 AM Page: 1547 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/15/02ISR Number: 3884190-5Report Type:Expedited (15-DaCompany Report #02-03-0233 Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dehydration Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 50-700MG QD ORAL Date:03/15/02ISR Number: 3884192-9Report Type:Expedited (15-DaCompany Report #02-03-0235 Age:74 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Aspiration Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 25-37.5 MG QD ORAL Date:03/15/02ISR Number: 3884194-2Report Type:Expedited (15-DaCompany Report #02-03-0242 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Health Clozapine - Ivax Professional Pharmaceuticals, Inc. Tablets PS ORAL 300 MG QD ORAL Date:03/15/02ISR Number: 3884321-7Report Type:Expedited (15-DaCompany Report #PHBS2002CA03306 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Respiratory Distress Foreign Clozaril (Clozapine) Health Tablet PS ORAL ORAL Professional Other Date:03/15/02ISR Number: 3884324-2Report Type:Expedited (15-DaCompany Report #PHBS2002AU03075 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril (Clozapine) Urinary Tract Infection Health Tablet PS OPHTHALMIC 500 MG/D, Professional OPHTHALMIC Other Losec (Omeprazole) C Date:03/15/02ISR Number: 3884326-6Report Type:Expedited (15-DaCompany Report #PHBS2002CA01603 Age: Gender:Unknown I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Insipidus Foreign Clozaril (Clozapine) Health Tablet PS ORAL 300 MG/DAY, Professional ORAL Other 22-Feb-2006 08:30 AM Page: 1548 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/15/02ISR Number: 3884476-4Report Type:Expedited (15-DaCompany Report #PHFR2001GB02347 Age:62 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Foreign Clozaril (Clozapine) Hospitalization - Blood Creatine Health Unknown PS ORAL ORAL Initial or Prolonged Phosphokinase Increased Professional Olanzapine(Olanzapin Other C-Reactive Protein Other e) C Increased Lorazepam C Diarrhoea Ranitidine(Ranitidin Dysarthria e) C Hepatitis Chlorpromazine(Chlor Lower Respiratory Tract promazine) C Infection Pain Renal Impairment Date:03/15/02ISR Number: 3884477-6Report Type:Expedited (15-DaCompany Report #PHFR2002GB00969 Age:19 YR Gender:Male I/FU:U Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aspartate Foreign Clozaril(Clozapine) Aminotransferase Health Tablet PS ORAL 300 MG/DAY, Increased Professional ORAL Blood Alkaline Phosphatase Increased Blood Bilirubin Increased Dehydration Drug Level Increased Electrocardiogram Abnormal Gamma-Glutamyltransferase Increased Ketonuria Ventricular Hypertrophy Date:03/15/02ISR Number: 3884506-XReport Type:Expedited (15-DaCompany Report #PHEH2002US01165 Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Health Clozaril (Clozapine) Initial or Prolonged Metastatic Neoplasm Professional Tablet PS ORAL SEE IMAGE Other Peripheral Circulatory Chemotherapeutics, Failure Other SS Neurontin (Gabapentin) C Depakote (Valproate Semisodium) C Lithium C Cogentin (Benzatropine Mesilate) C Date:03/15/02ISR Number: 3884518-6Report Type:Expedited (15-DaCompany Report #PHEH2001US07000 Age:50 YR Gender:Female I/FU:I Outcome PT Death Dehydration Drug Interaction 22-Feb-2006 08:30 AM Page: 1549 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Drug Toxicity Upper Respiratory Tract Infection Report Source Product Role Manufacturer Route Dose Duration Health Clozaril (Clozapine) Professional Tablet PS ORAL 450 MG, ORAL Nyquil (Ephedrine Sulfate, Ethanol, Paracetamol) SS Geodon (Ziprasidone Hydrochloride) C Anafranil C Wellbutrin - Slow Release(Amfebutamone Hydrochloride) C Depakote (Valproate Semisodium) C Cogentin (Benzatropine Mesilate) C Date:03/15/02ISR Number: 3884723-9Report Type:Expedited (15-DaCompany Report #PHEH2002US02453 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) Professional Tablet PS ORAL 25 MG/DAY, ORAL Date:03/18/02ISR Number: 3884191-7Report Type:Direct Company Report #CTU 163579 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Malaise Generic (Clozaril) PS 450MG/DAY Pharmaceutical Product Complaint Date:03/18/02ISR Number: 3884945-7Report Type:Expedited (15-DaCompany Report #PHBS2002AU00940 Age: Gender:Unknown I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Foreign Clozaril Initial or Prolonged Malignant Melanoma Health (Clozapine)Tablet PS ORAL ORAL Schizophrenia Professional Other Date:03/18/02ISR Number: 3885020-8Report Type:Expedited (15-DaCompany Report #PHBS2002CA03522 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Cancer Foreign Clozaril (Clozapine) Health Tablet PS ORAL ORAL Professional Other 22-Feb-2006 08:30 AM Page: 1550 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/18/02ISR Number: 3885026-9Report Type:Expedited (15-DaCompany Report #PHFR2002GB01080 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Foreign Clozaril (Clozapine) Corrected Interval Health Tablet PS ORAL 50MG/DAY, Prolonged Professional ORAL Electrocardiogram Qt Prolonged Electrocardiogram T Wave Amplitude Decreased Date:03/18/02ISR Number: 3885029-4Report Type:Expedited (15-DaCompany Report #PHFR2002GB00487 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coronary Artery Occlusion Foreign Clozaril (Clozapine) PS 450MG/DAY, Drug Level Increased Study Cocaine (Cocaine) SS Drug Toxicity Health Alcohol (Ethanol) SS Myocardial Infarction Professional Cannabis (Cannabis) C Other Risperidone (Risperidone) C Benzodiazepine (No Ingredients/Substanc es) C Opium Alkaloids Total (Opium Alkaloids Total) C Date:03/18/02ISR Number: 3885031-2Report Type:Expedited (15-DaCompany Report #PHBS2002AU03041 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatitis C Foreign Clozaril (Clozapine) Liver Function Test Health Tablet PS 225 MG, QD Abnormal Professional Cogentin (Benza Nausea Other Tropine Mesilate) C Vomiting Thymine (Thymidine) C Diazepam C Midazolam (Midazolam) C Date:03/18/02ISR Number: 3885035-XReport Type:Direct Company Report #CTU 163591 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Apnoea Clozaril PS ORAL 400 MG 1 ORAL Coma Restoril SS ORAL 30 MG 1 ORAL Hypotension Pulse Absent Date:03/18/02ISR Number: 3885093-2Report Type:Expedited (15-DaCompany Report #PHEH2002US02451 Age:35 YR Gender:Female I/FU:I Outcome PT Other Blood Glucose Increased Complications Of Maternal Exposure To Therapeutic 22-Feb-2006 08:30 AM Page: 1551 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Drugs Diabetes Mellitus Report Source Product Role Manufacturer Route Dose Duration Health Clozapril Professional (Clozapine) Tablet PS ORAL 200 MG/DAY, ORAL Avandia (Rosiglitazone Maleate) C Insulin (Insulin) C Zoloft (Sertraline Hydrochloride) C Date:03/18/02ISR Number: 3885128-7Report Type:Expedited (15-DaCompany Report #PHBS2001AU10052 Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiomyopathy Foreign Clozaril (Clozapine) Dilatation Ventricular Study Tablet PS ORAL 500 MG/DAY, Sinus Tachycardia Health ORAL Professional Other Date:03/18/02ISR Number: 3885130-5Report Type:Expedited (15-DaCompany Report #PHFR2002GB01067 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aspartate Foreign Clozaril(Clozapine)T Initial or Prolonged Aminotransferase Health ablet PS ORAL 120MG MAINE/ Increased Professional 150MG NOCTE, Blood Creatine Other ORAL Phosphokinase Increased Cardiomyopathy Diarrhoea Myalgia Pulmonary Oedema Pyrexia Date:03/18/02ISR Number: 3885131-7Report Type:Expedited (15-DaCompany Report #PHFR2002GB01078 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril(Clozapine) Non-Insulin-Dependent Health Tablet PS ORAL ORAL Professional Other Date:03/18/02ISR Number: 3885161-5Report Type:Expedited (15-DaCompany Report #PHNU2002DE00829 Age:60 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Granulocytopenia Foreign Leponex/Clozaril Laboratory Test Health (Clozapine) Interference Professional (Clozapine) Tablet PS ORAL ORAL Leukocytosis Other Haldol C Lymphocytosis 22-Feb-2006 08:30 AM Page: 1552 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/18/02ISR Number: 3885193-7Report Type:Expedited (15-DaCompany Report #PHFR2001GB03240 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eye Inflammation Foreign Clozaril(Clozapine) Retinal Vasculitis Health Tablet PS ORAL 300 MG, BID, Vision Blurred Professional ORAL White Blood Cell Count Other Increased Date:03/18/02ISR Number: 3885194-9Report Type:Expedited (15-DaCompany Report #PHNU2002DE00574 Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acute Lymphocytic Foreign Leponex/Clozaril Initial or Prolonged Leukaemia Health (Clozapine) Erythropenia Professional (Clozapine) Tablet PS ORAL 500MG/DAY, Granulocytopenia Other ORAL Leukopenia Orfiril "Desitin" Lymphocytosis (Valproate Sodium) Psychotic Disorder Enteric-Film-Coated Thrombocytopenia Tablet SS ORAL 1800MG/DAY, ORAL Tambocor (Flecainide Acetate) Tablet C Novodigal Tablet C Mevinacor C Risperdal (Risperidone) Film-Coated Tablet C Zyprexa (Olanzapine) Film-Coated Tablet C Benzodiazepines (No Ingredients/Substanc es) C Chemotherapeutics, Other (Chemotherapeutics, Other) C Date:03/19/02ISR Number: 3884685-4Report Type:Expedited (15-DaCompany Report #C2002-0091.01 Age:53 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Fatigue Health Clozapine Tablets 25 Status Epilepticus Professional Mg Mylan PS ORAL 25 MG @ 7AM, Urinary Tract Infection Other 25 MG @ 8PM; ORAL Clozapine Tablets 100 Mg Mylan SS ORAL 100 MG Q AM, 100 MG Q NOON, 200MG QHS; ORAL Phenytoin C Divalproex Sodium C 22-Feb-2006 08:30 AM Page: 1553 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/19/02ISR Number: 3884686-6Report Type:Expedited (15-DaCompany Report #C2002-0358.01 Age:60 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Brain Neoplasm Health Clozapine Tablets Confusional State Professional 100 Mg Mylan PS ORAL 100MG Q AM, Other 200MG Q HS, THEN 100MG Q AM, 300MG Q HS ORAL Date:03/19/02ISR Number: 3884689-1Report Type:Expedited (15-DaCompany Report #C2002-0354.01 Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional 100 Mg Mylan PS ORAL 100MG Q AM, Other 200MG Q HS, ORAL Potassium Chloride C Omeprazole C Furosemide C Fluvastatin C Metoclopramide C Loxapine C Benztropine C Fluvoxamine C Gemfibrozil C Hydrocodone/Apap C Diazepam C Date:03/19/02ISR Number: 3884691-XReport Type:Expedited (15-DaCompany Report #C2001-3664-.01 Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Health Clozapine Tablets White Blood Cell Count Professional 100 Mg Mylan PS Mylan ORAL 300MG BID Decreased Other ORAL Benztropine C Gemfirbrozil C Atorvastatin C Propranolol C Date:03/19/02ISR Number: 3884829-4Report Type:Direct Company Report #CTU 163618 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Clozapine Pkg By Initial or Prolonged Syndrome Udl PS Udl ORAL 200MG AM AND NOON (PO); 300MG AT BEDTIME 22-Feb-2006 08:30 AM Page: 1554 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/19/02ISR Number: 3885443-7Report Type:Expedited (15-DaCompany Report #PHFR2001GB01759 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Foetal Distress Syndrome Foreign Clozaril(Clozapine) Maternal Drugs Affecting Health Tablet PS ORAL 500MG/DAY,ORA Foetus Professional L Other Date:03/19/02ISR Number: 3885496-6Report Type:Expedited (15-DaCompany Report #PHEH2002US02453 Age:78 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Clozaril (Clozapine) Hospitalization - Congestive Professional Tablet PS ORAL 25 MG/DAY, Initial or Prolonged Cough ORAL Dysphagia Sinemet (Levodopa, Dyspnoea Carbidopa_ C Parkinson'S Disease Norvasc C Pneumonia Aspiration Vitamin A And D Pyrexia (Retinol) C White Blood Cell Count Magnesium C Increased Viaming E C Aspirin "Bayer" C Tasmar (Tolcapone) C Date:03/19/02ISR Number: 3886571-2Report Type:Expedited (15-DaCompany Report #221710 Age:70 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Depression Foreign Tasmar (Tolcapone) Hospitalization - Hepatitis Literature 100 Mg PS ORAL 50 MG 2PER Initial or Prolonged Neuroleptic Malignant Health DAY ORAL Syndrome Professional Madopar Dr Parkinson'S Disease Other (Benserazide / Psychotic Disorder Levodopa) 250 Mg SS ORAL 250 MG 3 PER DAY ORAL 7035 DAY Ditropan (Oxybutynin Chloride) 5 Mg SS ORAL 5 MG DAILY ORAL Tryptizol (Amitriptyline Hydrochloride) 25 Mg SS ORAL 25 MG DAILY ORAL Motilium (Domperidone) 10 Mg SS ORAL 10 MG 3 PER DAY ORAL Leponex (Clozapine) 25 Mg SS ORAL 6.25 MG 3 PER DAY ORAL Celebrex (Celecoxib) 100 Mg SS ORAL 100 MG 3 PER DAY ORAL Pk-Merz (Amantadine Sulfate) C Konakion Injection (Phytonadione) C 22-Feb-2006 08:30 AM Page: 1555 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/20/02ISR Number: 3886159-3Report Type:Expedited (15-DaCompany Report #PHBS2002CA03190 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coronary Artery Disease Foreign Clozaril (Clozapine) Health Tablet PS ORAL 500 MG/D, Professional ORAL Other Citalopram (Citalopram) C Epival (Valproate Semisodium) C Chlorpromazine (Chlorpromazine) C Date:03/20/02ISR Number: 3886365-8Report Type:Expedited (15-DaCompany Report #PHEH2002US02538 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozaril(Clozapine) Professional Tablet PS ORAL 50 MG, QD, ORAL Dynacirc (Isradipine) C Accupril (Quinapril Hydrochloride) C Dilantin C Date:03/21/02ISR Number: 3886959-XReport Type:Expedited (15-DaCompany Report #PHFR2001GB02347 Age:62 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Foreign Clozaril (Clozapine) PS ORAL ORAL Hospitalization - Blood Alkaline Health Olanapine Initial or Prolonged Phosphatase Increased Professional (Olanzapine) C Other Blood Bilirubin Increased Other Lorazepam C Blood Creatine Ranitidine Phosphokinase Increased (Ranitidine) C Blood Creatinine Chlorpromazine Increased (Chlorpromazine) C Blood Potassium Decreased Blood Sodium Decreased Blood Urea Increased C-Reactive Protein Increased Diarrhoea Dysarthria Hepatitis Jaundice Lower Respiratory Tract Infection Malaise Pain Renal Impairment Vomiting 22-Feb-2006 08:30 AM Page: 1556 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/21/02ISR Number: 3886973-4Report Type:Expedited (15-DaCompany Report #PHFR2002GB01127 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Distension Foreign Clozaril(Clozapine) Life-Threatening Abdominal Pain Health Tablet PS ORAL 200MG/DAY, Hospitalization - Blood Pressure Decreased Professional ORAL Initial or Prolonged Cardiac Arrest Other Lansoprazole Colectomy (Lansoprazole) C Hypovolaemia Diazepam C Sepsis Olanzapine Stomatitis Necrotising (Olanzapine) C Ranitidine (Ranitidine) C Haloperidol C Lactulose C Date:03/21/02ISR Number: 3887080-7Report Type:Expedited (15-DaCompany Report #PHFR2002GB01114 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Intestinal Ischaemia Foreign Clozaril(Clozapine)T Health ablet PS ORAL ORAL Professional Other Date:03/22/02ISR Number: 3886577-3Report Type:Expedited (15-DaCompany Report #02-03-0236 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Respiratory Failure Health Clozapine Tablets PS Ivax Professional Pharmaceuticals, Other Inc. ORAL 200-800MG QD ORAL Date:03/22/02ISR Number: 3886578-5Report Type:Expedited (15-DaCompany Report #02-03-0245 Age:83 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine Tablets PS Ivax Hospitalization - Renal Failure Acute Professional Pharmaceuticals, Initial or Prolonged Upper Respiratory Tract Other Inc. ORAL 12.5 MG BID Infection ORAL Date:03/22/02ISR Number: 3886580-3Report Type:Expedited (15-DaCompany Report #01-11-0622 Age:69 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Breast Cancer Stage Iv Health Clozapine Tablets PS Ivax Dysphagia Professional Pharmaceuticals, Inc. ORAL 25MG BID ORAL 22-Feb-2006 08:30 AM Page: 1557 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/22/02ISR Number: 3887631-2Report Type:Direct Company Report #CTU 164053 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Clozaril 100mg PS ORAL 350 MG PO HS Initial or Prolonged Hemiparesis Clozaril 25mg SS Muscle Twitching Elavil C Zyprexa C Xanax C Date:03/22/02ISR Number: 3887633-6Report Type:Direct Company Report #CTU 164054 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depressed Level Of Clozaril 100 Mg PS ORAL 400 MG PO HS Initial or Prolonged Consciousness Geodon C Drooling Zyprexa C Dysarthria Remeron C Hypotonia Prozac C Mental Status Changes Ambien C Date:03/22/02ISR Number: 3887695-6Report Type:Expedited (15-DaCompany Report #02P-163-0188315-00 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Leukopenia Health Depakote (Divalproex Neutropenia Professional Sodium) (Divalproex Other Sodium) PS ORAL 1750 MG, 1 IN 1 D, PER ORAL Clozapine SS ORAL 525 MG, 1 IN 1 D, PER ORAL Quetiapine Fumarate SS ORAL 700 MG, 1 IN 1 D, PER ORAL Levothyroxine C Lithium C Date:03/22/02ISR Number: 3887778-0Report Type:Expedited (15-DaCompany Report #GB8934519MAR2002 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Health Efexor (Venlafaxine Grand Mal Convulsion Professional Hydrochloride, Other Tablet, O) PS ORAL ORAL Clozaril (Clozapine, , O) SS ORAL 350 MG 1X PER 1 DAY ORAL Pirenzepine (Pirenzepine) C Date:03/24/02ISR Number: 3887624-5Report Type:Expedited (15-DaCompany Report #PHBS2002NL03644 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozapine(Clozapine) PS 200 MG, BID Lung Infiltration Literature Fluvoxamine Pyrexia Health (Fluvoxamine) C Professional Oxazepam (Oxazepam) C Zuclopenthixol 22-Feb-2006 08:30 AM Page: 1558 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Zuclopenthixol) C Date:03/25/02ISR Number: 3888089-XReport Type:Direct Company Report #CTU 164105 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cyanosis Clozaril 100mg Hospitalization - Oxygen Saturation Novartis PS Novartis ORAL 200MG Q Initial or Prolonged Decreased 20:00 ORAL Required Pulmonary Embolism Tamoxifen 10mg SS ORAL 10MG BID ORAL Intervention to Syncope Zoloft C Prevent Permanent Ecasa C Impairment/Damage Synthroid C Tamoxifen C Cimetidine C Clonazepam C Benzotropine C Acetaminophen C Trazodone C Clozapine C Questran C Vitamin E C Calicum Carbonate C Thiothixene C Lorazepam C Date:03/25/02ISR Number: 3888253-XReport Type:Expedited (15-DaCompany Report #2002UW03416 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dehydration Health Prilosec PS ORAL 20 MG QAM PO Initial or Prolonged Dyspepsia Professional Clozapine SS ORAL 600 MG HS PO Electrolyte Imbalance Vomiting Date:03/25/02ISR Number: 3888600-9Report Type:Expedited (15-DaCompany Report #C2002-0577.01 Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozapine PS Mylan ORAL 900MG QD, Differential White Blood Professional ORAL Cell Count Abnormal Other Thyroid Gland Cancer Date:03/25/02ISR Number: 3888605-8Report Type:Expedited (15-DaCompany Report #C2002-0720.01 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Mylan ORAL 37.5MG QD, Professional ORAL Other 22-Feb-2006 08:30 AM Page: 1559 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/25/02ISR Number: 3888607-1Report Type:Expedited (15-DaCompany Report #C2002-0721.01 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Health Clozapine PS Mylan ORAL 400 MG QD, Professional ORAL Other Date:03/25/02ISR Number: 3888610-1Report Type:Expedited (15-DaCompany Report #C2002-0242.01 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Circulatory Collapse Health Clozapine PS ORAL 100 MG QD, Coronary Artery Occlusion Professional ORAL Myocardial Infarction Other Topirimate C Divalproex Sodium C Risperdal C Citalopram C Venlafaxine Xr C Clonidine C Amantadine C Fexofenadine C Azelastine Nasal Spray C Triamcinolone Nasal Spray C Medroxyprogesterone Contraceptive Injection C Date:03/25/02ISR Number: 3888703-9Report Type:Expedited (15-DaCompany Report #PHFR2002GB00642 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Level Increased Foreign Clozaril (Clozapine) Hepatic Steatosis Study Tablet PS ORAL 550MG/DAY, Lower Respiratory Tract Health ORAL Infection Professional Amoxicillin Sudden Death Other (Amoxicillin) C Lithium (Lithium Carbonate) C Citalopram (Citalopram) C Hyoscine (Hyoscine) C Date:03/25/02ISR Number: 3888705-2Report Type:Expedited (15-DaCompany Report #PHFR2002GB01154 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiac Murmur Foreign Clozaril(Clozapine) Health Tablet PS ORAL ORAL Professional Other 22-Feb-2006 08:30 AM Page: 1560 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/25/02ISR Number: 3888707-6Report Type:Expedited (15-DaCompany Report #PHBS2002AU03673 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bundle Branch Block Foreign Clozaril(Clozapine) Electrocardiogram Pr Health Tablet PS ORAL 100 MG, QD, Prolongation Professional ORAL Other Date:03/25/02ISR Number: 3888720-9Report Type:Expedited (15-DaCompany Report #PHBS2002DE03656 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Foreign Clozapine Initial or Prolonged Anxiety Literature (Clozapine) PS ORAL 400 MG/D, Blood Potassium Decreased Health ORAL Dehydration Professional Delirium Other Depressed Level Of Consciousness Drug Level Above Therapeutic Electrocardiogram T Wave Abnormal Electroencephalogram Abnormal Hallucination, Auditory Hallucination, Visual Hypothermia Intentional Overdose Leukocytosis Memory Impairment Miosis Subileus Suicide Attempt Tachycardia Date:03/25/02ISR Number: 3888722-2Report Type:Expedited (15-DaCompany Report #PHFR2002GB01010 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Drug Interaction Foreign Clozaril (Clozapine Drug Level Above Health Tablet PS ORAL 350 MG/DAY, Therapeutic Professional ORAL Grand Mal Convulsion Other Venlafaxine (Venlafaxine) C Pirenzepine (Pirenzepine) C Date:03/26/02ISR Number: 3889042-2Report Type:Expedited (15-DaCompany Report #PHEH2002US02853 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Lung Neoplasm Malignant Other Clozaril (Clozapine) Initial or Prolonged Tablet PS ORAL 450MG, ORAL Niacin C Asa C 22-Feb-2006 08:30 AM Page: 1561 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/26/02ISR Number: 3889231-7Report Type:Expedited (15-DaCompany Report #C2002-0578.01 Age:86 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death White Blood Cell Count Health Clozapine Tablets 25 Abnormal Professional Mg Mylan PS ORAL 25 MG QD, Other ORAL Date:03/26/02ISR Number: 3889790-4Report Type:Expedited (15-DaCompany Report #PHBS2002SE03681 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acute Febrile Foreign Leponex (Clozapine) PS Initial or Prolonged Neutrophilic Dermatosis Health Lithium (Lithium) C Professional Other Date:03/26/02ISR Number: 3889792-8Report Type:Expedited (15-DaCompany Report #PHNU2002DE01076 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Mitral Valve Prolapse Foreign Leponex/Clozaril(Clo Palpitations Health zapine) (Clozapine) Ventricular Extrasystoles Professional Tablet PS ORAL 275MG/DAY, Other ORAL Fevarin (Fluvoxamine Maleate) C Date:03/26/02ISR Number: 3889825-9Report Type:Expedited (15-DaCompany Report #PHFR2001GB03294 Age:55 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Neoplasm Malignant Foreign Clozaril (Clozapine) Metastases To Bone Health Tablet PS ORAL 250 M/DAY, Professional ORAL Other Date:03/26/02ISR Number: 3889859-4Report Type:Expedited (15-DaCompany Report #PHBS2002SE03681 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acute Febrile Foreign Leponex(Clozapine) PS Initial or Prolonged Neutrophilic Dermatosis Health Lithium (Lithium) C Pyrexia Professional Rash Other Date:03/27/02ISR Number: 3890808-3Report Type:Direct Company Report #CTU 164397 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Myocarditis Clozapine 100mg Mylan Pharmaceuticals PS Mylan Pharmaceuticals ORAL 50MG AM, 100MG HS PO Risperidone C Benztropine C 22-Feb-2006 08:30 AM Page: 1562 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/27/02ISR Number: 3890861-7Report Type:Expedited (15-DaCompany Report #C2002-0793.01 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death White Blood Cell Count Health Clozapine Tablets 25 Abnormal Professional Mg Mylan PS ORAL 12.5MG QD, Other ORAL Date:03/27/02ISR Number: 3890864-2Report Type:Expedited (15-DaCompany Report #C2002-0354.01 Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Glucose Increased Health Clozapine Tablets Circulatory Collapse Professional 100 Mg Mylan PS ORAL 100 MG Q AM, Drug Level Changed Other 200 MG, ORAL Medication Error Potassium Chloride C Obsessive-Compulsive Omeprazole C Disorder Furosemide C Fluvastatin C Metoclopramide C Loxapine C Benztropine C Fluvoxamine C Gemfibrozil C Hydrocodone/Apap C Diazepam C Date:03/27/02ISR Number: 3890900-3Report Type:Expedited (15-DaCompany Report #PHEH2002US02785 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Breast Cancer Stage Iv Other Clozaril (Clozapine) Tablet PS ORAL 250 MG, ORAL Date:03/27/02ISR Number: 3890990-8Report Type:Expedited (15-DaCompany Report #PHFR2001GB02974 Age:26 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Alcohol Poisoning Foreign Clozaril (Clozapine) Choking Study Tablet PS ORAL 100 MG, TID, Drug Level Increased Health ORAL Intentional Overdose Professional Paracetamol Other (Paracetamol) SS Alcohol (Ethanol) SS Date:03/27/02ISR Number: 3891029-0Report Type:Expedited (15-DaCompany Report #PHBS2002SE03818 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Meningitis Foreign Leponex (Clozapine) Hospitalization - Mobility Decreased Consumer Unknown PS Initial or Prolonged Muscle Spasms Other Muscle Spasticity Myocarditis Pyrexia Therapeutic Agent Toxicity 22-Feb-2006 08:30 AM Page: 1563 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/28/02ISR Number: 3890219-0Report Type:Expedited (15-DaCompany Report #309776 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Clonic Convulsion Levodopa PS Roche Initial or Prolonged Drug Withdrawal Syndrome Clozaril SS Medication Error Paroxetine SS Memory Impairment Pramipexole C Neuroleptic Malignant Syndrome Oral Intake Reduced Date:03/29/02ISR Number: 3892331-9Report Type:Expedited (15-DaCompany Report #PHNU2002DE01138 Age:69 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anorexia Foreign Leponex (Clozapine) Decreased Activity Other Tablet PS ORAL ORAL Hypotension Aspirin "Bayer" C Leukocytosis Pain Date:03/29/02ISR Number: 3892334-4Report Type:Expedited (15-DaCompany Report #PHFR2002GB01173 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Peritonsillar Abscess Foreign Clozaril (Clozapine) Initial or Prolonged Health (Clozapine) Tablet PS ORAL ORAL Professional Date:03/29/02ISR Number: 3892348-4Report Type:Expedited (15-DaCompany Report #PHNU2002DE01120 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Colitis Foreign Leponex/Clozaril Diarrhoea Health (Clozapine)(Clozapin Eosinophilia Professional e) Tablet, 100 Mg PS ORAL ORAL Leukocytosis Other Date:03/29/02ISR Number: 3892584-7Report Type:Expedited (15-DaCompany Report #PHNU2002DE01127 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiomegaly Foreign Leponex / Clozaril Electrocardiogram Health (Clozapine) Abnormal Professional (Clozapine) Tablet PS ORAL 300MG/DAY, Psychotic Disorder Other ORAL Date:04/01/02ISR Number: 3892036-4Report Type:Expedited (15-DaCompany Report #308614 Age:28 YR Gender:Male I/FU:F Outcome PT Hospitalization - Agranulocytosis Initial or Prolonged Cellulitis Drug Interaction Extrapyramidal Disorder Laryngeal Oedema 22-Feb-2006 08:30 AM Page: 1564 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Leukopenia Purulence Thrombocytopenia Report Source Product Role Manufacturer Route Dose Duration Tonsillitis Interferon Alfa-2a PS Roche Clozapine SS 1096 DAY Date:04/01/02ISR Number: 3892093-5Report Type:Expedited (15-DaCompany Report #NSADSS2002004781 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Atrial Flutter Risperdal PS ORAL Cardiomyopathy Clozapine SS ORAL Coronary Artery Disease Date:04/01/02ISR Number: 3892761-5Report Type:Direct Company Report #CTU 164674 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Clozapine Ivax Hospitalization - Pharmaceuticals PS Ivax Pharmacertuals ORAL 250MG PO Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage Date:04/01/02ISR Number: 3893111-0Report Type:Expedited (15-DaCompany Report #PHNU2002DE01127 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiomegaly Foreign Leponex / Clozaril Electrocardiogram Health (Clozapine) Abnormal Professional (Clozapine) Tablet PS ORAL 300MG/DAY, Other ORAL Date:04/01/02ISR Number: 3893112-2Report Type:Expedited (15-DaCompany Report #PHFR2001GB03196 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril (Clozapine) Non-Insulin-Dependent Health Tablet PS ORAL 700MG/DAY, Professional ORAL Other Sulpiride (Sulpiride) C Date:04/01/02ISR Number: 3893114-6Report Type:Expedited (15-DaCompany Report #PHBS2002AU02135 Age:60 YR Gender:Male I/FU:I Outcome PT Death Asthenia Hospitalization - Coordination Abnormal Initial or Prolonged Dizziness Other Drug Level Increased Dysstasia Eating Disorder Fall 22-Feb-2006 08:30 AM Page: 1565 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Malaise Oral Intake Reduced Somnolence Report Source Product Role Manufacturer Route Dose Duration Suicidal Ideation Foreign Clozaril (Clozapine) Study Tablet PS ORAL 400-500 Health MG/DAY, ORAL Professional Clonazepam Other (Clonzepam) SS Lipex C Epilim C Cipramil C Temazepam C Zoloft 9sertraline Hydrochloride) C Cardizem (Diltiazem Hydrochloride) C Pepcidin C Alphapril C Lipitor (Atovastatin) C Daonil C Renetac C Date:04/01/02ISR Number: 3893116-XReport Type:Expedited (15-DaCompany Report #PHFR2002GB01217 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Keratitis Foreign Clozaril (Clozapine) Health Tablet PS ORAL 300 MG/DAY, Professional ORAL Other Date:04/01/02ISR Number: 3893119-5Report Type:Expedited (15-DaCompany Report #PHBS2002SE03818 Age:72 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Fall Foreign Leponex (Clozapine) Hospitalization - Fatigue Consumer Tablet PS Initial or Prolonged Feeling Abnormal Other Waran (Warfarin Meningitis Sodium) C Muscle Spasms Cipramil C Muscle Spasticity Daonil C Myocarditis Enconcort C Pyrexia Glucophage "Abic" C Therapeutic Agent Hermolepsin C Toxicity Inhibace "Andreu" C Lasix Retard C Lomir C Triobe (Pyridoxine) C Insulatard (Insulin Human Injection, Isophane) C Cisordinol (Zuclopenthixol Hydrochloride, Clophenthixol Hydrochloride) C Stesolid C 22-Feb-2006 08:30 AM Page: 1566 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/01/02ISR Number: 3893143-2Report Type:Expedited (15-DaCompany Report #PHRM2002FR00589 Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperglycaemia Foreign Leponex (Clozapine) Initial or Prolonged Hypertriglyceridaemia Health Tabelet PS ORAL SEE IMAGE Polydipsia Professional Polyuria Other Weight Decreased Date:04/01/02ISR Number: 3893149-3Report Type:Expedited (15-DaCompany Report #D0038136A Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Intentional Overdose Foreign Paxil Tablet Hospitalization - Suicide Attempt Health (Paroxetine Initial or Prolonged Tachycardia Professional Hydrochloride) PS ORAL 4 TABLET Tremor SINGLE DOSE/ORAL Clozapine Tablet (Clozapine) SS ORAL 100 TABLET / SINGLE DOSE / ORAL Date:04/01/02ISR Number: 3893254-1Report Type:Expedited (15-DaCompany Report #02-03-0272 Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc PS Ivax Pharmaceuticals, Inc ORAL 12.5-25MG QD ORAL Date:04/01/02ISR Number: 3893255-3Report Type:Expedited (15-DaCompany Report #02-03-0273 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatitis C Health Clozapine Tablets PS Ivax Professional Pharmaceuticals, Inc ORAL 500MG QD ORAL Axid C Date:04/01/02ISR Number: 3893256-5Report Type:Expedited (15-DaCompany Report #02-03-0267 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hip Fracture Health Clozapine Tablets PS Ivax Pharmaceuticals Initial or Prolonged Professional Inc ORAL 12.5-75MG QD Other ORAL Florinef C Paxil C Zantac C Mirapex C Sinemet-Cr C 22-Feb-2006 08:30 AM Page: 1567 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/01/02ISR Number: 3893257-7Report Type:Expedited (15-DaCompany Report #02-03-0266 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Health Clozapine Tablets PS Ivax Initial or Prolonged Refusal Of Treatment By Professional Pharmaceuticals, Inc ORAL 200MG BID Patient Other ORAL 7 MON Accupril C Asa C Date:04/01/02ISR Number: 3893283-8Report Type:Expedited (15-DaCompany Report #309776 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Withdrawal Syndrome Literature Levodopa (Levodopa) PS 900 MG DAILY Initial or Prolonged Medication Error Health Clozaril (Clozapine) SS 50 MG DAILY Neuroleptic Malignant Professional Paroxetine Syndrome (Paroxetine) SS 20 MG DAILY Parkinsonism Pramipexol (Pramipexole) C Date:04/01/02ISR Number: 3893296-6Report Type:Expedited (15-DaCompany Report #PHFR2002GB01080 Age:65 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Q Wave Foreign Clozaril(Clozapine) Abnormal Health Tablet PS ORAL 50MG/DAY, Electrocardiogram Qt Professional ORAL Corrected Interval Other Prolonged Date:04/01/02ISR Number: 3893298-XReport Type:Expedited (15-DaCompany Report #PHBS2002CA03306 Age:25 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dyspnoea Foreign Clozaril (Clozapine) Respiratory Distress Health Tablet PS ORAL 150 MG/D, Professional ORAL Other Epival (Valproate Semisodium) C Risperdal (Risperidone) C Date:04/01/02ISR Number: 3893422-9Report Type:Expedited (15-DaCompany Report #C2002-0468.01 Age:84 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Chronic Obstructive Health Clozapine Tablets 25 Pulmonary Disease Professional Mg PS Mylan ORAL 75MG Q HS Pneumonia Other ORAL Carbidopa/Levodopa C Loratadine C Morphine C Quetiapine C Diazepam C Levofloxacin C Flumadine C 22-Feb-2006 08:30 AM Page: 1568 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/01/02ISR Number: 3893423-0Report Type:Expedited (15-DaCompany Report #02-03-0286 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Glucose Abnormal Health Clozapine PS Ivax Professional Pharmaceuticals, Inc ORAL 325MG QD ORAL Other Date:04/01/02ISR Number: 3893425-4Report Type:Expedited (15-DaCompany Report #02-03-0278 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Gastrointestinal Health Clozapine Tablets PS Ivax Haemorrhage Professional Pharmaceuticals, Inc ORAL ORAL Other Date:04/01/02ISR Number: 3893426-6Report Type:Expedited (15-DaCompany Report #02-03-0284 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coronary Artery Embolism Health Clozapine Tablets PS Ivax Pharmaceuticals Professional Inc ORAL 625-750MG QD Other ORAL Date:04/01/02ISR Number: 3893428-XReport Type:Expedited (15-DaCompany Report #02-03-0282 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neoplasm Malignant Health Clozapine Tablets PS Ivax Professional Pharmaceuticals, Inc ORAL 500-800MG Other ORAL Date:04/01/02ISR Number: 3893431-XReport Type:Expedited (15-DaCompany Report #02-03-0285 Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Multi-Organ Failure Health Clozapine Tablets PS Ivax Respiratory Failure Professional Pharmaceuticals, Inc ORAL 100-600MG QD Other ORAL Date:04/01/02ISR Number: 3893467-9Report Type:Expedited (15-DaCompany Report #PHEH2002US02398 Age:78 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cognitive Disorder Health Clozaril (Clozapine) Hip Fracture Professional Tablet PS ORAL 25MG DAILY, Parkinson'S Disease ORAL Sinemet (Carbidopa) C Date:04/01/02ISR Number: 3893488-6Report Type:Expedited (15-DaCompany Report #PHFR2001GB03371 Age:41 YR Gender:Female I/FU:F Outcome PT Report Source Other Hypogammaglobulinaemia Foreign Immune System Disorder Health Professional 22-Feb-2006 08:30 AM Page: 1569 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Product Role Manufacturer Route Dose Duration Clozaril(Clozapine) Tablet PS 300MG MANE, 350 NOCTE, ORAL Clomipramine (Clomipramine) C Date:04/01/02ISR Number: 3893489-8Report Type:Expedited (15-DaCompany Report #PHNU2002DE01127 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiomegaly Foreign Leponex / Clozaril Echocardiogram Abnormal Health (Clozapine) Electrocardiogram Professional (Clozapine) Tablet PS ORAL 300MG/DAY, Abnormal Other ORAL Psychotic Disorder Date:04/01/02ISR Number: 3893562-4Report Type:Expedited (15-DaCompany Report #PHFR2001GB03460 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Pressure Increased Foreign Clozaril(Clozapine)T Other Coronary Artery Occlusion Health ablet PS ORAL 225 Rash Professional MG/DAY,ORAL; Rash Pruritic Other 100 MG/DAY, White Blood Cell Count ORAL Increased Date:04/01/02ISR Number: 3893678-2Report Type:Expedited (15-DaCompany Report #C2002-0510.01 Age:69 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Disease Progression Health Clozapine Tablets Pancreatic Carcinoma Professional 100mg Mylan PS Mylan ORAL 100MG BID, Other ORAL Metformin C Glipizide C Etodolac C Metoprolol C Loratidine/Pseudoeph edrine C Hydrocodone/Apap C Iron C Tolterodine C Date:04/01/02ISR Number: 3895206-4Report Type:Periodic Company Report #2001086628US Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Health Adriamycin Pfs Professional (Doxorubicin Other Hydrochloride) Solution, Sterile PS Cytoxan 22-Feb-2006 08:30 AM Page: 1570 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Cyclophosphamide) SS Clozapine (Clozapine) SS Date:04/02/02ISR Number: 3894200-7Report Type:Expedited (15-DaCompany Report #NSADSS2002004781 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Atrial Flutter Foreign Risperdal (Tablet) Cardiomyopathy Health (Risperidone) PS ORAL 2 MG, ORAL Eosinophilic Pneumonia Professional Clozapine Company (Clozapine) SS ORAL ORAL Representative Date:04/02/02ISR Number: 3894846-6Report Type:Expedited (15-DaCompany Report #A206369 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Foreign Ziprasidone PS ORAL 160.00 MG Initial or Prolonged Anxiety Consumer TOTAL:DAILY:O Hyperhidrosis RAL Panic Attack Leponex SS ORAL 100.00 MG TOTAL:DAILY:O RAL Haldol (Haloperidol) C Seroxat (Paroxetine) C Theralen C Date:04/03/02ISR Number: 3893813-6Report Type:Expedited (15-DaCompany Report #C2002-0532.01 Age:31 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional 100mg Mylan PS Mylan ORAL 500MG, QD, Other ORAL Oxycodone Controlled Release C Date:04/03/02ISR Number: 3893816-1Report Type:Expedited (15-DaCompany Report #C2002-0890.01 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 150MG Q AM, Other 200MG Q HS, ORAL Metformin C Various Inhalers And Breathing Treatments C Date:04/03/02ISR Number: 3894789-8Report Type:Direct Company Report #CTU 164940 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Eosinophil Count Clozapine 100 Mg Increased 1vax (2-Goldline) PS ORAL 200 MG PO H.S.; 100 A 22-Feb-2006 08:30 AM Page: 1571 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report PO AM Date:04/03/02ISR Number: 3895699-2Report Type:Expedited (15-DaCompany Report #PHFR2002GB01210 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bundle Branch Block Foreign Clozaril (Clozapine) Heart Rate Increased Health (Clozapine) Tablet PS ORAL 12.5MG/DAY, Palpitations Professional ORAL Other Haloperidol Decanoate (Haloperidol Decanoate) C Haloperidol C Date:04/03/02ISR Number: 3896863-9Report Type:Expedited (15-DaCompany Report #C2002-0879.01 Age:73 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bronchitis Health Clozapine Tablets Hepatic Neoplasm Professional 100 Mg Mylan PS ORAL 100MG BID, Malignant Other ORAL Lung Neoplasm Malignant Pneumonia Date:04/04/02ISR Number: 3895640-2Report Type:Expedited (15-DaCompany Report #PHEH2002US03072 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Health Clozaril(Clozapine) PS ORAL 100 MG, UNK, Professional ORAL Date:04/04/02ISR Number: 3895642-6Report Type:Expedited (15-DaCompany Report #PHEH2002US03107 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Clozaril (Clozapine) PS ORAL 400 MG, UNK, Congestive Professional ORAL Date:04/04/02ISR Number: 3895788-2Report Type:Expedited (15-DaCompany Report #PHBS2002IT04146 Age:43 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Hyperglycaemia Foreign Leponex (Clozapine) PS ORAL 400 MG/DAY, Hypertriglyceridaemia Health ORAL Professional Other Date:04/04/02ISR Number: 3895790-0Report Type:Expedited (15-DaCompany Report #PHRM2002FR01034 Age:31 YR Gender:Male I/FU:I Outcome PT Hospitalization - Diabetes Mellitus Initial or Prolonged Insulin-Dependent Hypercholesterolaemia Hypertriglyceridaemia 22-Feb-2006 08:30 AM Page: 1572 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Weight Decreased Report Source Product Role Manufacturer Route Dose Duration Foreign Leponex (Clozapine) Health Tablet PS ORAL 75 MG DAILY, Professional ORAL Other Date:04/05/02ISR Number: 3895639-6Report Type:Expedited (15-DaCompany Report #C2002-0819.01 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bladder Cancer Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 50 MG QD, Other ORAL Clozapine Tablets 100 Mg Mylan SS Mylan ORAL 100 MG QD, ORAL Date:04/05/02ISR Number: 3896321-1Report Type:Direct Company Report #CTU 165071 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dizziness Clozapine 100mg Tabs PS ORAL 200MG PO BID Initial or Prolonged Fall Depakote 500mg Tabs SS ORAL 500MG PO BID Pancytopenia Ranitidine 150mg Pyrexia Tabs SS ORAL 150MG PO BID Benztropine C Docusate C Propranolol C Date:04/05/02ISR Number: 3896322-3Report Type:Direct Company Report #CTU 165072 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pyrexia Clozapine PS ORAL 125MG PO BID Initial or Prolonged Tachycardia Divalprox C Acetaminophen C Chlorpromazine C Date:04/08/02ISR Number: 3897015-9Report Type:Expedited (15-DaCompany Report #02-03-0297 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Literature Clozapine (Ivax Initial or Prolonged Blood Amylase Increased Health Pharmaceuticals, Inc Other Dehydration Professional Tablets PS ORAL 50MG BID ORAL 8 MON Diabetic Ketoacidosis Sertraline C Glycosylated Haemoglobin Ranitidine C Increased Trihexyphenidyl C Lipase Increased Vomiting Weight Fluctuation 22-Feb-2006 08:30 AM Page: 1573 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/08/02ISR Number: 3897017-2Report Type:Expedited (15-DaCompany Report #02-03-0302 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine -Ivax Professional Pharmaceuticals, Inc Other Tablets PS 600MG QD ORAL Date:04/08/02ISR Number: 3897019-6Report Type:Expedited (15-DaCompany Report #02-04-0299 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Health Clozapine - Ivax Initial or Prolonged Reflux Oesophagitis Professional Pharmaceuticals, Inc Other Tablets PS ORAL 100-500MG QD ORAL Date:04/08/02ISR Number: 3897021-4Report Type:Expedited (15-DaCompany Report #02-03-0301 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hepatic Neoplasm Health Clozapine - Ivax Malignant Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 50-125MG QD ORAL Date:04/08/02ISR Number: 3897022-6Report Type:Expedited (15-DaCompany Report #02-03-0295 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Toxicity Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Inc Other Tablets PS ORAL 400MG QD ORAL Coumadin Tablets SS ORAL Date:04/08/02ISR Number: 3897404-2Report Type:Expedited (15-DaCompany Report #02P-056-0190259-00 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Ileus Paralytic Foreign Akineton Lp Renal Impairment Health (Akineton) Shock Professional (Biperiden) PS ORAL 4 MG 1 IN 1 D PER ORAL Zopiclone SS 7.5 MG 2 IN 1 D PER ORAL Levomepromazine SS ORAL 25 MG 2 IN 1 D PER ORAL Lorazepam SS ORAL 2.5 MG 3 IN 1 D PER ORAL Leponex SS ORAL 100 MG 1 IN 1 D PER ORAL 22-Feb-2006 08:30 AM Page: 1574 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/09/02ISR Number: 3896720-8Report Type:Direct Company Report #CTU 165228 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Unevaluable Event Clozapine PS Mylan ORAL CLOZAPINE Intervention to 300MG Q ORAL Prevent Permanent Clozapine 100mg Impairment/Damage Mylan SS Mylan ORAL CLOZAPIN 400 MG Q ORAL Ativan C Paxil C Date:04/09/02ISR Number: 3897876-3Report Type:Expedited (15-DaCompany Report #ENT 2002-0043 (0) Age:87 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Rhabdomyolysis Health Comtan (Entacapone) PS ORAL ORAL Professional Leponex SS ORAL ORAL Levodopa-Carbidopa C Exelon C Date:04/10/02ISR Number: 3898124-0Report Type:Expedited (15-DaCompany Report #PHEH2002US01131 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Apnoea Health Clozaril (Clozapine) Hospitalization - Bradycardia Professional Tablet PS ORAL 75 MG AM + Initial or Prolonged Cardiac Arrest 100MG HS, Dehydration ORAL Gastroenteritis Tylenol Haematemesis (Paracetamol) C Leukocytosis Colace C Pleural Effusion Fosamax (Alendronate Respiratory Arrest Sodium) C Milk Of Magnesia C Naprosyn C Acetaminophen (Paracetamol) C Vitamin E C Calcium C Cogentin (Benzatropine Mesilate) C Nizoral (Ketoconazole) C Dulcolax C Date:04/10/02ISR Number: 3898128-8Report Type:Expedited (15-DaCompany Report #PHEH2002US03106 Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozaril Professional (Clozapine)Tablet PS ORAL ORAL 22-Feb-2006 08:30 AM Page: 1575 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/10/02ISR Number: 3898237-3Report Type:Expedited (15-DaCompany Report #PHBS2002CA03522 Age:56 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Cancer Foreign Clozaril(Clozapine)T Neutrophil Count Health ablet PS ORAL 200 MG/DAY, Decreased Professional ORAL White Blood Cell Count Other Epival (Valproate Decreased Semisodium) C Altace (Ramipril) C Celebrex (Celecoxib) C Glyburide C Colace C Topamax (Topiramate) C Date:04/10/02ISR Number: 3898334-2Report Type:Expedited (15-DaCompany Report #PHFR2002GB00834 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anaemia Foreign Clozaril (Clozapine) Change Of Bowel Habit Study Tablet PS ORAL 600MG/DAY, Colon Cancer Health ORAL Constipation Professional Metformin Metastases To Liver Other (Metformin) C Weight Decreased Olanzapine (Olanzapine) C Date:04/10/02ISR Number: 3898338-XReport Type:Expedited (15-DaCompany Report #PHFR2001GB03141 Age:59 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Pressure Increased Foreign Clozaril (Clozapine) Feeling Abnormal Health Tablet PS ORAL 100MG Heart Rate Increased Professional MANE/125MG Transient Ischaemic Other NOCTE, ORAL Attack Date:04/10/02ISR Number: 3898466-9Report Type:Expedited (15-DaCompany Report #PHFR2001GB03151 Age:55 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril (Clozapine) PS ORAL 600MG/DAY, Health ORAL Professional Other Date:04/10/02ISR Number: 3898660-7Report Type:Expedited (15-DaCompany Report #PHRM2002FR01067 Age:32 YR Gender:Male I/FU:I Outcome PT Life-Threatening Acute Respiratory Hospitalization - Distress Syndrome Initial or Prolonged Confusional State Diabetic Hyperosmolar Coma Diabetic Ketoacidosis Dialysis Hyperglycaemia 22-Feb-2006 08:30 AM Page: 1576 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hypotension Hypovolaemic Shock Leukocytosis Report Source Product Role Manufacturer Route Dose Duration Renal Failure Acute Foreign Leponex (Clozapine) Tachycardia Health Tablet PS ORAL 200 MG, TID, Professional ORAL Other Clozapine (Clozapine) Tablet SS ORAL 600 MG/DAY, ORAL Loxen C Primperan (Metoclopramide) C Smecta "Ipsen" (Smectite) Powder C Date:04/10/02ISR Number: 3899482-3Report Type:Expedited (15-DaCompany Report #C2002-0898.01 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional 100mg Mylan PS Mylan ORAL 650MG, QD, Other ORAL Benztropine C Fluoxetine C Haloperidol C Lorazepam C Oxybutynin C Date:04/10/02ISR Number: 3903702-6Report Type:Expedited (15-DaCompany Report #308614 Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Foreign Interferon Alfa-2a Initial or Prolonged Disturbance In Attention Literature (Interferon Alfa-2a) PS INTRA-UTERINE 6 MILLIONIU 3 Drug Interaction Health PER WEEK Electrocardiogram Professional Clozapine(Clozapine) SS 150 MG DAILY 1096 DAY Abnormal Extrapyramidal Disorder Laryngeal Oedema Leukopenia Lymphadenopathy Purulence Thrombocytopenia Tonsillitis Date:04/11/02ISR Number: 3899479-3Report Type:Expedited (15-DaCompany Report #B0263840A Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Foreign Paxil (Formulation Initial or Prolonged Fluctuation Unknown) (Paroxetine Overdose Hydrochloride) PS ORAL ORAL Pulse Abnormal Clozapine (Formulation Unknown) (Clozapine) SS ORAL 800 MG PER DAY ORAL Diazepam (Formulation 22-Feb-2006 08:30 AM Page: 1577 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Unknown) (Diazepam) SS Date:04/12/02ISR Number: 3900198-5Report Type:Expedited (15-DaCompany Report #034-0945-M0200002 Age:21 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Foreign Gabapentin Drug Interaction Health (Gabapentin) PS ORAL 1200 MG(TID), Neutropenia Professional PER ORAL Company Clozapine SS ORAL 350 MG (TWICE Representative DAILY), PER ORAL Date:04/12/02ISR Number: 3900706-4Report Type:Expedited (15-DaCompany Report #C2002-0911.01 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 400MG Q HS, Other ORAL Date:04/15/02ISR Number: 3900688-5Report Type:Expedited (15-DaCompany Report #02-04-0324 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Congestive Cardiomyopathy Health Clozapine - Ivax Sudden Death Professional Pharmaceuticals, Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 450MG QD ORAL Date:04/15/02ISR Number: 3900690-3Report Type:Expedited (15-DaCompany Report #02-04-0325 Age:71 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 400MG QD ORAL Date:04/15/02ISR Number: 3900692-7Report Type:Expedited (15-DaCompany Report #C2002-0977.01 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Health Clozapine Tablets Convulsion Professional 100 Mg Mylan PS Mylan ORAL 100MG BID, Pharmaceutical Product Other 500MG Q HS, Complaint ORAL 22-Feb-2006 08:30 AM Page: 1578 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/15/02ISR Number: 3900696-4Report Type:Expedited (15-DaCompany Report #02-03-0242 Age:25 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anoxia Health Clozapine Tablets - Convulsion Professional Ivax Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 100MG AM ORAL Ativan C Depakote C Celexa C Date:04/15/02ISR Number: 3900697-6Report Type:Expedited (15-DaCompany Report #02-04-0308 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS ORAL 225MG QD ORAL Date:04/15/02ISR Number: 3900698-8Report Type:Expedited (15-DaCompany Report #02-04-0309 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chronic Obstructive Health Clozapine Tablets - Initial or Prolonged Pulmonary Disease Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 100-400MG QD ORAL Date:04/15/02ISR Number: 3900699-XReport Type:Expedited (15-DaCompany Report #02-04-0310 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neoplasm Malignant Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 500-900 QD ORAL Date:04/15/02ISR Number: 3900700-3Report Type:Expedited (15-DaCompany Report #02-04-0315 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Health Clozapine Tablets, Initial or Prolonged Thyroid Disorder Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 600-650MG QD ORAL 22-Feb-2006 08:30 AM Page: 1579 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/15/02ISR Number: 3900701-5Report Type:Expedited (15-DaCompany Report #02-04-0322 Age:73 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arthritis Health Clozine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 200-300MG QD ORAL Date:04/15/02ISR Number: 3901243-3Report Type:Expedited (15-DaCompany Report #PHRM2002FR01056 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Ileus Paralytic Foreign Leponex(Clozapine) Hospitalization - Renal Failure Health Tablet PS ORAL 200 MG, BID, Initial or Prolonged Shock Professional ORAL Other Imovane (Zopiclone) Tablet SS ORAL 15 MG, QD, ORAL Akineton Retard (Biperiden Hydrochloride) Slow Release Tablet SS ORAL 4 MG, QD, ORAL Nozinan (Levomepromazine) Tablet SS ORAL 50 MG, QD, ORAL Temesta (Lorazepam) Tablet SS ORAL 7.5 MG, QD, ORAL Date:04/15/02ISR Number: 3901244-5Report Type:Expedited (15-DaCompany Report #PHRM2002FR01067 Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Acute Respiratory Foreign Leponex(Clozapine)Ta Hospitalization - Distress Syndrome Health blet PS ORAL 200 MG, TID, Initial or Prolonged Confusional State Professional ORAL Diabetic Hyperosmolar Other Clozapine Coma (Clozapine) Tablet SS ORAL 600 MG/DAY, Diabetic Ketoacidosis ORAL Dialysis Loxen C Diarrhoea Primperan Hyperglycaemia (Metoclopramide) C Hypotension Smecta "Ipsen" Hypovolaemic Shock (Smectite) C Ketonuria Leukocytosis Renal Failure Acute Sinus Tachycardia Tachypnoea 22-Feb-2006 08:30 AM Page: 1580 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/15/02ISR Number: 3901496-1Report Type:Expedited (15-DaCompany Report #PHFR2002GB01053 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Foreign Clozaril (Clozapine) Initial or Prolonged Fluctuation Health Tablet PS ORAL ORAL/SEE Pulse Abnormal Professional IMAGE Other Paroxetine (Paroxetine) SS Diazepam (Diazepam) SS Date:04/15/02ISR Number: 3901497-3Report Type:Expedited (15-DaCompany Report #PHFR2002GB01010 Age:21 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Drug Interaction Foreign Clozaril (Clozapine) Hospitalization - Grand Mal Convulsion Health Tablet PS ORAL SEE IMAGE Initial or Prolonged Professional Venlafaxine Other (Venlafaxine) SS 150 MG, BID Pirenzepine (Pirenzepine) C Date:04/16/02ISR Number: 3901383-9Report Type:Expedited (15-DaCompany Report #C2002-0956.01 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan Other Date:04/16/02ISR Number: 3901388-8Report Type:Expedited (15-DaCompany Report #02-03-0273 Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatitis C Health Clozapine - Ivax Professional Pharmaceuticals, Inc. Tablets PS ORAL 500 MG QD ORAL Date:04/16/02ISR Number: 3901389-XReport Type:Expedited (15-DaCompany Report #02-02-0203 Age:68 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Inguinal Hernia Health Clozapine - Ivax Hospitalization - Intestinal Obstruction Professional Pharmaceuticals, Initial or Prolonged Pneumonia Other Inc. Tablets PS Ivax Respiratory Failure Pharmaceuticals, Inc. ORAL 200 MG QHS ORAL Date:04/16/02ISR Number: 3901390-6Report Type:Expedited (15-DaCompany Report #02-04-0340 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pancreatic Carcinoma Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, 22-Feb-2006 08:30 AM Page: 1581 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Inc. PS Ivax Pharmaceuticals, Inc. ORAL 200-500MG QD ORAL Date:04/16/02ISR Number: 3901391-8Report Type:Expedited (15-DaCompany Report #02-04-0335 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS ORAL ORAL Date:04/16/02ISR Number: 3901392-XReport Type:Expedited (15-DaCompany Report #02-04-0333 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dementia Health Clozapine - Ivax Parkinson'S Disease Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 25MG QD ORAL Date:04/16/02ISR Number: 3901393-1Report Type:Expedited (15-DaCompany Report #02-04-0334 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiomyopathy Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 150-400MG QD ORAL Date:04/16/02ISR Number: 3901394-3Report Type:Expedited (15-DaCompany Report #02-04-0327 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hepatic Failure Health Clozapine - Ivax Renal Failure Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 400-600MG QD ORAL Date:04/16/02ISR Number: 3901395-5Report Type:Expedited (15-DaCompany Report #02-04-0326 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Neoplasm Malignant Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 150-425MG QD ORAL Chemotherapy C Date:04/16/02ISR Number: 3901434-1Report Type:Expedited (15-DaCompany Report #PHBS2001NZ04156 Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Hospitalization - Cardiomyopathy Foreign Initial or Prolonged Hypertension Health Other Pulmonary Congestion Professional 22-Feb-2006 08:30 AM Page: 1582 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Product Role Manufacturer Route Dose Duration Clozaril(Clozapine) Tablet PS ORAL 375 MG/D, ORAL Date:04/16/02ISR Number: 3901438-9Report Type:Expedited (15-DaCompany Report #PHFR2001GB03294 Age:55 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bronchial Carcinoma Foreign Clozaril(Clozapine) Lung Carcinoma Cell Type Health Tablet PS ORAL 250MG/DAY, Unspecified Stage Iv Professional ORAL Metastases To Bone Other Date:04/16/02ISR Number: 3901488-2Report Type:Expedited (15-DaCompany Report #PHFR2002GB01173 Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Clozaril (Clozapine) Initial or Prolonged Phosphokinase Increased Health (Clozapine) Tablet PS ORAL ORAL Lower Respiratory Tract Professional Infection Other Peritonsillar Abscess Respiratory Failure Date:04/16/02ISR Number: 3901498-5Report Type:Expedited (15-DaCompany Report #PHFR2002GB00969 Age:19 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dehydration Foreign Clozaril (Clozapine) Drug Level Increased Health Tablet PS ORAL 300MG/DAY, Electrocardiogram Professional ORAL Abnormal Other Ketonuria Liver Function Test Abnormal Starvation Ventricular Hypertrophy Weight Decreased Date:04/16/02ISR Number: 3901505-XReport Type:Expedited (15-DaCompany Report #PHNU2002DE01275 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Growth Retardation Foreign Leponex/Clozaril Maternal Drugs Affecting Health (Clozapine) Foetus Professional (Clozapine) PS TRANSPLACENTAL TRANSPLACENTA Other L 22-Feb-2006 08:30 AM Page: 1583 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/16/02ISR Number: 3901723-0Report Type:Expedited (15-DaCompany Report #PHEH2002US03107 Age:38 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Clozaril (Clozapine) Hospitalization - Congestive Professional Tablet PS ORAL 400 MG, ORAL Initial or Prolonged Circulatory Collapse Xanax (Alprazolam) C Tegretol C Prozac (Fluoxetine Hydrochloride) C Neurontin (Gabapentin) C Axid (Nizatidine) C Date:04/16/02ISR Number: 3901846-6Report Type:Expedited (15-DaCompany Report #PHBS2002LU04496 Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dehydration Foreign Clozapine(Clozapine) PS 18.75 Hospitalization - Delirium Tremens Literature MG/DAY,UNKNOW Initial or Prolonged Myocardial Infarction Health N Professional Levodopa (Levodopa) C Date:04/16/02ISR Number: 3901849-1Report Type:Expedited (15-DaCompany Report #PHBS2002LU04502 Age:76 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eosinophilia Foreign Clozapine(Clozapine) PS 18.6 MG/DAY, Renal Failure Acute Literature UNKNOWN Health L-Dopa (Levodopa) C Professional Bromocriptine (Bromocriptine) C Date:04/16/02ISR Number: 3901850-8Report Type:Expedited (15-DaCompany Report #PHBS2002LU04503 Age:57 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cholangitis Foreign Clozapine(Clozapine) PS 75 MG/DAY, Grand Mal Convulsion Literature UNKNOWN Health L-Dopa (Levodopa) C Professional Date:04/16/02ISR Number: 3901852-1Report Type:Expedited (15-DaCompany Report #PHNU2002DE01076 Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bundle Branch Block Right Foreign Leponex/Clozaril PS ORAL UNK,UNK, ORAL Mitral Valve Prolapse Health Fevarin(Fluvoxamine Palpitations Professional Maleate) C Ventricular Extrasystoles Date:04/16/02ISR Number: 3901871-5Report Type:Expedited (15-DaCompany Report #PHBS2002CA02865 Age:37 YR Gender:Female I/FU:F Outcome PT Hospitalization - Asthma Initial or Prolonged Pyrexia 22-Feb-2006 08:30 AM Page: 1584 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Rales Report Source Product Role Manufacturer Route Dose Duration Foreign Clozaril (Clozapine) Health Tablet PS ORAL 325 MG/D, Professional ORAL Other Lopresor (Metoprolol Tartrate, Metoprolol Tartrate) Tablet SS ORAL SEE IMAGE Metoprolol (Metoprolol) SS Dalmane (Flurazepam Hydrochloride) C Lipidil (Fenofibrate) C Pantoloc "Byk" (Pantoprazole Sodium) C Sennosides A+B (Sennoside A+B) C Docusate (Docusate) C Amitriptyline (Amitriptyline) C Bricanyl C Pulmicort C Date:04/16/02ISR Number: 3901872-7Report Type:Expedited (15-DaCompany Report #PHFR2002GB00916 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abortion Induced Foreign Clozaril (Clozapine) Pregnancy Other Tablet PS ORAL 325 MG/DAY, ORAL Valproate Sodium C Date:04/16/02ISR Number: 3901874-0Report Type:Expedited (15-DaCompany Report #PHBS2002AU04281 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Constipation Foreign Clozaril (Clozapine) Megacolon Health Tablet PS ORAL SEE IMAGE Professional Other Date:04/16/02ISR Number: 3901875-2Report Type:Expedited (15-DaCompany Report #PHNU2002DE00539 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Leponex / Clozaril Weight Increased Health Clozapine) Professional (Clozapine) Tablet PS ORAL 100 MG/DAY, Other ORAL 22-Feb-2006 08:30 AM Page: 1585 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/16/02ISR Number: 3901876-4Report Type:Expedited (15-DaCompany Report #PHBS2002AU03075 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril (Clozapine) Non-Insulin-Dependent Health Tablet PS OPHTHALMIC 500 MG/D, Urinary Tract Infection Professional OPHTHALMIC Other Losec (Omeprazole) C Vioxx (Rofecoxib) C Panadol (Paracetamol) C Date:04/16/02ISR Number: 3901880-6Report Type:Expedited (15-DaCompany Report #PHBS2002NZ04061 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Conjunctivitis Infective Foreign Clozaril (Clozapine) Erythema Health Tablet PS ORAL 250 MG/D, Face Oedema Professional ORAL Herpes Zoster Other Zovirax "Gloxo Liver Function Test Wellcome" C Abnormal Date:04/16/02ISR Number: 3901987-3Report Type:Expedited (15-DaCompany Report #PHNU2002DE01242 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cutaneous Lupus Foreign Leponec /Clozaril Erythematosus Health (Clozapine) Professional (Clozapine) Tablet PS ORAL ORAL Other Date:04/16/02ISR Number: 3901989-7Report Type:Expedited (15-DaCompany Report #PHRM2002FR01103 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Congestive Cardiomyopathy Foreign Leponex (Clozapine) PS ORAL 500 MG DAILY, Initial or Prolonged Health ORAL Professional Previscan Company (Fluindione) C Representative Diacor (Diltiazem Other Hydrochloride) C Date:04/16/02ISR Number: 3902012-0Report Type:Expedited (15-DaCompany Report #PHBS2002LU04500 Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Transient Ischaemic Foreign Clozapine Attack Literature (Clozapine) PS 37.5 MG/DAY Health L-Dopa (Levodopa) C Professional Bromocriptine Other (Bromocriptine) C 22-Feb-2006 08:30 AM Page: 1586 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/16/02ISR Number: 3902057-0Report Type:Expedited (15-DaCompany Report #PHEH2002US02451 Age:35 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Health Clozaril (Clozapine) Drug Exposure During Professional Tablet PS ORAL 200MG/DAY Pregnancy ORAL Pregnancy Avandia (Rosiglitazone Maleate) C Insulin (Insulin) C Zoloft (Sertraline Hydrochloride) C Date:04/16/02ISR Number: 3902062-4Report Type:Expedited (15-DaCompany Report #PHEH2002US03254 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hodgkin'S Disease Health Clozaril Professional (Clozapine)Tablet PS ORAL 175 MG QD ORAL Cogentin (Benzatropine Mesilate) C Date:04/16/02ISR Number: 3902081-8Report Type:Expedited (15-DaCompany Report #PHEH2002US03072 Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Health Clozaril (Clozapine) Hospitalization - Professional Tablet PS ORAL 150 MG/DAY, Initial or Prolonged ORAL Haldol C Cogentin (Benzatropine Mesilate) C Prozac (Fluoxetine Hydrochloride) C Valium C Ditropan (Oxybutynin) C Lasix C K-Dur C Prinivil (Lisinopril) C Glucotrol (Glipizide) C Coreg (Carvedilol) C Aspirin "Bayer" C Lanoxin C Date:04/16/02ISR Number: 3902239-8Report Type:Expedited (15-DaCompany Report #PHFR2002GB00990 Age:55 YR Gender:Male I/FU:F Outcome PT Other Anaemia Macrocytic Fatigue Lethargy Leukocytosis 22-Feb-2006 08:30 AM Page: 1587 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Monocyte Count Abnormal Myelofibrosis Neutrophilia Report Source Product Role Manufacturer Route Dose Duration Platelet Count Decreased Foreign Clozaril (Clozapine) Somnolence Health (Clozapine) Tablet PS ORAL 200 MG/DAY, Professional ORAL Other Ascorbic Acid (Ascorbic Acid) C Paroxetine (Paroxetine) C Ferrous Sulfate C Multivitamins (Ascorbic Acid, Panthenol, Retinol) C Date:04/16/02ISR Number: 3902265-9Report Type:Expedited (15-DaCompany Report #PHFR2002GB01009 Age:50 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Subarachnoid Haemorrhage Foreign Clozaril(Clozapine) Initial or Prolonged Health Tablet PS ORAL 400MG/DAY, Professional ORAL Other Date:04/17/02ISR Number: 3901922-8Report Type:Expedited (15-DaCompany Report #C2002-0091.01 Age:53 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Health Clozapine Tablets 25 Fatigue Professional Mg Mylan PS Mylan ORAL 25 MG @ 7AM, Pharmaceutical Product Other 25MG @ 8PM, Complaint ORAL Somnolence Clozapine Tablets Status Epilepticus 100 Mg Mylan SS Mylan ORAL 100MG Q AM, Urinary Tract Infection 100MG Q NOON, 200MG QHS, ORAL Divalproex Sodium (1500mg Qhs) C Phenytoin C Trazodone C Propranolol La C Ethinyl Estradiol/Norgestrol C Lactulose C Berocca Plus (Qd) C Lorazepam C Haloperidol C Trihexyphenidyl C Gabapentin C Date:04/17/02ISR Number: 3901988-5Report Type:Expedited (15-DaCompany Report #PHFR2002GB01277 Age:39 YR Gender:Female I/FU:I Outcome PT Other Cardiac Murmur Dyspnoea Hypertension 22-Feb-2006 08:30 AM Page: 1588 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tachycardia Report Source Product Role Manufacturer Route Dose Duration Foreign Clozaril (Clozapine) Health Tablet PS ORAL 100 MG/DAY, Professional ORAL Other Date:04/17/02ISR Number: 3902555-XReport Type:Expedited (15-DaCompany Report #02P-062-0188087-00 Age:18 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Foreign Akineton (Biperiden) Initial or Prolonged Sinus Tachycardia Health (Biperiden) PS ORAL 8 MG, 1 IN 1 Professional D, PER ORAL Leponex SS ORAL SEE IMAGE Date:04/18/02ISR Number: 3902609-8Report Type:Direct Company Report #CTU 166089 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Deep Vein Thrombosis Clozapine PS 500 MG HS Initial or Prolonged Vitamin E C Asa C Celexa C Klonopin C Date:04/18/02ISR Number: 3902611-6Report Type:Direct Company Report #CTU 166091 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Pericardial Effusion Clozapine PS 200 MG AM, Tachycardia 300 MG HS (INCREASING DOSES) Effexor C Colace C Quetiapine C Date:04/18/02ISR Number: 3902915-7Report Type:Expedited (15-DaCompany Report #PHBS2002AU04756 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiopulmonary Failure Foreign Clozaril (Clozapine) PS ORAL 300 MG/DAY, Pneumonia Study ORAL Health Professional Other Date:04/18/02ISR Number: 3902917-0Report Type:Expedited (15-DaCompany Report #PHBS2002TW04687 Age:34 YR Gender:Female I/FU:I Outcome PT Hospitalization - Aspartate Initial or Prolonged Aminotransferase Increased 22-Feb-2006 08:30 AM Page: 1589 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Asthenia Blood Creatine Phosphokinase Increased Report Source Product Role Manufacturer Route Dose Duration C-Reactive Protein Foreign Clozapine Increased Literature (Clozapine) Unknown PS 250 MG/DAY, Delusion Health UNKNOWN Depressed Level Of Professional Consciousness Other Dyskinesia Hallucination, Auditory Hyperhidrosis Leukocytosis Muscle Rigidity Neuroleptic Malignant Syndrome Oedema Peripheral Persecutory Delusion Pyrexia Respiratory Rate Increased Tachycardia Urinary Retention Water Intoxication Date:04/18/02ISR Number: 3902918-2Report Type:Expedited (15-DaCompany Report #PHRM2002FR01158 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Intentional Overdose Foreign Leponex Hospitalization - Suicide Attempt Health (Clozapine)Tablet PS ORAL 500 MG DAILY Initial or Prolonged Professional , ORAL ; 1400 Other MG, ONCE/SINGLE, ORAL Date:04/18/02ISR Number: 3902948-0Report Type:Expedited (15-DaCompany Report #PHEH2001US09288 Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Health Clozaril (Clozapine) PS ORAL 400 MG/DAY, Initial or Prolonged Dizziness Professional ORAL Fall Depakote (Valproate Pancytopenia Semisodium) SS 500 MG, BID Pyrexia Ranitidine (Ranitidine) SS 150 MG, BID Benzotropine (Benzotropine Mesilate) C Docusate Sodium C Propranolol C Valproic Acid C Date:04/18/02ISR Number: 3903093-0Report Type:Expedited (15-DaCompany Report #PHBS2002CA02694 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Death Pneumonia Foreign Study 22-Feb-2006 08:30 AM Page: 1590 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Health Professional Other Product Role Manufacturer Route Dose Duration Clozaril (Clozapine) Tablet PS ORAL ORAL Biaxin (Clarithromycin) C Date:04/18/02ISR Number: 3903094-2Report Type:Expedited (15-DaCompany Report #PHBS2001CA09027 Age:47 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Intentional Overdose Foreign Clozaril (Clozapine) PS ORAL 900 MG/D, Hospitalization - Neutrophil Count Study ORAL; 18 Initial or Prolonged Increased Health TABLETS/D, Pneumonia Aspiration Professional ORAL Suicide Attempt Other Motilium "Byk White Blood Cell Count Gulden" Abnormal (Domperidone) C Pantoloc "Solvay" (Pantoprazole Sodium) C Date:04/18/02ISR Number: 3903108-XReport Type:Expedited (15-DaCompany Report #PHFR2002GB01222 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Albumin Increased Foreign Clozaril (Clozapine) Initial or Prolonged Blood Alkaline Health Unknown PS ORAL 200 MG/DAY Phosphatase Increased Professional ORAL Blood Bicarbonate Other Docusate Sodium C Decreased Gliclazide Blood Calcium Decreased (Gliclazide) C Blood Cholesterol Increased Blood Osmolarity Increased Blood Sodium Decreased Blood Triglycerides Increased Electrolyte Imbalance Fatigue Hyperglycaemia Polydipsia Polyuria Red Blood Cell Sedimentation Rate Increased Date:04/18/02ISR Number: 3903124-8Report Type:Expedited (15-DaCompany Report #PHBS2002AU04562 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Clonic Convulsion Foreign Clozaril (Clozapine) PS ORAL 100 MG, BID, Initial or Prolonged Hypoxia Health ORAL Transient Ischaemic Professional Attack 22-Feb-2006 08:30 AM Page: 1591 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/18/02ISR Number: 3903223-0Report Type:Expedited (15-DaCompany Report #C2002-0991.01 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pharmaceutical Product Health Clozapine Tablets 25 Complaint Professional Mg Mylan PS Mylan ORAL 25 MG BID, Other THEN 50 MG BID, ORAL Buspirone C Carbidopa/Levodopa C Conjugated Estrogens C Divalproex C Pantoprazole C Date:04/18/02ISR Number: 3903224-2Report Type:Expedited (15-DaCompany Report #C2002-0990.01 Age:82 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 50 MG Q HS, Other ORAL Clozapine Tablets 100 Mg Mylan SS Mylan ORAL 200MG QHS, ORAL Date:04/18/02ISR Number: 3903225-4Report Type:Expedited (15-DaCompany Report #C2002-0358.01 Age:82 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Brain Neoplasm Health Clozapine Tablets Confusional State Professional 100 Mg Mylan PS Mylan ORAL 100 MG Q AM, Other 200MG Q HS, THEN 100MG Q AM, 300 MG Q HS, ORAL Chlorpromazine C Benztropine C Lorazepam C Date:04/18/02ISR Number: 3903226-6Report Type:Expedited (15-DaCompany Report #C2002-0720.01 Age:47 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Biliary Cirrhosis Primary Health Clozapine Tablets 25 Blood Bilirubin Increased Professional Mg Mylan PS Mylan ORAL 37.5MG - 50MG Sepsis Other QD, ORAL Furosemide C Spironolactone C Metronidazole C Colchicine C Glipizide C Urosodiol C Lithium C 22-Feb-2006 08:30 AM Page: 1592 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/18/02ISR Number: 3903227-8Report Type:Expedited (15-DaCompany Report #C2002-1029.01 Age:91 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 12.5MG QD, Other ORAL Acetaminophen/Codein e C Albuterol C Bromocriptine C Carbidopa/Levodopa Er C Potassium C Rofecoxib C Spironolactone C Date:04/18/02ISR Number: 3903672-0Report Type:Expedited (15-DaCompany Report #PHBS2002AU04676 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Clozaril (Clozapine) Chronic Obstructive Health Tablet PS ORAL 50 MG & 450 Pulmonary Disease Professional MG/DAY, ORAL Respiratory Failure Other Serevent (Salmeterol Xinafoate) C Flixotide Glaxo (Fluticasone Propionate) C Epilim C Cipramil C Frusemide C Ranitidine (Ranitidine) C Benztropine Mesylate (Benzatropine Mesilate) C Augmentin (Clavulanate Potassium) C Date:04/18/02ISR Number: 3904246-8Report Type:Expedited (15-DaCompany Report #PHFR2002GB01305 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Body Temperature Foreign Clozaril Initial or Prolonged Increased Health (Clozapine)Tablet PS ORAL 600 Cellulitis Professional MG/DAY,ORAL Deep Vein Thrombosis Other Neutrophil Count Increased White Blood Cell Count Increased 22-Feb-2006 08:30 AM Page: 1593 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/22/02ISR Number: 3904729-0Report Type:Expedited (15-DaCompany Report #PHEH2002US03444 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Body Temperature Health Clozaril(Clozapine) Hospitalization - Increased Professional Tablet PS ORAL 100 MG/DAY, Initial or Prolonged Pneumonia ORAL Pulmonary Congestion Clonazepam C Respiratory Failure Depakote (Valproate Sepsis Semisodium) C Ditropan Xl (Oxybutynin Hydrochloride) C Zoloft (Sertraline Hydrochloride) C Motrin C Mom-Hot (Methyl Salicylate, Extractum Fluidum Capsici) C Temazepam C Dulco-Laxo C Date:04/22/02ISR Number: 3905412-8Report Type:Expedited (15-DaCompany Report #PHBS2001CA09027 Age:47 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Intentional Overdose Foreign Clozaril(Clozapine) Hospitalization - Pneumonia Aspiration Study Tablet PS ORAL SEE IMAGE Initial or Prolonged Suicide Attempt Health Motilium "Byk Professional Gulden" Other (Domperidone) C Pantoloc "Solvay" (Pantoprazole Sodium) C Date:04/23/02ISR Number: 3905930-2Report Type:Expedited (15-DaCompany Report #PHBS2002AU00941 Age:37 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Laboratory Test Abnormal Foreign Clozaril(Clozapine) Troponin Health Tablet PS ORAL 800 MG, QD, Professional ORAL Other Clonazepam C Panadol (Paracetamol) C Date:04/23/02ISR Number: 3905931-4Report Type:Expedited (15-DaCompany Report #PHNU2002DE00913 Age:20 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiomyopathy Foreign Leponex / Clozaril Dilatation Ventricular Health (Clozapine)(Clozapin Myocarditis Professional e) Tablet PS ORAL ORAL Sinus Tachycardia Other Fluanxol "Bayer" Streptococcal Serology (Flupentixol Positive Dihydrochloride) C Ventricular Hypertrophy Akineton (Biperiden Ventricular Hypokinesia Hydrochloride) C 22-Feb-2006 08:30 AM Page: 1594 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/23/02ISR Number: 3905933-8Report Type:Expedited (15-DaCompany Report #PHFR2001GB03240 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eye Inflammation Foreign Clozaril(Clozapine) Macular Oedema Health Tablet PS ORAL 300 MG, BID, Retinal Professional ORAL Neovascularisation Other Retinal Pigmentation Retinal Vasculitis Retinitis Sarcoidosis Uveitis Vision Blurred White Blood Cell Count Increased Date:04/23/02ISR Number: 3905936-3Report Type:Expedited (15-DaCompany Report #PHBS2002AU03673 Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bundle Branch Block Foreign Clozaril(Clozapine) Electrocardiogram Pr Health Tablet PS ORAL 100 MG, QD, Prolongation Professional ORAL Date:04/23/02ISR Number: 3905938-7Report Type:Expedited (15-DaCompany Report #PHBS2002CO04597 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Distension Foreign Leponex(Clozapine) Abdominal Pain Health Tablet PS ORAL 300 MG/DAY, Acute Abdomen Professional ORAL Diarrhoea Other Rivotril C Headache Fenergan Pyrexia (Promethazine) C Sinogan C Date:04/23/02ISR Number: 3905940-5Report Type:Expedited (15-DaCompany Report #PHNU2002DE00476 Age:33 YR Gender:Male I/FU:I Outcome PT Hospitalization - Alanine Aminotransferase Initial or Prolonged Increased Blood Creatine Phosphokinase Increased Blood Creatinine Increased Blood Urea Increased Bundle Branch Block Left Cardiac Failure Cardiomegaly Congestive Cardiomyopathy Drug Level Decreased Dyspnoea Dyspnoea Exertional Ejection Fraction Decreased Electrocardiogram Qrs Complex Abnormal 22-Feb-2006 08:30 AM Page: 1595 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Gamma-Glutamyltransferase Increased Hepatic Enzyme Increased Report Source Product Role Manufacturer Route Dose Duration Laboratory Test Abnormal Foreign Leponex / Clozaril Mitral Valve Incompetence Health (Clozapine)(Clozapin Myocarditis Professional e) Tablet PS ORAL ORAL Productive Cough Other Novadral "Goedecke" Sinus Tachycardia (Norfenefrine Hydrochloride) C Zyloric "Fresenius" C Date:04/23/02ISR Number: 3905958-2Report Type:Expedited (15-DaCompany Report #PHBS2002NZ00899 Age:70 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Level Increased Foreign Clozaril (Clozapine) Erythema Health Tablet PS ORAL 250 MG/DAY , Incontinence Professional ORAL,SEE Lethargy Other IMAGE Metastases To Liver Nausea Pruritus Tremor Vomiting Weight Decreased Date:04/23/02ISR Number: 3906015-1Report Type:Expedited (15-DaCompany Report #PHRM2002FR01145 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Glomerulonephritis Acute Foreign Leponex Initial or Prolonged Renal Failure Acute Health (Clozapine)Tablet PS ORAL 50 MG/DAY, Professional ORAL Other Depakine C Lithium (Lithium) C Date:04/23/02ISR Number: 3906017-5Report Type:Expedited (15-DaCompany Report #PHBS2002AU04748 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril (Clozapine) Non-Insulin-Dependent Study Capsule PS ORAL 600 MG/DAY, Health ORAL Professional Aropax C Other Desmopressin (Desmopressin) C Date:04/23/02ISR Number: 3906020-5Report Type:Expedited (15-DaCompany Report #PHFR2001GB03321 Age:67 YR Gender:Male I/FU:F Outcome PT Death Agitation Hospitalization - Alveolitis Fibrosing Initial or Prolonged Angina Pectoris Other Iron Deficiency Anaemia Myocardial Ischaemia Orthostatic Hypotension 22-Feb-2006 08:30 AM Page: 1596 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Respiratory Distress Report Source Product Role Manufacturer Route Dose Duration Foreign Clozaril (Clozapine) Health Tablet PS ORAL 350MG/DAY, Professional ORAL Other Steroids Nos (No Ingredients/Substanc es) C Venlafaxine (Venlafaxine) C Prednisolone C Lansoprazole (Lansoprazole) C Nystatin (Nystatin) C Calcichew-D3 C Cloxapen (Cloxacillin Sodium) C Date:04/23/02ISR Number: 3906158-2Report Type:Expedited (15-DaCompany Report #PHFR2002GB01302 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Atrioventricular Block Foreign Clozaril(Clozapine) First Degree Health Tablet PS ORAL 175 MG/DAY, Dysarthria Professional ORAL Orthostatic Hypotension Other Pyrexia Date:04/23/02ISR Number: 3906831-6Report Type:Expedited (15-DaCompany Report #C2002-1118.01 Age:81 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Clozapine Tablets 25 Congestive Professional Mg Mylan PS Mylan ORAL 150 MG QD, Respiratory Tract Other THEN 50 MG Infection QD, ORAL Donazepil C Hydrocodone/Acetamin ophen Elixir C Metoclopramide C Multivitamins C Sertraline C Date:04/23/02ISR Number: 3906832-8Report Type:Expedited (15-DaCompany Report #C2002-1081.01 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 150 MG BID, Other ORAL 22-Feb-2006 08:30 AM Page: 1597 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/23/02ISR Number: 3906835-3Report Type:Expedited (15-DaCompany Report #C2002-1029.01 Age:91 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozapine Tablets 25 Neoplasm Malignant Professional Mg Mylan PS Mylan ORAL 12.5 MG QD, Other ORAL Acetaminophen/Codein e C Albuterol C Bromocriptine C Carbidopa/Levodopa Er C Potassium C Spironolactone C Date:04/23/02ISR Number: 3906846-8Report Type:Expedited (15-DaCompany Report #C2002-0721.01 Age:74 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 200 MG BID Other ORAL Levothyroxine C Lisinopril C Ranitidine C Insulin 70/30 C Valproic Acid C Date:04/23/02ISR Number: 3906854-7Report Type:Expedited (15-DaCompany Report #C2002-0793.01 Age:78 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death White Blood Cell Count Health Clozapine Tablets 25 Abnormal Professional Mg Mylan PS Mylan ORAL 12.5 MG QD Other ORAL Date:04/25/02ISR Number: 3907437-5Report Type:Expedited (15-DaCompany Report #02-04-0299 Age:52 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Health Clozapine Tablets - Initial or Prolonged Reflux Oesophagitis Professional Ivax Other Pharmacetuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 100-500MG QD ORAL Butalbital C Acetaminophen And Caffeine C Effexor Xr C Vioxx C Seroquel C Humulin Regular Silding Scale C Humulin N C Metformin C 22-Feb-2006 08:30 AM Page: 1598 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/25/02ISR Number: 3907439-9Report Type:Expedited (15-DaCompany Report #02-04-0361 Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Health Clozapine Tablets - Pneumonia Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 37.5MG QD ORAL Date:04/25/02ISR Number: 3907441-7Report Type:Expedited (15-DaCompany Report #02-04-0347 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ankle Fracture Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc ORAL 200MG QD ORAL Date:04/25/02ISR Number: 3907443-0Report Type:Expedited (15-DaCompany Report #02-04-0350 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Suicide Attempt Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc ORAL 500MG QD ORAL Date:04/25/02ISR Number: 3907445-4Report Type:Expedited (15-DaCompany Report #02-04-0358 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neuroleptic Malignant Health Clozapine Hospitalization - Syndrome Professional Tablets-Ivax Initial or Prolonged Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc ORAL 600MG QD ORAL Date:04/25/02ISR Number: 3907446-6Report Type:Expedited (15-DaCompany Report #02-04-0365 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Decubitus Ulcer Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc ORAL 300MG QD ORAL 22-Feb-2006 08:30 AM Page: 1599 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/25/02ISR Number: 3907510-1Report Type:Direct Company Report #CTU 166673 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Diabetic Ketoacidosis Clozapine 100 Mg Haemodynamic Instability Tabs/Zenith Goldline PS Zenith Goldline 100 MG AM & 5 Hyperglycaemia TABS HS Hyperlipidaemia Clozapine 25 Mg Tabs Metabolic Disorder Zenith Goldline SS Zenith Goldline ORAL 25 MG PO BID Overdose Prozac C Pancreatitis Acute Atenolol C Pyrexia Ibuprofen C Respiratory Failure Prilosec C Date:04/26/02ISR Number: 3908205-0Report Type:Expedited (15-DaCompany Report #PHEH2002US03520 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozaril(Clozapine)T Professional ablet PS ORAL 700 MG, ORAL Date:04/26/02ISR Number: 3908313-4Report Type:Expedited (15-DaCompany Report #PHEH2001US10220 Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Lymphocyte Count Health Clozaril(Clozapine) Initial or Prolonged Decreased Professional Tablet PS ORAL 600MG, ORAL Prozac (Fluoxetine Hydrochloride) C Klonopin C Haldol C Cogentin (Benzatropine Mesilate) C Date:04/26/02ISR Number: 3908320-1Report Type:Expedited (15-DaCompany Report #PHEH2002US03522 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bronchopneumonia Health Clozaril(Clozapine) Hospitalization - Cardiac Arrest Professional Tablet PS ORAL 300MG, QHS, Initial or Prolonged Emphysema ORAL Synthroid C Albuterol C Depo Provera C Date:04/26/02ISR Number: 3908323-7Report Type:Expedited (15-DaCompany Report #PHEH2002US03107 Age:38 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Circulatory Collapse Health Clozaril(Clozapine) Hospitalization - Pneumonia Professional Tablet PS ORAL 400 MG, ORAL Initial or Prolonged Xanax (Alprazolam) C Tegretol C Prozac (Fluoxetine Hydrochloride) C Neurotin (Gabapentin) C 22-Feb-2006 08:30 AM Page: 1600 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Axid (Nizatidine) C Date:04/26/02ISR Number: 3908356-0Report Type:Expedited (15-DaCompany Report #PHBS2002AU04781 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Retinal Toxicity Foreign Melleril(Thioridazin Health e Hydrochloride) Professional Tablet PS ORAL ORAL Other Clozaril(Clozapine) Tablet SS ORAL 450 MG ORAL Date:04/26/02ISR Number: 3908365-1Report Type:Expedited (15-DaCompany Report #PHBS2002NL05040 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiomyopathy Foreign Clozapine Initial or Prolonged Chest Pain Literature (Clozapine) PS 400 MG/D Dyspnoea Health Venlafaxine(Venlafax Face Oedema Professional ine) SS 375 MG/D Oedema Peripheral Other Date:04/26/02ISR Number: 3908368-7Report Type:Expedited (15-DaCompany Report #PHBS2002CA03584 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Discomfort Foreign Clozaril (Clozapine) Initial or Prolonged Anorexia Study Tablet PS ORAL 75 MG/D ORAL Other Asthenia Health Epival (Valproate Atrial Fibrillation Professional Semisodium) C Body Temperature Other Clonazepam C Increased Ativan C Diarrhoea Synthroid C Dyspepsia Cogentin Endocarditis (Benzatropine Hypotension Mesilate) C Influenza Flomax Influenza Like Illness (Morniflumate) C Insomnia Lethargy Lymphocyte Count Decreased Nausea Pyrexia Somnolence Tachycardia Vomiting Weight Decreased Date:04/26/02ISR Number: 3908472-3Report Type:Expedited (15-DaCompany Report #PHEH2002US03610 Age:67 YR Gender:Female I/FU:I Outcome PT Other Breast Cancer Cerebrovascular Accident Drooling Dysarthria 22-Feb-2006 08:30 AM Page: 1601 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Leukopenia Transient Ischaemic Attack Report Source Product Role Manufacturer Route Dose Duration Health Clozaril (Clozapine) Professional Tablet PS ORAL 400 MG, QD, ORAL Chemotherapeutics, Other (Chemotherapeutics, Other) SS Date:04/26/02ISR Number: 3908540-6Report Type:Expedited (15-DaCompany Report #PHBS2002FI04865 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acute Myeloid Leukaemia Foreign Leponex (Clozapine) Initial or Prolonged Health Unknown PS 200 MG, BID, Professional Other Date:04/26/02ISR Number: 3908541-8Report Type:Expedited (15-DaCompany Report #PHBS2002BR04785 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Foreign Leponex (Clozapine) Health Tablet PS ORAL 1) 0, ORAL; Professional 2) 100 MG, Other TID, ORAL Date:04/26/02ISR Number: 3908545-5Report Type:Expedited (15-DaCompany Report #PHBS2002AU04835 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Exposure Foreign Clozaril (Clozapine) Initial or Prolonged Medication Error Health Tablet PS ORAL 200 MG, Professional ONCE/SINGLE, Other ORAL Temazepam C Valproate Sodium C Cipramil C Zyprexa (Olanzapine) C Valium C Date:04/26/02ISR Number: 3908547-9Report Type:Expedited (15-DaCompany Report #PHNU2002DE01350 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Atrioventricular Block Foreign Leponex / Clozaril Health (Clozapine) Professional (Clozapine) Tablet PS ORAL 25MG/DAY, Other ORAL Diltiazem (Diltiazem) SS ORAL ORAL 22-Feb-2006 08:30 AM Page: 1602 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/26/02ISR Number: 3908599-6Report Type:Expedited (15-DaCompany Report #PHHO2002ZA03089 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Apgar Score Low Foreign Clozaril PS TRANSPLACENTAL TRANSPLACENTA Congenital Anomaly Congenital Anomaly Study L Maternal Drugs Affecting Health Leponex (Clozapine) Foetus Professional Tablet SS TRANSPLACENTAL TRANSPLACENTA Neonatal Disorder Other L Pneumonia Aspiration Premature Baby Date:04/26/02ISR Number: 3908610-2Report Type:Expedited (15-DaCompany Report #PHEH2002US03611 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bundle Branch Block Left Health Clozaril Chest Pain Professional Congestive Cardiomyopathy (Clozapine) PS ORAL 500MG, ORAL Dilatation Ventricular Clozapine SS Dyspnoea Exertional Lanoxin C Ejection Fraction Zestril (Lisinopril) C Decreased Coreg Electrocardiogram (Carvedilol) C Abnormal Influenza Mitral Valve Incompetence Sinus Tachycardia Tricuspid Valve Incompetence Viral Infection Date:04/26/02ISR Number: 3908783-1Report Type:Expedited (15-DaCompany Report #PHBS2001AU10940 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Norepinephrine Increased Foreign Clozaril(Clozapine) Health Tablet PS ORAL 300 MG, TID, Professional ORAL Other Zocor"Dieckmann" C Prazosin(Prazosin) C Temazepam C Date:04/26/02ISR Number: 3908889-7Report Type:Expedited (15-DaCompany Report #PHNU2001DE01077 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abortion Induced Foreign Leponex / Clozaril Drug Exposure During Health (Clozapine) Tablet PS ORAL 50-0 Pregnancy Professional 25MG/DAY, Maternal Drugs Affecting ORAL Foetus Pregnancy Psychotic Disorder 22-Feb-2006 08:30 AM Page: 1603 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/26/02ISR Number: 3908890-3Report Type:Expedited (15-DaCompany Report #PHFR2002GB01383 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tachypnoea Foreign Clozaril (Clozapine) Health Tablet PS Professional Lisinopril C Amitriptyline C Antidiabetics (No Ingredients/Substanc es) C Date:04/29/02ISR Number: 3909114-3Report Type:Direct Company Report #CTU 166883 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Creatine Clozapine PS 200MG AM Phosphokinase Increased 250MG HS Blood Pressure Abnormal Doxazosin C Confusional State Benatropine C Hypoxia Lorazepam C Malaise Muscle Rigidity Pyrexia Date:04/29/02ISR Number: 3909716-4Report Type:Expedited (15-DaCompany Report #02P-056-0191868-00 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Amniocentesis Abnormal Foreign Tranxene Tablets Initial or Prolonged Caesarean Section Health (Tranxene) Required Foetal Heart Rate Professional (Clorazepate Intervention to Increased Other Dipotassium) Prevent Permanent Oligohydramnios (Clorazepate PS 50 MG, 2 IN 1 Impairment/Damage D Tropatepine Hydrochloride SS 10 MG, 1 IN 1 D Clozapine SS 400 MG, 1 IN 1 D Hydroxyzine Hydrochloride C Sertraline Hydrochloride C Trithione C Nitrazepam C Date:04/29/02ISR Number: 3909816-9Report Type:Expedited (15-DaCompany Report #PHFR2002GB01399 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyspnoea Foreign Clozaril Face Oedema Health (Clozapine)Tablet PS ORAL ORAL Menorrhagia Professional Nausea Other Oedema Peripheral Vomiting 22-Feb-2006 08:30 AM Page: 1604 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/29/02ISR Number: 3909819-4Report Type:Expedited (15-DaCompany Report #PHFR2002GB01276 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Heart Rate Increased Foreign Clozaril (Clozapine) Initial or Prolonged Ileus Paralytic Health Tablet PS ORAL 450 MG/DAY, Other Inflammatory Bowel Professional ORAL Disease Other Orphenadrine C Rectal Haemorrhage Date:04/29/02ISR Number: 3909846-7Report Type:Expedited (15-DaCompany Report #PHBS2002AU00752 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Toxicity Foreign Clozaril(Clozapine) Study Tablet PS ORAL 650 MG/DAY, Health ORAL Professional Epilim C Other Efexor (Venlafaxine Hydrochloride) C Date:04/29/02ISR Number: 3909847-9Report Type:Expedited (15-DaCompany Report #PHFR2002GB01404 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bundle Branch Block Right Foreign Clozaril(Clozapine) Initial or Prolonged Electrocardiogram T Wave Health Tablet PS ORAL 400 MG/DAY, Other Inversion Professional ORAL Neutrophil Count Other Increased Vomiting White Blood Cell Count Increased Date:04/29/02ISR Number: 3909848-0Report Type:Expedited (15-DaCompany Report #PHNU2002DE00883 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Prolactin Increased Foreign Leponex/ Clozaril Initial or Prolonged Galactorrhoea Health (Clopazine) Tablet PS ORAL 250 MG/DAY, Professional ORAL Other Solian (Amisulpride) Tablet SS ORAL <1200 MG/DAY, ORAL Fluanxol "Bayer" (Flupentixol Dihydrochloride) SS ORAL 7.5 MG/DAY, ORAL Saroten Retard (Amitriptyline Hydrochloride) C Date:04/29/02ISR Number: 3909875-3Report Type:Expedited (15-DaCompany Report #PHBS2002CA05085 Age:36 YR Gender:Male I/FU:I Outcome PT Other Blood Pressure Increased Increased Appetite 22-Feb-2006 08:30 AM Page: 1605 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Malaise Nausea Photosensitivity Reaction Report Source Product Role Manufacturer Route Dose Duration Skin Discolouration Foreign Clozapril Weight Increased Study (Clozapine) Tablet PS ORAL 300 MG/DAY, Health ORAL Professional Gravol Other (Dimenhydraminate) C Date:04/29/02ISR Number: 3910964-8Report Type:Expedited (15-DaCompany Report #02P-056-0191627-00 Age:2 DY Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abdominal Distension Foreign Tranxene Tablets Caesarean Section Health (Tranxene) Complications Of Maternal Professional (Clorazepate Exposure To Therapeutic Other Dipotassium) Drugs (Clorazepate) PS Foetal Disorder Tropatepine Foetal Heart Rate Hydrochloride SS Decreased Clozapine SS Gastrointestinal Disorder Hypotonia Neonatal Malaise Maternal Drugs Affecting Foetus Meconium Ileus Oligohydramnios Oral Intake Reduced Pallor Stridor Vomiting Neonatal Date:04/30/02ISR Number: 3908653-9Report Type:Direct Company Report #CTU 166886 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blood Glucose Increased Clozapine PS ORAL 600MG PO QHS Intervention to Fluphenazine C Prevent Permanent Lorazepam C Impairment/Damage Gabapentin C Quetiaprine C Date:04/30/02ISR Number: 3909679-1Report Type:Expedited (15-DaCompany Report #C2002-0546.01 Age:64 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Haemorrhage Health Clozapine Tablets Syncope Professional 100 Mg Mylan PS Mylan ORAL 100MG BID, Other ORAL Gabapentin C 22-Feb-2006 08:30 AM Page: 1606 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/30/02ISR Number: 3910269-5Report Type:Expedited (15-DaCompany Report #PHRM2002FR01260 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abdominal Distension Foreign Leponex (Clozapine) Amniotic Cavity Disorder Health Tablet PS TRANSPLACENTAL TRANSPLACENTA Caesarean Section Professional L Complications Of Maternal Other Tranxene Exposure To Therapeutic (Clorazepatedipotass Drugs ium) SS TRANSPLACENTAL TRANSPLACENTA Feeding Disorder Neonatal L Foetal Arrhythmia Lepticur Hypotonia Neonatal (Tropatepine Ileus Paralytic Hydrochloride) SS TRANSPLACENTAL TRANSPLACENTA Malaise L Maternal Drugs Affecting Sulfarlem (Anethole Foetus Trithione) C Pallor Atarax (Hydroxyzine Vomiting Hydrochloride) C Vomiting Neonatal Zoloft (Sertraline X-Ray Abnormal Hydrochloride) C Mogadon C Date:04/30/02ISR Number: 3910271-3Report Type:Expedited (15-DaCompany Report #PHBS2002CA05151 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Haemolytic Anaemia Foreign Clozaril (Clozapine) Health Tablet PS ORAL ORAL Professional Other Date:04/30/02ISR Number: 3910273-7Report Type:Expedited (15-DaCompany Report #PHBS2002AU05028 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Mitral Valve Incompetence Foreign Clozaril (Clozapine) Health Tablet PS ORAL 600 MG, BID, Professional ORAL Other Valproate Sodium C Diazepam C Date:04/30/02ISR Number: 3910295-6Report Type:Expedited (15-DaCompany Report #PHFR2001GB03360 Age:48 YR Gender:Female I/FU:F Outcome PT Life-Threatening Abdominal Pain Lower Anorexia Back Pain Blood Bicarbonate Decreased Blood Creatinine Increased Blood Potassium Increased Blood Sodium Decreased Blood Urea Increased C-Reactive Protein Increased Dialysis 22-Feb-2006 08:30 AM Page: 1607 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Electrolyte Imbalance Haematuria Hyponatraemic Syndrome Report Source Product Role Manufacturer Route Dose Duration Malaise Foreign Clozaril Oliguria Health (Clozapine)Tablet PS ORAL 750MG/DAY, Oral Intake Reduced Professional ORAL Proteinuria Other Benztropeine Renal Tubular Necrosis (Benztropeine) C Rhabdomyolysis Prochlorperazine Somnolence (Prochlorperazine) C Vomiting Iron Sulfate C Haloperidol C Nifedipine C Thyroxine C Date:04/30/02ISR Number: 3910315-9Report Type:Expedited (15-DaCompany Report #PHRM2002FR01224 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatinine Foreign Leponex(Clozapine)Ta Initial or Prolonged Decreased Health blet PS ORAL 400 MG, BID, Other Diabetes Mellitus Professional ORAL Insulin-Dependent Other Gamma-Glutamyltransferase Increased Glycosuria Hypercholesterolaemia Hyperglycaemia Hypertriglyceridaemia Ketonuria Polydipsia Polyuria Weight Decreased Date:04/30/02ISR Number: 3910386-XReport Type:Expedited (15-DaCompany Report #PHBS2002AU04281 Age:35 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Constipation Foreign Clozaril (Clozapine) Emotional Distress Health Tablet PS ORAL 100 MG, QD, Megacolon Professional ORAL, SEE Other IMAGE Clopixol Acutard (Zuclopenthixol Acetate) C Date:04/30/02ISR Number: 3910387-1Report Type:Expedited (15-DaCompany Report #PHBS2002GB05065 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Clonic Convulsion Foreign Clozapine Initial or Prolonged Diabetic Ketoacidosis Literature (Clozapine) Unknown PS 700 MG/D Hyperglycaemia Health Professional Other 22-Feb-2006 08:30 AM Page: 1608 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/30/02ISR Number: 3922710-2Report Type:Periodic Company Report #ZONI000679 (0) Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Zonegran Professional (Zonisamide) PS ORAL 300 MG DAILY ORAL Clozaril (Clozapine) SS ORAL 100 MG DAILY ORAL Calcium C Citalopram C Estradiol C Lactulose C Lamotrigine C Naproxen C Phenytoin C Polycarbophil C Thioridazine C Date:05/01/02ISR Number: 3911066-7Report Type:Expedited (15-DaCompany Report #PHBS2002CH05281 Age:79 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Accidental Exposure Foreign Leponex(Clozapine) Coma Health Tablet PS ORAL ORAL Disturbance In Attention Professional Lithium (Lithium) SS Drug Interaction Other Glucophage Forte C Hypothermia Tiatral C Miosis Fosamax (Alendronate Stupor Sodium) C Toxicologic Test Abnormal Calcimagon C Importal C Xalatan (Latanoprost) C Amiodarone (Amiodarone) C Nitroderm C Date:05/01/02ISR Number: 3911233-2Report Type:Expedited (15-DaCompany Report #PHNU2002DE01444 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Foreign Leponex/Clozaril Anxiety Consumer (Clozapine/Clozapine Drug Effect Decreased ) Tablet PS ORAL SEE IMAGE Electrocardiogram Qt Seroxat "Smithkline Prolonged Beecham" (Paroxetine Obsessive Thoughts Hydrochloride) SS ORAL SEE IMAGE Suicide Attempt Tavor (Lorazepam) Tablet SS ORAL 0.5 MG, BID, ORAL Valium Tablet C Date:05/01/02ISR Number: 3911336-2Report Type:Expedited (15-DaCompany Report #PHEH2002US02630 Age:74 YR Gender:Female I/FU:I Outcome PT Other Eating Disorder Electroencephalogram 22-Feb-2006 08:30 AM Page: 1609 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Abnormal Muscular Weakness Parkinson'S Disease Peripheral Sensory Report Source Product Role Manufacturer Route Dose Duration Neuropathy Health Clozaril (Clozapine) PS ORAL 500MG, ORAL ; Professional 50MG AM + 200MG HS, ORAL Date:05/03/02ISR Number: 3911935-8Report Type:Expedited (15-DaCompany Report #C2002-1233.01 Age:69 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Mylan ORAL 200MG BID Professional ORAL Other Date:05/03/02ISR Number: 3912154-1Report Type:Direct Company Report #CTU 167279 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blood Triglycerides Clozapine PS Ivax ORAL 150MG QHS Intervention to Increased ORAL Prevent Permanent High Density Lipoprotein Luvox C Impairment/Damage Decreased Acetaminophen C Cepacol Loz C Clotrimazole C Maalox C Milk Of Mag/Cascara C Orajel C Ceftin C Date:05/06/02ISR Number: 3912144-9Report Type:Expedited (15-DaCompany Report #02-04-0386 Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Clozapine PS Ivax Congestive Professional Pharmaceuticals, Inc ORAL 12.5-37.5MG Other QD ORAL Date:05/06/02ISR Number: 3912147-4Report Type:Expedited (15-DaCompany Report #02-04-0396 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine Tablets PS Ivax Professional Pharmaceuticals, Inc ORAL 7.8-375MG QD Other ORAL Date:05/06/02ISR Number: 3912148-6Report Type:Expedited (15-DaCompany Report #02-04-0385 Age:66 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Respiratory Failure Health Clozapine Tablets PS Ivax Professional Pharmaceuticals, Inc ORAL 150MG QD ORAL Other 22-Feb-2006 08:30 AM Page: 1610 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/06/02ISR Number: 3912150-4Report Type:Expedited (15-DaCompany Report #02-04-0380 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Obsessive-Compulsive Health Clozapine Tablets PS Ivax Initial or Prolonged Disorder Professional Pharmaceuticals, Inc ORAL 300MG QD ORAL Other Date:05/06/02ISR Number: 3912159-0Report Type:Expedited (15-DaCompany Report #02-04-0369 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Respiratory Arrest Health Clozapine Tablets PS Ivax Professional Pharmaceuticals, Inc ORAL 375MG QD ORAL Other Date:05/06/02ISR Number: 3912162-0Report Type:Expedited (15-DaCompany Report #02-04-0367 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Nervous System Disorder Health Clozapine Tablets PS Ivax Professional Pharmaceuticals, Inc ORAL 18.7-75MG QD Other ORAL Date:05/06/02ISR Number: 3912164-4Report Type:Expedited (15-DaCompany Report #02-04-0376 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neoplasm Malignant Health Clozapine Tablets PS Ivax Professional Pharmaceuticals, Inc ORAL 25MG QD ORAL Other Date:05/07/02ISR Number: 3912892-0Report Type:Expedited (15-DaCompany Report #PHBS2002CA01291 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Back Pain Foreign Clozaril(Clozapine) Hospitalization - Chills Health Tablet PS ORAL 225 MG, QHS, Initial or Prolonged Diarrhoea Professional ORAL Flushing Other Levothyroxine Kidney Infection (Levothyroxine) C Neuroleptic Malignant Salmon Oil C Syndrome Pravastatin Pain In Extremity (Pravastatin) C Pneumonia Lithium Carbonate C Rhabdomyolysis Oxybutynin (Oxybutynin) C Date:05/07/02ISR Number: 3913153-6Report Type:Expedited (15-DaCompany Report #FR8971026APR2002 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Ileus Paralytic Health Temesta (Lorazepam, Hospitalization - Renal Failure Professional Tablet, 0) PS ORAL 7.5 MG 1X PER Initial or Prolonged Shock Other 1 DAY, ORAL Akineton Retard (Biperiden 22-Feb-2006 08:30 AM Page: 1611 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride, 0,) SS ORAL 1 TABLET 1X PER DAY, ORAL Imovane (Zopiclone, 0) SS ORAL 15 MG 1X PER 1 DAY, ORAL Leponex (Clozapine, 0) SS ORAL 200 MG 2X PER 1 DAY, ORAL Nozinan (Levomepromazine, 0,) SS ORAL 50 MG 1X PER 1 DAY, ORAL Date:05/07/02ISR Number: 3913254-2Report Type:Expedited (15-DaCompany Report #FR8971026APR2002 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Ileus Paralytic Foreign Temesta (Lorazepam, Hospitalization - Renal Failure Health 0) PS ORAL 7.5 MG 1X PER Initial or Prolonged Shock Professional 1 DAY ORAL Other Akineton Retard (Biperiden Hydrochloride, 0) SS ORAL 1 TABLET 1X PER 1 DAY ORAL Imovane (Zopiclone, 0) SS ORAL 15 MG 1X PER 1 DAY ORAL Leponex (Clozapine, 0) SS ORAL 200 MG 2X PER 1 DAY ORAL Nozinan (Levomepromazine, 0) SS ORAL 50 MG 1X PER 1 DAY ORAL Date:05/07/02ISR Number: 3913352-3Report Type:Expedited (15-DaCompany Report #PHBS2002LU04502 Age:76 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eosinophilia Foreign Clozapine Renal Failure Acute Literature (Clozapine) Unknown PS 18.6 MG/DAY Renal Impairment Health L-Dopa (Levodopa) C Professional Bromocritptine Other (Bromocriptine) C Date:05/07/02ISR Number: 3913354-7Report Type:Expedited (15-DaCompany Report #PHBS2002LU04496 Age:68 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dehydration Foreign Clozapine Hospitalization - Delirium Tremens Literature (Clozapine) Unknown PS 18.75 MG/DAY Initial or Prolonged Myocardial Infarction Health Levodopa (Levodopa) C Professional Other 22-Feb-2006 08:30 AM Page: 1612 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/07/02ISR Number: 3913443-7Report Type:Expedited (15-DaCompany Report #PHFR2002GB01443 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril(Clozapine) Non-Insulin-Dependent Health Tablet PS ORAL ORAL Professional Other Date:05/07/02ISR Number: 3913468-1Report Type:Expedited (15-DaCompany Report #PHFR2002GB01455 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Foreign Clozaril (Clozapine) Initial or Prolonged Drug Withdrawal Syndrome Health Tablet PS ORAL ORAL Other Professional Other Date:05/07/02ISR Number: 3913469-3Report Type:Expedited (15-DaCompany Report #PHFR2002GB01487 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dialysis Foreign Clozaril (Clozapine) Health Tablet PS ORAL 350MG/DAY, Professional ORAL Other Date:05/07/02ISR Number: 3913585-6Report Type:Expedited (15-DaCompany Report #PHEH2002US03574 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) Mesenteric Occlusion Professional Tablet PS ORAL ORAL Myocardial Infarction Date:05/07/02ISR Number: 3913621-7Report Type:Expedited (15-DaCompany Report #PHEH2002US03986 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozaril Lung Squamous Cell Professional (Clozapine)Tablet PS ORAL 750 MG, ORAL Carcinoma Stage Chemotherapeutics, Unspecified Other Pneumonia (Chemotherapeutics, Other) SS Wellbutrin (Amfebutamone Hydrochloride) C Chlorpromazine (Chlorpromazine) C Darvocet-N (Dextropropoxyphene Napsilate, Paracetamol) C 22-Feb-2006 08:30 AM Page: 1613 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/07/02ISR Number: 3913634-5Report Type:Expedited (15-DaCompany Report #PHBS2002US05283 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Body Mass Index Increased Literature Clozapine Glucose Tolerance Health (Clozapine) PS 300 MG/D Impaired Professional Hypertriglyceridaemia Hypopnoea Increased Appetite Middle Insomnia Oxygen Saturation Decreased Sedation Sleep Apnoea Syndrome Snoring Weight Increased Date:05/07/02ISR Number: 3913750-8Report Type:Expedited (15-DaCompany Report #PHFR2002GB01221 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Constipation Foreign Clozaril Haematemesis Health (Clozapine)Tablet PS ORAL 300 MG/DAY, Hiatus Hernia Professional ORAL Lethargy Other Lansoprazole Oesophagitis (Lansoprazole) C Pyrexia Sensation Of Heaviness Date:05/07/02ISR Number: 3916795-7Report Type:Periodic Company Report #11662038 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Health Cytoxan Professional (Cyclophosphamide) PS 3 MON Clozapine SS Adriamycin (Doxorubicin Hcl) SS 3 MON Date:05/08/02ISR Number: 3913953-2Report Type:Expedited (15-DaCompany Report #C2002-0911.01 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pulmonary Embolism Health Clozapine Tablets Sudden Death Professional 100 Mg Mylan PS ORAL 400MG Q HS, Other ORAL Alprazolam C Date:05/08/02ISR Number: 3913954-4Report Type:Expedited (15-DaCompany Report #C2002-0956.01 Age:57 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional 100 Mg Mylan PS ORAL 400MG/DAY, Other ORAL 22-Feb-2006 08:30 AM Page: 1614 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/08/02ISR Number: 3913955-6Report Type:Expedited (15-DaCompany Report #C2002-0990.01 Age:82 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Confusional State Health Clozapine Tablets 25 Hypoaesthesia Professional Mg Mylan PS ORAL 50MG Q HS, Other ORAL Clozapine Tablets 100 Mg Mylan SS ORAL 200MG QHS, ORAL Date:05/08/02ISR Number: 3914207-0Report Type:Expedited (15-DaCompany Report #PHBS2002LU04500 Age:71 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Transient Ischaemic Foreign Clozapine(Clozapine) PS 37.5 MG/DAY Attack Literature L-Dopa C Health Bromocriptine Professional (Bromocriptine) C Other Date:05/08/02ISR Number: 3914260-4Report Type:Expedited (15-DaCompany Report #PHNU2002DE01505 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Leponex/Clozaril Gamma-Glutamyltransferase Health (Clozapine) Increased Professional (Clozapine) Tablet PS ORAL ORAL Hypercholesterolaemia Other Hypertriglyceridaemia Date:05/08/02ISR Number: 3914264-1Report Type:Expedited (15-DaCompany Report #PHFR2002GB01496 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dialysis Foreign Clozaril (Clozapine) Renal Impairment Health Tablet PS ORAL 550MG/DAY, Professional ORAL Other Date:05/08/02ISR Number: 3914602-XReport Type:Expedited (15-DaCompany Report #PHBS2002CA05304 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperhidrosis Foreign Clozaril (Clozapine) Incoherent Study Tablet PS ORAL 300 MG/D, Insomnia Other ORAL Salivary Hypersecretion Zyprexa (Olanzapine) C Sedation Risperidone (Risperidone) C Neurontin (Gabapentin) C Lithium (Lithium) C 22-Feb-2006 08:30 AM Page: 1615 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/08/02ISR Number: 3914648-1Report Type:Expedited (15-DaCompany Report #PHBS2001AU10052 Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiac Disorder Foreign Clozaril(Clozapine) Cardiomyopathy Study Tablet PS ORAL 500 MG/DAY, Dilatation Ventricular Health ORAL Drug Withdrawal Syndrome Professional Echocardiogram Abnormal Other Mitral Valve Incompetence Psychotic Disorder Pulmonary Valve Incompetence Sinus Tachycardia Tricuspid Valve Incompetence Ventricular Hypokinesia Date:05/08/02ISR Number: 3914651-1Report Type:Expedited (15-DaCompany Report #PHRM2002FR01257 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Distension Foreign Leponex(Clozapine) Initial or Prolonged Caesarean Section Health Tablet PS ORAL 400 MG PER Complications Of Maternal Professional DAY, ORAL Exposure To Therapeutic Other Tranxene(Clorazepate Drugs Dipotassium) Tablet SS ORAL 100 MG PER Feeding Disorder Neonatal DAY, ORAL Foetal Heart Rate Lepticur Disorder (Tropatepine Hypotonia Hydrochloride) SS ORAL 10 MG, QD, Malaise ORAL Maternal Drugs Affecting Sulfarlem (Anethole Foetus Trithione) C Meconium Ileus Atarax (Hydroxyzine Neonatal Disorder Hydrochloride) C Oligohydramnios Zoloft (Sertraline Pain Hydrochloride) C Pallor Mogadon C Pregnancy Premature Rupture Of Membranes Vomiting Neonatal Date:05/08/02ISR Number: 3914661-4Report Type:Expedited (15-DaCompany Report #PHBS2002LU04503 Age:57 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cholangitis Foreign Clozapine(Clozapine) PS 75 MG/DAY Grand Mal Convulsion Literature L-Dopa (Levodopa) C Health Professional Other 22-Feb-2006 08:30 AM Page: 1616 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/08/02ISR Number: 3914694-8Report Type:Expedited (15-DaCompany Report #C2002-1237.01 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Myocarditis Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 200MG Q HS, ORAL Clozapine Tablets 25 Mg Mylan SS Mylan ORAL 75MG Q HS, ORAL Divalproex Sodium C Date:05/08/02ISR Number: 3914980-1Report Type:Expedited (15-DaCompany Report #PHEH2002US04068 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abscess Health Clozaril(Clozapine)T Alopecia Professional ablet PS ORAL 400 MG, BID, Amnesia ORAL Aortic Valve Replacement Pericarditis Subacute Endocarditis Date:05/08/02ISR Number: 3914990-4Report Type:Expedited (15-DaCompany Report #PHEH2002US04016 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Health Clozaril (Clozapine) Professional Tablet PS ORAL 100 MG, ORAL Date:05/09/02ISR Number: 3915304-6Report Type:Expedited (15-DaCompany Report #PHEH2002US04192 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyspnoea Health Clozaril(Clozapine)T Restrictive Pulmonary Professional ablet PS ORAL 875 MG, QD, Disease ORAL Celexa C Klonopin C Loxapine(Loxapine) C Geodon(Ziprasidone Hydrochloride) C Propantheline Bromide (Propantheline Bromide) C Vitamin E C Baclofen C Lansoprazole (Lansoprazole) C Date:05/09/02ISR Number: 3915305-8Report Type:Expedited (15-DaCompany Report #PHEH2002US04195 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril(Clozapine) Professional Tablet PS ORAL 50 MG, ORAL 22-Feb-2006 08:30 AM Page: 1617 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/09/02ISR Number: 3915306-XReport Type:Expedited (15-DaCompany Report #PHEH2002US04201 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiomyopathy Health Clozaril Initial or Prolonged Professional (Clozapine)Tablet PS ORAL SEE IMAGE Date:05/09/02ISR Number: 3915308-3Report Type:Expedited (15-DaCompany Report #PHEH2002US04054 Age:92 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozaril Professional (Clozapine)Tablet PS ORAL 12.5 MG, BID, ORAL Isopto Tears(Methylcellulos e, Benzalkonium Chloride) C Multivitamins(Ascorb ic Acid,Panthenol, Retinol) C Wellbutrin(Amfebutam one Hydrochloride) C Haldol C Albuterol C Klonopin C Glucotrol Xl (Glipizide) C Date:05/09/02ISR Number: 3915391-5Report Type:Expedited (15-DaCompany Report #PHBS2002AU04781 Age:43 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Retinal Pigmentation Foreign Melleril Retinal Toxicity Health (Thioridazine Professional Hydrochloride) Other Tablet PS ORAL ORAL Clozaril (Clozapine) Tablet SS ORAL 450 MG, ORAL Date:05/09/02ISR Number: 3915396-4Report Type:Expedited (15-DaCompany Report #PHFR2002GB01514 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dilatation Atrial Foreign Clozaril (Clozapine) Electrocardiogram St-T Health Tablet PS ORAL 150MG/DAY, Change Professional ORAL Heart Rate Increased Other Hypotension Date:05/09/02ISR Number: 3915397-6Report Type:Expedited (15-DaCompany Report #PHFR2002GB01528 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Polycythaemia Foreign Clozaril (Clozapine) Health Tablet PS ORAL 475MG/DAY, Professional ORAL Other 22-Feb-2006 08:30 AM Page: 1618 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/09/02ISR Number: 3915398-8Report Type:Expedited (15-DaCompany Report #PHFR2002GB01511 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril (Clozapine) Non-Insulin-Dependent Health Tablet PS ORAL 250MG/DAY, Professional ORAL Other Date:05/09/02ISR Number: 3915413-1Report Type:Expedited (15-DaCompany Report #PHFR2002GB01510 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Epilepsy Foreign Clozaril (Clozapine) Study Tablet PS ORAL 400 MG/DAY, Health ORAL Professional Other Date:05/09/02ISR Number: 3915414-3Report Type:Expedited (15-DaCompany Report #PHFR2002GB01388 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Foreign Clozaril (Clozapine) Initial or Prolonged Chest X-Ray Abnormal Health Tablet PS ORAL 300 MG/DAY, Dyspnoea Professional ORAL Haemoptysis Other Lansoprazole Pleural Infection (Lansoprazole) C Respiratory Tract Infection Date:05/09/02ISR Number: 3915415-5Report Type:Expedited (15-DaCompany Report #PHNU2002DE01543 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Foreign Leponex / Clozaril Phosphokinase Increased Health (Clozapine) C-Reactive Protein Professional (Clozapine) Tablet PS ORAL 275 MG/DAY, Increased Other ORAL Dizziness Date:05/09/02ISR Number: 3915416-7Report Type:Expedited (15-DaCompany Report #PHFR2002GB01529 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Haemoptysis Foreign Clozaril (Clozapine) Pharyngolaryngeal Pain Health Tablet PS ORAL 400 MG/DAY, White Blood Cell Count Professional ORAL Increased Other Date:05/09/02ISR Number: 3915417-9Report Type:Expedited (15-DaCompany Report #PHFR2002GB01528 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Other Haemoglobin Increased Foreign Polycythaemia Health Professional 22-Feb-2006 08:30 AM Page: 1619 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Product Role Manufacturer Route Dose Duration Clozaril (Clozapine) Tablet PS ORAL 475 MG/DAY, ORAL Date:05/09/02ISR Number: 3915420-9Report Type:Expedited (15-DaCompany Report #PHBS2002AU05427 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Brain Neoplasm Foreign Clozaril (Clozapine) Initial or Prolonged Circulatory Collapse Health Tablet PS ORAL 200 MG, QD, Depressed Level Of Professional ORAL Consciousness Other Hallucination, Visual Intracranial Injury Loss Of Consciousness Date:05/09/02ISR Number: 3915421-0Report Type:Expedited (15-DaCompany Report #PHBS2002AU05424 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bundle Branch Block Right Foreign Clozaril (Clozapine) Electrocardiogram Qt Health Tablet PS ORAL 500 MG/D, Prolonged Professional ORAL Neutrophilia Other Date:05/09/02ISR Number: 3915436-2Report Type:Expedited (15-DaCompany Report #PHBS2002AU05479 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Nephrotic Syndrome Foreign Clorazil (Clozapine) Health Tablet PS ORAL 175 MG/D, Professional ORAL Date:05/09/02ISR Number: 3915470-2Report Type:Expedited (15-DaCompany Report #PHFR2002GB01173 Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Clozaril (Clozapine) Initial or Prolonged Phosphokinase Increased Health (Clozapine) Tablet PS ORAL 500MG DAY Lower Respiratory Tract Professional ORAL Infection Paroxetine Peritonsillar Abscess (Paroxetine) C Pharyngitis Nicorette Patch C Respiratory Failure Date:05/09/02ISR Number: 3915471-4Report Type:Expedited (15-DaCompany Report #PHBS2002CA05085 Age:36 YR Gender:Male I/FU:F Outcome PT Other Blood Pressure Increased Increased Appetite Malaise Nausea 22-Feb-2006 08:30 AM Page: 1620 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Photosensitivity Reaction Sinusitis Skin Discolouration Report Source Product Role Manufacturer Route Dose Duration Weight Increased Foreign Clozaril (Clozapine) Study Tablet PS ORAL 300 MG DAY Health ORAL Professional Gravol (Dimenhydrinate) C Date:05/09/02ISR Number: 3915525-2Report Type:Expedited (15-DaCompany Report #C2002-1247.01 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Other Clozapine Tablets 100mg Mylan PS Mylan ORAL 100MG TID, ORAL Chlorpromazine (200mg Bid) C Lithium (600mg Bid) C Mirtazipine(45mg Q Hs) C Primidone(100mg Tid) C Propranolol(20mg Qid) C Date:05/09/02ISR Number: 3915526-4Report Type:Expedited (15-DaCompany Report #C2002-1246.01 Age:85 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 12.5 MG QD, Other ORAL Date:05/10/02ISR Number: 3914954-0Report Type:Expedited (15-DaCompany Report #PHEH2002US03767 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Lymph Node Pain Health Clozaril (Clozapine) Lymphoma Professional Tablet PS ORAL 700 MG/DAY, ORAL Zyprexa (Olanzapine) C Geodon (Ziprasidone Hydrochloride) C Topamax (Topiramate) C Artane (Trihexyphenidyl Hydrochloride) C Date:05/10/02ISR Number: 3914957-6Report Type:Expedited (15-DaCompany Report #PHEH2002US04231 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozaril (Clozapine) Professional Tablet PS ORAL 25 MG, ORAL 22-Feb-2006 08:30 AM Page: 1621 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/10/02ISR Number: 3914991-6Report Type:Expedited (15-DaCompany Report #PHEH2002US04234 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aneurysm Other Clozaril(Clozapine)T ablet PS ORAL ORAL Date:05/10/02ISR Number: 3915715-9Report Type:Expedited (15-DaCompany Report #C2002-0990.01 Age:82 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Confusional State Health Clozapine Tablets 25 General Physical Health Professional Mg Mylan PS ORAL 50MG Q HS, Deterioration Other ORAL Hypoaesthesia Clozapine Tablets 100 Mg Mylan SS ORAL 200MG QHS, ORAL Date:05/10/02ISR Number: 3915716-0Report Type:Expedited (15-DaCompany Report #C2002-0898.01 Age:44 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional 100 Mg Mylan PS ORAL 300MG G AM Other AND 350MG G HS, ORAL Benztropine C Fluoxetine C Haloperidol C Lorazepam C Oxybutynin C Aspirin C Date:05/10/02ISR Number: 3915717-2Report Type:Expedited (15-DaCompany Report #C2002-1118.01 Age:81 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Clozapine Tablets 25 Congestive Professional Mg Mylan PS ORAL 150MG QD, Respiratory Tract Other THEN 50MG Infection QAM, ORAL Donazepil C Hydrocodone/Acetamin ophen Elixir C Metoclopramide C Multivitamins C Sertraline C Cefaclor C Albuterol C Ciprofloxacin C Acetaminophen (Prn) C Vitamin C C Promethazine (Prn) C 22-Feb-2006 08:30 AM Page: 1622 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/10/02ISR Number: 3915718-4Report Type:Expedited (15-DaCompany Report #C2002-1029.01 Age:91 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozapine Tablets 25 Neoplasm Malignant Professional Mg Mylan PS ORAL 12.5MG QD, Other ORAL Acetaminophen/Codein e C Albuterol C Bromocriptine C Carbidopa/Levodopa Er C Potassium C Rofecoxib C Spironolactone C Date:05/10/02ISR Number: 3915719-6Report Type:Expedited (15-DaCompany Report #C2002-0977.01 Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Health Clozapine Tablets Convulsion Professional 100 Mg Mylan PS ORAL 100MG BID, Other 500MG Q HS, ORAL Date:05/10/02ISR Number: 3915721-4Report Type:Expedited (15-DaCompany Report #C2002-0793.01 Age:78 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death White Blood Cell Count Health Clozapine Tablets 25 Abnormal Professional Mg Mylan PS ORAL 12.5MG QD, Other ORAL Date:05/10/02ISR Number: 3915722-6Report Type:Expedited (15-DaCompany Report #02-04-0358 Age:58 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neuroleptic Malignant Health Clozapine - Ivax Hospitalization - Syndrome Professional Pharmaceuticals, Initial or Prolonged Other Inc. Tablets PS ORAL 600MG QD ORAL Zyprexa Tablets SS ORAL ORAL Date:05/10/02ISR Number: 3915724-XReport Type:Expedited (15-DaCompany Report #02-05-0411 Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 62.5MG QD ORAL 22-Feb-2006 08:30 AM Page: 1623 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/10/02ISR Number: 3915725-1Report Type:Expedited (15-DaCompany Report #02-05-0399 Age:88 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Respiratory Failure Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 37.5MG QD ORAL Date:05/10/02ISR Number: 3915726-3Report Type:Expedited (15-DaCompany Report #02-05-0398 Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 25-37.5 MG QD ORAL Date:05/10/02ISR Number: 3915727-5Report Type:Expedited (15-DaCompany Report #02-05-0397 Age:69 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neoplasm Malignant Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 50-150MG QD ORAL Date:05/10/02ISR Number: 3915728-7Report Type:Expedited (15-DaCompany Report #02-04-0395 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 200-400MG QD ORAL Date:05/15/02ISR Number: 3916381-9Report Type:Direct Company Report #CTU 168080 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cough Clozaril 250mg Pm, Hospitalization - Dyspnoea 200mg Am 450mg/Day PS ORAL 450MG/DAY PO 10 YR Initial or Prolonged Oedema Peripheral Prozac C Required Intervention to Prevent Permanent Impairment/Damage 22-Feb-2006 08:30 AM Page: 1624 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/15/02ISR Number: 3917284-6Report Type:Direct Company Report #CTU 168180 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neutropenia Clozapine 100mg Ivax PS Ivax ORAL 100MG AM, HS ORAL Clozapine 25mg Ivax SS Ivax Risperidone 2mg C Lorazepam 1mg C Atorvastatin 10mg C Benztropine 1mg C Simethicone 80mg C Amlodipine 5mg C Tamsulosin 0.4mg C Date:05/15/02ISR Number: 3917352-9Report Type:Expedited (15-DaCompany Report #A210200 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Effect Decreased Health Ziprasidone Po PS ORAL ORAL Hospitalization - Psychotic Disorder Professional Clozapine SS Initial or Prolonged Date:05/16/02ISR Number: 3917562-0Report Type:Expedited (15-DaCompany Report #02-05-0422 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mania Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceutcals, Inc. Other Tablets PS Ivax Pharmaceuticals, Inc. ORAL 300-500MG QD ORAL Date:05/16/02ISR Number: 3917822-3Report Type:Expedited (15-DaCompany Report #A0367651A Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Potassium Decreased Health Paxil (Formulation Initial or Prolonged Dehydration Professional Unknown) (Paroxetine Dizziness Company Hydrochloride) PS ORAL ORAL Mitral Valve Prolapse Representative Methylphenidate Hcl Nervous System Disorder (Formulation Orthostatic Hypotension Unknown) Tachycardia (Methylphenidate Hcl) SS ORAL ORAL Clozapine (Formulation Unkown) (Clozapine) SS ORAL ORAL Date:05/17/02ISR Number: 3918469-5Report Type:Expedited (15-DaCompany Report #02-05-0421 Age:49 YR Gender:Male I/FU:I Outcome PT Death Renal Failure Other Respiratory Tract 22-Feb-2006 08:30 AM Page: 1625 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Infection Report Source Product Role Manufacturer Route Dose Duration Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 150MG BID ORAL Buspar C Lithium C Trazodone C Date:05/17/02ISR Number: 3918473-7Report Type:Expedited (15-DaCompany Report #02-05-0420 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Health Clozapine - Ivax Initial or Prolonged Diabetic Ketoacidosis Professional Pharmaceuticals, Eosinophilia Inc. Tablets PS Ivax Pericarditis Pharmaceuticals, Inc ORAL 300MG BID ORAL Lamictal C Zoloft C Haldol C Depakote C Date:05/17/02ISR Number: 3918477-4Report Type:Expedited (15-DaCompany Report #02-05-0426 Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Other Clozapine - Ivax Hyperventilation Pharmaceuticals, Hypoxia Inc. Tablets PS Ivax Pharmaceuticals, Inc ORAL 25MG QD ORAL Date:05/17/02ISR Number: 3918480-4Report Type:Expedited (15-DaCompany Report #02-05-0417 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. PS Ivax Pharmaceuticals, Inc. ORAL 500MG QD ORAL Date:05/17/02ISR Number: 3918486-5Report Type:Expedited (15-DaCompany Report #02-05-0418 Age:69 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Death Health Clozapine - Ivax Professional Pharmaceuticals, Inc PS Ivax Other Pharmaceuticals, Inc ORAL 25-150MG QD ORAL 22-Feb-2006 08:30 AM Page: 1626 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/17/02ISR Number: 3918489-0Report Type:Expedited (15-DaCompany Report #02-05-0429 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dehydration Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. PS Ivax Pharmaceuticals, Inc ORAL 500MG QD ORAL Date:05/17/02ISR Number: 3918496-8Report Type:Expedited (15-DaCompany Report #C2002-0991.01 Age:79 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg Mylan PS ORAL 25MG BID, Other THEN 50MG BID, ORAL Buspirone C Carbidopa/Levodopa C Conjugated Estrogens C Divalproex C Pantoprazole C Date:05/17/02ISR Number: 3918530-5Report Type:Direct Company Report #CTU 168385 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Respiratory Failure Health Clozaril 100mg PS ORAL 100MG BID Hospitalization - Ventricular Tachycardia Professional ORAL Initial or Prolonged Clonazepam 1mg SS ORAL 1MG BID ORAL Date:05/17/02ISR Number: 3918929-7Report Type:Expedited (15-DaCompany Report #PHFR2002GB00573 Age:52 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cerebellar Syndrome Foreign Clozaril (Clozapine) Coordination Abnormal Health Tablet PS ORAL 100 MG AM Nuclear Magnetic Professional 150 MG PM, Resonance Imaging Other ORAL Abnormal Lithium (Lithium) C Pain Olanzapine Paraesthesia (Olanzapine) C Mirtazapine (Mirtazapine) C Date:05/17/02ISR Number: 3918930-3Report Type:Expedited (15-DaCompany Report #PHEH2002US01165 Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Leukopenia Health Clozaril(Clozapine)T Hospitalization - Lung Carcinoma Cell Type Professional ablet PS ORAL SEE IMAGE Initial or Prolonged Unspecified Stage Iv Chemotherapeutics,Ot Peripheral Circulatory her(Chemotherapeutic Failure s, Other) SS Neurontin (Gabapentin) C Depakote(Valproate Semisodium) C 22-Feb-2006 08:30 AM Page: 1627 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lithium (Lithium) C Cogentin(Benzatropin e Mesilate) C Date:05/17/02ISR Number: 3918997-2Report Type:Expedited (15-DaCompany Report #PHBS2002AU05385 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Catatonia Foreign Clozaril (Clozapine) Initial or Prolonged Neutrophil Count Abnormal Health Tablet PS ORAL 150 MG/D, Renal Failure Professional ORAL Sepsis Other White Blood Cell Count Abnormal Date:05/20/02ISR Number: 3919250-3Report Type:Expedited (15-DaCompany Report #PHEH2002US02451 Age:35 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Complications Of Maternal Health Clozaril (Clozapine) Exposure To Therapeutic Professional Tablet PS ORAL 200 MG/DAY, Drugs ORAL Diabetes Mellitus Avandia Drug Exposure During (Rosiglitazone Pregnancy Maleate) C Pregnancy Insulin (Insulin) C Zoloft (Sertraline Hydrochloride) C Date:05/20/02ISR Number: 3919294-1Report Type:Expedited (15-DaCompany Report #PHNU2002DE01444 Age:30 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Foreign Leponex/Clozaril Initial or Prolonged Anxiety Health (Clozapine) Regimen Other Condition Aggravated Professional #2 PS ORAL 800MG/DAY, Drug Effect Decreased Other ORAL; 300MG Electrocardiogram Qt TO 800MG/DAY Prolonged INCREAS , Obsessive Thoughts ORAL Suicide Attempt Seroxat Regimen 2, Regimen 3 SS Smith Kline ORAL 50MG/DAY; ORAL; 10MG/DAY; ORAL; 50MG/DAY; Tavor (Lorazepam) Tablet SS ORAL 0.5 MG, BID; ORAL Valium C Date:05/20/02ISR Number: 3919297-7Report Type:Expedited (15-DaCompany Report #PHFR2002GB00836 Age:45 YR Gender:Female I/FU:F Outcome Life-Threatening Hospitalization - 22-Feb-2006 08:30 AM Page: 1628 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Initial or Prolonged PT Report Source Product Role Manufacturer Route Dose Duration Blood Pressure Decreased Foreign Clozaril(Clozapine) Empyema Health Tablet PS ORAL ORAL Fatigue Professional Lansoprazole Hiatus Hernia Other (Lansoprazole) C Hypotension Oesophageal Carcinoma Oesophageal Stenosis Oesophageal Ulcer Weight Decreased White Blood Cell Count Increased Date:05/20/02ISR Number: 3919298-9Report Type:Expedited (15-DaCompany Report #PHFR2001GB03506 Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Enteritis Necroticans Foreign Clozaril(Clozapine) Hospitalization - Intestinal Ischaemia Study Tablet PS ORAL SEE IMAGE Initial or Prolonged Intestinal Obstruction Health Diazepam C Malaise Professional Olanzapine Multi-Organ Failure Other (Olanzapine) C Sepsis Lansoprazole (Lansoprazole) C Date:05/20/02ISR Number: 3919361-2Report Type:Expedited (15-DaCompany Report #PHBS2002BR05487 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Alkaline Foreign Clozaril (Clozapine) Initial or Prolonged Phosphatase Increased Health Tablet PS ORAL ORAL Gamma-Glutamyltransferase Professional Increased Other Hepatic Enzyme Increased Leukocytosis Prothrombin Time Shortened Pyrexia Thrombocytopenia Date:05/20/02ISR Number: 3919364-8Report Type:Expedited (15-DaCompany Report #PHBS2002BR04534 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abscess Foreign Leponex (Clozapine) Tonsillitis Health Tablet PS ORAL ORAL Professional Diazepam C Other Neuroleptics C Date:05/20/02ISR Number: 3919367-3Report Type:Expedited (15-DaCompany Report #PHBS2002CA05724 Age:50 YR Gender:Female I/FU:I Outcome PT Life-Threatening Blood Creatine Phosphokinase Increased 22-Feb-2006 08:30 AM Page: 1629 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Bundle Branch Block Left Chest Pain Ejection Fraction Report Source Product Role Manufacturer Route Dose Duration Decreased Foreign Clozaril (Clozapine) Health Tablet PS ORAL 100 OR 125 Professional MG/D, ORAL Other Olanzapine (Olanzapine) C Lamictal C Imovane C Date:05/20/02ISR Number: 3919371-5Report Type:Expedited (15-DaCompany Report #PHNU2002DE01612 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Foreign Leponex / Clozaril Initial or Prolonged Liver Function Test Health (Clozapine) Other Abnormal Professional (Clozapine) Tablet PS ORAL 250 MG/DAY, Rhabdomyolysis Other ORAL Seroquel (Quetiapine) SS ORAL 800 MG/DAY, ORAL Date:05/20/02ISR Number: 3919488-5Report Type:Expedited (15-DaCompany Report #C2002-0879.01 Age:73 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bronchitis Health Clozapine Tablets Hepatic Neoplasm Professional 100 Mg Mylan PS Mylan ORAL 100MG, BID, Malignant Other ORAL Lung Neoplasm Malignant Pneumonia Date:05/20/02ISR Number: 3919498-8Report Type:Expedited (15-DaCompany Report #C2002-1411.01 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pancreatic Carcinoma Health Clozapine Tablets 25 Metastatic Professional Mg Mylan PS Mylan ORAL 25MG Q HS, Other ORAL Acetaminophen C Clonidine Patch C Amlodipine C Phenytoin C Mirtazapine C Multivitamin C Acetaminophen/Codein e C Date:05/20/02ISR Number: 3919527-1Report Type:Expedited (15-DaCompany Report #PHNU2002DE01657 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Other Diabetes Mellitus Foreign Ketoacidosis Study Health Professional 22-Feb-2006 08:30 AM Page: 1630 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Product Role Manufacturer Route Dose Duration Leponex / Clozaril (Clozapine) PS ORAL 500-600 MG/DAY, ORAL Date:05/20/02ISR Number: 3919582-9Report Type:Expedited (15-DaCompany Report #PHBS2002AU05672 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Ischaemia Foreign Clozaril (Clozapine) Study Tablet PS ORAL 650 MG/D, Health ORAL Professional Other Date:05/20/02ISR Number: 3919618-5Report Type:Expedited (15-DaCompany Report #PHNU2002DE01656 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Leponex / Clozaril Hypertriglyceridaemia Study (Clozapine) Health (Clozapine) Tablet PS ORAL 300MG/DAY, Professional ORAL Other Date:05/20/02ISR Number: 3919634-3Report Type:Expedited (15-DaCompany Report #PHBS2002BE05759 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Leponex (Clozapine) Health Tablet PS ORAL 500 MG/D, Professional ORAL Other Date:05/20/02ISR Number: 3919637-9Report Type:Expedited (15-DaCompany Report #PHRM2002FR01347 Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Foreign Leponex(Clozapine) Initial or Prolonged International Normalised Health Tablet PS ORAL 25 MG, QD, Ratio Increased Professional ORAL Prothrombin Level Other Previscan(Fluindione Decreased ) SS ORAL ORAL Date:05/20/02ISR Number: 3919639-2Report Type:Expedited (15-DaCompany Report #PHBS2002BR04646 Age:28 YR Gender:Female I/FU:I Outcome PT Hospitalization - Anorexia Nervosa Initial or Prolonged Constipation Cough Gastrointestinal Injury Hyperhidrosis Hypersensitivity 22-Feb-2006 08:30 AM Page: 1631 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pain Pruritus Pyrexia Report Source Product Role Manufacturer Route Dose Duration Salivary Hypersecretion Foreign Leponex(Clozapine) Sleep Disorder Consumer Tablet PS ORAL 100 MG, QID, Weight Decreased Other ORAL Akineton (Biperiden Hydrochloride) C Dormonid (Midazolam) C Fenergan (Promethazine) C Rivotril Tablet C Levomepromazine Maleate (Levomepromazine Maleate) C Date:05/20/02ISR Number: 3919641-0Report Type:Expedited (15-DaCompany Report #PHEH2002US03278 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chronic Leukaemia Health Clozaril (Clozapine) Leukocytosis Professional Tablet PS ORAL 700 MG/DAY, Lymphadenopathy ORAL Geodon (Ziprasidone Hydrochloride) C Celexa C Date:05/20/02ISR Number: 3919682-3Report Type:Expedited (15-DaCompany Report #PHFR2002GB01569 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Foreign Clozaril(Clozapine) Sudden Death Study Tablet PS ORAL 500 MG/DAY, Health ORAL Professional Other Date:05/20/02ISR Number: 3919695-1Report Type:Expedited (15-DaCompany Report #PHEH2002US04407 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozaril(Clozapine) Professional Tablet PS ORAL 75 MG, ORAL Date:05/20/02ISR Number: 3919823-8Report Type:Expedited (15-DaCompany Report #PHBS2002CA05293 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Foreign Clozari Blood Glucose Increased Study (Clozapine)Tablet PS ORAL 300 MG/D, Lipids Increased Health ORAL Professional 22-Feb-2006 08:30 AM Page: 1632 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/21/02ISR Number: 3919693-8Report Type:Expedited (15-DaCompany Report #PHEH2002US04367 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bundle Branch Block Right Health Clozaril(Clozapine) Fatigue Professional Tablet PS ORAL 150 MG, ORAL Leukocytosis Klonopin C Myocardial Infarction Haldol C Neutrophilia Pyrexia Tachycardia Date:05/22/02ISR Number: 3921543-0Report Type:Expedited (15-DaCompany Report #PHNU2002DE01672 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Withdrawal Syndrome Foreign Leponex / Clozaril Initial or Prolonged Hypertonia Health (Clozapine)(Clozapin Other Orthostatic Hypotension Professional e) Tablet PS ORAL SEE IMAGE Pyrexia Other Tavor (Lorazepam) Somnolence Tablet SS Syncope Date:05/22/02ISR Number: 3921545-4Report Type:Expedited (15-DaCompany Report #PHRM2002FR01396 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Foreign Leponex (Clozapine) Initial or Prolonged Drug Interaction Health Tablet PS ORAL 400 MG DAILY, Orthostatic Hypotension Professional ORAL Partial Seizures Other Androcur (Cyproterone Acetate) SS ORAL ORAL Estreva (Estradiol) SS ORAL ORAL Zoloft (Sertraline Hydrochloride) C Date:05/22/02ISR Number: 3921552-1Report Type:Expedited (15-DaCompany Report #PHBS2002BR04646 Age:28 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anorexia Nervosa Foreign Leponex (Clozapine) Initial or Prolonged Constipation Consumer Tablet PS ORAL 100 MG, QID, Cough Other ORAL Gastrointestinal Injury Akineton (Biperiden Hyperhidrosis Hydrochloride) C Hypersensitivity Dormonid (Midazolam) Insomnia Tablet C Pain Fenergan Pruritus (Promethazine) Pyrexia Tablet C Salivary Hypersecretion Rivotril Tablet C Weight Decreased Levomepromazine Maleate (Levomepromazine Maleate) C 22-Feb-2006 08:30 AM Page: 1633 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/22/02ISR Number: 3921556-9Report Type:Expedited (15-DaCompany Report #PHBS2002BR04785 Age:30 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Foreign Leponex (Clozapine) Health Tablet PS ORAL SEE IMAGE Professional Haloperidol C Other Date:05/22/02ISR Number: 3921562-4Report Type:Expedited (15-DaCompany Report #PHFR2002GB01487 Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amyloidosis Foreign Clozaril (Clozapine) Renal Failure Health Tablet PS ORAL 350MG/DAY, Professional ORAL Other Aspirine C Ferrograd (Ferrous Sulfate Exsiccated) C Glimepiride (Glimepiride) C Fenofibrate (Fenofibrate) C Ramipril (Ramipril) C Date:05/22/02ISR Number: 3922396-7Report Type:Expedited (15-DaCompany Report #PHBS2002AU05385 Age:41 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Catatonia Foreign Clozaril (Clozapine) Initial or Prolonged Ketoacidosis Health Tablet PS ORAL 150 MG/D, Neuroleptic Malignant Professional ORAL Syndrome Other Renal Failure Sepsis Date:05/22/02ISR Number: 3922397-9Report Type:Expedited (15-DaCompany Report #PHBS2002AU04562 Age:70 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Clonic Convulsion Foreign Clozaril (Clozapine) Initial or Prolonged Hypoxia Health Tablet PS ORAL 100 MG, BID, Disability Transient Ischaemic Professional ORAL Attack Other Thyroxine C Ventolin C Fluxotide "Allen & Hanburys" (Fluticasone Propionate) C Valproate Sodium C Lithium Carbonate C Aspirin "Bayer" C Prednisolone C 22-Feb-2006 08:30 AM Page: 1634 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/22/02ISR Number: 3922398-0Report Type:Expedited (15-DaCompany Report #PHBS2002AU04835 Age:64 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Exposure Foreign Clozaril Initial or Prolonged Health (Clozapine)Tablet PS ORAL 200 MG, Professional ONCE/SINGLE, Other ORAL Temazepam C Valproate Sodium C Cipramil C Zyprexa (Olanzapine) C Valium C Date:05/22/02ISR Number: 3922549-8Report Type:Expedited (15-DaCompany Report #PHNU2002DE01120 Age:51 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Colitis Foreign Leponex / Clozaril Eosinophilia Health (Clozapine) Professional (Clozapine) Tablet, Other 100 Mg PS ORAL ORAL Date:05/22/02ISR Number: 3922562-0Report Type:Expedited (15-DaCompany Report #PHNU2002DE01612 Age:55 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Leponex / Clozaril Initial or Prolonged Increased Health (Clozapine) Other Aspartate Professional (Clozapine) Tablet PS ORAL 250 MG/DAY, Aminotransferase Other ORAL Increased Seroquel Blood Alkaline (Quetiapine) Phosphatase Increased Film-Coated Tablet SS ORAL 800MG/DAY, Blood Creatine ORAL Phosphokinase Blood Creatine Phosphokinase Increased Blood Lactate Dehydrogenase Increased Contusion Fall Gamma-Glutamyltransferase Increased Pyrexia Rhabdomyolysis Date:05/22/02ISR Number: 3922563-2Report Type:Expedited (15-DaCompany Report #PHBS2002AU04898 Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Foreign Clozaril PS ORAL 400 MG/DAY, Drug Level Increased Health ORAL Professional Valproate Sodium Other (Valproate Sodium) SS ORAL ORAL Citalopram (Citalopram) C 22-Feb-2006 08:30 AM Page: 1635 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/22/02ISR Number: 3922564-4Report Type:Expedited (15-DaCompany Report #PHBS2002DK05756 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Ketoacidosis Foreign Leponex (Clozapine) PS ORAL 175 MG, BID, Initial or Prolonged Health ORAL Professional Daonil C Other Cipramil C Date:05/22/02ISR Number: 3922565-6Report Type:Expedited (15-DaCompany Report #PHBS2002NZ05735 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyspnoea Foreign Clozaril PS ORAL 150 MG/D, Initial or Prolonged Hepatocellular Damage Health ORAL Tachycardia Professional Other Date:05/22/02ISR Number: 3922566-8Report Type:Expedited (15-DaCompany Report #PHFR2002GB01610 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Foreign Clozaril PS ORAL 300MG/DAY, Prolonged Health ORAL Hypotension Professional Pyrexia Other Tachycardia Date:05/23/02ISR Number: 3920960-2Report Type:Direct Company Report #CTU 168731 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pharmaceutical Product Clozapine PS Ivax Pharmaceuticals ORAL 600 MG DAILY Complaint ORAL White Blood Cell Count Clozapine SS Ivax Pharmaceuticals ORAL 50 MG DAILY Decreased IN AM ORAL Date:05/23/02ISR Number: 3920975-4Report Type:Direct Company Report #CTU 168750 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pharmaceutical Product Clozapine 100mg Ivax Complaint Pharmaceuticals PS Ivax Pharmaceuticals ORAL 400MG AT 8 PM White Blood Cell Count ORAL Decreased Clozapine 25mg Ivax Pharmaceuticals SS Ivax Pharmaceuticals ORAL 50MG AT 8AM ORAL Date:05/23/02ISR Number: 3921893-8Report Type:Direct Company Report #CTU 168801 Age:41 YR Gender:Male I/FU:I Outcome PT Other Condition Aggravated Delusion Disturbance In Attention Hallucination, Auditory Incoherent 22-Feb-2006 08:30 AM Page: 1636 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Mental Status Changes Report Source Product Role Manufacturer Route Dose Duration Clozapine 25 Mg PS 25MG 2 TABLETS 3X/DAY, 1 AT BEDTIME Clozapine 100 Mg SS 100 MG 3X/DAY 300 MG AT BEDTIME Date:05/23/02ISR Number: 3921916-6Report Type:Expedited (15-DaCompany Report #PHBS2002AU05385 Age:41 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Catatonia Foreign Clozaril (Clozapine) Initial or Prolonged Ketoacidosis Health Tablet PS ORAL 150 MG/D, Neuroleptic Malignant Professional ORAL Syndrome Other Renal Failure Sepsis White Blood Cell Disorder Date:05/23/02ISR Number: 3921917-8Report Type:Expedited (15-DaCompany Report #PHFR2002GB01639 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Breast Cancer Foreign Clozaril (Clozapine) Initial or Prolonged Health Tablet PS ORAL 350MG/DAY, Professional ORAL Other Date:05/23/02ISR Number: 3921918-XReport Type:Expedited (15-DaCompany Report #PHFR2002GB01637 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Gastric Cancer Foreign Clozaril (Clozapine) Metastasis Health Tablet PS ORAL 200MG/DAY, Terminal State Professional ORAL Other Date:05/23/02ISR Number: 3921919-1Report Type:Expedited (15-DaCompany Report #PHFR2002GB01598 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Foreign Clozapine Initial or Prolonged Non-Insulin-Dependent Health (Clozapine) Tablet PS ORAL ORAL Professional Other Date:05/23/02ISR Number: 3921920-8Report Type:Expedited (15-DaCompany Report #PHFR2002GB01623 Age:51 YR Gender:Female I/FU:I Outcome PT Hospitalization - Cardiac Failure Initial or Prolonged Congestive 22-Feb-2006 08:30 AM Page: 1637 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Cardiomegaly Cardiomyopathy Report Source Product Role Manufacturer Route Dose Duration Foreign Clozaril (Clozapine) Health Tablet PS ORAL ORAL Professional Lofepramine Other (Lofepramine) C Procyclidine (Procyclidine) C Date:05/23/02ISR Number: 3922629-7Report Type:Expedited (15-DaCompany Report #C2002-1456.01 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional 100mg Mylan PS Mylan ORAL 500MG Q HS, Other ORAL Date:05/23/02ISR Number: 3922632-7Report Type:Expedited (15-DaCompany Report #C2002-1401.01 Age:71 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 50MG QD, ORAL Other Date:05/23/02ISR Number: 3922635-2Report Type:Expedited (15-DaCompany Report #C2002-1247.01 Age:54 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Influenza Like Illness Other Clozapine Tablets Myocardial Infarction 100 Mg Mylan PS Mylan ORAL 100 MG Q AM AND 200 MG Q PM, ORAL Chlorpromazine C Lithium Carbonte C Mirtazipine C Primidone C Propranolol C Fibercon C Bisacodyl Suppository (M-W-F) C Bisacodyl C Date:05/23/02ISR Number: 3922638-8Report Type:Expedited (15-DaCompany Report #C2002-1237.01 Age:24 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Myocarditis Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 200 MG Q HS, ORAL Clozapine Tablets 25 Mg Mylan SS Mylan ORAL 75 MG Q HS, ORAL Divalproex Sodium C 22-Feb-2006 08:30 AM Page: 1638 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/24/02ISR Number: 3922496-1Report Type:Direct Company Report #CTU 168930 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Rofecoxib PS 50 MG QDAY Cardio-Respiratory Arrest Naproxen SS 500 MG PRN UP Gastrointestinal TO TID 500 Haemorrhage BID Clozapine SS 250 Q HS Chlorpromazine SS 200 Q HS Mvi/Folic Ac C Levothyroxine C Chlorzoxazone C Gabapentin C Nefazodone C Clonazepam C Oxycodone Cr C Vit C C Date:05/24/02ISR Number: 3923021-1Report Type:Expedited (15-DaCompany Report #PHEH2002US04631 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Health Clozaril (Clozapine) Hospitalization - Cardiac Failure Professional Tablet PS ORAL 300 MG, BID, Initial or Prolonged Congestive ORAL 730 DAY Dizziness Celexa C Fatigue Insulin (Insulin) C Malaise Sleep Disorder Date:05/24/02ISR Number: 3923152-6Report Type:Expedited (15-DaCompany Report #PHBS2002BE05759 Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Leponex (Clozapine) PS ORAL 400 MG/D, Health ORAL Professional Temesta C Other Atarax (Hydroxyzine Hydrochloride) C Date:05/24/02ISR Number: 3923155-1Report Type:Expedited (15-DaCompany Report #PHBS2002AU05427 Age:46 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Brain Neoplasm Foreign Clozaril Hospitalization - Circulatory Collapse Health (Clozapine) PS ORAL 200 MG, QD, Initial or Prolonged Hallucination, Visual Professional ORAL Loss Of Consciousness Other Date:05/24/02ISR Number: 3923209-XReport Type:Expedited (15-DaCompany Report #PHFR2002GB01615 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Foreign Clozaril (Clozapine) PS ORAL 450 MG/DAY, Prolonged Health ORAL Syncope Professional Other 22-Feb-2006 08:30 AM Page: 1639 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/24/02ISR Number: 3923237-4Report Type:Expedited (15-DaCompany Report #PHFR2002GB01528 Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Haemoglobin Increased Foreign Clozaril (Clozapine) PS ORAL 600 MG/DAY, Marrow Hyperplasia Health ORAL Polycythaemia Professional Propranolol C Other Date:05/24/02ISR Number: 3923252-0Report Type:Expedited (15-DaCompany Report #PHFR2002GB01496 Age:20 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Peritoneal Dialysis Foreign Clozaril Renal Impairment Health (Clozapine) PS ORAL 550 MG/DAY, Professional ORAL Other Date:05/28/02ISR Number: 3923140-XReport Type:Expedited (15-DaCompany Report #02-05-0438 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dyspnoea Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 400-600MG QD ORAL Date:05/28/02ISR Number: 3923151-4Report Type:Expedited (15-DaCompany Report #02-05-0431 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aneurysm Health Clozapine - Ivax Gastrointestinal Disorder Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 150-400 MG QD ORAL Date:05/28/02ISR Number: 3923156-3Report Type:Expedited (15-DaCompany Report #02-05-0451 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Literature Clozapine - Ivax Initial or Prolonged Dyspnoea Health Pharmaceuticals, Electrocardiogram Professional Inc. Tablets PS Ivax Abnormal Pharmaceuticals, Electrocardiogram St Inc. Tablets ORAL 25-100MG QD Segment Elevation ORAL Heart Rate Increased Benztropine Mesylate C Palpitations Diazepam C Pericarditis Respiratory Rate Increased Troponin I Increased 22-Feb-2006 08:30 AM Page: 1640 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/29/02ISR Number: 3925639-9Report Type:Expedited (15-DaCompany Report #C2002-1490.01 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 100 MG Q AM, Other 400 MG Q PM, ORAL Date:05/29/02ISR Number: 3925641-7Report Type:Expedited (15-DaCompany Report #C2002-1491.01 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bedridden Health Clozapine Tablets Cardiac Disorder Professional 100 Mg Mylan PS Mylan ORAL 100MG Q AM Constipation Other AND 200MG Q HS, ORAL Nph Insulin C Acetaminophen / Codeine C Docusate Sodium C Fluoxetine C Levothroxine Sodium C Metformin C Date:05/29/02ISR Number: 3926095-7Report Type:Expedited (15-DaCompany Report #PHEH2002US02630 Age:74 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Clonic Convulsion Health Clozaril (Clozapine) Initial or Prolonged Clostridial Infection Professional Tablet PS ORAL 500MG, ORAL Other Clostridium Colitis SEE IMAGE SEC Computerised Tomogram Albuterol C Abnormal Atrovent Drug Level Increased (Ipratropium Dysarthria Bromide) C Eating Disorder Colace C Electroencephalogram Norvasc C Abnormal Fosamax (Alendronate Lethargy Sodium) C Manganese Decreased Prinivil Movement Disorder (Lisinopril) C Muscular Weakness Plavix (Clopidogrel Oral Intake Reduced Sulfate) C Parkinson'S Disease Simethicone Peripheral Sensory (Simeticone) C Neuropathy Theravite-M Pneumonitis (Vitamins Nos) C Polyneuropathy Valproic Acid C Sleep Apnoea Syndrome Haldol C Date:05/29/02ISR Number: 3926206-3Report Type:Expedited (15-DaCompany Report #PHFR2002IE01691 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Abuser Foreign Clozaril (Clozapine) Initial or Prolonged Gastrointestinal Health Tablet PS ORAL 700MG/DAY, Haemorrhage Professional ORAL Other Aspirine 22-Feb-2006 08:30 AM Page: 1641 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Acetylsalicylic Acid) SS ORAL ORAL Date:05/30/02ISR Number: 3927910-3Report Type:Expedited (15-DaCompany Report #C2002-1514.01 Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg Mylan PS ORAL 25MG QD, ORAL Other Antibiotics C Pain Medications C Date:05/31/02ISR Number: 3926440-2Report Type:Direct Company Report #CTU 169253 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutrophil Count Abnormal Clozapine 100 Mg PS ORAL 300 MGM PO BID Seroquel C Depakote C Clonidine C Artane C Haldol C Date:05/31/02ISR Number: 3926907-7Report Type:Expedited (15-DaCompany Report #PHEH2002US04768 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drooling Health Clozaril(Clozapine) Initial or Prolonged Ear Infection Professional Tablet PS ORAL 400 MG, BID, Sedation ORAL Depakote (Valproate Semisodium) C Lamictal C Risperdal (Risperidone) C Synthroid C Date:05/31/02ISR Number: 3926908-9Report Type:Expedited (15-DaCompany Report #PHEH2002US04729 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dysphagia Health Clozaril(Clozapine) Hospitalization - Lung Neoplasm Malignant Professional Tablet PS ORAL 300 MG, TID, Initial or Prolonged Pneumonia ORAL Stress Formula Multi B Complex W/C 500 (Vitamins Nos) C Zantac C Trazodone (Trazodone) C Depakote (Valproate Semisodium) C Colace C Peri-Colace (Casanhranol) C Zyprexa (Olanzapine) C Lorazepam C 22-Feb-2006 08:30 AM Page: 1642 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Albuterol C Date:05/31/02ISR Number: 3926909-0Report Type:Expedited (15-DaCompany Report #PHEH2002US03683 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozaril(Clozapine) Sudden Death Professional Tablet PS ORAL 50 MG, ORAL 730 DAY Date:05/31/02ISR Number: 3926927-2Report Type:Expedited (15-DaCompany Report #PHEH2002US04544 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Toxicity Study Clozaril(Clozapine) Health Tablet PS ORAL 100MG AM Professional +150MG HS, ORAL Prozac (Fluoxetine Hydrochloride) C Xanax (Alprazolam) C Depakote (Valproate Semisodium) C Premarin (Estrogens Conjugated) C Provera C Seroquel (Quetiapine) C Ditropan (Oxybutynin) C Claritin (Loratadine) C Albuterol C Benztropeine (Benztropeine) C Ambien (Zolpidem Tartrate) C Biaxin (Clarithromycin) C Synthroid C Date:05/31/02ISR Number: 3927100-4Report Type:Expedited (15-DaCompany Report #PHEH2002US04688 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Non-Hodgkin'S Lymphoma Health Clozaril (Clozapine) Professional Tablet PS ORAL ORAL Date:05/31/02ISR Number: 3927147-8Report Type:Expedited (15-DaCompany Report #PHBS2002BE06113 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrial Tachycardia Foreign Leponex (Clozapine) PS ORAL UNK, UNK, Initial or Prolonged Cardiomyopathy Health ORAL Ejection Fraction Professional Asaflow C Decreased Other Tenormin C Ventricular Tachycardia Sotalex (Sotalol Hydrochloride) C 22-Feb-2006 08:30 AM Page: 1643 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/31/02ISR Number: 3927307-6Report Type:Expedited (15-DaCompany Report #PHBS2002AU06165 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Withdrawal Syndrome Foreign Clozaril (Clozapine) Suicidal Ideation Health Tablet PS ORAL 550 MG, QD, Professional ORAL Other Date:05/31/02ISR Number: 3927310-6Report Type:Expedited (15-DaCompany Report #PHBS2002NZ06137 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Impaired Healing Foreign Clozaril (Clozapine) Infection Health Tablet PS ORAL 425 MG/D, Lower Limb Fracture Professional ORAL Other Date:06/03/02ISR Number: 3927333-7Report Type:Direct Company Report #CTU 169364 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Gait Disturbance Clozapine (100mg) Metabolic Disorder (Clozaril) PS ORAL 100MG 2 IN AM 4 AT HS ORAL Date:06/03/02ISR Number: 3928461-2Report Type:Expedited (15-DaCompany Report #PHBS2002AU06110 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Disorder Foreign Melleril(Thioridazin Initial or Prolonged Conduction Disorder Health e Hydrochloride) Electrocardiogram Qt Professional Tablet PS ORAL ORAL Prolonged Other Clozaril(Clozapine) Tablet SS 400 MG/D Date:06/03/02ISR Number: 3928463-6Report Type:Expedited (15-DaCompany Report #PHBS2002AU6079 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Malaise Foreign Clozaril(Clozapine) Initial or Prolonged Mental Disorder Study Tablet PS ORAL 650 MG/D, Other Other ORAL Date:06/03/02ISR Number: 3928465-XReport Type:Expedited (15-DaCompany Report #PHBS2002AU05424 Age:38 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bundle Branch Block Right Foreign Clozaril (Clozapine) Electrocardiogram Qt Health Tablet PS ORAL 500 MG/D, Corrected Interval Professional ORAL Prolonged Other Fluoxetine Electrocardiogram Qt (Fluoxetine) C Prolonged Neutrophilia 22-Feb-2006 08:30 AM Page: 1644 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/03/02ISR Number: 3928468-5Report Type:Expedited (15-DaCompany Report #PHFR2002GB01511 Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril (Clozapine) Non-Insulin-Dependent Health Tablet PS ORAL 250 MG, BID, Polydipsia Professional ORAL Other Date:06/03/02ISR Number: 3928471-5Report Type:Expedited (15-DaCompany Report #PHBS2001AU12218 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiac Disorder Foreign Clozaril (Clozapine) Chest Pain Health Tablet PS ORAL ORAL Professional Other Date:06/03/02ISR Number: 3928489-2Report Type:Expedited (15-DaCompany Report #PHFR2002GB01708 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril(Clozapine) Insulin-Dependent Health Tablet PS ORAL 400MG/DAY, Professional ORAL Other Date:06/03/02ISR Number: 3928508-3Report Type:Expedited (15-DaCompany Report #PHFR2002GB01717 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bradycardia Foreign Clozaril (Clozapine) Electrocardiogram Qt Health (Clozapine) Tablet PS ORAL ORAL Prolonged Professional Heart Rate Irregular Other Hypotension Date:06/03/02ISR Number: 3928695-7Report Type:Expedited (15-DaCompany Report #PHFR2002GB01710 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Rectal Prolapse Foreign Clozaril (Clozapine) Health Tablet PS ORAL 800MG/DAY, Professional ORAL Other Date:06/04/02ISR Number: 3928120-6Report Type:Expedited (15-DaCompany Report #C2002-1081.01 Age:83 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accident Health Clozapine Tablets Fall Professional 100 Mg Mylan PS Mylan ORAL 150 MG BID, Hypomania Other ORAL Limb Injury Sertraline C Dovalproex Sodium C Cryproheptadine C Montelukast C 22-Feb-2006 08:30 AM Page: 1645 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Furosemide C Prednisone C Potassium Chloride C Ferrous Sulfate C Oxygen C Multivitamin With Iron C Protein Drink C Fluticasone/Salmeter ol C Ipratropium Inhaler C Clarithromycin Xl C Guaifenesin C Sulfamethoxazole/Tri methoprim Ds C Date:06/04/02ISR Number: 3928125-5Report Type:Expedited (15-DaCompany Report #02-05-0467 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Pain Upper Literature Clozapine - Ivax Acute Abdomen Health Pharmaceuticals, Blood Pressure Decreased Professional Inc. Tablets PS Ivax Colonic Haemorrhage Pharmaceuticals, Confusional State Inc. ORAL 750MG QD ORAL 6 YR Constipation Medroxyprogeseterone Cyanosis Acetate C Faecaloma Valproate Sodium C Gastrointestinal Necrosis Psyllium C Hypotension Omeprazole C Intestinal Ischaemia Large Intestinal Obstruction Malaise Megacolon Multi-Organ Failure Peritonitis Septic Shock Tachycardia Tachypnoea Vomiting Date:06/04/02ISR Number: 3928128-0Report Type:Expedited (15-DaCompany Report #02-05-0462 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc ORAL 250-350MG QD ORAL Date:06/04/02ISR Number: 3928129-2Report Type:Expedited (15-DaCompany Report #02-05-0475 Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Death Pneumonia Health Professional 22-Feb-2006 08:30 AM Page: 1646 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Product Role Manufacturer Route Dose Duration Clozapine - Ivax Pharmaceuticals, Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 625MG QD ORAL Date:06/04/02ISR Number: 3928131-0Report Type:Expedited (15-DaCompany Report #02-03-0236 Age:61 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Respiratory Failure Health Clozapine - Ivax Wheezing Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc ORAL 200-800MG QD ORAL Zyprexa C Date:06/05/02ISR Number: 3928159-0Report Type:Expedited (15-DaCompany Report #C2002-1554.01 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg Mylan PS ORAL 75MG QD THEN Other 50MG QD ORAL Acetaminophen (Prn) C Albuterol Nebulizer C Captopril C Digoxin C Docusate/Casanthrono l C Furosemide C Guaifenesin La C Isosorbide Mononitrate C Levo-Thyroxine C Lithium C Milk Of Magnesia (Prn) C Multivitamins C Phenytoin C Potassium C Risperdal C Spironolactone C Tramodol C Warfarin C Date:06/06/02ISR Number: 3928663-5Report Type:Expedited (15-DaCompany Report #WAES 0205USA03417 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Health Vioxx PS Merck & Co., Inc ORAL Cardio-Respiratory Arrest Professional Naproxen SS Gastric Haemorrhage Clozapine SS Naproxen SS 1 DAY Chlorpromazine SS 22-Feb-2006 08:30 AM Page: 1647 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Folic Acid C Vitamins (Unspecified) C Levothyroxine Sodium C Chlorzoxazone C Gabapentin C ORAL Gabapentin C ORAL Nefazodone Hydrochloride C ORAL Clonazepam C Oxycodone C Oxycodone C Ascorbic Acid C Date:06/07/02ISR Number: 3929800-9Report Type:Direct Company Report #CTU 169706 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Clozaril 100mg Initial or Prolonged Neutropenia Novartis PS Novartis ORAL 200 MG 12 Required NOON, 300 MG Intervention to HS PO Prevent Permanent Orthocyclen C Impairment/Damage Docusate C Toprimate C Clonazepam C Ibuprofen C Risperidone C Date:06/07/02ISR Number: 3929807-1Report Type:Direct Company Report #CTU 169710 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Clozapine 100mg Po Initial or Prolonged White Blood Cell Count Tablet PS ORAL 400MG PO QD 41 DAY Decreased Date:06/07/02ISR Number: 3929820-4Report Type:Direct Company Report #CTU 169728 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neuroleptic Malignant Clozapine All Doses PS TITRUATED UP Required Syndrome FROM Intervention to 25-125MGQ12 Prevent Permanent Impairment/Damage Date:06/10/02ISR Number: 3930731-9Report Type:Expedited (15-DaCompany Report #02-05-0438 Age:49 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Neoplasm Malignant Health Clozapine - Ivax Respiratory Failure Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 400-600MG QD ORAL 22-Feb-2006 08:30 AM Page: 1648 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/10/02ISR Number: 3930755-1Report Type:Expedited (15-DaCompany Report #02-05-0474 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Gangrene Health Clozapine - Ivax Hospitalization - Pneumonia Professional Pharmaceuticals, Initial or Prolonged Sepsis Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 300MG QD ORAL Date:06/10/02ISR Number: 3930757-5Report Type:Expedited (15-DaCompany Report #02-05-0483 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bipolar Disorder Health Clozapine - Ivax Initial or Prolonged Chemical Poisoning Professional Pharmaceuticals, Depression Other Inc. PS Ivax Psychotic Disorder Pharmaceuticals, Inc. ORAL 25-37.5MG QD ORAL Date:06/10/02ISR Number: 3930759-9Report Type:Expedited (15-DaCompany Report #02-05-0485 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Respiratory Disorder Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 150MG QD ORAL Date:06/10/02ISR Number: 3930768-XReport Type:Expedited (15-DaCompany Report #02-05-0486 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Liver Function Test Health Clozapine - Ivax Abnormal Professional Pharmaceuticals, Pneumothorax Other Inc. Tablets PS ORAL 550MG QD ORAL Date:06/10/02ISR Number: 3930778-2Report Type:Expedited (15-DaCompany Report #02-05-0490 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Fall Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 400MG QD ORAL Date:06/10/02ISR Number: 3930781-2Report Type:Expedited (15-DaCompany Report #02-05-0497 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, 22-Feb-2006 08:30 AM Page: 1649 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Inc. ORAL 400-500MG QD ORAL Date:06/10/02ISR Number: 3930786-1Report Type:Expedited (15-DaCompany Report #C2002-1633.01 Age:90 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablet 25 Professional Mg Mylan PS Mylan ORAL 12.5MG BID Other ORAL Levothyroxine C Lorazepam C Propoxyphene Napsylate/Apap C Risperidone C Date:06/10/02ISR Number: 3930927-6Report Type:Direct Company Report #CTU 169801 Age:71 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Constipation Clozaril PS Date:06/10/02ISR Number: 3931275-0Report Type:Expedited (15-DaCompany Report #PHBS2002AU03321 Age:47 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Foreign Clozaril (Clozapine) Initial or Prolonged Confusional State Study Tablet PS ORAL 100 MG/D, Disability Diabetes Mellitus Health ORAL Pyrexia Professional Venlafaxine Other (Venlafaxine) C Date:06/10/02ISR Number: 3931276-2Report Type:Expedited (15-DaCompany Report #PHNU2002DE01606 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Exposure Foreign Leponex / Clozaril Initial or Prolonged Fatigue Health (Clozapine) Professional (Clozapine) Tablet, Other 100 Mg PS ORAL 100 MG, ONCE/SINGLE, ORAL Risperdal (Risperidone) C Diazepam C Melperone (Melperone) C Propra-Ratiopharm C Pantozol (Pantoprazole Sodium) C 22-Feb-2006 08:30 AM Page: 1650 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/10/02ISR Number: 3931277-4Report Type:Expedited (15-DaCompany Report #PHFR2002GB01746 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cerebrovascular Accident Foreign Clozaril (Clozapine) Transient Ischaemic Health Tablet PS ORAL 300MG/DAY, Attack Professional ORAL Other Date:06/10/02ISR Number: 3931329-9Report Type:Expedited (15-DaCompany Report #PHNU2001DE01815 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Foreign Leponex/Clozaril Circulatory Collapse Health (Clozapine) Drug Level Increased Professional (Clozapine) Tablet PS ORAL SEE IMAGE Myocarditis Other Right Ventricular Failure Shock Date:06/10/02ISR Number: 3931340-8Report Type:Expedited (15-DaCompany Report #PHBS2002CA06475 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Suicide Attempt Foreign Clozaril(Clozapine) Study Tablet PS ORAL ORAL Health Professional Other Date:06/10/02ISR Number: 3931342-1Report Type:Expedited (15-DaCompany Report #PHBS2002CA02852 Age:51 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Constipation Foreign Clozaril(Clozapine)T Hospitalization - Diabetes Mellitus Study ablet PS ORAL 200 MG, QD, Initial or Prolonged Diabetic Ketoacidosis Health ORAL Ileus Paralytic Professional Paroxetine Vomiting Other (Paroxetine) C Weight Decreased Epival (Valproate Semisodium) C Diovol C Date:06/10/02ISR Number: 3931351-2Report Type:Expedited (15-DaCompany Report #PHBS2002AU06223 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Overdose Foreign Clozaril(Clozapine) Initial or Prolonged Injection Site Phlebitis Health Tablet PS ORAL ORAL Rash Professional Soft Tissue Injury Other White Blood Cell Count Increased 22-Feb-2006 08:30 AM Page: 1651 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/11/02ISR Number: 3933417-XReport Type:Expedited (15-DaCompany Report #WAES 0205USA03417 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Apnoea Health Tab Vioxx 50 Mg PS ORAL 50 Arrhythmia Professional MG/DAILY/PO Cardiac Arrest Naproxen Unk SS SEE IMAGE Gastric Haemorrhage Clozapine Unk SS 250 MG/HS Haematocrit Abnormal Chlorpromazine Unk SS 200 MG/HS Haemoglobin Abnormal Ascorbic Acid C Platelet Count Abnormal Chlorzoxazone C Red Blood Cell Count Clonazepam C Abnormal Folic Acid C Weight Decreased Gabapentin C White Blood Cell Count Levothyroxine Sodium C Abnormal Nefazodone Hydrochloride C Oxycodone C Vitamins C Date:06/12/02ISR Number: 3931904-1Report Type:Expedited (15-DaCompany Report #C2002-1411.01 Age:75 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pancreatic Carcinoma Health Clozapine Tablets 25 Metastatic Professional Mg Mylan PS Mylan ORAL 25MG Q HS, Other ORAL Acetaminophen C Clonidine Patch C Amlodipine C Phenytoin C Mirtazapine C Multivitamin C Acetaminophen/Codein e C Date:06/12/02ISR Number: 3932801-8Report Type:Expedited (15-DaCompany Report #PHBS2002AU06561 Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hysterectomy Foreign Clozaril (Clozapine) Initial or Prolonged Health Tablet PS ORAL 250 MG, QD, Professional ORAL Other Date:06/12/02ISR Number: 3932865-1Report Type:Expedited (15-DaCompany Report #PHNU2002DE01870 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dialysis Foreign Leponex (Clozapine) PS ORAL ORAL Initial or Prolonged Drug Toxicity Health Truxal Other Nephritis Interstitial Professional (Chlorprothixene Renal Failure Acute Other Hydrochloride) C 22-Feb-2006 08:30 AM Page: 1652 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/12/02ISR Number: 3932878-XReport Type:Expedited (15-DaCompany Report #PHEH2002US03051 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abortion Spontaneous Health Clozaril(Clozapine) Complications Of Maternal Professional Tablet PS ORAL ORAL Exposure To Therapeutic Risperdal Drugs (Risperidone) C Drug Exposure During Pregnancy Pregnancy Date:06/12/02ISR Number: 3932901-2Report Type:Expedited (15-DaCompany Report #PHEH2002US05043 Age:74 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozaril(Clozapine) Hospitalization - Pneumonia Aspiration Professional Tablet PS ORAL 25 MG, ORAL Initial or Prolonged Respiratory Failure Sinemet (Levodopa, Sepsis Carbidopa) C Cozaar(Losartan Potassium) C Ativan C Kcl-Retard C Bumex (Bumetanide) C Date:06/12/02ISR Number: 3932903-6Report Type:Expedited (15-DaCompany Report #PHFR2002GB01769 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Foot Fracture Foreign Clozaril (Clozapine) Initial or Prolonged Loss Of Consciousness Health Tablet PS ORAL 200MG/DAY, Lower Respiratory Tract Professional ORAL Infection Other Date:06/12/02ISR Number: 3932904-8Report Type:Expedited (15-DaCompany Report #PHEH2002US05116 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Haemoglobin Decreased Health Clozaril(Clozapine) Initial or Prolonged Leukopenia Professional Tablet PS ORAL 400 MG/DAY, Other Neutropenia ORAL Psychotic Disorder Depakote (Valproate Thrombocytopenia Semisodium) C Urinary Tract Infection Colace C Date:06/12/02ISR Number: 3932935-8Report Type:Expedited (15-DaCompany Report #PHNU2002DE00596 Age:55 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Leponex/ Clozaril Drowning Health (Clozapine)(Clozapin Professional e) PS ORAL SEE IMAGE Other Trevilor (Venlafaxine Hydrochloride) C Tavor C Pantozol 22-Feb-2006 08:30 AM Page: 1653 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Pantoprazole Sodium) C Bifiteral "Solvat Arzneimittel" C Date:06/12/02ISR Number: 3932949-8Report Type:Expedited (15-DaCompany Report #PHBS2002NZ06299 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Interaction Foreign Clozapine(Clozapine) Neuroleptic Malignant Health Tablet PS ORAL 100 GM/D, Syndrome Professional ORAL Other Omeprazole(Omeprazol e) SS ORAL 20 MG/D, ORAL Benztropine Mesylate (Benzatropine Mesilate) C Enalapril (Enalapril) C Clonazepam C Date:06/12/02ISR Number: 3932993-0Report Type:Expedited (15-DaCompany Report #PHEH2002US05040 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Health Clozaril (Clozapine) Professional Tablet PS ORAL 200 MG, ORAL Date:06/12/02ISR Number: 3933016-XReport Type:Expedited (15-DaCompany Report #PHFR2002GB01780 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Haemolytic Anaemia Foreign Clozaril (Clozapine) PS ORAL ORAL Health Professional Other Date:06/12/02ISR Number: 3933019-5Report Type:Expedited (15-DaCompany Report #PHFR2002GB01779 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperkalaemia Foreign Clozaril (Clozapine) Initial or Prolonged Renal Impairment Health Tablet PS ORAL 550 MG/DAY, Professional ORAL Other Lithium (Lithium) C Date:06/12/02ISR Number: 3933337-0Report Type:Expedited (15-DaCompany Report #PHBS2002AU04781 Age:43 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Retinal Degeneration Foreign Melleril(Thioridazin Retinal Disorder Health e Hydrochloride) Professional Tablet PS ORAL ORAL Other Clozaril (Clozapine) SS ORAL 450 MG, ORAL 22-Feb-2006 08:30 AM Page: 1654 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/12/02ISR Number: 3933338-2Report Type:Expedited (15-DaCompany Report #PHBS2002NL05040 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Foreign Clozapine(Clozapine) PS SEE IMAGE Initial or Prolonged Congestive Literature Venlafaxine Chest Pain Health (Venlafaxine) SS 375 MG/D Dyspnoea Professional Face Oedema Other Fatigue Hepatic Pain Myocarditis Oedema Peripheral Tachycardia Weight Increased Date:06/12/02ISR Number: 3933580-0Report Type:Expedited (15-DaCompany Report #PHBS2002AU05427 Age:46 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Brain Neoplasm Foreign Clozaril (Clozapine) Hospitalization - Circulatory Collapse Health Tablet PS ORAL 200 MG. QD, Initial or Prolonged Hallucination, Visual Professional ORAL Loss Of Consciousness Other Date:06/12/02ISR Number: 3933582-4Report Type:Expedited (15-DaCompany Report #PHBS2002AU05479 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Nephrotic Syndrome Foreign Clozaril (Clozapine) Systemic Lupus Health Tablet PS ORAL 175 MG/D, Erythematosus Professional ORAL Other Olanzapine (Olanzapine) C Flupentixol (Flupentixol) C Date:06/12/02ISR Number: 3933631-3Report Type:Expedited (15-DaCompany Report #PHBS2001AU08482 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death C-Reactive Protein Foreign Clozaril (Clozapine) Increased Study Tablet PS ORAL 300 MG/DAY, Drug Level Increased Health ORAL Drug Toxicity Professional Alcohol(Ethanol) SS Leukocytosis Other Lower Respiratory Tract Infection Neutrophilia Ventricular Hypertrophy Date:06/12/02ISR Number: 3933638-6Report Type:Expedited (15-DaCompany Report #PHNU2002DE01889 Age:63 YR Gender:Female I/FU:I Outcome PT Death Arrhythmia Other Cardiac Arrest Drug Interaction 22-Feb-2006 08:30 AM Page: 1655 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Erythema Eye Swelling Hyperhidrosis Report Source Product Role Manufacturer Route Dose Duration Hypersensitivity Foreign Leponex/Clozaril PS ORAL 12.5 MG/DAY, Insomnia Health ORAL Psychotic Disorder Professional Distraneurin Restlessness Other (Clomethiazole Tachycardia Edisilate) SS ORAL ONCE/SINGLE, White Blood Cell Count ORAL Increased Prothazin (Promethazine Hydrochloride) SS ORAL ONCE, SINGLE/ORAL Zyprexa(Olanzapine) C Acetylsalicylic Acid C Dipiperon (Pipamperone) C Date:06/12/02ISR Number: 3933644-1Report Type:Expedited (15-DaCompany Report #PHFR2002GB01569 Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Foreign Clozaril(Clozapine) Sudden Death Study Tablet PS ORAL 500 MG/DAY, Health ORAL Professional Other Date:06/12/02ISR Number: 3933646-5Report Type:Expedited (15-DaCompany Report #PHFR2002GB01747 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Myelofibrosis Foreign Clozapine(Clozapine) Other Health Tablet PS ORAL 200MG/DAY, Professional ORAL Other Paroxetine (Paroxetine) C Vitamin C (Ascorbic Acid) C Blood Transfusion, Auxiliary Products (No Ingredients/Substanc es) C Date:06/12/02ISR Number: 3933649-0Report Type:Expedited (15-DaCompany Report #PHBS2002DK06593 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Dialysis Foreign Leponex(Clozapine) Hospitalization - Diplegia Health Tablet PS ORAL ORAL Initial or Prolonged Gastrointestinal Professional Serenase(Haloperidol Hypomotility Other ) Tablet SS ORAL ORAL Intentional Overdose Oxapax(Oxazepam) Liver Disorder Tablet SS ORAL ORAL Loss Of Consciousness Lithium (Lithium) Renal Failure Tablet C Suicide Attempt 22-Feb-2006 08:30 AM Page: 1656 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/12/02ISR Number: 3933650-7Report Type:Expedited (15-DaCompany Report #PHBS2002FI06538 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - C-Reactive Protein Foreign Leponex(Clozapine) PS 50 MG/D Initial or Prolonged Increased Health Leukocytosis Professional White Blood Cell Count Other Increased Date:06/12/02ISR Number: 3933652-0Report Type:Expedited (15-DaCompany Report #PHBS2002DE06598 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Foreign Clozapine(Clozapine) PS 400 MG/DAY; Atypical Mycobacterial Literature 600 MG/DAY Infection Health Rifampicin(Rifampici Chest X-Ray Abnormal Professional n) SS Drug Interaction Other Isoniazid C Drug Level Decreased Pyrazinamide C Hepatitis C Insomnia Leukocytosis Malaise Pulmonary Cavitation Pyrexia Red Blood Cell Sedimentation Rate Increased Restlessness Sensation Of Foreign Body Throat Irritation Tuberculosis Date:06/13/02ISR Number: 3934466-8Report Type:Expedited (15-DaCompany Report #PHBS2002BR04646 Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anorexia Nervosa Foreign Leponex (Clozapine) Initial or Prolonged Chest Pain Consumer Tablet PS ORAL 100 MG, QID, Constipation Other ORAL Cough Akineton (Biperiden Gastrointestinal Injury Hydrochloride) C Hyperhidrosis Dormonid (Midazolam) C Hypersensitivity Fenergan Insomnia (Promethazine) C Pain Rivotril C Pruritus Levomepromazine Pyrexia Maleate Salivary Hypersecretion (Levomepromazine Maleate) C Kava-Kava Rhizoma (Kava-Kava Rhizoma) C Metalic Aurun C 22-Feb-2006 08:30 AM Page: 1657 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/14/02ISR Number: 3934147-0Report Type:Expedited (15-DaCompany Report #C2002-1675.01 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatitis C Health Clozapine Tablets Initial or Prolonged Pleural Effusion Professional 100 Mg Mylan PS ORAL 550MG QD, Other Pneumonia Other ORAL Pneumothorax Date:06/14/02ISR Number: 3934149-4Report Type:Expedited (15-DaCompany Report #C2002-1604.01 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Choking Health Clozapine Tablets Professional 100 Mg Mylan PS ORAL 200MG, BID, Other 300MG Q HS, ORAL Atorvastatin C Buspirone C Metformin C Propranolol C Date:06/17/02ISR Number: 3935512-8Report Type:Expedited (15-DaCompany Report #2002UW07934 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Toxicity Health Seroquel PS ORAL 600 MG HS PO Professional Clozaril SS 800 MG QD Cogentin SS 2 MG BID Paxil SS 30 MG Risperidone C Date:06/18/02ISR Number: 3934974-XReport Type:Expedited (15-DaCompany Report #PHBS2002AU03532 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Insulin Resistant Foreign Clozaril (Clozapine) Initial or Prolonged Diabetes Health Tablet PS ORAL 300 MG, QD, Professional ORAL Other Metformin (Metformin C Date:06/18/02ISR Number: 3934986-6Report Type:Expedited (15-DaCompany Report #PHFR2002GB01830 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Urinary Tract Infection Foreign Clozaril (Clozapine) Initial or Prolonged Health Tablet PS ORAL 500MG/DAY,ORA Professional L Other Date:06/18/02ISR Number: 3934988-XReport Type:Expedited (15-DaCompany Report #PHBS2002CA06744 Age: Gender: I/FU:I Outcome PT Report Source Other Lymphadenopathy Foreign Pericarditis Health Professional 22-Feb-2006 08:30 AM Page: 1658 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Product Role Manufacturer Route Dose Duration Clozaril (Clozapine) PS ORAL ORAL Date:06/18/02ISR Number: 3935535-9Report Type:Expedited (15-DaCompany Report #02-06-0500 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Chronic Obstructive Health Clozapine - Ivax Pulmonary Disease Professional Pharmaceuticals, Respiratory Failure Other Inc. Tablets PS Ivax Pharmaceuticals, Inc ORAL 700-950MG QD ORAL Date:06/18/02ISR Number: 3935560-8Report Type:Expedited (15-DaCompany Report #C2002-1490.01 Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets PS Mylan ORAL 100 MG Q AM, Professional 400 MG Q PM, Other ORAL Date:06/18/02ISR Number: 3935562-1Report Type:Expedited (15-DaCompany Report #C2002-1456.01 Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pancreas Transplant Health Clozapine Tablets Rejection Professional 100 Mg Mylan PS Mylan ORAL 500 MG Q HS, Pulmonary Embolism Other ORAL Oxybutynin C Paroxetine C Date:06/18/02ISR Number: 3935564-5Report Type:Expedited (15-DaCompany Report #02-06-0507 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine PS Ivax Professional Pharmaceuticals, Other Inc. ORAL 150-500MG QD ORAL Date:06/18/02ISR Number: 3935567-0Report Type:Expedited (15-DaCompany Report #02-06-0501 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pulmonary Embolism Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablet PS Ivax Pharmaceuticals, Inc. ORAL 50 MG QAM ORAL ; 400 MG QHS ORAL 22-Feb-2006 08:30 AM Page: 1659 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/18/02ISR Number: 3935572-4Report Type:Expedited (15-DaCompany Report #02-04-0324 Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Congestive Cardiomyopathy Health Clozapine - Ivax Eosinophilia Professional Pharmaceuticals, Exercise Tolerance Inc. Tablets PS Ivax Decreased Pharmaceuticals, Sudden Death Inc. ORAL 24-450 MG QD ORAL Seroquel SS Haldol C Atrovent C Vanceril C Date:06/18/02ISR Number: 3935576-1Report Type:Expedited (15-DaCompany Report #02-04-0334 Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Clozapine - Ivax Cardiomegaly Professional Pharmaceuticals, Cardiomyopathy Other Inc. Tablets PS Ivax Pharmaceuticals ORAL 200 MG BID Pulmonary Oedema ORAL Ventricular Hypokinesia Potassium Chloride C Lasix C Accupril C Lanoxin C Cogentin C Date:06/18/02ISR Number: 3935580-3Report Type:Expedited (15-DaCompany Report #02-05-0420 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Ketoacidosis Health Clozapine - Ivax Initial or Prolonged Drug Level Decreased Professional Pharmaceuticals, Eosinophilia Inc. Tablets PS Ivax Pericarditis Pharmaceuticals, Inc. ORAL 300MG QHS ORAL Lamictal C Zoloft C Haloperidol C Depakote C Perphenazine C Eskalith - Slow Release C Date:06/18/02ISR Number: 3935643-2Report Type:Expedited (15-DaCompany Report #02-06-0508 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Parkinson'S Disease Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 62.5 MG QD ORAL 22-Feb-2006 08:30 AM Page: 1660 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/18/02ISR Number: 3935644-4Report Type:Expedited (15-DaCompany Report #02-06-0512 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 375-550MG QD ORAL Date:06/18/02ISR Number: 3935646-8Report Type:Expedited (15-DaCompany Report #02-06-0516 Age:91 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Respiratory Arrest Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 25-62MG QD ORAL Date:06/18/02ISR Number: 3935648-1Report Type:Expedited (15-DaCompany Report #02-06-0518 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Choking Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmacetuicals, Inc. ORAL 75-350MG QD ORAL Date:06/18/02ISR Number: 3935650-XReport Type:Expedited (15-DaCompany Report #02-06-0506 Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cachexia Health Clozapine - Ivax Oral Intake Reduced Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 50-75MG QD ORAL Date:06/18/02ISR Number: 3935651-1Report Type:Expedited (15-DaCompany Report #02-06-0504 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Clozapine - Ivax Initial or Prolonged Suicide Attempt Professional Pharmaceuticals, Other Inc. Tablets PS Ivax - Pharmaceuticals, Inc. ORAL ORAL 22-Feb-2006 08:30 AM Page: 1661 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/18/02ISR Number: 3935653-5Report Type:Expedited (15-DaCompany Report #02-06-0489 Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Neoplasm Health Clozapine - Ivax Hospitalization - Respiratory Disorder Professional Pharmaceuticals, Initial or Prolonged Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 100-300MG QD ORAL Date:06/18/02ISR Number: 3935654-7Report Type:Expedited (15-DaCompany Report #02-060491 Age:76 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Respiratory Arrest Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 50-75MG QD ORAL Date:06/18/02ISR Number: 3935762-0Report Type:Expedited (15-DaCompany Report #PHEH2002US03767 Age:22 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Health Clozaril (Clozapine) Enuresis Professional Tablet PS ORAL 700 MG/DAY, Hodgkin'S Disease Nodular ORAL Sclerosis Stage Zyprexa (Olanzapine) C Unspecified Geodon (Ziprasidone Hyperhidrosis Hydrochloride) C Lymph Node Pain Topamax (Topiramate) C Red Blood Cell Artane Sedimentation Rate (Trihexyphenidyl Increased Hydrochloride) C Weight Decreased Date:06/18/02ISR Number: 3935829-7Report Type:Expedited (15-DaCompany Report #PHEH2002US04407 Age:60 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Health Clozaril(Clozapine) Circulatory Collapse Professional Tablet, 25 Mg PS ORAL 75 MG, QHS, Dyspnoea ORAL Myocardial Infarction Luvox (Fluvoxamine Orthostatic Hypotension Maleate) C Wheezing Klonopin C Multivitamins (Ascorbic Acid, Panthenol, Retinol) C Maalox (Aluminium Hydroxide Gel) C Milk Of Magnesia C Lotensin C Nystatine (Nystatin) C Colace C Insulin Novolin 70/30 (Insulin Human 22-Feb-2006 08:30 AM Page: 1662 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Semisynthetic, Insulin Isophane Human Semisynthetic) C Keflex (Cefalexin Monohydrate) C Oscal C Imodium "Janssen" (Loperamide Hydrochloride) C Neosporin /Usa/ (Bacitracin Zinc, Polymyxin B Sulfate) C Date:06/18/02ISR Number: 3935840-6Report Type:Expedited (15-DaCompany Report #PHEH2002US05133 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Exposure Health Clozaril(Clozapine) Initial or Prolonged Cerebrovascular Accident Professional Tablet PS ORAL 500 MG, QD, Medication Error ORAL Date:06/18/02ISR Number: 3935933-3Report Type:Expedited (15-DaCompany Report #PHFR2002GB01822 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acute Coronary Syndrome Foreign Clozaril (Clozapine) Initial or Prolonged Health Tablet PS ORAL 400 MG/DAY, Professional ORAL Other Date:06/18/02ISR Number: 3936122-9Report Type:Expedited (15-DaCompany Report #PHBS2002CA05992 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Anaemia Foreign Clozaril(Clozapine) PS ORAL 375 MG/D, Duodenitis Study ORAL Gastrointestinal Health Risperidone Haemorrhage Professional (Risperidone) C Hiatus Hernia Other Iron Sulfate C Oesophagitis Clonazepam C Maalox (Aluminium Hydroxide Gel) C Date:06/18/02ISR Number: 3936123-0Report Type:Expedited (15-DaCompany Report #PHBS2002SE06825 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Formication Foreign Leponex(Clozapine) Gastric Disorder Health Tablet PS ORAL SEE IMAGE Intracranial Pressure Professional Nozinan C Increased Other Cisordinol - Slow Lung Abscess Release Nasal Disorder (Zuclopenthixol Salivary Hypersecretion Decanoate) C Snoring Disipal Syncope (Orphenadrine Ventricular Fibrillation Hydrochloride) C 22-Feb-2006 08:30 AM Page: 1663 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/18/02ISR Number: 3936125-4Report Type:Expedited (15-DaCompany Report #PHFR2002GB01179 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Accidental Exposure Foreign Clozaril(Clozapine) Accidental Overdose Health Tablet PS ORAL 2 X 100 MG Asthenia Professional TABLETS ONCE, Circulatory Collapse Other ORAL Dizziness Dothiepin Dysarthria (Dosulepin) C Headache Hormones (Hormones) C Hypotension Sinutab Lack Of Spontaneous "Parke-Davis" Speech (Paracetamol, Phenyltoloxamine Citrate) C Date:06/19/02ISR Number: 3935767-XReport Type:Expedited (15-DaCompany Report #PHEH2002US05280 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cyanosis Health Clozaril (Clozapine) Hospitalization - Fall Professional Tablet PS ORAL 300MG Initial or Prolonged Haemoglobin Decreased AM+400MG HS, Mouth Haemorrhage ORAL Myocardial Infarction Haldol Decanoate Transient Ischaemic (Haloperidol Attack Deconoate) C Date:06/19/02ISR Number: 3935932-1Report Type:Expedited (15-DaCompany Report #PHR2002GB01812 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Haemoptysis Foreign Clozaril Initial or Prolonged Hypotension Health (Clozapine)(Clozapin Oesophagitis Professional e) PS ORAL ORAL Tachycardia Other Date:06/19/02ISR Number: 3936369-1Report Type:Expedited (15-DaCompany Report #PHBS2002DK06593 Age:22 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Dialysis Foreign Leponex ( Clozapine) Hospitalization - Diplegia Health Tablet PS ORAL ORAL, 100 Initial or Prolonged Gastrointestinal Professional TABLETS/D, Hypomotility Other ORAL Intentional Overdose Serenase Liver Disorder (Haloperidol) SS ORAL ORAL Loss Of Consciousness Oxapax (Oxazepam) Renal Failure Tablet SS ORAL ORAL Rhabdomyolysis Lithium (Lithium) C Suicide Attempt 22-Feb-2006 08:30 AM Page: 1664 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/19/02ISR Number: 3936399-XReport Type:Expedited (15-DaCompany Report #PHFR2002GB01847 Age:45 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dialysis Foreign Clozaril (Clozapine) Renal Failure Chronic Health Tablet PS ORAL 475 MG/DAY, Professional ORAL Other Date:06/19/02ISR Number: 3936401-5Report Type:Expedited (15-DaCompany Report #PHBS2002SE06864 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Deep Vein Thrombosis Foreign Leponex (Clozapine) Health Tablet PS ORAL 200 MG/D, Professional ORAL Other Date:06/19/02ISR Number: 3936413-1Report Type:Expedited (15-DaCompany Report #PHFR2002IE01691 Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Folate Decreased Foreign Clozaril (Clozapine) Initial or Prolonged Gastrointestinal Health Tablet PS ORAL 650MG/DAY, Haemorrhage Professional ORAL Haemorrhoids Other Aspirine(Acetylsalic Hypochromic Anaemia ylic Acid) SS ORAL ORAL Serum Ferritin Decreased Andrews Liver Salt Stomach Discomfort (Magnesium Sulfate) SS Vitamin B12 Decreased Date:06/19/02ISR Number: 3936415-5Report Type:Expedited (15-DaCompany Report #PHBS2001CA12728 Age:32 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiomyopathy Foreign Clozaril(Clozapine) Enuresis Health Tablet PS ORAL 350 MG, QHS, Tachycardia Professional ORAL Ventricular Failure Other Singular C Theophylline C Fosamax (Alendronate Sodium) C Flovent (Fluticasone Propionate) C Ddavp (Desmopressin) Nasal Spray C Bcp-Synphonic C Date:06/19/02ISR Number: 3936419-2Report Type:Expedited (15-DaCompany Report #PHBS2002AU05672 Age:27 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Overdose Foreign Clozaril (Clozapine) Coma Study Tablet PS ORAL 650 MG/D, Mental Impairment Health ORAL Myocardial Ischaemia Professional Other 22-Feb-2006 08:30 AM Page: 1665 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/19/02ISR Number: 3936765-2Report Type:Expedited (15-DaCompany Report #PHEH2002US05236 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Choking Health Clozaril (Clozapine) PS ORAL 100 MG AM + Professional 50 MG 12 N+200 HS, ORAL Lorazepam C Multivitamins (Retinol, Pathenol, Ascorbic Acid) C Claritin (Loratadine) C Benztropeine (Benztropeine) C Vitamin E C Pyridoxine (Pyridoxine) C Tylenol (Paracetamol) C Date:06/19/02ISR Number: 3938218-4Report Type:Expedited (15-DaCompany Report #WAES 0206CHE00018 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Zocor PS Merck & Co., Inc ORAL Initial or Prolonged Phosphokinase Increased Clozapine SS ORAL Disability Tendon Rupture Lamotrigine C ORAL Other Alprazolam C ORAL Valsartan C ORAL Date:06/21/02ISR Number: 3937595-8Report Type:Expedited (15-DaCompany Report #C2002-1664.01 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Treatment Noncompliance Health Clozapine Tablets 25 White Blood Cell Count Professional Mg Mylan PS ORAL 50MG, QD, Abnormal Other ORAL Carbidopa/Levodopa C Digoxin C Ipratropium Bromide C Levothyroxine Sodium C Nitroglycerin C Date:06/21/02ISR Number: 3938034-3Report Type:Expedited (15-DaCompany Report #PHFR2002GB01560 Age:52 YR Gender:Male I/FU:I Outcome PT Hospitalization - Constipation Initial or Prolonged Gastrointestinal Haemorrhage Hiatus Hernia Neutrophilia Oesophagitis Pneumonia Urinary Retention Vomiting White Blood Cell Count 22-Feb-2006 08:30 AM Page: 1666 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Increased Report Source Product Role Manufacturer Route Dose Duration Foreign Clozaril (Clozapine) Health Tablet PS ORAL 100 MG MANE, Professional 300 MG NOCTE. Other ORAL Date:06/21/02ISR Number: 3938057-4Report Type:Expedited (15-DaCompany Report #PHFR2002GB01554 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anaemia Foreign Clozaril (Clozapine) Drug Abuser Other Tablet PS ORAL 200 MG, ONCE/SINGLE, ORAL Alcohol (Ethanol) SS Date:06/21/02ISR Number: 3938248-2Report Type:Expedited (15-DaCompany Report #PHNU2002DE01242 Age:31 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cutaneous Lupus Foreign Leponex / Clozaril Erythematosus Health (Clozapine) Professional (Clozapine) Tablet PS ORAL 150 MG, QD, Other ORAL Date:06/21/02ISR Number: 3938258-5Report Type:Expedited (15-DaCompany Report #PHBS2002SE06864 Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Deep Vein Thrombosis Foreign Leponex (Clozapine) Health Tablet PS ORAL 200 MG/D, Professional ORAL Other Date:06/21/02ISR Number: 3938268-8Report Type:Expedited (15-DaCompany Report #PHBS2002AU06079 Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Malaise Foreign Clozaril (Clozapine) Initial or Prolonged Mental Disorder Study Tablet PS ORAL 650 MG/D, Other Health ORAL Professional Other Date:06/21/02ISR Number: 3938306-2Report Type:Expedited (15-DaCompany Report #PHFR2002GB01780 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Haemolytic Anaemia Foreign Clozaril (Clozapine) PS ORAL ORAL Health Professional Other 22-Feb-2006 08:30 AM Page: 1667 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/21/02ISR Number: 3938309-8Report Type:Expedited (15-DaCompany Report #PHFR2002GB01717 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Foreign Clozaril (Clozapine) Prolonged Health (Clozapine) Tablet PS ORAL ORAL; SEE Heart Rate Irregular Professional IMAGE Hypotension Other Valproate Sodium C Sinus Bradycardia Hyoscine Hydrobromide C Date:06/21/02ISR Number: 3938311-6Report Type:Expedited (15-DaCompany Report #PHRM2002FR01145 Age:63 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Glomerulonephritis Acute Foreign Leponex (Clozapine) Initial or Prolonged Nephritis Interstitial Health Tablet PS ORAL 350 MG/DAY, Pyrexia Professional ORAL Renal Failure Acute Other Valproic Acid C Systemic Inflammatory Alfuzosin Response Syndrome (Alfuzosin) C Vasculitis Vitamin B Nos (Vitamin B Nos) C Vitamin B6 C Date:06/21/02ISR Number: 3938325-6Report Type:Expedited (15-DaCompany Report #PHFR2002GB01688 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Lower Respiratory Tract Foreign Clozaril (Clozapine) Initial or Prolonged Infection Health Tablet PS ORAL 500 MG Lung Disorder Professional INDIVIDUAL Pulmonary Embolism Other DOSES, ORAL Omeprazole (Omeprazole) C Date:06/21/02ISR Number: 3938327-XReport Type:Expedited (15-DaCompany Report #PHBS2002CA06870 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diverticulitis Foreign Clozaril (Clozapine) Leukocytosis Health Tablet PS ORAL ORAL Upper Respiratory Tract Professional Infection Other Date:06/21/02ISR Number: 3938329-3Report Type:Expedited (15-DaCompany Report #PHFR2002GB01854 Age:66 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Body Temperature Foreign Clozaril (Clozapine) Increased Health Tablet PS Confusional State Professional Dysuria Other Urinary Tract Infection 22-Feb-2006 08:30 AM Page: 1668 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/24/02ISR Number: 3939042-9Report Type:Expedited (15-DaCompany Report #02-06-0554 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Brain Contusion Health Clozapine Tablets PS Ivax Hospitalization - Cerebrovascular Accident Professional Pharmaceuticals, Inc ORAL 200-275MG QD Initial or Prolonged Fall Other ORAL Date:06/24/02ISR Number: 3939046-6Report Type:Expedited (15-DaCompany Report #02-06-0557 Age:67 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neoplasm Malignant Health Clozapine Tablets PS Ivax Professional Pharmaceuticals, Inc ORAL 50-250MG QD Other ORAL Date:06/24/02ISR Number: 3939048-XReport Type:Expedited (15-DaCompany Report #02-06-0558 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Renal Failure Health Clozapine Tablets PS Ivax Initial or Prolonged Professional Pharmaceuticals, Inc ORAL 400-600MG QD Other ORAL Date:06/24/02ISR Number: 3939050-8Report Type:Expedited (15-DaCompany Report #02-06-0547 Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukaemia Health Clozapine Professional Tablets-Ivax Pharmaceuticals, Inc PS Ivax Pharmaceuticals, Inc. ORAL 200MG TID ORAL Prevacid C Metamucil C Multivitamins C Flomax C Prednisone C Reglan C Klonopin C Depakote C Date:06/24/02ISR Number: 3939052-1Report Type:Expedited (15-DaCompany Report #02-06-0524 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Road Traffic Accident Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 550-600MG QD ORAL 22-Feb-2006 08:30 AM Page: 1669 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/24/02ISR Number: 3939053-3Report Type:Expedited (15-DaCompany Report #02-06-0525 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Choking Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc ORAL 750-800MG QD ORAL Date:06/24/02ISR Number: 3939056-9Report Type:Expedited (15-DaCompany Report #02-06-0529 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Clozapine Professional Tablets-Ivax Other Pharmaceuticals,Inc. PS Ivax Pharmaceuticals, Inc ORAL 425MG QD ORAL Date:06/24/02ISR Number: 3939065-XReport Type:Expedited (15-DaCompany Report #02-06-0539 Age:66 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine Tablets PS Ivax Professional Pharmaceuticals, Inc ORAL 12.5MG QD; Other ORAL Date:06/24/02ISR Number: 3939066-1Report Type:Expedited (15-DaCompany Report #02-06-0546 Age:69 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Health Clozapine Tablets- Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceutical, Inc. ORAL 50-150MG QD ORAL Date:06/24/02ISR Number: 3939070-3Report Type:Expedited (15-DaCompany Report #02-06-0545 Age:71 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Amyotrophic Lateral Health Clozapine Tablets - Sclerosis Professional Ivax Disease Progression Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 37.5-275MG QD ORAL Date:06/24/02ISR Number: 3939071-5Report Type:Expedited (15-DaCompany Report #02-06-0549 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Breast Cancer Stage Iv Health Clozapine Tablets- Cardiac Arrest Professional Ivax Other Pharmaceuticals, 22-Feb-2006 08:30 AM Page: 1670 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Inc. PS Ivax Pharmaceuticals, Inc. ORAL 50-200MG QD ORAL Date:06/24/02ISR Number: 3939118-6Report Type:Expedited (15-DaCompany Report #02-06-0532 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anxiety Health Clozapine PS Ivax Cardiac Arrest Professional Pharmaceuticals, Inc ORAL 350MG AM ORAL Dyspnoea Other Celexa C Feeling Cold Zoloft C Mellaril C Procardia C Actos C Amaryl C Date:06/24/02ISR Number: 3939120-4Report Type:Expedited (15-DaCompany Report #02-06-0537 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine PS Ivax Professional Pharmaceuticals, Inc ORAL 250-450MG QD Other ORAL Date:06/24/02ISR Number: 3939121-6Report Type:Expedited (15-DaCompany Report #02-06-0538 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Electrolytes Health Clozapine PS Ivax Initial or Prolonged Abnormal Professional Pharmaceuticals, Inc ORAL 350-600MG QD Blood Sodium Abnormal Other ORAL Polydipsia Date:06/24/02ISR Number: 3939123-XReport Type:Expedited (15-DaCompany Report #02-06-0559 Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neoplasm Malignant Health Clozapine PS Ivax Sarcoma Professional Pharmaceuticals, Inc ORAL 300-350MG QD Other ORAL Date:06/24/02ISR Number: 3939124-1Report Type:Expedited (15-DaCompany Report #02-06-0560 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chronic Obstructive Health Clozapine PS Ivax Initial or Prolonged Pulmonary Disease Professional Pharmaceuticals, Inc ORAL 475-550MG QD Other ORAL 22-Feb-2006 08:30 AM Page: 1671 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/25/02ISR Number: 3939439-7Report Type:Expedited (15-DaCompany Report #WAES 0206CHE00018 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Tab Zocor Initial or Prolonged Phosphokinase Increased Other (Simvastatin) PS ORAL 20 MG/DAILY Disability Tendon Rupture Cap Clozapine SS ORAL 250 MG/DAILY Other Alprazolam C Lamotrigine C Valsartan C Date:06/25/02ISR Number: 3939514-7Report Type:Expedited (15-DaCompany Report #EMADSS2002003794 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Foreign Haldol (Unspecified) Hypertension Health (Haloperidol) PS Professional Clozapine (Clozapine) SS LOW DOSE Date:06/25/02ISR Number: 3940072-1Report Type:Expedited (15-DaCompany Report #2002GB00910 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blood Pressure Increased Foreign Seroquel PS ORAL 150 MG BID PO Intervention to Drug Interaction Health Clozaril SS Prevent Permanent Palpitations Professional Oxybutynin SS 7.5 MG BID Impairment/Damage Other Amitriptyline SS ORAL 50 MG HS PO Frusemide C Perindopril C Carbamazepine C Paroxetine C Date:06/26/02ISR Number: 3940264-1Report Type:Expedited (15-DaCompany Report #PHFR2002GB01866 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Distension Foreign Clozaril PS ORAL 400 MG/DAY, Convulsion Study ORAL Drooling Health Citalopram Face Oedema Professional (Citalopram) C Malaise Other Hyoscine (Hyoscine) C Skin Discolouration Movecil (Pyricarbate) C Date:06/26/02ISR Number: 3940270-7Report Type:Expedited (15-DaCompany Report #PHBS2002SE07015 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diarrhoea Foreign Leponex (Clozapine) Other Urinary Tract Infection Health Tablet PS ORAL 450 MG/D, Professional ORAL Other Lexinor (Norfloxacin) Tablet SS ORAL 400 MG/D, ORAL Hibernal(Chlorpromaz ine Hydrochloride) Tablet SS ORAL 200 MG/D, 22-Feb-2006 08:30 AM Page: 1672 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL Laktulose "Dak" C Vitamineral (Vitamins Nos) C Date:06/26/02ISR Number: 3940271-9Report Type:Expedited (15-DaCompany Report #PHBS2002SE07021 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anorexia Foreign Leponex (Clozapine) Hospitalization - Arteriosclerosis Health Tablet PS ORAL 100 MG, BID, Initial or Prolonged Aspiration Bronchial Professional ORAL Bronchopneumonia Other Arthrotec Coma (Misoprostol) C Electrocardiogram Inolaxol (Sterculia) C Abnormal Folacin Tablet C Epilepsy Haldol C Fungal Infection Oralvite (Vitamins Glucose Urine Present Nos) C Hyperglycaemia Furix C Hypotension Spironolakton "Nm Hypothermia Pharma" C Hypotonia Cisordinol Pancreatitis Chronic (Zuclopenthixol Pulmonary Oedema Hydrochloride, Sepsis Clopenthixol Urinary Retention Hydrochloride) C Urine Glucose False Importal C Positive Date:06/26/02ISR Number: 3940273-2Report Type:Expedited (15-DaCompany Report #PHBS2002GR07180 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Anaemia Foreign Loponex (Clonzapine) Disability Anorexia Health Tablet PS ORAL SEE IMAGE Decreased Appetite Professional Haematocrit Decreased Other Multiple Myeloma Osteolysis Tooth Disorder Tooth Extraction Weight Decreased Date:06/26/02ISR Number: 3940438-XReport Type:Direct Company Report #CTU 170946 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Clozapine PS Zenith Goldline 100MG Q AM Initial or Prolonged AND 300MG HS Ribavarin SS Peg Intron SS Schering Atenolol C Casanthranol/Docusat e Minoxidil C 22-Feb-2006 08:30 AM Page: 1673 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/26/02ISR Number: 3940490-1Report Type:Expedited (15-DaCompany Report #PHFR2002GB01894 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Infectious Mononucleosis Foreign Clorazil (Clozapine) Hospitalization - Pharyngitis Health Tablet PS ORAL 700 MG/DAY, Initial or Prolonged Respiratory Arrest Professional ORAL Other Date:06/26/02ISR Number: 3940589-XReport Type:Expedited (15-DaCompany Report #C2002-1755.01 Age:85 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Other Clozapine Tablets 25 Mg Mylan PS ORAL 25MG, QD, ORAL Date:06/26/02ISR Number: 3940595-5Report Type:Expedited (15-DaCompany Report #C2002-0991.01 Age:79 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg Mylan PS ORAL 25MG, BID, Other THEN 50MG BID, ORAL Buspirone C Carbidopa/Levodopa C Conjugated Estrogens C Divalproex C Pantoprazole C Alprazolam C Lorazepam C Acetaminophen C Hydrocodone/Chlorphe niramine C Guaifenesin C Date:06/26/02ISR Number: 3940597-9Report Type:Expedited (15-DaCompany Report #C2002-1756.01 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg Mylan PS 50MG QD Other Clozapine Tablets 100 Mg Mylan SS 400MG QD Divalproex Sodium C Gabapentin C Lorazepam C Date:06/26/02ISR Number: 3940609-2Report Type:Expedited (15-DaCompany Report #PHBS2002SE07019 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arteriosclerosis Foreign Leponex (Clozapine) Bronchitis Health Tablet PS ORAL 200 MG/D, Professional ORAL Other Cisordinol - Slow Release 22-Feb-2006 08:30 AM Page: 1674 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Zuclopenthixol Decanoate) Solution For Injection C Nozinan Tablet C Date:06/26/02ISR Number: 3940612-2Report Type:Expedited (15-DaCompany Report #PHFR2002GB01448 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril (Clozapine) Health Tablet PS ORAL 450 MG/DAY, Professional ORAL Other Date:06/26/02ISR Number: 3940688-2Report Type:Expedited (15-DaCompany Report #C2002-1754.01 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozapine Tablets Professional 100 Mg; Mylan PS Mylan ORAL 200 MG Q AM, Other 300 MG Q HS, ORAL Alendronate Sodium C Amlodipine C Benztropine C Carbamazepine C Mometasone Furoate C Naproxen C Omeprazole C Phenytoin C Propoxyphene/Acetami nophen C Date:06/26/02ISR Number: 3940766-8Report Type:Expedited (15-DaCompany Report #PHBS2002AU05672 Age:27 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Overdose Foreign Clozaril (Clozapine) Coma Study Tablet PS ORAL 650 MG/D, Coronary Artery Disease Health ORAL Mental Impairment Professional Myocardial Ischaemia Other Date:06/26/02ISR Number: 3940829-7Report Type:Expedited (15-DaCompany Report #PHFR2002GB01639 Age:34 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Breast Cancer Foreign Clozaril(Clozapine) Initial or Prolonged Health Tablet PS ORAL 350MG/DAY, Professional ORAL Other 22-Feb-2006 08:30 AM Page: 1675 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/27/02ISR Number: 3940533-5Report Type:Direct Company Report #CTU 171143 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pericardial Effusion Clozapine PS ORAL 150MG PO 7 AM Pleural Effusion AND 830 PM Pneumonia Date:06/27/02ISR Number: 3940608-0Report Type:Expedited (15-DaCompany Report #PHBS2002AU06904 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Appendicitis Perforated Foreign Clozaril (Clozapine) Sepsis Study Tablet PS ORAL 300 MG/D, Health ORAL Professional Other Date:06/27/02ISR Number: 3940697-3Report Type:Direct Company Report #CTU 171104 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Level Below Clozapine 100 Mg Tab Initial or Prolonged Therapeutic (Mylan) PS Mylan ORAL 300 MG PO HS Pharmaceutical Product Complaint Date:06/27/02ISR Number: 3940895-9Report Type:Expedited (15-DaCompany Report #PHEH2002US05577 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other B-Cell Lymphoma Health Clozaril (Clozapine) Lymphadenopathy Professional Tablet PS ORAL 300 MG, QD, Thrombocytopenia ORAL Date:06/27/02ISR Number: 3940934-5Report Type:Expedited (15-DaCompany Report #PHEH2002US05514 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Level Increased Health Clozaril (Clozapine) Lymphoma Professional Tablet PS ORAL 500 MG, QD, ORAL Prozac (Fluoxetine Hydrochloride) C Klonopin C Date:06/27/02ISR Number: 3941332-0Report Type:Expedited (15-DaCompany Report #PHFR2002GB01569 Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Epilepsy Foreign Clozaril (Clozapine) Study Tablet PS ORAL 550 MG/DAY, Health ORAL Professional Other 22-Feb-2006 08:30 AM Page: 1676 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/27/02ISR Number: 3941338-1Report Type:Expedited (15-DaCompany Report #PHFR2002GB01892 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypoaesthesia Foreign Clozaril (Clozapine) Initial or Prolonged Lower Limb Fracture Health Tablet PS ORAL ORAL Professional Other Date:06/27/02ISR Number: 3941426-XReport Type:Expedited (15-DaCompany Report #PHBS2002AU05672 Age:27 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Overdose Foreign Clozaril (Clozapine) Coma Study Tablet PS ORAL 650 MG/D ORAL Coronary Artery Disease Health Mental Impairment Professional Myocardial Ischaemia Date:06/27/02ISR Number: 3941430-1Report Type:Expedited (15-DaCompany Report #PHFR2002GB01798 Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Lymphoma Foreign Clozaril (Clozapine) Health Tablet PS ORAL 700 MG DAY Professional ORAL Date:06/27/02ISR Number: 3941432-5Report Type:Expedited (15-DaCompany Report #PHFR2002GB01511 Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Glucose Increased Foreign Clozaril (Clozapine) Diabetes Mellitus Health Tablet PS ORAL 250 BID ORAL Inadequate Control Professional Diabetes Mellitus Non-Insulin-Dependent Glycosuria Polydipsia Date:06/27/02ISR Number: 3941820-7Report Type:Expedited (15-DaCompany Report #PHFR2002GB01891 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Oliguria Foreign Clozaril Pneumonia Health (Clozapine)Tablet PS ORAL 400 MG/DAY, Professional ORAL Other Date:06/27/02ISR Number: 3984120-1Report Type:Periodic Company Report #WAES 0205USA00585 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Interaction Health Tab Vioxx 25 Mg PS ORAL 25 Drug Level Increased Professional MG/DAILY/PO Extrapyramidal Disorder Clozapine SS Olanzapine SS Biaxin C 22-Feb-2006 08:30 AM Page: 1677 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Phenergan With Codeine C Date:06/28/02ISR Number: 3941555-0Report Type:Expedited (15-DaCompany Report #02-06-0554 Age:52 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Health Clozapine Tablets - Hospitalization - Closed Head Injury Professional Ivax Initial or Prolonged Fall Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 200-275 MG QD ORAL Date:06/28/02ISR Number: 3941557-4Report Type:Expedited (15-DaCompany Report #02-06-0567 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 150-600 MG QD ORAL Date:06/28/02ISR Number: 3941559-8Report Type:Expedited (15-DaCompany Report #02-06-0574 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Intracranial Aneurysm Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 300 MG QD ORAL Date:06/28/02ISR Number: 3941560-4Report Type:Expedited (15-DaCompany Report #02-06-0573 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ankle Fracture Health Clozapine Tablets Initial or Prolonged Professional - Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 550 MG QD ORAL 22-Feb-2006 08:30 AM Page: 1678 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/28/02ISR Number: 3941563-XReport Type:Expedited (15-DaCompany Report #02-06-0575 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Gastrointestinal Health Clozapine Tablets - Haemorrhage Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 325 - 400MG QD ORAL Date:06/28/02ISR Number: 3941938-9Report Type:Expedited (15-DaCompany Report #PHEH2002US05555 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hypoglycaemia Health Clozaril(Clozapine) Medication Error Professional Tablet PS ORAL 250 MG, ORAL Glucotrol (Glipizide) C Date:06/28/02ISR Number: 3942000-1Report Type:Expedited (15-DaCompany Report #PHFR2002GB01935 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Upper Limb Fracture Foreign Clozaril (Clozapine) Health Tablet PS Professional Other Date:06/28/02ISR Number: 3942114-6Report Type:Expedited (15-DaCompany Report #PHNU2002DE02055 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Renal Failure Foreign Leponex (Clozapine) Health Unknown PS Professional Company Representative Other Date:07/01/02ISR Number: 3942423-0Report Type:Direct Company Report #CTU 171339 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Pressure Decreased Clozapine PS SEE IMAGE Hospitalization - Blood Pressure Systolic Fluoxetine SS SEE IMAGE Initial or Prolonged Increased Trazodone SS SEE IMAGE Required Dizziness Ranitidine SS SEE IMAGE Intervention to Nausea Valproic Acid C Prevent Permanent Toxicologic Test Abnormal Fluoxetine C Impairment/Damage Atenolol C 22-Feb-2006 08:30 AM Page: 1679 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/01/02ISR Number: 3943780-1Report Type:Expedited (15-DaCompany Report #PHNU2002DE01138 Age:69 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anorexia Foreign Leponex (Clozapine) Decreased Activity Consumer Tablet PS ORAL ORAL Hypotension Other Aspirin "Bayer" C Leukocytosis Pain Salivary Hypersecretion Date:07/01/02ISR Number: 3943781-3Report Type:Expedited (15-DaCompany Report #PHBS2002CA06475 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delirium Foreign Clozaril (Clozapine) Initial or Prolonged Emotional Disorder Study Tablet PS ORAL ORAL General Physical Health Health Deterioration Professional Hallucination, Visual Other Suicide Attempt Date:07/01/02ISR Number: 3943790-4Report Type:Expedited (15-DaCompany Report #PHBS2002CH07150 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Amyotrophy Foreign Leponex (Clozapine) Initial or Prolonged Blood Creatine Health Tablet PS ORAL 250 MG/D, Disability Phosphokinase Increased Professional ORAL Tendon Rupture Other Zocor "Dieckmann" (Simvastatin) SS ORAL 20 MG/D, ORAL Lamictal C Xanax - Slow Release (Alprozolam) C Diovan "Ciba-Geigy" C Date:07/01/02ISR Number: 3943791-6Report Type:Expedited (15-DaCompany Report #PHBS2002AU07121 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Atrioventricular Block Foreign Clozaril (Clozapine) First Degree Health Tablet PS ORAL 300 MG/DAY, Professional ORAL Other Date:07/01/02ISR Number: 3943792-8Report Type:Expedited (15-DaCompany Report #PHFR2002GB01937 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abortion Spontaneous Foreign Clozaril (Clozapine) Complications Of Maternal Health Tablet PS ORAL ORAL Exposure To Therapeutic Professional Drugs Other Maternal Drugs Affecting Foetus 22-Feb-2006 08:30 AM Page: 1680 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/01/02ISR Number: 3943813-2Report Type:Expedited (15-DaCompany Report #PHFR20021E01936 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ankle Fracture Foreign Clozaril (Clozapine) Initial or Prolonged Health Tablet PS ORAL 450 MG/DAY, Professional ORAL Other Date:07/01/02ISR Number: 3943815-6Report Type:Expedited (15-DaCompany Report #PHBS2002NZ07051 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiomyopathy Foreign Clozaril (Clozapine) Myocarditis Health Tablet PS ORAL ORAL Professional Other Date:07/01/02ISR Number: 3943817-XReport Type:Expedited (15-DaCompany Report #PHNU2002DE02076 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Haemoglobin Decreased Foreign Leponex (Clozapine) Initial or Prolonged Oedema Peripheral Health Tablet PS ORAL 25 MG/DAY, Pulmonary Oedema Professional ORAL Other Madopar (Benserazide Hydrochloride, Levodopa) C Date:07/01/02ISR Number: 3944007-7Report Type:Expedited (15-DaCompany Report #EMADSS2002003874 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dementia Foreign Reminyl (Tablet) Initial or Prolonged Dystonia Health (Galantamine) PS ORAL 24 MG, DAILY, Gait Disturbance Professional ORAL Dipiperon (Unspecified) (Pipamperone) SS ORAL 160 MG, DAILY, ORAL Leponex (Clozapine) SS ORAL 37.5 MG, DAILY, ORAL Akatinol Mematine (Memantine Hydrochloride) C Pressomen (Estrogens Conjugated) C Stilnox (Zolipidem) C Date:07/02/02ISR Number: 3943408-0Report Type:Expedited (15-DaCompany Report #PHFR2002GB01959 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Obsessive-Compulsive Foreign Clozaril (Clozapine) Disorder Health Tablet PS ORAL ORAL Professional Other 22-Feb-2006 08:30 AM Page: 1681 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/02/02ISR Number: 3943409-2Report Type:Expedited (15-DaCompany Report #PHFR2002GB02003 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Obsessive-Compulsive Foreign Clozaril (Clozapine) Disorder Health Tablet PS ORAL ORAL Professional Other Date:07/02/02ISR Number: 3943410-9Report Type:Expedited (15-DaCompany Report #PHFR2002GB01975 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Lung Abscess Foreign Clozaril (Clozapine) Initial or Prolonged Health Tablet PS ORAL 600 MG/DAY, Professional ORAL Fluoxetine (Fluoxetine) C Procyclidine (Procyclidine) C Co-Codamol (Paracetamol) C Date:07/02/02ISR Number: 3943412-2Report Type:Expedited (15-DaCompany Report #2002SE03908 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Foreign Seroquel PS ORAL 400 MG DAILY Cyanosis Health PO Dyspnoea Professional Solian SS ORAL 400 MG DAILY Hyponatraemia Other PO Neuroleptic Malignant Tegretol SS ORAL 800 MG DAILY Syndrome PO Pyrexia Tegretol SS INTRAVENOUS 200 MG DAILY Tachycardia IV Leponex Novartis SS Novartis Lasix C Coversum C Aspirin Cardio C Aldactone C Date:07/02/02ISR Number: 3943583-8Report Type:Expedited (15-DaCompany Report #PHBS2002CH07405 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Foreign Tegretol Hospitalization - Congestive Cardiomyopathy Health (Carbamazepine) Initial or Prolonged Convulsion Professional Unknown PS ORAL 200 TO 800 Disability Hepatic Cirrhosis Other MG/DAY, ORAL Hyponatraemia Leponex (Clozapine) Intracardiac Thrombus Unknown SS ORAL ORAL Neuroleptic Malignant Solian (Amisulpride) SS ORAL 400 MG/DAY, Syndrome ORAL Pneumonia Seroquel (Quetiapine Pulmonary Embolism Fumarate) SS ORAL 400 MG/DAY, Pulmonary Haemorrhage ORAL Pulmonary Infarction Lasix C Coversum (Perindopril) C 22-Feb-2006 08:30 AM Page: 1682 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Aspirin Cardio C Aldactone C Date:07/02/02ISR Number: 3943588-7Report Type:Expedited (15-DaCompany Report #PHNU2002DE01659 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Cholesterol Foreign Leponex / Clozaril Increased Health (Clozapine) Blood Triglycerides Professional (Clozapine) Tablet PS ORAL SEE IMAGE Increased Other Electrocardiogram T Wave Abnormal Exercise Electrocardiogram Abnormal High Density Lipoprotein Decreased Hyperlipidaemia Low Density Lipoprotein Increased Platelet Count Decreased Weight Increased Date:07/02/02ISR Number: 3943820-XReport Type:Expedited (15-DaCompany Report #PHEH2002US05574 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Acute Leukaemia Health Clozaril (Clozapine) Leukocytosis Professional Tablet PS ORAL 550 MG, QD, Red Blood Cell Count ORAL Decreased Benadryl C Thrombocytopenia Depakote (Valproate Semisodium) C Date:07/02/02ISR Number: 3957254-5Report Type:Direct Company Report #CTU 173431 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Clozapine (Clozaril) Hospitalization - Leukopenia - Novartis PS Novartis 400 MG BID 4 YR Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage Date:07/03/02ISR Number: 3944196-4Report Type:Expedited (15-DaCompany Report #PHEH2002US05738 Age:16 YR Gender:Male I/FU:I Outcome PT Hospitalization - Blood Creatine Initial or Prolonged Phosphokinase Increased Body Temperature Increased Chills Dyspnoea 22-Feb-2006 08:30 AM Page: 1683 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lethargy Liver Function Test Abnormal Report Source Product Role Manufacturer Route Dose Duration Nausea Health Clozaril (Clozapine) Neck Injury Professional Tablet PS ORAL 100 MG, TID, Tachycardia ORAL Vomiting Depakote (Valproate Semisodium) C Celexa C Artane (Trihexyphenidyl Hydrochloride) C Date:07/03/02ISR Number: 3944467-1Report Type:Expedited (15-DaCompany Report #PHFR2002GB01637 Age:57 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Gastric Cancer Foreign Clozaril (Clozapine) Metastasis Health Tablet PS ORAL 200 MG/DAY, Professional ORAL Other Date:07/03/02ISR Number: 3944470-1Report Type:Expedited (15-DaCompany Report #PHNU2002DE01350 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Atrioventricular Block Foreign Leponex / Clozaril Health (Clozapine)(Clozapin Professional e) Tablet PS ORAL 25 MG/DAY, Other ORAL Diltiazem (Diltiazem) SS ORAL ORAL Date:07/03/02ISR Number: 3944660-8Report Type:Expedited (15-DaCompany Report #PHNU2002DE02131 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Leponex / Clozaril Initial or Prolonged Increased Study (Clozapine) Aspartate Health (Clozapine) Tablet PS ORAL 75 75MG/DAY; Aminotransferase Professional ORAL; SEE Increased Other IMAGE Blood Alkaline Phosphatase Increased Eosinophilia Gamma-Glutamyltransferase Increased Lipase Increased Date:07/03/02ISR Number: 3944661-XReport Type:Expedited (15-DaCompany Report #PHNU2002DE02117 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Hospitalization - Eosinophilia Foreign Initial or Prolonged Pancreatitis Acute Study Health Professional 22-Feb-2006 08:30 AM Page: 1684 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Product Role Manufacturer Route Dose Duration Leponex / Clozaril (Clozapine) (Clozapine) Tablet PS ORAL SEE IMAGE Date:07/03/02ISR Number: 3944662-1Report Type:Expedited (15-DaCompany Report #PHFR2002GB01980 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Foreign Clozaril (Clozapine) Hypotension Health Tablet PS ORAL 100 MG, Medication Error Professional ONCE/SINGLE; Somnolence Other ORAL Vision Blurred Vomiting Date:07/03/02ISR Number: 3944664-5Report Type:Expedited (15-DaCompany Report #PHFR2002GB01976 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Heat Stroke Foreign Clozaril (Clozapine) Initial or Prolonged Platelet Count Decreased Health Tablet PS ORAL 600MG/DAY, Shock Professional ORAL Date:07/03/02ISR Number: 3944665-7Report Type:Expedited (15-DaCompany Report #PHBS2002AU01539 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril (Clozapine) Insulin Resistant Study Tablet PS 400 MG, QD, Diabetes Health Atenolol C Weight Increased Professional Ranitidine (Ranitidine) C Date:07/03/02ISR Number: 3944757-2Report Type:Expedited (15-DaCompany Report #C2002-1554.01 Age:78 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Clozapine Tablets 25 Congestive Professional Mg Mylan PS Mylan ORAL 75 MG QD, Cardiovascular Disorder Other THEN 50 MG QD, ORAL Acetaminophen C Albuterol Nebulizer C Captopril C Digoxin C Docusate / Casanthronol C Furosemide C Guaifenesin La C Isosorbide Mononitrate C Levo-Thyroxine C Lithium C Milk Of Magnesia C 22-Feb-2006 08:30 AM Page: 1685 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Multivitamins C Phenytoin C Potassium C Risperdal C Spironolactone C Tramodal C Warfarin C Simethicone C Date:07/03/02ISR Number: 3945526-XReport Type:Expedited (15-DaCompany Report #PHEH2002US04822 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Leukopenia Health Clozaril (Clozapine) Other Meningitis Streptococcal Professional Tablet PS ORAL 750 MG/DAY, ORAL Seroquel (Quetiapine) C Cogentin (Benzatropine Mesilate) C Vitamin E C Date:07/03/02ISR Number: 3945690-2Report Type:Expedited (15-DaCompany Report #PHNU2002DE02148 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Circulatory Collapse Foreign Leponex /Clozaril Initial or Prolonged Hypotension Health (Clozapine) PS ORAL 25 MG, Transient Ischaemic Professional ONCE/SINGLE, Attack Other ORAL Atacand (Candesartan Cilexetil) C Norvasc C Date:07/03/02ISR Number: 3945697-5Report Type:Expedited (15-DaCompany Report #PHNU2002DE02146 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Cholesterol Foreign Leponex/Clozaril Increased Health (Clozapine) PS ORAL 300 MG/DAY, Blood Triglycerides Professional ORAL Increased Other Trevilor High Density Lipoprotein (Venlafaxine Decreased Hydrochloride) Hyperlipidaemia Unknown SS ORAL 300 MG/DAY, ORAL Date:07/03/02ISR Number: 3945700-2Report Type:Expedited (15-DaCompany Report #PHNU2002DE02145 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Polycythaemia Foreign Leponex/Clozaril Consumer (Clozapine) PS ORAL 450 MG/DAY , Other ORAL 22-Feb-2006 08:30 AM Page: 1686 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/03/02ISR Number: 3945702-6Report Type:Expedited (15-DaCompany Report #PHFR2002GB01966 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Foreign Clozaril (Clozapine) PS Hypertension Health Seroquel (Quetiapine Palpitations Professional Fumarate) SS ORAL 300 MG/DAY, Other ORAL Oxybutynin (Oxybutynin) SS 15 MG/DAY Amitriptyline (Amitriptyline) SS ORAL 50 MG/DAY, ORAL Frusemide C Perindopril (Perindopril) C Carbamazepine C Paroxetine (Paroxetine) C Date:07/04/02ISR Number: 3944115-0Report Type:Expedited (15-DaCompany Report #C2002-1909.01 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Clozapine Tablets Professional 100 Mg Mylan PS ORAL 800 MG QD, Other ORAL Clozapine Tablets 25 Mg Mylan SS ORAL 50 MG QD, ORAL Gabapentin C Mirtazapine C Olanzapine C Pantoprazole C Quetiapine C Sertraline C Date:07/04/02ISR Number: 3944116-2Report Type:Expedited (15-DaCompany Report #C2002-1836.01 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 200 MG QD, Other ORAL Date:07/04/02ISR Number: 3944117-4Report Type:Expedited (15-DaCompany Report #C2002-1866.01 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional 100 Mg Mylan PS ORAL 700 MG QD, Other ORAL 22-Feb-2006 08:30 AM Page: 1687 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/08/02ISR Number: 3945621-5Report Type:Expedited (15-DaCompany Report #PHNU2002DE02136 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Leponex (Clozapine) Initial or Prolonged Increased Study Tablet PS ORAL SEE IMAGE Ammonia Increased Health Atosil Anticholinergic Syndrome Professional (Isopromethazine Aspartate Hydrochloride) SS ORAL SEE IMAGE Aminotransferase Tavor C Increased Bifiteral "Solvay Blood Bilirubin Increased Arzneimittel" C Delirium Haldol "Janssen" C Gamma-Glutamyltransferase Glianimon Increased (Benperidol) C Neuroleptic Malignant Syndrome Pallor Subileus Date:07/08/02ISR Number: 3945792-0Report Type:Expedited (15-DaCompany Report #PHFR2002GB01822 Age:37 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acute Coronary Syndrome Foreign Clozaril (Clozapine) Initial or Prolonged Coronary Artery Disease Health Tablet PS ORAL 400MG/DAY,ORA Hypercholesterolaemia Professional L Other Thyroxine C Lithium Carbonate Slow Release Tablet C Venlafaxine (Venlafaxine) C Date:07/08/02ISR Number: 3945796-8Report Type:Expedited (15-DaCompany Report #PHNU2002DE01672 Age:61 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Leponex/Clozaril Initial or Prolonged Phosphokinase Increased Health (Clozapine) Other Drug Withdrawal Syndrome Professional (Clozapine) Tablet PS ORAL SEE IMAGE Hypertonia Other Tavor (Lorazepam) Muscle Rigidity Tablet SS Orthostatic Hypotension Pneumonia Pyrexia Somnolence Syncope Date:07/08/02ISR Number: 3945823-8Report Type:Expedited (15-DaCompany Report #PHFR2002GB01935 Age:25 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Upper Limb Fracture Foreign Clozaril (Clozapine) Health Tablet PS Professional Other 22-Feb-2006 08:30 AM Page: 1688 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/08/02ISR Number: 3945836-6Report Type:Expedited (15-DaCompany Report #PHNU2002DE01870 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dialysis Foreign Leponex/Clozaril Initial or Prolonged Nephritis Interstitial Health (Clozapine) Other Renal Failure Acute Professional (Clozapine) Tablet PS ORAL 350MG/DAY, Other ORAL Truxal (Chlorprothixene Hydrochloride) Sugar-Coated Tablet C Zyprexa (Olanzapine) C Stangyl (Trimipramine Maleate) C Tavor Tablet C Date:07/08/02ISR Number: 3945839-1Report Type:Expedited (15-DaCompany Report #PHFR2002GB01615 Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Foreign Clozaril (Clozapine) Prolonged Health Tablet PS ORAL 450MG/DAY, Syncope Professional ORAL Other Date:07/09/02ISR Number: 3945141-8Report Type:Direct Company Report #CTU 171785 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Clozaril PS Clozapine SS Date:07/09/02ISR Number: 3945561-1Report Type:Expedited (15-DaCompany Report #C2002-1664.01 Age:76 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Medication Error Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 50 MG QD, Other ORAL Carbidopa/Levodopa C Digoxin C Ipratropiium Bromide C Levothyroxine Sodium C Nitroglycerin C Date:07/09/02ISR Number: 3945564-7Report Type:Expedited (15-DaCompany Report #02-06-0584 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Clozapine Tablets Professional - Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 100-900MG QD ORAL 22-Feb-2006 08:30 AM Page: 1689 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/09/02ISR Number: 3945566-0Report Type:Expedited (15-DaCompany Report #02-06-0585 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fracture Health Clozapine PS Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. ORAL 300-500MG QD ORAL Date:07/09/02ISR Number: 3945919-0Report Type:Direct Company Report #CTU 171924 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Clozaril (Clozapine) Cardiovascular Disorder - 400 Mg PS 400 MG ? FREQ Coronary Artery Fleets Enema SS Atherosclerosis Dyspnoea Faecaloma Hypertensive Cardiomegaly Myocardial Infarction Date:07/09/02ISR Number: 3946279-1Report Type:Expedited (15-DaCompany Report #PHEH2002US05957 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatitis C Health Clozaril (Clozapine) Leukopenia Professional Tablet PS ORAL 700 MG, QD, Thrombocytopenia ORAL; 500 MG, QD; 300 MG, QD 3650 DAY Date:07/09/02ISR Number: 3946284-5Report Type:Expedited (15-DaCompany Report #PHEH2002US05871 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatitis C Health Clozaril(Clozapine) Leukopenia Professional Tablet PS ORAL 200 MG, QD, Neutropenia ORAL Date:07/09/02ISR Number: 3946427-3Report Type:Expedited (15-DaCompany Report #PHEH2002US05577 Age:57 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other B-Cell Lymphoma Health Clozaril (Clozapine) Leukopenia Professional Tablet PS ORAL 300 MG, QD, Lymphadenopathy ORAL Neutropenia Adriamycin Thrombocytopenia (Doxorubicin) SS Cytoxan (Cyclophosphamide) SS Etoposide (Etoposide) SS 22-Feb-2006 08:30 AM Page: 1690 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/09/02ISR Number: 3946769-1Report Type:Expedited (15-DaCompany Report #PHEH2002US04318 Age:81 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Clozaril (Clozapine) Sepsis Professional Tablet PS ORAL 37.5 MG DAILY ORAL Date:07/09/02ISR Number: 3946817-9Report Type:Expedited (15-DaCompany Report #PHEH2002US05787 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Health Clozaril (Clozapine) Non-Insulin-Dependent Professional Tablet PS ORAL ORAL ; 200 Drug Level Increased MG, QD, ORAL Tachycardia ; 300 MG, QD, ORAL Clozapine (Clozapine) SS Pravacol C Date:07/09/02ISR Number: 3946819-2Report Type:Expedited (15-DaCompany Report #PHEH2002US05617 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Overdose Health Clozaril (Clozapine) Drug Interaction Professional Tablet PS ORAL 200 MG, QID, Drug Level Increased Company ORAL Representative Seroquel (Quetiapine Fumarate) SS Paxil (Paroxetine Hydrochloride) SS Cogentin (Benzatropine Mesilate SS Date:07/09/02ISR Number: 3946983-5Report Type:Expedited (15-DaCompany Report #PHBS2002US07607 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiomyopathy Literature Clozapine Initial or Prolonged Drug Ineffective Health (Clozapine) PS 125 MG/D Other Electrocardiogram St Professional Segment Elevation Pulmonary Oedema Date:07/09/02ISR Number: 3947101-XReport Type:Expedited (15-DaCompany Report #PHBS2002CA07699 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatinine Foreign Clozaril (Clozapine) Increased Health (Clozapine) PS Blood Urea Increased Professional Dehydration Other Drug Level Increased 22-Feb-2006 08:30 AM Page: 1691 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/09/02ISR Number: 3947117-3Report Type:Expedited (15-DaCompany Report #USA/00/01128/LEX Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coma Health Clozaril (Clozapine) Hospitalization - Drug Level Increased Professional (Clozapine) Tablet PS ORAL 250 MG, QD, Initial or Prolonged Overdose ORAL Stupor Cocaine (Cocaine) SS UNSPECIFIED (UNK) Valium (Diazepam) (Diazepam) C Date:07/09/02ISR Number: 3947178-1Report Type:Expedited (15-DaCompany Report #PHBS2002BE07671 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hepatic Necrosis Foreign Leponex(Clozapine) Hyperpyrexia Health Tablet PS ORAL 12.5 MG/DAY, Professional ORAL Other Levodopa (Levodopa) C Comtan C Pergolide Mesilate (Pergolide Mesilate) C Date:07/09/02ISR Number: 3947315-9Report Type:Expedited (15-DaCompany Report #PHFR2002GB01894 Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Clozaril (Clozapine) Life-Threatening Cerebral Ventricle Health Tablet PS ORAL 700MG/DAY, Hospitalization - Dilatation Professional ORAL Initial or Prolonged Dyspnoea Other Anaesthetics (No Infectious Mononucleosis Ingredients/Substanc Intracranial Aneurysm es) SS Intracranial Pressure Citalopram Increased (Citalopram) C Obstructive Airways Lofepramine Disorder (Lofepramine) C Pharyngitis Pneumonia Respiratory Arrest Streptococcal Infection Subarachnoid Haemorrhage Tonsillectomy Date:07/09/02ISR Number: 3947353-6Report Type:Expedited (15-DaCompany Report #PHBS2002CA07699 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatinine Foreign Clozaril (Clozapine) Increased Health (Clozapine) Unknown PS Blood Urea Increased Professional Dehydration Other Drug Level Increased 22-Feb-2006 08:30 AM Page: 1692 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/09/02ISR Number: 3947447-5Report Type:Expedited (15-DaCompany Report #PHFR2002GB02019 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Appendicitis Foreign Clozaril(Clozapine) Initial or Prolonged Health Tablet PS ORAL 700MG/DAY, Professional ORAL Other Date:07/09/02ISR Number: 3947448-7Report Type:Expedited (15-DaCompany Report #PHNU2002DE00476 Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Leponex / Clozaril Initial or Prolonged Increased Health (Clozapine) Blood Creatine Professional (Clozapine) Tablets PS ORAL ORAL Phosphokinase Increased Other Novadral "Goedecke" Blood Creatinine (Norfenefrine Increased Hydrochloride) C Blood Urea Increased Zyloric "Fresenius" C Bundle Branch Block Left Cardiac Failure Cardiomegaly Congestive Cardiomyopathy Cough Dyspnoea Dyspnoea Exertional Ejection Fraction Decreased Electrocardiogram Qrs Complex Abnormal Gamma-Glutamyltransferase Increased Hepatic Enzyme Increased Laboratory Test Abnormal Left Ventricular Failure Mitral Valve Incompetence Myocarditis Sinus Tachycardia Date:07/09/02ISR Number: 3947472-4Report Type:Expedited (15-DaCompany Report #PHBS2002AU07651 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Crohn'S Disease Foreign Clozapine Leukopenia Study (Clozapine) Tablet PS ORAL 400 MG/DAY, Neutropenia Health ORAL Professional Other Date:07/09/02ISR Number: 3947633-4Report Type:Expedited (15-DaCompany Report #PHFR2002GB01882 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Arthritis Foreign Clozaril (Clozapine) Weight Increased Consumer Tablet PS ORAL ORAL 2190 DAY Other 22-Feb-2006 08:30 AM Page: 1693 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/10/02ISR Number: 3946465-0Report Type:Expedited (15-DaCompany Report #C2002-1891.01 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death White Blood Cell Disorder Health Clozapine Tablets 25 Professional Mg Mylan PS ORAL 50MG QD, ORAL Other Clozapine Tablets 100 Mg Mylan SS ORAL 500MG QD, ORAL Haloperidol C Date:07/11/02ISR Number: 3948270-8Report Type:Expedited (15-DaCompany Report #PHBS2002AU05427 Age:46 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Brain Neoplasm Foreign Clozaril Hospitalization - Circulatory Collapse Health (Clozapine)Tablet PS ORAL 200 MG, QD, Initial or Prolonged Hallucination, Visual Professional ORAL Loss Of Consciousness Other Medication For Shock Hydatid Cysts C Date:07/11/02ISR Number: 3948271-XReport Type:Expedited (15-DaCompany Report #PHBS2002NZ07051 Age:23 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Influenza Foreign Clozaril Hospitalization - Myocarditis Health (Clozapine)Tablet PS ORAL 400 MG/D, Initial or Prolonged Professional ORAL Other Other Date:07/11/02ISR Number: 3948273-3Report Type:Expedited (15-DaCompany Report #PHFR2002GB01804 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Foreign Clozaril PS ORAL 38.5MG/DAY, Initial or Prolonged Cold Sweat Health ORAL Feeling Cold Professional Heart Rate Irregular Other Irritable Bowel Syndrome Malaise Pallor Restlessness Date:07/11/02ISR Number: 3948330-1Report Type:Expedited (15-DaCompany Report #PHFR2002GB01831 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Foreign Clozaril (Clozapine) Initial or Prolonged Dizziness Health Tablet PS SEE IMAGE Other Drug Level Increased Professional Orthostatic Hypotension Red Blood Cell Sedimentation Rate Increased Somnolence 22-Feb-2006 08:30 AM Page: 1694 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/11/02ISR Number: 3948331-3Report Type:Expedited (15-DaCompany Report #PHFR2002GB02068 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Renal Failure Foreign Clozaril (Clozapine) Initial or Prolonged Health Tablet PS ORAL 500 MG/DAY, Professional ORAL Date:07/11/02ISR Number: 3948333-7Report Type:Expedited (15-DaCompany Report #PHBS2002CA07686 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiomegaly Foreign Clozaril (Clozapine) Cardiomyopathy Study Tablet PS ORAL ORAL Ejection Fraction Health Zoloft (Sertraline Decreased Professional Hydrochloride) C Hypertension Risperdal Ventricular Extrasystoles (Risperidone) C Kemadren (Procyclidine Hydrochloride0 C Oxybutynin (Oxybutynin Hydrochloride) C Ativan C Date:07/11/02ISR Number: 3948353-2Report Type:Expedited (15-DaCompany Report #PHBS2002AU02908 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Shock Foreign Clozaril (Clozapine) Urinary Tract Infection Health Tablet PS ORAL 550 MG/DAY, Professional ORAL Other Lithium Carbonate C Haloperidol C Benzhexol (Trihexyphenidyl) C Citalopram (Citalopram) C Pulmicort C Date:07/11/02ISR Number: 3948354-4Report Type:Expedited (15-DaCompany Report #PHRM2002FR01792 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alpha 2 Globulin Foreign Leponex (Clozapine) Initial or Prolonged Increased Health Tablet PS ORAL ORAL Other Blood Fibrinogen Professional Lysanxia (Prazepam0 C Increased Other Deroxat C C-Reactive Protein Increased Inflammation Red Blood Cell Sedimentation Rate Increased 22-Feb-2006 08:30 AM Page: 1695 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/11/02ISR Number: 3948394-5Report Type:Expedited (15-DaCompany Report #PHFR2002GB02082 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Lung Neoplasm Malignant Foreign Clozaril (Clozapine) Neoplasm Malignant Health Tablet PS ORAL ORAL Throat Cancer Professional Doxycycline Other (Doxycycline) C Oramorph (Morphine Sulfate) C Date:07/11/02ISR Number: 3948395-7Report Type:Expedited (15-DaCompany Report #PHFR2002GB02098 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Tuberculosis Foreign Clozaril (Clozapine) Initial or Prolonged Health Tablet PS ORAL 550 MG/DAY, Professional ORAL Other Omeprazole (Omeprazole) C Pyridoxine (Pyridoxine) C Flucloxacillin (Flucloxacillin) C Date:07/11/02ISR Number: 3948396-9Report Type:Expedited (15-DaCompany Report #PHFR2002GB02099 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Ovarian Cancer Foreign Clozaril (Clozapine) Health Tablet PS ORAL ORAL Professional Other Date:07/11/02ISR Number: 3948930-9Report Type:Expedited (15-DaCompany Report #PHEH2002US04822 Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Leukopenia Health Clozaril Other Meningitis Streptococcal Professional (Clozapine)Tablet PS ORAL 750 MG /DAY, ORAL Seroquel (Quetiapine) C Cogentin (Benzatropine Mesilate) C Vitamin E C Date:07/11/02ISR Number: 3948945-0Report Type:Expedited (15-DaCompany Report #PHEH2002US06042 Age:30 YR Gender:Male I/FU:I Outcome PT Hospitalization - Blood Potassium Decreased Initial or Prolonged Blood Sodium Decreased Chest Pain Confusional State Depressed Level Of Consciousness 22-Feb-2006 08:30 AM Page: 1696 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Disorientation Dyspnoea Hypoventilation Report Source Product Role Manufacturer Route Dose Duration Lethargy Health Clozaril PS ORAL 300 MG/DAY, Pyrexia Professional ORAL; 200 Tachycardia MG/DAY Zyprexa (Olanzapine) C Haldol "Janssen" C Valproic Acid C Date:07/11/02ISR Number: 3949203-0Report Type:Expedited (15-DaCompany Report #PHBS2002CA07699 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dehydration Foreign Clozaril (Clozapine) Drug Level Increased Health (Clozapine) PS Extrapyramidal Disorder Professional Effexor (Venlafaxine Renal Failure Other Hydrochloride) C Serotonin Syndrome Lamictal "Burroughs Wellcome" C Date:07/12/02ISR Number: 3948041-2Report Type:Expedited (15-DaCompany Report #C2002-1245.01 Age:77 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg Mylan PS ORAL 12.5MG QD, Other ORAL Date:07/12/02ISR Number: 3948327-1Report Type:Expedited (15-DaCompany Report #PHNU2002DE01889 Age:63 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Leponex PS ORAL 125MG/DAY, Drug Interaction Health ORAL Erythema Professional Distraneurin Eye Swelling Other (Clomethiazole Hyperhidrosis Edisilate) SS ORAL ONCE/SINGLE, Hypersensitivity ORAL Hypotension Prothazin Insomnia (Promethazine Leukocytosis Hydrochloride) SS ORAL ONCE/SINGLE, Myocarditis ORAL Restlessness Zyprexa (Olanzapine) C Tachyarrhythmia Acetylsalicylic Acid C Dipiperon (Pipamperone) Tablet C Tiapridex (Tiapride Hydrochloride) Tablet C Date:07/12/02ISR Number: 3948488-4Report Type:Direct Company Report #CTU 172264 Age: Gender:Female I/FU:I Outcome PT Hospitalization - Abnormal Behaviour Initial or Prolonged Catatonia 22-Feb-2006 08:30 AM Page: 1697 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pharmaceutical Product Complaint Treatment Noncompliance Report Source Product Role Manufacturer Route Dose Duration Clozapine 600 Mg PS Date:07/15/02ISR Number: 3948863-8Report Type:Expedited (15-DaCompany Report #02-07-0610 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Clozapine - Ivax Hospitalization - Professional Pharmaceuticals, Initial or Prolonged Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 200-600MG QD ORAL Date:07/15/02ISR Number: 3948864-XReport Type:Expedited (15-DaCompany Report #02-07-0598 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine-Ivax Professional Pharmaceuticals, Other Inc. PS Ivax Pharmaceuticals, Inc. ORAL 200-500MG QD ORAL Date:07/15/02ISR Number: 3948865-1Report Type:Expedited (15-DaCompany Report #02-07-0593 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asthma Health Clozapine-Ivax Professional Pharmaceuticals, Other Inc. PS Ivax Pharmaceuticals, Inc. ORAL 225-500MG QD ORAL Date:07/15/02ISR Number: 3949122-XReport Type:Expedited (15-DaCompany Report #02-07-0594 Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Respiratory Failure Health Clozapine Tablets - Initial or Prolonged Staphylococcal Infection Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 25 MG QD ORAL Prozac C Eskalith C Oxybutynin C Requip C Nolvadex C 22-Feb-2006 08:30 AM Page: 1698 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/15/02ISR Number: 3949125-5Report Type:Expedited (15-DaCompany Report #02-07-0599 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Self-Injury Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 200-500 MG QD ORAL Date:07/15/02ISR Number: 3949127-9Report Type:Expedited (15-DaCompany Report #02-07-0602 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neoplasm Malignant Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 425-850 MG QD ORAL Date:07/15/02ISR Number: 3949130-9Report Type:Expedited (15-DaCompany Report #02-03-0606 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ankle Fracture Health Clozapine Tablets - Initial or Prolonged Fall Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 600 MG QD ORAL Date:07/15/02ISR Number: 3949550-2Report Type:Expedited (15-DaCompany Report #PHNU2002DE02268 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthma Foreign Leponex / Clozaril Health (Clozapine) Professional (Clozapine) Tablet PS ORAL 12.5 MG 2.5 Other MG 2.5MG-25MG, ORAL Oxazepam (Oxazepam) Tablet C Pantozol (Pantoprazole Sodium) C Euthyrox Tablet C Aricept (Donepezil Hydrochloride) Film-Coated Tablet C 22-Feb-2006 08:30 AM Page: 1699 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/15/02ISR Number: 3949568-XReport Type:Expedited (15-DaCompany Report #PHFR2002GB02117 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Appendiceal Abscess Foreign Clozaril(Clozapine) Initial or Prolonged Sepsis Health Tablet PS 625MG/DAY Surgery Professional Other Date:07/15/02ISR Number: 3949576-9Report Type:Expedited (15-DaCompany Report #PHBS2002NZ07000 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bundle Branch Block Right Foreign Clozaril (Clozapine) Drug Level Increased Health Tablet PS ORAL 275 MG/D, Eosinophilia Professional ORAL Tachycardia Other Thrombocythaemia Date:07/15/02ISR Number: 3949578-2Report Type:Expedited (15-DaCompany Report #PHBS2002AU07892 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Accidental Exposure Foreign Clozaril (Clozapine) Malaise Study Tablet PS ORAL SEE IMAGE Staring Health Professional Other Date:07/15/02ISR Number: 3949590-3Report Type:Expedited (15-DaCompany Report #PHNU2002DE02351 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Leponex / Clozaril Health (Clozapine) Professional (Clozapine) Tablet PS ORAL ORAL Company Representative Other Date:07/15/02ISR Number: 3949686-6Report Type:Expedited (15-DaCompany Report #PHEH2002US06113 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Parkinson'S Disease Other Clozaril (Clozapine) Tablet PS ORAL 375 MG/DAY, ORAL Sinemet (Levodopa, Carbidopa) C Comtan C Vioxx (Rofecoxib) C Trazodone (Trazodone) C Digoxin C Prilosec (Omeprazole) C 22-Feb-2006 08:30 AM Page: 1700 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/15/02ISR Number: 3949734-3Report Type:Expedited (15-DaCompany Report #PHBS2002CA06604 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Clozaril (Clozapine) Hospitalization - Confusional State Study Tablet PS ORAL 225 MG, QHS, Initial or Prolonged Cystitis Health ORAL Drug Interaction Professional Procyclidine Myocardial Infarction Other (Procyclidine) C Pyrexia Trazodone Somnolence (Trazodone) C Zyprexa (Olanzapine) C Fluanxol "Bayer" (Flupentixol Dihydrochloride) C Date:07/16/02ISR Number: 3949273-XReport Type:Expedited (15-DaCompany Report #C2002-1490.01 Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional 100 Mg Mylan PS ORAL 100MG Q AM, Other 400 MG Q PM, ORAL Divalproex Sodium (500mg Bid), Mirtazapine (30mg Qhs) C Date:07/16/02ISR Number: 3949795-1Report Type:Expedited (15-DaCompany Report #PHBS2002AU07584 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiomyopathy Foreign Clozaril Study (Clozapine) PS ORAL 375 MG/D, Health ORAL Professional Other Date:07/16/02ISR Number: 3949797-5Report Type:Expedited (15-DaCompany Report #PHBS2002AU07579 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Foreign Clozaril Initial or Prolonged Ankle Fracture Study (Clozapine) PS ORAL 325 MG/D, Disability Impaired Healing Health ORAL Infection Professional Leg Amputation Other Neutrophil Count Decreased Postoperative Infection Date:07/16/02ISR Number: 3949823-3Report Type:Expedited (15-DaCompany Report #PHFR2002GB02049 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Other Panic Attack Foreign Health 22-Feb-2006 08:30 AM Page: 1701 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Other Product Role Manufacturer Route Dose Duration Clozaril (Clozapine) Tablet PS ORAL 250MG/DAY,ORA L : 200MG/DAY, ORAL Date:07/16/02ISR Number: 3949846-4Report Type:Expedited (15-DaCompany Report #PHBS2002BE07671 Age:66 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Creatine Foreign Leponex Phosphokinase Increased Health (Clozapine)Tablet PS ORAL 12.5 MG/DAY, Blood Culture Positive Professional ORAL Blood Urea Increased Other Comtan C Cholecystitis Acute Sinemet(Levodopa, Cholelithiasis Carbidopa) C Hepatic Necrosis Lexotan(Bromazepam) C Hyperglycaemia Paroxetine(Paroxetin Hyperpyrexia e) C Staphylococcal Infection Eldepryl C Thrombocytopenia Prolopa (Benserazide Hydrochloride, Levodopa) Tablet C Date:07/16/02ISR Number: 3949885-3Report Type:Expedited (15-DaCompany Report #PHBS2002FI07864 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Foreign Leponex (Clozapine) Initial or Prolonged Drug Level Increased Health Tablet PS ORAL SEE IMAGE Professional Subutex Other (Buprenorphine Hydrochloride) C Date:07/16/02ISR Number: 3949886-5Report Type:Expedited (15-DaCompany Report #PHBS2002AU07894 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Ineffective Foreign Clozaril(Clozapine) Enuresis Study Tablet PS ORAL 400 MG/DAY, Lung Infection Health ORAL Otitis Media Professional Salivary Hypersecretion Other Urinary Tract Infection Weight Increased Date:07/16/02ISR Number: 3949887-7Report Type:Expedited (15-DaCompany Report #PHBS2002AU07902 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Hospitalization - Cardiomyopathy Foreign Initial or Prolonged Laboratory Test Abnormal Study Medication Error Health Nodal Arrhythmia Professional 22-Feb-2006 08:30 AM Page: 1702 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Product Role Manufacturer Route Dose Duration Clozaril (Clozapine) Tablet PS ORAL 500 MG, QD, ORAL Date:07/16/02ISR Number: 3949919-6Report Type:Expedited (15-DaCompany Report #PHBS2002CA07953 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Immunoglobulin A Foreign Clozaril Decreased Health (Clozapine) PS ORAL 300 MG/D, Blood Immunoglobulin G Professional ORAL Decreased Other Blood Immunoglobulin M Decreased Leukopenia Lymphocyte Count Decreased Neutropenia Pneumonia Date:07/16/02ISR Number: 3949923-8Report Type:Expedited (15-DaCompany Report #PHBS2002CA08016 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Nervous System Disorder Foreign Clozaril (Clozapine) Health Tablet PS ORAL 200 MG/DAY, Professional ORAL Other Docusate Calcium (Docusate Calcium) C Domperidone (Domperidone) C Furosemide C Ranitidine (Ranitidine) C Date:07/16/02ISR Number: 3949926-3Report Type:Expedited (15-DaCompany Report #PHBS2002CA08015 Age:87 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bronchitis Foreign Clozaril Deep Vein Thrombosis Health (Clozapine) PS ORAL 25 MG/DAY, Leukocytosis Professional ORAL Pulmonary Embolism Other Antibiotics (No Ingredients/Substanc es) C Date:07/16/02ISR Number: 3950003-6Report Type:Expedited (15-DaCompany Report #S02-GER-01391-01 Age:60 YR Gender:Female I/FU:I Outcome PT Hospitalization - Abdominal Pain Initial or Prolonged Agitation Intestinal Dilatation 22-Feb-2006 08:30 AM Page: 1703 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Nausea Report Source Product Role Manufacturer Route Dose Duration Foreign Cipramil (Citalopram Health Hydrobromide) PS ORAL 30 MG QD PO Professional Cipramil (Citalopram Other Hydrobromide) SS ORAL 20 MG QD PO Cipramil (Citalopram Hydrobromide) SS ORAL 40 MG QD PO Leponex "Novartis" (Clozapine) SS ORAL 350 MG QD PO Leponex "Novartis" (Clozapine) SS ORAL 25 MG QD PO Dipiperon (Pipamperone) SS ORAL 120 MG QD PO Dipiperon (Pipamperone) SS Pirenzepin (Pirenzepine) SS ORAL 125 MG QD PO Pirenzepin (Pirenzepine) SS Tavor (Lorazepam) C Orfiril (Valproate Sodium) C Dyazide C Date:07/18/02ISR Number: 3950193-5Report Type:Direct Company Report #CTU 172499 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Acute Febrile Leponex 100mg PS ORAL 150MG Neutrophilic Dermatosis 50-0-0-100 Delirium ORAL Diarrhoea Dyspnoea Oedema Peripheral Paresis Pericardial Effusion Pleural Effusion Polyserositis Date:07/18/02ISR Number: 3950335-1Report Type:Expedited (15-DaCompany Report #C2002-2010.01 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pharmaceutical Product Health Clozapine Tablets PS ORAL 300MG QD, Complaint Professional ORAL Respiratory Distress Other Date:07/18/02ISR Number: 3951239-0Report Type:Expedited (15-DaCompany Report #PHBS2002AU07121 Age:20 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Atrioventricular Block Foreign Clozaril(Clozapine) First Degree Health Tablet PS ORAL 300 MG/DAY, Electrocardiogram Qrs Professional ORAL Complex Prolonged Other 22-Feb-2006 08:30 AM Page: 1704 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/18/02ISR Number: 3951269-9Report Type:Expedited (15-DaCompany Report #PHBS2002AU07579 Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Foreign Clozaril (Clozapine) Initial or Prolonged Amputation Study Tablet PS ORAL 325 MG/D, Disability Ankle Fracture Health ORAL Infection Professional Leukopenia Other Neutrophil Count Decreased Open Fracture Date:07/18/02ISR Number: 3951443-1Report Type:Expedited (15-DaCompany Report #S02-GER-01391-01 Age:60 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Constipation Foreign Cipramil (Citalopram Initial or Prolonged Flatulence Health Hydrobromide) PS ORAL 30 MG QD PO Professional Cipramil (Citalopram Other Hydrobromide) SS ORAL 20 MG QD PO Cipramil (Citalopram Hydrobromide) SS ORAL 40 MG QD PO Leponex "Novartis" (Clozapine) SS ORAL 350 MG QD PO Leponex "Novartis" (Clozapine) SS ORAL 25 MG QD PO Dipiperon (Pipamperone) SS Pirenzepin (Pirenzepine) SS ORAL 125 MG QD PO Pirenzepin (Pirenzepine) SS Tavor (Lorazepam) C Orfiril(Valproate Sodium) C Dyazide C Date:07/18/02ISR Number: 3951607-7Report Type:Expedited (15-DaCompany Report #PHFR2002GB02174 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Malaise Foreign Clozaril Hospitalization - Septic Shock Health (Clozapine) PS ORAL ORAL Initial or Prolonged Professional Other Date:07/18/02ISR Number: 3951608-9Report Type:Expedited (15-DaCompany Report #PHNU2002DE02350 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Discomfort Foreign Leponex / Clozaril Abdominal Pain Health (Clozapine) PS ORAL ORAL Abdominal Rigidity Professional Leukocytosis Company Pyrexia Representative Other 22-Feb-2006 08:30 AM Page: 1705 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/18/02ISR Number: 3951610-7Report Type:Expedited (15-DaCompany Report #PHBS2002CA08110 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Disorder Foreign Clozaril Haemoglobin Decreased Health (Clozapine) PS ORAL ORAL Leukocytosis Professional Red Blood Cell Other Sedimentation Rate Increased Thrombocythaemia Date:07/19/02ISR Number: 3951238-9Report Type:Expedited (15-DaCompany Report #PHFR2002GB01894 Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Clozaril(Clozapine) Life-Threatening Dilatation Ventricular Health Tablet PS ORAL 700MG/DAY, Hospitalization - Dyspnoea Professional ORAL Initial or Prolonged Hypoxic Encephalopathy Other Anaesthetics(No Infectious Mononucleosis Ingredients/Substanc Intracranial Aneurysm es) SS Intracranial Pressure Citalopram Increased (Citalopram) C Obstructive Airways Lofepramine Disorder (Lofepramine) C Pharyngitis Lansoprazole Pneumonia (Lansoprazole) C Respiratory Arrest Lactulose C Streptococcal Infection Subarachnoid Haemorrhage Tonsillitis Date:07/19/02ISR Number: 3951510-2Report Type:Expedited (15-DaCompany Report #PHFR2002GB01980 Age:21 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Foreign Clozaril (Clozapine) Hypotension Health Tablet PS ORAL 100 MG, Medication Error Professional ONCE/SINGLE, Somnolence Other ORAL Vision Blurred Citalopram Vomiting (Citalopram) SS ORAL 40 MG, ONCE/SINGLE, ORAL Date:07/19/02ISR Number: 3951511-4Report Type:Expedited (15-DaCompany Report #PHFR2002GB01710 Age:47 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Constipation Foreign Clozaril (Clozapine) Other Rectal Prolapse Health Tablet PS ORAL 800 MG/DAY, Professional ORAL Other Chlorpromazine (Chlorpromazine) C Lorazepam C 22-Feb-2006 08:30 AM Page: 1706 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/19/02ISR Number: 3951512-6Report Type:Expedited (15-DaCompany Report #PHNU2002DE01505 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Uric Acid Increased Foreign Leponex / Clozaril Diabetes Mellitus Health (Clozapine) Gamma-Glutamyltransferase Professional (Clozapine) Tablet PS ORAL ORAL Increased Other Hypercholesterolaemia Hypertriglyceridaemia Date:07/19/02ISR Number: 3951522-9Report Type:Expedited (15-DaCompany Report #PHFR2002GB02152 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril(Clozapine) Health Tablet PS ORAL 500 MG/DAY, Professional ORAL Other Date:07/19/02ISR Number: 3951650-8Report Type:Expedited (15-DaCompany Report #PHBS2002AU08140 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Foreign Clozaril (Clozapine) Completed Suicide Study Tablet PS ORAL 400 MG/DAY, Overdose Health ORAL Professional Olanzapine Other (Olanzapine) SS Haloperidol (Haloperidol) SS Metazapine SS Clonidine Hydrochloride(Clonid ine Hydrochloride) SS Date:07/19/02ISR Number: 3951651-XReport Type:Expedited (15-DaCompany Report #PHBS2002AU08141 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening C-Reactive Protein Foreign Clozaril (Clozapine) Increased Health Tablet PS ORAL ORAL Myocardial Infarction Professional Other Date:07/19/02ISR Number: 3951734-4Report Type:Expedited (15-DaCompany Report #PHBS2002CO08154 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetes Mellitus Foreign Leponex (Clozapine) Infarction Health Tablet PS ORAL 150 MG/DAY, Professional ORAL Company Paroxetine C Representative Other 22-Feb-2006 08:30 AM Page: 1707 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/22/02ISR Number: 3951653-3Report Type:Expedited (15-DaCompany Report #02-07-0626 Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine Tablets PS Ivax Pulmonary Embolism Professional Pharmaceuticals, Inc ORAL 12.5-125MG QD Other ORAL Date:07/22/02ISR Number: 3951655-7Report Type:Expedited (15-DaCompany Report #02-07-0618 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mania Health Clozapine Tablets PS Ivax Initial or Prolonged Professional Pharmaceuticals, Inc ORAL 200-300MG QD Other ORAL Date:07/22/02ISR Number: 3951656-9Report Type:Expedited (15-DaCompany Report #02-07-0621 Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Aspiration Health Clozapine Tablets PS Ivax Professional Pharmaceuticals, Inc ORAL 200-300MG QD Other ORAL Date:07/22/02ISR Number: 3951657-0Report Type:Expedited (15-DaCompany Report #02-07-0622 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Osteomyelitis Health Clozapine Tablets PS Ivax Parkinson'S Disease Professional Pharmaceuticals, Inc ORAL 50-75MG QD Other ORAL Date:07/22/02ISR Number: 3952125-2Report Type:Expedited (15-DaCompany Report #PHEH2002US06099 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatitis C Other Clozaril (Clozapine) Unknown PS ORAL 200MG AM/300MG HS, ORAL Interferon (Interferon) C Date:07/23/02ISR Number: 3952394-9Report Type:Expedited (15-DaCompany Report #C2002-1514.01 Age:84 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine Tablets 25 Professional Mg Mylan PS ORAL 25 MG, Other QD,ORAL Antibiotics C Pain Medications C 22-Feb-2006 08:30 AM Page: 1708 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/23/02ISR Number: 3953074-6Report Type:Expedited (15-DaCompany Report #PHEH2002US06264 Age:79 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozaril Professional (Clozapine)Tablet PS ORAL 25 MG/DAY, ORAL Sinemet (Carbidopa, Levodopa) C Date:07/23/02ISR Number: 3953568-3Report Type:Expedited (15-DaCompany Report #PHBS2002BE07671 Age:66 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Creatine Foreign Leponex (Clozapine) Phosphokinase Increased Health Tablet PS ORAL 12.5 MG/DAY, Blood Creatine Professional ORAL Phosphokinase Mb Other Comtan C Increased Sinemet (Levodopa, Blood Culture Positive Carbidopa) C Blood Urea Increased Lexotan (Bromazepam) C Cholecystitis Acute Paroxetine Hepatic Necrosis (Paroxetine) Tablet C Hyperglycaemia Eldepryl C Hyperpyrexia Prolopa (Benserazide Liver Function Test Hydrochloride, Abnormal Levodopa) Tablet C Staphylococcal Infection Thrombocytopenia Date:07/24/02ISR Number: 3953179-XReport Type:Expedited (15-DaCompany Report #2002UW09817 Age:11 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Granulocytopenia Other Seroquel PS ORAL 200 MG HS PO Required Leukopenia Clozapine SS ORAL 25 MG QAM PO Intervention to Depakote - Slow Prevent Permanent Release SS ORAL 500 MG BID PO Impairment/Damage Senokot C Miralax C Lithium C Clozaril C Date:07/24/02ISR Number: 3953583-XReport Type:Expedited (15-DaCompany Report #DE9096003JUL2002 Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Cholesterol Foreign Trevilor Increased Health (Venlafaxine Blood Triglycerides Professional Hydrochloride, ,0) PS ORAL 300MG DAILY Increased ORAL High Density Lipoprotein Leponex (Clozapine, Decreased ,0) SS ORAL 300 MG DAILY Hyperlipidaemia ORAL 22-Feb-2006 08:30 AM Page: 1709 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/24/02ISR Number: 3954752-5Report Type:Expedited (15-DaCompany Report #C2002-1401.01 Age:71 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Unevaluable Event Health Clozapine Tablets 25 Professional Mg Mylan PS ORAL 25MG BID, Other ORAL Carbidopa/Levodopa C Carbidopa/Levodopa Er C Lorazepam C Amantadine C Metoprolol C Date:07/24/02ISR Number: 3955180-9Report Type:Expedited (15-DaCompany Report #A210200 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Condition Aggravated Health Ziprasidone Hospitalization - Psychotic Disorder Professional (Ziprasidone) PS ORAL ORAL Initial or Prolonged Clozapine (Clozapine) SS Date:07/25/02ISR Number: 3953428-8Report Type:Direct Company Report #CTU 172938 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiac Failure Clozapine - Clozaril PS ORAL 400 MG BID PO Hospitalization - Hypokinesia Initial or Prolonged Date:07/25/02ISR Number: 3953980-2Report Type:Expedited (15-DaCompany Report #PHEH2002US06191 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Colon Cancer Clozaril (Clozapine) Initial or Prolonged Gastrointestinal Tablet PS ORAL 700 MG DAY, Haemorrhage ORAL Aciphex (Rabeprazole Sodium) C Ferrous Sulfate C Multivitamins (Ascorbic Acid, Panthenol, Retinol) C Date:07/25/02ISR Number: 3954283-2Report Type:Direct Company Report #CTU 172976 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Clozapine (Clozaril) PS ORAL 400MG PO QHS Initial or Prolonged Neuroleptic Malignant PRIOR TO Syndrome ADMIT Psychotic Disorder Ziprasidone (Geodon) SS ORAL 60MG PO BID Pyrexia Valproic Acid (Depakote) C Oxcarbazepine (Trileptal) C Sertraline (Zoloft) C 22-Feb-2006 08:30 AM Page: 1710 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Clomipramine (Nafranil) C Benztropine (Cogentin) C Corgard C Ditropan C Lisinopril C Synthroid C Phenytoin (Dilantin) C Date:07/26/02ISR Number: 3955681-3Report Type:Expedited (15-DaCompany Report #C2002-1891.01 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death White Blood Cell Count Health Clozapine Tablets 25 Abnormal Professional Mg Mylan PS Mylan ORAL 50 MG QD, Other ORAL Clozapine Tablets 100 Mg Mylan SS Mylan ORAL 500 MG QD, ORAL Haloperidol Decanoate C Paroxetine C Date:07/26/02ISR Number: 3956640-7Report Type:Expedited (15-DaCompany Report #PHFR2002GB02180 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril (Clozapine) Health Tablet PS ORAL 500MG/DAY, Professional ORAL Other Date:07/26/02ISR Number: 3956641-9Report Type:Expedited (15-DaCompany Report #PHFR2002GB02158 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril (Clozapine) Non-Insulin-Dependent Health Tablet PS ORAL 25-75MG BID, Professional ORAL Other Haloperidol C Procyclidine (Procylclidine) C Lorazepam C Date:07/26/02ISR Number: 3956642-0Report Type:Expedited (15-DaCompany Report #PHFR2002IE01936 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ankle Fracture Foreign Clozaril (Clozapine) Initial or Prolonged Health Tablet PS ORAL 450 MG/DAY, Professional ORAL Other 22-Feb-2006 08:30 AM Page: 1711 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/26/02ISR Number: 3956643-2Report Type:Expedited (15-DaCompany Report #PHRM2002FR01103 Age:61 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Congestive Cardiomyopathy Foreign Leponex (Clozapine) Initial or Prolonged Loss Of Consciousness Health Tablet PS ORAL 600 MG DAILY, Professional ORAL Company Previscan Representative (Fluindione) C Other Diacor (Diltiazem Hydrochloride) C Date:07/26/02ISR Number: 3956644-4Report Type:Expedited (15-DaCompany Report #PHFR2002GB01959 Age:34 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Obsessive-Compulsive Foreign Clozaril (Clozapine) PS ORAL 100MG MANE Disorder Health AND 200MG Somnolence Professional NOCTE, ORAL Other Prozac (Fluoxetine Hydrochloride) C Date:07/26/02ISR Number: 3956665-1Report Type:Expedited (15-DaCompany Report #PHBS2002CA08104 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetes Mellitus Foreign Clozaril(Clozapine) Inadequate Control Health Tablet PS ORAL SEE IMAGE Medication Error Professional Zyprexa (Olanzapine) C Other Lamictal "Burroughs Wellcome" C Neurontin (Gabapentin) C Zuclopenthixol Decanoate (Zuclopenthixol Decanoate) C Metformin (Metformin) C Novolin (Insulin Human Injectio, Isophane) C Adalat Xl C Diovan "Novartis" C Tenormin C Date:07/26/02ISR Number: 3956670-5Report Type:Expedited (15-DaCompany Report #PHFR2002GB02176 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril (Clozapine) Health Tablet PS ORAL 350MG/DAY, Professional ORAL 22-Feb-2006 08:30 AM Page: 1712 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/29/02ISR Number: 3955052-XReport Type:Direct Company Report #CTU 173115 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Salivary Hypersecretion Geodon PS ORAL 80MG PO BID Clozaril SS ORAL 225MG PO QAM AND 250MG PO HS Clozaril SS Date:07/29/02ISR Number: 3955067-1Report Type:Direct Company Report #CTU 173114 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required White Blood Cell Count Clozaril PS ORAL 300MG PO Q AM Intervention to Decreased AND 475 PO HS Prevent Permanent Clozaril SS Impairment/Damage Date:07/29/02ISR Number: 3955852-6Report Type:Expedited (15-DaCompany Report #02-07-0631 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Health Clozapine - Ivax Initial or Prolonged Lower Limb Fracture Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 525-625MG QD ORAL Date:07/29/02ISR Number: 3955854-XReport Type:Expedited (15-DaCompany Report #02-07-0641 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine- Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 450MG QD ORAL Date:07/29/02ISR Number: 3956018-6Report Type:Expedited (15-DaCompany Report #PHBS2002US08185 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Literature Clozapine Drug Interaction Health (Clozapine) Unknown PS 25 MG/DAY Drug Level Increased Professional Modafinil Fall (Modafinil) SS SEE IMAGE Gait Disturbance Haloperidol C Hypoxia Quetiapine Sinus Tachycardia (Quetiapine) C Divalproex (Valproate Semisodium) C Gabapentin (Gabapentin C Benztropine C Lorazepam C 22-Feb-2006 08:30 AM Page: 1713 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/29/02ISR Number: 3956274-4Report Type:Expedited (15-DaCompany Report #PHBS2002GR07180 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Anaemia Foreign Leponex (Clozapine) Disability Anorexia Health Tablet PS ORAL 5 TABLETS/D, Malignant Neoplasm Of Professional ORAL, 3 Islets Of Langerhans Other TABLETS/D, Osteolysis ORAL Tooth Disorder Tooth Extraction Weight Decreased Date:07/29/02ISR Number: 3956334-8Report Type:Expedited (15-DaCompany Report #PHFR2002GB01975 Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Lung Abscess Foreign Clozaril (Clozapine) Initial or Prolonged Health Tablet PS ORAL 600MG/DAY, Professional ORAL Other Procyclidine (Procyclidines) SS Co-Codamol (Paracetamol) SS Prozac (Fluoxetine Hydrochloride) C Date:07/29/02ISR Number: 3956335-XReport Type:Expedited (15-DaCompany Report #PHFR2002GB01610 Age:57 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Foreign Clozaril (Clozapine) Dizziness Health Tablet PS ORAL 300MG/DAY, Electrocardiogram Qt Professional ORAL Prolonged Other Ranitidine Hypotension (Ranitidine) C Malaise Pyrexia Tachycardia Date:07/29/02ISR Number: 3956336-1Report Type:Expedited (15-DaCompany Report #PHBS2002CA06604 Age:60 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Myocardial Foreign Clozaril (Clozapine) Hospitalization - Infarction Study Tablet PS ORAL 225 MG, QHS, Initial or Prolonged Confusional State Health ORAL Cystitis Professional Procyclidine Drug Interaction Other (Procyclidine) C Somnolence Trazodone (Trazodone) C Zyprexa (Olanzapine) C Fluanxol "Bayer" (Flupentixol Dihydrochloride) C Restoril C Terbutaline (Terbutaline) Inhaler C 22-Feb-2006 08:30 AM Page: 1714 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Ces (Estrogens Conjugated) C Date:07/29/02ISR Number: 3956337-3Report Type:Expedited (15-DaCompany Report #PHBS2002AU03041 Age:20 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatitis C Foreign Clozaril (Clozapine) Health Tablet PS ORAL SEE IMAGE Professional Cogentin Other (Benzatropine Mesilate) C Thymine C Diazepam C Midazolam (Midazolam) C Date:07/29/02ISR Number: 3956346-4Report Type:Expedited (15-DaCompany Report #PHFR2002GB02174 Age:43 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Colonic Obstruction Foreign Clozaril (Clozapine) Hospitalization - Septic Shock Health Tablet PS ORAL ORAL Initial or Prolonged Professional Voltarol C Other Seroxat "Ciba-Geigy" C Valium C Dihydrocodeine (Dihydrocodeine) C Date:07/29/02ISR Number: 3956362-2Report Type:Expedited (15-DaCompany Report #PHFR2002GB02019 Age:23 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Appendicitis Foreign Clozaril(Clozapine)T Initial or Prolonged Diarrhoea Health ablet PS ORAL 200MG/BID, Professional 300MG NOCTE, Other ORAL Zopiclone C Senna (Senna) Tablet C Tramadol (Tramadol) C Date:07/29/02ISR Number: 3956456-1Report Type:Expedited (15-DaCompany Report #2002GB00910 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blood Pressure Increased Foreign Seroquel PS ORAL 150 MG BID PO Intervention to Drug Interaction Health Clozaril SS Prevent Permanent Palpitations Professional Oxybutynin SS 7.5 MG BID Impairment/Damage Other Amitriptyline SS ORAL 50 MG HS PO Frusemide C Perindopril C Carbamazepine C Paroxetine C 22-Feb-2006 08:30 AM Page: 1715 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/29/02ISR Number: 3980718-5Report Type:Periodic Company Report #2002-04-0757 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Interferon PS Neutrophil Count Professional Clozaril SS ORAL 400 MG QHS Decreased Other ORAL Neurontin C Haldol Decanoate C Cogentin C Klonopin C Date:07/29/02ISR Number: 4156317-1Report Type:Periodic Company Report #2002-04-0757 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Interferon PS Neutrophil Count Professional Clozaril SS ORAL 400 MG QHS Decreased Other ORAL Neurontin C Haldol Decanoate C Cogentin C Klonopin C Date:07/30/02ISR Number: 3955998-2Report Type:Expedited (15-DaCompany Report #2002002021 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Health Geodon Cardiac Disorder Professional (Ziprasidone) PS ORAL ORAL Cardiac Failure Clozaril (Clozapine) SS ORAL ORAL Congestive Haldol (Haloperidol) C Cardiomegaly Cogentin Dyskinesia (Benztropine) C Dyspnoea Tachycardia Thinking Abnormal Date:07/31/02ISR Number: 3955928-3Report Type:Expedited (15-DaCompany Report #C2002-2150.01 Age:69 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 100MG BID, Other ORAL Carbidopa/Levodopa C Furosemide C Glyburide C Milk Of Magnesia C Multivitamins C Paroxetine C Propranolol C 22-Feb-2006 08:30 AM Page: 1716 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/01/02ISR Number: 3956818-2Report Type:Expedited (15-DaCompany Report #C2002-1755.01 Age:85 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Infection Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 25 MG QD, Other ORAL Date:08/01/02ISR Number: 3956820-0Report Type:Expedited (15-DaCompany Report #C2002-2151.01 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Carcinoma Cell Type Health Clozapine Tablets Unspecified Stage Iv Professional 100 Mg Mylan PS Mylan ORAL 25 MG QD Metastases To Pancreas Other TITRATED UP Neoplasm Malignant TO 250 MG QD, Pneumonia ORAL Spinal Disorder Albuterol C Clonazepam C Epoetin C Fluphenazine C Furosemide C Gatifloxacin C Megesterol Acetate C Morphine C Oxycodone C Pantoprazole C Potassium C Risperidone C Senna S C Warfarin C Zolpidem C Date:08/01/02ISR Number: 3957541-0Report Type:Expedited (15-DaCompany Report #PHBS2002AU07902 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Disorder Foreign Clozaril (Clozapine) Initial or Prolonged Cardiomyopathy Study Tablet PS ORAL 500 MG, QD, Consciousness Fluctuating Health ORAL Injury Professional Nodal Arrhythmia Other Troponin I Increased Date:08/01/02ISR Number: 3957600-2Report Type:Expedited (15-DaCompany Report #PHBS2002GR08316 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Leponex (Clozapine) Health Unknown PS UNKNOWN 600 MG/DAY, Professional UNKNOWN Other 22-Feb-2006 08:30 AM Page: 1717 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/01/02ISR Number: 3957602-6Report Type:Expedited (15-DaCompany Report #PHBS2002GR08338 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Splenic Cyst Foreign Leponex (Clozapine) Initial or Prolonged Health Tablet PS ORAL 150 MG/DAY, Professional ORAL Other Date:08/01/02ISR Number: 3957603-8Report Type:Expedited (15-DaCompany Report #PHFR2002GB02197 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Infection Foreign Clozaril (Clozapine) Initial or Prolonged Road Traffic Accident Health Tablet PS ORAL 500MG/DAY, Professional ORAL Other Date:08/01/02ISR Number: 3957621-XReport Type:Expedited (15-DaCompany Report #PHBS2002NZ08356 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Foreign Clozaril (Clozapine) Phosphokinase Increased Health Tablet PS ORAL 400 MG/DAY, Drug Withdrawal Syndrome Professional ORAL Dyskinesia Other Insulin C Grimacing Epilim C Hypocalcaemia Antibiotics (No Pyrexia Ingredients/Substanc Speech Disorder es) C Tetany Date:08/01/02ISR Number: 3957624-5Report Type:Expedited (15-DaCompany Report #PHFR2002GB02194 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Tuberculosis Foreign Clozaril (Clozapine) Initial or Prolonged Health Tablet PS ORAL 550MG/DAY, Professional ORAL Other Fluoxetine (Fluoxetine) C Zantac C Rifater Tablet C Ethambutol (Ethambutol) C Pyridoxine (Pyridoxine) C Leflunomide (Leflunomide) C Date:08/01/02ISR Number: 3957625-7Report Type:Expedited (15-DaCompany Report #PHBS2002FI08314 Age:53 YR Gender:Female I/FU:I Outcome PT Other Alpha-1 Acid Glycoprotein Increased C-Reactive Protein Increased 22-Feb-2006 08:30 AM Page: 1718 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Drug Level Increased Pneumonia Bacterial Report Source Product Role Manufacturer Route Dose Duration Foreign Clozapine Literature (Clozapine) Unknown PS 500 MG/DAY Health Perphenazine Professional (Perphenazine) C Other Ibuprofen C Laxatives (No Ingredients/Substanc es) C Salbutamol C Fluticasone Propionate (Fluticasone Propionate) C Salmeterol (Salmeterol) C Date:08/01/02ISR Number: 3957627-0Report Type:Expedited (15-DaCompany Report #PHBS2002CA05724 Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Creatine Foreign Clozaril (Clozapine) Phosphokinase Increased Health Tablet PS ORAL 100 OR 125 Bundle Branch Block Left Professional MG/D, ORAL Chest Pain Other Olanzapine Ejection Fraction (Olanzapine) C Decreased Lamictal C Imovane C Date:08/01/02ISR Number: 3957751-2Report Type:Expedited (15-DaCompany Report #PHEH2001US08284 Age:43 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lymphoma Health Clozaril (Clozapine) Professional Tablet PS ORAL ORAL Vioxx (Rofecoxib) C Efexor Xr (Venlafaxine) C Docusate Sodium C Vitamin E C Date:08/01/02ISR Number: 3957755-XReport Type:Expedited (15-DaCompany Report #PHEH2002US06389 Age:53 YR Gender:Female I/FU:I Outcome PT Hospitalization - Acidosis Initial or Prolonged Blood Creatinine Decreased Cardiac Tamponade Dehydration Dyspnoea Hypotension Pericardial Effusion Pericarditis Renal Failure Acute Shock 22-Feb-2006 08:30 AM Page: 1719 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Urinary Tract Infection Report Source Product Role Manufacturer Route Dose Duration Health Clozaril Professional (Clozapine)Tablet PS ORAL 500 MG/DAY, ORAL Zestoretic "Haessle" (Lisinopril) C Glucophage "Abic" C Remeron (Mirtazapine) C Hydroxyzine Pamoate (Hydroxyzine Embonate) C Peri-Colace (Casanthranol) C Date:08/01/02ISR Number: 3958131-6Report Type:Expedited (15-DaCompany Report #PHFR2002GB02117 Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Appendiceal Abscess Foreign Clozaril (Clozapine) Initial or Prolonged Gamma-Glutamyltransferase Health Tablet PS ORAL 575 MG/DAY, Increased Professional ORAL; 625 Ultrasound Scan Other MG/DAY, ORAL Amisulpride (Amisulpride) C Citalopram (Citalopram) C Lansoprazole (Lansoprazole) C Hyoscine (Hyoscine) C Senna (Senna) C Ferrous Sulfate C Date:08/01/02ISR Number: 3958135-3Report Type:Expedited (15-DaCompany Report #PHFR2002GB02281 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Cancer Foreign Clozaril (Clozapine) Health Tablet PS Professional Other Date:08/01/02ISR Number: 3958147-XReport Type:Expedited (15-DaCompany Report #PHFR2002GB02175 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Congestive Cardiomyopathy Foreign Clozaril Thrombosis Study (Clozapine)Tablet PS ORAL 500MG/DAY Health ORAL Professional Other 22-Feb-2006 08:30 AM Page: 1720 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/01/02ISR Number: 3958153-5Report Type:Expedited (15-DaCompany Report #PHFR2002IE02289 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Surgery Foreign Clozaril (Clozapine) Initial or Prolonged Health Tablet PS ORAL 350 MG/DAY Professional ORAL Other Date:08/01/02ISR Number: 3958158-4Report Type:Expedited (15-DaCompany Report #PHFR2002GB02049 Age:54 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Panic Attack Foreign Clozaril Sleep Disorder Health (Clozapine) PS ORAL 250MG/DAY Professional ORAL Other Date:08/01/02ISR Number: 3958166-3Report Type:Expedited (15-DaCompany Report #PHBS2002AU06561 Age:71 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hysterectomy Foreign Clozaril Initial or Prolonged Health (Clozapine)Tablet PS ORAL 250 MG QD Professional ORAL Other Date:08/01/02ISR Number: 3958168-7Report Type:Expedited (15-DaCompany Report #PHFR2002GB01937 Age:30 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abortion Induced Foreign Clozaril Complications Of Maternal Health Exposure To Therapeutic Professional (Clozapine) PS ORAL 400-600 Drugs Other MG/DAY ORAL Intra-Uterine Death Maternal Drugs Affecting Foetus Date:08/01/02ISR Number: 3958191-2Report Type:Expedited (15-DaCompany Report #PHBS2002NZ08500 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Cholesterol Foreign Clozaril Increased Health (Clozapine)Tablet PS ORAL 300 MG/DAY, Hyperlipidaemia Professional ORAL Other Date:08/01/02ISR Number: 3958197-3Report Type:Expedited (15-DaCompany Report #PHNU2002DE02505 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypothyroidism Foreign Leponex/Clozaril Health (Clozapine Professional )(Clozapine) Tablet PS ORAL ORAL Other Tavor C 22-Feb-2006 08:30 AM Page: 1721 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/01/02ISR Number: 3958273-5Report Type:Expedited (15-DaCompany Report #PHBS2001CA09564 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cholelithiasis Foreign Clozaril Other Pulmonary Embolism Study (Clozapine) PS ORAL 50 MG/DAY, Shock Health ORAL Professional Estrogen Nos Other (Estrogens Nos) C Celexa C Date:08/01/02ISR Number: 3958274-7Report Type:Expedited (15-DaCompany Report #PHFR2002GB02283 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ankle Fracture Foreign Clozaril (Clozapine) Initial or Prolonged Health Tablet PS ORAL ORAL Other Professional Other Date:08/01/02ISR Number: 3958275-9Report Type:Expedited (15-DaCompany Report #PHFR2002GB02150 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Endocarditis Bacterial Foreign Clozaril Initial or Prolonged Sepsis Health (Clozapine) PS ORAL ORAL Professional Other Date:08/01/02ISR Number: 3958276-0Report Type:Expedited (15-DaCompany Report #PHFR2002GB02082 Age:56 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Neoplasm Malignant Foreign Clozaril Neoplasm Malignant Health (Clozapine) PS ORAL 900MG/DAY, Throat Cancer Professional ORAL Other Doxycycline (Doxycycline) C Oramorph (Morphine Sulfate) C Date:08/01/02ISR Number: 3958326-1Report Type:Expedited (15-DaCompany Report #PHBS2002AU08598 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Overdose Foreign Clozaril (Clozapine) Initial or Prolonged Balance Disorder Study Tablet PS ORAL SEE IMAGE Dizziness Health Dysarthria Professional Medication Error Other Date:08/01/02ISR Number: 3958328-5Report Type:Expedited (15-DaCompany Report #PHFR2002GB02320 Age:45 YR Gender:Female I/FU:I Outcome PT Other Blood Alkaline Phosphatase Increased 22-Feb-2006 08:30 AM Page: 1722 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hepatic Steatosis Report Source Product Role Manufacturer Route Dose Duration Foreign Clozaril (Clozapine) Health Tablet PS Professional Paroxetine Other (Paroxetine) C Date:08/01/02ISR Number: 3961048-4Report Type:Periodic Company Report #11815065 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Toxicity Health Coumadin Tabs Initial or Prolonged Professional (Warfarin Sodium) PS ORAL ORAL Clozapine SS ORAL 400 MILLIGRAM, 1/1 DAY ORAL Date:08/02/02ISR Number: 3957152-7Report Type:Expedited (15-DaCompany Report #C2002-2152.01 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 100 MG BID, Other ORAL Date:08/02/02ISR Number: 3957153-9Report Type:Expedited (15-DaCompany Report #C2002-1985.01 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pharmaceutical Product Health Clozapine Tablets Initial or Prolonged Complaint Professional 100 Mg Mylan PS Mylan ORAL 300MG Q HS, Other Other ORAL Date:08/05/02ISR Number: 3958440-0Report Type:Expedited (15-DaCompany Report #PHEH2002US06636 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Cholesterol Other Clozaril (Clozapine) PS ORAL 750 MG, QHS, Increased ORAL Completed Suicide Zoloft C Social Avoidant Behaviour Date:08/05/02ISR Number: 3958475-8Report Type:Expedited (15-DaCompany Report #HQ3521630JUL2002 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Interaction Health Effexor Xr Drug Level Above Professional (Venlafaxine Therapeutic Hydrochloride, Sudden Death Capsule, Extended Release) PS ORAL 225 MG 1X PER 1 DAY, ORAL Clozapine (Clozapine, ) SS ORAL ORAL Fluoxetine 22-Feb-2006 08:30 AM Page: 1723 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride (Fluoxetine Hydrochloride,) SS ORAL ORAL Date:08/05/02ISR Number: 3958520-XReport Type:Expedited (15-DaCompany Report #PHFR2002GB02343 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Platelet Count Increased Foreign Clozaril (Clozapine) PS ORAL 450MG/DAY, Initial or Prolonged Health ORAL Professional Other Date:08/05/02ISR Number: 3958910-5Report Type:Expedited (15-DaCompany Report #PHFR2002GB02341 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Foreign Clozaril (Clozapine) Initial or Prolonged Shock Health Tablet PS ORAL 300MG/DAY, Professional ORAL Other Date:08/05/02ISR Number: 3958914-2Report Type:Expedited (15-DaCompany Report #PHFR2002GB02318 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Lower Limb Fracture Foreign Clozaril (Clozapine) Wound Infection Health Tablet PS ORAL ORAL Professional Other Date:08/05/02ISR Number: 3958947-6Report Type:Expedited (15-DaCompany Report #PHEH2002US06389 Age:53 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acidosis Health Clozaril Initial or Prolonged Blood Creatinine Abnormal Professional (Clozapine)Tablet PS ORAL 500 MG/DAY, Cardiac Tamponade ORAL Cardiomyopathy Zestoretic "Haessle" Dehydration (Lisinopril) C Dyspnoea Glucophage "Abic" C Hypotension Remeron Pericardial Effusion (Mirtazapine) C Pericarditis Hydroxyzine Pamoate Renal Failure Acute (Hydroxyzine Shock Embonate) C Urinary Tract Infection Peri-Colace (Casanthranol) C Date:08/05/02ISR Number: 3958967-1Report Type:Expedited (15-DaCompany Report #PHBS2002AU07651 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Crohn'S Disease Foreign Leukopenia Study Neutropenia Health Professional 22-Feb-2006 08:30 AM Page: 1724 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Product Role Manufacturer Route Dose Duration Clozapine (Clozapine) Tablet PS ORAL 400 MG/DAY, ORAL Date:08/05/02ISR Number: 3958968-3Report Type:Expedited (15-DaCompany Report #PHFR2002GB01882 Age:41 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Arthralgia Foreign Clozaril (Clozapine) Arthritis Health Tablet PS ORAL SEE IMAGE Hypermobility Syndrome Professional Salbutamol C Weight Increased Other Beclometasone C Venlafaxine (Venlafaxine) C Ranitidine (Ranitidine) C Rofecoxib (Rofecoxib) C Thyroxine C Salmeterol (Salmeterol) C Gaviscon (Sodium Alginate) C Date:08/06/02ISR Number: 3958946-4Report Type:Expedited (15-DaCompany Report #02-07-0650 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Health Clozapine PS Ivax Professional Pharmaceuticals, Other Inc. ORAL 150-450 MG QD ORAL Date:08/06/02ISR Number: 3958948-8Report Type:Expedited (15-DaCompany Report #02-07-0643 Age:86 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Neoplasm Health Clozapine PS Ivax Professional Pharmaceuticals, Other Inc. ORAL 25-50 MG QD ORAL Date:08/06/02ISR Number: 3958953-1Report Type:Expedited (15-DaCompany Report #02-07-0644 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Health Clozapine PS Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. ORAL 50-500 MG QD ORAL 22-Feb-2006 08:30 AM Page: 1725 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/06/02ISR Number: 3958954-3Report Type:Expedited (15-DaCompany Report #02-07-0645 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine PS Ivax Professional Phaarmaceuticals, Other Inc. ORAL 150-200 MG QD ORAL Date:08/06/02ISR Number: 3958956-7Report Type:Expedited (15-DaCompany Report #02-07-0646 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Health Clozapine PS Ivazx Initial or Prolonged Professional Pharmaceuticals, Other Inc. ORAL 200-400 MG QD ORAL Date:08/06/02ISR Number: 3958961-0Report Type:Expedited (15-DaCompany Report #02-07-0647 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine PS Ivax Professional Pharmaceuticals, Other Inc. ORAL 125-300 MG QD ORAL Date:08/06/02ISR Number: 3958962-2Report Type:Expedited (15-DaCompany Report #02-07-0648 Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dementia Health Clozapine PS ORAL 25-50 MG QD Professional ORAL Other Date:08/06/02ISR Number: 3959113-0Report Type:Expedited (15-DaCompany Report #02-06-0529 Age:47 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Clozapine PS Ivax Professional Pharmaceuticals, Other Inc. ORAL 425 QD ORAL Zyprexa C Depakote C Lorazepam C Date:08/06/02ISR Number: 3959115-4Report Type:Expedited (15-DaCompany Report #02-07-0649 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neoplasm Malignant Health Clozapine Tablets PS Ivax Professional Pharmaceuticals, Other Inc. ORAL 300-500MG ORAL 22-Feb-2006 08:30 AM Page: 1726 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/06/02ISR Number: 3959116-6Report Type:Expedited (15-DaCompany Report #02-07-0660 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Body Temperature Health Clozapine PS Ivax Initial or Prolonged Increased Professional Pharmaceuticals, Haemothorax Inc. ORAL 400MG BID Lobar Pneumonia ORAL Pleural Effusion Valproic Acid C Tuberculin Test Positive Date:08/06/02ISR Number: 3959117-8Report Type:Expedited (15-DaCompany Report #02-07-0667 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Health Clozapine PS Ivax Pharmaceuticals Initial or Prolonged Hip Fracture Professional Inc ORAL 550-750MG QD Other ORAL Date:08/06/02ISR Number: 3959119-1Report Type:Expedited (15-DaCompany Report #02-07-0668 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 400-700MG QD ORAL Date:08/06/02ISR Number: 3959120-8Report Type:Expedited (15-DaCompany Report #02-07-0669 Age:82 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Road Traffic Accident Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 25-50MG QD ORAL Date:08/06/02ISR Number: 3959122-1Report Type:Expedited (15-DaCompany Report #02-07-0670 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alcoholism Health Clozapine PS Ivax Initial or Prolonged Drug Abuser Professional Pharmaceuticals, Other Inc. ORAL 25-600MG QD ORAL 22-Feb-2006 08:30 AM Page: 1727 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/06/02ISR Number: 3959123-3Report Type:Expedited (15-DaCompany Report #02-07-0671 Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dementia Health Clozapine PS Ivax Professional Pharmaceuticals, Other Inc. ORAL 25-375MG QD ORAL Date:08/06/02ISR Number: 3959217-2Report Type:Expedited (15-DaCompany Report #PHEH2002US06522 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Health Clozaril(Clozapine) Initial or Prolonged Anxiety Professional Tablet PS ORAL 500 MG, ORAL Chest Pain Topamax(Topiramate) SS Confusional State Actagen(Triprolidine Depressed Level Of Hydrochloride) SS Consciousness Seroquel (Quetiapine Dyspnoea Fumarate) C Electrocardiogram T Wave Celexa C Amplitude Increased Colace C Intentional Overdose Lethargy Pain In Extremity Psychotic Disorder Visual Disturbance Water Intoxication Date:08/06/02ISR Number: 3959310-4Report Type:Expedited (15-DaCompany Report #A208671 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coma Health Ziprasidone Hospitalization - Neuroleptic Malignant Professional (Ziprasidone) PS ORAL 120 MG (BID), Initial or Prolonged Syndrome ORAL Required Clozapine Intervention to (Clozapine) SS ORAL 400 MG (QHS), Prevent Permanent ORAL Impairment/Damage Oxybutynin (Oxybutynin) C Nadolol (Nadolol) C Lisinopril (Lisinopril) C Levothyroxine (Levothyroxine) C Divalproex Ec (Valproate Semisodium) C Clomipramine (Clomipramine) C Valproic Acid (Valproic Acid) C Benzotropine (Benzatropine Mesilate) C Dilantin (Phenytoin Sodium) C 22-Feb-2006 08:30 AM Page: 1728 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/06/02ISR Number: 3959327-XReport Type:Expedited (15-DaCompany Report #PHBS2001CA07241 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cerebrovascular Accident Foreign Clozaril Residual Urine Volume Study (Clozapine) PS ORAL 300 MG/D,ORAL Health Vasotec C Professional Epival Other (Valproate Semisodium) C Wellbutrin (Bupropion Hydrochloride) C Date:08/06/02ISR Number: 3959333-5Report Type:Expedited (15-DaCompany Report #118469 Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Literature Zoloft Tablets PS 200.00 MG Cardiomegaly Health TOTAL:DAILY Cardiomyopathy Professional Clozapine SS 200.00 MG Coronary Artery Disease TOTAL:BID Coronary Artery Occlusion Risperidone C Hepatic Steatosis Atenolol C Sudden Cardiac Death Lorazepam C Pseudoephedrine C Unspecified Medications C Date:08/06/02ISR Number: 3959375-XReport Type:Expedited (15-DaCompany Report #PHEH2002US06640 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukocytosis Health Clozaril(Clozapine) Lymphocytic Leukaemia Professional Tablet PS ORAL 50 MG AM + 300 MG HS, ORAL Depakote (Valproate Semisodium) C Zoloft (Sertraline Hydrochloride) C Date:08/06/02ISR Number: 3959405-5Report Type:Expedited (15-DaCompany Report #PHFR2002GB02294 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Foreign Clozaril Drug Level Decreased Health (Clozapine) PS ORAL ORAL Professional Chemotherapeutics, Other Other (Chemotherapeutics, Other) SS 22-Feb-2006 08:30 AM Page: 1729 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/06/02ISR Number: 3959406-7Report Type:Expedited (15-DaCompany Report #PHFR2002GB02050 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Mass Foreign Clozaril Anaemia Health (Clozapine) PS ORAL 300 MG/DAY, Ascites Professional ORAL Platelet Count Increased Other Lorazepam C Vomiting Weight Decreased Date:08/06/02ISR Number: 3959407-9Report Type:Expedited (15-DaCompany Report #PHFR2002GB02005 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cognitive Disorder Foreign Clozaril Dysarthria Health (Clozapine) PS 400MG/DAY: Memory Impairment Professional REGIMEN #2 Nuclear Magnetic Other 325MG/DAY Resonance Imaging Brain Valproate Sodium C Abnormal Amisulpride (Amisulpride) C Date:08/06/02ISR Number: 3959408-0Report Type:Expedited (15-DaCompany Report #PHFR2002GB01568 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Alkaline Foreign Clozaril Phosphatase Increased Health (Clozapine) PS ORAL 600MG/DAY, Condition Aggravated Professional ORAL Convulsion Other Metformin Hepatic Steatosis (Metformin) C Glicliazide (Gliclazide) C Date:08/06/02ISR Number: 3959410-9Report Type:Expedited (15-DaCompany Report #PHBS2002CA06872 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Conjunctival Hyperaemia Foreign Clozaril Gastroenteritis Health (Clozapine) PS ORAL 100 MG/D, Vomiting Professional ORAL Other Date:08/06/02ISR Number: 3959497-3Report Type:Expedited (15-DaCompany Report #PHFR2002GB01976 Age:27 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Foreign Clozaril (Clozapine) Initial or Prolonged Syndrome Health Tablet PS ORAL 600MG/DAY,ORA Shock Professional L Other 22-Feb-2006 08:30 AM Page: 1730 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/06/02ISR Number: 3959507-3Report Type:Expedited (15-DaCompany Report #D/96/00655/LEX Age:19 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Apallic Syndrome Foreign Leponex (Clozapine) Hospitalization - Arrhythmia Literature Tablet PS ORAL ORAL Initial or Prolonged Brain Oedema Health Tavor (Lorazepam) SS Disability Cardio-Respiratory Arrest Professional Cerebral Ischaemia Other Drug Interaction Medication Error Date:08/06/02ISR Number: 3959586-3Report Type:Expedited (15-DaCompany Report #A0374696A Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Health Paxil Initial or Prolonged Drug Interaction Professional Tablet-Controlled Medication Error Release (Paroxetine Hydrochloride) PS ORAL 25 MG/ PER DAY/ORAL Clozapine (Formulation Unknown) (Clozapine) SS 300 MG /PER DAY Lithium Carbonate C Mirtazapine C Date:08/06/02ISR Number: 3959656-XReport Type:Expedited (15-DaCompany Report #A210200 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Effect Decreased Health Ziprasidone Hospitalization - Psychotic Disorder Professional (Ziprasidone) PS ORAL ORAL Initial or Prolonged Clozapine (Clozapine) SS Date:08/07/02ISR Number: 3959396-7Report Type:Expedited (15-DaCompany Report #C2002-2235.01 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neoplasm Malignant Other Clozapine Tablets 25 Mg Mylan PS ORAL ORAL Clozapine Tablets 100 Mg Mylan SS ORAL ORAL Date:08/07/02ISR Number: 3959398-0Report Type:Expedited (15-DaCompany Report #C2002-2234.01 Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg Mylan PS ORAL 25 MG, QD, Other ORAL Citalopram C Donepezil C Glimepiride C Lorazepam C Multivitamin C 22-Feb-2006 08:30 AM Page: 1731 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Ramipril C Risperidone C Date:08/07/02ISR Number: 3959495-XReport Type:Expedited (15-DaCompany Report #C2002-2255.02 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional 100mg Mylan PS Mylan ORAL 200MG, QD, Other ORAL Baclofen C Bumetanide C Conjugated Estrogen C Gabapentin C Imipramine C Interferon B 1-A C Lactulose C Medroxyprogesterone C Methylphenidate C Multivitamin C Oxybutynin C Oxycodone/Acetaminop hen C Potassium Chloride C Ranitidine C Tizanidine C Zaroxolyn C Date:08/07/02ISR Number: 3959503-6Report Type:Expedited (15-DaCompany Report #C2002-1604.01 Age:56 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Choking Health Clozapine Tablets Professional 100 Mg Mylan PS ORAL 200MG, BID, Other 300 MG Q HR, ORAL Atorvastatin C Buspirone C Metformin C Propranolol C Date:08/07/02ISR Number: 3959505-XReport Type:Expedited (15-DaCompany Report #C2002-2010.01 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Respiratory Distress Health Clozapine Tablets Professional 100 Mg Mylan PS ` ORAL 100 MG Q AM, Other 200 MG Q HR, ORAL 16 Unknown Medication C 22-Feb-2006 08:30 AM Page: 1732 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/07/02ISR Number: 3959506-1Report Type:Expedited (15-DaCompany Report #C2002-2255.01 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 50 MG QD, Other ORAL Clozapine Tablets 100 Mg Mylan SS Mylan ORAL 200 MG QD, ORAL Ciprofloxacin/Hydroc ortisone Otic C Fluoxetine C Furosemide C Lactulose C Levofloxacin C Levothyroxine C Oxybutynin C Potassium Chloride C Promethazine C Sulfamethoxazole/Tri methoprim C Date:08/07/02ISR Number: 3963766-0Report Type:Expedited (15-DaCompany Report #C2002-2265.01 Age:67 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 100 MG QD, Other ORAL Amlodipine C Celecoxib C Fentanyl Pacth C Fluoxetine C Furosemide C Ipratropium And Albuterol Inhaler C Nitroglycerin Patch C Propoxyphene/Acetami nophen C Ranitidine C Date:08/08/02ISR Number: 3960710-7Report Type:Expedited (15-DaCompany Report #PHBS2002CA08790 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozapine Study (Clozapine) Tablet PS ORAL 50 MG BID Health ORAL Professional Other Date:08/08/02ISR Number: 3960712-0Report Type:Expedited (15-DaCompany Report #PHFR2002GB02368 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Hospitalization - Appendicitis Foreign Initial or Prolonged Health Professional 22-Feb-2006 08:30 AM Page: 1733 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Product Role Manufacturer Route Dose Duration Clozaril (Clozapine) Tablet PS ORAL 300MG/DAY ORAL Date:08/08/02ISR Number: 3960736-3Report Type:Expedited (15-DaCompany Report #PHBS2002AU07892 Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Accidental Exposure Foreign Clozaril (Clozapine) Malaise Study Tablet PS ORAL SEE IMAGE Medication Error Health Myocarditis Professional Staring Other Date:08/08/02ISR Number: 3960739-9Report Type:Expedited (15-DaCompany Report #PHFR2002GB02197 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Aspiration Foreign Clozaril (Clozapine) Hospitalization - Infection Health Tablet PS ORAL 500MG/DAY, Initial or Prolonged Laparotomy Professional ORAL Pelvic Fracture Other Respiratory Depression Road Traffic Accident Urinary Bladder Rupture Date:08/08/02ISR Number: 3960899-XReport Type:Expedited (15-DaCompany Report #PHBS2002CA06604 Age:60 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Myocardial Foreign Clozaril Hospitalization - Infarction Study (Clozapine)Tablet PS ORAL 225 MG, QHS, Initial or Prolonged Cardiac Arrest Health ORAL Confusional State Professional Procyclidine C Coronary Artery Other Trazodone C Atherosclerosis Zyprexa (Olanzapine) C Coronary Artery Stenosis Fluxanol "Bayer" Cystitis (Flupentixol Drug Interaction Dihydrochloride) C Somnolence Restoril C Terbutaline C Ces (Estrogens Conjugated) C Date:08/08/02ISR Number: 3961163-5Report Type:Expedited (15-DaCompany Report #PHBS2002CO08154 Age:72 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asthenia Foreign Leponex Other Blood Creatinine Health (Clozapine)Tablet PS ORAL 150 MG /DAY, Increased Professional ORAL Diabetes Mellitus Company Paroxetine Leukocytosis Representative (Paroxetine) C Myocardial Infarction Other 22-Feb-2006 08:30 AM Page: 1734 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/09/02ISR Number: 3960097-XReport Type:Expedited (15-DaCompany Report #PHEH2002US01460 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bronchial Obstruction Health Clozaril(Clozapine)T Circulatory Collapse Professional ablet PS ORAL 500 MG/DAY, Respiratory Tract ORAL Infection Zoloft (Sertraline Hydrochloride) C Date:08/09/02ISR Number: 3960132-9Report Type:Direct Company Report #CTU 173837 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Neutrophil Count Valproic Acid 250mg PS ORAL 1500MG Q 6 PM Intervention to Decreased ORAL Prevent Permanent Clozapine 25mg SS ORAL 25MG Q HS Impairment/Damage ORAL Date:08/09/02ISR Number: 3961505-0Report Type:Expedited (15-DaCompany Report #PHEH2001US06736 Age:69 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Clonic Convulsion Literature Clozaril (Clozapine) Initial or Prolonged Drug Withdrawal Syndrome Health Tablet PS ORAL SEE IMAGE 7650 DAY Electroencephalogram Professional Sinemet C Abnormal Medication Error Rebound Effect Date:08/09/02ISR Number: 3961837-6Report Type:Expedited (15-DaCompany Report #PHNU2002DE01656 Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Leponex / Clozaril Fatigue Study (Clozapine) Hypertriglyceridaemia Health (Clozapine) Tablet, Thirst Professional 100 Mg PS ORAL SEE IMAGE Weight Increased Other Jarsin (Hypericum Extract) Sugar-Coated Tablet C Gastrozepin (Pirenzepine Dihydrochloride) Tablet C Seroxat "Smith Kline Beecham" Film-Coated Tablet C Baldrian-Dispert (Valeriana Officinalis Root) C Date:08/09/02ISR Number: 3961844-3Report Type:Expedited (15-DaCompany Report #PHFR2002GB02465 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Other Pemphigoid Foreign Study 22-Feb-2006 08:30 AM Page: 1735 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Health Professional Other Product Role Manufacturer Route Dose Duration Clozaril (Clozapine) Tablet PS ORAL ORAL Date:08/09/02ISR Number: 3961847-9Report Type:Expedited (15-DaCompany Report #PHFR2002GB02438 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Clozaril (Clozapine) Study Tablet PS ORAL 75MG/DAY, Health ORAL Professional Amisulpride Other (Amisulpride) C Date:08/09/02ISR Number: 3961848-0Report Type:Expedited (15-DaCompany Report #PHFR2002GB02390 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Carotid Arterial Embolus Foreign Clozapine Congestive Cardiomyopathy Health (Clozapine) Tablet PS ORAL 250 MG, BID, Dyspnoea Professional ORAL Full Blood Count Abnormal Other Venlafaxine Intracardiac Thrombus (Venlafaxine) C Liver Function Test Diazepam C Abnormal Lymphocytosis Neutrophilia Sudden Death Thrombocythaemia Date:08/09/02ISR Number: 3961901-1Report Type:Expedited (15-DaCompany Report #PHFR2002GB02281 Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Cancer Foreign Clozaril PS ORAL 425MG/DAY, Health ORAL Professional Venlafaxine (Venlafaxine) C Atenolol C Bendrofluazide (Bendroflumethiazide ) C Date:08/09/02ISR Number: 3961905-9Report Type:Expedited (15-DaCompany Report #PHFR2002GB02209 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Asthma Foreign Clozaril PS ORAL 500MG/DAY, Pneumonia Health ORAL Professional Rabeprazole Other (Rabeprazole) C Carbamazepine C Clomipramine (Clomipramine) C Clonidine 22-Feb-2006 08:30 AM Page: 1736 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Clonidine) C Procyclidine (Procyclidine) C Amisulpride (Amisulpride) C Senna (Senna) C Date:08/09/02ISR Number: 3961906-0Report Type:Expedited (15-DaCompany Report #PHBS2002CA09112 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Foreign Clozaril (Clozapine) Heat Stroke Health Tablet PS ORAL ORAL Professional Other Date:08/09/02ISR Number: 3961907-2Report Type:Expedited (15-DaCompany Report #PHFR2002GB01866 Age:43 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Distension Foreign Clozaril (Clozapine) Cardio-Respiratory Arrest Study Tablet PS ORAL 400 MG/DAY, Convulsion Health ORAL Drug Level Increased Professional Citalopram Face Oedema Other (Citalopram) C Malaise Hyoscine (Hyoscine) C Salivary Hypersecretion Movecil Skin Discolouration (Pyricarbate) C Date:08/12/02ISR Number: 3961449-4Report Type:Expedited (15-DaCompany Report #DE9116919JUL2002 Age:20 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Apallic Syndrome Literature Tavor (Lorazepam, Disability Brain Hypoxia Unspec, 0) PS Cardio-Respiratory Arrest Leponex (Clozapine, Pain , 0) SS Date:08/13/02ISR Number: 3962753-6Report Type:Expedited (15-DaCompany Report #PHBS2002AU07416 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Clozaril (Clozapine) Other Electrocardiogram Qrs Health Tablet PS ORAL 300 MG/DAY, Complex Abnormal Professional ORAL Eosinophilia Other Seroquel (Quetiapine Palpitations Fumarate) C Sinus Tachycardia Ventricular Hypertrophy Date:08/13/02ISR Number: 3962815-3Report Type:Expedited (15-DaCompany Report #PHRM2002FR01994 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Cognitive Deterioration Foreign Leponex (Clozapine) Cognitive Disorder Consumer Tablet PS Condition Aggravated Other 22-Feb-2006 08:30 AM Page: 1737 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/13/02ISR Number: 3962816-5Report Type:Expedited (15-DaCompany Report #PHNU2002DE01657 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Leponex / Clozaril Hyperglycaemia Study (Clozapine) Ketoacidosis Health (Clozapine) Tablet PS ORAL 500-600 Professional MG/DAY, ORAL; Other 800 MG/DAY, ORAL Date:08/13/02ISR Number: 3963016-5Report Type:Expedited (15-DaCompany Report #PHEH2002USUS06825 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukocytosis Health Clozaril (Clozapine) PS ORAL ORAL : 50MG Leukopenia Professional AM + 75MG HS, Neoplasm Malignant ORAL Clozapine (Clozapine) SS Date:08/14/02ISR Number: 3962129-1Report Type:Expedited (15-DaCompany Report #02-07-0663 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Abuser Health Clozapine Tablets - Initial or Prolonged Family Stress Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 300MG QD ORAL Date:08/14/02ISR Number: 3962132-1Report Type:Expedited (15-DaCompany Report #02-08-0685 Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetes Mellitus Health Clozapine Tablets - Hypertension Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 200MG QD ORAL Date:08/14/02ISR Number: 3962134-5Report Type:Expedited (15-DaCompany Report #02-08-0686 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Literature Clozapine Tablets PS ORAL 25-450MG ORAL Drug Level Increased Health Modafinil SS 100-300MG 37 DAY Fall Professional Levothyroxine Sodium C Gait Disturbance Furosemide C Hypoxia Potassium C Oxygen Saturation Docusate Sodium C Decreased Sedation Sinus Tachycardia 22-Feb-2006 08:30 AM Page: 1738 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/14/02ISR Number: 3962149-7Report Type:Expedited (15-DaCompany Report #02-08-0687 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Catatonia Foreign Clozapine Tablets PS ORAL 50-350 MG QD Initial or Prolonged Condition Aggravated Literature ORAL Drug Interaction Health Risperidone SS 4-16 MG QD Drug Toxicity Professional Diazepam C Dysphagia Neuroleptic Malignant Syndrome Date:08/14/02ISR Number: 3962155-2Report Type:Direct Company Report #CTU 174091 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyspnoea Clozaril PS ORAL 400MG PO QD Dyspnoea Paroxysmal (LONGTERM) Nocturnal Albuterol C Oedema Flovent C Orthopnoea Digoxin C Toprol Xl C Lasix C Monopril C Date:08/14/02ISR Number: 3963239-5Report Type:Expedited (15-DaCompany Report #PHBS2002AU07121 Age:20 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Atrioventricular Block Foreign Clozaril (Clozapine) First Degree Health Tablet PS ORAL 300 MG, QD, Bundle Branch Block Right Professional ORAL Conduction Disorder Other Electrocardiogram Abnormal Date:08/14/02ISR Number: 3963242-5Report Type:Expedited (15-DaCompany Report #PHBS2002AU07894 Age:17 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Drug Ineffective Foreign Clozaril (Clozapine) Disability Enuresis Study Tablet PS ORAL 400 MG/DAY, Lung Infection Health ORAL Otitis Media Professional Valproate Sodium C Salivary Hypersecretion Other Cipramil C Urinary Tract Infection Weight Increased Date:08/14/02ISR Number: 3963259-0Report Type:Expedited (15-DaCompany Report #D/96/00655/LEX Age:19 YR Gender:Female I/FU:F Outcome PT Life-Threatening Apallic Syndrome Hospitalization - Arrhythmia Initial or Prolonged Brain Damage Disability Brain Oedema Bulimia Nervosa Cardio-Respiratory Arrest 22-Feb-2006 08:30 AM Page: 1739 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Cerebral Ischaemia Drug Interaction Psychomotor Hyperactivity Report Source Product Role Manufacturer Route Dose Duration Weight Decreased Foreign Leponex (Clozapine) Literature Tablet PS ORAL ORAL Health Tavor (Lorazepam) SS Professional Other Date:08/14/02ISR Number: 3963263-2Report Type:Expedited (15-DaCompany Report #PHFR2002GB02050 Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Mass Foreign Clozaril (Clozapine) Initial or Prolonged Anaemia Health Tablet PS ORAL 300 MG/DAY, Other Ascites Professional ORAL Breast Cancer Recurrent Other Lorazepam C Malaise Platelet Count Increased Vomiting Weight Decreased Date:08/14/02ISR Number: 3963264-4Report Type:Expedited (15-DaCompany Report #PHFR2002GB02180 Age:38 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril (Clozapine) Health Tablet PS ORAL 500 MG/DAY, Professional ORAL Other Date:08/14/02ISR Number: 3963266-8Report Type:Expedited (15-DaCompany Report #PHFR2002GB02318 Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ankle Fracture Foreign Clozaril (Clozapine) Initial or Prolonged Wound Infection Health Tablet PS ORAL ORAL Other Professional Other Date:08/14/02ISR Number: 3963291-7Report Type:Expedited (15-DaCompany Report #PHNU2002DE02650 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Medication Error Foreign Leponex / Clozaril Initial or Prolonged Health (Clozapine) Professional (Clozapine) Tablet PS ORAL 150 MG, Other ONCE/SINGLE, ORAL Lithium (Lithium) C Remergil (Mirtazapine) C 22-Feb-2006 08:30 AM Page: 1740 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/14/02ISR Number: 3963313-3Report Type:Expedited (15-DaCompany Report #PHBS2002AU09128 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiomyopathy Foreign Clozaril (Clozapine) Diastolic Dysfunction Health Tablet PS ORAL ORAL Ventricular Hypertrophy Professional Other Date:08/14/02ISR Number: 3963314-5Report Type:Expedited (15-DaCompany Report #PHBS2002AU09126 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dilatation Ventricular Foreign Clozaril Ventricular Hypertrophy Health (Clozapine)Tablet PS ORAL ORAL Professional Date:08/14/02ISR Number: 3963316-9Report Type:Expedited (15-DaCompany Report #PHBS2002AU09267 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aortic Valve Stenosis Foreign Clozaril (Clozapine) Ventricular Hypertrophy Health Tablet PS Professional Other Date:08/14/02ISR Number: 3963323-6Report Type:Expedited (15-DaCompany Report #PHBS2002AU09127 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiomyopathy Foreign Clozaril (Clozapine) Ventricular Hypertrophy Health Tablet PS ORAL ORAL Professional Other Date:08/14/02ISR Number: 3963349-2Report Type:Expedited (15-DaCompany Report #PHFR2002GB02407 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Obsessive-Compulsive Foreign Clozaril (Clozapine) Disorder Health (Clozapine) Unknown PS Professional Valproate Sodium C Other Date:08/14/02ISR Number: 3963725-8Report Type:Expedited (15-DaCompany Report #PHEH2002US06570 Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lymphoma Other Clozaril (Clozapine) Other Parkinson'S Disease Tablet PS ORAL 250MG , ORAL Hytrin (Terazosin Hydrochloride) C Depakote (Valproate Semisodium) C Wellbutrin (Bupropion Hydrochloride) C 22-Feb-2006 08:30 AM Page: 1741 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sinemet C Date:08/15/02ISR Number: 3963596-XReport Type:Expedited (15-DaCompany Report #02-08-0690 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neoplasm Malignant Health Clozapine PS Ivax Professional Pharmaceuticals, Other Inc. ORAL 400MG QD ORAL Date:08/15/02ISR Number: 3963597-1Report Type:Expedited (15-DaCompany Report #02-08-0689 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pancreatic Carcinoma Health Clozapine PS Ivax Professional Pharmaceuticals, Other Inc. ORAL 100-200MG QD ORAL Date:08/15/02ISR Number: 3963598-3Report Type:Expedited (15-DaCompany Report #02-07-0652 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine PS Ivax Professional Pharmaceuticals, Other Inc. ORAL 75-325MG QD ORAL Date:08/15/02ISR Number: 3963600-9Report Type:Expedited (15-DaCompany Report #02-08-0691 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Chronic Obstructive Health Clozapine PS Ivax Pulmonary Disease Professional Pharmaceuticals, Other Inc. ORAL 300-500MG QD ORAL Date:08/15/02ISR Number: 3963642-3Report Type:Expedited (15-DaCompany Report #02-08-0692 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Malignant Melanoma Health Clozapine PS Ivax Professional Pharmaceuticals, Other Inc. ORAL 500-575MG QD ORAL Date:08/15/02ISR Number: 3963643-5Report Type:Expedited (15-DaCompany Report #02-08-0704 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Health Clozapine PS Ivax Professional Pharmaceuticals, Other Inc. ORAL 300-800MG QD ORAL 22-Feb-2006 08:30 AM Page: 1742 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/15/02ISR Number: 3963644-7Report Type:Expedited (15-DaCompany Report #02-08-0707 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine PS Ivax Professional Pharmaceuticals, Other Inc. ORAL 300-500MG QD ORAL Date:08/15/02ISR Number: 3963646-0Report Type:Expedited (15-DaCompany Report #02-08-0693 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Clozapine PS Ivax Hospitalization - Congestive Professional Pharmaceuticals, Initial or Prolonged Chronic Obstructive Other Inc. ORAL 25 MG QD ORAL Pulmonary Disease Senna S C Pulmonary Embolism Coumadin C Pulmonary Oedema Phazyme C Furosemide C Calcium Carbonate C Fosamax C Neurontin C Lanoxin C Prevacid C Prinivil C Prednisone C Paxil C Docusate Sodium C Xopenex Inhalation Solution C Date:08/15/02ISR Number: 3963671-XReport Type:Expedited (15-DaCompany Report #PHNU2002DE01559 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Foreign Leponex (Clozapine) Initial or Prolonged Intentional Overdose Health Tablet PS ORAL 300 MG, QD, Suicide Attempt Professional ORAL Other Haldol Decanoate (Haloperidol Decanoate) Solution SS INTRAMUSCULAR 2 ML, BIW, INTRAMUSCULAR Date:08/15/02ISR Number: 3963933-6Report Type:Expedited (15-DaCompany Report #PHBS2002AU05385 Age:41 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Catatonia Foreign Clozaril (Clozapine) Initial or Prolonged Diabetic Ketoacidosis Health Tablet PS ORAL 150 MG/DAY Neuroleptic Malignant Professional ORAL Syndrome Other Renal Failure Sepsis 22-Feb-2006 08:30 AM Page: 1743 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/15/02ISR Number: 3963949-XReport Type:Expedited (15-DaCompany Report #PHBS2002AU09124 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Ventricular Hypertrophy Foreign Clozaril (Clozapine) Health Tablet PS ORAL ORAL Professional Other Date:08/15/02ISR Number: 3964113-0Report Type:Expedited (15-DaCompany Report #PHFR2002GB02174 Age:43 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Colonic Obstruction Foreign Clozaril (Clozapine) Hospitalization - Hepatic Cirrhosis Health Tablet PS ORAL 200 MG/DAY, Initial or Prolonged Malaise Professional ORAL Septic Shock Other Voltarol C Dihydrocodeine (Dihydrocodeine) C Paroxetine (Paroxetine) C Valium C Risperidone (Risperidone) C Df118 (Dihydrocodeine Bitartrate) C Procyclidine (Procyclidine) C Date:08/15/02ISR Number: 3964122-1Report Type:Expedited (15-DaCompany Report #PHBS2002CA09112 Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Clozaril (Clozapine) Hospitalization - Fatigue Health Tablet PS ORAL 550 MG, QHS, Initial or Prolonged Heart Valve Stenosis Professional ORAL Heat Stroke Other Cogentin Malaise (Benzatropine Paranoia Mesilate) C Sinus Tachycardia Colace C Ventricular Hypertrophy Metoprolol (Metoprolol) C Date:08/15/02ISR Number: 3964324-4Report Type:Expedited (15-DaCompany Report #PHFR2002GB02034 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Viral Myocarditis Foreign Clozaril (Clozapine) Hospitalization - Health Tablet PS ORAL 750 MG/DAY, Initial or Prolonged Professional ORAL Other Valproate Sodium C 22-Feb-2006 08:30 AM Page: 1744 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/15/02ISR Number: 3964325-6Report Type:Expedited (15-DaCompany Report #PHFR2002GB02441 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril (Clozapine) Hyperhidrosis Study Tablet PS ORAL ORAL Neuroleptic Malignant Health Valproate Sodium C Syndrome Professional Pain Other Social Avoidant Behaviour Thirst Decreased Date:08/16/02ISR Number: 3964265-2Report Type:Expedited (15-DaCompany Report #02P-163-0197539-00 Age:11 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Granulocytopenia Health Depakote Er Required Leukopenia Professional (Divalproex Sodium) Intervention to Other (Divalproex Sodium) PS ORAL 500 MG, 2 IN Prevent Permanent 1 D, PER ORAL Impairment/Damage Clozapine SS ORAL 25 MG, 1 IN 1 D, PER ORAL Quetiapine SS ORAL 200 MG, 1 IN 1 D, PER ORAL Senna Fruit C Macrogol C Date:08/19/02ISR Number: 3963520-XReport Type:Direct Company Report #CTU 174443 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abdominal Pain Upper Quetiapine PS 1 DOSE Hospitalization - Blood Pressure Systolic Ranitidine SS Initial or Prolonged Increased ... SS Required Chest Pain Clozapine SS Intervention to Dizziness Valproic Acid SS Prevent Permanent Electrocardiogram St Docusate SS 1 DOSE Impairment/Damage Segment Depression Electrocardiogram T Wave Abnormal Fall Head Injury Hyperhidrosis Myocardial Ischaemia Overdose Sinus Tachycardia Vomiting Date:08/19/02ISR Number: 3964700-XReport Type:Expedited (15-DaCompany Report #PHEH2002US06749 Age:79 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Leukocytosis Health Clozaril (Clozapine) Hospitalization - Pneumonia Professional Tablet PS ORAL 12.5 MG, BID, Initial or Prolonged ORAL Amiodarone (Amiodarone) C Captopril C Sinemet-Cr C 22-Feb-2006 08:30 AM Page: 1745 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Metoprolol (Metoprolol) C Darvocet-N (Dextropropoxyphene Napsilate, Paracetamol) C Compazine (Prochlorperazine Edisylate) C Lanoxin C Mirapex "Boehringer Ingelheim" (Pramipexole Dihydrochloride) C Exelon (Rivastigmine Tartrate) C Flomax "Boehringer Ingelheim" (Tamsulosin Hydrochloride) C Date:08/19/02ISR Number: 3964753-9Report Type:Expedited (15-DaCompany Report #2002003203 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Foreign Sertraline Initial or Prolonged Confusional State Consumer (Sertraline) PS ORAL 400 MG Disability Convulsion (DAILY), ORAL Other Fall Haloperidol SS Loss Of Consciousness Clozapine Memory Impairment (Clozapine) SS Social Avoidant Behaviour Date:08/20/02ISR Number: 3963958-0Report Type:Expedited (15-DaCompany Report #319690 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancreatitis Necrotising Xenical PS Roche Initial or Prolonged Leponex SS Depakine SS Date:08/20/02ISR Number: 3964559-0Report Type:Direct Company Report #CTU 174641 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Decreased Activity Clozapine 25 And Dizziness 100mg Zenith Drug Level Increased Goldline PS Zenith Goldline Fall Provigil 100mg Gait Disturbance Cephalon SS Cephalon Hypoxia Haloperidol C Sedation Quetiapine C Tachycardia Divalproex C Gabapentin C Benztropine C Furosemide C Potassium C Docusate Na C 22-Feb-2006 08:30 AM Page: 1746 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/20/02ISR Number: 3964674-1Report Type:Expedited (15-DaCompany Report #C2002-1514.01 Age:84 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine Tablets 25 Respiratory Failure Professional Mg Mylan PS Mylan ORAL 25MG, QD, Other ORAL Doxycycline C Hydrocodone/Apap C Levothyroxine C Date:08/20/02ISR Number: 3964677-7Report Type:Expedited (15-DaCompany Report #C2002-1866.01 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Health Clozapine Tablets Professional 100 Mg Mylan PS ORAL 700MG, QD, Other ORAL Fluoxetine C Date:08/20/02ISR Number: 3965206-4Report Type:Expedited (15-DaCompany Report #PHEH2002US06853 Age:89 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Pain Upper Health Clozaril(Clozapine) Cardiac Failure Professional Tablet PS ORAL ORAL Circulatory Collapse Vomiting Date:08/20/02ISR Number: 3965327-6Report Type:Expedited (15-DaCompany Report #PHFR2002GB02556 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Medication Error Foreign Clozaril Initial or Prolonged Overdose Study (Clozapine)(Clozapin Sedation Health e) Tablet PS 400 MG , Professional ONCE/SINGLE; Other SEE IMAGE Date:08/20/02ISR Number: 3965916-9Report Type:Expedited (15-DaCompany Report #PHNU2002DE01275 Age:6 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Exposure During Foreign Leponex Pregnancy Health /Clozaril(Clozapine) Growth Retardation Professional (Clozapine) PS TRANSPLACENTAL TRANSPLACENTA Maternal Drugs Affecting Other L Foetus Date:08/21/02ISR Number: 3965858-9Report Type:Expedited (15-DaCompany Report #2002003203 Age:24 YR Gender:Male I/FU:F Outcome PT Hospitalization - Abnormal Behaviour Initial or Prolonged Confusional State Disability Convulsion Other Fall 22-Feb-2006 08:30 AM Page: 1747 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Loss Of Consciousness Memory Impairment Palpitations Report Source Product Role Manufacturer Route Dose Duration Social Avoidant Behaviour Foreign Sertraline Consumer (Sertraline) PS ORAL 200 MG (DAILY), ORAL Haloperidol (Haloperidol) SS Clozapine (Clozapine) SS Deptran (Doxepin Hydrochloride) SS 75 MG (DAILY) Oxycodone (Oxycodone) C Date:08/21/02ISR Number: 3965895-4Report Type:Expedited (15-DaCompany Report #PHBS2002AU09436 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Foot Fracture Foreign Clozaril (Clozapine) Health Tablet PS ORAL ORAL Professional Other Date:08/21/02ISR Number: 3965901-7Report Type:Expedited (15-DaCompany Report #PHBS2002CA08914 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Constipation Foreign Clozaril(Clozapine) Hepatic Steatosis Study Tablet PS ORAL 200 MG/D, Weight Increased Health ORAL Professional Celexa C Other Date:08/21/02ISR Number: 3965903-0Report Type:Expedited (15-DaCompany Report #PHBS2002AU09460 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril(Clozapine) Health Tablet PS ORAL ORAL Professional Other Date:08/21/02ISR Number: 3965904-2Report Type:Expedited (15-DaCompany Report #PHBS2002AU09362 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Autoimmune Foreign Clozaril(Clozapine) Thrombocytopenia Study Unknown PS 300 MG/D Hepatitis C Health Platelet Count Abnormal Professional Other 22-Feb-2006 08:30 AM Page: 1748 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/21/02ISR Number: 3966318-1Report Type:Expedited (15-DaCompany Report #C2002-2433.01 Age:88 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pharmaceutical Product Health Clozapine Tablets 25 Complaint Professional Mg PS Mylan ORAL 125 MG QD, Other ORAL Date:08/21/02ISR Number: 3966376-4Report Type:Expedited (15-DaCompany Report #PHFR2002GB02465 Age:30 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Localised Infection Foreign Clozaril (Clozapine) Pemphigoid Study Tablet PS ORAL 350MG/DAY, Health ORAL Professional Amitriptyline Other (Amitriptyline) C Depo Provera C Date:08/21/02ISR Number: 3966593-3Report Type:Expedited (15-DaCompany Report #PHBS2002AU09520 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Body Temperature Foreign Clozaril (Clozapine) PS 600 MG/D Increased Study Lymphocyte Morphology Other Abnormal Mobility Decreased Neutropenia Pain Viral Infection Date:08/21/02ISR Number: 3966594-5Report Type:Expedited (15-DaCompany Report #PHFR2002GB02414 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Foreign Clozaril (Clozapine) Increased Health Tablet PS ORAL 400 MG/DAY, Aspartate Professional ORAL Aminotransferase Other Venlafaxine Increased (Venlafaxine) C Eosinophilia Mean Cell Haemoglobin Increased Mean Cell Volume Increased Date:08/21/02ISR Number: 3966600-8Report Type:Expedited (15-DaCompany Report #PHBS2002CL09816 Age:34 YR Gender:Male I/FU:I Outcome PT Hospitalization - Abnormal Behaviour Initial or Prolonged Anxiety Balance Disorder Blood Triglycerides Increased Musculoskeletal Stiffness Photosensitivity Reaction 22-Feb-2006 08:30 AM Page: 1749 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tinnitus Report Source Product Role Manufacturer Route Dose Duration Foreign Leponex (Clozapine) Consumer Tablet PS ORAL SEE IMAGE Other Crismol (Ipratropium Bromide, Fenoterol Hydrobromide) C Valcote C Date:08/21/02ISR Number: 3966601-XReport Type:Expedited (15-DaCompany Report #PHBS2002AU09761 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Foreign Clozaril(Clozapine) Initial or Prolonged Drug Level Increased Study Tablet PS ORAL SEE IMAGE Mental Impairment Health Professional Other Date:08/21/02ISR Number: 3966602-1Report Type:Expedited (15-DaCompany Report #PHBS2002AU09759 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiac Disorder Foreign Clozaril (Clozapine) Ejection Fraction Health Tablet PS ORAL 400 MG/DAY, Decreased Professional ORAL Other Date:08/21/02ISR Number: 3966607-0Report Type:Expedited (15-DaCompany Report #PHFR2002IE02544 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Epilepsy Foreign Clozaril (Clozapine) Study Tablet PS ORAL ORAL Health Professional Other Date:08/22/02ISR Number: 3966841-XReport Type:Expedited (15-DaCompany Report #PHFR2002GB02293 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Foreign Clozaril(Clozapine) Initial or Prolonged Pneumonia Health Tablet PS ORAL 125MG/DAY, Other Professional ORAL Other Date:08/22/02ISR Number: 3966843-3Report Type:Expedited (15-DaCompany Report #PHBS2002CA07953 Age:40 YR Gender:Male I/FU:F Outcome PT Other Hypogammaglobulinaemia Immune System Disorder Leukopenia Lymphocyte Count 22-Feb-2006 08:30 AM Page: 1750 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Decreased Neutropenia Pneumonia Report Source Product Role Manufacturer Route Dose Duration Foreign Clozaril Health (Clozapine) Tablet PS ORAL ORAL Professional Clonazepam C Other Date:08/22/02ISR Number: 3966959-1Report Type:Expedited (15-DaCompany Report #PHFR2002IE02533 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Pressure Increased Foreign Clozaril (Clozapine) Norepinephrine Increased Study Tablet PS ORAL 325 MG/DAY, Health ORAL Professional Other Date:08/22/02ISR Number: 3966966-9Report Type:Expedited (15-DaCompany Report #PHNU2002DE02569 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukocytosis Foreign Leponex / Clozaril Lymphopenia Health (Clozapine) Neoplasm Malignant Professional (Clozapine) Tablet PS ORAL 175 MG/DAY, Neutrophilia Other ORAL Date:08/22/02ISR Number: 3966976-1Report Type:Expedited (15-DaCompany Report #C2002-2235.01 Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Malignant Melanoma Health Clozapine Tablets 25 Neoplasm Malignant Professional Mg Mylan PS Mylan ORAL 75 MG QAM, 75 Other MG QHS, ORAL Clozapine Tablets 100 Mg Mylan SS Mylan ORAL 100 MG QAM, 100 MG QHS, ORAL Date:08/22/02ISR Number: 3966978-5Report Type:Expedited (15-DaCompany Report #02-08-0709 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 75 MG QD ORAL Date:08/22/02ISR Number: 3966980-3Report Type:Expedited (15-DaCompany Report #02-08-0708 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Death Dehydration Health Professional 22-Feb-2006 08:30 AM Page: 1751 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Product Role Manufacturer Route Dose Duration Clozapine - Ivax Pharmaceuticals, Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 100-400 MG QD ORAL Date:08/22/02ISR Number: 3967312-7Report Type:Expedited (15-DaCompany Report #PHFR2002GB02483 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Foreign Clozaril (Clozapine) Initial or Prolonged Inadequate Control Study Tablet PS ORAL 500 MG/DAY, Diabetic Coma Health ORAL Professional Fluoxetine Other (Fluoxetine) C Date:08/22/02ISR Number: 3967313-9Report Type:Expedited (15-DaCompany Report #PHBS2002AU09129 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Acquired Cardiac Septal Foreign Clozaril (Clozapine) Defect Health Tablet PS ORAL ORAL Hypertrophy Professional Ventricular Hypertrophy Other Date:08/22/02ISR Number: 3967314-0Report Type:Expedited (15-DaCompany Report #PHFR2002IE02487 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Foreign Clozaril (Clozapine) Diabetes Mellitus Study Tablet PS ORAL 525 MG/DAY, Health ORAL Professional Chlorpromazine Other (Chlorpromazine) C Antihypertensives C Date:08/22/02ISR Number: 3967341-3Report Type:Expedited (15-DaCompany Report #PHBS2002NZ08926 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril (Clozapine) Weight Increased Health Tablet PS ORAL 300 MG/D, Professional ORAL Other Date:08/23/02ISR Number: 3967216-XReport Type:Expedited (15-DaCompany Report #GB9147215AUG2002 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Minocin Medication Error Professional (Minocycline, Unspec) PS UNSTATED 22-Feb-2006 08:30 AM Page: 1752 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Clozaril (Clozapine, , 0) SS Valproate Sodiun (Valproate Sodium) C Seroxat (Paroxetine Hydrochloride) C Trimethoprim (Trimethoprim) C Date:08/23/02ISR Number: 3967417-0Report Type:Expedited (15-DaCompany Report #PHEH2002US06984 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Cancer Health Clozaril (Clozapine) Pharyngitis Professional Tablet PS ORAL 225 MG, QHS, ORAL Kytril (Granisetron) C Compazine (Prochlorperazine Edisylate) C Decadron C Date:08/23/02ISR Number: 3967424-8Report Type:Expedited (15-DaCompany Report #PHEH2002US03254 Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hodgkin'S Disease Health Clozaril (Clozapine) Professional Tablet PS ORAL 175 MG, QD, ORAL Cogentin (Benzatropine Mesilate) C Date:08/26/02ISR Number: 3967513-8Report Type:Expedited (15-DaCompany Report #PHEH2002US06570 Age:72 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lymphoma Health Clozaril (Clozapine) Other Nasal Cavity Cancer Professional Tablet PS ORAL 250MG ORAL Parkinson'S Disease Hytrin (Terazosin Squamous Cell Carcinoma Hydrochloride) C Depakote (Valproate Semisodium) C Wellbutrin (Bupropion Hydrochloride) C Sinemet C Date:08/26/02ISR Number: 3967606-5Report Type:Expedited (15-DaCompany Report #PHFR2002GB02218 Age: Gender:Male I/FU:I Outcome PT Life-Threatening Haemoglobin Decreased Hospitalization - Haemolytic Anaemia Initial or Prolonged Medication Error Pneumonia Klebsiella Pneumothorax 22-Feb-2006 08:30 AM Page: 1753 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sepsis Report Source Product Role Manufacturer Route Dose Duration Foreign Clozaril (Clozapine) Health Tablet PS ORAL 450 MG, Professional ONCE/SINGLE, Other ORAL Quetiapine (Quetiapine) C Date:08/26/02ISR Number: 3967757-5Report Type:Expedited (15-DaCompany Report #PHFR2002GB02670 Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Transient Ischaemic Foreign Clozaril (Clozapine) Attack Health Tablet PS ORAL 750 MG/DAY, Professional ORAL Other Date:08/26/02ISR Number: 3967758-7Report Type:Expedited (15-DaCompany Report #PHBS2002AU09638 Age:19 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Discomfort Foreign Clozaril(Clozapine) PS Initial or Prolonged Dizziness Health Electrocardiogram Qt Professional Prolonged Other Date:08/26/02ISR Number: 3967759-9Report Type:Expedited (15-DaCompany Report #PHBS2002CO09479 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acute Respiratory Failure Foreign Leponex Initial or Prolonged Leukocytosis Health (Clozapine)Tablet PS ORAL 200 MG/D, Neutrophilia Professional ORAL Other Lorazepam C Valproate Sodium C Levomepromazine C Date:08/26/02ISR Number: 3967972-0Report Type:Expedited (15-DaCompany Report #PHBS2002AU09877 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Clozaril (Clozapine) Cardiomyopathy Study Tablet PS ORAL 200 MG/D, Neuroleptic Malignant Health ORAL Syndrome Professional Olanzapine Other (Olanzapine) C Epilium C Efexor (Venlafaxine Hydrochloride) C 22-Feb-2006 08:30 AM Page: 1754 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/26/02ISR Number: 3968040-4Report Type:Expedited (15-DaCompany Report #PHEH2002US07350 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatitis Health Clozaril PS Professional Date:08/26/02ISR Number: 3968041-6Report Type:Expedited (15-DaCompany Report #PHEH2002US07336 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatitis C Health Clozaril PS ORAL ORAL Professional Date:08/27/02ISR Number: 3966631-8Report Type:Expedited (15-DaCompany Report #C2002-2152.01 Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional 100 Mg Mylan PS ORAL 100MG BID, Other ORAL Date:08/27/02ISR Number: 3966632-XReport Type:Expedited (15-DaCompany Report #C2002-2151.01 Age:49 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Neoplasm Malignant Health Clozapine Tablets Metastases To Pancreas Professional 100 Mg Mylan PS ORAL 25MG QD Pneumonia Other TITRATED UP TO 250MG QD, ORAL Albuterol C Clonazepam C Epoetin C Fluphenazine C Furosemide C Gatifloxacin C Megesterol Acetate C Morphine C Oxycodone C Pantoprazole C Potassium C Risperidone C Senna S C Warfarin C Zolpidem C Nicotine Patch C Date:08/27/02ISR Number: 3966633-1Report Type:Expedited (15-DaCompany Report #C2002-2234.01 Age:85 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death General Physical Health Health Clozapine Tablets 25 Deterioration Professional Mg Mylan PS Mylan ORAL 25 MG QD, Other ORAL Citalopram C Donepezil C Glimepiride C 22-Feb-2006 08:30 AM Page: 1755 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lorazepam C Ramipril C Risperidone C Multivitamin C Date:08/27/02ISR Number: 3968292-0Report Type:Expedited (15-DaCompany Report #B0277136A Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Foreign Eskalith Initial or Prolonged Cerebral Atrophy Literature (Formulation Drug Interaction Health Unknown) (Lithium Electroencephalogram Professional Carbonate) PS UNKNOWN UNKNOWN Abnormal Carbamazepine Fall (Formulation Muscle Twitching Unknown) Tremor (Carbamazepine) SS UNKNOWN UNKNOWN 10 DAY Clozapine (Formulation Unknown) (Clozapine) SS UNKNOWN UNKNOWN Date:08/27/02ISR Number: 3968293-2Report Type:Expedited (15-DaCompany Report #B0276937A Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Foreign Eskalith Initial or Prolonged Alanine Aminotransferase Literature (Formulation Increased Health Unknown) (Lithium Drug Interaction Professional Carbonate) PS Red Blood Cell Count Carbamazepine Increased (Formulation Tremor Unknown) (Carbamazepine) SS UNKNOWN UNKNOWN 13 DAY Clozapine (Formulation Unknown) (Clozapine) SS UNKNOWN Date:08/28/02ISR Number: 3969364-7Report Type:Expedited (15-DaCompany Report #PHBS2002AU08809 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Gastric Perforation Foreign Clozaril (Clozapine Initial or Prolonged Oesophagitis Health Tablet PS ORAL 350 MG/D, Stomach Discomfort Professional ORAL Vomiting Other Date:08/28/02ISR Number: 3969499-9Report Type:Expedited (15-DaCompany Report #PHNU2002DE02650 Age:56 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Exposure Foreign Leponex / Clozaril Initial or Prolonged Eosinophilia Health (Clozapine) Medication Error Professional (Clozapine) Tablet PS ORAL 150 MG, Other ONCE/SINGLE, ORAL Lithium (Lithium) Tablet C 22-Feb-2006 08:30 AM Page: 1756 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Remergil (Mirtazapine) Tablet C Date:08/30/02ISR Number: 3969486-0Report Type:Expedited (15-DaCompany Report #C2002-2255.01 Age:74 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Disease Recurrence Health Clozapine Tablets 25 Hypotension Professional Mg PS Mylan ORAL 50MG QD, ORAL Mental Status Changes Other Clozapine Tablets Urinary Tract Infection 100mg SS Mylan ORAL 200MG QD, ORAL Ciprofloxacin/Hydroc ortisone Otic C Fluoxetine C Furosemide C Lactulose C Levofloxacin C Levothyroxine C Oxybutynin (5mg) C Potassium Chloride (10meq) C Promethazine (25mg) C Sulfamethoxazole/Tri methoprim C Date:08/30/02ISR Number: 3969493-8Report Type:Expedited (15-DaCompany Report #2002UW11582 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Other Seroquel PS ORAL 100 MG QD PO Initial or Prolonged Clozapine SS 25 TO 50 MG DAILY Depakote C 500 MG BID Date:09/03/02ISR Number: 3969571-3Report Type:Expedited (15-DaCompany Report #02-08-0707 Age:41 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Atherosclerosis Health Clozapine - Ivax Hypertension Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 300MG HS ORAL Date:09/03/02ISR Number: 3969572-5Report Type:Expedited (15-DaCompany Report #02-07-0598 Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Health Clozapine - Ivax Lethargy Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL SEE IMAGE 22-Feb-2006 08:30 AM Page: 1757 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/03/02ISR Number: 3969573-7Report Type:Expedited (15-DaCompany Report #02-07-0667 Age:55 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Health Clozapine - Ivax Initial or Prolonged Hip Fracture Professional Pharmaceuticals, Required Other Inc. Tablets PS Ivax Intervention to Pharmaceuticals, Prevent Permanent Inc. ORAL SEE IMAGE Impairment/Damage Prinivil SS 10MG QD Amaryl C Lescol C Vistaril C Date:09/03/02ISR Number: 3969574-9Report Type:Expedited (15-DaCompany Report #02-08-0706 Age:74 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Aspiration Health Clozapine - Ivax Hospitalization - Professional Pharmaceuticals, Initial or Prolonged Other Inc. Tablets PS Ivax Pharmaceuticals, Inc ORAL 75-100MG QD ORAL Date:09/03/02ISR Number: 3969575-0Report Type:Expedited (15-DaCompany Report #02-08-0745 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Self-Injury Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals ORAL 50-400MG QD ORAL Date:09/03/02ISR Number: 3969915-2Report Type:Direct Company Report #CTU 175500 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Clozapine PS 150MG AM, Initial or Prolonged Pharmaceutical Product 4PM, 200MG Other Complaint HS Date:09/03/02ISR Number: 3971634-3Report Type:Expedited (15-DaCompany Report #JACGER2000000222 Age:18 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutropenia Foreign Haldol PS ORAL MG, DAILY Initial or Prolonged Health ORAL Professional Leponex (Clozapine) SS ORAL MG, DAILY, ORAL Ciatyl-Z (Zuclopenthixol Hydrochloride) C Taxilan (Perazine) C Tavor (Lorazepam) C Sulp (Sulpiride) C Risperdal (Tablet) (Risperidone) C Akineton (Biperiden 22-Feb-2006 08:30 AM Page: 1758 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride) C Date:09/05/02ISR Number: 3971880-9Report Type:Expedited (15-DaCompany Report #PHEH2002US06391 Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Health Clozaril (Clozapine) Initial or Prolonged Phosphokinase Increased Professional Tablet, 10mg PS ORAL 100 MG, BID, Chest Pain ORAL Diabetes Mellitus Cogentin Dyspnoea (Benzatropine Electrocardiogram Mesilate) C Abnormal Ddavp(Desmopressin) C Glucose Urine Present Depo Provera C Hyperglycaemia Clindets Tachycardia (Clindamycin Phosphate) C Date:09/05/02ISR Number: 3972243-2Report Type:Expedited (15-DaCompany Report #PHFR2002GB02194 Age:31 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Tuberculosis Foreign Clozaril (Clozapine) Initial or Prolonged Health Tablet PS ORAL 550 Other Professional MG/DAY,ORAL Other Fluoxetine (Fluoxetine) C Zantac C Rifater Tablet C Ethambutol (Ethambutol) C Pyridoxine (Pyridoxine) C Leflunomide (Leflunomide) C Date:09/05/02ISR Number: 3972245-6Report Type:Expedited (15-DaCompany Report #PHFR2002GB01975 Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Lung Abscess Foreign Clozaril (Clozapine) Initial or Prolonged Health Tablet PS ORAL 600MG/DAY,ORA Professional L Other Procyclidine (Procyclidine) C Co-Codamol (Paracetamol) C Prozac (Fluoxetine Hydrochloride) C Date:09/05/02ISR Number: 3972252-3Report Type:Expedited (15-DaCompany Report #PHBS2002DE10000 Age: Gender: I/FU:I Outcome PT Report Source Hospitalization - Confusional State Foreign Initial or Prolonged Disorientation Literature Medication Error Health Professional 22-Feb-2006 08:30 AM Page: 1759 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Product Role Manufacturer Route Dose Duration Leponex (Clozapine) Tablet PS ORAL 100 MG/D, ORAL Date:09/05/02ISR Number: 3972253-5Report Type:Expedited (15-DaCompany Report #PHNU2002DE02876 Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coma Foreign Leponex / Clozaril Hospitalization - Overdose Consumer (Clozapine)(Clozapin Initial or Prolonged Pneumonia Other e) Tablet, 100mg PS ORAL SEE IMAGE Other Renal Impairment Antibiotics C Suicide Attempt Vomiting Date:09/05/02ISR Number: 3972275-4Report Type:Expedited (15-DaCompany Report #PHBS2002AU10139 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Ketoacidosis Foreign Clozaril (Clozapine) Initial or Prolonged Health Tablet PS ORAL 600 MG/D, Professional ORAL Other Date:09/05/02ISR Number: 3972567-9Report Type:Direct Company Report #CTU 175815 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blunted Affect Clozapine 100mg PS ORAL 2TT QAM AND Depression 3TTT QHS PO Disturbance In Attention Drug Effect Decreased Pharmaceutical Product Complaint Somnolence Date:09/05/02ISR Number: 3972651-XReport Type:Expedited (15-DaCompany Report #PHBS2002CA10170 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Clozaril (Clozapine) Study Tablet PS ORAL ORAL Health Professional Other Date:09/05/02ISR Number: 3972954-9Report Type:Expedited (15-DaCompany Report #PHNU2002DE02850 Age: Gender:Female I/FU:I Outcome PT Report Source Other Dystonia Foreign Health Professional 22-Feb-2006 08:30 AM Page: 1760 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Product Role Manufacturer Route Dose Duration Leponex / Clozaril PS ORAL ORAL Date:09/05/02ISR Number: 3972957-4Report Type:Expedited (15-DaCompany Report #PHFR2002GB02368 Age:31 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Appendicitis Perforated Foreign Clozaril Initial or Prolonged Postoperative Infection Health (Clozapine) PS ORAL 300 MG/NOCTE, Professional ORAL Other Date:09/05/02ISR Number: 3972958-6Report Type:Expedited (15-DaCompany Report #PHFR2002GB02438 Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Clozaril Study (Clozapine) PS ORAL 75MG/DAY, Health ORAL Professional Amisulpride C Other Date:09/05/02ISR Number: 3972962-8Report Type:Expedited (15-DaCompany Report #PHBS2002NZ10041 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Clozaril (Clozapine) Other Health Tablet PS ORAL ORAL Professional Other Date:09/05/02ISR Number: 3972963-XReport Type:Expedited (15-DaCompany Report #PHBS2002CA08102 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Foreign Clozaril (Clozapine) Coma Study Tablet PS ORAL ORAL Heat Stroke Health Effexor - Slow Locked-In Syndrome Professional Release (Venlafaxine Myelitis Other Hydrochloride) C Neuroleptic Malignant Ditropan Syndrome (Oxybutynin) C Pyrexia Norvasc C Renal Impairment Premarin (Estrogens Rhabdomyolysis Conjugated) C Senokot Tablet C Losec (Omeprazole) C .. C 22-Feb-2006 08:30 AM Page: 1761 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/05/02ISR Number: 3973027-1Report Type:Expedited (15-DaCompany Report #PHNU2002DE02855 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Foreign Leponex / Clozaril Abnormal Health (Clozapine) Ventricular Extrasystoles Professional (Clozapine) Tablet PS ORAL 200& 100 Other MG/DAY, ORAL Seroquel (Quetiapine Fumarate) Film-Coated Tablet C Haldol "Janssen" Tablet C Date:09/05/02ISR Number: 3973080-5Report Type:Expedited (15-DaCompany Report #PHNU2002DE02876 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coma Foreign Leponex / Clozaril Hospitalization - Intentional Self-Injury Consumer (Clozapine)(Clozapin Initial or Prolonged Overdose e) Tablet PS ORAL ONCE/SINGLE; Other Pneumonia 100 MG, TID; Renal Impairment 50 MG, TID Suicide Attempt ORAL Vomiting Antibiotics C Date:09/05/02ISR Number: 3973129-XReport Type:Expedited (15-DaCompany Report #PHFR2002GB01708 Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril (Clozapine) Insulin-Dependent Health Tablet PS ORAL 200 MG, BID, Diabetic Ketoacidosis Professional ORAL Malaise Other Overweight Date:09/05/02ISR Number: 3973143-4Report Type:Expedited (15-DaCompany Report #PHFR2002IE02289 Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cholelithiasis Foreign Clozaril (Clozapine) PS ORAL 350 MG/DAY, Health ORAL Professional Other Date:09/05/02ISR Number: 3973194-XReport Type:Expedited (15-DaCompany Report #PHFR2002GB02592 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Abnormal Foreign Clozaril (Clozapine) Initial or Prolonged Haematemesis Study Tablet PS ORAL ORAL; 50 MG Other Haemorrhage Health QD Peptic Ulcer Haemorrhage Professional Aspirine C Pulse Abnormal Other Haloperidol C White Blood Cell Count Procyclidine Increased (Procyclidine) C Diazepam C 22-Feb-2006 08:30 AM Page: 1762 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/05/02ISR Number: 3973387-1Report Type:Expedited (15-DaCompany Report #C2002-2754.01 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 400MG Q AM, Other 400MG Q HS, ORAL Benztropine Mesylate C Ferrous Sulfate C Fluoxetine Hcl C Date:09/05/02ISR Number: 3973673-5Report Type:Expedited (15-DaCompany Report #PHBS2002AU09761 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Foreign Clozaril (Clozapine) Initial or Prolonged Drug Level Increased Study Tablet PS ORAL SEE IMAGE Mental Impairment Health Professional Other Date:09/06/02ISR Number: 3973161-6Report Type:Expedited (15-DaCompany Report #EMADSS2002005201 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Creatine Foreign Haldol (Unspecified) Hospitalization - Phosphokinase Increased Health (Haloperidol) PS Initial or Prolonged Chills Professional Leponex (Clozapine) SS Condition Aggravated Eunerpan (Melperone Delirium Hydrochloride) C Extrapyramidal Disorder Neuroleptic Malignant Syndrome Pneumonia Rhabdomyolysis Date:09/09/02ISR Number: 3973019-2Report Type:Direct Company Report #CTU 175905 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Anoxic Encephalopathy Clozaril Hospitalization - Apallic Syndrome (Clozapine)-Novartis PS Novartis SEE DOSAGE Initial or Prolonged Cardio-Respiratory Arrest CHART Disability Coma Atenolol C Convulsion Ketoconazole C Sinus Arrhythmia Seroquel C Wellbutrin C Date:09/09/02ISR Number: 3974026-6Report Type:Expedited (15-DaCompany Report #PHBS2002CA10243 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cognitive Disorder Foreign Clozaril (Clozapine) Initial or Prolonged Study Tablet PS ORAL ORAL Health Professional Other 22-Feb-2006 08:30 AM Page: 1763 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/09/02ISR Number: 3974157-0Report Type:Expedited (15-DaCompany Report #PHBS2002AU07708 Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Foreign Clozaril (Clozapine) Hospitalization - Pneumonia Aspiration Study Tablet PS ORAL 450 MG/DAY, Initial or Prolonged Health ORAL Disability Professional Aspirine C Other Efexor (Venlafaxine Hydrochloride) C Date:09/09/02ISR Number: 3974160-0Report Type:Expedited (15-DaCompany Report #PHBS2002CA04386 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Haemoglobin Increased Foreign Clozaril(Clozapine) Medication Error Health Tablet PS ORAL ORAL Respiratory Arrest Professional Moduret Tablet C Other Colace Tablet C Isoptin (Verapamil Hydrochloride) Tablet C Combivent (Ipratropium Bromide, Salbutamol Sulfate) C Date:09/09/02ISR Number: 3974239-3Report Type:Expedited (15-DaCompany Report #PHEH2002US05957 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Health Clozaril (Clozapine) Hepatitis C Professional Tablet PS ORAL 550 MG, QD, Leukopenia ORAL Thrombocytopenia Zoloft (Sertraline Hydrochloride) C Date:09/09/02ISR Number: 3974332-5Report Type:Expedited (15-DaCompany Report #HQ3252816JUL2002 Age:58 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Fall Health Effexor Xr PS ORAL 1 MG 4X PER 1 Parkinson'S Disease Professional DAY, ORAL Clozapine (Clozapine, Unspec) SS ORAL 400-500MG/DAY , ORAL Betaseron (Albumin Human/Glucose/Interf eron Beta) C Diovan Hct (Hydrochlorothiazide /Valsartan) C Humalog (Insulin Lispro) C Protonix (Pantoprazole) C Tamoxifen (Tamoxifen) C Verapamil 22-Feb-2006 08:30 AM Page: 1764 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Verapamil) C Insulin Human (Insulin Human) C Date:09/09/02ISR Number: 3974333-7Report Type:Expedited (15-DaCompany Report #HQ3993229AUG2002 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Health Ativan PS ORAL 1 MG 4X PER 1 Renal Cell Carcinoma Professional DAY, ORAL Stage Unspecified Clozapine Tremor (Clozapine, ) SS OROPHARINGEAL 400-500MG/DAY , ORAL SEE IMAGE Haldol (Haloperidol) C Paxil (Paroxetine Hydrochloride) C Date:09/10/02ISR Number: 3973913-2Report Type:Expedited (15-DaCompany Report #02-08-0755 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Choking Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 150-300MG QD ORAL Date:09/10/02ISR Number: 3973915-6Report Type:Expedited (15-DaCompany Report #02-08-0756 Age:81 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine Tablets - Other Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 25-300 MG QD ORAL Date:09/10/02ISR Number: 3973918-1Report Type:Expedited (15-DaCompany Report #02-08-0758 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Neoplasm Malignant Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 200-600 MG QD ORAL 22-Feb-2006 08:30 AM Page: 1765 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/10/02ISR Number: 3973925-9Report Type:Expedited (15-DaCompany Report #02-08-0761 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine PS ORAL 200-300MG QD Professional ORAL Other Date:09/10/02ISR Number: 3973927-2Report Type:Expedited (15-DaCompany Report #02-08-0767 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Neoplasm Malignant Health Clozapine PS ORAL 50-400MG QD Professional ORAL Other Date:09/10/02ISR Number: 3973929-6Report Type:Expedited (15-DaCompany Report #02-08-0768 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine PS ORAL 300MG QD ORAL Professional Other Date:09/10/02ISR Number: 3973931-4Report Type:Expedited (15-DaCompany Report #02-08-0769 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Thrombosis Health Clozapine PS ORAL 25MG QD PO Professional Other Date:09/11/02ISR Number: 3974211-3Report Type:Expedited (15-DaCompany Report #PHEH2002US07613 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Circulatory Collapse Health Clozaril (Clozapine) Initial or Prolonged Cognitive Disorder Professional Tablet PS ORAL 300 MG, BID, Drug Level Increased ORAL Fall Synthroid C Muscular Weakness Toprol Xl Tooth Abscess (Metoprolol Succinate) C Protonix C Pharmacia Colace C Anafranil C Niacin C Date:09/11/02ISR Number: 3974446-XReport Type:Expedited (15-DaCompany Report #PHBS2002NZ08500 Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Cholesterol Foreign Clozaril(Clozapine) PS ORAL 300 MG/DAY, Increased Health ORAL Diabetes Mellitus Professional Hyperlipidaemia Other 22-Feb-2006 08:30 AM Page: 1766 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/11/02ISR Number: 3974447-1Report Type:Expedited (15-DaCompany Report #98HQ-10118 Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Foreign Rifampicin(Rifampici Drug Interaction Literature n) PS 600 MG/DAY Drug Level Decreased Health Clozapine(Clozapine) SS SEE IMAGE Drug Withdrawal Syndrome Professional Isoniazid Hepatitis C Other (Isoniazid) C Insomnia Pyrazinamide Physical Assault (Pyrazinamide) C Restlessness Schizophrenia Date:09/11/02ISR Number: 3974470-7Report Type:Expedited (15-DaCompany Report #PHBS2002CA04386 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Haemoglobin Increased Foreign Clozaril Pneumonia Health (Clozapine) PS ORAL ORAL Respiratory Arrest Professional Moduret Tablet C Sleep Apnoea Syndrome Other Colace Tablet C Treatment Noncompliance Isoptin (Verapamil Hydrochloride) Tablet C Combivent (Ipratropium Bromide, Salbutamol Sulfate) C Date:09/12/02ISR Number: 3974425-2Report Type:Expedited (15-DaCompany Report #WAES 0209USA00839 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Prinivil PS Merck & Co., Inc ORAL Initial or Prolonged Hip Fracture Clozapine SS ORAL Other Clozapine SS ORAL Amaryl C 1 YR Lescol C 1 YR Vistaril C Date:09/12/02ISR Number: 3975246-7Report Type:Expedited (15-DaCompany Report #PHBS2002DE06598 Age:33 YR Gender:Male I/FU:F Outcome PT Other Aggression Chest X-Ray Abnormal Condition Aggravated Drug Interaction Drug Level Decreased Feeling Abnormal Hepatitis C Insomnia Leukocytosis Malaise Mycobacterial Infection Pulmonary Cavitation Red Blood Cell Sedimentation Rate 22-Feb-2006 08:30 AM Page: 1767 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Increased Restlessness Throat Irritation Tuberculosis Report Source Product Role Manufacturer Route Dose Duration White Blood Cell Count Foreign Clozapine Increased Literature (Clozapine) PS 400 MG/DAY; Health SEE IMAGE Professional Rifampicin Other (Rifampicin) SS Isoniazid C Pyrazinamide C Date:09/12/02ISR Number: 3975248-0Report Type:Expedited (15-DaCompany Report #PHBS2002AU10139 Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Foreign Clozaril (Clozapine) Initial or Prolonged Diabetic Ketoacidosis Study Tablet PS ORAL 600 MG/D,ORAL Shock Health Professional Other Date:09/12/02ISR Number: 3975305-9Report Type:Expedited (15-DaCompany Report #PHBS2002CA08102 Age:54 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Foreign Clozaril (Clozapine) Cerebrovascular Accident Study Tablet PS ORAL ORAL Coma Health Effexor - Slow Heat Stroke Professional Release (Venlafaxine Locked-In Syndrome Other Hydrochloride) C Neuroleptic Malignant Ditropan Syndrome (Oxybutynin) C Pyrexia Norvasc C Renal Impairment Premarin (Estrogens Rhabdomyolysis Conjugated) C Senokot C Losec (Omeprazole) C Premarin (Estrogens Conjugated) C Date:09/12/02ISR Number: 3975311-4Report Type:Expedited (15-DaCompany Report #PHBS2002AU10249 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril (Clozapine) PS 375 MG/D Study Other Date:09/12/02ISR Number: 3975320-5Report Type:Expedited (15-DaCompany Report #PHBS2002BR10248 Age:25 YR Gender:Male I/FU:I Outcome PT Other Blindness Condition Aggravated Drug Ineffective Dysphagia Dysuria 22-Feb-2006 08:30 AM Page: 1768 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Ejaculation Disorder Weight Decreased Report Source Product Role Manufacturer Route Dose Duration Foreign Leponex (Clozapine) PS ORAL 800 MG/D, Consumer ORAL Other Estilazini Tablet C Date:09/12/02ISR Number: 3975566-6Report Type:Expedited (15-DaCompany Report #PHFR2002GB00852 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abnormal Behaviour Foreign Clozaril(Clozapine) Other Asthenia Study Tablet PS ORAL 700MG/DAY, C-Reactive Protein Health ORAL Increased Professional Valproate Sodium C Cardiac Arrest Other Sulpiride Confusional State (Sulpiride) C Dizziness Chlorpromazine Fall (Chlorpromazine) C Hepatic Failure Procyclidine Hypotension (Procyclidine) C Myocardial Infarction Nocturia Renal Failure Renal Tubular Necrosis White Blood Cell Count Increased Date:09/12/02ISR Number: 3975568-XReport Type:Expedited (15-DaCompany Report #PHBS2002AU09127 Age:49 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Ventricular Hypertrophy Foreign Clozaril (Clozapine) Health Tablet PS ORAL 200 MG, QHS, Professional ORAL Zoloft (Sertraline Hydrochloride) C Cogentin (Benzatropine Mesilate) C Date:09/12/02ISR Number: 3975572-1Report Type:Expedited (15-DaCompany Report #PHBS2002AU09126 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dilatation Ventricular Foreign Clozaril(Clozapine) Sinus Tachycardia Health Tablet PS ORAL 500 MG, QD, Ventricular Hypertrophy Professional ORAL Date:09/12/02ISR Number: 3975575-7Report Type:Expedited (15-DaCompany Report #PHBS2002AU09128 Age:53 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diastolic Dysfunction Foreign Clozaril (Clozapine) Ventricular Hypertrophy Health Tablet PS ORAL ORAL Professional 22-Feb-2006 08:30 AM Page: 1769 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/12/02ISR Number: 3975580-0Report Type:Expedited (15-DaCompany Report #PHBS2002AU09129 Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dilatation Ventricular Foreign Clozaril(Clozapine) Echocardiogram Abnormal Health Tablet PS ORAL ORAL Electrocardiogram T Wave Professional Losec (Omeprazole) C Abnormal Cisapride Hyperglycaemia (Cisapride) C Sinus Tachycardia Zoloft (Sertraline Ventricular Hypertrophy Hydrochloride) C Zocor "Dieckmann" C Date:09/12/02ISR Number: 3975589-7Report Type:Expedited (15-DaCompany Report #PHBS2002AU09824 Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Fall Foreign Clozaril (Clozapine) Troponin I Increased Study Tablet PS ORAL 300 MG, QD, Health ORAL Professional Date:09/12/02ISR Number: 3975640-4Report Type:Expedited (15-DaCompany Report #PHEH2002US07839 Age:89 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coma Health Clozaril (Clozapine) Other Convulsion Professional Tablet PS ORAL 25 MG/DAY, ORAL 365 DAY Date:09/12/02ISR Number: 3975648-9Report Type:Expedited (15-DaCompany Report #PHEH2002US05957 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Health Clozaril (Clozapine) Fatigue Professional Tablet PS ORAL 550 MG, QD, Hepatitis C ORAL; 350 MG, Leukopenia QD, ORAL Thrombocytopenia Zoloft (Sertraline White Blood Cell Count Hydrochloride) C Decreased Date:09/12/02ISR Number: 3975912-3Report Type:Expedited (15-DaCompany Report #C2002-2783.01 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Consumer Clozapine Tablets Health 100mg Mylan PS Mylan ORAL 100MG Q AM, Professional 200MG Q HS, Other ORAL Albuterol C Amiodarone C Atorvastatin C Furosemide C Hydrocodone Bitartrate & Acetaminophen C Potassium C 22-Feb-2006 08:30 AM Page: 1770 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sulfamethoxazole & Trimethoprim C Warfarin Sodium C Date:09/12/02ISR Number: 3975914-7Report Type:Expedited (15-DaCompany Report #C2002-2234.01 Age:85 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 25 MG QD ORAL Other Celexa 20 Mg Forest SS Forest ORAL 20 MG Q AM, ORAL Citalopram C Donepezil C Glimepiride C Lorazepam C Multivitamin C Ramipril C Risperidone C Levothyroxine C Date:09/12/02ISR Number: 3975920-2Report Type:Expedited (15-DaCompany Report #C2002-2490.01 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 25MG Q AM, 75 Other MG Q HS ORAL Furosemide C Propranolol Hcl C Valproic Acid C Venlafaxine Xr C Date:09/13/02ISR Number: 3975652-0Report Type:Expedited (15-DaCompany Report #PHFR2002GB02848 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetic Ketoacidosis Foreign Clozaril(Clozapine)( Health Clozapine)Tablet PS ORAL 350MG/DAY, Professional ORAL Other Omeprazole (Omeprazole) C Date:09/13/02ISR Number: 3975654-4Report Type:Expedited (15-DaCompany Report #PHNU2002DE03017 Age:59 YR Gender:Female I/FU:I Outcome PT Other C-Reactive Protein Increased Hepatic Cirrhosis Hepatic Steatosis Hepatomegaly Hyperhidrosis Pyrexia Red Blood Cell Sedimentation Rate Increased 22-Feb-2006 08:30 AM Page: 1771 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Ultrasound Liver Abnormal Report Source Product Role Manufacturer Route Dose Duration Foreign Leponex/Clozaril Health Cloazpine) Professional (Clozapine)Tablet PS ORAL 250MG/DAY, Other ORAL Date:09/13/02ISR Number: 3975655-6Report Type:Expedited (15-DaCompany Report #PHNU2002DE02268 Age:72 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthma Foreign Leponex/Clozaril(Clo Health zapine)(Clozapine)Ta Professional blet PS ORAL SEE IMAGE, Other ORAL Oxazepam (Oxazepam) C Pantozol (Pantoprazole Sodium) C Euthyrox C Aricept(Donepezil Hydrochloride) C Date:09/13/02ISR Number: 3975811-7Report Type:Expedited (15-DaCompany Report #PHFR2002GB02293 Age:56 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Foreign Clozaril (Clozapine) Initial or Prolonged Pneumonia Health Tablet PS ORAL 125MG/DAY, Other Professional ORAL Other Date:09/13/02ISR Number: 3975813-0Report Type:Expedited (15-DaCompany Report #PHBS2002AU09124 Age:39 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dilatation Atrial Foreign Clozaril (Clozapine) Sinus Tachycardia Health Tablet PS ORAL 500 MG, QD, Ventricular Hypertrophy Professional ORAL Other Date:09/13/02ISR Number: 3975832-4Report Type:Expedited (15-DaCompany Report #PHFR2002GB02783 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Withdrawal Syndrome Foreign Clozaril (Clozapine) Thinking Abnormal Study (Clozapine) Tablet PS ORAL 100 MG DAY, Weight Decreased Health ORAL Professional Other 22-Feb-2006 08:30 AM Page: 1772 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/13/02ISR Number: 3975840-3Report Type:Expedited (15-DaCompany Report #PHNU2002DE01889 Age:63 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Foreign Leponex / Clozaril Bacterial Infection Health (Clozapine) Cardiac Arrest Professional (Clopazine) Tablet PS ORAL 125 MG/DAY, Coronary Artery Other ORAL Atherosclerosis Distraneurin Coronary Artery Stenosis (Clomethazole Drug Interaction Edisilate) SS ORAL ONCE/SINGLE, Erythema ORAL Eye Swelling Prothazin Faecaloma (Promethazine Gastrointestinal Disorder Hydrochloride) SS ORAL ONCE/SINGLE, Hepatic Congestion ORAL Hyperhidrosis Zyprexa (Olanzapine) C Hypersensitivity Acetylsalicylic Acid C Hypertensive Cardiomegaly Dipiperon Hypotension (Pipamperone) C Insomnia Tiapridex (Tiapride Left Ventricular Failure Hydrochloride) C Myocardial Fibrosis Myocarditis Pleural Effusion Psychotic Disorder Pulmonary Congestion Pulmonary Oedema Renal Disorder Restlessness Spleen Congestion Tachycardia Date:09/13/02ISR Number: 3975900-7Report Type:Expedited (15-DaCompany Report #D/96/00655/LEX Age:19 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Apallic Syndrome Foreign Leponex/Clozaril Hospitalization - Arrhythmia Literature (Clozapine) Initial or Prolonged Arthropathy Health (Clozapine) Tablet PS ORAL ORAL Disability Brain Oedema Professional Tavor (Lorazepam) Cardio-Respiratory Arrest Other Tablet SS ORAL ORAL Cerebral Ischaemia Drug Interaction Dysphagia Hypoxic Encephalopathy Intestinal Functional Disorder Medication Error Mental Impairment Movement Disorder Muscle Atrophy Pain Date:09/13/02ISR Number: 3976123-8Report Type:Expedited (15-DaCompany Report #PHEH2002US08005 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Death Cardiovascular Disorder Health Professional 22-Feb-2006 08:30 AM Page: 1773 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Company Representative Product Role Manufacturer Route Dose Duration Clozaril (Clozapine) Tablet PS 200 MG, QD Date:09/13/02ISR Number: 3976126-3Report Type:Expedited (15-DaCompany Report #PHEH2002US05574 Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Leukaemia Health Clozaril(Clozapine) Other Red Blood Cell Count Professional Tablet PS ORAL 100MG AM + Decreased 300 MG HS, Thrombocytopenia ORAL Benadryl C Divalproex Sodium (Valproate Semisodium) C Aciphex (Rabeprazole Sodium) C Date:09/13/02ISR Number: 3976201-3Report Type:Expedited (15-DaCompany Report #PHNU2002DE03041 Age:67 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aggression Foreign Leponex/Clozaril Life-Threatening Akathisia Consumer (Clozapine)(Clozapin Other Blood Creatine Other e) Tablet PS ORAL ORAL Phosphokinase Increased Haldol Cerebral Atrophy "Janssen"(Haloperido Colitis Ischaemic l) SS Coma Distraneurin(Clometh Computerised Tomogram iazole Abnormal Edisilate)Unknown SS Decubitus Ulcer Eunerpan (Melperone Delirium Hydrochloride) C Dementia Elobact (Cefuroxime Electroencephalogram Axetil) C Abnormal General Physical Health Deterioration Hypertonia Muscle Rigidity Muscle Spasms Neuroleptic Malignant Syndrome Oedema Oliguria Pain In Extremity Pleural Effusion Pneumonia Pyrexia Rhabdomyolysis Urosepsis 22-Feb-2006 08:30 AM Page: 1774 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/13/02ISR Number: 3976267-0Report Type:Expedited (15-DaCompany Report #PHBS2002NO10793 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Myocardial Foreign Leponex (Clozapine) Infarction Health Tablet PS ORAL ORAL Cardiac Failure Professional Other Date:09/16/02ISR Number: 3976762-4Report Type:Expedited (15-DaCompany Report #PHEH2002US08033 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Clozaril PS Professional Clozapine (Clozapine) SS Date:09/17/02ISR Number: 3976443-7Report Type:Expedited (15-DaCompany Report #02-09-0770 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drowning Health Clozapine Tablets Professional -Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 200-600MG QD ORAL Date:09/17/02ISR Number: 3976444-9Report Type:Expedited (15-DaCompany Report #02-09-0771 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Peritoneal Disorder Health Clozapine Tablets - Sepsis Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 600-700MG QD ORAL Date:09/17/02ISR Number: 3976445-0Report Type:Expedited (15-DaCompany Report #02-08-0787 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Brain Neoplasm Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 300-5500MG QD ORAL 22-Feb-2006 08:30 AM Page: 1775 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/17/02ISR Number: 3976446-2Report Type:Expedited (15-DaCompany Report #02-09-0778 Age:76 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Haemorrhage Health Clozapine Tablets - Initial or Prolonged Pleural Effusion Professional Ivax Post Procedural Other Pharmaceuticals, Complication Inc. PS Ivax Renal Impairment Pharmaceuticals, Inc. ORAL 25MG QD ORAL Coumadin C Cordarone C Bumex C Nph-Insulin C Isordil C Prinivil C Reglan C Insulin, Regular C Date:09/17/02ISR Number: 3976447-4Report Type:Expedited (15-DaCompany Report #02-08-0802 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cystitis Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 250-300MG QD ORAL Date:09/17/02ISR Number: 3976451-6Report Type:Expedited (15-DaCompany Report #02-09-0791 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neoplasm Malignant Company Clozapine Tablets - Representative Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 250-300MG QD ORAL Date:09/17/02ISR Number: 3976452-8Report Type:Expedited (15-DaCompany Report #02-09-0772 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Leukocytosis Health Clozapine Tablets - Leukopenia Professional Ivax Neoplasm Malignant Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 125MG BID ORAL Chemotherapy C 22-Feb-2006 08:30 AM Page: 1776 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/17/02ISR Number: 3976453-XReport Type:Expedited (15-DaCompany Report #02-09-0786 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Fall Health Clozapine Tablets - Head Injury Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 100-400MG QD ORAL Date:09/17/02ISR Number: 3976819-8Report Type:Expedited (15-DaCompany Report #PHBS2002AU10884 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Ovarian Cancer Foreign Clozaril (Clozarine) Health Tablet PS ORAL ORAL Professional Company Representative Other Date:09/17/02ISR Number: 3976992-1Report Type:Direct Company Report #CTU 176706 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neutropenia Clozapine PS Date:09/17/02ISR Number: 3977323-3Report Type:Expedited (15-DaCompany Report #PHRM2002FR02252 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Foreign Leponex(Clozapine) Phosphokinase Increased Health Tablet PS ORAL 500 MG DAILY, Blood Creatinine Professional ORAL Increased Other Myalgia Date:09/18/02ISR Number: 3977517-7Report Type:Direct Company Report #CTU 176799 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Tremor Clozapine PS Initial or Prolonged Date:09/18/02ISR Number: 3979970-1Report Type:Expedited (15-DaCompany Report #PHFR2002GB01714 Age:41 YR Gender:Male I/FU:I Outcome PT Hospitalization - Blood Creatinine Initial or Prolonged Increased Blood Sodium Decreased Blood Urea Increased Confusional State Decreased Appetite Dizziness 22-Feb-2006 08:30 AM Page: 1777 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Gastritis Hyperhidrosis Jaundice Report Source Product Role Manufacturer Route Dose Duration Nausea Foreign Clozaril (Clozapine) Oesophageal Candidiasis Health Tablet PS ORAL 300 MG, BID, Professional ORAL Other Procyclidine (Procyclidine) C Epilim C Prednisolone C Diazepam C Becloforte "Allen & Hanburys Ltd" (Beclometasone Dipropionate) C Salbutamol C Date:09/18/02ISR Number: 3979978-6Report Type:Expedited (15-DaCompany Report #PHBS2002GR10563 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Leponex (Clozapine) PS ORAL 100 TO 400 Electrocardiogram Health MG/D, ORAL Abnormal Professional Melleril Hypercholesterolaemia Other (Thioridazine Myocardial Infarction Hydrochloride) SS ORAL 100 TO 200 MG/D, ORAL Date:09/18/02ISR Number: 3979981-6Report Type:Expedited (15-DaCompany Report #PHBS2002NZ10269 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cholecystitis Foreign Clozaril (Clozapine) Drug Level Increased Health Tablet PS ORAL 400 MG/D, Professional ORAL Other Haloperidol C Valproate Sodium C Fluoxetine (Fluoxetine) C Benztropine Mesylate (Benzatropine Mesilate) C Date:09/18/02ISR Number: 3979985-3Report Type:Expedited (15-DaCompany Report #PHNU2002DE02958 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abortion Spontaneous Foreign Leponex/Clozaril Complications Of Maternal Health (Clozapine)(Clozapin Exposure To Therapeutic Professional e) Tablet PS ORAL 100 MG/DAY, Drugs Other ORAL Maternal Drugs Affecting Foetus 22-Feb-2006 08:30 AM Page: 1778 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/18/02ISR Number: 3980101-2Report Type:Expedited (15-DaCompany Report #PHEH2002US08003 Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Clozaril(Clozapine) Respiratory Distress Professional Tablet PS ORAL 50 MG, ORAL Date:09/18/02ISR Number: 3980116-4Report Type:Expedited (15-DaCompany Report #PHEH2002US07606 Age:89 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Multi-Organ Failure Health Clozaril(Clozapine) Professional Tablet PS ORAL 19 MG, ORAL Date:09/18/02ISR Number: 3980234-0Report Type:Expedited (15-DaCompany Report #PHFR2002GB02407 Age:18 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Obsessive-Compulsive Foreign Clozaril (Clozapine) Disorder Health (Clozapine) PS ORAL 400 MG, QD, Professional ORAL Other Valproate Sodium C Chlorpomazine (Chlorpromazine) C Date:09/18/02ISR Number: 3980236-4Report Type:Expedited (15-DaCompany Report #PHBS2002NZ10041 Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Clozaril (Clozapine) Other Cough Health Tablet PS ORAL 100 MG, QHS, Professional ORAL Other Lithium Carbonate C Omeprazole (Omeprazole) C Date:09/18/02ISR Number: 3980832-4Report Type:Expedited (15-DaCompany Report #PHFR2002IE02544 Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Epilepsy Foreign Clozaril (Clozapine) Study Tablet PS ORAL ORAL Health Professional Other Date:09/18/02ISR Number: 3980835-XReport Type:Expedited (15-DaCompany Report #PHBS2002AU09520 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Body Temperature Foreign Clozaril (Clozapine) PS 600 MG/D Increased Study Lymphocyte Morphology Other Abnormal Neutropenia Pain Viral Infection 22-Feb-2006 08:30 AM Page: 1779 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/19/02ISR Number: 3977688-2Report Type:Expedited (15-DaCompany Report #HQ4229716SEP2002 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Catatonia Health Temesta (Lorazepam, Other Dystonia Professional Tablet) PS ORAL SEE IMAGE 1 DAY Extrapyramidal Disorder Other Clozapine Salivary Hypersecretion (Clozapine,) SS ORAL SEE IMAGE 1 DAY Remeron(Mirtazapine) SS ORAL SEE IMAGE Date:09/19/02ISR Number: 3977810-8Report Type:Expedited (15-DaCompany Report #PHFR2002GB02751 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril (Clozapine) Overweight Health (Clozapine) Tablet PS ORAL 225 MG, BID, Professional ORAL Other Buscopan (Hyoscine Butylbromide) C Date:09/19/02ISR Number: 3977825-XReport Type:Expedited (15-DaCompany Report #PHBS2002AU09877 Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Clozaril(Clozapine) Cardiomyopathy Study Tablet PS ORAL 200 MG/D, Circulatory Collapse Health ORAL Neuroleptic Malignant Professional Olanzapine Syndrome Other (Olanzapine) C Shock Epilim C Efexor (Venlafaxine Hydrochloride) C Date:09/19/02ISR Number: 3977897-2Report Type:Expedited (15-DaCompany Report #PHBS2002CA10170 Age:59 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Clozaril (Clozapine) Study Tablet PS ORAL ORAL Health Celexa Tablet C Professional Nozinan Tablet C Other Dalmane (Flurazepam Hydrochloride) C Metamucil "Proctor & Gamble" (Ispaghula Husk, Glucose Monohydrate) C Ativan Tablet C Date:09/19/02ISR Number: 3978194-1Report Type:Expedited (15-DaCompany Report #PHBS2002AU10604 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dilatation Ventricular Foreign Clozaril (Clozapine) Ejection Fraction Health Tablet PS ORAL 300 MG, BID; Decreased Professional ORAL Other Tegretol (Carbamazepine) SS 22-Feb-2006 08:30 AM Page: 1780 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Fluoxetine (Fluoxetine) C Date:09/19/02ISR Number: 3978520-3Report Type:Expedited (15-DaCompany Report #PHFR2002IE02533 Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Pressure Increased Foreign Clozaril (Clozapine) Norepinephrine Increased Study Tablet PS ORAL 325 MG/DAY, Other ORAL Date:09/19/02ISR Number: 3980356-4Report Type:Expedited (15-DaCompany Report #C2002-2182.01 Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 25 MG TID, Other ORAL Clozapine Tablets 100 Mg Mylan SS Mylan ORAL 100 MG Q HS, ORAL Date:09/20/02ISR Number: 3978532-XReport Type:Expedited (15-DaCompany Report #C2002-2547.01 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional 100 Mg Mylan PS ORAL 150MG QD, Other ORAL Acetaminophen C Clonidine C Diltiazem C Fluconazole C Ketoconazole Cream C Lisinopril C Ranitidine C Senna C Date:09/20/02ISR Number: 3978536-7Report Type:Expedited (15-DaCompany Report #C2002-2491.01 Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Infection Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 12.5MG, QD, Other ORAL Carbidopa/Levodopa C Ciprofloxacin C Docusate/Casanthrano l C Levofloxacin C Morphine C Propoxyphene/Acetami nophen C Simethicone C Tramodol C Warfarin C 22-Feb-2006 08:30 AM Page: 1781 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/20/02ISR Number: 3979923-3Report Type:Direct Company Report #CTU 176924 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Loss Of Consciousness Clozaril PS ORAL ORAL Hospitalization - Polyuria Initial or Prolonged Thirst Required Intervention to Prevent Permanent Impairment/Damage Date:09/23/02ISR Number: 3979188-2Report Type:Expedited (15-DaCompany Report #02-09-0801 Age:74 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neoplasm Malignant Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 100MG QD ORAL Date:09/23/02ISR Number: 3979189-4Report Type:Expedited (15-DaCompany Report #02-09-0800 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neoplasm Malignant Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 312 .5MG QD ORAL Date:09/23/02ISR Number: 3979191-2Report Type:Expedited (15-DaCompany Report #02-09-0803 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alcoholism Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 300-500MG QD ORAL Date:09/23/02ISR Number: 3979193-6Report Type:Expedited (15-DaCompany Report #02-09-0814 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiomegaly Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS ORAL UNKNOWN ORAL Date:09/24/02ISR Number: 3980418-1Report Type:Expedited (15-DaCompany Report #M0968-2002 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Health Mirtazapine, Initial or Prolonged Pyrexia Professional Clozapine PS ORAL 30 MG 42 WK Clozapine SS ORAL 300 MG 15 WK Diazepam C 22-Feb-2006 08:30 AM Page: 1782 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/24/02ISR Number: 3980998-6Report Type:Expedited (15-DaCompany Report #C2002-2152.01 Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Clozapine Tablets Disease Recurrence Professional 100 Mg Mylan PS ORAL 100MG, BID, Pneumonia Other ORAL Ciprofloxacin SS Insulin C Date:09/24/02ISR Number: 3981010-5Report Type:Expedited (15-DaCompany Report #02-09-0821 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Other Clozapine Tablets - Ivax Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 600MG QD ORAL Date:09/24/02ISR Number: 3981020-8Report Type:Expedited (15-DaCompany Report #02-09-0831 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Health Clozapine Tablets - Weight Increased Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 50-625MG QD ORAL Date:09/24/02ISR Number: 3981315-8Report Type:Expedited (15-DaCompany Report #PHNU2002DE03111 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Gamma-Glutamyltransferase Foreign Leponex/ Clozaril Increased Health (Clozapine) Hyperlipidaemia Professional (Clozapine) Tablet PS ORAL UNK, UNK, Other ORAL Remergil (Mirtazapine) C Date:09/24/02ISR Number: 3981317-1Report Type:Expedited (15-DaCompany Report #PHBS2002ZA08693 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abortion Spontaneous Foreign Leponex Complications Of Maternal Health (Clozapine)Tablet PS ORAL UNK, UNK, Exposure To Therapeutic Professional ORAL Drugs Other Flupentixol Maternal Drugs Affecting Dihydrochloride Foetus (Flupentixol Dihydrochloride) C 22-Feb-2006 08:30 AM Page: 1783 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/25/02ISR Number: 3981628-XReport Type:Expedited (15-DaCompany Report #PHFR2002GB02438 Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Clozaril(Clozapine) Drug Level Decreased Study Tablet PS ORAL 75MG/DAY, Health ORAL Professional Amisulpride Other (Amisulpride) C Date:09/25/02ISR Number: 3982309-9Report Type:Expedited (15-DaCompany Report #B0279668A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Level Decreased Literature Ziprasidone Hcl Initial or Prolonged Haemodialysis Health (Ziprasidone Hcl) Neuroleptic Malignant Professional (Formulation Syndrome Unknown) PS 2 WK Pancreatitis Lithium Salt (Lithium Salt) (Formulation Unknown) SS YR Clozapine (Clozapine) (Formulation Unknown) SS YR Date:09/27/02ISR Number: 3981622-9Report Type:Expedited (15-DaCompany Report #PHBS2002MX11289 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Neoplasm Malignant Foreign Leponex(Clozapine) Metastases To Central Consumer Tablet PS ORAL 400 Nervous System Other MG/DAY,ORAL Date:09/27/02ISR Number: 3982439-1Report Type:Expedited (15-DaCompany Report #C2002-2603.01 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional 100 Mg Mylan PS ORAL 750MG QD, Other ORAL Amitriptyline C Benztropine C Diclofenac/Misoprost ol C Fenofibrate C Fluticasone Inhaler C Ipratropium/Albutero l C Lansoprazole C Risperidone C Sertraline C 22-Feb-2006 08:30 AM Page: 1784 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/27/02ISR Number: 3982440-8Report Type:Expedited (15-DaCompany Report #C2002-2604.01 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg Mylan PS ORAL 12.5MG QD, Other ORAL Date:09/27/02ISR Number: 3982442-1Report Type:Expedited (15-DaCompany Report #C2002-1633.01 Age:90 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg Mylan PS ORAL 12.5MG BID, Other ORAL Levothyroxine C Lorazepam C Propoxyphene C Napsylate/Apap C Risperidone C Date:09/27/02ISR Number: 3984215-2Report Type:Expedited (15-DaCompany Report #PHFR2002GB02991 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Foreign Clozapine Sudden Death Other (Clozapine) PS Olanzapine (Olanzapine) C Date:09/27/02ISR Number: 3984224-3Report Type:Expedited (15-DaCompany Report #PHFR2002GB02731 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cognitive Disorder Foreign Clozaril (Clozapine) Diabetes Mellitus Study Tablet PS ORAL 325 MG/DAY, Non-Insulin-Dependent Health ORAL Somnolence Professional Hyoscine Other Hydrobromide C Amisulpride (Amisulpride) C Propranolol C Valproate Sodium C Lamotrigine C Date:09/27/02ISR Number: 3984260-7Report Type:Expedited (15-DaCompany Report #PHBS2002AU09362 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Autoimmune Foreign Clozaril (Clozapine) Thrombocytopenia Study Unknown PS UNKNOWN 300 MG/D, Hepatitis C Health UNKNOWN Platelet Count Abnormal Professional Artane Other (Trihexyphenidyl Hydrochloride) C 22-Feb-2006 08:30 AM Page: 1785 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/27/02ISR Number: 3984263-2Report Type:Expedited (15-DaCompany Report #PHEH2002US02534 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Circulatory Collapse Other Clozaril (Clozapine) Drug Toxicity Tablet PS ORAL 600 MG, QD, Osteoarthritis ORAL Pain In Extremity Paxil C Shock Lorazepam C Sudden Death Date:09/27/02ISR Number: 3984293-0Report Type:Expedited (15-DaCompany Report #PHFR2002GB02758 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Foreign Clozaril (Clozapine) Increased Study (Clozapine) Tablet PS ORAL 450 MG/DAY, Aspartate Health ORAL Aminotransferase Professional Olanzapine Increased Other (Olanzapine) C Diarrhoea Risperidone Eosinophilia (Risperidone) C Neutrophilia Upper Respiratory Tract Infection Date:09/27/02ISR Number: 3984295-4Report Type:Expedited (15-DaCompany Report #PHBS2002NO10793 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Myocardial Foreign Leponex (Clozapine) Infarction Health Tablet PS ORAL ORAL Cardiac Failure Professional Other Date:09/27/02ISR Number: 3985031-8Report Type:Expedited (15-DaCompany Report #PHBS2002AU08598 Age:49 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Overdose Foreign Clozaril Initial or Prolonged Balance Disorder Study (Clozapine)Tablet PS ORAL SEE IMAGE Dizziness Health Dysarthria Professional Medication Error Date:09/27/02ISR Number: 3985035-5Report Type:Expedited (15-DaCompany Report #PHFR2002GB02974 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Infertility Male Foreign Clozaril (Clozapine) Sperm Count Decreased Health Tablet PS ORAL 400 MG/DAY, Urinary Incontinence Professional ORAL Other Paroxetine (Paroxetine) C 22-Feb-2006 08:30 AM Page: 1786 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/01/02ISR Number: 3982682-1Report Type:Expedited (15-DaCompany Report #02-09-0835 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Oesophageal Carcinoma Health Clozapine PS Ivax ORAL 200-650MG QD Professional ORAL Other Date:10/01/02ISR Number: 3982683-3Report Type:Expedited (15-DaCompany Report #02-09-0826 Age:78 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dysphagia Health Clozapine PS Ivax ORAL 200-250MG QD Initial or Prolonged Hypotonia Professional ORAL Disability Malaise Other Date:10/01/02ISR Number: 3982684-5Report Type:Expedited (15-DaCompany Report #02-09-0813 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Fall Health Clozapine - Ivax Hospitalization - Hip Fracture Professional Pharmaceuticals, Initial or Prolonged Post Procedural Other Inc. Tablets PS ORAL 200-450MG QD Complication ORAL Thrombosis Date:10/01/02ISR Number: 3983125-4Report Type:Expedited (15-DaCompany Report #02-09-0839 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bladder Cancer Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS ORAL ORAL Date:10/01/02ISR Number: 3983126-6Report Type:Expedited (15-DaCompany Report #02-09-0841 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Health Clozapine Tablets PS Ivax Initial or Prolonged Injury Professional Pharmaceuticals, Other Inc. ORAL 50-75MG QD; ORAL Date:10/01/02ISR Number: 3983127-8Report Type:Expedited (15-DaCompany Report #02-09-0840 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Foreign Body Trauma Health Clozapine Tablets PS Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. ORAL 200MG QD; ORAL 22-Feb-2006 08:30 AM Page: 1787 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/01/02ISR Number: 3983712-3Report Type:Direct Company Report #CTU 177626 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Clozapine PS ORAL 25MG PO QD Initial or Prolonged Polydipsia TAPER UP TO Polyuria 150 MG PO QD Prolixin Decanoate C Divalproex C Date:10/01/02ISR Number: 3984340-6Report Type:Expedited (15-DaCompany Report #PHBS2002AU11185 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depressed Mood Foreign Clozaril (Clozapine) Initial or Prolonged Hallucination, Auditory Study Tablet PS ORAL 400 MG/DAY, Intentional Overdose Health ORAL; 2600 Refusal Of Treatment By Professional MG, Patient Other ONCE/SINGLE, Suicide Attempt ORAL Date:10/01/02ISR Number: 3984525-9Report Type:Expedited (15-DaCompany Report #PHFR2002GB03070 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Medication Error Foreign Clozaril (Clozapine) Initial or Prolonged Other Tablet PS ORAL 125 MG/DAY, ORAL Chlorpromazine (Chlorpromazine) C Estrogen Nos (Estrogen Nos) C Procyclidine (Procyclidine) C Tolterodine (Tolterodine) C Date:10/01/02ISR Number: 3986241-6Report Type:Expedited (15-DaCompany Report #PHEH2002US08492 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatic Cirrhosis Health Clozaril (Clozapine) Initial or Prolonged Leukopenia Professional Tablet PS ORAL ORAL Platelet Count Decreased Portal Hypertension Splenomegaly Date:10/01/02ISR Number: 4008792-0Report Type:Periodic Company Report #2002UW02223 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Leukopenia Health Seroquel PS ORAL 700 MG DAILY Liver Function Test Professional PO Abnormal Clozapine SS ORAL 525 MG QD PO Neutropenia Depakote SS ORAL 1750 MG QD PO Levothyroxine C Lithium C Interferon C 22-Feb-2006 08:30 AM Page: 1788 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/01/02ISR Number: 4027311-6Report Type:Periodic Company Report #2001UW05683 Age:39 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Neutropenia Health Seroquel "Zeneca" PS "Zeneca" ORAL 25 MG BID PO Intervention to Psychotic Disorder Professional Seroquel "Zeneca" SS "Zeneca" 400 MG HS Prevent Permanent Seroquel "Zeneca" SS "Zeneca" ORAL 500 MG HS PO Impairment/Damage Clozaril SS 300 MG DAILY Zyprexa C Iron Supplement C Klonopin C Date:10/01/02ISR Number: 4027330-XReport Type:Periodic Company Report #2001UW09811 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Neuroleptic Malignant Health Seroquel "Zeneca" PS 150-200 MG Intervention to Syndrome Professional Clozaril SS Prevent Permanent Impairment/Damage Date:10/01/02ISR Number: 4027457-2Report Type:Periodic Company Report #2002UW09817 Age:11 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Granulocytopenia Seroquel PS ORAL 200 MG HS PO Required Leukopenia Clozapine SS ORAL 25 MG QAM PO Intervention to Depakote - Slow Prevent Permanent Release SS ORAL 500 MG BID PO Impairment/Damage Senokot C Clozaril C Miralax C Lithium C Date:10/02/02ISR Number: 3983130-8Report Type:Expedited (15-DaCompany Report #02-09-0821 Age:53 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Other Clozapine - Ivax Pharmaceuticals, Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 600 MG QD ORAL Date:10/02/02ISR Number: 3983135-7Report Type:Expedited (15-DaCompany Report #02-09-0860 Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Neoplasm Malignant Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 300-600MG QD ORAL 22-Feb-2006 08:30 AM Page: 1789 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/02/02ISR Number: 3986140-XReport Type:Expedited (15-DaCompany Report #PHFR2002GB01937 Age:30 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abortion Induced Foreign Clozaril(Clozapine) Complications Of Maternal Health Tablet PS ORAL 400-600MG/DAY Exposure To Therapeutic Professional , ORAL Drugs Other Condition Aggravated Intra-Uterine Death Maternal Drugs Affecting Foetus Mental Impairment Pregnancy Date:10/02/02ISR Number: 3986827-9Report Type:Expedited (15-DaCompany Report #PHBS2002AU11312 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cataract Foreign Clozaril(Clozapine)T Consumer ablet PS ORAL 1000 MG/DAY, Other ORAL Dieldrin () (Continued) SS Date:10/02/02ISR Number: 3986828-0Report Type:Expedited (15-DaCompany Report #PHBS2002AU11370 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril Non-Insulin-Dependent Study (Clozapine)Tablet PS ORAL 200 MG/DAY, Health ORAL Professional Other Date:10/02/02ISR Number: 3986841-3Report Type:Expedited (15-DaCompany Report #PHBS2002AU09877 Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Clozaril (Clozapine) Cardiomyopathy Study Tablet PS ORAL 200 MG/D, Neuroleptic Malignant Health ORAL Syndrome Professional Olanzapine Shock Other (Olanzapine) C Epilim C Efexor (Venlafaxine Hydrochloride) C Date:10/03/02ISR Number: 3983131-XReport Type:Expedited (15-DaCompany Report #01-11-0633 Age:74 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neoplasm Malignant Health Clozapine - Ivax Pneumonia Professional Pharmaceuticals, Inc. Tablets PS Ivax Pharmaceuticals, Inc. OPHTHALMIC 75MG BID ORAL 22-Feb-2006 08:30 AM Page: 1790 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/03/02ISR Number: 3983133-3Report Type:Expedited (15-DaCompany Report #02-09-0872 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Leukaemia Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL ORAL Date:10/03/02ISR Number: 3983134-5Report Type:Expedited (15-DaCompany Report #02-09-0862 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chronic Obstructive Health Clozapine - Ivax Initial or Prolonged Pulmonary Disease Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 12.5-400MG QD ORAL Date:10/03/02ISR Number: 3985794-1Report Type:Expedited (15-DaCompany Report #02-09-0855 Age:67 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dehydration Health Clozapine-Ivam Hospitalization - Myocardial Infarction Professional Pharmaceuticals, Initial or Prolonged Urinary Tract Infection Other Inc. Tablets PS ORAL 12.5-50 MG ORAL Date:10/03/02ISR Number: 3985796-5Report Type:Expedited (15-DaCompany Report #02-09-0854 Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dehydration Health Clozapine-Ivax Hospitalization - Myocardial Infarction Professional Pharmaceuticals, Initial or Prolonged Urinary Tract Infection Other Inc. Tablets PS ORAL 50-75MGQD ORAL Date:10/03/02ISR Number: 3985846-6Report Type:Expedited (15-DaCompany Report #02-09-0859 Age:71 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Renal Failure Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL ORAL Date:10/03/02ISR Number: 3985847-8Report Type:Expedited (15-DaCompany Report #02-09-0856 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatitis C Health Clozapine - Ivax Leukopenia Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, 22-Feb-2006 08:30 AM Page: 1791 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Inc. ORAL 300-500 MG QD ORAL Date:10/03/02ISR Number: 3985849-1Report Type:Expedited (15-DaCompany Report #C2002-2643.01 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 200 MG, QD Other ORAL Furosemide C Lorazepam C Morphine Er Tablets C Morphine Sulfate Liquid C Pantoprazole C Risperidone C Spironolactone C Date:10/03/02ISR Number: 3986311-2Report Type:Expedited (15-DaCompany Report #02-09-0853 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Clozapine-Ivax Drug Toxicity Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 400MG QHS ORAL Fluphenazine Decanoate Injectable Solution SS INTRAMUSCULAR 1.25CC Q2WKS INTRAMUSCULAR Date:10/03/02ISR Number: 3986320-3Report Type:Expedited (15-DaCompany Report #02-09-0851 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Clozapine- Ivam Congestive Professional Pharmaceuticals, Respiratory Failure Other Inc. Tablets PS ORAL 150MG QD ORAL Date:10/03/02ISR Number: 3986321-5Report Type:Expedited (15-DaCompany Report #02-09-0836 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine-Ivax Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 500/700MGQD ORAL Date:10/03/02ISR Number: 3986557-3Report Type:Expedited (15-DaCompany Report #02-09-0855 Age:67 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dehydration Health Clozapine PS Ivax Hospitalization - Myocardial Infarction Professional Pharmaceuticals, Initial or Prolonged Urinary Tract Infection Other Inc. ORAL 12.5-50MG ORAL 22-Feb-2006 08:30 AM Page: 1792 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/03/02ISR Number: 3986561-5Report Type:Expedited (15-DaCompany Report #02-09-0854 Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dehydration Health Clozapine - Ivax Hospitalization - Myocardial Infarction Professional Pharmaceuticals, Initial or Prolonged Urinary Tract Infection Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 50-75 MG QD ORAL Date:10/03/02ISR Number: 3987092-9Report Type:Expedited (15-DaCompany Report #PHEH2002US07336 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatitis C Health Clozaril (Clozapine) Professional Tablet PS ORAL 250MG, ORAL Date:10/03/02ISR Number: 3987912-8Report Type:Expedited (15-DaCompany Report #PHFR2002GB02992 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Foreign Clozaril Salivary Hypersecretion Study (Clozapine)(Clozapin Health e)Tablet PS ORAL ORAL Professional Other Date:10/03/02ISR Number: 3988019-6Report Type:Expedited (15-DaCompany Report #2002003203 Age:24 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Foreign Sertraline Initial or Prolonged Confusional State Consumer (Sertraline) PS ORAL 200 MG Disability Convulsion (DAILY), ORAL Other Fall Haloperidol Loss Of Consciousness (Haloperidol) SS Memory Impairment Clozapine Palpitations (Clozapine) SS Social Avoidant Behaviour Deptran (Doxepin Hydrochloride0 SS 75 MG DAILY Oxycodone (Oxycodone) C Date:10/03/02ISR Number: 3988885-4Report Type:Expedited (15-DaCompany Report #HQ3521630JUL2002 Age:46 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Interaction Health Effexor Xr Drug Level Above Professional (Venlafaxine Therapeutic Hydrochloride, Sudden Death Capsule, Extended Release) PS ORAL 225 MG 1X PER 1 DAY, ORAL Clozapine (Clozapine,) SS ORAL 150 MG TWICE DAILY AND AT BEDTIME, ORAL 22-Feb-2006 08:30 AM Page: 1793 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Fluoxetine Hydrochloride (Fluoxetine Hydrochloride,) SS ORAL 10 MG DAILY, ORAL Ferrous Sulfate (Ferrous Sulfate) C Date:10/03/02ISR Number: 3988888-XReport Type:Expedited (15-DaCompany Report #PHEH2002US07278 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiomegaly Health Clozaril (Clozapine) Other Coronary Artery Disease Professional Tablet PS ORAL 300MG AM + Syncope 400MG HS, ORAL Lithium (Lithium) C Date:10/04/02ISR Number: 3985661-3Report Type:Direct Company Report #CTU 177914 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Unevaluable Event Clozapine 25 Mg Ivax PS Ivax ORAL 25 MG PO Intervention to Prevent Permanent Impairment/Damage Date:10/04/02ISR Number: 3988977-XReport Type:Expedited (15-DaCompany Report #C2002-2491.01 Age:84 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Fall Health Clozapine Tablets 25 Hip Fracture Professional Mg Mylan PS ORAL 12.5MG QD, Infection Other ORAL Carbidopa/Levodopa C Ciprofloxacin C Docusate/Casanthrano l C Levofloxacin C Morphine C Propoxyphene/Acetami nophen C Simethicone C Tramadol C Warfarin C Date:10/04/02ISR Number: 3988979-3Report Type:Expedited (15-DaCompany Report #C2002-2637.01 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 200MG Q AM, Other 200MG G NOON, ORAL Clozapine Tablets 25 Mg Mylan SS Mylan ORAL 50MG Q HS, ORAL 22-Feb-2006 08:30 AM Page: 1794 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/07/02ISR Number: 3987500-3Report Type:Expedited (15-DaCompany Report #C2002-2783.01 Age:50 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Neoplasm Malignant Consumer Clozapine Tablets Health 100 Mg Mylan PS Mylan ORAL 100MG Q AM, Professional 200MG Q HS, Other ORAL Albuterol C Amiodarone C Atorvastatin C Furosemide C Hydrocodone Bitartrate & Acetaminophen C Potassium C Sulfamethoxazole & Trimethoprim C Warfarin Sodium C Date:10/07/02ISR Number: 3989179-3Report Type:Expedited (15-DaCompany Report #PHFR2002GB02150 Age:60 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Asthenia Foreign Clozaril (Clozapine) Hospitalization - Dizziness Health Tablet PS ORAL ORAL Initial or Prolonged Dyspnoea Professional Olanzapine Endocarditis Bacterial Other (Olanzapine) C Hypotension Frusemide C Staphylococcal Sepsis Aspirine C Tachycardia Amiloride (Amiloride) C Nifedipine C Atorvastatin (Atorvastatin) C Atenolol C Paroxetine (Paroxetine) C Isosorbide Mononitrate C Gtn C Date:10/07/02ISR Number: 3989284-1Report Type:Expedited (15-DaCompany Report #PHFR2002GB02933 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chest Discomfort Foreign Clozaril (Clozapine) Dyspepsia Study Tablet PS ORAL 500 MG/DAY, Electrocardiogram Health ORAL Abnormal Professional Gaviscon (Sodium Fatigue Other Alginate) C Hypothyroidism Carbamazepine C Sinus Tachycardia Depakote (Valproate Semisodium) C 22-Feb-2006 08:30 AM Page: 1795 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/07/02ISR Number: 3989578-XReport Type:Expedited (15-DaCompany Report #NZ/98/00116/LEX Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Foreign Clozaril Phosphokinase Increased Health (Clozapine/Clozapine Drug Interaction Professional ) Tablet PS ORAL 600 MG/DAY, Grand Mal Convulsion Other ORAL Intracranial Aneurysm Losec (Omeprazole) (Omeprazole) SS ORAL 20 MG/DAY, ORAL Amoxycillin (Amoxicillin) C Metronidazole (Metronidazole) C Date:10/07/02ISR Number: 3989581-XReport Type:Expedited (15-DaCompany Report #C2002-2150.01 Age:79 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Urosepsis Health Clozapine Tablets Professional 100mg Mylan PS Mylan ORAL 100 MG BID, Other THEN 100MG/DAY THEN 50 MG/DAY,ORAL Carbidopa/Levodopa C Furosemide C Glyburide C Milk Of Magnesia C Multivitamins C Paroxetine C Propranol C Date:10/07/02ISR Number: 3989596-1Report Type:Expedited (15-DaCompany Report #PHRM2002FR01556 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abnormal Faeces Foreign Leponex Colitis Ulcerative Health (Clozapine) PS ORAL 500 MG PER Gastrointestinal Professional DAY, ORAL Hypomotility Other Largactil (Chlorpromazine Hydrochloride) SS 400 MG DAILY Lepticur (Tropatepine Hydrochloride) Tablet SS ORAL 2 DF PER DAY, ORAL Depakine C Teralithe Slow Release C Lysanxia (Prazepam) C 22-Feb-2006 08:30 AM Page: 1796 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/07/02ISR Number: 3989642-5Report Type:Expedited (15-DaCompany Report #PHBS2002AU09991 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Decreased Foreign Clozaril (Clozapine) Initial or Prolonged Hepatic Steatosis Health Tablet PS ORAL 400 MG/D, Other Pancreatitis Professional ORAL Other Glimepiride (Glimepiride) C Pethidine (Pethidine) C Epilim C Ditropan (Oxybutynin) C Avandia (Rosiglitazone Maleate) C Gemfibrozil (Gemfibrozil) C Date:10/07/02ISR Number: 3989695-4Report Type:Expedited (15-DaCompany Report #PHBS2002NZ10269 Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cholecystitis Foreign Clozaril (Clozapine) Drug Level Increased Health Tablet PS ORAL 400 MG/D, Professional ORAL Other Haloperidol C Valproate Sodium C Fluoxetine (Fluoxetine) C Benztropine Mesylate (Benzatropine Mesilate) C Date:10/07/02ISR Number: 3989866-7Report Type:Expedited (15-DaCompany Report #PHBS2001NZ09401 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Circulatory Collapse Foreign Clozaril (Clozapine) Initial or Prolonged Drug Interaction Health Tablet PS ORAL 475 MG/D, Drug Level Increased Professional ORAL Epilepsy Other Omeprazole Loss Of Consciousness (Omeprazole) SS UNKNOWN Shock Olanzapine (Olanzapine) C Risperidone (Risperidone) C Paroxetine (Paroxetine) C Date:10/07/02ISR Number: 3989882-5Report Type:Expedited (15-DaCompany Report #PHBS2002AU11516 Age:66 YR Gender:Female I/FU:I Outcome PT Hospitalization - Acute Myocardial Initial or Prolonged Infarction Coronary Artery Disease Diabetes Mellitus 22-Feb-2006 08:30 AM Page: 1797 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Non-Insulin-Dependent Report Source Product Role Manufacturer Route Dose Duration Foreign Clozaril (Clozapine) Study Unknown PS UNKNOWN 275 MG/DAY, Health UNKNOWN Professional Simvastatin C Other Ranitidine (Ranitidine) C Date:10/07/02ISR Number: 3989884-9Report Type:Expedited (15-DaCompany Report #PHFR2002GB02323 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthma Foreign Clozaril (Clozapine) Convulsion Health Tablet PS ORAL ORAL Fatigue Professional Somnolence Other Weight Increased Date:10/09/02ISR Number: 3991218-0Report Type:Expedited (15-DaCompany Report #PHBS2002BR11745 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutrophil Count Foreign Clozaril Decreased Health (Clozapine) PS ORAL 100 MG, BID, Platelet Count Decreased Professional ORAL Psoriasis Other Lorax White Blood Cell Count (Loracarbef) C Decreased Date:10/09/02ISR Number: 3991221-0Report Type:Expedited (15-DaCompany Report #PHFR2002GB02870 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Gastroenteritis Foreign Clozaril Study (Clozapine) PS ORAL 575 MG/DAY, Health ORAL Professional Chlorpromazine C Other Diazepam C Valproate Sodium C Hyoscine C Date:10/09/02ISR Number: 3991630-XReport Type:Expedited (15-DaCompany Report #PHFR2001IE02952 Age:60 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril (Clozapine) Non-Insulin-Dependent Health Tablet PS ORAL 200 MG/DAY, Professional ORAL Other Fenofibrate (Fenofibrate) C Diazepam C Sertraline (Sertraline) C Epilim C Omeprazole 22-Feb-2006 08:30 AM Page: 1798 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Omeprazole) C Aspirine C Date:10/10/02ISR Number: 3992029-2Report Type:Expedited (15-DaCompany Report #PHBS2002CA10768 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Dysarthria Foreign Clozaril (Clozapine) Electrocardiogram Qt Study Tablet PS ORAL 200 MG/DAY, Prolonged Health ORAL Metabolic Encephalopathy Professional Clonazepam C Myocarditis Other Ativan C Neuroleptic Malignant Lactulose C Syndrome Docusate (Docusate) C Psychotic Disorder Tylenol (Parcetamol) C Viral Infection Salbutamol C Levaquin (Levofloxacin) C Ventolin C Cosyntropin C Synacthen C Date:10/10/02ISR Number: 3992033-4Report Type:Expedited (15-DaCompany Report #PHBS2002PH11493 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypertrophy Foreign Leponex (Clozapine) Sepsis Health Tablet PS ORAL ORAL Tachycardia Professional Other Date:10/10/02ISR Number: 3992038-3Report Type:Expedited (15-DaCompany Report #PHFR2002GB02892 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Foreign Clozaril (Clozapine) Electroencephalogram Study (Clozapine) Tablet PS ORAL 500 MG/DAY, Abnormal Health ORAL Encephalopathy Professional Other Date:10/10/02ISR Number: 3992129-7Report Type:Expedited (15-DaCompany Report #PHFR2002GB02767 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Coma Foreign Clozaril(Clozapine) Initial or Prolonged Small Intestinal Study Tablet PS ORAL ORAL Obstruction Health Professional Other Date:10/10/02ISR Number: 3992137-6Report Type:Expedited (15-DaCompany Report #PHRM2002FR02348 Age:32 YR Gender:Female I/FU:I Outcome PT Hospitalization - Drug Toxicity Initial or Prolonged Electrocardiogram T Wave 22-Feb-2006 08:30 AM Page: 1799 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Inversion Report Source Product Role Manufacturer Route Dose Duration Foreign Leponex (Clozapine) Health Tablet PS ORAL 4 DF DAILY, Professional ORAL Other Date:10/10/02ISR Number: 3992161-3Report Type:Expedited (15-DaCompany Report #PHBS2001AU12457 Age:27 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Foreign Clozaril (Clozapine) Initial or Prolonged Diabetic Ketoacidosis Study Tablet PS ORAL 400 MG, QD, Weight Increased Health ORAL Professional Other Date:10/10/02ISR Number: 3992162-5Report Type:Expedited (15-DaCompany Report #PHBS2002CL09816 Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Foreign Leponex (Clozapine) Initial or Prolonged Anxiety Consumer Tablet PS ORAL SEE IMAGE Balance Disorder Other Crismol (Ipratropium Blood Triglycerides Bromide, Fenoterol Increased Hydrobromide) C Epilepsy Valcote C Musculoskeletal Stiffness Trileptal "Novartis" C Photosensitivity Reaction Tinnitus Date:10/10/02ISR Number: 3992166-2Report Type:Expedited (15-DaCompany Report #PHBS2002AU08140 Age:27 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Foreign Clozaril (Clozapine) Completed Suicide Study Tablet PS ORAL 400 MG/DAY, Overdose Health ORAL Professional Olanzapine Other (Olanzapine) SS Haloperidol (Haloperidol) SS Metazapine () SS Clonidine Hydrochloride (Clonidine Hyrdochloride) SS Date:10/10/02ISR Number: 3992754-3Report Type:Expedited (15-DaCompany Report #PHEH2002US08599 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hodgkin'S Disease Health Clozaril (Clozapine) Leukopenia Professional Tablet PS ORAL ORAL 22-Feb-2006 08:30 AM Page: 1800 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/11/02ISR Number: 3992457-5Report Type:Expedited (15-DaCompany Report #C2002-2604.01 Age:76 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Parkinson'S Disease Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 12.5 MG QD, Other ORAL Date:10/11/02ISR Number: 3992472-1Report Type:Expedited (15-DaCompany Report #C2002-2837.01 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional 25mg Mylan PS Mylan ORAL 25 MG QD, Other ORAL Clozapine Tablets 100mg Mylan SS Mylan ORAL 100MG QD, ORAL Divalproex C Prednisone C Quinapril C Albuterol Nebulizer Solution C Ipratropium Nebulizer Solution C Diltiazem C Date:10/11/02ISR Number: 3992474-5Report Type:Expedited (15-DaCompany Report #02-09-0894 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Vaginal Haemorrhage Health Clozapine Ivan Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivan Pharmaceuticals, Inc. ORAL 300-900 MG QD ORAL Date:10/11/02ISR Number: 3992477-0Report Type:Expedited (15-DaCompany Report #02-10-0882 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Potassium Decreased Health Clozapine Ivax Initial or Prolonged Fall Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc ORAL 250-300MG QD ORAL Date:10/11/02ISR Number: 3992480-0Report Type:Expedited (15-DaCompany Report #02-10-0883 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine Ivax Respiratory Failure Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 200MG QD ORAL 22-Feb-2006 08:30 AM Page: 1801 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/11/02ISR Number: 3992545-3Report Type:Expedited (15-DaCompany Report #02-10-0892 Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Colectomy Health Clozapine Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 250MG QD ORAL Date:10/11/02ISR Number: 3992554-4Report Type:Expedited (15-DaCompany Report #02-10-0881 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Foreign Clozapine Tablets PS ORAL 100MG ORAL Initial or Prolonged Blood Creatinine Literature Increased Health Fall Professional Hallucination Loss Of Consciousness Rhabdomyolysis Date:10/15/02ISR Number: 3993488-1Report Type:Expedited (15-DaCompany Report #2002060444 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asthenia Health Dilantin Suspension Influenza Like Illness Professional (Phenytoin Sodium) PS Overweight Clozapine SS ORAL 150 MG (BID), White Blood Cell Count ORAL Increased Sertraline Hydrochloride C Lithium Carbonate C Tocopherol C Prednisone C Ranitidine C Date:10/16/02ISR Number: 3992570-2Report Type:Direct Company Report #CTU 178820 Age:66 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Constipation Clozaril PS Hospitalization - Neutrophil Count Initial or Prolonged Decreased Date:10/16/02ISR Number: 3992585-4Report Type:Direct Company Report #CTU 178827 Age:71 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Constipation Clozaril PS Date:10/16/02ISR Number: 3993030-5Report Type:Expedited (15-DaCompany Report #PHRM2002FR00793 Age:23 YR Gender:Female I/FU:F Outcome PT Other Cardiomyopathy Sinus Tachycardia 22-Feb-2006 08:30 AM Page: 1802 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Ventricular Hypokinesia Weight Increased Report Source Product Role Manufacturer Route Dose Duration Foreign Leponex(Clozapine) Health Tablet PS ORAL 2.5 TAB/DAY, Professional ORAL Floxyfral (Fluvoxamine Maleate) Tablet SS ORAL ORAL Temesta Tablet (Lorazepam) SS ORAL 1 TAB/DAY, ORAL Lepticur (Tropatepine Hydrochloride) Tablet SS ORAL 2 TAB/DAY, ORAL Date:10/16/02ISR Number: 3993039-1Report Type:Expedited (15-DaCompany Report #PHBS2001CA12728 Age:31 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiomyopathy Foreign Clozaril (Clozapine) Enuresis Health Tablet PS ORAL 375 MG, QHS; Sinus Tachycardia Professional ORAL Ventricular Failure Other Fosamax (Alendronate Ventricular Hypokinesia Sodium) C Tylenol (Paracetamol) C Fosamax (Alendronate Sodium) C Advair (Fluticasone Propionate, Salmeterol Xinafoate) C Ddavp (Desmopressin) Nasal Spray C Docusate (Docusate) C Combivent (Salbutamol Sulfate, Ipratropium Bromide) C Theo-Dur C Prednisone C Plaquenil (Hydroxychloroquine Phosphate) C Celebrex (Celecoxib) C Date:10/16/02ISR Number: 3993129-3Report Type:Expedited (15-DaCompany Report #PHFR2002GB02710 Age:32 YR Gender:Male I/FU:I Outcome PT Life-Threatening Acute Respiratory Hospitalization - Distress Syndrome Initial or Prolonged Brain Oedema Dehydration Disseminated Intravascular Coagulation Hallucination 22-Feb-2006 08:30 AM Page: 1803 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Heat Exhaustion Hepatic Failure Loss Of Consciousness Report Source Product Role Manufacturer Route Dose Duration Neuroleptic Malignant Foreign Clozaril (Clozapine) Syndrome Study Tablet PS ORAL 200 MG, BID, Neutropenia Health ORAL Renal Failure Professional Rhabdomyolysis Other Shock Date:10/16/02ISR Number: 3993132-3Report Type:Expedited (15-DaCompany Report #PHBS2002BR09550 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anaemia Foreign Leponex (Clozapine) Other Chest Pain Health Tablet PS ORAL ORAL; 200 Professional MG/D, ORAL; Other 100 MG, BID, ORAL Amplictil (Chlorpromazine) C Semap (Penfluridol) C Date:10/16/02ISR Number: 3993154-2Report Type:Expedited (15-DaCompany Report #PHBS2002AU09638 Age:18 YR Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Discomfort Foreign Clozaril (Clozapine) Initial or Prolonged Dizziness Health Tablet PS ORAL ORAL Electrocardiogram Qt Professional Efexor (Venlafaxine Prolonged Other Hydrochloride) C Date:10/16/02ISR Number: 3993188-8Report Type:Expedited (15-DaCompany Report #PHEH2002US08005 Age:72 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiomegaly Health Clozaril (Clozapine) PS ORAL 200 MG,QD, Cardiovascular Disorder Professional ORAL Hypotension Company Glucotrol Xl Leukocytosis Representative (Glipizide) C Pulse Absent Avandia (Rosiglitazone Maleate) C Tenormin C Prinivil (Lisinopril) C Procardia Xl C Synthroid C Lipitor (Atorvastatin) C Glucophage "Abic" C Colace C Ferrous Sulfate C 22-Feb-2006 08:30 AM Page: 1804 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/16/02ISR Number: 3993531-XReport Type:Expedited (15-DaCompany Report #PHBS2002AU11825 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Colitis Foreign Clozaril (Clozapine) Initial or Prolonged Crohn'S Disease Study Tablet PS ORAL 125MG/D, ORAL Small Intestinal Obstruction Date:10/16/02ISR Number: 3993534-5Report Type:Expedited (15-DaCompany Report #PHBS2002CL11851 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Overdose Study Leponex (Clozapine) Initial or Prolonged Suicide Attempt Health Tablet PS ORAL ORAL Professional Other Date:10/16/02ISR Number: 3993536-9Report Type:Expedited (15-DaCompany Report #PHFR2002GB03160 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Foreign Clozaril (Clozapine) Sudden Death Other Tablets PS ORAL ORAL Depixol (Flupentixol Decanoate) C Date:10/16/02ISR Number: 3993537-0Report Type:Expedited (15-DaCompany Report #PHBS2002NZ10116 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Catecholamines Urine Foreign Clozaril (Clozapine) Increased Health Tablet PS ORAL 12.5 MG/D, Chest Pain Professional ORAL / SEE Headache Other IMAGE Hypertension Premarin (Estrogens Conjugated) C Omeprazole (Omeprazole) C Nitrazepam C Clonazepam C Fluoxetne (Fluoxetine) C Date:10/16/02ISR Number: 3993541-2Report Type:Expedited (15-DaCompany Report #PHNU2002DE03347 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cataract Foreign Leponex/Clozaril Health (Clozapine) Professional (Clozapine) Tablet PS ORAL 12.5 MG/DAY, Other ORAL 22-Feb-2006 08:30 AM Page: 1805 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/16/02ISR Number: 3993586-2Report Type:Expedited (15-DaCompany Report #PHBS2002AU10876 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alcohol Poisoning Foreign Clozaril(Clozapine) Initial or Prolonged Drug Dependence Study Tablet PS ORAL ORAL Other Intentional Overdose Other Methadone Sedation (Methadone) C Suicide Attempt Diazepam C Date:10/16/02ISR Number: 3993607-7Report Type:Direct Company Report #CTU 178866 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abnormal Faeces Clozaril 100mg Hospitalization - Cogwheel Rigidity Tablet Novartis PS Novartis 100MG TID PO Initial or Prolonged Diarrhoea Citalopram C Required Drooling Depakote Er C Intervention to Drug Withdrawal Syndrome Risperidone C Prevent Permanent Dysphagia Trihexyphenidyl C Impairment/Damage Hallucination Head Injury Hypoxia Infection Lethargy Liver Function Test Abnormal Neuroleptic Malignant Syndrome Pain Pancreatitis Pneumonia Date:10/16/02ISR Number: 3994960-0Report Type:Expedited (15-DaCompany Report #PHBS2002PH12156 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Leukaemia Foreign Leponex (Clozapine) Other Unknown PS Date:10/16/02ISR Number: 3995482-3Report Type:Expedited (15-DaCompany Report #PHBS2002AU10604 Age:27 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dilatation Ventricular Foreign Clozaril (Clozapine) Ejection Fraction Health Tablet PS ORAL 300 MG, BID, Decreased Professional ORAL Other Tegretol(Carbamazepi ne) SS ORAL 200 MG, BID, ORAL Fluoxetine (Fluoxetine) C 22-Feb-2006 08:30 AM Page: 1806 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/17/02ISR Number: 3991725-0Report Type:Expedited (15-DaCompany Report #C2002-2875.01 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Clozapine Tablets Other 100 Mg Mylan PS ORAL 150MG/DAY, THEN 100MG/DAY, ORAL Date:10/17/02ISR Number: 3993768-XReport Type:Direct Company Report #CTU 178902 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Neutrophil Count Clozapine 100mg PS ORAL 300MG DAY Intervention to Decreased ORAL Prevent Permanent Impairment/Damage Date:10/17/02ISR Number: 3995651-2Report Type:Expedited (15-DaCompany Report #PHFR2002GB03305 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thyroxine Free Increased Foreign Clozaril (Clozapine) Vomiting Study Tablet PS ORAL 600 MG/DAY, White Blood Cell Count Health ORAL Increased Professional Other Date:10/17/02ISR Number: 3995653-6Report Type:Expedited (15-DaCompany Report #PHBS2002CH12207 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aggression Foreign Clozapine Agitation Literature (Clozapine) PS SEE IMAGE Completed Suicide Health Hallucinations, Mixed Professional Other Date:10/17/02ISR Number: 3995677-9Report Type:Expedited (15-DaCompany Report #PHBS2002CA08102 Age:54 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Foreign Clozaril (Clozapine) Other Cardiomegaly Study Tablet PS ORAL 650 MG/DAY, Central Pontine Health ORAL Myelinolysis Professional Effexor - Slow Cerebrovascular Accident Other Release (Venlafaxine Coma Hydrochloride) C Fatigue Norvasc C Heat Stroke Ditropan Locked-In Syndrome (Oxybutynin) C Neuroleptic Malignant Premarin (Estrogens Syndrome Conjugated) C Pulmonary Oedema Senokot Tablet C Renal Impairment Losec (Omeprazole) C Rhabdomyolysis 22-Feb-2006 08:30 AM Page: 1807 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/17/02ISR Number: 3996358-8Report Type:Expedited (15-DaCompany Report #PHBS2002US11935 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Withdrawal Syndrome Literature Clozapine Initial or Prolonged Leukopenia Health (Clozapine) PS 550 MG/D Paranoia Professional Sertraline Pericardial Effusion (Sertraline) C Pericarditis Divalproex Sodium Polyserositis (Valproate Speech Disorder Semisodium) C Benztropine Mesylate (Benzatropine Mesilate) C Olanzapine (Olanzapine) C Loxapine (Loxapine) C Cyproheptadine (Cyproheptadine) C Date:10/17/02ISR Number: 3996366-7Report Type:Expedited (15-DaCompany Report #PHEH2002US08816 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Enuresis Health Clozaril(Clozapine) Initial or Prolonged Gastrointestinal Disorder Professional Tablet PS ORAL 600 MG/DAY, Tachycardia ORAL Ferrous Sulfate (Ferrous Sulfate) SS Colace C Klonopin C Reglan (Metoclopramide) C Atenolol C Prozac (Fluoxetine Hydrochloride) C Date:10/17/02ISR Number: 3996377-1Report Type:Expedited (15-DaCompany Report #PHFR2002GB03219 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypertensive Crisis Foreign Clozaril (Clozapine) Shock Study Tablet PS ORAL ORAL Health Adalat C Professional Other Date:10/17/02ISR Number: 3996431-4Report Type:Expedited (15-DaCompany Report #PHEH2002US07520 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coordination Abnormal Health Clozaril Initial or Prolonged Delirium Professional (Clozapine)Tablet PS ORAL 100 MG, BID, Leukocytosis ORAL Pyrexia Geodon (Ziprasidone Renal Failure Chronic Hydrochloride) C Urinary Incontinence Depakote (Valprate Semisodium) C Atenolol C 22-Feb-2006 08:30 AM Page: 1808 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prevacid (Lansoprazole) C Valproic Acid C Date:10/17/02ISR Number: 3996500-9Report Type:Expedited (15-DaCompany Report #PHEH2002US06175 Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Other Clozaril (Clozapine) Chronic Obstructive Tablet PS ORAL 700 MG, ORAL Pulmonary Disease Pneumonia Date:10/17/02ISR Number: 3997132-9Report Type:Expedited (15-DaCompany Report #PHEH2002US08861 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Leukocytosis Health Clozaril (Clozapine) Respiratory Distress Professional Tablet PS ORAL 200 MG, TID, ORAL Risperdal (Risperidone) C Cogentin (Benzatropine Mesilate) C Diazide (Gliclazide) C Date:10/18/02ISR Number: 3995633-0Report Type:Expedited (15-DaCompany Report #C2002-2637.01 Age:46 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Health Clozapine Tablets Professional 100 Mg Mylan PS ORAL 600 MG/DAY, Other ORAL Clozapine Tablets 25 Mg Mylan SS ORAL 50MG Q HS, ORAL Ziprasidone C Buspirone C Benztropine C Phenytoin C Phenytoin C Venlafaxine C Date:10/18/02ISR Number: 3995637-8Report Type:Expedited (15-DaCompany Report #C2002-2930.01 Age:67 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg Mylan PS ORAL 12.5MG Q AM, Other 12.5MG Q HS, ORAL Carbidopa/Levodopa C 22-Feb-2006 08:30 AM Page: 1809 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/18/02ISR Number: 3996706-9Report Type:Expedited (15-DaCompany Report #PHFR2002GB03311 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril(Clozapine) Other Tablet PS ORAL UNK, UNK, ORAL Date:10/18/02ISR Number: 3996730-6Report Type:Expedited (15-DaCompany Report #PHBS2002CA11037 Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Upper Foreign Clozaril Initial or Prolonged Cholelithiasis Study (Clozapine) PS ORAL UNK, UNK, Gallbladder Pain Health ORAL Hepatomegaly Professional Jaundice Other Date:10/18/02ISR Number: 3997621-7Report Type:Expedited (15-DaCompany Report #PHEH2002US08682 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Cholesterol Health Clozaril (Clozapine) Other Increased Professional Tablet PS ORAL 550 MG/DAY, Dilatation Atrial ORAL Low Density Lipoprotein Haloperidol C Increased Risperidone Myocardial Infarction (Risperidone) C Ventricular Hypokinesia Fluoxetine (Fluoxetine) C Valproic Acid C Lorazepam C Propranolol C Amlodipine Besilate C Date:10/18/02ISR Number: 3998158-1Report Type:Expedited (15-DaCompany Report #PHEH2002US08973 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Other Clozaril (Clozapine) Other Fall Unknown PS ORAL 75 MG, QD, General Physical Health ORAL Deterioration Head Injury Date:10/21/02ISR Number: 3998229-XReport Type:Expedited (15-DaCompany Report #PHFR2002GB02592 Age:56 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Abnormal Foreign Clozaril (Clozapine) PS SEE IMAGE Initial or Prolonged Haematemesis Study Aspirine C Other Peptic Ulcer Haemorrhage Health Haloperidol C Pulse Abnormal Professional Procyclidine(Procycl White Blood Cell Count Other idine) C Increased Diazepam C 22-Feb-2006 08:30 AM Page: 1810 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/21/02ISR Number: 3998230-6Report Type:Expedited (15-DaCompany Report #PHBS2002CA10768 Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agitation Foreign Clozaril (Clozapine) Blood Urine Present Study Tablet PS ORAL 200 MG/DAY, Coma Health ORAL Delirium Professional Levaquin(Levofloxaci Depressed Level Of Other n) SS UNKNOWN 500 MG/DAY Consciousness Clonazepam C Dysarthria Ativan C Electrocardiogram Qt Lactulose C Prolonged Docusate(Docusate0 C Extrapyramidal Disorder Tylenol(Paracetamol) C Gait Disturbance Salbutamol C Metabolic Encephalopathy Ventolin C Myocarditis Cosyntropin C Nasopharyngitis Synacthen C Neuroleptic Malignant Syndrome Psychotic Disorder Tachycardia Date:10/22/02ISR Number: 3996067-5Report Type:Direct Company Report #CTU 179179 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Confusional State Clozxaril PS ORAL 300 MG PO QAM Hospitalization - Hallucination, Auditory 600MG PO Initial or Prolonged Libido Increased QHS[DAILY IN Disability Pharmaceutical Product HOSPITAL] Required Complaint Intervention to Tardive Dyskinesia Prevent Permanent Thinking Abnormal Impairment/Damage Date:10/22/02ISR Number: 3996076-6Report Type:Direct Company Report #CTU 179278 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Electrocardiogram T Wave Clozapine PS ORAL 300 MG PO BID 30 DAY Inversion Paroxetine C Eosinophil Count Increased Myocarditis Date:10/22/02ISR Number: 3996210-8Report Type:Direct Company Report #CTU 179255 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Myocarditis Clozapine PS 100MG /150MG Hospitalization - Pneumonitis Q HS Initial or Prolonged Sinus Tachycardia Olanzapine (Zyprexa) SS 10MG QHS Required Intervention to Prevent Permanent Impairment/Damage 22-Feb-2006 08:30 AM Page: 1811 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/22/02ISR Number: 3997509-1Report Type:Expedited (15-DaCompany Report #PHEH2002US08918 Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Health Clozaril (Clozapine) Leukaemia Professional Tablet PS ORAL 250 MG/DAY, ORAL Date:10/22/02ISR Number: 3997793-4Report Type:Expedited (15-DaCompany Report #C2002-2643.01 Age:42 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hepatic Cirrhosis Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 200MG QD, Other ORAL Furosemide C Lorazepam C Morphine Er Tablets C Morphine Sulfate Liquid C Pantooprazole C Risperidone C Spironolactone C Date:10/23/02ISR Number: 3999358-7Report Type:Expedited (15-DaCompany Report #PHBS2002EC12246 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ileus Paralytic Foreign Leponex(Clozapine)Ta Initial or Prolonged Health blet PS ORAL ORAL Professional Omeprazole Other (Omeprazole) C Digestive Enzymes C Date:10/23/02ISR Number: 3999364-2Report Type:Expedited (15-DaCompany Report #PHBS2002AU09436 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Foot Fracture Foreign Clozaril(Clozapine) Health Tablet PS ORAL 650 MG/D, Professional ORAL Other Date:10/23/02ISR Number: 3999375-7Report Type:Expedited (15-DaCompany Report #PHBS2002PH11493 Age:30 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypertrophy Foreign Leponex(Clozapine) Initial or Prolonged Sepsis Health Tablet PS ORAL 300 MG/DAY, Tachycardia Professional ORAL Other Rivotril C 22-Feb-2006 08:30 AM Page: 1812 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/23/02ISR Number: 3999376-9Report Type:Expedited (15-DaCompany Report #PHNU2002DE03421 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Benign Breast Neoplasm Foreign Leponex/Clozaril Fibroma Health (Clozapine)(Clozapin Hyperprolactinaemia Professional e) Tablet PS ORAL 75MG/DAY,ORAL Other 150MG/DAY, ORAL Impromen(Bromperidol ) SS ORAL ORAL Date:10/23/02ISR Number: 3999378-2Report Type:Expedited (15-DaCompany Report #PHBS2002AU08598 Age:49 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Overdose Foreign Clozaril(Clozapine) Initial or Prolonged Balance Disorder Study Tablet PS ORAL SEE IMAGE Dizziness Health Dysarthria Professional Medication Error Other Neutrophil Count Increased Treatment Noncompliance White Blood Cell Count Increased Date:10/23/02ISR Number: 3999391-5Report Type:Expedited (15-DaCompany Report #PHBS2002AU09991 Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Decreased Foreign Clozaril (Clozapine) Initial or Prolonged Diabetes Mellitus Health Tablet PS ORAL 400 MG/D, Hepatic Steatosis Professional ORAL Pancreatitis Other Glimepiride C Somnolence Pethidine C Epilim C Ditropan (Oxybutynin) C Avandia (Rosiglitazone Maleate) C Gemfibrozil C Date:10/23/02ISR Number: 3999393-9Report Type:Expedited (15-DaCompany Report #PHNU2002DE02505 Age:23 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Fatigue Foreign Leponex / Clozaril Hypothyroidism Health (Clozapine) Professional (Clozapine) Tablet PS ORAL ORAL Other Tavor C 22-Feb-2006 08:30 AM Page: 1813 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/23/02ISR Number: 3999455-6Report Type:Expedited (15-DaCompany Report #PHFR2002GB02976 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Foreign Clozaril (Clozapine) Autonomic Neuropathy Study (Clozapine) Tablet PS ORAL ORAL Dizziness Health Sodium Valproate C Hypotension Professional Lamotrigine C Overdose Other Amisulpride Tachycardia (Amisulpride) C Zopiclone C Diazepam C Date:10/23/02ISR Number: 3999461-1Report Type:Expedited (15-DaCompany Report #PHFR2002GB03309 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Withdrawal Syndrome Foreign Clozaril(Clozapine) Initial or Prolonged Shock Study Tablet PS ORAL 300MG/DAY, Health ORAL Professional Other Date:10/23/02ISR Number: 3999511-2Report Type:Expedited (15-DaCompany Report #PHEH2002US05738 Age:16 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Faeces Health Clozaril (Clozapine) Initial or Prolonged Chills Professional Tablet PS ORAL 12.5 MG, BID; Diarrhoea 100 MG, TID, Drooling ORAL Drug Withdrawal Syndrome Depakote (Valproate Dysphagia Semisodium) C Dyspnoea Celexa C Hallucination Artane Head Injury (Trihexyphenidyl Hypoxia Hydrochloride) C Lethargy Risperdal Liver Function Test (Risperidone) C Abnormal Musculoskeletal Stiffness Neuroleptic Malignant Syndrome Pancreatitis Tachycardia Vomiting Date:10/23/02ISR Number: 3999754-8Report Type:Expedited (15-DaCompany Report #PHEH2002US08998 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukaemia Health Clozaril(Clozapine) Professional Tablet PS ORAL ORAL Clozapine(Clozapine) SS ORAL 650 MG, QD, ORAL Risperdal (Risperidone) C Cogentin (Benzatropine 22-Feb-2006 08:30 AM Page: 1814 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Mesilate) C Date:10/23/02ISR Number: 3999759-7Report Type:Expedited (15-DaCompany Report #PHEH2002US08917 Age:73 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozaril(Clozapine) Coronary Artery Disease Professional Tablet PS ORAL 125 MG/DAY, Parkinson'S Disease ORAL Sinemet C Date:10/24/02ISR Number: 3999325-3Report Type:Expedited (15-DaCompany Report #02-09-0821 Age:53 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals ORAL 600MG QD ORAL Zyprexa C Detrol La C Depakote C Date:10/24/02ISR Number: 3999331-9Report Type:Expedited (15-DaCompany Report #02-10-0916 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Respiratory Failure Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc ORAL 12.5-200MG QD ORAL Date:10/24/02ISR Number: 3999333-2Report Type:Expedited (15-DaCompany Report #02-10-0915 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Respiratory Health Clozapine - Ivax Distress Syndrome Professional Pharmaceuticals, Inc PS Ivax Intestinal Obstruction Other Pharmaceuticals, Inc ORAL 600-800MG QD Post Procedural ORAL Complication Date:10/24/02ISR Number: 4000133-8Report Type:Expedited (15-DaCompany Report #PHEH2002US09028 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Health Clozaril(Clozapine) Initial or Prolonged Drug Interaction Professional Tablet PS 500 MG/DAY, Drug Level Increased ORAL; 25 Medication Error MG/DAY, ORAL; 50 MG/DAY Ativan C Tylenol W/Codeine No. 3 (Paracetamol) C Depakote (Valproate Semisodium) C Synthroid C 22-Feb-2006 08:30 AM Page: 1815 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prilosec (Omeprazole) C Albuterol C Date:10/24/02ISR Number: 4000424-0Report Type:Expedited (15-DaCompany Report #PHRM2002FR02543 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Level Above Foreign Leponex (Clozapine) Therapeutic Health Tablet PS ORAL ORAL Overdose Professional Teralhite (Lithium Suicide Attempt Other Carbonate) SS ORAL ORAL Toxicologic Test Abnormal Amoxapine (Amoxapine) C Diazepam C Date:10/24/02ISR Number: 4000426-4Report Type:Expedited (15-DaCompany Report #PHRM2002FR02509 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Lymphopenia Foreign Leponex (Clozapine) Initial or Prolonged Pyrexia Health Tablet PS 200 MG PER Other White Blood Cell Count Professional DAY Decreased Other Date:10/25/02ISR Number: 4002158-5Report Type:Expedited (15-DaCompany Report #C2002-2992.01 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pharmaceutical Product Health Clozapine Tablets Complaint Professional 100 Mg Mylan PS Mylan ORAL 300 MG BID, Other ORAL Date:10/28/02ISR Number: 4000503-8Report Type:Expedited (15-DaCompany Report #02-07-0660 Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Health Clozapine - Ivax Initial or Prolonged Dyspnoea Professional Pharmaceuticals, Haemothorax Inc. Tablets PS Ivax Lobar Pneumonia Pharmaceuticals, Palpitations Inc. ORAL 400MG BID Pleural Effusion ORAL Pneumonia Divalproex Sodium SS ORAL 1000MG BID Tuberculin Test Positive ORAL Haloperidol C Date:10/28/02ISR Number: 4000504-XReport Type:Expedited (15-DaCompany Report #02-10-0920 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Congestive Cardiomyopathy Health Clozapine - Ivax Mitral Valve Incompetence Professional Pharmaceuticals, Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 200MG AM 22-Feb-2006 08:30 AM Page: 1816 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL; 400MG HS ORAL Clozaril Tablets SS ORAL ORAL Doxepin C Prozac C Date:10/28/02ISR Number: 4002319-5Report Type:Expedited (15-DaCompany Report #GB9214521OCT2002 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Health Ativan (Lorazepam, Professional Injection, 0) PS INTRAMUSCULAR 2 MG IM Other Clozapine (Clozapine, , 0) SS ORAL 450 MG ORAL Amisulpride (Amisulpride) C Sertaline (Sertraline) C Valproate Sodium (Valproate Sodium) C Hyoscine (Hyoscine) C Date:10/28/02ISR Number: 4002402-4Report Type:Expedited (15-DaCompany Report #DE9209317OCT2002 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Overdose Health Tavor (Lorazepam, Initial or Prolonged Sedation Professional Tablet, 0) PS ORAL 10 TABLETS Suicide Attempt (OVERDOSE Vomiting AMOUNT 5MG) ORAL Leponex (Clozapine, , ) SS ORAL 50 TABLETS (OVERDOSE AMOUNT 2500 MG ORAL Solian (Amisulpride, , 0) SS ORAL 100 TABLETS (OVERDOSE COUNT 10G) ORAL Zoloft (Sertraline Hydrochloride, , 0) SS ORAL 100 TABLETS (OVERDOSE AMOUNT 10G) ORAL Date:10/28/02ISR Number: 4002558-3Report Type:Expedited (15-DaCompany Report #PHBS2002AU09362 Age:47 YR Gender:Male I/FU:F Outcome PT Hospitalization - Autoimmune Initial or Prolonged Thrombocytopenia Other Haematocrit Decreased Haemoglobin Decreased Hepatitis C Leukocytosis Pneumonia 22-Feb-2006 08:30 AM Page: 1817 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Red Blood Cell Count Decreased Report Source Product Role Manufacturer Route Dose Duration Foreign Clozaril(Clozapine) Study Unknown PS 300 MG/D Health Artane Professional (Thrihexyphenidyl Other Hydrochloride) C Date:10/28/02ISR Number: 4002561-3Report Type:Expedited (15-DaCompany Report #PHFR2002GB02592 Age:56 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Abnormal Foreign Clozaril(Clozapine)T Initial or Prolonged Haematemesis Study ablet PS ORAL ORAL; SEE Other Haemorrhage Health IMAGE Peptic Ulcer Haemorrhage Professional Aspirine C Pulse Abnormal Other Haloperidol C White Blood Cell Count Procyclidine Increased (Procyclidine) C Diazepam C Date:10/28/02ISR Number: 4002651-5Report Type:Expedited (15-DaCompany Report #PHBS2002AU09761 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Foreign Clozaril (Clozapine) Initial or Prolonged Drug Level Increased Study Tablet PS ORAL 500 MG/DAY, Lipids Increased Health ORAL 400 Mental Impairment Professional MG/DAY, ORAL Other 100 MG/BID,ORAL Date:10/29/02ISR Number: 4001126-7Report Type:Direct Company Report #CTU 179793 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Clozapine -Mylan PS Mylan 25MG BID Pharmaceutical Product Complaint Date:10/29/02ISR Number: 4001152-8Report Type:Expedited (15-DaCompany Report #C2002-3050.01 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 100 MG Q Other AM,400MG QPM ORAL Benztropine C Clonazepam C Haloperidol C Unknown Inhalers C Lansoprazole C Morphine C Paroxetine C 22-Feb-2006 08:30 AM Page: 1818 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/29/02ISR Number: 4001627-1Report Type:Expedited (15-DaCompany Report #PHBS2002NZ12748 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Foreign Clozapine(Clozapine) PS SEE IMAGE Drug Interaction Literature Omeprazole(Omeprazol Drug Level Increased Health e) SS Professional Other Date:10/29/02ISR Number: 4001629-5Report Type:Expedited (15-DaCompany Report #PHBS2002NZ12747 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Foreign Clozapine(Clozapine) PS 475 MG/D Drug Interaction Literature Omeprazole(Omeprazol Drug Level Increased Health e) SS Loss Of Consciousness Professional Date:10/29/02ISR Number: 4002988-XReport Type:Expedited (15-DaCompany Report #2002AP03327 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Convulsion Foreign Losec PS Intervention to Drug Interaction Literature Clozapine SS 475 MG DAILY 3 YR Prevent Permanent Drug Level Increased Health Impairment/Damage Loss Of Consciousness Professional Other Date:10/29/02ISR Number: 4003133-7Report Type:Expedited (15-DaCompany Report #2002UW14288 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asthenia Foreign Seroquel PS ORAL 325 MG DAILY Blood Pressure Decreased Health PO Convulsion Professional Alesse SS ORAL 1 DF DAILY PO Drug Interaction Other Topamax SS ORAL 150 MG BID PO Drug Level Increased Clozaril SS ORAL 400 MG DAILY Dyspnoea PO Oedema Peripheral Effexor - Slow Pulmonary Embolism Release SS ORAL 187.5 MG Tachycardia DAILY PO Ativan C Flonase C Haldol "Janssen" C Vitamin B12 C Date:10/29/02ISR Number: 4003543-8Report Type:Expedited (15-DaCompany Report #PHEH2002US07613 Age:51 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Circulatory Collapse Health Clozaril (Clozapine) Initial or Prolonged Cognitive Disorder Professional Tablet PS ORAL 300 MG, BID, Drug Level Increased ORAL Fall Sythroid C Muscular Weakness Toprol Xl Tooth Abscess (Metoprolol Tooth Extraction Succinate) C 22-Feb-2006 08:30 AM Page: 1819 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Protonix "Pharmcia" C Colace C Anafranil C Niacin C Artane (Trihexyphenidyl Hydrochloride) C Tricor (Fenofibrate) C Anafranil C Date:10/30/02ISR Number: 4002411-5Report Type:Direct Company Report #CTU 180001 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Congestive Cardiomyopathy Clozapine 100mg Tabs 2 Am 4 Hs PS Prozac C Doxepin C Ativan C Date:10/30/02ISR Number: 4002563-7Report Type:Expedited (15-DaCompany Report #C2002-2837.01 Age:55 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Chronic Obstructive Health Clozapine Tablets 25 Pulmonary Disease Professional Mg Mylan PS Mylan ORAL 25 MG QD, Other ORAL Clozapine Tablets 100 Mg Mylan SS Mylan ORAL 100 MG QD, ORAL Divalproex C Prednisone C Quinapril C Albuterol C Nebulizer Solution C Ipratropium Nebulizer Solution C Diltiazem Xt C Amlodipine C Cefuroxime C Date:10/30/02ISR Number: 4002566-2Report Type:Expedited (15-DaCompany Report #C2002-2491.01 Age:84 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Fall Health Clozapine Tablets 25 Hip Fracture Professional Mg Mylan PS Mylan ORAL 12.5 MG QD, Infection Other ORAL Carbidopa/Levodopa C Ciprofloxacin C Docusate/Casanthrano C Levofloxacin C Morphine C Propoxyphene/Acetami nophen C Simethicone C Tramodol C Warfarin C 22-Feb-2006 08:30 AM Page: 1820 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Calcium Carbonate C Hydrochlorothiazide C Lorazepam C Acetaminophen C Ciprofloxacin C Date:10/30/02ISR Number: 4002568-6Report Type:Expedited (15-DaCompany Report #C2002-3034.01 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Neoplasm Malignant Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 200 MG Q AM, Other 700MG Q HS, ORAL Date:10/30/02ISR Number: 4004009-1Report Type:Expedited (15-DaCompany Report #PHEH2002US09127 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Health Clozaril (Clozapine) Initial or Prolonged Phosphokinase Increased Professional Tablet PS ORAL 350 MG BID Psychotic Disorder ORAL Urinary Tract Infection Paxil C Ativan C Date:10/30/02ISR Number: 4004012-1Report Type:Expedited (15-DaCompany Report #PHEH2002US08918 Age:64 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Health Clozaril (Clozapine) Leukaemia Professional Tablet PS ORAL 250 MG DAY ORAL Chemotherapeutics, Other (Chemotherapeutics,O ther) SS Date:10/30/02ISR Number: 4004244-2Report Type:Expedited (15-DaCompany Report #PHFR2002GB03377 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Foreign Clozaril (Clozapine) Health Tablet PS ORAL 450 MG/DAY, Professional ORAL Other Lorazepam (Lorazepam) SS INTRAMUSCULAR 2 MG/DAY, INTRAMUSCULAR Amisulpride (Amisulpride) C Sertraline (Sertraline) C Valaproate Sodium C Hyoscine (Hyoscine) C 22-Feb-2006 08:30 AM Page: 1821 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/30/02ISR Number: 4004294-6Report Type:Expedited (15-DaCompany Report #PHEH2002US09148 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Clozaril(Clozapine) Gun Shot Wound Professional Tablet PS ORAL 800 MG/DAY, Hallucination, Auditory ORAL Date:10/30/02ISR Number: 4004302-2Report Type:Expedited (15-DaCompany Report #PHEH2002US09140 Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Decubitus Ulcer Health Clozaril(Clozapine) Professional Tablet PS ORAL 137.5 MG/DAY, ORAL Date:10/30/02ISR Number: 4004517-3Report Type:Expedited (15-DaCompany Report #PHEH2002US08973 Age:75 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebral Haemorrhage Health Clozaril (Clozapine) PS ORAL 75 MG, QD, Other Fall Professional ORAL Head Injury Date:10/30/02ISR Number: 4004522-7Report Type:Expedited (15-DaCompany Report #PHEH2002US08003 Age:82 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Clozaril (Clozapine) Respiratory Distress Professional Tablet PS ORAL 50 MG, ORAL Date:10/31/02ISR Number: 4004049-2Report Type:Expedited (15-DaCompany Report #2002AP03326 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Convulsion Foreign Losec PS 2 WK Intervention to Drug Interaction Literature Clozapine SS 600 MG DAILY 2 WK Prevent Permanent Drug Level Increased Health Clozapine SS 300 MG DAILY Impairment/Damage Professional Other Date:10/31/02ISR Number: 4005011-6Report Type:Expedited (15-DaCompany Report #PHBS2002CA07638 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Congestive Cardiomyopathy Foreign Clozaril (Clozapine) Study Tablet PS ORAL ORAL Health Professional Other 22-Feb-2006 08:30 AM Page: 1822 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/01/02ISR Number: 4005188-2Report Type:Expedited (15-DaCompany Report #02-10-0944 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 25-125MG QD ORAL Date:11/01/02ISR Number: 4005189-4Report Type:Expedited (15-DaCompany Report #02-10-0946 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Gastrointestinal Disorder Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 250-800MG QD ORAL Date:11/01/02ISR Number: 4005193-6Report Type:Expedited (15-DaCompany Report #02-10-0953 Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 250-450MG QD ORAL Date:11/01/02ISR Number: 4005197-3Report Type:Expedited (15-DaCompany Report #02-10-0954 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Lung Neoplasm Malignant Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc ORAL 300-600MG QD ORAL Date:11/01/02ISR Number: 4005204-8Report Type:Expedited (15-DaCompany Report #02-09-0819 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ascites Health Clozapine - Ivax Initial or Prolonged Eosinophilia Professional Pharmaceuticals, Hepatitis Other Inc. Tablets PS Ivax Leukocytosis Pharmaceuticals, Pericardial Effusion Inc. ORAL 250MG QHS Pleural Effusion ORAL Splenomegaly Trilafon C 22-Feb-2006 08:30 AM Page: 1823 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/01/02ISR Number: 4005218-8Report Type:Expedited (15-DaCompany Report #02-10-0940 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Haemolytic Uraemic Health Clozapine - Ivax Initial or Prolonged Syndrome Professional Pharmaceuticals, Thrombotic Other Inc. Tablets PS Ivax Thrombocytopenic Purpura Pharmaceuticals, Inc. ORAL 600MG QD ORAL Date:11/01/02ISR Number: 4005224-3Report Type:Expedited (15-DaCompany Report #C2002-3104.01 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 600MG QD, Other ORAL Quetiapine Fumarate C Date:11/01/02ISR Number: 4005234-6Report Type:Expedited (15-DaCompany Report #C2002-3077.01 Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Other Clozapine Tablets 100 Mg Mylan PS Mylan ORAL 300 MG DAY, ORAL Clozapine Tablets 25 Mg Mylan SS Mylan ORAL 25 MG/DAY/ORAL Date:11/01/02ISR Number: 4005241-3Report Type:Expedited (15-DaCompany Report #C2002-3155.01 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Intentional Self-Injury Health Clozapine Tablets Other Tongue Biting Professional 100 Mg Mylan PS Mylan ORAL 300MG BID, TAPERED OFF, ORAL Date:11/01/02ISR Number: 4005243-7Report Type:Expedited (15-DaCompany Report #C2002-3078.01 Age:89 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 50MG, QD, Other ORAL Acidophillus C Aspirin C Bisacodyl C Cephalexin C Digoxin C Docusate C Ferrous Sulfate C Furosemide C Hydrocortisone Cream C Ibuprofen C Lorazepam C 22-Feb-2006 08:30 AM Page: 1824 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Milk Of Magnesia C Morphine C Moxifloxacin C Multivitamins C Potassium C Quetiapine C Ranitidine C Tylenol With Codeine C Venlafaxine C Date:11/01/02ISR Number: 4005519-3Report Type:Expedited (15-DaCompany Report #2002UW14393 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Dizziness Foreign Seroquel PS ORAL 500 MG QD PO Intervention to Loss Of Consciousness Health Clozaril SS ORAL 150 MG QD PO Prevent Permanent Professional Nifedipine C Impairment/Damage Other Date:11/04/02ISR Number: 4003665-1Report Type:Direct Company Report #CTU 180289 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Clozapine 100mg PS 1 Q AM, 1 4 Drug Effect Decreased PM, 3 HS Pharmaceutical Product Complaint Psychotic Disorder Date:11/04/02ISR Number: 4005930-0Report Type:Expedited (15-DaCompany Report #PHEH2002US08599 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Ineffective Health Clozaril (Clozapine) Hodgkin'S Disease Professional Tablet PS ORAL 400 MG/DAY, Leukopenia ORAL; SEE IMAGE Date:11/04/02ISR Number: 4006210-XReport Type:Expedited (15-DaCompany Report #PHFR2002GB03448 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Ketoacidosis Foreign Clozaril PS ORAL ORAL Initial or Prolonged Health Professional Other Date:11/04/02ISR Number: 4006213-5Report Type:Expedited (15-DaCompany Report #PHBS2002AU08809 Age:34 YR Gender:Male I/FU:F Outcome PT Hospitalization - Oesophageal Haemorrhage Initial or Prolonged Oesophageal Rupture Oesophageal Ulcer Haemorrhage Oesophagitis 22-Feb-2006 08:30 AM Page: 1825 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Stomach Discomfort Vomiting Report Source Product Role Manufacturer Route Dose Duration Foreign Clozaril PS ORAL 350 MG/D, Health ORAL Professional Other Date:11/05/02ISR Number: 4003416-0Report Type:Expedited (15-DaCompany Report #B0283622A Age:66 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Glucose Increased Consumer Deroxat PS Glaxo Wellcome ORAL 20MG Per day Blood Pressure Decreased Trimebutine SS ORAL 3UNIT Per day 32 DAY Bradycardia Leponex SS ORAL 500MG Per day Depressed Level Of Lepticur SS ORAL 5MG Per day Consciousness Diamicron SS ORAL 160MG Per day Diarrhoea Depakine SS ORAL 600MG Per day Fatigue Noctamide C Pyrexia Heptamyl C ORAL 45DROP Three Tachycardia times per day Torsade De Pointes Seglor C ORAL 90DROP Per Ventricular Failure day Tranxene C ORAL Tercian C INTRAMUSCULAR Date:11/05/02ISR Number: 4006686-8Report Type:Expedited (15-DaCompany Report #PHEH2002US09299 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aggression Health Clozaril (Clozapine) Hospitalization - Choking Professional Tablet PS ORAL 250 MG, BID, Initial or Prolonged Delusion ORAL Fall Altace (Ramipril) C Weight Decreased Pravacol C Asa C Lotensin C Atrovent (Ipratropium Bromide) C Ambien (Zolpidem Tartrate) C Date:11/05/02ISR Number: 4006688-1Report Type:Expedited (15-DaCompany Report #PHEH2002US09332 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Health Clozaril (Clozapine) Salivary Hypersecretion Professional Tablet PS ORAL 300 MG, BID, ORAL Zyprexa (Olanzapine) SS Lithium (Lithium) C Artane (Trihexyphenidyl Hydrochloride) C Glucotrol Xl (Glipizide) C Actos / Usa / 22-Feb-2006 08:30 AM Page: 1826 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Pioglitazone Hydrochloride, Pioglitazone) C Date:11/05/02ISR Number: 4006689-3Report Type:Expedited (15-DaCompany Report #PHEH2002US09300 Age:67 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Breast Cancer Health Clozaril (Clozapine) Other Breast Mass Professional Tablet PS ORAL 325 MG, ORAL Leukopenia Chemotherapeutic , Other (Chemotherapeutics, Other) SS Prempro (Estrogens Conjugated) C Levoxyl C Buspar C Xanax (Alprazolam) C Date:11/05/02ISR Number: 4006844-2Report Type:Expedited (15-DaCompany Report #PHRM2002FR02696 Age:1 DY Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Malaise Foreign Leponex (Clozapine) Initial or Prolonged Maternal Drugs Affecting Health Tablet PS TRANSPLACENTAL TRANSPLACENTA Foetus Professional L Neonatal Apnoeic Attack Other Neonatal Respiratory Distress Syndrome Oxygen Saturation Decreased Premature Baby Premature Labour Date:11/05/02ISR Number: 4006845-4Report Type:Expedited (15-DaCompany Report #PHRM2002FR02695 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Complications Of Maternal Foreign Leponex (Clozapine) Initial or Prolonged Exposure To Therapeutic Health Tablet PS ORAL 300 MG PER Drugs Professional DAY, ORAL Maternal Drugs Affecting Other Foetus Premature Baby Premature Labour Date:11/05/02ISR Number: 4006846-6Report Type:Expedited (15-DaCompany Report #PHNU2002DE03551 Age:34 YR Gender:Female I/FU:I Outcome PT Hospitalization - Breech Presentation Initial or Prolonged Caesarean Section Other Complications Of Maternal Exposure To Therapeutic Drugs Drug Exposure Via Breast Milk 22-Feb-2006 08:30 AM Page: 1827 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Maternal Drugs Affecting Foetus Pregnancy Report Source Product Role Manufacturer Route Dose Duration Premature Baby Foreign Leponex / Clozaril Premature Rupture Of Consumer (Clozapine) Membranes Other (Clozapine) Tablet PS ORAL 12.5 MG/DAY, ORAL Date:11/05/02ISR Number: 4006857-0Report Type:Expedited (15-DaCompany Report #PHNU2002DE03516 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pancreatitis Necrotising Foreign Leponex / Clozaril Health (Clozapine) Professional (Clozapine) Tablet PS ORAL 200 TO 250 Other MG/DAY, ORAL Date:11/05/02ISR Number: 4006858-2Report Type:Expedited (15-DaCompany Report #PHFR2002GB03121 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Foreign Clozaril (Clozapine) Bundle Branch Block Study (Clozapine) Tablet PS ORAL ORAL; 150 Constipation Health MG, BID, ORAL Electrocardiogram T Wave Professional Abnormal Other Hypotension Malaise Tachycardia Date:11/05/02ISR Number: 4006863-6Report Type:Expedited (15-DaCompany Report #PHFR2002GB00920 Age:30 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyspnoea Exertional Foreign Clozaril (Clozapine) Electrocardiogram Qt Health Tablet PS ORAL 325MG/DAY, Corrected Interval Professional ORAL Prolonged Other Paroxetine C Tachycardia Benzhexol (Trihexyphenidyl) C Ranitidine C Date:11/05/02ISR Number: 4006968-XReport Type:Expedited (15-DaCompany Report #PHNU2002DE03347 Age:52 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cataract Foreign Leponex / Clozaril Vitreous Opacities Health (Clozapine) Professional (Clozapine) Tablet PS ORAL 25 TO 75 Other MG/DAY, ORAL 22-Feb-2006 08:30 AM Page: 1828 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/06/02ISR Number: 4006909-5Report Type:Expedited (15-DaCompany Report #C2002-3080.01 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Facial Palsy Health Clozapine Tablets Initial or Prolonged Pharmaceutical Product Professional 100 Mg Mylan PS Mylan ORAL 300 MG Q HS, Other Complaint Other ORAL Viral Infection Acetaminophen C Cocusate Sodium/Casanthranol C Lansoprazole C Lorazepam C Magnesium Hydroxide C Nicotine Transdermal C Date:11/06/02ISR Number: 4006911-3Report Type:Expedited (15-DaCompany Report #C2002-3130.01 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Appendicitis Perforated Health Clozapine Tablets Cardiac Arrest Professional 100 Mg Mylan PS Mylan ORAL 100 MG Q AM, Peritonitis Other 100MG G 4PM, 500 MG QHS, ORAL Divalproex Sodium C Docusate Sodium C Folic Acid C Lactulose C Lithium Carbonate C Multivitamin C Olanzapine C Topiramate C Vitamin C C Date:11/06/02ISR Number: 4006912-5Report Type:Expedited (15-DaCompany Report #C2002-2643.01 Age:42 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 200 MG QD, Other ORAL Furosemide C Lorazepam C Morphine Er Tablets C Morphine Sulfate Liquid C Pantoprazole C Risperidone C Spironolactone C Date:11/06/02ISR Number: 4007902-9Report Type:Expedited (15-DaCompany Report #PHBS2002AU09757 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Foreign Clozaril(Clozapine) Initial or Prolonged Drug Level Increased Health Tablet PS ORAL 350 MG/DAY, Hypotonia Professional ORAL Infection Other Barbiturates(No Overdose Ingredients/Substanc 22-Feb-2006 08:30 AM Page: 1829 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report es) SS Date:11/06/02ISR Number: 4008558-1Report Type:Expedited (15-DaCompany Report #PHBS2002CH12207 Age:52 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aggression Foreign Clozapine Agitation Literature (Clozapine) PS SEE IMAGE Catatonia Health Completed Suicide Professional Fear Other Hallucination, Auditory Hallucinations, Mixed Suicidal Ideation Date:11/07/02ISR Number: 4008337-5Report Type:Expedited (15-DaCompany Report #PHFR2002GB03487 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Self-Injury Foreign Clozaril (Clozapine) Initial or Prolonged Study Tablet PS ORAL ORAL Health Professional Other Date:11/07/02ISR Number: 4008391-0Report Type:Expedited (15-DaCompany Report #C2002-3156.01 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Health Clozapine Tablets Mitral Valve Prolapse Professional 100 Mg Mylan PS Mylan ORAL 200MG TID, Other ORAL Docusate Sodium C Date:11/07/02ISR Number: 4008520-9Report Type:Expedited (15-DaCompany Report #PHFR2002IE03107 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Amylase Increased Foreign Clozaril (Clozapine) Initial or Prolonged Headache Study Tablet PS ORAL SEE IMAGE Intentional Overdose Health Paracetamol Lethargy Professional (Paracetamol) Tablet SS ORAL SEE IMAGE Loss Of Consciousness Other Nausea Somnolence Suicide Attempt Tachycardia Vomiting Date:11/07/02ISR Number: 4008883-4Report Type:Expedited (15-DaCompany Report #02P-163-0203153-00 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Aggression Health Depakote 500mg Intervention to Convulsion Professional (Depakote) Prevent Permanent Headache Other (Divalproex Sodium) Impairment/Damage (Divalproex Sodium) PS ORAL 500 MG, 2 IN 22-Feb-2006 08:30 AM Page: 1830 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report 1 D, PER ORAL Clozapine SS ORAL 200 MG, 2 IN 1 D, PER ORAL Sertraline Hydrochloride C Date:11/07/02ISR Number: 4008982-7Report Type:Expedited (15-DaCompany Report #PHBS2002CA13121 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Disease Recurrence Foreign Clozaril (Clozapine) PS UNK, UNK, Drug Interaction Health UNKNOWN Psychotic Disorder Professional Biaxin Other (Clarithromycin) C Date:11/07/02ISR Number: 4009294-8Report Type:Expedited (15-DaCompany Report #PHEH2002US09329 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Breast Cancer Health Clozaril (Clozapine) Initial or Prolonged Leukopenia Professional Tablet PS ORAL 800 MG/DAY, Other Postoperative Infection ORAL Ditropan (Oxybutynin) C Prozac (Fluoxetine Hydrochloride) C Depakote (Valproate Semisodium) C Ativan C Risperdal (Risperidone) C Chemotherapeutics, Other (Chemotherapeutics, Other) C Date:11/08/02ISR Number: 4009091-3Report Type:Expedited (15-DaCompany Report #PHEH2002US09420 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Suicide Attempt Health Clozaril(Clozapine) Initial or Prolonged Tachycardia Professional Tablet PS ORAL 325 MG, QD, ORAL Prozac (Fluoxetine Hydrochloride) C Hydroxyzine (Hydroxyzine) C Neurontin (Gabapentin) C Date:11/08/02ISR Number: 4009094-9Report Type:Expedited (15-DaCompany Report #PHEH2002US09127 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Health Clozaril(Clozapine) Initial or Prolonged Phosphokinase Increased Professional Tablet PS ORAL 25 & 350 MG, Psychotic Disorder QHS, ORAL Urinary Tract Infection Paxil C 22-Feb-2006 08:30 AM Page: 1831 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Ativan C Date:11/08/02ISR Number: 4009362-0Report Type:Expedited (15-DaCompany Report #PHNU2002DE02850 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dystonia Foreign Leponex/Clozaril Pleurothotonus Health (Clozapine)(Clozapin Professional e) Tablet PS ORAL ORAL Other Date:11/08/02ISR Number: 4009364-4Report Type:Expedited (15-DaCompany Report #PHBS2002NZ10116 Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Catecholamines Urine Foreign Clozaril (Clozapine) Increased Health Tablet PS ORAL 12.5 MG/D, Chest Pain Professional ORAL; 25 Headache Other MG/D, ORAL; Hypertension 75 MG/D, ORAL Premarin (Estrogens Conjugated) C Omeprazole (Omeprazole) C Nitrazepam C Clonazepam C Fluoxetine (Fluoxetine) C Date:11/08/02ISR Number: 4009723-XReport Type:Expedited (15-DaCompany Report #PHEH2002US09111 Age:86 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coma Health Clozaril (Clozapine) Dehydration Professional Tablet PS ORAL 12.5 MG/DAY, Pneumonia Aspiration ORAL; 25 Renal Failure MG/DAY, ORAL Date:11/08/02ISR Number: 4009756-3Report Type:Expedited (15-DaCompany Report #PHEH2002US09401 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Intraocular Melanoma Health Clozaril(Clozapine) Professional Tablet PS ORAL 200 MG, Company BID,ORAL Representative Depakote (Valproate Semisodium) C Klonopin C Date:11/08/02ISR Number: 4009913-6Report Type:Expedited (15-DaCompany Report #PHEH2002US09451 Age:81 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Aspiration Other Clozaril (Clozapine) Tablet PS ORAL 88 MG/DAY, ORAL 22-Feb-2006 08:30 AM Page: 1832 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/08/02ISR Number: 4009915-XReport Type:Expedited (15-DaCompany Report #PHEH2002US02534 Age:57 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arthralgia Other Clozaril (Clozapine) Other Circulatory Collapse Tablet PS ORAL 600 MG, QD, Drug Level Increased ORAL Drug Toxicity Paxil C Hepatic Steatosis Lorazepam C Osteoarthritis Shock Uterine Leiomyoma Date:11/08/02ISR Number: 4010117-1Report Type:Expedited (15-DaCompany Report #PHFR2002IE03525 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Congestive Cardiomyopathy Foreign Clozaril (Clozapine) Sudden Death Study Tablet PS ORAL 600 MG/DAY, Health ORAL Professional Sulpiride Other (Sulpiride) C Date:11/08/02ISR Number: 4010163-8Report Type:Expedited (15-DaCompany Report #PHBS2002AU09761 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Foreign Clozaril(Clozapine) Initial or Prolonged Drug Level Increased Study Tablet PS ORAL SEE IMAGE Mental Impairment Health Professional Other Date:11/08/02ISR Number: 4010169-9Report Type:Expedited (15-DaCompany Report #PHRM2002FR02168 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatitis A Foreign Leponex(Clozapine) Initial or Prolonged Health Tablet PS ORAL 12.5 MG, QD, Other Professional ORAL Other Exelon (Rivastigmine Tartrate) C Date:11/08/02ISR Number: 4010243-7Report Type:Expedited (15-DaCompany Report #PHFR2002GB03305 Age:34 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Bilirubin Increased Foreign Clozaril (Clozapine) Gilbert'S Syndrome Study Tablet PS ORAL 600 MG/DAY, Spherocytic Anaemia Health ORAL Thyroxine Free Increased Professional Valproate Sodium C Vomiting Other Folic Acid C White Blood Cell Count Multivitamins Increased (Retinol, Panthenol, Ascorbic Acid) C Diazepam C 22-Feb-2006 08:30 AM Page: 1833 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/08/02ISR Number: 4010620-4Report Type:Expedited (15-DaCompany Report #PHNU2002DE03628 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Oculogyration Foreign Leponex / Clozaril Weight Increased Health (Clozapine) Professional (Clozapine) Tablet PS ORAL 225 MG/DAY, Other ORAL Date:11/08/02ISR Number: 4012028-4Report Type:Expedited (15-DaCompany Report #PHBS2002BR11745 Age:49 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutrophil Count Foreign Clozaril(Clozapine) Decreased Health Tablet PS ORAL 100 MG, BID, Platelet Count Decreased Professional ORAL Psoriasis Other Lorax (Loracarbef) White Blood Cell Count Tablet C Decreased Date:11/08/02ISR Number: 4012271-4Report Type:Expedited (15-DaCompany Report #PHBS2002AU13078 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pancytopenia Foreign Clozaril(Clozapine) Health Tablet PS ORAL ORAL Professional Fludarabine Other (Fludarabine) C Chemotherapeutics, Other (Chemotherapeutics, Other) C Date:11/11/02ISR Number: 4008323-5Report Type:Direct Company Report #CTU 180665 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eosinophilia Clozapine 25mg Tachycardia Ivax PS Ivax ORAL 75 PO BID Date:11/13/02ISR Number: 4010634-4Report Type:Expedited (15-DaCompany Report #C2002-3124.01 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 100MG TID, Other ORAL Date:11/13/02ISR Number: 4010636-8Report Type:Expedited (15-DaCompany Report #C2002-2637.01 Age:46 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Health Clozapine Tablets Head Injury Professional 100 Mg Mylan PS Mylan ORAL 600MG/DAY, Other ORAL Clozapine Tablets 25 Mg Mylan SS Mylan ORAL 50MG Q HS, 22-Feb-2006 08:30 AM Page: 1834 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL Ziprasidone C Buspirone C Benztropine C Phenytoin C Venlafaxine Er C Date:11/13/02ISR Number: 4010642-3Report Type:Expedited (15-DaCompany Report #02-10-0976 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hernia Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc ORAL 700MG QD ORAL Date:11/13/02ISR Number: 4010643-5Report Type:Expedited (15-DaCompany Report #02-10-0975 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 25-800MG QD ORAL Date:11/13/02ISR Number: 4010644-7Report Type:Expedited (15-DaCompany Report #02-10-0974 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dehydration Health Clozapine - Ivax Initial or Prolonged Renal Failure Professional Pharmaceuticals, Sepsis Other Inc. PS Ivax Pharmaceuticals, Inc ORAL ORAL Date:11/13/02ISR Number: 4010645-9Report Type:Expedited (15-DaCompany Report #02-10-0970 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Hepatitis C Health Clozapine - Ivax Other Neutropenia Professional Pharmaceuticals, Renal Failure Other Inc. Tablets PS Ivax White Blood Cell Count Pharmaceuticals, Inc ORAL 125MG QD ORAL Decreased Date:11/13/02ISR Number: 4010646-0Report Type:Expedited (15-DaCompany Report #02-10-0969 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Health Clozapine -Ivax Initial or Prolonged Professional Pharmaceuticals, Other Other Inc. Tablets PS Ivax Pharmceuticals, Inc ORAL 200MG QD ORAL 22-Feb-2006 08:30 AM Page: 1835 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/13/02ISR Number: 4010647-2Report Type:Expedited (15-DaCompany Report #02-10-0964 Age:87 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc ORAL 25-37.5 MG QD ORAL Date:11/13/02ISR Number: 4010648-4Report Type:Expedited (15-DaCompany Report #02-10-0963 Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetes Mellitus Health Clozapine - Ivax Myocardial Infarction Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc ORAL 12.5-50MG QD ORAL Date:11/13/02ISR Number: 4010649-6Report Type:Expedited (15-DaCompany Report #02-09-0854 Age:71 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dehydration Health Clozapine - Ivax Hospitalization - Myocardial Infarction Professional Pharmaceuticals, Initial or Prolonged Urinary Tract Infection Other Inc. Tablets PS Ivax Pharmaceuticals, Inc ORAL 37.5MG BID ORAL Levodopa - Carbidopa C Paxil C Lactulose C Oxybutynin C Protonix C Date:11/13/02ISR Number: 4010656-3Report Type:Expedited (15-DaCompany Report #02-11-0984 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cervix Carcinoma Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc ORAL 500-700MG QD ORAL Date:11/13/02ISR Number: 4010657-5Report Type:Expedited (15-DaCompany Report #02-10-0977 Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Fall Health Clozapine - Ivax Head Injury Professional Pharmaceuticals, Sudden Death Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 25MG QD ORAL 22-Feb-2006 08:30 AM Page: 1836 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/13/02ISR Number: 4011967-8Report Type:Expedited (15-DaCompany Report #PHBS2002CA13296 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Alkaline Foreign Clozaril (Clozapine) Initial or Prolonged Phosphatase Increased Health Tablet PS ORAL SEE IMAGE Cholelithiasis Professional Lamotrigine C Haemoglobin Decreased Other Colace C Pain Ranitidine Vomiting (Ranitidine) C White Blood Cell Count Increased Date:11/13/02ISR Number: 4011968-XReport Type:Expedited (15-DaCompany Report #PHNU2002DE03696 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Foreign Leponex Clozaril Drug Interaction Health (Clozapine) Drug Level Increased Professional (Clozapine) Tablet PS ORAL 300 MG/DAY, Other ORAL Hypnorex - Slow Release (Lithium Carbonate) Slow Release Tablet SS ORAL ORAL Date:11/13/02ISR Number: 4011996-4Report Type:Expedited (15-DaCompany Report #HQ5049305NOV2002 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Alkaline Health Protonix Phosphatase Increased Professional (Pantoprazole, Blood Creatine Tablet, Delayed Phosphokinase Increased Release) PS 40 MG 1X PER Cardiac Enzymes Increased 1 DAY Jaundice Cholestatic Clozapine (Clozapine, ) SS ORAL 300 MG DAILY, ORAL Date:11/13/02ISR Number: 4012112-5Report Type:Expedited (15-DaCompany Report #02P-163-0203565-00 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Health Divalproex Sodium Initial or Prolonged Dyspnoea Professional (Depakote) Required Haemothorax Other (Divalproex Sodium) Intervention to Lobar Pneumonia (Divalproex Sodium) PS ORAL 100 MG, 2 IN Prevent Permanent Palpitations 1 D, ORAL Impairment/Damage Pleural Effusion Clozapine SS ORAL 400 MG, 2 IN Pyrexia 1 D, ORAL Tuberculin Test Positive Haloperidol C Date:11/14/02ISR Number: 4012531-7Report Type:Expedited (15-DaCompany Report #02P-056-0203435-00 Age:66 YR Gender:Male I/FU:I Outcome PT Death Asthenia Blood Pressure Decreased 22-Feb-2006 08:30 AM Page: 1837 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Body Temperature Increased Bradycardia Report Source Product Role Manufacturer Route Dose Duration Cardiac Arrest Foreign Depakine Syrup Diabetes Mellitus Health (Sodium Valproate) Diarrhoea Professional (Sodium Valproate) Faecaloma (Sodium Valproate) PS ORAL 600 MG 1 IN 1 Heart Rate Increased D, ORAL Torsade De Pointes Trimebutine SS ORAL 300 MG , 1 IN 1 D, ORAL Clozapine SS ORAL 500 MG , 1 IN 1 D, ORAL Tropatepine Hydrochloride SS ORAL 5 MG 1 IN 1 D ORAL Paroxetine Hydrochloride SS ORAL 20 MG, 1 IN 1 D, ORAL Gliclazide SS ORAL 80 MG, 2 IN 1 D, ORAL Lormetazepam C Heptaminol Hydrochloride C Dihydroergotamine Mesilate C Date:11/14/02ISR Number: 4013507-6Report Type:Expedited (15-DaCompany Report #HQ5196212NOV2002 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Deep Vein Thrombosis Health Ativan (Lorazepam, Pulmonary Embolism Professional Tablet) PS ORAL 0.5 MG 2X PER Other 1 DAY ORAL Clomipramine (Clomipramine) SS ORAL 100 MG 1X PER 1 DAY ORAL Clozapine (Clozapine) SS ORAL 375 MG 1X PER 1 DAY ORAL Date:11/15/02ISR Number: 4011364-5Report Type:Direct Company Report #CTU 181019 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Clozaril PS ORAL 50MG HS ORAL Initial or Prolonged Delirium Olanzepine SS ORAL 10MG BID ORAL Dry Mouth Apap C Haemodynamic Instability Divalproex C Mental Status Changes Gabapentin C Mydriasis Haldol C Pneumonia Lorazepam C Pyrexia Chlorpromazine C Tachycardia Benztropine C 22-Feb-2006 08:30 AM Page: 1838 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/15/02ISR Number: 4012565-2Report Type:Expedited (15-DaCompany Report #C2002-3190.01 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 150MG Q AM, Other 400MG Q HS, ORAL Lorazepam C Date:11/15/02ISR Number: 4012566-4Report Type:Expedited (15-DaCompany Report #C2002-3206.01 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Other Clozapine Tablets 100 Mg Mylan PS Mylan ORAL 300 Q AM, 400MG Q HS; ORAL Clozapine Tablets 25 Mg Mylan SS Mylan ORAL 50MG QAM ORAL Amlodipine C Bupropion C Divalproex Sodium C Haloperidol C Date:11/15/02ISR Number: 4013378-8Report Type:Expedited (15-DaCompany Report #PHEH2002US09584 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozaril (Clozapine) Professional Tablet PS ORAL 600 MG, QD, ORAL Date:11/15/02ISR Number: 4014035-4Report Type:Expedited (15-DaCompany Report #PHEH2002US08998 Age:57 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chronic Lymphocytic Other Clozaril (Clozapine) Leukaemia Stage 0 Tablet PS ORAL ORAL Clozapine (Clozapine) SS ORAL 650 MG, QD, ORAL Risperdal (Risperidone) C Cogentin (Benzatropine Mesilate) C Lopid (Gemfibrozil) C Nasacort (Triamcinolone Acetonide) C Glucophage "Abic" C Cimetidine C Colace C Lipitor (Atorvastatin) C Multivitamins (Retinol, Panthenol, Ascorbic Acid) C 22-Feb-2006 08:30 AM Page: 1839 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Asa C Lotensin C Humulin (Insulin Human, Insulin Isophane, Human Biosynthetic) C Date:11/15/02ISR Number: 4014083-4Report Type:Expedited (15-DaCompany Report #PHFR2002GB02318 Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ankle Fracture Foreign Clozaril Initial or Prolonged Haemoglobin Decreased Health (Clozapine)Tablet PS ORAL ORAL Other Wound Infection Professional Other Date:11/15/02ISR Number: 4014309-7Report Type:Expedited (15-DaCompany Report #PHBS2002FI13465 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyspnoea Foreign Leponex (Clozapine) Initial or Prolonged Peritonitis Other Tablet PS ORAL 300 MG/D ORAL Cipramil C Date:11/15/02ISR Number: 4014311-5Report Type:Expedited (15-DaCompany Report #PHBS2002CA13463 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Insipidus Foreign Clozaril (Clozapine) Study Unknown PS ORAL ORAL Health Lithium (Lithium) C Professional Date:11/15/02ISR Number: 4014376-0Report Type:Expedited (15-DaCompany Report #PHBS2002CH13357 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Level Increased Foreign Leponex(Clozapine) PS SEE IMAGE Initial or Prolonged Gait Disturbance Health Convulex Pneumonia Professional "Byk-Gulden" Sedation Other (Valproate Sodium) SS SEE IMAGE Thrombocytopenia Dafalgan (Paracetamol) C Date:11/15/02ISR Number: 4014583-7Report Type:Expedited (15-DaCompany Report #PHBS2002BR11745 Age:42 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Leponex (Clozapine) Neutrophil Count Health Tablet PS ORAL 100 MG, BID, Decreased Professional ORAL Platelet Count Decreased Other Lorax (Loracarbef) C Psoriasis 22-Feb-2006 08:30 AM Page: 1840 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/15/02ISR Number: 4014585-0Report Type:Expedited (15-DaCompany Report #PHBS2002CA13121 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Foreign Clozaril (Clozapine) PS 900 MG/D Drug Interaction Health Biaxin Hallucination Professional (Clarithromycin) SS 250 MG, BID Psychotic Disorder Other Date:11/18/02ISR Number: 4011533-4Report Type:Direct Company Report #CTU 181149 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Atrioventricular Block Clozaril PS 50MG, QAM , Hospitalization - Complete 75MG 8PM Initial or Prolonged Atrioventricular Block Lamictal SS 50MG QAM, Second Degree 100MG Q PM Bradycardia Medication Error Torsade De Pointes Date:11/18/02ISR Number: 4013274-6Report Type:Expedited (15-DaCompany Report #PHEH2002US09486 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Leukocytosis Health Clozaril (Clozapine) Hospitalization - Pneumonia Professional Tablet PS ORAL SEE IMAGE, Initial or Prolonged ORAL Date:11/18/02ISR Number: 4013707-5Report Type:Expedited (15-DaCompany Report #PHEH2002US09502 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Cancer Health Clozaril (Clozapine) Leukopenia Professional Tablet PS ORAL ORAL Chemotherapeutics, Other (Chemotherapeutics, Other) SS Date:11/18/02ISR Number: 4014930-6Report Type:Expedited (15-DaCompany Report #PHFR2002GB03598 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril (Clozapine) Study Tablet PS ORAL ORAL Health Glibenclamide C Professional Other Date:11/18/02ISR Number: 4155127-9Report Type:Periodic Company Report #2002-08-0382 Age:51 YR Gender:Male I/FU:I Outcome PT Neutrophil Count Decreased White Blood Cell Count 22-Feb-2006 08:30 AM Page: 1841 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Decreased Report Source Product Role Manufacturer Route Dose Duration Health Peg-Intron Professional (Peginterferon Other Alfa-2b) Injectable Powder PS SUBCUTANEOUS SUBCUTANEOUS Rebetol (Ribavirin) Capsules SS ORAL ORAL Clozapine Tablets SS ORAL SEE IMAGE Aspirin C Citalopram C Docusate C Gemfibrozil C Lactulose C Lithium C Date:11/19/02ISR Number: 4012830-9Report Type:Direct Company Report #CTU 181334 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Clozaril 100mg PS ORAL 300MG PO AM / Overdose 400MG PO HS Psychotic Disorder Clozaril 25mg SS White Blood Cell Count Abnormal Date:11/19/02ISR Number: 4013600-8Report Type:Expedited (15-DaCompany Report #02-10-0882 Age:66 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Potassium Decreased Health Clozapine - Ivax Initial or Prolonged Fall Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 250-300MG QD ORAL Date:11/19/02ISR Number: 4013601-XReport Type:Expedited (15-DaCompany Report #02-11-0990 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Health Clozapine - Ivax Scar Professional Pharmaceuticals, Suicide Attempt Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 250-500MG QD ORAL Date:11/19/02ISR Number: 4013602-1Report Type:Expedited (15-DaCompany Report #02-11-0995 Age:78 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, 22-Feb-2006 08:30 AM Page: 1842 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Inc. ORAL 50-62.5 MG QD ORAL Date:11/19/02ISR Number: 4013603-3Report Type:Expedited (15-DaCompany Report #02-11-1005 Age:82 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 100-500MG QD ORAL Date:11/19/02ISR Number: 4013605-7Report Type:Expedited (15-DaCompany Report #02-11-1006 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Literature Clozapine Tablets PS ORAL 550MG ORAL 9 YR Initial or Prolonged Agitation Health Sertraline C Chest Pain Professional Divalproex Sodium C Condition Aggravated Benztropine Mesylate C Delusion Dyspnoea Exertional Fear Hallucinations, Mixed Insomnia Irritability Leukopenia Nausea Paranoia Pericarditis Persecutory Delusion Pleural Effusion Pneumonia Polyserositis Pressure Of Speech Restlessness Sleep Disorder Vomiting Date:11/19/02ISR Number: 4013606-9Report Type:Expedited (15-DaCompany Report #C2002-3078.01 Age:89 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 50MG QD, ORAL Other Acidophillus C Aspirin C Bisacodyl C Cephalexin C Digoxin C Docusate C Ferrous Sulfate C Furosemide C Hydrocortisone Cream C Ibuprofen C Lorazepam C Milk Of Magnesia C 22-Feb-2006 08:30 AM Page: 1843 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Morphine C Moxifloxacin C Multivitamins C Potassium C Quetiapine C Ranitidine C Tylenol With Codeine C Venlafaxine C Date:11/20/02ISR Number: 4014651-XReport Type:Expedited (15-DaCompany Report #C2002-3244.01 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Metastatic Neoplasm Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 150 MG QD, Other TITRATED TO 450 MG QD, ORAL Date:11/20/02ISR Number: 4015173-2Report Type:Expedited (15-DaCompany Report #PHEH2002US08567 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Clozaril (Clozapine) Initial or Prolonged Anaemia Professional Tablet PS ORAL SEE IMAGE Other Blood Potassium Decreased Detrol (Tolterodine Blood Pressure Decreased L-Tartrate) C Coma Folic Acid C Confusional State Sulfasalazine Convulsion (Sulfasalazine) C Cyanosis Pepcid C Disorientation Docusate (Docusate) C Dyspnoea Citrucel Electroencephalogram (Methylcellulose) C Abnormal Vitamin E C Excoriation Zoloft (Sertraline Fall Hydrochloride) C Heart Rate Increased Heart Rate Irregular Lethargy Mouth Haemorrhage Mydriasis Nocturia Orthostatic Hypotension Pallor Pupil Fixed Tremor Date:11/20/02ISR Number: 4015397-4Report Type:Expedited (15-DaCompany Report #PHFR2002GB03536 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Clozaril (Clozapine) Depression Study Tablet PS ORAL 50 MG/DAY, Health ORAL Professional Mirtazapine Other (Mirtazapine) C Lofepramine 22-Feb-2006 08:30 AM Page: 1844 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Lofepramine) C Date:11/20/02ISR Number: 4015399-8Report Type:Expedited (15-DaCompany Report #PHFR2002GB03328 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Ketoacidosis Foreign Clozaril (Clozapine) PS ORAL 375 MG/DAY, Initial or Prolonged Study ORAL Health Amisulpride(Amisulpr Professional ide) C Date:11/20/02ISR Number: 4015400-1Report Type:Expedited (15-DaCompany Report #PHFR2002GB03497 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Colitis Ischaemic Foreign Clozaril (Clozapine) Initial or Prolonged Constipation Study Tablet PS ORAL ORAL Other Diarrhoea Health Mesenteric Vein Professional Thrombosis Other Date:11/20/02ISR Number: 4015416-5Report Type:Expedited (15-DaCompany Report #PHFR2002GB02670 Age:73 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Transient Ischaemic Foreign Clozaril (Clozapine) Attack Study Tablet PS ORAL 750 MG/DAY, Health ORAL Professional Other Date:11/20/02ISR Number: 4015476-1Report Type:Expedited (15-DaCompany Report #PHNU2002DE03347 Age:52 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cataract Foreign Leponex / Clozaril Condition Aggravated Health (Clozapine) Vitreous Opacities Professional (Clozapine) Tablet PS ORAL 25 TO Other 75MG/DAY, ORAL Date:11/20/02ISR Number: 4015480-3Report Type:Expedited (15-DaCompany Report #PHFR2002GB03347 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Intraocular Pressure Foreign Clozaril (Clozapine) Increased Study Tablet PS ORAL 250MG/DAY, Vision Blurred Health ORAL Professional Other 22-Feb-2006 08:30 AM Page: 1845 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/20/02ISR Number: 4015481-5Report Type:Expedited (15-DaCompany Report #PHNU2002DE02567 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abortion Foreign Leponex / Clozaril Complications Of Maternal Health (Clozapine) Exposure To Therapeutic Professional (Clozapine) Tablet PS ORAL 200MG/DAY, Drugs Other ORAL Maternal Drugs Affecting Levomepromazine Foetus Tablet C Pregnancy Uterine Haemorrhage Date:11/20/02ISR Number: 4015483-9Report Type:Expedited (15-DaCompany Report #PHFR2002GB03667 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Atrioventricular Block Foreign Clozaril (Clozapine) Second Degree Study Tablet PS ORAL 100 MG, BID, Dysarthria Health ORAL Electrocardiogram St Professional Segment Depression Other Gait Disturbance Hemiparesis Myocardial Infarction Shock Date:11/20/02ISR Number: 4016662-7Report Type:Expedited (15-DaCompany Report #PHFR2002GB02974 Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aspermia Foreign Clozaril Urinary Incontinence Health (Clozapine)Tablet PS ORAL 200 MG, BID, Professional ORAL Other Paroxetne (Paroxetne) C Sertraline (Sertraline) C Date:11/20/02ISR Number: 4016769-4Report Type:Expedited (15-DaCompany Report #PHFR2002GB02014 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiac Failure Foreign Clozaril Myocardial Ischaemia Health (Clozapine)Tablet PS ORAL ORAL Tachycardia Professional Other Date:11/20/02ISR Number: 4016776-1Report Type:Expedited (15-DaCompany Report #PHFR2002GB03600 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Depressed Level Of Foreign Clozaril(Clozapine) Consciousness Study Tablet PS ORAL ORAL Diabetes Mellitus Health Drug Level Increased Professional Other 22-Feb-2006 08:30 AM Page: 1846 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/20/02ISR Number: 4016778-5Report Type:Expedited (15-DaCompany Report #PHBS2002CA13686 Age:67 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Confusional State Foreign Clozaril(Clozapine) Other General Physical Health Other Tablet PS ORAL ORAL Deterioration Myocardial Infarction Date:11/20/02ISR Number: 4016787-6Report Type:Expedited (15-DaCompany Report #PHBS2002NZ12717 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Proteus Infection Foreign Clozaril (Clozapine) Initial or Prolonged Urinary Tract Infection Health Tablet PS ORAL ORAL Professional Co-Trimoxazole Other (Sulfamethoxazole) C Oxybutynin (Oxybutynin) C Econazole Nitrate Cream C Methotrimeprazine C Clomipramine (Clomipramine) C Granocol (Franfula Extract, Sterculia) C Lithium Carbonate C Date:11/20/02ISR Number: 4016794-3Report Type:Expedited (15-DaCompany Report #HQ5049305NOV2002 Age:23 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Health Protonix Phosphokinase Increased Professional (Pantoprazole, Cardiac Enzymes Increased Tablet, Delayed Jaundice Cholestatic Release) PS 40 MG 1X PER White Blood Cell Count 1 DAY Decreased Clozapine (Clozapine,) SS ORAL 300 MG DAILY, ORAL Date:11/20/02ISR Number: 4016990-5Report Type:Periodic Company Report #PHEH2002US08165 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Exelon Initial or Prolonged Fall Professional (Rivastagmine) PS ORAL 1.5 MG, BID, Joint Dislocation ORAL Clozapine(Clozapine) SS ORAL SEE IMAGE Klonopin C Imipramine (Imipramine) C Cogentin (Benzatropine Mesilate) C Prozac (Fluoxetine Hydrochloride) C 22-Feb-2006 08:30 AM Page: 1847 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/21/02ISR Number: 4013206-0Report Type:Direct Company Report #CTU 181452 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diarrhoea Clozapine Initial or Prolonged Nausea (Clozapine) Capsule Renal Failure 200 Mg PS 100 MG BID Sepsis Benztropine C Vomiting Tenormin C Synthroid C Effexor Xr C Date:11/21/02ISR Number: 4015900-4Report Type:Expedited (15-DaCompany Report #PHEH2002US09856 Age:88 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozaril (Clozapine) PS ORAL ORAL Professional Date:11/21/02ISR Number: 4015905-3Report Type:Expedited (15-DaCompany Report #PHEH2002US02534 Age:57 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Level Increased Other Clozaril(Clozapine) Other Drug Toxicity Tablet PS ORAL 600 MG, QD, Hepatic Steatosis ORAL Osteoarthritis Paxil C Shock Lorazepam C Uterine Leiomyoma Date:11/21/02ISR Number: 4016376-3Report Type:Expedited (15-DaCompany Report #PHBS2001CA09564 Age:32 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cholelithiasis Foreign Clozaril Other Pulmonary Embolism Study (Clozapine) PS ORAL 50 MG/DAY, Shock Health ORAL Professional Estrogen Nos Other (Estrogen Nos) C Celexa C Date:11/22/02ISR Number: 4016164-8Report Type:Expedited (15-DaCompany Report #PHBS2001CA07241 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asthenia Foreign Clozaril(Clozapine) Other Brain Neoplasm Study Tablet PS ORAL 300 MG/D, Cerebrovascular Accident Health ORAL Functional Residual Professional Vasotec C Capacity Abnormal Other Epival (Valproate Semisodium) C Wellbutrin (Bupropion Hydrochloride) C 22-Feb-2006 08:30 AM Page: 1848 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/22/02ISR Number: 4017134-6Report Type:Expedited (15-DaCompany Report #02-11-1027 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Collapse Of Lung Health Clozapine -Ivax Initial or Prolonged Road Traffic Accident Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals , Inc ORAL 25-350MG QD ORAL Date:11/22/02ISR Number: 4017136-XReport Type:Expedited (15-DaCompany Report #02-11-1025 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Abuser Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 400-650MG QD ORAL Date:11/22/02ISR Number: 4017139-5Report Type:Expedited (15-DaCompany Report #02-10-0974 Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Health Clozapine- Ivax Initial or Prolonged Dehydration Professional Pharmaceuticals, Diarrhoea Other Inc. Tablets PS Ivax Nausea Pharmaceuticals, Pyrexia Inc. ORAL 100MG BID Renal Failure ORAL Sepsis Benztropine Mesylate C Vomiting Tenormin C Synthroid C Effexor Xr C Date:11/22/02ISR Number: 4017141-3Report Type:Expedited (15-DaCompany Report #02-10-0920 Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Congestive Cardiomyopathy Health Clozapine - Ivax Mitral Valve Incompetence Professional Pharmaceuticals, Ventricular Hypokinesia Inc. Tablets PS Ivax Pharmaceuticals, Inc ORAL SEE IMAGE Clozaril Tablets SS ORAL ORAL Doxepin C Prozac C Ativan C Date:11/22/02ISR Number: 4017142-5Report Type:Expedited (15-DaCompany Report #02-09-0854 Age:71 YR Gender:Female I/FU:F Outcome PT Death Dehydration Hospitalization - Drug Withdrawal Syndrome Initial or Prolonged Dyskinesia Hypotension Myocardial Infarction 22-Feb-2006 08:30 AM Page: 1849 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Rhabdomyolysis Shock Tachycardia Report Source Product Role Manufacturer Route Dose Duration Urinary Tract Infection Health Clozapine - Ivax Professional Phamaceuticals, Inc. Other Tablets PS Ivax Pharmaceuticals, Inc. ORAL 75MG QD ORAL Levodopa-Carbidopa C Paxil C Lactulose C Oxybutynin C Protonix C Date:11/22/02ISR Number: 4018535-2Report Type:Periodic Company Report #PHEH2002US03014 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Nightmare Company Clozaril(Clozapine) Obsessive-Compulsive Representative (Cont.) PS ORAL 175 MG, ORAL Disorder Propranolol C Celexa C Ativan C Geodon (Ziprasidone Hydrochloride) C Date:11/22/02ISR Number: 4018536-4Report Type:Periodic Company Report #PHEH2002US03703 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oligomenorrhoea Health Clozaril(Clozapine) Professional (Cont.) PS ORAL 150 MG/DAY, ORAL Date:11/22/02ISR Number: 4018538-8Report Type:Periodic Company Report #PHEH2002US04199 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dental Caries Health Clozaril(Clozapine) Dry Mouth Professional (Cont.) PS ORAL 100 MG, ORAL Salivary Hypersecretion Benadryl C Tooth Loss Date:11/22/02ISR Number: 4018539-XReport Type:Periodic Company Report #PHEH2002US04242 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alopecia Health Clozaril Professional (Clozapine) (Cont.) PS ORAL 300 MG/DAY, Company ORAL Representative Paxil (Paroxetine Hydrochloride) SS ORAL 20 MG/DAY, ORAL Oral Contraceptive Nos C 22-Feb-2006 08:30 AM Page: 1850 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/22/02ISR Number: 4018540-6Report Type:Periodic Company Report #PHEH2002US04289 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Amylase Increased Health Clozaril Professional (Clozapine) (Cont.) PS ORAL ORAL Depakote (Valproate Semisodium) C Date:11/22/02ISR Number: 4018542-XReport Type:Periodic Company Report #PHEH2002US05428 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Arthritis Other Clozaril Clozapine) (Cont.) PS ORAL 125 MG, ORAL Allergy Medication C Date:11/22/02ISR Number: 4018543-1Report Type:Periodic Company Report #PHEH2002US06555 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Interaction Health Clozaril Fall Professional (Clozapine) (Cont.) PS ORAL 100 MG AM+ Increased Appetite 200MG HS, Muscle Spasms ORAL Somnolence Topamax (Topiramate) SS Weight Increased Depakate (Valproate Semisodium) C Paxil C Zantac C Lipitor (Atorvastatin) C Tetracycline (Tetracycline) C Ddavp (Desmopressin) C Date:11/22/02ISR Number: 4018544-3Report Type:Periodic Company Report #PHEH2002US06718 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Chills Health Clozaril Hyperglycaemia Professional (Clozapine) (Cont.) PS ORAL 100MG AM + Leukocytosis 300MG HS, Pyrexia ORAL; SEE Typhoid Fever IMATE Date:11/22/02ISR Number: 4018545-5Report Type:Periodic Company Report #PHEH2002US06985 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Health Clozaril PS ORAL 250 MG, QD, Professional ORAL Lithium (Lithium) C Zyprexa (Olanzapine0 C Oxazepam (Oxazepam) C 22-Feb-2006 08:30 AM Page: 1851 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/22/02ISR Number: 4018546-7Report Type:Periodic Company Report #PHEH2002US07298 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Other Clozaril No Adverse Drug Effect (Clozapine) PS ORAL 100 MG ONE DOSE, ORAL Date:11/22/02ISR Number: 4018549-2Report Type:Periodic Company Report #PHEH2002US07520 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Health Clozaril Initial or Prolonged Coordination Abnormal Professional (Clozapine) PS ORAL 100 MG, BID, Lethargy Company ORAL Pyrexia Representative Geodon (Ziprasidone Hydrochloride) C Depakote (Valproate Semisodium) C Date:11/22/02ISR Number: 4018551-0Report Type:Periodic Company Report #PHEH2002US07648 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiomyopathy Health Clozaril PS ORAL ORAL Ventricular Tachycardia Professional Company Representative Date:11/22/02ISR Number: 4018553-4Report Type:Periodic Company Report #PHEH2002US07698 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Convulsion Health Clozaril Motor Dysfunction Professional (Clozapine) (Cont.) PS ORAL SEE IMAGE Somnolence Buspar C Risperdal (Risperidone) C Lithobid C Cogentin (Benzatropine Mesilate) C Inderal C Date:11/22/02ISR Number: 4018554-6Report Type:Periodic Company Report #PHEH2002US07959 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Clozaril PS ORAL 600 MG/DAY, Initial or Prolonged Professional ORAL Ddavp (Desmopressin) C Lithium Carbonate C Combivent (Ipratropium Bromide, Salbutamol Sulfate) C Antihyperglycemic Medication C 22-Feb-2006 08:30 AM Page: 1852 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/22/02ISR Number: 4018556-XReport Type:Periodic Company Report #PHEH2002US07960 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Health Clozaril PS ORAL 600 MG, ORAL Initial or Prolonged Hypotension Professional Seroquel (Quetiapine Muscle Spasms Fumarate) C Myalgia Depakote (Valproate Thrombocytopenia Semisodium) C Robaxin (Methocarbamol) C Aspirin C Bayer Naprosyn C Date:11/22/02ISR Number: 4018558-3Report Type:Periodic Company Report #PHEH2002US08096 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Liver Function Test Health Clozaril PS ORAL 25 MG, QD, Abnormal Professional ORAL Axid (Nizatidine) C Haldol "Janssen" C Jansen Date:11/22/02ISR Number: 4018559-5Report Type:Periodic Company Report #PHEH2002US08195 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril PS ORAL 700 MG, QD, Professional ORAL Date:11/22/02ISR Number: 4018560-1Report Type:Periodic Company Report #PHEH2002US08204 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril PS ORAL ORAL Hospitalization - Psychotic Disorder Professional Initial or Prolonged Date:11/22/02ISR Number: 4018561-3Report Type:Periodic Company Report #PHEH2002US08321 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abdominal Pain Health Clozaril PS ORAL 600 MG, QD, Hospitalization - Abdominal Tenderness Professional ORAL Initial or Prolonged Colostomy Norvasc C Intestinal Obstruction Desferal Shock (Deferoxamine Mesilate) C Nexium (Esomeprazole) C Naprosyn C Depakote (Valproate Semisodium) C Artane (Trihexyphenidyl Hydrochloride) C 22-Feb-2006 08:30 AM Page: 1853 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Cogentin (Benzatropine Mesilate) C Zyprexa (Olanzapine) C Ativan C Date:11/22/02ISR Number: 4018563-7Report Type:Periodic Company Report #PHEH2002US08383 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiomyopathy Health Clozaril PS ORAL 350 MG/DAY, Professional ORAL Allopurinol C Date:11/22/02ISR Number: 4018564-9Report Type:Periodic Company Report #PHEH2002US08567 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Clozaril (Clozapine) PS ORAL 700 MG; 400 Initial or Prolonged Professional MG: QHS, ORAL Detrol (Tolterodine L-Tartrate) C Folic Acid C Sulfasalazine (Sulfasalazine) C Pepcid C Docusate (Docusate) C Citracal (Calcium Citrate) C Vitamin E C Zoloft (Sertraline Hyrochloride) C Date:11/22/02ISR Number: 4018565-0Report Type:Periodic Company Report #PHEH2002US08570 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Clozaril Initial or Prolonged Professional (Clozapine) PS ORAL 400 MG; 200 MG: QHS , ORAL Flovent (Fluticasone Propionate) C Albuterol C Docusate (Docusate) C Prevacid (Lansoprazole) C Nasonex (Mometasone Furoate) C Lipitor (Atorvastatin) C Accolate C Apap (Paracetamol) C Skelaxin (Metaxalone) C Nadolol (Nadolol) C Detrol (Tolterodine L-Tartrate) C 22-Feb-2006 08:30 AM Page: 1854 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Aricept (Donepezil Hydrochloride) C Protonix "Pharmacia" C Prozac (Fluoxetine Hydrochloride) C Sulindac (Sulindac) C Date:11/22/02ISR Number: 4018566-2Report Type:Periodic Company Report #PHEH2002US08652 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Health Clozaril Professional (Clozapine) PS ORAL 50 MG, BID, ORAL Inhaler C Date:11/22/02ISR Number: 4018567-4Report Type:Periodic Company Report #PHEH2002US08682 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril Professional (Clozapine) PS ORAL ORAL Date:11/22/02ISR Number: 4018568-6Report Type:Periodic Company Report #PHEH2001US08328 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Amenorrhoea Health Clozaril Hypertension Professional (Clozapine) PS ORAL 350 MG, BID, Nausea ORAL Date:11/22/02ISR Number: 4018570-4Report Type:Periodic Company Report #PHEH2001US09316 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Balance Disorder Health Clozaril Difficulty In Walking Professional (Clozapine) PS ORAL ORAL: 200MG Muscular Weakness DAILY Neuropathy Peripheral Risperdal Psychotic Disorder (Risperidone) C Date:11/22/02ISR Number: 4018571-6Report Type:Periodic Company Report #PHEH2001US09339 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Face Oedema Health Clozaril Parotid Gland Enlargement Professional (Clozapine) PS ORAL 300MG DAILY, Salivary Hypersecretion ORAL Serzone (Nefazodone Hydrochloride) C Effexor (Venlafaxine Hydrochloride) C Famotidine C 22-Feb-2006 08:30 AM Page: 1855 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/22/02ISR Number: 4018572-8Report Type:Periodic Company Report #PHEH2001US09596 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Teeth Brittle Health Clozaril Professional (Clozapine) PS ORAL 400MG DAILY, ORAL Date:11/22/02ISR Number: 4018574-1Report Type:Periodic Company Report #PHEH2002US01673 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Creatinine Health Clozaril Increased Professional (Clozapine) PS ORAL 400 MG/DAY, ORAL Geodon (Ziprasidone Hydrochloride) C Date:11/22/02ISR Number: 4018575-3Report Type:Periodic Company Report #PHEH2002US01792 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Mouth Ulceration Health Clozaril Professional (Clozapine) PS ORAL 100 MG, BID, ORAL Thorazine (Chlorpromazine Hydrochloride) C Topamax (Topiramate) C Date:11/22/02ISR Number: 4018883-6Report Type:Periodic Company Report #PHEH2002US06090 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Liver Function Test Health Clozaril Abnormal Professional (Clozapine) PS ORAL 100 MG/DAY, Musculoskeletal ORAL Discomfort Cogentin Oedema Peripheral (Benzatropine Palpitations Mesilate) C Sinus Tachycardia Zyrtec (Cetirizine Hydrochloride) C Senokot C Flonase (Fluticasone Propionate) C Aciphex (Rabeprazole Sodium) C Fibercon (Polycarbophil Calcium) C Lovenox (Heparin-Fraction, Sodium Salt) C Astelin (Azelastine Hydrochloride) C Vicodin (Paracetamol) C Ventolin C 22-Feb-2006 08:30 AM Page: 1856 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/22/02ISR Number: 4018884-8Report Type:Periodic Company Report #PHEH2002US06175 Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Other Clozaril (Clozapine) PS ORAL 700 MG, ORAL Date:11/22/02ISR Number: 4018885-XReport Type:Periodic Company Report #PHEH2002US06292 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Health Clozaril Leukopenia Professional (Clozapine) PS ORAL 300 MG/DAY, ORAL Cogentin (Benzatropine Mesilate) C Diovan "Ciba-Geigy" C Ciba-Geigy Date:11/22/02ISR Number: 4018886-1Report Type:Periodic Company Report #PHEH2002US06520 Age:78 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril Professional (Clozapine) PS ORAL 100MG, ORAL Date:11/22/02ISR Number: 4018887-3Report Type:Periodic Company Report #PHEH2002US06571 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anorexia Health Clozaril Initial or Prolonged Dehydration Professional (Clozapine) PS ORAL 300 MG, QD, Psychotic Disorder ORAL Weight Decreased Zyprexa (Olanzapine) SS Celexa (Citalopram Hydrobromide) SS Synthroid C Date:11/22/02ISR Number: 4018888-5Report Type:Periodic Company Report #PHEH2002US06586 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Health Clozaril Initial or Prolonged Haematocrit Decreased Professional (Clozapine) PS ORAL 50MG AM + 150 Other Haemoglobin Decreased MG HS, ORAL Leukopenia Zyprexa (Olanzapine) C Lymphocyte Count Decreased Monocyte Count Decreased Platelet Morphology Abnormal Red Blood Cell Count Decreased Vomiting 22-Feb-2006 08:30 AM Page: 1857 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/22/02ISR Number: 4018889-7Report Type:Periodic Company Report #PHEH2002US06677 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pericarditis Health Clozaril Professional (Clozapine) PS ORAL 325 MG, ORAL Date:11/22/02ISR Number: 4018890-3Report Type:Periodic Company Report #PHEH2002US06685 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Clozaril Initial or Prolonged Professional (Clozapine) PS SEE IMAGE Inderal C Dilantin C Artane (Trihexyphenidyl Hydrochloride) C Risperdal (Risperidone) C Atenolol C Prilosec (Omeprazole) C Date:11/22/02ISR Number: 4018891-5Report Type:Periodic Company Report #PHEH2002US06688 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril Hospitalization - Professional (Clozapine) PS Initial or Prolonged Date:11/22/02ISR Number: 4018892-7Report Type:Periodic Company Report #PHEH2002US06711 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Clozaril Professional (Clozapine) PS ORAL ORAL Date:11/22/02ISR Number: 4018893-9Report Type:Periodic Company Report #PHEH2002US06719 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Clozaril PS ORAL ORAL Initial or Prolonged Professional Paxil C Date:11/22/02ISR Number: 4018894-0Report Type:Periodic Company Report #PHEH2002US06746 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Faecaloma Health Clozaril Initial or Prolonged Leukopenia Professional (Clozapine) PS ORAL 900 MG, QD, Neutropenia ORAL Pharyngitis Avandia Pyrexia (Rosiglitazone Maleate) C Peri-Colace 22-Feb-2006 08:30 AM Page: 1858 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Casanthranol) C Glucophage C Insulin C Zestril (Lisinopril) C Multivitamins (Retinol, Panthenol, Ascorbic Acid) C Navane (Tiotixene) C Date:11/22/02ISR Number: 4018895-2Report Type:Periodic Company Report #PHEH2002US06861 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Clozaril Professional (Clozapine) PS ORAL 300 MG, QHS, ORAL Paxil (Paroxetine Hydrochloride) SS Artane (Trihexyphenidyl Hydrochloride) C Lithium C Levothyroxine C Date:11/22/02ISR Number: 4018896-4Report Type:Periodic Company Report #PHEH2002US06892 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Other Clozaril (Clozapine) PS ORAL 38 MG, QD, ORAL Date:11/22/02ISR Number: 4018897-6Report Type:Periodic Company Report #PHEH2002US06893 Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) Hospitalization - Professional Tablet PS ORAL 125MG, ORAL Initial or Prolonged Date:11/22/02ISR Number: 4018898-8Report Type:Periodic Company Report #PHEH2002US07006 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Oedema Peripheral Health Clozaril (Clozapine) PS ORAL 700 MG, BID, Initial or Prolonged Pyrexia Professional ORAL Zoloft (Sertraline Hydrochloride) C Tamoxifen C Arthrotec (Misoprostol) C Zantac C Lactulose C Citrucel (Methylcellulose) C 22-Feb-2006 08:30 AM Page: 1859 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/22/02ISR Number: 4018899-XReport Type:Periodic Company Report #PHEH2002US07233 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutrophil Percentage Health Clozaril (Clozapine) PS ORAL 200 MG/DAY, Decreased Professional ORAL Depakote (Valproate Semisodium) C Geodon (Ziprasidone Hydrochloride) C Artane (Trihexyphenidyl Hydrochloride) C Date:11/22/02ISR Number: 4018900-3Report Type:Periodic Company Report #PHEH2002US07295 Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Health Clozaril Initial or Prolonged Tachycardia Professional (Clozapine) PS ORAL 250 MG, QD, ORAL; 200 MG,QD Ssri C Risperdal (Risperidone) C Olanzapine C Clonidine C Ritalin C Date:11/22/02ISR Number: 4018901-5Report Type:Periodic Company Report #PHEH2002US07457 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Bilirubin Increased Health Clozaril Initial or Prolonged Chromaturia Professional (Clozapine) PS ORAL 200 MG, QHS, Hepatitis ORAL Liver Function Test Efexor (Venlafaxine Abnormal Hydrochloride) C Nausea Klonopin C Pyrexia Date:11/22/02ISR Number: 4018902-7Report Type:Periodic Company Report #PHEH2002US07496 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Health Clozaril PS ORAL 200MG AM + Initial or Prolonged Leukopenia Professional 300MG HS, Psychotic Disorder Company ORAL; 300 Representative MG, BID, ORAL Clozapine (Clozapine) SS Buspar C Inderal-La C Motrin C 22-Feb-2006 08:30 AM Page: 1860 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/22/02ISR Number: 4018903-9Report Type:Periodic Company Report #PHEH2002US04999 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Deep Vein Thrombosis Health Clozaril Professional (Clozapine) PS ORAL ORAL Company Representative Date:11/22/02ISR Number: 4018904-0Report Type:Periodic Company Report #PHEH2002US05041 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Health Clozaril PS ORAL 200 MG, ORAL Leukopenia Professional Depakote (Valproate Semisodium) C Trazodone (Trazodone) C Seroquel (Quetiapine) C Propranolol C Cogentin (Benzatropine Mesilate) C Lopid (Gemfibrozil) C Haldol C Prevacid (Lansoprazole) C Synthroid C Metformin C Tylenol (Paracetamol) C Date:11/22/02ISR Number: 4018905-2Report Type:Periodic Company Report #PHEH2002US05157 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mental Status Changes Health Clozaril (Clozapine) PS ORAL 400 MG, QHS, Initial or Prolonged Neuroleptic Malignant Professional ORAL Syndrome Depakote (Valproate Pyrexia Semisodium) C Renal Impairment Topamax (Topiramate) C Shock Seroquel (Quetiapine) C Inderal C Date:11/22/02ISR Number: 4018906-4Report Type:Periodic Company Report #PHEH2002US05330 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Health Clozaril Initial or Prolonged Leukopenia Professional (Clozapine) PS ORAL 50MG AM + 250MG HS, ORAL Geodon (Ziprasidone Hydrochloride) C Cogentin (Benzatropine Mesilate) C 22-Feb-2006 08:30 AM Page: 1861 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Multivitamins (Retinol, Panthenol, Ascorbic Acid) C Lamictal C Prolixin (Fluphenazine Hydrochloride) C Tylenol (Paracetamol) C Date:11/22/02ISR Number: 4018907-6Report Type:Periodic Company Report #PHEH2002US05425 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Upper Health Clozaril Anorexia Professional (Clozapine) PS ORAL 300 MG, TID, Fatigue ORAL Influenza Like Illness Clonidine Pyrexia (Clonidine) C Somnolence Prolixin Stomach Discomfort (Fluphenazine Weight Decreased Hydrochloride) C Prozac (Fluoxetine Hydrochloride) C Cogentin (Benzatropine Mesilate) C Tagamet Oral C Colace C Date:11/22/02ISR Number: 4018908-8Report Type:Periodic Company Report #PHEH2002US05954 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Clozaril Initial or Prolonged Electroencephalogram Professional (Clozapine) PS ORAL SEE IMAGE Abnormal ORAL Zyprexa (Olanzapine) C Prozac (Fluoxetine Hydrochloride) C Date:11/22/02ISR Number: 4018909-XReport Type:Periodic Company Report #PHEH2002US05968 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Other Clozaril (Clozapine) PS ORAL 700 MG, ORAL Date:11/22/02ISR Number: 4018910-6Report Type:Periodic Company Report #PHEH2002US06041 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Small Intestinal Health Clozaril Initial or Prolonged Obstruction Professional (Clozapine) PS ORAL SEE IMAGE, ORAL Dilantin C Cogentin 22-Feb-2006 08:30 AM Page: 1862 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Benzatropine Mesilate) C Ativan C Date:11/22/02ISR Number: 4018911-8Report Type:Periodic Company Report #PHEH2002US06072 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Delusion Consumer Clozaril Depression (Clozapine) PS ORAL 400 MG/DAY, Fatigue ORAL Hallucination Provigil (Modafinil) C Psychotic Disorder Depakote (Valproate Shock Semisodium) C Somnolence Date:11/22/02ISR Number: 4018912-XReport Type:Periodic Company Report #PHEH2002US06083 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Health Clozaril PS ORAL 300 MG, ORAL Initial or Prolonged Leukopenia Professional Tegretol C Dilantin C Mysoline (Primidone) C Astra Date:11/22/02ISR Number: 4018913-1Report Type:Periodic Company Report #USA/99/01213/LEX Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diarrhoea Health Clozaril Influenza Like Illness Professional (Clozapine)(Clozapin Viral Myocarditis e)Tablet PS ORAL 300 MG, ORAL Vomiting Atenolol C Chlorpromazine C Amantadine C Date:11/22/02ISR Number: 4018914-3Report Type:Periodic Company Report #PHEH2001US08034 Age:80 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril(Clozapine)T Professional ablet PS ORAL 50MG, ORAL Date:11/22/02ISR Number: 4018915-5Report Type:Periodic Company Report #PHEH2001US08035 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozaril(Clozapine)T Hospitalization - Leukopenia Professional ablet PS ORAL 375 MG/DAY, Initial or Prolonged Company ORAL Representative Lorazepam C Levothyroxine (Levothyroxine) C Premarin(Estrogens Conjugated) C Tums C 22-Feb-2006 08:30 AM Page: 1863 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Peri-Colace(Casanthr anol) C Iron C Benzotropine(Benzatr opine Mesilate) C Lithium (Lithium) C Haloperidol C Hyoscyamine (Hyoscyamine) C Docusate(Docusate) C Date:11/22/02ISR Number: 4018918-0Report Type:Periodic Company Report #PHEH2001US08225 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Health Clozaril(Clozapine)T Initial or Prolonged Leukopenia Professional ablet PS ORAL 500 MG/DAY, ORAL Cogentin (Benzatropine Mesilate) C Ativan C Prolixin (Fluphenazine Hydrochloride) C Date:11/22/02ISR Number: 4018927-1Report Type:Periodic Company Report #PHEH2001US08270 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Health Clozaril(Clozapine) Initial or Prolonged Neutropenia Professional Tablet PS ORAL ORAL Date:11/22/02ISR Number: 4018928-3Report Type:Periodic Company Report #PHEH2001US08330 Age:18 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Health Clozaril(Clozapine) Initial or Prolonged Neutropenia Professional Tablet PS ORAL 450 MG/DAY, ORAL Neurontin (Gabapentin) C Depakote(Valproate Semisodium) C Klonopin C Lithium(Lithium) C Date:11/22/02ISR Number: 4018929-5Report Type:Periodic Company Report #PHEH2001US08701 Age:88 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril(Clozapine) Professional Tablet PS ORAL 37.5MG, ORAL 22-Feb-2006 08:30 AM Page: 1864 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/22/02ISR Number: 4018930-1Report Type:Periodic Company Report #PHEH2001US08705 Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Health Clozaril(Clozapine)T Initial or Prolonged Neutropenia Professional ablet PS ORAL 350MG DAILY, Thrombocytopenia ORAL Date:11/22/02ISR Number: 4018931-3Report Type:Periodic Company Report #PHEH2001US08707 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyspnoea Health Clozaril(Clozapine)T Initial or Prolonged Pulmonary Embolism Professional ablet PS ORAL 125 MG/DAY, Company ORAL Representative Haldol C Depakote (Valproate Semisodium) C Coumadin "Boots" (Warfarin Sodium) C Glucophage "Abic" C Prolixin (Fluphenazine Hydrochloride) C Hydroxyzine (Hydroxyzine) C Date:11/22/02ISR Number: 4018932-5Report Type:Periodic Company Report #PHEH2001US08743 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Health Clozaril(Clozapine)T Initial or Prolonged Professional ablet PS ORAL 300MG, ORAL; 500MG, ORAL Date:11/22/02ISR Number: 4018933-7Report Type:Periodic Company Report #PHEH2001US08868 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril(Clozapine) Professional Tablet PS ORAL 300 MG, BID, ORAL Clozapine(Clozapine) SS ORAL ORAL Cogentin (Benzatropine Mesilate) C Depakote (Valproate Semisodium) C Date:11/22/02ISR Number: 4018934-9Report Type:Periodic Company Report #PHEH2001US08869 Age:36 YR Gender:Female I/FU:I Outcome PT Hospitalization - Chest Pain Initial or Prolonged Diarrhoea Eosinophil Count Increased Gastrointestinal Disorder 22-Feb-2006 08:30 AM Page: 1865 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hallucination, Auditory Pallor Pneumonia Report Source Product Role Manufacturer Route Dose Duration Pulmonary Embolism Health Clozaril (Clozapine) Professional Tablet PS ORAL 300 MG/DAY, ORAL Seroquel (Quetiapine) C Risperdal (Risperidone) C Topamax (Topiramate) C Effexor (Venlafaxine Hydrochloride) C Benzodiazepines C Date:11/22/02ISR Number: 4018935-0Report Type:Periodic Company Report #PHEH2001US08970 Age:67 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) Professional Tablet PS ORAL 50 MG DAILY, ORAL Sinemet C Parlodel C Ethopropazine (Profenamine) C Date:11/22/02ISR Number: 4018936-2Report Type:Periodic Company Report #PHEH2001US08995 Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril(Clozapine) Professional Tablet PS ORAL 25 MG, TID, ORAL Date:11/22/02ISR Number: 4018937-4Report Type:Periodic Company Report #PHEH2001US09025 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Clozaril (Clozapine) Initial or Prolonged Professional Tablet PS ORAL 500 MG/DAY, ORAL Depakote (Valproate Semisodium) SS ORAL 1000 MG, BID, ORAL Ativan C Zyprexa (Olanzapine) C Anafranil C Date:11/22/02ISR Number: 4018938-6Report Type:Periodic Company Report #PHEH2001US09099 Age:12 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pyrexia Health Clozaril (Clozapine) Initial or Prolonged Professional Tablet PS ORAL 150 MG DAILY, ORAL; 100 MG DAILY, ORAL 22-Feb-2006 08:30 AM Page: 1866 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Depakote (Valproate Semisodium) C Date:11/22/02ISR Number: 4018939-8Report Type:Periodic Company Report #PHEH2001US09139 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Health Clozaril(Clozapine) Initial or Prolonged Professional Tablet PS ORAL 75 MG, BID, ORAL Date:11/22/02ISR Number: 4018940-4Report Type:Periodic Company Report #PHEH2001US09199 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Health Clozaril (Clozapine) Pharyngitis Professional Tablet PS ORAL 450 MG/DAY, Pyrexia ORAL White Blood Cell Count Seroquel Decreased (Quetiapine) C Date:11/22/02ISR Number: 4018941-6Report Type:Periodic Company Report #PHEH2001US09240 Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) Professional Tablet PS ORAL 225MG DAILY, ORAL Date:11/22/02ISR Number: 4018942-8Report Type:Periodic Company Report #PHEH2001US09279 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Priapism Health Clozaril (Clozapine) Initial or Prolonged Professional Tablet PS ORAL 300 MG/DAY, ORAL Depakote (Valproate Semisodium) C Buspar C Date:11/22/02ISR Number: 4018943-XReport Type:Periodic Company Report #PHEH2001US09282 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Health Clozaril Initial or Prolonged White Blood Cell Count Professional (Clozapine) PS ORAL 500 MG/DAY, Decreased ORAL Zyprexa (Olanzapine) C Date:11/22/02ISR Number: 4018944-1Report Type:Periodic Company Report #PHEH2001US09336 Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutropenia Health Clozaril (Clozapine) Initial or Prolonged Professional Tablet PS ORAL 475 MG, UNK, 22-Feb-2006 08:30 AM Page: 1867 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL Buspar C Wellbutrin (Amfebutamone Hydrochloride) C Depakote (Valproate Semisodium) C Date:11/22/02ISR Number: 4018945-3Report Type:Periodic Company Report #PHEH2001US09487 Age:79 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) Professional Tablet PS ORAL 25MG DAILY, ORAL Lanoxin C Lasix C Ativan C Sinemet C Senokot C Vitamin B12 C Date:11/22/02ISR Number: 4018946-5Report Type:Periodic Company Report #PHEH2001US09489 Age:77 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Other Clozaril (Clozapine) Tablet PS ORAL 12.5 MG, BID, ORAL Date:11/22/02ISR Number: 4018947-7Report Type:Periodic Company Report #PHEH2001US09491 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Health Clozaril (Clozapine) Initial or Prolonged Leukopenia Professional Tablet PS ORAL 100MG AM + Oedema Peripheral 300MG HS, Pallor ORAL Thrombosis Date:11/22/02ISR Number: 4018948-9Report Type:Periodic Company Report #PHEH2001US09516 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Haematocrit Decreased Health Clozaril (Clozapine) Haemoglobin Decreased Professional Tablet PS ORAL 600 MG/DAY, Red Blood Cell Count ORAL Decreased Tofranil C Multiple Vitamins (Ascorbic And, Retinol, Vitamin B Nos) C Colace C 22-Feb-2006 08:30 AM Page: 1868 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/22/02ISR Number: 4018949-0Report Type:Periodic Company Report #PHEH2001US09523 Age:80 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) Professional Tablet PS ORAL 12.5 MG/DAY, ORAL Sinemet C Zoloft (Sertraline Hydrochloride) C Nadolol (Nadolol) C Lanoxin C K-Dur C Aricept (Donepezil Hydrochloride) C Zocor "Merck" C Coumadin "Boots" (Warfarin Sodium) C Synthroid C Date:11/22/02ISR Number: 4018950-7Report Type:Periodic Company Report #PHEH2001US09552 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Consumer Clozaril (Clozapine) Initial or Prolonged Dysarthria Tablet PS ORAL ORAL Myocardial Infarction Date:11/22/02ISR Number: 4018951-9Report Type:Periodic Company Report #PHEH2001US09580 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypotension Health Clozaril (Clozapine) Initial or Prolonged Professional Tablet PS ORAL 700 MG/DAY, ORAL Depakote (Valproate Semisodium) C Zantac C Glyburide C Combivent (Ipratropium Bromide, Salbutamol Sulfate) C Allegra-D (Fexofenadine) C Lactulose C Date:11/22/02ISR Number: 4018952-0Report Type:Periodic Company Report #PHEH2001US09698 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Headache Health Clozaril (Clozapine) Initial or Prolonged Infection Professional Tablet PS ORAL 125 MG, BID, Nausea ORAL Pleural Effusion Remeron Psychotic Disorder (Mirtazapine) C Pyrexia Tegretol C Respiratory Arrest Singulair "Merck" (Montelukast Sodium) C 22-Feb-2006 08:30 AM Page: 1869 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/22/02ISR Number: 4019941-2Report Type:Periodic Company Report #PHEH2001US09822 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Delusion Consumer Clozaril Hallucination (Clozapine) PS ORAL SEE IMAGE Clozapine (Clozapine) SS ORAL 500 MG/DAY, ORAL Lorazepam C Mirtazapine (Mirtazapine) C Zolpidem (Zolpidem) C Haldol C Date:11/22/02ISR Number: 4019943-6Report Type:Periodic Company Report #PHEH2001US09868 Age:78 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Intestinal Obstruction Health Clozaril PS ORAL 87.5 MG Professional DAILY, ORAL Lasix C Multivitamin And Mineral Supplement C Vitamin Nos C Celexa C Tylenol (Paracetamol) C Klonopin C Asa C Nicoderm C Lanoxin C Depo Provera C Date:11/22/02ISR Number: 4019945-XReport Type:Periodic Company Report #PHEH2001US09877 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril PS ORAL 50 MG, ORAL Professional Date:11/22/02ISR Number: 4019947-3Report Type:Periodic Company Report #PHEH2001US10098 Age:21 YR Gender:Male I/FU:I Outcome PT Hospitalization - Abdominal Pain Initial or Prolonged Anaemia Anorexia Blood Urine Present Chills Dysuria Hallucination, Auditory Hallucination, Visual Hypoproteinaemia Hypoxia Leukocytosis Nausea Nephritis Interstitial Oxygen Saturation 22-Feb-2006 08:30 AM Page: 1870 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Decreased Pleural Effusion Pyrexia Report Source Product Role Manufacturer Route Dose Duration Health Clozaril PS ORAL 300 MG, ORAL Professional Depakote (Valproate Semisodium) C Zyprexa (Olanzapine) C Symmetrel C Valproic Acid C Cogentin (Benzatropine Mesilate) C Date:11/22/02ISR Number: 4019949-7Report Type:Periodic Company Report #PHEH2001US10103 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Health Clozaril (Clozapine) Initial or Prolonged Lethargy Professional Tablet PS ORAL 700 MG/DAY, Leukocytosis ORAL Lithium (Lithium) C Depakote (Valproate Semisodium) C Zoloft (Sertraline Hydrochloride) C Date:11/22/02ISR Number: 4019950-3Report Type:Periodic Company Report #PHEH2001US10116 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Health Clozaril (Clozapine) PS ORAL 50 MG, QHS, Initial or Prolonged Erectile Dysfunction Professional ORAL Disability Priapism Effexor (Venlafaxine Hydrochloride) SS Klonopin C Lithium (Lithium) C Date:11/22/02ISR Number: 4019952-7Report Type:Periodic Company Report #PHEH2001US10174 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) Professional (Cont.) PS ORAL 550 MG, ORAL Klonopin C Celexa C Date:11/22/02ISR Number: 4019954-0Report Type:Periodic Company Report #PHEH2001US10266 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Health Clozaril Leukopenia Professional (Clozapine) PS ORAL 500 MG DAILY, Neutropenia ORAL Seroquel (Quetiapine) C 22-Feb-2006 08:30 AM Page: 1871 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/22/02ISR Number: 4019955-2Report Type:Periodic Company Report #PHEH2001US10327 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Gastric Ulcer Company Clozaril (Clozapine) Initial or Prolonged Representative (Cont.) PS ORAL 300 MG DAILY, ORAL Depakote (Valproate Semisodium) C Prevacid (Lansoprazole) C Claritin (Loratadine) C Date:11/22/02ISR Number: 4019957-6Report Type:Periodic Company Report #PHEH2002US00527 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Triglycerides Health Clozaril (Clozapine) Increased Professional (Cont.) PS ORAL 100 MG DAILY, Grand Mal Convulsion ORAL; 200 Psychotic Disorder MG/DAY, ORAL Weight Increased Effexor (Venlafaxine Hydrochloride) C Xanax (Alprazolam) C Topamax (Topiramate) C Date:11/22/02ISR Number: 4019966-7Report Type:Periodic Company Report #PHEH2002US00539 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Health Clozaril(Clozapine)T Initial or Prolonged Professional ablet PS ORAL 400 M/DAY, ORAL Valproic Acid C Seroquel (Quetiapine) C Clonopin C Date:11/22/02ISR Number: 4019967-9Report Type:Expedited (15-DaCompany Report #PHEH2002US00540 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Clozaril Initial or Prolonged Professional (Clozapine)Tablet PS ORAL 600 MG/DAY, ORAL Zantac C Detrol (Tolterodine L-Tartrate) C Navane (Tiotixene) C Cogentin (Benzatropine Mesilate) C 22-Feb-2006 08:30 AM Page: 1872 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/22/02ISR Number: 4019969-2Report Type:Periodic Company Report #PHEH2002US00763 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Clozaril(Clozapine)T Professional ablet PS ORAL SEE IMAGE Clozaril(Clozapine)T ablet SS Date:11/22/02ISR Number: 4019972-2Report Type:Periodic Company Report #PHEH2002US00898 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Syncope Health Clozaril(Clozapine)T Initial or Prolonged Ventricular Tachycardia Professional ablet PS ORAL ORAL Zoloft(Sertraline Hydrochloride) C Metoprolol (Metoprolol) C Depakote (Valproate Semisodium) C Zatac C Atorvastatin(Atorvas tatin) C Asa C Captorpil C Date:11/22/02ISR Number: 4019974-6Report Type:Periodic Company Report #PHEH2002US01002 Age:93 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril(Clozarine)T Professional ablet PS ORAL ORAL Date:11/22/02ISR Number: 4019975-8Report Type:Periodic Company Report #PHEH2002US01130 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Cholesterol Health Clozari(Clozapine)Ta Initial or Prolonged Increased Professional blet PS ORAL 600 MG/DAY, Blood Triglycerides ORAL Increased Leukopenia Neutropenia Psychotic Disorder Weight Increased White Blood Cell Disorder Date:11/22/02ISR Number: 4019977-1Report Type:Periodic Company Report #PHEH2002US01297 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Difficulty In Walking Health Clozaril(Clozapine)T Dizziness Professional ablet PS ORAL 600 MG/DAY, Orthostatic Hypotension ORAL 22-Feb-2006 08:30 AM Page: 1873 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/22/02ISR Number: 4019980-1Report Type:Periodic Company Report #PHEH2002US01388 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril(Clozapine)T Professional ablet PS ORAL 400 MG, BID, ORAL Klonopin C Cogentin (Benzatropine Mesilate) C Vistaril (Hydroxyzine Embonate) C Date:11/22/02ISR Number: 4019982-5Report Type:Periodic Company Report #PHEH2002US01408 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Clozaril(Clozapine)T Initial or Prolonged Professional ablet PS ORAL 725 MG DAILY, Company ORAL Representative Clozapine (Clozapine)100mg SS ORAL 725 MD DAILY, ORAL Date:11/22/02ISR Number: 4019986-2Report Type:Periodic Company Report #PHEH2002US01477 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril(Clozapine)T Professional ablet PS ORAL 500MG, ORAL Haldol C Date:11/22/02ISR Number: 4019990-4Report Type:Periodic Company Report #PHEH2002US01555 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chest Pain Health Clozaril Convulsion Professional (Clozapine) PS ORAL 550 MG DAILY, Dyspnoea ORAL Malaise Zoloft Palpitations (Sertraline Pyrexia Hydrochloride) C Tachycardia Date:11/22/02ISR Number: 4019992-8Report Type:Periodic Company Report #PHEH2002US01708 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Bradycardia Health Clozaril Hospitalization - Cyanosis Professional (Cloazpine) PS ORAL 800 MG/DAY, Initial or Prolonged Head Injury ORAL Hyperhidrosis Vistaril Hypotension (Hydroxyzine Loss Of Consciousness Embonate) SS 4 22-Feb-2006 08:30 AM Page: 1874 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/22/02ISR Number: 4019993-XReport Type:Periodic Company Report #PHEH2002US01780 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Operation Health Clozaril Initial or Prolonged Chest Pain Professional (Clozapine) PS ORAL 200 MG/DAY, Leukopenia ORAL Celexa C Valproic Acid C Date:11/22/02ISR Number: 4019994-1Report Type:Periodic Company Report #PHEH2002US01795 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Homicidal Ideation Health Clozaril Initial or Prolonged Pneumonia Professional (Cloazpine) PS ORAL 400 MG/DAY, White Blood Cell Count Company ORAL Decreased Representative Paxil C Trazodone C Date:11/22/02ISR Number: 4019997-7Report Type:Periodic Company Report #PHEH2002US01796 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Grand Mal Convulsion Health Clozaril (Clozapine) PS ORAL 500 MG/DAY, Initial or Prolonged Professional ORAL Valproic Acid C Date:11/22/02ISR Number: 4020002-7Report Type:Periodic Company Report #PHEH2002US01875 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril PS ORAL 600 MG DAILY, Professional ORAL Cloazapine (Clozapine) SS Valproic Acid C Dilantin C Phenobarbital C Levothyroxine C Paxil C Ativan C Date:11/22/02ISR Number: 4020008-8Report Type:Periodic Company Report #PHEH2002US01926 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Clozaril (Clozapine) PS ORAL 600 MG, Professional DAILY, ORAL Prozac (Fluoxetine Hydrochloride) C 22-Feb-2006 08:30 AM Page: 1875 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/22/02ISR Number: 4020012-XReport Type:Periodic Company Report #PHEH2002US01989 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Health Clozaril Initial or Prolonged Myocardial Infarction Professional (Clozapine) PS ORAL 550 MG, DAILY, ORAL Date:11/22/02ISR Number: 4020013-1Report Type:Periodic Company Report #PHEH2002US01992 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiac Disorder Other Clozaril (Clozapine) PS ORAL ORAL Date:11/22/02ISR Number: 4020014-3Report Type:Periodic Company Report #PHEH2002US02064 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Brain Hypoxia Health Clozaril Hospitalization - Cardiac Arrest Professional (Clozapine) PS Initial or Prolonged Chest Pain Sinemet C Disability Coma Comtan C Myocardial Infarction Aricept C Prilosec C Date:11/22/02ISR Number: 4020015-5Report Type:Periodic Company Report #PHEH2002US02097 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Health Clozaril (Clozapine) Initial or Prolonged Neutropenia Professional Tablet PS ORAL 75MG AM+100MG Pyrexia HS, ORAL Omeprazole (Omeprazole) C Trazodone (Trazodone) C Ziprasidone (Ziprasidone) C Paxil C Date:11/22/02ISR Number: 4020016-7Report Type:Periodic Company Report #PHEH2002US02315 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Health Clozaril (Clozapine) Fall Professional Tablet PS ORAL ORAL Knee Arthroplasty Date:11/22/02ISR Number: 4020017-9Report Type:Periodic Company Report #PHEH2002US02397 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Health Clozaril (Clozapine) Abnormal Professional Tablet PS ORAL 450MG, ORAL Myocarditis Paxil C Ambien (Zolpidem 22-Feb-2006 08:30 AM Page: 1876 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tartrate) C Amantadine (Amantadine) C Benadryl C Ditropan Xl (Oxybutynih Hydrochloride) C Coreton (Labetalol Hydrocloride) C Ativan C Wellbutrin (Amfebutamone Hydrochloride) C Date:11/22/02ISR Number: 4020018-0Report Type:Periodic Company Report #PHEH2002US02422 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Health Clozaril (Clozapine) Initial or Prolonged Professional Tablet PS ORAL ORAL Celexa C Depakote (Valproate Semisodium) C Date:11/22/02ISR Number: 4020019-2Report Type:Periodic Company Report #PHEH2002US02680 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Leukopenia Health Clozaril (Clozapine) Neutropenia Professional Tablet PS ORAL 300MG AM + 250MG HS, ORAL Date:11/22/02ISR Number: 4020020-9Report Type:Periodic Company Report #PHEH2002US02688 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocarditis Health Clozaril (Clozapine) Professional Tablet PS ORAL 650 MG/DAY, ORAL Cogentin (Benzatropine Mesilate) C Date:11/22/02ISR Number: 4020021-0Report Type:Periodic Company Report #PHEH2002US02999 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Priapism Health Clozaril (Clozapine) Initial or Prolonged Professional Tablet PS ORAL 200 MG/DAY, ORAL; SEE IMAGE 22-Feb-2006 08:30 AM Page: 1877 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/22/02ISR Number: 4020022-2Report Type:Periodic Company Report #PHEH2002US03074 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Health Clozaril (Clozapine) Leukopenia Professional Tablet PS ORAL 100MG AM + 300MG HS, ORAL Depakote (Valproate Semisodium) C Ranitidine (Ranitidine) C Terazosin (Terazosin) C Atenolol C Medrin (Embramine) C Date:11/22/02ISR Number: 4020024-6Report Type:Periodic Company Report #PHEH2002US03189 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram St-T Health Clozaril (Clozapine) Change Professional Tablet PS ORAL 375MG, ORAL Orthostatic Hypotension Ventricular Extrasystoles Date:11/22/02ISR Number: 4020027-1Report Type:Periodic Company Report #PHEH2002US03235 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Health Clozaril (Clozapine) Initial or Prolonged Pharyngitis Professional Tablet PS ORAL 400 MG, BID, Pyrexia ORAL Klonopin C Topamax (Topiramate) C Haldol C Zypexa (Olanzapine) C Cogentin (Benzatropine Mesilate) C Date:11/22/02ISR Number: 4020033-7Report Type:Periodic Company Report #PHEH2002US03262 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Decreased Appetite Health Clozaril Initial or Prolonged Professional (Clozapine) PS ORAL 200 MG AM + 250 MG HS, ORAL Tylenol (Paracetamol) C Albuterol C Mylanta (Aluminium Hydroxide Gel, Dried, Simeticone) C Ativan C Multivitamins (Ascorbic Acid, Panthenol, Retinol) C 22-Feb-2006 08:30 AM Page: 1878 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Depakote (Valproate Semisodium) C Haldol C Lithium (Lithium) C Megace (Megestrol Acetate) C Oral Contraceptive Nos (Oral Contraceptive Nos) C Oscal C Date:11/22/02ISR Number: 4020034-9Report Type:Periodic Company Report #PHEH2002US03277 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Body Temperature Health Clozaril Increased Professional (Clozapine) PS ORAL 350 MG/DAY, Constipation ORAL Electrocardiogram Abnormal Pericardial Disease Tachycardia Weight Decreased White Blood Cell Count Abnormal Date:11/22/02ISR Number: 4020038-6Report Type:Periodic Company Report #PHEH2002US03370 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Echocardiogram Abnormal Health Clozaril Ejection Fraction Professional (Clozapine) PS ORAL 200 MG, BID, Decreased ORAL Eosinophil Count Prozac (Fluoxetine Increased Hydrochloride) C Fatigue Zyrtec (Cetirizine Myocarditis Hydrochloride) C Tachycardia Seroquel (Quetiapine Fumarate) C Date:11/22/02ISR Number: 4020039-8Report Type:Periodic Company Report #PHEH2002US03400 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pyrexia Health Clozaril Initial or Prolonged Tachycardia Professional (Clozapine) PS ORAL 125 MG, BID, ORAL Divalproex Sodium (Valproate Semisodium) C Acetaminophen (Paracetamol) C Chlorpromazine (Chlorpromazine) C 22-Feb-2006 08:30 AM Page: 1879 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/22/02ISR Number: 4020040-4Report Type:Periodic Company Report #PHEH2002US03415 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril Professional (Clozapine) PS ORAL 100 MG/DAY, ORAL Date:11/22/02ISR Number: 4020041-6Report Type:Periodic Company Report #PHEH2002US03523 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Health Clozaril Initial or Prolonged Professional (Clozapine) PS ORAL 200MG NOON + 300MG, HS, ORAL Ortho Cyclen (Norgestimate) C Synthroid C Colace C Date:11/22/02ISR Number: 4020042-8Report Type:Periodic Company Report #PHEH2002US03626 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozaril Hospitalization - Pneumonia Professional (Clozapine) PS ORAL 50MG PM + Initial or Prolonged Vomiting 100MG HS, ORAL Neurontin (Gabapentin) C Remeron (Mirtazapine) C Cogentin (Benzatropine Mesilate) C Date:11/22/02ISR Number: 4020043-XReport Type:Periodic Company Report #PHEH2002US03663 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukocytosis Health Clozaril Initial or Prolonged Pneumonia Professional (Clozapine) PS ORAL 300 MG, BID, ORAL Xanax (Alprazolam) C Date:11/22/02ISR Number: 4020044-1Report Type:Periodic Company Report #PHEH2002US03769 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pulmonary Embolism Health Clozaril Professional (Clozapine) PS ORAL 500 MG, ORAL 22-Feb-2006 08:30 AM Page: 1880 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/22/02ISR Number: 4020045-3Report Type:Periodic Company Report #PHEH2002US03793 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril Professional (Clozapine) PS ORAL 100MG AM + 300MG. HS, ORAL Prolixin (Fluphenazine Hydrochloride) C Avandia (Rosiglitazone Maleate) C Glucophage Abic C Glyburide C Docusate (Docusate) C Date:11/22/02ISR Number: 4020048-9Report Type:Periodic Company Report #PHEH2002US03971 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril Professional (Clozapine) PS ORAL 400 MG, ORAL Effexor (Venlafaxine Hydrochloride) C Date:11/22/02ISR Number: 4020050-7Report Type:Periodic Company Report #PHEH2002US04060 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril Professional (Clozapine) PS ORAL 600 MG , QHS, Company ORAL Representative Theophylline C Prevacid (Lansoprazole) C Verapamil (Verapamil) C Benadryl C Paxil C Date:11/22/02ISR Number: 4020051-9Report Type:Periodic Company Report #PHEH2002US04067 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Health Clozaril Initial or Prolonged Head Injury Professional (Clozapine) PS ORAL 400 MG , BID, Syncope ORAL Date:11/22/02ISR Number: 4020052-0Report Type:Periodic Company Report #PHEH2002US04174 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril Professional (Clozapine) PS ORAL ORAL 22-Feb-2006 08:30 AM Page: 1881 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/22/02ISR Number: 4020053-2Report Type:Periodic Company Report #PHEH2002US04478 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hallucination, Auditory Health Clozaril PS ORAL 300 MG/DAY, Headache Professional ORAL; SEE IMAGE Cogentin (Benzatropine Mesilate) C Date:11/22/02ISR Number: 4020054-4Report Type:Periodic Company Report #PHEH2002US04624 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Level Increased Health Clozaril PS ORAL 300 MG, QD, Initial or Prolonged Grand Mal Convulsion Professional ORAL Other Muscle Twitching Vioxx (Rofecoxib) SS ORAL 50 MG, ORAL Guanfacine (Guanfacine) C Neurontin (Gabapentin) C Adderall (Dexamfetamine Sulfate, Dexamefetamine Saccharate, C Cogentin (Benzatropine Mesilate) C Tetracycline (Tetracycline) C Date:11/22/02ISR Number: 4020055-6Report Type:Periodic Company Report #PHEH2002US04695 Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril PS ORAL 375 MG/DAILY, Professional ORAL Ecotrin C Levothroid C Niacin C Propranolol C Vitamin E C Vitamin B6 C Prempro (Esgtrogens Conjugated) C Ditropan (Oxybutynin) C Guaifenex C Detrol (Tolterodine L-Tartrate) C Arthritis Pain Formula (Paracetamol) C Lactulose C Lorazepam C Ibuprofen C Benadryl C Docusate (Docusate) C 22-Feb-2006 08:30 AM Page: 1882 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Milk Of Magnesia C Medlizine C Date:11/22/02ISR Number: 4020056-8Report Type:Periodic Company Report #PHEH2002US04719 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril PS ORAL ORAL Professional Date:11/22/02ISR Number: 4020057-XReport Type:Periodic Company Report #PHEH2002US04731 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agranulocytosis Health Clozaril PS ORAL 550 MG/DAY, Other Death Professional ORAL Leukopenia Glyburide C Neutropenia Effexor (Venlafaxine Hydrochloride) C Detrol (Tolterodine L-Tartrate) C Date:11/22/02ISR Number: 4020058-1Report Type:Periodic Company Report #PHEH2002US04769 Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril PS ORAL 200 MG, ORAL Professional Date:11/22/02ISR Number: 4020059-3Report Type:Periodic Company Report #PHEH2001US06231 Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Health Clozaril (Clozapine) PS ORAL 625 MG, ORAL Initial or Prolonged Leukopenia Professional Synthroid C Other Neutropenia Company Lotensin C Psychotic Disorder Representative Ditropan (Oxybutynin) C Neurontin (Gabapentin) C Date:11/22/02ISR Number: 4020060-XReport Type:Periodic Company Report #PHEH2001US06441 Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Face Oedema Health Clozaril Initial or Prolonged Grand Mal Convulsion Professional (Clozapine) PS ORAL SEE IMAGE Muscular Weakness Lithium Oedema Peripheral (Lithium) C Sedation Cogentin Weight Increased (Benzatropine Mesilate) C Ziac C Haldol C Depakote 22-Feb-2006 08:30 AM Page: 1883 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Valproate Semisodium) C Multivitamins And Iron C Date:11/22/02ISR Number: 4020061-1Report Type:Periodic Company Report #PHEH2001US06675 Age:49 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozaril Hospitalization - Psychotic Disorder Professional (Clozapine) PS ORAL 300MG DAILY, Initial or Prolonged White Blood Cell Count ORAL Decreased Cogentin (Benzatropine Mesilate) C Date:11/22/02ISR Number: 4020062-3Report Type:Periodic Company Report #PHEH2001US06710 Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Health Clozaril Initial or Prolonged Professional (Clozapine) PS ORAL SEE IMAGE Date:11/22/02ISR Number: 4020063-5Report Type:Periodic Company Report #PHEH2001US06740 Age:27 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukocytosis Health Clozaril Initial or Prolonged Leukopenia Professional (Clozapine) PS ORAL SEE IMAGE Psychotic Disorder Risperdal (Risperidone) C Neurontin (Gabapentin) C Cogentin (Benzatropine Mesilate) C Date:11/22/02ISR Number: 4020064-7Report Type:Periodic Company Report #PHEH2001US07407 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukocytosis Health Clozaril Initial or Prolonged Professional (Clozapine) PS ORAL 450 MG, ORAL Celexa C Geodon (Ziprasidone Hydrochloride) C Cogentin (Benzatropine Mesilate) C Citalopram (Citalopram) C Ziprasidone (Ziprasidone) C 22-Feb-2006 08:30 AM Page: 1884 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/22/02ISR Number: 4020066-0Report Type:Periodic Company Report #PHEH2001US07408 Age:28 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pyrexia Health Clozaril Initial or Prolonged Professional (Clozapine) PS ORAL 100 MG, BID Risperidone (Risperidone) C Date:11/22/02ISR Number: 4020068-4Report Type:Periodic Company Report #PHEH2001US07509 Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozaril Hospitalization - Leukopenia Professional (Clozapine) PS ORAL 400 MG/DAY, Initial or Prolonged Psychotic Disorder Company ORAL Representative Depakote (Valproate Semisodium) C Date:11/22/02ISR Number: 4020069-6Report Type:Periodic Company Report #PHEH2001US07545 Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozaril Professional (Clozapine) PS ORAL 400 MG, ORAL Chemotherapeutics, Other (Chemotherapeutics, Other) SS Date:11/25/02ISR Number: 4015017-9Report Type:Direct Company Report #CTU 181633 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Constipation Clozapine 100 Mg Initial or Prolonged Faecaloma Mylan PS Mylan ORAL 500 MG Required Intestinal Obstruction DIVIDED BID Intervention to ORAL Prevent Permanent Lansoprazole C Impairment/Damage Haloperidol Decanoate C Benztropine C Multivitamin C Ferrous Sulfate C Docusate Sodium C Milk Of Magnesia C Fluoxetine C Docusate Sodium /Casanthrol C Date:11/25/02ISR Number: 4016225-3Report Type:Expedited (15-DaCompany Report #02P-163-0203565-00 Age:38 YR Gender:Male I/FU:F Outcome Hospitalization - Initial or Prolonged Required Intervention to 22-Feb-2006 08:30 AM Page: 1885 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Anxiety Health Divalproex Sodium Haemothorax Professional (Depakote) Lobar Pneumonia Other (Divalproex Sodium) Palpitations (Divalproex Sodium) PS ORAL 100 MG, 2 IN Pleural Effusion 1 D, ORAL Pyrexia Clozapine SS ORAL 400 MG, 2 IN Tuberculin Test Positive 1 D, ORAL Haloperidol C Date:11/25/02ISR Number: 4016272-1Report Type:Expedited (15-DaCompany Report #2002066231 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Interaction Health Zoloft (Sertraline) PS ORAL ORAL Drug Level Above Professional Clozapine SS Therapeutic Company Representative Date:11/25/02ISR Number: 4016560-9Report Type:Expedited (15-DaCompany Report #C2002-2875.01 Age:54 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Clozapine Tablets Other 100 Mg Mylan PS Mylan ORAL 150MG/DAY, THEN 100 MG/DAY, ORAL Date:11/25/02ISR Number: 4016561-0Report Type:Expedited (15-DaCompany Report #C2002-3252.01 Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 25 MG Q HS Other ORAL Bupropion Hcl C Carbidopa/Levodopa C Famotidine C Levothyroxine Sodium C Zinc Sulfate C Date:11/25/02ISR Number: 4016562-2Report Type:Expedited (15-DaCompany Report #02-11-1009 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Death Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc ORAL 100MG QAM ORAL Tricor C Metoprolol C 22-Feb-2006 08:30 AM Page: 1886 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/25/02ISR Number: 4017422-3Report Type:Expedited (15-DaCompany Report #MK200211-0197-1 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Deep Vein Thrombosis Foreign Clomipramine PS Pulmonary Embolism Clozaril SS 375MG Lorazepam SS Date:11/26/02ISR Number: 4016290-3Report Type:Expedited (15-DaCompany Report #C2002-3297.01 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Mylan ORAL 25MG Q AM, Professional 50MG AT Q Other 12:00PM, ORAL Clozapine SS Mylan ORAL 500MG Q HS, ORAL Date:11/26/02ISR Number: 4017429-6Report Type:Expedited (15-DaCompany Report #PHBS2002CA14023 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Appendicitis Perforated Foreign Clozaril Study (Clozapine)Tablet PS ORAL ORAL Health Professional Other Date:11/26/02ISR Number: 4017442-9Report Type:Expedited (15-DaCompany Report #PHFR2002GB01514 Age:36 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dilatation Atrial Foreign Clozaril Electrocardiogram St-T Health (Clozapine)Tablet PS ORAL 250MG/DAY, Change Professional ORAL Heart Rate Increased Other Hypotension Tachycardia Weight Increased Date:11/26/02ISR Number: 4017460-0Report Type:Expedited (15-DaCompany Report #PHBS2002CL11851 Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Foreign Leponex (Clozapine) Initial or Prolonged Confusional State Study Tablet PS ORAL ORAL; 2.5 G, Intentional Overdose Health QD, ORAL Suicide Attempt Professional Other Date:11/26/02ISR Number: 4017464-8Report Type:Expedited (15-DaCompany Report #PHBS2002CA14025 Age:48 YR Gender:Unknown I/FU:I Outcome PT Report Source Death Myocardial Infarction Foreign Study Health 22-Feb-2006 08:30 AM Page: 1887 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Other Product Role Manufacturer Route Dose Duration Clozaril (Clozapine) Tablet PS ORAL ORAL Date:11/26/02ISR Number: 4017467-3Report Type:Expedited (15-DaCompany Report #PHBS2002AU11288 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Non-Hodgkin'S Lymphoma Foreign Clozaril(Clozapine) Initial or Prolonged Pancytopenia Study Tablet PS ORAL 275 TO 400 Health MG/DAY, ORAL Professional Fludarabine(Fludarab Other ine) SS INTRAVENOUS 50 MG, INTRAVENOUS Date:11/26/02ISR Number: 4017598-8Report Type:Expedited (15-DaCompany Report #PHFR2002GB02465 Age:30 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Localised Infection Foreign Clozaril (Clozapine) Pemphigoid Study Tablet PS ORAL 350 MG DAY Health ORAL Professional Amitriptyline Other (Amitriptyline) C Depo Provera C Date:11/26/02ISR Number: 4017646-5Report Type:Expedited (15-DaCompany Report #PHFR2002GB03056 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anorexia Foreign Clozaril (Clozapine) Initial or Prolonged Cholangitis Study (Clozapine) Tablet PS ORAL 400 MG/DAY, Cholelithiasis Health ORAL Diarrhoea Professional Carbamazepine Dry Skin Other (Carbamazepine, Dysphagia Carbamazepine) SS ORAL 500 MG/DAY, Fatigue ORAL Hepatitis Haloperidol C Leukopenia Modecate "Squibb" Nausea (Fluphenazine Neutropenia Decanoate) C Pyrexia Depixol (Flupentixol Rash Maculo-Papular Decanoate) C Skin Exfoliation Tachycardia Date:11/26/02ISR Number: 4017828-2Report Type:Expedited (15-DaCompany Report #PHFR2002GB02180 Age:38 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril(Clozapine) Health Tablet PS ORAL 500MG/DAY, Professional ORAL Other Lithium (Lithium) C Prozac (Fluoxetine 22-Feb-2006 08:30 AM Page: 1888 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride) C Date:11/26/02ISR Number: 4017829-4Report Type:Expedited (15-DaCompany Report #PHBS2002AU13078 Age: Gender:Unknown I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pancytopenia Foreign Clozaril(Clozapine) Health Tablet PS ORAL ORAL Professional Fludarabine Other (Fludarabine) C Chemotherapeutics, Other C Date:11/26/02ISR Number: 4017837-3Report Type:Expedited (15-DaCompany Report #PHBS2002AU10604 Age:27 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dilatation Ventricular Foreign Clozaril (Clozapine) Ejection Fraction Health Tablet PS ORAL 300 MG, BID, Decreased Professional ORAL Other Tegretol (Carbamazepine) SS ORAL 200 MG, BID, ORAL Fluoxetine (Fluoxetine) C Date:11/26/02ISR Number: 4017864-6Report Type:Expedited (15-DaCompany Report #PHBS2002AU11185 Age:20 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Foreign Clozaril (Clozapine) Initial or Prolonged Drug Abuser Study Tablet PS ORAL 400 MG/DAY, Hallucination, Auditory Health ORAL; 2600 Intentional Overdose Professional MG, Mental Disorder Other ONCE/SINGLE, Suicide Attempt ORAL Cannabis (Cannabis) SS Valproate Sodium C Date:11/26/02ISR Number: 4017866-XReport Type:Expedited (15-DaCompany Report #PHBS2002AU08809 Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Haemoglobin Decreased Foreign Clozaril (Clozapine) Initial or Prolonged Oesophageal Haemorrhage Health Tablet PS ORAL ORAL Oesophagitis Professional Stomach Discomfort Other Vomiting Date:11/26/02ISR Number: 4017867-1Report Type:Expedited (15-DaCompany Report #PHFR2002GB03219 Age:40 YR Gender:Male I/FU:F Outcome PT Hospitalization - Circulatory Collapse Initial or Prolonged Coma Other Epilepsy Hypertensive Crisis 22-Feb-2006 08:30 AM Page: 1889 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Postictal State Tachycardia Report Source Product Role Manufacturer Route Dose Duration Foreign Clozaril (Clozapine) Study Tablet PS ORAL 600 MG/DAY, Health ORAL Professional Adalat C Other Ace Inhibitor Nos C Date:11/26/02ISR Number: 4017871-3Report Type:Expedited (15-DaCompany Report #PHNR2002AU00478 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drooling Foreign Clozaril (Clozapine) Initial or Prolonged Gastrointestinal Disorder Study (Clozapine) Unknown PS ORAL 225 -425 Mobility Decreased Health MG/DAY, ORAL Speech Disorder Professional Other Date:11/26/02ISR Number: 4017917-2Report Type:Expedited (15-DaCompany Report #PHBS2002CA09485 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Constipation Foreign Clozaril Ileus Paralytic Study (Clozapine) PS ORAL 625 MG, QHS, Megacolon Health ORAL Professional Seroquel (Quetiapine Other Fumarate) C Omeprazole (Omeprazole) C Epival (Valproate Semisodium) C Date:11/26/02ISR Number: 4017939-1Report Type:Expedited (15-DaCompany Report #PHBS2002AU13078 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pancytopenia Foreign Clozaril (Clozapine) Health Tablet PS ORAL ORAL Professional Fludarabine Other (Fludarabine) C Chemotherapeutics, Other (Chemotherapeutics, Other) C Date:11/26/02ISR Number: 4018064-6Report Type:Expedited (15-DaCompany Report #2002060444 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asthenia Health Dilantin Suspension Influenza Like Illness Professional (Phenytoin Sodium) PS White Blood Cell Count Clozapine SS ORAL 150 MG Increased (BID),ORAL Sertraline Hydrochloride C Lithium Carbonate C 22-Feb-2006 08:30 AM Page: 1890 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tocopherol C Prednisone C Ranitidine C Date:11/26/02ISR Number: 4018119-6Report Type:Expedited (15-DaCompany Report #HQ3993229AUG2002 Age:54 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Fall Health Ativan Lorazepam, Parkinson'S Disease Professional Tablet) PS ORAL 1 MG 4X PER 1 Sedation DAY, ORAL Clozapine (Clozapine, ) SS ORAL 400-500MG/;DA Y, ORAL Ativan (Lorazepam, Tablet) SS ORAL 1 MG 3X PER 1 DAY, ORAL Haldol (Haloperidol) C Paxil (Paroxetine Hydrochloride) C Date:11/26/02ISR Number: 4018247-5Report Type:Expedited (15-DaCompany Report #PHEH2002US09840 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Choking Health Clozaril (Clozapine) Professional Tablet PS ORAL SEE IMAGE Efexor Xr (Venlafaxine) C Date:11/26/02ISR Number: 4036532-8Report Type:Periodic Company Report #02-06-0577 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine Tablets- Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc PS Ivax Pharmaceuticals, Inc. ORAL 450MG QD ORAL Date:11/27/02ISR Number: 4019288-4Report Type:Expedited (15-DaCompany Report #GB9132902AUG2002 Age:22 YR Gender:Male I/FU:I Outcome PT Death Aspartate Aminotransferase Increased Basophil Count Increased Blood Alkaline Phosphatase Increased Blood Creatinine Increased Blood Thyroid Stimulating Hormone Increased Blood Urea Increased Carotid Arterial Embolus Cerebral Ischaemia 22-Feb-2006 08:30 AM Page: 1891 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Congestive Cardiomyopathy Dyspnoea Gamma-Glutamyltransferase Report Source Product Role Manufacturer Route Dose Duration Increased Foreign Efexor Xl Intracardiac Thrombus Health (Venlafaxine Lymphocyte Count Professional Hydrochloride) PS ORAL SEE IMAGE Increased Other Clozapine Neutrophil Count (Clozapine) SS ORAL 250 MG 2X PER Increased 1 DAY Platelet Count Abnormal Diazepam (Diazepam) C Red Blood Cell Count Decreased White Blood Cell Count Increased Date:11/27/02ISR Number: 4019363-4Report Type:Expedited (15-DaCompany Report #CATIE1-0316 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Triglycerides Study Clozapine (Colloidal Initial or Prolonged Abnormal Health Silicon Dioxide) Diabetes Mellitus Professional Capsule, 200 Mg PS Dyspnoea High Density Lipoprotein Abnormal Hyperhidrosis Date:11/27/02ISR Number: 4019404-4Report Type:Expedited (15-DaCompany Report #CATIE1-0316 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Triglycerides Study Clozapine (Colloidal Initial or Prolonged Increased Health Silicon Dioxide) Diabetes Mellitus Professional Capsule, 200mg PS High Density Lipoprotein Decreased Date:11/27/02ISR Number: 4019602-XReport Type:Expedited (15-DaCompany Report #C2002-3034.01 Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Neoplasm Malignant Health Clozapine Tablets Professional 100 Mg Mylan PS ORAL 200MG Q AM, Other 700MG Q HS, ORAL Date:11/27/02ISR Number: 4019605-5Report Type:Expedited (15-DaCompany Report #C2002-3104.01 Age:49 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 600 MG QD, Other ORAL Quetiapine Fumarate C 22-Feb-2006 08:30 AM Page: 1892 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/27/02ISR Number: 4019606-7Report Type:Expedited (15-DaCompany Report #C2002-3369.01 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Urinary Tract Infection Health Clozapine Tablets Initial or Prolonged Professional 100 Mg Mylan PS ORAL 100MG BID, Other Other ORAL Divalproex Sodium C Fluoxetine C Haloperidol C Propranolol C Date:11/27/02ISR Number: 4019610-9Report Type:Expedited (15-DaCompany Report #C2002-3365.01 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 50MG Q HS, Other ORAL Clozapine Tablets 100 Mg Mylan SS Mylan ORAL 100MG QAM, 300MG QHS, ORAL Date:11/29/02ISR Number: 4018422-XReport Type:Expedited (15-DaCompany Report #A122356 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abnormal Behaviour Consumer Ziprasidone Hospitalization - Atherosclerosis Health (Ziprasidone) PS ORAL 120 MG (BID), Initial or Prolonged Cardiac Arrest Professional ORAL Catatonia Clozaril (Clozapine) SS 400 MG Condition Aggravated (DAILY) Constipation Lamictal Coronary Artery Occlusion (Lamotrigine) Dilatation Ventricular (Lamotrigine) C Drooling Ativan (Lorazepam) Drug Interaction (Lorazepam) C Drug Level Above Casanthranol/Docusat Therapeutic e Sodium Drug Level Below (Peri-Colace) C Therapeutic Metamucil (Psyllium) Electroencephalogram (Psyllium Abnormal Hydrophilic Endocardial Fibrosis Mucilloid) C Hallucination Celexa (Citalopram) Liver Disorder (Citalopram Mitral Valve Prolapse Hydrobromide) C Myositis Inderal Scar (Propranolol) (Propanolol Hydrochloride) C Cogentin (Benzatropine Mesilate) C 22-Feb-2006 08:30 AM Page: 1893 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/02ISR Number: 4018868-XReport Type:Expedited (15-DaCompany Report #HQ5483622NOV2002 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Catatonia Health Protonix Drug Interaction Professional (Pantoprazole, Drug Level Above Company Tablet, Delayed Therapeutic Representative Release) PS Clozaril (Clozapine,) SS Date:11/29/02ISR Number: 4019076-9Report Type:Expedited (15-DaCompany Report #PHEH2002US02451 Age:35 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Complications Of Maternal Health Clozaril (Clozapine) Exposure To Therapeutic Professional Tablet PS ORAL 200 MG/DAY, Drugs ORAL Diabetes Mellitus Avandia (Rosiglitazone Maleate) C Insulin (Insulin) C Zoloft (Sertraline Hydrochloride) C Date:11/29/02ISR Number: 4019880-7Report Type:Expedited (15-DaCompany Report #02P-114-0204522-00 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Agranulocytosis Foreign Depakine Tablets Intervention to Health (Sodium Valproate) Prevent Permanent Professional (Sodium Valproate) Impairment/Damage (Sodium Valproate) PS ORAL 2000 MG, 1 IN 1 D, PER ORAL Clozapine SS ORAL 450 MG, 1 IN 1 D, PER ORAL Date:12/02/02ISR Number: 4020759-5Report Type:Expedited (15-DaCompany Report #325901 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Disorientation Foreign Rivotril Excoriation Study (Clonazepam) PS Grand Mal Convulsion Health Aurorix Insomnia Professional (Moclobemide) SS ORAL 300 MG DAILY Schizoaffective Disorder ORAL Leponex (Clozapine) SS ORAL 800 MG DAILY ORAL Seroquel (Quetapine Fumarate) SS ORAL 50 MG DAILY ORAL Fluanxol (Flupentixol) SS ORAL 5 MG DAILY ORAL Orfiril (Valproate Sodium) C 22-Feb-2006 08:30 AM Page: 1894 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/02/02ISR Number: 4024814-5Report Type:Expedited (15-DaCompany Report #02P-163-0205256-00 Age:53 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Hydrocodone/Acetamin Health ophen (Vicodin) Professional (Hydrocodone/Acetami nophen) (Hydrocodone/Acetami PS Clozapine SS Zolpidem SS Date:12/03/02ISR Number: 4020690-5Report Type:Expedited (15-DaCompany Report #PHBS2002CA14249 Age:66 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bronchitis Foreign Clozaril (Clozapine) PS ORAL ORAL Initial or Prolonged Lung Infection Study Lung Neoplasm Malignant Health Professional Other Date:12/03/02ISR Number: 4020712-1Report Type:Expedited (15-DaCompany Report #PHBS2002BR11745 Age:42 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Leponex Neutrophil Count Health (Clozapine)Tablet PS ORAL 100 MG, BID, Decreased Professional ORAL Platelet Count Decreased Other Lorax Psoriasis (Loracarbef)Tablet C Date:12/03/02ISR Number: 4020723-6Report Type:Expedited (15-DaCompany Report #PHRM2002FR02348 Age:31 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Toxicity Foreign Leponex Initial or Prolonged Electrocardiogram T Wave Health (Clozapine)Tablet PS ORAL 300 MG DAILY, Inversion Professional ORAL; 4 MG, Suicide Attempt Other ONCE/SINGLE, ORAL Zyprexa C Date:12/03/02ISR Number: 4020727-3Report Type:Expedited (15-DaCompany Report #PHBS2002AU09877 Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Clozaril Hospitalization - Circulatory Collapse Study (Clozapine)Tablet PS ORAL 200 MG/D, Initial or Prolonged Pyrexia Health ORAL Professional Olanzapine C Other Epilim C Efexor (Venlafaxine Hydrochloride) C 22-Feb-2006 08:30 AM Page: 1895 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/03/02ISR Number: 4021011-4Report Type:Expedited (15-DaCompany Report #PHEH2002US04192 Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Restrictive Pulmonary Health Clozaril (Clozapine) Disease Professional Tablet PS ORAL 875 MG, QD, ORAL Celexa C Klonopin C Loxapine (Loxapine) C Geodon (Ziprasidone Hydrochloride) C Propantheline Bromide (Propantheline Bromide) C Vitamin E C Baclofen C Lansoprazole (Lansoprazole) C Date:12/03/02ISR Number: 4021016-3Report Type:Expedited (15-DaCompany Report #2002068179 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardio-Respiratory Arrest Neurontin Initial or Prolonged Delirium (Gabapentin) PS Other Geodon (Ziprasidone) SS 120 MG BID Clozappine SS Lithium SS Date:12/03/02ISR Number: 4021388-XReport Type:Expedited (15-DaCompany Report #02P-056-0204742-00 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Foreign Depakote (Divalproex Blister Health Sodium) (Divalproex Pancytopenia Professional Sodium) PS ORAL 500 MG, 4 IN Staphylococcal Sepsis 1 D, ORAL Streptococcal Sepsis Clozapine SS ORAL 25 MG, 16 IN 1 D, PER ORAL Date:12/03/02ISR Number: 4021473-2Report Type:Expedited (15-DaCompany Report #EMADSS2002003794 Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Foreign Haldol (Unspecified) Hypertension Health (Haloperidol) PS 5 MG, DAILY Professional Clozaril (Clozapine) SS ORAL 300 MG , DAILY ORAL Epilim Chrono (Valproate Sodium) C 22-Feb-2006 08:30 AM Page: 1896 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/03/02ISR Number: 4021734-7Report Type:Expedited (15-DaCompany Report #PHNU2002DE03871 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Difficulty In Walking Foreign Leponex/Clozaril Electroencephalogram Study (Clozapine)(Clozapin Abnormal Health e) Tablet PS ORAL SEE IMAGE Excoriation Professional Gastrozepin Fall Other (Pirenzepine Gait Disturbance Dihydrochloride) C Grand Mal Convulsion Cipramil C Tegretal C Date:12/03/02ISR Number: 4021966-8Report Type:Expedited (15-DaCompany Report #PHRM2002FR02855 Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Foreign Leponex (Clozapine) Initial or Prolonged Diabetic Ketoacidosis Health Tablet PS ORAL 12.5 MG, QD, Professional ORAL Other Tegretol Retard (Carbamazepine, Carbamazepine) Extended Release Tablet C Lioresal "Novartis" Tablet C Atarax (Hydroxyzine Hydrochloride) Tablet C Rivotril Tablet C Date:12/04/02ISR Number: 4018919-2Report Type:Expedited (15-DaCompany Report #WAES 0211GBR00288 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anaemia Decadron Tablets PS Merck & Co., Inc ORAL 42 DAY Hospitalization - Blood Pressure Clozapine SS ORAL Initial or Prolonged Fluctuation Procyclidine Constipation Hydrochloride C ORAL Dyspnoea Lansoprazole C ORAL Fatigue Diazepam C ORAL Immunosuppression Promethazine Infection Hydrochloride C ORAL Loss Of Consciousness Lymphocyte Count Decreased Neutrophilia Platelet Count Decreased Pneumocystis Jiroveci Pneumonia Renal Failure Date:12/04/02ISR Number: 4020828-XReport Type:Expedited (15-DaCompany Report #02-11-1066 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Hospitalization - Suicide Attempt Health Initial or Prolonged Professional 22-Feb-2006 08:30 AM Page: 1897 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Product Role Manufacturer Route Dose Duration Clozapine Tablets - Ivax Pharmaceuticals, Inc. PS ORAL 200-400MG QD ORAL Date:12/04/02ISR Number: 4020830-8Report Type:Expedited (15-DaCompany Report #02-11-1063 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS ORAL 800MG QD ORAL Date:12/04/02ISR Number: 4020832-1Report Type:Expedited (15-DaCompany Report #02-11-1059 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS ORAL 300-500MG QD ORAL Date:12/04/02ISR Number: 4020836-9Report Type:Expedited (15-DaCompany Report #02-11-1055 Age:76 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dehydration Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS ORAL 12.5-25MG QD ORAL Date:12/04/02ISR Number: 4020937-5Report Type:Expedited (15-DaCompany Report #02-11-1051 Age:69 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neoplasm Malignant Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL ORAL Date:12/04/02ISR Number: 4020938-7Report Type:Expedited (15-DaCompany Report #02-11-1046 Age:37 YR Gender:Male I/FU:I Outcome PT Hospitalization - Blood Triglycerides Initial or Prolonged Abnormal Other Diabetes Mellitus Dyspnoea 22-Feb-2006 08:30 AM Page: 1898 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report High Density Lipoprotein Abnormal Hyperhidrosis Report Source Product Role Manufacturer Route Dose Duration Weight Increased Health Clozapine - Ivax Professional Pharmaceuticals, Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 200 MG ORAL Date:12/04/02ISR Number: 4020941-7Report Type:Expedited (15-DaCompany Report #02-11-1045 Age:81 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Clozapine - Ivax Congestive Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 100 - 400 MG QD ORAL Date:12/04/02ISR Number: 4020943-0Report Type:Expedited (15-DaCompany Report #02-11-1043 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Fatigue Health Clozapine - Ivax Myocardial Infarction Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 500 MG QD ORAL Date:12/04/02ISR Number: 4021546-4Report Type:Expedited (15-DaCompany Report #PHFR2002GB03667 Age:62 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Atrioventricular Block Foreign Clozaril (Clozapine) Second Degree Study Tablet PS ORAL 100 MG, BID, Dysarthria Health ORAL Electrocardiogram Professional Abnormal Other Electrocardiogram St Segment Depression Gait Disturbance Hemiparesis Myocardial Infarction Shock Date:12/04/02ISR Number: 4021554-3Report Type:Expedited (15-DaCompany Report #PHEH2002US10040 Age:74 YR Gender:Female I/FU:I Outcome PT Death Cardio-Respiratory Arrest Hospitalization - Colon Cancer Initial or Prolonged General Physical Health Deterioration Large Intestinal Obstruction 22-Feb-2006 08:30 AM Page: 1899 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report White Blood Cell Count Increased Report Source Product Role Manufacturer Route Dose Duration Health Clozaril(Clozapine)T Professional ablet PS ORAL ORAL Sinemet C Tasmar (Tolcapone) C Antihypertensives C Date:12/04/02ISR Number: 4021566-XReport Type:Expedited (15-DaCompany Report #GB9214521OCT2002 Age:26 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Foreign Ativan Health (Lorazepam) PS INTRAMUSCULAR 2 MG 1X PER 1 Professional DAY 1 DAY Other Clozapine (Clozapine) SS ORAL 450 MG Amisulpride (Amisulpride) C Sertraline (Sertraline) C Valproate Sodium (Valproate Sodium) C Hyoscine (Hyoscine) C Date:12/04/02ISR Number: 4022009-2Report Type:Expedited (15-DaCompany Report #PHBS2002AU10884 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Ovarian Cancer Foreign Clozaril(Clozapine) PS ORAL ORAL Health Professional Company Representative Other Date:12/04/02ISR Number: 4022010-9Report Type:Expedited (15-DaCompany Report #PHBS2002AU06561 Age:71 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ovarian Cancer Foreign Clozaril (Clozapine) Initial or Prolonged Health Tablet PS ORAL 250 MG, QD, Other Professional ORAL Other Date:12/04/02ISR Number: 4022085-7Report Type:Expedited (15-DaCompany Report #PHBS2001CA12200 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Foreign Clozaril(Clozapine) Hospitalization - Breast Cancer Study Tablet PS ORAL 350 MG, QHS, Initial or Prolonged Cardiac Failure Health ORAL Congestive Professional Chemotherapeutics, Pleural Effusion Other Other Pneumonia (Chemotherapeutics, Renal Failure Acute Other) SS 22-Feb-2006 08:30 AM Page: 1900 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochlorothiazide C Glyburide C Tamoxifen C Vancomycin (Vancomycin) C Amphoceterin C Metformin C Loxapine (Loxapine) C Date:12/04/02ISR Number: 4022086-9Report Type:Expedited (15-DaCompany Report #PHBS2002CA14117 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Parkinson'S Disease Foreign Clozaril Study (Clozapine) PS ORAL ORAL Health Professional Other Date:12/04/02ISR Number: 4022316-3Report Type:Expedited (15-DaCompany Report #PHBS2002CL11851 Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Foreign Leponex (Clozapine) Initial or Prolonged Confusional State Study Tablet PS ORAL ORAL ; 2.5 Intentional Overdose Health G, QD, ORAL Suicide Attempt Professional Other Date:12/04/02ISR Number: 4022317-5Report Type:Expedited (15-DaCompany Report #PHFR2002GB03624 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypertriglyceridaemia Foreign Clozaril (Clozapine) Initial or Prolonged Pancreatitis Health Tablet PS ORAL 450 MG/DAY, Disability Professional ORAL Other Other Lipostat C Fenofibrate (Fenofibrate) C Irbesartan (Irbesartan) C Neurontin (Gabapentin) C Insulin (Insulin) C Date:12/04/02ISR Number: 4022359-XReport Type:Expedited (15-DaCompany Report #PHBS2002CA14025 Age:48 YR Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Clozaril(Clozapine) Hospitalization - Intestinal Obstruction Study Tablet PS ORAL ORAL Initial or Prolonged Myocardial Infarction Health Loxapine (Loxapine) C Professional Seroquel (Quetiapine Other Fumarate) C 22-Feb-2006 08:30 AM Page: 1901 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/05/02ISR Number: 4024431-7Report Type:Periodic Company Report #HQ9377811DEC2001 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Priapism Health Effexor Xr Other Professional (Venlafaxine Hydrochloride, Capsule, Extended Release) PS ORAL 300 MG 1 X PER 1 DAY, ORAL Clozaril (Clozapine, ) SS ORAL 50 MG 1X PER 1 DAY, ORAL Klonopin (Clonazepam, ) SS ORAL 2 MG 1X PER 1 DAY, ORAL Lithium (Lithium, ) SS ORAL 300 MG TO 1500 MG DAILY AT BEDTIME, ORAL Date:12/06/02ISR Number: 4020267-1Report Type:Direct Company Report #CTU 182254 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Clozapine 25mg Ivax PS Ivax 25mg ORAL 25MG AM AND Initial or Prolonged Syndrome HS ORAL Olanzapine 20mg Lilly SS Lilly ORAL 20MG 5 PM ORAL Date:12/06/02ISR Number: 4020348-2Report Type:Direct Company Report #CTU 182205 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - No Adverse Drug Effect Clozapine PS Initial or Prolonged Disability Date:12/06/02ISR Number: 4021878-XReport Type:Expedited (15-DaCompany Report #C2002-3367.01 Age:79 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg Mylan PS ORAL 25MG Q HS, Other ORAL Carbidopa/Levodopa C Docusate Sodium C Entacapone C Lactulose C Midodrine Hci C 22-Feb-2006 08:30 AM Page: 1902 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/09/02ISR Number: 4020964-8Report Type:Direct Company Report #CTU 182411 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Clozaril 150 Mg Po Initial or Prolonged Epilepsy Tid PS Fall Haldol Decanoate 75 Neuroleptic Malignant Mg Q Month SS Syndrome Cogentin C Rhabdomyolysis Date:12/09/02ISR Number: 4023321-3Report Type:Expedited (15-DaCompany Report #PHEH2002US09622 Age:81 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Leukocytosis Health Clozaril Hospitalization - Pneumonia Professional (Clozapine) PS ORAL 125 MG, QD, Initial or Prolonged Staphylococcal Sepsis ORAL Trental "Albert-Roussel" (Pentofylline) C Amiodarone (Amiodarone) C Coumadin "Boots" (Warfarin Sodium) C Boots Lasix C K-Lor C Proamatine (Midorine Hydrochloride) C Armour Thyroid (Thyroid) C Aricept (Donepezil Hydrochloride) C Sinemet C Reglan (Metoclopramide) C Ativan C Maalox C Triaminic C Date:12/09/02ISR Number: 4023526-1Report Type:Expedited (15-DaCompany Report #2002069039 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Foreign Gabapentin Clonic Convulsion Health (Gabapentin) PS ORAL 1800 MG Condition Aggravated Professional (DAILY), ORAL Loss Of Consciousness Clozapine SS ORAL 750 MG Urinary Incontinence (DAILY), ORAL Venlafaxine C Date:12/09/02ISR Number: 4023616-3Report Type:Expedited (15-DaCompany Report #PHBS2002US14232 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Ketoacidosis Literature Clozapine(Clozapine) PS 25 MG/D ; 550 Initial or Prolonged Fatigue Health MG/D Professional Valproic Acid C 22-Feb-2006 08:30 AM Page: 1903 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Olanzapine C Risperidone C Date:12/09/02ISR Number: 4023623-0Report Type:Expedited (15-DaCompany Report #PHEH2002US00871 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Catatonia Consumer Clozaril(Clozapine) Constipation Tablet PS ORAL 400MG DAILY, Drooling ORAL Drug Level Increased Celexa C Drug Toxicity Lamictal C Toxicologic Test Abnormal Ativan C Tremor Geodon(Ziprasidone Hydrochloride) C Date:12/09/02ISR Number: 4023805-8Report Type:Expedited (15-DaCompany Report #PHRM2002FR02252 Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Back Pain Foreign Leponex (Clozapine) Blood Creatine Health Tablet PS ORAL 500 MG DAILY, Phosphokinase Increased Professional ORAL Blood Creatinine Other Increased Muscle Spasms Pain In Extremity Date:12/09/02ISR Number: 4023807-1Report Type:Expedited (15-DaCompany Report #PHFR2002GB02175 Age:22 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspartate Foreign Clozaril (Clozapine) Aminotransferase Study Tablet PS ORAL SEE IMAGE Increased Health Venlafaxine C Blood Alkaline Professional Diazepam C Phosphatase Increased Other Blood Thyroid Stimulating Hormone Increased Carotid Arterial Embolus Cerebral Ischaemia Congestive Cardiomyopathy Dyspnoea Gamma-Glutamyltransferase Increased Intracardiac Thrombus Liver Function Test Abnormal Lymphocytosis Neutrophilia Rouleaux Formation Thrombocythaemia 22-Feb-2006 08:30 AM Page: 1904 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/09/02ISR Number: 4023849-6Report Type:Expedited (15-DaCompany Report #PHRM2002FR02894 Age:66 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bradycardia Foreign Leponex(Clozapine) Cardiac Arrest Health Tablet PS ORAL 500 MG DAILY, Diarrhoea Professional ORAL Fatigue Other Trimebutine Hypotension (Trimebutine) SS ORAL 3 DF DAILY, Pyrexia ORAL Tachycardia Lepticur Torsade De Pointes (Tropatepine Hydrochloride) SS ORAL 5 MG DAILY, ORAL Deroxat (Paroxetine Hydrochloride) SS ORAL 20 MG PER DAY, ORAL Diamicron (Gliclazide) Tablet SS ORAL 160 MG DAILY, ORAL Depakine (Valproate Sodium) Syrup SS ORAL 600 MG DAILY, ORAL Noctamid (Lormetazepam) C Hept-A-Myl (Heptaminol Hydrochloride) C Seglor Solution C Tranxene (Clorazepate Dipotassium) C Tercian (Cyamemazine) C Date:12/09/02ISR Number: 4023851-4Report Type:Expedited (15-DaCompany Report #PHFR2002GB03911 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril (Clozapine) Study (Clozapine) Tablet PS ORAL ORAL Health Professional Other Date:12/09/02ISR Number: 4023853-8Report Type:Expedited (15-DaCompany Report #PHFR2002GB03314 Age:40 YR Gender:Male I/FU:I Outcome PT Hospitalization - Anorexia Initial or Prolonged Blood Creatine Other Phosphokinase Increased Blood Pressure Abnormal Cardiovascular Disorder Diabetes Mellitus Heart Rate Increased Lower Respiratory Tract Infection Malaise Neuroleptic Malignant 22-Feb-2006 08:30 AM Page: 1905 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Syndrome Tachycardia Report Source Product Role Manufacturer Route Dose Duration Foreign Clozaril (Clozapine) Study Tablet PS 12.5 MG ONCE Health DOSE ONLY; Professional 50 MG/DAY, Other ORAL Glimepiride (Glimepiride) C Date:12/09/02ISR Number: 4024023-XReport Type:Expedited (15-DaCompany Report #PHBS2002DE14237 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acute Febrile Foreign Clozapine(Clozapine) PS SEE IMAGE Initial or Prolonged Neutrophilic Dermatosis Literature Risperidone C Bence Jones Protein Urine Health Present Professional Diarrhoea Other Electroencephalogram Abnormal Lymphadenopathy Oedema Peripheral Pericardial Effusion Pleural Effusion Polyserositis Date:12/10/02ISR Number: 4023682-5Report Type:Expedited (15-DaCompany Report #C2002-2992.01 Age:59 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine Tablets Professional 100 Mg Mylan PS ORAL 300MG BID, Other ORAL Bupropion Sr C Mirtazapine C Olanzapine C Famotidine C Flucanazole C Date:12/10/02ISR Number: 4023683-7Report Type:Expedited (15-DaCompany Report #C2002-3244.01 Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozapine Tablets Metastatic Neoplasm Professional 100 Mg Mylan PS ORAL 150MG, QD, Other TITRATED TO 450MG QD, ORAL Oxycodone C Oxycodone/Apap C Tamoxifen C Albuterol C Docusate C Lactulose C Lorazepam C Chlorpromazine (Prn) C 22-Feb-2006 08:30 AM Page: 1906 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/10/02ISR Number: 4023689-8Report Type:Expedited (15-DaCompany Report #02-12-1081 Age:86 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hip Fracture Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 12.5-50MG QD ORAL Date:12/10/02ISR Number: 4023691-6Report Type:Expedited (15-DaCompany Report #02-11-1077 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Neoplasm Malignant Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 900MG QD ORAL Date:12/10/02ISR Number: 4024678-XReport Type:Expedited (15-DaCompany Report #PHEH2002US09990 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatic Cirrhosis Health Clozaril Initial or Prolonged Hepatitis C Professional (Clozapine) PS ORAL 75 MG, QD, Other Leukopenia ORAL Liver Transplant Prograf C Rapamune (Sirolimus) C Bactrim Ds (Sulfamethoxazole) C Date:12/10/02ISR Number: 4024793-0Report Type:Expedited (15-DaCompany Report #PHEH2002US06640 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukocytosis Health Clozaril Lymphocytic Leukaemia Professional (Clozapine)Tablet PS ORAL 50 MG AM +300 MG HS, ORAL Depakote (Valproate Semisodium) C Zoloft (Sertraline Hydrochloride) C Date:12/10/02ISR Number: 4024883-2Report Type:Expedited (15-DaCompany Report #PHBS2002FI13465 Age:31 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyspnoea Foreign Leponex (Clozapine) Initial or Prolonged Peritonitis Other Tablet PS ORAL 300 MG/D, ORAL Cipramil C Date:12/10/02ISR Number: 4024885-6Report Type:Expedited (15-DaCompany Report #PHFR2002GB03600 Age:19 YR Gender:Female I/FU:F Outcome PT Other Depressed Level Of Consciousness Diabetes Mellitus 22-Feb-2006 08:30 AM Page: 1907 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Drug Level Increased Hyperphagia Lower Respiratory Tract Report Source Product Role Manufacturer Route Dose Duration Infection Foreign Clozaril (Clozapine) Study Tablet PS ORAL 150 MG, BID, Health ORAL Professional Zopiclone C Other Haloperidol C Atropine (Atropine) C Procyclidine (Procyclidine) C Kwells C Date:12/10/02ISR Number: 4024955-2Report Type:Expedited (15-DaCompany Report #PHFR2002GB03683 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Glucose Increased Foreign Clozaril Other Bronchopneumonia Study (Clozapine)(Clozapin Cardiac Arrest Health e) Tablet PS ORAL 300 MG/DAY Ketoacidosis Professional ORAL Obesity Other Pulmonary Thrombosis Date:12/10/02ISR Number: 4024956-4Report Type:Expedited (15-DaCompany Report #PHRM2002FR02956 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Erythema Nodosum Foreign Leponex(Clozapine) Inflammation Health Tablet PS ORAL 400 MG DAILY, Professional ORAL Other Date:12/10/02ISR Number: 4024993-XReport Type:Expedited (15-DaCompany Report #PHNU2002DE03017 Age:59 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Foreign Leponex / Clozaril Increased Health (Clozapine)(Clozapin Aspartate Professional e) Tablet PS ORAL SEE IMAGE, Aminotransferase Other ORAL Increased Blood Alkaline Phosphatase Increased C-Reactive Protein Increased Gamma-Glutamyltransferase Increased Hepatic Cirrhosis Hepatic Steatosis Hepatomegaly Hyperhidrosis Pyrexia Red Blood Cell Sedimentation Rate Increased 22-Feb-2006 08:30 AM Page: 1908 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/10/02ISR Number: 4024997-7Report Type:Expedited (15-DaCompany Report #PHRM2002FR00589 Age:31 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperglycaemia Foreign Leponex(Clozapine) Initial or Prolonged Hyperlipidaemia Literature Tablet PS ORAL SEE IMAGE 366 DAY Hypertriglyceridaemia Health Polydipsia Professional Polyuria Other Weight Decreased Weight Increased Date:12/10/02ISR Number: 4025000-5Report Type:Expedited (15-DaCompany Report #PHNU2002DE01657 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Decreased Activity Foreign Leponex / Clozaril Diabetic Ketoacidosis Study (Clozapine)(Clozapin Malnutrition Health e) Tablet PS ORAL 400-800MG/DAY Oral Intake Reduced Professional , ORAL Other Date:12/10/02ISR Number: 4025043-1Report Type:Expedited (15-DaCompany Report #PHBS2002CA14724 Age:79 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Lower Gastrointestinal Foreign Clozaril (Clozapine) Initial or Prolonged Haemorrhage Study Tablet PS ORAL ORAL Neutrophil Count Abnormal Health White Blood Cell Count Professional Abnormal Other Date:12/10/02ISR Number: 4025051-0Report Type:Expedited (15-DaCompany Report #PHFR2002GB03313 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Diabetic Hyperglycaemic Foreign Clozaril (Clozapine) Other Coma Study Tablet PS ORAL ORAL Diabetic Ketoacidosis Health Professional Other Date:12/10/02ISR Number: 4025239-9Report Type:Expedited (15-DaCompany Report #PHBS2002CA13582 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatic Function Abnormal Foreign Clozaril (Clozapine) Initial or Prolonged Hepatic Steatosis Health Tablet PS ORAL 350 MG/D; Hepatomegaly Professional ORAL Overweight Other Hexavitamin Tachycardia (Retinol) C Cogentin (Benzatropine Mesilate) C Inderal "Imperial Chemical Industries" C Ativan C Loxapine (Loxapine) C 22-Feb-2006 08:30 AM Page: 1909 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/10/02ISR Number: 4025241-7Report Type:Expedited (15-DaCompany Report #PHBS2002NZ14727 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Foreign Clozaril (Clozapine) Initial or Prolonged Dizziness Other Tablet PS ORAL 300 MG/D; Other Hypertension ORAL Hypotension Aropax C Suicidal Ideation Zopiclone C Cogentin (Benzatropine Mesilate) C Amitriptyline (Amitriptyline) C Oxybutynin Hydrochloride C Plendil C Accupril (Quinapril Hydrochloride) C Thyroxine C Oxis Turbuhaler "Astra Zeneca" C Ventoline Inhalator C Omeprazole C Date:12/10/02ISR Number: 4025242-9Report Type:Expedited (15-DaCompany Report #PHFR2002GB02322 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Distension Foreign Clozaril (Clozapine) Hospitalization - Bowel Sounds Abnormal Health Tablet PS ORAL SEE IMAGE Initial or Prolonged Cardiac Arrest Professional Valproate Sodium C Intestinal Obstruction Other Procyclidine (Procyclidine) C Date:12/10/02ISR Number: 4025245-4Report Type:Expedited (15-DaCompany Report #PHNR2002AU00522 Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Abuser Foreign Clozaril (Clozapine) Initial or Prolonged Somnolence Health (Clozapine) Tablet PS ORAL 50 MG, ONCE; Professional ORAL Other Date:12/10/02ISR Number: 4025246-6Report Type:Expedited (15-DaCompany Report #PHNR2002AU00523 Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Abuser Foreign Clozaril (Clozapine) Initial or Prolonged Medication Error Health (Clozapine) Tablet PS ORAL 50 MG, ORAL Professional Other 22-Feb-2006 08:30 AM Page: 1910 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/10/02ISR Number: 4025417-9Report Type:Expedited (15-DaCompany Report #PHNR2002AU00499 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dehydration Foreign Clozaril (Clozapine) Initial or Prolonged Liver Disorder Study (Clozapine) PS 12.5-200MG Renal Failure Acute Health Vomiting Professional Other Date:12/10/02ISR Number: 4025418-0Report Type:Expedited (15-DaCompany Report #PHFR2002GB03678 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Clozaril (Clozapine) Other Circulatory Collapse Study (Clozapine) Tablet PS ORAL ORAL Convulsion Health Chlorpromazine Haemoglobin Decreased Professional (Chlorpromazine) C Malaise Other Platelet Count Increased Pneumonia Shock Date:12/10/02ISR Number: 4025423-4Report Type:Expedited (15-DaCompany Report #PHBS2002CA13945 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Angiopathy Foreign Clozaril (Clozapine) Cardiomegaly Study Tablet PS ORAL 700 MG/D; Diastolic Dysfunction Health ORAL Mitral Valve Incompetence Professional Lithium Carbonate C Myocarditis Other Valproic Acid C Pulmonary Vascular Disorder Tricuspid Valve Incompetence Vasodilatation Date:12/10/02ISR Number: 4025436-2Report Type:Expedited (15-DaCompany Report #PHFR2002GB03876 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Foreign Clozaril (Clozapine) Phosphokinase Increased Study (Clozapine) Tablet PS ORAL 400 MG/DAY; Confusional State Health ORAL Electrocardiogram St Professional Carbimazole C Segment Elevation Other Irritability Somnolence Date:12/11/02ISR Number: 4021669-XReport Type:Direct Company Report #CTU 182569 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Ineffective Clozapine PS Pharmaceutical Product Loxitane C Complaint Celexa C 22-Feb-2006 08:30 AM Page: 1911 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/11/02ISR Number: 4023726-0Report Type:Expedited (15-DaCompany Report #02-10-0892 Age:68 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Colon Cancer Health Clozapine Tablets - Initial or Prolonged Lower Gastrointestinal Professional Ivax Haemorrhage Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 100MG QAM ORAL; 150MG QPM ORAL Sinemet C Oscal C Vitamin D C Date:12/11/02ISR Number: 4025343-5Report Type:Expedited (15-DaCompany Report #K200201967 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Overdose Foreign Kemadrin Somnolence Health (Procyclidine) Professional Tablet, 5 Mg PS Other Clozapine (Clozapine) SS ORAL ORAL Date:12/12/02ISR Number: 4025421-0Report Type:Expedited (15-DaCompany Report #C2002-2603.01 Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine Tablets Professional 100 Mg Mylan PS ORAL 750MG QD; Other ORAL Amitriptyline C Benztropine C Diclofenac/Misoprost ol C Fenofibrate C Fluticasone Inhaler C Ipratropium/Albutero l C Lansoprazole C Risperidone C Sertraline C Date:12/12/02ISR Number: 4026270-XReport Type:Expedited (15-DaCompany Report #PHBS2002BR11745 Age:42 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Leponex Neutrophil Count Health (Clozapine) PS ORAL 100 MG, BID, Decreased Professional ORAL Platelet Count Decreased Other Lorax (Loracarbef) Psoriasis Tablet C 22-Feb-2006 08:30 AM Page: 1912 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/12/02ISR Number: 4026271-1Report Type:Expedited (15-DaCompany Report #PHFR2002GB03377 Age:26 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Foreign Clozaril (Clozapine) PS ORAL 350 MG/DAY Health ORAL Professional Lorazepam Other (Lorazepam) SS INTRAMUSCULAR 2 MG DAY INTRAMUSCULAR Amisulpride (Amisulpride) C Sertraline (Sertraline) C Valproate Sodium C Hyoscine C Date:12/12/02ISR Number: 4026272-3Report Type:Expedited (15-DaCompany Report #PHFR2002GB01114 Age:34 YR Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspergillosis Foreign Clozaril Gastrointestinal Necrosis Health (Clozapine) PS ORAL ORAL Intestinal Ischaemia Professional Loperamide C Sepsis Other Diazepam C Lansoprazole C Haloperidol C Benzhexol (Trihexyphenidyl) C Lorazepam C Date:12/12/02ISR Number: 4026331-5Report Type:Expedited (15-DaCompany Report #M1261-2002 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Pressure Dexamethasone PS ORAL 8 MG, ORAL 6 WK Fluctuation Clozapine SS ORAL 600 MG, ORAL 11 YR Leukocytosis Procyclidine C Loss Of Consciousness Lansoprazole C Lymphopenia Diazepam C Platelet Count Decreased Promethezine Pneumocystis Jiroveci Hydrochloride C Pneumonia Renal Failure Date:12/12/02ISR Number: 4026375-3Report Type:Expedited (15-DaCompany Report #PHEH2002US10189 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozaril Professional (Clozapine) PS ORAL 300 MG/DAY, ORAL Atenolol C Klonopin C Prozac (Fluoxetine Hydrochloride) C 22-Feb-2006 08:30 AM Page: 1913 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/13/02ISR Number: 4025642-7Report Type:Expedited (15-DaCompany Report #C2002-3442.01 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Other Clozapine Tablets 100 Mg Mylan PS Mylan ORAL 500 MG/DAY, ORAL Date:12/13/02ISR Number: 4025646-4Report Type:Expedited (15-DaCompany Report #02-12-1094 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hepatic Neoplasm Health Clozapine- Ivax Malignant Professional Pharmaceuticals, Lung Neoplasm Malignant Other Inc. Tablets PS Ivax Pharmaceuticals ORAL 500 MG QD ORAL Date:12/13/02ISR Number: 4025647-6Report Type:Expedited (15-DaCompany Report #02-12-1093 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals ORAL 500-600 MG QD ORAL Date:12/13/02ISR Number: 4025649-XReport Type:Expedited (15-DaCompany Report #02-12-1092 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 50-650 MG QD ORAL Date:12/13/02ISR Number: 4025650-6Report Type:Expedited (15-DaCompany Report #02-12-1091 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neoplasm Malignant Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Phamaceuticals, Inc. ORAL 125-600 MG QD ORAL Date:12/13/02ISR Number: 4025651-8Report Type:Expedited (15-DaCompany Report #02-12-1084 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Respiratory Disorder Health Clozapine - Ivax Sleep Apnoea Syndrome Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 400 MG QD ORAL 22-Feb-2006 08:30 AM Page: 1914 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/14/02ISR Number: 4042024-2Report Type:Expedited (15-DaCompany Report #02-12-1165 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neoplasm Malignant Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Other Inc. Tablets PS ORAL 25-450MG QD ORAL Date:12/14/02ISR Number: 4042034-5Report Type:Expedited (15-DaCompany Report #02-12-1112 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Gastrointestinal Disorder Health Clozapine Tablets - Hospitalization - Professional Ivax Initial or Prolonged Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc ORAL 550MG QD ORAL Date:12/14/02ISR Number: 4042038-2Report Type:Expedited (15-DaCompany Report #C2002-3639.01 Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Other Clozapine Tablets 100 Mg Mylan PS Mylan ORAL 300MG/DAY, ORAL Clozapine Tablets 25 Mg SS ORAL 75MG/DAY, ORAL Date:12/16/02ISR Number: 4026776-3Report Type:Expedited (15-DaCompany Report #PHBS2002US15024 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Catatonia Health Protonix $At Drug Interaction Professional (Pantoprazole) Drug Level Increased Tablet PS ORAL ORAL Parkinsonism Clozaril (Clozapine) SS Date:12/16/02ISR Number: 4026777-5Report Type:Expedited (15-DaCompany Report #PHEH2002US10350 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Level Increased Health Clozaril (Clozapine) Drug Toxicity Professional Tablet PS ORAL 200MG AM+100MG NOON+200MG PM, ORAL Seroquel (Quetiapine Fumarate) C Ativan C Cogentin (Benzatropine Mesilate) C Depakote (Valproate Semisodium) C Haldol ("Janssen") C Zantac C 22-Feb-2006 08:30 AM Page: 1915 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Keflex (Cefalexin Monohydrate) C Prevacid (Lansoprazole) C Levaquin (Levofloxacin) C Metronidazole C Date:12/16/02ISR Number: 4026778-7Report Type:Expedited (15-DaCompany Report #PHEH2002US10207 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Circulatory Collapse Study Clozaril (Clozapine) Drug Level Increased Health Tablet PS ORAL 300 MG, BID, Drug Toxicity Professional ORAL Lipitor C Paxil C Date:12/16/02ISR Number: 4026780-5Report Type:Expedited (15-DaCompany Report #PHEH2002US09990 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatic Cirrhosis Health Clozaril (Clozapine) Initial or Prolonged Hepatitis C Professional Tablet PS ORAL 50 MG QD ORAL Other Leukopenia Prograf C Liver Transplant Rapamune (Sirolimus) C Bactrim Ds (Sulfamethoxazole) C Vitamin E C Paxil C Prevacid (Lansoprazole) C Oxycodone C Aspirin "Bayer" C Levaquin (Levofloxacin) C Date:12/16/02ISR Number: 4026861-6Report Type:Expedited (15-DaCompany Report #HQ5675909DEC2002 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dehydration Health Protonix Initial or Prolonged Diarrhoea Professional (Pantoprazole, Drug Interaction Tablet, Delayed Drug Level Increased Release) PS ORAL 40 MG 1X PER Drug Toxicity 1 DAY ORAL Malaise Clozaril (Clozapine, Nausea ) SS ORAL 700 MG 1X PER Viral Infection 1 DAY ORAL Vomiting Depakote (Valproate Semisodium) C Topamax (Topiramate) C 22-Feb-2006 08:30 AM Page: 1916 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/16/02ISR Number: 4026880-XReport Type:Periodic Company Report #EMADSS2002007591 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hemianopia Foreign Serenase (Injection) Initial or Prolonged Hyperprolactinaemia Health (Haloperidol) PS INTRAMUSCULAR 200 M, Disability Pituitary Tumour Professional WEEKLY, IM ; Required 600 MG , Intervention to DAILY, IM Prevent Permanent Leponex (Clozapine) SS 600 MG, Impairment/Damage DAILY, Rivotril (Clonazepam) C Truxal (Chlorprothixene Hydrochloride) C Novaluzid (Novaluzide) C Date:12/16/02ISR Number: 4027047-1Report Type:Expedited (15-DaCompany Report #PHEH2002US10331 Age:81 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dehydration Health Clozaril (Clozapine) Hospitalization - Professional Tablet PS ORAL 50 MG/DAY, Initial or Prolonged ORAL Date:12/16/02ISR Number: 4027049-5Report Type:Expedited (15-DaCompany Report #PHEH2002US10274 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Malaise Health Clozaril (Clozapine) Pneumonia Professional Tablet PS ORAL ORAL Respiratory Arrest Date:12/16/02ISR Number: 4027191-9Report Type:Expedited (15-DaCompany Report #PHFR2002GB02283 Age:55 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ankle Fracture Foreign Clozaril(Clozapine) Initial or Prolonged Health Tablet PS ORAL 325MG/DAY, Other Professional ORAL Other Date:12/16/02ISR Number: 4027220-2Report Type:Expedited (15-DaCompany Report #PHRM2002FR03026 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alveolitis Allergic Foreign Leponex(Clozapine) Initial or Prolonged Health Tablet PS ORAL ORAL Professional Other 22-Feb-2006 08:30 AM Page: 1917 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/16/02ISR Number: 4027224-XReport Type:Expedited (15-DaCompany Report #PHFR2002GB02206 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Interaction Foreign Clozaril(Clozapine) Other Mental Impairment Study Tablet PS ORAL 450MG/DAY, Health ORAL Professional Other Date:12/16/02ISR Number: 4027242-1Report Type:Expedited (15-DaCompany Report #PHBS2002CA14117 Age:70 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Myocardial Foreign Clozaril (Clozapine) Infarction Study Tablet PS ORAL 12.5 MG, BID, Parkinson'S Disease Health ORAL Professional Dilantin C Other Prednisone C Methotrexate (Methotrexate) C Date:12/16/02ISR Number: 4027244-5Report Type:Expedited (15-DaCompany Report #PHBS2002CA14249 Age:66 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bronchitis Foreign Clozaril (Clozapine) Initial or Prolonged Lung Carcinoma Cell Type Study Tablet PS ORAL 225 MG/D, Unspecified Recurrent Health ORAL; 575 Professional MG/D,ORAL Other Zoloft (Sertraline Hydrochloride) C Serax (Oxazepam) C Date:12/16/02ISR Number: 4027540-1Report Type:Expedited (15-DaCompany Report #PHFR2002GB04026 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril (Clozapine) Electrocardiogram Study Tablet PS ORAL ORAL Abnormal Health Professional Other Date:12/16/02ISR Number: 4027543-7Report Type:Expedited (15-DaCompany Report #PHFR2002GB04030 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril (Clozapine) Non-Insulin-Dependent Health Tablet PS ORAL 500 MG/DAY, Professional ORAL Other Venlafaxine (Venlafaxine) C Valproate Sodium C Becotide (Beclometasone Dipropionate) C Salbutamol C 22-Feb-2006 08:30 AM Page: 1918 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/16/02ISR Number: 4027546-2Report Type:Expedited (15-DaCompany Report #PHNU2002DE04054 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Leponex / Clozaril Health (Clozapine) Professional (Clozapine) Tablet PS ORAL 300MG/DAY, Other ORAL Anti-Diabetics C Date:12/16/02ISR Number: 4027608-XReport Type:Expedited (15-DaCompany Report #PHFR2002GB02068 Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Nephropathy Toxic Foreign Clozaril (Clozapine) Initial or Prolonged Renal Failure Health Tablet PS ORAL 500 MG/DAY, Professional ORAL Other Lithium(Lithium) SS Date:12/16/02ISR Number: 4027614-5Report Type:Expedited (15-DaCompany Report #PHNR2002AU00543 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Foreign Clozaril (Clozapine) Initial or Prolonged Loss Of Consciousness Health (Clozapine) Tablet PS ORAL ORAL 91 DAY Syncope Professional Other Date:12/16/02ISR Number: 4028169-1Report Type:Expedited (15-DaCompany Report #PHBS2002NZ14706 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bundle Branch Block Right Foreign Clozaril (Clozapine) Glucose Tolerance Health Tablet PS ORAL 550 MG/D, Impaired Professional ORAL Syncope Other Date:12/16/02ISR Number: 4028171-XReport Type:Expedited (15-DaCompany Report #PHFR2002GB03883 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Foreign Clozaril (Clozapine) International Normalised Study Tablet PS ORAL 200MG/DAY, Ratio Increased Health ORAL Professional Warfarin (Warfarin) SS ORAL 6MG/DAY, ORAL Other Fluoxetine (Fluoxetine) C Zopiclone C Digoxin C Orphenadrine (Orphenadrine) C 22-Feb-2006 08:30 AM Page: 1919 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/16/02ISR Number: 4030284-3Report Type:Expedited (15-DaCompany Report #PHBS2002NZ14997 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bundle Branch Block Right Foreign Clozaril Electrocardiogram Study (Clozapine)Tablet PS ORAL ORAL Abnormal Health Professional Other Date:12/16/02ISR Number: 4030285-5Report Type:Expedited (15-DaCompany Report #PHBS2002DK14873 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hemianopia Homonymous Foreign Leponex(Clozapine)Ta Initial or Prolonged Hyperprolactinaemia Health blet PS ORAL 600 MG/DL, Disability Pituitary Tumour Benign Professional ORAL Visual Disturbance Other Serenase Dekanoat(Haloperidol Decanoate)Injection SS INTRAMUSCULAR 200 MG, QW, INTRAMUSCULAR Rivotril C Truxal (Chlorprothixene Hydrochloride)Tablet C Norvalusid Tablet C Date:12/16/02ISR Number: 4030286-7Report Type:Expedited (15-DaCompany Report #PHBS2002HK14712 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukaemia Foreign Clozaril(Clozapine)T Initial or Prolonged Pancytopenia Health ablet PS ORAL 300 MG/D, Professional ORAL Other Date:12/17/02ISR Number: 4027076-8Report Type:Expedited (15-DaCompany Report #C2002-3104.01 Age:49 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 600MG, QD, Other ORAL Quetiapine Fumarate C Date:12/17/02ISR Number: 4027077-XReport Type:Expedited (15-DaCompany Report #C2002-3077.01 Age:63 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Other Clozapine Tablets Myocardial Infarction 100 Mg Mylan PS Mylan ORAL 300MG/DAY, Post Procedural ORAL Complication Clozapine Tablets 25 Mg Mylan SS Mylan ORAL 25MG/DAY, ORAL Divaloproex Sodium C Venlofaxin C 22-Feb-2006 08:30 AM Page: 1920 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/18/02ISR Number: 4025703-2Report Type:Direct Company Report #CTU 183005 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Activated Partial Clozapine 450 Mg Thromboplastin Time Daily PS ORAL ORAL 1509A Prolonged 300 HS Laboratory Test Abnormal Valproate 2000 Mg Daily SS 1000 MG BID 10 YR Lansoprazole C Thiothixene C Oxybutinin C Phenytoin C Acetaminophen C Docusate C Naphazoline C Selenium C Hc Cream C Antacid C Date:12/18/02ISR Number: 4029378-8Report Type:Expedited (15-DaCompany Report #CATIE1-0308 Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Study Clozapine Initial or Prolonged Blood Glucose Increased Health (Clozapine) Capsule, Other Catheter Related Professional 200mg PS UNKNOWN 100 MG, BID, Infection UNK ; UNK, Chest X-Ray Abnormal UNK, UNK Decreased Appetite Benztropine C Dehydration Tenormin C Depressed Level Of Synthroid C Consciousness Effexor Xr C Diarrhoea Dizziness Eosinophilia Gastrointestinal Infection Haemodialysis Malaise Pneumonia Polyp Pulmonary Oedema Pyrexia Renal Failure Renal Tubular Necrosis Respiratory Distress Sepsis Syncope Ventricular Extrasystoles Vomiting Weight Increased White Blood Cell Count Increased 22-Feb-2006 08:30 AM Page: 1921 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/18/02ISR Number: 4029726-9Report Type:Expedited (15-DaCompany Report #PHEH2002US10350 Age:56 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Level Increased Health Clozaril (Clozapine) Drug Toxicity Professional Tablet PS ORAL SEE IMAGE Ativan C Seroquel (Quetiapine Fumarate) C Depakote (Valproate Semisodium) C Cogentin (Benzatropine Mesilate) C Haldol "Janssen" C Janssen Zantac C Keeflex (Cefalexin Monohydrate) C Prevacid (Lansoprazole) C Levaquin (Levofloxacin) C Metronidazole (Metronidazole) C Date:12/19/02ISR Number: 4029618-5Report Type:Expedited (15-DaCompany Report #PHEH2002US10301 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Haemorrhage Health Clozaril Initial or Prolonged Head Injury Professional (Clozapine)Tablet PS ORAL SEE IMAGE Other Hypothermia Haldol "Janssen" C Laceration Pneumonia Psychotic Disorder Date:12/19/02ISR Number: 4029725-7Report Type:Expedited (15-DaCompany Report #PHEH2002US10395 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neoplasm Malignant Health Clozaril (Clozapine) Professional Tablet PS ORAL 400M G, QD, ORAL Date:12/19/02ISR Number: 4030223-5Report Type:Expedited (15-DaCompany Report #PHBS2001FR06331 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Foreign Leponex (Clozapine) Drug Interaction Literature Unknown PS 150 MG/D Health Oxazepam (Oxazepam) SS 200 MG/D Professional Other 22-Feb-2006 08:30 AM Page: 1922 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/19/02ISR Number: 4030238-7Report Type:Expedited (15-DaCompany Report #PHNR2002AU00499 Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dehydration Foreign Clozaril Initial or Prolonged Hepatocellular Damage Study (Clozapine)(Clozapin Renal Failure Acute Health e)Unknown PS 12.5-200MG Professional Other Date:12/19/02ISR Number: 4030314-9Report Type:Expedited (15-DaCompany Report #PHBS2002CA07638 Age:38 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Congestive Cardiomyopathy Foreign Clozaril (Clozapine) Myocardial Fibrosis Study Tablet PS ORAL ORAL Health Professional Other Date:12/19/02ISR Number: 4030583-5Report Type:Expedited (15-DaCompany Report #PHFR2002GB02870 Age:53 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dehydration Foreign Clozaril Gastroenteritis Study (Clozapine)(Clozapin Sudden Death Health e)Tablet PS ORAL 575 MG/DAY, Professional ORAL Other Chlorpromazine (Chlorpromazine) C Diazepam C Valproate Sodium C Hyoscine (Hyoscine) C Date:12/20/02ISR Number: 4030961-4Report Type:Expedited (15-DaCompany Report #K200202018 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Level Increased Foreign Kemadrin Initial or Prolonged Hypotension Other (Procyclidine) Loss Of Consciousness Tablet, 5 Mg PS Overdose Clozapine Shock (Clozapine) SS Olanzapine (Olanzapine) SS Date:12/20/02ISR Number: 4031300-5Report Type:Expedited (15-DaCompany Report #C2002-3050.01 Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional 100 Mg Mylan PS ORAL 100MG Q AM, Other 400MG Q PM, ORAL Benztropine C Clonazepam C Haloperidol C Unknown Inhalers C 22-Feb-2006 08:30 AM Page: 1923 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lansoprazole C Morphine C Paroxetine C Date:12/20/02ISR Number: 4031818-5Report Type:Expedited (15-DaCompany Report #C2002-3473.01 Age:67 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Other Clozapine Tablets 25 Mg Mylan PS Mylan ORAL 50 MG Q AM, 50 MG Q HS,ORAL Clozapine Tablets 100 Mg Mylan SS Mylan ORAL 100 MG Q AM, 300MG Q HS, ORAL Citalopram Hydrobromide C Atorvastatin C Conjugated Estrogens C Diphenhydramine Hci C Docusate Sodium C Guaifenesin C Lorazepam C Olanzapine C Propoxyphene Napsylate/Acetaminop hen C Ranitidine C Trihexyphenidyl C Date:12/23/02ISR Number: 4030573-2Report Type:Expedited (15-DaCompany Report #C2002-3297.01 Age:39 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asthma Health Clozapine PS Mylan ORAL 25MG Q AM, Overweight Professional 50MG AT Q Other 12:00PM, ORAL Clozapine Tablts 100 Mg Mylan SS Mylan ORAL 500 MG Q HS, ORAL Fluphenazine C Sertraline C Buspirone C Benztropine C Date:12/23/02ISR Number: 4030577-XReport Type:Expedited (15-DaCompany Report #C2002-3532.01 Age:87 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Mylan ORAL 12.5MG Q AM, Professional ORAL Other Azithromycin C Conjugated Estrogens C Docusate Sodium C Epoetin Alfa C Fluconazole C Folic Acid C 22-Feb-2006 08:30 AM Page: 1924 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Furosemide C Insulin 70/30 C Iron C Levofloxacin C Morphine Sulfate C Progestins C Quinapril Hcl C Simvastatin C Venlafaxine C Vitamin B12 C Vitamin B6 C Date:12/23/02ISR Number: 4030579-3Report Type:Expedited (15-DaCompany Report #C2002-3369.01 Age:26 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fatigue Health Clozapine Tablets Initial or Prolonged Malaise Professional 100 Mg Mylan PS Mylan ORAL 100MG BID, Other Urinary Tract Infection Other ORAL Divalproex Sodium C Fluoxetine C Haloperidol C Propranolol C Acetaminophen C Date:12/23/02ISR Number: 4030587-2Report Type:Expedited (15-DaCompany Report #C2002-3206.01 Age:46 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Other Clozapine PS Mylan ORAL 300 Q AM, 400MG Q HS, ORAL Clozapine SS Mylan ORAL 50MG, QAM, ORAL Amlodipine C Buproprion Sr C Divalproex Sodium C Haloperidol C Date:12/23/02ISR Number: 4031302-9Report Type:Expedited (15-DaCompany Report #C2002-3365.01 Age:57 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine Tablets Professional 100 Mg Mylan PS ORAL 50MG Q HS, Other ORAL Clozapine Tablets 100 Mg Mylan SS ORAL 100MG QAM, 300MG QHS, ORAL Date:12/23/02ISR Number: 4031303-0Report Type:Expedited (15-DaCompany Report #C2002-3190.01 Age:46 YR Gender:Female I/FU:F Outcome PT Report Source Death Intentional Self-Injury Health Suicide Attempt Professional 22-Feb-2006 08:30 AM Page: 1925 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Product Role Manufacturer Route Dose Duration Clozapine Tablets 100 Mg Mylan PS ORAL 150 MG Q AM, 400MG Q HS, ORAL Lorazepam C Ziprasidone C Pantoprazole C Date:12/23/02ISR Number: 4031304-2Report Type:Expedited (15-DaCompany Report #C2002-3529.01 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Metastases To Liver Health Clozapine Tablets Neoplasm Malignant Professional 100 Mg Mylan PS ORAL 600MG QD, Other ORAL Benztropine C Furosemide C Haloperidol (Prn) C Lactulose C Letrozole C Spironolactone C Date:12/23/02ISR Number: 4034479-4Report Type:Expedited (15-DaCompany Report #PHNU2002DE04220 Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Arrhythmia Foreign Leponex/Clozaril Hospitalization - Atrial Fibrillation Health (Clozapine) PS ORAL 25 MG, QD, Initial or Prolonged Blood Glucose Increased Professional ORAL Other Cardiomegaly Other Elcrit(Clozapine) SS ORAL ORAL Dialysis Atosil Dysphagia (Isopromethazine Fall Hydrochloride) SS Neuroleptic Malignant Beloc-Zoc Mite Syndrome (Metoprolol Oedema Peripheral Succinate) C Pneumonia Acetylsalicylic Acid C Pulmonary Oedema Plavix (Clopidogrel Renal Failure Acute Sulfate) C Rhabdomyolysis Digimerck C Skin Discolouration Solian (Amisulpride) C Date:12/24/02ISR Number: 4034033-4Report Type:Expedited (15-DaCompany Report #PHBS2001FR06331 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Foreign Leponex (Clozapine) Cardio-Respiratory Arrest Literature Unknown PS 150 MG/D Circulatory Collapse Health Oxazepam (Oxazepam) SS 200 MG/D Conduction Disorder Professional Drug Interaction Other Orthostatic Hypotension 22-Feb-2006 08:30 AM Page: 1926 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/24/02ISR Number: 4034311-9Report Type:Expedited (15-DaCompany Report #02-12-1134 Age:74 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals ORAL 150-175MG QD ORAL Date:12/24/02ISR Number: 4034449-6Report Type:Expedited (15-DaCompany Report #PHNR2002AU00601 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril (Clozapine) Urinary Incontinence Health (Clozapine) Tablet PS ORAL 450MG/DAY, Professional ORAL Other Date:12/24/02ISR Number: 4034450-2Report Type:Expedited (15-DaCompany Report #PHNU2002DE04174 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Antinuclear Antibody Foreign Leponex / Clozaril Positive Health (Clozapine) Biliary Cirrhosis Professional (Clozapine) Tablet PS ORAL 18.75 MG/DAY, Other ORAL Chloraldurat C Date:12/24/02ISR Number: 4034514-3Report Type:Expedited (15-DaCompany Report #02-12-1118 Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Intestinal Obstruction Health Clozapine PS Ivax Sepsis Professional Pharmaceuticals, Other Inc. ORAL 100MG QD ORAL Date:12/24/02ISR Number: 4034515-5Report Type:Expedited (15-DaCompany Report #02-10-0974 Age:44 YR Gender:Male I/FU:F Outcome PT Hospitalization - Asthenia Initial or Prolonged Catheter Related Other Infection Decreased Appetite Dehydration Depressed Level Of Consciousness Dialysis Diarrhoea Dizziness Gastrointestinal Infection Hypoxia Pneumonia Pulmonary Oedema Renal Failure Renal Tubular Necrosis Sepsis 22-Feb-2006 08:30 AM Page: 1927 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Stridor Syncope Weight Increased Report Source Product Role Manufacturer Route Dose Duration Wheezing Health Clozapine PS ORAL 100MG BID Professional ORAL Other Benztropine Mesylate C Tenormin C Synthroid C Effexor Xr C Date:12/24/02ISR Number: 4034516-7Report Type:Expedited (15-DaCompany Report #02-11-1046 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Triglycerides Health Clozapine PS Ivax Initial or Prolonged Increased Professional Pharmaceuticals, Other Diabetes Mellitus Inc. ORAL SEE IMAGE Dyspnoea High Density Lipoprotein Decreased Weight Increased Date:12/24/02ISR Number: 4034517-9Report Type:Expedited (15-DaCompany Report #02-12-1108 Age:81 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neoplasm Malignant Health Clozapine PS Ivax Professional Pharmaceuticals, Other Inc. ORAL 32MG QD ORAL Date:12/24/02ISR Number: 4034518-0Report Type:Expedited (15-DaCompany Report #02-12-1109 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sepsis Health Clozapine PS Ivax Professional Pharmaceuticals, Other Inc. ORAL 25-300MG QD ORAL Date:12/24/02ISR Number: 4034519-2Report Type:Expedited (15-DaCompany Report #02-12-1124 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Parkinson'S Disease Health Clozapine PS Ivax Pneumonia Professional Pharmaceuticals, Other Inc., ORAL 37.5-87.5MG ORAL Date:12/24/02ISR Number: 4034520-9Report Type:Expedited (15-DaCompany Report #02-12-1125 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine PS Ivax Professional Pharmaceuticals, Other Inc. ORAL 100-400MG QD ORAL 22-Feb-2006 08:30 AM Page: 1928 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/24/02ISR Number: 4034521-0Report Type:Expedited (15-DaCompany Report #02-12-1133 Age:67 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Neoplasm Malignant Health Clozapine PS Ivax Professional Pharmaceuticals. Other Inc. ORAL 50-500MG QD ORAL Date:12/26/02ISR Number: 4030778-0Report Type:Direct Company Report #CTU 183330 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Diabetes Mellitus Clozapine 100mg & 25 Intervention to Mg Tablets Ivax Prevent Permanent Pharm PS Ivax Pharm 125 MG BID Impairment/Damage Date:12/26/02ISR Number: 4030810-4Report Type:Direct Company Report #CTU 183374 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiac Failure Clozaril PS Hospitalization - Congestive Initial or Prolonged Cardiomyopathy Pulmonary Oedema Date:12/26/02ISR Number: 4031696-4Report Type:Periodic Company Report #01-11-0611 Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablet PS Ivax Pharmaceuticals, Inc ORAL 25-175MG QD ORAL Date:12/26/02ISR Number: 4031697-6Report Type:Periodic Company Report #01-11-0615 Age:86 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Tardive Dyskinesia Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 25-75MG QD ORAL Zyprexa Tablets SS ORAL ORAL Mellaril Tablets SS ORAL ORAL Cogentin C Date:12/26/02ISR Number: 4031698-8Report Type:Periodic Company Report #01-11-0618 Age:45 YR Gender:Female I/FU:F Outcome PT Death Arrhythmia Other Convulsion 22-Feb-2006 08:30 AM Page: 1929 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Respiratory Disorder Report Source Product Role Manufacturer Route Dose Duration Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc ORAL 13-75MG QD ORAL Date:12/26/02ISR Number: 4031699-XReport Type:Periodic Company Report #01-11-0620 Age:38 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Required Pharmaceuticals, Inc ORAL 700MG QD ORAL Intervention to Prozac Tablets SS ORAL 40MG AM ORAL Prevent Permanent Valproic Acid C Impairment/Damage Date:12/26/02ISR Number: 4031700-3Report Type:Periodic Company Report #01-11-0625 Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc ORAL 275-850MG QD ORAL Date:12/26/02ISR Number: 4031701-5Report Type:Periodic Company Report #01-11-0631 Age:72 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozapine - Ivax Hospitalization - Pneumonia Professional Pharmaceuticals, Initial or Prolonged Pyrexia Inc. Tablets PS Ivax Other Pharmaceuticals, Inc ORAL 150MG QD ORAL Date:12/26/02ISR Number: 4031702-7Report Type:Periodic Company Report #01-10-0589 Age:49 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Other Inc. Tablets PS Ivax Pharmaceuticals, Inc ORAL 700MG QD ORAL Luvox SS ORAL 50MG QD ORAL Oxybutynin C Celebrex C 22-Feb-2006 08:30 AM Page: 1930 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/26/02ISR Number: 4031703-9Report Type:Periodic Company Report #01-11-0592 Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Other Inc. Tablets PS Ivax Pharmaceuticals, Inc SEE IMAGE Hydrocortison Cream C Cardizem C Date:12/26/02ISR Number: 4031704-0Report Type:Periodic Company Report #01-11-0595 Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozapine - Ivax Other Professional Pharmaceuticals, Inc. Tablets PS Ivax Pharmaceuticals, Inc ORAL 300-600MG QD ORAL Date:12/26/02ISR Number: 4031713-1Report Type:Periodic Company Report #02-11-1054 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Unevaluable Event Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 850 MG QD ORAL Date:12/26/02ISR Number: 4031714-3Report Type:Periodic Company Report #02-11-1060 Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 400-575 MG QD ORAL Date:12/26/02ISR Number: 4031715-5Report Type:Periodic Company Report #02-11-1062 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pneumonia Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 12.5 -200 MG QD ORAL 22-Feb-2006 08:30 AM Page: 1931 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/26/02ISR Number: 4031716-7Report Type:Periodic Company Report #02-11-1064 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Health Clozapine Tablets - Initial or Prolonged Thrombocytopenia Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 375-600 MG QD ORAL Depakote C Klonopin C Seroquel C Date:12/26/02ISR Number: 4031717-9Report Type:Periodic Company Report #02-11-1065 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozapine Tablets - Other Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 200 MG QD ORAL Chemotherapy Unknown SS Date:12/26/02ISR Number: 4031718-0Report Type:Periodic Company Report #02-11-1067 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 400-800 MG QD ORAL Date:12/26/02ISR Number: 4031719-2Report Type:Periodic Company Report #02-11-1069 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Nervousness Health Clozapine Tablets - Initial or Prolonged Paranoia Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 100-175MG QD ORAL Date:12/26/02ISR Number: 4031720-9Report Type:Periodic Company Report #02-11-1074 Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Hospitalization - Personality Disorder Health Initial or Prolonged Unevaluable Event Professional 22-Feb-2006 08:30 AM Page: 1932 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Product Role Manufacturer Route Dose Duration Clozapine Tablets - Ivax Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 12.5 - 200 MG QD ORAL Date:12/26/02ISR Number: 4031721-0Report Type:Periodic Company Report #01-10-0577 Age:34 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Health Clozapine Tablets - Initial or Prolonged Abnormal Professional Ivax Required Other Pharmaceuticals, Intervention to Inc. PS Ivax Prevent Permanent Pharmaceuticals, Impairment/Damage Inc. ORAL 300 MG BID ORAL Prolixin C Wellbutrin - Slow Release C Valproic Acid C Date:12/26/02ISR Number: 4031722-2Report Type:Periodic Company Report #01-08-0427 Age:14 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electroencephalogram Health Clozapine Tablets - Initial or Prolonged Abnormal Professional Ivax Headache Pharmaceuticals, Vomiting Inc. PS Ivax Pharmaceuticals, Inc. ORAL 75MG BID ORAL Trazodone C Haldol C Prozac C Date:12/26/02ISR Number: 4031731-3Report Type:Periodic Company Report #02-03-0296 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 425-500MG QD ORAL 22-Feb-2006 08:30 AM Page: 1933 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/26/02ISR Number: 4031732-5Report Type:Periodic Company Report #02-03-0303 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL ORAL Date:12/26/02ISR Number: 4031733-7Report Type:Periodic Company Report #02-03-0305 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL ORAL Date:12/26/02ISR Number: 4031734-9Report Type:Periodic Company Report #02-03-0306 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozapine - Ivax Other Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 400 MG QHS ORAL Celexa C Chlorpromazine C Depakote C Lorazepam C Haloperidol C Date:12/26/02ISR Number: 4031735-0Report Type:Periodic Company Report #02-03-0317 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 650MG QD ORAL Date:12/26/02ISR Number: 4031736-2Report Type:Periodic Company Report #02-03-0359 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 50-400MG QD ORAL 22-Feb-2006 08:30 AM Page: 1934 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/26/02ISR Number: 4031737-4Report Type:Periodic Company Report #02-04-0300 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 100-350MG QD ORAL Date:12/26/02ISR Number: 4031738-6Report Type:Periodic Company Report #02-04-0304 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Leukopenia Health Clozapine - Ivax Other Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 200 MG BID ORAL Adriamycin SS INTRAVENOUS INTRAVENOUS Cytoxan SS INTRAVENOUS Celexa C Cogentin C Date:12/26/02ISR Number: 4031739-8Report Type:Periodic Company Report #02-04-0307 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anorexia Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 275MG QD ORAL Date:12/26/02ISR Number: 4031740-4Report Type:Periodic Company Report #02-04-0313 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Leukopenia Health Clozapine - Ivax Other Professional Pharmaceuticals, Required Other Inc. Tablets PS Ivax Intervention to Pharmaceuticals, Prevent Permanent Inc. ORAL 350MG QD ORAL 2 YR Impairment/Damage Risperidone C Benztropine Mesylate C Lorazepam C Atorvastatin C Date:12/26/02ISR Number: 4031748-9Report Type:Periodic Company Report #02-06-0498 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine- Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, 22-Feb-2006 08:30 AM Page: 1935 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Inc. 25-600MG QD ORAL Date:12/26/02ISR Number: 4031749-0Report Type:Periodic Company Report #02-06-0499 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozapine- Ivax Required Professional Pharmaceuticals, Intervention to Inc. Tablets PS Ivax Prevent Permanent Pharmaceuticals, Impairment/Damage Inc. ORAL 100MG BID ORAL Celexa C Multivitamins C Revia C Cc Enulose C Ensure C Zyprexa C Robinul C Metamucil C Haladol C Propantheline C Colace C Cogentin C Topamax I C Date:12/26/02ISR Number: 4031752-0Report Type:Periodic Company Report #02-06-0503 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Unevaluable Event Health Clozapine- Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 75-100MG QD ORAL Date:12/26/02ISR Number: 4031753-2Report Type:Periodic Company Report #02-06-0510 Age:11 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Leukopenia Health Clozapine- Ivax Other Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 25 MG AM ORAL Seroquel Tablets SS ORAL 200MG AM ORAL Depakote Tablets SS ORAL ER 500MG BID ORAL; SEE IMAGE Date:12/26/02ISR Number: 4031754-4Report Type:Periodic Company Report #02-06-0511 Age:69 YR Gender:Female I/FU:I Outcome PT Report Source Hospitalization - Personality Disorder Health Initial or Prolonged Professional 22-Feb-2006 08:30 AM Page: 1936 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Product Role Manufacturer Route Dose Duration Clozapine- Ivax Pharmaceuticals, Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 100-500MG QD ORAL Date:12/26/02ISR Number: 4031755-6Report Type:Periodic Company Report #02-06-0513 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pulmonary Embolism Health Clozapine- Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 300-35-MG QD ORAL Date:12/26/02ISR Number: 4031756-8Report Type:Periodic Company Report #02-06-0514 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Health Clozapine- Ivax Professional Pharmaceuticals, Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 300MG QAM ORAL;SEE IMAGE Depakote 500mg C Haladol 2 Mg C Benadryl C Theo-Dur C Cogentin C Date:12/26/02ISR Number: 4031757-XReport Type:Periodic Company Report #02-06-0515 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine- Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 150-200MG QD ORAL Date:12/26/02ISR Number: 4031758-1Report Type:Periodic Company Report #02-06-0517 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Health Clozapine- Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, 22-Feb-2006 08:30 AM Page: 1937 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Inc. ORAL ORAL .. C Date:12/26/02ISR Number: 4031759-3Report Type:Periodic Company Report #02-06-0519 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine- Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 100MG QD ORAL Date:12/26/02ISR Number: 4034686-0Report Type:Expedited (15-DaCompany Report #PHEH2002US10331 Age:81 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Condition Aggravated Health Clozaril Hospitalization - Dehydration Professional (Clozapine)Tablet PS ORAL 100 MG , QD, Initial or Prolonged Dementia Alzheimer'S Type ORAL Oligodipsia Date:12/26/02ISR Number: 4034756-7Report Type:Expedited (15-DaCompany Report #PHNU2002DE04152 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bundle Branch Block Foreign Leponex / Clozaril Electrocardiogram Health (Clozapine) Repolarisation Professional (Clozapine) Tablet PS ORAL 600 MG/DAY, Abnormality Other ORAL Hypertension Date:12/26/02ISR Number: 4034853-6Report Type:Expedited (15-DaCompany Report #PHNU2002DE04122 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sarcoidosis Foreign Leponex/Clozaril Health (Clozapine) Professional (Clozapine) Tablet PS ORAL ORAL Other Date:12/26/02ISR Number: 4034855-XReport Type:Expedited (15-DaCompany Report #PHBS2002AU11825 Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Colitis Foreign Clozaril (Clozapine) Initial or Prolonged Crohn'S Disease Study Tablet PS ORAL 125 MG/D, Small Intestinal Other ORAL Obstruction Venlafaxine (Venlafaxine) C Valproate Sodium C 22-Feb-2006 08:30 AM Page: 1938 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/26/02ISR Number: 4034858-5Report Type:Expedited (15-DaCompany Report #PHBS2002FI08314 Age:53 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alpha-1 Acid Glycoprotein Foreign Clozapine(Clozapine) PS 500 MG/DAY, Increased Literature Perphenazine C-Reactive Protein Health (Perphenazine) C Increased Professional Ibuprofen C Drug Level Increased Other Laxatives C Lung Infiltration Salbutamol C Pneumonia Bacterial Fluticasone Pyrexia Propionate C Salmeterol C Date:12/26/02ISR Number: 4035554-0Report Type:Expedited (15-DaCompany Report #PHBS2002CA15318 Age:18 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Overdose Foreign Clozaril(Clozapine) Initial or Prolonged Suicide Attempt Study Tablet PS ORAL SEE IMAGE Health Professional Other Date:12/26/02ISR Number: 4036238-5Report Type:Periodic Company Report #02-10-0909 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Health Clozapine Tablets PS Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. ORAL 50-30MG QD ORAL Date:12/26/02ISR Number: 4036240-3Report Type:Periodic Company Report #02-10-0910 Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Health Clozapine Tablets PS Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. ORAL 200-600MG QD ORAL Date:12/26/02ISR Number: 4036244-0Report Type:Periodic Company Report #02-10-0911 Age:81 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Health Clozapine Tablets PS Ivax Initial or Prolonged Professional Pharmaceuticals, Other Other Inc. ORAL 25-50MG QD ORAL Date:12/26/02ISR Number: 4036246-4Report Type:Periodic Company Report #02-10-0912 Age:27 YR Gender:Male I/FU:I Outcome Life-Threatening Other 22-Feb-2006 08:30 AM Page: 1939 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Required Intervention to Prevent Permanent PT Report Source Product Role Manufacturer Route Dose Duration Impairment/Damage Agranulocytosis Health Clozapine Tablets PS Ivax Professional Pharmaceuticals, Other Inc. ORAL 300MG BID ORAL Celexa C Date:12/26/02ISR Number: 4036248-8Report Type:Periodic Company Report #02-10-0913 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Leukopenia Health Clozapine - Ivax Other Professional Pharmaceuticals, Required Other Inc. Tablets PS Ivax Pharmaceuticals Intervention to , Inc. ORAL 25MG BID Prevent Permanent ORAL; SEE Impairment/Damage IMAGE Peg-Intron Injectables SS SUBCUTANEOUS 120MCG WEEKLY SUBCUTANEO Alprazolam C Sertraline C L-Thyroxin C Doss C Rebetol C Date:12/26/02ISR Number: 4036250-6Report Type:Periodic Company Report #02-10-0918 Age:18 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 75MG QD ORAL Date:12/26/02ISR Number: 4036252-XReport Type:Periodic Company Report #02-10-0924 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Health Clozapine Tablets PS Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. ORAL 250-900MG QD ORAL Date:12/26/02ISR Number: 4036255-5Report Type:Periodic Company Report #02-10-0925 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine Tablets PS Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. ORAL 675-800MG QD ORAL 22-Feb-2006 08:30 AM Page: 1940 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/26/02ISR Number: 4036256-7Report Type:Periodic Company Report #02-10-0926 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Unevaluable Event Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 225-700MG QD ORAL Date:12/26/02ISR Number: 4036261-0Report Type:Periodic Company Report #02-10-0927 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 150-300MG QD ORAL Date:12/26/02ISR Number: 4036264-6Report Type:Periodic Company Report #02-10-0928 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc ORAL 600-700 MG QD ORAL Date:12/26/02ISR Number: 4036265-8Report Type:Periodic Company Report #02-10-0929 Age:73 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine PS Ivax Initial or Prolonged Professional Pharmaceuticals, Inc ORAL 50-250MG QD Other ORAL Date:12/26/02ISR Number: 4036267-1Report Type:Periodic Company Report #02-10-0930 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intestinal Obstruction Health Clozapine Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc ORAL 74-450MG QD ORAL 22-Feb-2006 08:30 AM Page: 1941 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/26/02ISR Number: 4036268-3Report Type:Periodic Company Report #02-10-0931 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 100-175MG QD ORAL Date:12/26/02ISR Number: 4036270-1Report Type:Periodic Company Report #02-10-0932 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucination Health Clozapine PS Ivax Initial or Prolonged Professional Pharmaceuticals, Inc ORAL 25-200MG QD Other ORAL Date:12/26/02ISR Number: 4036272-5Report Type:Periodic Company Report #02-10-0934 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Health Clozapine PS Ivax Initial or Prolonged Professional Pharmaceuticals, Other Other Inc. ORAL 50MG QD ORAL Date:12/26/02ISR Number: 4036274-9Report Type:Periodic Company Report #02-10-0936 Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine PS Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. ORAL 100MG TID ORAL Date:12/26/02ISR Number: 4036281-6Report Type:Periodic Company Report #02-10-0938 Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Health Clozapine PS Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. ORAL ORAL Date:12/26/02ISR Number: 4036282-8Report Type:Periodic Company Report #02-10-0942 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Health Clozapine PS Ivax Professional Pharmaceuticals, Inc ORAL 475MG QD ORAL Other Ultram Tablets SS ORAL 50MG QD ORAL 22-Feb-2006 08:30 AM Page: 1942 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/26/02ISR Number: 4036283-XReport Type:Periodic Company Report #02-10-0947 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine PS Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. ORAL 50-700MG QD ORAL Date:12/26/02ISR Number: 4036285-3Report Type:Periodic Company Report #02-10-0948 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 275-600 MG QD ORAL Date:12/26/02ISR Number: 4036286-5Report Type:Periodic Company Report #02-10-0949 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hostility Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 100-600 MG QD ORAL Date:12/26/02ISR Number: 4036287-7Report Type:Periodic Company Report #02-10-0950 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 200-900 MG QD ORAL Date:12/26/02ISR Number: 4036288-9Report Type:Periodic Company Report #02-10-0951 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine Tablets - Initial or Prolonged Weight Decreased Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 400-600 MG QD ORAL 22-Feb-2006 08:30 AM Page: 1943 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/26/02ISR Number: 4036291-9Report Type:Periodic Company Report #02-10-0955 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 25-525MG QD ORAL Date:12/26/02ISR Number: 4036294-4Report Type:Periodic Company Report #02-10-0958 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Unevaluable Event Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 50-900 MG QD ORAL Date:12/26/02ISR Number: 4036298-1Report Type:Periodic Company Report #02-10-0961 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Tachycardia Health Clozapine Tablets - Initial or Prolonged Professional Ivax Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 25-500 MG QHS ORAL Risperdal C Seroquel C Ativan C Lipitor C Docusate C Date:12/26/02ISR Number: 4036301-9Report Type:Periodic Company Report #02-10-0962 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiovascular Disorder Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 450-600MG QD ORAL 22-Feb-2006 08:30 AM Page: 1944 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/26/02ISR Number: 4036303-2Report Type:Periodic Company Report #02-10-0965 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bronchitis Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 100-125 MG QD ORAL Date:12/26/02ISR Number: 4036305-6Report Type:Periodic Company Report #02-10-0966 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 100-125MG ORAL Date:12/26/02ISR Number: 4036310-XReport Type:Periodic Company Report #02-10-0968 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 100-200MG QD ORAL Date:12/26/02ISR Number: 4036312-3Report Type:Periodic Company Report #02-10-0971 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 100-250MG QD ORAL Date:12/26/02ISR Number: 4036314-7Report Type:Periodic Company Report #02-10-0972 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 250-600MG QD 22-Feb-2006 08:30 AM Page: 1945 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL Date:12/26/02ISR Number: 4036316-0Report Type:Periodic Company Report #02-10-0978 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 50-800MG QD ORAL Date:12/26/02ISR Number: 4036317-2Report Type:Periodic Company Report #02-10-0979 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperglycaemia Health Clozapine Tablets - Required Professional Ivax Intervention to Other Pharmaceuticals, Prevent Permanent Inc. PS Ivax Impairment/Damage Pharmaceuticals, Inc. ORAL 100MG BID ORAL Cogentin C Synthroid C Insulin C Date:12/26/02ISR Number: 4036320-2Report Type:Periodic Company Report #02-11-0985 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 100-250MG QD ORAL Date:12/26/02ISR Number: 4036323-8Report Type:Periodic Company Report #02-11-0987 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 500MG QD ORAL 22-Feb-2006 08:30 AM Page: 1946 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/26/02ISR Number: 4036325-1Report Type:Periodic Company Report #02-11-0991 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Unevaluable Event Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 650MG QD ORAL Date:12/26/02ISR Number: 4036327-5Report Type:Periodic Company Report #02-11-0992 Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Unevaluable Event Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 250-500MG QD ORAL Date:12/26/02ISR Number: 4036328-7Report Type:Periodic Company Report #02-11-0996 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Unevaluable Event Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 500MG QD ORAL Date:12/26/02ISR Number: 4036329-9Report Type:Periodic Company Report #02-08-0720 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pulmonary Embolism Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 25-325MG QD ORAL Date:12/26/02ISR Number: 4036331-7Report Type:Periodic Company Report #02-08-0721 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Unevaluable Event Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 25-37.5MG QD ORAL 22-Feb-2006 08:30 AM Page: 1947 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/26/02ISR Number: 4036332-9Report Type:Periodic Company Report #02-08-0722 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Unevaluable Event Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 300-450MG QD ORAL Date:12/26/02ISR Number: 4036333-0Report Type:Periodic Company Report #02-08-0723 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hostility Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 100-300MG QD ORAL Date:12/26/02ISR Number: 4036335-4Report Type:Periodic Company Report #02-08-0724 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 600-700MG QD ORAL Date:12/26/02ISR Number: 4036336-6Report Type:Periodic Company Report #02-08-0726 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 400MG HS ORAL Date:12/26/02ISR Number: 4036337-8Report Type:Periodic Company Report #02-08-0727 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Health Clozapine Tablets - Initial or Prolonged Dyspnoea Professional Ivax Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 150MG QHS ORAL 22-Feb-2006 08:30 AM Page: 1948 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Effexor C Date:12/26/02ISR Number: 4036339-1Report Type:Periodic Company Report #02-08-0731 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Health Clozapine Tablets - Initial or Prolonged Gait Disturbance Professional Ivax Other Pneumonia Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 900MG QD ORAL Date:12/26/02ISR Number: 4036340-8Report Type:Periodic Company Report #02-08-0746 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 675MG QD ORAL Date:12/26/02ISR Number: 4036342-1Report Type:Periodic Company Report #02-08-0747 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Unevaluable Event Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 125-225MG QD ORAL Date:12/26/02ISR Number: 4036344-5Report Type:Periodic Company Report #02-08-0698 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine PS Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. ORAL 450-600MG QD ORAL Date:12/26/02ISR Number: 4036346-9Report Type:Periodic Company Report #02-08-0699 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Amnesia Health Clozapine PS Ivax Initial or Prolonged Convulsion Professional Pharmaceuticals, Other Thinking Abnormal Inc. ORAL 100MG AM ORAL; 400MG HS ORAL Exelon SS ORAL 1.5MG BID ORAL 22-Feb-2006 08:30 AM Page: 1949 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Klonopin C Imipramine C Cogentin C Prozac C Date:12/26/02ISR Number: 4036348-2Report Type:Periodic Company Report #02-08-0701 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine PS Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. ORAL 100-500MG QD ORAL Date:12/26/02ISR Number: 4036350-0Report Type:Periodic Company Report #02-08-0702 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozapine PS Ivax Other Professional Pharmaceuticals, Other Inc. ORAL 200MG HS ORAL Lorazepam C Nizatidine C Risperdal C Celexa C Synthroid C Fluocinonide C Geodon C Sulfamethoxazole W/Trimethoprim C Nortriptyline Hydrochloride C Spectazole C Lac-Hydrin C Seroquel C Propoxyphene Napsylate W/Acetaminophene C Promethazine C Date:12/26/02ISR Number: 4036352-4Report Type:Periodic Company Report #02-08-0710 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine PS Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. ORAL 400MG QD ORAL Date:12/26/02ISR Number: 4036353-6Report Type:Periodic Company Report #02-08-0711 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine PS Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. ORAL 400-600MG QD ORAL 22-Feb-2006 08:30 AM Page: 1950 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/26/02ISR Number: 4036357-3Report Type:Periodic Company Report #02-08-0712 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Influenza Like Illness Health Clozapine PS Ivax Initial or Prolonged Rhinitis Professional Pharmaceuticals, Other Inc. ORAL 125MG QD ORAL Date:12/26/02ISR Number: 4036364-0Report Type:Periodic Company Report #02-08-0713 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Health Clozapine PS Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. ORAL 300-400MG QD ORAL Date:12/26/02ISR Number: 4036368-8Report Type:Periodic Company Report #02-08-0718 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Health Clozapine PS Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. ORAL 350MG QD ORAL Date:12/26/02ISR Number: 4036372-XReport Type:Periodic Company Report #02-08-0719 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine PS Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. ORAL 175-775MG QD ORAL Date:12/26/02ISR Number: 4036376-7Report Type:Periodic Company Report #02-07-0657 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 25-400MG QD ORAL Date:12/26/02ISR Number: 4036378-0Report Type:Periodic Company Report #02-07-0659 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 350MG QHS ORAL 22-Feb-2006 08:30 AM Page: 1951 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/26/02ISR Number: 4036382-2Report Type:Periodic Company Report #02-07-0664 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 600-700 MG QD ORAL Date:12/26/02ISR Number: 4036384-6Report Type:Periodic Company Report #02-07-0666 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 300-800MG QD ORAL Date:12/26/02ISR Number: 4036385-8Report Type:Periodic Company Report #02-07-0672 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Unevaluable Event Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 25-800MG QD ORAL Date:12/26/02ISR Number: 4036388-3Report Type:Periodic Company Report #02-07-0677 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 100MG QAM ORAL 200MG QHS ORAL Date:12/26/02ISR Number: 4036390-1Report Type:Periodic Company Report #02-08-0688 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Unevaluable Event Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL ORAL 22-Feb-2006 08:30 AM Page: 1952 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/26/02ISR Number: 4036393-7Report Type:Periodic Company Report #02-08-0694 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 150-600MG QD ORAL Date:12/26/02ISR Number: 4036395-0Report Type:Periodic Company Report #02-08-0696 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 50-150MG QD ORAL Date:12/26/02ISR Number: 4036398-6Report Type:Periodic Company Report #02-08-0697 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Infection Health Clozapine - Ivax Initial or Prolonged Pulmonary Embolism Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 700-800MG QD ORAL Date:12/26/02ISR Number: 4036404-9Report Type:Periodic Company Report #02-07-0637 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 25-50 MG QD ORAL Depakote SS 500MG BID Seroquel SS 100MG QD Date:12/26/02ISR Number: 4036405-0Report Type:Periodic Company Report #02-07-0638 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 300-500MG QD ORAL 22-Feb-2006 08:30 AM Page: 1953 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/26/02ISR Number: 4036406-2Report Type:Periodic Company Report #02-07-0639 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Unevaluable Event Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 550-600MG QD ORAL Date:12/26/02ISR Number: 4036407-4Report Type:Periodic Company Report #02-04-0351 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Gastritis Health Clozapine-Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 75MG QD ORAL Date:12/26/02ISR Number: 4036408-6Report Type:Periodic Company Report #02-04-0352 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Malaise Health Clozapine-Ivax Initial or Prolonged Pharyngitis Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 400MG QD ORAL Date:12/26/02ISR Number: 4036411-6Report Type:Periodic Company Report #02-04-0353 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Unevaluable Event Health Clozapine-Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 25-37MG QD ORAL Date:12/26/02ISR Number: 4036412-8Report Type:Periodic Company Report #02-07-0640 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 100MG BID ORAL Stelazine SS 40MG QHS Date:12/26/02ISR Number: 4036416-5Report Type:Periodic Company Report #02-07-0642 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Unevaluable Event Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, 22-Feb-2006 08:30 AM Page: 1954 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Inc. PS Ivax Pharmaceuticals, Inc. ORAL 300MG QD ORAL Date:12/26/02ISR Number: 4036418-9Report Type:Periodic Company Report #02-07-0651 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 200MG BID ORAL Propranolol C Trazodone C Date:12/26/02ISR Number: 4036419-0Report Type:Periodic Company Report #02-04-0354 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Unevaluable Event Health Clozapine -Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 75-600MG ORAL Date:12/26/02ISR Number: 4036421-9Report Type:Periodic Company Report #02-04-0355 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Unevaluable Event Health Clozapine -Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 600-750MG QD ORAL Date:12/26/02ISR Number: 4036422-0Report Type:Periodic Company Report #02-07-0653 Age:81 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Unevaluable Event Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 25-75MG QD ORAL Date:12/26/02ISR Number: 4036423-2Report Type:Periodic Company Report #02-04-0356 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Unevaluable Event Health Clozapine -Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 25-600MG QD ORAL 22-Feb-2006 08:30 AM Page: 1955 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/26/02ISR Number: 4036424-4Report Type:Periodic Company Report #02-07-0654 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 250-500MG QD PO Date:12/26/02ISR Number: 4036425-6Report Type:Periodic Company Report #02-04-0362 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine -Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 150-200MG QD ORAL Date:12/26/02ISR Number: 4036426-8Report Type:Periodic Company Report #02-04-0363 Age:8 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Leukopenia Health Clozapine -Ivax Other Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 125MG QD ORAL Risperidone C Tenex 1mg C Tenex 0.5mg C Lithium C Thorazine C Benadryl C Date:12/26/02ISR Number: 4036427-XReport Type:Periodic Company Report #02-07-0655 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 100MG AM ; 400MG HS :ORAL Chemotherapy SS Date:12/26/02ISR Number: 4036428-1Report Type:Periodic Company Report #02-04-0364 Age:66 YR Gender:Male I/FU:I Outcome Life-Threatening Hospitalization - Initial or Prolonged Other Required 22-Feb-2006 08:30 AM Page: 1956 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Intervention to Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Agranulocytosis Health Clozapine -Ivax Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 200-300MG QD ORAL Lamotrigine C Lithium C Date:12/26/02ISR Number: 4036429-3Report Type:Periodic Company Report #02-04-0368 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Unevaluable Event Health Clozapine -Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 400-500MG QD ORAL Date:12/26/02ISR Number: 4036430-XReport Type:Periodic Company Report #02-06-0520 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 400 MG QD ORAL Date:12/26/02ISR Number: 4036431-1Report Type:Periodic Company Report #02-01-0020 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Unevaluable Event Health Clozapine Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 75-100MG QD ORAL Date:12/26/02ISR Number: 4036432-3Report Type:Periodic Company Report #02-01-0026 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 225-400MG QD ORAL 22-Feb-2006 08:30 AM Page: 1957 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/26/02ISR Number: 4036434-7Report Type:Periodic Company Report #02-01-0027 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 50-650MG QD ORAL Date:12/26/02ISR Number: 4036435-9Report Type:Periodic Company Report #02-01-0028 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 100-700MG QD ORAL Date:12/26/02ISR Number: 4036436-0Report Type:Periodic Company Report #02-01-0029 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Unevaluable Event Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 225-250MG QD ORAL Date:12/26/02ISR Number: 4036437-2Report Type:Periodic Company Report #02-01-0030 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Health Clozapine - Ivax Initial or Prolonged Personality Disorder Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 250-400MG QD ORAL Date:12/26/02ISR Number: 4036438-4Report Type:Periodic Company Report #02-01-0033 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucination, Auditory Health Clozapine - Ivax Initial or Prolonged Personality Disorder Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 250 MG QD ORAL 22-Feb-2006 08:30 AM Page: 1958 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/26/02ISR Number: 4036439-6Report Type:Periodic Company Report #02-01-0034 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Other Clozapine - Ivax Initial or Prolonged Pharmaceuticals, Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 50-500MG QD ORAL Date:12/26/02ISR Number: 4036440-2Report Type:Periodic Company Report #02-01-0035 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hostility Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL ORAL Date:12/26/02ISR Number: 4036441-4Report Type:Periodic Company Report #02-01-0036 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 100MG QD ORAL Date:12/26/02ISR Number: 4036442-6Report Type:Periodic Company Report #02-01-0038 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Health Clozapine Tablets Initial or Prolonged Professional - Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 300-400 MG QD ORAL Date:12/26/02ISR Number: 4036443-8Report Type:Periodic Company Report #02-01-0040 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Health Clozapine Tablets Professional - Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 400 MG QAM ORAL ; 500MG QPM ORAL Prinivil C Benztropine Mesylate C 22-Feb-2006 08:30 AM Page: 1959 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Depakote C Date:12/26/02ISR Number: 4036444-XReport Type:Periodic Company Report #02-01-0044 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozapine Tablets Hospitalization - Blood Creatine Professional - Ivax Initial or Prolonged Phosphokinase Increased Other Pharmaceuticals, Other Cough Inc. PS Ivax Dyspnoea Pharmaceuticals, Pyrexia Inc. ORAL 150 MG QD Thrombocytopenia ORAL Date:12/26/02ISR Number: 4036445-1Report Type:Periodic Company Report #02-06-0522 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 350-500MG QD ORAL Date:12/26/02ISR Number: 4036446-3Report Type:Periodic Company Report #02-01-0046 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiovascular Disorder Health Clozapine Tablets Professional - Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 6.25 MG BID ORAL Levodopa-Carbidopa C Mirapex "Pharmacia-Upjohn" C Pulmicort C Date:12/26/02ISR Number: 4036447-5Report Type:Periodic Company Report #02-01-0047 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Health Clozapine Tablets Initial or Prolonged Professional - Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 100-400MG QD ORAL 22-Feb-2006 08:30 AM Page: 1960 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/26/02ISR Number: 4036450-5Report Type:Periodic Company Report #02-01-0049 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Health Clozapine Tablets Initial or Prolonged Professional - Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 25-400 MG QD ORAL Date:12/26/02ISR Number: 4036452-9Report Type:Periodic Company Report #02-01-0050 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Health Clozapine Tablets Initial or Prolonged Professional - Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 100-550 MG QD ORAL Date:12/26/02ISR Number: 4036454-2Report Type:Periodic Company Report #02-01-0051 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Health Clozapine Tablets Initial or Prolonged Professional - Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 325-400 MG ORAL Date:12/26/02ISR Number: 4036456-6Report Type:Periodic Company Report #02-06-0523 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozapine - Ivax Hospitalization - Professional Pharmaceuticals, Initial or Prolonged Other Inc. Tablets PS Ivax Other Pharmaceuticals, Inc. ORAL 100MG QAM ORAL Atenolol C Minoxidil C Casanthranol C Ribavirin C Intereferon Alfa-2b C Date:12/26/02ISR Number: 4036458-XReport Type:Periodic Company Report #02-01-0052 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Hospitalization - Drug Ineffective Health Initial or Prolonged Professional 22-Feb-2006 08:30 AM Page: 1961 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Product Role Manufacturer Route Dose Duration Clozapine Tablets - Ivax Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 300-700 MG QD ORAL Date:12/26/02ISR Number: 4036460-8Report Type:Periodic Company Report #02-06-0526 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL ORAL Date:12/26/02ISR Number: 4036462-1Report Type:Periodic Company Report #02-01-0053 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Unevaluable Event Health Clozapine Tablets Initial or Prolonged Professional - Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 6.2 - 400 MG QD ORAL Date:12/26/02ISR Number: 4036463-3Report Type:Periodic Company Report #02-06-0534 Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bronchitis Health Clozapine - Ivax Initial or Prolonged Leukopenia Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 500MG QD ORAL Date:12/26/02ISR Number: 4036464-5Report Type:Periodic Company Report #02-06-0535 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 25-500MG QD ORAL 22-Feb-2006 08:30 AM Page: 1962 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/26/02ISR Number: 4036466-9Report Type:Periodic Company Report #01-12-0754 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS ORAL ORAL Date:12/26/02ISR Number: 4036467-0Report Type:Periodic Company Report #02-06-0536 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 50-600MG QD ORAL Date:12/26/02ISR Number: 4036468-2Report Type:Periodic Company Report #01-12-0755 Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Unevaluable Event Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 25-37.5MG QD ORAL Date:12/26/02ISR Number: 4036469-4Report Type:Periodic Company Report #02-06-0540 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Leukopenia Health Clozapine - Ivax Other Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 600MG HS ORAL Klonopin C Neurontin C Date:12/26/02ISR Number: 4036470-0Report Type:Periodic Company Report #01-12-0756 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Other Inc. Tablets PS ORAL 400MG HS ORAL Required Lithium C Intervention to Lithium C Prevent Permanent Albuterol Sulfate C Impairment/Damage Propranolol C 22-Feb-2006 08:30 AM Page: 1963 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/26/02ISR Number: 4036471-2Report Type:Periodic Company Report #01-12-0757 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 50-400MG QD ORAL Date:12/26/02ISR Number: 4036472-4Report Type:Periodic Company Report #02-06-0542 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Health Clozapine - Ivax Initial or Prolonged Dizziness Professional Pharmaceuticals, Drug Ineffective Other Inc. Tablets PS Ivax Electrocardiogram Pharmaceuticals, Abnormal Inc. ORAL 25-300MG QHS Leukocytosis ORAL Date:12/26/02ISR Number: 4036473-6Report Type:Periodic Company Report #02-06-0543 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 150-700MG QD ORAL Date:12/26/02ISR Number: 4036474-8Report Type:Periodic Company Report #01-12-0758 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 50-200MG QD ORAL Date:12/26/02ISR Number: 4036475-XReport Type:Periodic Company Report #01-12-0759 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS 500-600MG QD Date:12/26/02ISR Number: 4036477-3Report Type:Periodic Company Report #02-08-0748 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Inc Other Tablets PS Ivax Pharmaceuticals, Inc ORAL ORAL 22-Feb-2006 08:30 AM Page: 1964 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/26/02ISR Number: 4036478-5Report Type:Periodic Company Report #02-01-0003 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Other Inc. Tablets PS 100-150MG QD Date:12/26/02ISR Number: 4036480-3Report Type:Periodic Company Report #02-08-0749 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diarrhoea Health Clozapine - Ivax Initial or Prolonged Eosinophilia Professional Pharmaceuticals, Pyrexia Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 100 MG HS; ORAL Date:12/26/02ISR Number: 4036481-5Report Type:Periodic Company Report #02-01-0004 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Infection Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS 150-500MG QD Date:12/26/02ISR Number: 4036483-9Report Type:Periodic Company Report #02-08-0757 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 700 MG QD; ORAL Date:12/26/02ISR Number: 4036484-0Report Type:Periodic Company Report #02-01-0005 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS 50MG QD Date:12/26/02ISR Number: 4036485-2Report Type:Periodic Company Report #02-08-0760 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozapine - Ivax Professional Pharmaceuticals, Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 450 - 600MG QD; ORAL Thorazine C 22-Feb-2006 08:30 AM Page: 1965 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Nortriptyline C Depakote C Benadryl C Ddavp C Trileptal C Date:12/26/02ISR Number: 4036486-4Report Type:Periodic Company Report #02-01-0006 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS 200MG QD Date:12/26/02ISR Number: 4036488-8Report Type:Periodic Company Report #02-08-0762 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Health Clozapine - Ivax Initial or Prolonged Syndrome Professional Pharmaceuticals, Other Other Inc. Tablets PS Ivax Required Pharmaceuticals, Inc ORAL 12.5 -250MG Intervention to QD; ORAL Prevent Permanent Haldol Decanoate Impairment/Damage Injectable Solution SS INTRAMUSCULAR 150-200MG; INTRAMUSCULAR Cogentin C Depakote C Date:12/26/02ISR Number: 4036489-XReport Type:Periodic Company Report #02-01-0007 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. 800MG QD Date:12/26/02ISR Number: 4036491-8Report Type:Periodic Company Report #02-08-0766 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 12.5-400 MG QD; ORAL Iron Sulfate C 22-Feb-2006 08:30 AM Page: 1966 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/26/02ISR Number: 4036492-XReport Type:Periodic Company Report #02-01-0009 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. 50-150MG QD Date:12/26/02ISR Number: 4036495-5Report Type:Periodic Company Report #02-01-0010 Age:87 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Unevaluable Event Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 25-250MG QD ORAL Date:12/26/02ISR Number: 4036496-7Report Type:Periodic Company Report #02-08-0783 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Company Clozapine - Ivax Initial or Prolonged Representative Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 300-600 MG QD; ORAL Date:12/26/02ISR Number: 4036498-0Report Type:Periodic Company Report #02-01-0011 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Paranoia Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. 900MG QD Date:12/26/02ISR Number: 4036499-2Report Type:Periodic Company Report #02-09-0773 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Unevaluable Event Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 25-400MG QD; ORAL 22-Feb-2006 08:30 AM Page: 1967 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/26/02ISR Number: 4036501-8Report Type:Periodic Company Report #02-09-0774 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 300 MG QD; ORAL Date:12/26/02ISR Number: 4036502-XReport Type:Periodic Company Report #02-01-0012 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine - Ivaz Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc 100-475MG QD Date:12/26/02ISR Number: 4036504-3Report Type:Periodic Company Report #02-09-0775 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Clozapine - Ivax Headache Professional Pharmaceuticals, Hostility Inc. Tablets PS Ivax Pharmaceuticals Inc. ORAL 200MG QAM, HS; ORAL Depakote SS ORAL 500 MG BID; ORAL Zoloft C Date:12/26/02ISR Number: 4036505-5Report Type:Periodic Company Report #02-01-0013 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. 300MG QD Date:12/26/02ISR Number: 4036509-2Report Type:Periodic Company Report #02-07-0620 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dizziness Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL ORAL Ibuprofen SS 22-Feb-2006 08:30 AM Page: 1968 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/26/02ISR Number: 4036510-9Report Type:Periodic Company Report #02-01-0014 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. 200-400MG QD Date:12/26/02ISR Number: 4036511-0Report Type:Periodic Company Report #02-07-0623 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Unevaluable Event Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 100-500MG QD ORAL Date:12/26/02ISR Number: 4036513-4Report Type:Periodic Company Report #02-01-0017 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. 150-400MG QD Date:12/26/02ISR Number: 4036514-6Report Type:Periodic Company Report #02-07-0627 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Health Clozapine Tablets - Initial or Prolonged Liver Function Test Professional Ivax Other Abnormal Other Pharmaceuticals, Required Stevens-Johnson Syndrome Inc. PS Ivax Intervention to Pharmaceuticals, Prevent Permanent Inc. ORAL 200MG BID Impairment/Damage ORAL Zyprexa C Date:12/26/02ISR Number: 4036516-XReport Type:Periodic Company Report #02-07-0628 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL ORAL 22-Feb-2006 08:30 AM Page: 1969 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/26/02ISR Number: 4036517-1Report Type:Periodic Company Report #02-07-0629 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 850MG QD ORAL Date:12/26/02ISR Number: 4036518-3Report Type:Periodic Company Report #02-01-0018 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. 25 - 750MG QD Date:12/26/02ISR Number: 4036519-5Report Type:Periodic Company Report #02-01-0019 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Unevaluable Event Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 75-300MG QD ORAL Date:12/26/02ISR Number: 4036520-1Report Type:Periodic Company Report #02-07-0632 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 250-600MG QD ORAL Date:12/26/02ISR Number: 4036522-5Report Type:Periodic Company Report #02-07-0633 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthma Health Clozapine Tablets - Initial or Prolonged Depression Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 150-600MG QD, ORAL 22-Feb-2006 08:30 AM Page: 1970 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/26/02ISR Number: 4036523-7Report Type:Periodic Company Report #02-07-0634 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Unevaluable Event Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 400MG QD ORAL Date:12/26/02ISR Number: 4036524-9Report Type:Periodic Company Report #02-07-0635 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 100MG BID ORAL Rocephin C Depo Provera C Novolin C Niferex C Vitamin B12 C Vitamin E C Coumadin C Caltrate + D C Cogentin C Chronulac C Luvox C Lasix C Valproic Acid C Gabitril C Retin A Cream C Date:12/26/02ISR Number: 4036525-0Report Type:Periodic Company Report #02-07-0636 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 100-300MG QD ORAL Date:12/26/02ISR Number: 4036526-2Report Type:Periodic Company Report #02-06-0566 Age:36 YR Gender:Male I/FU:I Outcome Hospitalization - Initial or Prolonged Required Intervention to Prevent Permanent 22-Feb-2006 08:30 AM Page: 1971 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Thrombocytopenia Health Clozapine Tablets PS Ivax Professional Pharmaceuticals, Other Inc. ORAL 600-700MG QD ORAL Celexa C Klonopin C Alprazolam C Date:12/26/02ISR Number: 4036527-4Report Type:Periodic Company Report #02-06-0569 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine Tablets PS Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. ORAL 400-550MG QD ORAL Date:12/26/02ISR Number: 4036528-6Report Type:Periodic Company Report #02-06-0570 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine Tablets- Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc PS Ivax Pharmaceuticals, Inc. ORAL 600MG QD ORAL Date:12/26/02ISR Number: 4036529-8Report Type:Periodic Company Report #02-06-0571 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Paranoia Health Clozapine Tablets- Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc PS Ivax Pharmaceuticals, Inc. ORAL 350MG QD ORAL Date:12/26/02ISR Number: 4036530-4Report Type:Periodic Company Report #02-06-0572 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Unevaluable Event Health Clozapine Tablets PS Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. ORAL 50-75MG QD ORAL Date:12/26/02ISR Number: 4036531-6Report Type:Periodic Company Report #02-06-0576 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Health Clozapine Tablets PS Ivax Initial or Prolonged Professional Pharmaceuticals, Inc. ORAL 275MG QD ORAL 22-Feb-2006 08:30 AM Page: 1972 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Xanax C Cardizem C Lamictal C Digoxin C Date:12/26/02ISR Number: 4036533-XReport Type:Periodic Company Report #02-06-0578 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Health Clozapine Tablets- Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc PS Ivax Pharmaceuticals, Inc. ORAL ORAL Date:12/26/02ISR Number: 4036534-1Report Type:Periodic Company Report #02-06-0579 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Health Clozapine Tablets- Initial or Prolonged Professional Ivax Other Other Pharmaceuticals, Inc PS Ivax Pharmaceuticals, Inc. ORAL 300-900MG QD ORAL Date:12/26/02ISR Number: 4036535-3Report Type:Periodic Company Report #02-06-0580 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Liver Function Test Health Clozapine Tablets- Initial or Prolonged Abnormal Professional Ivax Required Salivary Hypersecretion Other Pharmaceuticals, Inc PS Ivax Intervention to Somnolence Pharmaceuticals, Prevent Permanent Inc. ORAL 175MG QD ORAL Impairment/Damage Geodon C Date:12/26/02ISR Number: 4036681-4Report Type:Periodic Company Report #02-07-0605 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozapine Tablets - Other Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 400MG HS ORAL Zoloft C Glucophage C Date:12/26/02ISR Number: 4036682-6Report Type:Periodic Company Report #02-07-0607 Age:37 YR Gender:Female I/FU:I Outcome Life-Threatening Hospitalization - 22-Feb-2006 08:30 AM Page: 1973 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Initial or Prolonged Other Required Intervention to PT Report Source Product Role Manufacturer Route Dose Duration Prevent Permanent Agranulocytosis Health Clozapine Tablets - Impairment/Damage Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 25MG QD ORAL Date:12/26/02ISR Number: 4036683-8Report Type:Periodic Company Report #02-07-0608 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Syncope Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 25-900MG QD ORAL Date:12/26/02ISR Number: 4036684-XReport Type:Periodic Company Report #02-07-0609 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 100-500 MG QD ORAL Date:12/26/02ISR Number: 4036685-1Report Type:Periodic Company Report #02-07-0612 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 800MG QD ORAL Date:12/26/02ISR Number: 4036686-3Report Type:Periodic Company Report #02-07-0613 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Extrapyramidal Disorder Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 50-150 MG QD ORAL 22-Feb-2006 08:30 AM Page: 1974 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/26/02ISR Number: 4036687-5Report Type:Periodic Company Report #02-07-0614 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Health Clozapine Tablets - Initial or Prolonged Drug Ineffective Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL ORAL Date:12/26/02ISR Number: 4036688-7Report Type:Periodic Company Report #02-07-0615 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperhidrosis Health Clozapine Tablets - Initial or Prolonged Lethargy Professional Ivax Required Liver Function Test Other Pharmaceuticals, Intervention to Abnormal Inc. PS Ivax Prevent Permanent Pharmaceuticals, Impairment/Damage Inc. ORAL 75 MG AM ORAL ; 125 MG PM ORAL Paxil C Ritalin C Date:12/26/02ISR Number: 4036689-9Report Type:Periodic Company Report #02-07-0616 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 350MG BID ORAL Remeron C Peri-Colace C Albuterol Sulfate C Date:12/26/02ISR Number: 4036690-5Report Type:Periodic Company Report #02-07-0617 Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Sepsis Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 150MG QD ORAL Date:12/26/02ISR Number: 4036707-8Report Type:Periodic Company Report #01-12-0707 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Hospitalization - Psychotic Disorder Health Initial or Prolonged Professional 22-Feb-2006 08:30 AM Page: 1975 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Product Role Manufacturer Route Dose Duration Clozapine - Ivax Pharmaceuticals, Inc. Tablets PS ORAL 300-400MG D ORAL Date:12/26/02ISR Number: 4036708-XReport Type:Periodic Company Report #01-12-0708 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozapine - Ivax Liver Function Test Professional Pharmaceuticals, Abnormal Inc. Tablets PS ORAL 700MG QD ORAL Depakote C Lipitor C Date:12/26/02ISR Number: 4036709-1Report Type:Periodic Company Report #01-12-0709 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 300-700MG QD ORAL Date:12/26/02ISR Number: 4036711-XReport Type:Periodic Company Report #01-12-0710 Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 350MG QD ORAL Chemotherapy Unknown SS Date:12/26/02ISR Number: 4036712-1Report Type:Periodic Company Report #01-12-0711 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS ORAL ORAL Date:12/26/02ISR Number: 4036713-3Report Type:Periodic Company Report #01-12-0713 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 100-400MG QD ORAL 22-Feb-2006 08:30 AM Page: 1976 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/26/02ISR Number: 4036715-7Report Type:Periodic Company Report #01-12-0714 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Other Inc. Tablets PS ORAL 400MG QHS Required ORAL Intervention to Depakote C Prevent Permanent Zyprexa C Impairment/Damage Prozac C Desyrel C Artane C Dilantin C Date:12/26/02ISR Number: 4036716-9Report Type:Periodic Company Report #01-12-0718 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 300-900MG QD ORAL Date:12/26/02ISR Number: 4036718-2Report Type:Periodic Company Report #01-12-0719 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 150-350MG QD ORAL Date:12/26/02ISR Number: 4036719-4Report Type:Periodic Company Report #01-12-0720 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 50-250MG QD ORAL Date:12/26/02ISR Number: 4036752-2Report Type:Periodic Company Report #01-12-0666 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozapine - Ivax Required Professional Pharmaceuticals, Intervention to Other Inc. Tablets PS Ivax Prevent Permanent Pharmaceuticals, Impairment/Damage Inc. ORAL 250MG QHS ORAL Zyprexa C Prolixin C Depakote C 22-Feb-2006 08:30 AM Page: 1977 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/26/02ISR Number: 4036753-4Report Type:Periodic Company Report #01-12-0667 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. 400MG HS; 350MG HS; 400MG HS Date:12/26/02ISR Number: 4036755-8Report Type:Periodic Company Report #01-12-0672 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Unknown PS Ivax Pharmaceuticals, Inc. 700MG QD Cytoxan Tablets SS ORAL ORAL Adriamycin Injectable SS Date:12/26/02ISR Number: 4036756-XReport Type:Periodic Company Report #01-12-0674 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Phrmaceuticals, Inc. ORAL 150-700MG QD ORAL Date:12/26/02ISR Number: 4036758-3Report Type:Periodic Company Report #01-12-0677 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Unevaluable Event Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 100MG QD ORAL Date:12/26/02ISR Number: 4036765-0Report Type:Periodic Company Report #01-12-0678 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. 22-Feb-2006 08:30 AM Page: 1978 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/26/02ISR Number: 4036766-2Report Type:Periodic Company Report #01-12-0682 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. 12.5-275MG QD Date:12/26/02ISR Number: 4036768-6Report Type:Periodic Company Report #01-12-0690 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 500-350MG QD ORAL Date:12/26/02ISR Number: 4036769-8Report Type:Periodic Company Report #01-12-0691 Age:91 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine - Ivax Other Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 50-75MG QD ORAL Date:12/26/02ISR Number: 4036771-6Report Type:Periodic Company Report #01-12-0692 Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Unevaluable Event Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 100-200MG QD ORAL Date:12/26/02ISR Number: 4036808-4Report Type:Periodic Company Report #01-12-0693 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukocytosis Health Clozapine Tablets - Professional Ivax Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 650MG QD ORAL Neurontin C Humibid C Theophylline C Zithromax C 22-Feb-2006 08:30 AM Page: 1979 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Glucotrol C Verapamil C Digoxin C Depakote C Levaquin C Albuterol Sulfate C Lasix C Potassium C Prednisone C Prinivil C Date:12/26/02ISR Number: 4036810-2Report Type:Periodic Company Report #01-12-0695 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 150-400MG QD ORAL Date:12/26/02ISR Number: 4036811-4Report Type:Periodic Company Report #01-12-0697 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 50-300MG QD ORAL Date:12/26/02ISR Number: 4036813-8Report Type:Periodic Company Report #01-12-0698 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 100-400MG QD ORAL Date:12/26/02ISR Number: 4036815-1Report Type:Periodic Company Report #01-12-0699 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hostility Health Clozapine Tablets - Initial or Prolonged Personality Disorder Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 450MG QD ORAL 22-Feb-2006 08:30 AM Page: 1980 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/26/02ISR Number: 4036816-3Report Type:Periodic Company Report #01-12-0700 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Grand Mal Convulsion Health Clozapine Tablets - Required Urinary Incontinence Professional Ivax Intervention to Pharmaceuticals, Prevent Permanent Inc. PS Ivax Impairment/Damage Pharmaceuticals, Inc. ORAL 400MG QD ORAL Ddavp C Date:12/26/02ISR Number: 4036818-7Report Type:Periodic Company Report #01-12-0703 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 75-550MG QD ORAL Date:12/26/02ISR Number: 4036819-9Report Type:Periodic Company Report #01-12-0704 Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hostility Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 100MG QD ORAL Date:12/26/02ISR Number: 4036820-5Report Type:Periodic Company Report #01-12-0705 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 37.5-62.5MG Q ORAL Date:12/26/02ISR Number: 4036821-7Report Type:Periodic Company Report #01-12-0706 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 500MG QD ORAL 22-Feb-2006 08:30 AM Page: 1981 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/26/02ISR Number: 4036824-2Report Type:Periodic Company Report #02-05-0450 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozapine - Ivax Hospitalization - Professional Pharmaceuticals, Initial or Prolonged Other Inc. Tablets PS ORAL 600-650MG QD Other ORAL Date:12/26/02ISR Number: 4036825-4Report Type:Periodic Company Report #02-05-0452 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Health Clozapine - Ivax Initial or Prolonged Somnolence Professional Pharmaceuticals, Other Other Inc. Tablets PS ORAL 200-400MG QD ORAL Chemotherapy SS Date:12/26/02ISR Number: 4036826-6Report Type:Periodic Company Report #02-05-0453 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Sepsis Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 75-225 QD ORAL Date:12/26/02ISR Number: 4036828-XReport Type:Periodic Company Report #02-05-0454 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 450MG QD ORAL Date:12/26/02ISR Number: 4036829-1Report Type:Periodic Company Report #02-05-0455 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 550MG QHS ORAL Lamictal C Effexor C Wellbutrin C Geodon C Date:12/26/02ISR Number: 4036830-8Report Type:Periodic Company Report #02-05-0456 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 400 MG QD ORAL 22-Feb-2006 08:30 AM Page: 1982 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/26/02ISR Number: 4036831-XReport Type:Periodic Company Report #02-05-0461 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Inc PS ORAL 100 MG HS Other ORAL Depakote C Date:12/26/02ISR Number: 4036832-1Report Type:Periodic Company Report #02-05-0463 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine -Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 500MG QD ORAL Date:12/26/02ISR Number: 4036833-3Report Type:Periodic Company Report #02-05-0464 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozapine - Ivax Hospitalization - Professional Pharmaceuticals, Initial or Prolonged Other Inc. Tablets PS ORAL 400 MG 8PM Other ORAL Date:12/26/02ISR Number: 4036834-5Report Type:Periodic Company Report #02-05-0465 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Health Clozapine-Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 300-900MG QD ORAL Date:12/26/02ISR Number: 4036837-0Report Type:Periodic Company Report #02-05-0436 Age:86 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Unevaluable Event Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 12.5-250MG QD ORAL Date:12/26/02ISR Number: 4036838-2Report Type:Periodic Company Report #02-05-0437 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 200-400MG QD 22-Feb-2006 08:30 AM Page: 1983 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL Date:12/26/02ISR Number: 4036841-2Report Type:Periodic Company Report #02-05-0439 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 50MG AM ORALL; SEE IMAGE Combivent C Flovent C Prednisone C Date:12/26/02ISR Number: 4036842-4Report Type:Periodic Company Report #02-05-0440 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Health Clozapine Tablets - Initial or Prolonged Professional Ivax Required Other Pharmaceuticals, Intervention to Inc. PS Ivax Prevent Permanent Pharmaceuticals, Impairment/Damage Inc. ORAL 100MG QAM ORAL; SEE IMAGE Date:12/26/02ISR Number: 4036843-6Report Type:Periodic Company Report #02-05-0442 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Clozapine Tablets - Professional Ivax Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 400MG BID ORAL Depakote C Cogentin C Dilantin C Diprosone C Date:12/26/02ISR Number: 4036844-8Report Type:Periodic Company Report #02-05-0443 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 650MG ORAL 22-Feb-2006 08:30 AM Page: 1984 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/26/02ISR Number: 4036845-XReport Type:Periodic Company Report #02-05-0444 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 25-400MG QD ORAL Date:12/26/02ISR Number: 4036846-1Report Type:Periodic Company Report #02-05-0447 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 300-400MG QD ORAL Date:12/26/02ISR Number: 4036847-3Report Type:Periodic Company Report #02-05-0448 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 300-400MG QD ORAL Date:12/26/02ISR Number: 4036849-7Report Type:Periodic Company Report #02-05-0449 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 25-700MG QD ORAL Date:12/26/02ISR Number: 4036851-5Report Type:Periodic Company Report #02-05-0410 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Unevaluable Event Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmacetuticals, Inc. ORAL 255-600MG QD 22-Feb-2006 08:30 AM Page: 1985 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL Date:12/26/02ISR Number: 4036853-9Report Type:Periodic Company Report #02-05-0412 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Health Clozapine Tablets PS Ivax Initial or Prolonged Professional Pharmaceuticals,Inc. ORAL 125-550MG QD Other ORAL Date:12/26/02ISR Number: 4036855-2Report Type:Periodic Company Report #02-05-0413 Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozapine Tablets - Other Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 25-50MG QD ORAL Chemotherapy SS Date:12/26/02ISR Number: 4036858-8Report Type:Periodic Company Report #02-05-0423 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Unevaluable Event Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 12.5 MG QD ORAL Date:12/26/02ISR Number: 4036859-XReport Type:Periodic Company Report #02-05-0424 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hostility Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 450-550MG QD ORAL Date:12/26/02ISR Number: 4036860-6Report Type:Periodic Company Report #02-05-0425 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 128-600MG QD 22-Feb-2006 08:30 AM Page: 1986 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL Date:12/26/02ISR Number: 4036861-8Report Type:Periodic Company Report #02-05-0430 Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 150MG QHS ORAL Date:12/26/02ISR Number: 4036862-XReport Type:Periodic Company Report #02-05-0432 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Unevaluable Event Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 25-300MG QD ORAL Date:12/26/02ISR Number: 4036863-1Report Type:Periodic Company Report #02-05-0433 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Unevaluable Event Foreign Clozapine Tablets - Initial or Prolonged Health Ivax Professional Pharmaceuticals, Other Inc. PS Ivax Pharmaceuticals, Inc. ORAL 200MG QD ORAL Date:12/26/02ISR Number: 4036864-3Report Type:Periodic Company Report #02-05-0434 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intestinal Obstruction Health Clozapine Tablets PS Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. ORAL 525-650MG QD ORAL Date:12/26/02ISR Number: 4036865-5Report Type:Periodic Company Report #02-04-0405 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc ORAL 250-325MG QD ORAL 22-Feb-2006 08:30 AM Page: 1987 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/26/02ISR Number: 4036866-7Report Type:Periodic Company Report #02-04-0407 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Inc Other Tablets PS Ivax Pharmaceuticals, Inc ORAL 300-550MG QD ORAL Date:12/26/02ISR Number: 4036867-9Report Type:Periodic Company Report #02-04-0967 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Inc Other Other Tablets PS Ivax Pharmaceuticals, Inc ORAL 400MG QD ORAL Date:12/26/02ISR Number: 4036868-0Report Type:Periodic Company Report #02-05-0401 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bipolar I Disorder Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Inc Other Tablets PS Ivax Pharmaceuticals, Inc ORAL 50-300MG QD ORAL Date:12/26/02ISR Number: 4036869-2Report Type:Periodic Company Report #02-05-0402 Age:94 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Unevaluable Event Health Clozapine - Ivax Professional Pharmaceuticals, Inc Other Tablets PS Ivax Pharmaceuticals, Inc ORAL 200MG QD ORAL Date:12/26/02ISR Number: 4036870-9Report Type:Periodic Company Report #02-05-0403 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Inc Other Tablets PS Ivax Pharmaceuticals, Inc ORAL 100-250MG QD ORAL Date:12/26/02ISR Number: 4036871-0Report Type:Periodic Company Report #02-05-0404 Age:85 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Unevaluable Event Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc ORAL 12.5-25MG QD ORAL 22-Feb-2006 08:30 AM Page: 1988 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/26/02ISR Number: 4036872-2Report Type:Periodic Company Report #02-05-0406 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Inc Other Tablets PS Ivax Pharmaceuticals, Inc ORAL 100MG BID ORAL : 200MG PM ORAL : 300MG HS ORAL Date:12/26/02ISR Number: 4036873-4Report Type:Periodic Company Report #02-05-0408 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Inc Other Tablets PS Ivax Pharmaceuticals, Inc ORAL 650MG QD ORAL Date:12/26/02ISR Number: 4036874-6Report Type:Periodic Company Report #02-05-0409 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Inc Other Tablets PS Ivax Pharmaceuticals, Inc ORAL 300MG QD ORAL Date:12/26/02ISR Number: 4036875-8Report Type:Periodic Company Report #02-11-1019 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 50-400 MG QD ORAL Date:12/26/02ISR Number: 4036876-XReport Type:Periodic Company Report #02-11-1020 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 650MG QD ORAL Date:12/26/02ISR Number: 4036877-1Report Type:Periodic Company Report #02-11-1023 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS ORAL ORAL 22-Feb-2006 08:30 AM Page: 1989 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/26/02ISR Number: 4036878-3Report Type:Periodic Company Report #02-11-1024 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 125-700MG QD ORAL Date:12/26/02ISR Number: 4036879-5Report Type:Periodic Company Report #02-11-1026 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aspiration Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 150-300MG ORAL Date:12/26/02ISR Number: 4036880-1Report Type:Periodic Company Report #02-11-1028 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 50-300MG QD ORAL Date:12/26/02ISR Number: 4036881-3Report Type:Periodic Company Report #02-11-1030 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 25-525MG QD ORAL Date:12/26/02ISR Number: 4036882-5Report Type:Periodic Company Report #02-11-1031 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Myasthenic Syndrome Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 25-450MG QD ORAL Date:12/26/02ISR Number: 4036883-7Report Type:Periodic Company Report #02-11-1032 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Other Inc. Tablets PS ORAL 37.5-150MG QD ORAL 22-Feb-2006 08:30 AM Page: 1990 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/26/02ISR Number: 4036884-9Report Type:Periodic Company Report #02-11-1033 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 300MG QD ORAL Date:12/26/02ISR Number: 4036885-0Report Type:Periodic Company Report #02-04-0370 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 400-700MG QD ORAL Date:12/26/02ISR Number: 4036887-4Report Type:Periodic Company Report #02-04-0371 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 50-800MG QD ORAL Date:12/26/02ISR Number: 4036888-6Report Type:Periodic Company Report #02-04-0372 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Required Other Inc. Tablets PS ORAL 100MG BID Intervention to ORAL; 250MG Prevent Permanent HS ORAL Impairment/Damage Interferon SS 1200/10 KIT Date:12/26/02ISR Number: 4036889-8Report Type:Periodic Company Report #02-04-0373 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Unevaluable Event Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 375-475MG QD ORAL Date:12/26/02ISR Number: 4036890-4Report Type:Periodic Company Report #02-04-0374 Age:82 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Unevaluable Event Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 25-67MG QD ORAL 22-Feb-2006 08:30 AM Page: 1991 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/26/02ISR Number: 4036892-8Report Type:Periodic Company Report #02-04-0375 Age:96 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Unevaluable Event Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 12.5-250MG QD ORAL Date:12/26/02ISR Number: 4036894-1Report Type:Periodic Company Report #02-04-0377 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 600MG QD ORAL Date:12/26/02ISR Number: 4036896-5Report Type:Periodic Company Report #02-04-0379 Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 12.5 MG QD ORAL Date:12/26/02ISR Number: 4036898-9Report Type:Periodic Company Report #02-04-0382 Age:87 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Other Inc. Tablets PS ORAL 100-125MG QD ORAL Date:12/26/02ISR Number: 4036899-0Report Type:Periodic Company Report #02-04-0400 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 400MG QHS ORAL Prolixin Decanoate C Paxil C Lorazepam C Symmetrel C Date:12/26/02ISR Number: 4036900-4Report Type:Periodic Company Report #02-11-1034 Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intestinal Obstruction Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Other Pharmaceuticals, Inc PS Ivax Pharmaceuticals, Inc ORAL 100-550 MG QD ORAL 22-Feb-2006 08:30 AM Page: 1992 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/26/02ISR Number: 4036901-6Report Type:Periodic Company Report #02-11-1041 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc PS Ivax Pharmaceuticals, Inc ORAL 175-700MG QD ORAL Date:12/26/02ISR Number: 4036902-8Report Type:Periodic Company Report # 02-11-1042 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc PS Ivax Pharmaceuticals, Inc ORAL 200-800MG QD ORAL Date:12/26/02ISR Number: 4036903-XReport Type:Periodic Company Report #02-11-1044 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc PS ORAL 100-300MG QD ORAL Date:12/26/02ISR Number: 4036904-1Report Type:Periodic Company Report #02-11-1047 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc PS Ivax Pharmaceuticals, Inc ORAL 100-300MG QD ORAL Date:12/26/02ISR Number: 4036905-3Report Type:Periodic Company Report #02-11-1048 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pneumonia Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc PS Ivax Pharmaceuticals, Inc ORAL 50-700MG QD ORAL Date:12/26/02ISR Number: 4036907-7Report Type:Periodic Company Report #02-11-1049 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Unevaluable Event Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc PS Ivax Pharmaceuticals, Inc ORAL 325MG QD ORAL 22-Feb-2006 08:30 AM Page: 1993 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/26/02ISR Number: 4036910-7Report Type:Periodic Company Report #02-11-1050 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc PS Ivax Pharmaceuticals, Inc ORAL 600MG QD ORAL Date:12/26/02ISR Number: 4036911-9Report Type:Periodic Company Report #02-11-1052 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc PS Ivax Pharmaceuticals, Inc ORAL 200-400MG QD ORAL Date:12/26/02ISR Number: 4036913-2Report Type:Periodic Company Report # 02-11-1053 Age:67 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Unevaluable Event Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc PS Ivax Pharmaceuticals, Inc ORAL 100-700MG QD ORAL Date:12/26/02ISR Number: 4036914-4Report Type:Periodic Company Report #02-04-0316 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Unevaluable Event Health Clozapine-Ivax Professional Pharmaceuticals, Inc Other Tablets PS Ivax Pharmaceuticals, Inc ORAL 25-900MG QD ORAL Date:12/26/02ISR Number: 4036915-6Report Type:Periodic Company Report #02-04-0318 Age:52 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine-Ivax Initial or Prolonged Professional Pharmaceuticals, Inc Other Tablets PS Ivax Pharmaceuticals, Inc ORAL 75-175MG QD ORAL Date:12/26/02ISR Number: 4036916-8Report Type:Periodic Company Report #02-04-0319 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Clozapine-Ivax Initial or Prolonged Pharmaceuticals, Inc Tablets PS Ivax Pharmaceuticals, Inc ORAL 650-800MG QD 22-Feb-2006 08:30 AM Page: 1994 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL Date:12/26/02ISR Number: 4036918-1Report Type:Periodic Company Report #02-04-0320 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine-Ivax Initial or Prolonged Professional Pharmaceuticals, Inc Other Tablets PS Ivax Pharmaceuticals, Inc ORAL 50-400MG QD ORAL Date:12/26/02ISR Number: 4036928-4Report Type:Periodic Company Report #02-04-0321 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozapine-Ivax Hospitalization - Professional Pharmaceuticals, Inc Initial or Prolonged Other Tablets PS Ivax Other Pharmaceuticals, Inc ORAL 200MG BID Required ORAL Intervention to Benztropine Mesylate C Prevent Permanent Paroxetin C Impairment/Damage Date:12/26/02ISR Number: 4036929-6Report Type:Periodic Company Report #02-04-0329 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Health Clozapine-Ivax Initial or Prolonged Professional Pharmaceuticals, Inc Other Tablets PS Ivax Pharmaceuticals, Inc ORAL 150-700MG QD ORAL Date:12/26/02ISR Number: 4036930-2Report Type:Periodic Company Report #02-04-0330 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Other Clozapine-Ivax Initial or Prolonged Pharmaceuticals, Inc Tablets PS Ivax Pharmaceuticals, Inc ORAL 150-400MG QD ORAL Date:12/26/02ISR Number: 4036931-4Report Type:Periodic Company Report #02-04-0331 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine-Ivax Initial or Prolonged Professional Pharmaceuticals, Inc Other Tablets PS Ivax Pharmaceuticals, Inc ORAL 125-700MG QD ORAL 22-Feb-2006 08:30 AM Page: 1995 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/26/02ISR Number: 4036932-6Report Type:Periodic Company Report #02-04-0336 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Health Clozapine-Ivax Initial or Prolonged Leukopenia Professional Pharmaceuticals, Inc Required Myalgia Tablets PS Ivax Intervention to Pharyngitis Pharmaceuticals, Inc ORAL 12.5-77MG Prevent Permanent Pyrexia ORAL Impairment/Damage Tremor Seroquel C Vomiting Wellbutrin C Depakote Er C Vistaril C Date:12/26/02ISR Number: 4036933-8Report Type:Periodic Company Report #02-04-0337 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Unevaluable Event Health Clozapine-Ivax Professional Pharmaceuticals, Inc Other Tablets PS Ivax Pharmaceuticals, Inc ORAL ORAL Date:12/26/02ISR Number: 4036940-5Report Type:Periodic Company Report #02-04-0338 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Unevaluable Event Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 300-400MG QD ORAL Date:12/26/02ISR Number: 4036941-7Report Type:Periodic Company Report #02-04-0339 Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Health Clozapine - Ivax Initial or Prolonged Psychotic Disorder Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 125 QD ORAL Lasix C Date:12/26/02ISR Number: 4036942-9Report Type:Periodic Company Report #02-04-0341 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Unevaluable Event Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 750MG QD ORAL Date:12/26/02ISR Number: 4036943-0Report Type:Periodic Company Report #02-04-0342 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 400MG QD ORAL 22-Feb-2006 08:30 AM Page: 1996 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/26/02ISR Number: 4036944-2Report Type:Periodic Company Report #02-04-0343 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 100-400MG QD ORAL Date:12/26/02ISR Number: 4036945-4Report Type:Periodic Company Report #02-04-0344 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 450MG QD ORAL Date:12/26/02ISR Number: 4036946-6Report Type:Periodic Company Report #02-04-0345 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Other Clozapine - Ivax Initial or Prolonged Delusion Pharmaceuticals, Hallucination Inc. Tablets PS ORAL 500-900MG QD Hostility ORAL Paranoia Date:12/26/02ISR Number: 4036948-XReport Type:Periodic Company Report #02-04-0346 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine - Ivax Initial or Prolonged Professional Pharmceuticals, Inc. Other Tablets PS ORAL 250-600MG QD ORAL Thorazine C Date:12/26/02ISR Number: 4036949-1Report Type:Periodic Company Report #02-04-0348 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 400-450MG QD ORAL Date:12/26/02ISR Number: 4036950-8Report Type:Periodic Company Report #02-04-0349 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Health Clozapine - Ivax Initial or Prolonged Drug Ineffective Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 50-400MG QD ORAL 22-Feb-2006 08:30 AM Page: 1997 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/26/02ISR Number: 4036951-XReport Type:Periodic Company Report #02-09-0776 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc ORAL 100-700MG QD ORAL Date:12/26/02ISR Number: 4036952-1Report Type:Periodic Company Report #02-09-0779 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablet PS Ivax Pharmaceuticals, Inc. ORAL 400-900MG QD ORAL Date:12/26/02ISR Number: 4036953-3Report Type:Periodic Company Report #02-09-0784 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 500-700MG QD ORAL Date:12/26/02ISR Number: 4036954-5Report Type:Periodic Company Report #02-09-0788 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine - Ivax Professional Pharmaceuticals , Other Inc PS Ivax Pharmaceuticals, Inc ORAL 300-600MG QD ORAL Date:12/26/02ISR Number: 4036955-7Report Type:Periodic Company Report #02-09-0789 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Unevaluable Event Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc ORAL 500-600MG QD ORAL 22-Feb-2006 08:30 AM Page: 1998 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/26/02ISR Number: 4036956-9Report Type:Periodic Company Report #02-09-0790 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc ORAL 300-950MG QD ORAL Date:12/26/02ISR Number: 4036958-2Report Type:Periodic Company Report #02-09-0804 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 200-400MG QD ORAL Date:12/26/02ISR Number: 4036959-4Report Type:Periodic Company Report #02-09-0805 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc ORAL 400MG BID ORAL Date:12/26/02ISR Number: 4036960-0Report Type:Periodic Company Report #02-09-0806 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc ORAL ORAL Date:12/26/02ISR Number: 4036962-4Report Type:Periodic Company Report #02-09-0807 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Unevaluable Event Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 300-625MG QD ORAL Date:12/26/02ISR Number: 4037023-0Report Type:Periodic Company Report #02-05-0466 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Life-Threatening Leukopenia Health Other Professional 22-Feb-2006 08:30 AM Page: 1999 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Product Role Manufacturer Route Dose Duration Clozapine Tablets - Ivax Pharmaceuticals, Inc. PS ORAL 300-400MG QD ORAL Date:12/26/02ISR Number: 4037025-4Report Type:Periodic Company Report #02-05-0468 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Other Pharmaceuticals, Inc. PS ORAL ORAL Date:12/26/02ISR Number: 4037027-8Report Type:Periodic Company Report #02-05-0469 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Unevaluable Event Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS ORAL ORAL Date:12/26/02ISR Number: 4037028-XReport Type:Periodic Company Report #02-05-0473 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS ORAL 550-600MG QD ORAL Date:12/26/02ISR Number: 4037029-1Report Type:Periodic Company Report #02-05-0476 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Unevaluable Event Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS ORAL 50-75MG QD ORAL Date:12/26/02ISR Number: 4037030-8Report Type:Periodic Company Report #02-05-0477 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Health Clozapine Tablets - Initial or Prolonged Syncope Professional Ivax Other Other Pharmaceuticals, Inc. PS ORAL 500MG HS ORAL 22-Feb-2006 08:30 AM Page: 2000 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/26/02ISR Number: 4037031-XReport Type:Periodic Company Report #02-05-0478 Age:71 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pyrexia Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS ORAL 25-75MG QD ORAL Date:12/26/02ISR Number: 4037032-1Report Type:Periodic Company Report #02-05-0479 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS ORAL 500-700MG QD ORAL Depakote C Date:12/26/02ISR Number: 4037034-5Report Type:Periodic Company Report #02-05-0480 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS ORAL 250MG QD ORAL Date:12/26/02ISR Number: 4037036-9Report Type:Periodic Company Report #02-05-0481 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Lung Disorder Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS ORAL 25-400MG QD ORAL Date:12/26/02ISR Number: 4037038-2Report Type:Periodic Company Report #02-06-0544 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc ORAL 25-700MG QD ORAL Date:12/26/02ISR Number: 4037040-0Report Type:Periodic Company Report #02-06-0550 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Weight Decreased Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax 22-Feb-2006 08:30 AM Page: 2001 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pharmaceuticals, Inc ORAL 400-600MG QD ORAL Date:12/26/02ISR Number: 4037041-2Report Type:Periodic Company Report #02-06-0551 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucination Health Clozapine - Ivax Initial or Prolonged Paranoia Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc ORAL 300-350MG QD ORAL Date:12/26/02ISR Number: 4037042-4Report Type:Periodic Company Report #02-06-0552 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc ORAL 300-400MG ORAL Ativan C Depakote C Date:12/26/02ISR Number: 4037043-6Report Type:Periodic Company Report #02-06-0553 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bronchitis Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc ORAL 300-400MG QD ORAL Date:12/26/02ISR Number: 4037044-8Report Type:Periodic Company Report #02-06-0561 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc ORAL 50-475MG QD ORAL Date:12/26/02ISR Number: 4037046-1Report Type:Periodic Company Report #02-06-0562 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Unevaluable Event Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc ORAL 450MG QD ORAL 22-Feb-2006 08:30 AM Page: 2002 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/26/02ISR Number: 4037047-3Report Type:Periodic Company Report #02-06-0563 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Other Inc. Tablets PS Ivax Pharmaceuticals, Inc ORAL 500MG QD ORAL Date:12/26/02ISR Number: 4037049-7Report Type:Periodic Company Report #02-06-0564 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc ORAL 25-37.5MG QD ORAL Date:12/26/02ISR Number: 4037050-3Report Type:Periodic Company Report #02-06-0565 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc ORAL 400MG QD ORAL Date:12/26/02ISR Number: 4037052-7Report Type:Periodic Company Report #02-06-0582 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Health Clozapine Tablets - Initial or Prolonged Nausea Professional Ivax Vomiting Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc ORAL ORAL Date:12/26/02ISR Number: 4037054-0Report Type:Periodic Company Report #02-06-0583 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Unevaluable Event Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc ORAL 100-350MG ORAL Date:12/26/02ISR Number: 4037055-2Report Type:Periodic Company Report #02-06-0590 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Other Clozapine Tablets - Initial or Prolonged Ivax Pharmaceuticals, Inc. PS Ivax 22-Feb-2006 08:30 AM Page: 2003 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pharmaceuticals, Inc ORAL 400-600MG QD ORAL Date:12/26/02ISR Number: 4037057-6Report Type:Periodic Company Report #02-06-0591 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc ORAL 200-600MG QD ORAL Date:12/26/02ISR Number: 4037058-8Report Type:Periodic Company Report #02-06-0600 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc ORAL 500-700MG QD ORAL Date:12/26/02ISR Number: 4037059-XReport Type:Periodic Company Report #02-07-0589 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc ORAL 125-450MG QD ORAL Date:12/26/02ISR Number: 4037060-6Report Type:Periodic Company Report #02-07-0592 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc ORAL 100-400MG QD ORAL Date:12/26/02ISR Number: 4037061-8Report Type:Periodic Company Report #02-07-0595 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Unevaluable Event Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc ORAL 50-250MG QD ORAL 22-Feb-2006 08:30 AM Page: 2004 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/26/02ISR Number: 4037063-1Report Type:Periodic Company Report #02-07-0597 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc ORAL 500-700MG QD ORAL Date:12/26/02ISR Number: 4037065-5Report Type:Periodic Company Report #02-07-0601 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc ORAL 150MG QD ORAL Date:12/26/02ISR Number: 4037066-7Report Type:Periodic Company Report #02-11-0997 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Unevaluable Event Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 350-500 MG QD ORAL Date:12/26/02ISR Number: 4037068-0Report Type:Periodic Company Report #02-11-0999 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS ORAL 550-600MG QD ORAL Date:12/26/02ISR Number: 4037069-2Report Type:Periodic Company Report #02-11-1000 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 50-300MG QD ORAL 22-Feb-2006 08:30 AM Page: 2005 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/26/02ISR Number: 4037079-5Report Type:Periodic Company Report #02-11-1001 Age:87 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Unevaluable Event Health Clozapine Tablets - Hospitalization - Professional Ivax Initial or Prolonged Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 25-500MG QD ORAL Date:12/26/02ISR Number: 4037080-1Report Type:Periodic Company Report #02-11-1002 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Other Clozapine Tablets - Initial or Prolonged Ivax Pharmaceuticals, Inc. PS ORAL 150-400MG QD ORAL Date:12/26/02ISR Number: 4037082-5Report Type:Periodic Company Report #02-11-1003 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Grand Mal Convulsion Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 200-600MG QD ORAL Date:12/26/02ISR Number: 4037083-7Report Type:Periodic Company Report #02-11-1007 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 75-400MG QD ORAL Date:12/26/02ISR Number: 4037085-0Report Type:Periodic Company Report #02-11-1008 Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS ORAL 75MG TID ORAL Ferrous Sulfate C Tums C Zyperxa C Zantac C 22-Feb-2006 08:30 AM Page: 2006 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Clonidine C Lorazepam C Albuterol Sulfate C Morphine Sulfate C Date:12/26/02ISR Number: 4037086-2Report Type:Periodic Company Report #02-11-1016 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 300-450MG QD ORAL Date:12/26/02ISR Number: 4037088-6Report Type:Periodic Company Report #02-11-1017 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Health Clozapine Tablets - Initial or Prolonged Personality Disorder Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 200MG QD ORAL Date:12/26/02ISR Number: 4037099-0Report Type:Periodic Company Report #02-10-0889 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Other Inc. Tablets PS Ivax Pharaceuticals, Inc. ORAL 50-88MG QD ORAL Date:12/26/02ISR Number: 4037102-8Report Type:Periodic Company Report #02-10-0890 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. PS Ivax Pharmaceuticals, Inc. ORAL 400-500MG QD ORAL Date:12/26/02ISR Number: 4037104-1Report Type:Periodic Company Report #02-10-0898 Age:67 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax 22-Feb-2006 08:30 AM Page: 2007 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pharmaceuticals, Inc. ORAL ORAL Date:12/26/02ISR Number: 4037121-1Report Type:Periodic Company Report #02-10-0899 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 175-300MG QD ORAL Date:12/26/02ISR Number: 4037141-7Report Type:Periodic Company Report #02-10-0900 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 200-800MG QD ORAL Date:12/26/02ISR Number: 4037168-5Report Type:Periodic Company Report #02-10-0901 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 300MG QD ORAL Date:12/26/02ISR Number: 4037196-XReport Type:Periodic Company Report #02-10-0903 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Urinary Incontinence Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 400 - 900MG QD ORAL Date:12/26/02ISR Number: 4037230-7Report Type:Periodic Company Report #02-10-0906 Age:74 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozapine - Ivax Other Professional Pharmaceuticals, Required Other Inc. Tablets PS Ivax Intervention to Pharmaceuticals, Prevent Permanent Inc. ORAL 6.25-37.5MG/D Impairment/Damage ORAL Docusate Sodium C 22-Feb-2006 08:30 AM Page: 2008 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Psyllium Bulk Powder C Sinemet C Macrobid C Seroquel C Date:12/26/02ISR Number: 4037261-7Report Type:Periodic Company Report #02-10-0907 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 450-600MG QD ORAL Date:12/26/02ISR Number: 4037291-5Report Type:Periodic Company Report #02-10-0908 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 900MG QD ORAL Date:12/26/02ISR Number: 4038157-7Report Type:Periodic Company Report #01-12-0721 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 500MG QD ORAL Date:12/26/02ISR Number: 4038161-9Report Type:Periodic Company Report #01-12-0725 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. 300-600MG QD ORAL Date:12/26/02ISR Number: 4038162-0Report Type:Periodic Company Report #01-12-0728 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Unevaluable Event Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 25-750MG QD 22-Feb-2006 08:30 AM Page: 2009 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL Date:12/26/02ISR Number: 4038163-2Report Type:Periodic Company Report #01-12-0733 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 500-950MG QD ORAL Dilantin C Depakote C Prolixin C Date:12/26/02ISR Number: 4038164-4Report Type:Periodic Company Report #01-12-0734 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Infection Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 400-500MG QD ORAL Date:12/26/02ISR Number: 4038165-6Report Type:Periodic Company Report #01-12-0736 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 25-125MG QD ORAL Date:12/26/02ISR Number: 4038166-8Report Type:Periodic Company Report #01-12-0737 Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 400-700MG QD ORAL Date:12/26/02ISR Number: 4038167-XReport Type:Periodic Company Report #01-12-0739 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 150-600MG QD ORAL 22-Feb-2006 08:30 AM Page: 2010 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/26/02ISR Number: 4038168-1Report Type:Periodic Company Report #01-12-0741 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 200-400MG QD ORAL Date:12/26/02ISR Number: 4038169-3Report Type:Periodic Company Report #01-12-0742 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 300MG QD ORAL Date:12/26/02ISR Number: 4038170-XReport Type:Periodic Company Report #01-11-0653 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delusion Health Clozapine - Ivax Initial or Prolonged Hostility Professional Pharmaceuticals, Paranoia Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 150-400MG QD ORAL Date:12/26/02ISR Number: 4038171-1Report Type:Periodic Company Report #01-11-0654 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 900MG QD ORAL Date:12/26/02ISR Number: 4038172-3Report Type:Periodic Company Report #01-11-0655 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Liver Function Test Health Clozapine - Ivax Abnormal Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 25-400MG QD ORAL 22-Feb-2006 08:30 AM Page: 2011 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/26/02ISR Number: 4038173-5Report Type:Periodic Company Report #01-11-0656 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 300-500MG QD ORAL Date:12/26/02ISR Number: 4038174-7Report Type:Periodic Company Report #01-11-0659 Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 50-150MG QD ORAL Date:12/26/02ISR Number: 4038175-9Report Type:Periodic Company Report #01-11-0660 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 600-750MG QD ORAL Date:12/26/02ISR Number: 4038177-2Report Type:Periodic Company Report #01-11-0661 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Dependence Health Clozapine - Ivax Initial or Prolonged Drug Ineffective Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. 25-30MG QD Date:12/26/02ISR Number: 4038178-4Report Type:Periodic Company Report #01-11-0669 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. 425-800MG QD 22-Feb-2006 08:30 AM Page: 2012 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/26/02ISR Number: 4038180-2Report Type:Periodic Company Report #01-11-0679 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 100-300MG QD ORAL Date:12/26/02ISR Number: 4038183-8Report Type:Periodic Company Report #01-12-0664 Age:52 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozapine - Ivax Hospitalization - Pneumonia Professional Pharmaceuticals, Initial or Prolonged Other Inc. Tablets PS Ivax Other Pharmaceuticals, Required Inc. 400MG QHS Intervention to Accupril C Prevent Permanent Remeron C Impairment/Damage Bactrim Ds C Keflex C Levaquin C Effexor Xr C Date:12/26/02ISR Number: 4038186-3Report Type:Periodic Company Report #02-03-0279 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 100-600MG QD ORAL Date:12/26/02ISR Number: 4038192-9Report Type:Periodic Company Report #02-03-0280 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 75-800MG QD ORAL Date:12/26/02ISR Number: 4038193-0Report Type:Periodic Company Report #02-03-0283 Age:41 YR Gender:Male I/FU:I Outcome Life-Threatening Hospitalization - Initial or Prolonged 22-Feb-2006 08:30 AM Page: 2013 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Required Intervention to PT Report Source Product Role Manufacturer Route Dose Duration Prevent Permanent Agranulocytosis Health Clozapine Tablets - Impairment/Damage Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 250MG QD ORAL Klonopin C Topamax C Risperidone C Prozac C Date:12/26/02ISR Number: 4038196-6Report Type:Periodic Company Report #02-03-0287 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Other Pharmaceuticals, Required Inc. PS Ivax Intervention to Pharmaceuticals, Prevent Permanent Inc. ORAL 250MG BID Impairment/Damage ORAL Lorazepam C Date:12/26/02ISR Number: 4038198-XReport Type:Periodic Company Report #02-03-0288 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 300-900MG QD ORAL Date:12/26/02ISR Number: 4038199-1Report Type:Periodic Company Report #02-03-0289 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 800MG QD ORAL Date:12/26/02ISR Number: 4038200-5Report Type:Periodic Company Report #02-03-0291 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, 22-Feb-2006 08:30 AM Page: 2014 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Inc. PS Ivax Pharmaceuticals, Inc. ORAL 150-800MG QD ORAL Date:12/26/02ISR Number: 4038201-7Report Type:Periodic Company Report #02-03-0292 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Carditis Health Clozapine Tablets - Initial or Prolonged Hypotension Professional Ivax Other Sepsis Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 100-400MG QD ORAL Remeron C Zocor C Phenergan C Prilosec C Potassium C Prozac C Oxaprozin C Glucophage C Insulin Humulin-N C Benadryl C Ambien C Lasix C Date:12/26/02ISR Number: 4038203-0Report Type:Periodic Company Report #02-03-0293 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozapine Tablets - Other Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 50MG HS ORAL Sinemet C Celexa C Clonazepam C Date:12/26/02ISR Number: 4038205-4Report Type:Periodic Company Report #02-03-0294 Age:67 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine Tablets - Initial or Prolonged Tremor Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 100-300M QD ORAL 22-Feb-2006 08:30 AM Page: 2015 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/26/02ISR Number: 4038215-7Report Type:Periodic Company Report #02-05-0482 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 75-250 QD ORAL Date:12/26/02ISR Number: 4038216-9Report Type:Periodic Company Report #02-05-0484 Age:88 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Unevaluable Event Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 12.5 MG QD ORAL Date:12/26/02ISR Number: 4038218-2Report Type:Periodic Company Report #02-05-0488 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Unevaluable Event Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 100-600 MG QD ORAL Date:12/26/02ISR Number: 4038220-0Report Type:Periodic Company Report #02-05-0493 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 400-450 MG QD ORAL Date:12/26/02ISR Number: 4038222-4Report Type:Periodic Company Report #02-05-0502 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 25-75MG QD ORAL 22-Feb-2006 08:30 AM Page: 2016 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/26/02ISR Number: 4038223-6Report Type:Periodic Company Report #02-05-0521 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Other Clozapine - Ivax Initial or Prolonged Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 25-150 MG QD ORAL Lithium Unknown SS Date:12/26/02ISR Number: 4038225-XReport Type:Periodic Company Report #02-06-0492 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intestinal Obstruction Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 12.5 - 650MG QD ORAL Date:12/26/02ISR Number: 4038227-3Report Type:Periodic Company Report #02-06-0494 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Unevaluable Event Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 400-500 MG QD ORAL Date:12/26/02ISR Number: 4038229-7Report Type:Periodic Company Report #02-06-0495 Age:66 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delirium Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 100 -150MG ORAL Date:12/26/02ISR Number: 4038231-5Report Type:Periodic Company Report #02-06-0496 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL ORAL 22-Feb-2006 08:30 AM Page: 2017 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/26/02ISR Number: 4038232-7Report Type:Periodic Company Report #01-11-0641 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Health Clozapine Tablets PS Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Date:12/26/02ISR Number: 4038233-9Report Type:Periodic Company Report #01-11-0644 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Health Clozapine Tablets PS Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. ORAL 250-800MG QD ORAL Date:12/26/02ISR Number: 4038234-0Report Type:Periodic Company Report #01-11-0645 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine Tablets PS Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. ORAL 250-300MG QD ORAL Date:12/26/02ISR Number: 4038237-6Report Type:Periodic Company Report #01-11-0646 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Health Clozapine Tablets PS Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. ORAL 25MG QD ORAL Date:12/26/02ISR Number: 4038239-XReport Type:Periodic Company Report #01-11-0647 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiovascular Disorder Health Clozapine Tablets PS Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. ORAL 300-500MG QD ORAL Date:12/26/02ISR Number: 4038243-1Report Type:Periodic Company Report #01-11-0648 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intestinal Obstruction Health Clozapine Tablets PS Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. ORAL 25-100MG QD ORAL 22-Feb-2006 08:30 AM Page: 2018 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/26/02ISR Number: 4038244-3Report Type:Periodic Company Report #01-11-0649 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Health Clozapine Tablets PS Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. ORAL 500-700MG QD ORAL Date:12/26/02ISR Number: 4038247-9Report Type:Periodic Company Report #01-11-0650 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Health Clozapine Tablets PS Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. ORAL 25-300MG QD ORAL Date:12/26/02ISR Number: 4038249-2Report Type:Periodic Company Report #01-11-0651 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Health Clozapine Tablets PS Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. ORAL 400-800MG QD ORAL Date:12/26/02ISR Number: 4038252-2Report Type:Periodic Company Report #01-11-0652 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Unevaluable Event Health Clozapine Tablets PS Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. ORAL 425-600MG QD ORAL Date:12/26/02ISR Number: 4038256-XReport Type:Periodic Company Report #02-02-0175 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL ORAL Date:12/26/02ISR Number: 4038258-3Report Type:Periodic Company Report #02-02-0179 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 400MG QD ORAL 22-Feb-2006 08:30 AM Page: 2019 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/26/02ISR Number: 4038262-5Report Type:Periodic Company Report #02-02-0184 Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancreatitis Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 12.5-300MG QD ORAL Date:12/26/02ISR Number: 4038265-0Report Type:Periodic Company Report #02-02-0185 Age:71 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dizziness Health Clozapine Tablets - Initial or Prolonged Hallucination Professional Ivax Hypotension Other Pharmaceuticals, Neuroleptic Malignant Inc. PS Ivax Syndrome Pharmaceuticals, Inc. ORAL 12.5MG QAM ORAL Requip C Date:12/26/02ISR Number: 4038267-4Report Type:Periodic Company Report #02-02-0186 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Health Clozapine Tablets - Initial or Prolonged Congestive Professional Ivax Personality Disorder Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 100-600MG QD ORAL Date:12/26/02ISR Number: 4038271-6Report Type:Periodic Company Report #02-02-0187 Age:88 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Unevaluable Event Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 400MG QD ORAL Date:12/26/02ISR Number: 4038272-8Report Type:Periodic Company Report #02-02-0188 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drooling Health Clozapine Tablets - Initial or Prolonged Drug Level Increased Professional Ivax Hypotension Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, 22-Feb-2006 08:30 AM Page: 2020 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Inc. ORAL 350MG QD ORAL Topamax C Antacid Liquid Plus Simethicone C Risperdal C Trihexyphenidyl C Date:12/26/02ISR Number: 4038274-1Report Type:Periodic Company Report #02-02-0191 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 300MG QD ORAL Date:12/26/02ISR Number: 4038276-5Report Type:Periodic Company Report #02-02-0195 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets - Hospitalization - Pneumonia Professional Ivax Initial or Prolonged Somnolence Other Pharmaceuticals, Other Inc. PS Ivax Pharmaceuticals, Inc. ORAL 25MG ORAL Glucophage C Zoloft C Avandia C Date:12/26/02ISR Number: 4038278-9Report Type:Periodic Company Report #02-02-0196 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 75-225MG QD ORAL Date:12/26/02ISR Number: 4038295-9Report Type:Periodic Company Report #02-02-0200 Age:86 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 75MG QD ORAL 22-Feb-2006 08:30 AM Page: 2021 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/26/02ISR Number: 4038298-4Report Type:Periodic Company Report #02-02-0201 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozapine - Ivax Other Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 625MG QD ORAL Xanax C Cogentin C Risperdal C Date:12/26/02ISR Number: 4038301-1Report Type:Periodic Company Report #02-02-0202 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 37.5-100MG QD ORAL Date:12/26/02ISR Number: 4038303-5Report Type:Periodic Company Report #02-02-0204 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL ORAL Date:12/26/02ISR Number: 4038306-0Report Type:Periodic Company Report #02-02-0205 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 300MG QD ORAL Date:12/26/02ISR Number: 4038308-4Report Type:Periodic Company Report #02-02-0206 Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 50-300 QD ORAL 22-Feb-2006 08:30 AM Page: 2022 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/26/02ISR Number: 4038311-4Report Type:Periodic Company Report #02-02-0207 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Oedema Health Clozapine - Ivax Initial or Prolonged Pyrexia Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 50MG BID ORAL Seroquel C Eskalith C Neurontin C Zantac C Date:12/26/02ISR Number: 4038314-XReport Type:Periodic Company Report #02-02-0208 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 500-900MG QD ORAL Date:12/26/02ISR Number: 4038318-7Report Type:Periodic Company Report #02-02-0210 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 400-1200MG QD ORAL Date:12/26/02ISR Number: 4038319-9Report Type:Periodic Company Report #02-02-0217 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 250MG QD ORAL Date:12/26/02ISR Number: 4038324-2Report Type:Periodic Company Report #01-12-0743 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Health Clozapine PS Ivax Initial or Prolonged Professional Pharmacetuticals, Other Inc. ORAL 25MG QD ORAL 22-Feb-2006 08:30 AM Page: 2023 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/26/02ISR Number: 4038326-6Report Type:Periodic Company Report #01-12-0745 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Health Clozapine PS Ivax Initial or Prolonged Professional Pharmacetuticals, Other Other Inc. ORAL ORAL Date:12/26/02ISR Number: 4038327-8Report Type:Periodic Company Report #01-12-0746 Age:67 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intestinal Obstruction Health Clozapine PS Ivax Initial or Prolonged Pneumonia Professional Pharmacetuticals, Other Other Inc. ORAL 75-300MG QD ORAL Date:12/26/02ISR Number: 4038328-XReport Type:Periodic Company Report #01-12-0747 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Health Clozapine PS Ivax Initial or Prolonged Professional Pharmacetuticals, Other Other Inc. ORAL ORAL Date:12/26/02ISR Number: 4038331-XReport Type:Periodic Company Report #01-12-0748 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine PS Ivax Initial or Prolonged Professional Pharmacetuticals, Other Inc. ORAL 250-400MG QD ORAL Date:12/26/02ISR Number: 4038333-3Report Type:Periodic Company Report #01-12-0749 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Health Clozapine PS Ivax Required Professional Pharmacetuticals, Intervention to Other Inc. ORAL SEE IMAGE Prevent Permanent Adderall C Impairment/Damage Fluoxetine C Clonazepam C Date:12/26/02ISR Number: 4038335-7Report Type:Periodic Company Report #01-12-0750 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucination, Auditory Health Clozapine PS Ivax Initial or Prolonged Professional Pharmacetuticals, Other Inc. ORAL 350-500MG QD ORAL 22-Feb-2006 08:30 AM Page: 2024 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/26/02ISR Number: 4038336-9Report Type:Periodic Company Report #01-12-0751 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Clozapine PS Ivax Initial or Prolonged Professional Pharmacetuticals, Required Other Inc. ORAL SEE IMAGE Intervention to Cogentin C Prevent Permanent Depakote C Impairment/Damage Seroquel C Date:12/26/02ISR Number: 4038339-4Report Type:Periodic Company Report #01-12-0752 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Paranoia Health Clozapine PS Ivax Initial or Prolonged Professional Pharmacetuticals, Other Inc. ORAL 250-475NG QD ORAL Date:12/26/02ISR Number: 4038341-2Report Type:Periodic Company Report #01-12-0753 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hostility Health Clozapine PS Ivax Initial or Prolonged Paranoia Professional Pharmacetuticals, Psychotic Disorder Other Inc. ORAL 400MG QD ORAL Date:12/26/02ISR Number: 4038350-3Report Type:Periodic Company Report #02-09-0837 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 100-600MG QD ORAL Date:12/26/02ISR Number: 4038352-7Report Type:Periodic Company Report #02-09-0842 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 500-600MG QD ORAL Date:12/26/02ISR Number: 4038354-0Report Type:Periodic Company Report #02-09-0847 Age:39 YR Gender:Male I/FU:I Outcome Required Intervention to Prevent Permanent 22-Feb-2006 08:30 AM Page: 2025 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Eosinophilia Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 190-300MG QD ORAL Buspar C Depakote C Zyprexa C Cogentin C Date:12/26/02ISR Number: 4038356-4Report Type:Periodic Company Report #02-09-0848 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 225 MG QD ORAL Date:12/26/02ISR Number: 4038357-6Report Type:Periodic Company Report #02-09-0852 Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 50-400NG QD ORAL Date:12/26/02ISR Number: 4038359-XReport Type:Periodic Company Report #02-09-0857 Age:85 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Unevaluable Event Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 12.5 MG QD ORAL Date:12/26/02ISR Number: 4038360-6Report Type:Periodic Company Report #02-09-0858 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Unevaluable Event Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 300-800MG QD ORAL 22-Feb-2006 08:30 AM Page: 2026 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/26/02ISR Number: 4038362-XReport Type:Periodic Company Report #02-09-0861 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Other Clozapine - Ivax Initial or Prolonged Phosphokinase Increased Pharmaceuticals, Other Jaundice Cholestatic Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 100MG QAM ORAL Protonix SS 40MG QD Date:12/26/02ISR Number: 4038364-3Report Type:Periodic Company Report #02-09-0863 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Unevaluable Event Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 75-300MG QD ORAL Date:12/26/02ISR Number: 4038365-5Report Type:Periodic Company Report #02-09-0865 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 200MG BID ORAL Date:12/26/02ISR Number: 4038427-2Report Type:Periodic Company Report #02-09-0868 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL ORAL Date:12/26/02ISR Number: 4038433-8Report Type:Periodic Company Report #02-09-0869 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL ORAL 22-Feb-2006 08:30 AM Page: 2027 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/26/02ISR Number: 4038437-5Report Type:Periodic Company Report #02-09-0870 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delusion Health Clozapine - Ivax Initial or Prolonged Hallucination Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 400 MG QD ORAL Date:12/26/02ISR Number: 4038439-9Report Type:Periodic Company Report #02-09-0871 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucination Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL ORAL Date:12/26/02ISR Number: 4038441-7Report Type:Periodic Company Report #02-09-0893 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiovascular Disorder Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 350-550MG QD ORAL Date:12/26/02ISR Number: 4038443-0Report Type:Periodic Company Report #02-10-0884 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucination Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 100-600MG QD ORAL Date:12/26/02ISR Number: 4038445-4Report Type:Periodic Company Report #02-10-0885 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 50-300MG QD ORAL 22-Feb-2006 08:30 AM Page: 2028 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/26/02ISR Number: 4038447-8Report Type:Periodic Company Report #02-10-0886 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bipolar I Disorder Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 12.5-650MG QD ORAL Date:12/26/02ISR Number: 4038468-5Report Type:Periodic Company Report #02-10-0887 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 150-600MG QD ORAL Date:12/26/02ISR Number: 4038470-3Report Type:Periodic Company Report #02-10-0888 Age:78 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Unevaluable Event Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL ORAL Date:12/26/02ISR Number: 4038473-9Report Type:Periodic Company Report #02-09-0812 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 300-600MG QD ORAL Date:12/26/02ISR Number: 4038474-0Report Type:Periodic Company Report #02-09-0815 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 100-450MG QD ORAL 22-Feb-2006 08:30 AM Page: 2029 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/26/02ISR Number: 4038475-2Report Type:Periodic Company Report #02-09-0816 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Health Clozapine Tablets - Initial or Prolonged Personality Disorder Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 75-400MG QD ORAL Date:12/26/02ISR Number: 4038478-8Report Type:Periodic Company Report #02-09-0820 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthma Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 100MG QD ORAL Date:12/26/02ISR Number: 4038480-6Report Type:Periodic Company Report #02-09-0822 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Health Clozapine Tablets - Initial or Prolonged Pneumonia Professional Ivax Other Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL SEE IMAGE Xanax C Zyprexa C Date:12/26/02ISR Number: 4038482-XReport Type:Periodic Company Report #02-09-0824 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 625-650MG QD ORAL Date:12/26/02ISR Number: 4038483-1Report Type:Periodic Company Report #02-09-0825 Age:69 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 150MG BID 22-Feb-2006 08:30 AM Page: 2030 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL Dilantin SS SEE IMAGE Zoloft C Lithium Carbonate C Vitamin E C Prednisone C Ranitidine C Date:12/26/02ISR Number: 4038485-5Report Type:Periodic Company Report #02-09-0827 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 100-500MG QD ORAL Date:12/26/02ISR Number: 4038486-7Report Type:Periodic Company Report #02-09-0828 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL ORAL Date:12/26/02ISR Number: 4038488-0Report Type:Periodic Company Report #02-09-0832 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 25MG QD ORAL Date:12/26/02ISR Number: 4038849-XReport Type:Periodic Company Report #02-01-0067 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Health Clozapine Tablets PS Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. ORAL 50-600MG QD ORAL Date:12/26/02ISR Number: 4038851-8Report Type:Periodic Company Report #02-01-0068 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Hospitalization - Depression Health Initial or Prolonged Professional 22-Feb-2006 08:30 AM Page: 2031 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Product Role Manufacturer Route Dose Duration Clozapine Tablets PS Ivax Pharmaceuticals, Inc ORAL 200MG QD ORAL Date:12/26/02ISR Number: 4038853-1Report Type:Periodic Company Report #02-01-0069 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc ORAL 275-500MG QD ORAL Date:12/26/02ISR Number: 4038854-3Report Type:Periodic Company Report #02-01-0070 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc ORAL 400-600MG QD ORAL Chemotherapy SS Date:12/26/02ISR Number: 4038855-5Report Type:Periodic Company Report #02-01-0071 Age:93 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Unevaluable Event Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc ORAL 175MG QD ORAL Date:12/26/02ISR Number: 4038856-7Report Type:Periodic Company Report #02-01-0072 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Health Clozapine Tablets PS Ivax Initial or Prolonged Professional Pharmaceuticals, Inc ORAL 600-800MG QD Other ORAL Date:12/26/02ISR Number: 4038857-9Report Type:Periodic Company Report #02-01-0073 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Other Inc. Tablets PS Ivax Pharmaceuticals, Inc ORAL 75-350MG QD ORAL 22-Feb-2006 08:30 AM Page: 2032 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/26/02ISR Number: 4038858-0Report Type:Periodic Company Report #02-01-0075 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Unevaluable Event Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals Inc ORAL 12.5-400MG QD ORAL Date:12/26/02ISR Number: 4038859-2Report Type:Periodic Company Report #02-01-0077 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Deep Vein Thrombosis Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc ORAL 150MG QD ORAL Date:12/26/02ISR Number: 4038860-9Report Type:Periodic Company Report #02-01-0078 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine -Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc ORAL 400-525MG QD ORAL Date:12/26/02ISR Number: 4038861-0Report Type:Periodic Company Report #02-02-0160 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 600MG QHS ORAL Topamax C Trilafon C Glucophage C Gemfibrozil C Theophylline - Slow Release C Colace C Xenical C Multivitamins C Kemadrin C Bisacodyl C Zestril C Prevacid C Serevent C 22-Feb-2006 08:30 AM Page: 2033 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/26/02ISR Number: 4038862-2Report Type:Periodic Company Report #02-02-0162 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pulmonary Embolism Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 350MG QD ORAL Date:12/26/02ISR Number: 4038863-4Report Type:Periodic Company Report #02-02-0164 Age:77 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL ORAL Date:12/26/02ISR Number: 4038864-6Report Type:Periodic Company Report #02-02-0165 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 300-500MG QD ORAL Date:12/26/02ISR Number: 4038865-8Report Type:Periodic Company Report #02-02-0166 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 400-900MG QD ORAL Date:12/26/02ISR Number: 4038866-XReport Type:Periodic Company Report #02-02-0168 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hostility Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 100-800MG QD ORAL 22-Feb-2006 08:30 AM Page: 2034 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/26/02ISR Number: 4038867-1Report Type:Periodic Company Report #02-02-0169 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiovascular Disorder Health Clozapine Tablets - Initial or Prolonged Wheezing Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 200MG QD ORAL Date:12/26/02ISR Number: 4038868-3Report Type:Periodic Company Report #02-02-0170 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozapine Tablets - Other Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 200MG BID ORAL Date:12/26/02ISR Number: 4038869-5Report Type:Periodic Company Report #02-02-0171 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 600MG QD ORAL Date:12/26/02ISR Number: 4038871-3Report Type:Periodic Company Report #02-02-0172 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hostility Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 150-500MG QD ORAL Date:12/26/02ISR Number: 4038872-5Report Type:Periodic Company Report #02-02-0140 Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Failure To Thrive Health Clozapine-Ivax Unevaluable Event Professional Pharmaceuticals, Inc Other Tablets PS Ivax Pharmaceuticals, Inc ORAL 25MG QD ORAL 22-Feb-2006 08:30 AM Page: 2035 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/26/02ISR Number: 4038873-7Report Type:Periodic Company Report #02-02-0141 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine-Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 500-400MG QD ORAL Date:12/26/02ISR Number: 4038875-0Report Type:Periodic Company Report #02-02-0144 Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Unevaluable Event Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc ORAL 50GM QD ORAL Date:12/26/02ISR Number: 4038876-2Report Type:Periodic Company Report #02-02-0145 Age:71 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Health Clozapine-Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc ORAL 300MG QD ORAL Date:12/26/02ISR Number: 4038878-6Report Type:Periodic Company Report #02-02-0146 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Health Clozapine-Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc ORAL 75MH QHS ORAL Interferon Injectable SS SUBCUTANEOUS 80MCG SQ. QWK Ribavirin C Effexor C Zoloft C Haldol C Risperidone C Olanzapine C Date:12/26/02ISR Number: 4038880-4Report Type:Periodic Company Report #02-02-0151 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Health Clozapine-Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 50-375MG QD ORAL 22-Feb-2006 08:30 AM Page: 2036 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/26/02ISR Number: 4038881-6Report Type:Periodic Company Report #02-02-0152 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucination Health Clozapine-Ivax Initial or Prolonged Hyperhidrosis Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 25-250MG QD ORAL Date:12/26/02ISR Number: 4038883-XReport Type:Periodic Company Report #02-02-0156 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Unevaluable Event Health Clozapine-Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 100MG AM ORAL Date:12/26/02ISR Number: 4038884-1Report Type:Periodic Company Report #02-02-0157 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine-Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 50MG QD ORAL Date:12/26/02ISR Number: 4038886-5Report Type:Periodic Company Report #02-02-0159 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Health Clozapine-Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc ORAL 475MG QD ORAL Geodon C Date:12/26/02ISR Number: 4038888-9Report Type:Periodic Company Report #02-02-0123 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Unevaluable Event Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 75-400MG QD ORAL Date:12/26/02ISR Number: 4038889-0Report Type:Periodic Company Report #02-02-0124 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 400-500MG QD 22-Feb-2006 08:30 AM Page: 2037 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL Date:12/26/02ISR Number: 4038890-7Report Type:Periodic Company Report #02-02-0125 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 300-325MG QD ORAL Date:12/26/02ISR Number: 4038892-0Report Type:Periodic Company Report #02-02-0126 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neurosis Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 250-450MG QD ORAL Date:12/26/02ISR Number: 4038893-2Report Type:Periodic Company Report #02-02-0127 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Gastritis Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 300-700MG QD ORAL Date:12/26/02ISR Number: 4038894-4Report Type:Periodic Company Report #02-02-0129 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 500MG HS ORAL Seroquel C Zoloft C Date:12/26/02ISR Number: 4038895-6Report Type:Periodic Company Report #02-02-0131 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Other Inc. Tablets PS ORAL 150MG QD ORAL Date:12/26/02ISR Number: 4038896-8Report Type:Periodic Company Report #02-02-0133 Age:44 YR Gender:Female I/FU:I Outcome Hospitalization - Initial or Prolonged Required Intervention to Prevent Permanent 22-Feb-2006 08:30 AM Page: 2038 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 300MG HS ORAL Date:12/26/02ISR Number: 4038897-XReport Type:Periodic Company Report #02-02-0136 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS ORAL SEE IMAGE Haldol C Neurontin C Cogentin C Ranitidine C Date:12/26/02ISR Number: 4038898-1Report Type:Periodic Company Report #02-02-0138 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 600MG QD ORAL Date:12/26/02ISR Number: 4038899-3Report Type:Periodic Company Report #02-01-0054 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL ORAL Date:12/26/02ISR Number: 4038900-7Report Type:Periodic Company Report #02-01-0055 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 400-500MG QD ORAL Date:12/26/02ISR Number: 4038901-9Report Type:Periodic Company Report #02-01-0056 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucination Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, 22-Feb-2006 08:30 AM Page: 2039 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Inc. ORAL 150 MG QD ORAL Date:12/26/02ISR Number: 4038902-0Report Type:Periodic Company Report #02-01-0057 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Health Clozapine - Ivax Initial or Prolonged Gastritis Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 600-900MG QD ORAL Date:12/26/02ISR Number: 4038903-2Report Type:Periodic Company Report #02-01-0061 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 400MG QAM ORAL; 500MG QHS ORAL Ibuprofen C Acetaminophen C Seroquel C Propanolol C Date:12/26/02ISR Number: 4038909-3Report Type:Periodic Company Report #02-01-0062 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 250-450MG QD ORAL Wellbutrin - Slow Release C Prempro C Seroquel C Depakote Ec C Oxybutynin Hydrochloride C Levoxyl C Date:12/26/02ISR Number: 4038911-1Report Type:Periodic Company Report #02-01-0063 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 200-600MG QD 22-Feb-2006 08:30 AM Page: 2040 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL Date:12/26/02ISR Number: 4038913-5Report Type:Periodic Company Report #02-01-0064 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 600MG QD ORAL Date:12/26/02ISR Number: 4038915-9Report Type:Periodic Company Report #02-01-0065 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 75-400MG QD ORAL Date:12/26/02ISR Number: 4038918-4Report Type:Periodic Company Report #02-01-0066 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 400MG QD ORAL Date:12/26/02ISR Number: 4038919-6Report Type:Periodic Company Report #02-01-0099 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc ORAL 450-550MG QD ORAL Date:12/26/02ISR Number: 4038920-2Report Type:Periodic Company Report #02-01-0100 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delusion Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 100-150MG QD ORAL 22-Feb-2006 08:30 AM Page: 2041 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/26/02ISR Number: 4038921-4Report Type:Periodic Company Report #02-01-0112 Age:67 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Unevaluable Event Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Inc Other Tablets PS Ivax Pharmaceuticals, Inc. ORAL 200MG QD ORAL Date:12/26/02ISR Number: 4038922-6Report Type:Periodic Company Report #02-01-0113 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyspepsia Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 300MG QD ORAL Date:12/26/02ISR Number: 4038924-XReport Type:Periodic Company Report #02-02-0114 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Myocardial Infarction Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc ORAL 100-500 MG QD ORAL Date:12/26/02ISR Number: 4038926-3Report Type:Periodic Company Report #02-02-0117 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 200-500MG QD ORAL Date:12/26/02ISR Number: 4038927-5Report Type:Periodic Company Report #02-02-0119 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 50-575MG QD ORAL 22-Feb-2006 08:30 AM Page: 2042 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/26/02ISR Number: 4038930-5Report Type:Periodic Company Report #02-02-0120 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 700MG QD ORAL Date:12/26/02ISR Number: 4038932-9Report Type:Periodic Company Report #02-02-0121 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 75-400MG QD ORAL Date:12/26/02ISR Number: 4038934-2Report Type:Periodic Company Report #02-02-0122 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 200-600MG QD ORAL Date:12/26/02ISR Number: 4038936-6Report Type:Periodic Company Report #02-01-0079 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 100MG QAM ORAL Vasotec C Premarin C Calcium Carbonate C Lipitor C Ventolin C Tylenol C Synthroid C Colace C Zoloft C Depakote C Cogentin C Date:12/26/02ISR Number: 4038938-XReport Type:Periodic Company Report #02-01-0081 Age:86 YR Gender:Male I/FU:I Outcome PT Report Source Death Unevaluable Event Health Professional 22-Feb-2006 08:30 AM Page: 2043 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Product Role Manufacturer Route Dose Duration Clozapine - Tablets Ivax Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL ORAL Date:12/26/02ISR Number: 4038940-8Report Type:Periodic Company Report #02-01-0083 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 500MG QD ORAL Date:12/26/02ISR Number: 4038942-1Report Type:Periodic Company Report #02-01-0084 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Health Clozapine Tablets - Initial or Prolonged Professional Ivax Pharmaceutical, Other Inc. PS Ivax Pharmaceuticals, Inc. ORAL 900 MG ORAL Date:12/26/02ISR Number: 4038943-3Report Type:Periodic Company Report #02-01-0087 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 250MG QD ORAL Date:12/26/02ISR Number: 4038944-5Report Type:Periodic Company Report #02-01-0088 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 900MG QD ORAL 22-Feb-2006 08:30 AM Page: 2044 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/26/02ISR Number: 4038945-7Report Type:Periodic Company Report #02-01-0089 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 200MG QD ORAL Date:12/26/02ISR Number: 4038947-0Report Type:Periodic Company Report #02-01-0091 Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Unevaluable Event Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 160MG QD ORAL Date:12/26/02ISR Number: 4038949-4Report Type:Periodic Company Report #02-01-0096 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 600MG QD ORAL Depakote C Clomipramine C Klonopin C Date:12/26/02ISR Number: 4038951-2Report Type:Periodic Company Report #02-01-0097 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Influenza Like Illness Health Clozapine Tablets - Initial or Prolonged Respiratory Disorder Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 50-150MG QD ORAL Date:12/26/02ISR Number: 4038954-8Report Type:Periodic Company Report #02-03-0255 Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Laboratory Test Abnormal Health Clozapine Tablets - Initial or Prolonged Respiratory Disorder Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 25-175 MG QD 22-Feb-2006 08:30 AM Page: 2045 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL Date:12/26/02ISR Number: 4038957-3Report Type:Periodic Company Report #02-03-0257 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucination Health Clozapine Tablets - Initial or Prolonged Personality Disorder Professional Ivax Psychotic Disorder Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 400 MG QD ORAL Date:12/26/02ISR Number: 4038959-7Report Type:Periodic Company Report #02-03-0259 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Infection Health Clozapine Tablets - Initial or Prolonged Leukocytosis Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 600 MG QD ORAL Date:12/26/02ISR Number: 4038961-5Report Type:Periodic Company Report #02-03-0264 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 500 MG HS ORAL Trileptal C Colace C Metamucil C Seroquel C Benadryl C Lithobid C Date:12/26/02ISR Number: 4038963-9Report Type:Periodic Company Report #02-03-0265 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 400 MG QD ORAL 22-Feb-2006 08:30 AM Page: 2046 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/26/02ISR Number: 4038964-0Report Type:Periodic Company Report #02-03-0269 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozapine Tablets - Required Professional Ivax Intervention to Other Pharmaceuticals, Prevent Permanent Inc. PS Ivax Impairment/Damage Pharmaceuticals, Inc. ORAL 900 MG QD ORAL Trileptal C Thorazine C Seroquel C Depakote C Chlorpromazine C Date:12/26/02ISR Number: 4038965-2Report Type:Periodic Company Report #02-03-0271 Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Unevaluable Event Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 12.5-56.2 MG QD ORAL Date:12/26/02ISR Number: 4038967-6Report Type:Periodic Company Report #02-03-0274 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Health Clozapine PS Ivax Pharmacuticals, Thrombocytopenia Professional Inc. ORAL 150 MG QD Other ORAL Carboplatin SS INTRAVENOUS 480 MG INTRAVENOUS Vp-16 SS INTRAVENOUS 120 MG INTRAVENOUS Date:12/26/02ISR Number: 4038968-8Report Type:Periodic Company Report #02-03-0275 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets - Hospitalization - Pneumonia Professional Ivax Initial or Prolonged Other Pharmaceuticals, Other Inc. PS Ivax Pharmaceuticals, Inc. ORAL 250-450MG QD ORAL 22-Feb-2006 08:30 AM Page: 2047 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/26/02ISR Number: 4038970-6Report Type:Periodic Company Report #02-03-0276 Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 550 MG QD ORAL Date:12/26/02ISR Number: 4039013-0Report Type:Periodic Company Report #02-03-0237 Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Health Clozapine Tablets - Initial or Prolonged Hallucination Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 50-150MG QD ORAL Date:12/26/02ISR Number: 4039014-2Report Type:Periodic Company Report #02-03-0239 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Faecaloma Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 350-600MG QD ORAL Date:12/26/02ISR Number: 4039015-4Report Type:Periodic Company Report #02-03-0240 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Vomiting Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 300-650MG QD ORAL Date:12/26/02ISR Number: 4039016-6Report Type:Periodic Company Report #02-03-0241 Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 500MG QD ORAL 22-Feb-2006 08:30 AM Page: 2048 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/26/02ISR Number: 4039018-XReport Type:Periodic Company Report #02-03-0247 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 350-500MG QD ORAL Date:12/26/02ISR Number: 4039019-1Report Type:Periodic Company Report #02-03-0248 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS ORAL 550-700MG QD ORAL Date:12/26/02ISR Number: 4039020-8Report Type:Periodic Company Report #02-03-0249 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 50-475MG QD ORAL Date:12/26/02ISR Number: 4039021-XReport Type:Periodic Company Report #02-03-0250 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Health Clozapine Tablets - Initial or Prolonged Pneumonia Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL ORAL Neurontin C Seroquel C Depakote C Celexa C Propanolol C Date:12/26/02ISR Number: 4039022-1Report Type:Periodic Company Report #02-03-0251 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax 22-Feb-2006 08:30 AM Page: 2049 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pharmaceuticals, Inc. ORAL 350-600MG QD ORAL Date:12/26/02ISR Number: 4039023-3Report Type:Periodic Company Report #02-03-0252 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 150-250MG QD ORAL Date:12/26/02ISR Number: 4039024-5Report Type:Periodic Company Report #02-02-0220 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine Tablets PS Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. ORAL 25-400MG QD ORAL Date:12/26/02ISR Number: 4039025-7Report Type:Periodic Company Report #02-02-0221 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Health Clozapine PS Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. ORAL 300-800MG QD ORAL Date:12/26/02ISR Number: 4039026-9Report Type:Periodic Company Report #02-03-0211 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiovascular Disorder Health Clozapine PS Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. ORAL 400MG QD ORAL Date:12/26/02ISR Number: 4039027-0Report Type:Periodic Company Report #02-03-0212 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine PS Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. ORAL 100MG BID ORAL 22-Feb-2006 08:30 AM Page: 2050 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/26/02ISR Number: 4039028-2Report Type:Periodic Company Report #02-03-0213 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Disorder Health Clozapine PS Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. ORAL 400-450 MG QD ORAL Date:12/26/02ISR Number: 4039029-4Report Type:Periodic Company Report #02-03-0214 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucination Health Clozapine PS Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. ORAL 650MG QD ORAL Date:12/26/02ISR Number: 4039030-0Report Type:Periodic Company Report #02-03-0215 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypotension Health Clozapine PS Ivax Initial or Prolonged Personality Disorder Professional Pharmaceuticals, Other Inc. ORAL 250 MG QD ORAL Lopressor C Cogentin C Depakote C Risperdal C Isosorbide C Diovan C Trazodone C Claritin C Metoprolol C Date:12/26/02ISR Number: 4039031-2Report Type:Periodic Company Report #02-03-0222 Age:74 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Unevaluable Event Health Clozapine. PS Ivax Professional Pharmaceuticals, Other Inc. ORAL 62.5 MG QD ORAL Date:12/26/02ISR Number: 4039032-4Report Type:Periodic Company Report #02-03-0223 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Health Clozapine PS Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. ORAL 150-475 MG QD ORAL 22-Feb-2006 08:30 AM Page: 2051 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/26/02ISR Number: 4039035-XReport Type:Periodic Company Report #02-03-0228 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Infection Health Clozapine PS Ivax Leukopenia Professional Pharmaceuticals, Pyrexia Inc. ORAL 50MG QD ORAL Syncope Accupril C Depakote C Avandia C Glucophage C Tetracycline C Cogentin C Aspirin C Date:12/27/02ISR Number: 4034602-1Report Type:Expedited (15-DaCompany Report #PHBS2002CH15250 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Foreign Clozapine PS ORAL 100 MG, QD, Initial or Prolonged Hypertension Literature ORAL Hyporeflexia Health Fluoxetine Immobile Professional (Fluoxetine) SS Loss Of Consciousness Other Myopathy Renal Impairment Rhabdomyolysis Tachycardia Troponin I Increased Date:12/27/02ISR Number: 4034646-XReport Type:Expedited (15-DaCompany Report #PHRM2002FR02252 Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Back Pain Foreign Leponex (Clozapine) Blood Creatine Health Tablet PS ORAL 400 MG DAILY, Phosphokinase Increased Professional ORAL Blood Creatinine Other Increased Muscle Spasms Myalgia Pain In Extremity Date:12/27/02ISR Number: 4034879-2Report Type:Expedited (15-DaCompany Report #PHEH2002US10391 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Injury Asphyxiation Health Clozaril Leukocytosis Professional (Clozapine) PS ORAL 75 MG, QD, Weight Increased ORAL Date:12/27/02ISR Number: 4035609-0Report Type:Expedited (15-DaCompany Report #PHFR2002GB04174 Age:48 YR Gender:Female I/FU:I Outcome PT Other Blood Pressure Increased Heart Rate Decreased Hypothermia 22-Feb-2006 08:30 AM Page: 2052 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Thrombocytopenia Report Source Product Role Manufacturer Route Dose Duration Foreign Clozaril Study (Clozapine)(Clozapin Health e) PS ORAL 175 MG/DAY, Professional ORAL Other Date:12/30/02ISR Number: 4034471-XReport Type:Expedited (15-DaCompany Report #PHFR2002GB03487 Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Self-Injury Foreign Clozaril(Clozapine) Initial or Prolonged Intestinal Obstruction Study Tablet PS ORAL ORAL Health Professional Other Date:12/30/02ISR Number: 4034477-0Report Type:Expedited (15-DaCompany Report #PHNU2002DE04231 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Coronary Artery Foreign Leponex/Clozaril Restenosis Health (Clozapine) Myocardial Infarction Professional (Clozapine) Tablet PS ORAL 300 MG/DAY, Other ORAL Date:12/30/02ISR Number: 4035715-0Report Type:Expedited (15-DaCompany Report #PHRM2002FR00589 Age:31 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperglycaemia Foreign Leponex Initial or Prolonged Hyperlipidaemia Literature (Clozapine)Tablet PS ORAL SEE IMAGE 366 DAY Hypertriglyceridaemia Health Polydipsia Professional Polyuria Other Weight Decreased Weight Increased Date:12/30/02ISR Number: 4035767-8Report Type:Expedited (15-DaCompany Report #02-12-1142 Age:74 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Parkinson'S Disease Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc.Tablets PS ORAL 100MG QD ORAL Date:12/30/02ISR Number: 4035777-0Report Type:Expedited (15-DaCompany Report #02-12-1143 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Oesophageal Ulcer Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 25-525MG QD ORAL 22-Feb-2006 08:30 AM Page: 2053 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/30/02ISR Number: 4035779-4Report Type:Expedited (15-DaCompany Report #02-12-1144 Age:96 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 6.2-77.5MG QD ORAL Date:12/30/02ISR Number: 4035782-4Report Type:Expedited (15-DaCompany Report #02-12-1145 Age:84 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Parkinson'S Disease Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 12-62.5MG QD ORAL Date:12/30/02ISR Number: 4035787-3Report Type:Expedited (15-DaCompany Report #PHBS2001FR06332 Age:27 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Foreign Leponex(Clozapine) Initial or Prolonged Bundle Branch Block Right Literature Unknown PS Delirium Health Clonazepam(Clonazepa Drug Effect Decreased Professional m) SS Drug Interaction Other Haloperidol Electrocardiogram Decanoate Abnormal (Haloperidol Schizophrenia, Decanoate) C Disorganised Type Chlorpromazine Shock (Chlorpromazine) C Syncope Date:12/30/02ISR Number: 4035806-4Report Type:Expedited (15-DaCompany Report #PHBS2002US15493 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Literature Clozapine(Clozapine) Initial or Prolonged Blood Pressure Health Unknown PS 550 MG/D Fluctuation Professional Norethindrone(Noreth Dizziness isterone) SS Drug Interaction Drug Level Above Therapeutic Heart Rate Abnormal Somnolence Date:12/30/02ISR Number: 4035814-3Report Type:Expedited (15-DaCompany Report #PHEH2002US10618 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Brain Neoplasm Health Clozaril(Clozapine)T Professional ablet PS 22-Feb-2006 08:30 AM Page: 2054 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/30/02ISR Number: 4035825-8Report Type:Expedited (15-DaCompany Report #PHEH2002US10395 Age:54 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neoplasm Malignant Study Clozaril (Clozapine) Tablet PS ORAL 400 MG, QD, ORAL Date:12/30/02ISR Number: 4035838-6Report Type:Expedited (15-DaCompany Report #PHFR2002GB03497 Age:54 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Colitis Ischaemic Foreign Clozaril (Clozapine) Hospitalization - Constipation Study Tablet PS ORAL ORAL Initial or Prolonged Dehydration Health Other Diarrhoea Professional Mesenteric Vein Other Thrombosis Weight Decreased Date:12/30/02ISR Number: 4035843-XReport Type:Expedited (15-DaCompany Report #PHNR2002AU00591 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Withdrawal Syndrome Foreign Clozaril (Clozapine) PS 600 MG/DAY Initial or Prolonged Study Amisulpride C Health Professional Other Date:12/30/02ISR Number: 4035853-2Report Type:Expedited (15-DaCompany Report #PHNR2002AU00605 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Foreign Clozaril (Clozapine) Phosphokinase Increased Other (Clozapine) Tablet PS ORAL 100MG MANE Bundle Branch Block AND 350 MG NOCTE, ORAL Date:12/30/02ISR Number: 4035893-3Report Type:Expedited (15-DaCompany Report #PHFR2002GB00990 Age:55 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukocytosis Foreign Clozaril(Clozapine)( Monocyte Count Abnormal Health Clozapine) Tablet PS ORAL 200MG/DAY, Myelofibrosis Professional ORAL Neutrophilia Other Ascorbic Acid C Paroxetine C Ferrous Sulfate C Multivitamins (Panthenol, Retinol) C 22-Feb-2006 08:30 AM Page: 2055 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/30/02ISR Number: 4035899-4Report Type:Expedited (15-DaCompany Report #PHFR2002GB04121 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Transient Ischaemic Foreign Clozaril (Clozapine) Attack Health (Clozapine) Tablet PS ORAL ORAL Professional Aspirine C Other Date:12/30/02ISR Number: 4035907-0Report Type:Expedited (15-DaCompany Report #PHEH2002US09784 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Asthenia Health Clozaril (Clozapine) Hospitalization - Blood Glucose Increased Professional Tablet PS ORAL SEE IMAGE Initial or Prolonged Coma Clozaril SS 300 MG, QD Other Grand Mal Convulsion Pancreatitis Pneumonia Aspiration Rash Weight Increased Date:12/30/02ISR Number: 4035908-2Report Type:Expedited (15-DaCompany Report #PHEH2002US09329 Age:43 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Breast Cancer Health Clozaril (Clozapine) Initial or Prolonged Breast Infection Professional Tablet PS ORAL 800 MG/DAY, Other Incontinence ORAL Leukopenia Ditropan (Oxybutynin) C Prozac (Fluoxetine Hydrochloride) C Depakote (Valproate Semisodium) C Ativan C Risperdal C Vitamin E C Date:12/30/02ISR Number: 4036014-3Report Type:Expedited (15-DaCompany Report #PHNU2002DE03753 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Foreign Leponex/Clozaril Pancreatitis Acute Health (Clozapine) PS ORAL 75MG/DAY, Professional ORAL Other Locol (Fluvastatin Sodium) SS ORAL 20 MG, QD, ORAL Fluanxol (Flupentixol Dihydrochloride) Sugar-Coated SS Bayer ORAL 4MG/DAY, ORAL Tavor (Lorazepam) SS ORAL 1 MG/DAY, ORAL Glucophage (Metformin Hydrochloride) Film-Coated SS Merck ORAL 1500 MG/DAY, 22-Feb-2006 08:30 AM Page: 2056 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL Harpagin (Benzbromarone) SS ORAL 20 MG, QD, ORAL Date:12/30/02ISR Number: 4036111-2Report Type:Expedited (15-DaCompany Report #PHBS2002CA15545 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Congenital Nose Foreign Clozaril (Clozapine) Initial or Prolonged Malformation Health Tablet PS TRANSPLACENTAL TRANSPLANCENT Hypoglycaemia Neonatal Professional AL Maternal Drugs Affecting Other Foetus Neonatal Apnoeic Attack Date:12/30/02ISR Number: 4036158-6Report Type:Expedited (15-DaCompany Report #PHBS2002ES15295 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Obsessive-Compulsive Foreign Clozapine(Clozapine) Disorder Literature Unknown PS 200 MG/D Health Paroxetine C Professional Other Date:12/30/02ISR Number: 4036159-8Report Type:Expedited (15-DaCompany Report #PHFR2002GB04176 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Foreign Clozaril(Clozapine) Initial or Prolonged Study Unknown PS ORAL 250 MG/DAY, Health ORAL Professional Other Date:12/30/02ISR Number: 4036160-4Report Type:Expedited (15-DaCompany Report #PHFR2002GB03945 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Clozaril Initial or Prolonged Increased Study (Clozapine)(Clozapin Other Asthma Health e) Tablet PS ORAL 200 MG, BID, Clonic Convulsion Professional ORAL Diabetes Mellitus Other Dyspnoea Pneumonia Shock Tachycardia White Blood Cell Count Increased 22-Feb-2006 08:30 AM Page: 2057 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/30/02ISR Number: 4036537-7Report Type:Expedited (15-DaCompany Report #PHFR2002GB03798 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Foreign Clozaril Initial or Prolonged Bundle Branch Block Right Study (Clozapine)(Clozapin Other Dilatation Atrial Health e)Tablet PS ORAL 475 MG/DAY, Palpitations Professional ORAL Supraventricular Other Extrasystoles Supraventricular Tachycardia Date:12/30/02ISR Number: 4036608-5Report Type:Expedited (15-DaCompany Report #PHHO2002CA10388 Age:62 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Toxicity Foreign Clozapine Initial or Prolonged Fall Study (Clozapine) (Tablet) PS Hip Fracture Health Professional Other Date:12/30/02ISR Number: 4036609-7Report Type:Expedited (15-DaCompany Report #PHFR2002GB04242 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Circulatory Collapse Foreign Clozaril (Clozapine) Deep Vein Thrombosis Study (Tablet) PS 400MG/DAY Shock Health Professional Other Date:12/31/02ISR Number: 4033494-4Report Type:Expedited (15-DaCompany Report #C2002-3578.01 Age:86 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Other Clozapine Tablets 25 Mg Mylan PS ORAL 100MG, QD, THEN DECREASED TO 87.5MG QD ORAL Date:12/31/02ISR Number: 4037017-5Report Type:Expedited (15-DaCompany Report #02P-163-0203565-00 Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Health Divalproex Sodium Initial or Prolonged Dyspnoea Professional (Depakote) Required Haemothorax Other (Divalproex Sodium) Intervention to Lobar Pneumonia (Divalproex Sodium) PS ORAL 100 MG, 2 IN Prevent Permanent Palpitations 1 D, ORAL Impairment/Damage Pleural Effusion Clozapine SS ORAL 400 MG, 2 IN Pyrexia 1 D, ORAL Tuberculin Test Positive Haloperidol C 22-Feb-2006 08:30 AM Page: 2058 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/03/03ISR Number: 4035477-7Report Type:Direct Company Report #USP 55432 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Clozaril PS Novartis Pharm Colazal SS Salix Pharm Date:01/03/03ISR Number: 4038235-2Report Type:Expedited (15-DaCompany Report #C2002-3608.01 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Other Clozapine Tablets 100 Mg Mylan PS Mylan ORAL 200MG QD, ORAL Clozapine Tablets 25 Mg Mylan SS Mylan ORAL 75 MG QD, ORAL Date:01/06/03ISR Number: 4036011-8Report Type:Expedited (15-DaCompany Report #B0288724A Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Nephropathy Toxic Consumer Lithium PS Glaxo Wellcome UNKNOWN Initial or Prolonged Renal Failure Clozaril SS ORAL 500MG per day Other Date:01/06/03ISR Number: 4037048-5Report Type:Expedited (15-DaCompany Report #C2002-3130.01 Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Appendicitis Perforated Health Clozapine Tablets Cardiac Arrest Professional 100 Mg Mylan PS ORAL 100MG, Q AM, Peritonitis Other 100MG Q 4PM, 500MG QHS, ORAL Divalproex Sodium C Docusate Sodium C Folic Acid C Lactulose C Lithium Carbonate C Multivitamin C Olanzapine C Topiramate C Vitamin C C Date:01/06/03ISR Number: 4037051-5Report Type:Expedited (15-DaCompany Report #C2002-3252.01 Age:84 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg Mylan PS ORAL 25 MG, Q HS, Other ORAL Bupropion Hcl C Carbidopa/Levodopa C Famotidine C Levothyroxine Sodium C Zinc Sulfate C 22-Feb-2006 08:30 AM Page: 2059 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/06/03ISR Number: 4039734-XReport Type:Expedited (15-DaCompany Report #DE9384527DEC2002 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Accidental Exposure Health Tavor (Lorazepam, Condition Aggravated Professional Tablet, O) PS ORAL 1 TABLET ORAL 1 DAY Stupor Dominal (Prothipendyl Hydrochloride, , O) SS ORAL 1 TABLET (80 MG) ORAL 1 DAY Leponex (Clozapine, , O) SS 1 TABLET (100 MG) Date:01/07/03ISR Number: 4039282-7Report Type:Expedited (15-DaCompany Report #DE9384527DEC2002 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Accidental Exposure Health Tavor (Lorazepam, Condition Aggravated Professional Tablet, 0) PS ORAL 1 TABLET Stupor (STRENGTH NOT SPECIFIED) 1 DAY Dominal (Prothipendyl Hydrochloride, 0) SS ORAL 1 TABLET (80 MG) 1 DAY Leponex (Clozapine, , 0) SS ORAL 1 TABLET (100 MG) Date:01/07/03ISR Number: 4040348-6Report Type:Expedited (15-DaCompany Report #C2002-3623.01 Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine Tablets 25 Professional Mg Mylan PS ORAL 75MG Q HS, Other ORAL Clozapine Tablets 100 Mg Mylan SS ORAL 300MG Q AM, 200 MG Q PM, ORAL Azithromycin C Benztropine C Cetirizine C Divalproex Sodium C Fluticasone Nasal Spray C Furosemide C Ipratropium/Albutero l Nasal Inhaler C Levo-Thyroxine C Levofloxcin C Potassium C Prednisone C Tamoxifen C 22-Feb-2006 08:30 AM Page: 2060 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/08/03ISR Number: 4038617-9Report Type:Direct Company Report #CTU 184038 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Impaired Self-Care Clozapine PS ORAL 100 MG III PO Paranoia HS Stereotypy Clozapine SS 25 MG II PO Q Thinking Abnormal DAY Date:01/10/03ISR Number: 4040839-8Report Type:Expedited (15-DaCompany Report #C2002-3635.01 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional 100 Mg Mylan PS ORAL 20MG Q HS, Other ORAL Date:01/10/03ISR Number: 4040841-6Report Type:Expedited (15-DaCompany Report #C2002-3634.01 Age:73 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg Mylan PS ORAL 50MG QD, THEN Other 25MG QD, ORAL Calcium C Hydrocortisone C Lactulose C Levothyroxine C Nitroglycerin Patches C Pantoprazole C Sertraline C Simvastatin C Tamsulosin C Date:01/10/03ISR Number: 4040857-XReport Type:Expedited (15-DaCompany Report #C2002-3637.01 Age:78 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Aspiration Other Clozapine Tablets 25 Mg Mylan PS Mylan ORAL 37.5MG Q AM, 25MG G PM, ORAL Carbidopa And Levodopa Er C Tamsulosin Hcl C Date:01/10/03ISR Number: 4040858-1Report Type:Expedited (15-DaCompany Report #C2002-3636.01 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Renal Failure Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 37.5MG/DAY, Other ORAL Fluvoxamine Maleate C Ramipril C 22-Feb-2006 08:30 AM Page: 2061 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/10/03ISR Number: 4041039-8Report Type:Expedited (15-DaCompany Report #NSADSS2003000763 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Health Haldol (Unspecified) Initial or Prolonged Confusional State Professional (Haloperidol) PS 10 MG, PRN Gait Disturbance Clozapine Medication Error (Clozapine) SS ORAL 250 MG, Treatment Noncompliance DAILY, ORAL Congentin (Benzatropine Mesilate) C Clonidine (Clonidine) C Fluoxetine (Fluoxetine) C Date:01/10/03ISR Number: 4041119-7Report Type:Expedited (15-DaCompany Report #PHEH2002US10609 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiac Failure Health Clozaril (Clozapine) Hospitalization - Congestive Professional Tablet PS ORAL ORAL Initial or Prolonged Cardiomyopathy Leukocytosis Myocarditis Date:01/10/03ISR Number: 4041154-9Report Type:Expedited (15-DaCompany Report #PHNR2003AU00441 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bundle Branch Block Right Foreign Clozaril (Clozapine) Dizziness Health (Clozapine) Tablet PS ORAL 600MG/DAY, Electrocardiogram Qt Professional ORAL Corrected Interval Other Pravachol C Prolonged Muscle Twitching Sinus Tachycardia Syncope Date:01/10/03ISR Number: 4041252-XReport Type:Expedited (15-DaCompany Report #PHFR2002GB04300 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Diabetes Mellitus Foreign Clozaril (Clozapine) PS ORAL ORAL Ketoacidosis Health Valproate Sodium C Professional Hyoscine Other Hydrobromide Tablet C Senna C Date:01/10/03ISR Number: 4041260-9Report Type:Expedited (15-DaCompany Report #PHFR2002GB04303 Age:50 YR Gender:Male I/FU:I Outcome PT Other C-Reactive Protein Increased Cardiac Murmur Pyrexia 22-Feb-2006 08:30 AM Page: 2062 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sinus Tachycardia Report Source Product Role Manufacturer Route Dose Duration Foreign Clozaril (Clozapine) PS ORAL 300MG/DAY, Study ORAL Health Professional Other Date:01/10/03ISR Number: 4041261-0Report Type:Expedited (15-DaCompany Report #PHNR2002AU00639 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatitis C Foreign Clozaril (Clozapine) Study (Clozapine) PS 500-200MG/DAY Health Professional Other Date:01/10/03ISR Number: 4041263-4Report Type:Expedited (15-DaCompany Report #PHFR2002IE04310 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cellulitis Foreign Clozaril (Clozapine) Deep Vein Thrombosis Study (Clozapine) PS ORAL 500 MG/DAY, White Blood Cell Count Health ORAL Increased Professional Other Date:01/10/03ISR Number: 4041273-7Report Type:Expedited (15-DaCompany Report #PHFR2002GB02992 Age:51 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Foreign Clozaril Other Myocardial Infarction Study (Clozapine)(Clozapin Salivary Hypersecretion Health e) Tablet PS ORAL 300 MG/DAY, Professional ORAL Other Date:01/13/03ISR Number: 4040672-7Report Type:Direct Company Report #USP 55453 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Colazal PS Salix Pharm 750 MG CAPSULE Clozaril SS Novartis Pharm 25 MG TABLET Date:01/13/03ISR Number: 4041266-XReport Type:Direct Company Report #CTU 184339 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eosinophil Count Clozapine 100mg Increased Ivax PS Ivax ORAL 100 MG QPM ORAL Clozapine 25 Mg Ivax SS Ivax ORAL 25 MG QPM ORAL 22-Feb-2006 08:30 AM Page: 2063 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Eskalith C Methylphenidate C Date:01/13/03ISR Number: 4041490-6Report Type:Expedited (15-DaCompany Report #PHEH2003US00454 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozaril (Clozapine) Professional Tablet PS ORAL 500 MG/DAY, ORAL Date:01/13/03ISR Number: 4041491-8Report Type:Expedited (15-DaCompany Report #PHEH2002US10737 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ankle Fracture Health Clozaril (Clozapine) Initial or Prolonged Diabetic Ketoacidosis Professional Tablet PS ORAL 400 MG/DAY, ORAL Glucophage "Abic" C Glucotrol (Glipizide) C Date:01/13/03ISR Number: 4041492-XReport Type:Expedited (15-DaCompany Report #PHEH2002US03793 Age:55 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozaril (Clozapine) Coronary Artery Disease Professional Tablet PS ORAL 100MG AM + Diabetes Mellitus 300MG HS, Non-Insulin-Dependent ORAL Prolixin (Fluphenazine Hydrochloride) C Avandia (Rosiglitazone Maleate) C Glucophage "Abic" C Glyburide C Docusate (Docusate) C Date:01/13/03ISR Number: 4041495-5Report Type:Expedited (15-DaCompany Report #PHEH2002US10737 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ankle Fracture Health Clozaril (Clozapine) Initial or Prolonged Diabetic Ketoacidosis Professional Tablet PS ORAL 400 MG/DAY, ORAL Glucophage "Abic" C Glucotrol (Glipizide) C 22-Feb-2006 08:30 AM Page: 2064 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/13/03ISR Number: 4041496-7Report Type:Expedited (15-DaCompany Report #PHEH2002US03793 Age:55 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozaril (Clozapine) Coronary Artery Disease Professional Tablet PS ORAL 100MG AM + Diabetes Mellitus 300MG HS, Non-Insulin-Dependent ORAL Prolixin (Fluophenazine Hydrochloride) C Avandia (Rosiglitazone Maleate) C Glucophage "Abic" C Glyburide C Docusate (Docusate) C Date:01/13/03ISR Number: 4041848-5Report Type:Expedited (15-DaCompany Report #PHBS2002CA13686 Age:67 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Atelectasis Foreign Clozaril (Clozapine) Other Cardio-Respiratory Arrest Study Tablet PS ORAL 62.5 MG Confusional State Health DAILY, ORAL Convulsion Professional Dilantin (Phenytoin General Physical Health Other Sodium) SS Deterioration Metformin C Myocardial Infarction Valium C Pneumonia Lipitor C Red Blood Cell Synthroid C Sedimentation Rate Amantadine Increased (Amantadine) C Tachycardia Date:01/13/03ISR Number: 4041854-0Report Type:Expedited (15-DaCompany Report #PHNU2002DE04122 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sarcoidosis Foreign Leponex/ Clozaril Health (Clozapine) Professional (Clozapine) Tablet PS ORAL ORAL; 300 Other MG/DAY, ORAL Date:01/13/03ISR Number: 4041878-3Report Type:Expedited (15-DaCompany Report #PHFR2002GB04174 Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Pressure Foreign Clozaril Fluctuation Study (Clozapine) PS ORAL 125MG + 175 Bradycardia Health MG/DAY, ORAL Heart Rate Irregular Professional Zopiclone C Hypertension Other Haloperidol C Hypothermia Gliclazide C Tachycardia Neo-Mercazole Thrombocytopenia (Carbimazole) C Levonorgestrel (Levonorgestrel) C 22-Feb-2006 08:30 AM Page: 2065 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/13/03ISR Number: 4041882-5Report Type:Expedited (15-DaCompany Report #PHFR2002IE04310 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cellulitis Foreign Clozaril (Clozapine) Deep Vein Thrombosis Study (Clozapine) Unknown PS ORAL 500 MG/DAY, White Blood Cell Count Health ORAL Increased Professional Other Date:01/13/03ISR Number: 4041883-7Report Type:Expedited (15-DaCompany Report #PHFR2002GB01305 Age:44 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Body Temperature Foreign Clozaril(Clozapine) Initial or Prolonged Increased Health Tablet PS ORAL 600 MG/DAY, Cellulitis Professional ORAL Deep Vein Thrombosis Other Neutrophil Count Increased White Blood Cell Count Increased Date:01/13/03ISR Number: 4041893-XReport Type:Expedited (15-DaCompany Report #PHFR2002GB04300 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Diabetes Mellitus Foreign Clozaril (Clozapine) PS ORAL ORAL Ketoacidosis Health Valproate Sodium C Professional Hyoscine Other Hydrobromide Tablet C Senna Tablet C Date:01/13/03ISR Number: 4041896-5Report Type:Expedited (15-DaCompany Report #PHFR2002GB02767 Age:49 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Coma Foreign Clozaril (Clozapine) Initial or Prolonged Diabetic Ketoacidosis Study Tablet PS ORAL ORAL Small Intestinal Health Obstruction Professional Other Date:01/13/03ISR Number: 4041899-0Report Type:Expedited (15-DaCompany Report #PHFR2002GB00990 Age:55 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Macrocytic Foreign Clozaril (Clozapine) Fatigue Health (Clozapine) Tablet PS ORAL 200MG/DAY, Lethargy Professional ORAL Leukocytosis Other Ascorbic Acid C Monocyte Count Abnormal Paroxetine C Myelofibrosis Ferrous Sulfate C Neutrophilia Multivitamins Platelet Count Decreased (Panthenol, Retinol) C Somnolence Procyclidine (Procyclidine) C Vitamin C C 22-Feb-2006 08:30 AM Page: 2066 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/13/03ISR Number: 4041901-6Report Type:Expedited (15-DaCompany Report #PHFR2002IE04310 Age:61 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Body Temperature Foreign Clozaril (Clozapine) Increased Study (Clozapine) PS ORAL 500 MG/DAY, Cellulitis Health ORAL White Blood Cell Count Professional Increased Other Date:01/13/03ISR Number: 4041912-0Report Type:Expedited (15-DaCompany Report #PHNU2002DE03516 Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Foreign Clozaril (Clozapine) Pancreatitis Necrotising Health ( Clozapine) Tablet PS ORAL 200 TO Professional 250MG/DAY, Other ORAL Date:01/13/03ISR Number: 4042065-5Report Type:Expedited (15-DaCompany Report #PHBS2000AU10829 Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Interaction Foreign Clozaril Haemorrhage Health (Clozapine)(Clozapin Professional e) Tablet PS ORAL 75 MG/D, ORAL Other Methadone(Methadone) SS 3 DAY Heroin (Diamorhpine) C Olanzapine C Date:01/13/03ISR Number: 4042081-3Report Type:Expedited (15-DaCompany Report #PHFR2002IE00998 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Diabetes Mellitus Foreign Clozaril (Clozapine) Hospitalization - Diabetic Coma Health Tablet PS ORAL SEE IMAGE Initial or Prolonged Professional Insulin (Insulin) C Other Haloperidol C Lithium (Lithium) C Valproate Sodium C Date:01/13/03ISR Number: 4042108-9Report Type:Expedited (15-DaCompany Report #PHFR2002GB04320 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypotension Foreign Clozaril (Clozapine) PS ORAL 500 MG/DAY, Lethargy Study ORAL Medication Error Health Clozaril SS ORAL 650 MG/DAY, Nasopharyngitis Professional ORAL Somnolence Other Clozaril SS 500 MG, QD Date:01/13/03ISR Number: 4042165-XReport Type:Expedited (15-DaCompany Report #PHFR2002GB03945 Age:49 YR Gender:Female I/FU:F Outcome Hospitalization - Initial or Prolonged 22-Feb-2006 08:30 AM Page: 2067 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other PT Report Source Product Role Manufacturer Route Dose Duration Alanine Aminotransferase Foreign Clozaril (Clozapine) Increased Study (Clozapine) Tablet PS ORAL 200 MG, BID, Asthma Health ORAL Blood Bilirubin Increased Professional Clonic Convulsion Other Diabetes Mellitus Pneumonia Shock Tachycardia Date:01/14/03ISR Number: 4041898-9Report Type:Expedited (15-DaCompany Report #PHFR2002GB04174 Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Pressure Foreign Clozaril (Clozapine) PS ORAL 125MG + Fluctuation Study 175MG/DAY, Bradycardia Health ORAL Heart Rate Irregular Professional Zopiclone C Hypothermia Other Haloperidol C Tachycardia Gliclazide C Thrombocytopenia Neo-Mercazole (Carbimazole) C Levonorgestrel (Levonorgestrel) C Date:01/14/03ISR Number: 4041902-8Report Type:Expedited (15-DaCompany Report #PHFR2002GB03598 Age:51 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bundle Branch Block Left Foreign Clozaril (Clozapine) Diabetes Mellitus Study Tablet PS ORAL 300 MG/DAY, Electrocardiogram Health ORAL Abnormal Professional Glibenclamide C Sinus Tachycardia Other Metformin C Ventricular Hypokinesia Date:01/14/03ISR Number: 4042016-3Report Type:Expedited (15-DaCompany Report #PHFR2002GB04324 Age: Gender:Male I/FU:I Outcome PT Other Abnormal Dreams Agitation Alopecia Arthralgia Chest Wall Pain Constipation Depression Diarrhoea Dizziness Dry Mouth Dyskinesia Dysuria Flushing Hepatocellular Damage Insomnia 22-Feb-2006 08:30 AM Page: 2068 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Memory Impairment Mouth Ulceration Movement Disorder Report Source Product Role Manufacturer Route Dose Duration Neuroleptic Malignant Foreign Clozaril Syndrome Consumer (Clozapine) PS ORAL ORAL Pain Other Risperidone Palpitations (Risperidone) SS 3 MG, BID, Paraesthesia Prozac (Fluoxetine Photosensitivity Reaction Hydrochloride) SS 7.5 ML/DAY, Polyuria Pruritus Rash Restlessness Rhinorrhoea Shock Somnolence Speech Disorder Vision Blurred Weight Increased Date:01/14/03ISR Number: 4042023-0Report Type:Expedited (15-DaCompany Report #02-12-1162 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hysterectomy Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 25-400 MG QD ORAL Date:01/14/03ISR Number: 4042028-XReport Type:Expedited (15-DaCompany Report #03-01-0002 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Bence Jones Protein Urine Foreign Clozapine Tablets PS ORAL 25-150MG QD Hospitalization - Present Literature ORAL 17 DAY Initial or Prolonged Biopsy Skin Abnormal Health Blood Creatine Professional Phosphokinase Increased Blood Fibrinogen Decreased Body Temperature Increased C-Reactive Protein Increased Delirium Diarrhoea Drug Ineffective Dyspnoea Electroencephalogram Abnormal Lymphadenopathy Oedema Peripheral Pericardial Effusion Pleural Effusion Rash Red Blood Cell Sedimentation Rate Increased Respiratory Disorder 22-Feb-2006 08:30 AM Page: 2069 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/14/03ISR Number: 4042039-4Report Type:Expedited (15-DaCompany Report #03-01-0003 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Clozapine Tablets - Overdose Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc ORAL 13.4-475MG QD ORAL Date:01/14/03ISR Number: 4042040-0Report Type:Expedited (15-DaCompany Report #03-01-0016 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Road Traffic Accident Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL ORAL Date:01/14/03ISR Number: 4042041-2Report Type:Expedited (15-DaCompany Report #03-01-0014 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Neoplasm Malignant Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL ORAL Date:01/14/03ISR Number: 4042043-6Report Type:Expedited (15-DaCompany Report #03-01-0010 Age:86 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 50MG QD ORAL Date:01/14/03ISR Number: 4042142-9Report Type:Expedited (15-DaCompany Report #PHFR2002GB01305 Age:44 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Body Temperature Foreign Clozaril (Clozapine) Initial or Prolonged Increased Health Tablet PS ORAL 600MG/DAY, Cellulitis Professional ORAL Disease Recurrence Other Neutrophil Count Increased White Blood Cell Count Increased 22-Feb-2006 08:30 AM Page: 2070 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/14/03ISR Number: 4042145-4Report Type:Expedited (15-DaCompany Report #PHBS2002CA13686 Age:67 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Atelectasis Foreign Clozaril (Clozapine) Other Cardio-Respiratory Arrest Study Tablet PS ORAL 62.5 MG Confusional State Health DAILY, ORAL Convulsion Professional Dilantin (Phenytoin Electrocardiogram St Other Sodium) SS Segment Elevation Metformin C General Physical Health Valium C Deterioration Lipitor C Lobar Pneumonia Synthroid C Myocardial Infarction Amantadine Red Blood Cell (Amantadine) C Sedimentation Rate Increased Tachycardia Date:01/14/03ISR Number: 4043031-6Report Type:Expedited (15-DaCompany Report #2003000349 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Ileus Paralytic Foreign Ziprasidone Hospitalization - Health (Ziprasidone) PS ORAL 160 MG (BID), Initial or Prolonged Professional ORAL Company Clozapine Representative (Clozapine) SS ORAL 600 MG, ORAL Clonazepam C Date:01/15/03ISR Number: 4042376-3Report Type:Expedited (15-DaCompany Report #C2002-3633.01 Age:76 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 75 MG QD, Other THEN 25 MG QD, ORAL Clozapine Tablets 100 Mg Mylan SS Mylan ORAL 100 MG QD, ORAL Date:01/16/03ISR Number: 4042967-XReport Type:Direct Company Report #CTU 184733 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Heart Rate Increased Clozaril PS 50MG Q HS Initial or Prolonged Hyperhidrosis Seraquil SS 50MG AT HS Pyrexia Tremor Date:01/16/03ISR Number: 4043689-1Report Type:Expedited (15-DaCompany Report #PHEH2002US09784 Age:24 YR Gender:Male I/FU:I Outcome Life-Threatening Hospitalization - Initial or Prolonged 22-Feb-2006 08:30 AM Page: 2071 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other PT Report Source Product Role Manufacturer Route Dose Duration Asthenia Health Clozaril(Clozapine) Blood Glucose Increased Professional Tablet PS ORAL 350 MG, QD, Coma ORAL Grand Mal Convulsion Pancreatitis Pneumonia Aspiration Rash Weight Increased Date:01/16/03ISR Number: 4044078-6Report Type:Expedited (15-DaCompany Report #PHNU2001DE02054 Age:42 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Eosinophilia Foreign Leoponex / Clozaril Initial or Prolonged Pancreatitis Literature (Clozapine) (Clozapine) Tablet PS ORAL 12.5 MG/DAY, ORAL; 150 MG, TID, ORAL Xanef C Dipiperon (Pipamperone) C Amaryl (Glimepiride) C Date:01/16/03ISR Number: 4044079-8Report Type:Expedited (15-DaCompany Report #PHBS2002NZ12748 Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Foreign Clozapine Drug Level Increased Literature (Clozapine) Unknown PS 600 MG/D; 300 Grand Mal Convulsion Health MG/D Professional Omeprazole Other (Omeprazole) SS Date:01/16/03ISR Number: 4044080-4Report Type:Expedited (15-DaCompany Report #PHBS2002NZ12747 Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Foreign Clozapine Drug Interaction Literature (Clozapine) Unknown PS 475 MG/D Drug Level Increased Health Omeprazole Loss Of Consciousness Professional (Omeprazole) SS Other Date:01/16/03ISR Number: 4044118-4Report Type:Expedited (15-DaCompany Report #PHNU2002DE02351 Age:34 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Appetite Disorder Foreign Leponex / Clozaril Diabetes Mellitus Health (Clozapine) Inadequate Control Professional (Clozapine) Tablet PS ORAL 100 TO Diabetes Mellitus Other 300MG/DAY, Insulin-Dependent ORAL Tavor Tablet C Seroquel (Quetiapine 22-Feb-2006 08:30 AM Page: 2072 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Fumarate) Film-Coated Tablet C Biguanides C Date:01/16/03ISR Number: 4044145-7Report Type:Expedited (15-DaCompany Report #PHFR2002GB03566 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril (Clozapine) Study Tablet PS ORAL 150 MG/DAY, Health ORAL Professional Chlorpromazine Other (Chlorpromazine) C Temazepam C Beclazone (Beclometasone Dipropionate) I Date:01/16/03ISR Number: 4044148-2Report Type:Expedited (15-DaCompany Report #PHBS2003CA00616 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Level Increased Foreign Clozaril (Clozapine) Drug Toxicity Health Tablet PS ORAL 800 MG/D, Salivary Hypersecretion Professional ORAL Sedation Other Date:01/16/03ISR Number: 4044149-4Report Type:Expedited (15-DaCompany Report #PHRM2003FR00461 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Foreign Leponex / Lx Initial or Prolonged Health (Clozapine) Tablet PS ORAL 400 MG, QD, Professional ORAL Other Date:01/16/03ISR Number: 4044157-3Report Type:Expedited (15-DaCompany Report #PHFR2002GB04299 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Foreign Clozaril (Clozapine) Initial or Prolonged Study (Clozapine) PS ORAL 150MG/MANE Health 300MG/NOCTE, Professional ORAL Other Citalopram (Citalopram) C Date:01/16/03ISR Number: 4044167-6Report Type:Expedited (15-DaCompany Report #PHFR2003GB00454 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Accidental Exposure Foreign Clozaril (Clozapine) PS ORAL ORAL Hospitalization - Health Initial or Prolonged Professional Other 22-Feb-2006 08:30 AM Page: 2073 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/16/03ISR Number: 4044168-8Report Type:Expedited (15-DaCompany Report #PHFR2002GB03799 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Level Increased Foreign Clozaril (Clozapine) Drug Toxicity Study (Clozapine) Tablet PS ORAL 900 MG/DAY, Hepatic Steatosis Health ORAL Shock Professional Other Date:01/21/03ISR Number: 4045052-6Report Type:Expedited (15-DaCompany Report #C2003-0020.01 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Clozapine Tablets 100 Mg Mylan PS Mylan ORAL 400MG HS, ORAL Divalproex Sodium C Topiramate C Date:01/21/03ISR Number: 4045056-3Report Type:Expedited (15-DaCompany Report #C2002-3442.01 Age:78 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Other Clozapine Tablets 100 Mg Mylan PS Mylan ORAL 500MG/DAY, ORAL Lansoprazole C Aspirin C Levothyroxine C Losartan C Fluticasone/Sametrol Inhaler C Date:01/21/03ISR Number: 4045059-9Report Type:Expedited (15-DaCompany Report #C2002-3529.01 Age:66 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Metastases To Liver Health Clozapine Tablets Multi-Organ Failure Professional 100 Mg Mylan PS Mylan ORAL 600MG QD, Neoplasm Malignant Other ORAL Benztropine C Furosemide C Haloperidol (Prn) C Lactulose C Letrozole C Spironolactone C Date:01/21/03ISR Number: 4045318-XReport Type:Expedited (15-DaCompany Report #PHNR2003AU00441 Age:38 YR Gender:Male I/FU:F Outcome PT Other Bundle Branch Block Right Dizziness Electrocardiogram Qt Corrected Interval Prolonged Electrocardiogram Qt 22-Feb-2006 08:30 AM Page: 2074 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prolonged Muscle Twitching Sinus Tachycardia Syncope Report Source Product Role Manufacturer Route Dose Duration Foreign Clozaril (Clozapine) Study (Clozapine)Tablet PS ORAL 600 MG/DAY, Health ORAL Professional Pravachol C Other Date:01/21/03ISR Number: 4045457-3Report Type:Expedited (15-DaCompany Report #NSADSS2003001055 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Gastroenteritis Viral Study Risperidone Initial or Prolonged Ileus Paralytic Health (Unspecified) Sinus Tachycardia Professional (Risperidone) PS Small Intestinal Clozapine Obstruction (Clozapine) SS Depakote (Valproate Semisodium) C Klonopin (Clonzepam) C Lipitor (Atorvastatin) C Vasotec (Enalapril Maleate) C Neurontin (Gabapentin) C Zoloft (Sertraline Hydrochloride) C Trazodone (Trazodone) C Iron (Iron) C Multivitamins (Multivitamins) C Insulin 70/30 (Human Mixtard) C Colace (Docusate Sodium) C Date:01/21/03ISR Number: 4045481-0Report Type:Expedited (15-DaCompany Report #PHEH2003US00534 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Health Clozaril (Clozapine) Initial or Prolonged Diabetic Coma Professional Tablet PS ORAL ORAL Diabetic Ketoacidosis Pancreatitis Date:01/21/03ISR Number: 4045683-3Report Type:Expedited (15-DaCompany Report #03-01-0044 Age:66 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 50-400MG QD 22-Feb-2006 08:30 AM Page: 2075 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL Date:01/21/03ISR Number: 4045684-5Report Type:Expedited (15-DaCompany Report #03-01-0033 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Health Clozapine Tablets - Treatment Noncompliance Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 300MG QD ORAL Date:01/21/03ISR Number: 4045685-7Report Type:Expedited (15-DaCompany Report #03-01-0030 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cellulitis Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 100MG QD ORAL Date:01/21/03ISR Number: 4045687-0Report Type:Expedited (15-DaCompany Report #03-01-0029 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hip Fracture Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 150-175MG QD ORAL Date:01/21/03ISR Number: 4045688-2Report Type:Expedited (15-DaCompany Report #03-01-0024 Age:81 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 12.5-100MG QD ORAL Date:01/21/03ISR Number: 4045690-0Report Type:Expedited (15-DaCompany Report #03-01-0023 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. PS Ivax Pharmaceuticals, Inc. ORAL 400MG QD ORAL 22-Feb-2006 08:30 AM Page: 2076 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/21/03ISR Number: 4045693-6Report Type:Expedited (15-DaCompany Report #03-01-0021 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Clozapine Tablets - Congestive Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 100-500MG QD ORAL Date:01/21/03ISR Number: 4045756-5Report Type:Expedited (15-DaCompany Report #PHBS2002CA13686 Age:67 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Atelectasis Foreign Clozaril(Clozapine) Other Cardio-Respiratory Arrest Study Tablet PS ORAL 62.5 MG Confusional State Health DAILY, ORAL Convulsion Professional Dilantin(Phenytoin General Physical Health Other Sodium) SS UNK, UNK, UNK Deterioration Metformin C Myocardial Infarction Valium C Pneumonia Lipitor C Synthroid C Amantadine (Amantadine) C Celexa C Acetylsalicylic Acid C Date:01/21/03ISR Number: 4045892-3Report Type:Expedited (15-DaCompany Report #PHFR2002GB01442 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Hyperhidrosis Foreign Clozaril (Clozapine) Hospitalization - Hypotension Health Tablet PS ORAL 350 MG/DAY, Initial or Prolonged Influenza Like Illness Professional ORAL Lower Respiratory Tract Other Cipramil C Infection Melleril "Novaritis" C Neutrophil Count Olanzapine C Increased Polycythaemia Sinusitis Tachycardia Date:01/22/03ISR Number: 4044745-4Report Type:Expedited (15-DaCompany Report #C2003-0019.01 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pharmaceutical Product Health Clozapine Tablets 25 Complaint Professional Mg Mylan PS Mylan ORAL 50MG BID, Other ORAL Clozapine Tablets 100 Mg Mylan SS Mylan ORAL 100MG BID, ORAL 22-Feb-2006 08:30 AM Page: 2077 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/23/03ISR Number: 4046310-1Report Type:Expedited (15-DaCompany Report #PHBS2002AU11288 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Brain Neoplasm Foreign Clozaril Initial or Prolonged Non-Hodgkin'S Lymphoma Study (Clozapine) PS ORAL 275 TO 400 Pancytopenia Health MG/DAY, ORAL Professional Fludarabine Other (Fludarabine) SS INTRAVENOUS 50 MG, INTRAVENOUS Date:01/23/03ISR Number: 4046386-1Report Type:Expedited (15-DaCompany Report #C2003-0036.01 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Infection Health Clozapine Tablets Pharmaceutical Product Professional 100 Mg Mylan PS Mylan ORAL 100 MG Q AM, Complaint Other 400MG Sepsis QHS,ORAL Amlodipine C Chlordiazepoxide/Ami triptyline C Divalproex Sodium C Estropipate C Famotidine C Guanfacine Hcl C Lamotrigine C Lorazepam C Loxapine Succinate C Montelukast Sodium C Quetiapine Fumarate C Rofecoxib C Simvastatin C Venlafaxine C Verapamil Hcl C Date:01/23/03ISR Number: 4046426-XReport Type:Expedited (15-DaCompany Report #PHFR2002GB02676 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Foreign Clozaril(Clozapine) Initial or Prolonged Non-Insulin-Dependent Study Tablet PS ORAL 350 MG/DAY, Disability Health ORAL Other Professional Omeprazole Other (Omeprazole) C Lactulose C Date:01/23/03ISR Number: 4046436-2Report Type:Expedited (15-DaCompany Report #PHFR2002GB01854 Age:66 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Foreign Clozaril(Clozapine) Increased Health Tablet PS ORAL 150 MG/DAY, Confusional State Professional ORAL Fall Other Depakote (Valproate Haemoglobin Decreased Semisodium) C Urinary Incontinence Diclofenac C Urinary Tract Infection 22-Feb-2006 08:30 AM Page: 2078 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/23/03ISR Number: 4046437-4Report Type:Expedited (15-DaCompany Report #PHFR2002GB01892 Age:46 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Foreign Clozaril (Clozapine) Initial or Prolonged Femur Fracture Health Tablet PS ORAL ORAL Hypoaesthesia Professional Lower Limb Fracture Other Date:01/23/03ISR Number: 4046439-8Report Type:Expedited (15-DaCompany Report #PHRM2003FR00454 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Foreign Leponex (Clozapine) Health Tablet PS ORAL 200 MG PER Professional DAY, ORAL Other Zyprexa C Tranxene (Clorazepate Dipotassium) C Gardenal Aventis C Date:01/23/03ISR Number: 4046442-8Report Type:Expedited (15-DaCompany Report #PHFR2002GB04303 Age:50 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other C-Reactive Protein Foreign Clozaril (Clozapine) Increased Study Unknown PS ORAL 300MG/DAY, Cardiac Murmur Health ORAL Gastrointestinal Professional Infection Other Sinus Tachycardia Date:01/23/03ISR Number: 4046450-7Report Type:Expedited (15-DaCompany Report #PHFR2002GB01242 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Foreign Clozaril (Clozapine) Increased Health Tablet PS ORAL 275 MG, BID, Blood Alkaline Professional ORAL Phosphatase Increased Other Venlafaxine C Blood Bilirubin Increased Diazepam C Blood Sodium Decreased Blood Urea Decreased C-Reactive Protein Increased Gamma-Glutamyltransferase Increased Liver Function Test Weight Increased Date:01/23/03ISR Number: 4046577-XReport Type:Expedited (15-DaCompany Report #PHEH2000US09161 Age:47 YR Gender:Female I/FU:F Outcome PT Other Inflammatory Carcinoma Of Breast Stage Iv Leukopenia 22-Feb-2006 08:30 AM Page: 2079 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Metastases To Bone Report Source Product Role Manufacturer Route Dose Duration Health Clozaril (Clozapine) Professional (Clozapine) Tablet PS ORAL 300 MG, TID, ORAL Zyprexa C Cogentin (Benzatropine Mesilate) C Date:01/23/03ISR Number: 4046581-1Report Type:Expedited (15-DaCompany Report #PHEH2003US00582 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Collapse Of Lung Health Clozaril (Clozapine) Other Mass Professional Tablet PS ORAL 800 MG, QD, ORAL Date:01/23/03ISR Number: 4046672-5Report Type:Expedited (15-DaCompany Report #NZ/98/00116/LEX Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Foreign Clozaril Phosphokinase Increased Study (Clozapine)(Clozapin Drug Interaction Health e) Tablet PS ORAL 600 MG/DAY, Epileptic Aura Professional ORAL Grand Mal Convulsion Other Losec Intracranial Aneurysm (Omeprazole)(Omepraz Postictal State ole) SS ORAL 20 MG/DAY, ORAL Amoxycillin (Amoxicillin) C Metronidazole (Metronidazole) C Date:01/23/03ISR Number: 4046674-9Report Type:Expedited (15-DaCompany Report #PHBS2001NZ09401 Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Foreign Clozaril (Clozapine) Initial or Prolonged Drug Level Increased Study Tablet PS ORAL 475 MG/D, Epilepsy Health ORAL Loss Of Consciousness Professional Omeprazole Shock Other (Omeprazole) SS Olanzapine C Risperidone C Paroxetine C Date:01/23/03ISR Number: 4046675-0Report Type:Expedited (15-DaCompany Report #PHRM2002FR02348 Age:31 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Toxicity Foreign Leponex (Clozapine) Initial or Prolonged Electrocardiogram T Wave Health Tablet PS ORAL SEE IMAGE Inversion Professional Zyprexa C Suicide Attempt Other 22-Feb-2006 08:30 AM Page: 2080 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/23/03ISR Number: 4046702-0Report Type:Expedited (15-DaCompany Report #PHEH2002US10737 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Ankle Fracture Health Clozaril(Clozapine) Hospitalization - Delirium Professional Tablet PS ORAL 400 MG/DAY, Initial or Prolonged Diabetic Ketoacidosis ORAL Glucophage Abic C Glucotrol (Glipizide) C Citalopram (Citalopram) C Olanzapine C Perphenazine (Perphenazine) C Date:01/23/03ISR Number: 4046890-6Report Type:Expedited (15-DaCompany Report #PHFR2002GB03710 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Foreign Clozaril (Clozapine) Initial or Prolonged Non-Insulin-Dependent Study (Clozapine) Tablet PS ORAL 350 MG/DAY, Diabetic Ketoacidosis Health ORAL Professional Paroxetine C Other Hyoscine (Hyoscine) C Date:01/23/03ISR Number: 4047524-7Report Type:Expedited (15-DaCompany Report #PHNR2002AU00543 Age:61 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coma Foreign Clozaril(Clozapine)( Hospitalization - Intentional Overdose Health Clozapine)Tablet PS ORAL ORAL Initial or Prolonged Syncope Professional Tamoxifen C Other Date:01/23/03ISR Number: 4047528-4Report Type:Expedited (15-DaCompany Report #PHFR2002GB03903 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Clozaril (Clozapine) Drug Level Increased Study Tablet PS ORAL ORAL Malaise Health Pallor Professional Other Date:01/27/03ISR Number: 4047744-1Report Type:Expedited (15-DaCompany Report #03-01-0051 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Health Clozapine Tablets - Initial or Prolonged Neoplasm Malignant Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 25MG QD ORAL 22-Feb-2006 08:30 AM Page: 2081 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/27/03ISR Number: 4047746-5Report Type:Expedited (15-DaCompany Report #03-01-0050 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neoplasm Malignant Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 600-800MG QD ORAL Date:01/27/03ISR Number: 4047748-9Report Type:Expedited (15-DaCompany Report #02-12-1118 Age:68 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Intestinal Obstruction Health Clozapine Tablets - Sepsis Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 100MG QD ORAL Date:01/27/03ISR Number: 4047750-7Report Type:Expedited (15-DaCompany Report #02-10-0975 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL SEE IMAGE Imipramine C Synthroid C Date:01/27/03ISR Number: 4047753-2Report Type:Expedited (15-DaCompany Report #03-01-0055 Age:88 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chronic Obstructive Health Clozapine Tablets - Initial or Prolonged Pulmonary Disease Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 25MG QD ORAL Date:01/27/03ISR Number: 4047754-4Report Type:Expedited (15-DaCompany Report #02-12-1134 Age:74 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Health Clozapine Tablet - Initial or Prolonged Salivary Hypersecretion Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL SEE IMAGE Risperdal C 22-Feb-2006 08:30 AM Page: 2082 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Cogentin C Trazodone C Date:01/27/03ISR Number: 4048001-XReport Type:Expedited (15-DaCompany Report #PHEH2003US00627 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozaril (Clozapine) Pleural Effusion Professional Tablet PS ORAL 1000 MG/DAY, ORAL Date:01/27/03ISR Number: 4048126-9Report Type:Expedited (15-DaCompany Report #PHEH2002US05577 Age:57 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death B-Cell Lymphoma Health Clozaril (Clozapine) Other Leukopenia Professional Tablet PS ORAL 300 MG, QD, Neutropenia ORAL Thrombocytopenia Adriamycin (Doxorubicin) SS Cytoxan (Cyclophosphamide) SS Etoposide (Etoposide) SS Date:01/27/03ISR Number: 4048595-4Report Type:Expedited (15-DaCompany Report #PHHO2003CA00643 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril (Clozapine) Study Tablet PS Health Professional Date:01/27/03ISR Number: 4048776-XReport Type:Expedited (15-DaCompany Report #PHNR2002AU00478 Age:25 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Discomfort Foreign Clozaril Initial or Prolonged Drooling Study (Clozapine)(Clozapin Gastrointestinal Disorder Health e) PS ORAL 350 MG, ORAL Mobility Decreased Professional Risperdal C Speech Disorder Other Cogentin (Benzatropine Mesilate) C Date:01/27/03ISR Number: 4048779-5Report Type:Expedited (15-DaCompany Report #PHBS2003CH00901 Age:62 YR Gender:Female I/FU:I Outcome PT Hospitalization - Anaemia Initial or Prolonged Bone Scan Abnormal C-Reactive Protein Increased Diverticulum Iron Deficiency Anaemia 22-Feb-2006 08:30 AM Page: 2083 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Leukocytosis Thrombocythaemia Report Source Product Role Manufacturer Route Dose Duration Foreign Leponex (Clozapine) PS 50 MG/D, Health Reniten C Professional Zurcal (Pantoprazole Other Sodium) C Metformin C Midazolam (Midazolam) C Date:01/27/03ISR Number: 4048789-8Report Type:Expedited (15-DaCompany Report #PHFR2002GB03992 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Triglycerides Foreign Clozaril (Clozapine) Increased Study Tablet PS ORAL 500 MG/DAY, Diabetes Mellitus Health ORAL ; 400 Hypertension Professional MG/DAY, ORAL Other ; 300 MG/DAY, ORAL Bendrofluazide (Bendroflumethiazide ) C Date:01/27/03ISR Number: 4048795-3Report Type:Expedited (15-DaCompany Report #PHFR2002GB03095 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anorexia Foreign Clozaril(Clozapine) Initial or Prolonged Bacterial Infection Study Tablets PS ORAL 150 MG/DAY, Cerebral Atrophy Health ORAL Cryptococcosis Professional Temazepam C Fluid Overload Other Trazodone Hypertonia (Trazodone) C Hyporeflexia Valproate Sodium C Hypotension Lorazepam C Ischaemia Amisulpride Lacunar Infarction (Amisulpride) C Musculoskeletal Stiffness Neuroleptic Malignant Syndrome Oral Intake Reduced Parkinsonism Pneumonia Sepsis Staphylococcal Infection Tachycardia Urinary Tract Infection Date:01/28/03ISR Number: 4047974-9Report Type:Expedited (15-DaCompany Report #B0290333A Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Level Increased Paroxetine PS Glaxo Wellcome ORAL Sinus Tachycardia Clozaril SS ORAL 22-Feb-2006 08:30 AM Page: 2084 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/29/03ISR Number: 4048879-XReport Type:Expedited (15-DaCompany Report #C2002-3634.01 Age:73 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tables 25 Professional Mg Mylan PS ORAL 50 MG QD, Other THEN 25 MG QD, ORAL Calcium, Hydrocortisone C Lactulose C Lexothyroxine C Nitroglycerin Patches C Pantoprazole C Sertraline C Tamsulosin C Simvastatin C Date:01/29/03ISR Number: 4049776-6Report Type:Expedited (15-DaCompany Report #PHFR2002GB01812 Age:53 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Haemoptysis Foreign Clozaril (Clozapine) Initial or Prolonged Hypotension Health (Clozapine) Unknown PS ORAL ORAL Lower Respiratory Tract Professional Infection Other Melaena Oesophagitis Tachycardia Urinary Retention Date:01/29/03ISR Number: 4049828-0Report Type:Expedited (15-DaCompany Report #PHFR2002GB01848 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Activated Partial Foreign Clozaril(Clozapine) Thromboplastin Time Study Tablet PS ORAL 475 MG/DAY, Prolonged Health ORAL Thrombocytopenia Professional Other Date:01/29/03ISR Number: 4049829-2Report Type:Expedited (15-DaCompany Report #PHFR2002GB04136 Age:39 YR Gender:Female I/FU:I Outcome PT Other C-Reactive Protein Increased Dyspnoea Headache Lymphocyte Count Decreased Monocyte Count Increased Nausea Palpitations Platelet Count Increased Pyrexia Tachycardia Tachypnoea 22-Feb-2006 08:30 AM Page: 2085 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Vomiting Report Source Product Role Manufacturer Route Dose Duration Foreign Clozaril(Clozapine) PS ORAL 150 MG, BID, Study ORAL Health Amisulpride Professional (Amisulpride) C Other Lorazepam C Procyclidine (Procyclidine) C Date:01/29/03ISR Number: 4049846-2Report Type:Expedited (15-DaCompany Report #PHNU2003DE00546 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Colitis Ischaemic Foreign Leponex / Clozaril Initial or Prolonged Colonic Polyp Health (Clozapine) Professional (Clozapine) Tablet PS ORAL 100 MG, TID, Other ORAL Dipiperon (Pipamperone) Tablet, 40 Mg SS ORAL 160 MG/DAY, ORAL Tavor C Timonil Slow Release C Salofalk "Falk" (Mesalazine) C Acetylsalicylic Acid C Date:01/29/03ISR Number: 4050006-XReport Type:Expedited (15-DaCompany Report #PHEH2003US00723 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bone Sarcoma Health Clozaril (Clozapine) Professional Tablet PS ORAL ORAL Date:01/29/03ISR Number: 4050032-0Report Type:Expedited (15-DaCompany Report #PHEH2003US00687 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozaril (Clozapine) Professional Tablet PS ORAL 500 MG, QD, ORAL Date:01/29/03ISR Number: 4050090-3Report Type:Expedited (15-DaCompany Report #PHFR2003GB00565 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cerebrovascular Accident Foreign Clozaril (Clozapine) Circulatory Collapse Study Tablet PS ORAL 400 MG/DAY, Drug Interaction Health ORAL Road Traffic Accident Professional Tramadol SS INJECTION NOS Shock Citalopram C 22-Feb-2006 08:30 AM Page: 2086 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/29/03ISR Number: 4050091-5Report Type:Expedited (15-DaCompany Report #PHFR2003GB00581 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Foreign Clozaril (Clozapine) PS ORAL 300 MG/DAY, Increased Study ORAL Blood Alkaline Health Phosphatase Increased Professional C-Reactive Protein Increased Diarrhoea Eosinophil Count Increased Gamma-Glutamyltransferase Increased Malaise Nausea Vomiting White Blood Cell Count Increased Date:01/29/03ISR Number: 4050169-6Report Type:Expedited (15-DaCompany Report #PHFR2003GB00567 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypoaesthesia Foreign Clozaril (Clozapine) Muscle Twitching Study (Clozapine) PS ORAL 150 MG/DAY Oedema Peripheral Consumer ORAL Paraesthesia Tranexamic Acid C Rash Swelling Date:01/29/03ISR Number: 4050171-4Report Type:Expedited (15-DaCompany Report #PHBS2002CA13570 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Empyema Foreign Clozaril (Clozapine) Initial or Prolonged Pleural Effusion Study Tablet PS ORAL 500 MG/D ORAL Other Pneumonia Health Epival (Valproate Upper Respiratory Tract Professional Semisodium) C Infection Risperdal C Viral Infection Ativan C Cogentin (Benzatropine Mesilate) C Tylenol C Pantoloc (Pantoprazole Sodium) C Date:01/29/03ISR Number: 4054341-0Report Type:Expedited (15-DaCompany Report #02-09-0894 Age:61 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Vaginal Haemorrhage Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, 22-Feb-2006 08:30 AM Page: 2087 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Inc. ORAL 100MG BID ORAL; 300MG TID ORAL Date:01/30/03ISR Number: 4049392-6Report Type:Expedited (15-DaCompany Report #B0290594A Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Consumer Lithium PS Glaxo Wellcome Initial or Prolonged Coordination Abnormal Clozaril SS ORAL 284 DAY Other Dehydration Diabetes Insipidus Grand Mal Convulsion Date:01/30/03ISR Number: 4049796-1Report Type:Expedited (15-DaCompany Report #03-01-0073 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Adenocarcinoma Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 700MG QD ORAL Loxitane C Cogentin C Paxil C Date:01/30/03ISR Number: 4049797-3Report Type:Expedited (15-DaCompany Report #03-01-0072 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Urinary Retention Health Clozapine Tablets - Initial or Prolonged Urinary Tract Infection Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 75 MG QD ORAL Date:01/30/03ISR Number: 4049799-7Report Type:Expedited (15-DaCompany Report #03-01-0066 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Irritable Bowel Syndrome Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 50-325 MG QD ORAL Date:01/30/03ISR Number: 4049803-6Report Type:Expedited (15-DaCompany Report #03-01-0015 Age:81 YR Gender:Female I/FU:I Outcome PT Report Source Death Coronary Artery Disease Health Multi-Organ Failure Professional 22-Feb-2006 08:30 AM Page: 2088 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Product Role Manufacturer Route Dose Duration Clozapine Tablets - Ivax Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 12.5 MG QHS ORAL Insulin C Date:01/30/03ISR Number: 4049804-8Report Type:Expedited (15-DaCompany Report #02-11-1063 Age:52 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL SEE IMAGE Estradiol C Medroxyprogesterone C Levothroid C Celexa C Lorazepam C Date:01/30/03ISR Number: 4049806-1Report Type:Expedited (15-DaCompany Report #03-01-0077 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Oral Intake Reduced Health Clozapine Tablets - Hospitalization - Pneumonia Professional Ivax Initial or Prolonged Refusal Of Treatment By Other Pharmaceuticals, Patient Inc. PS Ivax Pharmaceuticals, Inc. ORAL 75 MG QD ORAL Clozaril C Date:01/30/03ISR Number: 4049813-9Report Type:Expedited (15-DaCompany Report #03-01-0002 Age:44 YR Gender:Female I/FU:F Outcome PT Life-Threatening Bence Jones Protein Urine Hospitalization - Present Initial or Prolonged Biopsy Skin Abnormal Blood Fibrinogen Increased Body Temperature Increased C-Reactive Protein Increased Delirium Diarrhoea Drug Ineffective Electroencephalogram Abnormal 22-Feb-2006 08:30 AM Page: 2089 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lymphadenopathy Oedema Oedema Peripheral Report Source Product Role Manufacturer Route Dose Duration Pericardial Effusion Foreign Clozapine Tablets PS ORAL 25-150MG QD Pleural Effusion Literature ORAL 17 DAY Rash Health Red Blood Cell Professional Sedimentation Rate Increased Respiratory Disorder Suspiciousness White Blood Cell Count Increased Date:01/30/03ISR Number: 4050484-6Report Type:Expedited (15-DaCompany Report #PHFR2002GB02129 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Diabetes Mellitus Foreign Clozaril (Clozapine) Insulin-Dependent Health Tablet PS ORAL 600MG/DAY, Professional ORAL Other Flupentixol Decanoate (Flupentixol Decanoate) C Procyclidine (Procyclidine) C Buspirone (Buspirone) C Cloral Betaine (Cloral Betaine) C Date:01/30/03ISR Number: 4050495-0Report Type:Expedited (15-DaCompany Report #PHFR2003GB00599 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril (Clozapine) Study (Clozapine) PS ORAL ORAL Health Professional Other Date:01/30/03ISR Number: 4050511-6Report Type:Expedited (15-DaCompany Report #PHNR2002AU00591 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Foreign Clozaril (Clozapine) Initial or Prolonged Abdominal Pain Upper Study (Clozapine) PS 600MG/DAY, Drug Withdrawal Syndrome Health Amisulpride Nausea Professional (Amisulpride) C Vomiting Other 22-Feb-2006 08:30 AM Page: 2090 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/31/03ISR Number: 4050376-2Report Type:Expedited (15-DaCompany Report #C2002-3633.01 Age:76 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Health Clozapine Tablets 25 Myocardial Infarction Professional Mg Mylan PS Mylan ORAL 75MG QD, THEN Pneumonia Other 25MG QD, ORAL Clozapine Tablets 100 Mg Mylan SS Mylan ORAL 100MG QD, ORAL Insulin C Alendronate C Fludrocortisone C Lansoprazole C Celecoxib C Glipizide C Pentoxifylline Er C Gabapentin C Gemfibrozil C Zafirlukast C Pioglitazone C Polysaccharide Iron Complex C Tolterodine C Date:01/31/03ISR Number: 4050378-6Report Type:Expedited (15-DaCompany Report #C2003-0092.01 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 600MG QD, Other ORAL Date:01/31/03ISR Number: 4050380-4Report Type:Expedited (15-DaCompany Report #C2002-3050.01 Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Effect Decreased Health Clozapine Tablets Drug Interaction Professional 100 Mg Mylan PS Mylan ORAL 200MG Q AM, Other 400MG Q PM, ORAL Paxil Tablets 40 Mg Glaxosmithkline SS Glaxosmithkline ORAL 40MG QD, ORAL Benztropine C Clonazepam C Haloperidol C Unknown Inhalers C Lansoprazole C Morphine C Ziprasidone C Date:01/31/03ISR Number: 4050428-7Report Type:Expedited (15-DaCompany Report #PHNU2002DE03628 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Foreign Leponex / Clozaril Oculogyration Health (Clozapine)(Clozapin Weight Increased Professional e) Tablet PS ORAL SEE IMAGE Other 22-Feb-2006 08:30 AM Page: 2091 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/31/03ISR Number: 4050429-9Report Type:Expedited (15-DaCompany Report #PHFR2002GB03903 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Clozaril(Clozapine) Drug Level Increased Study Tablet PS ORAL ORAL Malaise Health Pallor Professional Other Date:01/31/03ISR Number: 4050774-7Report Type:Expedited (15-DaCompany Report #PHEH2003US00864 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Leukaemia Health Clozaril (Clozapine Professional ) Tablet PS ORAL 350 MG, QD, ORAL Date:01/31/03ISR Number: 4051103-5Report Type:Expedited (15-DaCompany Report #PHFR2002GB03678 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Clozaril (Clozapine) Other Circulatory Collapse Study (Clozapine) Tablet PS ORAL ORAL Condition Aggravated Health Chlorpromazine Convulsion Professional (Chlorpromazine) C Emphysema Other Haemoglobin Decreased Neutrophilia Platelet Count Increased Pneumonia Shock White Blood Cell Count Increased Date:01/31/03ISR Number: 4051108-4Report Type:Expedited (15-DaCompany Report #PHBS2002NL13937 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Level Increased Foreign Leponex (Clozapine) Initial or Prolonged Liver Function Test Health Tablet PS ORAL ORAL; 100 Abnormal Professional MG/D, ORAL Lung Crepitation Other Risperidone C Lung Infiltration Temazepam C Oedema Peripheral Oxazepam (Oxazepam) C Red Blood Cell Sedimentation Rate Increased Thrombocythaemia Date:01/31/03ISR Number: 4051135-7Report Type:Expedited (15-DaCompany Report #PHFR2002GB04303 Age:50 YR Gender:Male I/FU:F Outcome PT Report Source Other Cardiac Murmur Foreign Gastroenteritis Study Sinus Tachycardia Health Professional 22-Feb-2006 08:30 AM Page: 2092 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Product Role Manufacturer Route Dose Duration Clozaril (Clozapine) Unknown PS ORAL 300MG/DAY, ORAL Date:01/31/03ISR Number: 4051194-1Report Type:Expedited (15-DaCompany Report #PHFR2002GB04200 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alpha Hydroxybutyrate Foreign Clozaril (Clozapine) PS ORAL 250 MG/DAY, Initial or Prolonged Dehydrogenase Increased Study ORAL Other Blood Creatine Health Lorazepam C Phosphokinase Increased Professional Thyroxine C Chest Pain Other Dyspnoea Eyelid Oedema Face Oedema Liver Function Test Abnormal Date:01/31/03ISR Number: 4051308-3Report Type:Expedited (15-DaCompany Report #PHEH2002US10274 Age:44 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Health Clozaril(Clozapine)T Pneumonia Professional ablet PS ORAL 600 MG, QHS, Respiratory Arrest ORAL Prozac (Fluoxetine Hydrochloride) C Depakote (Valproate Semisodium) C Date:02/03/03ISR Number: 4051412-XReport Type:Expedited (15-DaCompany Report #PHBS2003US01075 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Basal Cell Carcinoma Literature Clozapine(Clozapine) PS 400 MG/D, Drug Ineffective Health UNKNOWN; SEE Paranoia Professional IMAGE 1825 DAY Haloperidol Decanoate (Haloperidol Decanoate) C Date:02/03/03ISR Number: 4051413-1Report Type:Expedited (15-DaCompany Report #PHEH2003US00907 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aneurysm Other Clozaril(Clozapine) Initial or Prolonged Back Pain Tablet PS ORAL 800 MG/DAY, Leukopenia ORAL Spinal Cord Disorder Luvox (Fluvoxamine Maleate) C 22-Feb-2006 08:30 AM Page: 2093 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/03/03ISR Number: 4051466-0Report Type:Expedited (15-DaCompany Report #PHNU2003DE00613 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Foreign Leponex/Clozaril Initial or Prolonged Csf Protein Increased Health (Clozapine) Other Drug Level Increased Professional (Clozapine) Tablet PS ORAL 800 MG/DAY, Other ORAL Date:02/03/03ISR Number: 4051471-4Report Type:Expedited (15-DaCompany Report #PHHO2003CA01197 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril (Clozapine) Study Tablet PS Health Professional Other Date:02/03/03ISR Number: 4051503-3Report Type:Expedited (15-DaCompany Report #NSADSS2003004003 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Loss Of Consciousness Study Risperidone Initial or Prolonged Road Traffic Accident Health (Unspecified) Professional (Risperidone) PS Clozapine (Clozapine) SS Hydroxyzine Pamoate C Zoxor (Simvastatin) C Food Supplements C Date:02/03/03ISR Number: 4051513-6Report Type:Expedited (15-DaCompany Report #PHEH2003US00853 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acute Respiratory Failure Health Clozaril (Clozapine) Initial or Prolonged Pneumonia Professional Tablet PS ORAL 600 MG, QD, ORAL Depakote (Valproate Semisodium) C Zoloft (Sertraline Hydrochloride) C Cogentin (Benzatropine Mesilate) C Vitamin E C Alprazolam (Alprazolam) C Date:02/03/03ISR Number: 4051514-8Report Type:Expedited (15-DaCompany Report #PHEH2003US00982 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neoplasm Malignant Health Clozaril (Clozapine) Professional Tablet PS ORAL ORAL 22-Feb-2006 08:30 AM Page: 2094 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/03/03ISR Number: 4052095-5Report Type:Expedited (15-DaCompany Report #PHFR2003GB00614 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril (Clozapine) PS ORAL ORAL Study Health Professional Other Date:02/03/03ISR Number: 4052096-7Report Type:Expedited (15-DaCompany Report #PHBS2003CA01162 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Intraocular Pressure Foreign Clozaril(Clozapine)T Increased Health ablet PS ORAL 300 MG/D, Professional ORAL Other Ativan C Date:02/03/03ISR Number: 4052135-3Report Type:Expedited (15-DaCompany Report #PHFR2002IE00998 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Diabetes Mellitus Foreign Clozaril (Clozapine) Hospitalization - Diabetic Coma Health Tablet PS ORAL SEE IMAGE Initial or Prolonged Diabetic Ketoacidosis Professional Insulin (Insulin) C Other Haloperidol C Lithium (Lithium) C Valproate Sodium C Zopiclone C Citalopram (Citalopram) C Priadel C Date:02/03/03ISR Number: 4052147-XReport Type:Expedited (15-DaCompany Report #PHBS2002CA13686 Age:67 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Atelectasis Foreign Clozaril (Clozapine) Other Cardio-Respiratory Arrest Study Tablet PS ORAL 62.5MG, Confusional State Health DAILY, ORAL Convulsion Professional Dilantin (Phenytoin Drug Level Below Other Sodium) SS Therapeutic Metformin C Electrocardiogram St Valium C Segment Elevation Lipitor C General Physical Health Synthroid C Deterioration Amantadine C Myocardial Infarction Celexa C Pneumonia Acetylsalicylic Acid C Red Blood Cell Sedimentation Rate Increased Tachycardia 22-Feb-2006 08:30 AM Page: 2095 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/03/03ISR Number: 4053063-XReport Type:Periodic Company Report #FLUV00202000136 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Luvox (Fluvoxamine Initial or Prolonged Fall Professional Maleate) PS ORAL 50 MG QD PO, Lumbar Vertebral Fracture 25 MG QD PO Clozapine (Clozapine) SS ORAL 650 MG DAILY PO, 700 MG QD PO, 300 MG DAILY PO Oxybutynin (Oxytynin) C Celebrex (Celecoxib) C Date:02/04/03ISR Number: 4051360-5Report Type:Expedited (15-DaCompany Report #C2002-3637.01 Age:78 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Failure To Thrive Other Clozapine Tablets 25 Pneumonia Aspiration Mg Mylan PS ORAL 37.5 MG Q AM, 25 MG Q PM, ORAL Carbidopa C Levodopa Er C Tamsulosin Hcl C Hydrocodone/Apap C Chlorzoxazone C Acetaminophen C Multivitamin With Mineral (Qd) C Fleet Enema/Bisacodyl C Suppository (Prn Constipation) C Milk Of Magnesia C Date:02/04/03ISR Number: 4052654-XReport Type:Expedited (15-DaCompany Report #GB9147215AUG2002 Age:28 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Minocin Medication Error Professional (Minocycline, Treatment Noncompliance Other Unspec) PS Clozaril (Clozapine, , 0) SS 800 MG (FREQUENCY UNKNOWN) Valproate Sodium C Seroxat (Paroxetine Hydrochloride) C Trimethoprim C 22-Feb-2006 08:30 AM Page: 2096 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/06/03ISR Number: 4053613-3Report Type:Expedited (15-DaCompany Report #C2003-0145.01 Age:87 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg Mylan PS ORAL 25MG, BID, Other ORAL Clonazepam C Furosemide C Morphine Sulfate C Olanzapine C Prochlorperazine C Senna C Carbidopa/Levodopa C Date:02/06/03ISR Number: 4053614-5Report Type:Expedited (15-DaCompany Report #C2003-0147.01 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Clozapine Tablets Professional 100 Mg Mylan PS ORAL 200MG, Q HS, Other ORAL Clonazepam C Estazolam C Date:02/07/03ISR Number: 4054318-5Report Type:Expedited (15-DaCompany Report #03-01-0091 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 300-600MG QD ORAL Date:02/07/03ISR Number: 4054319-7Report Type:Expedited (15-DaCompany Report #03-01-0090 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 300-400MG QD ORAL Date:02/07/03ISR Number: 4054320-3Report Type:Expedited (15-DaCompany Report #03-01-0089 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Health Clozapine - Ivax Fall Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 150-400MG QD ORAL 22-Feb-2006 08:30 AM Page: 2097 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/07/03ISR Number: 4054321-5Report Type:Expedited (15-DaCompany Report #03-01-0088 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 400-500MG QD ORAL Date:02/07/03ISR Number: 4054322-7Report Type:Expedited (15-DaCompany Report #03-01-0086 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine - Ivax Treatment Noncompliance Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 50-600MG QD ORAL Date:02/07/03ISR Number: 4054323-9Report Type:Expedited (15-DaCompany Report #03-01-0097 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Laryngeal Cancer Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 400MG QD ORAL Date:02/07/03ISR Number: 4054324-0Report Type:Expedited (15-DaCompany Report #03-01-0096 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Chronic Obstructive Health Clozapine - Ivax Pulmonary Disease Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL SEE IMAGE ORAL Date:02/07/03ISR Number: 4054327-6Report Type:Expedited (15-DaCompany Report #C2002-3623.01 Age:63 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 75MG Q HS, Other ORAL Clozapine Tablets 100 Mg Mylan SS Mylan ORAL 300MG Q A, 200 MG Q PM, ORAL Azithromycin C Benztropine C Cetirizine C Divalproex Sodium C 22-Feb-2006 08:30 AM Page: 2098 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Fluticasone Nasal Spray C Furosemide C Ipratropium /Albuterol Nasal Inhaler C Levo-Thyroxine C Levofloxacin C Potassium C Prednisone C Tamoxifen C Date:02/07/03ISR Number: 4054328-8Report Type:Expedited (15-DaCompany Report #03-01-0116 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anorexia Health Clozapine Tablets - Initial or Prolonged Dehydration Professional Ivax Lethargy Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL ORAL Zyprexa C Clonazepam C Ranitidine C Lorazepam C Zoloft C Risperdal C Folic Acid C Levodopa-Carbidopa C Benztropine Mesylate C Date:02/07/03ISR Number: 4054329-XReport Type:Expedited (15-DaCompany Report #03-01-0102 Age:90 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiopulmonary Failure Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 25MG QD ORAL Date:02/07/03ISR Number: 4054330-6Report Type:Expedited (15-DaCompany Report #03-01-0100 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Lung Neoplasm Malignant Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 600MG QD ORAL 22-Feb-2006 08:30 AM Page: 2099 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/07/03ISR Number: 4054331-8Report Type:Expedited (15-DaCompany Report #03-01-0099 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL ORAL Date:02/07/03ISR Number: 4054332-XReport Type:Expedited (15-DaCompany Report #03-01-0095 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hypothermia Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL ORAL Date:02/07/03ISR Number: 4054333-1Report Type:Expedited (15-DaCompany Report #03-01-0093 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Potassium Decreased Health Clozapine Tablets - Initial or Prolonged Crohn'S Disease Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 300MG QD ORAL Date:02/07/03ISR Number: 4054334-3Report Type:Expedited (15-DaCompany Report #03-01-0092 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 50MG QD ORAL Date:02/07/03ISR Number: 4054339-2Report Type:Expedited (15-DaCompany Report #02-12-1172 Age:71 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Clozapine Tablets - Hospitalization - Congestive Professional Ivax Initial or Prolonged Pneumonia Other Pharmaceuticals, Sepsis Inc. PS Ivax Pharmaceuticals, Inc. ORAL 200MG QHS ORAL 22-Feb-2006 08:30 AM Page: 2100 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/07/03ISR Number: 4054340-9Report Type:Expedited (15-DaCompany Report #02-10-0946 Age:62 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Gastrointestinal Disorder Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 250-800MG QD ORAL Date:02/07/03ISR Number: 4054342-2Report Type:Expedited (15-DaCompany Report #02-03-0224 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Neoplasm Malignant Health Clozapine Tablets - Hospitalization - Professional Ivax Initial or Prolonged Other Pharmaceuticals, Other Inc. PS Ivax Pharmaceuticals, Inc. ORAL 800-900MG QD ORAL Date:02/10/03ISR Number: 4054620-7Report Type:Expedited (15-DaCompany Report #PHNU2002DE03696 Age:21 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Foreign Leponex/Clozaril Drug Interaction Health (Clozapine/Clozapine Drug Level Increased Professional ) Tablet PS ORAL 300MG/DAY, Grand Mal Convulsion Other ORAL Petit Mal Epilepsy Hypnorex - Slow Release (Lithium Carbonate) Slow Release Tablet SS ORAL 150MG/DAY, ORAL Date:02/10/03ISR Number: 4054639-6Report Type:Direct Company Report #CTU 186314 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Vein Disorder Clozaril 500ml Daily PS Intervention to Eskalith 900 Ml Prevent Permanent Daily SS Impairment/Damage Date:02/10/03ISR Number: 4054699-2Report Type:Expedited (15-DaCompany Report #PHHO2002CA10388 Age:62 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Foreign Clozapine Initial or Prolonged Coordination Abnormal Study (Clozapine) Tablet PS Drug Toxicity Health Epival (Valproate Fall Professional Semisodium) C Hip Fracture Other Malaise 22-Feb-2006 08:30 AM Page: 2101 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/10/03ISR Number: 4054763-8Report Type:Direct Company Report #CTU 186322 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiomyopathy Clozaril PS ORAL 350MG BID Initial or Prolonged Mitral Valve Incompetence ORAL Required Zoloft C Intervention to Risperdal C Prevent Permanent Lithium C Impairment/Damage Wellbutrin C Date:02/11/03ISR Number: 4054619-0Report Type:Expedited (15-DaCompany Report #C2002-3608.01 Age:70 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Metastatic Neoplasm Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 200MG Q AM Other AND Q HS, ORAL Clozapine SS Mylan ORAL 25MG Q AM AND 50 MG Q HS, ORAL Digoxin C Aspirin Enteric Coated C Potassium C Levothyroxine C Fexofenadine C Acetaminophen C Albuterol Inhaler C Famotidine C Divalproex Sodium C Date:02/11/03ISR Number: 4055736-1Report Type:Direct Company Report #CTU 186444 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Screen Positive Clozapine 200mg Mylan PS Mylan 200MG AM/400MG PM 1 YR Paroxetine SS 40MG QD Haldol C Clonazepam C Geodon C Previcid C Cogentin C Oramorph C Promethazine C Date:02/11/03ISR Number: 4056474-1Report Type:Expedited (15-DaCompany Report #PHEH2003US00910 Age:20 YR Gender:Male I/FU:I Outcome PT Hospitalization - Aggression Initial or Prolonged Catatonia Convulsion Dry Mouth Feeling Hot Headache 22-Feb-2006 08:30 AM Page: 2102 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Incontinence Mania Speech Disorder Report Source Product Role Manufacturer Route Dose Duration Consumer Clozaril (Clozapine) Tablet PS ORAL 700 MG/DAY, ORAL Dilantin C Klonopin C Seroquel (Quetiapine Fumarate) C Date:02/11/03ISR Number: 4056520-5Report Type:Expedited (15-DaCompany Report #PHNU2002DE04220 Age:61 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Arrhythmia Foreign Leponex / Clozaril Hospitalization - Atrial Fibrillation Health (Clozapine) Initial or Prolonged Blood Glucose Increased Professional (Clozapine) Tablet PS ORAL 25 MG, QD, Other Cardiomegaly Other ORAL Dialysis Elcrit (Clozapine) SS ORAL ORAL Dysphagia Atosil Fall (Isopromethazine Gamma-Glutamyltransferase Hydrochloride) C Increased Beloc-Zoc Mite Neuroleptic Malignant (Metoprolol Syndrome Succinate) C Oedema Peripheral Acetylsalicylic Acid C Pneumonia Plavix (Clopidogrel Pulmonary Oedema Sulfate) C Renal Failure Acute Digimerck C Rhabdomyolysis Solian (Amisulpride) C Skin Discolouration Date:02/11/03ISR Number: 4056525-4Report Type:Expedited (15-DaCompany Report #PHFR2002GB04176 Age:31 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Foreign Clozaril (Clozapine) PS ORAL 250MG/DAY, Initial or Prolonged Non-Insulin-Dependent Study ORAL Disability Eyelid Ptosis Health Hyoscine C Iiird Nerve Paralysis Professional Lansoprazole C Other Lofepramine C Date:02/11/03ISR Number: 4056528-XReport Type:Expedited (15-DaCompany Report #PHNU2003DE00678 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Foreign Leponex / Clozaril Initial or Prolonged Non-Insulin-Dependent Health (Clozapine) Other Lung Neoplasm Professional (Clozapine) Tablet PS ORAL 100 MG/DAY, Other ORAL 22-Feb-2006 08:30 AM Page: 2103 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/11/03ISR Number: 4056531-XReport Type:Expedited (15-DaCompany Report #PHBS2003IT01302 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Foreign Leponex (Clozapne) Health Tablet PS ORAL 25 MG/D, ORAL Professional Zyprexa C Other Entumin C Date:02/11/03ISR Number: 4056716-2Report Type:Expedited (15-DaCompany Report #PHFR2002GB04115 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Complications Of Maternal Foreign Clozaril Exposure To Therapeutic Health (Clozapine)(Clozapin Drugs Professional e) Tablet PS ORAL 350 MG/DAY, Maternal Drugs Affecting Other ORAL Foetus Diazepam C Stillbirth Sertaline (Sertraline) C Zopiclone C Date:02/11/03ISR Number: 4057203-8Report Type:Expedited (15-DaCompany Report #PHFR2002GB01847 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Dialysis Foreign Clozaril (Clozapine) Other Renal Failure Chronic Health Tablet PS ORAL 275 MG/DAY, Professional ORAL; 600 Other MG/DAY, ORAL Epilim Chrono C Atorvastatin C Lactulose C Omeprazole C Frusemide C Calcichew C Hydroxocobalamin C Erythropoietin C Date:02/12/03ISR Number: 4056016-0Report Type:Expedited (15-DaCompany Report #C2002-3050.01 Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Effect Decreased Health Clozapine Tablets Drug Interaction Professional 100 Mg Mylan PS ORAL 200MG Q AM, Other 400MG Q PM ORAL YR Paxil Tablets 40 Mg Glaxosmithkline SS Glaxosmithkline ORAL 40MG, QD, ORAL Benztropine C Clonazepam C Haloperidol Injection C Unknown Inhalers C Lansoprazole C Morphine C Ziprasidone C 22-Feb-2006 08:30 AM Page: 2104 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/12/03ISR Number: 4056787-3Report Type:Expedited (15-DaCompany Report #PHFR2003GB00715 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Diabetic Ketoacidosis Foreign Clozaril(Clozapine) PS ORAL ORAL Lower Respiratory Tract Study Taxol C Infection Health Carboplatin(Carbopla Professional tin) C Other Date:02/12/03ISR Number: 4056961-6Report Type:Expedited (15-DaCompany Report #PHFR2002GB04094 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cerebral Infarction Foreign Clozaril (Clozapine) Cerebrovascular Accident Study (Clozapine)(Clozapin Cerebrovascular Disorder Health e) Tablet PS ORAL 725 MG/DAY, Drug Level Increased Professional ORAL Obesity Amisulpride C Citalopram C Valproate Sodium C Hyoscine Hydrobromide C Omeprazole C Amisulpride C Date:02/12/03ISR Number: 4057242-7Report Type:Expedited (15-DaCompany Report #EMADSS2003001016 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Risperdal Health (Unspecified)(Risper Professional idone) PS Leponex (Clozapine) SS Date:02/12/03ISR Number: 4057869-2Report Type:Expedited (15-DaCompany Report #PHEH2002US10391 Age:49 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozaril (Clozapine) Condition Aggravated Professional Tablet PS ORAL SEE IMAGE Delusion Eskalith C Hypersomnia Klonopin C Leukocytosis Sleep Apnoea Syndrome Somnolence Weight Increased Date:02/12/03ISR Number: 4057870-9Report Type:Expedited (15-DaCompany Report #PHEH2003US00982 Age:55 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other B-Cell Lymphoma Health Clozaril(Clozapine) Professional Tablet PS ORAL 400 MG/DAY, ORAL 1825 DAY Depakote (Valproate Semisodium) C Clomipramine 22-Feb-2006 08:30 AM Page: 2105 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Clomipramine) C Date:02/12/03ISR Number: 4058653-6Report Type:Expedited (15-DaCompany Report #PHBS2002AU02886 Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiomegaly Foreign Clozaril(Clozapine) Hospitalization - Pneumonia Health Tablet PS ORAL ORAL Initial or Prolonged Ventricular Hypokinesia Professional Clomipramine Other (Clomipramine) C Haloperidol C Date:02/12/03ISR Number: 4058655-XReport Type:Expedited (15-DaCompany Report #PHFR2002GB04250 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril(Clozapine) Glucose Tolerance Test Study Unknown PS ORAL 550 MG/DAY, Abnormal Health ORAL Professional Hyoscine(Hyoscine) C Other Date:02/13/03ISR Number: 4057295-6Report Type:Expedited (15-DaCompany Report #C2003-0198.01 Age:85 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Other Clozapine Tablets 25 Mg Mylan PS ORAL 500MG QD, ORAL Citalopram C Donepezil C Lansoprazole C Date:02/13/03ISR Number: 4057305-6Report Type:Expedited (15-DaCompany Report #C2003-0240.01 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Other Clozapine Tablets 25 Mg Mylan PS Mylan ORAL 50MG/DAY ORAL Date:02/13/03ISR Number: 4057359-7Report Type:Expedited (15-DaCompany Report #PHFR2003GB00792 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dizziness Foreign Clozaril (Clozapine) PS ORAL ORAL Hypertension Health Neuroleptic Malignant Professional Syndrome Subarachnoid Haemorrhage Date:02/13/03ISR Number: 4057511-0Report Type:Expedited (15-DaCompany Report #PHFR2003GB00684 Age:59 YR Gender:Male I/FU:I Outcome PT Other Dizziness Emphysema 22-Feb-2006 08:30 AM Page: 2106 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Fatigue Hypotension Tachyarrhythmia Report Source Product Role Manufacturer Route Dose Duration White Blood Cell Count Foreign Clozaril(Clozapine) PS ORAL ORAL Increased Study Health Professional Other Date:02/13/03ISR Number: 4057560-2Report Type:Expedited (15-DaCompany Report #PHFR2003GB00582 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Drop Attacks Foreign Clozaril (Clozapine) PS ORAL 350MG/DAY, Hospitalization - Loss Of Consciousness Study ORAL; Initial or Prolonged Respiratory Arrest Health 200MG/DAY, Other Sleep Apnoea Syndrome Professional ORAL Other Date:02/13/03ISR Number: 4057723-6Report Type:Expedited (15-DaCompany Report #PHNU2003DE00751 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cholecystitis Foreign Leponex / Clozaril Initial or Prolonged Health (Clozapine) Professional (Clozapine) Tablet PS ORAL 225 MG/DAY, Other ORAL Date:02/13/03ISR Number: 4057909-0Report Type:Expedited (15-DaCompany Report #PHEH2003US00534 Age:41 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Diabetic Coma Health Clozaril (Clozapine) Hospitalization - Diabetic Ketoacidosis Professional Tablet, 100mg PS ORAL 300 MG, QD, Initial or Prolonged Hepatitis A Virus ORAL Hepatitis B Virus Prozac (Fluoxetine Hepatitis C Virus Hydrochloride) C Pancreatitis Vitamin E C Lipitor C Date:02/13/03ISR Number: 4057963-6Report Type:Expedited (15-DaCompany Report #PHEH2002US04060 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Chronic Obstructive Health Clozaril(Clozapine) Pulmonary Disease Professional Tablet PS ORAL 600 MG, QHS, Company ORAL Representative Theophylline C Prevacid (Lansoprazole) C Verapamil (Verapamil) C Benadryl C Paxil C 22-Feb-2006 08:30 AM Page: 2107 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/13/03ISR Number: 4057983-1Report Type:Expedited (15-DaCompany Report #PHFR2003GB00717 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Transient Ischaemic Foreign Clozaril Attack Study (Clozapine)(Clozapin Health e) Unknown PS ORAL ORAL Professional Lithium (Lithium) C Other Date:02/13/03ISR Number: 4057984-3Report Type:Expedited (15-DaCompany Report #PHFR2002GB04132 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arrhythmia Foreign Clozaril(Clozapine) Initial or Prolonged Atrioventricular Block Study Tablet PS ORAL 600 MG/DAY, Other Complete Health ORAL Atrioventricular Block Professional Simvastatin C First Degree Other Sertraline Bundle Branch Block Left (Sertraline) C C-Reactive Protein Sulpiride Increased (Sulpiride) C Convulsion Aspirine C Hypertension Diazepam C Left Ventricular Failure Tolbutamide Myocarditis (Tolbutamide) C Overdose Ramipril (Ramipril) C Pneumonia Aspiration Renal Impairment Shock Staphylococcal Sepsis Streptococcal Sepsis Ventricular Tachycardia Date:02/19/03ISR Number: 4057656-5Report Type:Direct Company Report #CTU 186809 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Medication Error Clozaril 25 Mg PS ORAL 25 MG 5 QHS Initial or Prolonged Somnolence PO 2 QHS PO Sinemet C Tasmir C Zanaflex C Paxil Cr C Aricept C Celebrex C Requip C Date:02/19/03ISR Number: 4058263-0Report Type:Expedited (15-DaCompany Report #03-01-0065 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Respiratory Arrest Health Clozapine Tablets - Sleep Apnoea Syndrome Professional Ivax Other Pharmaceuticals, Inc. PS ` ORAL 300MG QD ORAL 22-Feb-2006 08:30 AM Page: 2108 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/19/03ISR Number: 4058269-1Report Type:Expedited (15-DaCompany Report #03-02-0120 Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Urinary Tract Infection Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc ORAL 25MG QD ORAL Klonopin C Amantidine C Lovenox C Detrol C Flomax C Risperdal C Lotrel C Aspirin C Prozac C Depakote C Chlorpromazine C Clonidine C Flagyl C Date:02/19/03ISR Number: 4058272-1Report Type:Expedited (15-DaCompany Report #03-02-0130 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc PS Ivax Pharmaceuticals, Inc ORAL 300-450MG QD ORAL Date:02/19/03ISR Number: 4058276-9Report Type:Expedited (15-DaCompany Report #03-02-0139 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Renal Failure Health Clozapine Tablets - Professional Ivax Pharmaceuticals, Inc PS Ivax Pharmaceuticals, Inc ORAL 200-300MG QD ORAL Date:02/19/03ISR Number: 4058278-2Report Type:Expedited (15-DaCompany Report #03-02-0140 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Neoplasm Malignant Health Clozapine Tablets - Other Respiratory Failure Professional Ivax Other Pharmaceuticals, Inc PS Ivax Pharmaceuticals, Inc ORAL 600-1100MG QD ORAL 22-Feb-2006 08:30 AM Page: 2109 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/19/03ISR Number: 4058287-3Report Type:Expedited (15-DaCompany Report #03-02-0141 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Infection Health Clozapine Tablets - Initial or Prolonged Pneumonia Professional Ivax Testicular Disorder Other Pharmaceuticals, Inc PS Ivax Pharmaceuticals, Inc ORAL ORAL Date:02/19/03ISR Number: 4058290-3Report Type:Expedited (15-DaCompany Report #03-02-0144 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chronic Obstructive Health Clozapine Tablets - Initial or Prolonged Pulmonary Disease Professional Ivax Coma Other Pharmaceuticals, Inc PS Ivax Pneumonia Pharmaceuticals, Inc ORAL 50-400MG QD Sepsis ORAL Date:02/19/03ISR Number: 4058293-9Report Type:Expedited (15-DaCompany Report #02-12-1177 Age:81 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Chronic Obstructive Health Clozapine Tablets - Pulmonary Disease Professional Ivax Hypoxia Other Pharmaceuticals, Inc PS Ivax Respiratory Tract Pharmaceuticals, Inc ORAL 100MG BID Infection ORAL Date:02/19/03ISR Number: 4059682-9Report Type:Expedited (15-DaCompany Report #A044-002-004156 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutropenia Foreign Aricept (Donepezil) PS ORAL 5 MG, 1 IN 1 Initial or Prolonged Health D, PER ORAL Professional Bromazepam (Bromazepam) SS ORAL 3 MG, PER ORAL Clozapine (Clozapine) SS ORAL 25 MG, PER ORAL Cyamemazine Tartrate (Cyamemazine) SS ORAL 25 DROPS, PER ORAL Levofloxacine (Tavanic) C ORAL 500 MG, PER ORAL Date:02/19/03ISR Number: 4059753-7Report Type:Expedited (15-DaCompany Report #EMADSS2003001211 Age:49 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Foreign Zydol (Unspecified) Initial or Prolonged Drug Interaction Health (Tramadol Pain Professional Hydrochloride) PS Shock Other Clozaril (Clozapine) SS ORAL ORAL Citalopram (Citalopram) C 22-Feb-2006 08:30 AM Page: 2110 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/19/03ISR Number: 4059823-3Report Type:Expedited (15-DaCompany Report #EMADSS2003001171 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arrhythmia Foreign Haldol Decanoate Initial or Prolonged Atrial Fibrillation Health (Injection) Professional (Haloperidol Decanoate) PS INTRAMUSCULAR 75 MG, 1 IN 4 WEEK (S), IM Leponex (Clozapine) SS ORAL SEE IMAGE Glianimon (Benperidol) SS ORAL SEE IMAGE Zeldox SS ORAL SEE IMAGE Ximovan (Zopiclone) C Pantozol (Pantoprazole Sodium) C Date:02/19/03ISR Number: 4059831-2Report Type:Expedited (15-DaCompany Report #B0292199A Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Alcohol Poisoning Foreign Paracetamol Choking (Formulation Drug Toxicity Unknown) (Generic) Intentional Overdose (Acetaminophen) PS Clozapine (Formulation Unknown) (Clozapine) SS ORAL 100 MG/ THREE TIMES PER DAY/ ORAL Date:02/19/03ISR Number: 4059839-7Report Type:Expedited (15-DaCompany Report #EMADSS2003001211 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Foreign Zydol (Unspecified) Initial or Prolonged Drug Interaction Health (Tramadol Shock Professional Hydrochloride) PS Clozaril (Clozapine) SS ORAL ORAL Citalopram (Citalopram) C Date:02/20/03ISR Number: 4058604-4Report Type:Direct Company Report #CTU 186909 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bronchospasm Clozapine PS 100MG 2 Q PM Pharmaceutical Product Depakote C Complaint Date:02/20/03ISR Number: 4059018-3Report Type:Direct Company Report #CTU 186962 Age:46 YR Gender:Male I/FU:I Outcome PT Death Acute Respiratory Distress Syndrome Cardiogenic Shock 22-Feb-2006 08:30 AM Page: 2111 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Cardiomyopathy Myocarditis Respiratory Arrest Report Source Product Role Manufacturer Route Dose Duration Clozaril Novartis PS Novartis ORAL 200 MG BID ORAL Date:02/20/03ISR Number: 4059477-6Report Type:Expedited (15-DaCompany Report #C2003-0284.01 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pharmaceutical Product Health Clozapine Tablets Complaint Professional 100 Mg Mylan PS Mylan ORAL 250MG QD, Other THEN 300MG QD, ORAL Date:02/20/03ISR Number: 4062669-3Report Type:Periodic Company Report #2002-10-3284 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agitation Health Peg-Intron Required Anxiety Professional (Peginterferon Intervention to Insomnia Other Alfa-2b) Injectable Prevent Permanent Irritability Powder PS SUBCUTANEOUS 120 MCG QWK Impairment/Damage Leukopenia SUBCUTANEOUS Neutropenia Rebetol (Ribavirin) Suicidal Ideation Capsules SS ORAL 1000 MG QD PO ORAL Clozapine SS ORAL 550-600MG QD ORAL Alprazolam C Sertraline Hcl C L-Thyroxin C Doss C Date:02/21/03ISR Number: 4061910-0Report Type:Expedited (15-DaCompany Report #C2002-3633.01 Age:76 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Health Clozapine Tablets 25 Myocardial Infarction Professional Mg Mylan PS Mylan ORAL 75MG QD, THEN Pneumonia Other 25MG QD, ORAL Clozapine Tablets 100 Mg Mylan SS Mylan ORAL 100MG QD, ORAL Insulin C Alendronate C Fludrcortisone C Lansoprazole C Celecoxib C Glipizide C Pentoxifylline Er C Gabapentin C Gemfibrozil C Zafirlukast C Pioglitazone C Polysaccharide Iron Complex C Tolterodine C 22-Feb-2006 08:30 AM Page: 2112 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/21/03ISR Number: 4062105-7Report Type:Expedited (15-DaCompany Report #PHBS2003NL01496 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Haemoglobin Increased Foreign Leponex (Clozapine) Initial or Prolonged Liver Function Test Health Tablet PS 300 MG/D 21 DAY Abnormal Professional Risperdal C Lung Crepitation Other Oedema Peripheral Red Blood Cell Sedimentation Rate Increased Thrombocythaemia Date:02/21/03ISR Number: 4062110-0Report Type:Expedited (15-DaCompany Report #PHRM2002FR01260 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abdominal Distension Foreign Leponex(Clozapine)Ta Amenorrhoea Health blet PS TRANSPLACENTAL TRANSPLACENTA Amniotic Cavity Disorder Professional L Caesarean Section Other Tranxene(Clorazepate Feeding Disorder Neonatal Dipotassium) SS TRANSPLACENTAL TRANSPLACENTA Foetal Arrhythmia L Hypotonia Neonatal Lepticur Ileus Paralytic (Tropatepine Malaise Hydrochloride) SS TRANSPLACENTAL TRANSPLACENTA Maternal Drugs Affecting L Foetus Sulfarlem (Anethole Oligohydramnios Trithione) C Pain Atarax (Hydroxyzine Vomiting Hydrochloride) C Zoloft (Sertraline Hydrochloride) C Mogadon C Date:02/21/03ISR Number: 4062111-2Report Type:Expedited (15-DaCompany Report #PHFR2003GB00581 Age:17 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Foreign Clozaril Increased Study (Clozapine)(Clozapin Blood Alkaline Health e) PS ORAL 300 MG/DAY, Phosphatase Increased Professional ORAL C-Reactive Protein Other Diazepam C Increased Risperidone C Diarrhoea Eosinophil Count Increased Gamma-Glutamyltransferase Increased Malaise Nausea Vomiting White Blood Cell Count Increased 22-Feb-2006 08:30 AM Page: 2113 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/21/03ISR Number: 4062113-6Report Type:Expedited (15-DaCompany Report #PHBS2003CA01501 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Foreign Clozapine Drug Interaction Literature (Clozapine) Unknown PS 425 MG/D Hallucination, Auditory Health Gabapentin Insomnia Professional (Gabapentin) SS 300 MG/D Paranoia Other Procyclidine Psychotic Disorder (Procyclidine) C Divalproex Sodium (Valproate Semisodium) C Fluoxetine (Fluoxetine) C Date:02/21/03ISR Number: 4062659-0Report Type:Expedited (15-DaCompany Report #PHBS2003CA01162 Age:24 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Intraocular Pressure Foreign Clozaril (Clozapine) Increased Health Tablet PS ORAL SEE IMAGE Professional Ativan C Other Date:02/21/03ISR Number: 4064817-8Report Type:Expedited (15-DaCompany Report #PHFR2002GB03911 Age:25 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril Non-Insulin-Dependent Study (Clozapine) PS ORAL 200 MG Health BID/300 MG Professional NOCTE, ORAL Other Effexor (Venlafaxine Hydrochloride) C Valproate Sodium C Becotide (Beclometasone Dipropionate) C Salbutamol C Date:02/21/03ISR Number: 4064819-1Report Type:Expedited (15-DaCompany Report #PHFR2003GB00774 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Endometrial Cancer Foreign Clozaril Ovarian Cancer Health (Clozapine) PS ORAL 650 MG/DAY, Ovarian Cyst Professional ORAL Other Seroxat C Smith Kline Beecham Date:02/21/03ISR Number: 4064820-8Report Type:Expedited (15-DaCompany Report #PHNU2003DE00823 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Drug Interaction Foreign Leponex / Clozaril PS ORAL 170 MG, QD, Neuralgia Health ORAL Professional Solian (Amisulpride) SS 600 MG/DAY Other Melperone 22-Feb-2006 08:30 AM Page: 2114 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Melperone) C Date:02/21/03ISR Number: 4064822-1Report Type:Expedited (15-DaCompany Report #PHNR2003AU00525 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Exposure Foreign Clozaril Initial or Prolonged Health (Clozapine) PS ORAL 350 MG, Professional ONCE/SINGLE, Other ORAL Antipsychotics C Date:02/21/03ISR Number: 4064823-3Report Type:Expedited (15-DaCompany Report #PHFR2002GB04345 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Breath Sounds Abnormal Foreign Clozaril Cardiac Arrest Study (Clozapine) PS ORAL 325 MG/DAY, Influenza Like Illness Health ORAL Sleep Disorder Professional Hyoscine (Hyoscine) C Other Omeprazole (Omeprazole) C Date:02/24/03ISR Number: 4065109-3Report Type:Expedited (15-DaCompany Report #PHFR2003GB00785 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Choking Foreign Clozaril (Clozapine) Gastrointestinal Motility Health (Clozapine) Unknown PS ORAL 350 MG, BID, Disorder Professional ORAL Other Ketoconazole (Ketoconazole) C Lactulose C Salbutamol C Beclometasone C Aspirine C Dermalex (Squalane) C Procyclidine (Procyclidine) C Docusate Sodium) C Date:02/25/03ISR Number: 4061303-6Report Type:Direct Company Report #CTU 187303 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Pulmonary Oedema Clozaril 400mg Hs PS ORAL 400MG PO QHS Drug Toxicity Date:02/25/03ISR Number: 4061948-3Report Type:Direct Company Report #CTU 187399 Age:36 YR Gender:Female I/FU:I Outcome PT Hospitalization - Blood Glucose Increased Initial or Prolonged Body Temperature Increased Bowel Sounds Abnormal Decreased Appetite 22-Feb-2006 08:30 AM Page: 2115 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Difficulty In Walking Drug Interaction Dysuria Report Source Product Role Manufacturer Route Dose Duration Haematocrit Decreased Clozapine Generic Haemoglobin Decreased Mylan PS Mylan 100MG TID Laboratory Test Abnormal Lethargy Red Blood Cell Sedimentation Rate Increased Vomiting Date:02/25/03ISR Number: 4062577-8Report Type:Expedited (15-DaCompany Report #03-02-0167 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 25-800MG QD ORAL Date:02/25/03ISR Number: 4062578-XReport Type:Expedited (15-DaCompany Report #03-02-0159 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Lower Limb Fracture Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 300-500MG QD ORAL Date:02/25/03ISR Number: 4062579-1Report Type:Expedited (15-DaCompany Report #03-02-0161 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Aspiration Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Other Inc. Tablets PS ORAL 300-700MG QD ORAL Date:02/25/03ISR Number: 4062580-8Report Type:Expedited (15-DaCompany Report #03-02-0162 Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Gastrointestinal Health Clozapine - Ivax Initial or Prolonged Haemorrhage Professional Pharmaceuticals, Other Gout Other Inc. Tablets PS Ivax Renal Failure Pharmaceuticals, Inc. ORAL 250-700 MG QD ORAL 22-Feb-2006 08:30 AM Page: 2116 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/03ISR Number: 4062825-4Report Type:Expedited (15-DaCompany Report #03-02-0166 Age:89 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Health Clozapine- Ivax Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 25-50MG QD ORAL Date:02/25/03ISR Number: 4062828-XReport Type:Expedited (15-DaCompany Report #03-02-0177 Age:86 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Parkinson'S Disease Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 18.8MG QD ORAL Date:02/25/03ISR Number: 4062829-1Report Type:Expedited (15-DaCompany Report #03-02-0179 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Respiratory Failure Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc., Tablets PS ORAL 150-600MG QD ORAL Date:02/25/03ISR Number: 4062831-XReport Type:Expedited (15-DaCompany Report #03-02-0180 Age:81 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Health Clozapine - Ivax Initial or Prolonged Parkinson'S Disease Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 7-14MG QD ORAL Date:02/25/03ISR Number: 4062923-5Report Type:Expedited (15-DaCompany Report #C2003-0145.01 Age:87 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Mylan ORAL 25MG BID, Professional ORAL Other Clonazepam C Furosemide C Morphine Sulfate C Olanzapine C Prochlorperazine C Senna C Carbidopa/Levodopa C Date:02/25/03ISR Number: 4062933-8Report Type:Expedited (15-DaCompany Report #C2003-0385.01 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 100MG Q AM, Other 100MG Q HS, 22-Feb-2006 08:30 AM Page: 2117 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL Date:02/25/03ISR Number: 4065335-3Report Type:Expedited (15-DaCompany Report #PHFR2002GB04077 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Complications Of Maternal Foreign Clozaril (Clozapine) Exposure To Therapeutic Study Tablet PS ORAL 200MG/DAY, Drugs Health ORAL Gestational Diabetes Professional Other Date:02/26/03ISR Number: 4066023-XReport Type:Expedited (15-DaCompany Report #PHBS2003US01713 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Literature Clozapine Drug Level Increased Health (Clozapine) PS SEE IMAGE Excoriation Professional Fluvoxamine Obsessive-Compulsive (Fluvoxamine) SS SEE IMAGE Disorder Risperidone C Clomipramine (Clomipramine) C Date:02/26/03ISR Number: 4066590-6Report Type:Expedited (15-DaCompany Report #PHFR2003GB00772 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Clozaril(Clozapine) Study Unknown PS ORAL ORAL Health Professional Other Date:02/26/03ISR Number: 4066675-4Report Type:Expedited (15-DaCompany Report #PHFR2003GB00614 Age:51 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril (Clozapine) Study Unknown PS ORAL ORAL Consumer Seroquel (Quetiapine Other Fumarate) C Date:02/26/03ISR Number: 4066683-3Report Type:Expedited (15-DaCompany Report #PHNU2003DE00751 Age:42 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cholecystitis Foreign Leponex/Clozaril Initial or Prolonged Cholelithiasis Health (Clozapine)(Clozapin Professional e) Tablet PS ORAL 25-50 50 Other MG/DAY, ORAL 22-Feb-2006 08:30 AM Page: 2118 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/03ISR Number: 4066727-9Report Type:Expedited (15-DaCompany Report #PHFR2002IE01913 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebral Atrophy Foreign Clozaril(Clozapine) Initial or Prolonged Grand Mal Convulsion Health Tablet PS ORAL SEE IMAGE Hyponatraemia Professional Kemadrin Inappropriate Other (Procyclidine Antidiuretic Hormone Hydrochloride) C Secretion Diazepam C Incontinence Imodium "Janssen" Loss Of Consciousness (Loperamide Pneumonia Hydrochloride) C Shock Zimovane C Date:02/26/03ISR Number: 4066890-XReport Type:Expedited (15-DaCompany Report #PHFR2002GB04264 Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Foreign Clozaril(Clozapine) PS 250MG/DAY Increased Study Anticholinergic Syndrome Health Blood Sodium Increased Professional Constipation Other Dry Mouth Gamma-Glutamyltransferase Increased Liver Function Test Abnormal Polydipsia Salivary Hypersecretion Vision Blurred Date:02/26/03ISR Number: 4067121-7Report Type:Expedited (15-DaCompany Report #PHFR2003GB00768 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Exposure Foreign Clozaril (Clozapine) Initial or Prolonged Health Unknown PS ORAL ORAL Professional Other Date:02/26/03ISR Number: 4067123-0Report Type:Expedited (15-DaCompany Report #PHFR2003GB00660 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dysfunctional Uterine Foreign Clozaril (Clozapine) Bleeding Health Unknown PS ORAL 100 Vaginal Haemorrhage Professional MG/AM/3/NOCTE Other , ORAL Microgynon (Levonorgestrel) C Yasmin (Drospirenone) C Prozac (Fluoxetine Hydrochloride) C Terazosin (Terazosin) C Cilest 22-Feb-2006 08:30 AM Page: 2119 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Norgestimate) C Date:02/26/03ISR Number: 4067152-7Report Type:Expedited (15-DaCompany Report #PHFR2003GB00831 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Circulatory Collapse Foreign Clozaril (Clozapine) Hypotonia Study Unknown PS ORAL ORAL Sensation Of Heaviness Health Professional Other Date:02/27/03ISR Number: 4064887-7Report Type:Direct Company Report #CTU 187611 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Clozapine (Mylan) PS 100MG TABS, 2 Initial or Prolonged Difficulty In Walking BID Escherichia Infection Clozaril C Pyrexia Haldol C Rash Depakote Ec C Red Blood Cell Cogentin C Sedimentation Rate Benadryl C Abnormal Multivits With Urinary Tract Infection Minerals C Vasculitis Lipitor C Oscal D C Fosomax C Date:02/27/03ISR Number: 4064895-6Report Type:Direct Company Report #CTU 187602 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neuroleptic Malignant Clozapine PS ORAL 500MG ORAL Syndrome Date:02/27/03ISR Number: 4066744-9Report Type:Expedited (15-DaCompany Report #C2003-0315.01 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pharmaceutical Product Health Clozapine Tablets Complaint Professional 100 Mg Mylan PS ORAL 900MG QD, Other ORAL Date:02/27/03ISR Number: 4066746-2Report Type:Expedited (15-DaCompany Report #C2003-0318.01 Age:69 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Health Clozapine Tablets Professional 100 Mg Mylan PS ORAL 100MG Q AM, Other 200MG Q PM, ORAL 22-Feb-2006 08:30 AM Page: 2120 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/27/03ISR Number: 4066916-3Report Type:Expedited (15-DaCompany Report #PHFR2003GB00871 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Gastrointestinal Pain Foreign Clozaril (Clozapine) Haemoglobin Decreased Health Unknown PS ORAL 650MG/DAY, Hypotension Professional ORAL Malaise Other Sudden Death Vomiting White Blood Cell Count Increased Date:02/27/03ISR Number: 4066935-7Report Type:Expedited (15-DaCompany Report #PHBS2002AU04842 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Foreign Clozaril (Clozapine) Study Tablet PS ORAL 450 MG/DAY, Health ORAL Professional Droperidol(Droperido Company l) SS INTRAMUSCULAR PRN, Representative INTRAMUSCULAR Other Date:02/27/03ISR Number: 4067060-1Report Type:Expedited (15-DaCompany Report #PHFR2003GB00621 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Gastrooesophageal Reflux Foreign Clozaril(Clozapine) Disease Study (Clozapine) PS ORAL 400MG/DAY, Tachycardia Health ORAL Professional Risperidone C Other Paroxetine C Kwells C Ranitidine (Ranitidine) C Date:02/27/03ISR Number: 4067075-3Report Type:Expedited (15-DaCompany Report #PHFR2003IE00498 Age:28 YR Gender:Male I/FU:I Outcome PT Life-Threatening Blood Bicarbonate Hospitalization - Decreased Initial or Prolonged Blood Chloride Increased Blood Electrolytes Abnormal Blood Urea Increased Coma Grand Mal Convulsion Haematocrit Decreased Haemoglobin Decreased Lymphocyte Count Decreased Malaise Neutrophil Count Increased Overdose Pco2 Decreased 22-Feb-2006 08:30 AM Page: 2121 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pneumonia Aspiration Po2 Increased Red Blood Cell Count Report Source Product Role Manufacturer Route Dose Duration Decreased Foreign Clozaril (Clozapine) Urinary Retention Study Unknown PS ORAL 450MG/DAY, Health ORAL Professional Epilim C Other Date:02/27/03ISR Number: 4067077-7Report Type:Expedited (15-DaCompany Report #PHNU2003DE00992 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Leponex/Clozaril Health (Clozapine) Tablet PS ORAL 125MG/DAY, Professional ORAL Other Date:02/27/03ISR Number: 4067078-9Report Type:Expedited (15-DaCompany Report #PHNR2003AU00572 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Upper Foreign Clozaril (Clozapine) Anaemia Health (Clozapine) Tablet PS ORAL 500MG/DAY, Lower Gastrointestinal Professional ORAL Haemorrhage Other Nausea Vomiting Date:02/27/03ISR Number: 4067134-5Report Type:Expedited (15-DaCompany Report #PHFR2003GB00772 Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Clozaril (Clozapine) PS ORAL ORAL Hospitalization - Mental Impairment Study Initial or Prolonged Sudden Death Health Professional Other Date:02/27/03ISR Number: 4067140-0Report Type:Expedited (15-DaCompany Report #PHFR2003GB00768 Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Exposure Foreign Clozaril (Clozapine) PS ORAL 200 MG, ONCE, Initial or Prolonged Health ORAL Professional Depixol (Flupentixol Other Decanoate) C Lorazepam C Date:02/27/03ISR Number: 4067143-6Report Type:Expedited (15-DaCompany Report #PHNU2002DE04054 Age: Gender:Male I/FU:F Outcome PT Report Source Other Diabetes Mellitus Foreign Health Professional 22-Feb-2006 08:30 AM Page: 2122 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Product Role Manufacturer Route Dose Duration Leponex / Clozaril (Clozapine) (Clozapine) Tablet PS ORAL SEE IMAGE Anti-Diabetics C Date:02/27/03ISR Number: 4067168-0Report Type:Expedited (15-DaCompany Report #PHFR2003IE00885 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Facial Palsy Foreign Clozaril (Clozapine) Pharyngitis Health Unknown PS ORAL ORAL Professional Camcolit C Other Epilim C Effexor (Venlafaxine Hydrochloride) C Cogentin (Benzatropine Mesilate) C Date:02/27/03ISR Number: 4067172-2Report Type:Expedited (15-DaCompany Report #PHNR2003AU00555 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiac Disorder Foreign Clozaril Echocardiogram Abnormal Health (Clozapine)(Clozapin Professional e) Unknown PS Other Date:02/27/03ISR Number: 4067186-2Report Type:Expedited (15-DaCompany Report #PHNR2003AU00558 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Enzymes Increased Foreign Clozaril (Clozapine) Initial or Prolonged Influenza Like Illness Health Tablet PS ORAL 50 MG MANE, Sinus Tachycardia Professional 250MG NOCTE, Other ORAL Date:02/27/03ISR Number: 4067251-XReport Type:Expedited (15-DaCompany Report #PHBS2003DK01665 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Blister Foreign Leponex (Clozapine) Oedema Peripheral Health Tablet PS ORAL 300 MG, BID, Pruritus Professional ORAL Rash Other Skin Fissures Date:02/27/03ISR Number: 4067540-9Report Type:Expedited (15-DaCompany Report #PHHO2003CA01203 Age: Gender:Male I/FU:I Outcome PT Report Source Other Chronic Myeloid Leukaemia Foreign Leukopenia Study 22-Feb-2006 08:30 AM Page: 2123 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Health Professional Other Product Role Manufacturer Route Dose Duration Clozaril (Clozapine) Tablet PS 100 MG, BID, Botox (Botulinum Toxin Type A) Injection C Date:02/27/03ISR Number: 4067611-7Report Type:Expedited (15-DaCompany Report #PHFR2002GB01531 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cellulitis Foreign Clozaril (Clozapine) Initial or Prolonged Thrombophlebitis Health Tablet PS ORAL 250MG/DAY, Other Superficial Professional ORAL Other Sertraline (Sertraline) C Date:02/27/03ISR Number: 4067629-4Report Type:Expedited (15-DaCompany Report #PHEH2003US01507 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Basal Cell Carcinoma Health Clozaril(Clozapine) Professional Tablet PS ORAL ORAL 2920 DAY Date:02/27/03ISR Number: 4067729-9Report Type:Expedited (15-DaCompany Report #PHEH2002US03520 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozaril (Clozapine) Coronary Artery Professional Tablet PS ORAL 700 MG, ORAL Atherosclerosis Date:02/27/03ISR Number: 4067896-7Report Type:Expedited (15-DaCompany Report #PHBS2003ZA02055 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abortion Spontaneous Foreign Leponex (Clozapine) Complications Of Maternal Consumer Tablet PS ORAL ORAL Exposure To Therapeutic Other Drugs Maternal Drugs Affecting Foetus Date:02/28/03ISR Number: 4065969-6Report Type:Direct Company Report #CTU 187730 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Fear Generic Clozaril PS 22-Feb-2006 08:30 AM Page: 2124 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/28/03ISR Number: 4066755-3Report Type:Expedited (15-DaCompany Report #03-02-0193 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Chronic Obstructive Health Clozapine Tablets - Hospitalization - Pulmonary Disease Professional Ivax Initial or Prolonged Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 500-1600MG QD ORAL Date:02/28/03ISR Number: 4066758-9Report Type:Expedited (15-DaCompany Report #03-02-0189 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Orthopedic Procedure Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 400-650MG QD ORAL Date:02/28/03ISR Number: 4066759-0Report Type:Expedited (15-DaCompany Report #03-02-0188 Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 200MG QD ORAL Date:02/28/03ISR Number: 4066761-9Report Type:Expedited (15-DaCompany Report #03-02-0183 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sepsis Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals ORAL ORAL Date:02/28/03ISR Number: 4066763-2Report Type:Expedited (15-DaCompany Report #03-02-0181 Age:92 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Aspiration Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL ORAL 22-Feb-2006 08:30 AM Page: 2125 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/28/03ISR Number: 4067470-2Report Type:Expedited (15-DaCompany Report #2003000349 Age:27 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death General Physical Health Foreign Ziprasidone Hospitalization - Deterioration Health (Ziprasidone) PS ORAL 160 MG (BID), Initial or Prolonged Ileus Paralytic Professional ORAL Company Clozapine Representative (Clozapine) SS ORAL 600 MG, ORAL Clonazepam C Date:02/28/03ISR Number: 4068187-0Report Type:Expedited (15-DaCompany Report #03P-062-0211080-00 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Medication Error Foreign Akineton (Biperiden) Initial or Prolonged Respiratory Failure Health (Biperiden) PS ORAL 2 MG, 19 IN 1 Salivary Hypersecretion Professional ONCE, PER Suicide Attempt ORAL Chlorazepam SS ORAL 5 MG, 3 IN 1 ONCE, PER ORAL Sertraline Hydrochloride SS ORAL 50 MG, 10 IN 1 ONCE, PER ORAL Clozapine SS ORAL 100 MG, 40 IN 1 ONCE, PER ORAL Parstelin SS ORAL 16 TABLET, 1 IN 1 ONCE, PER ORAL Diazepam SS ORAL 10 MG, 15 IN 1 ONCE, PER ORAL Prothipendyl Hydrochloride SS ORAL 80 MG, 20 IN 1 ONCE, PER ORAL Olanzapine SS ORAL 10 MG, 1 IN 1 ONCE, PER ORAL Date:03/03/03ISR Number: 4066126-XReport Type:Direct Company Report #CTU 187799 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neutrophil Count Clozapine 100mg Decreased Zenith PS Zenith ORAL 275 MG HS PO White Blood Cell Count Clozapine 25mg Decreased Zenith SS Zenith Losartan C Docusate C Senna C 22-Feb-2006 08:30 AM Page: 2126 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/03/03ISR Number: 4069008-2Report Type:Expedited (15-DaCompany Report #PHBS2003DK01665 Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Blister Foreign Leponex Dry Skin Health (Clozapine) PS ORAL 300 MG, BID, Oedema Peripheral Professional ORAL Rash Other Stesolid C Rash Maculo-Papular Serenase C Rash Pruritic Panodil C Skin Fissures Akineton (Biperiden Hydrochloride) C Zyrtec (Cetirizne Hydrochloride) C Date:03/03/03ISR Number: 4069234-2Report Type:Expedited (15-DaCompany Report #PHFR2003GB00565 Age:49 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cerebral Haemorrhage Foreign Clozaril (Clozapine) Hospitalization - Cerebrovascular Accident Study Tablet PS ORAL 200MG/2XDAY, Initial or Prolonged Drug Interaction Health ORAL Disability Hemiparesis Professional Tramadol (Tramadol) C Road Traffic Accident Other Citalopram Shock (Citalopram) C Thyroxine C Date:03/03/03ISR Number: 4069246-9Report Type:Expedited (15-DaCompany Report #PHEH2003US01603 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Health Clozaril (Clozapine) PS ORAL ORAL Drug Toxicity Professional Date:03/03/03ISR Number: 4069248-2Report Type:Expedited (15-DaCompany Report #PHEH2003US01608 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Health Clozaril (Clozapine) Initial or Prolonged Haemorrhage Intracranial Professional Tablet PS ORAL 500 MG, ORAL Other Head Injury Date:03/03/03ISR Number: 4069351-7Report Type:Expedited (15-DaCompany Report #PHEH2003US01572 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hepatic Neoplasm Health Clozaril (Clozapine) Malignant Professional Tablet PS ORAL 300 MG, QD, ORAL Date:03/03/03ISR Number: 4069427-4Report Type:Expedited (15-DaCompany Report #PHFR2002GB02641 Age:34 YR Gender:Female I/FU:F Outcome PT Report Source Other Cough Foreign Eosinophilia Study Lymphopenia Health 22-Feb-2006 08:30 AM Page: 2127 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Other Product Role Manufacturer Route Dose Duration Clozaril (Clozapine) Tablet PS ORAL ORAL Date:03/03/03ISR Number: 4069432-8Report Type:Expedited (15-DaCompany Report #PHEH2003US01071 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Testicular Atrophy Health Clozaril Professional (Clozapine) PS ORAL ORAL Paxil C Seroquel (Quetiapine Fumarate) C Klonopin C Wellbutrin (Bupropion Hydrochloride) C Thorazine (Chlorpromazine Hydrochloride) C Cogentin (Benzatropine Mesilate) C Date:03/03/03ISR Number: 4069504-8Report Type:Expedited (15-DaCompany Report #PHBS2002NZ11295 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Atherosclerosis Foreign Clozaril (Closapine) Other Cardiomegaly Health Tablet PS ORAL 275 MG/DAY, Congestive Cardiomyopathy Professional ORAL Drug Level Increased Other Drug Toxicity Electrocardiogram Abnormal Full Blood Count Abnormal Left Ventricular Failure Malaise Myocarditis Pulmonary Congestion Pulmonary Oedema Syncope Vasovagal Date:03/03/03ISR Number: 4092902-3Report Type:Periodic Company Report #HQ5489725NOV2002 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Interaction Health Protonix Drug Level Above Professional (Pantoprazole, Therapeutic Company Tablet, Delayed Representative Release) PS Clozaril (Clozapine) SS 22-Feb-2006 08:30 AM Page: 2128 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/04/03ISR Number: 4069892-2Report Type:Expedited (15-DaCompany Report #PHFR2003GB00971 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eye Rolling Foreign Clozaril (Clozapine) PS ORAL 300 MG AM & Oculogyration Health 480 MG PM, Professional ORAL Other Benzhexol (Trihexyphenidyl) C Paroxetine C Date:03/04/03ISR Number: 4069924-1Report Type:Expedited (15-DaCompany Report #PHBS2003CA01501 Age:23 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hallucination Foreign Clozapine(Clozapine) PS 425MG/D Paranoia Literature Gabapentin Thinking Abnormal Health (Gabapentin) SS 300 MG/D Professional Procyclidine Other (Procyclidine) C Divalproex Sodium (Valproate Semisodium) C Fluoxetine (Fluoxetine) C Date:03/04/03ISR Number: 4070545-5Report Type:Expedited (15-DaCompany Report #PHRM2003FR00863 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Colitis Ulcerative Foreign Leponex Hospitalization - Faecaloma Health (Clozapine)Tablet PS Initial or Prolonged Intestinal Obstruction Professional Opiods (No Necrotising Colitis Other Ingredients/Substanc es) SS Date:03/04/03ISR Number: 4070609-6Report Type:Expedited (15-DaCompany Report #PHEH2002US09712 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Pulmonary Oedema Health Clozaril (Clozapine) Other Hypercholesterolaemia Professional Tablet PS ORAL 400 Hypertension MG/DAY,ORAL Therapeutic Agent Toxicity Date:03/04/03ISR Number: 4070964-7Report Type:Expedited (15-DaCompany Report #PHEH2003US01603 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bronchitis Chronic Health Clozaril(Clozapine)T Convulsion Professional ablet PS ORAL 100MG AT 4PM Drug Toxicity + 350MG QHS, ORAL Depakote (Valproate Semisodium) C Humulini(Insulin Human, Insulin 22-Feb-2006 08:30 AM Page: 2129 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Isophane, Human Biosynthetic) C Glucophage "Abic" C Avandia (Rosiglitazone Maleate) C Date:03/04/03ISR Number: 4070966-0Report Type:Expedited (15-DaCompany Report #PHEH2003US01680 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Emphysema Health Clozaril(Clozapine)T Initial or Prolonged Leukopenia Professional ablet PS ORAL 700 MG, QD, Pneumothorax ORAL Multivitamins(Panthe nol, Retinol) SS Cogentin (Benzatropine Mesilate) C Ativan C Zantac C Date:03/05/03ISR Number: 4066132-5Report Type:Direct Company Report #CTU 187965 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neutrophil Count Clozapine 100mg Ivax Decreased (Zenith) PS Ivax (Zenith) ORAL 250MG AM PO Clozapine 25mg Ivax (Zenith) SS Ivax (Zenith) ORAL 300MG HS PO Docusate C Multivitamin C Lorazepam C Date:03/05/03ISR Number: 4070208-6Report Type:Periodic Company Report #2002062383 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Qt Health Geodon (Ziprasidone) PS 80 MG (BID) Initial or Prolonged Prolonged Professional Clozapine SS Other Nausea Metoclopramide C Urinary Tract Infection Levothyroxine C Vomiting Topiramate C Lansoprazole C Date:03/05/03ISR Number: 4071186-6Report Type:Expedited (15-DaCompany Report #PHEH2003US01795 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Myocardial Health Clozaril Infarction Professional (Clozapine) PS ORAL ORAL 22-Feb-2006 08:30 AM Page: 2130 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/05/03ISR Number: 4071249-5Report Type:Expedited (15-DaCompany Report #PHFR2003GB00973 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Gait Disturbance Foreign Clozaril(Clozapine) Psychotic Disorder Study Unknown PS ORAL ORAL Restlessness Health Tachycardia Professional Thinking Abnormal Other Date:03/05/03ISR Number: 4071298-7Report Type:Expedited (15-DaCompany Report #PHFR2002GB03903 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Clozarilclozapine) Drug Level Increased Study Tablet PS ORAL ORAL Malaise Health Pallor Professional Other Date:03/05/03ISR Number: 4071308-7Report Type:Expedited (15-DaCompany Report #PHNU2002DE04231 Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coronary Artery Foreign Leponex / Clozaril Other Restenosis Other (Clozapine) Myocardial Infarction (Clozapine) Tablet PS ORAL 300 MG/DAY, ORAL Date:03/05/03ISR Number: 4071314-2Report Type:Expedited (15-DaCompany Report #PHFR2003GB00582 Age:41 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Drop Attacks Foreign Clozaril(Clozapine) Hospitalization - Hypotonia Study Unknown PS ORAL 350 MG/DAY, Initial or Prolonged Loss Of Consciousness Health ORAL; Other Lower Respiratory Tract Professional 200MG/DAY, Infection Other ORAL Respiratory Arrest Sleep Apnoea Syndrome Date:03/05/03ISR Number: 4071334-8Report Type:Expedited (15-DaCompany Report #PHFR2003GB00883 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abnormal Behaviour Foreign Clozaril (Clozapine) Incontinence Study Unknown PS ORAL 450 MG/DAY, Obsessive-Compulsive Health ORAL Disorder Professional Venlafaxine Urinary Tract Infection Other (Venlafaxine) C Weight Increased Lansoprazole (Lansoprazole) C Nizoral (Ketoconazole) C Daktacort C Atorvastatin C 22-Feb-2006 08:30 AM Page: 2131 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/05/03ISR Number: 4071335-XReport Type:Expedited (15-DaCompany Report #PHFR2003GB00982 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril (Clozapine) Ketoacidosis Study Unknown PS ORAL ORAL Health Professional Other Date:03/06/03ISR Number: 4071088-5Report Type:Expedited (15-DaCompany Report #C2003-0092.01 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Health Clozapine Tablets Pharmaceutical Product Professional 100 Mg Mylan PS Mylan ORAL 600MG QD, Complaint Other ORAL Septic Shock Date:03/06/03ISR Number: 4071092-7Report Type:Expedited (15-DaCompany Report #C2003-0386.01 Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 100 MG QD, Other ORAL Albuterol C Buproprion C Carbidopa/Levodopa C Docusate C Donepezil C Fluticasone C Furosemide C Guaifenesin C Levalbuterol Inhalation Solution C Tolterodine C Vitamin E C Date:03/06/03ISR Number: 4071094-0Report Type:Expedited (15-DaCompany Report #C2003-0387.01 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death White Blood Cell Count Health Clozapine Tablets Increased Professional 100 Mg/Mylan PS Mylan ORAL 300MG AM, Other 500MG PM, ORAL Date:03/07/03ISR Number: 4071718-8Report Type:Expedited (15-DaCompany Report #03-02-0232 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 200-225MG QD ORAL 22-Feb-2006 08:30 AM Page: 2132 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/07/03ISR Number: 4071719-XReport Type:Expedited (15-DaCompany Report #03-02-0231 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hip Fracture Health Clozapine - Ivax Initial or Prolonged Pneumonia Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 450-550MG QD ORAL Date:03/07/03ISR Number: 4071720-6Report Type:Expedited (15-DaCompany Report #03-02-0221 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hypoxia Health Clozapine - Ivax Lobar Pneumonia Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 175-425MG QD ORAL Date:03/07/03ISR Number: 4071721-8Report Type:Expedited (15-DaCompany Report #03-02-0219 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mania Health Clozapine - Ivax Initial or Prolonged Speech Disorder Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL SEE IMAGE Lithium Citrate C Lithium Citrate C Date:03/07/03ISR Number: 4071722-XReport Type:Expedited (15-DaCompany Report #03-02-0218 Age:76 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neoplasm Malignant Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 37.5-125MG QD ORAL Date:03/07/03ISR Number: 4071723-1Report Type:Expedited (15-DaCompany Report #03-02-0208 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Health Clozapine - Ivax Initial or Prolonged Foot Fracture Professional Pharmaceuticals, Gait Disturbance Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 100MG BID ORAL Xanax C Serzone C 22-Feb-2006 08:30 AM Page: 2133 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/07/03ISR Number: 4071724-3Report Type:Expedited (15-DaCompany Report #03-02-0204 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapin - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals ORAL 500MG QD ORAL Date:03/07/03ISR Number: 4071725-5Report Type:Expedited (15-DaCompany Report #03-02-0207 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chronic Obstructive Health Clozapine - Ivax Initial or Prolonged Pulmonary Disease Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 600MG QD ORAL Date:03/07/03ISR Number: 4071726-7Report Type:Expedited (15-DaCompany Report #03-01-0099 Age:75 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL SEE IMAGE Date:03/07/03ISR Number: 4071866-2Report Type:Expedited (15-DaCompany Report #C2003-0421.01 Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death White Blood Cell Count Health Clozapine Tablets Increased Professional 100 Mg Mylan PS Mylan ORAL 200MG BID, Other ORAL Lorazepam C Pantoprazole Sodium C Quetiapine Fumarate C Date:03/07/03ISR Number: 4072409-XReport Type:Expedited (15-DaCompany Report #03-02-0236 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Foreign Clozapine Tablets PS ORAL 750 MG QD Initial or Prolonged Neuroleptic Malignant Literature ORAL 29 MON Other Syndrome Health Risperidone Tablets SS ORAL 3-4 MG QD Schizophrenia Professional ORAL 3 MON Date:03/07/03ISR Number: 4072602-6Report Type:Expedited (15-DaCompany Report #PHBS2002NZ11295 Age:47 YR Gender:Male I/FU:F Outcome PT Death Arrhythmia Other Atherosclerosis Cardiomegaly Cardiomyopathy Drug Level Increased 22-Feb-2006 08:30 AM Page: 2134 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Drug Toxicity Inflammation Left Ventricular Failure Report Source Product Role Manufacturer Route Dose Duration Liver Disorder Foreign Clozaril (Clozapine) Myocarditis Health Tablet PS ORAL 275 MG/DAY, Pulmonary Oedema Professional ORAL Renal Disorder Ventricular Hypertrophy Date:03/07/03ISR Number: 4072610-5Report Type:Expedited (15-DaCompany Report #PHFR2001GB03460 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Pressure Increased Foreign Clozaril (Clozapine) Coronary Artery Occlusion Health Tablet PS ORAL 225 MG/DAY, Neuroleptic Malignant Professional ORAL; Syndrome Other 100MG/DAY, Rash ORAL Date:03/07/03ISR Number: 4072618-XReport Type:Expedited (15-DaCompany Report #PHNR2003AU00555 Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiac Disorder Foreign Leponex / Clozaril Cardiomyopathy Health (Clozapine) Electrocardiogram Professional (Clozapine) Tablet PS ORAL ORAL Abnormal Other Date:03/07/03ISR Number: 4072712-3Report Type:Expedited (15-DaCompany Report #PHEH2003US01599 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozaril(Clozapine) Professional Tablet PS ORAL 500; 650 MG/DAY, ORAL Seroquel(Quetiapine Fumarate) C Date:03/07/03ISR Number: 4072950-XReport Type:Expedited (15-DaCompany Report #PHFR2002GB03052 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Foetal Heart Rate Foreign Clozaril (Clozapine) Initial or Prolonged Abnormal Study Tablets PS ORAL 300MG/DAY, Other Foetal Heart Rate Health ORAL Decreased Professional Fluoxetine Foetal Heart Rate Other (Fluoxetine) C Disorder Procyclidine Maternal Drugs Affecting (Procyclidine) C Foetus 22-Feb-2006 08:30 AM Page: 2135 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/07/03ISR Number: 4072959-6Report Type:Expedited (15-DaCompany Report #PHBS2003CA02113 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Disease Recurrence Foreign Clozapine Initial or Prolonged Drug Interaction Literature (Clozapine) PS 750 MG/D, Potentiation Health Risperidone Neuroleptic Malignant Professional (Risperidone) SS 6 MG/D, Syndrome Other Psychotic Disorder Date:03/07/03ISR Number: 4072999-7Report Type:Expedited (15-DaCompany Report #PHNR2003AU00575 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril (Clozapine) Drug Level Decreased Health Tablet PS ORAL ORAL Hyperlipidaemia Professional Treatment Noncompliance Other Date:03/11/03ISR Number: 4073650-2Report Type:Expedited (15-DaCompany Report #C2003-0428.01 Age:69 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Other Clozapine Tablets 25 Mg Mylan PS Mylan UNKNOWN UNK Date:03/11/03ISR Number: 4073655-1Report Type:Expedited (15-DaCompany Report #C2003-0025.01 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Health Clozapine Tablets Pharmaceutical Product Professional 100 Mg Mylan PS Mylan ORAL 400 MG QD, Complaint Other ORAL Pulmonary Embolism Date:03/13/03ISR Number: 4073236-XReport Type:Expedited (15-DaCompany Report #03-03-0269 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 600 MG QD ORAL Date:03/13/03ISR Number: 4073237-1Report Type:Expedited (15-DaCompany Report #03-03-0266 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozapine - Ivax Pneumonia Professional Pharmaceuticals, Inc Other Tablets PS Ivax Pharmaceuticals, Inc. ORAL 50-425MG QD ORAL 22-Feb-2006 08:30 AM Page: 2136 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/13/03ISR Number: 4073238-3Report Type:Expedited (15-DaCompany Report #03-03-0262 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Other Clozapine - Ivax Dehydration Pharmaceuticals, Nausea Inc. Tablets PS Ivax Vomiting Pharmaceuticals, Inc. ORAL 400-700MG QD ORAL Date:03/13/03ISR Number: 4073239-5Report Type:Expedited (15-DaCompany Report #03-03-0248 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dehydration Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 250 MG QD ORAL Date:03/13/03ISR Number: 4073296-6Report Type:Expedited (15-DaCompany Report #03-03-0242 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Gastrointestinal Health Clozapine - Ivax Initial or Prolonged Haemorrhage Professional Pharmaceuticals, Pneumonia Inc. Tablets PS ORAL 100MG QAM Pulmonary Embolism ORAL 5 YR Coumadin C Lithium C Vitamin E C Ativan C Restoril C Protonix C Levaquin C Date:03/13/03ISR Number: 4073311-XReport Type:Expedited (15-DaCompany Report #03-03-0270 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hepatic Neoplasm Health Clozapine - Ivax Malignant Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 75-300MG QD ORAL Date:03/13/03ISR Number: 4073314-5Report Type:Expedited (15-DaCompany Report #03-03-0274 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Clozapine - Ivax Initial or Prolonged Dehydration Professional Pharmaceuticals, Treatment Noncompliance Other Inc. Tablets PS ORAL 12.5-250MG QD ORAL 22-Feb-2006 08:30 AM Page: 2137 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/13/03ISR Number: 4075595-0Report Type:Expedited (15-DaCompany Report #PHFR2003GB01163 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Resection Of Rectum Foreign Clozaril (Clozapine) Health Unknown PS ORAL ORAL Professional Other Date:03/13/03ISR Number: 4076035-8Report Type:Expedited (15-DaCompany Report #PHEH2003US01849 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Health Clozaril (Clozapine) Leukopenia Professional Tablet PS ORAL 200 MG/DAY, Obesity ORAL Interferon (Interferon) C Paxil C Celexa C Lexapro C Date:03/13/03ISR Number: 4076053-XReport Type:Expedited (15-DaCompany Report #PHFR2003GB00772 Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Clozaril (Clozapine) Hospitalization - Drug Level Decreased Study Unknown PS ORAL ORAL Initial or Prolonged Mental Impairment Health Professional Other Date:03/13/03ISR Number: 4076056-5Report Type:Expedited (15-DaCompany Report #PHFR2003GB01036 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hepatic Function Abnormal Foreign Clozapine Liver Function Test Health (Clozapine) Unknown PS ORAL 350 MG/DAY, Abnormal Professional ORAL Weight Decreased Other Ranitidine C Diazepam C Chlorpromazine C Date:03/13/03ISR Number: 4076109-1Report Type:Expedited (15-DaCompany Report #PHNU2002DE04174 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Antinuclear Antibody Foreign Leponex / Clozaril Positive Health (Clozapine) Biliary Cirrhosis Professional (Clozapine) Tablet PS ORAL 25MG/DAY, Other ORAL Chloraldurat C 22-Feb-2006 08:30 AM Page: 2138 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/13/03ISR Number: 4076111-XReport Type:Expedited (15-DaCompany Report #PHBS2003ZA02055 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abortion Spontaneous Foreign Leponex (Clozapine) Blighted Ovum Consumer Tablet PS ORAL ORAL Complications Of Maternal Other Exposure To Therapeutic Drugs Foetal Heart Rate Abnormal Date:03/13/03ISR Number: 4076147-9Report Type:Expedited (15-DaCompany Report #PHFR2002GB02283 Age:55 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ankle Fracture Foreign Clozaril(Clozapine) Initial or Prolonged Fall Health Tablet PS ORAL 325MG/DAY, Other Neutropenia Professional ORAL Other Date:03/13/03ISR Number: 4076149-2Report Type:Expedited (15-DaCompany Report #PHHO2003CA02689 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril Study (Clozapine)(Clozapin Health e) Tablet PS Professional Other Date:03/13/03ISR Number: 4076180-7Report Type:Expedited (15-DaCompany Report #PHNR2003AU00589 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Haematuria Foreign Clozaril (Clozapine) Initial or Prolonged Proteinuria Health Tablet PS ORAL 125MG/DAY, Pyrexia Professional ORAL Red Blood Cell Other Abnormality Treatment Noncompliance Date:03/13/03ISR Number: 4076181-9Report Type:Expedited (15-DaCompany Report #PHFR2003GB01018 Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Lymphocyte Count Foreign Clozaril (Clozapine) PS ORAL ORAL Decreased Study Health Professional Other 22-Feb-2006 08:30 AM Page: 2139 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/13/03ISR Number: 4076225-4Report Type:Expedited (15-DaCompany Report #PHEH2003US01680 Age:31 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Langerhans' Cell Health Clozaril (Clozapine) Initial or Prolonged Granulomatosis Professional Tablet PS ORAL 700 MG, QD, Leukopenia ORAL Pneumothorax 2-Cda (Cladribine) SS INTRAVENOUS INTRAVENOUS Psychotic Disorder Multivitamins (Panthenol, Retinol) SS Cogentin (Benzatropine Mesilate) C Ativan C Zantac C Xanax (Alprazolam) C Date:03/13/03ISR Number: 4076259-XReport Type:Expedited (15-DaCompany Report #PHEH2003US01769 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Health Clozaril (Clozapine) Lung Disorder Professional Tablet PS ORAL 100 MG, BID, Myocardial Infarction ORAL Date:03/13/03ISR Number: 4076267-9Report Type:Expedited (15-DaCompany Report #PHBS2003US02354 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Literature Clozapine Constipation Health (Clozapine) PS SEE IMAGE Delusion Professional Perphenazine Diabetes Mellitus (Perphenazine) SS 40 MG/DAY, Non-Insulin-Dependent Divalproex Sodium Drug Ineffective (Valproate Enuresis Semisodium) SS 1500 MG, BID, Gastrooesophageal Reflux Lorazepam Disease (Lorazepam) SS 0.5 MG, BID, Hypercholesterolaemia Doxazosin Hypertension (Doxazosin) C Hypertriglyceridaemia Gemfibrozil Logorrhoea (Gemfibrozil) C Obesity Ranitidine Hydrochloride C Glyburide C Docusate Sodium C Lactulose C Date:03/13/03ISR Number: 4076374-0Report Type:Expedited (15-DaCompany Report #PHEH2003US00864 Age:47 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coronary Artery Other Clozaril (Clozapine) Atherosclerosis Tablet PS ORAL 350 MG, QD, Coronary Artery ORAL Thrombosis Leukaemia 22-Feb-2006 08:30 AM Page: 2140 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/13/03ISR Number: 4076375-2Report Type:Expedited (15-DaCompany Report #PHEH2002US10040 Age:74 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Health Clozaril (Clozapine) Hospitalization - Colon Cancer Professional Tablet PS ORAL ORAL Initial or Prolonged White Blood Cell Count Sinemet C Increased Tasmar (Tolcapone) C Antihypertensives C Dopamine (Dopamine) C Aricept (Donepezil Hydrochloride) C Mirapex "Boehringer Ingelheim" (Pramipexole Dihydrochloride) C Date:03/17/03ISR Number: 4074726-6Report Type:Direct Company Report #CTU 188861 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutrophil Count Clozaril PS ORAL 100 MG PO Q 4 Initial or Prolonged Decreased PM + 400 MG White Blood Cell Count PO QHS Decreased SEVERAL YEARS Maxzide C Orlistat C Clonidine C Provigil C Topamax C Tricor C Axid C Celexa C Colace C Multivitamin C Date:03/18/03ISR Number: 4078182-3Report Type:Expedited (15-DaCompany Report #PHFR2003GB00871 Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Circulatory Collapse Foreign Clozaril (Clozapine) PS ORAL 650MG/DAY, Full Blood Count Abnormal Study ORAL Haemoglobin Decreased Health Lansoprazole Hypotension Professional (Lansoprazole) C Mediastinitis Other Oesophageal Rupture Shock Sudden Death Date:03/18/03ISR Number: 4078473-6Report Type:Expedited (15-DaCompany Report #PHFR2003GB00971 Age:33 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Oculogyration Foreign Clozaril (Clozapine) Health Unknown PS ORAL 300MG AM & Professional 480 MG PM, Other ORAL Benzhexol (Trihexyphenidyl) C 22-Feb-2006 08:30 AM Page: 2141 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Paroxetine C Date:03/18/03ISR Number: 4078474-8Report Type:Expedited (15-DaCompany Report #PHFR2002GB03903 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Clozaril (Clozapine) Drug Level Increased Study Tablet PS ORAL ORAL Health Professional Other Date:03/18/03ISR Number: 4085106-1Report Type:Periodic Company Report #2002105438US Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Adriamycin Other Professional Pfs(Doxorubicin Hydrochlordie)Soluti on, Sterile PS Clozapine(Clozapine) SS ORAL 200 MG, BID, ORAL Cytoxan(Cyclophospha mide) SS INTRAVENOUS IV Celexa (Citalopram Hydrobromide) C Cogentin (Benzatropine Mesilate) C Date:03/19/03ISR Number: 4077254-7Report Type:Direct Company Report #USP 55486 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Clozapine PS Date:03/19/03ISR Number: 4078094-5Report Type:Expedited (15-DaCompany Report #C2003-0491.01 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Pharmaceutical Product Professional 100 Mg Mylan PS ORAL 100MG Q HS, Complaint Other ORAL Benztropine Mesylate C Haloperidol C Sertraline Hcl C Date:03/19/03ISR Number: 4078096-9Report Type:Expedited (15-DaCompany Report #C2003-0490.01 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine Tablets Professional 100 Mg Mylan PS ORAL 200MG Q AM, Other 300MG Q PM, ORAL 22-Feb-2006 08:30 AM Page: 2142 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/19/03ISR Number: 4078115-XReport Type:Expedited (15-DaCompany Report #C2003-0532.01 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neoplasm Malignant Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 300MG QD, Other ORAL Clozapine Tablets 25 Mg Mylan SS Mylan ORAL 75MG QD, ORAL Date:03/19/03ISR Number: 4078494-3Report Type:Expedited (15-DaCompany Report #PHEH2003US02039 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intervertebral Disc Consumer Clozaril (Clozapine) Initial or Prolonged Protrusion Tablet PS ORAL 800 MG, QD, Pyrexia ORAL Luvox (Fluvoxamine Maleate) C Date:03/19/03ISR Number: 4078514-6Report Type:Expedited (15-DaCompany Report #PHEH2003US00853 Age:37 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acute Respiratory Failure Health Clozaril (Clozapine) Initial or Prolonged Chronic Sinusitis Professional Tablet PS ORAL 600 MG, QD, Cryptogenic Organizing ORAL Pneumonia Depakote (Valproate Dizziness Postural Semisodium) C Dyspnoea Zoloft (Sertraline Fall Hydrochloride) C Oedema Peripheral Cogentin Parainfluenzae Virus (Benzatropine Infection Mesilate) C Pulmonary Haemorrhage Vitamin E C Alprazolam (Alprazolam) C Tegretol (Carbamazepine) C Flonase C Flovent C Serevent (Salmeterol Xinafoate) C Combivent (Salbutamol Sulfate) C Levaquin (Levofloxacin) C Posture D "Wyeth-Ayerst" C Date:03/19/03ISR Number: 4078515-8Report Type:Expedited (15-DaCompany Report #PHEH2003US02112 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Health Clozaril (Clozapine) Professional Tablet PS ORAL 300 MG/DAY, ORAL Klonopin C Lithium (Lithium) C 22-Feb-2006 08:30 AM Page: 2143 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Artane (Trihexyphenidyl Hydrochloride) C Neurontin (Gabapentin) C Zoloft (Sertraline Hydrochloride) C Premarin (Estrogens Conjugated) C Colace C Oxybutynin (Oxybutynin) C Propranolol C Protonix "Pharmacia" C Lantus (Insulin Glargine) C Glucophage "Abic" C Glucotrol (Glipizide) C Date:03/19/03ISR Number: 4078581-XReport Type:Expedited (15-DaCompany Report #PHFR2003GB00891 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Foreign Clozaril (Clozapine) Lymphocyte Count Study Unknown PS ORAL 300 MG/DAY, Decreased Health ORAL Professional Lithium (Lithium) C Other Date:03/19/03ISR Number: 4078585-7Report Type:Expedited (15-DaCompany Report #PHEH2003US01572 Age:72 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hepatic Neoplasm Health Clozaril (Clozapine) Malignant Professional Tablet PS ORAL 300 MG, QD, Malignant Neoplasm ORAL Progression Date:03/19/03ISR Number: 4078589-4Report Type:Expedited (15-DaCompany Report #PHEH2003US02126 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Lymphopenia Consumer Clozaril Initial or Prolonged Pneumonia Viral (Clozapine)Tablet PS Date:03/19/03ISR Number: 4078941-7Report Type:Expedited (15-DaCompany Report #PHFR2003GB01143 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozapine(Clozapine) Peroneal Nerve Palsy Health Unknown PS ORAL 350MG/DAY, Professional ORAL Other Thyroxine C Omeprazole (Omeprazole) C 22-Feb-2006 08:30 AM Page: 2144 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/19/03ISR Number: 4079132-6Report Type:Expedited (15-DaCompany Report #PHFR2003GB00973 Age:22 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Confusional State Foreign Clozaril (Clozapine) PS ORAL 100 MG, BID, Gait Disturbance Study ORAL Psychotic Disorder Health Restlessness Professional Sinus Tachycardia Other Thinking Abnormal Verbigeration Date:03/19/03ISR Number: 4079134-XReport Type:Expedited (15-DaCompany Report #PHBS2003IT02516 Age:69 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pemphigoid Foreign Deponex (Clozapine) Initial or Prolonged Health Tablet PS ORAL 25 MG/DAY, Professional ORAL Other Date:03/19/03ISR Number: 4079137-5Report Type:Expedited (15-DaCompany Report #PHNR2003AU00641 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Renal Failure Foreign Clozaril (Clozapine) Hospitalization - Therapeutic Agent Health (Clozapine) Tablet PS ORAL 250 MG, Initial or Prolonged Toxicity Professional ONCE/DAY, Other ORAL Ranitidin "Aliud Pharma" C Valproate Sodium C Alanzapine C Lithium (Lithium) C Diazepam C Ceclor C Date:03/19/03ISR Number: 4079186-7Report Type:Expedited (15-DaCompany Report #PHBS2003CA02553 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Balance Disorder Foreign Clozaril (Clozapine) Condition Aggravated Consumer Tablet PS ORAL 350 MG/DAY, Constipation Other ORAL Dizziness Quetiapine Drug Ineffective (Quetiapine) C Dysphagia Epival (Valproate Sedation Semisodium) C Self Mutilation Losec (Omeprazole) C Date:03/20/03ISR Number: 4078682-6Report Type:Expedited (15-DaCompany Report #C2003-0502.01 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 12.5MG Q HS, Other ORAL Acetaminophen C 22-Feb-2006 08:30 AM Page: 2145 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Carbidopa/Levodopa C Megesterol C Milk Of Magnesia C Morphine Solution C Multivitamins C Nitrofurantoin C Pantoprazole C Triamterene/Hctz Tablets C Vitamin C C Zinc C Date:03/20/03ISR Number: 4080137-XReport Type:Expedited (15-DaCompany Report #PHFR2003GB00591 Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Foreign Clozaril (Clozapine) PS ORAL 350MG/DAY, Initial or Prolonged Constipation Study ORAL Other Dehydration Health Drug Level Increased Professional Drug Withdrawal Syndrome Other Nausea Oliguria Phaeochromocytoma Sinus Tachycardia Tachycardia Date:03/20/03ISR Number: 4080754-7Report Type:Expedited (15-DaCompany Report #PHFR2002GB03903 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Clozaril(Clozapine) PS SEE IMAGE Drug Level Above Study Therapeutic Health Malaise Professional Pallor Other Date:03/20/03ISR Number: 4080756-0Report Type:Expedited (15-DaCompany Report #PHRM2003FR00949 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Leukocytosis Foreign Leponex(Clozapine) Pneumoconiosis Health Tablet PS ORAL ORAL Septic Shock Professional Tranxene(Clorazepate Other Dipotassium) Tablet, 50mg SS ORAL 125 MG PER DAY, ORAL Nozinan(Levomepromaz ine) Tablet SS ORAL 100 MG DAILY, ORAL Date:03/20/03ISR Number: 4080822-XReport Type:Expedited (15-DaCompany Report #MO262-2003 Age:35 YR Gender:Male I/FU:I Outcome PT Hospitalization - Alanine Aminotransferase Initial or Prolonged Increased 22-Feb-2006 08:30 AM Page: 2146 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Aspartate Aminotransferase Increased Report Source Product Role Manufacturer Route Dose Duration Blood Alkaline Health Mirtazapine PS ORAL 15 MG/30 MG 38 DAY Phosphatase Increased Professional Clozapine SS ORAL 25 MG/250 Blood Lactate MG/300 MG/225 Dehydrogenase Decreased MG/300 MG/200 Gamma-Glutamyltransferase MG 33 DAY Increased Clomipramine Hepatosplenomegaly Hydrochloride SS ORAL 37.5 MG/75 Liver Function Test MG/112 MG/150 Abnormal MG 5 DAY Venlafaxine Hydrochloride SS ORAL 75 MG/375 MG/225 MG 13 DAY Lorazepam C Zolpidem C Date:03/21/03ISR Number: 4079523-3Report Type:Expedited (15-DaCompany Report #03-03-0302 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dementia Alzheimer'S Type Health Clozapine - Ivax Myocardial Infarction Professional Pharmaceuticals, Other Inc. Tablets PS Ivax ORAL 18.7MG QD ORAL Date:03/21/03ISR Number: 4079530-0Report Type:Expedited (15-DaCompany Report #03-03-0303 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neoplasm Malignant Health Clozapine Tables - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 100-500MG QD ORAL Date:03/21/03ISR Number: 4079531-2Report Type:Expedited (15-DaCompany Report #03-02-0203 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 100MG BID ORAL Glyburide C 22-Feb-2006 08:30 AM Page: 2147 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/21/03ISR Number: 4079532-4Report Type:Expedited (15-DaCompany Report #03-01-0051 Age:62 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arrhythmia Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 150-300MG QD ORAL Bupropion C Lamictal C Date:03/21/03ISR Number: 4079533-6Report Type:Expedited (15-DaCompany Report #03-02-0193 Age:58 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Respiratory Failure Health Clozapine Tables - Hospitalization - Chronic Obstructive Professional Ivax Initial or Prolonged Pulmonary Disease Other Pharmaceuticals, Sepsis Inc. PS Ivax Pharmaceuticals, Inc. ORAL 500-1600MG QD ORAL Date:03/21/03ISR Number: 4079534-8Report Type:Expedited (15-DaCompany Report #C2003-0386.01 Age:68 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 100MG QD, Other ORAL Albuterol C Buproprion C Carbidopa/Levodopa C Docusate C Donepezil C Fluticasone C Furosemide C Guaifenesin C Levalbuterol Inhalation Solution C Tolterodine C Vitamin E C Date:03/21/03ISR Number: 4079536-1Report Type:Expedited (15-DaCompany Report #C2003-0198.01 Age:85 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 50MG QD, ORAL Other Citalopram C Donepezil C Lansoprazole C 22-Feb-2006 08:30 AM Page: 2148 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/21/03ISR Number: 4079537-3Report Type:Expedited (15-DaCompany Report #C2003-0528.01 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Sepsis Health Clozapine Tablets 25 Initial or Prolonged Professional Mg Mylan PS Mylan ORAL 50MG TID, Other Other ORAL Calcium With Vitamin D C Divalproex Sodium C Docusate C Ferrous Sulfate C Levothyroxine C Olanzapine C Date:03/21/03ISR Number: 4082140-2Report Type:Expedited (15-DaCompany Report #PHFR2003GB00747 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Foreign Clozaril (Clozapine) PS ORAL 150MG/DAY, Arthralgia Study ORAL Arthropathy Health Hyoscine (Hyposcine) C Dyspnoea Professional Naproxen C Lymphopenia Other Procyclidine Red Blood Cell (Procyclidine) C Sedimentation Rate Paracetamol C Increased Date:03/21/03ISR Number: 4082193-1Report Type:Expedited (15-DaCompany Report #PHFR2002GB03408 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Foreign Clozaril (Clozapine) Hallucination, Auditory Study Tablet PS 200MG/DAY; Headache Health SEE IMAGE Leukocytosis Professional Mirtazapine Overdose Other (Mirtazapine) C Psychotic Disorder Tachycardia Temporal Lobe Epilepsy White Blood Cells Urine Positive Date:03/21/03ISR Number: 4082194-3Report Type:Expedited (15-DaCompany Report #PHHO2003CA02946 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Confusional State Foreign Clozaril (Clozapine) Drug Toxicity Study Tablet PS Hyperhidrosis Health Nausea Professional Tachycardia Other 22-Feb-2006 08:30 AM Page: 2149 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/24/03ISR Number: 4082278-XReport Type:Expedited (15-DaCompany Report #PHEH2003US02218 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Health Clozaril (Clozapine) Initial or Prolonged Professional Tablet PS ORAL ORAL Date:03/24/03ISR Number: 4082279-1Report Type:Expedited (15-DaCompany Report #PHEH2003US02219 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Health Clozaril (Clozapine) Professional Tablet PS ORAL ORAL Clozapine (Clozapine) SS Date:03/24/03ISR Number: 4082284-5Report Type:Expedited (15-DaCompany Report #PHEH2003US02220 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Health Clozaril (Clozapine) Professional Tablet PS ORAL ORAL Date:03/24/03ISR Number: 4082383-8Report Type:Expedited (15-DaCompany Report #PHEH2002US09833 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Chest Wall Pain Health Clozaril (Clozapine) Hospitalization - Diabetic Complication Professional Tablet PS ORAL 500 MG QD, Initial or Prolonged Hypoglycaemia ORAL Pulmonary Embolism Topamax (Topiramate) C Toxicologic Test Abnormal Zoloft (Sertraline Hydrochloride) C Wellbutrin - Slow Release (Bupropion Hydrochloride) C Kcl C Avandia (Rosiglitazone Maleate) C Lasix C Warfarin (Warfarin) C Date:03/24/03ISR Number: 4082747-2Report Type:Expedited (15-DaCompany Report #PHFR2002IE02533 Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Pressure Increased Foreign Clozaril (Clozapine) Epinephrine Increased Study Tablet PS ORAL 300 MG/DAY, Tachycardia Health ORAL Vanillyl Mandelic Acid Professional Lofepramine Urine Increased Other (Lofepramine) C Venlafaxine (Venlafaxine) C Citalopram (Citalopram) C 22-Feb-2006 08:30 AM Page: 2150 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/24/03ISR Number: 4082770-8Report Type:Expedited (15-DaCompany Report #PHEH2003US02322 Age:73 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Other Clozaril(Clozapine) Tablet PS ORAL 50 MG/DAY, ORAL Date:03/24/03ISR Number: 4082815-5Report Type:Expedited (15-DaCompany Report #PHEH2003US02150 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Confusional State Health Clozaril (Clozapine) Dizziness Professional Tablet PS ORAL 350 MG/DAY, Dysarthria ORAL Encephalopathy Cogentin Gait Disturbance (Benzatropine Pallor Mesilate) C Speech Disorder Depakote (Valproate Semisodium) C Date:03/24/03ISR Number: 4082874-XReport Type:Expedited (15-DaCompany Report #PHNR2003AU00506 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abnormal Behaviour Foreign Clozaril (Clozapine) Hospitalization - Cardiac Arrest Health (Clozapine) Tablet PS ORAL 25 MG, ORAL; Initial or Prolonged Cough Professional SEE IMAGE Other Cyanosis Other Olanzapine C Depressed Level Of Diazepam C Consciousness Oxazepam (Oxazepam) C Electromechanical Dissociation Hypoventilation Loss Of Consciousness Restlessness Shock Sudden Death Syncope Urinary Incontinence Date:03/24/03ISR Number: 4082877-5Report Type:Expedited (15-DaCompany Report #PHNR2003AU00620 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mental Disorder Foreign Clozaril (Clozapine) PS Initial or Prolonged Treatment Noncompliance Study Health Professional Other Date:03/25/03ISR Number: 4082981-1Report Type:Expedited (15-DaCompany Report #C2003-0421.01 Age:71 YR Gender:Female I/FU:F Outcome PT Death Death Gastrointestinal Haemorrhage 22-Feb-2006 08:30 AM Page: 2151 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Refusal Of Treatment By Relative White Blood Cell Count Report Source Product Role Manufacturer Route Dose Duration Increased Health Clozapine Tablet 100 Professional Mg Mylan PS Mylan ORAL 200 MG, BID, Other ORAL Lorazepam C Pantoprazole Sodium C Quetiapine Fumarate C Date:03/25/03ISR Number: 4082982-3Report Type:Expedited (15-DaCompany Report #C2003-0240.01 Age:75 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Other Clozapine Tablets 25 Mg Mylan PS Mylan ORAL 50MG/DAY, ORAL ; SEVERAL YEARS Date:03/25/03ISR Number: 4082984-7Report Type:Expedited (15-DaCompany Report #C2003-0535.01 Age:66 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Post Procedural Other Clozapine Tablets Complication 100 Mg Mylan PS Mylan ORAL 400 MG Q AM, Small Intestinal 400 MG Q HS, Obstruction ORAL Buspirone C Levothyroxine Sodium C Loxapine Succinate C Omeprazole C Propranolol Hcl C Topiramate C Date:03/26/03ISR Number: 4082682-XReport Type:Direct Company Report #CTU 189580 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Congestive Cardiomyopathy Clozapine - 100mg Intervention to Ejection Fraction And 25 Mg Tabs PS ORAL 375 MG PO QHS Prevent Permanent Decreased Cogentin C Impairment/Damage Lethargy Klonopin C Ventricular Hypokinesia Mineral Oil C Vitamin E C Colace C Asa C Protonix C Metamucil C Lisinopril C Lithium C Date:03/26/03ISR Number: 4083775-3Report Type:Direct Company Report #CTU 189489 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neutrophil Count Clozapine 100mg Decreased Zenith PS Zenith ORAL 100 MG 22-Feb-2006 08:30 AM Page: 2152 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report MORNING ORAL 200 MG BEDTIME ORAL Date:03/27/03ISR Number: 4079619-6Report Type:Expedited (15-DaCompany Report #GB-ROCHE-334455 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Clonazepam PS Roche ORAL Phosphokinase Increased Diazepam SS Roche ORAL Leukopenia Clozaril SS ORAL Mental Disorder Clozaril SS ORAL Orphenadrine SS ORAL Date:03/27/03ISR Number: 4084932-2Report Type:Expedited (15-DaCompany Report #PHEH2003US02230 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Health Clozaril (Clozapine) Initial or Prolonged Cardiomegaly Professional Tablet PS ORAL 25 MG, ORAL; Other Cough 50 MG, ORAL Hallucination Vitamin E C Psychotic Disorder Lithium (Lithium) C Zocor Dieckmann C Asa C Vioxx C Quetiapine (Quetiapine) C Cetimil (Nedocromil Sodium) C Date:03/27/03ISR Number: 4085236-4Report Type:Expedited (15-DaCompany Report #PHNU2003DE01237 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Foreign Leponex / Clozaril Initial or Prolonged Hepatitis Study (Clozapine)(Clozapin Health e) Tablet PS ORAL SEE IMAGE Professional Anafranil(Clomiprami Other ne Hydrochloride) Slow Release Tablet SS ORAL SEE IMAGE Remergil(Mirtazapine ) SS ORAL SEE IMAGE Trevilor (Venlafaxine Hydrochloride) SS ORAL SEE IMAGE Tavor C Stilnox (Zolpidem) C Date:03/27/03ISR Number: 4085896-8Report Type:Expedited (15-DaCompany Report #03-03-0314 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Renal Surgery Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 400MG QD ORAL 22-Feb-2006 08:30 AM Page: 2153 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/27/03ISR Number: 4086536-4Report Type:Expedited (15-DaCompany Report #PHEH2003US02303 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozaril(Clozapine) Neoplasm Malignant Professional Tablet PS ORAL 100 MG, ORAL Date:03/27/03ISR Number: 4086805-8Report Type:Expedited (15-DaCompany Report #03P-062-0213684-00 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Bowel Sounds Abnormal Foreign Akineton(Biperiden) Hospitalization - Loss Of Consciousness Health (Biperiden) PS ORAL ONCE, PER Initial or Prolonged Respiratory Depression Professional ORAL Suicide Attempt Clozapin SS ORAL ONCE, PER ORAL Benperidol SS ORAL ONCE, PER ORAL Chlorprothixene Hydrochloride SS ORAL ONCE, PER ORAL Date:03/27/03ISR Number: 4086906-4Report Type:Expedited (15-DaCompany Report #PHNU2003DE01335 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Acute Foreign Leponex Clozaril Cardiac Failure Health (Clozapine) Congestive Professional (Clozapine) Tablet PS ORAL 100 & Right Ventricular Failure Other 400MG/DAY, Sudden Cardiac Death ORAL Haldol Depot (Haloperidol Decanoate) C Haldol "Jansen" C Solian (Amisulpride) C Cipramil C Allopurinol C Bronchoretard C Ferro-Sanol Duodenal C Ranitidine (Ranitidine) C Prothazin C Date:03/28/03ISR Number: 4083388-3Report Type:Direct Company Report #CTU 189698 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Unevaluable Event Clozaril 100mg PS 100MG AM 450 IN EVE Date:03/28/03ISR Number: 4086782-XReport Type:Expedited (15-DaCompany Report #03P-062-0211080-00 Age:51 YR Gender:Female I/FU:F Outcome Hospitalization - Initial or Prolonged Required 22-Feb-2006 08:30 AM Page: 2154 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Intervention to Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Coma Foreign Akineton(Biperiden) Mydriasis Health (Biperiden) PS ORAL 2 MG, 19 IN 1 Overdose Professional ONCE, PER Pneumonia Aspiration ORAL Respiratory Failure Chlorazepam SS ORAL 5 MG, 3 IN 1 Salivary Hypersecretion ONCE, PER Suicide Attempt ORAL Sertraline Hydrocloride SS ORAL 50 MG, 10 IN 1 ONCE, PER ORAL Clozapine SS ORAL 100 MG, 40 IN ONCE, PER ORAL Parstelin SS ORAL 16 TABLET, 1 IN 1 ONCE, PER ORAL Diazepam SS ORAL 10 MG, 15 IN 1 ONCE, PER ORAL Prothipendyl Hydrochloride SS ORAL 80 MCG, 20 IN 1 ONCE, PER ORAL Olanzapine SS ORAL 10 MG, 1 IN 1 ONCE, PER ORAL Date:03/31/03ISR Number: 4084028-XReport Type:Direct Company Report #CTU 189793 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required White Blood Cell Count Clozapine PS ORAL 100MG 200MG Intervention to Decreased QD ORAL Prevent Permanent Impairment/Damage Date:03/31/03ISR Number: 4087419-6Report Type:Expedited (15-DaCompany Report #03P-056-0213999-00 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - White Blood Cell Count Foreign Akineton (Biperiden) Initial or Prolonged Increased Health (Biperiden) PS ORAL PER ORAL Professional Pipotiazine SS INTRAMUSCULAR 300 MG, 1 IN 2 M, INTRA-MUSCULA R Clozapine SS ORAL SEE IMAGE Clonazepam C 22-Feb-2006 08:30 AM Page: 2155 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/31/03ISR Number: 4087484-6Report Type:Expedited (15-DaCompany Report #334455 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Foreign Clonzaepam Phosphokinase Increased Other (Clonzaepam) PS ORAL 2 MG 4 PER Mental Disorder DAY ORAL White Blood Cell Count Clozaril (Clozapine) SS ORAL 250 MG 2 PER Decreased DAY ORAL Diazepam (Diazepam) SS ORAL 20 MG 4 PER DAY ORAL Orphenadrine (Orphenadrine Citrate) SS ORAL 50 MG 2 PER DAY ORAL Date:03/31/03ISR Number: 4087612-2Report Type:Expedited (15-DaCompany Report #PHEH2003US02377 Age:67 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Gastrointestinal Health Clozaril (Clozapine) Haemorrhage Professional Tablet PS ORAL 100 MG AM + 175 MG HS, ORAL Synthroid C Vitamin E C Mylanta (Simeticone, Aluminium Hydroxide Gel, Dried) C Milk Of Magnesia C Date:03/31/03ISR Number: 4087628-6Report Type:Expedited (15-DaCompany Report #PHEH2003US02302 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Health Clozaril (Clozapine) Pituitary Tumour Benign Professional Tablet PS ORAL 300 MG/DAY, Company ORAL Representative Date:04/01/03ISR Number: 4085704-5Report Type:Expedited (15-DaCompany Report #C2003-0428.01 Age:69 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan Other Date:04/01/03ISR Number: 4085706-9Report Type:Expedited (15-DaCompany Report #C2003-0092.01 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Health Clozapine (Tablets Septic Shock Professional 100 Mg Mylan) PS Mylan ORAL 600MG, QD, Other ORAL 22-Feb-2006 08:30 AM Page: 2156 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/01/03ISR Number: 4085790-2Report Type:Expedited (15-DaCompany Report #03-03-0351 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ankle Fracture Health Clozapine - Ivax Initial or Prolonged Limb Injury Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 50-500MG QD ORAL Date:04/01/03ISR Number: 4085792-6Report Type:Expedited (15-DaCompany Report #03-02-0231 Age:54 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hip Fracture Health Clozapine Tablets - Initial or Prolonged Pneumonia Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 700 MG QD ORAL Date:04/01/03ISR Number: 4085798-7Report Type:Expedited (15-DaCompany Report #03-03-0315 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 300MG QD ORAL Date:04/01/03ISR Number: 4085800-2Report Type:Expedited (15-DaCompany Report #03-01-0280 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Circulatory Collapse Health Clozapine Tablets - Dizziness Professional Ivax Drug Level Above Other Pharmaceuticals, Therapeutic Inc. PS Ivax Drug Toxicity Pharmaceuticals, Emphysema Inc. ORAL 550MG QD ORAL Foreign Body Aspiration Luvox SS 100MG QD Respiratory Failure Klonopin C Cogentin C Date:04/01/03ISR Number: 4085802-6Report Type:Expedited (15-DaCompany Report #03-03-0332 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neoplasm Malignant Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 100-500MG QD 22-Feb-2006 08:30 AM Page: 2157 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL Date:04/01/03ISR Number: 4085803-8Report Type:Expedited (15-DaCompany Report #03-03-0333 Age:67 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Peptic Ulcer Health Clozapine Tablets - Initial or Prolonged Pneumonia Professional Ivax Reflux Oesophagitis Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 300-9000MG QD ORAL Date:04/01/03ISR Number: 4085806-3Report Type:Expedited (15-DaCompany Report #03-03-0334 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Health Clozapine Tablets - Cyanosis Professional Ivax Liver Function Test Other Pharmaceuticals, Abnormal Inc. PS Ivax Pharmaceuticals, Inc. ORAL 600MG QD ORAL Date:04/01/03ISR Number: 4085810-5Report Type:Expedited (15-DaCompany Report #03-03-0335 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Health Clozapine Tablets - Initial or Prolonged Professional Ivax Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 100-150MG QD ORAL Date:04/02/03ISR Number: 4085664-7Report Type:Expedited (15-DaCompany Report #C2003-0622.01 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 100MG BID, Other ORAL Clozapine Tablets 25 Mg Mylan SS Mylan ORAL 50MG, BID, ORAL Aspirin C Benztropine Mesylate C Celecoxib C Cyclobenzaprine C Docusate Sodium C Ranitidine C 22-Feb-2006 08:30 AM Page: 2158 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/03/03ISR Number: 4088071-6Report Type:Expedited (15-DaCompany Report #C2003-0623.01 Age:81 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional 100 Mg Mylan PS ORAL 100MG Q HS, Other ORAL Gabapentin C Hydroxyzine Pamoate C Levofloxacin C Lorazepam C Metoprolol C Date:04/03/03ISR Number: 4088075-3Report Type:Expedited (15-DaCompany Report #C2003-0025.01 Age:55 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Health Clozapine Tablets Choking Professional 100 Mg Mylan PS ORAL 400 MG QD, Injury Asphyxiation Other ORAL Pharmaceutical Product Gabapentin C Complaint Benztropine C Pulmonary Embolism Clonazepam C Date:04/03/03ISR Number: 4089356-XReport Type:Expedited (15-DaCompany Report #2003012803 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Geodon (Ziprasidone) PS ORAL 160 MG (BID), Initial or Prolonged Coma Professional ORAL Sepsis Clozapine Vomiting (Clozapine) SS ORAL 400 MG White Blood Cell Count (DAILY), ORAL Increased Benzatropine Mesilate C Date:04/03/03ISR Number: 4104762-2Report Type:Expedited (15-DaCompany Report #C2003-0932.01 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Ineffective Health Clozapine Tablets 25 Oral Intake Reduced Professional Mg Mylan PS ORAL 50MG/DAY, Other ORAL Date:04/04/03ISR Number: 4089661-7Report Type:Expedited (15-DaCompany Report #PHEH2002US06640 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chronic Lymphocytic Health Clozaril (Clozapine) Leukaemia Professional Tablet PS ORAL 50 MG AM + Leukocytosis 300 MG HS, ORAL Depakote (Valproate Semisodium) C Zoloft (Sertraline Hydrochloride) C 22-Feb-2006 08:30 AM Page: 2159 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/04/03ISR Number: 4089674-5Report Type:Expedited (15-DaCompany Report #PHEH2003US00454 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiomyopathy Health Clozaril (Clozapine) Syncope Professional Tablet PS ORAL 500MG , QD, ORAL Propranolol C Haldol "Janssen" C Klonopin C Cogentin (Benzatropine Mesilate) C Date:04/04/03ISR Number: 4089700-3Report Type:Expedited (15-DaCompany Report #PHEH2003US02522 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Oesophageal Carcinoma Health Clozaril(Clozapine)T Professional ablet PS ORAL 350 MG, QD, ROAL Vistaril(Hydroxyzine Embonate) C Bendadryl "Parke Davis" Aut C Date:04/04/03ISR Number: 4090089-4Report Type:Expedited (15-DaCompany Report #PHNU2003DE01412 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Activated Partial Foreign Leponex / Clozaril Initial or Prolonged Thromboplastin Time Health (Clozapine)(Clozapin Other Prolonged Professional e) Tablet PS ORAL SEE IMAGE Anaemia Other Blood Immunoglobulin A Decreased Blood Immunoglobulin G Decreased Diarrhoea Pneumonia Protein Total Decreased Pyrexia Date:04/04/03ISR Number: 4090094-8Report Type:Expedited (15-DaCompany Report #PHBS2003BR03019 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Disorder Foreign Leponex (Clozapine) Health Tablet PS ORAL 400 MG/D, Professional ORAL Other Date:04/04/03ISR Number: 4090098-5Report Type:Expedited (15-DaCompany Report #PHFR2003GB01069 Age:57 YR Gender:Male I/FU:I Outcome Hospitalization - Initial or Prolonged 22-Feb-2006 08:30 AM Page: 2160 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other PT Report Source Product Role Manufacturer Route Dose Duration Blood Creatine Foreign Clozaril (Clozapine) PS ORAL 400MG/DAY, Phosphokinase Increased Study ORAL Cerebrovascular Accident Health Lofepramine Chest Pain Professional (Lofepramine) C Circulatory Collapse Other Electroencephalogram Abnormal Haemoglobin Decreased Hallucination, Auditory Shock Toxic Induced Encephalopathy Urinary Tract Infection Date:04/04/03ISR Number: 4090162-0Report Type:Expedited (15-DaCompany Report #PHNU2003DE01414 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Apathy Foreign Leponex / Clozaril Diabetes Mellitus Health (Clozapine) PS ORAL 100 MG/DAY, Non-Insulin-Dependent Professional ORAL Other Date:04/04/03ISR Number: 4090163-2Report Type:Expedited (15-DaCompany Report #PHBS2002AU13145 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatitis C Foreign Clozaril Hypersplenism Health (Clozapine) PS ORAL 200 MG/D, Mental Disorder Professional ORAL Neutropenia Other Haloperidol C Thrombocytopenia Olanzapine C White Blood Cell Count Decreased Date:04/04/03ISR Number: 4090168-1Report Type:Expedited (15-DaCompany Report #PHBS2002AU09991 Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Upper Foreign Clozaril (Clozapine) Initial or Prolonged Blood Glucose Decreased Health Tablets PS ORAL 400 MG/D, Diabetes Mellitus Professional ORAL Hepatic Steatosis Other Glimepiride(Glimepir Influenza Like Illness ide) C Lipase Increased Pethidine Pancreatitis (Pethidine) C Somnolence Epilim C Ditropan (Oxybutynin) C Avandia (Rosiglitazone Maleate) C Gemfibrozil (Gemfibrozil) C 22-Feb-2006 08:30 AM Page: 2161 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/04/03ISR Number: 4090388-6Report Type:Expedited (15-DaCompany Report #PHNU2003DE01358 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Foreign Leponex / Clozaril Electrocardiogram Qt Health (Clozapine) Corrected Interval Professional (Clozapine) Tablet PS ORAL 400 MG/DAY, Prolonged Other ORAL Electroencephalogram Citalopram Abnormal (Citalopram) C Obsessive Thoughts Date:04/04/03ISR Number: 4090391-6Report Type:Expedited (15-DaCompany Report #PHFR2003GB00673 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Haemoglobin Decreased Foreign Clozaril (Clozapine) Study (Clozapine) Unknown PS ORAL 400MG/DAY, Health ORAL Professional Procyclidine Other (Procyclidine) C Date:04/04/03ISR Number: 4090393-XReport Type:Expedited (15-DaCompany Report #PHNU2000DE02113 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Leponex / Clozaril Insulin-Dependent Health (Clozapine) Glycosylated Haemoglobin Professional (Clozapine) Tablet PS ORAL ORAL Increased Other Date:04/04/03ISR Number: 4090407-7Report Type:Expedited (15-DaCompany Report #PHNU2003DE01393 Age:90 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Activated Partial Foreign Leponex / Clozaril Thromboplastin Time Health (Clozapine) Prolonged Professional (Clozapine) Tablet PS ORAL 12.5 MG, QD, Alanine Aminotransferase Company ORAL Increased Representative Aspartate Other Aminotransferase Increased Blood Lactate Dehydrogenase Increased Gamma-Glutamyltransferase Increased Leukocytosis Date:04/04/03ISR Number: 4090409-0Report Type:Expedited (15-DaCompany Report #PHNU2003DE00546 Age:58 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Colitis Ischaemic Foreign Leponex / Clozaril Initial or Prolonged Intestinal Polyp Health (Clozapine) Proctocolitis Professional (Clozapine) Tablets PS ORAL 100 MG, TID, Other ORAL Dipiperon 22-Feb-2006 08:30 AM Page: 2162 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Pipamperone) Tablet, 40 Mg SS ORAL 160 MG/DAY, ORAL Tavor C Timonil C Salofalk "Falk" (Mesalazine) C Acetylsalicylic Acid C Date:04/04/03ISR Number: 4090412-0Report Type:Expedited (15-DaCompany Report #PHNU2002DE04152 Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bundle Branch Block Left Foreign Leponex / Clozaril Bundle Branch Block Right Health (Clozapine) Electrocardiogram Professional (Clozapine) Tablet PS ORAL SEE IMAGE Repolarisation Other Abnormality Hypertensive Crisis Date:04/04/03ISR Number: 4090551-4Report Type:Expedited (15-DaCompany Report #PHFR2003GB01348 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Upper Foreign Clozaril (Clozapine) Overdose Study Unknown PS ORAL ORAL Health Lorazepam Professional (Lorazepam) SS Other Hyoscine (Hyoscine) SS Procyclidine (Procyclidine) SS Fluoxetine (Fluoxetine) SS Date:04/04/03ISR Number: 4090553-8Report Type:Expedited (15-DaCompany Report #PHBS2003BR03019 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Unevaluable Event Foreign Leponex (Clozapine) Health Tablet PS ORAL ORAL Professional Other Date:04/04/03ISR Number: 4090625-8Report Type:Expedited (15-DaCompany Report #PHFR2003GB00591 Age:14 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Foreign Clozaril (Clozapine) Initial or Prolonged Constipation Study Unknown PS ORAL 350 MG/DAY, Other Dizziness Health ORAL Drug Level Increased Professional Drug Withdrawal Syndrome Other Norepinephrine Increased Phaeochromocytoma Sinus Tachycardia 22-Feb-2006 08:30 AM Page: 2163 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/04/03ISR Number: 4090640-4Report Type:Expedited (15-DaCompany Report #PHFR2003GB00684 Age:59 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dizziness Foreign Clozaril (Clozapine) PS ORAL 250 MG/DAY, Initial or Prolonged Eating Disorder Study ORAL Other Emphysema Health Rabeprazole Fatigue Professional (Rabeprazole) C Hypotension Other Fluvastatin Lower Respiratory Tract (Fluvastatin) C Infection Folic Acid C Neuroleptic Malignant Becotide Syndrome (Beclometasone Neutrophil Count Dipropionate) C Increased Zopiclone C Oral Intake Reduced Tachyarrhythmia White Blood Cell Count Increased Date:04/04/03ISR Number: 4090671-4Report Type:Expedited (15-DaCompany Report #PHFR2003GB01415 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Medication Error Foreign Clozaril(Clozapine)T Initial or Prolonged Health ablet PS ORAL 100 X 25 MG, Professional ORAL Other Date:04/04/03ISR Number: 4090931-7Report Type:Expedited (15-DaCompany Report #PHFR2003GB01381 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Foreign Clozaril(Clozapine)U Initial or Prolonged Escherichia Urinary Tract Study nknown PS ORAL 900 MG/DAY, Infection Health ORAL Professional Other Date:04/04/03ISR Number: 4090932-9Report Type:Expedited (15-DaCompany Report #PHFR2003GB01398 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Foreign Clozaril Initial or Prolonged Study (Clozapine)Unknown PS ORAL 300MG/DAY, Health ORAL Professional Other Date:04/04/03ISR Number: 4090935-4Report Type:Expedited (15-DaCompany Report #PHHO2003CA03934 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatinine Foreign Clozaril Initial or Prolonged Increased Study (Clozapine)Tablet PS 37.5 MG, QD Pyrexia Health Risperdal C Professional Other 22-Feb-2006 08:30 AM Page: 2164 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/04/03ISR Number: 4090937-8Report Type:Expedited (15-DaCompany Report #PHFR2003GB00831 Age:25 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Circulatory Collapse Foreign Clozaril Hypotonia Study (Clozapine)Unknown PS ORAL 300 MG /DAY, Sensation Of Heaviness Health ORAL Professional Other Date:04/04/03ISR Number: 4090940-8Report Type:Expedited (15-DaCompany Report #PHFR2003GB01367 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetic Coma Foreign Clozaril Gamma-Glutamyltransferase Study (Clozapine)Unknown PS ORAL ORAL Increased Health Metformin,Nateglinid Professional e (Nateglinide, Other Metformin) C Date:04/07/03ISR Number: 4085835-XReport Type:Expedited (15-DaCompany Report #GB-GLAXOSMITHKLINE-B0290333A Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Level Increased Consumer Paroxetine PS Glaxosmithkline ORAL Sinus Tachycardia Clozaril SS ORAL Omeprazole C ORAL 20MG per day Phenoxymethylpenicil lin C Glaxosmithkline ORAL 250MG Twice per day Date:04/07/03ISR Number: 4089759-3Report Type:Expedited (15-DaCompany Report #03-03-0362 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Other Clozapine - Ivax Other Congestive Pharmaceuticals, Dysphagia Inc. Tablets PS ORAL 25MG QD ORAL Parkinson'S Disease Pneumonia Senile Dementia Date:04/07/03ISR Number: 4089761-1Report Type:Expedited (15-DaCompany Report #03-03-0365 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 200-600MD QD ORAL Date:04/07/03ISR Number: 4089764-7Report Type:Expedited (15-DaCompany Report #03-03-0366 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Death Myocardial Infarction Health Professional 22-Feb-2006 08:30 AM Page: 2165 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Product Role Manufacturer Route Dose Duration Clozapine Tablets - Ivax Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 500-675MG QD ORAL Date:04/07/03ISR Number: 4089768-4Report Type:Expedited (15-DaCompany Report #03-03-0369 Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiopulmonary Failure Health Clozapine Tablets - Hospitalization - Chronic Obstructive Professional Ivax Initial or Prolonged Pulmonary Disease Other Pharmaceuticals, Neutrophil Count Inc. Tablets PS Ivax Increased Pharmaceuticals, White Blood Cell Count Inc. ORAL 50-55MG QD Increased ORAL Date:04/07/03ISR Number: 4089772-6Report Type:Expedited (15-DaCompany Report #03-03-0370 Age:71 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Health Clozapine Tablets - Hospitalization - Mania Professional Ivax Initial or Prolonged Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 50-300MG QD ORAL Date:04/07/03ISR Number: 4089784-2Report Type:Expedited (15-DaCompany Report #03-03-0377 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neoplasm Malignant Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 400-700MG QD ORAL Date:04/07/03ISR Number: 4089802-1Report Type:Expedited (15-DaCompany Report #03-02-0139 Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Abuser Health Clozapine Tablets - Drug Screen Positive Professional Ivax Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 200-300MG QD 22-Feb-2006 08:30 AM Page: 2166 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL Date:04/07/03ISR Number: 4089804-5Report Type:Expedited (15-DaCompany Report #03-03-0262 Age:18 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Clozapine Tablets - Dehydration Professional Ivax Electrolyte Imbalance Other Pharmaceuticals, Malaise Inc. PS Ivax Nausea Pharmaceuticals, Overdose Inc. ORAL 700MG QD ORAL Viral Infection Fluoxetine SS ORAL 40MG QAM ORAL Vomiting Propanolol C ... C Date:04/07/03ISR Number: 4089807-0Report Type:Expedited (15-DaCompany Report #03-03-0361 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 75-775MG QD ORAL Date:04/07/03ISR Number: 4089810-0Report Type:Expedited (15-DaCompany Report #03-03-0357 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Infection Health Clozapine Tablets - Initial or Prolonged Jaw Disorder Professional Ivax Necrosis Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 200-60MG QD ORAL Date:04/07/03ISR Number: 4089812-4Report Type:Expedited (15-DaCompany Report #03-03-0356 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine Tablets - Other Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 200-600MG QD ORAL 22-Feb-2006 08:30 AM Page: 2167 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/08/03ISR Number: 4086291-8Report Type:Expedited (15-DaCompany Report #GB-GLAXOSMITHKLINE-B0296292A Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Lithium Carbonate PS Glaxosmithkline UNKNOWN 800MG Per day Initial or Prolonged Blood Creatinine Clozapine SS ORAL 300MG Twice Increased per day 296 DAY Blood Sodium Increased Ranitidine C Glaxosmithkline ORAL 150MG Twice Blood Urea Increased per day Coordination Abnormal Sodium Phosphate C Dehydration Diabetes Insipidus Grand Mal Convulsion Date:04/08/03ISR Number: 4091081-6Report Type:Expedited (15-DaCompany Report #C2003-0502.01 Age:74 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg Mylan PS ORAL 12.5MG Q HS, Other ORAL Acetaminophen C Carbidopa/ Levodopa C Megesterol C Milk Of Magnesia C Morphine Solution C Multivitamin C Nitrofurantoin C Pantoprazole C Triamterene/ Hctz Tablets C Vitamin C C Zinc C Date:04/08/03ISR Number: 4091083-XReport Type:Expedited (15-DaCompany Report #C2003-0660.01 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiomyopathy Health Clozapine Tablets Professional 100 Mg Mylan PS ORAL 50MG Q AM AND Other 200MG Q HS, ORAL Bupropron C Escitalopram C Levothyroxine C Topiramate C Date:04/08/03ISR Number: 4091966-0Report Type:Expedited (15-DaCompany Report #03P-082-0214595-00 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Foreign Valproic Acid Initial or Prolonged Asthenia Literature (Depakene) (Valproic Drug Interaction Acid) (Valproic White Blood Cell Count Acid) PS 1000 MG Decreased Clozapine (Clozapine) SS 325 MG, 1 D Olanzapine C Clonazepam C 22-Feb-2006 08:30 AM Page: 2168 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/09/03ISR Number: 4090369-2Report Type:Direct Company Report #CTU 190519 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neutrophil Count Clozapine 100 Mg Zenith/Goldline PS Zenith/Goldline ORAL 250 MG QAM ORAL Clozapine 25 Mg Zenith/Goldline SS Zenith/Goldline ORAL 300 MG HS ORAL Docusate C Lorazepam C Multivitamin C Date:04/09/03ISR Number: 4091061-0Report Type:Direct Company Report #CTU 190527 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neutrophil Count Clozapine 25mg Zenith/Goldline PS Zenith/Goldline ORAL 50MG/TI PO Clotrimazole Cream C Lactic Acid Lotion C Senna C Date:04/09/03ISR Number: 4092382-8Report Type:Expedited (15-DaCompany Report #PHFR2003GB01430 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebral Haemorrhage Foreign Clozaril Hypertension Study (Clozapine) PS ORAL 500 MG/DAY, Other ORAL Date:04/09/03ISR Number: 4092388-9Report Type:Expedited (15-DaCompany Report #PHNR2003AU00734 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Foreign Clozaril (Clozapine) Initial or Prolonged Drug Abuser Health (Clozapine) Tablet PS ORAL ORAL Somnolence Professional Morphine Sulphate () SS Other Date:04/09/03ISR Number: 4092481-0Report Type:Expedited (15-DaCompany Report #PHFR2003GB01389 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Foreign Clozaril (Clozapine) Phosphokinase Increased Study Unknown PS ORAL ORAL Chest Pain Health Dyspnoea Professional Electrocardiogram P Wave Other Abnormal Electrocardiogram St Segment Elevation Labile Blood Pressure Tachycardia 22-Feb-2006 08:30 AM Page: 2169 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/09/03ISR Number: 4092484-6Report Type:Expedited (15-DaCompany Report #PHFR2003IE01467 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bundle Branch Block Right Foreign Clozaril (Clozapine) Electrocardiogram T Wave Study (Clozapine) Unknown PS ORAL 12.5 MG, QD, Abnormal Health ORAL Sinus Tachycardia Professional Other Date:04/09/03ISR Number: 4092515-3Report Type:Expedited (15-DaCompany Report #PHNU2003DE01485 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Catatonia Foreign Leponex / Clozaril Health (Clozapine) Professional (Clozapine) Tablet PS ORAL 400 TO 600 Other MG/DAY, ORAL Date:04/09/03ISR Number: 4092517-7Report Type:Expedited (15-DaCompany Report #PHNU2003DE01484 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Catatonia Foreign Leponex / Clozaril Health (Clozapine) Professional (Clozapine) Tablet PS ORAL 400MG/DAY, Other ORAL Tavor C Date:04/09/03ISR Number: 4092521-9Report Type:Expedited (15-DaCompany Report #PHNU2003DE01483 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Catatonia Foreign Leponex / Clozaril Health (Clozapine) Professional (Clozapine) Tablet PS ORAL 600 MG/DAY, Other ORAL Date:04/09/03ISR Number: 4092530-XReport Type:Expedited (15-DaCompany Report #PHNU2003DE01470 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bundle Branch Block Left Foreign Leponex / Clozaril Eosinophilia Health (Clozapine) Ventricular Extrasystoles Professional (Clozapine) Tablet PS ORAL 250 MG DAILY, Other ORAL Date:04/09/03ISR Number: 4092536-0Report Type:Expedited (15-DaCompany Report #PHFR2003GB00717 Age:56 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Transient Ischaemic Foreign Clozaril(Clozapine)( Attack Study Clozapine) PS ORAL 100MG/DAY, Health ORAL Professional Lithium(Lithium) C Other Cyproterone(Cyproter one) C 22-Feb-2006 08:30 AM Page: 2170 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Procyclidine9procycl idine) C Becotide(Beclometaso ne Dipropionate) C Date:04/09/03ISR Number: 4092566-9Report Type:Expedited (15-DaCompany Report #PHFR2003GB01375 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril (Clozapine) PS ORAL 125 MG, BID, Inadequate Control Study ORAL Dyspnoea Health Lower Respiratory Tract Professional Infection Other Malaise Pharyngitis Tachycardia Viral Infection Wheezing Date:04/09/03ISR Number: 4092576-1Report Type:Expedited (15-DaCompany Report #PHNR2003AU00620 Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mental Disorder Foreign Clozaril Initial or Prolonged Treatment Noncompliance Study (Clozapine) PS Health Professional Other Date:04/09/03ISR Number: 4092579-7Report Type:Expedited (15-DaCompany Report #PHHO2003CA01197 Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril Inadequate Control Study (Clozapine) PS Health Effexor (Venlafaxine Professional Hydrochloride) C Other Lorazepam C Date:04/09/03ISR Number: 4092651-1Report Type:Expedited (15-DaCompany Report #PHHO2003CA03569 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chest Discomfort Foreign Clozaril (Clozapine) Chest Pain Study Tablet PS Dyspnoea Health Panic Attack Professional Tachycardia Other Date:04/09/03ISR Number: 4092653-5Report Type:Expedited (15-DaCompany Report #PHFR2003GB01282 Age:31 YR Gender:Male I/FU:I Outcome Hospitalization - Initial or Prolonged 22-Feb-2006 08:30 AM Page: 2171 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other PT Report Source Product Role Manufacturer Route Dose Duration Aggression Foreign Clozaril (Clozapine) PS ORAL 225MG/DAY, Diarrhoea Study ORAL Eosinophil Count Health Zopiclone C Increased Professional Diazepam C White Blood Cell Count Other Chlorpromazine Increased (Chlorpromazine) C Lorazepam C Date:04/09/03ISR Number: 4092655-9Report Type:Expedited (15-DaCompany Report #PHNU2003DE01482 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Obsessive Thoughts Foreign Leponex / Clozaril Health (Clozapine) Professional (Clozapine) Tablet PS ORAL 500 TO Other 600MG/DAY, ORAL Date:04/09/03ISR Number: 4092656-0Report Type:Expedited (15-DaCompany Report #PHNU2003DE01481 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Obsessive Thoughts Foreign Leponex / Clozaril Health (Clozapine) Professional (Clozapine) Tablet PS ORAL 250MG/DAY, Other ORAL Date:04/09/03ISR Number: 4092657-2Report Type:Expedited (15-DaCompany Report #PHNU2003DE00613 Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Foreign Leponex / Clozaril Initial or Prolonged Csf Protein Increased Health (Clozapine)(Clozapin Other Drug Level Increased Professional e) Tablet PS ORAL SEE IMAGE Neoplasm Other Date:04/09/03ISR Number: 4092659-6Report Type:Expedited (15-DaCompany Report #PHNU2003DE00678 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Foreign Leponex / Clozaril Initial or Prolonged Non-Insulin-Dependent Health (Clozapine)(Clozapin Other Inflammation Professional e) Tablet PS ORAL 100 Leukocytosis Other MG/DAY,ORAL Lung Neoplasm Date:04/09/03ISR Number: 4092793-0Report Type:Expedited (15-DaCompany Report #PHNR2003AU00727 Age: Gender:Male I/FU:I Outcome PT Hospitalization - Therapeutic Agent Initial or Prolonged Toxicity White Blood Cell Count 22-Feb-2006 08:30 AM Page: 2172 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Increased Report Source Product Role Manufacturer Route Dose Duration Foreign Clozaril (Clozapine) Other (Clozapine)Tablet PS ORAL ORAL Clozaril (Clozapine) (Clozapine) Tablet SS ORAL RESTSRTED, ORAL Date:04/09/03ISR Number: 4093021-2Report Type:Expedited (15-DaCompany Report #PHEH2003US02700 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatic Neoplasm Health Clozaril (Clozapine) Malignant Professional Tablet PS ORAL ORAL Company Representative Date:04/09/03ISR Number: 4093055-8Report Type:Expedited (15-DaCompany Report #PHEH2003US02617 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dysphagia Health Clozaril (Clozapine) Parkinson'S Disease Professional Tablet PS ORAL 25 MG/DAY, Pneumonia Aspiration ORAL Date:04/10/03ISR Number: 4088151-5Report Type:Expedited (15-DaCompany Report #CH-GLAXOSMITHKLINE-B0296700A Age:64 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Renal Interstitial Quilonorm PS Glaxosmithkline ORAL 13 YR Fibrosis Leponex SS ORAL YR Tubulointerstitial Nephritis Date:04/10/03ISR Number: 4091455-3Report Type:Direct Company Report #CTU 190640 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Constipation Haldol Decanoate PS INTRAMUSCULAR 150MG IM Q4 Initial or Prolonged Rectal Tenesmus WEEKS Clozapine SS ORAL 300MG PO BIID Glucophage SS ORAL 500MG PO BID Haldol C Zocor C Colace C Clozapine C Glucophage C Depakote C Lactulose C 22-Feb-2006 08:30 AM Page: 2173 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/14/03ISR Number: 4094117-1Report Type:Expedited (15-DaCompany Report #03-04-0416 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 300-900MG QD ORAL Date:04/14/03ISR Number: 4094120-1Report Type:Expedited (15-DaCompany Report #03-04-0415 Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neoplasm Malignant Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL ORAL Date:04/14/03ISR Number: 4094122-5Report Type:Expedited (15-DaCompany Report #03-04-0405 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 450-800MG QD ORAL Date:04/14/03ISR Number: 4094129-8Report Type:Expedited (15-DaCompany Report #03-04-0398 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 400-700MG QD ORAL Date:04/14/03ISR Number: 4094132-8Report Type:Expedited (15-DaCompany Report #03-02-0228 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agranulocytosis Health Clozapine - Ivax Life-Threatening Leukopenia Professional Pharmaceuticals, Other Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL ORAL Chemotherapy Unknown SS 22-Feb-2006 08:30 AM Page: 2174 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/15/03ISR Number: 4095240-8Report Type:Expedited (15-DaCompany Report #03-04-0423 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Colitis Other Clozapine - Tablets PS Ivax Pharmaceuticals, Inc. ORAL 550-900MG QD ORAL Date:04/15/03ISR Number: 4095241-XReport Type:Expedited (15-DaCompany Report #03-03-0306 Age:88 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine - Tablets PS Ivax Other Professional Pharmaceuticals, Other Inc. ORAL 12.5-50MG QD ORAL Date:04/15/03ISR Number: 4095242-1Report Type:Expedited (15-DaCompany Report #03-03-0305 Age:74 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Clozapine - Ivax Congestive Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 50MG QHS ORAL Date:04/15/03ISR Number: 4095243-3Report Type:Expedited (15-DaCompany Report #03-01-0051 Age:62 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Lung Neoplasm Malignant Health Clozapine - Tablets PS Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. ORAL 150-300MG QD ORAL Bupropion 200mg Qpm C Lamictal 150mg C Date:04/15/03ISR Number: 4095245-7Report Type:Expedited (15-DaCompany Report #03-04-0446 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Brain Neoplasm Benign Health Clozapine - Tablets PS Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. ORAL 200MG QD ORAL Date:04/15/03ISR Number: 4095255-XReport Type:Expedited (15-DaCompany Report #03-04-0442 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Back Disorder Health Clozapine - Ivax Initial or Prolonged Surgery Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 25-325MG QD ORAL 22-Feb-2006 08:30 AM Page: 2175 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/15/03ISR Number: 4095256-1Report Type:Expedited (15-DaCompany Report #03-04-0438 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL ORAL Date:04/15/03ISR Number: 4095258-5Report Type:Expedited (15-DaCompany Report #03-04-0435 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL ORAL Date:04/15/03ISR Number: 4095260-3Report Type:Expedited (15-DaCompany Report #03-04-0434 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hip Arthroplasty Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 100-400MG QD ORAL Date:04/15/03ISR Number: 4095261-5Report Type:Expedited (15-DaCompany Report #03-04-0433 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pleural Infection Other Clozapine - Ivax Initial or Prolonged Pharmaceuticals, Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 250-500MG QD ORAL Date:04/15/03ISR Number: 4095263-9Report Type:Expedited (15-DaCompany Report #03-04-0432 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bone Marrow Disorder Other Clozapine - Ivax Initial or Prolonged Pharmaceuticals, Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 525MG QD ORAL Chemotherapy For Acute Blast Cell Condition C 22-Feb-2006 08:30 AM Page: 2176 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/15/03ISR Number: 4095363-3Report Type:Expedited (15-DaCompany Report #PHBS2003US03651 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coma Literature Clozapine(Clozapine) Death Health Unknown PS 350 MG/D Drug Level Increased Professional Haloperidol C Drug Toxicity Gabapentin Treatment Noncompliance (Gabapentin) C Ranitidine (Ranitidine) C Benztropeine (Benztropeine) C Contraceptives Uns (Contraceptives Uns) C Docusate Sodium C Date:04/15/03ISR Number: 4095388-8Report Type:Expedited (15-DaCompany Report #PHEH2003US02709 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Other Clozaril (Clozapine0 Tablet PS Date:04/15/03ISR Number: 4095389-XReport Type:Expedited (15-DaCompany Report #PHEH2002US10698 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aortic Aneurysm Other Clozaril (Clozapine) Chest Pain Tablet PS ORAL ORAL Haematocrit Decreased Wellbutrin Hyperkalaemia (Bupropion Hypotension Hydrochloride) C International Normalised Prozac (Fluoxetine Ratio Increased Hydrochloride) C Occult Blood Positive Digoxin C Renal Failure Lasix C Respiratory Arrest Zocor "Merck" C Sinemet C Florinef (Fludrocortisone Acetate) C Eldepryl C Permax (Pergolide Mesilate) C Seroquel (Quetiapine, Fumarate) C Comtan C Date:04/15/03ISR Number: 4095501-2Report Type:Expedited (15-DaCompany Report #PHNR2003AU00641 Age:41 YR Gender:Male I/FU:F Outcome PT Life-Threatening Blood Alkaline Hospitalization - Phosphatase Increased Initial or Prolonged C-Reactive Protein Increased Dialysis 22-Feb-2006 08:30 AM Page: 2177 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Haematocrit Decreased Neutrophil Count Increased Report Source Product Role Manufacturer Route Dose Duration Platelet Count Increased Foreign Clozaril Red Blood Cell Count Other (Clozapine)(Clozapin Decreased e) Tablet PS ORAL 250, 300 MG/ Renal Failure ONCE/DAY, Therapeutic Agent ORAL Toxicity Lithium (Lithium) SS 625 MG, BID White Blood Cell Count Ranitidin "Aliud Increased Pharma" C Valproate Sodium C Alanzapine C Diazepam C Ceclor C Date:04/15/03ISR Number: 4095672-8Report Type:Expedited (15-DaCompany Report #PHEH2003US01507 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Basal Cell Carcinoma Other Clozaril (Clozapine) Tablet PS ORAL 500 MG , QHS, ORAL Oscal 500-D C Albuterol C Advair (Salmeterol Xinafoate) C Date:04/15/03ISR Number: 4095756-4Report Type:Expedited (15-DaCompany Report #PHEH2003US02814 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Lip And/Or Oral Cavity Health Clozaril (Clozapine) Cancer Professional Tablet PS ORAL 725 MG, ORAL Oral Soft Tissue Disorder Date:04/15/03ISR Number: 4095923-XReport Type:Expedited (15-DaCompany Report #PHFR2003GB01321 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Chloride Increased Foreign Clozaril(Clozapine) PS ORAL 350MG/DAY, Blood Sodium Increased Study ORAL Constipation Health Priadel C Decreased Appetite Professional Drug Eruption Other Hepatic Steatosis Rash Erythematous Rash Psoriaform Weight Decreased Date:04/15/03ISR Number: 4095997-6Report Type:Expedited (15-DaCompany Report #PHNU2003DE01559 Age: Gender:Female I/FU:I Outcome PT Other Leukocytosis Lymphopenia Viral Infection 22-Feb-2006 08:30 AM Page: 2178 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Vomiting Report Source Product Role Manufacturer Route Dose Duration Foreign Leponex / Clozaril Health (Clozapine) Professional (Clozapine) Tablet PS ORAL ORAL Date:04/15/03ISR Number: 4096139-3Report Type:Expedited (15-DaCompany Report #PHFR2003GB01486 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Exposure Foreign Clozaril(Clozapine) PS ORAL 225MG ONE Initial or Prolonged Heart Rate Decreased Health DOSE, ORAL Other Hypotension Professional Olanzapine C Medication Error Other Date:04/15/03ISR Number: 4096245-3Report Type:Expedited (15-DaCompany Report #PHFR2003GB00715 Age:32 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Glucose Fluctuation Foreign Clozaril (Clozapine) PS ORAL 150MG MANE/ Hospitalization - Diabetic Ketoacidosis Study 350 MG NOCTE, Initial or Prolonged Hypothermia Health ORAL Lower Respiratory Tract Professional Dexamethasone Infection Other (Dexamethasone) SS ORAL 4 MG, BID, Shock ORAL Taxol C Carboplatin (Carboplatin) C Premarin (Estrogens Conjugated) C Domperidone (Domperidone) C Multivitamins (Panthenol, Retinol) C Hyoscine Hydrobromide C Date:04/15/03ISR Number: 4096255-6Report Type:Expedited (15-DaCompany Report #PHNR2003AU00747 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dehydration Foreign Clozaril (Clozapine) Orthostatic Hypotension Health (Clozapine) Tablet PS ORAL 300MG/DAY, Tachycardia Professional ORAL Ventricular Hypokinesia Other Date:04/15/03ISR Number: 4096261-1Report Type:Expedited (15-DaCompany Report #PHNR2003AU00742 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril (Clozapine) Non-Insulin-Dependent Study (Clozapine) Tablet PS 75-300MG/DAY Health Professional Other 22-Feb-2006 08:30 AM Page: 2179 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/15/03ISR Number: 4096263-5Report Type:Expedited (15-DaCompany Report #PHBS2003BR03669 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypoglycaemia Foreign Leponex (Clozapine) Weight Decreased Health Tablet PS ORAL ORAL Professional Diazepam C Other Date:04/15/03ISR Number: 4096264-7Report Type:Expedited (15-DaCompany Report #PHBS2003IE03619 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bundle Branch Block Right Foreign Clozaril (Clozapine) Tachycardia Health Tablet PS ORAL 12.5 MG/D, Professional ORAL Other Date:04/15/03ISR Number: 4096301-XReport Type:Expedited (15-DaCompany Report #PHHO2003CA02689 Age:54 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril (Clozapine) Insulin-Dependent Study (Clozapine) Tablet PS Health Professional Other Date:04/15/03ISR Number: 4096577-9Report Type:Expedited (15-DaCompany Report #PHFR2003GB01464 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril(Clozapine) Insulin-Dependent Study Unknown PS ORAL 500MG/DAY, Health ORAL Professional Other Date:04/16/03ISR Number: 4097133-9Report Type:Expedited (15-DaCompany Report #K200201967 Age:16 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Confusional State Foreign Kemadrin Depressed Level Of Health (Procyclidine) Consciousness Professional Tablet, 5 Mg PS ORAL ORAL Overdose Other Clozapine Sinus Tachycardia (Clozapine) SS ORAL ORAL Somnolence Date:04/17/03ISR Number: 4092205-7Report Type:Expedited (15-DaCompany Report #GB-GLAXOSMITHKLINE-B0297400A Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Drug Interaction Consumer Lamotrigine PS Glaxosmithkline ORAL 25MG See Salivary Hypersecretion dosage text 22 DAY Clozapine SS ORAL Aspirin C Glaxosmithkline ORAL 22-Feb-2006 08:30 AM Page: 2180 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Bendrofluazide C Glaxosmithkline ORAL Lactulose C ORAL Date:04/17/03ISR Number: 4097582-9Report Type:Expedited (15-DaCompany Report #C2003-0755.1 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Carcinoma Cell Type Health Clozapine Tablets Unspecified Stage Iv Professional 100 Mg Mylan PS Mylan ORAL 300 MG, QHS, Other ORAL Asthma Medications C Diabetic Medications C Date:04/18/03ISR Number: 4098669-7Report Type:Expedited (15-DaCompany Report #B0297339A Age:6 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Liver Function Test Foreign Paracetamol Hospitalization - Abnormal (Formulation Initial or Prolonged Overdose Unknown) Required (Acetaminophen) PS ORAL ORAL Intervention to Clozapine Prevent Permanent (Formulation Impairment/Damage Unknown) (Clozapine) SS Date:04/18/03ISR Number: 4098727-7Report Type:Expedited (15-DaCompany Report #PHFR2003GB00982 Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Alkaline Foreign Clozaril(Clozapine) Hospitalization - Phosphatase Increased Study Unknown PS ORAL 750 MG/DAY, Initial or Prolonged Blood Bicarbonate Health ORAL Other Decreased Professional Multivitamins C Blood Bilirubin Increased Valproate Sodium Unk C Blood Cholesterol Increased Blood Potassium Decreased Blood Sodium Decreased Blood Triglycerides Increased Blood Urea Decreased Blood Urine Present Confusional State Diabetes Mellitus Insulin-Dependent High Density Lipoprotein Increased Ketoacidosis Date:04/18/03ISR Number: 4098743-5Report Type:Expedited (15-DaCompany Report #PHEH2003US02961 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Carditis Health Clozaril (Clozapine) Dyspnoea Professional Tablet PS ORAL 800 MG, QD, Hyperhidrosis Company ORAL Tachycardia Representative 22-Feb-2006 08:30 AM Page: 2181 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/18/03ISR Number: 4098840-4Report Type:Expedited (15-DaCompany Report #PHFR2003GB01309 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril(Clozapine) Non-Insulin-Dependent Study Unknown PS ORAL 250 MG/DAY, Health ORAL Professional Lofepramine Other (Lofepramine) C Date:04/18/03ISR Number: 4098843-XReport Type:Expedited (15-DaCompany Report #PHBS2002NO10793 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Myocardial Foreign Leponex(Clozapine) Infarction Health Tablet PS ORAL 400 MG/D, Cardiac Failure Professional ORAL Cardiomegaly Other Plendil C Palpitations Sudden Cardiac Death Date:04/18/03ISR Number: 4098922-7Report Type:Expedited (15-DaCompany Report #PHBS2003BR03669 Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypoglycaemia Foreign Leponex(Clozapine) Weight Decreased Health Tablet PS ORAL ORAL Professional Diazepam C Company Representative Other Date:04/21/03ISR Number: 4098436-4Report Type:Expedited (15-DaCompany Report #C2003-0743.01 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Insomnia Health Clozapine Tablets Initial or Prolonged Restlessness Professional 100 Mg Mylan PS Mylan ORAL 300 MG QD, Other Speech Disorder ORAL ; Weight Decreased SEVERAL MONTHS Lithium SS SEVERAL MONTHS Date:04/22/03ISR Number: 4099628-0Report Type:Expedited (15-DaCompany Report #C2003-0826.01 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Other Clozapine Tablets Pharmaceutical Product 100 Mg Mylan PS Mylan ORAL 600MG/DAY, Complaint ORAL 22-Feb-2006 08:30 AM Page: 2182 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/22/03ISR Number: 4099631-0Report Type:Expedited (15-DaCompany Report #C2003-0490.01 Age:56 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 200MG Q AM, Other 300MG Q PM, ORAL Glyburide C Metformin C Enalapril C Gemfibrozil C Potassium C Levothyroxine C Hydrochlorothiazide C Glimepride C Beclomethasone Inhaler C Date:04/23/03ISR Number: 4099713-3Report Type:Expedited (15-DaCompany Report #C2002-3634.01 Age:73 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Parkinson'S Disease Health Clozapine PS Mylan ORAL 50MG, QD, Professional THEN 25MG QD, Other ORAL Calcium C Hydrocortisone C Lactulose C Levothyroxine C Nitroglycerin Patches C Pantoprazole C Sertraline C Simvastatin C Tamsulosin C Date:04/23/03ISR Number: 4101865-3Report Type:Expedited (15-DaCompany Report #PHNR2003AU00589 Age:19 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Haematuria Foreign Clozaril (Clozapine) Proteinuria Health (Clozapine) Tablet PS ORAL 125 MG/DAY, Pyrexia Professional ORAL Red Blood Cell Other Abnormality Treatment Noncompliance Date:04/23/03ISR Number: 4101869-0Report Type:Expedited (15-DaCompany Report #PHFR2003IE01467 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bundle Branch Block Right Foreign Clozaril (Clozapine) Electrocardiogram T Wave Study (Clozapine) Unknown PS ORAL 12.5 MG, QD, Abnormal Health ORAL Sinus Tachycardia Professional Chlorpromazine Other (Chlorpromazine) C Flurazepam (Flurazepam) C 22-Feb-2006 08:30 AM Page: 2183 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/23/03ISR Number: 4102211-1Report Type:Expedited (15-DaCompany Report #2003-BP-02209RO Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Health Lithium Carbonate Initial or Prolonged Aphasia Professional Capsules Usp, 300 Mg Blood Pressure Increased Other (Lithium Carbonate) PS ORAL PO Drug Interaction Clozapine Insomnia (Clozapine) SS ORAL 300 MG QD Restlessness (100 MG), PO; Weight Decreased SEVERAL MONTHS Date:04/23/03ISR Number: 4112459-8Report Type:Periodic Company Report #A0372683A Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Epilepsy Health Lithium Carbonate Initial or Prolonged Therapeutic Agent Professional (Lithium Carbonate) Toxicity (Generic) PS Clozapine Tablet SS ORAL PER DAY / ORAL Date:04/24/03ISR Number: 4102174-9Report Type:Expedited (15-DaCompany Report #PHRM2003FR00863 Age:19 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Colitis Ulcerative Foreign Leponex(Clozapine) Hospitalization - Colonic Haemorrhage Health Tablet PS ORAL 200 MG/DAY, Initial or Prolonged Intestinal Ischaemia Professional ORAL Intestinal Obstruction Other Laudanum (Opium Metabolic Acidosis Tincture) C Necrotising Colitis Depamide(Valpromide) C Pyrexia Stilnox (Zolpidem) C Renal Failure Acute Atarax (Hydroxyzine Rhabdomyolysis Hydrochloride) C Shock Tachycardia Date:04/24/03ISR Number: 4102176-2Report Type:Expedited (15-DaCompany Report #PHNU2003DE01484 Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Catatonia Foreign Leponex / Clozaril Health (Clozapine)(Clozapin Professional e) Tablet PS ORAL 400 MG/DAY, Other ORAL Laubeel C Atarax (Hydroxyzine Hydrochloride) C Truxal (Chlorprothixene Hydrochloride) C Solian (Amisulpride) C Glianimon (Benperidol) C 22-Feb-2006 08:30 AM Page: 2184 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/24/03ISR Number: 4102504-8Report Type:Expedited (15-DaCompany Report #2003016066 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Body Temperature Health Sertraline Increased Professional (Sertraline) PS 100 MG Drug Toxicity (DAILY) Toxicologic Test Abnormal Clozapine White Blood Cell Count (Clozapine) SS ORAL DAILY (ORAL) Increased Date:04/24/03ISR Number: 4102698-4Report Type:Expedited (15-DaCompany Report #PHFR2003GB01657 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Obsessive-Compulsive Foreign Clozaril Disorder Health (Clozapine) PS ORAL 500 MG, QD, Professional ORAL Company Representative Other Date:04/24/03ISR Number: 4102812-0Report Type:Expedited (15-DaCompany Report #PHFR2003GB01656 Age:80 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Accidental Exposure Foreign Clozaril(Clozapine) Hypotension Health Tablet PS ORAL 125 MG, Medication Error Professional ONCE/SINGLE, Sedation Other ORAL Date:04/24/03ISR Number: 4102813-2Report Type:Expedited (15-DaCompany Report #PHNU2003DE01650 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diarrhoea Foreign Leponex/Clozaril Eosinophil Count Health (Clozapine) Increased Professional (Clozapine) Tablet PS ORAL 250 MG/DAY, Fibrin D Dimer Increased Other ORAL Urinary Tract Infection Date:04/25/03ISR Number: 4102892-2Report Type:Expedited (15-DaCompany Report #C2003-0893.01 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Emphysema Health Clozapine Tablets Professional 100 Mg Mylan PS ORAL 200MG Q AM Other AND 400MG Q HS, ORAL Clozapine Tablets 25 Mg Mylan SS ORAL 50MG AM, ORAL Albuterol Inhalation Solution C Buspirone (20mg Tid) C Diazepam (5mg Bid) C Docusate Sodium (100mg Q Hs) C Fluticasone/Salmeter 22-Feb-2006 08:30 AM Page: 2185 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ol Inhaler (250/50 Bid) C Gabapentin (300mg Bid, 600mg Q Hs) C Ipratropium Inhalation Solution C Ipratropium Inhaler C Multivitamin (Qd) C Nicotine Inhaler C Nicotine Patch (21mg Qd) C Paroxetine (50mg Q Hs) C Prednisone (5mg Qd) C Senna (8.6mg Qd) C Date:04/25/03ISR Number: 4102893-4Report Type:Expedited (15-DaCompany Report #C2003-0894.01 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrial Fibrillation Health Clozapine Tablets Initial or Prolonged Drooling Professional 100 Mg Mylan PS ORAL 100MG Q AM, Other Drug Hypersensitivity 300MG QHS Heart Rate Increased THEN 100MG Medication Error QAM AND 400MG Pulse Pressure Increased Q HS, ORAL Divalproex Sodium C Lorazepam (Prn) C Multivitamin C Unknown Nasal Spray C Date:04/25/03ISR Number: 4117269-3Report Type:Periodic Company Report #NSADSS2002038408 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Therapeutic Response Health Ultram (50 Mg Increased Professional Tablet) (Tramadol Hydrochloride) PS ORAL 50 MG, DAILY, ORAL Clozaril(Clozapine) SS ORAL 475 MG, DAILY, ORAL Vioxx(Rofecoxib) C Prevacid(Lansoprazol e) C Cogentin(Benzatropin e Mesilate) C Date:04/28/03ISR Number: 4101321-2Report Type:Direct Company Report #CTU 191776 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Clozaril PS Ivax ORAL 400 MG HS AND 200 MG AM PO 22-Feb-2006 08:30 AM Page: 2186 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/28/03ISR Number: 4101327-3Report Type:Direct Company Report #CTU 191777 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Adhesions Clozapine PS Condition Aggravated Thorazine SS Intestinal Obstruction Seroquel SS Vistaril SS Date:04/28/03ISR Number: 4103057-0Report Type:Expedited (15-DaCompany Report #03-03-0362 Age:76 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aphagia Other Clozapine - Ivax Other Cardiac Failure Pharmaceuticals, Congestive Inc. Tablets PS Ivax Parkinson'S Disease Pharmaceuticals, Pneumonia Inc. ORAL 25 MG QD ORAL Senile Dementia Date:04/28/03ISR Number: 4103058-2Report Type:Expedited (15-DaCompany Report #02-10-0954 Age:53 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Neoplasm Malignant Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc ORAL 300-600 QD ORAL Date:04/28/03ISR Number: 4103059-4Report Type:Expedited (15-DaCompany Report #03-03-0279 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Health Clozapine - Ivax Hospitalization - Professional Pharmaceuticals, Initial or Prolonged Other Inc.; Tablets PS Ivax Pharmaceuticals, Inc. ORAL 25-900 MG QD ORAL Date:04/28/03ISR Number: 4103060-0Report Type:Expedited (15-DaCompany Report #03-04-0454 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Appendicitis Perforated Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 500 MG QD ORAL 22-Feb-2006 08:30 AM Page: 2187 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/28/03ISR Number: 4103061-2Report Type:Expedited (15-DaCompany Report #03-04-0456 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Oesophageal Rupture Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 600 MG QD ORAL Date:04/28/03ISR Number: 4103064-8Report Type:Expedited (15-DaCompany Report #03-04-0457 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Neoplasm Malignant Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 400-600 MG QD ORAL Date:04/28/03ISR Number: 4103065-XReport Type:Expedited (15-DaCompany Report #03-04-0459 Age:88 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Aspiration Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 100-200MG QD ORAL Date:04/28/03ISR Number: 4103288-XReport Type:Expedited (15-DaCompany Report #C2003-0315.01 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 900MG QD, Other ORAL Paroxetine C Divalproex C Date:04/28/03ISR Number: 4103289-1Report Type:Expedited (15-DaCompany Report #C2003-0318-01 Age:69 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Myocardial Health Clozapine Tablets Infarction Professional 100 Mg Mylan PS Mylan ORAL 100MG, Q AM, Pneumonia Other 200MG Q PRN, ORAL 22-Feb-2006 08:30 AM Page: 2188 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/28/03ISR Number: 4103292-1Report Type:Expedited (15-DaCompany Report #C2003-0803.01 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Choking Other Clozapine Tablets 100 Mg Mylan PS Mylan ORAL 100MG Q AM, 200 MG Q PRN, ORAL Date:04/28/03ISR Number: 4103295-7Report Type:Expedited (15-DaCompany Report #C2003-0622.01 Age:72 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 100 MG, BID, Other ORAL Clozapine Tablets 25 Mg Mylan SS Mylan ORAL 50MG BID, ORAL Aspirin C Benztropine Mesylate C Celecoxib C Cyclobenzapine C Docusate Sodium C Ranitidine C Date:04/28/03ISR Number: 4103326-4Report Type:Expedited (15-DaCompany Report #PHEH2003US01728 Age:84 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anaemia Other Clozaril(Clozapine) Hospitalization - Atrial Fibrillation Tablet PS 100 MG, QD Initial or Prolonged Hypertension Risperdal C Hypokalaemia Flomax "Boehringer Leukocytosis Ingelheim" Myocardial Infarction (Tamsulosin Renal Failure Hydrochloride) C Multivitamins (Retinol, Panthenol) C Vitamin E C Date:04/28/03ISR Number: 4103333-1Report Type:Expedited (15-DaCompany Report #PHEH2003US02934 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Cancer Health Clozaril (Clozapine) Professional Tablet PS Date:04/28/03ISR Number: 4103555-XReport Type:Expedited (15-DaCompany Report #03-04-0460 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neoplasm Malignant Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 200-350MG QD ORAL 22-Feb-2006 08:30 AM Page: 2189 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/28/03ISR Number: 4103556-1Report Type:Expedited (15-DaCompany Report #03-04-0461 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Appendicectomy Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 750-900MG QD ORAL Date:04/28/03ISR Number: 4103557-3Report Type:Expedited (15-DaCompany Report #03-04-0468 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine - Ivax Treatment Noncompliance Professional Pharmaceuticals , Other Inc. Tablets PS ORAL 50-600MG QD ORAL Date:04/28/03ISR Number: 4103558-5Report Type:Expedited (15-DaCompany Report #03-04-0471 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS ORAL ORAL Date:04/28/03ISR Number: 4103882-6Report Type:Expedited (15-DaCompany Report #PHNR2003AU00681 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Arrhythmia Foreign Clozaril (Clozapine) Bundle Branch Block Right Study Tablet PS Health Professional Other Date:04/28/03ISR Number: 4103901-7Report Type:Expedited (15-DaCompany Report #PHFR2003GB00834 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Cholesterol Foreign Clozaril (Clozapine) Increased Study (Clozapine) PS ORAL 150MG MANE & Blood Triglycerides Health 200MG Increased Professional NOCTE,ORAL Diabetes Mellitus Other Diabetic Ketoacidosis Overweight Date:04/28/03ISR Number: 4103902-9Report Type:Expedited (15-DaCompany Report #PHFR2003GB01610 Age:45 YR Gender:Female I/FU:I Outcome PT Other Coma Cyanosis Hypotension Malaise Syncope Vasovagal 22-Feb-2006 08:30 AM Page: 2190 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Vomiting Report Source Product Role Manufacturer Route Dose Duration Foreign Clozaril (Clozapine) PS ORAL 175MG/DAY, Study ORAL Health Professional Other Date:04/28/03ISR Number: 4103915-7Report Type:Expedited (15-DaCompany Report #PHRM2003FR01325 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperglycaemia Foreign Leponex(Clozapine) Hypertriglyceridaemia Health Tablet PS ORAL 300 MG/DAY, Weight Increased Professional ORAL Other Date:04/28/03ISR Number: 4103941-8Report Type:Expedited (15-DaCompany Report #PHFR2003GB01508 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril(Clozapine) Study Unknown PS ORAL ORAL Health Professional Other Date:04/28/03ISR Number: 4104197-2Report Type:Expedited (15-DaCompany Report #PHFR2003GB01047 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ankle Fracture Foreign Clozaril (Clozapine) Initial or Prolonged Blood Alkaline Study Unknown PS ORAL 325MG/DAY, Other Phosphatase Increased Health ORAL Blood Cholesterol Professional Increased Other Blood Glucose Increased Fall Neutropenia Date:04/28/03ISR Number: 4104201-1Report Type:Expedited (15-DaCompany Report #PHBS2003DE04023 Age:23 YR Gender:Female I/FU:I Outcome PT Hospitalization - Drug Level Decreased Initial or Prolonged Drug Level Increased Extrapyramidal Disorder Hallucination Insomnia Nightmare Oculogyration Poisoning Schizophrenia Sedation Suicide Attempt Treatment Noncompliance 22-Feb-2006 08:30 AM Page: 2191 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Urinary Incontinence Report Source Product Role Manufacturer Route Dose Duration Foreign Clozapine Literature (Clozapine) Unknown PS SEE IMAGE Health Citalopram Professional (Citalopram) C Other Lorazepam C Date:04/28/03ISR Number: 4104355-7Report Type:Expedited (15-DaCompany Report #PHNU2003DE01603 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Foreign Clozaril Initial or Prolonged Haemorrhage Intracranial Health (Clozapine)Tablet PS ORAL ORAL Other Hemiplegia Transient Professional Intracranial Venous Sinus Other Thrombosis Sepsis Date:04/28/03ISR Number: 4104459-9Report Type:Expedited (15-DaCompany Report #PHHO2003CA04395 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Disorder Foreign Clozaril (Clozapine) Initial or Prolonged Myocardial Infarction Study Tablet PS Health Professional Other Date:04/28/03ISR Number: 4104461-7Report Type:Expedited (15-DaCompany Report #PHFR2003GB01430 Age:49 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Brain Herniation Foreign Clozaril (Clozapine) Cardiac Arrest Study Unknown PS ORAL 250 MG, BID, Cerebral Haemorrhage Health ORAL Respiratory Arrest Professional Propranolol C Shock Other Subdural Haematoma Date:04/28/03ISR Number: 4104479-4Report Type:Expedited (15-DaCompany Report #PHNR2003AU00761 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Atrial Fibrillation Foreign Clozaril (Clozapine) Required Diabetes Mellitus Study (Clozapine) PS 450MG/DAY, Intervention to Health Prevent Permanent Professional Impairment/Damage Other 22-Feb-2006 08:30 AM Page: 2192 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/28/03ISR Number: 4104487-3Report Type:Expedited (15-DaCompany Report #PHHO2003CA03195 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Foreign Clozaril (Clozapine) Death Study Tablet PS ORAL SEE IMAGE Haematocrit Decreased Health Seroquel (Quetiapine Haemoglobin Decreased Professional Fumarate) C Red Blood Cell Count Other Tegretol C Decreased Loxapine (Loxapine) C Urinary Tract Infection Zuclopenthixol (Zuclopenthixol) C Surfak (Docusate Calcium) C Date:04/29/03ISR Number: 4104630-6Report Type:Direct Company Report #CTU 191918 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Lethargy Clozapine 25mg Mental Status Changes Tablets Pneumonia Zenith-Goldine PS Zenith-Goldline ORAL 1/2 TAB PO Respiratory Distress QHS Valproic Acid C Synthroid C Prevacid C Ecotrin C Zocor C Flomax C Detrol La C Metamuril C Oscal D C Multivitamins And Minerals C Haldol C Tylenol C Ativan C Artifical Tears C Albuterol C Normal Saline C Zyprexa C Selsen Shampoo C Nupurcaival 1% Ointment C Tucks C Lowilla Soap C Lubriderm Lotion C Nives Creme C Date:05/01/03ISR Number: 4106483-9Report Type:Expedited (15-DaCompany Report #03P-028-0217147-00 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Drug Interaction Foreign Valproic Acid Intervention to Neutropenia Literature (Depakene) (Valproic Prevent Permanent White Blood Cell Count Health Acid) (Valproic Impairment/Damage Decreased Professional Acid) PS 1500 MG, 1 IN 1 D Divalproex Sodium (Depakote) 22-Feb-2006 08:30 AM Page: 2193 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Divalproex Sodium) (Divalproex Sodium) SS 1500 MG, 1 IN 1 D APPROXIMATELY 1999 Haloperidol SS SEE IMAGE Clozapine SS SEE IMAGE Risperidone SS 2 MG, 1 IN 1 D, Levomepromazine C Procyclidine C Date:05/02/03ISR Number: 4106049-0Report Type:Expedited (15-DaCompany Report #03-04-0502 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Ketoacidosis Literature Clozapine Tablets PS ORAL 25-550MG QD Initial or Prolonged Health ORAL Other Professional Olanzapine C Date:05/02/03ISR Number: 4106050-7Report Type:Expedited (15-DaCompany Report #03-01-0059 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Myocardial Health Clozapine - Ivax Infarction Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 200MG BID ORAL Zestril SS Date:05/02/03ISR Number: 4106052-0Report Type:Expedited (15-DaCompany Report #03-03-0335 Age:50 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 100-150MG QD ORAL Date:05/02/03ISR Number: 4106055-6Report Type:Expedited (15-DaCompany Report #03-03-0334 Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Health Clozapine - Ivax Cyanosis Professional Pharmaceuticals, Liver Function Test Other Inc. Tablets PS Ivax Abnormal Pharmaceuticals, Inc. ORAL 600MG QD ORAL 22-Feb-2006 08:30 AM Page: 2194 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/02/03ISR Number: 4106058-1Report Type:Expedited (15-DaCompany Report #C2003-0947.01 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Body Temperature Health Clozapine Tablets Increased Professional 100 Mg Mylan PS Mylan ORAL 100 MG QID, Circulatory Collapse Other THEN 100 MG Dyspnoea TID, ORAL Fatigue Sertraline C General Physical Health Deterioration Infection Influenza Like Illness White Blood Cell Count Date:05/02/03ISR Number: 4106090-8Report Type:Expedited (15-DaCompany Report #03-04-0480 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Clozapine Tablets PS ORAL 150MG QD ORAL 9 DAY Drug Interaction Literature Oxazepam Unknown SS 300MG QD Health Professional Date:05/02/03ISR Number: 4106242-7Report Type:Expedited (15-DaCompany Report #C2003-0719.01 Age:82 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Other Clozapine Tablets 25 Mg Mylan PS Mylan ORAL 12.5MG Q AM, 37.5MG Q HS, ORAL Paroxetine C Date:05/02/03ISR Number: 4106248-8Report Type:Expedited (15-DaCompany Report #C2003-0933.01 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Interaction Health Clozapine Tablets Sudden Death Professional 100 Mg Mylan PS Mylan ORAL 150MG QD, Other ORAL Haloperidol Decanoate Injection SS INTRAMUSCULAR 250MG Q 3 WEEKS, INTRAMUSCULAR INJECTION Benztropine Mesylate C Date:05/02/03ISR Number: 4106250-6Report Type:Expedited (15-DaCompany Report #C2003-0931.01 Age:69 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Other Clozapine Tablets 25 Mg Mylan PS Mylan ORAL 75MG Q HS, ORAL 22-Feb-2006 08:30 AM Page: 2195 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/02/03ISR Number: 4106277-4Report Type:Expedited (15-DaCompany Report #C2003-0962.01 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Clozapine Ivax PS Ivax ORAL 700MG D, ORAL Initial or Prolonged Dehydration Professional Fluoxetine Capsules Other Electrolyte Imbalance Other 20 Mg Mylan SS Mylan 40MG Q AM Overdose Propranolol C Viral Infection Date:05/02/03ISR Number: 4106293-2Report Type:Expedited (15-DaCompany Report #03-04-0501 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Literature Clozapine Tablets PS ORAL 175MG QD ORAL Initial or Prolonged Ketoacidosis Health Clonazepam C Other Professional Lithium C Venlafaxine C Date:05/02/03ISR Number: 4106688-7Report Type:Expedited (15-DaCompany Report #PHFR2003GB01494 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Pressure Decreased Foreign Clozaril(Clozapine) PS ORAL 12.5 MG, QD, Blood Pressure Diastolic Study ORAL; 50 MG, Increased Health BID, ORAL Circulatory Collapse Professional Condition Aggravated Other Syncope Vasovagal Date:05/02/03ISR Number: 4106887-4Report Type:Expedited (15-DaCompany Report #PHHO2003CA04317 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Glucose Increased Foreign Clozaril(Clozapine) PS SEE IMAGE Other Chest Discomfort Study Rivotril C Condition Aggravated Health Cogetin Myocardial Infarction Professional (Benzatropine Temporal Lobe Epilepsy Other Mesilate) C Colace C Bisacodyl C Date:05/02/03ISR Number: 4106915-6Report Type:Expedited (15-DaCompany Report #PHRM2003FR01330 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Lymphoma Foreign Leponex (Clozapine) Initial or Prolonged Health Tablet PS ORAL 400 MG/DAY, Professional ORAL Other Risperdal Tablet C Parkinane (Trihexyphenidyl Hydrochloride) Tablet C Valium Tablet C Lipanthyl "Fournier" (Fenofibrate) Tablet C 22-Feb-2006 08:30 AM Page: 2196 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/02/03ISR Number: 4106916-8Report Type:Expedited (15-DaCompany Report #PHBS2003CA04211 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diarrhoea Foreign Clozaril (Clozapine) Headache Health Tablet PS ORAL ORAL Lymphocyte Count Professional Decreased Other Nausea Pyrexia Tachycardia Vomiting Date:05/02/03ISR Number: 4107002-3Report Type:Expedited (15-DaCompany Report #PHNU2003DE01485 Age:31 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Foreign Leponex / Clozaril Initial or Prolonged Blood Creatinine Health (Clozapine) Other Increased Professional (Clozapine) Tablet PS ORAL 400MG/DAY, Required Blood Lactate Other ORAL Intervention to Dehydrogenase Increased Solian (Amisulpride) Prevent Permanent Catatonia Tablet SS ORAL 100MG/DAY, Impairment/Damage Hyperhidrosis ORAL Laboratory Test Abnormal Truxal Pyrexia (Chlorprothixene Restlessness Hydrochloride) C Stereotypy Stupor Date:05/02/03ISR Number: 4107019-9Report Type:Expedited (15-DaCompany Report #PHNU2003DE01704 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Immunoglobulin G Foreign Leponex /Clozaril Decreased Health (Clozapine)Tablet PS ORAL ORAL Blood Immunoglobulin M Professional Decreased Other Disease Recurrence Immunoglobulins Decreased Pneumonia Date:05/02/03ISR Number: 4107155-7Report Type:Expedited (15-DaCompany Report #PHEH2003US03244 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Health Clozaril (Clozapine) Initial or Prolonged Diabetic Ketoacidosis Professional Tablet PS ORAL 500 MG/DAY, Lethargy ORAL Liver Function Test Lipitor C Abnormal Inderal C Date:05/02/03ISR Number: 4107161-2Report Type:Expedited (15-DaCompany Report #PHEH2003US03250 Age:54 YR Gender:Female I/FU:I Outcome PT Other Hepatic Neoplasm Malignant 22-Feb-2006 08:30 AM Page: 2197 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Leukopenia Neoplasm Malignant Report Source Product Role Manufacturer Route Dose Duration Health Clozaril (Clozapine) Professional Tablet PS ORAL ORAL Date:05/07/03ISR Number: 4107841-9Report Type:Direct Company Report #CTU 192492 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Clozapine Tablets - Initial or Prolonged Hemiparesis Mylan Inc PS Mylan Inc 295.7 Disability Hypoaesthesia Wheezing Date:05/07/03ISR Number: 4108994-9Report Type:Expedited (15-DaCompany Report #PHHO2003CA04395 Age:72 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Foreign Clozaril(Clozapine) Hospitalization - Death Study Tablet PS Initial or Prolonged Myocardial Infarction Health Professional Other Date:05/07/03ISR Number: 4108997-4Report Type:Expedited (15-DaCompany Report #PHFR2002GB00836 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Empyema Foreign Clozaril (Clozapine) Life-Threatening Hiatus Hernia Health Tablet PS ORAL 125MG/DAY, Hospitalization - Hypotension Professional ORAL Initial or Prolonged Oesophageal Carcinoma Other Lansoprazole(Lansopr Oesophageal Stenosis azole) C Oesophageal Ulcer Date:05/07/03ISR Number: 4109185-8Report Type:Expedited (15-DaCompany Report #PHNU2003DE00678 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - C-Reactive Protein Foreign Leponex / Clozaril Initial or Prolonged Increased Health (Clozapine) Other Diabetes Mellitus Professional (Clozapine) Tablet PS ORAL 100 MG/DAY, Leukocytosis Other ORAL Lung Neoplasm Date:05/07/03ISR Number: 4109189-5Report Type:Expedited (15-DaCompany Report #PHHO2003CA04957 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Glucose Increased Foreign Clozaril (Clozapine) Hospitalization - Diabetic Ketoacidosis Study Unknown PS Initial or Prolonged Pancreatitis Health Seroquel (Quetiapine Professional Fumarate) C Other Insulin (Insulin) C 22-Feb-2006 08:30 AM Page: 2198 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/07/03ISR Number: 4109237-2Report Type:Expedited (15-DaCompany Report #PHBS2002ES15295 Age:22 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Obsessive-Compulsive Foreign Clozapine Disorder Literature (Clozapine) Unknown PS 200 MG/D Health Paroxetine C Professional Other Date:05/07/03ISR Number: 4109246-3Report Type:Expedited (15-DaCompany Report #PHNU2003DE00992 Age:23 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Leponex / Clozaril Insulin-Dependent Health (Clozapine) Professional (Clozapine) Tablet PS ORAL 125 MG/DAY, Other ORAL Date:05/07/03ISR Number: 4109255-4Report Type:Expedited (15-DaCompany Report #PHFR2003GB01774 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Drug Interaction Foreign Cozaril (Clozapine) PS ORAL 400MG/DAY, Salivary Hypersecretion Health ORAL Professional Lamictal Glaxo Other Wellcome (Lamotrigine) SS ORAL 25 00MG, ORAL Aspirine C Bendrofluazide (Bendroflumethiazide ) C Lactulose C Date:05/07/03ISR Number: 4109257-8Report Type:Expedited (15-DaCompany Report #PHFR2003GB01767 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril (Clozapine) PS ORAL 275 MG/DY, Health ORAL Professional Thyroxine C Other Valproate Sodium C Ibuprofen C Date:05/07/03ISR Number: 4109407-3Report Type:Expedited (15-DaCompany Report #PHFR2003GB01759 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiac Disorder Foreign Clozapine Vasodilatation Health (Clozapine) Unknown PS Wheezing Professional Other 22-Feb-2006 08:30 AM Page: 2199 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/07/03ISR Number: 4109499-1Report Type:Expedited (15-DaCompany Report #PHFR2003GB00715 Age:32 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Glucose Fluctuation Foreign Clozaril (Clozapine) Hospitalization - Circulatory Collapse Study Unknown PS ORAL 150MG Initial or Prolonged Dehydration Health MANE/350 MG Diabetes Mellitus Professional NOCTE, ORAL Insulin-Dependent Other Dexamethasone(Dexame Diabetic Ketoacidosis thasone) SS ORAL 4 MG, BID, Hypothermia ORAL Lower Respiratory Tract Taxol C Infection Carboplatin (Carboplatin) C Premarin (Estrogens Conjugated) C Domperidone (Domperidone) C Multivitamins (Panthenol, Retinol) C Hyoscine Hydrobromide C Chemotherapeutics, Other (Chemotherapeutics, Other) C Date:05/07/03ISR Number: 4109540-6Report Type:Expedited (15-DaCompany Report #PHBS2003HU04422 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Lupus Encephalitis Foreign Leponex (Clozapine) Health Tablet PS ORAL 300 MG/D. Professional ORAL Other Tolvon (Mianserin Hydrochloride) C Quamatel C Date:05/08/03ISR Number: 4105840-4Report Type:Expedited (15-DaCompany Report #FR-ROCHE-337127 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutrophil Count Rivotril PS Roche ORAL Initial or Prolonged Increased Leponex SS ORAL White Blood Cell Count Leponex SS ORAL LOWERED Increased DOSAGE Leponex SS ORAL Piportil Longum-4 SS INTRAMUSCULAR REPORTED AS 300 MG TWICE Akineton Retard SS ORAL Date:05/08/03ISR Number: 4109525-XReport Type:Expedited (15-DaCompany Report #C2003-0972.01 Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional 100 Mg Mylan PS ORAL 300MG 1 HS, Other ORAL Clozapine Tablets 25 22-Feb-2006 08:30 AM Page: 2200 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Mg Mylan SS ORAL 50 MG QAM, ORAL Date:05/08/03ISR Number: 4109528-5Report Type:Expedited (15-DaCompany Report #C2003-0971.01 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg Mylan PS ORAL 50MG QD, ORAL Other Alprazolam C Azithromycin C Carbidopa/Levodopa C Divalproex Sodium C Fentanyl Patches C Nystatin C Date:05/08/03ISR Number: 4110141-4Report Type:Expedited (15-DaCompany Report #NSADSS2003020918 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Haldol Decanoate Disease Recurrence Professional (Injection) Drug Interaction Company (Haloperidol Hallucination Representative Decanoate) PS INTRAMUSCULAR 250 MG, 1 IN Hypotension 3 WEEK(S), IM Pulmonary Embolism Clozapine (Clozapine) SS ORAL 150 MG, DAILY, ORAL Benztropine Mesylate (Benzatropine Mesilate) C Date:05/09/03ISR Number: 4108298-4Report Type:Direct Company Report #CTU 192591 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Rash Clozapine Tabs Intervention to Urticaria (Ivax) PS Ivax 200 MG H.S. Prevent Permanent Impairment/Damage Date:05/09/03ISR Number: 4109751-XReport Type:Expedited (15-DaCompany Report #03-04-0523 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Appendicitis Perforated Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc ORAL 800MG QD ORAL Date:05/09/03ISR Number: 4109755-7Report Type:Expedited (15-DaCompany Report #03-04-0525 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrolyte Imbalance Health Clozapine - Ivax Initial or Prolonged Polydipsia Professional Pharmaceuticals, Other Inc. Tablets PS Ivax 22-Feb-2006 08:30 AM Page: 2201 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pharmaceuticals, Inc ORAL 25-300MG QD ORAL Date:05/09/03ISR Number: 4109764-8Report Type:Expedited (15-DaCompany Report #03-05-0524 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Respiratory Failure Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc ORAL 12.5-450MG QD ORAL Date:05/09/03ISR Number: 4109765-XReport Type:Expedited (15-DaCompany Report #03-05-0526 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neoplasm Malignant Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 400-700MG QD ORAL Chemotherapy For Cancer C Date:05/09/03ISR Number: 4109766-1Report Type:Expedited (15-DaCompany Report #03-05-0536 Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Health Clozapine - Ivax Pneumonia Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc ORAL ORAL Date:05/09/03ISR Number: 4109767-3Report Type:Expedited (15-DaCompany Report #03-03-0334 Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Alanine Aminotransferase Health Clozapine - Ivax Increased Professional Pharmaceuticals, Aspartate Other Inc. Tablets PS Ivax Aminotransferase Pharmaceuticals, Increased Inc. ORAL 200MG TID Blood Alkaline ORAL Phosphatase Increased Depakote SS 250MG BID Convulsion Celexa C Status Epilepticus Zyprexa C Trileptal C Date:05/09/03ISR Number: 4109768-5Report Type:Expedited (15-DaCompany Report #C2003-0386.01 Age:68 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Parkinson'S Disease Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 100MG Q HS Other ORAL 22-Feb-2006 08:30 AM Page: 2202 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Clozapine Tablets 25 Mg Mylan SS Mylan ORAL 25MG Q AM ORAL Albuterol C Buproprion C Carbidopa/Levodopa C Docusate C Donepezil C Fluticasone C Furosemide C Guaifenesin C Levalbuterol Inhalation Solution C Tolterodine C Vitamin E C Pergolide C Citalopram C Date:05/09/03ISR Number: 4109769-7Report Type:Expedited (15-DaCompany Report #C2003-0284.01 Age:34 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pulmonary Embolism Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 250MG QD, Other THEN 300MG QD, ORAL Venlafaxiner Er (37.5 Mg Bid) C Date:05/09/03ISR Number: 4111271-3Report Type:Expedited (15-DaCompany Report #C2003-0722.01 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 100MG QD, Other ORAL Date:05/09/03ISR Number: 4111272-5Report Type:Expedited (15-DaCompany Report #C2003-0893.01 Age:62 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Emphysema Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 200MG Q AM Other AND 400MG Q HS, ORAL Clozapine Tablets 25 Mg Mylan SS Mylan ORAL 50MG AM, ORAL Albuterol Inhalation Solution C Buspirone (20mg Tid) C Diazepam (5mg Bid) C Docusate Sodium (100mg Q Hs) C Fluticasone/Salmeter ol Inhaler C Gabapentin C Ipratropium Inhalation Solution C 22-Feb-2006 08:30 AM Page: 2203 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Ipratropium Inhaler C Multivitamin C Nicotine Inhaler C Nicotine Patch C Paroxetine(50mg Q Hs) C Prednisone (5mg Qd) C Senna (8.6mg Qd) C Nitrofurantoin C Ipratropium/Albutero l Aerosol C Date:05/09/03ISR Number: 4119852-8Report Type:Periodic Company Report #02P-163-0199017-00 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Health Depakote Tablets Initial or Prolonged Professional (Depakote) Other (Divalproex Sodium) (Divalproex Sodium) PS 500 MG, 2 IN 1 D Clozapine SS ORAL MG, 1 IN 1 D, ORAL Quetiapine SS 100 MG, 1 IN 1 D Date:05/12/03ISR Number: 4111285-3Report Type:Expedited (15-DaCompany Report #HQWYE051005MAY03 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Arrhythmia Health Temesta (Lorazepam, Depressed Level Of Professional Tablet) PS ORAL 2.5 MG 1X PER Consciousness 1 DAY ORAL 1 DAY Hyperventilation Clozapine Overdose (Clozapine, ) SS Somnolence Leponex "Novartis" Transient Ischaemic (Clozapine, ) SS 200MG AT 7:30 Attack AM, 100MG AT 10:05, AND 200MG AT 11: AM Lithium (Lithium, ) SS Valproate Sodium (Valproate Sodium, ) SS Date:05/13/03ISR Number: 4110808-8Report Type:Expedited (15-DaCompany Report #C2003-0826.01 Age:58 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Myocardial Other Clozapine Tablets Infarction 100 Mg Mylan PS Mylan ORAL 600MG/DAY, Pharmaceutical Product ORAL Complaint Divalproex Soidum Er C Risperidone C Nizatidine C Atorvastatin C 22-Feb-2006 08:30 AM Page: 2204 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/13/03ISR Number: 4111547-XReport Type:Expedited (15-DaCompany Report #2003AP01803 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Acute Foreign Seroquel PS ORAL 700 MG DAILY Sudden Death Health PO Professional Clozapine SS 200 MG DAILY Other Date:05/14/03ISR Number: 4112422-7Report Type:Expedited (15-DaCompany Report #HQWYE051005MAY03 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electroencephalogram Health Temesta (Lorazepam, Abnormal Professional Tablet) PS ORAL 2.5 MG 1X PER Somnolence 1 DAY ORAL 1 DAY Transient Ischaemic Convulex (Valproate Attack Sodium) SS ORAL 2400 MG 1X PER 1 DAY ORAL Leponex "Novartis" (Clozapine) SS 900 MG 1X PER 1 DAY Quilonorm (Lithium Acetate) SS 1340 MG 1X PER 1 DAY Agiolax (Chamomile/Plantago Seed/Senna Fruit) C Transipeg (Macrogol) C Salzen (Clofenamide) C Date:05/14/03ISR Number: 4113644-1Report Type:Expedited (15-DaCompany Report #C2003-0719.01 Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Other Clozapine Tablets 25 Mg Mylan PS Mylan ORAL 12.5 MG Q AM, 37.5 Q HS, ORAL Paroxetine C Date:05/14/03ISR Number: 4113645-3Report Type:Expedited (15-DaCompany Report #C2003-0722.01 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 100MG, QD, Other ORAL Date:05/14/03ISR Number: 4113646-5Report Type:Expedited (15-DaCompany Report #C2003-0709.01 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neoplasm Malignant Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 800MG QD, Other ORAL 22-Feb-2006 08:30 AM Page: 2205 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/14/03ISR Number: 4114066-XReport Type:Direct Company Report #CTU 193042 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Clozapine (Mylan) PS Mylan ORAL 550 MG DVD Abnormal (DIVIDED DOSES) 51 DAY Pepcid C Hydroxyzine C Valproic Acid C Propanolol C Actifed C Motrin C Beclomethasone C Zoloft C Maxide C Date:05/15/03ISR Number: 4112791-8Report Type:Expedited (15-DaCompany Report #PHEH2003US02929 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Health Clozaril (Clozapine) Leukopenia Professional Tablet PS ORAL 450 MG/DAY, Neutropenia ORAL Peritoneal Carcinoma Efexor Xr (Venlafaxine) C Valium C Date:05/15/03ISR Number: 4112842-0Report Type:Expedited (15-DaCompany Report #PHEH2003US01849 Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Health Clozaril(Clozapine) Obesity Professional Tablet PS ORAL 200 MG/DAY, ORAL Peginterferon Alfa-2a (Peginterferon Alfa-2a) C Ribavirin (Ribavirin) C Glyburide C Paxil C Celexa C Lexapro C Date:05/15/03ISR Number: 4112851-1Report Type:Expedited (15-DaCompany Report #PHEH2003US03250 Age:54 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Back Pain Health Clozaril (Clozapine) Condition Aggravated Professional Tablet PS ORAL ORAL Follicle Centre Lymphoma, Pravachol C Follicular Grade I, Ii, Efexor (Venlafaxine Iii Stage Ii Hydrochloride) C Leukopenia Depakote (Valproate Paraesthesia Semisodium) C Tylenol C Multivitamins 22-Feb-2006 08:30 AM Page: 2206 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Panthenol, Retinol) C Date:05/15/03ISR Number: 4113093-6Report Type:Expedited (15-DaCompany Report #PHNR2003AU00827 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Foreign Clozaril Initial or Prolonged Influenza Like Illness Study (Clozapine)(Clozapin Other Liver Function Test Health e) Tablet PS ORAL 375MG/DAY, Abnormal Professional ORAL Viral Oesophagitis Other Valproate Sodium C Date:05/15/03ISR Number: 4113155-3Report Type:Expedited (15-DaCompany Report #PHFR2003GB01163 Age:60 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Rectosigmoid Cancer Foreign Clozaril(Clozapine) PS ORAL 350 MG/DAY, Initial or Prolonged Health ORAL Other Professional Metformin C Other Gliclazide C Captopril C Hyoscine(Hyoscine) C Date:05/15/03ISR Number: 4113161-9Report Type:Expedited (15-DaCompany Report #DEWYE127612MAY03 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Pain Upper Study Tavor(Lorazepam, Breast Pain Tablet, 0) PS ORAL 3,4,5,4,6,1 Nausea MG 1X PER 1 Pain In Extremity DAY 14 DAY Vomiting Haldol (Haloperidol, , 0) SS ORAL 10,5,10 MG 1X PER 1 DAY 1 DAY Leponex(Clozapine, , 0) SS ORAL 12.5,25,12.5 MG 1X PER 1 DAY 2 DAY Paspertin (Metoclopramide Hydrochloride) C Trevilor (Venlafaxine Hydrochloride) C Tamoxifen(Tamoxifen) C Date:05/15/03ISR Number: 4113200-5Report Type:Expedited (15-DaCompany Report #PHBS2003CA04211 Age:24 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diarrhoea Foreign Clozaril (Clorapine) Headache Health Tablet PS ORAL ORAL Lymphocyte Count Professional Decreased Other Nausea Pyrexia Tachycardia Vomiting 22-Feb-2006 08:30 AM Page: 2207 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/15/03ISR Number: 4113248-0Report Type:Expedited (15-DaCompany Report #PHFR2002GB04345 Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Alcohol Poisoning Foreign Clozaril (Clozapine) PS ORAL 325 MG/DAY, Breath Sounds Abnormal Study ORAL Cardiac Arrest Other Hyoscine (Hyoscine) C Cardiac Disorder Omeprazole Drug Toxicity (Omeprazole) C Fibrosis Influenza Like Illness Pneumonia Aspiration Sleep Disorder Ventricular Hypertrophy Date:05/15/03ISR Number: 4113250-9Report Type:Expedited (15-DaCompany Report #PHFR2003GB01464 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Foreign Clozaril (Clozapine) Initial or Prolonged Diabetes Mellitus Study Unknown PS ORAL 500MG/DAY, Insulin-Dependent Health ORAL Polydipsia Professional Other Date:05/15/03ISR Number: 4113253-4Report Type:Expedited (15-DaCompany Report #PHFR2003GB01656 Age:80 YR Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Accidental Exposure Foreign Clozaril (Clozapine) Haemoglobin Decreased Health Unknown PS ORAL 125 MG, Hypotension Professional ONCE/SINGLE, Sedation Other ORAL Somnolence Lansoprazole (Lansoprazole) C Multivitamins (Panthenol, Retinol) C Zoplicone C Olanzapine C Mirtazapine (Mirtazapine) C Depakote (Valproate Semisodium) C Date:05/15/03ISR Number: 4113263-7Report Type:Expedited (15-DaCompany Report #PHFR2003GB01804 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Foreign Clozaril(Clozapine) Drug Level Increased Study Unknown PS ORAL 500MG/DAY, Health ORAL Professional Other 22-Feb-2006 08:30 AM Page: 2208 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/15/03ISR Number: 4113302-3Report Type:Expedited (15-DaCompany Report #PHNU2003DE01483 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abnormal Behaviour Foreign Leponex /Clozaril Catatonia Health (Clozapine) Tablet PS ORAL 650 MG/DAY, Condition Aggravated Professional ORAL Depressed Level Of Other Glianimon Consciousness (Benperidol) C Eye Movement Disorder Nemexin (Naltrexone Psychotic Disorder Hydrochloride) Restlessness Film-Coated C Date:05/15/03ISR Number: 4113303-5Report Type:Expedited (15-DaCompany Report #PHFR2003GB01389 Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Foreign Clozaril(Clozapine) Phosphokinase Increased Study Unknown PS ORAL ORAL Chest Pain Health Dyspnoea Professional Ecg P Wave Inverted Other Electrocardiogram Abnormal Electrocardiogram St Segment Elevation Endocarditis Labile Blood Pressure Tachycardia Date:05/15/03ISR Number: 4113324-2Report Type:Expedited (15-DaCompany Report #PHFR2003GB01813 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Renal Failure Foreign Clozaril (Clozapine) Initial or Prolonged Study Unknown PS ORAL 75MG/DAY, Health ORAL Professional Other Date:05/15/03ISR Number: 4113327-8Report Type:Expedited (15-DaCompany Report #PHFR2003GB01809 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anorgasmia Foreign Clozaril (Clozapine) Initial or Prolonged Cardiac Disorder Study Unknown PS ORAL 350MG/DAY, Tachycardia Health ORAL Torsade De Pointes Professional Ventricular Extrasystoles Date:05/15/03ISR Number: 4113335-7Report Type:Expedited (15-DaCompany Report #PHNR2003AU00734 Age:40 YR Gender:Male I/FU:F Outcome PT Hospitalization - Confusional State Initial or Prolonged Dehydration Depressed Level Of Consciousness 22-Feb-2006 08:30 AM Page: 2209 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Drug Abuser Somnolence Report Source Product Role Manufacturer Route Dose Duration Foreign Clozaril (Clozapine) Health (Clozapine) Tablet PS ORAL 300MG/DAY, Professional ORAL Other Morphine Sulfate() SS Paracetamol C Tramenol C Date:05/15/03ISR Number: 4113338-2Report Type:Expedited (15-DaCompany Report #PHNU2003DE01755 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Level Increased Foreign Leponex / Clozaril Health (Clozapine) Professional (Clozapine) Tablet PS ORAL 350 MG/DAY, Other ORAL Acetylcysteine C Paroxetine C Cefuhexal (Cefuroxime) C Date:05/15/03ISR Number: 4113346-1Report Type:Expedited (15-DaCompany Report #PHNR2003AU00483 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Lymphopenia Foreign Clozaril (Clozapine Normochromic Normocytic Other ) (Clozapine) Tablet PS ORAL 225 MG/DAY, Anaemia ORAL Thrombocytopenia Olanzapine C White Blood Cell Count Ativan C Decreased Temazepam C Efexor (Venlafaxine Hydrochloride) C Date:05/15/03ISR Number: 4113347-3Report Type:Expedited (15-DaCompany Report #PHFR2003GB01859 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Accidental Exposure Foreign Clozaril (Clozapine) Medication Error Health Tablet PS ORAL 100 MG, Overdose Professional ONCE/SINGLE, Other ORAL Date:05/15/03ISR Number: 4113349-7Report Type:Expedited (15-DaCompany Report #PHFR2003GB01845 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Accidental Exposure Foreign Clozaril (Clozapine) Hypokinesia Health Unknown PS ORAL 100 MG, Medication Error Professional ONCE/SINGLE, Somnolence Other ORAL 22-Feb-2006 08:30 AM Page: 2210 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/15/03ISR Number: 4113351-5Report Type:Expedited (15-DaCompany Report #PHBS2003SE04589 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Leponex (Clozapine) Health Tablet PS ORAL 300 MG/D,ORAL Professional Rebetol (Ribavirin) C Other Pegintron "Essex Chemie" (Peginterferon Alfa-2b) C Date:05/15/03ISR Number: 4113352-7Report Type:Expedited (15-DaCompany Report #PHBS2003NZ04565 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Acute Foreign Clozaril (Clozapine) Sudden Death Health Tablet PS ORAL SEE IMAGE Weight Increased Professional Quetiapine Other (Quetiapine) C Date:05/15/03ISR Number: 4113357-6Report Type:Expedited (15-DaCompany Report #PHNU2003DE01704 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Immunoglobulin G Foreign Leponex /Clozaril Decreased Health (Clozapine) Blood Immunoglobulin M Professional (Clozapine) Tablet PS ORAL 300 MG/DAY, Decreased Other ORAL Bronchitis Immunoglobulins Decreased Pneumonia Date:05/16/03ISR Number: 4112440-9Report Type:Expedited (15-DaCompany Report #2003012803 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Geodon (Ziprasidone) PS ORAL 160 MG (BID) Initial or Prolonged Coma Professional ORAL Sepsis Clozapine Vomiting (Clozapine) SS ORAL 400 MG White Blood Cell Count (DAILY) ORAL Increased Benzatropine Mesilate C Date:05/16/03ISR Number: 4112894-8Report Type:Expedited (15-DaCompany Report #C2003-1056.01 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Clozapine Tablets Congestive Professional 100 Mg Mylan PS Mylan ORAL 400MG QD, Chronic Obstructive Other ORAL Pulmonary Disease Diabetes Mellitus Parkinson'S Disease Pulmonary Fibrosis 22-Feb-2006 08:30 AM Page: 2211 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/16/03ISR Number: 4112916-4Report Type:Expedited (15-DaCompany Report #C2003-1060.01 Age:89 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg Mylan PS ORAL 25MG QD, ORAL Other Date:05/16/03ISR Number: 4112918-8Report Type:Expedited (15-DaCompany Report #C2003-1111.01 Age:69 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neoplasm Malignant Health Clozapine Tablets 25 White Blood Cell Count Professional Mg Mylan PS Mylan 37.5MG BID, Increased Other 25MG QD Carbidopa & Levodopa C Celecoxib C Clonidine C Enalapril Maleate C Enoxaparin Sodium C Fludrocortisone Acetate C Ipratropium Bromide C Levothyroxine Sodium C Scopolamine Patch C Tanafit Ointment C Trazodone C Date:05/16/03ISR Number: 4112921-8Report Type:Expedited (15-DaCompany Report #C2003-1126.01 Age:67 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 12.5MG BID, Other ORAL Date:05/16/03ISR Number: 4112934-6Report Type:Expedited (15-DaCompany Report #PHNU2003DE01414 Age:66 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Apathy Foreign Leponex / Clozaril Diabetes Mellitus Health (Clozapine)(Clozapin Non-Insulin-Dependent Professional e) Tablet PS ORAL 100MG/DAY, Increased Appetite Other ORAL : 50 Weight Increased MG/DAY, ORAL Date:05/19/03ISR Number: 4111166-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-11662038 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Cytoxan PS Bristol-Myers Squibb Company ORAL 300 in the morning, 400 at bedtime. 3 MON Clozapine SS Adriamycin SS 3 MON Synthroid C Ativan C 22-Feb-2006 08:30 AM Page: 2212 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Citalopram Hydrobromide C In the morning Perphenazine C At bedtime Date:05/19/03ISR Number: 4112955-3Report Type:Expedited (15-DaCompany Report #PHBS2003US04724 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Breast Tenderness Literature Clozapine(Clozapine) Initial or Prolonged Chest Discomfort Unknown PS 25 MG/D, : Diabetic Ketoacidosis 125 MG/D, Dyspnoea 150 MG/D Hyperventilation Lorazepam C Lethargy Risperidone C Metrorrhagia Benztropeine Muscle Spasms (Benztropeine) C Nausea Multivitamins Vomiting (Retinol, Panthenol) C Weight Decreased Calcium C Date:05/19/03ISR Number: 4113221-2Report Type:Expedited (15-DaCompany Report #HQWYE187014MAY03 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Effexor (Venlafaxine Initial or Prolonged Drug Interaction Professional Hydrochloride, White Blood Cell Count Unspec) PS ORAL UNKNOWN, ORAL Increased Clozapine (Clozapine, ) SS ORAL 400-500 MG DAILY, ORAL Date:05/19/03ISR Number: 4115108-8Report Type:Expedited (15-DaCompany Report #PHBS2003CA04799 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cerebrovascular Accident Foreign Clozaril (Clozapine) Endocarditis Health Tablet PS ORAL ORAL Thrombosis Professional Other Date:05/20/03ISR Number: 4114558-3Report Type:Expedited (15-DaCompany Report #03-05-0545 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetic Complication Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 250-575MG QD ORAL 22-Feb-2006 08:30 AM Page: 2213 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/20/03ISR Number: 4114561-3Report Type:Expedited (15-DaCompany Report #C2003-0962.01 Age:18 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Clozapine Ivax PS Ivax ORAL 700M GD, THEN Initial or Prolonged Dehydration Professional 200MG BID, Other Nausea Other ORAL Viral Infection Fluoxetine Capsules Vomiting 20 Mg Mylan SS Mylan 40MG Q AM Propranolol C Date:05/20/03ISR Number: 4114564-9Report Type:Expedited (15-DaCompany Report #C2003-1110.01 Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pharmaceutical Product Health Clozapine Tablets Complaint Professional 100 Mg Mylan PS Mylan ORAL 100 MG QAM, Other 100 M G Q12PM, 400MG QHS, ORAL Albuterol Nebulizer C Docusate Sodium C Ipratropium Bromide Nebulizer C Mineral Oil C Multivitamin C Oral Laxative C Valproic Acid Syrup C Date:05/20/03ISR Number: 4114566-2Report Type:Expedited (15-DaCompany Report #03-05-0550 Age:91 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hip Fracture Health Clozapine Tablets - Pneumonia Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 37.5-50MG QD ORAL Date:05/20/03ISR Number: 4114585-6Report Type:Expedited (15-DaCompany Report #03-05-0542 Age:86 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Clozapine Tablets PS ORAL 175MG ORAL Initial or Prolonged Phosphokinase Increased Literature L-Thyroxin C Other Coma Health Donepezil C Confusional State Professional Coumadin C Depressed Level Of Trazodone C Consciousness Medication Error Miosis Muscle Rigidity Myoclonus Pupillary Reflex Impaired 22-Feb-2006 08:30 AM Page: 2214 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/20/03ISR Number: 4114588-1Report Type:Expedited (15-DaCompany Report #03-05-0563 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Foreign Clozapine Tablets PS ORAL ORAL 3 YR Initial or Prolonged Apathy Literature Daonil C Blood Glucose Increased Health Diabetic Ketoacidosis Professional Ketonuria Metabolic Acidosis Date:05/20/03ISR Number: 4114637-0Report Type:Expedited (15-DaCompany Report #03-05-0567 Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Health Clozapine Tablets - Hospitalization - Cardiac Arrest Professional Ivax Initial or Prolonged Pneumonia Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 87.5MG QD ORAL Date:05/20/03ISR Number: 4114639-4Report Type:Expedited (15-DaCompany Report #03-05-0566 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Body Temperature Health Clozapine Tablets - Initial or Prolonged Increased Professional Ivax Urosepsis Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 125-250MG QD ORAL Date:05/20/03ISR Number: 4114642-4Report Type:Expedited (15-DaCompany Report #03-04-0471 Age:50 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 800MG QD ORAL Date:05/20/03ISR Number: 4114643-6Report Type:Expedited (15-DaCompany Report #03-02-0165 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accident Health Clozapine Tablets - Drug Interaction Professional Ivax Pharmaceuticals, Inc. PS ORAL SEE IMAGE 3 YR Paroxetine Unknown SS 40MG QD 3 YR Geodon C Haldol Decanoate C Cogentin C 22-Feb-2006 08:30 AM Page: 2215 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Clonazepam C Clonazepam C Oramorph C Date:05/20/03ISR Number: 4114644-8Report Type:Expedited (15-DaCompany Report #03-05-0543 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coronary Artery Disease Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 400MG QD ORAL Date:05/20/03ISR Number: 4114645-XReport Type:Expedited (15-DaCompany Report #03-05-0544 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 250-450MG QD ORAL Date:05/20/03ISR Number: 4115382-8Report Type:Expedited (15-DaCompany Report #2003UW06017 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Zestril PS Professional Clozapine SS ORAL 200 MG BID PO Date:05/21/03ISR Number: 4114224-4Report Type:Expedited (15-DaCompany Report #C2003-0933.01 Age:21 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Disease Recurrence Health Clozapine Tablets Hallucination Professional 100 Mg Mylan PS ORAL 150MG QD, Hypotension Other ORAL Pulmonary Embolism Haloperidol Decanoate Injection SS INTRAMUSCULAR 250MG Q 3 WEEKS, INTRAMUSCULAR INJECTION Benztropine Mesylate C Citalopram C Date:05/21/03ISR Number: 4114225-6Report Type:Expedited (15-DaCompany Report #C2003-0709.01 Age:56 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neoplasm Malignant Health Clozapine Tablets Professional 100 Mg Mylan PS ORAL 800MG QD, Other ORAL 22-Feb-2006 08:30 AM Page: 2216 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Benztropine C Omeprazole C Valproic Acid C Acetaminopen/Codeine Elixir C Date:05/21/03ISR Number: 4115492-5Report Type:Expedited (15-DaCompany Report #PHHO2003CA04632 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agranulocytosis Foreign Clozaril (Clozapine) PS 700 MG, QD; Pneumonia Study UNK Health Lasix C Professional Neurontin Other (Gabapentin) C Nizoral (Ketoconazole) C Haloperidol C Nozinan C Date:05/21/03ISR Number: 4115514-1Report Type:Expedited (15-DaCompany Report #PHHO2003CA04395 Age:72 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aortic Valve Stenosis Foreign Clozaril Hospitalization - Cardiac Disorder Study (Clozapine)Tablet PS 200 MG Initial or Prolonged Cardiac Failure Health Lasix C Cardiac Murmur Professional Haloperidol C Ecchymosis Other Lovenox Hypokalaemia (Heparin-Fraction, Myocardial Infarction Sodium Salt) C Pulmonary Oedema Epival (Valproate Tachypnoea Semisodiium) C K-Dur C Entrophen C Levothyroxine Sodium C Kaochlor C Aldactone C Zyprexa C Risperdal C Date:05/21/03ISR Number: 4115572-4Report Type:Expedited (15-DaCompany Report #PHEH2003US03250 Age:54 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Back Pain Health Clozaril(Clozapine) Follicle Centre Lymphoma, Professional Tablet PS ORAL 100 MG, QD, Follicular Grade I, Ii, ORAL Iii Stage Ii Pravachol C Leukopenia Efexor (Venlafaxine Lymphocyte Count Hydrochloride) C Decreased Depakote (Valproate Neutropenia Semisodium) C Paraesthesia Tylenol C Multivitamins (Panthenol, Retinol) C 22-Feb-2006 08:30 AM Page: 2217 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/21/03ISR Number: 4115587-6Report Type:Expedited (15-DaCompany Report #PHFR2003IE01890 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril (Clozapine) PS ORAL 500 MG/DAY, Study ORAL Health Professional Other Date:05/21/03ISR Number: 4115590-6Report Type:Expedited (15-DaCompany Report #PHFR2003GB01018 Age:72 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Lymphocyte Count Foreign Clozaril (Clozapine) PS ORAL ORAL Decreased Study Health Professional Other Date:05/21/03ISR Number: 4115601-8Report Type:Expedited (15-DaCompany Report #PHNU2003DE01863 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Apraxia Foreign Leponex / Clozaril Initial or Prolonged Balance Disorder Health (Clozapine) Coma Professional (Clozapine) Tablet) PS ORAL 100 DF, Disorientation Other ONCE/SINGLE, Intentional Overdose ORAL Date:05/21/03ISR Number: 4115656-0Report Type:Expedited (15-DaCompany Report #PHNR2003AU00761 Age:54 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Atrial Fibrillation Foreign Clozaril (Clozapine) Diabetes Mellitus Study (Clozapine) PS 450MG/DAY Health Valproate Sodium C Professional Other Date:05/21/03ISR Number: 4115752-8Report Type:Expedited (15-DaCompany Report #PHNR2003AU00661 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Mental Disorder Foreign Clozaril (Clozapine) Hospitalization - Neutropenia Study Tablet PS ORAL 275 MG DAILY, Initial or Prolonged Health ORAL Professional Valium C Other Date:05/21/03ISR Number: 4115773-5Report Type:Expedited (15-DaCompany Report #PHNU2003DE01559 Age:20 YR Gender:Female I/FU:F Outcome PT Other Leukocytosis Lymphopenia Viral Infection 22-Feb-2006 08:30 AM Page: 2218 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Vomiting Report Source Product Role Manufacturer Route Dose Duration Foreign Leponex / Clozaril Health (Clozapine)(Clozapin Professional e) Tablet PS ORAL 150 MG/DAY, Other ORAL Beloc Zok (Metoprolol Succinate) C Syprine (Trientine Dihydrochloride) C Date:05/21/03ISR Number: 4115792-9Report Type:Expedited (15-DaCompany Report #PHFR2002GB01975 Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Clozaril (Clozapine) Hospitalization - Lung Abscess Health Tablet PS ORAL 600MG/DAY, Initial or Prolonged Professional ORAL Other Procyclidine (Procyclidine) C Co-Codamol C Prozac (Fluoxetine Hydrochloride) C Date:05/21/03ISR Number: 4115812-1Report Type:Expedited (15-DaCompany Report #PHFR2003GB01923 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Foreign Clozaril (Clozapine) PS ORAL 800MG/DAY, Initial or Prolonged Drug Level Decreased Study ORAL Other Infection Health Malaise Professional Muscle Twitching Other Salivary Hypersecretion Sinus Tachycardia Date:05/21/03ISR Number: 4115836-4Report Type:Expedited (15-DaCompany Report #PHHO2003CA04126 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Cholesterol Foreign Clozaril (Clozapine) Increased Study Tablet PS 20 MG Hypertriglyceridaemia Health Effexor-Xr Weight Increased Professional (Venlafaxine Other Hydrochloride) C Orap (Pimozide) C Seroquel (Quetiapine Fumarate) C Date:05/21/03ISR Number: 4115839-XReport Type:Expedited (15-DaCompany Report #PHFR2002IE00998 Age:45 YR Gender:Female I/FU:F Outcome Life-Threatening Hospitalization - 22-Feb-2006 08:30 AM Page: 2219 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Initial or Prolonged PT Report Source Product Role Manufacturer Route Dose Duration Diabetes Mellitus Foreign Clozaril (Clozapine) Inadequate Control Study Tablet PS ORAL SEE IMAGE Diabetic Coma Health Insulin (Insulin) C Diabetic Ketoacidosis Professional Haloperidol C Loss Of Consciousness Other Lithium (Lithium) C Valproate Sodium C Zopiclone C Citalopram (Citalopram) C Priadel C Date:05/22/03ISR Number: 4116158-8Report Type:Expedited (15-DaCompany Report #PHEH2003US02709 Age:55 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozaril(Clozapine) Professional Tablet PS ORAL 750 MG/DAY, ORAL 2190 DAY Premarin Vaginal Cream (Estorgens Conjugated) C Albuterol C Ditropan Xl (Oxybutynin Hydrochloride) C Cogentin (Benzatropine Mesilate) C Senna C Zyprexa C Klonopin C Inderal "Wyeth-Ayerst" C Paxil C Singulair "Dieckmann" (Montelukast Sodium) C Norvasc C Flovent C Flonase C Certagen (Vitamins Nos) C Date:05/22/03ISR Number: 4116280-6Report Type:Direct Company Report #USP 51136 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Lamprene PS Geigy CAPSULE Clozaril SS Sandoz TABLET 22-Feb-2006 08:30 AM Page: 2220 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/22/03ISR Number: 4116398-8Report Type:Expedited (15-DaCompany Report #PHEH2003US03770 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Cancer Health Clozaril(Clozapine) Professional Tablet PS ORAL 200 MG, QD, ORAL Date:05/22/03ISR Number: 4116407-6Report Type:Expedited (15-DaCompany Report #PHEH2003US03288 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Health Clozaril(Clozapine) Initial or Prolonged Delusion Professional Tablet PS ORAL SEE IMAGE Other Hallucination Aripiprazole Neuroleptic Malignant (Aripiprazole) C Syndrome Lamictal C Obsessive-Compulsive Lorazepam C Disorder Trazodone Paranoia (Trazodone) C Water Intoxication Abilify C Date:05/22/03ISR Number: 4116566-5Report Type:Expedited (15-DaCompany Report #PHFR2002GB04249 Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Creatine Foreign Clozaril (Clozapine) PS ORAL ORAL Hospitalization - Phosphokinase Increased Study Initial or Prolonged Blood Urine Present Health Cardiomegaly Professional Confusional State Other Diarrhoea Dysphagia General Physical Health Deterioration Granuloma Hypotension Left Ventricular Failure Malaise Myocarditis Necrosis Pericarditis Pleural Effusion Pneumonia Aspiration Pneumonitis Protein Urine Present Pulmonary Oedema Pyrexia Sarcoidosis Sedation Ventricular Failure Ventricular Tachycardia Vomiting White Blood Cell Count Increased 22-Feb-2006 08:30 AM Page: 2221 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/22/03ISR Number: 4116587-2Report Type:Expedited (15-DaCompany Report #PHHO2003CA06099 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril(Clozapine)T Insulin-Dependent Study ablet PS Glucose Urine Health Professional Other Date:05/22/03ISR Number: 4116710-XReport Type:Expedited (15-DaCompany Report #PHNU2003DE01898 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Leponex/Clozaril(Clo Health zapine) Professional (Clozapine)Tablet PS ORAL SEE IMAGE Company Representative Other Date:05/22/03ISR Number: 4116711-1Report Type:Expedited (15-DaCompany Report #PHFR2003GB01611 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Foreign Clozaril (Clozapine) PS ORAL 450MG/DAY, Initial or Prolonged Non-Insulin-Dependent Study ORAL Fatigue Health Valproate Sodium C Infection Professional Polydipsia Other Polyuria Date:05/22/03ISR Number: 4116741-XReport Type:Expedited (15-DaCompany Report #PHHO2003CA04957 Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Glucose Increased Foreign Clozaril (Clozapine) PS Hospitalization - Diabetic Ketoacidosis Study Seroquel (Quetiapine Initial or Prolonged Neutropenia Health Fumarate) C Pancreatitis Professional Insulin (Insulin) C Other Date:05/22/03ISR Number: 4116746-9Report Type:Expedited (15-DaCompany Report #PHFR2003GB01959 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Foreign Clozaril (Clozapine) PS ORAL ORAL Initial or Prolonged Neurological Eyelid Study Prozac (Fluoxetine Other Disorder Health Hydrochloride) C Ophthalmoplegia Professional Other 22-Feb-2006 08:30 AM Page: 2222 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/22/03ISR Number: 4116931-6Report Type:Direct Company Report #CTU 193717 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neutrophil Count Clozapine PS Ivax ORAL 50 MG HS White Blood Cell Count ORAL Desmopressin Acet. C Quetiapine -Seroquel- C Date:05/22/03ISR Number: 4116937-7Report Type:Direct Company Report #CTU 193722 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neutrophil Count Clozapine PS Ivax ORAL 50 MG HS White Blood Cell Count ORAL Clozapine SS Ivax Lithium Citrate C Docusate C Date:05/22/03ISR Number: 4116938-9Report Type:Direct Company Report #CTU 193723 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neutrophil Count Clozapine 25 Mg Decreased Ivax PS Ivax ORAL 75MG BID ORAL Lithium C Senna C Lorazepam C Divalproex C Lactulose C Date:05/23/03ISR Number: 4114817-4Report Type:Expedited (15-DaCompany Report #US-GLAXOSMITHKLINE-A0409042A Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Interaction Paxil PS Glaxosmithkline ORAL 40MG Per day 3 YR Overdose Clozapine SS ORAL 3 YR Geodon C 80MG Twice per day 1 YR Haldol Decanoate C INTRAMUSCULAR 120MG Weekly 1 YR Cogentin C 1.5MG Twice per day 1 YR Clonazepam C 1MG Twice per day Clonazepam C 4MG At night Oramorph C Glaxosmithkline 30MG Twice per day Date:05/23/03ISR Number: 4115996-5Report Type:Expedited (15-DaCompany Report #C2003-1136.01 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 200MG BID, Other ORAL Famotidine C 22-Feb-2006 08:30 AM Page: 2223 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Gabapentin C Insulin C Lente (Sliding Scale,) C Levothyroxine Sodium C Phenytoin C Date:05/23/03ISR Number: 4116029-7Report Type:Expedited (15-DaCompany Report #C2003-0743.01 Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Clozapine Tablets Initial or Prolonged Catatonia Professional 100 Mg Mylan PS Mylan ORAL 300 MG, QD, Other Insomnia ORAL Neuroleptic Malignant Lithium 300 Mg SS ORAL 600 MG Q AM Syndrome AND 900 MG Q Restlessness HS, ORAL Serotonin Syndrome Speech Disorder Weight Decreased Date:05/23/03ISR Number: 4116032-7Report Type:Expedited (15-DaCompany Report #C2003-0971.01 Age:76 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Parkinson'S Disease Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 50 MG QD, Other ORAL Alprazolam C Azithromycin C Carbidopa/Levodopa C Divalproex Sodium C Fentanyl Patches C Nystatin C Date:05/23/03ISR Number: 4116048-0Report Type:Expedited (15-DaCompany Report #C2003-0972.01 Age:61 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neoplasm Malignant Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 300 MG Q HS, Other ORAL Clozapine Tablets 25 Mg Mylan SS Mylan ORAL 50 MG QAM, ORAL Date:05/23/03ISR Number: 4116719-6Report Type:Expedited (15-DaCompany Report #5216 Age:21 YR Gender:Male I/FU:I Outcome PT Blood Disorder Drug Interaction Neutropenia Neutrophil Count Increased Pyrexia White Blood Cell Count 22-Feb-2006 08:30 AM Page: 2224 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Increased Report Source Product Role Manufacturer Route Dose Duration Literature Erythromycin PS Clozapine SS 600 MG Date:05/28/03ISR Number: 4117066-9Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12281218 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Antipsychotic Drug Level Abilify PS Otsuka Above Therapeutic Pharmaceutical Drug Interaction Company, Ltd. No information reported Clozaril I No information reported Date:05/28/03ISR Number: 4119091-0Report Type:Expedited (15-DaCompany Report #PHFR2003GB01881 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Increased Foreign Clozaril (Clozapine) PS ORAL SEE IMAGE Initial or Prolonged C-Reactive Protein Study Valproate Sodium C Other Increased Health Diarrhoea Professional Eosinophil Count Other Increased Haemoglobin Decreased Infection Lymphocyte Count Decreased Malaise Neutrophil Count Increased Pyrexia Tachycardia White Blood Cell Count Increased Date:05/28/03ISR Number: 4119190-3Report Type:Expedited (15-DaCompany Report #PHFR2003GB01989 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Malignant Melanoma Foreign Clozapine Disability Health (Clozapine) Unknown PS ORAL ORAL Other Professional Tranexamic Acid Other (Tranexamic Acid) C Olanzapine C Ferrous Sulphate C 22-Feb-2006 08:30 AM Page: 2225 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/28/03ISR Number: 4119193-9Report Type:Expedited (15-DaCompany Report #PHNU2003DE01899 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Leponex / Clozaril Non-Insulin-Dependent Health (Clozapine) Tablet PS ORAL SEE IMAGE Professional Company Representative Other Date:05/28/03ISR Number: 4119199-XReport Type:Expedited (15-DaCompany Report #PHBS2003BR04980 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Full Blood Count Abnormal Foreign Leponex (Clozapine) Haemoglobin Decreased Health Tablet PS ORAL 400 MG/D, Neutrophil Count Professional ORAL Increased Other Neutrophil Toxic Granulation Present Red Blood Cell Count Decreased White Blood Cell Count Increased Date:05/29/03ISR Number: 4119535-4Report Type:Expedited (15-DaCompany Report #03-05-0599 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 200-450MG QD ORAL Date:05/29/03ISR Number: 4119537-8Report Type:Expedited (15-DaCompany Report #03-05-0585 Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Infection Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 75-416MG QD ORAL Date:05/29/03ISR Number: 4119539-1Report Type:Expedited (15-DaCompany Report #03-05-0584 Age:46 YR Gender:Female I/FU:I Outcome PT Hospitalization - Coma Initial or Prolonged Dialysis Gastrointestinal Haemorrhage 22-Feb-2006 08:30 AM Page: 2226 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Peritonitis Pneumonia Procedural Complication Report Source Product Role Manufacturer Route Dose Duration Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 400-800MG QD ORAL Date:05/29/03ISR Number: 4119541-XReport Type:Expedited (15-DaCompany Report #03-05-0583 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Upper Limb Fracture Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 400-500MG QD ORAL Date:05/29/03ISR Number: 4119543-3Report Type:Expedited (15-DaCompany Report #03-05-0582 Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 200-550MG QD ORAL Date:05/29/03ISR Number: 4119717-1Report Type:Expedited (15-DaCompany Report #03-05-0575 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Clozapine Tablets - Congestive Professional Ivax Chronic Obstructive Other Pharmaceuticals, Pulmonary Disease Inc. PS Ivax Coronary Artery Disease Pharmaceuticals, Inc. ORAL 200-500MG QD ORAL Date:05/29/03ISR Number: 4119718-3Report Type:Expedited (15-DaCompany Report #03-05-0574 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 600-80MG QD 22-Feb-2006 08:30 AM Page: 2227 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL Date:05/29/03ISR Number: 4119719-5Report Type:Expedited (15-DaCompany Report #03-03-0361 Age:59 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 125MG QAM ORAL; 450 MG QHS ORAL Date:05/29/03ISR Number: 4120095-2Report Type:Expedited (15-DaCompany Report #PHNU2003DE00868 Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Leponex/Clozaril Life-Threatening Circulatory Collapse Health (Clozapine) Hospitalization - Shock Professional (Clozapine) Tablet PS ORAL 100 MG/DAY; Initial or Prolonged Other ORAL Nacom "Dupont Pharma" C Cabaseril (Cabergoline) C Beloc-Zoc Mite (Metoprolol Succinate) Slow Release Tablet, 47.5 Mg C Ranitic Film-Coated Tablet, 300 Mg Unk C Date:05/29/03ISR Number: 4120423-8Report Type:Expedited (15-DaCompany Report #PHFR2003GB01809 Age:24 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anorgasmia Foreign Clozaril (Clozapine) Electrocardiogram Qt Study Unknown PS ORAL 350MG/DAY, Corrected Interval Health ORAL Prolonged Professional Buspirone Exercise Capacity (Buspirone) C Decreased Hyoscine (Hyoscine) C Palpitations Sinus Tachycardia Torsade De Pointes Ventricular Extrasystoles Date:05/29/03ISR Number: 4120558-XReport Type:Expedited (15-DaCompany Report #PHFR2002GB04030 Age:25 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril (Clozapine) Non-Insulin-Dependent Health Tablet PS ORAL 500MG/DAY, Professional ORAL Other Venlafaxine 22-Feb-2006 08:30 AM Page: 2228 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Venlafaxine) C Valproate Sodium C Becotide (Beclometasone Dipropionate) C Salbutamol C Date:05/29/03ISR Number: 4120559-1Report Type:Expedited (15-DaCompany Report #PHFR2003GB01398 Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Foreign Clozaril (Clozapine) PS ORAL 300MG/DAY, Initial or Prolonged Non-Insulin-Dependent Study ORAL Health Fluoxetine Professional (Fluoxetine) C Other Hyoscine (Hyoscine) C Beclometasone C Vitamin B C Salbutamol C Date:05/29/03ISR Number: 4120561-XReport Type:Expedited (15-DaCompany Report #PHNU2003DE00678 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Foreign Leponex / Clozaril Initial or Prolonged Inflammation Health (Clozapine) Other Lung Neoplasm Professional (Clozapine) Tablet PS ORAL 100 MG/DAY, Other ORAL Ranitic Film-Coated Tablet C Date:05/29/03ISR Number: 4121056-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12221453 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drooling Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Clozaril SS Patient was withdrawn from Clozaril when Abilify was started. Date:05/29/03ISR Number: 4121058-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12222709 Age:4 DEC Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Extrapyramidal Disorder Abilify Tabs 30 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL Patient started on Abilify 15 mg and dose increased to Clozaril SS 22-Feb-2006 08:30 AM Page: 2229 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/30/03ISR Number: 4120590-6Report Type:Expedited (15-DaCompany Report #03-05-0612 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alcoholism Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 400-525MG QD ORAL Date:05/30/03ISR Number: 4120591-8Report Type:Expedited (15-DaCompany Report #03-05-0613 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hip Surgery Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 100-350MG QD ORAL Date:05/30/03ISR Number: 4120592-XReport Type:Expedited (15-DaCompany Report #03-05-0615 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cyst Health Clozapine - Ivax Initial or Prolonged Deep Vein Thrombosis Professional Pharmaceuticals, Phlebitis Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 150-700MG QD ORAL Date:05/30/03ISR Number: 4120593-1Report Type:Expedited (15-DaCompany Report #03-05-0616 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Crohn'S Disease Health Clozapine Tablets - Myocardial Infarction Professional Ivax Pharmaceuticals Other Inc. PS Ivax Pharmaceuticals, Inc. ORAL 400-1200MG QD ORAL Date:05/30/03ISR Number: 4120594-3Report Type:Expedited (15-DaCompany Report #03-05-0617 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hip Fracture Health Clozapine Tablets - Initial or Prolonged Professional Ivax Pharmaceuticals Other Inc. PS Ivax Pharmaceuticals, Inc. ORAL 500-700MG QD ORAL 22-Feb-2006 08:30 AM Page: 2230 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/30/03ISR Number: 4120595-5Report Type:Expedited (15-DaCompany Report #C2003-1056.01 Age:82 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Clozapine Tablets Congestive Professional 100 Mg Mylan PS Mylan ORAL 400MG QD, Chronic Obstructive Other ORAL Pulmonary Disease Pneumonia Date:05/30/03ISR Number: 4120596-7Report Type:Expedited (15-DaCompany Report #03-05-0536 Age:64 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Health Clozapine Tablets - Pneumonia Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 300MG QHS ORAL Risperdal C Moban C Loxitane C Date:05/30/03ISR Number: 4120599-2Report Type:Expedited (15-DaCompany Report #03-05-0632 Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Neoplasm Malignant Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 400-550 MG QD ORAL Date:05/30/03ISR Number: 4120602-XReport Type:Expedited (15-DaCompany Report #03-05-0566 Age:62 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Urosepsis Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 125-250 MG QD ORAL Date:05/30/03ISR Number: 4121246-6Report Type:Expedited (15-DaCompany Report #2003-BP-02209RO Age:29 YR Gender:Male I/FU:F Outcome PT Hospitalization - Akathisia Initial or Prolonged Aphasia Blood Pressure Increased Catatonia Diabetic Ketoacidosis 22-Feb-2006 08:30 AM Page: 2231 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Drug Interaction Heart Rate Increased Insomnia Report Source Product Role Manufacturer Route Dose Duration Neuroleptic Malignant Health Lithium Carbonate Syndrome Professional Capsules Usp, 300 Mg Pharmaceutical Product Other (Lithium Carbonate) PS ORAL PO Complaint Clozapine Psychomotor Hyperactivity (Clozapine) SS ORAL 300 MG QD Restlessness (100 MG), PO Rhabdomyolysis Serotonin Syndrome Urinary Tract Infection Weight Decreased Date:05/30/03ISR Number: 4121284-3Report Type:Expedited (15-DaCompany Report #HQWYE298421MAY03 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bronchopneumonia Health Benzhexol Initial or Prolonged Depressed Level Of Professional (Trihexyphenidyl, Other Consciousness Other Unspec) PS ORAL 2 MG 2X PER Somnolence 1 DAY Clozaril (Clozapine, ) SS 25 MG 2X PER 1 DAY 472 DAY Calcitonin C Salmon (Calcitonin, Salmon) C Vitamin D (Ergoclaciferl) C Date:06/02/03ISR Number: 4121632-4Report Type:Expedited (15-DaCompany Report #FRWYE148223MAY03 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Temesta (Lorazepam, Initial or Prolonged Epilepsy Professional Tablet) PS ORAL 3.75 MG 1X Other Other PER 1 DAY ORAL 2 YR Gardenal (Phenobarbital) SS ORAL 200 MG 1X PER 1 DAY ORAL 159 DAY Leponex (Clozapine) SS ORAL 400 MG 1X PER 1 DAY ORAL 157 DAY Parkinane Lp (Trihexyphenidyl, Capsule, Sustained Release) SS ORAL 10 G 1X PER 1 DAY ORAL 5 YR Date:06/02/03ISR Number: 4121640-3Report Type:Expedited (15-DaCompany Report #PHFR2003GB01486 Age:19 YR Gender:Male I/FU:F Outcome PT Hospitalization - Accidental Exposure Initial or Prolonged Heart Rate Decreased Other Hypotension Medication Error 22-Feb-2006 08:30 AM Page: 2232 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Neuroleptic Malignant Syndrome Report Source Product Role Manufacturer Route Dose Duration Foreign Clozaril (Clozapine) Health Unknown PS ORAL 250MG ONE Professional DOSE, ORAL Other Olanzapine C Date:06/02/03ISR Number: 4121677-4Report Type:Expedited (15-DaCompany Report #PHHO2003CA04457 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Lymphadenopathy Foreign Clozaril (Clozapine) Neutropenia Study Unknown PS Pharyngolaryngeal Pain Health Epival (Valproae Psychotic Disorder Professional Semisodium) C Viral Infection Other Halcoion (Triazolam) C Date:06/02/03ISR Number: 4121714-7Report Type:Expedited (15-DaCompany Report #PHNR2003AU00886 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Brain Scan Abnormal Foreign Clozaril Cerebral Atrophy Health (Clozapine)(Clozapin Convulsion Professional e) Tablet PS ORAL 400 MG/DAY, Other ORAL Date:06/02/03ISR Number: 4121726-3Report Type:Expedited (15-DaCompany Report #PHFR2003GB01615 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Pressure Foreign Clozaril(Clozapine) Other Fluctuation Study Unknown PS ORAL 300MG/DAY, C-Reactive Protein Health ORAL Increased Professional Zopiclone C Circulatory Collapse Other Valproate Semisodium Coma (Valproate Consciousness Fluctuating Semisodium) C Cyanosis Thyroxine C Dysarthria Venlafaxine Loss Of Consciousness (Venlafaxine) C Malaise Hyoscine (Hyoscine) C Syncope Tachycardia Date:06/02/03ISR Number: 4121737-8Report Type:Expedited (15-DaCompany Report #PHFR2003GB01995 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Distension Foreign Clozaril(Clozapine) Initial or Prolonged Ileus Paralytic Study Unknown PS ORAL UNK, UNK, Joint Swelling Health ORAL Malaise Professional 22-Feb-2006 08:30 AM Page: 2233 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/02/03ISR Number: 4121739-1Report Type:Expedited (15-DaCompany Report #PHNR2003AU00801 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diarrhoea Foreign Clozaril Initial or Prolonged Drug Hypersensitivity Health (Clozapine)(Clozapin Other Faecal Incontinence Professional e)Tablet PS ORAL 300-400MG/DAY Gastric Disorder Other , ORAL Gastroenteritis Eosinophilic Inflammatory Bowel Disease Vomiting Weight Decreased Date:06/02/03ISR Number: 4121868-2Report Type:Expedited (15-DaCompany Report #PHFR2003GB01312 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Albumin Decreased Foreign Clozaril (Clozapine) Hospitalization - Eating Disorder Study Unknown PS ORAL 300 MG/DAY, Initial or Prolonged Haemoglobin Decreased Health ORAL Neutrophil Count Professional Increased Other Pancreatitis Weight Decreased White Blood Cell Count Increased Date:06/02/03ISR Number: 4121943-2Report Type:Expedited (15-DaCompany Report #PHFR2003GB01321 Age:58 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Alkaline Foreign Clozaril(Clozapine) PS ORAL 350MG/DAY, Phosphatase Increased Study ORAL Blood Chloride Increased Health Priadel C Blood Sodium Increased Professional Quetiapine Constipation Other (Quetiapine) C Decreased Appetite Drug Eruption Gamma-Glutamyltransferase Increased Hepatic Steatosis Rash Erythematous Rash Psoriaform Weight Decreased Date:06/02/03ISR Number: 4121964-XReport Type:Expedited (15-DaCompany Report #PHBS2003NZ04565 Age:28 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Acute Foreign Clozaril(Clozapine)T Sudden Death Health ablet PS ORAL ORAL Weight Increased Professional Quetiapine Other (Quetiapine) C 22-Feb-2006 08:30 AM Page: 2234 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/02/03ISR Number: 4121983-3Report Type:Expedited (15-DaCompany Report #PHNR2003AU00575 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril(Clozapine)T Drug Level Decreased Health ablet PS ORAL ORAL Hyperlipidaemia Professional Pyridoxine Other (Pyridoxine) C Diazepam C Date:06/02/03ISR Number: 4121984-5Report Type:Expedited (15-DaCompany Report #PHFR2001GB03430 Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abscess Foreign Clozaril Initial or Prolonged Hepatic Failure Study (Clozapine)(Clozapin Other Oesophageal Carcinoma Health e)Tablet PS ORAL 800MG/DAY, Weight Decreased Professional ORAL Other Date:06/02/03ISR Number: 4121999-7Report Type:Expedited (15-DaCompany Report #PHFR2003GB01367 Age:60 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Coma Foreign Clozaril(Clozapine) Initial or Prolonged Diabetic Hyperosmolar Study Unknown PS ORAL ORAL Other Coma Health Metformin, Gamma-Glutamyltransferase Professional Nateglinide Increased Other (Nateglinide, Pneumonia Metformin) C Date:06/02/03ISR Number: 4122011-6Report Type:Expedited (15-DaCompany Report #PHFR2003GB02038 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Foreign Clozaril (Clozapine) PS ORAL ORAL Somnolence Other Date:06/02/03ISR Number: 4122012-8Report Type:Expedited (15-DaCompany Report #PHFR2003GB02036 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril Study (Clozapine) PS ORAL ORAL Health Ferrous Sulphate C Professional Other Date:06/02/03ISR Number: 4122270-XReport Type:Expedited (15-DaCompany Report #PHEH2003US02392 Age:89 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asthenia Health Clozaril (Clozapine) Other Disease Recurrence Professional Tablet PS ORAL 50 MG, TID, Failure To Thrive ORAL Infection Morphine (Morphine) C Pneumonia Aspiration Klonopin C 22-Feb-2006 08:30 AM Page: 2235 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Levoxyl C Tums C Milk Of Magnesia C Date:06/02/03ISR Number: 4122284-XReport Type:Expedited (15-DaCompany Report #PHEH2003US04308 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Renal Failure Health Clozaril (Clozapine) Professional Tablet PS ORAL 100 MG AM + 500 QD PRN, ORAL Flagyl "Aventis" (Metronidazole) C Levaquin (Levofloxacin) C Protonix "Pharmacia" C Risperdal C Kcl C Date:06/02/03ISR Number: 4122286-3Report Type:Expedited (15-DaCompany Report #PHEH2002US09990 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatic Cirrhosis Health Clozaril (Clozapine) Initial or Prolonged Hepatitis C Professional Tablet PS ORAL 50 MG, QD, Other Leukopenia ORAL Liver Transplant Prograf C White Blood Cell Count Rapamune (Sirolimus) C Increased Bactrim Ds (Sulfamethoxazole) C Vitamin E C Paxil C Prevacid (Lansoprazole) C Oxycodone (Oxycodone) C Aspirin "Bayer" C Levaquin (Levofloxacin) C Date:06/02/03ISR Number: 4122288-7Report Type:Expedited (15-DaCompany Report #PHEH2003US04327 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozaril (Clozapine) Lymphoma Professional Tablet PS Neutropenia Seroquel (Quetiapine Fumarate) C Ativan C Wellbutrin (Bupropion Hydrochloride) C 22-Feb-2006 08:30 AM Page: 2236 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/02/03ISR Number: 4122362-5Report Type:Expedited (15-DaCompany Report #PHEH2003US00582 Age:50 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Collapse Of Lung Health Clozaril (Clozapine) Other Iron Deficiency Anaemia Professional Tablet PS ORAL 400 MG BID+ Mass 50MG HS, ORAL Pneumonia Aspiration Cogentin (Benzatropine Mesilate) C Zyprexa C Depakote (Valproate Semisodium) C Date:06/02/03ISR Number: 4122545-4Report Type:Expedited (15-DaCompany Report #2003AP01803 Age:28 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Acute Foreign Seroquel PS ORAL 700 MG DAILY Sudden Death Health PO 6 MON Professional Clozaril SS 200 MG DAILY Other Date:06/02/03ISR Number: 4122566-1Report Type:Expedited (15-DaCompany Report #2003AP01803 Age:28 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Acute Foreign Seroquel PS ORAL 700 MG DAILY Sudden Death Health PO 6 MON Professional Clozaril SS 200 MG DAILY Other Date:06/03/03ISR Number: 4122237-1Report Type:Expedited (15-DaCompany Report #03-05-0614 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Health Clozapine PS Ivax Initial or Prolonged Psychotic Disorder Professional Pharmaceuticals, Inc ORAL 300-900MG QD Other ORAL Xenadrine SS Ephedra SS Date:06/04/03ISR Number: 4122557-0Report Type:Expedited (15-DaCompany Report #SE-GLAXOSMITHKLINE-B0113350A Age:34 YR Gender:Male I/FU:F Outcome PT Hospitalization - Abdominal Pain Initial or Prolonged Anuria Azotaemia Blood Creatinine Increased Chills Clostridium Colitis Hepatic Enzyme Increased Neuroleptic Malignant Syndrome Pneumonia Psychotic Disorder 22-Feb-2006 08:30 AM Page: 2237 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pyrexia Rash Renal Failure Report Source Product Role Manufacturer Route Dose Duration Renal Tubular Necrosis Cefuroxime Sodium PS Glaxosmithkline INTRAVENOUS 2.2G per day 10 DAY Rhabdomyolysis Allopurinol SS Glaxosmithkline UNKNOWN Sepsis Clozapine SS ORAL 300MG per day YR Thrombocytopenia Temesta C Vomiting Date:06/04/03ISR Number: 4122809-4Report Type:Expedited (15-DaCompany Report #C2003-1252.01 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 200 MG TID Other ORAL Clozapine Tablets 25 Mg Mylan SS Mylan ORAL 50 MG TID ORAL Digoxin C Triamterene & Hydrochlorothiazide C Warfarin Sodium C Date:06/04/03ISR Number: 4122815-XReport Type:Expedited (15-DaCompany Report #FLUV00303001391 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Foreign Floxyfral Initial or Prolonged Alcohol Withdrawal Health (Fluvoxamine Syndrome Professional Maleate) PS ORAL 100 MG DAILY; Alcoholism Other PO, 100 MG Bipolar Disorder DAILY; PO Chills Leponex (Clozapine) SS UNKNOWN 100 MG DAILY; Confusional State UNK, 300 MG Delirium DAILY; UNK, Depression 100 MG DAILY; Drug Interaction UNK, 100 MG Drug Level Decreased Sortis (Atorvastatin Excitability Calcium) C Gait Disturbance Zyloric Hepatitis (Allopurinol) C Hypercholesterolaemia Hyperuricaemia Liver Function Test Abnormal Nervous System Disorder Nocturia Parkinson'S Disease Restlessness Salivary Hypersecretion Date:06/04/03ISR Number: 4123592-9Report Type:Expedited (15-DaCompany Report #PHFR2003GB02072 Age:24 YR Gender:Male I/FU:I Outcome PT Hospitalization - Dyspnoea Initial or Prolonged Electrocardiogram 22-Feb-2006 08:30 AM Page: 2238 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Abnormal Palpitations Ventricular Extrasystoles Ventricular Tachycardia Report Source Product Role Manufacturer Route Dose Duration Foreign Clopzapine Health (Clozapine) Unknown PS ORAL 350 MG /DAY, Professional ORAL Other Ventolin C Hyoscine (Hyoscine) C Buspirone (Buspirone) C Date:06/04/03ISR Number: 4123729-1Report Type:Expedited (15-DaCompany Report #PHHO2003CA06308 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Foreign Clozaril (Clozapine) Grand Mal Convulsion Study Tablet PS 400 MG Sudden Death Health Epival (Valproate Professional Semisodium) C Other Date:06/04/03ISR Number: 4123803-XReport Type:Expedited (15-DaCompany Report #PHFR2003GB01323 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiomyopathy Foreign Clozaril (Clozapine) PS ORAL 100MG/MANE Hospitalization - Mental Impairment Study 250MG/NOCTE, Initial or Prolonged Pulmonary Oedema Health ORAL Other Respiratory Arrest Professional Weight Increased Other Date:06/04/03ISR Number: 4123807-7Report Type:Expedited (15-DaCompany Report #FRWYE148223MAY03 Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Condition Aggravated Foreign Temesta (Lorazepam, Hospitalization - Epilepsy Health Tablet, 0) PS ORAL 3.75 MG 1X Initial or Prolonged Professional PER 1 DAY 2 YR Other Gardenal (Phenobarbital, , 0) SS ORAL 200 MG 1X PER 1 DAY 159 DAY Leponex (Clozapine, , 0) SS ORAL 400 MG 1X PER 1 DAY 157 DAY Parkinane Lp (Trihexyphenidyl, Capsule, Sustained Release, 0) SS ORAL 10 G 1X PER 1 DAY 5 YR Date:06/04/03ISR Number: 4123872-7Report Type:Expedited (15-DaCompany Report #PHNR2003AU00917 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Hospitalization - Cardiac Disorder Foreign Initial or Prolonged Syncope Health Other Professional 22-Feb-2006 08:30 AM Page: 2239 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Product Role Manufacturer Route Dose Duration Clozaril (Clozapine)(Clozapin e) Tablet PS ORAL 450MG/DAY, ORAL Date:06/04/03ISR Number: 4123884-3Report Type:Expedited (15-DaCompany Report #PHNR2003AU00571 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Disorder Foreign Clozaril(Clozapine) Initial or Prolonged Circulatory Collapse Health Unknown PS 12.5-600 MG Other Dehydration Professional Valproate Sodium C Echocardiogram Abnormal Other Thyroxine C Pneumonia Frusemide C Salbutamol C Simvastatin C Ergocalciferol C Calcium Carbonate C Glibenclamide C Date:06/04/03ISR Number: 4124155-1Report Type:Expedited (15-DaCompany Report #PHFR2003GB02065 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bifascicular Block Foreign Clozaril(Clozapine) PS ORAL ORAL Electrocardiogram Study Abnormal Health Sinus Tachycardia Professional Somnolence Other Date:06/04/03ISR Number: 4124156-3Report Type:Expedited (15-DaCompany Report #PHHO2003CA06031 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Death Foreign Clozaril(Clozapine) PS Fall Study Synthroid C Urinary Incontinence Health Lithium Carbonate C Vomiting Professional Dalmane (Flurazepam Other Hydrochloride) C Clopixol (Zuclopenthixol Decanoate) C Date:06/04/03ISR Number: 4124157-5Report Type:Expedited (15-DaCompany Report #PHNR2003AU00915 Age:71 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Fall Foreign Clozaril (Clozapine) Study (Clozapine) Tablet PS ORAL 250MG/DAY, Health ORAL Professional Other 22-Feb-2006 08:30 AM Page: 2240 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/04/03ISR Number: 4124158-7Report Type:Expedited (15-DaCompany Report #PHFR2003GB01281 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Insulin Abnormal Foreign Clozaril(Clozapine) PS ORAL 475 MG/DAY, Hospitalization - Condition Aggravated Study ORAL Initial or Prolonged Dehydration Other Amisulpride Other Diabetes Mellitus (Amisulpride) C Insulin-Dependent Valproate Sodium C Diabetic Ketoacidosis Simvastatin C Drug Level Increased Insulatard (Insulin Loss Of Consciousness Human Injection, Respiratory Tract Isophane) C Infection Humalog (Insulin Lispro) C Kwells C Date:06/04/03ISR Number: 4124275-1Report Type:Expedited (15-DaCompany Report #PHFR2003GB02066 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyskinesia Foreign Clozaril (Clozapine) PS ORAL 300MG/DAY, Initial or Prolonged Dysuria Study ORAL Electrocardiogram Health Abnormal Professional Fall Other Hallucination, Visual Loss Of Control Of Legs Malaise Myalgia Pollakiuria Proteinuria Pyrexia Salivary Hypersecretion Sinus Tachycardia Vision Blurred Date:06/04/03ISR Number: 4124282-9Report Type:Expedited (15-DaCompany Report #PHNU2000DE02113 Age:27 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Leponex / Clozaril Insulin-Dependent Health (Clozapine) Professional (Clozapine) Tablet PS ORAL 400 MG/DAY, Other ORAL Date:06/04/03ISR Number: 4124472-5Report Type:Expedited (15-DaCompany Report #PHEH2003US04222 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Health Clozaril (Clozapine) Initial or Prolonged Condition Aggravated Professional Tablet PS ORAL 400 MG, QHS, Convulsion ORAL Psychotic Disorder Zoloft (Sertraline) C Antihypertensives C 22-Feb-2006 08:30 AM Page: 2241 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/04/03ISR Number: 4124798-5Report Type:Expedited (15-DaCompany Report #PHEH2003US03727 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tuberculin Test Positive Health Clozaril (Clozapine) Professional Tablet PS ORAL 275 MG, ORAL Valproic Acid C Sertraline (Sertraline) C Bupropion (Bupropion) C Date:06/04/03ISR Number: 4124799-7Report Type:Expedited (15-DaCompany Report #PHEH2003US04317 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pulmonary Embolism Health Clozaril (Clozapine) Road Traffic Accident Professional Tablet PS Date:06/05/03ISR Number: 4123665-0Report Type:Direct Company Report #CTU 195069 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Grand Mal Convulsion Clozapine 100mg PS ORAL 100MG AT BEDTIME ORAL Clozapine 25mg SS ORAL 25MG 2 TABS ORAL Date:06/05/03ISR Number: 4125442-3Report Type:Expedited (15-DaCompany Report #C2003-1111.01 Age:69 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neoplasm Malignant Health Clozapine Tablets White Blood Cell Count Professional 25 Mg Mylan PS Mylan 37.5 MG BID, Increased Other 25MG QD Carbidopa & Levodopa C Celecoxib C Clonidine C Enalapril Maleate C Enoxaparin Sodium C Fludrocortisone Acetate C Ipratropium Bromide C Levothyroxine Sodium C Scopolamine Patch C Tanafit Ointment C Trazodone C Clindamycin C Furosemide C Morphine C Clonazepam C Levofloxacin C Lactobacillus C Tramadol C Promethazine C Albuterol (Nebulizer) C Vancomyin Iv C Dextrose/Nacl C 22-Feb-2006 08:30 AM Page: 2242 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/06/03ISR Number: 4125457-5Report Type:Expedited (15-DaCompany Report #C2003-1292.01 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Chronic Obstructive Health Clozapine Tablets Pulmonary Disease Professional 100 Mg Mylan PS Mylan ORAL 500MG, QD, Other ORAL Date:06/09/03ISR Number: 4126027-5Report Type:Expedited (15-DaCompany Report #PHBS2003NL01496 Age:54 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Haemoglobin Increased Foreign Leponex(Clozapine) Initial or Prolonged Liver Function Test Health Tablet PS 300 MG/D 21 DAY Abnormal Professional Risperdal C Lung Crepitation Other Oedema Peripheral Red Blood Cell Sedimentation Rate Increased Thrombocythaemia Date:06/09/03ISR Number: 4126028-7Report Type:Expedited (15-DaCompany Report #PHBS2002NL13937 Age:54 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Level Increased Foreign Leponex(Clozapine) Initial or Prolonged Haemoglobin Increased Health Tablet PS ORAL 300 MG/DAY, Liver Function Test Professional ORAL; 100 Abnormal Other MG/D, ORAL Lung Crepitation Risperidone C Lung Infiltration Temazepam C Oedema Peripheral Oxazepam (Oxazepam) C Red Blood Cell Sedimentation Rate Increased Thrombocythaemia Date:06/09/03ISR Number: 4126029-9Report Type:Expedited (15-DaCompany Report #PHNU2003DE02109 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Upper Foreign Leponex / Clozaril Initial or Prolonged Acute Abdomen Health (Clozapine) Blood Bilirubin Increased Professional (Clozapine) Tablet PS ORAL 300MG/DAY, Hepatic Enzyme Increased Other ORAL Hepatotoxicity Perforation Bile Duct Surgery Date:06/09/03ISR Number: 4126030-5Report Type:Expedited (15-DaCompany Report #PHNU2003DE02103 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Vitreous Opacities Foreign Leponex / Clozaril Consumer (Clozapine)(Clozapin Other e) Tablet PS ORAL 100MG/DAY, ORAL 22-Feb-2006 08:30 AM Page: 2243 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/09/03ISR Number: 4126031-7Report Type:Expedited (15-DaCompany Report #PHFR2003GB02066 Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyskinesia Foreign Clozaril (Clozapine) Initial or Prolonged Dysuria Study Unknown PS ORAL 300MG/DAY, Electrocardiogram Health ORAL Abnormal Professional Hallucination, Visual Other Loss Of Control Of Legs Malaise Myalgia Myocarditis Pollakiuria Proteinuria Pyrexia Salivary Hypersecretion Tachycardia Tremor Vision Blurred Date:06/09/03ISR Number: 4126033-0Report Type:Expedited (15-DaCompany Report #PHHO2003CA06721 Age:78 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Foreign Clozaril(Clozapine) Study Tablet PS Health Professional Other Date:06/09/03ISR Number: 4126181-5Report Type:Expedited (15-DaCompany Report #PHNU2003DE01755 Age:23 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Level Increased Foreign Leponex / Clozaril Health (Clozapine) Professional (Clozapine) Tablet PS ORAL SEE IMAGE Other Clont (Metronidazole) Film-Coated Tablet SS ORAL SEE IMAGE Cefuhexal Film-Coated Tablet SS ORAL 250 MG, QID, ORAL Augmentan (Clavulanate Potassium) SS INTRAVENOUS 2.2 G, TID, INTRAVENOUS Seroxat "Smith Kline Beecham" Film-Coated Tablet C Haldol "Janssen-Cilag" Solution C Acc C Eugalac Syrup C Mucosolvan C Dihydergot Solution C Mono-Embolex (Heparin-Fraction, 22-Feb-2006 08:30 AM Page: 2244 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sodium Salt) C Benuron Tablet C Ciatyl-Z (Zuclopenthixol Hydrochloride, Zuclopenthixol Dihydrochloride) C Pirenzepine (Pirenzepine) Tablet C Mycofug Cream C Tetanol (Tetanus Toxoid) Solution For Injection C Date:06/10/03ISR Number: 4127285-3Report Type:Expedited (15-DaCompany Report #03-05-0641 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chronic Obstructive Health Clozapine - Tablets PS Ivax Initial or Prolonged Pulmonary Disease Professional Pharmaceuticals, Inc ORAL 300-325MG QD Pneumonia Other ORAL Date:06/10/03ISR Number: 4127289-0Report Type:Expedited (15-DaCompany Report #03-05-0651 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intestinal Perforation Health Clozapine - Tablets PS Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. ORAL 200-600MG QD ORAL Date:06/10/03ISR Number: 4127387-1Report Type:Expedited (15-DaCompany Report #03-05-0566 Age:62 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bone Marrow Disorder Health Clozapine Initial or Prolonged Urosepsis Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 250MG QD ORAL Synthroid C Xenical C Combivent C Date:06/11/03ISR Number: 4128086-2Report Type:Expedited (15-DaCompany Report #03P-056-0219993-00 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anticonvulsant Drug Level Foreign Depakine Chrono Below Therapeutic Health Tablets (Sodium Sudden Death Professional Valproate) PS ORAL SEE IMAGE Buspirone Hydrochloride SS ORAL 30 MG, 1 IN 1 D, ORAL Fluoxetine Hydrochloride SS ORAL 20 MG, 1 IN 1 D, ORAL 22-Feb-2006 08:30 AM Page: 2245 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Clozapine SS ORAL 6 UNIT, 1 IN 1 D, ORAL Date:06/12/03ISR Number: 4127936-3Report Type:Expedited (15-DaCompany Report #C2003-0781.01 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Other Clozapine Tablets 100 Mg Mylan PS Mylan ORAL 600MG/DAY ORAL Date:06/12/03ISR Number: 4127937-5Report Type:Expedited (15-DaCompany Report #C2003-1305.01 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 600MG/DAY, Other ORAL Date:06/12/03ISR Number: 4128732-3Report Type:Expedited (15-DaCompany Report #PHFR2003GB01348 Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Upper Foreign Clozaril(Clozapine) Alcohol Use Study Unknown PS ORAL 300MG/DAY, Overdose Health ORAL; 20X100 Somnolence Professional MG OVERDOSE Other Lorazepam(Lorazepam) Tablet SS ORAL 8 0X1 MG OVERDOSE, ORAL Hyoscine(Hyoscine) Tablet SS ORAL X 25 TABLETS OVERDOSE, ORAL Procyclidine(Procycl idine) Tablet SS ORAL 8 0X 5MG OVERDOSE, ORAL Fluoxetine(Fluoxetin e) Tablet SS ORAL 7-8X20 MG OVERDOSE, ORAL Alcohol(Ethanol) SS ORAL ORAL Date:06/12/03ISR Number: 4128739-6Report Type:Expedited (15-DaCompany Report #PHFR2003GB02149 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Obsessive-Compulsive Foreign Clozaril (Clozapine) Disorder Health Unknown PS ORAL ORAL Professional Company Representative Other 22-Feb-2006 08:30 AM Page: 2246 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/12/03ISR Number: 4128805-5Report Type:Expedited (15-DaCompany Report #PHFR2003GB02163 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Fall Foreign Clozaril (Clozapine) Loss Of Control Of Legs Study Unknown PS ORAL ORAL Health Professional Other Date:06/12/03ISR Number: 4128840-7Report Type:Expedited (15-DaCompany Report #PHFR2003GB01966 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bundle Branch Block Right Foreign Clozaril (Clozapine) PS ORAL 550MG/DAY, Tachycardia Study ORAL Health Professional Other Date:06/12/03ISR Number: 4128854-7Report Type:Expedited (15-DaCompany Report #PHFR2003GB01926 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Foreign Clozaril (Clozapine) PS ORAL 400 MG/DAY; Initial or Prolonged Depressed Level Of Study 20X100 MG; Consciousness Health ORAL Hypotension Professional Neutrophil Count Other Increased Overdose Respiratory Rate Increased Somnolence Tachycardia White Blood Cell Count Increased Date:06/12/03ISR Number: 4128864-XReport Type:Expedited (15-DaCompany Report #PHFR2002IE03522 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Foreign Clozaril (Clozapine) Increased Study Tablet PS ORAL ORAL Aspartate Health Alcohol(Ethanol) SS Aminotransferase Professional Benzodiazepines(No Increased Other Ingredients/Substanc Drug Interaction es) SS Liver Function Test Ativan C Abnormal Rivotril C Date:06/12/03ISR Number: 4128993-0Report Type:Expedited (15-DaCompany Report #PHEH2003US04327 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozaril Neutropenia Professional (Clozapine) PS Non-Hodgkin'S Lymphoma Seroquel (Quetiapine 22-Feb-2006 08:30 AM Page: 2247 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Fumarate) C Ativan C Wellbutrin (Bupropion Hydrochloride) C Date:06/12/03ISR Number: 4128994-2Report Type:Expedited (15-DaCompany Report #PHBS2002US15024 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Catatonia Health Protonix PS ORAL ORAL Drug Interaction Professional Clozaril(Clozapine) SS Drug Level Above Therapeutic Parkinsonism Date:06/12/03ISR Number: 4129336-9Report Type:Expedited (15-DaCompany Report #2003023497 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Health Geodon (Ziprasidone) PS 40 MG (BID) Initial or Prolonged Irritability Professional Clozapine Psychomotor Hyperactivity (Clozapine) SS ORAL 500 MG (DAILY), ORAL Date:06/13/03ISR Number: 4129362-XReport Type:Expedited (15-DaCompany Report #C2003-1307.01 Age:83 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg Mylan PS ORAL 12.5 MG QD, Other THEN 25 MG QD, ORAL Botulinum Toxin C Carbidopa/Levodopa C Docusate Sodium C Gaifenesin C Hydrocodone/Acetamin ophen C Multivitamin With Minerals C Oxycodone Oral Solution C Pergolide C Salsalate C Senna C Sorbitol C Vitamin C C Zinc Sulfate C Date:06/13/03ISR Number: 4129568-XReport Type:Expedited (15-DaCompany Report #PHFR2003GB02217 Age:32 YR Gender:Male I/FU:I Outcome PT Other Blood Creatinine Increased Electrocardiogram T Wave Abnormal 22-Feb-2006 08:30 AM Page: 2248 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tachycardia Report Source Product Role Manufacturer Route Dose Duration Foreign Clozaril (Clozapine) PS ORAL ORAL Study Health Professional Other Date:06/13/03ISR Number: 4129772-0Report Type:Expedited (15-DaCompany Report #HQWYE473005JUN03 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Health Effexor (Venlafaxine Grand Mal Convulsion Professional Hydrochloride, White Blood Cell Count Unspec) PS ORAL ORAL Decreased Clozapine (Clozapine, ) SS ORAL 500 MG 1X PER 1 DAY, ORAL; SEE IMAGE 3 YR Date:06/13/03ISR Number: 4129852-XReport Type:Expedited (15-DaCompany Report #PHNU2003DE01412 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Activated Partial Foreign Leponex / Clozaril Hospitalization - Thromboplastin Time Health (Clozapine)(Clozapin Initial or Prolonged Prolonged Professional e) Tablet PS ORAL SEE IMAGE Other Anaemia Other Blood Immunoglobulin A Decreased Blood Immunoglobulin G Decreased Cachexia Constipation Diarrhoea Gastrointestinal Disorder Pneumonia Protein Total Decreased Date:06/13/03ISR Number: 4129855-5Report Type:Expedited (15-DaCompany Report #PHHO2003CA06721 Age:78 YR Gender:Unknown I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Foreign Clozaril(Clozapine) Study Tablet PS ORAL ORAL Health Risperdal C Professional Other Date:06/16/03ISR Number: 4130140-6Report Type:Expedited (15-DaCompany Report #03-06-0690 Age:56 YR Gender:Female I/FU:I Outcome PT Hospitalization - Difficulty In Walking Initial or Prolonged Drooling Logorrhoea 22-Feb-2006 08:30 AM Page: 2249 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Mania Psychotic Disorder Report Source Product Role Manufacturer Route Dose Duration Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 400-600MG QD ORAL Trileptal SS Trileptal SS Date:06/16/03ISR Number: 4130144-3Report Type:Expedited (15-DaCompany Report #03-06-0682 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mania Health Clozapine - Ivax Initial or Prolonged Treatment Noncompliance Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 375-600MG QD ORAL Date:06/16/03ISR Number: 4130146-7Report Type:Expedited (15-DaCompany Report #03-05-0582 Age:63 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 600MG QD ORAL Date:06/16/03ISR Number: 4130149-2Report Type:Expedited (15-DaCompany Report #03-04-0452 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agranulocytosis Health Clozapine - Ivax Life-Threatening Myocardial Infarction Professional Pharmaceuticals, Other Neutropenia Other Inc. Tablets PS Ivax Required Pharmaceuticals, Intervention to Inc. ORAL 400MG QHS Prevent Permanent ORAL Impairment/Damage Citalopram C Date:06/16/03ISR Number: 4130151-0Report Type:Expedited (15-DaCompany Report #03-05-0659 Age:73 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Myocardial Health Clozapine - Ivax Infarction Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc ORAL 25-150MG QD ORAL 22-Feb-2006 08:30 AM Page: 2250 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/16/03ISR Number: 4130417-4Report Type:Expedited (15-DaCompany Report #PHFR2003GB02038 Age:50 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Accidental Exposure Foreign Clozaril (Clozapine) PS ORAL 400 MG, Medication Error Other ONCE/SINGLE, Somnolence ORAL Risperidone C Apo-Chlorpromazine (Chlorpromazine Hydrochloride) C Date:06/16/03ISR Number: 4130433-2Report Type:Expedited (15-DaCompany Report #PHRM2003FR01639 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukaemia Foreign Leponex(Clozapine)Ta Health blet PS ORAL ORAL Professional Company Representative Other Date:06/16/03ISR Number: 4130503-9Report Type:Expedited (15-DaCompany Report #PHEH2003US01910 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Study Clozaril (Clozapine) Coronary Artery Disease Health Tablet PS ORAL 400 MG, QHS, Professional ORAL Triphenidyl (Trihexyphenidyl Hydrochloride) C Stool Softener C Date:06/16/03ISR Number: 4130607-0Report Type:Expedited (15-DaCompany Report #PHNR2003AU00525 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Accidental Exposure Foreign Clozaril (Clozapine) Hospitalization - Dehydration Health Tablet PS ORAL 350 MG, Initial or Prolonged Medication Error Professional ONCE/SINGLE, Other ORAL Antipsychotics C Date:06/16/03ISR Number: 4130624-0Report Type:Expedited (15-DaCompany Report #PHFR2003GB01858 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril(Clozapine) PS ORAL SEE IMAGE Non-Insulin-Dependent Study Lithium (Lithium) C Sedation Health Hyoscine (Hyoscine) C Vomiting Professional Other 22-Feb-2006 08:30 AM Page: 2251 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/16/03ISR Number: 4130625-2Report Type:Expedited (15-DaCompany Report #PHHO2003CA05559 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Meningitis Foreign Clozaril(Clozapine) PS 600MG/DAY Study Health Professional Other Date:06/16/03ISR Number: 4130783-XReport Type:Expedited (15-DaCompany Report #USA/00/01128/LEX Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coma Health Clozaril Hospitalization - Drug Level Increased Professional (Clozapine) PS ORAL SEE IMAGE Initial or Prolonged Overdose Cocaine(Cocaine) SS Valium (Diazepam) SS Alcohol(Ethanol) SS Risperidone (Risperidone) SS Biaxin (Clarithromycin) C Date:06/17/03ISR Number: 4131601-6Report Type:Expedited (15-DaCompany Report #2003024145 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Medication Error Health Geodon (Ziprasidone) PS Hospitalization - Pyrexia Professional Clozapine Initial or Prolonged Rhabdomyolysis (Clozapine) SS ORAL 400 MG (BID), Other ORAL Quetiapine Fumarate (Quetiapine Fumarate) SS Risperidone (Risperidone) SS Sertraline Hydrochloride (Sertraline Hydrochloride) C Oxcarbazepine (Oxcarbazepine) C Bisacodyl (Bisacodyl) C Trazodone Hydrochloride (Trazodone Hydrochloride) C Hydroxyzine Embonate (Hydroxyzine Embonate) C Fluphenazine Decanoate (Fluphenazine Decanoate) C 22-Feb-2006 08:30 AM Page: 2252 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/17/03ISR Number: 4131816-7Report Type:Expedited (15-DaCompany Report #FR-JNFOC-20030600037 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - B-Cell Lymphoma Foreign Risperidone Initial or Prolonged Leukocytosis Health (Risperidone) PS IN 1 DAY Lymphocyte Morphology Professional Leponex (Clozapine) SS Abnormal Valium (Diazepam) C Lipanthyl (Fenofibrate) C Parkinane (Trihexyphenidyl Hydrochloride) C Date:06/18/03ISR Number: 4132036-2Report Type:Expedited (15-DaCompany Report #PHBS2001AU10052 Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiomyopathy Foreign Clozaril Chest Pain Study (Clozapine) PS ORAL 500 MG/DAY, Dilatation Ventricular Health ORAL Drug Withdrawal Syndrome Professional Dyspnoea Other Psychotic Disorder Sinus Tachycardia Date:06/18/03ISR Number: 4132056-8Report Type:Expedited (15-DaCompany Report #PHNR2003AU00968 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Clozaril Initial or Prolonged Phosphokinase Increased Health (Clozapine)(Clozapin Mental Disorder Professional e) Tablet PS ORAL SEE IMAGE Other Date:06/18/03ISR Number: 4132064-7Report Type:Expedited (15-DaCompany Report #PHFR2003GB02250 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Post Viral Fatigue Foreign Clozaril(Clozapine) Syndrome Health Unknown PS Professional Company Representative Other Date:06/18/03ISR Number: 4132068-4Report Type:Expedited (15-DaCompany Report #PHFR2002GB03903 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Foreign Clozaril (Clozapine) Cardiac Arrest Study Tablet PS ORAL SEE IMAGE Drug Level Increased Health Malaise Professional Pallor Other Sudden Death 22-Feb-2006 08:30 AM Page: 2253 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/18/03ISR Number: 4132264-6Report Type:Expedited (15-DaCompany Report #PHFR2003GB01859 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Accidental Exposure Foreign Clozaril (Clozapine) Overdose Health Tablet PS ORAL 100 MG, Professional ONCE/SINGLE, Other ORAL Date:06/18/03ISR Number: 4132268-3Report Type:Expedited (15-DaCompany Report #PHBS2003DK05846 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetic Ketoacidosis Foreign Clozapine Literature (Clozapine) Unknown PS Health Professional Other Date:06/18/03ISR Number: 4132269-5Report Type:Expedited (15-DaCompany Report #PHEH2003US04747 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coma Study Clozaril (Clozapine) Other Health Tablet PS ORAL ORAL Professional Date:06/18/03ISR Number: 4132275-0Report Type:Expedited (15-DaCompany Report #PHEH2003US04327 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozaril (Clozapine) Neutropenia Professional Tablet PS Non-Hodgkin'S Lymphoma Seroquel (Quetiapine Fumarate) C Ativan C Wellbutrin (Bupropion Hydrochloride) C Date:06/18/03ISR Number: 4132417-7Report Type:Expedited (15-DaCompany Report #PHEH2003US04744 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Health Clozaril (Clozapine) Drug Interaction Professional Tablet PS ORAL SEE IMAGE Company Risperdal Representative (Risperidone) SS Ativan (Lorazepam) SS Date:06/18/03ISR Number: 4132578-XReport Type:Expedited (15-DaCompany Report #PHEH2003US04222 Age:64 YR Gender:Female I/FU:F Outcome PT Hospitalization - Cerebral Ischaemia Initial or Prolonged Chest Pain Other Coma 22-Feb-2006 08:30 AM Page: 2254 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Condition Aggravated Convulsion Dyspnoea Report Source Product Role Manufacturer Route Dose Duration Encephalopathy Health Clozaril (Clozapine) PS ORAL 400 MG, QHS, Oral Discharge Professional ORAL Paranoia Zoloft (Sertraline Psychotic Disorder Hydrochloride) C Sedation Lotensin C Treatment Noncompliance Norvasc C Miralax (Macrogol) C Celebrex C Albuterol C Combivent (Salbutamol Sulfate) C Haldol C Janssen Multivitamins (Panthenol, Retinol) C Date:06/19/03ISR Number: 4132537-7Report Type:Expedited (15-DaCompany Report #03-06-0690 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Clozapine - Ivax Initial or Prolonged Drooling Professional Pharmaceuticals, Mania Other Inc. PS Ivax Psychotic Disorder Pharmaceuticals, Inc. ORAL 400-600MG QD ORAL Trileptal SS Date:06/20/03ISR Number: 4133236-8Report Type:Expedited (15-DaCompany Report #C2003-1431.01 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Neoplasm Malignant Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan 700 MG/DAY Other Date:06/20/03ISR Number: 4133631-7Report Type:Expedited (15-DaCompany Report #PHEH2003US01608 Age:49 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Clozaril (Clozapine) Initial or Prolonged Asthenia Professional Tablet PS ORAL 500 MG, ORAL Other Cerebrovascular Accident Prozac (Fluoxetine Confusional State Hydrochloride) C Facial Palsy Ativan C Fall Cogentin Haemorrhage Intracranial (Benzatropine Hallucination, Visual Mesilate) C Head Injury Theo-Dur C Paranoia 22-Feb-2006 08:30 AM Page: 2255 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/20/03ISR Number: 4133762-1Report Type:Expedited (15-DaCompany Report #PHEH2003US02112 Age:56 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Health Clozaril (Clozapine) Professional Tablet, 100mg PS ORAL 150MG AM + 200MG HS, ORAL Klonopin C Lithium (Lithium) C Artane (Trihexyphenidyl Hydrochloride) C Neurontin (Gabapentin) C Zoloft (Sertraline Hydrochloride) C Premarin (Estrogens Conjugated ) C Colace C Oxybutynin (Oxybutynin) C Propranolol C Protonix "Pharmacia" C Lantus (Insulin Glargine) C Glucophage "Abic" C Glucotrol (Glipizide) C Date:06/20/03ISR Number: 4133767-0Report Type:Expedited (15-DaCompany Report #PHEH2003US04863 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozaril (Clozapine) Professional Tablet PS ORAL SEE IMAGE Company Celexa C Representative Cogentin (Benzatropine Mesilate) C Risperdal C Lithium (Lithium) C Date:06/20/03ISR Number: 4133772-4Report Type:Expedited (15-DaCompany Report #PHNU2003DE01338 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthma Foreign Leponex/Clozaril Dizziness Health (Clozapine) Tablet PS ORAL SEE IMAGE Eosinophilia Professional Exercise Capacity Other Decreased Tachycardia Weight Increased 22-Feb-2006 08:30 AM Page: 2256 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/20/03ISR Number: 4133881-XReport Type:Expedited (15-DaCompany Report #THQ2003A00514 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cognitive Disorder Health Lansoprazole Initial or Prolonged Condition Aggravated Professional (Lansoprazole) PS 30 MG ( 1 D); Confusional State Other DAYS Haemoglobin Decreased Clozaril (Clozapine) SS ORAL 450 MG (1 D), Hallucination, Visual PER ORAL; Schizophrenia DAYS Date:06/20/03ISR Number: 4133914-0Report Type:Expedited (15-DaCompany Report #PHFR2003GB02292 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Neonatal Foreign Clozaril (Clozapine) PS TRANSPLACENTAL TRANSPLACENTA Maternal Drugs Affecting Health L Foetus Professional Sertraline Premature Baby Other (Sertraline) C Diazepam C Date:06/20/03ISR Number: 4133979-6Report Type:Expedited (15-DaCompany Report #PHFR2002GB01848 Age:33 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Activated Partial Foreign Clozaril (Clozapine) Thromboplastin Time Study Tablet PS ORAL 475 MG/DAY, Prolonged Health ORAL Systemic Lupus Professional Erythematosus Other Thrombocytopenia Date:06/20/03ISR Number: 4134128-0Report Type:Expedited (15-DaCompany Report #PHFR2003GB01759 Age:22 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiac Disorder Foreign Clozaril(Clozapine) Oedema Peripheral Health Unknown PS Vasodilatation Professional Atenolol C Wheezing Other Date:06/20/03ISR Number: 4134129-2Report Type:Expedited (15-DaCompany Report #PHFR2001GB03430 Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abscess Foreign Clozaril (Clozapine) Initial or Prolonged Dysphagia Study (Clozapine) Tablet PS ORAL 800MG/DAY, Other Fatigue Health ORAL; 125MG Haemoglobin Decreased Professional NAME & 250MG Hepatic Failure Other NOCTE, ORAL Oesophageal Stenosis Epilim Chrono C Pallor Weight Decreased 22-Feb-2006 08:30 AM Page: 2257 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/20/03ISR Number: 4134143-7Report Type:Expedited (15-DaCompany Report #PHNR2003AU00571 Age:39 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Disorder Foreign Clozaril (Clozapine) Initial or Prolonged Circulatory Collapse Study Unknown PS 12.5-600 MG Other Dehydration Health Valproate Sodium C Echocardiogram Abnormal Professional Thyroxine C Lobar Pneumonia Other Frusemide C Lymphocytosis Salbutamol C Lymphoproliferative Simvastatin C Disorder Ergocalciferol C Ventricular Dysfunction Calcium Carbonate C Glibenclamide C Date:06/20/03ISR Number: 4134176-0Report Type:Expedited (15-DaCompany Report #PHFR2002GB04115 Age:24 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Exposure During Foreign Clozaril (Clozapine) Pregnancy Health (Clozapine) Tablet PS ORAL 350 MG/DAY, Pregnancy Professional ORAL Premature Labour Other Diazepam C Sertraline (Sertraline) C Zopiclone C Date:06/20/03ISR Number: 4134180-2Report Type:Expedited (15-DaCompany Report #PHFR2003GB02292 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Neonatal Foreign Clozaril(Clozapine) Maternal Drugs Affecting Health Unknown PS TRANSPLACENTAL TRANSPLACENTA Foetus Professional L Premature Baby Other Sertraline (Sertraline) C Diazepam C Zopiclone C Date:06/20/03ISR Number: 4134192-9Report Type:Expedited (15-DaCompany Report #PHBS2003CA06100 Age:86 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Exposure Foreign Clozapine Initial or Prolonged Coma Literature (Clozapine) Unknown PS ORAL 175 MG/D, Confusional State Health ORAL Medication Error Professional L-Thyroxin "Henning Miosis Other Berlin" C Pupillary Reflex Impaired Donepezil C Coumadine (Warfarin Sodium) C Trazodone (Trazodone) C 22-Feb-2006 08:30 AM Page: 2258 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/20/03ISR Number: 4134195-4Report Type:Expedited (15-DaCompany Report #PHFR2003GB02234 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Clozaril (Clozapine) Urinary Tract Infection Study Unknown PS ORAL ORAL Health Professional Other Date:06/20/03ISR Number: 4134243-1Report Type:Expedited (15-DaCompany Report #PHNU2003DE02109 Age:20 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acute Abdomen Foreign Leponex/Clozaril Initial or Prolonged Blood Bilirubin Increased Health (Clozapine Tablet) PS ORAL 300 MG/DAY, Hepatic Enzyme Increased Professional ORAL Hepatotoxicity Other Perforation Bile Duct Date:06/24/03ISR Number: 4135209-8Report Type:Expedited (15-DaCompany Report #C2003-1252.01 Age:61 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 200MG TID, Other ORAL Clozapine Tablets 25 Mg Mylan SS Mylan ORAL 50MG TID, ORAL Digoxin C Triamterene & Hydrochlorothiazide C Warfarin Sodium C Potassium C Benztropine C Metolazone C Date:06/24/03ISR Number: 4135210-4Report Type:Expedited (15-DaCompany Report #03-06-0722 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Thyroid Gland Cancer Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 250-550MG QD ORAL Date:06/24/03ISR Number: 4135213-XReport Type:Expedited (15-DaCompany Report #03-06-0706 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Health Clozapine Tablets - Diabetic Complication Professional Ivax Other Pharmaceuticals, Inc. PS Ivax 22-Feb-2006 08:30 AM Page: 2259 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pharmaceuticals, Inc. ORAL 200-1300MG QD ORAL Date:06/24/03ISR Number: 4135233-5Report Type:Expedited (15-DaCompany Report #03-06-0705 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Triglycerides Health Clozapine - Ivax Increased Professional Pharmaceuticals, Diabetes Mellitus Other Inc. Tablets PS Ivax Hypochromic Anaemia Pharmaceuticals, Weight Increased Inc. ORAL 700-800MG QD ORAL Date:06/24/03ISR Number: 4135255-4Report Type:Expedited (15-DaCompany Report #03-06-0720 Age:87 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 75-137.5MG QD ORAL Date:06/24/03ISR Number: 4135257-8Report Type:Expedited (15-DaCompany Report #03-06-0696 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mania Health Clozapine - Ivax Initial or Prolonged Suicidal Ideation Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 300-800MG QD ORAL Date:06/24/03ISR Number: 4135258-XReport Type:Expedited (15-DaCompany Report #03-06-0704 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fracture Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 275-325MG QD ORAL Date:06/24/03ISR Number: 4135266-9Report Type:Expedited (15-DaCompany Report #03-06-0692 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Urinary Tract Infection Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 400MG QD ORAL 22-Feb-2006 08:30 AM Page: 2260 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/24/03ISR Number: 4135272-4Report Type:Expedited (15-DaCompany Report #C2003-1111.01 Age:69 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neoplasm Malignant Health Clozapine Tablets 25 Parkinson'S Disease Professional Mg Mylan PS Mylan 37.5 MG BID, White Blood Cell Count Other 25 MG QD, Increased GASTRIC TUBE Carbidopa & Levodopa C Celecoxib C Clonidine C Enalapril Maleate C Enoxaparin Sodium C Fludrocortisone Acetate C Ipratroprium Bromide C Levothyroxine Sodium C Scopolamine Patch C Tanafit Ointment C Trazodone C Clindamycin C Furosemide C Morphine C Clonazepam C Levofloxacin C Lactobacillus C Tramadol C Promethazine C Albuterol (Nebulizer) C Vancomycin C Dextrose/Naci C Chlorophyllin Copper Complex Ointment C Levalbuterol C Date:06/24/03ISR Number: 4135275-XReport Type:Expedited (15-DaCompany Report #C2003-1479.01 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Health Clozapine Tablets Initial or Prolonged Drug Level Professional 100 Mg Mylan PS Mylan ORAL 400MG Q HS, Other Dyspnoea THEN Lethargy 12.5MG/DAY UP Mental Status Changes TO 100MG/DAY Pneumonia ORAL Tachycardia Divalproex Sodium Er C White Blood Cell Count Folic Acid C Imipramine C Quetiapine C Date:06/24/03ISR Number: 4135278-5Report Type:Expedited (15-DaCompany Report #03-06-0708 Age:90 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 200MG QD ORAL 22-Feb-2006 08:30 AM Page: 2261 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/24/03ISR Number: 4135907-6Report Type:Expedited (15-DaCompany Report #C2003-1478.01 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neurodegenerative Health Clozapine Tablets 25 Disorder Professional Mg Mylan PS Mylan ORAL 50MG Q AM, Other 50MG Q HS, ORAL Date:06/25/03ISR Number: 4134720-3Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12281218 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Antipsychotic Drug Level Abilify PS Otsuka Above Therapeutic Pharmaceutical Dizziness Company, Ltd. No Drug Interaction information Orthostatic Hypotension reported Clozaril I No information reported Date:06/25/03ISR Number: 4135613-8Report Type:Direct Company Report #CTU 196635 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Grand Mal Convulsion Clozaril PS ORAL 500MG, 1 TAB Initial or Prolonged QA, ORAL Required Intervention to Prevent Permanent Impairment/Damage Date:06/25/03ISR Number: 4135913-1Report Type:Expedited (15-DaCompany Report #C2003-1110.01 Age:63 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Chronic Obstructive Health Clozapine Tablets Pulmonary Disease Professional 100 Mg Mylan PS Mylan ORAL 100MG QAM, Post Procedural Other 100MG Q12PM, Complication 400MG QHS, Prolapse Repair ORAL Albuterol Nebulizer C Docusate Sodium C Ipratropium Bromide Nebulizer C Mineral Oil C Multivitamin C Oral Laxative C Valproic Acid Syrup C Date:06/26/03ISR Number: 4136306-3Report Type:Expedited (15-DaCompany Report #03-05-0643 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Parkinson'S Disease Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax 22-Feb-2006 08:30 AM Page: 2262 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pharmaceuticals, Inc. ORAL 350MG QD ORAL Date:06/26/03ISR Number: 4136358-0Report Type:Direct Company Report #CTU 196714 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Overdose Clozapine -Ivax Pharm PS Ivax Pharm ORAL 200MG PO QHS 10 YR Date:06/26/03ISR Number: 4137148-5Report Type:Expedited (15-DaCompany Report #EMADSS2003001016 Age:65 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Risperdal Health (Risperidone) PS 2 MG, 1 IN 1 Professional DAY Leponex (Clozapine)Tablets SS ORAL 2.5 MG, 2 IN 1 DAY, ORAL Quilonum (Tablets) Lithium Acetate C Melperone (Melperone) C Pipamperone (Pipamperone) Tablets C Zopiclon (Zopiclone) Tablets C Date:06/27/03ISR Number: 4138156-0Report Type:Expedited (15-DaCompany Report #PHFR2002GB02082 Age:56 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Neoplasm Malignant Foreign Clozaril (Clorapine) Metastases To Bone Health Tablet PS ORAL 900MG/DAY, Neoplasm Malignant Professional ORAL Throat Cancer Other Doxycycline (Doxycycline) C Oramorph (Morphine Sulfate) C Date:06/27/03ISR Number: 4138160-2Report Type:Expedited (15-DaCompany Report #PHNU2003DE02316 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Lymphopenia Foreign Leponex/ Clozaril Health (Clozapine) Professional (Clozapine) Tablet PS ORAL UP TO Other 300MG/DAY, ORAL 22-Feb-2006 08:30 AM Page: 2263 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/27/03ISR Number: 4138182-1Report Type:Expedited (15-DaCompany Report #PHFR2003GB02416 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Foreign Clozaril (Clozapine) PS ORAL ORAL Body Temperature Study Increased Health Diarrhoea Professional Neutrophil Count Other Increased Tachycardia Vomiting White Blood Cell Count Increased Date:06/27/03ISR Number: 4138185-7Report Type:Expedited (15-DaCompany Report #PHFR2003GB01615 Age:60 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Pressure Foreign Clozaril (Clozapine) Other Fluctuation Study Unknown PS ORAL 300 MG/DAY, C-Reactive Protein Health ORAL Increased Professional Zopiclone C Circulatory Collapse Valproate Semisodium C Coma Thyroxine C Consciousness Fluctuating Venlafaxine C Cyanosis Hyoscine C Dysarthria Loss Of Consciousness Malaise Syncope Tachycardia Date:06/27/03ISR Number: 4138186-9Report Type:Expedited (15-DaCompany Report #PHNU2003DE02304 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aspartate Foreign Leponex/Clozaril Aminotransferase Health (Clozapine) PS ORAL UP Increased Professional TO400MG/DAY, Blood Alkaline Other ORAL Phosphatase Increased Maaloxan C Diarrhoea Eosinophilia Gamma-Glutamyltransferase Increased Hepatitis A Leukocytosis Pyrexia Date:06/27/03ISR Number: 4138215-2Report Type:Expedited (15-DaCompany Report #PHFR2003GB01563 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Foreign Clozaril (Clozapine) Study Unknown PS ORAL ORAL Health Haloperidol C Professional Other 22-Feb-2006 08:30 AM Page: 2264 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/27/03ISR Number: 4138305-4Report Type:Expedited (15-DaCompany Report #PHFR2003GB02369 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Withdrawal Syndrome Foreign Clozaril Hyperhidrosis Study (Clozapine)(Clozapin Hypotension Health e) Unknown PS ORAL ORAL Neuroleptic Malignant Professional Haloperidol C Syndrome Other Olanzapine C Tachycardia Lorazepam C Date:06/27/03ISR Number: 4138395-9Report Type:Expedited (15-DaCompany Report #PHFR2003GB02250 Age: Gender:Unknown I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Post Viral Fatigue Foreign Clozaril(Clozapine) Syndrome Health Unknown PS ORAL ORAL Professional Company Representative Other Date:06/27/03ISR Number: 4138397-2Report Type:Expedited (15-DaCompany Report #PHNU2003DE00918 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Triglycerides Foreign Leponex / Clozaril Initial or Prolonged Increased Health (Clozapine)(Clozapin Other C-Reactive Protein Professional e) Tablet PS ORAL UP TO 100 MG, Increased Other TID, ORAL Granulocytopenia Pleon Haematocrit Decreased Ra(Sulfasalazine) Haemoglobin Decreased Film-Coated Tablet SS ORAL ORAL Leukopenia Amaryl (Glimepiride) C Pneumonia Baldrian-Dispert Red Blood Cell Count (Valeriana Decreased Officinalis Root) C Date:06/27/03ISR Number: 4138401-1Report Type:Expedited (15-DaCompany Report #PHFR2003GB02388 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril(Clozapine) Non-Insulin-Dependent Study Unknown PS ORAL ORAL Health Professional Other Date:06/27/03ISR Number: 4138406-0Report Type:Expedited (15-DaCompany Report #PHFR2003IE01744 Age:23 YR Gender:Male I/FU:I Outcome PT Hospitalization - Abdominal Discomfort Initial or Prolonged Abdominal Pain Upper Disability Constipation Other Dyspepsia Gastric Ulcer Haemorrhage Haemoglobin Decreased 22-Feb-2006 08:30 AM Page: 2265 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Intestinal Obstruction Psychotic Disorder Upper Gastrointestinal Report Source Product Role Manufacturer Route Dose Duration Haemorrhage Foreign Clozaril(Clozapine) Vomiting Study Unknown PS ORAL SEE IMAGE Health Quetiapine Professional (Quetiapine) C Other Date:06/27/03ISR Number: 4138469-2Report Type:Expedited (15-DaCompany Report #PHFR2003GB02416 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Foreign Clozaril (Clozapine) Body Temperature Study Unknown PS ORAL ORAL Increased Health Diarrhoea Professional Neutrophil Count Other Increased Tachycardia Vomiting White Blood Cell Count Increased Date:06/27/03ISR Number: 4138480-1Report Type:Expedited (15-DaCompany Report #PHFR2003GB02065 Age:18 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bifascicular Block Foreign Clozaril (Clozapine) Electrocardiogram Change Study Unknown PS ORAL ORAL Sinus Tachycardia Health Olanzapine C Somnolence Professional Other Date:06/27/03ISR Number: 4138519-3Report Type:Expedited (15-DaCompany Report #PHFR2003IE01991 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Foreign Clozaril (Clozapine) Initial or Prolonged Sepsis Study Unknown PS ORAL ORAL Urinary Tract Infection Health White Blood Cell Count Professional Increased Other Date:06/27/03ISR Number: 4138556-9Report Type:Expedited (15-DaCompany Report #PHFR2003GB01804 Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Contusion Foreign Clozaril (Clozapine) PS ORAL 500MG/DAY, Convulsion Study ORAL Drug Level Increased Health Fall Professional Other 22-Feb-2006 08:30 AM Page: 2266 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/27/03ISR Number: 4138582-XReport Type:Expedited (15-DaCompany Report #PHNU2003DE02248 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abnormal Faeces Foreign Leponex/ Clozaril Other Body Temperature Health (Clozapine) Increased Professional (Clozapine) Tablet PS ORAL UP TO 400 C-Reactive Protein Other MG/DAY, ORAL Increased / SEE IMAGE Cardiac Failure Acute Trileptal Cholecystitis "Norvartis" Chromaturia Flm-Coated Tablet C Diarrhoea Tavor Tablet C Drug Level Above Haldol "Janssen" Therapeutic Tablet C Encopresis Akineton (Biperiden Enuresis Hydrochloide) C Faeces Pale Lipase Increased Pharyngitis Salivary Hypersecretion Shock Sudden Death Ultrasound Abdomen Abnormal Date:06/27/03ISR Number: 4138689-7Report Type:Expedited (15-DaCompany Report #GB8934519MAR2002 Age:21 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Foreign Efexor PS ORAL 150 MG 2X PER Initial or Prolonged Drug Level Above Health 1 DAY Therapeutic Professional Clozaril (Clozapine) SS ORAL 25-350 MG PER Fall Other DAY Grand Mal Convulsion Pirenzepine Loss Of Consciousness (Pirenzepine) C Muscle Twitching Date:06/27/03ISR Number: 4139216-0Report Type:Expedited (15-DaCompany Report #PHFR2003GB00599 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril Study (Clozapine)(Clozapin Health e) PS ORAL ORAL Professional Other Date:06/27/03ISR Number: 4139230-5Report Type:Expedited (15-DaCompany Report #PHFR2003GB02430 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozapine(Clozapine) Insulin-Dependent Health Unknown PS ORAL 425MG/DAY, Professional ORAL Other 22-Feb-2006 08:30 AM Page: 2267 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/27/03ISR Number: 4139232-9Report Type:Expedited (15-DaCompany Report #PHFR2002GB02082 Age:56 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bone Neoplasm Malignant Foreign Clozaril (Clozapine) Cervix Carcinoma Health Tablet PS ORAL 900MG/DAY, Epilepsy Professional ORAL Lung Neoplasm Malignant Other Doxycycline C Metastases To Bone Oramorph (Morphine Pain Sulfate) C Pleurisy Pneumonia Throat Cancer Date:06/27/03ISR Number: 4139234-2Report Type:Expedited (15-DaCompany Report #PHFR2003GB02217 Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatinine Foreign Clozaril (Clozapine) Increased Study Unknown PS ORAL ORAL Electrocardiogram T Wave Health Abnormal Professional Tachycardia Other Date:06/27/03ISR Number: 4139235-4Report Type:Expedited (15-DaCompany Report #PHBS2003BR06275 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Full Blood Count Abnormal Foreign Leponex(Clozapine) Health Tablet PS ORAL 25 MG, TID, Professional ORAL Other Date:06/27/03ISR Number: 4139240-8Report Type:Expedited (15-DaCompany Report #PHBS2003JP06417 Age:69 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Foreign Clozapine Initial or Prolonged Depressed Level Of Consumer (Clozapine) Tablet PS ORAL 100 MG, Consciousness Other ONCE/SINGLE, Drug Toxicity ORAL Medication Error Wypax (Lorazepam) SS ORAL 1 MG, Neutrophil Count ONCE/SINGLE, Decreased ORAL Somnolence Mucosolvan C Vomiting Grandaxin White Blood Cell Count (Tofisopam) C Decreased Depas (Etizolam) C Pariet (Rabeprazole Sodium) C Marzulene C Date:06/27/03ISR Number: 4139300-1Report Type:Expedited (15-DaCompany Report #PHFR2003GB02225 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Death Epilepsy Foreign Study 22-Feb-2006 08:30 AM Page: 2268 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Health Professional Other Product Role Manufacturer Route Dose Duration Clozaril (Clozapine) PS ORAL 450MG/DAY ORAL Amisulpride (Amisulpride) C Valproate Sodium C Hyoscine (Hyoscine) C Date:06/30/03ISR Number: 4139152-XReport Type:Expedited (15-DaCompany Report #03-06-0749 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Urosepsis Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 100-200MG QD ORAL Date:06/30/03ISR Number: 4139154-3Report Type:Expedited (15-DaCompany Report #03-06-0744 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 50-450MG QD ORAL Date:06/30/03ISR Number: 4139155-5Report Type:Expedited (15-DaCompany Report #03-06-0743 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Huntington'S Chorea Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 50-275MG QD ORAL Date:07/02/03ISR Number: 4140149-4Report Type:Direct Company Report #CTU 197149 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Clozapine 200mg Qid PS 200MG BID AND Required Fall 400MG HS Intervention to Limb Injury Geoden C Prevent Permanent Pharmaceutical Product Buspar C Impairment/Damage Complaint Eff Xr C 22-Feb-2006 08:30 AM Page: 2269 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/02/03ISR Number: 4141157-XReport Type:Expedited (15-DaCompany Report #PHNR2003AU00917 Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Disorder Foreign Clozaril Initial or Prolonged Cardiomyopathy Health (Clozapine)(Clozapin Other Electrocardiogram Qt Professional e) Tablet PS ORAL 450MG/DAY, Prolonged Other ORAL Syncope Chlorpromazine(Chlor promazine) SS Amisulpride (Amisulpride) C Date:07/02/03ISR Number: 4141200-8Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20030602919 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Loss Of Consciousness Foreign Risperdal Initial or Prolonged Multiple Drug Overdose Health (Risperidone) Sedation Professional Unspecified PS 84 MG, Vomiting Clozapine (Clozapine) Unspecified SS ORAL 9100 MG, ORAL Date:07/02/03ISR Number: 4141262-8Report Type:Expedited (15-DaCompany Report #PHEH2003US05103 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Trileptal Initial or Prolonged Difficulty In Walking Professional (Oxcarbazepine) PS Drooling Clozapine(Clozapine) SS Logorrhoea Mania Psychotic Disorder Date:07/02/03ISR Number: 4141469-XReport Type:Expedited (15-DaCompany Report #PHEH2003US03770 Age:53 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Inflammatory Carcinoma Of Health Clozaril (Clozapine) The Breast Professional Tablet PS ORAL 100 MG, BID; ORAL Date:07/02/03ISR Number: 4141651-1Report Type:Expedited (15-DaCompany Report #PHNU2003DE02248 Age:23 YR Gender:Male I/FU:F Outcome PT Death Abnormal Faeces Other Alanine Aminotransferase Increased Aspartate Aminotransferase Increased Blood Bilirubin Increased Body Temperature C-Reactive Protein Increased Cardiac Failure 22-Feb-2006 08:30 AM Page: 2270 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Cholecystitis Chromaturia Diarrhoea Report Source Product Role Manufacturer Route Dose Duration Drug Level Increased Foreign Clozapine Encopresis Health (Clozapine) PS ORAL UP TO 400 Enuresis Professional MG/DAY, ORAL Faeces Discoloured Other Trileptal Gamma-Glutamyltransferase Film-Coated Tablet C Novartis Increased Tavor Tablet C Lipase Increased Haldol "Janssen" Myocarditis Tablet C Pharyngolaryngeal Pain Akineton (Biperiden Salivary Hypersecretion Hydrochloride) C Shock Sudden Death Ultrasound Abdomen Abnormal Date:07/02/03ISR Number: 4141665-1Report Type:Expedited (15-DaCompany Report #2003027343 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Epilepsy Foreign Zoloft (Sertraline) PS ORAL 100 MG Hospitalization - Health (DAILY), ORAL Initial or Prolonged Professional Clozapine (Clozapine) SS ORAL 650 MG (DAILY), ORAL Levothyroxine Sodium (Levothyroxine Sodium) C Lorazepam (Lorazepam) C Date:07/02/03ISR Number: 4141724-3Report Type:Direct Company Report #CTU 197162 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Faecaloma Clozapine 100mg Initial or Prolonged Intestinal Obstruction Mylan PS Mylan 300MG QAM , 500MG HS Date:07/07/03ISR Number: 4142154-0Report Type:Expedited (15-DaCompany Report #DE-GLAXOSMITHKLINE-D0041254A Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Health Quilonum Retard PS Glaxosmithkline ORAL 9 DAY Initial or Prolonged Enuresis Professional Anafranil SS ORAL 44 DAY Fall Haldol SS ORAL 63 DAY Grand Mal Convulsion Taxilan SS ORAL 50MG per day 5 DAY Myoclonus Leponex SS ORAL 2 DAY Nervous System Disorder Akineton C UNKNOWN Tongue Biting 22-Feb-2006 08:30 AM Page: 2271 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/07/03ISR Number: 4142646-4Report Type:Expedited (15-DaCompany Report #C2003-1305.01 Age:54 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Appendicitis Perforated Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 600MG/DAY, Other ORAL Date:07/07/03ISR Number: 4144378-5Report Type:Expedited (15-DaCompany Report #03P-009-0222841-00 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diarrhoea Foreign Akineton (Biperiden) PS ORAL 4 MG, 1 IN 1 Initial or Prolonged Grand Mal Convulsion Health D, PER ORAL Professional Clozapine SS ORAL SEE IMAGE Haloperidol SS ORAL SEE IMAGE Cipralex SS ORAL SEE IMAGE Buspirone Hydrochloride C Metoprolol Tartrate C Enalapril Maleate C Simvastatin C Omeprazole C Date:07/07/03ISR Number: 4144729-1Report Type:Expedited (15-DaCompany Report #03P-062-0222823-00 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Grand Mal Convulsion Foreign Akineton Retard Initial or Prolonged Health (Akineton) Professional (Biperiden) (Biperiden) PS ORAL 4 MG, 1 IN 1 D, PER ORAL Clozapine SS ORAL SEE IMAGE Haloperidol SS INTRAVENOUS SEE IMAGE Citalopram Hydrobromide SS ORAL SEE IMAGE Diazepam C Date:07/08/03ISR Number: 4143131-6Report Type:Expedited (15-DaCompany Report #FR-BRISTOL-MYERS SQUIBB COMPANY-12311320 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abnormal Behaviour Health Buspar-10 Tabs PS Bristol-Myers Squibb Hospitalization - Coma Professional Company ORAL 25 MON Initial or Prolonged Drug Level Increased Prozac SS ORAL 25 MON Other Electroencephalogram Depakine SS ORAL 250mg qd Abnormal 05-Sep-02 to Petit Mal Epilepsy 07-Nov-02,the Sudden Death n 500mg qd 07-Nov-02 to Leponex SS ORAL 700mg daily from 01-Feb-01 to 08-Aug-02, then 600 mg 22-Feb-2006 08:30 AM Page: 2272 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/08/03ISR Number: 4143259-0Report Type:Direct Company Report #CTU 197426 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Level Increased Clozapine 100mg Initial or Prolonged Faecaloma (Mylan) PS Mylan ORAL 300MG PO Q AM Required ; 500MG PO HS 6 MON Intervention to Clonazepam C Prevent Permanent Topiramate C Impairment/Damage Rabeprazole C Docusate/Sennosides C Psyllium C Sorbitol C Oral Moisturizer C Date:07/08/03ISR Number: 4144053-7Report Type:Expedited (15-DaCompany Report #C2003-0385.01 Age:49 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Mylan ORAL 100MG Q AM, Professional 100MG Q HS Other ORAL Date:07/08/03ISR Number: 4144791-6Report Type:Expedited (15-DaCompany Report #PHBS2003CA05112 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Delusional Disorder, Foreign Clozaril(Clozapine) Unspecified Type Health Tablet PS ORAL 500 MG/D; 350 Dysphemia Professional MG/D; ORAL Other Risperdal C Seroquel (Quetiapine Fumarate) C Date:07/08/03ISR Number: 4144794-1Report Type:Expedited (15-DaCompany Report #PHNU2003DE01358 Age:38 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Foreign Leponex / Clozaril Electrocardiogram Qt Health (Clozapine)(Clozapin Corrected Interval Professional e) Tablet PS ORAL UP TO 175 Prolonged Other MG/DAY, ORAL Electroencephalogram Cipramil(Citalopram Abnormal Hydrobromide) Obsessive Thoughts Film-Coated Tablet SS ORAL 40MG/DAY, ORAL Beloc(Metoprolol Tartrate) Unknown SS Clomipramine (Clomipramine) C Date:07/08/03ISR Number: 4144804-1Report Type:Expedited (15-DaCompany Report #03-05-0640 Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets - Lung Cancer Metastatic Professional Ivax Metastases To Bone Other Pharmaceuticals, 22-Feb-2006 08:30 AM Page: 2273 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Inc. PS Ivax Pharmaceuticals, Inc. ORAL 100MG QD ORAL Date:07/08/03ISR Number: 4144806-5Report Type:Expedited (15-DaCompany Report #03-05-0643 Age:43 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Disease Progression Health Clozapine Tablets - Parkinson'S Disease Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 350MG QD ORAL Date:07/08/03ISR Number: 4144807-7Report Type:Expedited (15-DaCompany Report #PHFR2003GB01642 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril(Clozapine) Enuresis Study Unknown PS UNK, UNK, UNK Weight Decreased Other Venlafaxine (Venlafaxine) C Date:07/08/03ISR Number: 4144808-9Report Type:Expedited (15-DaCompany Report #03-02-0165 Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiomegaly Health Clozapine-Ivax Cardiomyopathy Professional Pharmaceuticals, Drug Interaction Inc. Tablets PS Ivax Pharmaceutical, Drug Toxicity Inc. ORAL 200MG AM ORAL 3 YR Focal Nodular Hyperplasia Paroxetine SS 40MG QD 3 YR Hepatomegaly Geodon C Pulmonary Congestion Haldol Decanoate C Cogentin C Clonazepam C Oramorph C Date:07/08/03ISR Number: 4144811-9Report Type:Expedited (15-DaCompany Report #03-06-0769 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bursitis Health Clozapine-Ivax Initial or Prolonged Cellulitis Professional Pharmaceuticals, Pleural Effusion Other Inc. Tablets PS Ivax Pharmaceutials, Inc ORAL 250MG BID ORAL Divalproex Sodium C Haloperidol C Decanoate C 22-Feb-2006 08:30 AM Page: 2274 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/08/03ISR Number: 4144813-2Report Type:Expedited (15-DaCompany Report #03-06-0757 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Health Clozapine -Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 300-900MG QD ORAL Date:07/08/03ISR Number: 4144823-5Report Type:Expedited (15-DaCompany Report #03-06-0697 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozapine Tablets - Professional Ivax Pharmaceuticals Other Inc. PS Ivax Pharmaceuticals Inc. ORAL 200-900MG QD ORAL Prandin C Lipitor C Synthroid C Lisinopril C Buspar C Depakote C Date:07/08/03ISR Number: 4144824-7Report Type:Expedited (15-DaCompany Report #03-06-0702 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 600MG HS ORAL Amantadione C Serzone C Topamax C Ambien C Depakote C Date:07/08/03ISR Number: 4144828-4Report Type:Expedited (15-DaCompany Report #03-06-0756 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neoplasm Malignant Health Clozapine -Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 325-550 MG QD ORAL 22-Feb-2006 08:30 AM Page: 2275 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/08/03ISR Number: 4144830-2Report Type:Expedited (15-DaCompany Report #03-06-0768 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Colitis Health Clozapine - Ivax Initial or Prolonged Professional Pharamceuticals, Other Inc. Tablets PS ORAL 400-700 QD ORAL Date:07/08/03ISR Number: 4144832-6Report Type:Expedited (15-DaCompany Report #03-06-0786 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neoplasm Malignant Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 300 MG QD ORAL Date:07/08/03ISR Number: 4144833-8Report Type:Expedited (15-DaCompany Report #03-06-0785 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hepatic Function Abnormal Health Clozapine - Ivax Hepatic Neoplasm Professional Pharmaceuticals, Malignant Other Inc. Tablets PS Ivax Hepatomegaly Pharmaceuticals, Inc. ORAL 300-400 MG QD ORAL Date:07/08/03ISR Number: 4144834-XReport Type:Expedited (15-DaCompany Report #03-06-0781 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Fluid Retention Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL ORAL Date:07/08/03ISR Number: 4144970-8Report Type:Expedited (15-DaCompany Report #PHFR2002GB03678 Age:35 YR Gender:Male I/FU:F Outcome PT Death Cardiac Arrest Other Circulatory Collapse Convulsion Drug Level Increased Dyspnoea Empyema Haemoglobin Decreased Lower Respiratory Tract Infection Malaise Neutrophilia Platelet Count Increased Pneumonia 22-Feb-2006 08:30 AM Page: 2276 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report White Blood Cell Count Increased Report Source Product Role Manufacturer Route Dose Duration Foreign Clozaril (Clozapine) Study (Clozapine) Tablet PS ORAL ORAL Health Chlorpromazine Professional (Chlorpromazine) C Other Date:07/08/03ISR Number: 4144976-9Report Type:Expedited (15-DaCompany Report #PHFR2003GB02066 Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Body Temperature Foreign Clozaril (Clozapine) PS ORAL 300MG/DAY, Initial or Prolonged Increased Study ORAL Other Constipation Health Risperidone C Dyskinesia Professional Chlorpromazine Dysuria Other (Chlorpromazine) C Fall Zopiclone C Fatigue Hallucination, Visual Loss Of Control Of Legs Malaise Myalgia Myocarditis Pollakiuria Proteinuria Restlessness Salivary Hypersecretion Sinus Tachycardia Speech Disorder Tremor Troponin T Increased Urinary Tract Infection Vision Blurred Date:07/08/03ISR Number: 4144978-2Report Type:Expedited (15-DaCompany Report #PHBS2003NO06418 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Foreign Leponex (Clozapine) PS 300 MG/D Balance Disorder Health Coordination Abnormal Professional Disease Progression Other Disturbance In Attention Dyskinesia Dysphagia Dystonia Fall Gait Disturbance Hypoaesthesia Hypotonia Mental Impairment Nervous System Disorder Speech Disorder 22-Feb-2006 08:30 AM Page: 2277 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/08/03ISR Number: 4145022-3Report Type:Expedited (15-DaCompany Report #PHNU2002DE00827 Age:64 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Gait Disturbance Foreign Leponex/Clozaril Initial or Prolonged Pleurothotonus Study (Clozapine) Tablet PS ORAL 75MG/DAY, Health ORAL; SEE Professional IMAGE Other Clozapine (Clozapine) Tablet SS ORAL 200 MG/DAY, ORAL Date:07/08/03ISR Number: 4145084-3Report Type:Expedited (15-DaCompany Report #PHFR2003GB02480 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dystonia Foreign Clozaril (Clozapine) Oculogyration Study Unknown PS ORAL ORAL Tardive Dyskinesia Health Amisulpride C Professional Fluoxetine C Other Procyclidine C Date:07/08/03ISR Number: 4145119-8Report Type:Expedited (15-DaCompany Report #PHFR2002GB04062 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Foreign Clozaril (Clozapine) Blood Amylase Increased Study Tablet PS ORAL 225MG/DAY, C-Reactive Protein Health ORAL Increased Professional Lorazepam C Cardiac Arrest Other Haloperidol C Cholelithiasis Citalopram Circulatory Collapse (Citalopram) C Eosinophilia Olanzapine C Gastritis Valproate Sodium C Haemothorax Sodium Amytal Hepatosplenomegaly (Amobarbital Sodium) C Malaise Dihydrocodeine Myocardial Fibrosis (Dihydrocodeine) C Myocarditis Vioxx C Pleural Effusion Pulmonary Congestion Pulmonary Oedema Date:07/08/03ISR Number: 4145122-8Report Type:Expedited (15-DaCompany Report #PHFR2003GB02558 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril (Clozapine) PS ORAL 350MG/DAY, Lower Respiratory Tract Study ORAL Infection Other Neutrophil Count Increased 22-Feb-2006 08:30 AM Page: 2278 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/08/03ISR Number: 4145123-XReport Type:Expedited (15-DaCompany Report #PHFR2003GB02514 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Pressure Increased Foreign Clozaril (Clozapine) PS ORAL 150MG/DAY, Medication Error Study ORAL Health Haloperidol C Professional Other Date:07/08/03ISR Number: 4145125-3Report Type:Expedited (15-DaCompany Report #PHNR2003AU01007 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Clozaril (Clozapine) Initial or Prolonged Obsessive-Compulsive Study (Clozapine) PS Disorder Health Psychiatric Symptom Professional Sleep Disorder Other Date:07/08/03ISR Number: 4145126-5Report Type:Expedited (15-DaCompany Report #PHFR2003GB02510 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Medication Error Foreign Clozaril (Clozapine) PS ORAL 2 DAYS OF Initial or Prolonged Study MEDICATION, Other Health ORAL Professional Other Date:07/08/03ISR Number: 4145127-7Report Type:Expedited (15-DaCompany Report #PHNR2003AU00995 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asthma Foreign Clozaril (Clozapine) Hyperhidrosis Study (Clozapine) Tablet PS ORAL 50 MG, QD, Influenza Like Illness Health ORAL Myocardial Infarction Professional Salbutamol C Myocarditis Other Salmeterol C Pyrexia Fluticasone (Fluticasone) C Risperidone C Valproate Sodium C Date:07/08/03ISR Number: 4145128-9Report Type:Expedited (15-DaCompany Report #PHFR2003GB02500 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram St Foreign Clozaril (Clozapine) PS ORAL ORAL Segment Elevation Study Heart Rate Increased Health Hypertension Professional Other 22-Feb-2006 08:30 AM Page: 2279 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/08/03ISR Number: 4145150-2Report Type:Expedited (15-DaCompany Report #S03-AUT-02739-01 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electroencephalogram Foreign Cipralex Initial or Prolonged Abnormal Health (Escitalopram) PS ORAL 10 MG QD PO Grand Mal Convulsion Professional Haldol "Janssen" Tongue Biting Other (Haloperidol) SS Janssen ORAL 20 MG QD PO Haldol "Janssen" (Haloperidol) SS Janssen ORAL 10 MG QD PO Biperiden (Biperiden) SS ORAL 4 MG QD PO Leponex "Novartis" (Clozapine) SS Novartis ORAL 100 MG QD PO Leponex "Novartis" (Clozapine) SS Novartis ORAL 250 MG QD PO Leponex "Novartis" (Clozapine) SS Novartis ORAL 400 MG QD PO Leponex "Novartis" (Clozapine) SS Novartis ORAL 500 MG QD PO Leponex "Novartis" (Clozapine) SS Novartis ORAL 400 MG QD PO Leponex "Novartis" (Clozapine) SS Novartis ORAL 300 MG QD PO Bespar (Buspirone Hydrochloride) C Seloken (Metoprolol Tartrate) C Mepril (Enalapril Maleate) C Losec (Omeprazole) C Tannalbin (Albumin Tannate) C Zocord (Simvastatin) C Date:07/08/03ISR Number: 4145166-6Report Type:Expedited (15-DaCompany Report #PHRM2003FR01829 Age:78 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anticholinergic Syndrome Foreign Leponex(Clozapine) Initial or Prolonged Coma Health Tablet PS ORAL 25 MG, QW, Disturbance In Attention Professional ORAL Other Date:07/08/03ISR Number: 4145170-8Report Type:Expedited (15-DaCompany Report #PHFR2003GB02521 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Nephritis Foreign Clozapine(Clozapine) Initial or Prolonged Pyrexia Health Unknown PS ORAL ORAL; 600 Renal Impairment Professional MG/DAY Renal Tubular Disorder Other Fluphenazine Decanoate (Fluphenazine Decanoate) C Clopixol (Decanoate) (Zuclopenthixol Decanoate) C 22-Feb-2006 08:30 AM Page: 2280 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/08/03ISR Number: 4145176-9Report Type:Expedited (15-DaCompany Report #PHFR2003GB02505 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Body Temperature Foreign Clozaril (Clozapine) PS ORAL ORAL Initial or Prolonged Increased Study Diabetes Mellitus Health Inadequate Control Professional Other Date:07/08/03ISR Number: 4145179-4Report Type:Expedited (15-DaCompany Report #PHFR2003GB02506 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alcoholism Foreign Clozaril (Clozapine) PS ORAL ORAL Initial or Prolonged Aspartate Study Alcohol C Other Aminotransferase Health Increased Professional Blood Bicarbonate Other Increased Blood Creatine Phosphokinase Increased Blood Creatinine Increased Blood Potassium Decreased Blood Sodium Decreased Blood Urea Increased Eosinophil Count Decreased Malaise Oral Intake Reduced Pco2 Increased Vomiting Date:07/08/03ISR Number: 4145195-2Report Type:Expedited (15-DaCompany Report #PHEH2003US05369 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) Hospitalization - Diabetes Mellitus Professional Tablet PS ORAL 600 MG, QHS, Initial or Prolonged Non-Insulin-Dependent ORAL Dyspepsia Benadryl "Parke Respiration Abnormal Davis" C Salivary Hypersecretion Peri-Colace (Casanthranol) C Date:07/08/03ISR Number: 4145255-6Report Type:Expedited (15-DaCompany Report #PHFR2002GB02978 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Toxicity Foreign Clozaril (Clozapine) Sudden Death Study (Clozapine) Tablet PS ORAL 325 MG, BID, Health ORAL Professional Ranitidine C Other Senna C 22-Feb-2006 08:30 AM Page: 2281 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/08/03ISR Number: 4145309-4Report Type:Expedited (15-DaCompany Report #PHFR2003GB02524 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aggression Foreign Clozaril(Clozapine) PS ORAL ORAL Other Convulsion Study Valproate Sodium C Dyspnoea Health Diazepam C Respiratory Arrest Professional Other Date:07/08/03ISR Number: 4145389-6Report Type:Expedited (15-DaCompany Report #PHEH2003US04863 Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozaril(Clozapine) Professional Tablet PS ORAL SEE IMAGE Company Celexa C Representative Cogentin (Benzatropine Mesilate) C Risperdal C Lithium (Lithium) C Date:07/09/03ISR Number: 4146918-9Report Type:Expedited (15-DaCompany Report #03P-083-0222915-00 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Foreign Depakin(Depakene) Initial or Prolonged Eyelid Oedema Health (Sodium Fluid Retention Professional Valproate/Valproic Swelling Acid) PS Clozapine SS ORAL 500 MG, 1 IN 1 D, ORAL Date:07/10/03ISR Number: 4144486-9Report Type:Expedited (15-DaCompany Report #DE-GLAXOSMITHKLINE-D0041363A Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bradyarrhythmia Health Quilonum PS Glaxosmithkline ORAL Hypothermia Professional Taxilan SS ORAL Loss Of Consciousness Godamed SS Glaxosmithkline ORAL Clozapine SS ORAL Akineton SS ORAL Pirenzepin SS ORAL Dominal Forte SS ORAL Lorazepam SS ORAL Chlorprothixen SS ORAL Rivotril SS ORAL Orfiril SS ORAL Zyprexa SS ORAL Topamax SS ORAL Seroquel SS ORAL 22-Feb-2006 08:30 AM Page: 2282 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/10/03ISR Number: 4146402-2Report Type:Expedited (15-DaCompany Report #2003023497 Age:43 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Insomnia Health Geodon (Ziprasidone) PS ORAL 40 MG (BID), Initial or Prolonged Irritability Professional ORAL Other Psychomotor Hyperactivity Clozapine Psychotic Disorder (Clozapine) SS ORAL 500 MG (BID), Schizophrenia, ORAL Disorganised Type Social Avoidant Behaviour Treatment Noncompliance Date:07/10/03ISR Number: 4147624-7Report Type:Expedited (15-DaCompany Report #PHRM2003FR01780 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other General Physical Health Foreign Leponex (Clozapine) Deterioration Health Tablet PS ORAL 600 MG DAILY, Hepatic Neoplasm Professional ORAL Other Date:07/11/03ISR Number: 4145257-XReport Type:Expedited (15-DaCompany Report #US-GLAXOSMITHKLINE-A0409042A Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiomegaly Paxil PS Glaxosmithkline ORAL 40MG Per day 3 YR Congestive Cardiomyopathy Clozapine SS ORAL 3 YR Drug Interaction Geodon C 80MG Twice Focal Nodular Hyperplasia per day 1 YR Overdose Haldol Decanoate C INTRAMUSCULAR 120MG Weekly 1 YR Cogentin C 1.5MG Twice per day 1 YR Clonazepam C 1MG Twice per day Clonazepam C 4MG At night Oramorph C Glaxosmithkline 30MG Twice per day Date:07/11/03ISR Number: 4145656-6Report Type:Expedited (15-DaCompany Report #C2003-1626.01 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pulmonary Embolism Health Clozapine Tablets Venous Thrombosis Professional 100 Mg Mylan PS Mylan ORAL 100 MG Q AM Other AND 200 MG Q HS, ORAL Date:07/11/03ISR Number: 4146226-6Report Type:Direct Company Report #CTU 197722 Age: Gender:Female I/FU:I Outcome Life-Threatening Hospitalization - Initial or Prolonged Required Intervention to Prevent Permanent 22-Feb-2006 08:30 AM Page: 2283 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Necrotising Colitis Clozaril PS ORAL 100MG AT 1600 ORAL, 400 MG AT HS ORAL Date:07/11/03ISR Number: 4149758-XReport Type:Expedited (15-DaCompany Report #C2003-1601.01 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 600 MG/DAY, Other ORAL Date:07/14/03ISR Number: 4147748-4Report Type:Expedited (15-DaCompany Report #03-07-0806 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Renal Failure Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 250-500MG QD ORAL Date:07/14/03ISR Number: 4147749-6Report Type:Expedited (15-DaCompany Report #03-06-0716 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Neoplasm Malignant Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 100MG; 200 MG AM ORAL Klonopin C Depakote C Date:07/14/03ISR Number: 4147751-4Report Type:Expedited (15-DaCompany Report #03-06-0784 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Clozapine Tablets - Congestive Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 400-700MG QD ORAL 22-Feb-2006 08:30 AM Page: 2284 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/14/03ISR Number: 4147752-6Report Type:Expedited (15-DaCompany Report #03-06-0798 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Health Clozapine Tablets - Initial or Prolonged Femur Fracture Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 400-525MG QD ORAL Date:07/14/03ISR Number: 4147753-8Report Type:Expedited (15-DaCompany Report #03-07-0789 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Myocardial Infarction Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 150-200MG QD ORAL Date:07/14/03ISR Number: 4147755-1Report Type:Expedited (15-DaCompany Report #03-07-0790 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dehydration Health Clozapine Tablets - Initial or Prolonged Diarrhoea Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL ORAL Date:07/14/03ISR Number: 4147758-7Report Type:Expedited (15-DaCompany Report #03-07-0791 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Lung Neoplasm Malignant Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 450MG QD ORAL Date:07/14/03ISR Number: 4147760-5Report Type:Expedited (15-DaCompany Report #03-07-0792 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Neoplasm Malignant Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 300MG QD ORAL 22-Feb-2006 08:30 AM Page: 2285 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/14/03ISR Number: 4147764-2Report Type:Expedited (15-DaCompany Report #03-07-0807 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL ORAL Date:07/14/03ISR Number: 4147766-6Report Type:Expedited (15-DaCompany Report #03-07-0808 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neoplasm Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 100-500MG QD ORAL Date:07/14/03ISR Number: 4147978-1Report Type:Expedited (15-DaCompany Report #PHEH2003US04747 Age:56 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coma Study Clozaril (Clozapine) Other Death Health Tablet PS ORAL ORAL Hypoglycaemia Professional Lower Respiratory Tract Infection Metabolic Encephalopathy Renal Failure Date:07/14/03ISR Number: 4148642-5Report Type:Expedited (15-DaCompany Report #PHHO2003CA04957 Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Glucose Increased Foreign Clozaril (Clozapine) PS Hospitalization - Diabetic Ketoacidosis Study Seroquel (Quetiapine Initial or Prolonged Neutropenia Health Fumarate) C Pancreatitis Professional Insulin (Insulin) C White Blood Cell Count Other Zantac C Robaxacet (Methocarbamol) C Tylenol C Date:07/14/03ISR Number: 4148796-0Report Type:Expedited (15-DaCompany Report #PHNU2003DE02382 Age:56 YR Gender:Female I/FU:I Outcome PT Hospitalization - Bite Initial or Prolonged Blood Pressure Increased Disorientation Drug Interaction Drug Level Increased Electroencephalogram 22-Feb-2006 08:30 AM Page: 2286 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Abnormal Enuresis Epilepsy Fall Report Source Product Role Manufacturer Route Dose Duration Grand Mal Convulsion Foreign Anafranil(Clomiprami Hypokinesia Study ne Hydrochloride) Myoclonus Health Sugar-Coated Tablet PS ORAL SEE IMAGE Professional Leponex / Clozaril Other (Clozapine) (Clozapine) Tablet SS ORAL SEE IMAGE Quilonum - Slow Release SS ORAL SEE IMAGE Haldol "Janssen" (Haloperidol) SS Janssen ORAL SEE IMAGE Taxilan(Perazine) SS ORAL 50 MG/DAY, ORAL Date:07/14/03ISR Number: 4148982-XReport Type:Expedited (15-DaCompany Report #PHBS2002AU07892 Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Feeling Abnormal Foreign Clozaril (Clozapine) Medication Error Study Tablet PS ORAL 150 MG/D; 150 Myocarditis Health TO 600 MG Staring Professional OVER THE 2 Other DAYS, ORAL Date:07/15/03ISR Number: 4147133-5Report Type:Expedited (15-DaCompany Report #WAES 0307USA01475 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Health Fosamax PS Merck & Co., Inc ORAL 566 DAY Initial or Prolonged Purpura Professional Clozapine SS ORAL 118 DAY Pyrexia Lipitor SS ORAL 292 DAY Red Blood Cell Haloperidol C INTRAMUSCULAR Sedimentation Rate Divalproex Sodium C Increased Benztropine Mesylate C Urinary Tract Infection Diphenhydramine Vasculitis Hydrochloride C Minerals (Unspecified) And Vitamins (Unspecified) C Calcium Citrate And Cholecalciferol C Date:07/15/03ISR Number: 4148172-0Report Type:Expedited (15-DaCompany Report #C2003-1627.01 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Health Clozapine Tbalets 25 Death Professional Mg Mylan PS Mylan ORAL 75 MG QID, Other ORAL Clozapine Tablets 100 Mg Mylan SS Mylan ORAL 100 MG, QID, ORAL Docusate Calcium C Fluphenazine C Gemfibrozil C 22-Feb-2006 08:30 AM Page: 2287 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Levothyroxine C Lithium C Oxybutynin C Date:07/15/03ISR Number: 4149117-XReport Type:Expedited (15-DaCompany Report #MK200307-0401-1 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Pressure Increased Foreign Anafranil 25mg Drug Level Decreased Capsules 100 PS 225MG Enuresis Leponex SS Epilepsy Quilonum Slow Fall Release SS Grand Mal Convulsion Haldol SS Muscle Contractions Taxilan SS Involuntary Nervous System Disorder Schizoaffective Disorder Tic Date:07/15/03ISR Number: 4149259-9Report Type:Expedited (15-DaCompany Report #PHFR2003IE1950 Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Lymphocyte Count Foreign Clozaril Decreased Health (Clozapine) PS ORAL 850 MG/DAY, Platelet Count Decreased Professional ORAL Tachycardia Other Citalopram (Citalopram) C Epilim Chrono C Date:07/15/03ISR Number: 4149283-6Report Type:Expedited (15-DaCompany Report #PHFR2002GB02978 Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Creatinine Foreign Clozaril (Clozapine) Increased Study (Clozapine) Tablet PS ORAL 325 MG, BID, Dehydration Health ORAL; 2.5 MG, Drug Toxicity Professional ORAL Intentional Overdose Other Ranitidine Renal Impairment (Ranitidine) C Sudden Death Senna C Suicide Attempt Date:07/15/03ISR Number: 4149285-XReport Type:Expedited (15-DaCompany Report #PHFR2003GB02641 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril (Clozapine) Non-Insulin-Dependent Study Unknown PS ORAL 175 MG/DAY, Health ORAL Professional Other 22-Feb-2006 08:30 AM Page: 2288 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/15/03ISR Number: 4149494-XReport Type:Expedited (15-DaCompany Report #US-JNJFOC-20030701758 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Glucose Increased Health Risperdal Bowel Sounds Abnormal Professional (Risperidone) Creatine Phosphokinase Unspecified PS ORAL 1 MG, 2 IN 1 Decreased DAY, ORAL Decreased Appetite Clozapine Difficulty In Walking (Clozapine) SS 100 MG, 3 IN Drug Interaction 1 DAY Drug Toxicity Benztropine Dysuria (Benztropeine) C Haematocrit Decreased Divalproex Haemoglobin Decreased (Valproate Lethargy Semisodium) C Pyelonephritis Lithium (Lithium) C Red Blood Cell Propranolol Sedimentation Rate (Propranolol) C Increased Levothyroxine Vomiting (Levothyroxine) C White Blood Cell Count Ferrous Sulfate (Ferrous Sulfate) C Multivitamins (Multivitamins) C Gemfibrozil (Gemfibrozil) C Pioglitazone (Pioglitazone) C Psyllium Powder (Psyllium) C Docusate/Casanthrano l (Peri-Colace) C Metformin (Metformin) C Date:07/15/03ISR Number: 4154071-0Report Type:Expedited (15-DaCompany Report #PHFR2003GB02353 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Activities Of Daily Foreign Clozaril (Clozapine) Initial or Prolonged Living Impaired Study Tablet PS ORAL 100 MG/DAY, Other Blood Pressure Increased Health ORAL Body Temperature Professional Increased Other Lethargy Malaise Neutrophil Count Increased Urinary Tract Infection Date:07/16/03ISR Number: 4150019-3Report Type:Expedited (15-DaCompany Report #PHFR2003GB00591 Age:14 YR Gender:Female I/FU:F Outcome PT Hospitalization - Chest Pain Initial or Prolonged Constipation Other Dehydration Dizziness Drug Level Increased 22-Feb-2006 08:30 AM Page: 2289 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Drug Withdrawal Syndrome Headache Nausea Report Source Product Role Manufacturer Route Dose Duration Norepinephrine Increased Foreign Clozaril(Clozapine) PS ORAL 350MG/DAY, Sinus Tachycardia Study ORAL Urine Output Decreased Health Vomiting Professional Other Date:07/16/03ISR Number: 4150022-3Report Type:Expedited (15-DaCompany Report #PHBS2000AU10829 Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Interaction Foreign Clozaril Haemorrhage Health (Clozapine)(Clozapin Professional e)Tablet PS ORAL 75 MG/D, ORAL Other Methadone(Methadone) SS 3 DAY Heroin (Diamorphine) C Olanzapine C Date:07/16/03ISR Number: 4150183-6Report Type:Expedited (15-DaCompany Report #PHFR2003GB02587 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram St Foreign Clozaril (Clozapine) PS ORAL 150MG/DAY, Segment Elevation Study ORAL Sinus Tachycardia Health Professional Other Date:07/16/03ISR Number: 4150262-3Report Type:Expedited (15-DaCompany Report #PHFR2003GB02588 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozaril(Clozapine) Inadequate Control Study Unknown PS ORAL ORAL Drug Ineffective Health Trimethoprim C Leukopenia Professional Localised Infection Other Neutropenia Osteomyelitis Staphylococcal Infection White Blood Cell Count Decreased Date:07/16/03ISR Number: 4150264-7Report Type:Expedited (15-DaCompany Report #PHFR2002GB03859 Age:57 YR Gender:Male I/FU:I Outcome PT Hospitalization - Abdominal Distension Initial or Prolonged C-Reactive Protein Other Increased Constipation Diarrhoea Drug Interaction Gastroenteritis Nausea 22-Feb-2006 08:30 AM Page: 2290 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Vomiting White Blood Cell Count Increased Report Source Product Role Manufacturer Route Dose Duration Foreign Clozaril Study (Clozapine)(Clozapin Health e) Tablet PS ORAL 600 MG/DAY, Professional ORAL. Other Venlafaxine(Venlafax ine) SS SEE IMAGE Clomipramine (Clomipramine) C Date:07/16/03ISR Number: 4150302-1Report Type:Expedited (15-DaCompany Report #PHFR2003IE02599 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dystonia Foreign Clozaril (Clozapine) PS ORAL 600 MG/DAY, Eye Rolling Study ORAL Tremor Health Professional Other Date:07/16/03ISR Number: 4150406-3Report Type:Expedited (15-DaCompany Report #PHNU2003DE02454 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cervix Cancer Metastatic Foreign Leponex / Clozaril Initial or Prolonged Pancytopenia Health (Clozapine)(Clozapin Other Professional e) Tablet PS ORAL UP TO 250 Other MG/DAY, ORAL Cisplatin(Cisplatin) Solution For Infusion SS INFUSION Rapiotherapy(No Ingredients/Substanc es) SS Date:07/16/03ISR Number: 4150447-6Report Type:Expedited (15-DaCompany Report #PHFR2003GB02416 Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Foreign Clozaril(Clozapine)T Diarrhoea Study ablet PS ORAL ORAL Neutrophil Count Health Increased Professional Pyrexia Other Tachycardia Vomiting White Blood Cell Count Increased Date:07/16/03ISR Number: 4150459-2Report Type:Expedited (15-DaCompany Report #PHBS2003JP06417 Age:69 YR Gender:Female I/FU:F Outcome PT Hospitalization - Confusional State Initial or Prolonged Depressed Level Of 22-Feb-2006 08:30 AM Page: 2291 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Consciousness Drug Toxicity Leukopenia Medication Error Report Source Product Role Manufacturer Route Dose Duration Neutropenia Foreign Clozapine Vomiting Consumer (Clozapine) Tablet PS ORAL 100 MG, Other ONCE/SINGLE, ORAL Wypax (Lorazepam) SS ORAL 1 MG, ONCE/SINGLE, ORAL Mucosolvan C Grandaxin (Tofisopam) C Depas (Etizolam) C Pariet (Rabeprazole Sodium) C Marzulene C Date:07/16/03ISR Number: 4150752-3Report Type:Expedited (15-DaCompany Report #PHEH2003US05178 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Brain Neoplasm Health Clozaril (Clozapine) Leukopenia Professional Tablet PS ORAL ORAL 3650 DAY Date:07/16/03ISR Number: 4150759-6Report Type:Expedited (15-DaCompany Report #PHEH2003US03727 Age:42 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tuberculin Test Positive Health Clozaril (Clozapine) Professional Tablet PS ORAL 275 MG, ORAL Valproic Acid C Sertraline (Sertraline) C Bupropion (Bupropion) C Date:07/16/03ISR Number: 4150772-9Report Type:Expedited (15-DaCompany Report #PHNU2003DE02408 Age:37 YR Gender:Male I/FU:I Outcome PT Hospitalization - Alanine Aminotransferase Initial or Prolonged Increased Other Alpha Globulin Increased Asthenia Blood Albumin Decreased Blood Alkaline Phosphatase Increased Blood Lactate Dehydrogenase Increased C-Reactive Protein Increased Chest Pain Dyspnoea Echocardiogram Abnormal Electrocardiogram Ambulatory Abnormal Electrocardiogram T Wave 22-Feb-2006 08:30 AM Page: 2292 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Inversion Fibrin D Dimer Increased Gamma-Glutamyltransferase Increased Report Source Product Role Manufacturer Route Dose Duration Gastroenteritis Foreign Leponex / Clozaril Haematocrit Decreased Health (Clozapine) Haemoglobin Decreased Professional (Clozapine) Tablet PS ORAL 100MG/DAY, High Density Lipoprotein Other ORAL Decreased Low Density Lipoprotein Decreased Myocarditis Pericardial Effusion Pericarditis Platelet Count Increased Pyrexia Red Blood Cell Sedimentation Rate Increased Tachycardia Viral Infection White Blood Cell Count Increased White Blood Cell Disorder Date:07/16/03ISR Number: 4150823-1Report Type:Expedited (15-DaCompany Report #PHNR2003AU00939 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Level Increased Foreign Clozaril Drug Toxicity Study (Clozapine) PS 300-650 Health MG/DAY Professional Luvox (Fluvoxamine Other Maleate) SS 150 MG, QD Lithium C Date:07/16/03ISR Number: 4150979-0Report Type:Expedited (15-DaCompany Report #PHNR2003AU01027 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Appendicitis Foreign Clozaril (Clozapine) PS ORAL 600 MG, QD, Liver Function Test Health ORAL Abnormal Professional Paroxetine C Pancreatitis Other Date:07/16/03ISR Number: 4150981-9Report Type:Expedited (15-DaCompany Report #PHFR2003IE02073 Age:41 YR Gender:Male I/FU:I Outcome PT Life-Threatening Agitation Hospitalization - Cardiomyopathy Initial or Prolonged Convulsion Other Depressed Level Of Consciousness Diabetes Mellitus Disorientation Hepatic Failure Hyperhidrosis Hyperpyrexia 22-Feb-2006 08:30 AM Page: 2293 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hypotension Incontinence Myocarditis Report Source Product Role Manufacturer Route Dose Duration Renal Failure Foreign Clozaril (Clozapine) PS ORAL 300 MG/DAY, Tachycardia Study ORAL Health Valproate Sodium C Professional Clonazepam C Other Kwells Tablet C Date:07/16/03ISR Number: 4151016-4Report Type:Expedited (15-DaCompany Report #PHBS2003F107021 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Interaction Foreign Clozapine Gastroenteritis Health (Clozapine) PS Professional Loperamide Other (Loperamide) SS Date:07/16/03ISR Number: 4151017-6Report Type:Expedited (15-DaCompany Report #PHBS2003F107020 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Asthenia Foreign Leponex(Clozapine) Hospitalization - Atrial Fibrillation Health Tablet PS ORAL ORAL Initial or Prolonged Blood Glucose Increased Professional Biso-Puren Confusional State Other (Bisoprolol Diabetic Hyperosmolar Furmarate) C Coma Adalat C Disorientation Diurex Tablet C Escherichia Sepsis Fatigue Hypotonia Leukocytosis Polydipsia Polyuria Restlessness Tachycardia Urosepsis Date:07/16/03ISR Number: 4151018-8Report Type:Expedited (15-DaCompany Report #PHNU2003DE02473 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - C-Reactive Protein Foreign Leponex / Clozaril Initial or Prolonged Increased Health (Clozapine)(Clozapin Other Diarrhoea Professional e) Tablet PS ORAL 300 MG/DAY, Disturbance In Attention Other ORAL Drug Withdrawal Syndrome Orfiril "Desitin" C Musculoskeletal Stiffness Tavor C Parkinsonism Pyrexia Restlessness Speech Disorder 22-Feb-2006 08:30 AM Page: 2294 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/16/03ISR Number: 4151032-2Report Type:Expedited (15-DaCompany Report #PHFR2003GB02510 Age:44 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Foreign Clozaril(Clozapine) Initial or Prolonged Somnolence Study Tablet PS ORAL 2 DAYS OF Health MEDICATION, Professional ORAL Other Amisulpride (Amisulpride) C Propranolol C Date:07/17/03ISR Number: 4151215-1Report Type:Expedited (15-DaCompany Report #03P-062-0223625-00 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradyarrhythmia Foreign Akineton(Biperiden) Initial or Prolonged Hypothermia Health (Biperiden) PS ORAL PER ORAL Loss Of Consciousness Professional Perazine SS ORAL PER ORAL Poisoning Godamed SS ORAL PER ORAL Clozapine SS ORAL PER ORAL Pirenzepine SS ORAL PER ORAL Prothipendyl Hydrochloride SS ORAL PER ORAL Lorazepam SS ORAL PER ORAL Chlorprothixene SS ORAL PER ORAL Clonazepam SS ORAL PER ORAL Orfiril SS ORAL PER ORAL Olanzapine SS ORAL PER ORAL Topiramate SS ORAL PER ORAL Quetiapine SS ORAL PER ORAL Lithium Carbonate SS ORAL PER ORAL Date:07/17/03ISR Number: 4151278-3Report Type:Expedited (15-DaCompany Report #200301950 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Interaction Foreign Imodium Rx Food Poisoning Health Capsules(Loperamide Professional Hcl 2 Mg Per Other Capsule) 2 Mg/Capsule PS Clozapine SS ORAL PO Date:07/18/03ISR Number: 4152302-4Report Type:Expedited (15-DaCompany Report #PHHO2003CA08566 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Drug Interaction Foreign Clozaril (Clozapine) PS ORAL ORAL Hospitalization - Gastrointestinal Study Paxil (Paroxetine Initial or Prolonged Infection Health Hydrochloride) SS Intestinal Obstruction Professional Other 22-Feb-2006 08:30 AM Page: 2295 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/18/03ISR Number: 4152624-7Report Type:Expedited (15-DaCompany Report #2003029635 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Health Lipitor Initial or Prolonged Cutaneous Vasculitis Professional (Atorvastatin) PS ORAL 10 MG Neutrophil Count (DAILY), ORAL Decreased Clozapine Palpable Purpura (Clozapine) SS ORAL 100 MG Pyrexia (DAILY), ORAL Red Blood Cell Alendronate Sodium Sedimentation Rate (Alendronate Sodium) SS ORAL 35 MG Increased (WEEKLY), Urinary Tract Infection ORAL Haloperidol (Haloperidol) C Valproate Semisodium (Valproate Semisodium) C Benzatropine Mesilate (Benzatropine Mesilate) C Diphenhydramine (Diphenhydramine) C Multivitamins W/Minerals (Vitamins Nos, Minerals Nos) C Calcium Citrate (Calcium Citrate) C Ergocalciferol (Ergocalciferol) C Date:07/18/03ISR Number: 4152637-5Report Type:Expedited (15-DaCompany Report #PHEH2003US05717 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Dysarthria Health Clozaril (Clozapine) Hospitalization - Dyspnoea Professional Tablet PS ORAL 300 MG, QHS, Initial or Prolonged Hypoxia ORAL Leukocytoclastic Depakote (Valproate Vasculitis Semisodium) C Pericardial Effusion Pericardial Excision Pericarditis Rash Maculo-Papular Tachycardia Tachypnoea Date:07/21/03ISR Number: 4151793-2Report Type:Expedited (15-DaCompany Report #03-07-0810 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Aspiration Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 25-300MG QD ORAL 22-Feb-2006 08:30 AM Page: 2296 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/21/03ISR Number: 4151794-4Report Type:Expedited (15-DaCompany Report #03-05-0617 Age:56 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hip Fracture Health Clozapine - Tablets Initial or Prolonged Osteomyelitis Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 500-700MG QD ORAL Date:07/21/03ISR Number: 4151840-8Report Type:Expedited (15-DaCompany Report #03-07-0843 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Health Clozapine PS Ivax Non-Insulin-Dependent Professional Pharmaceuticals, Dry Mouth Inc. Fungal Skin Infection Blinded Study, Clozapine Or Placebo Unknown SS Triamcinolone C Aquaphor C Ativan C Toprol Xl C Depakote C Cogentin C Date:07/21/03ISR Number: 4151844-5Report Type:Expedited (15-DaCompany Report #03-07-0812 Age:66 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Health Clozapine PS Ivax Initial or Prolonged Upper Gastrointestinal Professional Pharmaceuticals, Haemorrhage Other Inc. ORAL 150-500MG QD ORAL Date:07/21/03ISR Number: 4152818-0Report Type:Expedited (15-DaCompany Report #PHRM2003FR01330 Age:46 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - B-Cell Lymphoma Foreign Leponex Initial or Prolonged Leukocytosis Health (Clonzapine) PS ORAL 400 MG/DAY, Lymphocytosis Professional ORAL Other Risperdal (Risperidone) SS ORAL 12 MG/DAY, ORAL Parkinaine (Trihexyphenidyl Hydrochloride) Slow Release C Valium Tablet C Lipanthyl (Fenofibrate) C Fournier 22-Feb-2006 08:30 AM Page: 2297 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/21/03ISR Number: 4152819-2Report Type:Expedited (15-DaCompany Report #PHBS2003IN07172 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Foreign Clozaril (Clozapine) PS ORAL 25 MG, TID, Health ORAL Professional Chlorpromazine Other (Chlorpromazine) C Date:07/21/03ISR Number: 4152858-1Report Type:Expedited (15-DaCompany Report #PHFR2003GB01758 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Arthralgia Foreign Clozaril(Clozapine) Arthritis Study Unknown PS ORAL 800 MG/DAY, Diabetes Mellitus Health ORAL Influenza Like Illness Professional Sulpiride(Sulpiride) SS ORAL 1200MG/DAY, Weight Decreased Other ORAL Metformin C Glipizide (Glipizide) C Hyoscine (Hyoscine) C Date:07/21/03ISR Number: 4152886-6Report Type:Expedited (15-DaCompany Report #PHFR2003GB02731 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Grandiosity Foreign Clozaril (Clozapine) PS ORAL ORAL Health Professional Other Date:07/21/03ISR Number: 4152938-0Report Type:Expedited (15-DaCompany Report #PHFR2003GB02728 Age:36 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Facial Palsy Foreign Clozaril(Clozapine) Health Tablet PS ORAL SEE IMAGE Professional Venlafaxine(Venlafax Other ine) SS ORAL 75 MG/DAY, ORAL Lithium(Lithium) SS ORAL 1200 MG/DAY, ORAL Date:07/21/03ISR Number: 4153060-XReport Type:Expedited (15-DaCompany Report #PHEH2003US05923 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drowning Health Clozaril (Cloazpine) Professional Tablet PS ORAL ORAL 244 DAY Klonopin C Remeron (Mirtazapine) C Prozac (Fluoxetine Hydrochloride) C Detrol (Tolterodine L-Tartrate) C 22-Feb-2006 08:30 AM Page: 2298 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/21/03ISR Number: 4153298-1Report Type:Expedited (15-DaCompany Report #PHNU2003DE02614 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bifascicular Block Foreign Leponex / Clozaril Bundle Branch Block Left Health (Clozapine) Bundle Branch Block Right Professional (Clozapine) Tablet PS ORAL 100 MG/DAY, Electrocardiogram Other ORAL Abnormal Pyrexia Sedation Sinus Tachycardia Date:07/21/03ISR Number: 4153303-2Report Type:Expedited (15-DaCompany Report #PHNU2003DE02644 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Leponex / Clozaril Initial or Prolonged Increased Health (Clozapine) Other Aspartate Professional (Clozapine) Tablet PS ORAL UP TO 150 Aminotransferase Other MG/DAY, ORAL Increased Cholecystitis Leukocytosis Pyrexia Date:07/22/03ISR Number: 4151231-XReport Type:Expedited (15-DaCompany Report #PHEH2003US05759 Age:35 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asthma Clozaril PS Novartis Sector: Respiratory Failure Pharma ORAL 225 mg, QD 3650 DAY White Blood Cell Count Seroquel C Increased Detrol C Rhinocort C Zyrtek C Prevacid C Albuterol C Serevent C Flovent C Date:07/22/03ISR Number: 4153819-9Report Type:Expedited (15-DaCompany Report #PHFR2003GB02689 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dysphemia Foreign Clozaril (Clozapine) PS ORAL ORAL Menorrhagia Study Salivary Hypersecretion Health Weight Increased Professional Other Date:07/22/03ISR Number: 4153826-6Report Type:Expedited (15-DaCompany Report #PHFR2003GB02687 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Other Diabetes Mellitus Foreign Study Health 22-Feb-2006 08:30 AM Page: 2299 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Other Product Role Manufacturer Route Dose Duration Clozaril(Clozapine) Tablet PS ORAL ORAL Date:07/22/03ISR Number: 4154068-0Report Type:Expedited (15-DaCompany Report #PHNU2002DE04220 Age:61 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Arrhythmia Foreign Leponex / Clozaril Hospitalization - Atrial Fibrillation Health (Clozapine) Initial or Prolonged Blood Glucose Increased Professional (Clozapine) Tablet PS ORAL SEE IMAGE Other Cardiomegaly Other Elcrit (Clozapine) SS ORAL 25 TO 100 Constipation MG/DAY, ORAL Coordination Abnormal Atosil Dehydration (Isopromethazine Dialysis Hydrochloride) C Dysphagia Beloc-Zoc Mite Eyelid Ptosis (Metoprolol Fall Succinate) C General Physical Health Acetylsalicylic Acid C Deterioration Plavix (Clopidogrel Neuroleptic Malignant Sulfate) C Syndrome Digimerck C Pneumonia Solian (Amisulpride) C Pulmonary Oedema Renal Failure Acute Rhabdomyolysis Skin Discolouration Tachycardia Thirst Date:07/22/03ISR Number: 4154073-4Report Type:Expedited (15-DaCompany Report #PHFR2003GB02133 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Constipation Foreign Clozaril (Clozapine) Initial or Prolonged Haemoglobin Decreased Study Tablet PS ORAL ORAL Megacolon Health Iron C Professional Other Date:07/22/03ISR Number: 4154075-8Report Type:Expedited (15-DaCompany Report #PHFR2003GB02295 Age:49 YR Gender:Female I/FU:I Outcome PT Other Anorexia Blood Alkaline Phosphatase Increased Blood Sodium Decreased Dehydration Fluid Intake Reduced Malaise Oral Intake Reduced Renal Failure Acute Tri-Iodothyronine Decreased 22-Feb-2006 08:30 AM Page: 2300 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Urinary Tract Infection Report Source Product Role Manufacturer Route Dose Duration Foreign Clozaril (Clozapine) Study (Clozapine) PS ORAL 800 MG/DAY, Health ORAL Professional Haloperidol C Other Lansoprazole (Lansoprazole) C Procyclidine (Procyclidine) C Efamast (Evening Primrose Oil) C Sertraline (Sertraline) C Trisilate (Choline Salicylate) C Date:07/22/03ISR Number: 4154601-9Report Type:Expedited (15-DaCompany Report #PHEH2003US05948 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Breast Cancer Health Clozaril (Clozapine) Cardiac Arrest Professional Tablet PS ORAL 700 MG, QD, Uterine Cancer ORAL Megace (Megestrol Acetate) C Dilantin C Zyrtec-D C Colace C Miralax (Macrogol) C Date:07/22/03ISR Number: 4154609-3Report Type:Expedited (15-DaCompany Report #PHEH2003US05932 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Uterine Leiomyoma Consumer Clozaril(Clozapine) Weight Increased Tablet PS ORAL ORAL Date:07/22/03ISR Number: 4154610-XReport Type:Expedited (15-DaCompany Report #PHEH2003US05759 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asthma Other Clozaril(Clozapine) Respiratory Failure Tablet PS ORAL 225 MG/DAY, ORAL Seroquel (Quetiapine Fumarate) C Detrol (Tolterodine L-Tartrate) C Rhinocort C Zyrtek (Cetirizine Hydrochloride) C Prevacid (Lansoprazole) C Albuterol C Serevent (Salmeterol Xinafoate) C 22-Feb-2006 08:30 AM Page: 2301 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Flovent C Date:07/23/03ISR Number: 4152375-9Report Type:Expedited (15-DaCompany Report #PHFR2003GB02258 Age:42 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Clozaril PS Novartis Sector: Initial or Prolonged Circulatory Collapse Pharma ORAL 602 DAY Other Coma Clozaril SS Novartis Sector: Constipation Pharma ORAL 300 mg/day Dissociation Drug Withdrawal Syndrome Energy Increased Furuncle Hypomania Loss Of Consciousness Medication Error Restlessness Sedation Weight Increased Date:07/23/03ISR Number: 4152429-7Report Type:Expedited (15-DaCompany Report #PHRM2003FR01584 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eosinophil Count Leponex PS Novartis Sector: Decreased Pharma ORAL 350mg/day Lymphocyte Count Daflon C ORAL 2g/day Decreased Lysanxia C ORAL 20mg/day Date:07/23/03ISR Number: 4152513-8Report Type:Expedited (15-DaCompany Report #PHRM2003FR01639 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chronic Lymphocytic Leponex PS Novartis Sector: Leukaemia Pharma ORAL 250 mg/day Lymphocyte Count Xanax C .5 mg, TID Increased Anafranil C ORAL 75 mg, BID Zoloft C ORAL 50 mg, BID Efexor C ORAL 50 mg, TID Date:07/23/03ISR Number: 4152631-4Report Type:Expedited (15-DaCompany Report #PHBS2000AU10829 Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Interaction Clozaril (Clozapine) PS Novartis Sector: Haemorrhage Pharma ORAL 75 mg/d 21600MIN Methadone SS 4320 MIN Heroin C INTRAVENOUS Olanzapine C 10mg/day 22-Feb-2006 08:30 AM Page: 2302 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/23/03ISR Number: 4154112-0Report Type:Expedited (15-DaCompany Report #PHBS2003F107021 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Interaction Foreign Clozapine(Clozapine) PS Gastroenteritis Health Loperamide Megacolon Professional (Loperamide) SS Other Date:07/23/03ISR Number: 4154119-3Report Type:Expedited (15-DaCompany Report #PHNR2003AU00915 Age:70 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Electrocardiogram St-T Foreign Clozaril (Clozapine) Change Study (Clozapine) Tablet PS ORAL 250 MG, QD, Fall Health ORAL Sinus Tachycardia Professional Diamicron C Other Zocor "Merck" C Merck Orudis C Astrix C Muralex (Oxazepam) C Zoloft(Sertraline Hydrochloride) C Anginine C Amlodipine C Date:07/23/03ISR Number: 4155212-1Report Type:Expedited (15-DaCompany Report #C2003-1733.01 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Treatment Noncompliance Other Clozapine Tablets 100 Mg Mylan PS Mylan ORAL 100MG BID, ORAL Gabapentin C Valproic Acid C Date:07/23/03ISR Number: 4155745-8Report Type:Expedited (15-DaCompany Report #2003029613 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypothermia Health Geodon (Ziprasidone) PS Initial or Prolonged Laboratory Test Abnormal Professional Clozapine Renal Failure Company (Clozapine) SS Unevaluable Event Representative All Other Therapeutic Products SS Date:07/24/03ISR Number: 4153374-3Report Type:Expedited (15-DaCompany Report #PHHO2003CA07100 Age:70 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Clozaril PS Novartis Sector: Life-Threatening Pneumonia Aspiration Pharma Hospitalization - Haloperidol SS 15 mg, QD Initial or Prolonged 22-Feb-2006 08:30 AM Page: 2303 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/24/03ISR Number: 4153383-4Report Type:Expedited (15-DaCompany Report #PHEH2003US06198 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hepatic Cancer Metastatic Clozaril PS Novartis Sector: Lung Cancer Metastatic Pharma ORAL UNK, UNK Date:07/24/03ISR Number: 4153385-8Report Type:Expedited (15-DaCompany Report #PHRM2003FR01780 Age:62 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Colon Neoplasm Leponex PS Novartis Sector: General Physical Health Pharma ORAL 600 mg daily Deterioration Hepatic Neoplasm Subileus Date:07/24/03ISR Number: 4153388-3Report Type:Expedited (15-DaCompany Report #PHEH2003US05932 Age:37 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Uterine Leiomyoma Clozaril PS Novartis Sector: Weight Increased Pharma ORAL UNK, UNK Date:07/24/03ISR Number: 4153410-4Report Type:Expedited (15-DaCompany Report #PHFR2003GB01995 Age:31 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Distension Clozaril PS Novartis Sector: Initial or Prolonged Constipation Pharma ORAL 300mg/day Dyspnoea Temazepam C ORAL 10mg/day Joint Swelling Lithium C ORAL 1000mg/day Venlafaxine C ORAL 150mg/day Depakote C ORAL 1500mg/day Date:07/24/03ISR Number: 4153411-6Report Type:Expedited (15-DaCompany Report #PHFR2003GB02661 Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chest Pain Clozaril PS Novartis Sector: Dyspnoea Pharma ORAL 400mg/day Haemoptysis Date:07/24/03ISR Number: 4153415-3Report Type:Expedited (15-DaCompany Report #PHFR2003GB02813 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Clozaril PS Novartis Sector: Pharma ORAL 300mg/day Date:07/24/03ISR Number: 4153488-8Report Type:Expedited (15-DaCompany Report #C2003-1687.01 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Other Clozapine Tablets 100 Mg Mylan PS Mylan ORAL 100MG QAM, 22-Feb-2006 08:30 AM Page: 2304 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report 300MG QPM Date:07/24/03ISR Number: 4156609-6Report Type:Expedited (15-DaCompany Report #2003029979 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Haematocrit Decreased Health Navane (Capsules) Initial or Prolonged Haemoglobin Decreased Professional (Thiothixene) PS Other Lymphocyte Count Clozapine Decreased (Clozapine) SS Myoglobin Blood Increased Gabapentin Priapism (Gabapentin) C Red Blood Cell Count Famotidine Decreased (Famotidine) C Benzatropine Mesilate (Benzatropine Mesilate) C Endal (Phenylephrine Hydrochloride, Guaifenesin) C Date:07/24/03ISR Number: 4156618-7Report Type:Expedited (15-DaCompany Report #PHFR2003GB02234 Age:27 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Clozaril(Clozapine) PS ORAL 225MG/DAY, Urinary Tract Infection Study ORAL White Blood Cell Count Health Topiramate Abnormal Professional (Topiramate) C Other Valproate Sodium C Date:07/24/03ISR Number: 4156624-2Report Type:Expedited (15-DaCompany Report #PHFR2003GB02278 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Foreign Clozaril(Clozapine) PS ORAL 400MG/DAY, Initial or Prolonged Inadequate Control Study ORAL Liver Function Test Health Gaviscon Advance C Abnormal Professional Temazepam C Vomiting Other Dihydrocodeine Weight Increased (Dihydrocodeine) C Lansoprazole (Lansoprazole) C Creon "Duphar" C Insulin (Insulin) C Humulin (Insulin Isophane, Human Biosynthetic, Insulin Human) C Thyroxine C Movicol (Macrogol) C Lactulose C Senna C Hyoscine Hydrobromide C Procyclidine (Procyclidine) C Sertraline 22-Feb-2006 08:30 AM Page: 2305 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Sertraline) C Salbutamol C Date:07/24/03ISR Number: 4156627-8Report Type:Expedited (15-DaCompany Report #PHNR2003AU01060 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Foreign Clozaril Initial or Prolonged Convulsion Study (Clozapine)(Clozapin Drug Interaction Health e) PS 300MG, MANE, Drug Level Increased Professional 600MG NOCTE Extrapyramidal Disorder Other Luvox(Fluvoxamine Incontinence Maleate) SS 100MG MAN Somnolence Largactil Tremor (Chlorpromazine Hydrochoride) SS 300MG BID Epilim C Lithium (Lithium) C Date:07/24/03ISR Number: 4156640-0Report Type:Expedited (15-DaCompany Report #PHFR2002GB02978 Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Creatinine Foreign Clozaril (Clozapine) Increased Study (Clozapine) Tablet PS ORAL 325 MG, BID, Completed Suicide Health ORAL; 2.5G, Dehydration Professional ORAL Drug Toxicity Other Ranitidine Intentional Overdose (Ranitidine) C Renal Impairment Senna C Sudden Death Date:07/25/03ISR Number: 4153859-XReport Type:Expedited (15-DaCompany Report #PHEH2003US06130 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Clozaril PS Novartis Sector: Initial or Prolonged Appendicectomy Pharma ORAL 600 mg, QHS 4649 DAY Bowel Sounds Abnormal Pyrexia Date:07/25/03ISR Number: 4153868-0Report Type:Expedited (15-DaCompany Report #PHFR2003GB02630 Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyspnoea Clozaril PS Novartis Sector: Joint Swelling Pharma ORAL 600mg/day Tachycardia Clozaril SS Novartis Sector: Pharma ORAL 400mg/day Atorvastatin C ORAL 10mg/day Date:07/25/03ISR Number: 4153871-0Report Type:Expedited (15-DaCompany Report #PHFR2002GB03083 Age:30 YR Gender:Male I/FU:F Outcome PT Disability Colitis Other Diarrhoea 22-Feb-2006 08:30 AM Page: 2306 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dyspepsia Eosinophilia Globulins Increased Report Source Product Role Manufacturer Route Dose Duration Nausea Clozaril (Clozapine) PS Novartis Sector: Pyrexia Pharma ORAL 300mg/day Vomiting Clonazepam C ORAL 1 mg, BID Cyclizine C 50 mg, QD Date:07/25/03ISR Number: 4153880-1Report Type:Expedited (15-DaCompany Report #PHFR2003GB02451 Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dystonia Clozaril PS Novartis Sector: Tardive Dyskinesia Pharma ORAL reduced to Tic 300mg/day Clozaril SS Novartis Sector: Pharma Clonazepam C ORAL 1 mg, BID Cyclizine C ORAL 50 mg, QD Date:07/25/03ISR Number: 4156883-6Report Type:Expedited (15-DaCompany Report #PHBS2002AU11866 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Glucose Increased Foreign Clozaril (Clozapine) Blood Triglycerides Study Tablet PS ORAL 300 MG, QD, Increased Health ORAL; ORAL Drug Ineffective Professional Heart Rate Irregular Other Hypertension Tachycardia Date:07/25/03ISR Number: 4156885-XReport Type:Expedited (15-DaCompany Report #PHFR2003GB02505 Age:49 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Foreign Clozaril(Clozapine) Initial or Prolonged Diabetes Mellitus Study Unknown PS ORAL 12.5 MG, BID, Inadequate Control Health ORAL Diet Refusal Professional Metformin C Pyrexia Other Glibenclamide C Date:07/25/03ISR Number: 4156891-5Report Type:Expedited (15-DaCompany Report #PHNU2003DE02369 Age:43 YR Gender:Male I/FU:I Outcome PT Life-Threatening Activated Partial Hospitalization - Thromboplastin Time Initial or Prolonged Prolonged Agranulocytosis Asthenia Blood Albumin Decreased Blood Bilirubin Increased Blood Calcitonin Increased Blood Calcium Decreased Blood Cholinesterase 22-Feb-2006 08:30 AM Page: 2307 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Decreased Blood Creatinine Increased Blood Fibrinogen Report Source Product Role Manufacturer Route Dose Duration Increased Foreign Leponex / Clozaril Blood Lactate Study (Clozapine) PS ORAL 12.5MG/DAY, Dehydrogenase Decreased Health ORAL; UP TO Blood Sodium Decreased Professional 600 MG/DAY, Blood Thyroid Stimulating Other ORAL; Hormone Decreased 600MG/DAY, Body Temperature Dipiperon Increased (Pipamperone) C Bone Marrow Depression C-Reactive Protein Increased Candidiasis Cough Culture Stool Positive Drug Toxicity Duodenitis Dysphagia Dysphonia Epstein-Barr Virus Antibody Positive Feeling Abnormal Fungal Infection Fungus Serology Test Positive Gastrointestinal Haemorrhage Gastrointestinal Obstruction General Physical Health Deterioration Infection Laryngitis Leukopenia Lung Infiltration Malaise Melaena Necrotising Oesophagitis Odynophagia Oesophagitis Oropharyngeal Swelling Pallor Pancytopenia Pathogen Resistance Pleural Effusion Productive Cough Pseudomonas Infection Pulmonary Congestion Rales Staphylococcal Infection Tachycardia Date:07/25/03ISR Number: 4157703-6Report Type:Expedited (15-DaCompany Report #PHNR2003AU01065 Age:29 YR Gender:Male I/FU:I Outcome PT Other Dyspnoea Electrocardiogram 22-Feb-2006 08:30 AM Page: 2308 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Abnormal Eosinophilia Fatigue Feeling Hot Report Source Product Role Manufacturer Route Dose Duration Nausea Foreign Clozaril (Clozapine) Pallor Health Unknown PS 250 MG, QD Pyrexia Professional Rash Other Troponin I Increased Viral Infection Viral Myocarditis Vomiting Date:07/25/03ISR Number: 4157748-6Report Type:Expedited (15-DaCompany Report #PHFR2003GB02587 Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram St Foreign Clozaril(Clozapine) PS ORAL 150MG/DAY, Segment Elevation Study ORAL Sinus Tachycardia Health Professional Other Date:07/28/03ISR Number: 4155450-8Report Type:Expedited (15-DaCompany Report #PHFR2003GB01312 Age:55 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Distension Clozaril PS Novartis Sector: Hospitalization - Anorexia Pharma ORAL 300mg/day Initial or Prolonged Ascites Blood Albumin Decreased Bronchial Obstruction Cardiac Arrest Foreign Body Aspiration Full Blood Count Increased Gastric Dilatation Haemoglobin Decreased Ileus Malaise Metabolic Disorder Neutrophil Count Increased Pancreatitis Pleural Effusion Vomiting Weight Decreased White Blood Cell Count Increased Date:07/28/03ISR Number: 4155492-2Report Type:Expedited (15-DaCompany Report #PHNR2003AU00976 Age:28 YR Gender:Male I/FU:F Outcome PT Hospitalization - Diabetic Ketoacidosis Initial or Prolonged Hyperglycaemia Hypoxia Lethargy Liver Function Test 22-Feb-2006 08:30 AM Page: 2309 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Abnormal Nausea Polydipsia Polyuria Report Source Product Role Manufacturer Route Dose Duration Clozaril PS Novartis Sector: Pharma ORAL Clozaril SS Novartis Sector: Pharma ORAL 275mg/day Panadol C Date:07/28/03ISR Number: 4155515-0Report Type:Expedited (15-DaCompany Report #PHNR2003AU01007 Age:42 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Obsessive-Compulsive Clozaril (Clozapine) PS Novartis Sector: Initial or Prolonged Disorder Pharma 3269 DAY Psychiatric Symptom Citalopram C 20 mg mane Sleep Disorder Thyroxine C 100 ug, QD Lamotrigine C 150 mg, BID Clonazepam C 1mg 5 times a day Celebrex C 200 mg, BID Levlen Ed C Unspecified Coloxyl With Senna C Unspecified Date:07/28/03ISR Number: 4155555-1Report Type:Expedited (15-DaCompany Report #PHFR2003GB02859 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Electrocardiogram Qt Clozaril PS Novartis Sector: Hospitalization - Prolonged Pharma ORAL Initial or Prolonged Tachycardia Torsade De Pointes Ventricular Extrasystoles Date:07/28/03ISR Number: 4155961-5Report Type:Direct Company Report #USP 50606 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Roxicet PS Roxane Clozaril SS Sandoz Date:07/28/03ISR Number: 4156280-3Report Type:Direct Company Report #USP 50542 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Cozaar PS Merck & Co TAB Clozaril SS Sandoz TAB Date:07/29/03ISR Number: 4156603-5Report Type:Expedited (15-DaCompany Report #03-07-0873 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Gastrooesophageal Reflux Health Clozapine PS Ivax ORAL 400-500MG QD Initial or Prolonged Disease Professional ORAL Other Pneumonia Other 22-Feb-2006 08:30 AM Page: 2310 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/29/03ISR Number: 4156605-9Report Type:Expedited (15-DaCompany Report #03-07-0849 Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arteriospasm Coronary Health Clozapine PS Ivax ORAL 650MG QD ORAL Cerebrovascular Accident Professional Myocardial Infarction Other Date:07/29/03ISR Number: 4156608-4Report Type:Expedited (15-DaCompany Report #03-07-0874 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozapine PS Ivax ORAL 250-350MG QD Hospitalization - Professional ORAL Initial or Prolonged Other Date:07/29/03ISR Number: 4156611-4Report Type:Expedited (15-DaCompany Report #03-06-0697 Age:43 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozapine PS Ivax ORAL 200-900MG QD Professional ORAL Other Prandin "Novo Nordisk" C Lipitor C Synthroid C Lisinopril C Buspar C Depakote C Date:07/29/03ISR Number: 4156622-9Report Type:Expedited (15-DaCompany Report #03-07-0875 Age:87 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Gastrointestinal Health Clozapine PS Ivax ORAL 12.5-25MG QD Carcinoma Professional ORAL Other Date:07/29/03ISR Number: 4156820-4Report Type:Expedited (15-DaCompany Report #03-07-0876 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ankle Fracture Health Clozapine PS Ivax ORAL 550-750MG QD Initial or Prolonged Fall Professional ORAL Other Date:07/29/03ISR Number: 4159658-7Report Type:Expedited (15-DaCompany Report #03P-062-0223625-00 Age:19 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradyarrhythmia Foreign Akineton (Biperiden) Initial or Prolonged Hypothermia Health (Biperiden) PS ORAL PER ORAL Loss Of Consciousness Professional Perazine SS ORAL PER ORAL Poisoning Godamed SS ORAL PER ORAL Clozapine SS ORAL PER ORAL Pirenzepine SS ORAL PER ORAL Prothipendyl 22-Feb-2006 08:30 AM Page: 2311 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride SS ORAL PER ORAL Lorazepam SS ORAL PER ORAL Chlorprothixene SS ORAL PER ORAL Clonazepam SS ORAL PER ORAL Orfiril SS ORAL PER ORAL Olanzapine SS ORAL PER ORAL Topiramate SS ORAL PER ORAL Quetiapine SS ORAL PER ORAL Lithium Carbonate SS ORAL PER ORAL Date:07/30/03ISR Number: 4158943-2Report Type:Expedited (15-DaCompany Report #PHNR2003AU00747 Age:25 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dehydration Clozaril (Clozapine) PS Novartis Sector: Orthostatic Hypotension Pharma ORAL 400mg/day Tachycardia Clozaril (Clozapine) SS Novartis Sector: Ventricular Dysfunction Pharma ORAL 300mg/day Cipramil C Unspecified Date:07/30/03ISR Number: 4158945-6Report Type:Expedited (15-DaCompany Report #PHBS2003NL07762 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dysarthria Leponex PS Novartis Sector: Initial or Prolonged Movement Disorder Pharma ORAL 1440 MIN Nervous System Disorder Acenocoumarol C UNKNOWN Acetaminophen C UNKNOWN Alendronic Acid C UNKNOWN Bumetanide C UNKNOWN Digoxin C UNKNOWN Tiotropium C UNKNOWN Allopurinol C UNKNOWN Theophylline C UNKNOWN Date:07/30/03ISR Number: 4158949-3Report Type:Expedited (15-DaCompany Report #PHFR2003GB02867 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Diabetes Mellitus Clozaril PS Novartis Sector: Insulin-Dependent Pharma ORAL 400 mg/day Lithium Carbonate C ORAL 1.2 g/day Chlorpromazine C ORAL 200 mg/day Carbamazepine C ORAL 1000 mg/day Risperidone C ORAL 1 mg, BID 80640MIN Date:07/30/03ISR Number: 4158956-0Report Type:Expedited (15-DaCompany Report #PHBS2002CA12262 Age:22 YR Gender:Male I/FU:F Outcome PT Hospitalization - Abdominal Pain Initial or Prolonged Abdominal Pain Upper Other Anxiety Appendicectomy Appendicitis Chills Cyanosis Decreased Appetite 22-Feb-2006 08:30 AM Page: 2312 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Drug Interaction Drug Level Increased Drug Toxicity Report Source Product Role Manufacturer Route Dose Duration Emotional Distress Clozaril PS Novartis Sector: Gastroenteritis Pharma ORAL 400 mg/day 141 DAY Helicobacter Paxil SS UNKNOWN 40 mg/day Helicobacter Gastritis Seroquel SS Hepatic Steatosis Hepatotoxicity Liver Function Test Abnormal Nausea Peritonitis Psychotic Disorder Pyrexia Vomiting Date:07/31/03ISR Number: 4158691-9Report Type:Direct Company Report #CTU 198972 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Clozaril 100 Mg PS ORAL 100 MG PO BID Initial or Prolonged Depakote C Date:07/31/03ISR Number: 4160323-0Report Type:Expedited (15-DaCompany Report #C2003-1844.01 Age:81 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 25 MG QAM, 25 Other MG Q PM, AND 50 MG Q HS, ORAL Alendronate Sodium C Divalproex Sodium C Furosemide C Date:08/01/03ISR Number: 4159258-9Report Type:Expedited (15-DaCompany Report #PHBS2003DE07967 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aplastic Anaemia Clozapine PS Novartis Sector: Initial or Prolonged Pyrexia Pharma UNKNOWN 50 mg/day Date:08/01/03ISR Number: 4159298-XReport Type:Expedited (15-DaCompany Report #PHEH2003US06342 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Gastrointestinal Disorder Clozaril PS Novartis Sector: Initial or Prolonged Pharma ORAL 700 mg, QD Clozaril SS Novartis Sector: Pharma ORAL 100 mg, BID 22-Feb-2006 08:30 AM Page: 2313 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/01/03ISR Number: 4162343-9Report Type:Expedited (15-DaCompany Report #C2003-1771.01 Age:87 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 12.5 MG Q HS, Other ORAL Buspirone C Carbidopa/Levodopa C Levofloxacin C Morphine Sulfate C Nitrofurantoin Monohydrate Macrocrystals C Date:08/01/03ISR Number: 4203281-2Report Type:Periodic Company Report #2003-05-3123 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Interferon Other Mental Disorder Professional Injectable PS Other Clozapine Tablets SS ORAL 500 MG QD ORAL Date:08/04/03ISR Number: 4160298-4Report Type:Expedited (15-DaCompany Report #PHNR2003AU00917 Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiomyopathy Metoprolol PS Novartis Sector: Initial or Prolonged Electrocardiogram Qt Pharma Other Prolonged Clozaril SS ORAL 450mg/day Syncope Largactil SS Solian C Date:08/04/03ISR Number: 4160302-3Report Type:Expedited (15-DaCompany Report #PHBS2003BR07834 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Leponex PS Novartis Sector: Initial or Prolonged Increased Pharma ORAL 100 mg/day 20160MIN Aldolase Increased Aspartate Aminotransferase Increased Blood Creatine Phosphokinase Increased Leukocytosis Myelocytosis Pyrexia Date:08/04/03ISR Number: 4160309-6Report Type:Expedited (15-DaCompany Report #PHFR2002GB02978 Age:42 YR Gender:Male I/FU:F Outcome PT Death Blood Creatinine Other Increased Blood Urea Increased Completed Suicide 22-Feb-2006 08:30 AM Page: 2314 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dehydration Drug Toxicity Intentional Overdose Report Source Product Role Manufacturer Route Dose Duration Renal Impairment Clozaril (Clozapine) PS Novartis Sector: Sudden Death Pharma ORAL 325 mg, BID Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL 2.5g Ranitidine C ORAL 150 mg, BID Senna C ORAL 2 tablets PRN Risperidone C Date:08/04/03ISR Number: 4160327-8Report Type:Expedited (15-DaCompany Report #PHHO2003CA01655 Age:49 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cerebrovascular Accident Clozaril (Clozapine) PS Novartis Sector: Hospitalization - Embolism Pharma ORAL 50 mg, UNK 1344 DAY Initial or Prolonged Date:08/04/03ISR Number: 4160330-8Report Type:Expedited (15-DaCompany Report #PHFR2003GB02785 Age:25 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Glucose Increased Clozaril PS Novartis Sector: Diabetes Mellitus Pharma ORAL 75mg/day Diabetic Hyperglycaemic Venlafaxine C UNKNOWN 225mg/day Coma Date:08/04/03ISR Number: 4160554-XReport Type:Expedited (15-DaCompany Report #PHEH2003US06453 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Ulcer Clozaril PS Novartis Sector: Pharma ORAL 200 mg/day 1095 DAY Date:08/04/03ISR Number: 4160568-XReport Type:Expedited (15-DaCompany Report #PHHO2003AR09467 Age:79 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bronchial Obstruction Lapenax PS Novartis Sector: Hospitalization - Cardiac Failure Pharma 50 mg / day Initial or Prolonged Leukopenia Reminyl C Nasopharyngitis Amitriptyline C Neutropenia Atenolol C Pneumonia Madopar C Sputum Retention Date:08/04/03ISR Number: 4160593-9Report Type:Expedited (15-DaCompany Report #PHNU2003DE02614 Age:22 YR Gender:Male I/FU:F Outcome PT Other Bifascicular Block Bundle Branch Block Left Bundle Branch Block Right Electrocardiogram Abnormal 22-Feb-2006 08:30 AM Page: 2315 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pyrexia Sedation Sinus Tachycardia Report Source Product Role Manufacturer Route Dose Duration Leponex / Clozaril (Clozapine) PS Novartis Sector: Pharma ORAL 100 mg/day 2880 MIN Lorazepam C 4 mg/day 2880 MIN Date:08/04/03ISR Number: 4160670-2Report Type:Expedited (15-DaCompany Report #PHNU2003DE02625 Age:83 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other C-Reactive Protein Leponex / Clozaril Increased (Clozapine) PS Novartis Sector: Pleural Infection Pharma ORAL 6.25 mg/day Pyrexia Date:08/04/03ISR Number: 4161016-6Report Type:Direct Company Report #CTU 199133 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abnormal Behaviour Lithium 300-600 PS Affect Lability Clozaril SS 50-100 Distractibility Geodon SS Educational Problem Ddavp SS .6 OR .8 Irritability Strattera SS 60 Obesity Lithium C 300-600 Weight Increased Date:08/04/03ISR Number: 4162149-0Report Type:Expedited (15-DaCompany Report #03-07-0879 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Obsessive-Compulsive Health Clozapine - Ivax Initial or Prolonged Disorder Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 200-300MG QD ORAL Date:08/04/03ISR Number: 4162150-7Report Type:Expedited (15-DaCompany Report #03-07-0869 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Normal Pressure Health Clozapine - Ivax Hydrocephalus Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 400MG QD ORAL Date:08/04/03ISR Number: 4162151-9Report Type:Expedited (15-DaCompany Report #03-07-0895 Age:77 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 100MG QD ORAL 22-Feb-2006 08:30 AM Page: 2316 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/04/03ISR Number: 4162152-0Report Type:Expedited (15-DaCompany Report #03-07-0905 Age:82 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cellulitis Health Clozapine - Ivax Initial or Prolonged Wound Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 20-50MG QD ORAL Date:08/04/03ISR Number: 4164394-7Report Type:Expedited (15-DaCompany Report #PHBS2003IN07717 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Disease Recurrence Foreign Clozapine Initial or Prolonged Drug Exposure During Literature (Clozapine) PS SEE IMAGE Pregnancy Health Eating Disorder Professional Foetal Growth Retardation Other General Nutrition Disorder Insomnia Intra-Uterine Death Malnutrition Maternal Drugs Affecting Foetus Oligohydramnios Stillbirth Date:08/05/03ISR Number: 4161762-4Report Type:Expedited (15-DaCompany Report #PHBS2002CA05195 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Clozaril PS Novartis Sector: Syncope Pharma ORAL 337.5 mg, QHS Zyprexa C UNKNOWN Risperdal C UNKNOWN Neurontin C UNKNOWN Epival C UNKNOWN Date:08/06/03ISR Number: 4162272-0Report Type:Expedited (15-DaCompany Report #PHFR2003GB02588 Age:52 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Clozaril PS Novartis Sector: Inadequate Control Pharma ORAL Leukopenia Trimethoprim C Localised Infection Neutropenia Osteomyelitis Staphylococcal Infection White Blood Cell Count Decreased 22-Feb-2006 08:30 AM Page: 2317 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/06/03ISR Number: 4162274-4Report Type:Expedited (15-DaCompany Report #PHFR2003GB01959 Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Glucose Increased Clozaril PS Novartis Sector: Hospitalization - Diabetes Mellitus Pharma ORAL 175mg/day Initial or Prolonged Eyelid Ptosis Prozac C Other Muscle Disorder Neoplasm Malignant Treatment Noncompliance Date:08/06/03ISR Number: 4162318-XReport Type:Expedited (15-DaCompany Report #PHBS2003SE07822 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Level Increased Leponex PS Novartis Sector: Other Muscle Spasms Pharma ORAL Overdose Date:08/06/03ISR Number: 4162337-3Report Type:Expedited (15-DaCompany Report #PHFR2003GB02986 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agitation Clozaril PS Novartis Sector: Hospitalization - Blood Glucose Increased Pharma ORAL 75mg/day 10080MIN Initial or Prolonged Diabetic Hyperglycaemic Venlafaxine C ORAL 225mg/day Disability Coma Fall Polydipsia Tachycardia Date:08/06/03ISR Number: 4162357-9Report Type:Expedited (15-DaCompany Report #PHFR2003GB02627 Age:33 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other C-Reactive Protein Clozaril PS Novartis Sector: Increased Pharma ORAL 275mg/day Globulins Increased Haematuria Hyperhidrosis Proteinuria Pyrexia Salivary Hypersecretion Tachycardia Urinary Tract Infection Date:08/06/03ISR Number: 4162360-9Report Type:Expedited (15-DaCompany Report #PHFR2003GB02494 Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Cholesterol Clozaril PS Novartis Sector: Increased Pharma ORAL 550 mg/day Blood Triglycerides Venlafaxine C UNKNOWN 150mg/day Increased Depakote C Hypertension Hyoscine C UNKNOWN 300ug/day Neuropathy Peripheral Propranolol C Diazepam C UNKNOWN 5mg/day Procyclidine C UNKNOWN 5mg/day 22-Feb-2006 08:30 AM Page: 2318 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Valproate Sodium C UNKNOWN 600mg/day Half-Inderal La C UNKNOWN 80mg/day Date:08/06/03ISR Number: 4162363-4Report Type:Expedited (15-DaCompany Report #PHFR2003IE03000 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Clozaril PS Novartis Sector: Non-Insulin-Dependent Pharma ORAL 478 DAY Psychotic Disorder Weight Increased Date:08/06/03ISR Number: 4162366-XReport Type:Expedited (15-DaCompany Report #PHFR2003GB02985 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Glucose Increased Clozaril PS Novartis Sector: Diabetes Mellitus Pharma ORAL 400 mg/day Lethargy Liver Function Test Abnormal Somnolence Date:08/06/03ISR Number: 4162370-1Report Type:Expedited (15-DaCompany Report #PHNU2003DE02921 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Level Increased Leponex / Clozaril Hypokalaemia (Clozapine) PS Novartis Sector: Salivary Hypersecretion Pharma ORAL up to 500 Tachycardia mg/day Weight Increased Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL 200mg/day 1440 MIN Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL 300mg/day Topamax C ORAL 150mg/day Spasmex C ORAL 100mg/day Fluctin I UNKNOWN 10mg/day Date:08/06/03ISR Number: 4162419-6Report Type:Expedited (15-DaCompany Report #PHNR2003AU01060 Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Clozaril (Clozapine) PS Novartis Sector: Initial or Prolonged Cerebrovascular Accident Pharma 300mg mane, Convulsion 600mg nocte Drug Ineffective Luvox SS 100mg mane Drug Interaction Largactil SS 300 mg, BID Drug Level Increased Epilim C 1.5 g, BID Extrapyramidal Disorder Lithium C 500 mg, BID Incontinence Lethargy Somnolence Tremor 22-Feb-2006 08:30 AM Page: 2319 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/06/03ISR Number: 4162448-2Report Type:Expedited (15-DaCompany Report #PHFR2003GB01813 Age:57 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dehydration Clozaril PS Novartis Sector: Initial or Prolonged Renal Failure Pharma ORAL 75mg/day 24480MIN Frusemide C Digoxin C Doxazosin C Atorvastatin C Spironolactone C Perindopril C Mixtard C Abidec C Atrovent C Warfarin C Date:08/06/03ISR Number: 4162484-6Report Type:Expedited (15-DaCompany Report #PHFR2003GB02661 Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chest Pain Clozaril PS Novartis Sector: Drop Attacks Pharma ORAL 400mg/day 947 DAY Drug Level Increased Dyspnoea Haemoptysis Myoclonus Date:08/06/03ISR Number: 4162486-XReport Type:Expedited (15-DaCompany Report #PHFR2003GB02787 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Glucose Increased Clozaril PS Novartis Sector: Circulatory Collapse Pharma ORAL 7200 MIN Coma Risperidone C ORAL 8-6mg/day Diabetes Mellitus Insulin-Dependent Dizziness Hypotension Ketoacidosis Polyuria Date:08/06/03ISR Number: 4162567-0Report Type:Expedited (15-DaCompany Report #CH-GLAXOSMITHKLINE-B0305584A Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Lithium Carbonate PS Glaxosmithkline Initial or Prolonged Grand Mal Convulsion Mefenamic Acid SS 9 DAY Memory Impairment Clozapine SS Muscle Twitching Sodium Valproate SS Myoclonus Laxative C Date:08/06/03ISR Number: 4162569-4Report Type:Expedited (15-DaCompany Report #DE-GLAXOSMITHKLINE-D0041363A Age:19 YR Gender:Female I/FU:F Outcome PT Hospitalization - Bradyarrhythmia Initial or Prolonged Hypothermia 22-Feb-2006 08:30 AM Page: 2320 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Loss Of Consciousness Report Source Product Role Manufacturer Route Dose Duration Quilonum Retard PS Glaxosmithkline ORAL Taxilan SS ORAL Godamed SS Glaxosmithkline ORAL Clozapine SS ORAL Akineton SS ORAL Pirenzepin SS ORAL Dominal Forte SS ORAL Lorazepam SS ORAL Chlorprothixen SS ORAL Rivotril SS ORAL Orfiril SS ORAL Zyprexa SS ORAL Topamax SS ORAL Seroquel SS ORAL Date:08/06/03ISR Number: 4164889-6Report Type:Expedited (15-DaCompany Report #C2003-1845.01 Age:69 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Atherosclerosis Health Clozapine Tablets Cardiac Failure Professional 100 Mg PS ORAL 100 MG Q HS, Congestive Other ORAL Pneumonia Clozapine Tablets 25 Mg SS ORAL 25 MG QHS, ORAL Docusate Sodium C Date:08/06/03ISR Number: 4164905-1Report Type:Expedited (15-DaCompany Report #C2003-1928.01 Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine Tablets 25 Professional Mg Mylan PS ORAL 150 MG QD, Other ORAL Pentoxifylline C Temazepam C Date:08/06/03ISR Number: 4166642-6Report Type:Expedited (15-DaCompany Report #DSA_23037_2003 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Foreign Temesta PS ORAL 3.75 MG QD PO Hospitalization - Health Phenobarbital SS ORAL 200MG QD PO Initial or Prolonged Professional Clozapine SS ORAL 400 MG QD PO Other Parkinane SS ORAL 10 G QD PO Date:08/07/03ISR Number: 4166180-0Report Type:Expedited (15-DaCompany Report #HQWYE903305AUG03 Age:40 YR Gender:Male I/FU:I Outcome PT Death Cardiac Arrest Cardiomyopathy Circulatory Collapse Hypocalcaemia 22-Feb-2006 08:30 AM Page: 2321 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hypokalaemia Hyponatraemia Neuroleptic Malignant Report Source Product Role Manufacturer Route Dose Duration Syndrome Health Efexor (Venlafaxine Shock Professional Hydrochloride, Other Tablet) PS ORAL ORAL Clozaril SS ORAL 200 MG 1X PER 1 DAY, ORAL Epilim (Valproate Sodium) SS ORAL ORAL Olanzapine SS ORAL ORAL Date:08/08/03ISR Number: 4163974-2Report Type:Expedited (15-DaCompany Report #PHEH2003US06749 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pharmaceutical Product Clozaril PS Novartis Sector: Initial or Prolonged Complaint Pharma ORAL 250 mg, QD Unevaluable Event Date:08/08/03ISR Number: 4165904-6Report Type:Expedited (15-DaCompany Report #C2003-1926.01 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Other Clozapine Tablets 100 Mg Mylan PS Mylan ORAL 400MG Q HS, ORAL Date:08/08/03ISR Number: 4166084-3Report Type:Expedited (15-DaCompany Report #C2003-1876.01 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coma Health Clozapine Tablets Sudden Death Professional 100 Mg Mylan PS Mylan ORAL 100MG Q AM & Other 4PM, 400MG Q HS, ORAL Benztropine C Clonazepam C Divalproex Sodium C Escitalopram C Prenatal Vitamin C Date:08/08/03ISR Number: 4167782-8Report Type:Expedited (15-DaCompany Report #HQWYE903705AUG03 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Health Artane Initial or Prolonged Aspartate Professional (Trihexyphenidyl, Aminotransferase Other Tablet) PS ORAL ORAL Gamma-Glutamyltransferase Clozaril (Clozapine) SS ORAL 300 MG 1X PER Hepatitis C 1 DAY ORAL Leukocytosis Pneumonia Thrombocytopenia 22-Feb-2006 08:30 AM Page: 2322 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/11/03ISR Number: 4164616-2Report Type:Expedited (15-DaCompany Report #PHFR2003GB02506 Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aspartate Clozaril PS Novartis Sector: Initial or Prolonged Aminotransferase Pharma ORAL 500mg/day 2247 DAY Other Increased Clozaril SS Novartis Sector: Blood Creatine Pharma ORAL Phosphokinase Increased Alcohol C Blood Creatinine Epilim Chrono C ORAL 16ukn/day Increased Lactulose C ORAL 40ml/day Blood Iron Decreased Diazepam C ORAL 2mg/day Blood Lactate Pabrinex C INTRAVENOUS 11520MIN Dehydrogenase Increased Blood Potassium Decreased Blood Sodium Decreased Blood Urea Increased C-Reactive Protein Increased Creatinine Renal Clearance Decreased Dehydration Eosinophil Count Decreased Malaise Oral Intake Reduced Pco2 Increased Renal Failure Rhabdomyolysis Vomiting Date:08/11/03ISR Number: 4164618-6Report Type:Expedited (15-DaCompany Report #PHBS2002SE07015 Age:60 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diarrhoea Leponex PS Novartis Sector: Other Sudden Death Pharma ORAL 450 mg/d 3761 DAY Urinary Tract Infection Lexinor SS ORAL 400 mg/d 2880 MIN Hibernal SS ORAL 200 mg/d Laktulose "Dak" C ORAL Vitamineral C ORAL Date:08/11/03ISR Number: 4164624-1Report Type:Expedited (15-DaCompany Report #PHFR2003GB03010 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Pressure Diastolic Clozaril PS Novartis Sector: Increased Pharma ORAL 400mg/day Body Temperature Clozaril SS Novartis Sector: Decreased Pharma ORAL 600mg/evening Heart Rate Increased dose Medication Error Date:08/11/03ISR Number: 4164733-7Report Type:Expedited (15-DaCompany Report #PHNR2003AU01140 Age:35 YR Gender:Male I/FU:I Outcome PT Hospitalization - Body Temperature Initial or Prolonged Increased 22-Feb-2006 08:30 AM Page: 2323 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Fatigue Nausea Viraemia Report Source Product Role Manufacturer Route Dose Duration Clozaril PS Novartis Sector: Pharma 12.5 mg/day 1440 MIN Clozaril SS Novartis Sector: Pharma 25 mg/day Date:08/11/03ISR Number: 4164832-XReport Type:Expedited (15-DaCompany Report #PHFR2003IE02949 Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bundle Branch Block Left Clozaril PS Novartis Sector: Initial or Prolonged Myocardial Infarction Pharma ORAL Date:08/11/03ISR Number: 4165354-2Report Type:Expedited (15-DaCompany Report #PHBS2003NL08282 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Glucose Increased Clozapine PS Novartis Sector: Diabetes Mellitus Pharma UNKNOWN 300 mg/day Date:08/11/03ISR Number: 4165355-4Report Type:Expedited (15-DaCompany Report #PHBS2003NL08283 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Glucose Increased Clozapine PS Novartis Sector: Diabetes Mellitus Pharma UNKNOWN 500 mg/day Glycosylated Haemoglobin Increased Date:08/11/03ISR Number: 4165361-XReport Type:Expedited (15-DaCompany Report #PHBS2003NL08285 Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Clozapine PS Novartis Sector: Pharma UNKNOWN Date:08/11/03ISR Number: 4165367-0Report Type:Expedited (15-DaCompany Report #PHNR2003AU00939 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Constipation Clozaril PS Novartis Sector: Drug Level Increased Pharma 300-650mg/day 980 DAY Drug Toxicity Luvox SS 150 mg, QD Lithium C 375 mg, BID Coloxyl With Senna C Date:08/11/03ISR Number: 4166522-6Report Type:Direct Company Report #CTU 199733 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Hospitalisation Clozaril Generic PS Hospitalization - Pharmaceutical Product Initial or Prolonged Complaint 22-Feb-2006 08:30 AM Page: 2324 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/11/03ISR Number: 4166525-1Report Type:Direct Company Report #CTU 199734 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Level Decreased Clozapine PS ORAL 100MG PO Q Pharmaceutical Product DAY Complaint Date:08/11/03ISR Number: 4166528-7Report Type:Direct Company Report #CTU 199235 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Affective Disorder Clozapine PS Condition Aggravated Lico3 C Pharmaceutical Product Complaint Psychotic Disorder Date:08/11/03ISR Number: 4166529-9Report Type:Direct Company Report #CTU 199736 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Condition Aggravated Clozapine PS Intervention to Pharmaceutical Product Prevent Permanent Complaint Impairment/Damage Psychotic Disorder Date:08/11/03ISR Number: 4166589-5Report Type:Direct Company Report #CTU 199751 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Headache Clozapine PS Mylan 200 MG BID Initial or Prolonged Malaise Valproic Acid SS 1000 MG BID Myalgia Haloperidol (Haldol) C Pyrexia Date:08/11/03ISR Number: 4167477-0Report Type:Expedited (15-DaCompany Report #03-07-0876 Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ankle Fracture Health Clozapine - Ivax Initial or Prolonged Fall Professional Pharmaceuticals, Post Procedural Other Inc. Tablets PS Ivax Complication Pharmaceuticals, Inc. ORAL 550-750MG QD ORAL Date:08/11/03ISR Number: 4167478-2Report Type:Expedited (15-DaCompany Report #03-07-0906 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 100-400MG QD ORAL 22-Feb-2006 08:30 AM Page: 2325 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/11/03ISR Number: 4167480-0Report Type:Expedited (15-DaCompany Report #03-07-0913 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc ORAL 300MG QD ORAL Date:08/11/03ISR Number: 4167481-2Report Type:Expedited (15-DaCompany Report #03-07-0914 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Health Clozapine -Ivax Cardiovascular Disorder Professional Pharmaceuticals, Hypertension Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 100-600MG QD ORAL Date:08/11/03ISR Number: 4167482-4Report Type:Expedited (15-DaCompany Report #03-07-0918 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pulmonary Oedema Health Clozapine -Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 87.5-500MG QD ORAL Date:08/11/03ISR Number: 4167483-6Report Type:Expedited (15-DaCompany Report #03-08-0925 Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Mass Health Clozapine -Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 50-300MG QD ORAL Date:08/11/03ISR Number: 4167485-XReport Type:Expedited (15-DaCompany Report #03-08-0928 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Health Clozapine - Ivax Initial or Prolonged Congestive Professional Pharmaceuticals, Chronic Obstructive Other Inc. Tablets PS Ivax Pulmonary Disease Pharmaceuticals, Inc. ORAL 100-400MG QD ORAL 22-Feb-2006 08:30 AM Page: 2326 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/11/03ISR Number: 4167486-1Report Type:Expedited (15-DaCompany Report #03-08-0934 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coronary Artery Disease Health Clozapine -Ivax Initial or Prolonged Dementia Professional Pharmaceuticals, Dementia Alzheimer'S Type Other Inc. Tablets PS Ivax Parkinson'S Disease Pharmaceuticals, Psychotic Disorder Inc. ORAL 100MG QD ORAL Date:08/11/03ISR Number: 4167490-3Report Type:Expedited (15-DaCompany Report #03-08-0935 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anorexia Health Clozapine -Ivax Initial or Prolonged Confusional State Professional Pharmaceuticals, Delirium Other Inc. Tablets PS Ivax Drug Toxicity Pharmaceuticals, Erythema Inc. ORAL 125-500MG QD Flushing ORAL Hallucination Hypoglycaemia Date:08/12/03ISR Number: 4166022-3Report Type:Expedited (15-DaCompany Report #PHFR2003GB03036 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Clozaril PS Novartis Sector: Treatment Noncompliance Pharma ORAL 400 mg/day Clozaril SS Novartis Sector: Pharma ORAL 1200mg Overdose Date:08/12/03ISR Number: 4166032-6Report Type:Expedited (15-DaCompany Report #PHNU2003DE02644 Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Leponex / Clozaril Initial or Prolonged Increased (Clozapine) PS Novartis Sector: Other Aspartate Pharma ORAL up to 150 Aminotransferase mg/day Increased Blood Alkaline Phosphatase Increased Cholecystitis Gallbladder Perforation Leukocytosis Pyrexia Date:08/12/03ISR Number: 4166033-8Report Type:Expedited (15-DaCompany Report #PHBS2003SE07822 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Leponex PS Novartis Sector: Other Drug Level Above Pharma ORAL Therapeutic Metabolic Disorder Muscle Spasms 22-Feb-2006 08:30 AM Page: 2327 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/12/03ISR Number: 4166034-XReport Type:Expedited (15-DaCompany Report #PHEH2003US06852 Age:29 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Trileptal PS Novartis Sector: Pharma ORAL 150 mg, BID 4320 MIN Trileptal SS Novartis Sector: Pharma ORAL 300 mg, BID 7200 MIN Trileptal SS Novartis Sector: Pharma ORAL 600 mg, BID Clozapine SS ORAL 200 mg, QD Motrin C ORAL 800 mg, TID Benadryl "Warner-Lambert" /Usa/ C UNK, PRN Prolixin C UNK, PRN Date:08/12/03ISR Number: 4166520-2Report Type:Direct Company Report #CTU 199732 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Clozapine 100mg PS THREE 100MG 1 WK Initial or Prolonged Aggression Clozapine 25mg SS TWO 25MG Other Condition Aggravated Drug Ineffective Pharmaceutical Product Complaint Date:08/13/03ISR Number: 4166824-3Report Type:Expedited (15-DaCompany Report #PHFR2003GB02133 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Constipation Clozaril PS Novartis Sector: Initial or Prolonged Haemoglobin Decreased Pharma ORAL 200mg/mane&30 Megacolon 0mg/nocte Clozaril SS Novartis Sector: Pharma ORAL 200mg/mane&25 0mg/nocte Iron C UNKNOWN Date:08/13/03ISR Number: 4166837-1Report Type:Expedited (15-DaCompany Report #PHEH2003US06652 Age:85 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Failure To Thrive Clozaril PS Novartis Sector: Pharma ORAL 37.5 mg, QHS Haloperidol C Paracetamol C Lorazepam C Roxanol C Date:08/13/03ISR Number: 4166996-0Report Type:Expedited (15-DaCompany Report #PHNR2003AU00506 Age:61 YR Gender:Female I/FU:F Outcome Death Hospitalization - Initial or Prolonged 22-Feb-2006 08:30 AM Page: 2328 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other PT Report Source Product Role Manufacturer Route Dose Duration Cardiac Arrest Clozaril (Clozapine) PS Novartis Sector: Circulatory Collapse Pharma ORAL 25 mg, UNK Loss Of Consciousness Clozaril (Clozapine) SS Novartis Sector: Sudden Death Pharma ORAL 50 mg, BID Urinary Incontinence Clozaril (Clozapine) SS Novartis Sector: Pharma 137.5 mg, UNK Oxazepam C 60 mg, QD Diazepam I ORAL 10 mg, TID Olanzapine I ORAL 10 mg, UNK Olanzapine I UNK, UNK Date:08/13/03ISR Number: 4167011-5Report Type:Expedited (15-DaCompany Report #PHFR2003GB02836 Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Upper Clozaril PS Novartis Sector: Initial or Prolonged Asthenia Pharma ORAL 250mg/day Other Cardiac Failure Clozaril SS Novartis Sector: Cardiomegaly Pharma ORAL 300mg/day Congestive Cardiomyopathy Clozaril SS Novartis Sector: Constipation Pharma ORAL 12.5 mg, QD Dizziness Benzhexol C ORAL 1mg/day 51840MIN Dyspnoea Amoxicillin C ORAL 500 mg, TID 12960MIN Fatigue Senna C ORAL 2 Tabs/day Intestinal Functional Disorder Palpitations Pulmonary Congestion Pulmonary Oedema Respiratory Disorder Sinus Tachycardia Swelling White Blood Cell Count Increased Date:08/14/03ISR Number: 4167571-4Report Type:Expedited (15-DaCompany Report #PHBS2003CH08209 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Leponex PS Novartis Sector: Initial or Prolonged Phosphokinase Increased Pharma UNKNOWN 300 to 500 Loss Of Consciousness mg/day Myoglobinaemia Edronax C UNKNOWN 4 mg/day Rhabdomyolysis Temesta C UNKNOWN 3 mg/day Novonorm C UNKNOWN 11520MIN Tolperisone C UNKNOWN Date:08/14/03ISR Number: 4167574-XReport Type:Periodic Company Report #US-GLAXOSMITHKLINE-A0382012A Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Stelazine PS Glaxosmithkline 40MG At night Clozapine SS ORAL 100MG Twice per day 35 DAY 22-Feb-2006 08:30 AM Page: 2329 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/14/03ISR Number: 4167672-0Report Type:Expedited (15-DaCompany Report #PHNU2003DE02454 Age:37 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cervix Cancer Metastatic Leponex / Clozaril Initial or Prolonged Pancytopenia (Clozapine) PS Novartis Sector: Other Pharma ORAL up to 250 mg/day Cisplatin SS Radiotherapy C UNKNOWN Date:08/14/03ISR Number: 4167702-6Report Type:Expedited (15-DaCompany Report #PHNU2003DE02949 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - T-Cell Lymphoma Stage Iv Leponex / Clozaril Initial or Prolonged (Clozapine) PS Novartis Sector: Other Pharma ORAL 100mg/day Date:08/14/03ISR Number: 4167757-9Report Type:Direct Company Report #CTU 199978 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Grand Mal Convulsion Clozapine 25mg Hospitalization - Zenith-Goldline PS Zenith-Goldline ORAL 50 MG QHS Initial or Prolonged ORAL Date:08/14/03ISR Number: 4168192-XReport Type:Expedited (15-DaCompany Report #PHNU2003DE02974 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Depressed Mood Leponex / Clozaril Drug Interaction (Clozapine) PS Novartis Sector: Pharma ORAL 12.5mg/day Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL up to 25mg/day Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL up to 200mg/day Doxycyclin "Stada" SS ORAL 200mg/day 30240MIN Zeldox /Gfr/ C UNKNOWN 20mg/day Date:08/14/03ISR Number: 4170324-4Report Type:Expedited (15-DaCompany Report #C2003-1897.01 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 300 MG Q HS, Other ORAL Candesartan/Hydrochl orothiazide C 22-Feb-2006 08:30 AM Page: 2330 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/14/03ISR Number: 4170338-4Report Type:Expedited (15-DaCompany Report #C2003-1914.01 Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pharmaceutical Product Health Clozapine Tablets Complaint Professional 100 Mg Mylan PS Mylan ORAL 100MG BID, Other ORAL Kci Supplement C Citalopram Hydrobromide C Divalproex Sodium C Furosemide C Levothyroxine Sodium C Risperidone C Trazodone C Date:08/14/03ISR Number: 4170341-4Report Type:Expedited (15-DaCompany Report #03-08-0947 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Neoplasm Malignant Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 200-800 MG QD ORAL Date:08/14/03ISR Number: 4170343-8Report Type:Expedited (15-DaCompany Report #03-08-0960 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cystitis Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 550MG QD ORAL Date:08/14/03ISR Number: 4170344-XReport Type:Expedited (15-DaCompany Report #03-08-0961 Age:48 MON Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine Tablets - Professional Ivax Pharmaceutical, Other Inc. PS Ivax Pharmaceutical, Inc. ORAL 50-100MG QD ORAL Date:08/14/03ISR Number: 4170346-3Report Type:Expedited (15-DaCompany Report #03-08-0964 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Heat Stroke Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, 22-Feb-2006 08:30 AM Page: 2331 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Inc. ORAL ORAL Date:08/14/03ISR Number: 4170372-4Report Type:Expedited (15-DaCompany Report #03-08-0946 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anaemia Health Clozapine PS Ivax Gastrointestinal Professional Pharmaceuticals, Haemorrhage Other Inc. ORAL 25-400MG QD ORAL Date:08/14/03ISR Number: 4170382-7Report Type:Expedited (15-DaCompany Report #C2003-1626.01 Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozapine PS Mylan ORAL 100MG Q AM Deep Vein Thrombosis Professional AND 200MG Q Pharmaceutical Product Other HS, ORAL Complaint Geodon SS Pfizer Pulmonary Embolism Trazodone C Clonazepam C Furosemide C Metformin C Verapamil C Date:08/15/03ISR Number: 4168383-8Report Type:Expedited (15-DaCompany Report #PHFR2003GB02811 Age:49 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Clozaril PS Novartis Sector: Hospitalization - Cerebral Infarction Pharma ORAL Initial or Prolonged Cerebrovascular Accident Clozaril SS Novartis Sector: Other Delirium Pharma ORAL 625mg/day Diabetes Mellitus Risperidone C ORAL 4mg/day Insulin-Dependent Risperidone C UNKNOWN 2mg/day Lower Respiratory Tract Lorazepam C ORAL 0.5mg/day Infection Desmopressin C ORAL 200ug/day Orthostatic Hypotension Lansoprazole C ORAL 30mg/day Pneumonia Aspiration Metformin C ORAL 500 mg, TID Sedation Metformin C ORAL 850 mg, TID Date:08/15/03ISR Number: 4168384-XReport Type:Expedited (15-DaCompany Report #PHBS2003FI07021 Age:36 YR Gender:Male I/FU:F Outcome PT Death Constipation Defaecation Urgency Diarrhoea Haemorrhagic Drug Interaction Food Poisoning Gastroenteritis Gastrointestinal Necrosis Haematemesis Hepatocellular Damage Loss Of Consciousness Megacolon Metabolic Acidosis Pneumonia 22-Feb-2006 08:30 AM Page: 2332 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Procedural Complication Renal Disorder Shock Report Source Product Role Manufacturer Route Dose Duration Clozapine PS Novartis Sector: Pharma ORAL 500 mg/d Loperamide SS ORAL 6 mg/d Date:08/15/03ISR Number: 4168998-7Report Type:Expedited (15-DaCompany Report #C2003-1627.01 Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozapine Tablets Condition Aggravated Professional 25mg Mylan PS Mylan ORAL 75MG QID, Convulsion Other ORAL Death Clozapine Tablets 100 Mg Mylan SS Mylan ORAL 100MG QID, ORAL Docusate Calcium C Fluphenazine C Gemfibrozil C Levothyroxine C Lithium C Oxybutynin C Fluphenazine Decanoate C Date:08/15/03ISR Number: 4168999-9Report Type:Expedited (15-DaCompany Report #C2003-1733.01 Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pharmaceutical Product Health Clozapine Tablets Complaint Professional 100mg Mylan PS Mylan ORAL 100MG BID, Treatment Noncompliance Other ORAL Gabapentin C Valproic Acid C Extended Phenytoin Sodium C Date:08/15/03ISR Number: 4170893-4Report Type:Direct Company Report #USP 56006 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Colazal PS Salix Pharmaceuticals CAPSULE Clozaril SS Novartis TABLET Date:08/18/03ISR Number: 4169294-4Report Type:Expedited (15-DaCompany Report #PHFR2003GB02416 Age:48 YR Gender:Female I/FU:F Outcome PT Hospitalization - Asthenia Initial or Prolonged Gastroenteritis Viral Other Neutrophil Count Increased Pyrexia Tachycardia White Blood Cell Count 22-Feb-2006 08:30 AM Page: 2333 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Increased Report Source Product Role Manufacturer Route Dose Duration Clozaril PS Novartis Sector: Pharma ORAL 200mg/day Venlafaxine C UNKNOWN Date:08/18/03ISR Number: 4169295-6Report Type:Expedited (15-DaCompany Report #PHFR2003GB02558 Age:38 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Glucose Increased Clozaril PS Novartis Sector: Diabetes Mellitus Pharma ORAL 350mg/day Feeling Abnormal Metformin C ORAL 1500mg/day Lower Respiratory Tract Hyoscine Infection Hydrobromide C ORAL 300ug/day Neutrophil Count Increased Date:08/18/03ISR Number: 4169297-XReport Type:Expedited (15-DaCompany Report #PHNR2003AU01186 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthma Clozaril PS Novartis Sector: Cardiac Failure Pharma ORAL 12 - 300 Dyspnoea mg/day Pulmonary Oedema Clozaril SS Novartis Sector: Pharma ORAL 12.5 - 400 mg/day Clozaril SS Novartis Sector: Pharma ORAL 300 mg/day Date:08/18/03ISR Number: 4169392-5Report Type:Expedited (15-DaCompany Report #PHFR2003GB03118 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Angioneurotic Oedema Clozaril PS Novartis Sector: Periorbital Oedema Pharma ORAL 125mg/mane& Somnolence 150mg/nocte 25920MIN Urinary Incontinence Co-Dydramol C UNKNOWN Losartan C UNKNOWN Sanatogen C UNKNOWN Date:08/18/03ISR Number: 4169398-6Report Type:Expedited (15-DaCompany Report #PHHO2003CA07305 Age:50 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Clozaril PS Novartis Sector: Hospitalization - Neutropenia Pharma ORAL 275 mg/day 93600MIN Initial or Prolonged Pyrexia Modecate C Tooth Abscess Fluconazole C Lithium C Lithium Carbonate C Benzotropine C Fluphenazine C 22-Feb-2006 08:30 AM Page: 2334 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/18/03ISR Number: 4170804-1Report Type:Direct Company Report #CTU 200153 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Intolerance Generic Clozaril PS ORAL 100 MG 3 PO Dyskinesia Navane C Feeling Abnormal Trihexiphenidyl C Pharmaceutical Product Complaint Treatment Noncompliance Date:08/18/03ISR Number: 4173068-8Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20030801932 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Foreign Risperdal Leukopenia Health (Risperidone) Thrombocytopenia Professional Tablets PS ORAL ORAL Clozapine (Clozapine) SS Date:08/18/03ISR Number: 4173221-3Report Type:Expedited (15-DaCompany Report #PHBS2003NL08283 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozapine(Clozapine) PS 500 MG/DAY Glycosylated Haemoglobin Literature Increased Health Professional Other Date:08/19/03ISR Number: 4170144-0Report Type:Expedited (15-DaCompany Report #PHFR2003GB03150 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Gait Disturbance Clozaril PS Novartis Sector: Medication Error Pharma ORAL 1x50mg Somnolence Lithium Carbonate C UNKNOWN Carbamazepine C UNKNOWN Quinine C UNKNOWN Phyllocontin C UNKNOWN Date:08/20/03ISR Number: 4170516-4Report Type:Expedited (15-DaCompany Report #PHFR2003GB02813 Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Clozaril PS Novartis Sector: Initial or Prolonged Diabetes Mellitus Pharma ORAL 150 mg, BID Other Insulin-Dependent Date:08/20/03ISR Number: 4170536-XReport Type:Expedited (15-DaCompany Report #PHEH2003US06852 Age:29 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Trileptal PS Novartis Sector: Pharma ORAL 150 mg, BID 4320 MIN Trileptal SS Novartis Sector: 22-Feb-2006 08:30 AM Page: 2335 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pharma ORAL 300 mg, BID 7200 MIN Trileptal SS Novartis Sector: Pharma ORAL 600 mg, BID Clozapine SS ORAL 200 mg, QD Motrin C ORAL 800 mg, TID Benadryl "Warner-Lambert" /Usa/ C UNK, PRN Prolixin C UNK, PRN Date:08/20/03ISR Number: 4170537-1Report Type:Expedited (15-DaCompany Report #PHNR2003AU00889 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Rigidity Clozaril PS Novartis Sector: Initial or Prolonged Constipation Pharma 25 - 900 Gastric Bypass mg/day Clozaril SS Novartis Sector: Pharma 12.5 - 300 mg/day Seroquel C Anafranil C Clonazepam C Buscopan C Oxybutynin C Panadeine Forte C Valproate Sodium C Date:08/20/03ISR Number: 4170544-9Report Type:Expedited (15-DaCompany Report #PHNU2003DE01718 Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Increased Leponex / Clozaril Initial or Prolonged Flatulence (Clozapine) PS Novartis Sector: Other Gastrointestinal Pain Pharma ORAL 5000 mg, Intentional Overdose ONCE/SINGLE 1440 MIN Suicide Attempt Zyprexa C UNKNOWN Vomiting Date:08/20/03ISR Number: 4170550-4Report Type:Expedited (15-DaCompany Report #PHNR2003AU01217 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bundle Branch Block Left Clozaril PS Novartis Sector: Electrocardiogram Pharma ORAL 12.5 - 600 Abnormal mg/day Qrs Axis Abnormal Epilim C ORAL 750 mg mane & 1000 mg nocte Serzone C 400 mg, BID Solian C 200 mg mane Date:08/20/03ISR Number: 4170674-1Report Type:Expedited (15-DaCompany Report #US-GLAXOSMITHKLINE-A0422255A Age:53 YR Gender:Male I/FU:F Outcome PT Hospitalization - Difficulty In Walking Initial or Prolonged Dissociation Dysstasia 22-Feb-2006 08:30 AM Page: 2336 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Fall Report Source Product Role Manufacturer Route Dose Duration Lithium PS Glaxosmithkline UNKNOWN Clozapine SS ORAL Date:08/20/03ISR Number: 4170907-1Report Type:Expedited (15-DaCompany Report #PHNU2003DE02949 Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Lactate Leponex / Clozaril Hospitalization - Dehydrogenase Increased (Clozapine) PS Novartis Sector: Initial or Prolonged T-Cell Lymphoma Stage Iv Pharma ORAL 100mg/day Other Date:08/20/03ISR Number: 4170913-7Report Type:Expedited (15-DaCompany Report #PHBS2003BR08645 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Upper Leponex PS Novartis Sector: Confusional State Pharma ORAL 100 mg, QID Headache Toothache Date:08/20/03ISR Number: 4170922-8Report Type:Expedited (15-DaCompany Report #PHBS2003ZA08670 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumothorax Leponex PS Novartis Sector: Initial or Prolonged White Blood Cell Count Pharma UNKNOWN Decreased Date:08/20/03ISR Number: 4170934-4Report Type:Expedited (15-DaCompany Report #PHNU2003DE01075 Age:17 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Leponex / Clozaril Increased (Clozapine) PS Novartis Sector: Aspartate Pharma ORAL up to Aminotransferase 300mg/day Increased Leponex / Clozaril Blood Alkaline (Clozapine) SS Novartis Sector: Phosphatase Increased Pharma ORAL 100mg/day Blood Cholinesterase Leponex / Clozaril Increased (Clozapine) SS Novartis Sector: Drug Level Increased Pharma ORAL 250mg/day Epstein-Barr Virus Leponex / Clozaril Antibody Positive (Clozapine) SS Novartis Sector: Gamma-Glutamyltransferase Pharma ORAL 225mg/day Increased Leponex / Clozaril Infectious Mononucleosis (Clozapine) SS Novartis Sector: Liver Function Test Pharma ORAL 200mg/day Abnormal Bifiteral "Philips" C ORAL 1 DF, QID Pyrexia Beloc-Zoc Mite C ORAL 23.75 mg, QD Viral Infection 22-Feb-2006 08:30 AM Page: 2337 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/20/03ISR Number: 4170935-6Report Type:Expedited (15-DaCompany Report #PHEH2003US06453 Age:70 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dyspnoea Clozaril PS Novartis Sector: Hospitalization - Hyperhidrosis Pharma ORAL 200 mg, QD 1095 DAY Initial or Prolonged Zoloft C Date:08/20/03ISR Number: 4171002-8Report Type:Expedited (15-DaCompany Report #PHEH2003US07251 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hepatic Neoplasm Clozaril PS Novartis Sector: Malignant Pharma ORAL 200 mg, QD Leukocytosis Date:08/20/03ISR Number: 4171006-5Report Type:Expedited (15-DaCompany Report #PHFR2003GB02981 Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fatigue Clozaril PS Novartis Sector: Initial or Prolonged Myocarditis Pharma ORAL 100mg/om Other Neutrophil Count 200mg/on 27360MIN Increased Risperidone C UNKNOWN 8 mg, QD Pyrexia Chlorpromazine C UNKNOWN 600 mg, QD Troponin T Increased Procyclidine C UNKNOWN 5 mg, BID Urinary Tract Infection Hyoscine C TRANSDERMAL 300mg/day White Blood Cell Count Haloperidol C UNKNOWN UNK, PRN Increased Lorazepam C UNKNOWN Zopiclone C UNKNOWN Date:08/20/03ISR Number: 4172834-2Report Type:Direct Company Report #CTU 200354 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Clozapine 100mg Initial or Prolonged Ivax PS ORAL 300 MG/ DAY Required PO Intervention to Lithium Carbonate C Prevent Permanent Olanzapine C Impairment/Damage Date:08/20/03ISR Number: 4173775-7Report Type:Expedited (15-DaCompany Report #C2003-1844.01 Age:81 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg Mylan PS ORAL 25MG Q AM, Other 25MG Q PRN, AND 50MG Q HS ORAL Alendronate Sodium C Divalproex Sodium C Furosemide C 22-Feb-2006 08:30 AM Page: 2338 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/21/03ISR Number: 4171394-XReport Type:Expedited (15-DaCompany Report #PHNU2003DE02304 Age:37 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Leponex / Clozaril Increased (Clozapine) PS Novartis Sector: Aspartate Pharma ORAL up to Aminotransferase 400mg/day 37440MIN Increased Maaloxan C UNKNOWN Blood Alkaline Movicol C UNKNOWN 2df/day 24480MIN Phosphatase Increased Blood Bilirubin Increased Diarrhoea Eosinophilia Gamma-Glutamyltransferase Increased Hepatitis A Hyperpyrexia Leukocytosis Date:08/22/03ISR Number: 4172004-8Report Type:Expedited (15-DaCompany Report #PHNR2003AU01214 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Clozaril PS Novartis Sector: Initial or Prolonged Drug Level Increased Pharma ORAL 25 - 750 Pneumonia mg/day Renal Failure Clozaril SS Novartis Sector: Pharma ORAL 400 - 600 mg/day Date:08/22/03ISR Number: 4172008-5Report Type:Expedited (15-DaCompany Report #PHNU2003DE01603 Age:49 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Leponex / Clozaril Initial or Prolonged Haemorrhage Intracranial (Clozapine) PS Novartis Sector: Other Hemiplegia Transient Pharma ORAL UNK, UNK Infective Thrombosis Solian C ORAL 500mg/day Intracranial Venous Sinus Thrombosis Thrombocytopenia Date:08/22/03ISR Number: 4172052-8Report Type:Expedited (15-DaCompany Report #PHNR2003AU01218 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiac Disorder Clozaril PS Novartis Sector: Pneumonia Pharma ORAL Pulmonary Fibrosis Date:08/22/03ISR Number: 4172338-7Report Type:Expedited (15-DaCompany Report #PHNU2003DE02473 Age:54 YR Gender:Female I/FU:F Outcome PT Hospitalization - C-Reactive Protein Initial or Prolonged Increased Other Diarrhoea 22-Feb-2006 08:30 AM Page: 2339 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Disturbance In Attention Drug Withdrawal Syndrome Musculoskeletal Stiffness Report Source Product Role Manufacturer Route Dose Duration Parkinsonism Leponex / Clozaril Pyrexia (Clozapine) PS Novartis Sector: Restlessness Pharma ORAL up to 300 Speech Disorder mg/day 47520MIN Orfiril "Desitin" C ORAL 1500mg/day Tavor C UNKNOWN Date:08/22/03ISR Number: 4173313-9Report Type:Direct Company Report #CTU 200461 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Condition Aggravated Clozapine 100 Mg Intervention to Diabetes Mellitus Tablet, Ivax PS Ivax ORAL 100 MG BID PO Prevent Permanent (INCREASED Impairment/Damage TITRATION) Risperdal 3mg Or 2mg Tablet, Janssen SS Janssen 3MG BID PO THEN 2MG BID PO Ativan C Risperdal M C Tylenol C Glucotrol Xl C Glucophage C Maalox C Milk Of Magnesia C Date:08/22/03ISR Number: 4176690-8Report Type:Expedited (15-DaCompany Report #C2003-2086.01 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 300 MG Q HS, Other ORAL Date:08/22/03ISR Number: 4176691-XReport Type:Expedited (15-DaCompany Report #C2003-2085.01 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Ill-Defined Disorder Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 200MG Q HS, Other ORAL Dextroamphetamine C Diazepam C Escitalopram Oxalate C Date:08/22/03ISR Number: 4176692-1Report Type:Expedited (15-DaCompany Report #C2003-0660.01 Age:44 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiomyopathy Health Clozapine Tablets Coma Professional 100 Mg Mylan PS Mylan ORAL 50MG Q AM AND Other 200MG Q HS, ORAL 22-Feb-2006 08:30 AM Page: 2340 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Metformin C Verapamil C Topiramate C Lamotrigine C Methylphenidate Hci C Levothyroxine C Bupropion Sr C Escitalopram C Date:08/22/03ISR Number: 4176693-3Report Type:Expedited (15-DaCompany Report #C2003-2105.01 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 25MG Q PM, Other ORAL Clozapine Tablets 100 Mg Mylan C Mylan ORAL 300MG Q AM, 400MG Q PM, ORAL Date:08/25/03ISR Number: 4172686-0Report Type:Expedited (15-DaCompany Report #PHEH2003US07469 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Toxicity Clozaril PS Novartis Sector: Overdose Pharma UNK,UNK Tylenol With Codeine SS 6 or 7 tablets taken Promethazine SS 50mg x 6 or 7 Neurontin C 800 mg, QHS Seroquel C 600 mg, QHS Klonopin C Date:08/25/03ISR Number: 4172819-6Report Type:Expedited (15-DaCompany Report #PHFR2003GB02502 Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Cholesterol Clozaril PS Novartis Sector: Increased Pharma ORAL 500mg/day Blood Triglycerides Hyoscine C TRANSDERMAL Increased Venlafaxine C ORAL 150mg/day Date:08/25/03ISR Number: 4172820-2Report Type:Expedited (15-DaCompany Report #PHHO2003CA09710 Age:45 YR Gender:Male I/FU:F Outcome PT Other Diabetes Mellitus Insulin-Dependent Drug Level Increased Electrocardiogram Qt Corrected Interval Prolonged Hepatic Failure Hepatitis C Polydipsia Polyuria 22-Feb-2006 08:30 AM Page: 2341 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Somnolence Urinary Incontinence Report Source Product Role Manufacturer Route Dose Duration Clozaril PS Novartis Sector: Pharma 50 mg, QD 1827 DAY Clozaril SS Novartis Sector: Pharma 200 mg, QHS 1827 DAY Lorazepam SS 2 mg, BID Insulin C Sertraline C 200 mg, UNK Colace C 100 mg, QD Lipitor C 10 mg, QD Ranitidine C 150 mg, BID Date:08/25/03ISR Number: 4172823-8Report Type:Expedited (15-DaCompany Report #PHNU2003DE03105 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Mallory-Weiss Syndrome Leponex / Clozaril Shock Haemorrhagic (Clozapine) PS Novartis Sector: Pharma ORAL up to 500 mg/day 77760MIN Date:08/25/03ISR Number: 4172824-XReport Type:Expedited (15-DaCompany Report #PHFR2003GB03191 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Clozaril PS Novartis Sector: Pharma ORAL 400 mg/day Clozaril SS Novartis Sector: Pharma 800mg overdose Date:08/25/03ISR Number: 4172827-5Report Type:Expedited (15-DaCompany Report #PHNR2003AU01225 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Diabetes Mellitus Clozaril PS Novartis Sector: Other Dystonia Pharma ORAL 12 - 600 Feeling Abnormal mg/day Suicidal Ideation Seroquel C up to 650 Weight Increased mg/day Citalopram C Valproate Sodium C Metformin C Anti-Asthmatics C Date:08/25/03ISR Number: 4173139-6Report Type:Expedited (15-DaCompany Report #PHNR2003AU01051 Age:22 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Helicobacter Infection Clozaril PS Novartis Sector: Initial or Prolonged Nausea Pharma ORAL 400 mg, QD Somnolence Amisulpride C ORAL Unspecified Vomiting 22-Feb-2006 08:30 AM Page: 2342 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/26/03ISR Number: 4173295-XReport Type:Expedited (15-DaCompany Report #PHEH2003US06342 Age:66 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Gastrointestinal Disorder Clozaril PS Novartis Sector: Initial or Prolonged Pulmonary Embolism Pharma ORAL 700 mg, QD Other Clozaril SS Novartis Sector: Pharma ORAL 100 mg, BID Date:08/26/03ISR Number: 4173384-XReport Type:Expedited (15-DaCompany Report #PHFR2003GB02661 Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Clozaril PS Novartis Sector: Initial or Prolonged Drop Attacks Pharma ORAL 400mg/day 947 DAY Other Drug Level Increased Dyspnoea Haemoptysis Mental Status Changes Myoclonic Epilepsy Date:08/26/03ISR Number: 4179519-7Report Type:Expedited (15-DaCompany Report #20030800001 Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatinine Other Ativan (Lorazepam) PS Initial or Prolonged Increased Clozapine (Clozaril) SS 75 MG DAILY Required Blood Sodium Increased Sertraline C Intervention to Blood Urea Increased Valproate Sodium C Prevent Permanent Dehydration Impairment/Damage Disease Recurrence Neuroleptic Malignant Syndrome Urinary Tract Infection White Blood Cell Count Increased Date:08/26/03ISR Number: 4179520-3Report Type:Expedited (15-DaCompany Report #200301950 Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Distension Foreign Imodium Rx Capsules Bacterial Toxaemia Health (Loperamide Hcl 2 Mg Drug Interaction Professional Per Capsule) Drug Level Above Other 2mg/Capsule PS ORAL 6 MG, PO Therapeutic Clozapine SS ORAL 500 MG DAILY Gastroenteritis PO Haematemesis Intra-Abdominal Haemorrhage Loss Of Consciousness Megacolon Melaena Necrotising Colitis Procedural Complication Procedural Hypotension Shock 22-Feb-2006 08:30 AM Page: 2343 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/27/03ISR Number: 4173768-XReport Type:Expedited (15-DaCompany Report #PHRM2003FR02204 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Skin Reaction Leponex PS Novartis Sector: Pharma ORAL Date:08/27/03ISR Number: 4174379-2Report Type:Expedited (15-DaCompany Report #PHNR2003AU01246 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Helicobacter Infection Clozaril PS Novartis Sector: Nausea Pharma 12 - 550 Vomiting mg/day Date:08/27/03ISR Number: 4174400-1Report Type:Expedited (15-DaCompany Report #PHBS2003IN07717 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Complications Of Maternal Clozapine PS Novartis Sector: Initial or Prolonged Exposure To Therapeutic Pharma UNKNOWN 12.5 mg/d Drugs Clozapine SS Novartis Sector: Oligohydramnios Pharma UNKNOWN 75 mg/d Pregnancy Clozapine SS Novartis Sector: Premature Baby Pharma UNKNOWN 50 mg/d Schizophrenia Clozapine SS Novartis Sector: Stillbirth Pharma UNKNOWN 62.5 mg/d Date:08/27/03ISR Number: 4174402-5Report Type:Expedited (15-DaCompany Report #PHFR2003GB02661 Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chest Pain Clozaril PS Novartis Sector: Drop Attacks Pharma ORAL 400mg/day Dyspnoea Haemoptysis Myoclonus Date:08/27/03ISR Number: 4174423-2Report Type:Expedited (15-DaCompany Report #PHFR2003GB02514 Age:23 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Pressure Increased Clozaril PS Novartis Sector: Medication Error Pharma ORAL 150mg/day Clozaril SS Novartis Sector: Pharma 150 mg, BID Haloperidol C 6 mg/day Date:08/27/03ISR Number: 4174427-XReport Type:Expedited (15-DaCompany Report #PHFR2003GB02234 Age:27 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Clozaril PS Novartis Sector: Urinary Tract Infection Pharma ORAL 225mg/day 84 DAY White Blood Cell Count Topiramate C ORAL 150mg/day Abnormal Valproate Sodium C ORAL 200mg/day 22-Feb-2006 08:30 AM Page: 2344 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/27/03ISR Number: 4174505-5Report Type:Expedited (15-DaCompany Report #PHFR2003GB03183 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Respiratory Arrest Clozaril PS Novartis Sector: Pharma ORAL Date:08/27/03ISR Number: 4174506-7Report Type:Expedited (15-DaCompany Report #PHBS2000AU12203 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Distension Clozaril (Clozapine) PS Novartis Sector: Anxiety Pharma ORAL UNK, UNK Arthralgia Clozaril (Clozapine) SS Novartis Sector: Blood Cholesterol Pharma ORAL 325 mg, QD Increased Terbutaline C Breast Pain Valproate Sodium C Diabetes Mellitus Pentacid C Dyspepsia Headache High Density Lipoprotein Decreased Hyperhidrosis Hypoglycaemia Influenza Like Illness Joint Stiffness Low Density Lipoprotein Increased Oedema Peripheral Pollakiuria Rheumatoid Arthritis Swollen Tongue Thirst Tremor Weight Increased Date:08/27/03ISR Number: 4178312-9Report Type:Expedited (15-DaCompany Report #03-08-1021 Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Foreign Clozapine Tablets PS ORAL ORAL Diabetes Mellitus Literature Tolbutamide C Drug Level Decreased Health Drug Toxicity Professional Mental Disorder Therapeutic Response Decreased Date:08/27/03ISR Number: 4178313-0Report Type:Expedited (15-DaCompany Report #03-08-1020 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Glucose Increased Foreign Clozapine Tablets PS ORAL 550 MG QD Glycosylated Haemoglobin Literature ORAL 5 YR Increased Health Paroxetine C Professional 22-Feb-2006 08:30 AM Page: 2345 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/27/03ISR Number: 4178321-XReport Type:Expedited (15-DaCompany Report #03-08-1019 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Clozapine Tablets PS ORAL 300MG QD ORAL Non-Insulin-Dependent Literature Weight Decreased Health Professional Date:08/27/03ISR Number: 4178338-5Report Type:Expedited (15-DaCompany Report #03-07-0885 Age:79 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Aspiration Health Clozapine-Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 25MG QHS ORAL Exelon 4.5mg Bid Oral C Colace Capsules 100mg Bid Oral C Aspirin Tablets 81mg W/Food Oral C Potassium Chloride 20meq Qd Oral C Lasix 40mg Qd Oral C Z-Bec Tablets Qd Oral C Flomax 0.4mg Qd Oral C Coumadin 7.5mg Qd Oral C Lanoxin Tablets 0.25mg Qd Oral C Combivent 2 Puffs Qid Inhalation C Zoloft 50mg Qhs Oral C Atrovent 500mg Qid Prn Inhalation C Albuterol Sulfate 0.5cc Qid Prn Inhalation C Milk Of Magnesia 30cc Prn Oral For Constipation C Tylenol 650mg Prn Oral For Pain C Pyridium 100mg Tid Prn Oral For Dysuria C Date:08/27/03ISR Number: 4178340-3Report Type:Expedited (15-DaCompany Report #03-07-0869 Age:75 YR Gender:Female I/FU:F Outcome PT Death Confusional State Coordination Abnormal Intestinal Obstruction Normal Pressure Hydrocephalus Renal Failure 22-Feb-2006 08:30 AM Page: 2346 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Urinary Incontinence Report Source Product Role Manufacturer Route Dose Duration Health Clozapine- Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 400MG QD ORAL Date:08/27/03ISR Number: 4178341-5Report Type:Expedited (15-DaCompany Report #03-08-1017 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Health Clozapine- Ivax Initial or Prolonged Mental Status Changes Professional Pharmaceuticals, Pyrexia Other Inc.Tablets PS Ivax Urinary Tract Infection Pharmaceuticals, Inc. ORAL 600MG QD ORAL Date:08/27/03ISR Number: 4178352-XReport Type:Expedited (15-DaCompany Report #03-08-1011 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acute Respiratory Health Clozapine- Ivax Initial or Prolonged Distress Syndrome Professional Pharmaceuticals, Urosepsis Other Inc. PS Ivax Pharmaceuticals, Inc. ORAL 200MG QD ORAL Prolixin C Ativan C Depakote C Synthroid C Lipitor C Protonix C Humalog C Zestril C Actos C Date:08/27/03ISR Number: 4178362-2Report Type:Expedited (15-DaCompany Report #03-08-1010 Age:66 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Clozapine-Ivax Other Congestive Professional Pharmaceuticals, Pneumonia Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 12.5-350MG QD ORAL Date:08/27/03ISR Number: 4178364-6Report Type:Expedited (15-DaCompany Report #03-08-0999 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chromosome Analysis Consumer Clozapine Tablets - Abnormal Ivax Chronic Myeloid Leukaemia Pharmaceuticals, Inc. PS Ivax 22-Feb-2006 08:30 AM Page: 2347 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pharmaceuticals, Inc. ORAL 700MG QD ORAL Date:08/27/03ISR Number: 4178365-8Report Type:Expedited (15-DaCompany Report #03-08-0997 Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozapine-Ivax Professional Pharmaceuticals, Other Inc.Tablets PS Ivax Pharmaceuticals, Inc. ORAL 200MG QD ORAL Date:08/27/03ISR Number: 4178366-XReport Type:Expedited (15-DaCompany Report #03-08-0986 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Other Clozapine - Ivax Initial or Prolonged Pharmaceuticals Inc. Tablets PS ORAL 100-500 MG QD ORAL Date:08/27/03ISR Number: 4178367-1Report Type:Expedited (15-DaCompany Report #03-08-0984 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Breast Tenderness Literature Clozapine Tablets PS ORAL 25-150 MG QD Initial or Prolonged Chest Discomfort Health ORAL 10 WK Other Diabetic Ketoacidosis Professional Lorazepam C Dyspnoea Risperidone C Glycosylated Haemoglobin Benztropine Mesylate C Increased Multivitamins C Hyperventilation Calcium C Lethargy Medroxyprogesterone C Metrorrhagia Muscle Spasms Nausea Vomiting Weight Decreased Date:08/27/03ISR Number: 4178369-5Report Type:Expedited (15-DaCompany Report #03-08-0981 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Lung Neoplasm Malignant Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Other Inc. Tablets PS ORAL 300 MG QD ORAL Date:08/27/03ISR Number: 4178370-1Report Type:Expedited (15-DaCompany Report #03-08-0969 Age:42 YR Gender:Male I/FU:I Outcome PT Hospitalization - Agranulocytosis Initial or Prolonged Oral Intake Reduced Other Oropharyngeal Swelling Peritonsillar Abscess 22-Feb-2006 08:30 AM Page: 2348 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pharyngitis Streptococcal Report Source Product Role Manufacturer Route Dose Duration Health Clozapine - Ivax Professional Pharmaceuticals, Inc. Tablets PS ORAL 150 MG QD ORAL Date:08/27/03ISR Number: 4178371-3Report Type:Expedited (15-DaCompany Report #03-07-0885 Age:79 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Aspiration Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 25 MG QD ORAL Exelon C Colace Capsules C Aspirin C Potassium Chloride C Lasix C Z-Bec Tablets C Flomax C Coumadin C Lanoxin C Combivent C Zoloft C Atrovent C Albuterol Sulfate C Milk Of Magenesia C Tylenol C Pyridium C Date:08/27/03ISR Number: 4178380-4Report Type:Expedited (15-DaCompany Report #03-06-0772 Age:91 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Health Clozapin-Ivax Professional Pharmaceuticals, Other Inc.Tablets PS ORAL 25-75 MG QD ORAL Date:08/27/03ISR Number: 4178830-3Report Type:Expedited (15-DaCompany Report #C2003-2079.01 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg Mylan PS ORAL 25MG/DAY, Other THEN 50MG/DAY, ORAL Date:08/28/03ISR Number: 4175026-6Report Type:Expedited (15-DaCompany Report #PHFR2003GB03299 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Accidental Exposure Clozaril PS Novartis Sector: Somnolence Pharma ORAL 2880 MIN 22-Feb-2006 08:30 AM Page: 2349 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/28/03ISR Number: 4175028-XReport Type:Expedited (15-DaCompany Report #PHNR2003AU01255 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Balance Disorder Clozaril PS Novartis Sector: Blood Ph Increased Pharma 25 - 125 Blood Potassium Increased mg/day 30240MIN Body Temperature Increased C-Reactive Protein Increased Chest Pain Dizziness Haemoglobin Decreased Headache Infection Orthostatic Hypotension Sedation Tachycardia Troponin Increased Date:08/28/03ISR Number: 4175049-7Report Type:Expedited (15-DaCompany Report #PHRM2003FR02220 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Haemoglobin Decreased Leponex PS Novartis Sector: Initial or Prolonged Neuroleptic Malignant Pharma ORAL 600 mg daily Syndrome Date:08/28/03ISR Number: 4175367-2Report Type:Expedited (15-DaCompany Report #PHHO2003CA10257 Age:27 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Binge Eating Clozaril PS Novartis Sector: Weight Increased Pharma ORAL UNK, UNK Synthroid C Venlafaxine C ORAL 300 mg, QD Metamucil "Procter & Gamble" C Date:08/28/03ISR Number: 4181129-2Report Type:Expedited (15-DaCompany Report #03-08-1031 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Gastrointestinal Disorder Health Clozapine - Ivax Hyperglycaemia Professional Pharmaceuticals, Renal Failure Other Inc. Tablets PS Ivax Pharmaceuticals, Inc ORAL 400-1000MG QD; ORAL Date:08/28/03ISR Number: 4181447-8Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030803798 Age:47 YR Gender:Female I/FU:I Outcome PT Hospitalization - Asthenia Initial or Prolonged Dizziness Drug Interaction Drug Level Increased 22-Feb-2006 08:30 AM Page: 2350 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Heart Rate Increased Psychotic Disorder Somnolence Report Source Product Role Manufacturer Route Dose Duration Therapy Non-Responder Literature Modicon Health (Ethynylestradiol/No Professional rethindrone) Tablets PS 1 DOSE(S), 1 IN 1 DAY Clozapine (Clozapine) SS Date:08/29/03ISR Number: 4175833-XReport Type:Expedited (15-DaCompany Report #PHNR2003AU01210 Age:25 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dilatation Ventricular Clozaril PS Novartis Sector: Dyspnoea Pharma ORAL 12.5 - Echocardiogram Abnormal 500mg/day 534 DAY Ejection Fraction Decreased Sinus Tachycardia Date:08/29/03ISR Number: 4175968-1Report Type:Expedited (15-DaCompany Report #PHFR2003GB03291 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Choking Clozaril PS Novartis Sector: Pharma ORAL Date:08/29/03ISR Number: 4175969-3Report Type:Expedited (15-DaCompany Report #PHNU2003DE03159 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fatigue Leponex / Clozaril Initial or Prolonged Hallucination (Clozapine) PS Novartis Sector: Other Intentional Overdose Pharma ORAL 10000 mg, Restlessness ONCE/SINGLE 1440 MIN Suicide Attempt Date:08/29/03ISR Number: 4175974-7Report Type:Expedited (15-DaCompany Report #PHFR2003GB03316 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abscess Clozaril PS Novartis Sector: Initial or Prolonged Diabetes Mellitus Pharma ORAL Other Non-Insulin-Dependent Date:08/29/03ISR Number: 4176036-5Report Type:Expedited (15-DaCompany Report #SE-GLAXOSMITHKLINE-B0113350A Age:34 YR Gender:Male I/FU:F Outcome PT Hospitalization - Abdominal Pain Initial or Prolonged Anuria Azotaemia Blood Creatinine Increased Chills 22-Feb-2006 08:30 AM Page: 2351 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Clostridium Colitis Haemodialysis Liver Function Test Report Source Product Role Manufacturer Route Dose Duration Abnormal Cefuroxime Sodium PS Glaxosmithkline INTRAVENOUS 2.2G per day 10 DAY Neuroleptic Malignant Allopurinol SS Glaxosmithkline UNKNOWN Syndrome Clozapine SS ORAL 300MG per day YR Pneumonia Temesta C Psychotic Disorder Pyrexia Rash Refusal Of Treatment By Patient Renal Tubular Necrosis Rhabdomyolysis Sepsis Vomiting Date:08/29/03ISR Number: 4181399-0Report Type:Expedited (15-DaCompany Report #C2003-2090.01 Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Other Clozapine Tablets 25 Mg Mylan PS Mylan ORAL 50MG QD, ORAL Clozapine Tablets 100 Mg Mylan SS Mylan ORAL 150MG QHS, ORAL Acetaminophen C Albuterol Sulfate C Eye Drops C Gabapentin C Lamotrigine C Levofloxacin C Lorazepam C Morphine Sulfate Oral Solution C Phenytoin Sodium C Vitamin B12 Injection C Date:08/29/03ISR Number: 4181400-4Report Type:Expedited (15-DaCompany Report #C2003-2134.01 Age:86 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 25MG Q HS, Other ORAL Citalopram Hydrobromide C Enalapril C Furosemide C Lorazepam C Potassium Chloride C Rivastigmine Tartrate C 22-Feb-2006 08:30 AM Page: 2352 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/29/03ISR Number: 4181401-6Report Type:Expedited (15-DaCompany Report #C2003-1962.01 Age:82 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 12.5MG Q AM, Other ORAL Clozapine Tablets 100 Mg Mylan SS Mylan ORAL 100MG QAM, ORAL Atorvastatin Calcium C Eye Ointment C Famotidine C Lactulose C Levoflaxacin C Mirtazapine C Oxycodone Hcl C Rivastigmine Tartrate C Rofecoxib C Trazodone Hcl C Date:08/29/03ISR Number: 4181402-8Report Type:Expedited (15-DaCompany Report #C2003-1845.01 Age:69 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Atherosclerosis Health Clozapine Tablets Cardiac Failure Professional 100 Mg PS ORAL 100MG Q HS, Congestive Other ORAL Pneumonia Clozapine Tablets 25 Sudden Death Mg SS ORAL 25MG QHS, ORAL Docusate Sodium C Date:08/29/03ISR Number: 4181403-XReport Type:Expedited (15-DaCompany Report #C2003-1876.01 Age:49 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coma Health Clozapine Tablets Sudden Death Professional 100 Mg Mylan PS Mylan ORAL 100 MG Q AM & Other 4PM, 400MG Q HS, ORAL Benztropine C Clonazepam C Divalproex Sodium C Escitalopram C Prenatal Vitamin (Qd) C Date:08/29/03ISR Number: 4181404-1Report Type:Expedited (15-DaCompany Report #C2003-1431.01 Age:60 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Neoplasm Malignant Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan 700MG/DAY Other 22-Feb-2006 08:30 AM Page: 2353 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/29/03ISR Number: 4182659-XReport Type:Expedited (15-DaCompany Report #2003AP02805 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Dystonia Foreign Seroquel PS ORAL 550 MG PO Malaise Consumer Seroquel SS ORAL 650 MG PO Suicidal Ideation Other Clozapine SS ORAL 25 MG PO Clozapine SS ORAL 100 MG PO Cipramil C Epilim C Diabex C Flixotide "Allen & Hanburys" C Oxis C Ventolin C Date:09/02/03ISR Number: 4176794-XReport Type:Expedited (15-DaCompany Report #PHFR2003GB02834 Age:54 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Body Temperature Clozaril PS Novartis Sector: Decreased Pharma ORAL 200mg/day Circulatory Collapse Metformin C ORAL Depressed Level Of Consciousness Eosinophil Count Increased Hypersomnia Malaise Orthostatic Hypotension Date:09/02/03ISR Number: 4176979-2Report Type:Expedited (15-DaCompany Report #PHFR2003IE03308 Age:39 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Complications Of Maternal Clozaril PS Novartis Sector: Exposure To Therapeutic Pharma ORAL Drugs Diabetes Mellitus Drug Exposure During Pregnancy Date:09/02/03ISR Number: 4177334-1Report Type:Expedited (15-DaCompany Report #PHFR2003GB03339 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Clozaril PS Novartis Sector: Initial or Prolonged Phosphokinase Increased Pharma Overdose Renal Impairment Date:09/02/03ISR Number: 4183637-7Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20030805071 Age:43 YR Gender:Male I/FU:I Outcome Life-Threatening Hospitalization - Initial or Prolonged 22-Feb-2006 08:30 AM Page: 2354 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Disability Other PT Report Source Product Role Manufacturer Route Dose Duration Cardio-Respiratory Arrest Foreign Risperdal Circulatory Collapse Health (Risperidone) PS ORAL 4 MG, 1 IN 1 Myocardial Infarction Professional DAY, ORAL Ventricular Fibrillation Clozapine (Clozapine) SS ORAL 800 MG, 1 IN 1 DAY, ORAL Date:09/02/03ISR Number: 4183640-7Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20030805070 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebral Infarction Foreign Risperdal Life-Threatening Cerebrovascular Accident Health (Risperidone) PS ORAL 4 MG, IN 1 Circulatory Collapse Professional DAY, ORAL Dizziness Clozapine Orthostatic Hypotension (Clozapine) SS ORAL 625 MG, IN 1 DAY, ORAL Desmopressin (Desmopressin) C Metformin (Metformin) C Lansoprazole (Lansoprazole) C Lorazepam (Lorazepam) C Date:09/02/03ISR Number: 4183716-4Report Type:Expedited (15-DaCompany Report #DSA_23142_2002 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Foreign Tavor PS ORAL 2 TAB ONCE PO Initial or Prolonged Somnolence Health Clozapine SS ORAL 4 TAB ONCE PO Tachycardia Professional Fevarin SS ORAL 1 TAB ONCE PO Other Date:09/03/03ISR Number: 4177726-0Report Type:Expedited (15-DaCompany Report #PHBS2001NZ09465 Age:57 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Clozaril PS Novartis Sector: Hospitalization - Drug Interaction Pharma ORAL 200 mg/day 47520MIN Initial or Prolonged Valproate Sodium C UNKNOWN 1500 mg/day Combivent C UNKNOWN Synermox C Olanzapine I UNKNOWN 10 mg/day Date:09/03/03ISR Number: 4177929-5Report Type:Expedited (15-DaCompany Report #PHBS2003BR08645 Age:24 YR Gender:Male I/FU:F Outcome PT Other Abdominal Pain Upper Asthenia Confusional State Constipation 22-Feb-2006 08:30 AM Page: 2355 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Diarrhoea Eye Pain Headache Report Source Product Role Manufacturer Route Dose Duration Insomnia Leponex PS Novartis Sector: Nausea Pharma ORAL 100 mg, QID Somnolence Leponex SS Novartis Sector: Toothache Pharma ORAL 200 mg/d Treatment Noncompliance Vomiting Weight Decreased Date:09/03/03ISR Number: 4177961-1Report Type:Expedited (15-DaCompany Report #PHNR2003AU01269 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alveolitis Clozaril PS Novartis Sector: Interstitial Lung Disease Pharma ORAL 12.5 mg, QD Clozaril SS Novartis Sector: Pharma ORAL 150 mg, QD Clozaril SS Novartis Sector: Pharma ORAL 300 mg, QD Clozaril SS Novartis Sector: Pharma ORAL 400 mg, QD Clozaril SS Novartis Sector: Pharma ORAL 600 mg, QD Clozaril SS Novartis Sector: Pharma ORAL 400 mg, QD Clozaril SS Novartis Sector: Pharma ORAL 350 mg, QD Clozaril SS Novartis Sector: Pharma ORAL 400 mg, QD Date:09/03/03ISR Number: 4177974-XReport Type:Expedited (15-DaCompany Report #PHFR2002GB02050 Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Mass Clozaril PS Novartis Sector: Other Anaemia Pharma ORAL 300mg/day Ascites Lorazepam C ORAL 4mg/day Breast Cancer Recurrent Malaise Platelet Count Increased Vomiting Weight Decreased Date:09/03/03ISR Number: 4183531-1Report Type:Expedited (15-DaCompany Report #C2003-2163.01 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 25MG QHS, Other ORAL 22-Feb-2006 08:30 AM Page: 2356 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/03/03ISR Number: 4184527-6Report Type:Expedited (15-DaCompany Report #2003029635 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Health Lipitor Initial or Prolonged Neutrophil Count Professional (Atorvastatin) PS ORAL 10 MG Decreased (DAILY), ORAL Urinary Tract Infection Clozapine Vasculitis (Clozapine) SS ORAL 100 MG (DAILY), ORAL Alendronate Sodium (Alendroante Sodium) SS ORAL 35 MG(WEEKLY), ORAL Haloperidol (Haloperidol) C Valproate Semisodium (Valproate Semisodium) C Benzatropine Mesilate (Benzatropine Mesilate) C Diphenhydramine (Diphenhydramine) C Multivitamins W/Minerals (Vitamins Nos, Minerals Nos) C Calcium Citrate (Calcium Citrate) C Ergocalciferol (Ergocalciferol) C Date:09/03/03ISR Number: 4186182-8Report Type:Expedited (15-DaCompany Report #C2003-1687.01 Age:53 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional 100 Mg Mylan PS ORAL 100MG Q AM, Other 300MG Q PM, ORAL Date:09/04/03ISR Number: 4179024-8Report Type:Expedited (15-DaCompany Report #PHNR2003AU01186 Age:60 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthma Clozaril PS Novartis Sector: Cardiac Failure Pharma ORAL 12 - 300 Dyspnoea mg/day Mental Disorder Clozaril SS Novartis Sector: Pulmonary Oedema Pharma ORAL 12.5 - 400 mg/day Clozaril SS Novartis Sector: Pharma ORAL 300 mg/day 22-Feb-2006 08:30 AM Page: 2357 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/04/03ISR Number: 4179025-XReport Type:Expedited (15-DaCompany Report #PHEH2003US07760 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Clozaril PS Novartis Sector: Insulin-Dependent Pharma ORAL UNK,UNK Diabetic Ketoacidosis Date:09/04/03ISR Number: 4179028-5Report Type:Expedited (15-DaCompany Report #PHRM2003FR02245 Age:80 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Overdose Leponex PS Novartis Sector: Initial or Prolonged Medication Error Pharma ORAL 200 mg, ONCE/SINGLE 1440 MIN Date:09/04/03ISR Number: 4179033-9Report Type:Expedited (15-DaCompany Report #PHFR2003GB02524 Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abnormal Behaviour Clozaril PS Novartis Sector: Other Aggression Pharma ORAL Cardiac Arrest Valproate Sodium C Convulsion Diazepam C Dyspnoea Respiratory Arrest Date:09/04/03ISR Number: 4179036-4Report Type:Expedited (15-DaCompany Report #PHNU2003DE03193 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Leponex / Clozaril Increased (Clozapine) PS Novartis Sector: Aspartate Pharma ORAL Aminotransferase Leponex / Clozaril Increased (Clozapine) SS Novartis Sector: Blood Alkaline Pharma ORAL Phosphatase Increased Cisplatin C 4320 MIN Gamma-Glutamyltransferase 5-Fluorouracil Increased "Biosyn" C 4320 MIN Gastric Cancer Liver Function Test Abnormal Metastases To Peritoneum Date:09/04/03ISR Number: 4179082-0Report Type:Expedited (15-DaCompany Report #PHNU2003DE01704 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Immunoglobulin G Leponex / Clozaril Decreased (Clozapine) PS Novartis Sector: Blood Immunoglobulin M Pharma ORAL 300 mg/day Decreased Immunoglobulins Decreased Pneumonia 22-Feb-2006 08:30 AM Page: 2358 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/04/03ISR Number: 4184675-0Report Type:Expedited (15-DaCompany Report #C2003-2162.01 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 100MG Q AM, Other 200MG Q PM, ORAL Benztropine C Ipratropium And Albuterol (Nebulizer) C Ipratropium And Albuterol (Inhaler) C Lorazepam C Magnesium Hydroxide C Morphine Sulfate C Olanzapine C Pantroprazole C Vitamins And Minerals C Date:09/05/03ISR Number: 4180089-8Report Type:Expedited (15-DaCompany Report #PHBS2003FR09193 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Clozapine PS Novartis Sector: Initial or Prolonged Body Mass Index Increased Pharma UNKNOWN Condition Aggravated Insulin C UNKNOWN 1.2 Ul/Kg/day Diabetes Mellitus Glycosylated Haemoglobin Increased Hyperglycaemia Polydipsia Polyuria Weight Increased Date:09/05/03ISR Number: 4180090-4Report Type:Expedited (15-DaCompany Report #PHFR2003IE01890 Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Clozaril PS Novartis Sector: Pharma ORAL 500 mg/day Sulpiride C ORAL 200mg/day Date:09/05/03ISR Number: 4180091-6Report Type:Expedited (15-DaCompany Report #PHFR2003GB03348 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebral Infarction Clozapine PS Novartis Sector: Cerebrovascular Accident Pharma ORAL 625mg/day Circulatory Collapse Risperdal SS ORAL 4mg/day Dizziness Desmopressin C ORAL 200ug/day Orthostatic Hypotension Metformin C ORAL 850 mg, TID Lansoprazole C ORAL 30mg/day Lorazepam C ORAL 0.5mg/day 22-Feb-2006 08:30 AM Page: 2359 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/05/03ISR Number: 4180109-0Report Type:Expedited (15-DaCompany Report #PHFR2003GB03341 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Clozaril (Clozapine) PS Novartis Sector: Ketoacidosis Pharma ORAL Date:09/08/03ISR Number: 4180752-9Report Type:Expedited (15-DaCompany Report #PHBS2003NL09322 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anorexia Clozapine PS Novartis Sector: Chills Pharma UNKNOWN 500 mg/d Drug Level Increased Clozapine SS Novartis Sector: Feeling Abnormal Pharma UNKNOWN 600 mg/d Infection Lansoprazole C UNKNOWN 60 mg/d Influenza Like Illness Oxazepam I UNKNOWN 100 to 200 Labile Blood Pressure mg/d Leukocytosis Pallor Pulse Pressure Decreased Pyrexia Red Blood Cell Sedimentation Rate Increased Reflux Oesophagitis Somatoform Disorder Vomiting Date:09/08/03ISR Number: 4180755-4Report Type:Expedited (15-DaCompany Report #PHBS2003NL09326 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Upper Clozapine PS Novartis Sector: Diarrhoea Pharma UNKNOWN 600 mg/d Drug Level Increased Clozapine SS Novartis Sector: Feeling Abnormal Pharma UNKNOWN 500 mg/d Incontinence Pyrexia Red Blood Cell Sedimentation Rate Increased Viral Infection Date:09/08/03ISR Number: 4180771-2Report Type:Expedited (15-DaCompany Report #PHFR2003GB03371 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Appendicitis Perforated Clozaril (Clozapine) PS Novartis Sector: Initial or Prolonged Pharma ORAL Date:09/08/03ISR Number: 4180797-9Report Type:Expedited (15-DaCompany Report #PHRM2003FR02288 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Leponex PS Novartis Sector: Drug Interaction Pharma ORAL 75mg/day Treatment Noncompliance Leponex SS Novartis Sector: 22-Feb-2006 08:30 AM Page: 2360 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pharma ORAL 300-400 mg/day Depakine SS ORAL Atarax C UNKNOWN Date:09/08/03ISR Number: 4180798-0Report Type:Expedited (15-DaCompany Report #PHFR2003GB03374 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Akathisia Clozaril (Clozapine) PS Novartis Sector: Diabetes Mellitus Pharma ORAL Electrocardiogram Qt Venlafaxine C UNKNOWN Prolonged Insomnia Date:09/08/03ISR Number: 4181092-4Report Type:Expedited (15-DaCompany Report #PHNU2003DE03227 Age:77 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Haemoglobin Decreased Leponex / Clozaril (Clozapine) PS Novartis Sector: Pharma ORAL up to 300mg/day Date:09/08/03ISR Number: 4186618-2Report Type:Expedited (15-DaCompany Report #C2003-2079.01 Age:69 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Aspiration Health Clozapine Tabelts 25 Professional Mg Mylan PS Mylan ORAL 25 MG/DAY, Other THEN 50 MG/DAY, ORAL Albuterol C Clorazepate C Diazepam C Docusate C Guaifenesin C Hyoscyamine C Lorazepam C Morphine C Bromocriptine C Levofloxacin C Date:09/09/03ISR Number: 4181233-9Report Type:Expedited (15-DaCompany Report #PHNR2003AU01282 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Toxicity Clozaril PS Novartis Sector: Pharma 25mg - 550 mg Citalopram SS Quetiapine SS Paracetamol SS 22-Feb-2006 08:30 AM Page: 2361 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/09/03ISR Number: 4181239-XReport Type:Expedited (15-DaCompany Report #PHEH2003US07940 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Aspiration Clozaril PS Novartis Sector: Pharma 50 mg, BID Date:09/09/03ISR Number: 4181241-8Report Type:Expedited (15-DaCompany Report #PHEH2003US07251 Age:41 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hepatic Neoplasm Clozaril PS Novartis Sector: Malignant Pharma ORAL 200 mg, QD Leukocytosis Simethicone C Sedation Celexa C Tardive Dyskinesia Lithium C Klonopin C Detrol C Hypotears C Vistaril C Tylenol C Nicotrol C Date:09/09/03ISR Number: 4181262-5Report Type:Expedited (15-DaCompany Report #PHFR2003GB02789 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Body Temperature Clozaril PS Novartis Sector: Initial or Prolonged Increased Pharma ORAL 200 mg/day Other Drug Toxicity Clozaril SS Novartis Sector: Electroencephalogram Pharma ORAL 187.5mg/day Abnormal Eye Rolling Myoclonic Epilepsy Pneumonia Sleep Apnoea Syndrome Tracheal Atresia Tracheal Disorder Date:09/09/03ISR Number: 4181263-7Report Type:Expedited (15-DaCompany Report #PHFR2003GB03392 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Clozaril PS Novartis Sector: Non-Insulin-Dependent Pharma ORAL Date:09/09/03ISR Number: 4181357-6Report Type:Expedited (15-DaCompany Report #PHBS2003DK09584 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Congestive Cardiomyopathy Leponex PS Novartis Sector: Hospitalization - Ejection Fraction Pharma ORAL 450 mg/d Initial or Prolonged Ejection Fraction Disability Decreased Ventricular Tachycardia 22-Feb-2006 08:30 AM Page: 2362 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/09/03ISR Number: 4181366-7Report Type:Expedited (15-DaCompany Report #PHBS2002NO10793 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Leponex PS Novartis Sector: Cardiomegaly Pharma ORAL 400 mg/d Dyspnoea Plendil C UNKNOWN 10 mg/d Myocardial Infarction Palpitations Date:09/09/03ISR Number: 4197457-0Report Type:Periodic Company Report #03-08-1049 Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Gastrointestinal Health Clozapine - Ivax Hospitalization - Haemorrhage Professional Pharmaceuticals, Initial or Prolonged Intestinal Obstruction Other Inc. Tablets PS ORAL 200-400MG QD ORAL Date:09/09/03ISR Number: 4197458-2Report Type:Periodic Company Report #03-08-0935 Age:46 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anorexia Health Clozapine - Ivax Initial or Prolonged Delirium Professional Pharmaceuticals, Hallucination Other Inc. Tablets PS ORAL 125-500MG QD Hypoglycaemia ORAL Vasodilatation Geodon Capsules C Loxapine Capsules C Diazepam Tablets C Benztropine Mesylate Tablets C Paxil Tablets Cr C Lorazepam Tablets C Propranolol Tablets C Fleet Enema C Date:09/09/03ISR Number: 4208126-2Report Type:Periodic Company Report #03-08-1048 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mania Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 125-150 MG QD ORAL Date:09/09/03ISR Number: 4208131-6Report Type:Periodic Company Report #03-08-0969 Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abscess Health Clozapine -Ivax Initial or Prolonged Agranulocytosis Professional Pharmaceuticals, Other Dyspnoea Inc. Tablets PS ORAL 100MG AM ORAL Required Myalgia Cogentin C Intervention to Pharyngitis Prevent Permanent Pyrexia Impairment/Damage 22-Feb-2006 08:30 AM Page: 2363 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/09/03ISR Number: 4208134-1Report Type:Periodic Company Report #03-04-0490 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Ineffective Health Clonazepam - Ivax Drug Level Increased Professional Pharmaceuticals, Inc. Tablets PS ORAL SEE IMAGE ORAL Fluphenazine Tablets SS ORAL 15 MG QHS ORAL Docusate C Artane C Vitamin E C Tolterodine La C Klonopin C Date:09/10/03ISR Number: 4183025-3Report Type:Expedited (15-DaCompany Report #PHFR2003GB03459 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Loss Of Consciousness Clozaril PS Novartis Sector: Initial or Prolonged Transient Ischaemic Pharma ORAL Other Attack Date:09/10/03ISR Number: 4183026-5Report Type:Expedited (15-DaCompany Report #PHBS2003NZ09438 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Discomfort Clozaril PS Novartis Sector: Initial or Prolonged Constipation Pharma ORAL 400 mg/d Drug Level Increased Terazosin C ORAL 2 mg/d Gastritis Liver Function Test Abnormal Rectal Haemorrhage Date:09/10/03ISR Number: 4183036-8Report Type:Expedited (15-DaCompany Report #PHFR2003GB03438 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Adverse Drug Reaction Clozaril PS Novartis Sector: Bradyphrenia Pharma ORAL 50mg/day 40320MIN Date:09/10/03ISR Number: 4183111-8Report Type:Expedited (15-DaCompany Report #PHNR2003AU01315 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Clozaril PS Novartis Sector: Increased Pharma Drug Level Increased Eosinophil Count Increased Hepatic Steatosis Lymphocyte Count Increased White Blood Cell Count Increased 22-Feb-2006 08:30 AM Page: 2364 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/10/03ISR Number: 4183115-5Report Type:Expedited (15-DaCompany Report #PHFR2003IE02599 Age:25 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dystonia Clozaril PS Novartis Sector: Eye Movement Disorder Pharma ORAL 600mg/day Eye Rolling Tremor Date:09/10/03ISR Number: 4186743-6Report Type:Direct Company Report #CTU 201587 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Disease Recurrence Clozapine - 100 Mg Intervention to Pharmaceutical Product Zenith PS Zenith ORAL 800 MG QHS PO Prevent Permanent Complaint Impairment/Damage Date:09/10/03ISR Number: 4187781-XReport Type:Expedited (15-DaCompany Report #C2003-2237.01 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional 100 Mg Mylan PS ORAL 200MG Q AM, Other 300MG Q HS ORAL Date:09/11/03ISR Number: 4183350-6Report Type:Expedited (15-DaCompany Report #PHFR2003GB03455 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Clozaril PS Novartis Sector: Somnolence Pharma ORAL 300mg/day Date:09/11/03ISR Number: 4183880-7Report Type:Expedited (15-DaCompany Report #PHHO2003CA06099 Age:23 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Clozaril PS Novartis Sector: Other Diabetes Mellitus Pharma Unknown 366 DAY Insulin-Dependent Glucose Urine Date:09/11/03ISR Number: 4183903-5Report Type:Expedited (15-DaCompany Report #PHHO2003CA08566 Age:45 YR Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Clostridial Infection Clozaril PS Novartis Sector: Hospitalization - Enterocolitis Infectious Pharma ORAL 550 UNK, QD Initial or Prolonged Intestinal Obstruction Paxil SS Quetiapine C Neurontin C 300 UNK, TID 22-Feb-2006 08:30 AM Page: 2365 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/11/03ISR Number: 4186941-1Report Type:Direct Company Report #CTU 201635 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Convulsion Clozapine 100 Mg PS ORAL 100 MG 1AM4HS Intervention to ORAL Prevent Permanent Impairment/Damage Date:09/11/03ISR Number: 4186972-1Report Type:Direct Company Report #CTU 201628 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Petit Mal Epilepsy Clozapine 25 Mg PS ORAL 25 MG TID Intervention to ORAL Prevent Permanent Clozapine 100 Mg SS ORAL 100 MG ORAL Impairment/Damage Date:09/11/03ISR Number: 4187357-4Report Type:Direct Company Report #CTU 201604 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Clozapine PS SEE IMAGE Initial or Prolonged Pericarditis Lithium (Roxane) SS Roxane SEE IMAGE Lithium (Roxane) SS Roxane Pepcid SS SEE IMAGE Date:09/12/03ISR Number: 4184684-1Report Type:Expedited (15-DaCompany Report #PHNU2003DE02248 Age:23 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abnormal Faeces Health Clozapine PS Novartis Sector: Other Alanine Aminotransferase Professional Pharma ORAL up to 400 Increased mg/day 36000MIN Aspartate Clozapine SS Novartis Sector: Aminotransferase Pharma ORAL 300mg/day 4320 MIN Increased Akineton C UNKNOWN Blood Bilirubin Increased Haldol "Janssen" C ORAL Body Temperature Trileptal "Novartis" I ORAL Increased Tavor I ORAL C-Reactive Protein Increased Cardiac Failure Cholecystitis Chromaturia Death Diarrhoea Drug Level Increased Encopresis Enuresis Inflammation Lipase Increased Myocarditis Pharyngolaryngeal Pain Salivary Hypersecretion Sudden Death Ultrasound Abdomen Abnormal 22-Feb-2006 08:30 AM Page: 2366 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/12/03ISR Number: 4184690-7Report Type:Expedited (15-DaCompany Report #PHBS2002AU04756 Age:79 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiopulmonary Failure Health Clozaril PS Novartis Sector: Cough Professional Pharma ORAL 150 mg, BID Pneumonia Temazepam C 10 mg nocte Pyrexia Paxam C 0.5 mg daily Respiratory Tract Infection Date:09/12/03ISR Number: 4185413-8Report Type:Expedited (15-DaCompany Report #PHFR2003GB03183 Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Potassium Decreased Health Clozaril PS Novartis Sector: Drug Level Increased Professional Pharma ORAL 500mg/day Hypoventilation Omeprazole C ORAL 20mg/day Respiratory Arrest Simvastatin C ORAL 10mg/day Respiratory Rate Gliclazide C ORAL 80mg/day Increased Bendrofluazide C ORAL 2.5mg/day Tachycardia Metformin C ORAL 1500mg/day Sando K C ORAL 2/DAY Date:09/12/03ISR Number: 4185433-3Report Type:Expedited (15-DaCompany Report #PHFR2003GB03291 Age:59 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asphyxia Health Clozaril PS Novartis Sector: Choking Professional Pharma ORAL 500mg/day 84 DAY Clozaril SS Novartis Sector: Pharma ORAL 550mg/day Zopiclone C ORAL 7.5mg/day 826 DAY Trimethoprim C ORAL 200mg/day 2880 MIN Thiamine C ORAL 100mg/day 772 DAY Date:09/12/03ISR Number: 4185434-5Report Type:Expedited (15-DaCompany Report #PHFR2003GB03316 Age:18 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abscess Health Clozaril PS Novartis Sector: Initial or Prolonged Diabetes Mellitus Professional Pharma ORAL Other Non-Insulin-Dependent Glycosylated Haemoglobin Increased Polydipsia Polyuria Weight Increased Date:09/12/03ISR Number: 4187801-2Report Type:Expedited (15-DaCompany Report #PHRM2003FR01566 Age:22 YR Gender:Female I/FU:F Outcome PT Hospitalization - Anaemia Initial or Prolonged Aplasia Other Bone Marrow Depression Crohn'S Disease Diarrhoea 22-Feb-2006 08:30 AM Page: 2367 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Haemoglobin Decreased Platelet Count Decreased Pyrexia Report Source Product Role Manufacturer Route Dose Duration Visual Acuity Reduced Leponex PS Novartis Sector: White Blood Cell Count Pharma ORAL 700 mg daily 164 DAY Decreased Pentasa "Ferring" SS ORAL 14400MIN Mopral SS ORAL 18720MIN Entocort C Xanax C Zoloft C ORAL 2 DF daily Date:09/12/03ISR Number: 4187803-6Report Type:Expedited (15-DaCompany Report #PHFR2000GB01993 Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Abscess Clozaril (Clozapine) PS Novartis Sector: Life-Threatening Abdominal Pain Pharma ORAL 650mg/day 1864 DAY Hospitalization - Appendicitis Perforated Lithium Carbonate C Initial or Prolonged Loss Of Consciousness Citalopram C Other Peritonitis Renal Failure Acute Sepsis Date:09/12/03ISR Number: 4187819-XReport Type:Expedited (15-DaCompany Report #PHFR2003GB03118 Age:46 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Angioneurotic Oedema Clozaril PS Novartis Sector: Initial or Prolonged Eye Disorder Pharma ORAL 125mg/mane& Face Oedema 150mg/nocte 25920MIN Nephritis Interstitial Co-Dydramol C UNKNOWN Periorbital Oedema Losartan C ORAL 50mg/day Somnolence Sanatogen C UNKNOWN Urinary Incontinence Date:09/12/03ISR Number: 4187823-1Report Type:Expedited (15-DaCompany Report #PHEH2003US08212 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Metastasis Clozaril PS Novartis Sector: Testis Cancer Pharma 250 mg, QHS Depakote C Date:09/12/03ISR Number: 4189798-8Report Type:Direct Company Report #CTU 201742 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pharmaceutical Product Clozaril PS 100 MG Complaint Reaction To Preservatives 22-Feb-2006 08:30 AM Page: 2368 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/15/03ISR Number: 4185720-9Report Type:Expedited (15-DaCompany Report #PHNU2003DE03295 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pharyngolaryngeal Pain Leponex / Clozaril Pyrexia (Clozapine) PS Novartis Sector: Viral Infection Pharma ORAL Date:09/15/03ISR Number: 4185726-XReport Type:Expedited (15-DaCompany Report #PHFR2003GB03514 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Faecaloma Clozaril PS Novartis Sector: Intestinal Ischaemia Pharma ORAL 1137 DAY Sudden Death Date:09/15/03ISR Number: 4185850-1Report Type:Expedited (15-DaCompany Report #WAES 0307USA01475 Age:49 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Health Fosamax PS Merck & Co., Inc ORAL 566 DAY Initial or Prolonged Neutrophil Count Professional Lipitor SS ORAL 292 DAY Other Decreased Clozaril SS ORAL 118 DAY Pyrexia Bactrim Ds Tablets SS ORAL Red Blood Cell Benztropine Mesylate C Sedimentation Rate Calcium Citrate And Increased Cholecalciferol C Urinary Tract Infection Diphenhydramine Vasculitis Hydrochloride C Divalproex Sodium C Haloperidol C INTRAMUSCULAR Minerals (Unspecified) And Vitamins (Unspecified) C Date:09/15/03ISR Number: 4189762-9Report Type:Expedited (15-DaCompany Report #03-09-1069 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Aspiration Health Clozapine Initial or Prolonged Professional Tablets-Ivax Other Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 50-350MG QD ORAL Date:09/15/03ISR Number: 4189763-0Report Type:Expedited (15-DaCompany Report #03-09-1065 Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acidosis Health Clozapine Initial or Prolonged Diabetes Mellitus Professional Tablets-Ivax Other Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 800-900MG QD 22-Feb-2006 08:30 AM Page: 2369 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL Date:09/15/03ISR Number: 4189766-6Report Type:Expedited (15-DaCompany Report #03-02-1068 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dialysis Health Clozapine Initial or Prolonged Renal Failure Professional Tablets-Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 50-600MG QD ORAL Date:09/15/03ISR Number: 4189767-8Report Type:Expedited (15-DaCompany Report #03-09-1070 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine Hospitalization - Pneumonia Aspiration Professional Tablets-Ivax Initial or Prolonged Urine Analysis Abnormal Other Pharmaceuticals, White Blood Cell Count Inc. PS Ivax Pharmaceuticals, Inc. ORAL 150MG BID ORAL Insulin 70/30 C Celebrex C Depakote C Dexedrine C Atrovent C Date:09/15/03ISR Number: 4189780-0Report Type:Expedited (15-DaCompany Report #03-09-1062 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Clozapine Initial or Prolonged Dehydration Professional Tablets-Ivax Schizophrenia Other Pharmaceuticals, Therapeutic Agent Inc. PS Ivax Toxicity Pharmaceuticals, Treatment Noncompliance Inc. ORAL 900MG QD ORAL Lithium SS Date:09/15/03ISR Number: 4189781-2Report Type:Expedited (15-DaCompany Report #03-09-1076 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pharmaceutical Product Health Clozapine Complaint Professional Tablets-Ivax White Blood Cell Count Pharmaceuticals, Decreased Inc. PS Ivax Pharmaceuticals, Inc. ORAL 75-475MG QD ORAL Chemotherapy SS 22-Feb-2006 08:30 AM Page: 2370 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/15/03ISR Number: 4189958-6Report Type:Expedited (15-DaCompany Report #C2003-2105.01 Age:24 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Operation Health Clozapine Tablets 25 Nasopharyngitis Professional Mg Mylan PS Mylan ORAL 25MG Q PM, Vomiting Other ORAL Clozapine Tablets 100 Mg Mylan SS Mylan ORAL 300MG Q AM, 400MG Q PM, ORAL Date:09/15/03ISR Number: 4189982-3Report Type:Expedited (15-DaCompany Report #03-05-0659 Age:73 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Myocardial Health Clozapine Tablets - Infarction Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 25MG BID ORAL Sinemet C Cardizem Cd C Macrodantin C Colace C Zoloft C Florinef C Prilosec C Date:09/16/03ISR Number: 4187499-3Report Type:Expedited (15-DaCompany Report #PHFR2003GB03534 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Clozaril PS Novartis Sector: Overdose Pharma ORAL 400 mg/day Clozaril SS Novartis Sector: Pharma 700 mg overdose Zimovane SS Date:09/16/03ISR Number: 4187505-6Report Type:Expedited (15-DaCompany Report #PHFR2002GB02050 Age:48 YR Gender:Female I/FU:F Outcome PT Death Abdominal Mass Hospitalization - Anaemia Initial or Prolonged Ascites Other Breast Cancer Recurrent Haemoglobin Decreased Malignant Neoplasm Progression Melaena Metastatic Neoplasm Oesophageal Ulcer Platelet Count Increased Pneumonia Vomiting Weight Decreased 22-Feb-2006 08:30 AM Page: 2371 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report White Blood Cell Count Increased Report Source Product Role Manufacturer Route Dose Duration Clozaril PS Novartis Sector: Pharma ORAL 300mg/day Lorazepam C ORAL 4mg/day Diclofenac C UNKNOWN Date:09/16/03ISR Number: 4187506-8Report Type:Expedited (15-DaCompany Report #PHFR2003GB02500 Age:18 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Clozaril PS Novartis Sector: Abnormal Pharma ORAL 101 DAY Electrocardiogram St Segment Elevation Heart Rate Increased Hypertension Malaise Date:09/16/03ISR Number: 4187509-3Report Type:Expedited (15-DaCompany Report #PHFR2003GB03455 Age:34 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Clozaril PS Novartis Sector: Overdose Pharma ORAL 300mg/day Somnolence Clozaril SS Novartis Sector: Treatment Noncompliance Pharma ORAL 10 x 100mg Date:09/16/03ISR Number: 4187527-5Report Type:Expedited (15-DaCompany Report #PHNU2003DE02822 Age:65 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Leponex / Clozaril Initial or Prolonged Increased (Clozapine) PS Novartis Sector: Other Aspartate Pharma ORAL up to 425 Aminotransferase mg/day 1255 DAY Increased Leponex / Clozaril Blood Creatine (Clozapine) SS Novartis Sector: Phosphokinase Increased Pharma ORAL Blood Creatine Glianimon C ORAL 23mg/day Phosphokinase Mb Blopress C ORAL 8mg/day Blood Creatine Pirenzepine C ORAL 75mg/day Phosphokinase Mb L-Thyroxin "Henning Increased Berlin" C ORAL 100A?g/day Blood Lactate Dehydrogenase Increased Liver Function Test Abnormal Pyrexia Sinusitis 22-Feb-2006 08:30 AM Page: 2372 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/16/03ISR Number: 4191213-5Report Type:Expedited (15-DaCompany Report #03-09-1102 Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Chronic Obstructive Health Clozapine Tablets - Pulmonary Disease Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 12.5-300MG QD ORAL 3 YR Date:09/16/03ISR Number: 4191221-4Report Type:Expedited (15-DaCompany Report #03-09-1101 Age:76 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 12.5-300MG QD ORAL Date:09/16/03ISR Number: 4191228-7Report Type:Expedited (15-DaCompany Report #C2003-2311.01 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 125MG Q HS, Other ORAL Date:09/16/03ISR Number: 4192879-6Report Type:Direct Company Report #CTU 201931 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Clozapine (Mylan) 300 Mg/D PS Mylan ORAL BID PO Date:09/17/03ISR Number: 4188750-6Report Type:Expedited (15-DaCompany Report #PHEH2003US08366 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Clozaril PS Novartis Sector: Drug Withdrawal Syndrome Pharma ORAL Date:09/17/03ISR Number: 4188760-9Report Type:Expedited (15-DaCompany Report #PHRM2003FR01566 Age:22 YR Gender:Female I/FU:F Outcome PT Hospitalization - Anaemia Initial or Prolonged Bone Marrow Depression Other Crohn'S Disease Diarrhoea Haemoglobin Decreased Platelet Count Decreased Pyrexia 22-Feb-2006 08:30 AM Page: 2373 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Visual Acuity Reduced White Blood Cell Count Decreased Report Source Product Role Manufacturer Route Dose Duration Leponex PS Novartis Sector: Pharma ORAL 700 mg daily 164 DAY Pentasa "Ferring" SS ORAL 14400MIN Mopral SS ORAL 18720MIN Entocort C Xanax C Zoloft C ORAL 2 DF daily Date:09/17/03ISR Number: 4191338-4Report Type:Expedited (15-DaCompany Report #PHFR2000GB01993 Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Abscess Foreign Clozaril (Clozapine) PS ORAL 650MG/DAY, Life-Threatening Abdominal Pain Health ORAL Hospitalization - Appendicitis Perforated Professional Lithium Carbonate C Initial or Prolonged Dialysis Other Citalopram Other Loss Of Consciousness (Citalopram) C Peritonitis Renal Failure Acute Sepsis Date:09/17/03ISR Number: 4191380-3Report Type:Expedited (15-DaCompany Report #PHNU2003DE02248 Age:23 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abnormal Faeces Foreign Clozapine Other Alanine Aminotransferase Health (Clozapine) Tablet PS ORAL SEE IMAGE Increased Professional Trileptal "Novartis C Novartis Aspartate Other Tavor C Aminotransferase Haldol "Janssen" C Increased Akineton (Biperiden Blood Bilirubin Increased Hydrochloride) C Body Temperature Increased C-Reactive Protein Increased Cardiac Failure Cholecystitis Chromaturia Diarrhoea Drug Level Increased Encopresis Enuresis Faeces Pale Gamma-Glutamyltransferase Increased Inflammation Lipase Increased Myocarditis Pharyngolaryngeal Pain Salivary Hypersecretion Shock Ultrasound Abdomen Abnormal 22-Feb-2006 08:30 AM Page: 2374 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/17/03ISR Number: 4192245-3Report Type:Expedited (15-DaCompany Report #PHHO2003CA08566 Age:45 YR Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Clostridial Infection Foreign Clozaril(Clozapine)T Hospitalization - Enterocolitis Infectious Study ablet PS ORAL 550 QD, ORAL Initial or Prolonged Intestinal Obstruction Health Paxil (Paroxetine Professional Hydrochloride) SS Other Quetiapine (Quetiapine) C Neurontin (Gabapentin) C Date:09/17/03ISR Number: 4192705-5Report Type:Expedited (15-DaCompany Report #PHRM2003FR01566 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Foreign Leponex (Clozapine) Initial or Prolonged Aplasia Health Tablet PS ORAL 700 MG DAILY, Other Crohn'S Disease Professional ORAL Diarrhoea Other Pentasa Ferring Haemoglobin Decreased (Mesalazine) SS Ferring ORAL ORAL Platelet Count Decreased Mopral(Omeprazole) SS ORAL ORAL Pyrexia Entocort C Visual Acuity Reduced Xanax (Alprazolam) C White Blood Cell Count Zoloft (Sertraline Decreased Hydrochloride) C Date:09/17/03ISR Number: 4192710-9Report Type:Expedited (15-DaCompany Report #PHBS2002AU04756 Age:79 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiopulmonary Failure Foreign Clozaril(Clozapine) Lower Respiratory Tract Study Tablet PS ORAL 150 MG, BID, Infection Health ORAL Pneumonia Professional Temazepam C Other Paxam (Piroxicam) C Date:09/17/03ISR Number: 4193511-8Report Type:Expedited (15-DaCompany Report #PHNR2003AU01315 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Foreign Clozaril(Clozapine) Increased Health Unknown PS Drug Level Increased Professional Eosinophil Count Company Increased Representative Hepatic Steatosis Other Lymphocyte Count Increased White Blood Cell Count Increased 22-Feb-2006 08:30 AM Page: 2375 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/17/03ISR Number: 4193533-7Report Type:Expedited (15-DaCompany Report #PHFR2003IE02599 Age:25 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dystonia Foreign Clozaril (Clozapine) PS ORAL 600MG/DAY, Eye Movement Disorder Study ORAL Eye Rolling Health Tremor Professional Other Date:09/18/03ISR Number: 4189124-4Report Type:Expedited (15-DaCompany Report #PHNU2003DE03374 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukocytosis Leponex / Clozaril Lymphopenia (Clozapine) PS Novartis Sector: Pharma ORAL 275 mg/day Cipramil C Date:09/18/03ISR Number: 4189130-XReport Type:Expedited (15-DaCompany Report #PHFR2003GB03539 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eye Pain Clozaril PS Novartis Sector: Oculogyration Pharma ORAL Amisulpride C UNKNOWN Date:09/18/03ISR Number: 4189133-5Report Type:Expedited (15-DaCompany Report #PHNR2003AU01239 Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Gastrooesophageal Reflux Clozaril PS Novartis Sector: Disease Pharma ORAL 25 - 500 Vomiting mg/day Date:09/18/03ISR Number: 4189135-9Report Type:Expedited (15-DaCompany Report #PHNU2003DE03318 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alveolitis Leponex / Clozaril Pulmonary Fibrosis (Clozapine) PS Novartis Sector: Pharma ORAL 25 mg/day Saroten "Bayer Vital" C Remergil C Tafil C Date:09/19/03ISR Number: 4189185-2Report Type:Expedited (15-DaCompany Report #PHFR2003IE03563 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Accidental Exposure Clozaril PS Novartis Sector: Medication Error Pharma ORAL 250mg once Somnolence Efexor C Risperidone C Losec C Aspirine C 22-Feb-2006 08:30 AM Page: 2376 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Zimovane C Vioxx C Lipitor C Isoptin C Date:09/19/03ISR Number: 4189216-XReport Type:Expedited (15-DaCompany Report #PHFR2003GB02562 Age:37 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Clozaril PS Novartis Sector: Conduction Disorder Pharma ORAL 300mg/day Electrocardiogram Clozaril SS Novartis Sector: Abnormal Pharma ORAL 25mg/day Electrocardiogram Qrs Stelazine C 30 mg, QD Complex Prolonged Procyclidine C Emotional Distress Cipramil C 40 mg, QD Hypertension Zanaflex C Tachycardia Arthrotec C 150mg/day Lorazepam C PRN Temazepam C PRN Hyoscine C ORAL 600mg/day Date:09/19/03ISR Number: 4189306-1Report Type:Expedited (15-DaCompany Report #PHFR2002GB04377 Age:61 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chronic Lymphocytic Clozaril PS Novartis Sector: Leukaemia Pharma ORAL 350 mg/day Lymphocyte Count Lansoprazole C Increased White Blood Cell Count Increased Date:09/19/03ISR Number: 4189310-3Report Type:Expedited (15-DaCompany Report #PHFR2003GB03562 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Clozaril PS Novartis Sector: Hyperthyroidism Pharma ORAL Date:09/19/03ISR Number: 4189314-0Report Type:Expedited (15-DaCompany Report #PHFR2003GB03339 Age:30 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Clozaril PS Novartis Sector: Initial or Prolonged Phosphokinase Increased Pharma ORAL 300 mg/day Overdose Clozaril SS Novartis Sector: Renal Impairment Pharma ORAL 3 g overdose Date:09/22/03ISR Number: 4190452-7Report Type:Expedited (15-DaCompany Report #PHFR2003GB03549 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Infection Clozaril PS Novartis Sector: Initial or Prolonged Overdose Pharma ORAL 600mg/day 187 DAY Clozaril SS Novartis Sector: 22-Feb-2006 08:30 AM Page: 2377 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pharma ORAL 2g overdose Venlafaxine SS UNKNOWN Date:09/22/03ISR Number: 4190464-3Report Type:Expedited (15-DaCompany Report #PHBS2003NZ10048 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiomegaly Clozaril PS Novartis Sector: Lobar Pneumonia Pharma ORAL 600 mg/d Clozaril SS Novartis Sector: Pharma ORAL 600 mg/d Clozaril SS Novartis Sector: Pharma ORAL 300 mg/d Date:09/22/03ISR Number: 4193294-1Report Type:Expedited (15-DaCompany Report #C2003-1876.01 Age:49 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coma Health Clozapine Tablets Sudden Death Professional 100 Mg Mylan PS ORAL 100 MG Q AM & Other 4PM, 400MG Q HS, ORAL Benztropine C Clonazepam C Divalproex Sodium C Escitalopram C Prenatal Vitamin (Qd) C Date:09/22/03ISR Number: 4194133-5Report Type:Expedited (15-DaCompany Report #2003-107875-NL Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutrophil Count Health Remeron PS ORAL 60 MG DAILY Initial or Prolonged Decreased Professional ORAL 5 WK Other White Blood Cell Count Clozapine SS ORAL 500 MG DAILY Decreased ORAL 30 MON Effexor C Trazodone C Serevent C Pulmicort C Albuterol Sulfate C Date:09/22/03ISR Number: 4194216-XReport Type:Direct Company Report #CTU 202243 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Condition Aggravated Clozapine - 100 Mg Intervention to Pharmaceutical Product Zenith PS Zenith ORAL 800 MG QHS PO Prevent Permanent Complaint Impairment/Damage 22-Feb-2006 08:30 AM Page: 2378 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/23/03ISR Number: 4190609-5Report Type:Expedited (15-DaCompany Report #PHFR2003GB03587 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Urea Decreased Clozaril PS Novartis Sector: Hypokalaemia Pharma ORAL 300mg/day Neutrophil Count Clozaril SS Novartis Sector: Increased Pharma 350mg/day White Blood Cell Count Increased Date:09/23/03ISR Number: 4190638-1Report Type:Expedited (15-DaCompany Report #PHBS2003NZ09807 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hodgkin'S Disease Clozaril PS Novartis Sector: Lymphopenia Pharma ORAL Date:09/23/03ISR Number: 4190653-8Report Type:Expedited (15-DaCompany Report #PHBS2003DE10078 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aplastic Anaemia Clozapine PS Novartis Sector: Aspergillosis Pharma UNKNOWN Pyrexia Skin Lesion Date:09/23/03ISR Number: 4190665-4Report Type:Expedited (15-DaCompany Report #PHHO2003CA11572 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Clozaril PS Novartis Sector: Initial or Prolonged Convulsion Pharma ORAL not reported 97920MIN Other Date:09/23/03ISR Number: 4191648-0Report Type:Expedited (15-DaCompany Report #PHFR2002GB01610 Age:57 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Clozaril PS Novartis Sector: Electrocardiogram Qt Pharma ORAL 300mg/day 533 DAY Prolonged Ranitidine C Hypotension Pyrexia Tachycardia Date:09/23/03ISR Number: 4191663-7Report Type:Expedited (15-DaCompany Report #WAES 0307USA01475 Age:49 YR Gender:Female I/FU:F Outcome PT Hospitalization - Anaemia Initial or Prolonged Neutrophil Count Other Decreased Pyrexia Red Blood Cell Sedimentation Rate Increased 22-Feb-2006 08:30 AM Page: 2379 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Urinary Tract Infection Vasculitis Report Source Product Role Manufacturer Route Dose Duration Fosamax PS Merck & Co., Inc ORAL 566 DAY Lipitor SS ORAL 292 DAY Clozaril SS ORAL 118 DAY Bactrim Ds Tablets SS ORAL Benztropine Mesylate C Calcium Citrate And Cholecalciferol C Diphenhydramine Hydrochloride C Divalproex Sodium C Haloperidol C INTRAMUSCULAR Minerals (Unspecified) And Vitamins (Unspecified) C Date:09/23/03ISR Number: 4191745-XReport Type:Expedited (15-DaCompany Report #PHEH2003US08366 Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Clozaril PS Novartis Sector: Initial or Prolonged Diabetes Mellitus Pharma ORAL 650 mg, QD Other Drug Withdrawal Syndrome Benadryl "Ache" C Hypertension Eskalith C Ketoacidosis Wellbutrin C Atenolol C Lipitor C Niaspan C Prilosec C Date:09/23/03ISR Number: 4191746-1Report Type:Expedited (15-DaCompany Report #PHEH2003US08596 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Injury Clozaril PS Novartis Sector: Road Traffic Accident Pharma ORAL 200 mg/day Date:09/23/03ISR Number: 4191747-3Report Type:Expedited (15-DaCompany Report #PHEH2003US08560 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Dizziness Clozaril PS Novartis Sector: Hospitalization - Hypotension Pharma ORAL Initial or Prolonged Myocarditis Lithium C Renal Failure Date:09/23/03ISR Number: 4191755-2Report Type:Expedited (15-DaCompany Report #PHNR2003AU01355 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Helicobacter Infection Clozaril PS Novartis Sector: Nausea Pharma 12.5 - 200 Vomiting mg/day Clozaril SS Novartis Sector: 22-Feb-2006 08:30 AM Page: 2380 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pharma 12.5 - 100 mg/day Seroquel C Valium C Date:09/23/03ISR Number: 4191756-4Report Type:Expedited (15-DaCompany Report #PHNR2003AU01358 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Helicobacter Infection Clozaril PS Novartis Sector: Initial or Prolonged Treatment Noncompliance Pharma 25 - 600 Other Vomiting mg/day Amisulpride C 200 mg/day Valproate Sodium C Date:09/23/03ISR Number: 4191759-XReport Type:Expedited (15-DaCompany Report #PHFR2003GB03583 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Clozaril PS Novartis Sector: Diabetic Ulcer Pharma ORAL 1401 DAY Date:09/23/03ISR Number: 4194644-2Report Type:Expedited (15-DaCompany Report #03-09-1105 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Colon Adenoma Health Clozapine - Ivax Diarrhoea Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 75-225MG QD ORAL Date:09/23/03ISR Number: 4194646-6Report Type:Expedited (15-DaCompany Report #03-09-1122 Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hip Fracture Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals Inc. ORAL 575MG QD ORAL Date:09/23/03ISR Number: 4194647-8Report Type:Expedited (15-DaCompany Report #03-08-1051 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 150-200MG QD ORAL 22-Feb-2006 08:30 AM Page: 2381 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/23/03ISR Number: 4194648-XReport Type:Expedited (15-DaCompany Report #03-09-1142 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Decreased Health Clozapine - Ivax Initial or Prolonged Hypotension Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 50-250MG QD ORAL Date:09/23/03ISR Number: 4194650-8Report Type:Expedited (15-DaCompany Report #03-08-1031 Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Feeling Abnormal Health Clozapine- Ivax Gastrointestinal Disorder Professional Pharmaceuticals, Hyperglycaemia Other Inc. Tablets PS Ivax Organ Failure Pharmaceuticals, Renal Failure Inc. ORAL SEE IMAGE Date:09/23/03ISR Number: 4194652-1Report Type:Expedited (15-DaCompany Report #03-09-1127 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Appendicitis Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablet PS Ivax Pharmaceuticals, Inc. ORAL 300-600MG QD ORAL Date:09/23/03ISR Number: 4194653-3Report Type:Expedited (15-DaCompany Report #03-09-1103 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Appendicitis Perforated Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 350MG QD ORAL Date:09/23/03ISR Number: 4194655-7Report Type:Expedited (15-DaCompany Report #03-09-1139 Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Aspiration Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 25-600MG QD ORAL Date:09/23/03ISR Number: 4194765-4Report Type:Expedited (15-DaCompany Report #03-09-1126 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Other Aplastic Anaemia Foreign Pyrexia Literature 22-Feb-2006 08:30 AM Page: 2382 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Health Professional Product Role Manufacturer Route Dose Duration Clozapine Tablets PS ORAL 50MG QD ORAL 1 WK Date:09/23/03ISR Number: 4199372-5Report Type:Expedited (15-DaCompany Report #PHEH2003US08366 Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Consumer Clozaril (Clozapine) Initial or Prolonged Diabetes Mellitus Tablet PS ORAL 650 MG, QD, Other Drug Withdrawal Syndrome ORAL Hypertension Benadryl "Ache" C Ketoacidosis Eskalith C Wellbutrin (Bupropion Hydrochloride) C Atenolol C Lipitor C Niaspan C Prilosec (Omeprazole) C Date:09/23/03ISR Number: 4199382-8Report Type:Expedited (15-DaCompany Report #PHEH2003US08596 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Injury Health Clozaril (Clozapine) Pharmaceutical Product Professional Tablet PS ORAL 200 MG/DAY, Complaint ORAL Road Traffic Accident Date:09/24/03ISR Number: 4193069-3Report Type:Expedited (15-DaCompany Report #PHNR2003AU01361 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Clozaril PS Novartis Sector: Ventricular Hypokinesia Pharma ORAL 37.5 - 375mg Date:09/24/03ISR Number: 4193081-4Report Type:Expedited (15-DaCompany Report #PHFR2003GB02145 Age:58 YR Gender:Male I/FU:F Outcome PT Hospitalization - Blood Calcium Decreased Initial or Prolonged Blood Creatinine Increased Blood Urea Increased Body Temperature Increased Bronchopneumonia Chest X-Ray Abnormal Crackles Lung Diarrhoea Gastrointestinal Hypomotility Hypotension Neutrophil Count 22-Feb-2006 08:30 AM Page: 2383 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Increased Renal Impairment Tachycardia Vomiting Report Source Product Role Manufacturer Route Dose Duration White Blood Cell Count Clozaril PS Novartis Sector: Increased Pharma ORAL 100 mg, BID 54720MIN Hyoscine C ORAL 24480MIN Valproate Sodium C ORAL UNK, UNK Date:09/24/03ISR Number: 4193088-7Report Type:Expedited (15-DaCompany Report #PHNR2003AU01169 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Helicobacter Infection Clozaril PS Novartis Sector: Nausea Pharma ORAL 12.5 - 300 Vomiting mg/day Date:09/24/03ISR Number: 4193091-7Report Type:Expedited (15-DaCompany Report #PHFR2003GB03610 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Clozaril PS Novartis Sector: Pharma ORAL Date:09/24/03ISR Number: 4193180-7Report Type:Expedited (15-DaCompany Report #PHNU2003DE03429 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Health Leponex / Clozaril Increased Professional (Clozapine) PS Novartis Sector: Aspartate Pharma ORAL 200 mg/day Aminotransferase Increased Hepatic Enzyme Increased Lipase Increased Date:09/24/03ISR Number: 4193188-1Report Type:Expedited (15-DaCompany Report #PHNR2003AU01170 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Helicobacter Infection Clozaril PS Novartis Sector: Nausea Pharma ORAL 25 - 325 Vomiting mg/day Clozaril SS Novartis Sector: Pharma 12 - 800 mg/day Seroquel C 600 mg/day Date:09/24/03ISR Number: 4199254-9Report Type:Expedited (15-DaCompany Report #2003AP03237 Age:24 YR Gender:Male I/FU:I Outcome PT Hospitalization - Diarrhoea Initial or Prolonged Electrocardiogram T Wave Inversion Heart Rate Increased Myocarditis 22-Feb-2006 08:30 AM Page: 2384 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pericardial Effusion Pleuritic Pain Pyrexia Report Source Product Role Manufacturer Route Dose Duration Ventricular Dysfunction Foreign Seroquel PS NI Vomiting Health Clozapril SS ORAL 300 MG DAILY; Professional PO Other Date:09/25/03ISR Number: 4193691-4Report Type:Expedited (15-DaCompany Report #PHNU2003DE02248 Age:23 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abnormal Faeces Clozapine PS Novartis Sector: Other Alanine Aminotransferase Pharma ORAL up to 400 Increased mg/day 36000MIN Aspartate Clozapine SS Novartis Sector: Aminotransferase Pharma ORAL 300mg/day 4320 MIN Increased Akineton C UNKNOWN Blood Bilirubin Increased Haldol "Janssen" C ORAL Body Temperature Trileptal "Novartis" I ORAL Increased Tavor I ORAL C-Reactive Protein Increased Cholecystitis Chromaturia Death Diarrhoea Drug Level Increased Encopresis Enuresis Inflammation Lipase Increased Myocarditis Pharyngolaryngeal Pain Salivary Hypersecretion Ultrasound Abdomen Abnormal Date:09/25/03ISR Number: 4197649-0Report Type:Expedited (15-DaCompany Report #C2003-2372.01 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Circulatory Collapse Health Clozapine Tablets Dyspnoea Professional 100 Mg Mylan PS Mylan ORAL 600MG QD, Myocardial Infarction Other ORAL Nausea Propranolol C Syncope Loratidine/Pseudoeph Vomiting edrine C Zonisamide C Citalopram C Date:09/25/03ISR Number: 4197691-XReport Type:Expedited (15-DaCompany Report #03-09-1162 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Crohn'S Disease Health Clozapine - Ivax Initial or Prolonged Depression Professional Pharmacuetucals, Hallucination Other Inc. Tablets PS Ivax 22-Feb-2006 08:30 AM Page: 2385 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pharmaceuticals Inc. ORAL 125-500MG QD ORAL Date:09/25/03ISR Number: 4197692-1Report Type:Expedited (15-DaCompany Report #03-09-1170 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine - Ivax Professional Pharmacueticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 350-500MG QD ORAL Date:09/25/03ISR Number: 4197693-3Report Type:Expedited (15-DaCompany Report #03-08-1048 Age:72 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Health Clozapine - Ivax Initial or Prolonged Mania Professional Pharmaceuticals, Required Treatment Noncompliance Other Inc. Tablets PS Ivax Intervention to Pharmaceuticals, Prevent Permanent Inc. ORAL 150MG QD ORAL Impairment/Damage Neurontin C Ativan C Lithium C Zyprexa C Abilify C Trazodone C Seroquel C Trileptal C Date:09/25/03ISR Number: 4197695-7Report Type:Expedited (15-DaCompany Report #03-09-1169 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Appendicectomy Health Clozapine - Ivax Initial or Prolonged Professional Pharmacuticals, Inc. Other Talbets PS Ivax Pharmaceuticals, Inc. ORAL 350-450MG QD ORAL Date:09/25/03ISR Number: 4200316-8Report Type:Expedited (15-DaCompany Report #MK200309-0425-1 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Congestive Cardiomyopathy Foreign Tofranil 25mg Initial or Prolonged Delusion Tablets 100 PS 75MG, DAILY Delusion Of Reference Leponex SS 100MG, DAILY Dysphoria Olanzapine C Mood Altered Risperidone C Panic Attack Quetiapine C Persecutory Delusion Bromperidol C Psychomotor Hyperactivity Primozide C Chlorpromazine C Paroxetine C Chlordesmethyldiazep 22-Feb-2006 08:30 AM Page: 2386 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report am C Date:09/26/03ISR Number: 4194937-9Report Type:Expedited (15-DaCompany Report #PHBS2003DE10079 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Eosinophilia Clozapine PS Novartis Sector: Granulocytopenia Pharma UNKNOWN Zygomycosis Date:09/26/03ISR Number: 4195447-5Report Type:Expedited (15-DaCompany Report #PHNR2003AU01363 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Glucose Increased Clozaril PS Novartis Sector: Blood Insulin Abnormal Pharma 25 - 275 Diabetes Mellitus mg/day 118 DAY Date:09/26/03ISR Number: 4195448-7Report Type:Expedited (15-DaCompany Report #PHNR2003AU01364 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Osmolarity Clozaril PS Novartis Sector: Initial or Prolonged Increased Pharma ORAL 25 - 350 Diabetes Insipidus mg/day Polyuria Urine Osmolarity Decreased Date:09/26/03ISR Number: 4195450-5Report Type:Expedited (15-DaCompany Report #PHFR2003GB03632 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Clozaril PS Novartis Sector: Electrocardiogram Qt Pharma ORAL Corrected Interval Prolonged Hyperglycaemia Date:09/26/03ISR Number: 4195457-8Report Type:Expedited (15-DaCompany Report #PHNU2003DE03182 Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neuroleptic Malignant Leponex / Clozaril Hospitalization - Syndrome (Clozapine) PS Novartis Sector: Initial or Prolonged Pneumonia Pharma ORAL Unknown Thrombocytopenia Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL 750mg/day Zyprexa SS ORAL 20 mg/day 5760 MIN Nipolept "Aventis" SS ORAL 150 mg/day 2880 MIN Haldol "Janssen" C ORAL 15 mg/day 15840MIN Solian C ORAL 800mg/day 53280MIN 22-Feb-2006 08:30 AM Page: 2387 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/26/03ISR Number: 4195458-XReport Type:Expedited (15-DaCompany Report #PHFR2003GB03650 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Clozaril PS Novartis Sector: Pharma ORAL Date:09/26/03ISR Number: 4195469-4Report Type:Expedited (15-DaCompany Report #PHFR2003GB03513 Age:38 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Clozaril PS Novartis Sector: Enuresis Pharma ORAL 400mg/day Hyperglycaemia Polyuria Date:09/26/03ISR Number: 4195470-0Report Type:Expedited (15-DaCompany Report #PHFR2003GB03299 Age:33 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Decreased Clozaril PS Novartis Sector: Initial or Prolonged Intentional Overdose Pharma ORAL 2880 MIN Other Somnolence Brufen "Abbott" SS UNKNOWN White Blood Cell Count Alcohol SS Increased Date:09/26/03ISR Number: 4195477-3Report Type:Expedited (15-DaCompany Report #PHNR2003AU01217 Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bundle Branch Block Left Clozaril PS Novartis Sector: Electrocardiogram Pharma ORAL 12.5 - 600 Abnormal mg/day Qrs Axis Abnormal Epilim C ORAL 750 mg mane & 1000 mg nocte Serzone C 400 mg, BID Solian C 200 mg mane Date:09/26/03ISR Number: 4196959-0Report Type:Expedited (15-DaCompany Report #C2003-2163.01 Age:74 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg Mylan PS ORAL 25MG QHS, Other ORAL Date:09/26/03ISR Number: 4196961-9Report Type:Expedited (15-DaCompany Report #C2003-2370.01 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiomegaly Health Clozapine Tablets Required Dizziness Professional 100 Mg Mylan PS ORAL 100 MG Q HS, Intervention to ORAL Prevent Permanent Bupropion Hcl C Impairment/Damage Famotidine C 22-Feb-2006 08:30 AM Page: 2388 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/26/03ISR Number: 4196962-0Report Type:Expedited (15-DaCompany Report #C2003-2428.01 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Health Clozapine Tablets 25 Fall Professional Mg Mylan PS ORAL 18.75 MG/DAY Hip Fracture Other ORAL Carbidopa/Levodopa C Selegilline C Entacapone C Hydroxyzine Pamoate C Meperidine C Date:09/26/03ISR Number: 4196963-2Report Type:Expedited (15-DaCompany Report #C2003-2429.01 Age:88 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neoplasm Malignant Health Clozapine Tablets 25 Professional Mg Mylan PS ORAL 12.5 MG, ORAL Other Hydrocodone Bitartrate/Acetamino phen C Pysillium Husk C Cyproheptadine C Levothyroxine C Amlodipine C Famotidine C Hctz C Date:09/26/03ISR Number: 4196966-8Report Type:Expedited (15-DaCompany Report #C2003-2384.01 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Intentional Self-Injury Health Clozapine Tablets Thermal Burn Professional 100 Mg Mylan PS ORAL 300 MG Q HS, Other ORAL Clozapine Tablets 25 Mg Mylan SS ORAL 50 MG Q HS, ORAL Venlafaxine C Date:09/26/03ISR Number: 4199376-2Report Type:Expedited (15-DaCompany Report #PHEH2003US08560 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Dizziness Health Clozaril (Clozapine) Hospitalization - Hypotension Professional Tablet PS ORAL ORAL Initial or Prolonged Myocarditis Lithium (Lithium) C Renal Failure Date:09/26/03ISR Number: 4209500-0Report Type:Periodic Company Report #2002UW11582 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Other Seroquel PS ORAL 100 MG QD PO Initial or Prolonged Clozapine SS 25 TO 50 MG DAILY Depakote SS 500 MG BID 22-Feb-2006 08:30 AM Page: 2389 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/26/03ISR Number: 4209611-XReport Type:Periodic Company Report #2003UW09257 Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Health Seroquel PS ORAL 100 MG BID PO Initial or Prolonged Neuroleptic Malignant Professional Clozapine SS ORAL 100 MG BID PO Required Syndrome Intervention to Prevent Permanent Impairment/Damage Date:09/26/03ISR Number: 4210267-0Report Type:Periodic Company Report #2002UW16567 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mental Status Changes Health Clozapine Vs Blinded Initial or Prolonged Professional Code Not Broken PS Seroquel SS ORAL 100 MG PO Protonix C Ativan C Imitrex "Cerenex" C Wellbutrin C Buspar C Date:09/26/03ISR Number: 4210329-8Report Type:Periodic Company Report #2002UW13876 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Decreased Appetite Consumer Seroquel PS ORAL 800 MG DAILY Intervention to Dry Mouth PO Prevent Permanent Energy Increased Seroquel SS ORAL 300 MG DAILY Impairment/Damage Gingivitis PO Insomnia Seroquel SS ORAL 200 MG TID PO Mania Clozaril SS 400 MG Pharyngolaryngeal Pain Nexium C Tardive Dyskinesia Ambien C Weight Decreased Trileptal "Ciba-Geigy" C Clozaril C Date:09/26/03ISR Number: 4210331-6Report Type:Periodic Company Report #2002UW15360 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Agitation Health Seroquel PS ORAL 50 MG PO Intervention to Anger Professional Seroquel SS ORAL 600 MG DAILY Prevent Permanent Delusional Disorder, PO Impairment/Damage Unspecified Type Clozaril SS 350 MG Tardive Dyskinesia Clozaril SS 25 MG Tremor Clozaril SS 100 MG Date:09/29/03ISR Number: 4196975-9Report Type:Expedited (15-DaCompany Report #PHFR2003GB03653 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Clozaril PS Novartis Sector: Pharma ORAL 22-Feb-2006 08:30 AM Page: 2390 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/29/03ISR Number: 4196978-4Report Type:Expedited (15-DaCompany Report #PHFR2003GB03036 Age:23 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Clozaril PS Novartis Sector: Overdose Pharma ORAL 400 mg/day Treatment Noncompliance Clozaril SS Novartis Sector: Pharma ORAL 1200mg Overdose Date:09/29/03ISR Number: 4196980-2Report Type:Expedited (15-DaCompany Report #PHFR2003GB03655 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Clozaril PS Novartis Sector: Pharma ORAL 1505 DAY Date:09/29/03ISR Number: 4196982-6Report Type:Expedited (15-DaCompany Report #PHNR2003AU01308 Age:49 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Conduction Disorder Clozaril PS Novartis Sector: Initial or Prolonged Electrocardiogram St Pharma ORAL 150 - 300 Other Segment Abnormal mg/day 33120MIN Electrocardiogram St-T Segment Abnormal Electrocardiogram T Wave Inversion Emphysema Fatigue Influenza Like Illness Leukocytosis Malaise Myocarditis Neutrophilia Palpitations Pneumonitis Pyrexia Tachycardia Date:09/29/03ISR Number: 4197119-XReport Type:Expedited (15-DaCompany Report #GB/96/01199/LEX Age:31 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Clozaril PS Novartis Sector: Gastrointestinal Pharma ORAL 12.5 mg, Haemorrhage ONCE/SINGLE 1440 MIN Haemoglobin Decreased Lactulose C ML 10 Hypotension Zopiclone C Nausea Date:09/30/03ISR Number: 4197702-1Report Type:Expedited (15-DaCompany Report #CA-BRISTOL-MYERS SQUIBB COMPANY-12393948 Age:53 YR Gender:Female I/FU:I Outcome PT Life-Threatening Fatigue Hospitalization - Orthostatic Hypotension Initial or Prolonged Sedation 22-Feb-2006 08:30 AM Page: 2391 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Supraventricular Tachycardia Syncope Report Source Product Role Manufacturer Route Dose Duration Aripiprazole PS Otsuka Pharmaceutical Company, Ltd. ORAL Clozapine SS ORAL 100 mg noon and supper, 50 mg hs Valproic Acid C present dose 500 mg noon/750 mg hs Pantoprazole C Lorazepam C Lactulose C Date:09/30/03ISR Number: 4202171-9Report Type:Expedited (15-DaCompany Report #C2003-2162.01 Age:62 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 100 MG Q AM, Other 200 MG Q PM, ORAL Benztropine C Ipratropium And Albuterol (Nebulizer) C Ipratropium And Albuterol (Inhaler) C Lorazepam C Magnesium Hydroxide C Morphine Sulfate C Olanzapine C Pantoprazole C Vitamins And Minerals C Guaifenesin La C Acetaminophen/Codein e C Date:09/30/03ISR Number: 4202172-0Report Type:Expedited (15-DaCompany Report #C2003-1928.01 Age:72 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 150 MG QD, Other ORAL Date:10/02/03ISR Number: 4199637-7Report Type:Expedited (15-DaCompany Report #PHNU2003DE03515 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Bradycardia Clozapine PS Novartis Sector: Hospitalization - Hypotension Pharma ORAL Unknown Initial or Prolonged Intentional Overdose Victim Of Crime 22-Feb-2006 08:30 AM Page: 2392 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/02/03ISR Number: 4199657-2Report Type:Expedited (15-DaCompany Report #PHFR2002GB03624 Age:33 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Amylase Increased Clozaril PS Novartis Sector: Initial or Prolonged Hypertriglyceridaemia Pharma ORAL 450 mg/day Disability Pancreatitis Lipostat C ORAL 20 mg/day Other Fenofibrate C ORAL 267 mg/day Irbesartan C ORAL 150 mg/day Neurontin C ORAL 20 mg/day Insulin C Date:10/02/03ISR Number: 4199665-1Report Type:Expedited (15-DaCompany Report #PHHO2003CA12037 Age:67 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Clozaril PS Novartis Sector: Pharma Date:10/02/03ISR Number: 4199669-9Report Type:Expedited (15-DaCompany Report #PHNR2003AU01065 Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Osmolarity Clozaril PS Novartis Sector: Initial or Prolonged Decreased Pharma 250 mg, QD Dyspnoea Electrocardiogram Abnormal Eosinophilia Fatigue Feeling Hot Haemoglobin Decreased Hypocalcaemia Hypochloraemia Hypokalaemia Hyponatraemia Lymphopenia Nausea Pallor Pyrexia Rash Troponin I Increased Viral Infection Viral Myocarditis Vomiting Date:10/02/03ISR Number: 4199674-2Report Type:Expedited (15-DaCompany Report #PHHO2003CA03195 Age:47 YR Gender:Female I/FU:F Outcome PT Death Convulsion Death Drug Level Increased Haematocrit Decreased Haemoglobin Decreased Hallucination, Auditory Psychotic Disorder Schizophrenia Screaming 22-Feb-2006 08:30 AM Page: 2393 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Urinary Tract Infection Report Source Product Role Manufacturer Route Dose Duration Clozaril PS Novartis Sector: Pharma ORAL 12.5 mg in morning and bedtime 8640 MIN Clozaril SS Novartis Sector: Pharma ORAL 50 mg morning and bedtime 1440 MIN Clozaril SS Novartis Sector: Pharma ORAL 50mg morning, 75 mg bedtime 1440 MIN Clozaril SS Novartis Sector: Pharma ORAL 50mg morning, 100mg bedtime 4320 MIN Clozaril SS Novartis Sector: Pharma ORAL 75mg morning, 125mg bedtime 4320 MIN Clozaril SS Novartis Sector: Pharma ORAL 100mg morning, 150mg bedtime 8640 MIN Clozaril SS Novartis Sector: Pharma ORAL 100mg morning, 200mg bedtime 1440 MIN Clozaril SS Novartis Sector: Pharma ORAL 100mg morning, 250mg bedtime 5760 MIN Clozaril SS Novartis Sector: Pharma ORAL 100mg morning, 300mg bedtime Seroquel C Tegretol C Zuclopenthixol C Surfak C Loxapine C Quetiapine C Date:10/02/03ISR Number: 4199682-1Report Type:Expedited (15-DaCompany Report #PHBS2003CA10555 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Respiratory Disorder Clozaril PS Novartis Sector: Hospitalization - Respiratory Failure Pharma UNKNOWN Initial or Prolonged Date:10/02/03ISR Number: 4199687-0Report Type:Expedited (15-DaCompany Report #PHBS2003NZ09438 Age:40 YR Gender:Male I/FU:F Outcome PT Hospitalization - Abdominal Discomfort Initial or Prolonged Constipation Drug Level Increased Gastritis Liver Function Test 22-Feb-2006 08:30 AM Page: 2394 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Abnormal Rectal Haemorrhage Report Source Product Role Manufacturer Route Dose Duration Clozaril PS Novartis Sector: Pharma ORAL 400 mg/d Clozaril SS Novartis Sector: Pharma ORAL 350 mg/day Terazosin C ORAL 2 mg/d Date:10/02/03ISR Number: 4199692-4Report Type:Expedited (15-DaCompany Report #PHBS2003PH10413 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Typhoid Fever Leponex PS Novartis Sector: Pharma ORAL Chloromycetin C UNKNOWN Co-Trimoxazole C UNKNOWN Date:10/02/03ISR Number: 4199834-0Report Type:Expedited (15-DaCompany Report #PHFR2003GB01389 Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Clozaril PS Novartis Sector: Initial or Prolonged Phosphokinase Increased Pharma ORAL 77 DAY Other Cardiac Failure Cardiac Murmur Dyspnoea Ecg P Wave Inverted Electrocardiogram St Segment Elevation Endocarditis Labile Blood Pressure Myocarditis Tachycardia Date:10/02/03ISR Number: 4200013-9Report Type:Expedited (15-DaCompany Report #PHNU2003DE03451 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Renal Failure Leponex / Clozaril (Clozapine) PS Novartis Sector: Pharma ORAL 150 mg/day Date:10/02/03ISR Number: 4200032-2Report Type:Expedited (15-DaCompany Report #PHEH2003US08708 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - White Blood Cell Count Clozaril PS Novartis Sector: Initial or Prolonged Decreased Pharma ORAL 600 mg, QD Other Mellaril C 22-Feb-2006 08:30 AM Page: 2395 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/02/03ISR Number: 4200123-6Report Type:Expedited (15-DaCompany Report #PHBS2003CA10418 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Lipoprotein Deficiency Clozapine PS Novartis Sector: Initial or Prolonged Pharma UNKNOWN Valproic Acid C UNKNOWN Date:10/02/03ISR Number: 4200134-0Report Type:Expedited (15-DaCompany Report #PHFR2003GB03708 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Accidental Exposure Leponex / Clozaril Overdose (Clozapine) PS Novartis Sector: Pharma ORAL 700mg/day total 63 x 100mg tabs 30240MIN Date:10/02/03ISR Number: 4202383-4Report Type:Expedited (15-DaCompany Report #03-09-1219 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Appendicitis Perforated Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 400MG QD ORAL Date:10/02/03ISR Number: 4202384-6Report Type:Expedited (15-DaCompany Report #03-09-1218 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 300MG QD ORAL Date:10/02/03ISR Number: 4202385-8Report Type:Expedited (15-DaCompany Report #03-09-1205 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Neoplasm Malignant Health Clozapine - Ivax Metastases To Central Professional Pharmaceuticals, Nervous System Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 300-500MG QD ORAL Date:10/02/03ISR Number: 4204266-2Report Type:Expedited (15-DaCompany Report #GBWYE309222SEP03 Age:28 YR Gender:Female I/FU:I Outcome PT Other Abdominal Pain Atrioventricular Block Atrioventricular Block First Degree 22-Feb-2006 08:30 AM Page: 2396 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Bradycardia Chest Discomfort Chest Pain Report Source Product Role Manufacturer Route Dose Duration Drug Ineffective Foreign Bisoprolol Eating Disorder Health (Bisoprolol, Unspec) PS UNKNOWN UNKNOWN, Influenza Like Illness Professional UNKNOWN Malaise Other Clozaril (Clozapine, Myalgia , O) SS ORAL 0.2 G 1X PER Neuroleptic Malignant 1 DAY; ORAL 531 DAY Syndrome Tachycardia Date:10/03/03ISR Number: 4200810-XReport Type:Expedited (15-DaCompany Report #PHNU2003DE01707 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Coagulopathy Leponex / Clozaril Deep Vein Thrombosis (Clozapine) PS Novartis Sector: Pneumonia Pharma ORAL 300mg/day Date:10/03/03ISR Number: 4201007-XReport Type:Expedited (15-DaCompany Report #PHHO2003CA03195 Age:47 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Clozaril PS Novartis Sector: Drug Toxicity Pharma ORAL 12.5 mg in Haematocrit Decreased morning and Haemoglobin Decreased bedtime 8640 MIN Hallucination Clozaril SS Novartis Sector: Hallucination, Auditory Pharma ORAL 50 mg morning Red Blood Cell Count and bedtime 1440 MIN Decreased Clozaril SS Novartis Sector: Schizophrenia Pharma ORAL 50mg morning, Urinary Tract Infection 75 mg bedtime 1440 MIN Clozaril SS Novartis Sector: Pharma ORAL 50mg morning, 100mg bedtime 4320 MIN Clozaril SS Novartis Sector: Pharma ORAL 75mg morning, 125mg bedtime 4320 MIN Clozaril SS Novartis Sector: Pharma ORAL 100mg morning, 150mg bedtime 8640 MIN Clozaril SS Novartis Sector: Pharma ORAL 100mg morning, 200mg bedtime 1440 MIN Clozaril SS Novartis Sector: Pharma ORAL 100mg morning, 250mg bedtime 5760 MIN Clozaril SS Novartis Sector: Pharma ORAL 100mg morning, 300mg bedtime Seroquel C Tegretol C Zuclopenthixol C 22-Feb-2006 08:30 AM Page: 2397 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Surfak C Loxapine C Quetiapine C Date:10/03/03ISR Number: 4201014-7Report Type:Expedited (15-DaCompany Report #PHFR2003GB03455 Age:34 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Depression Clozaril PS Novartis Sector: Overdose Pharma ORAL 300mg/day Somnolence Clozaril SS Novartis Sector: Pharma ORAL 10 x 100mg overdose Fish Oil C ORAL Date:10/03/03ISR Number: 4201023-8Report Type:Expedited (15-DaCompany Report #PHNR2003AU01387 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Clozaril PS Novartis Sector: Ejection Fraction Pharma ORAL 12.5 - 200 Decreased mg/day Electrocardiogram Qt Clozaril SS Novartis Sector: Prolonged Pharma ORAL 25 mg mane Hypotension and 50 mg Ischaemic Cardiomyopathy nocte Haloperidol C 2.5 mg, TID Olanzapine C 5 mg mane Imipramine C 5 mg mane Benztropine Mesylate C 2 mg mane Atenolol C 25 mg mane Clopidogrel C 75 mg mane Date:10/03/03ISR Number: 4203652-4Report Type:Expedited (15-DaCompany Report #C2003-2237.01 Age:55 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Health Clozapine PS Mylan ORAL 200MG Q AM, Professional 300MG Q HS, Other ORAL Zolpidem C Benztropine C Haloperidol Decanoate C Divalproex Sodium C Nifedipine C Lisinopril C Date:10/03/03ISR Number: 4203653-6Report Type:Expedited (15-DaCompany Report #C2003-2468.01 Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Neoplasm Malignant Health Clozapine PS Mylan ORAL 25MG,BID, Pneumonia Aspiration Professional ORAL Other Thioridazine C Valproic Acid C 22-Feb-2006 08:30 AM Page: 2398 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/03/03ISR Number: 4203655-XReport Type:Expedited (15-DaCompany Report #C2003-2488.01 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Mylan ORAL 400MG Q HS, Professional ORAL Other Divalproex Sodium C Date:10/03/03ISR Number: 4203659-7Report Type:Expedited (15-DaCompany Report #03-10-1223 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Health Clozapine PS Ivax Professional Pharmaceuticals, Other Inc. ORAL 300MG QD ORAL Date:10/03/03ISR Number: 4203661-5Report Type:Expedited (15-DaCompany Report #03-10-1224 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Health Clozapine PS Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. ORAL ORAL Date:10/03/03ISR Number: 4203662-7Report Type:Expedited (15-DaCompany Report #03-09-1220 Age:69 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Health Clozapine PS Ivax Pharmaceuticals Professional Inc ORAL 87.5-100MG QD Other ORAL Date:10/03/03ISR Number: 4203664-0Report Type:Expedited (15-DaCompany Report #03-09-1209 Age:76 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Health Clozapine PS Ivax Initial or Prolonged Urinary Tract Infection Professional Pharmaceuticals, Other Inc. ORAL 100-200MG QD ORAL Date:10/03/03ISR Number: 4205854-XReport Type:Expedited (15-DaCompany Report #03-10-1233 Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Health Clozapine - Ivax Cardiac Failure Professional Pharmaceuticals, Congestive Other Inc. Tablets PS ORAL 250-900MG QD Myocardial Infarction ORAL Date:10/06/03ISR Number: 4201982-3Report Type:Expedited (15-DaCompany Report #FR-ROCHE-348072 Age: Gender:Male I/FU:I Outcome PT Other Delirium Depression 22-Feb-2006 08:30 AM Page: 2399 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Fatigue Persecutory Delusion Salivary Hypersecretion Report Source Product Role Manufacturer Route Dose Duration Rivotril PS Roche UNKNOWN Leponex SS UNKNOWN Prozac C Date:10/06/03ISR Number: 4202049-0Report Type:Expedited (15-DaCompany Report #PHBS2003PH10413 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Leponex PS Novartis Sector: Hospitalization - Typhoid Fever Professional Pharma ORAL Initial or Prolonged Chloromycetin C UNKNOWN Co-Trimoxazole C UNKNOWN Date:10/06/03ISR Number: 4202058-1Report Type:Expedited (15-DaCompany Report #PHFR2003IE01744 Age:23 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Discomfort Health Clozaril PS Novartis Sector: Hospitalization - Abdominal Pain Upper Professional Pharma ORAL 100mg/day Initial or Prolonged Constipation Clozaril SS Novartis Sector: Disability Disease Recurrence Pharma ORAL 325mg/day 1049 DAY Other Dyspepsia Quetiapine C ORAL 750mg/day Gastrointestinal Haemorrhage Gastrointestinal Ulcer Haemoglobin Decreased Intestinal Obstruction Psychotic Disorder Vomiting Date:10/06/03ISR Number: 4202109-4Report Type:Expedited (15-DaCompany Report #PHBS2003DE10078 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aplastic Anaemia Clozapine PS Novartis Sector: Aspergillosis Pharma UNKNOWN Pyrexia Skin Lesion Date:10/06/03ISR Number: 4202117-3Report Type:Expedited (15-DaCompany Report #PHBS2003DE10079 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Eosinophilia Clozapine PS Novartis Sector: Granulocytopenia Pharma UNKNOWN Zygomycosis Date:10/07/03ISR Number: 4202536-5Report Type:Expedited (15-DaCompany Report #PHHO2003CA12425 Age:65 YR Gender:Male I/FU:I Outcome PT Death Angina Unstable Cardiac Death 22-Feb-2006 08:30 AM Page: 2400 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dehydration Report Source Product Role Manufacturer Route Dose Duration Clozaril PS Novartis Sector: Pharma not reported Clozaril SS Novartis Sector: Pharma 75 mg / day Date:10/07/03ISR Number: 4202545-6Report Type:Expedited (15-DaCompany Report #PHRM2003FR02245 Age:80 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Overdose Leponex PS Novartis Sector: Initial or Prolonged Medication Error Pharma ORAL 200 mg, ONCE/SINGLE 1440 MIN Date:10/07/03ISR Number: 4202546-8Report Type:Expedited (15-DaCompany Report #PHHO2003CA10164 Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Clozaril PS Novartis Sector: Hospitalization - Cellulitis Pharma ORAL Unknown 83520MIN Initial or Prolonged Diarrhoea Dilantin C 100 mg, UNK Febrile Neutropenia Quetiapine C 200 mg, UNK Pyrexia Celexa C 20 mg, QD Glyburide C 5 mg, BID Clonazepam C .5 mg, TID Metformin C 500 mg, 1 am + 2 pm Nozinan C 100 mg, TID Date:10/07/03ISR Number: 4206019-8Report Type:Expedited (15-DaCompany Report #PHFR2003GB01389 Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Clozaril ( Initial or Prolonged Phosphokinase Increased Study Clozapine) Unknown PS ORAL ORAL Other Cardiac Failure Health Cardiac Murmur Professional Ecg P Wave Inverted Other Electrocardiogram Abnormal Electrocardiogram St Segment Elevation Endocarditis Labile Blood Pressure Myocarditis Tachycardia Date:10/07/03ISR Number: 4206379-8Report Type:Expedited (15-DaCompany Report #PHEH2003US08708 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Lung Neoplasm Malignant Health Clozaril (Clozapine) Initial or Prolonged White Blood Cell Count Professional Tablet PS ORAL 600 MG, QD, Other Decreased ORAL Mellaril C 22-Feb-2006 08:30 AM Page: 2401 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/07/03ISR Number: 4206977-1Report Type:Expedited (15-DaCompany Report #03P-056-0235141-00 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aspartate Foreign Depakote (Divalproex Initial or Prolonged Aminotransferase Health Sodium) (Divalproex Increased Professional Sodium) PS ORAL 750 MG, 1 IN Blood Creatine 1 D, ORAL Phosphokinase Increased Clozapine SS ORAL ORAL Blood Lactate Bromazepam C Dehydrogenase Increased Clonazepam C Blood Potassium Increased Date:10/08/03ISR Number: 4203462-8Report Type:Expedited (15-DaCompany Report #PHFR2002GB02209 Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Asthma Clozaril PS Novartis Sector: Hospitalization - Lower Respiratory Tract Pharma ORAL 500mg/day 2396 DAY Initial or Prolonged Infection Rabeprazole C ORAL 10mg/day Pneumonia Carbamazepine C ORAL 800mg/day Clomipramine C UNKNOWN 150mg/day Clonidine C ORAL 100ug/day Procyclidine C ORAL 15mg/day Amisulpride C UNKNOWN 200mg/day Senna C UNKNOWN 2 tablets/day Date:10/08/03ISR Number: 4203589-0Report Type:Expedited (15-DaCompany Report #PHFR2002GB02174 Age:43 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiac Arrest Clozaril PS Novartis Sector: Hospitalization - Colonic Obstruction Pharma ORAL 200 mg/day 17280MIN Initial or Prolonged Constipation Voltarol C ORAL 150 mg/day Other Faecaloma Dihydrocodeine C UNKNOWN Ileostomy Paroxetine C ORAL 30mg/day 25920MIN Ileus Paralytic Valium C ORAL 10-20mg/day 25920MIN Septic Shock Risperidone C ORAL 4mg/day Df118 C ORAL 440mg/day Procyclidine C 5 mg/day Date:10/08/03ISR Number: 4204111-5Report Type:Expedited (15-DaCompany Report #PHFR2003IE01616 Age:48 YR Gender:Male I/FU:F Outcome PT Death Blood Cholesterol Other Increased Blood Pressure Fluctuation Blood Pressure Increased Cardiomyopathy Circulatory Collapse Coronary Artery Atherosclerosis Coronary Artery Stenosis Cough Decreased Appetite Fatigue Feeling Abnormal 22-Feb-2006 08:30 AM Page: 2402 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hallucination Hepatitis Hepatomegaly Report Source Product Role Manufacturer Route Dose Duration Hypersomnia Clozaril PS Novartis Sector: Irritability Pharma ORAL 50mg Lymphocyte Count nocte/75mg Increased mane Malaise Clozaril SS Novartis Sector: Monocyte Count Decreased Pharma ORAL 125mg/day 44640MIN Monocyte Count Increased Haloperidol C ORAL 5 mg, BID 34560MIN Myocardial Infarction Diazepam C ORAL 2 mg, BID 34560MIN Myocarditis Nephritis Interstitial Neutrophil Count Increased Oral Intake Reduced Pallor Pericarditis Pulmonary Congestion Pulmonary Oedema Restlessness Sleep Disorder Somnolence Sudden Death Urinary Incontinence White Blood Cell Count Increased Date:10/08/03ISR Number: 4204169-3Report Type:Expedited (15-DaCompany Report #PHFR2003GB03809 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Clozaril PS Novartis Sector: Initial or Prolonged Blood Pressure Pharma ORAL Fluctuation Body Temperature Increased Confusional State Diabetes Mellitus Inadequate Control Disorientation Heart Rate Irregular Hyperhidrosis Neuroleptic Malignant Syndrome Pulse Abnormal Date:10/08/03ISR Number: 4204170-XReport Type:Expedited (15-DaCompany Report #PHFR2002GB03890 Age:25 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bundle Branch Block Clozaril (Clozapine) PS Novartis Sector: Cardiac Disorder Pharma ORAL Chest Pain Electrocardiogram Abnormal Sinus Tachycardia Tachycardia 22-Feb-2006 08:30 AM Page: 2403 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/08/03ISR Number: 4204171-1Report Type:Expedited (15-DaCompany Report #PHFR2003GB02641 Age:60 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Clozaril PS Novartis Sector: Non-Insulin-Dependent Pharma ORAL 175 mg/day 451 DAY Hyperglycaemia Atenolol C ORAL 100 mg, QD Amlodipine C ORAL 10 mg, QD Diazepam C ORAL 5 mg, BID Date:10/08/03ISR Number: 4204173-5Report Type:Expedited (15-DaCompany Report #PHBS2003CA08896 Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Ammonia Increased Clozaril PS Novartis Sector: Athetosis Pharma ORAL 500 mg/d Electroencephalogram Clozaril SS Novartis Sector: Abnormal Pharma ORAL 600 mg/d Limb Injury Clozaril SS Novartis Sector: Movement Disorder Pharma ORAL 500 mg, QHS Muscle Spasms Clozaril SS Novartis Sector: Myoclonus Pharma ORAL 400 mg, QHS Nasopharyngeal Disorder Lithium C UNKNOWN Speech Disorder Risperdal C UNKNOWN UNK, UNK Fluanxol "Bayer" C UNKNOWN 60 mg, BIW Date:10/08/03ISR Number: 4204175-9Report Type:Expedited (15-DaCompany Report #PHNU2003DE03552 Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - C-Reactive Protein Leponex / Clozaril Initial or Prolonged Increased (Clozapine) PS Novartis Sector: Other Conjunctivitis Pharma ORAL 400 mg, BID Drug Interaction Leponex / Clozaril Drug Level Increased (Clozapine) SS Novartis Sector: Leukocytosis Pharma ORAL 300 mg, BID Psychotic Disorder Ciprobay SS ORAL 500 mg, BID 10080MIN Tracheobronchitis Solian C ORAL 300 mg, BID Atosil C ORAL 50 mg, TID Tavor C ORAL 1 mg, BID Iron C UNKNOWN Espumisan C ORAL Simethicone C ORAL Lactulose C ORAL Date:10/08/03ISR Number: 4204177-2Report Type:Expedited (15-DaCompany Report #PHNR2003AU01255 Age:48 YR Gender:Male I/FU:F Outcome PT Other Balance Disorder Blood Ph Increased Blood Potassium Increased Body Temperature Increased C-Reactive Protein Increased Chest Pain Dizziness Haemoglobin Decreased 22-Feb-2006 08:30 AM Page: 2404 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Headache Infection Orthostatic Hypotension Report Source Product Role Manufacturer Route Dose Duration Sedation Clozaril PS Novartis Sector: Tachycardia Pharma UNK, UNK 30240MIN Troponin Increased Lipitor C 20mg nocte White Blood Cell Count Thyroxine C 100 ug, QD Increased Date:10/08/03ISR Number: 4206069-1Report Type:Expedited (15-DaCompany Report #PHFR2003GB03708 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Accidental Exposure Foreign Leponex/Clozaril Overdose Health (Clozapine) Professional (Clozapine) Tablet PS ORAL 700MG/DAY Other TOTAL 63 X 100MG TABS, ORAL Date:10/08/03ISR Number: 4206097-6Report Type:Expedited (15-DaCompany Report #PHNU2003DE03451 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Renal Failure Foreign Leponex / Health Clozaril PS ORAL 150 MG/DAY, Professional ORAL Company Representative Other Date:10/08/03ISR Number: 4206120-9Report Type:Expedited (15-DaCompany Report #PHBS2003CA10418 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Lipoprotein Deficiency Foreign Clozapine Initial or Prolonged Literature (Clozapine) PS Health Valproic Acid C Professional Other Date:10/08/03ISR Number: 4206131-3Report Type:Expedited (15-DaCompany Report #PHBS2003PH10413 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Typhoid Fever Foreign Leponex(Clozapine) PS ORAL ORAL Health Chloromycetin C Professional Co-Trimoxazole(Sulfa Other methoxazole) C Date:10/08/03ISR Number: 4208735-0Report Type:Direct Company Report #CTU 203514 Age:39 YR Gender:Male I/FU:I Outcome Life-Threatening Hospitalization - 22-Feb-2006 08:30 AM Page: 2405 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Initial or Prolonged Required Intervention to Prevent Permanent PT Report Source Product Role Manufacturer Route Dose Duration Impairment/Damage Blood Sodium Decreased Clozapine 400 Mg Convulsion Bid-Ivax PS Ivax 400 MG BID Haematemesis Atorvastatin 20 Mg Haemodialysis Od Parke Davis SS Parke Davis 20 MG OD Neuroleptic Malignant Quetiapine 400 Mg Syndrome Bid Astrazeneca SS Astrazeneca 400 MG BID Polydipsia Metoprolol C Renal Failure Acute Enalapril C Rhabdomyolysis Monetasone Furoate Nasal Spray C Date:10/09/03ISR Number: 4207510-0Report Type:Expedited (15-DaCompany Report #C2003-2563.01 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozapine Tablets Professional 100 Mg Mylan PS ORAL 100MG Q AM, Other 300MG Q HS, ORAL Bupropion Hcl C Divalproex Sodium C Risperidone C Trazodone Hcl C Date:10/09/03ISR Number: 4208881-1Report Type:Direct Company Report #CTU 203590 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Myocarditis Clozapine PS ORAL 300 MG PO BID Required Zocor C Intervention to Prozac C Prevent Permanent Impairment/Damage Date:10/10/03ISR Number: 4205735-1Report Type:Expedited (15-DaCompany Report #PHFR2003GB03655 Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Clozaril PS Novartis Sector: Hyperglycaemia Pharma ORAL 650mg/day Valproate Sodium C ORAL 500 mg, BID Propranolol C UNKNOWN 10 mg, BID Ranitidine C UNKNOWN 150 mg, BID Date:10/10/03ISR Number: 4205739-9Report Type:Expedited (15-DaCompany Report #PHRM2003FR01639 Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Chronic Lymphocytic Leponex PS Novartis Sector: Other Leukaemia Pharma ORAL 250 mg/day Lymphocyte Count Xanax C .5 mg, TID Increased Anafranil C ORAL 75 mg, BID Zoloft C ORAL 50 mg, BID Efexor C ORAL 50 mg, TID 22-Feb-2006 08:30 AM Page: 2406 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/10/03ISR Number: 4206160-XReport Type:Expedited (15-DaCompany Report #PHNR2003AU01421 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Clozaril PS Novartis Sector: Drug Interaction Pharma 12 - 600 mg/day Amitriptyline SS Ssri C Date:10/10/03ISR Number: 4206176-3Report Type:Expedited (15-DaCompany Report #PHFR2003GB03819 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Adverse Event Clozaril PS Novartis Sector: Diabetes Mellitus Pharma 814 DAY Date:10/10/03ISR Number: 4206179-9Report Type:Expedited (15-DaCompany Report #PHNR2003AU01364 Age:27 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Osmolarity Clozaril PS Novartis Sector: Initial or Prolonged Increased Pharma ORAL 25 - 350 Disability Diabetes Insipidus mg/day Polyuria Urine Osmolarity Decreased Date:10/10/03ISR Number: 4208394-7Report Type:Expedited (15-DaCompany Report #03-09-1120 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diet Refusal Health Clozapine - Ivax Renal Failure Chronic Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 300-500MG HS ORAL Synthroid 0.1mg C Date:10/10/03ISR Number: 4208414-XReport Type:Expedited (15-DaCompany Report #C2003-2535.01 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine Tablets Professional 100 Mg Mylan PS ORAL 800MG Q HS, Other ORAL Olanzapine C Benztropine C Mesylate C Date:10/10/03ISR Number: 4208416-3Report Type:Expedited (15-DaCompany Report #C2003-2533.01 Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg Mylan PS ORAL 25MG QD, ORAL Other Carbidopa C Levodopa C 22-Feb-2006 08:30 AM Page: 2407 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Donepezil C Date:10/10/03ISR Number: 4208422-9Report Type:Expedited (15-DaCompany Report #03-09-1101 Age:76 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coma Health Clozapine - Ivax Myocardial Infarction Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 250MG BID ORAL Synthroid C Clonopin C Protonix C Singulair C Date:10/10/03ISR Number: 4208634-4Report Type:Expedited (15-DaCompany Report #PHBS2003DE10079 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Eosinophilia Foreign Clozapine Granulocytopenia Literature (Clozapine) Unknown PS Zygomycosis Health Professional Other Date:10/13/03ISR Number: 4206908-4Report Type:Expedited (15-DaCompany Report #PHBS2003IE10795 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Abuser Clozaril PS Novartis Sector: Pharma ORAL 1100 mg, ONCE/SINGLE Antidepressants C UNKNOWN Alcohol C UNKNOWN Date:10/13/03ISR Number: 4207489-1Report Type:Expedited (15-DaCompany Report #PHHO2003CA11851 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Clozaril PS Novartis Sector: Initial or Prolonged Cardiac Disorder Pharma ORAL 50mg noon, Other Diarrhoea 100mg supper, Drug Hypersensitivity 250mghs Fatigue Atenolol SS 0.25 mg, QD Myocarditis Remeron C Rash Imovane C ORAL 7.5 mg Tachycardia Date:10/14/03ISR Number: 4207675-0Report Type:Expedited (15-DaCompany Report #PHEH2003US09292 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetic Ketoacidosis Clozaril PS Novartis Sector: Pancreatitis Haemorrhagic Pharma ORAL UNK,UNK 22-Feb-2006 08:30 AM Page: 2408 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/14/03ISR Number: 4207986-9Report Type:Expedited (15-DaCompany Report #PHFR2003GB03824 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Circulatory Collapse Clozaril PS Novartis Sector: Initial or Prolonged Drop Attacks Pharma ORAL 500mg/day 81 DAY Eosinophil Count Increased Transient Ischaemic Attack Date:10/14/03ISR Number: 4208146-8Report Type:Expedited (15-DaCompany Report #PHFR2003GB03836 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intestinal Obstruction Clozaril PS Novartis Sector: Initial or Prolonged Surgery Pharma ORAL Date:10/14/03ISR Number: 4208147-XReport Type:Expedited (15-DaCompany Report #PHFR2003GB03549 Age:42 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Infection Clozaril PS Novartis Sector: Initial or Prolonged Overdose Pharma ORAL UNK, UNK 187 DAY Sedation Clozaril SS Novartis Sector: Somnolence Pharma ORAL 2g overdose Clozaril SS Novartis Sector: Pharma ORAL 200mg/day Venlafaxine SS UNKNOWN 450mg/day Venlafaxine SS UNKNOWN 300mg/day Date:10/14/03ISR Number: 4208649-6Report Type:Expedited (15-DaCompany Report #03-10-1241 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Ivax Hospitalization - Pneumonia Professional Pharmaceuticals, Initial or Prolonged Other Inc. ORAL 400-800 MG QD ORAL Date:10/15/03ISR Number: 4210075-0Report Type:Expedited (15-DaCompany Report #C2003-2384.01 Age:58 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accident Health Clozapine Tablets Intentional Self-Injury Professional 100 Mg Mylan PS Mylan ORAL 300 MG, QHS, Thermal Burn Other ORAL Clozapine Tablets 25 Mg Mylan SS Mylan ORAL 50 MG QHS ORAL Venlafaxine (Venlafaxine) C 22-Feb-2006 08:30 AM Page: 2409 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/15/03ISR Number: 4210089-0Report Type:Expedited (15-DaCompany Report #03-10-1257 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abnormal Behaviour Foreign Clozapine Tablets PS ORAL 12.5-75 MG QD Complications Of Maternal Literature ORAL Exposure To Therapeutic Health Drugs Professional Decreased Appetite Foetal Growth Retardation Heart Sounds Abnormal Indifference Insomnia Maternal Drugs Affecting Foetus Oligohydramnios Pregnancy Schizophrenia Stillbirth Vaginal Discharge Date:10/15/03ISR Number: 4210220-7Report Type:Expedited (15-DaCompany Report #03P-167-0235947-00 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Electrocardiogram Qt Foreign Epilim (Sodium Intervention to Prolonged Health Valproate) (Sodium Prevent Permanent Professional Valproate) (Sodium Impairment/Damage Valproate) PS Clozapine SS Date:10/16/03ISR Number: 4209480-8Report Type:Expedited (15-DaCompany Report #PHHO2003CA12742 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Respiratory Disorder Clozaril PS Novartis Sector: Initial or Prolonged Pharma not reported Other Date:10/16/03ISR Number: 4209515-2Report Type:Expedited (15-DaCompany Report #PHFR2003GB03882 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sperm Count Decreased Clozaril PS Novartis Sector: Pharma ORAL 400mg/day Date:10/16/03ISR Number: 4209529-2Report Type:Expedited (15-DaCompany Report #PHFR2003GB03374 Age:21 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Clozaril (Clozapine) PS Novartis Sector: Initial or Prolonged Blood Glucose Increased Pharma ORAL Other Diabetes Mellitus Venlafaxine C UNKNOWN Electrocardiogram Qt Prolonged Insomnia Lower Respiratory Tract Infection 22-Feb-2006 08:30 AM Page: 2410 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/16/03ISR Number: 4209530-9Report Type:Expedited (15-DaCompany Report #PHFR2003GB03908 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Oculogyration Clozaril PS Novartis Sector: Pharma ORAL Date:10/16/03ISR Number: 4209650-9Report Type:Expedited (15-DaCompany Report #PHFR2003GB03528 Age:25 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Depressed Level Of Clozaril PS Novartis Sector: Consciousness Pharma ORAL 600 mg Drug Abuser overdose Haemoglobin Decreased Venlafaxine C ORAL 150 mg/day Hypotension Lithium Chloride C ORAL 1000 mg/day White Blood Cell Count Olanzapine C ORAL 10 mg/day Increased Date:10/16/03ISR Number: 4209676-5Report Type:Expedited (15-DaCompany Report #PHEH2003US09261 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukaemia Clozaril PS Novartis Sector: Leukopenia Pharma UNK,UNK Abilify /Usa/ C Date:10/16/03ISR Number: 4209677-7Report Type:Expedited (15-DaCompany Report #PHFR2003GB03674 Age:51 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Back Pain Clozaril PS Novartis Sector: Initial or Prolonged Blood Glucose Increased Pharma ORAL 100 mg/day Other Body Temperature Clozaril SS Novartis Sector: Increased Pharma ORAL 150mg/day Chest Pain Diabetes Mellitus Inadequate Control Ill-Defined Disorder Malaise Musculoskeletal Pain Pain Urinary Tract Infection Viral Infection Date:10/16/03ISR Number: 4210878-2Report Type:Direct Company Report #CTU 203976 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Clozaril 150 Mg Initial or Prolonged Syndrome Novartis PS Novartis ORAL 150 MG PO BID [50 MG] Clozaril 150 Mg Novartis SS 100 MG 22-Feb-2006 08:30 AM Page: 2411 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/16/03ISR Number: 4211057-5Report Type:Expedited (15-DaCompany Report #C2003-2603.01 Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Other Clozapine Tablets 100 Mg Mylan PS ORAL 100MG Q AM, 300 MG Q PM, ORAL Albuterol Sulfate C Ipratropium Bromide C Calcium Carbonate C Magnesium Hydroxide C Captopril C Fluoxetine C Heparin C Insulin C Lactulose C Levofloxacin C Magnesium Citrate C Pantoprazole Sodium C Promethazine C Sulfamethaxazole C Trimethoprim C Date:10/16/03ISR Number: 4211058-7Report Type:Expedited (15-DaCompany Report #03-10-1286 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pleural Effusion Health Clozapine - Ivax Pulmonary Embolism Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 75-150MG ORAL Date:10/16/03ISR Number: 4211059-9Report Type:Expedited (15-DaCompany Report #03-08-0981 Age:55 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Lung Neoplasm Malignant Health Clozapine -Ivax Initial or Prolonged Professional Pharmaceuticals, Other Other Inc. Tablets PS ORAL 300MG QD ORAL Date:10/16/03ISR Number: 4213347-9Report Type:Expedited (15-DaCompany Report #DSA_23444_2003 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Foreign Ativan PS 6 MG PRN Initial or Prolonged Health Ativan SS 0.5 MG QWK Professional Clozaril SS 500 MG QD Other Cardura C Coversyl C Adalat C Lithium C Date:10/17/03ISR Number: 4210525-XReport Type:Expedited (15-DaCompany Report #PHRM2003FR02220 Age: Gender:Male I/FU:F Outcome PT Haemoglobin Decreased Infectious Mononucleosis 22-Feb-2006 08:30 AM Page: 2412 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pyrexia Report Source Product Role Manufacturer Route Dose Duration Leponex PS Novartis Sector: Pharma ORAL 600 mg daily Date:10/17/03ISR Number: 4210568-6Report Type:Expedited (15-DaCompany Report #PHFR2003IE03813 Age:46 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Clozaril PS Novartis Sector: Initial or Prolonged Increased Pharma ORAL 300mg/day 30240MIN Other Anorexia Clozaril SS Novartis Sector: Blood Creatinine Pharma ORAL 100 mg/day Increased Chlorpromazine SS Blood Pressure Increased Valproate Sodium C UNKNOWN Blood Urea Increased Body Temperature Increased Confusional State Disorientation Drug Interaction Eosinophil Count Increased Gamma-Glutamyltransferase Increased Liver Function Test Abnormal Nausea Tachycardia White Blood Cell Count Increased Date:10/17/03ISR Number: 4210651-5Report Type:Expedited (15-DaCompany Report #PHHO2003CA11572 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Clozaril PS Novartis Sector: Initial or Prolonged Convulsion Pharma ORAL not reported 1163 DAY Other Date:10/17/03ISR Number: 4210656-4Report Type:Expedited (15-DaCompany Report #PHFR2003GB03514 Age:22 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Faecaloma Clozaril PS Novartis Sector: Intestinal Ischaemia Pharma ORAL 900mg/day Amisulpride C ORAL 400mg/day Omeprazole C ORAL 20mg/day Date:10/17/03ISR Number: 4210657-6Report Type:Expedited (15-DaCompany Report #PHBS2003US11028 Age:34 YR Gender:Male I/FU:I Outcome PT Hospitalization - Difficulty In Walking Initial or Prolonged Drug Level Increased Myoclonus 22-Feb-2006 08:30 AM Page: 2413 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pyrexia Sedation Upper Respiratory Tract Report Source Product Role Manufacturer Route Dose Duration Infection Clozapine PS Novartis Sector: Pharma UNKNOWN 300 mg/d Clozapine SS Novartis Sector: Pharma ORAL 600 mg/d Clozapine SS Novartis Sector: Pharma UNKNOWN 400 mg/d Olanzapine C UNKNOWN 2.5 to 10 mg/d Benztropeine C UNKNOWN Propranolol C UNKNOWN Valproic Acid C UNKNOWN Date:10/17/03ISR Number: 4213377-7Report Type:Expedited (15-DaCompany Report #03-10-1261 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine - Ivax Professional Pharmaceuticals, Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL ORAL Date:10/20/03ISR Number: 4211961-8Report Type:Expedited (15-DaCompany Report #PHFR2003GB03412 Age:21 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dissociative Disorder Clozaril PS Novartis Sector: Feeling Jittery Pharma ORAL 225mg/day 71 DAY Jaw Disorder Pain In Jaw Date:10/20/03ISR Number: 4211965-5Report Type:Expedited (15-DaCompany Report #PHRM2003FR02192 Age:68 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Leponex PS Novartis Sector: Initial or Prolonged Diarrhoea Pharma ORAL 400 mg daily Gastrointestinal Disorder Orthostatic Hypotension Psychomotor Retardation Somnolence Date:10/20/03ISR Number: 4212052-2Report Type:Expedited (15-DaCompany Report #PHEH2003US08052 Age:53 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Fall Clozaril PS Novartis Sector: Injury Asphyxiation Pharma ORAL 100mg am Skin Injury +375mg pm Anafranil C Clomipramine C 22-Feb-2006 08:30 AM Page: 2414 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/20/03ISR Number: 4212056-XReport Type:Expedited (15-DaCompany Report #FR-ROCHE-348072 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Delirium Rivotril PS Roche UNKNOWN Depression Leponex SS UNKNOWN Fatigue Prozac C Persecutory Delusion Salivary Hypersecretion Date:10/20/03ISR Number: 4214255-XReport Type:Expedited (15-DaCompany Report #CA-BRISTOL-MYERS SQUIBB COMPANY-12393948 Age:53 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Fatigue Aripiprazole PS Otsuka Hospitalization - Orthostatic Hypotension Pharmaceutical Initial or Prolonged Sedation Company, Ltd. ORAL Supraventricular Clozapine SS ORAL 100 mg noon Tachycardia and supper, Syncope 50 mg hs Valproic Acid C present dose 500 mg noon/750 mg hs Pantoprazole C Lorazepam C Lactulose C Date:10/20/03ISR Number: 4214580-2Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030904720 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Literature Risperdal Depressed Level Of Health (Risperidone) Consciousness Professional Unspecified PS ORAL ORAL Hypotension Distributor Valproic Acid Multi-Organ Failure (Valproic Acid) SS Tachycardia Clonazepam (Clonazepam) SS Atorvastatin (Atorvastatin) SS Gabapentin (Gabapentin) SS Clozapine (Clozapine) SS Nizatidine (Nizatidine) SS Trihexyphenidyl (Trihexyphenidyl) SS Date:10/21/03ISR Number: 4215089-2Report Type:Expedited (15-DaCompany Report #PHFR2003GB03708 Age:23 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Accidental Exposure Clozaril PS Novartis Sector: Overdose Pharma ORAL 700mg/day total 63 x 100mg tabs 30240MIN Olanzapine C ORAL 20mg/on 22-Feb-2006 08:30 AM Page: 2415 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Paroxetine C ORAL 20mg/om Date:10/21/03ISR Number: 4215093-4Report Type:Expedited (15-DaCompany Report #PHNR2003AU01209 Age:52 YR Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Clozaril PS Novartis Sector: Drug Level Fluctuating Pharma 25 - 600 Treatment Noncompliance mg/day Multivit B SS Magnesium SS Calcium SS Quinate /Aus/ SS Date:10/21/03ISR Number: 4215095-8Report Type:Expedited (15-DaCompany Report #PHEH2003US09495 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dyspnoea Clozaril PS Novartis Sector: Hospitalization - Lung Neoplasm Malignant Pharma ORAL 400mg Initial or Prolonged Respiratory Arrest noon+500mg hs Date:10/21/03ISR Number: 4215097-1Report Type:Expedited (15-DaCompany Report #PHEH2003US09571 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Clozaril PS Novartis Sector: Congestive Pharma ORAL UNK, UNK Cardiomegaly Drug Toxicity Date:10/21/03ISR Number: 4215101-0Report Type:Expedited (15-DaCompany Report #PHFR2003GB03938 Age: YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiac Disorder Clozaril (Clozapine) PS Novartis Sector: Orthostatic Hypotension Pharma UNKNOWN 50mg/day 64800MIN Date:10/21/03ISR Number: 4215236-2Report Type:Expedited (15-DaCompany Report #PHFR2003GB03944 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Clozaril PS Novartis Sector: Pharma ORAL 30240MIN Date:10/21/03ISR Number: 4215241-6Report Type:Expedited (15-DaCompany Report #PHFR2003IE02949 Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bundle Branch Block Left Clozaril PS Novartis Sector: Initial or Prolonged Hypertensive Pharma ORAL Cardiomyopathy Myocardial Infarction 22-Feb-2006 08:30 AM Page: 2416 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/21/03ISR Number: 4216247-3Report Type:Expedited (15-DaCompany Report #2003UW12931 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Seroquel PS ORAL 800 MG DAILY Professional PO Clozapine SS ORAL 400 MG DAILY PO Risperdal SS 4 MG BID Depakote SS 1500 MG DAILY Date:10/22/03ISR Number: 4214057-4Report Type:Expedited (15-DaCompany Report #PHFR2003GB03289 Age:49 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Congestive Cardiomyopathy Clozaril PS Novartis Sector: Hospitalization - Cough Pharma ORAL Initial or Prolonged Deep Vein Thrombosis Lethargy Lower Respiratory Tract Infection Pulmonary Embolism Pyrexia Sputum Test Date:10/22/03ISR Number: 4214085-9Report Type:Expedited (15-DaCompany Report #PHNR2003AU01464 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Oesophageal Ulcer Clozaril PS Novartis Sector: Initial or Prolonged Respiratory Tract Pharma ORAL 12.5-200mg/da Infection y Date:10/22/03ISR Number: 4214177-4Report Type:Expedited (15-DaCompany Report #PHBS2003NZ09807 Age:21 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hodgkin'S Disease Clozaril PS Novartis Sector: Lymphopenia Pharma ORAL 350 mg/d Date:10/22/03ISR Number: 4214188-9Report Type:Expedited (15-DaCompany Report #PHNR2003AU01461 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Clozaril PS Novartis Sector: Initial or Prolonged Phosphokinase Increased Pharma ORAL 25 - 700 Convulsion mg/day Drug Withdrawal Syndrome Clonazepam C Rhabdomyolysis Date:10/22/03ISR Number: 4215643-8Report Type:Expedited (15-DaCompany Report #03-10-1287 Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aplastic Anaemia Health Clozapine Tablets - Initial or Prolonged Dyspnoea Professional Ivax Pharmaceuticals, 22-Feb-2006 08:30 AM Page: 2417 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Inc. PS Ivax Pharmaceuticals, Inc. ORAL 50MG 4PM ORAL Procrit C Vitamin B12 C Ferrous Sulfate C Prilosec C Aricept C Urecholine C Zocor C Megace C Metformin C Multivitamins Qd C Calcium Carbonate C Vitamin E C Date:10/22/03ISR Number: 4215670-0Report Type:Expedited (15-DaCompany Report #03-09-1103 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Appendicitis Perforated Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 350MG QD ORAL Date:10/22/03ISR Number: 4215708-0Report Type:Expedited (15-DaCompany Report #03-08-1031 Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Gastrointestinal Disorder Health Clozapine - Ivax General Physical Health Professional Pharmaceuticals, Deterioration Other Inc. Tablets PS Ivax Hyperglycaemia Pharmaceuticals, Loss Of Consciousness Inc. ORAL 100MG AM ORAL Organ Failure Depakote C Pulmonary Embolism Renal Artery Thrombosis Renal Failure Date:10/22/03ISR Number: 4215756-0Report Type:Expedited (15-DaCompany Report #03-10-1295 Age:27 YR Gender:Male I/FU:I Outcome PT Other Convulsion Hypotension Intentional Self-Injury Liver Function Test Abnormal Overdose Pneumonia Postoperative Infection Psychotic Disorder Pyrexia Renal Failure Acute Sepsis Staphylococcal Infection Suicide Attempt 22-Feb-2006 08:30 AM Page: 2418 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tachycardia Treatment Noncompliance Report Source Product Role Manufacturer Route Dose Duration Foreign Doxycycline Hyclate Other - Ipi Capsules PS Clozaril SS ORAL 50MG/DAY ORAL Midazolam SS INTRAVENOUS INTRVENOUS Chlorpromazine SS Date:10/22/03ISR Number: 4217043-3Report Type:Expedited (15-DaCompany Report #KII-2003-0003462 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Health Oxycontin Tablets Initial or Prolonged Confusional State Professional (Oxycodone Other Delusion Hydrochloride) Cr Mental Status Changes Tablet PS ORAL 100 TABLET, Multiple Drug Overdose ORAL Somnolence Soma (Carisoprodol SS ORAL ORAL Tearfulness Clonazepine (Clonazepam) SS ORAL ORAL Amfetamine (Amfetamine) SS Date:10/23/03ISR Number: 4215287-8Report Type:Expedited (15-DaCompany Report #PHNU2003DE03159 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Gastric Lavage Leponex / Clozaril Initial or Prolonged Hallucination (Clozapine) PS Novartis Sector: Other Intentional Overdose Pharma ORAL 10000 mg, Restlessness ONCE/SINGLE 1440 MIN Somnolence Suicide Attempt White Blood Cell Disorder Date:10/24/03ISR Number: 4216474-5Report Type:Expedited (15-DaCompany Report #PHFR2003GB03306 Age:60 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Clozaril PS Novartis Sector: Initial or Prolonged Convulsion Pharma ORAL 450mg/day Other Electroencephalogram Clozaril SS Novartis Sector: Abnormal Pharma 200mg/day Encephalopathy Aspirin "Bayer" C 75mg/day Fall Feeling Abnormal Full Blood Count Decreased Neutropenia Date:10/24/03ISR Number: 4216483-6Report Type:Expedited (15-DaCompany Report #PHFR2003GB04001 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Clozaril PS Novartis Sector: Drug Ineffective Pharma ORAL 66240MIN 22-Feb-2006 08:30 AM Page: 2419 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/24/03ISR Number: 4216487-3Report Type:Expedited (15-DaCompany Report #PHNU2003DE03429 Age:18 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Leponex / Clozaril Increased (Clozapine) PS Novartis Sector: Aspartate Pharma ORAL 200 mg/day Aminotransferase Increased Blood Amylase Increased Lipase Increased Liver Function Test Abnormal Pancreatic Enzymes Increased Date:10/24/03ISR Number: 4217442-XReport Type:Expedited (15-DaCompany Report #03-09-1065 Age:13 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Health Clozapine PS Ivax Pharmaceuticals Initial or Prolonged Fatigue Professional Inc. ORAL 800 MG QD Other Irritability Other ORAL Ketoacidosis Topamax C Guianfacine C Date:10/24/03ISR Number: 4217446-7Report Type:Expedited (15-DaCompany Report #C2003-2670.01 Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Atherosclerosis Health Clozapine PS Mylan ORAL 25 MG BID, Cardiac Failure Professional ORAL Congestive Other Acetaminophen C Hyperlipidaemia Ciprofloxacin C Digoxin C Esompeprazole Magnesium C Fentanyl Transdermal C Furosemide C Metformin/Gliprzide C Nitroglycern Transdermal C Date:10/24/03ISR Number: 4217469-8Report Type:Expedited (15-DaCompany Report #PHHO2003CA06099 Age:23 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Clozaril PS Novartis Sector: Other Diabetes Mellitus Pharma Unknown 365 DAY Insulin-Dependent Glucose Urine Date:10/24/03ISR Number: 4217486-8Report Type:Expedited (15-DaCompany Report #PHFR2003GB03674 Age:51 YR Gender:Female I/FU:F Outcome Hospitalization - Initial or Prolonged 22-Feb-2006 08:30 AM Page: 2420 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other PT Report Source Product Role Manufacturer Route Dose Duration Back Pain Clozaril PS Novartis Sector: Blood Glucose Increased Pharma ORAL 100 mg/day Body Temperature Clozaril SS Novartis Sector: Increased Pharma ORAL 150mg/day Chest Pain Clozaril SS Novartis Sector: Diabetes Mellitus Pharma ORAL 175mg/day Diabetes Mellitus Insulin SS Inadequate Control Trimethoprim C Malaise Musculoskeletal Pain Pain Urinary Tract Infection Viral Infection Date:10/24/03ISR Number: 4217492-3Report Type:Expedited (15-DaCompany Report #PHNU2003DE03593 Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Creatine Leponex / Clozaril Hospitalization - Phosphokinase Increased (Clozapine) PS Novartis Sector: Initial or Prolonged Electrocardiogram P Wave Pharma ORAL 50 mg, QD 1440 MIN Abnormal Leponex / Clozaril Electrocardiogram St (Clozapine) SS Novartis Sector: Segment Elevation Pharma ORAL 100 mg, QD 4320 MIN Electrocardiogram T Wave Clozapin Abnormal "Neuraxpharm" SS ORAL 10 g, Intentional Overdose ONCE/SINGLE 1440 MIN Pericardial Effusion Zoloft C ORAL 50mg/day Suicide Attempt Zoloft C ORAL Ventricular Hypokinesia Date:10/24/03ISR Number: 4217584-9Report Type:Expedited (15-DaCompany Report #PHNU2003DE03704 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Lymphocytosis Leponex / Clozaril Pseudo Lymphoma (Clozapine) PS Novartis Sector: Pharma ORAL 200 mg/day Date:10/24/03ISR Number: 4220004-1Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20031003649 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) Unspecified PS 4 MG, 2 IN 1 DAY, UNKNOWN Clozapine (Clozapine) SS 400 MG, 1 IN 1 DAY Depakote (Valproate Semisodium) SS 1500 MG, 1 IN 1 DAY Seroquel (Quetiapine Fumarate) SS 800 MG, 1 IN 22-Feb-2006 08:30 AM Page: 2421 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report 1 DAY Date:10/27/03ISR Number: 4218068-4Report Type:Expedited (15-DaCompany Report #PHFR2003GB02587 Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram St Clozaril PS Novartis Sector: Segment Elevation Pharma ORAL 150mg/day Sinus Tachycardia Clozaril SS Novartis Sector: Pharma ORAL 175mg/day Date:10/27/03ISR Number: 4218069-6Report Type:Expedited (15-DaCompany Report #PHFR2003GB03010 Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Pressure Increased Clozaril PS Novartis Sector: Body Temperature Pharma ORAL 100mg am & Decreased 300mg pm Heart Rate Increased Clozaril SS Novartis Sector: Medication Error Pharma ORAL 600mg/evening Overdose dose Clozaril SS Novartis Sector: Pharma 700 mg overdose Alcohol SS Benztropeine C ORAL 2 mg, BID Date:10/27/03ISR Number: 4218082-9Report Type:Expedited (15-DaCompany Report #PHFR2002GB03678 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Clozaril (Clozapine) PS Novartis Sector: Other Circulatory Collapse Pharma ORAL 900mg/day Convulsion Chlorpromazine I ORAL 400 mg/day Drug Level Increased Dyspnoea Empyema Feeling Abnormal Haemoglobin Decreased Lower Respiratory Tract Infection Malaise Neutrophil Count Increased Neutrophilia Platelet Count Increased Pneumonia White Blood Cell Count Increased Date:10/27/03ISR Number: 4218164-1Report Type:Expedited (15-DaCompany Report #PHFR2003IE01744 Age:23 YR Gender:Male I/FU:F Outcome Death Hospitalization - Initial or Prolonged Disability 22-Feb-2006 08:30 AM Page: 2422 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Discomfort Clozaril PS Novartis Sector: Abdominal Pain Upper Pharma ORAL 100mg/day Constipation Clozaril SS Novartis Sector: Dyspepsia Pharma ORAL 325mg/day 1049 DAY Gastric Ulcer Haemorrhage Quetiapine C ORAL 750mg/day Gastrointestinal Haemorrhage Gastrointestinal Ulcer Haemoglobin Decreased Intestinal Obstruction Myocardial Infarction Procedural Complication Vomiting Date:10/27/03ISR Number: 4218187-2Report Type:Expedited (15-DaCompany Report #PHHO2003CA12425 Age:65 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Chronic Obstructive Clozaril PS Novartis Sector: Pulmonary Disease Pharma ORAL 50 mg / day 2880 MIN Circulatory Collapse Clozaril SS Novartis Sector: Diabetic Complication Pharma ORAL 75 mg / day 2880 MIN Pneumonia Clonazepam C Epival C Insulin C Ativan C Date:10/27/03ISR Number: 4218826-6Report Type:Expedited (15-DaCompany Report #PHFR2003GB03651 Age:51 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drop Attacks Carbamazepine PS Novartis Sector: Initial or Prolonged Psychotic Disorder Pharma ORAL 400 mg, QD Other Clozaril SS ORAL 600mg/day Amitriptyline C ORAL 150 mg, QD Hyoscine C ORAL 1200 ug, QD Omeprazole C ORAL 20 mg, QD Procyclidine C ORAL 10 mg, QD Date:10/27/03ISR Number: 4218833-3Report Type:Expedited (15-DaCompany Report #PHFR2003IE02860 Age:44 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Crepitations Clozaril PS Novartis Sector: Gait Disturbance Pharma ORAL 12.5mg Hyperhidrosis mane/12.5mg Hyperpyrexia nocte 31680MIN Lower Respiratory Tract Clozaril SS Novartis Sector: Infection Pharma ORAL 25mg/day Neutrophil Count Clozaril SS Novartis Sector: Increased Pharma 325mg/day Pyrexia Lustral C UNKNOWN 50mg mane/day Tachycardia Premarin C UNKNOWN 1ukn/day White Blood Cell Count Increased 22-Feb-2006 08:30 AM Page: 2423 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/27/03ISR Number: 4220051-XReport Type:Direct Company Report #CTU 204664 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Clozapine PS 400 MG DAILY Life-Threatening Drug Interaction Accupril SS Drug Toxicity Hydrochlorothiazide SS Depakote C Piroxicam C Oxybutynin C Bisacodyl C Baclofen C Miralax C Lactulose C Date:10/27/03ISR Number: 4220617-7Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20031003644 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Health Risperdal White Blood Cell Count Professional (Risperidone) PS Decreased Clozapine (Clozapine) SS 100 - 425 MG DAILY Protonix (Pantoprazole) SS Lamotrigine (Lamotrigine) SS Klonopin (Clonazepam) SS Cogentin (Benzatropine Mesilate) C Zoloft (Sertraline Hydrochloride) C Date:10/27/03ISR Number: 4220982-0Report Type:Expedited (15-DaCompany Report #M1181-2003 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Circulatory Collapse Mirtazapine (See Initial or Prolonged Coordination Abnormal Attached Pages For Disorientation Additional Suspect Electrocardiogram T Wave Drugs) PS ORAL 60 MG Inversion Clozapine SS ORAL 150 MG Gait Disturbance Lithium Carbonate C Leukocytosis Neutrophilia Orthostatic Hypotension Pyrexia Date:10/28/03ISR Number: 4219210-1Report Type:Expedited (15-DaCompany Report #PHFR2003GB04024 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Clozaril (Clozapine) PS Novartis Sector: Initial or Prolonged Feeling Abnormal Pharma 450mg/day 22-Feb-2006 08:30 AM Page: 2424 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/28/03ISR Number: 4219213-7Report Type:Expedited (15-DaCompany Report #PHEH2003US09688 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Clozaril PS Novartis Sector: Hospitalization - Lung Cancer Metastatic Pharma ORAL 300 mg/day 79 DAY Initial or Prolonged Myocardial Infarction Risperdal C Topamax C Efexor C Date:10/28/03ISR Number: 4219346-5Report Type:Expedited (15-DaCompany Report #PHNU2003DE01557 Age:23 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Leponex / Clozaril Increased (Clozapine) PS Novartis Sector: Alcohol Use Pharma ORAL up to Aspartate 300mg/day Aminotransferase Leponex / Clozaril Increased (Clozapine) SS Novartis Sector: Gamma-Glutamyltransferase Pharma ORAL 100 mg/day Increased Alcohol SS ORAL Unknown Hepatic Enzyme Increased Hepatic Steatosis Hepatocellular Damage Splenomegaly Date:10/28/03ISR Number: 4219770-0Report Type:Expedited (15-DaCompany Report #PHHO2003CA13412 Age:79 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Respiratory Arrest Clozaril PS Novartis Sector: Pharma ORAL Date:10/28/03ISR Number: 4221055-3Report Type:Expedited (15-DaCompany Report #03-10-1318 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mania Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 400-600MG QD ORAL Date:10/28/03ISR Number: 4222608-9Report Type:Expedited (15-DaCompany Report #2003112713 Age:27 YR Gender:Male I/FU:I Outcome PT Hospitalization - Alcohol Use Initial or Prolonged Convulsion Other Hypotension Intentional Self-Injury Liver Function Test Abnormal Overdose Pneumonia 22-Feb-2006 08:30 AM Page: 2425 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Postoperative Infection Psychotic Disorder Renal Failure Acute Report Source Product Role Manufacturer Route Dose Duration Sepsis Foreign Doxycycline(Doxycycl Staphylococcal Infection Health ine) PS Suicide Attempt Professional Clozapine Tachycardia (Clozapine) SS ORAL 50 MG ORAL Midazolam (Midazolam) SS INTRAVENOUS INTRAVENOUS Chlorpromazine (Chlorpromazine) SS Date:10/29/03ISR Number: 4220803-6Report Type:Expedited (15-DaCompany Report #PHHO2003CA13478 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiomegaly Clozaril PS Novartis Sector: Dyspnoea Pharma 53280MIN Electrocardiogram T Wave Risperdal C 2 mg, UNK Amplitude Decreased Vitamin B6 C Eosinophil Count Vitamin B12 C Increased Lithium C Eosinophilia Lymphocyte Count Increased Myocarditis Neutrophil Count Increased Date:10/29/03ISR Number: 4220924-8Report Type:Expedited (15-DaCompany Report #PHNU2003DE02763 Age:19 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Leponex / Clozaril Hospitalization - Bundle Branch Block Right (Clozapine) PS Novartis Sector: Initial or Prolonged C-Reactive Protein Pharma ORAL up to 500 Increased mg/day Feeling Abnormal Leponex / Clozaril Hyponatraemia (Clozapine) SS Novartis Sector: Pyrexia Pharma ORAL 500mg/day 20160MIN Sepsis Solian C ORAL 600mg/day 18720MIN Sinus Tachycardia Solian C ORAL 800mg/day 2880 MIN Beloc-Zoc Mite C 47.5 mg, QD Date:10/29/03ISR Number: 4221270-9Report Type:Expedited (15-DaCompany Report #PHFR2003GB02638 Age:58 YR Gender:Female I/FU:F Outcome PT Other Body Temperature Decreased Dizziness Dyspepsia Feeling Abnormal Feeling Cold Gastritis Heart Rate Increased Hypotension Nausea 22-Feb-2006 08:30 AM Page: 2426 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Syncope Tremor Vomiting Report Source Product Role Manufacturer Route Dose Duration Clozaril PS Novartis Sector: Pharma ORAL 600mg/day Clozaril SS Novartis Sector: Pharma ORAL 700mg/day Date:10/29/03ISR Number: 4221273-4Report Type:Expedited (15-DaCompany Report #PHFR2003GB03341 Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Body Mass Index Increased Clozaril (Clozapine) PS Novartis Sector: Initial or Prolonged Diabetes Mellitus Pharma ORAL 350mg/day Other Electrolyte Imbalance Clozaril (Clozapine) SS Novartis Sector: Ketoacidosis Pharma ORAL 400mg/day Weight Increased Lithium Carbonate C 800mg/day Valproate Sodium C ORAL 800 mg, BID Date:10/29/03ISR Number: 4221275-8Report Type:Expedited (15-DaCompany Report #PHFR2003GB03809 Age:54 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Clozaril PS Novartis Sector: Initial or Prolonged Blood Creatine Pharma ORAL 21600MIN Phosphokinase Increased Quetiapine C Blood Pressure Fluctuation Body Temperature Increased Confusional State Diabetes Mellitus Inadequate Control Disorientation Fatigue Heart Rate Irregular Hyperhidrosis Neuroleptic Malignant Syndrome Silent Myocardial Infarction Date:10/29/03ISR Number: 4221285-0Report Type:Expedited (15-DaCompany Report #PHFR2003GB04066 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Clozaril PS Novartis Sector: Liver Function Test Pharma ORAL Abnormal Myoclonus Date:10/29/03ISR Number: 4221289-8Report Type:Expedited (15-DaCompany Report #PHNU2003DE03753 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pleurisy Leponex / Clozaril (Clozapine) PS Novartis Sector: 22-Feb-2006 08:30 AM Page: 2427 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pharma ORAL 112.5 mg/day 44640MIN Date:10/29/03ISR Number: 4221298-9Report Type:Expedited (15-DaCompany Report #PHFR2003GB03374 Age:21 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Clozaril (Clozapine) PS Novartis Sector: Initial or Prolonged Blood Glucose Increased Pharma ORAL 384 DAY Other Diabetes Mellitus Clozaril (Clozapine) SS Novartis Sector: Electrocardiogram Qt Pharma Prolonged Venlafaxine C UNKNOWN Gastroenteritis Insomnia Lower Respiratory Tract Infection Date:10/29/03ISR Number: 4221733-6Report Type:Expedited (15-DaCompany Report #PHNU2003DE03593 Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Creatine Leponex / Clozaril Hospitalization - Phosphokinase Increased (Clozapine) PS Novartis Sector: Initial or Prolonged Electrocardiogram P Wave Pharma ORAL 50 mg, QD 1440 MIN Abnormal Leponex / Clozaril Electrocardiogram St (Clozapine) SS Novartis Sector: Segment Elevation Pharma ORAL 100 mg, QD 4320 MIN Electrocardiogram T Wave Clozapin Abnormal "Neuraxpharm" SS ORAL 10 g, Electrocardiogram T Wave ONCE/SINGLE 1440 MIN Inversion Zoloft C ORAL 50mg/day Electrocardiogram T Wave Zoloft C ORAL Peaked Intentional Overdose Pericardial Effusion Suicide Attempt Ventricular Hypokinesia Date:10/29/03ISR Number: 4221853-6Report Type:Expedited (15-DaCompany Report #03-10-1348 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine PS Ivax Professional Pharmaceuticals, Other Inc. Tablets ORAL 400 MG QD ORAL Date:10/29/03ISR Number: 4221856-1Report Type:Expedited (15-DaCompany Report #03-10-1326 Age:74 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Lethargy Health Clozapine PS Ivax Initial or Prolonged Pneumonia Aspiration Professional Pharmaceuticals, Other Inc. Tablets ORAL 300 MG QD ORAL 22-Feb-2006 08:30 AM Page: 2428 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/29/03ISR Number: 4221860-3Report Type:Expedited (15-DaCompany Report #C2003-2428.01 Age:76 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Health Clozapine Tablets 25 Dysphagia Professional Mg Mylan PS Mylan ORAL 18.7 MG/DAY, Fall Other ORAL Hip Fracture Carbidopa/Levodopa C Selegiline C Entacapone C Hydroxyzine Pamoate C Meperidine C Date:10/29/03ISR Number: 4221869-XReport Type:Expedited (15-DaCompany Report #03-10-1286 Age:58 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pleural Effusion Health Clozapine PS Ivax Pneumonia Professional Pharmaceuticals, Pulmonary Embolism Other Inc. Tablets ORAL 75-150MG ORAL Date:10/29/03ISR Number: 4221871-8Report Type:Expedited (15-DaCompany Report #03-10-1342 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Health Clozapine - Ivax Vomiting Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL ORAL Date:10/29/03ISR Number: 4222204-3Report Type:Expedited (15-DaCompany Report #03-09-1101 Age:76 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coma Health Clozapine PS Ivax Myocardial Infarction Professional Pharmaceuticals, Other Inc. ORAL 250MG BID ORAL Synthroid C Klonopin C Protonix C Singulair C Celexa C Date:10/29/03ISR Number: 4222211-0Report Type:Expedited (15-DaCompany Report #03-09-1219 Age:39 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Appendicitis Perforated Health Clozapine PS Ivax Initial or Prolonged Diverticulitis Professional Pharmaceuticals, Other Inc. ORAL 400MG QD ORAL 22-Feb-2006 08:30 AM Page: 2429 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/29/03ISR Number: 4222212-2Report Type:Expedited (15-DaCompany Report #03-10-1328 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dehydration Health Clozapine PS Ivax Initial or Prolonged Mental Status Changes Professional Pharmaceuticals, Other Inc. ORAL 100-550MG QD ORAL Date:10/29/03ISR Number: 4222214-6Report Type:Expedited (15-DaCompany Report #03-10-1315 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Respiratory Failure Health Clozapine PS Ivax Professional Pharmaceuticals, Other Inc. ORAL 100-112.5MG ORAL Date:10/29/03ISR Number: 4223296-8Report Type:Expedited (15-DaCompany Report #6423 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Chest Discomfort Clozapine PS 50 MG Convulsion Midazolam SS INTRAVENOUS INTRAVENOUS Hypotension Chlorpromazine SS Sepsis Doxycycline SS Staphylococcal Infection Suicide Attempt Tachycardia Date:10/30/03ISR Number: 4223056-8Report Type:Expedited (15-DaCompany Report #03-10-1319 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Neoplasm Malignant Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc ORAL 350-400 MG QD ORAL Date:10/30/03ISR Number: 4224328-3Report Type:Expedited (15-DaCompany Report #DSA_23491_2003 Age:28 YR Gender:Male I/FU:I Outcome PT Other Aggression Agitation Blood Urine Cyanosis Drug Interaction Eye Rolling Neuroleptic Malignant Syndrome Pallor Protein Urine Present Respiratory Arrest Rhabdomyolysis Somnolence Supraventricular 22-Feb-2006 08:30 AM Page: 2430 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tachycardia Report Source Product Role Manufacturer Route Dose Duration Foreign Ativan PS INTRAMUSCULAR 2 MG QD IM Health Ativan SS ORAL 1 MG QD PO Professional Clozaril SS ORAL 0.3 G QD PO Other Clozaril SS ORAL 150 MG BID PO Amisulpride C Date:10/31/03ISR Number: 4223131-8Report Type:Expedited (15-DaCompany Report #PHEH2003US06277 Age:83 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Clozaril PS Novartis Sector: Congestive Pharma ORAL 12.5 mg, BID Prevacid C Lantus C Novolin R C Haldol "Janssen" C Ativan C Antibiotics For Topical Use C Artificial Tears C Aspirin "Bayer" C Lactulose C Ferrous Sulfate C Vioxx C Mag-Ox C Kcl C Lasix C Coreg C Tylenol C Date:10/31/03ISR Number: 4223624-3Report Type:Expedited (15-DaCompany Report #PHHO2003CA03195 Age:47 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Clozaril PS Novartis Sector: Drug Toxicity Pharma ORAL 12.5 mg in Haematocrit Decreased morning and Haemoglobin Decreased bedtime 8640 MIN Red Blood Cell Count Clozaril SS Novartis Sector: Decreased Pharma ORAL 50 mg morning Sudden Death and bedtime 1440 MIN Urinary Tract Infection Clozaril SS Novartis Sector: Pharma ORAL 50mg morning, 75 mg bedtime 1440 MIN Clozaril SS Novartis Sector: Pharma ORAL 50mg morning, 100mg bedtime 4320 MIN Clozaril SS Novartis Sector: Pharma ORAL 75mg morning, 125mg bedtime 4320 MIN Clozaril SS Novartis Sector: Pharma ORAL 100mg morning, 150mg bedtime 8640 MIN Clozaril SS Novartis Sector: Pharma ORAL 100mg 22-Feb-2006 08:30 AM Page: 2431 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report morning, 200mg bedtime 1440 MIN Clozaril SS Novartis Sector: Pharma ORAL 100mg morning, 250mg bedtime 5760 MIN Clozaril SS Novartis Sector: Pharma ORAL 100mg morning, 300mg bedtime Seroquel C Tegretol C Zuclopenthixol C Surfak C Loxapine C Quetiapine C Date:10/31/03ISR Number: 4224523-3Report Type:Expedited (15-DaCompany Report #C2003-2780.01 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Clozapine Tablets Other 100 Mg Mylan PS Mylan ORAL 100 MG Q AM AND 350 MG Q HS, ORAL Atorvastatin Calcium C Benztropine Besylate C Captopril C Coated Aspirin C Divalproex Sodium C Lactic Acid Cream C Lansoprazole C Lorazepam C Metoprolol Tartrate C Multivitamin C Sertraline Hcl C Date:10/31/03ISR Number: 4225429-6Report Type:Expedited (15-DaCompany Report #2003113870 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Akathisia Foreign Zeldox (Capsules) Drug Interaction Health (Ziprasidone) PS ORAL 80 MG, BID, Professional ORAL Clozapine SS ORAL 175 MG, ORAL Citalopram SS ORAL 40 MG, ORAL Date:11/03/03ISR Number: 4224474-4Report Type:Expedited (15-DaCompany Report #PHNR2003AU01027 Age:24 YR Gender:Male I/FU:F Outcome PT Hospitalization - Appendicitis Initial or Prolonged Blood Alkaline Phosphatase Increased Blood Glucose Increased Blood Uric Acid Increased Gamma-Glutamyltransferase Increased Liver Function Test 22-Feb-2006 08:30 AM Page: 2432 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Abnormal Pancreatitis Treatment Noncompliance Report Source Product Role Manufacturer Route Dose Duration Clozaril PS Novartis Sector: Pharma ORAL 175 - 700 mg/day Clozaril SS Novartis Sector: Pharma ORAL 600 mg nocte Paroxetine C 40 mg mane Date:11/03/03ISR Number: 4224475-6Report Type:Expedited (15-DaCompany Report #PHFR2002GB04264 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Clozaril PS Novartis Sector: Increased Pharma 250mg/day Anticholinergic Syndrome Blood Alkaline Phosphatase Increased Blood Sodium Increased Constipation Dry Mouth Gamma-Glutamyltransferase Increased Liver Function Test Abnormal Polydipsia Salivary Hypersecretion Vision Blurred Date:11/03/03ISR Number: 4224700-1Report Type:Expedited (15-DaCompany Report #PHFR2002GB00874 Age:32 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Clozaril PS Novartis Sector: Initial or Prolonged Diabetes Mellitus Pharma ORAL 800 mg/day Other Insulin-Dependent Amisulpride C UNKNOWN Valproate Sodium C UNKNOWN Metformin C UNKNOWN Gliclazide C UNKNOWN Date:11/03/03ISR Number: 4224701-3Report Type:Expedited (15-DaCompany Report #PHFR2002GB01610 Age:57 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiac Disorder Clozaril PS Novartis Sector: Dizziness Pharma ORAL 300mg/day 533 DAY Electrocardiogram Qt Ranitidine C Prolonged Hypotension Malaise Pyrexia Tachycardia 22-Feb-2006 08:30 AM Page: 2433 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/03ISR Number: 4224702-5Report Type:Expedited (15-DaCompany Report #PHFR2003GB04115 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Ketoacidosis Clozaril (Clozapine) PS Novartis Sector: Initial or Prolonged Pharma Date:11/03/03ISR Number: 4224838-9Report Type:Expedited (15-DaCompany Report #03-10-1353 Age:83 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine PS Ivax Hospitalization - Professional Pharmaceuticals, Initial or Prolonged Other Inc. ORAL 25MG QD ORAL Date:11/03/03ISR Number: 4224852-3Report Type:Expedited (15-DaCompany Report #03-10-1360 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Health Clozapine PS Ivax Myocardial Infarction Professional Pharmaceuticals, Inc ORAL 200-700MG QD Other ORAL Date:11/03/03ISR Number: 4224853-5Report Type:Expedited (15-DaCompany Report #03-10-1356 Age:69 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Aspiration Health Clozapine PS Ivax Professional Pharmaceuticals, Inc ORAL 12.5-25MG QD Other ORAL Date:11/03/03ISR Number: 4224855-9Report Type:Expedited (15-DaCompany Report #03-10-1365 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Lung Neoplasm Malignant Health Clozapine PS Ivax Professional Pharmaceuticals, Inc ORAL 600MG QD ORAL Other Date:11/03/03ISR Number: 4226642-4Report Type:Expedited (15-DaCompany Report #THQ2003A01307 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Attention-Seeking Health Zoton (Lansoprazole) PS ORAL DAY Initial or Prolonged Behaviour Professional Epilim (Valproate Coordination Abnormal Other Sodium) SS 1 DAY Disturbance In Attention Diazepam (Diazepam) SS Feeling Hot Ibuprofen Hyperhidrosis (Ibuprofen) SS Multiple Drug Overdose Clozapine Somnolence (Clozapine) SS 22-Feb-2006 08:30 AM Page: 2434 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/03ISR Number: 4227364-6Report Type:Expedited (15-DaCompany Report #C2003-2468.01 Age:61 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Effect Decreased Health Clozapine Tablets 25 Lung Neoplasm Malignant Professional Mg Mylan PS ORAL 25MG BID, Pneumonia Aspiration Other ORAL Thioridazine C Valproic Acid C Date:11/03/03ISR Number: 4227365-8Report Type:Expedited (15-DaCompany Report #C2003-2237.01 Age:55 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Clozapine Tablets Cerebrovascular Accident Professional 100 Mg Mylan PS ORAL 200MG Q AM, Hypertension Other 300MG Q HS, Pharmaceutical Product ORAL Complaint Zolpidem (5mg Q Hs) C Benztropine (0.5mg Q Hs) C Haloperidol Decanoate (150mg Q 4 Weeks) C Divalproex Sodium (500mg Q Am, 100mg Q Hs) C Nifedipine Xl (60mg Bid) C Lisinopril (10mg Q Am, Oxybutynin C Date:11/03/03ISR Number: 4227882-0Report Type:Periodic Company Report #PHEH2003US07968 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Oedema Health Clozaril (Clozapine) Initial or Prolonged Tachycardia Professional Tablet PS ORAL 150 MG, QD; ORAL Risperdal C Depakote (Valproate Semisodium) C Lasix C Multivitamins (Panthenol, Retinol) C Fish Oil C Vitamin E C Date:11/03/03ISR Number: 4227884-4Report Type:Periodic Company Report #PHEH2003US08036 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Clozaril (Clozapine) Initial or Prolonged Syncope Vasovagal Professional Tablet PS ORAL 12.5 MG, QD; Other ORAL (SEE IMAGE) Sinemet C Asa C Vasotec C 22-Feb-2006 08:30 AM Page: 2435 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Cardizem (Diltiazem Hydrochloride) C Calcium C Prilosec (Omeprazole) C Humibid C Percocet (Oxycodone Hydrochloride) C Calcitonin C Colace C Aricept (Donepezil Hydrochloride) C Allegra (Fexofenadine Hydrochloride) C Lactulose C Nasacort (Triamicinolone Acetonide) C Date:11/03/03ISR Number: 4227885-6Report Type:Periodic Company Report #PHEH2003US08052 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) Professional Tablet PS ORAL 100MG AM + 375MG PM, ORAL Anafranil C Clomipramine C Date:11/03/03ISR Number: 4227886-8Report Type:Periodic Company Report #PHEH2003US08492 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Intestinal Obstruction Health Clozaril (Clozapine) Hospitalization - Pneumonia Professional Tablet PS ORAL UNK, UNK; Initial or Prolonged ORAL Paxil C Seroquel (Quetiapine Fumarate) C Depakote (Valproate Semisodium) C Metamucil "Searle" (Psyllium Hydrophilic Mucilloid) C Milk Of Magnesia C Avista C Anafranil C Date:11/03/03ISR Number: 4227888-1Report Type:Periodic Company Report #PHEH2003US08509 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyponatraemia Health Clozaril (Clozapine) Professional Tablet PS UNKNOWN UNK, UNK, UNK 22-Feb-2006 08:30 AM Page: 2436 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/03ISR Number: 4227889-3Report Type:Periodic Company Report #PHEH2003US08540 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Health Clozaril (Clozapine) Initial or Prolonged Electroencephalogram Professional Tablet PS ORAL 550 MG, QD; Abnormal ORAL Fall Abilify Grand Mal Convulsion Skin Infection /Usa/(Aripiprazole) C Syncope Prinivil (Lisinopril) C Zantac C Lonox (Diphenoxylate Hydrochloride) C Date:11/03/03ISR Number: 4227891-1Report Type:Periodic Company Report #PHEH2003US08558 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sleep Apnoea Syndrome Health Clozaril (Clozapine) Tremor Professional Tablet PS ORAL 400 MG/DAY; Weight Increased ORAL (SEE IMAGE) Prilosec (Omeprazole) C Lamictal "Burroughs Wellcome" C Date:11/03/03ISR Number: 4227892-3Report Type:Periodic Company Report #PHEH2003US08792 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) Professional Tablet PS ORAL 31.25 MG, QD; ORAL Date:11/03/03ISR Number: 4227893-5Report Type:Periodic Company Report #PHEH2002US03262 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Decreased Appetite Health Clozaril (Clozapine) Initial or Prolonged Professional Tablet PS ORAL 200MG AM + 150MG HS; ORAL Tylenol C Albuterol C Mylanta (Alluminium Hydroxide Gel, Dried, Simeticone) C Ativan C Multivitamins (Panthenol, Retinol) C Depakote (Valproate Semisodium) C Haldol C Lithium C Megace (Megestrol 22-Feb-2006 08:30 AM Page: 2437 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Acetate) C Oral Contraceptive Nos C Oscal C Date:11/03/03ISR Number: 4227905-9Report Type:Periodic Company Report #PHEH2002US05425 Age:23 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Upper Health Clozaril (Clozapine) Anorexia Professional Tablet PS ORAL 200 MG, TID; Dyspepsia ORAL Fatigue Clonidine C Headache Prolixin Influenza Like Illness (Fluphenazine Pyrexia Hydrochloride) C Somnolence Unk C Stomach Discomfort Prozac (Fluoxetine Weight Decreased Hydrochloride) C Cogentin (Benzatropine Mesilate) C Tagamet Oral C Colace C Date:11/03/03ISR Number: 4227914-XReport Type:Periodic Company Report #PHEH2003US06776 Age:98 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) Professional Tablet PS ORAL 50 MG, QHS, ORAL Date:11/03/03ISR Number: 4227933-3Report Type:Periodic Company Report #PHEH2003US06948 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyspnoea Health Clozaril (Clozapine) Initial or Prolonged Pain In Extremity Professional Tablet PS ORAL 400 MG, QHS, Platelet Count Decreased ORAL Pulmonary Thrombosis Cogentin Thrombosis (Benzathropine Weight Increased Mesilate) C Celexa C Oral Contraceptive Nos (Oral Contraceptive Nos) C Date:11/03/03ISR Number: 4227944-8Report Type:Periodic Company Report #PHEH2003US07104 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Choking Consumer Clozaril (Clozapine) Convulsion Tablet PS ORAL 400 MG/DAY, Drooling ORAL Prolixin (Fluphenazine Hydrochloride) C 22-Feb-2006 08:30 AM Page: 2438 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Ativan C Prozac (Fluoxetine Hydrochloride) C Date:11/03/03ISR Number: 4227950-3Report Type:Periodic Company Report #PHEH2003US07370 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Clozaril (Clozapine) Professional Tablet PS ORAL 100MG NOON + 300 MG HS, ORAL Insulin (Insulin) C Welbutrin (Bupropion Hydrochloride) C Potassiuim (Potassium) C Diovan "Novartis" C Novartis Levothroid C Zantac C Lasix C Date:11/03/03ISR Number: 4227983-7Report Type:Periodic Company Report #PHEH2003US03378 Age:77 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Health Clozaril (Clozapine) Initial or Prolonged Dysarthria Professional Tablet PS ORAL 25 MG/DAY, Hypoaesthesia ORAL Medication Error Imdur C Post-Traumatic Stress Asa C Disorder Naturetin (Bendroflumethiazide ) C K-Dur C Zocor C Vitamin C C Vitamin E C Date:11/03/03ISR Number: 4227985-0Report Type:Periodic Company Report #PHEH2003US03396 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Myoclonus Health Clozaril (Clozapine) PS ORAL SEE IMAGE 91 YR Tic Professional Escitalopram (Escitalopram) C Cogentin (Benzatropine Mesilate) C Date:11/03/03ISR Number: 4227987-4Report Type:Periodic Company Report #PHEH2003US03481 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Headache Health Clozaril (Clozapine) Hypertension Professional Tablet PS ORAL 400 MG/DAY, Tachycardia ORAL 22-Feb-2006 08:30 AM Page: 2439 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/03ISR Number: 4227989-8Report Type:Periodic Company Report #PHEH2003US03529 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delusion Health Clozaril (Clozapine) Initial or Prolonged Leukopenia Professional Tablet PS ORAL SEE IMAGE Neutropenia Abilify C Psychotic Disorder Risperdal C Ativan C Celexa C Prolixin (Fluphenazone Hydrochloride) C Date:11/03/03ISR Number: 4227991-6Report Type:Periodic Company Report #PHEH2003US03703 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Body Temperature Health Clozaril (Clozapine) PS ORAL SEE IMAGE Increased Professional Tachycardia Date:11/03/03ISR Number: 4227992-8Report Type:Periodic Company Report #PHEH2003US03744 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tachycardia Health Clozaril (Clozapine) Professional Tablet PS ORAL 500 MG, QD, ORAL Topamax (Topiramate) C Risperdal C Date:11/03/03ISR Number: 4227994-1Report Type:Periodic Company Report #PHEH2003US03769 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cellulitis Health Clozaril (Clozapine) Granulocytosis Professional Tablet PS ORAL 600 MG, QD, Leukopenia ORAL Lung Abscess Tegretol (Carbamazepine) C L-Thyroxin C Chlorphenamine (Chlorphenamine) C Vitamin B6 C Flovent C Serevent (Salmetrol Xinafoate) C Lexapro C Date:11/03/03ISR Number: 4227996-5Report Type:Periodic Company Report #PHEH2003US03797 Age:62 YR Gender:Male I/FU:I Outcome PT Death Agranulocytosis Other Confusional State Leukopenia Pneumonia 22-Feb-2006 08:30 AM Page: 2440 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pyrexia Report Source Product Role Manufacturer Route Dose Duration Health Clozaril (Clozapine) Professional Tablet PS ORAL 125 MG QD,ORAL Abilfy C Paxil C Aggreno (Dipyridamole) C Depo Provera C Exelon (Rivastigmine Tartrate) C Date:11/03/03ISR Number: 4227999-0Report Type:Periodic Company Report #PHEH2003US03844 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neuroleptic Malignant Health Clozaril (Clozapine) PS ORAL ORAL Syndrome Professional Pyrexia Date:11/03/03ISR Number: 4228001-7Report Type:Periodic Company Report #PHEH2003US03845 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Level Changed Consumer Clozaril (Clozapine) PS ORAL ORAL Hospitalization - Hyperhidrosis Nortriptyline Initial or Prolonged Mental Status Changes (Nortriptyline) C Musculoskeletal Stiffness Neuroleptic Malignant Syndrome Pyrexia Suicide Attempt Date:11/03/03ISR Number: 4228010-8Report Type:Periodic Company Report #PHEH2003US02827 Age:89 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dysphagia Other Clozaril (Clozapine) Tablet PS ORAL 18.75 MG, QHS, ORAL Mineral Supplements C Multiplevitamins (Retinol, Panthenol) C Colace C Milk Of Magnesia C Celexa C Trimethoprim C Imdur C Neurontin (Gabaoentin) C Tylenol C 22-Feb-2006 08:30 AM Page: 2441 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/03ISR Number: 4228012-1Report Type:Periodic Company Report #PHEH2003US02846 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Parkinson'S Disease Health Clozaril (Clozapine) Professional Tablet PS ORAL 25 MG, QD, ORAL Sinemet C Florinef (Fludrocortisone Acetate) C Lodosyn C Parsitan (Profenaminehydrochl oride) C Proamatine (Midodrine Hydrochloride) C Date:11/03/03ISR Number: 4228014-5Report Type:Periodic Company Report #PHEH2003US07487 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) Professional Tablet PS ORAL 500 MG, QHS, ORAL Date:11/03/03ISR Number: 4228016-9Report Type:Periodic Company Report #PHEH2003US02905 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Clozaril (Clozapine) Neutropenia Professional Tablet PS ORAL 900 MG/DAY, ORAL Haldol C Janssen Gabapentin (Gabapentin) C Celexa C Depakote (Valproate Semisodium) C Amantadine (Amantadine) C Cogentin (Benzatropine Mesilate) C Date:11/03/03ISR Number: 4228018-2Report Type:Periodic Company Report #PHEH2003US02980 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozaril (Clozapine) Neutropenia Professional Tablet PS ORAL 450 MG/DAY, Sinus Arrhythmia ORAL 2555 DAY Sinus Bradycardia Lithobid C Zoloft (Sertraline Hydrochloride) C Zyprexa C 22-Feb-2006 08:30 AM Page: 2442 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/03ISR Number: 4228019-4Report Type:Periodic Company Report #PHEH2003US07525 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) Professional Tablet PS ORAL ORAL Efexor (Venlafaxine Hydrochloride) C Zyprexa C Insulin (Insulin) C Lescol "Novartis" C Enapril "Excell" C Metformin C Amaryl (Glimepiride) C Date:11/03/03ISR Number: 4228029-7Report Type:Periodic Company Report #PHEH2003US03005 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Psychotic Disorder Health Clozaril (Clozapine) Professional Tablet PS SEE IMAGE Celexa C Loxitane (Loxapine Succinate) C Date:11/03/03ISR Number: 4228031-5Report Type:Periodic Company Report #PHEH2003US03023 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dehydration Health Clozaril (Clozapine) Initial or Prolonged Diarrhoea Professional Tablet PS ORAL 200 MG/DAY, Influenza ORAL Leukopenia Prevacid (Lansoprazole) C Vitamin B12 C Celexa C Calcium Carbonate C Colace C Restoril C Ativan C Cogentin (Benzatropine Mesilate) C Date:11/03/03ISR Number: 4228033-9Report Type:Periodic Company Report #PHEH2003US03030 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dehydration Health Clozaril (Clozapine) Dizziness Professional Tablet PS ORAL SEE IMAGE Orthostatic Hypotension Luvox (Fluvoxamine Maleate) C Trazodone (Trazodone) C Lexapro C Lortab C Robaxin (Methocarbamol) C 22-Feb-2006 08:30 AM Page: 2443 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/03ISR Number: 4228034-0Report Type:Periodic Company Report #PHEH2003US03112 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Tachycardia Health Clozaril (Clozapine) PS ORAL 200 MG, QD, Initial or Prolonged Professional ORAL Date:11/03/03ISR Number: 4228036-4Report Type:Periodic Company Report #PHEH2003US03234 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) Professional Tablet PS ORAL 300 MG/DAY, ORAL Date:11/03/03ISR Number: 4228037-6Report Type:Periodic Company Report #PHEH2003US03299 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) Professional Tablet PS ORAL ORAL Date:11/03/03ISR Number: 4228043-1Report Type:Periodic Company Report #PHEH2003US07666 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Disorientation Consumer Clozaril (Clozapine) Initial or Prolonged Gait Disturbance Tablet PS ORAL 600 MG/DAY, Incoherent ORAL Lethargy Alprazolam Pulmonary Embolism (Alparazolam) C Urinary Incontinence Zoloft (Sertraline Weight Decreased Hydrochloride) C Lipitor C Date:11/03/03ISR Number: 4228048-0Report Type:Periodic Company Report #PHEH2003US07748 Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Back Pain Health Clozaril (Clozapine) Blood Pressure Increased Professional Tablet PS ORAL SEE IMAGE Dizziness Clonazepam C Periorbital Oedema Aricept (Donepezil Pyrexia Hydrochloride) C Levothyroxine (Levothyroxine) C Lisinopril (Lisinopril) C Propranolol C Amoxicillin C Ambien (Zolpidem Tartrate) C Tylenol C 22-Feb-2006 08:30 AM Page: 2444 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/03ISR Number: 4228050-9Report Type:Periodic Company Report #PHEH2003US07887 Age:67 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) Professional Tablet PS Company Representative Date:11/03/03ISR Number: 4228052-2Report Type:Periodic Company Report #PHEH2003US07888 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) Professional Tablet PS ORAL ORAL Company Representative Date:11/03/03ISR Number: 4228054-6Report Type:Periodic Company Report #PHEH2003US05433 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Breath Sounds Abnormal Health Clozaril(Clozapine) Initial or Prolonged Leukocytosis Professional Tablet PS ORAL 500 MG/DAY, Pneumonia ORAL Pyrexia Date:11/03/03ISR Number: 4228055-8Report Type:Periodic Company Report #PHEH2003US05490 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Other Clozaril(Clozapine) Tablet PS ORAL 250 MG/DAY, ORAL Date:11/03/03ISR Number: 4228056-XReport Type:Periodic Company Report #PHEH2003US05679 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Clozaril(Clozapine) Leukopenia Professional Tablet PS ORAL 900 MG/DAY, Neutropenia ORAL Risperidone C Date:11/03/03ISR Number: 4228057-1Report Type:Periodic Company Report #PHEH2003US05758 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pain Health Clozaril(Clozapine) Initial or Prolonged Professional Tablet PS ORAL ORAL Company Representative 22-Feb-2006 08:30 AM Page: 2445 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/03ISR Number: 4228058-3Report Type:Periodic Company Report #PHEH2003US05977 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Health Clozaril(Clozapine) Initial or Prolonged Confusional State Professional Tablet PS ORAL ORAL Drug Interaction Ativan (Lorazepam) SS ORAL 2 MG, TID, Haematocrit Decreased ORAL Haemoglobin Decreased Hyponatraemia Red Blood Cell Count Decreased Somnolence Urinary Incontinence Date:11/03/03ISR Number: 4228059-5Report Type:Periodic Company Report #PHEH2003US06182 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Clozaril(Clozapine) Thrombocytopenia Professional Tablet PS ORAL ORAL Lithium Carbonate C Buspar C Depakote (Valproate Semisodium C Date:11/03/03ISR Number: 4228060-1Report Type:Periodic Company Report #PHEH2003US06277 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril(Clozapine) Professional Tablet PS ORAL 12.5 MG, BID, ORAL Prevacid (Lansoprazole) C Lantus (Insulin Glargine) C Novolin R (Insulin Human) C Haldol "Janssen" C Ativan C Antibiotics For Topical Use C Artificial Tears C Aspirin "Bayer" C Lactulose C Ferrous Sulfate C Vioxx C Mag-Ox C Kcl C Lasix C Coreg (Carvedilol) C Tylenol C 22-Feb-2006 08:30 AM Page: 2446 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/03ISR Number: 4228061-3Report Type:Periodic Company Report #PHEH2003US06297 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Health Clozaril(Clozapine) Professional Tablet PS ORAL 400 MG, QD, ORAL Date:11/03/03ISR Number: 4228063-7Report Type:Periodic Company Report #PHEH2003US06439 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Pressure Decreased Health Clozaril(Clozapine) Fall Professional Tablet PS ORAL 12.5 MG/DAY, Head Injury ORAL Heart Rate Increased Pallor Syncope Date:11/03/03ISR Number: 4228065-0Report Type:Periodic Company Report #PHEH2003US06660 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Increased Health Clozaril(Clozapine) Initial or Prolonged Electrocardiogram Professional Tablet PS ORAL 50 MG Abnormal AM+200MG HS, Pyrexia ORAL Tachycardia Date:11/03/03ISR Number: 4228079-0Report Type:Periodic Company Report #PHEH2003US04776 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Ileus Health Clozaril(Clozapine) Professional Tablet PS ORAL ORAL Company Representative Date:11/03/03ISR Number: 4228080-7Report Type:Periodic Company Report #PHEH2003US04790 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Health Clozaril(Clozapine) Initial or Prolonged Congestive Professional Tablet PS ORAL 200 MG, BID, Fluid Retention ORAL Weight Increased Date:11/03/03ISR Number: 4228082-0Report Type:Periodic Company Report #PHEH2003US04866 Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Grand Mal Convulsion Health Clozaril(Clozapine) Myoclonus Professional Tablet PS ORAL 550 MG, QD, ORAL; SEE IMAGE 22-Feb-2006 08:30 AM Page: 2447 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/03ISR Number: 4228093-5Report Type:Periodic Company Report #PHEH2003US04947 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperglycaemia Health Clozaril(Clozapine) Professional Tablet PS ORAL ORAL 1095 DAY Company Representative Date:11/03/03ISR Number: 4228097-2Report Type:Periodic Company Report #PHEH2003US04948 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Clozaril(Clozapine) Professional Tablet PS ORAL 150 MG, ORAL Company Representative Date:11/03/03ISR Number: 4228102-3Report Type:Periodic Company Report #PHEH2003US04995 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Clozaril(Clozapine) Initial or Prolonged Blood Pressure Decreased Professional Tablet PS 350 MG, QD Circulatory Collapse Collapse Of Lung Incoherent Irritability Liver Function Test Abnormal Pneumonia White Blood Cell Count Increased Date:11/03/03ISR Number: 4228105-9Report Type:Periodic Company Report #PHEH2003US05077 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pneumonia Health Clozaril(Clozapine) Sepsis Professional Tablet PS ORAL 450 MG, ORAL White Blood Cell Count Decreased Date:11/03/03ISR Number: 4228107-2Report Type:Periodic Company Report #PHEH2003US05107 Age:69 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Health Clozaril(Clozapine) Initial or Prolonged Body Temperature Professional Tablet PS ORAL 25 MG, TID, Increased ORAL Sinemet C Exelon (Rivastigmine Tartate) C 22-Feb-2006 08:30 AM Page: 2448 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/03ISR Number: 4228110-2Report Type:Periodic Company Report #PHEH2003US05125 Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril(Clozapine) Professional Tablet PS ORAL 400 MG/DAY, ORAL Date:11/03/03ISR Number: 4228111-4Report Type:Periodic Company Report #PHEH2003US05150 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Clozaril(Clozapine) Other Myocarditis Tablet PS ORAL ORAL 91 DAY Vomiting Date:11/03/03ISR Number: 4228114-XReport Type:Periodic Company Report #PHEH2003US03987 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Health Clozaril (Clozapine) Initial or Prolonged Chills Professional Tablet PS ORAL 200 MG, BID, Confusional State ORAL Hepatitis Effexor (Venlafaxine Infection Hydrochloride) C Liver Function Test Synthroid C Abnormal Clonazepam C Mania Cogentin Memory Impairment (Benzatropine Pneumonia Mesilate) C Pyrexia Levoxyl C Sinusitis Seroquel (Quetiapine Tachycardia Fumarate) C Tremor Date:11/03/03ISR Number: 4228116-3Report Type:Periodic Company Report #PHEH2003US04050 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Health Clozaril (Clozapine) Drug Level Increased Professional Tablet PS ORAL 250 MG, ORAL Myoclonus Company Depakote (Valproate Representative Semisodium) C Date:11/03/03ISR Number: 4228119-9Report Type:Periodic Company Report #PHEH2003US04118 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pericarditis Health Clozaril (Clozapine) Professional Tablet PS ORAL ORAL Company Representative 22-Feb-2006 08:30 AM Page: 2449 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/03ISR Number: 4228121-7Report Type:Periodic Company Report #PHEH2003US04228 Age:71 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Aspiration Health Clozaril (Clozapine) Professional Tablet PS ORAL ORAL Date:11/03/03ISR Number: 4228122-9Report Type:Periodic Company Report #PHEH2003US04386 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) Professional Tablet PS ORAL ORAL Date:11/03/03ISR Number: 4228124-2Report Type:Periodic Company Report #PHEH2003US04447 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Confusional State Health Clozaril (Clozapine) Convulsion Professional Tablet PS ORAL 600 MG, BID, Gait Disturbance ORAL Dilantin C Synthroid C Imipramine (Imipramine) C Lorazepam C Date:11/03/03ISR Number: 4228127-8Report Type:Periodic Company Report #PHEH2003US04539 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) Professional Tablet PS ORAL 400 MG, QD, ORAL Trileptal "Novartis" C Seroquel (Quetiapine Fumarate) C Date:11/03/03ISR Number: 4228128-XReport Type:Periodic Company Report #PHEH2003US04555 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hallucination Health Clozaril (Clozapine) Herpes Simplex Professional Tablet PS ORAL 125 MG/DAY, Insomnia ORAL Leukopenia Nasal Abscess Rash Type Iv Hypersensitivity Reaction Date:11/03/03ISR Number: 4228132-1Report Type:Periodic Company Report #PHEH2003US04658 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Clozaril (Clozapine) Professional Tablet PS ORAL SEE IMAGE 22-Feb-2006 08:30 AM Page: 2450 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/03ISR Number: 4228134-5Report Type:Periodic Company Report #PHEH2003US04738 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Cholesterol Health Clozaril (Clozapine) Increased Professional Tablet PS ORAL 450 MG/DAY, Blood Triglycerides ORAL Increased Death Flushing Lipids Increased Nasopharyngitis Pain In Extremity Date:11/03/03ISR Number: 4228213-2Report Type:Periodic Company Report #PHEH2003US01865 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tachycardia Health Clozaril (Clozapine) Professional Tablet PS ORAL ORAL Date:11/03/03ISR Number: 4228215-6Report Type:Periodic Company Report #PHEH2003US02055 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Computerised Tomogram Health Clozaril (Clozapine) Initial or Prolonged Abnormal Professional Tablet PS ORAL 300 MG, QD, Drug Level Increased ORAL Hallucination Paxil C Oxygen Saturation Topomac (Topiramate) C Decreased Lovenox Pulmonary Embolism (Heparin-Fraction, Suicide Attempt Sodium Salt) C Tachycardia Date:11/03/03ISR Number: 4228217-XReport Type:Periodic Company Report #PHEH2003US02211 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Health Clozaril (Clozapine) Initial or Prolonged Hypertension Professional Tablet PS ORAL 500 MG, BID, Psychotic Disorder ORAL Weight Increased Provigil (Modafinil) C Celexa C Multivitamins (Retinol, Panthenol) C Colace C Clonidine (Clonidine) C Triamterene And Hydrochlorothiazid "Harris" C 22-Feb-2006 08:30 AM Page: 2451 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/03ISR Number: 4228224-7Report Type:Periodic Company Report #PHEH2003US02290 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Health Clozaril (Clozapine) Initial or Prolonged Haematocrit Decreased Professional Tablet PS ORAL 350 MG/DAY, Haemoglobin Decreased ORAL Red Blood Cell Count Decreased Date:11/03/03ISR Number: 4228226-0Report Type:Periodic Company Report #PHEH2003US02355 Age:87 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) Professional Tablet PS ORAL 87.5 MG/DAY, ORAL Albuterol C Apap C Asa C Toprol Xl (Metoprolol Succinate) C Nitroglycerin "A.L." C Robitussin-Dm C Milk Of Magnesia C Date:11/03/03ISR Number: 4228227-2Report Type:Periodic Company Report #PHEH2003US02397 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tachycardia Health Clozaril (Clozapine) Professional Tablet PS ORAL SEE IMAGE Depakote (Valproate Semisodium) C Risperdal C Micronor (Norethisterone) C Date:11/03/03ISR Number: 4228229-6Report Type:Periodic Company Report #PHEH2003US02499 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Health Clozaril (Clozapine) Hospitalization - Death Professional Tablet PS ORAL 25 MG, BID, Initial or Prolonged Psychotic Disorder Company ORAL Suicidal Ideation Representative Risperdal C Date:11/03/03ISR Number: 4228231-4Report Type:Periodic Company Report #PHEH2003US02547 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tachycardia Health Clozaril (Clozapine) Professional Tablet PS ORAL 300 MG AM + 400 MG HS, ORAL 22-Feb-2006 08:30 AM Page: 2452 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/03ISR Number: 4228236-3Report Type:Periodic Company Report #PHEH2003US02665 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozaril (Clozapine) Other Death Professional Tablet PS ORAL SEE IMAGE Hypotension Cogentin (Benzatropine Mesilate) C Depakote (Valproate Semisodium) C Prolixin (Fluphenazine Hydrochloride) C Neurontin (Gabapentin) C Trileptal "Ciba-Geigy" C Restoril C Date:11/03/03ISR Number: 4228238-7Report Type:Periodic Company Report #PHEH2003US02746 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Clozaril (Clozapine) Professional Tablet PS ORAL 500 MG, QD, ORAL Lipitor C Date:11/03/03ISR Number: 4228240-5Report Type:Periodic Company Report #PHEH2003US00671 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abscess Neck Health Clozaril (Clozapine) Initial or Prolonged Convulsion Professional Tablet PS ORAL 25 MG/DAY, ORAL Date:11/03/03ISR Number: 4228241-7Report Type:Periodic Company Report #PHEH2003US00823 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Circulatory Collapse Health Clozaril (Clozapine) Hospitalization - Psychotic Disorder Professional Tablet PS ORAL 325 MG, QD, Initial or Prolonged Skin Laceration ORAL Suicide Attempt Premarin (Estrogens Conjugated) C Zantac C Benztropine Mesylate (Benzatropine Mesilate) C Protonix "Pharmadia" C Date:11/03/03ISR Number: 4228245-4Report Type:Periodic Company Report #PHEH2003US00902 Age:47 YR Gender:Male I/FU:I Outcome PT Hospitalization - Ankle Fracture Initial or Prolonged Asthenia 22-Feb-2006 08:30 AM Page: 2453 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Atrial Fibrillation Balance Disorder Blood Pressure Decreased Report Source Product Role Manufacturer Route Dose Duration Dizziness Health Clozaril (Clozapine) Fall Professional Tablet PS ORAL 300 MG, QD, White Blood Cell Count ORAL Increased Seroquel (Quetiapine Fumarate) C Prozac (Fluoxetine Hydrochloride) C Date:11/03/03ISR Number: 4228248-XReport Type:Periodic Company Report #PHEH2003US01073 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Constipation Health Clozaril (Clozapine) Initial or Prolonged Small Intestinal Professional Tablet PS ORAL 300 MG AM + Obstruction 500MG HS, ORAL Date:11/03/03ISR Number: 4228257-0Report Type:Periodic Company Report #PHEH2003US01078 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Clozaril (Clozapine) Initial or Prolonged Loss Of Consciousness Professional Tablet PS ORAL 350 MG, QD, ORAL Date:11/03/03ISR Number: 4228260-0Report Type:Periodic Company Report #PHEH2003US01248 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Health Clozaril (Clozapine) Hospitalization - Cardiomyopathy Professional Tablet PS ORAL 300 MG/DAY, Initial or Prolonged Death ORAL Pneumonia Lithium (Lithium) C Prozac (Fluoxetine Hydrochloride) C Xanax (Alprazolam) C Risperdal C Date:11/03/03ISR Number: 4228263-6Report Type:Periodic Company Report #PHEH2003US01286 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Clozaril (Clozapine) Professional Tablet PS ORAL ORAL; 25 MG, BID, ORAL Date:11/03/03ISR Number: 4228266-1Report Type:Periodic Company Report #PHEH2003US01640 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Health Clozaril (Clozapine) Initial or Prolonged Leukopenia Professional Tablet PS ORAL 300 MG, BID, ORAL 22-Feb-2006 08:30 AM Page: 2454 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lithium (Lithium) C Multivitamins (Panthenol, Retinol) C Peri-Colace (Casanthranol) C Minerals Nos C Date:11/03/03ISR Number: 4228269-7Report Type:Periodic Company Report #PHEH2003US01727 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) Professional Tablet PS ORAL SEE IMAGE Date:11/03/03ISR Number: 4228271-5Report Type:Periodic Company Report #PHEH2003US01840 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diarrhoea Other Clozaril (Clozapine) Dizziness Tablet PS ORAL SEE IMAGE Headache Efexor(Venlafaxine Influenza Like Illness Hydrochloride) C Leukocytosis Loxitane (Loxapine Retching Succinate) C Ativan C Dilantin C Lipitor C Lamictal "Burroughs Wellcome" C Date:11/03/03ISR Number: 4228296-XReport Type:Periodic Company Report #PHEH2002US10616 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) Professional Tablet PS ORAL 25 MG, QD, ORAL Tylenol C Prevacid (Lansoprazole) C Aspirin "Bayer" C Celebrex C Diltiazem C Levothroid C Prednisone C Multiple Vitamins (Vitamin B Nos, Retinol) C Zinc Sulfate C Date:11/03/03ISR Number: 4228297-1Report Type:Periodic Company Report #PHEH2002US10645 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Clozaril (Clozapine) Professional Tablet PS ORAL ORAL 22-Feb-2006 08:30 AM Page: 2455 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/03ISR Number: 4228300-9Report Type:Periodic Company Report #PHEH2002US10660 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Health Clozaril (Clozapine) Initial or Prolonged Leukocytosis Professional Tablet PS ORAL 500 MG/DAY, Somnolence ORAL Synthroid C Lithobid C Ativan C Cogentin (Benzatropine Mesilate) C Date:11/03/03ISR Number: 4228302-2Report Type:Periodic Company Report #PHEH2002US10681 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Leukopenia Health Clozaril (Clozapine) Hospitalization - Pyrexia Professional Tablet PS ORAL ORAL Initial or Prolonged Vomiting Lithobid C Date:11/03/03ISR Number: 4228303-4Report Type:Periodic Company Report #PHEH2002US10721 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Clozaril (Clozapine) Initial or Prolonged Leukocytosis Professional Tablet PS ORAL 900 MG/DAY, ORAL Loxitane (Loxapine Succinate) C Zoloft (Sertraline Hydrochloride) C Mulivitamins (Panthenol, Retinol) C Peri-Colace (Casanthranol) C Klonopin C Potassium Chloride C Amiloride (Amiloride) C Atenolol C Synthroid C Date:11/03/03ISR Number: 4228306-XReport Type:Periodic Company Report #PHEH2002US10735 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Distension Health Clozaril (Clozapine) Initial or Prolonged Colonic Professional Tablet PS ORAL 300 MG, BID, Pseudo-Obstruction ORAL Faecaloma Depakote (Valproate Intestinal Functional Semisodium) C Disorder 22-Feb-2006 08:30 AM Page: 2456 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/03ISR Number: 4228308-3Report Type:Periodic Company Report #PHEH2002US10783 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Health Clozaril (Clozapine) Initial or Prolonged Neutropenia Professional Tablet PS OPHTHALMIC 300 MG, BID, Psychotic Disorder ORAL Trileptal "Novartis" C Prozac (Fluoxetine Hydrochloride) C Date:11/03/03ISR Number: 4228310-1Report Type:Periodic Company Report #PHEH2003US00464 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozaril (Clozapine) Hospitalization - Death Professional Tablet PS ORAL ORAL Initial or Prolonged Date:11/03/03ISR Number: 4228314-9Report Type:Periodic Company Report #PHEH2003US00584 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Atrial Fibrillation Health Clozaril (Clozapine) Tachycardia Professional Tablet PS ORAL ORAL Date:11/03/03ISR Number: 4228315-0Report Type:Periodic Company Report #PHEH2003US00656 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiomyopathy Health Clozaril (Clozapine) Hospitalization - Convulsion Professional Tablet PS ORAL 300 MG, QD, Initial or Prolonged Ejection Fraction ORAL Decreased Risperdal C Electrocardiogram Abnormal Electroencephalogram Abnormal Heart Rate Increased Date:11/03/03ISR Number: 4228325-3Report Type:Periodic Company Report #PHEH2002US09481 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiomegaly Health Clozaril (Clozapine) Cardiomyopathy Professional Tablet PS ORAL ORAL Dyspnoea Clozapine(Clozapine) SS ORAL 200 MG/DAY, Ejection Fraction ORAL Decreased Doxepin (Doxepin) C Mitral Valve Incompetence Prozac(Fluoxetine Ventricular Dysfunction Hydrochloride) C Ativan C 22-Feb-2006 08:30 AM Page: 2457 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/03ISR Number: 4228328-9Report Type:Periodic Company Report #PHEH2002US09579 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukocytosis Health Clozaril (Clozapine) Tachycardia Professional Tablet PS ORAL SEE IMAGE Wellbutrin (Bupropion Hydrochloride) C Seroquel (Quetiapine Fumarate) C Zocor "Dieckmann" C Proventil Inhaler C Serax (Oxazepam) C Klonopin C Erythromycin (Erythromycin) C Vistaril (Hydroxyzine Embonate) C Serevent (Salmeterol Xinafoate) C Trazodone (Trazodone) C Date:11/03/03ISR Number: 4228329-0Report Type:Periodic Company Report #PHEH2002US09836 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Health Clozaril(Clozapine)T Initial or Prolonged Neutropenia Professional ablet PS ORAL 500 MG/DAY, Psychotic Disorder ORAL Depakote(Valproate Semisodium) C Cogentin(Benzatropin e Mesilate) C Peri-Colace(Casanthr anol) C Ativan C Date:11/03/03ISR Number: 4228332-0Report Type:Periodic Company Report #PHEH2002US10038 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Health Clozaril (Clozapine) Initial or Prolonged Haemoglobin Decreased Professional Tablet PS ORAL 150 MG, BID, ORAL Depakote(Valproate Semisodium) C Wellbutrin(Ibuprofen Hydrochloride) C Date:11/03/03ISR Number: 4228334-4Report Type:Periodic Company Report #PHEH2002US10161 Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) Professional Tablet PS ORAL 162.5 MG/DAY, ORAL 22-Feb-2006 08:30 AM Page: 2458 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Celexa C Levothroid C Multivitamins (Panthenol, Retinol) C Haldol "Janssen" C Senokot C Date:11/03/03ISR Number: 4228335-6Report Type:Periodic Company Report #PHEH2002US10171 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombocytopenia Health Clozaril (Clozapine) Professional Tablet PS ORAL 250 MG/DAY, ORAL Depakote(Valproate Semisodium) SS ORAL 500 MG/DAY, ORAL Provigil (Modafinil) C Wellbutrin - Slow Release (Bupropion Hydrochloride) C Paxil C Klonopin C Date:11/03/03ISR Number: 4228338-1Report Type:Periodic Company Report #PHEH2002US10222 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Health Clozaril(Clozapine)T Initial or Prolonged Fatigue Professional ablet PS ORAL 300 MG/DAY, Heart Rate Increased ORAL Pyrexia Depakote (Valproate Semisodium) C Lithium (Lithium) C Geodon (Ziprasidone Hydrochloride) C Date:11/03/03ISR Number: 4228341-1Report Type:Periodic Company Report #PHEH2002US10260 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Grand Mal Convulsion Health Clozaril (Clozapine) Professional Tablet PS ORAL ORAL Concerta C Topamax(Topiramate) C Date:11/03/03ISR Number: 4228343-5Report Type:Periodic Company Report #PHEH2002US10367 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril Hypertension Professional (Clozapine)Tablet PS ORAL 400 MG, QD, ORAL Prozac (Fluoxetine Hydrochloride) C Lithium (Lithium) C Antihypertensives C 22-Feb-2006 08:30 AM Page: 2459 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/03ISR Number: 4228344-7Report Type:Periodic Company Report #PHEH2002US10480 Age:73 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Health Clozaril(Clozapine)T Leukopenia Professional ablet PS ORAL 50 MG/DAY, ORAL; 100 MG/DAY, ORAL Permax (Perfolide Mesilate) C Aricept (Donepezil Hydrochloride) C Exelon (Rivastigmine Tartrate) C Sinemet C Amantadine (Amantadine) C Date:11/03/03ISR Number: 4228346-0Report Type:Periodic Company Report #PHEH2002US10506 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Clozaril(Clozapine)T Initial or Prolonged Granulocytopenia Professional ablet PS ORAL 600 MG/DAY, Other Pneumonia ORAL Psychotic Disorder Colace C Cogentin (Benzatropine Mesilate) C Meclizine (Meclozine) C Zonegran (Zonisamide) C Date:11/03/03ISR Number: 4228349-6Report Type:Periodic Company Report #PHEH2002US09203 Age:69 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Other Clozaril (Clozapine) PS ORAL 400 MG/DAY, ORAL Date:11/03/03ISR Number: 4228351-4Report Type:Periodic Company Report #PHEH2002US09206 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) Professional Tablet PS ORAL 500 MG/DAY, ORAL Date:11/03/03ISR Number: 4228352-6Report Type:Periodic Company Report #PHEH2002US09208 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Urinary Incontinence Health Clozaril (Clozapine) PS ORAL 500 MG, QD, Professional ORAL 22-Feb-2006 08:30 AM Page: 2460 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/03ISR Number: 4228355-1Report Type:Periodic Company Report #PHEH2002US09213 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Health Clozaril (Clozapine) Initial or Prolonged Infection Professional Tablet PS ORAL 700 MG/DAY, Psychotic Disorder ORAL Pyrexia Dilantin C Ativan C Date:11/03/03ISR Number: 4228356-3Report Type:Periodic Company Report #PHEH2002US09249 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Cholesterol Health Clozaril (Clozapine) Increased Professional Tablet PS ORAL 800 MG, BID, Blood Triglycerides ORAL Increased Risperdal C Cardiomyopathy Date:11/03/03ISR Number: 4228357-5Report Type:Periodic Company Report #PHEH2002US09253 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Health Clozaril (Clozapine) Professional Tablet PS ORAL 450 MG, QD, ORAL Date:11/03/03ISR Number: 4228358-7Report Type:Periodic Company Report #PHEH2002US09312 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Health Clozaril (Clozapine) Leukocytosis Professional Tablet PS ORAL ORAL Lithium C Synthroid C Ddavp (Desmopressin) C Miralax (Macrogol) C Hytrin (Terazosin Hydrochloride) C Date:11/03/03ISR Number: 4228359-9Report Type:Periodic Company Report #PHEH2002US09337 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Grand Mal Convulsion Health Clozaril (Clozapine) Psychotic Disorder Professional Tablet PS ORAL 400 MG/DAY, ORAL Trileptal "Novartis" C Depakote (Valproate Semisodium) C Stelazine (Trifluoperazine Hydrochloride) C 22-Feb-2006 08:30 AM Page: 2461 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/03ISR Number: 4228360-5Report Type:Periodic Company Report #PHEH2002US09380 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest X-Ray Abnormal Health Clozaril (Clozapine) Initial or Prolonged Cough Professional Tablet PS ORAL ORAL Fatigue Olanzapine C Leukopenia Prostatic Disorder Pyrexia Viral Infection Date:11/03/03ISR Number: 4228361-7Report Type:Periodic Company Report #PHEH2002US09444 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Infection Health Clozaril (Clozapine) Initial or Prolonged Leukocytosis Professional Tablet PS ORAL 400 MG, QHS, Neutrophilia ORAL Pyrexia Neurontin Thrombocytopenia (Gabapentin) C Klonopin C Wellbutrin (Bupropion Hydrochloride) C Date:11/03/03ISR Number: 4228362-9Report Type:Periodic Company Report #USA/98/02731/LEX Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eosinophilia Health Clozaril (Clozapine) Pneumonia Professional Tablet PS ORAL 150 MG, BID, Upper Respiratory Tract ORAL; 500 Infection MG/DAY, ORAL Depakote (Valproate Semisodium) C Proventil (Salbutamol) C Accolate (Zafirlukast) C Pravacol C Depakene C Ferrous Sulfate C Advair (Salmeterol Xinafoate) C Albuterol C Date:11/03/03ISR Number: 4228363-0Report Type:Periodic Company Report #PHEH2002US08180 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Health Clozaril (Clozapine) Initial or Prolonged Coma Professional Tablet PS ORAL 450 MG/DAY, Convulsion ORAL Dyskinesia Eskalith C Pallor Inderal "Imperial Chemical Industries" C 22-Feb-2006 08:30 AM Page: 2462 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/03ISR Number: 4228364-2Report Type:Periodic Company Report #PHEH2002US08406 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chest Pain Health Clozaril (Clozapine) Professional Tablet PS ORAL 300 MG, QD, ORAL Navane (Tiotixene) C Date:11/03/03ISR Number: 4228365-4Report Type:Periodic Company Report #PHEH2002US08745 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Health Clozaril (Clozapine) Initial or Prolonged Professional Tablet PS ORAL ORAL Date:11/03/03ISR Number: 4228366-6Report Type:Periodic Company Report #PHEH2002US08782 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Health Clozaril (Clozapine) Leukopenia Professional Tablet PS ORAL 300 MG/DAY, Neutropenia ORAL Prozac (Fluoxetine Hydrochloride) C Date:11/03/03ISR Number: 4228367-8Report Type:Periodic Company Report #PHEH2002US08893 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Viral Health Clozaril (Clozapine) Initial or Prolonged Professional Tablet PS ORAL 650 MG/DAY, ORAL;250 MG/DAY, ORAL; 650 MG/DAY, ORAL Date:11/03/03ISR Number: 4228368-XReport Type:Periodic Company Report #PHEH2002US08974 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthma Other Clozaril (Clozapine) PS ORAL 100 MG, BID, Convulsion ORAL Influenza Like Illness Depakote (Valproate Semisodium) C Buspar C Inderal C Pamelor C Zoloft (Sertraline Hydrochloride) C Lipitor C Entocort C 22-Feb-2006 08:30 AM Page: 2463 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/03ISR Number: 4228369-1Report Type:Periodic Company Report #PHEH2002US08988 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Deep Vein Thrombosis Health Clozaril (Clozapine) Initial or Prolonged Dyspnoea Professional Tablet PS ORAL 450 MG, QD, Pain In Extremity ORAL Pulmonary Embolism Clozapine (Clozapine) SS ORAL 450 MG, QD, ORAL Zoloft (Sertraline Hydrochloride) C Date:11/03/03ISR Number: 4228372-1Report Type:Periodic Company Report #PHEH2002US09110 Age:89 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) Professional Tablet PS ORAL 100 MG, QD, ORAL Date:11/03/03ISR Number: 4228373-3Report Type:Periodic Company Report #PHEH2002US09179 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Health Clozaril (Clozapine) Initial or Prolonged White Blood Cell Count Professional Tablet PS ORAL SEE IMAGE Decreased Zoloft (Sertraline Hydrochloride) C Date:11/03/03ISR Number: 4228374-5Report Type:Periodic Company Report #PHEH2002US06520 Age:78 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) Professional Tablet PS ORAL 100 MG, ORAL Date:11/03/03ISR Number: 4228376-9Report Type:Periodic Company Report #PHEH2002US06892 Age:25 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Other Clozaril (Clozapine) Tablet PS ORAL 38 MG, QD, ORAL Date:11/03/03ISR Number: 4228378-2Report Type:Periodic Company Report #PHEH2002US07295 Age:12 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Health Clozaril (Clozapine) Initial or Prolonged Tachycardia Professional Tablet PS ORAL SEE IMAGE Ssri C Risperdal C Olanzapine C Clonidine C Ritalin C Benadryl "Parke 22-Feb-2006 08:30 AM Page: 2464 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Davis" C Date:11/03/03ISR Number: 4228382-4Report Type:Periodic Company Report #PHEH2002US07496 Age:34 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Health Clozaril (Clozapine) Initial or Prolonged Leukopenia Professional Tablet, 100 Mg PS ORAL 200 MG AM + Psychotic Disorder Company 300 MG HS, Representative ORAL Clozapine SS Buspar C Inderal-La C Motrin C Date:11/03/03ISR Number: 4228385-XReport Type:Periodic Company Report #PHEH2002US08321 Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abdominal Pain Health Clozaril (Clozapine) Hospitalization - Abdominal Tenderness Professional Tablet PS ORAL 600 MG, QD, Initial or Prolonged Circulatory Collapse ORAL Colostomy Norvasc C Intestinal Obstruction Desferal (Deferoxamine Mesilate) C Nexium (Esomeprazole) C Naproxyn C Depakote (Valproate Semisodium) C Artane (Trihexyphenidyl Hydrochloride) C Cogentin (Benzaptropine Mesilate) C Zyprexa C Ativan C Date:11/03/03ISR Number: 4228390-3Report Type:Periodic Company Report #PHEH2002US08570 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Circulatory Collapse Health Clozaril (Clozapine) Initial or Prolonged Convulsion Professional Tablet, 100 Mg PS ORAL 400 MG, QHS, Drug Interaction ORAL Drug Level Increased Prozac (Fluoxetine Orthostatic Hypotension Hydrochloride) SS Syncope Vasovagal Flovent C Albuterol C Docusate C Prevacid (Lansoprazole) C Nasonex (Mometasone Furoate) C Lipitor C Accolate C Apap C 22-Feb-2006 08:30 AM Page: 2465 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Skelaxin (Metaxalone) C Nadolol C Detrol (Tolterodine L-Tartrate) C Aricept (Donepezil Hydrochloride) C Protonix "Pharmacia" C Sulindac C Acetaminophen C Date:11/03/03ISR Number: 4228394-0Report Type:Periodic Company Report #PHEH2002US08652 Age:53 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) Professional Tablet PS ORAL 50 MG, BID, ORAL Inhaler C Date:11/04/03ISR Number: 4226066-XReport Type:Expedited (15-DaCompany Report #PHFR2003GB02588 Age:52 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Clozaril PS Novartis Sector: Diabetes Mellitus Pharma ORAL Inadequate Control Leukopenia Localised Infection Neutropenia Osteomyelitis Staphylococcal Infection White Blood Cell Count Decreased Date:11/05/03ISR Number: 4226678-3Report Type:Expedited (15-DaCompany Report #PHFR2003GB04137 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aggression Clozaril PS Novartis Sector: Other Death Pharma ORAL Diabetes Mellitus Insulin-Dependent Date:11/05/03ISR Number: 4226679-5Report Type:Expedited (15-DaCompany Report #PHRM2003FR02900 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Chronic Respiratory Leponex PS Novartis Sector: Hospitalization - Failure Pharma ORAL 100 mg/day Initial or Prolonged 22-Feb-2006 08:30 AM Page: 2466 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/05/03ISR Number: 4226691-6Report Type:Expedited (15-DaCompany Report #PHFR2003IE01744 Age:23 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Discomfort Clozaril PS Novartis Sector: Hospitalization - Abdominal Pain Upper Pharma ORAL 100mg/day Initial or Prolonged Constipation Clozaril SS Novartis Sector: Disability Disease Recurrence Pharma ORAL 325mg/day 1049 DAY Other Dyspepsia Quetiapine C ORAL 750mg/day Gastric Ulcer Gastrointestinal Haemorrhage Gastrointestinal Ulcer Haemoglobin Decreased Intestinal Obstruction Myocardial Infarction Oesophageal Ulcer Perforated Ulcer Psychotic Disorder Upper Gastrointestinal Haemorrhage Vomiting Date:11/05/03ISR Number: 4226700-4Report Type:Expedited (15-DaCompany Report #CA-BRISTOL-MYERS SQUIBB COMPANY-12393948 Age:53 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Fatigue Aripiprazole PS Otsuka Hospitalization - Orthostatic Hypotension Pharmaceutical Initial or Prolonged Sedation Company, Ltd. ORAL 11 DAY Supraventricular Clozapine SS ORAL 100 mg noon Tachycardia and supper, Syncope 50 mg hs 6 YR Valproic Acid C present dose 500 mg noon/750 mg hs Pantoprazole C Lorazepam C Lactulose C Date:11/05/03ISR Number: 4227726-7Report Type:Expedited (15-DaCompany Report #6423 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Chest Discomfort Clozapine PS ORAL 50 MG PO Convulsion Midazolm SS INTRAVENOUS IV Hypotension Doxycycline SS Pyrexia Chlorpromazine C Sepsis Staphylococcal Infection Tachycardia Date:11/06/03ISR Number: 4227739-5Report Type:Expedited (15-DaCompany Report #PHBS2003FI11906 Age:38 YR Gender:Male I/FU:I Outcome Hospitalization - Initial or Prolonged 22-Feb-2006 08:30 AM Page: 2467 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Disability PT Report Source Product Role Manufacturer Route Dose Duration Blood Glucose Increased Leponex PS Novartis Sector: Diabetes Mellitus Pharma ORAL 450 mg/d Glycosylated Haemoglobin Increased Subcutaneous Abscess Date:11/06/03ISR Number: 4227778-4Report Type:Expedited (15-DaCompany Report #PHEH2003US10020 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Heart Disease Congenital Clozaril PS Novartis Sector: Initial or Prolonged Pharma ORAL UNK, UNK Trileptal SS UNK, UNK Date:11/06/03ISR Number: 4228192-8Report Type:Expedited (15-DaCompany Report #03-11-1372 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Health Clozapine - Ivax Gastric Neoplasm Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 650-350MG QD ORAL Chemotherapy C Date:11/06/03ISR Number: 4228193-XReport Type:Expedited (15-DaCompany Report #03-10-1350 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coronary Artery Disease Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 250MG QD ORAL Date:11/06/03ISR Number: 4228194-1Report Type:Expedited (15-DaCompany Report #C2003-2163.01 Age:74 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Parkinson'S Disease Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 25MG QHS, Other ORAL Lorazepam C Mirtazipine C Lactulose C Propoxyphene/Apap C Collagenase Ointment C Pimecrolimus 1% Cream C 22-Feb-2006 08:30 AM Page: 2468 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/06/03ISR Number: 4228230-2Report Type:Expedited (15-DaCompany Report #03-10-1295 Age:27 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Acute Psychosis Foreign Doxycycline Hyclate Alcohol Use Other - Ipi Capsules PS Ipi Chest Pain Clozaril Unknown SS ORAL 50MG/DAY ORAL Convulsion Midazolam Unknown SS INTRAVENOUS INTRAVENOUS Device Related Infection Chlorpromazine SS Hypotension Intentional Self-Injury Liver Function Test Abnormal Overdose Pneumonia Postoperative Infection Renal Failure Acute Sepsis Staphylococcal Infection Suicide Attempt Tachycardia Date:11/07/03ISR Number: 4228708-1Report Type:Expedited (15-DaCompany Report #PHHO2003CA13478 Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiomegaly Clozaril PS Novartis Sector: Cardiomyopathy Pharma ORAL 300 mg, QD 53280MIN Dyspnoea Vitamin E C 800 UNK, BID Electrocardiogram T Wave Risperdal C 2 mg, UNK Amplitude Decreased Vitamin B6 C 400 UNK, QD Eosinophil Count Vitamin B12 C Increased Lithium C 1500 g, UNK Eosinophilia Lymphocyte Count Increased Myocarditis Neutrophil Count Increased Tachycardia White Blood Cell Count Increased Date:11/07/03ISR Number: 4228710-XReport Type:Expedited (15-DaCompany Report #PHFR2003GB03836 Age:57 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intestinal Obstruction Clozaril PS Novartis Sector: Initial or Prolonged Postoperative Adhesion Pharma ORAL 500mg/day Urinary Incontinence Oxybutynin SS Amisulpride C ORAL 600mg/day Diazepam C ORAL 20mg/day Temazepam C ORAL 20mg/day 22-Feb-2006 08:30 AM Page: 2469 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/07/03ISR Number: 4228793-7Report Type:Expedited (15-DaCompany Report #PHBS2003NO12023 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Level Decreased Leponex PS Novartis Sector: Pharma UNKNOWN 3650 DAY Leponex SS Novartis Sector: Pharma UNKNOWN 500 mg/d Leponex SS Novartis Sector: Pharma UNKNOWN 600 mg/d Leponex SS Novartis Sector: Pharma UNKNOWN 650 mg/d Bricanyl C UNKNOWN Pulmicort C UNKNOWN Date:11/07/03ISR Number: 4228795-0Report Type:Expedited (15-DaCompany Report #PHNR2003AU01525 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cholecystitis Clozaril PS Novartis Sector: Initial or Prolonged Pharma ORAL 12.5 - 450 mg/day Clozaril SS Novartis Sector: Pharma ORAL 12.5 - 25 mg/day Date:11/07/03ISR Number: 4228825-6Report Type:Expedited (15-DaCompany Report #PHFR2003GB04210 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Alanine Aminotransferase Clozaril PS Novartis Sector: Increased Pharma ORAL 350mg/day Blood Cholesterol Citalopram C ORAL 20 mg, QD Increased Lansoprazole C ORAL 15mg/nocte Diabetes Mellitus Flupentixol C ORAL 3 mg, PRN Gamma-Glutamyltransferase Paracetamol C ORAL 1 g, PRN Increased Glycosylated Haemoglobin Increased Weight Increased Date:11/07/03ISR Number: 4228847-5Report Type:Expedited (15-DaCompany Report #PHNR2003AU01476 Age:59 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bronchopneumonia Clozaril PS Novartis Sector: Refusal Of Treatment By Pharma ORAL 12 - 500 Patient mg/day Respiratory Failure Benztropine Mesylate C 0.5 mg nocte Folic Acid C 5 mg/day Calcitrol C .25 mg, BID Gaviscon C UNK, PRN Esomeprazole C 20 mg mane 22-Feb-2006 08:30 AM Page: 2470 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/07/03ISR Number: 4228855-4Report Type:Expedited (15-DaCompany Report #PHNR2003AU01421 Age:44 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Drug Interaction Clozaril PS Novartis Sector: Other Grand Mal Convulsion Pharma 12 - 600 mg/day Amitriptyline SS Paroxetine SS Date:11/07/03ISR Number: 4229013-XReport Type:Expedited (15-DaCompany Report #PHNR2003AU01536 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Glucose Increased Clozaril PS Novartis Sector: Blood Prolactin Increased Pharma ORAL 12.5 - 600 mg/day Date:11/07/03ISR Number: 4229027-XReport Type:Expedited (15-DaCompany Report #PHFR2003GB04235 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Haemoglobin Decreased Clozaril PS Novartis Sector: Pharma ORAL Date:11/07/03ISR Number: 4230552-6Report Type:Expedited (15-DaCompany Report #C2003-2670.01 Age:85 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Atherosclerosis Health Clozapine Tablets 25 Cardiac Failure Professional Mg Mylan PS Mylan ORAL 25 MG BID, Congestive Other ORAL Coronary Artery Disease Acetaminophen C Hyperlipidaemia Ciprofloxacin C Digoxin C Esompeprazole Magnesium C Fentanyl Transdermal C Furosemide C Metformin/Glipizide C Nitroglycerin Transdermal C Date:11/07/03ISR Number: 4230553-8Report Type:Expedited (15-DaCompany Report #C2003-2784.01 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Other Clozapine Tablets 100 Mg Mylan PS Mylan ORAL 300 MG Q HS, ORAL Lamotrigine C Oxcarbazepine C Valsartan C 22-Feb-2006 08:30 AM Page: 2471 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/07/03ISR Number: 4230554-XReport Type:Expedited (15-DaCompany Report #C2003-2785.01 Age:81 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 300 MG Q HS, Other ORAL Ceftriaxone Sodium C Divalproex Sodium C Lorazepam C Phenytoin Sodium C Tramadol C Date:11/07/03ISR Number: 4230555-1Report Type:Expedited (15-DaCompany Report #C2003-2370.01 Age:25 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiomegaly Health Clozapine Tablets Required Dizziness Professional 100 Mg Mylan PS Mylan ORAL 200MG Q HS, Intervention to Dyspnoea ORAL Prevent Permanent Fall Bupropion Hcl Sr C Impairment/Damage Famotidine C Date:11/07/03ISR Number: 4230557-5Report Type:Expedited (15-DaCompany Report #C2003-2603.01 Age:64 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Other Clozapine Tablets 100 Mg Mylan PS Mylan ORAL 100 MG Q AM, 300MG Q PM, ORAL Levofloxacin C Insulin N C Insulin R C Nitroglycerin Transdermal C Metoclopramide C Heparin C Pantoprazole C Calcium C Magnesium Citrate C Date:11/07/03ISR Number: 4230558-7Report Type:Expedited (15-DaCompany Report #C2003-2820.01 Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 200MG Q HS, Other ORAL Albuterol Inhalation Solution C Lansoprazole C Polyethylene Glycol Powder C 22-Feb-2006 08:30 AM Page: 2472 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/07/03ISR Number: 4230559-9Report Type:Expedited (15-DaCompany Report #C2003-2826.01 Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Disease Progression Health Clozapine Tablets 25 Parkinson'S Disease Professional Mg Mylan PS Mylan ORAL 25 MG HS, Pneumonia Aspiration Other ORAL Extended Phenytoin Sodium C Olmesartan Medoxomil C Quetiapine Fumarate C Temazepam C Date:11/07/03ISR Number: 4231581-9Report Type:Expedited (15-DaCompany Report #2003UW14175 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Hyperglycaemia Foreign Seroquel PS 125 MG DAILY Intervention to Leukopenia Health Clozaril SS Prevent Permanent Pancreatitis Professional Epival SS 500 MG BID Impairment/Damage Pulmonary Embolism Other Fluanxol SS Bayer 6 MG, DAILY Clonazepam C Paxil C Rivotril C Tenormin C Date:11/07/03ISR Number: 4231654-0Report Type:Expedited (15-DaCompany Report #2003UW14165 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Abdominal Pain Foreign Seroquel PS Intervention to Chills Health Clozaril SS ORAL 400 MG QD PO Prevent Permanent Cyanosis Professional Paxil SS ORAL 40 MG QD PO Impairment/Damage Decreased Appetite Other Clopixol (Decanoate) C Drug Level Increased Lorazepam C Gastritis Gastroenteritis Hepatic Steatosis Hepatotoxicity Increased Appetite Liver Function Test Abnormal Psychotic Disorder Pyrexia Vomiting Date:11/07/03ISR Number: 4231676-XReport Type:Expedited (15-DaCompany Report #PHFR2002GB01610 Age:57 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Foreign Clozaril (Clozapine) Dizziness Health Tablet PS ORAL 300MG/DAY, Electrocardiogram Qt Professional ORAL Prolonged Other Ranitidine Hypotension (Ranitidine) C Pyrexia Tachycardia 22-Feb-2006 08:30 AM Page: 2473 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/07/03ISR Number: 4231683-7Report Type:Expedited (15-DaCompany Report #PHFR2003GB04115 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Ketoacidosis Foreign Clozaril (Clozapine) Initial or Prolonged Study (Clozapine) PS Health Professional Other Date:11/07/03ISR Number: 4231685-0Report Type:Expedited (15-DaCompany Report #PHFR2002GB00874 Age:32 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Foreign Clozaril (Clozapine) Initial or Prolonged Diabetes Mellitus Health Tablet PS ORAL 800 MG/DAY, Other Insulin-Dependent Professional ORAL Other Amisulpride (Amisulpride) C Valproate Sodium C Metformin C Gliclazide C Date:11/10/03ISR Number: 4231207-4Report Type:Expedited (15-DaCompany Report #PHFR2003GB04250 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Clozaril PS Novartis Sector: Pharma ORAL Date:11/12/03ISR Number: 4233666-XReport Type:Expedited (15-DaCompany Report #03-10-1365 Age:54 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Clozapine Tablets - Other Ivax Pharmaceuticals, Inc. Tab PS Ivax Pharmaceuticals, Inc. ORAL 600MG QD ORAL Chemotherapy C Date:11/12/03ISR Number: 4233667-1Report Type:Expedited (15-DaCompany Report #03-11-1387 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neoplasm Malignant Health Clozapine Tablets - Neutropenia Professional Ivax Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 100MG QD ORAL 22-Feb-2006 08:30 AM Page: 2474 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/12/03ISR Number: 4233671-3Report Type:Expedited (15-DaCompany Report #C2003-2535.01 Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 800MG Q HS, Other ORAL Date:11/12/03ISR Number: 4233672-5Report Type:Expedited (15-DaCompany Report #03-10-1398 Age:86 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 50-62.5MG QD ORAL Date:11/12/03ISR Number: 4233674-9Report Type:Expedited (15-DaCompany Report #03-10-1383 Age:74 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozapine Tablets - Parkinson'S Disease Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL ORAL Date:11/12/03ISR Number: 4233754-8Report Type:Expedited (15-DaCompany Report #03-11-1399 Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 350MG QD ORAL Date:11/12/03ISR Number: 4233755-XReport Type:Expedited (15-DaCompany Report #03-11-1397 Age:77 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Osteoarthritis Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 50-150MG QD ORAL Date:11/12/03ISR Number: 4235054-9Report Type:Expedited (15-DaCompany Report #2003112713 Age:27 YR Gender:Male I/FU:F Outcome PT Hospitalization - Acute Psychosis Initial or Prolonged Convulsion Other Drug Dependence Hypotension Intentional Self-Injury 22-Feb-2006 08:30 AM Page: 2475 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Liver Function Test Abnormal Overdose Report Source Product Role Manufacturer Route Dose Duration Pneumonia Foreign Doxycycline Polytraumatism Health (Doxycycline) PS Renal Failure Acute Professional Clozapine Sepsis (Clozapine) SS ORAL 50 MG Staphylococcal Infection (DAILY), ORAL Suicide Attempt Midazolam Tachycardia (Midazolam) SS INTRAVENOUS INTRAVENOUS Chlorpromazine (Chlorpromazine) SS Date:11/12/03ISR Number: 4242074-7Report Type:Expedited (15-DaCompany Report #03-11-1396 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 600-700MG QD ORAL Date:11/13/03ISR Number: 4233861-XReport Type:Expedited (15-DaCompany Report #PHEH2003US09688 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Clozaril PS Novartis Sector: Hospitalization - Dysstasia Pharma ORAL 300 mg/day 79 DAY Initial or Prolonged Lung Cancer Metastatic Glucophage "Abic" C Malaise Multivitamins C Myocardial Infarction Omeprazole C Amaryl C Hydroxyzine Pamoate C Risperdal C Effexor-Xr C Topamax C Depakote C Geodon C Buspirone C Starlix C Lexapro /Usa/ C Date:11/13/03ISR Number: 4233873-6Report Type:Expedited (15-DaCompany Report #PHFR2003GB03699 Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Clozaril PS Novartis Sector: Pharma ORAL 22-Feb-2006 08:30 AM Page: 2476 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/13/03ISR Number: 4233897-9Report Type:Expedited (15-DaCompany Report #PHNR2003AU01537 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Clozaril PS Novartis Sector: Dyspnoea Pharma ORAL 250 - 600 Ventricular Dysfunction mg/day Date:11/13/03ISR Number: 4234106-7Report Type:Expedited (15-DaCompany Report #PHFR2003GB03539 Age:18 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eye Pain Clozaril PS Novartis Sector: Oculogyration Pharma ORAL Amisulpride SS UNKNOWN Date:11/13/03ISR Number: 4234110-9Report Type:Expedited (15-DaCompany Report #PHBS2003CH12163 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Clozapine PS Novartis Sector: Obsessive-Compulsive Pharma UNKNOWN 700 mg, QD Disorder Biperiden C UNKNOWN 4 mg, QD Oculogyration Buspirone C UNKNOWN 60 mg/d Sertraline C UNKNOWN 100 mg, QD Date:11/13/03ISR Number: 4234111-0Report Type:Expedited (15-DaCompany Report #PHNR2003AU01553 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Facial Palsy Clozaril PS Novartis Sector: Muscle Contractions Pharma ORAL 12.5 - 300 Involuntary mg/day Viral Infection Date:11/13/03ISR Number: 4234144-4Report Type:Expedited (15-DaCompany Report #PHFR2003GB03514 Age:22 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Pain Clozaril PS Novartis Sector: Bradycardia Pharma ORAL 900mg/day Circulatory Collapse Laxatives C UNKNOWN Constipation Amisulpride C ORAL 400mg/day Crying Omeprazole C ORAL 20mg/day Faecaloma General Physical Health Deterioration Intestinal Infarction Intestinal Ischaemia Pyrexia Urinary Tract Infection Vomiting 22-Feb-2006 08:30 AM Page: 2477 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/13/03ISR Number: 4234163-8Report Type:Expedited (15-DaCompany Report #PHFR2003GB04315 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Clozaril PS Novartis Sector: Pharma ORAL Date:11/13/03ISR Number: 4234164-XReport Type:Expedited (15-DaCompany Report #PHNU2003DE03907 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blister Leponex / Clozaril Dermatitis Contact (Clozapine) PS Novartis Sector: Erythema Pharma ORAL Date:11/13/03ISR Number: 4234510-7Report Type:Expedited (15-DaCompany Report #PHFR2003GB03836 Age:57 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intestinal Obstruction Clozaril PS Novartis Sector: Initial or Prolonged Postoperative Adhesion Pharma ORAL 500mg/day Urinary Incontinence Oxybutynin SS Clozaril SS Novartis Sector: Pharma ORAL 12.5mg/day Amisulpride C ORAL 600mg/day Diazepam C ORAL 20mg/day Temazepam C ORAL 20mg/day Date:11/13/03ISR Number: 4235902-2Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20030706436 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Facial Bones Fracture Foreign Risperdal Grand Mal Convulsion Health (Risperidone) Skin Laceration Professional Tablets PS ORAL 6 MG, ORAL Leponex (Clozapine) Tablets SS ORAL 25 MG, ORAL Zyprexa (Olanzapine) Tablets SS ORAL 20 MG, ORAL Cipramil (Citalopram Hydrobromide) Tablets SS ORAL 20 MG, ORAL Bronchoretard (Theophylline) C Berotec (Fenoterol Hydrobromide) Spray C Pulmicort (Budesonide) Spray C Date:11/13/03ISR Number: 4235950-2Report Type:Expedited (15-DaCompany Report #CATIE1-0500 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bronchitis Study Clozapine Diabetes Mellitus Health (Clozapine) Viral Infection Professional (Colloidal Silicon Dioxide) Capsules, 200mg PS 22-Feb-2006 08:30 AM Page: 2478 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lexapro C Trazodone C Albuterol Inhaler C Date:11/13/03ISR Number: 4236081-8Report Type:Expedited (15-DaCompany Report #03-10-1241 Age:61 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Circulatory Collapse Health Clozapine - Ivax Hospitalization - Communication Disorder Professional Pharmaceuticals, Initial or Prolonged Difficulty In Walking Other Inc. Tablets PS Ivax Pneumonia Pharmaceuticals, Urinary Tract Infection Inc. ORAL SEE IMAGE Synthroid C Celebrex C Fibercon C Captopril C Ativan C Topamax C Celebrex C Date:11/13/03ISR Number: 4236083-1Report Type:Expedited (15-DaCompany Report #03-11-1406 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Health Clozapine - Ivax Dysphagia Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceutial ORAL 150-350MG QD ORAL Date:11/14/03ISR Number: 4235474-2Report Type:Expedited (15-DaCompany Report #PHFR2003IE04327 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Clozaril PS Novartis Sector: Dizziness Pharma ORAL 250mg/day Encephalopathy Clozaril SS Novartis Sector: Fall Pharma ORAL 300mg/day Muscle Spasms Date:11/14/03ISR Number: 4235475-4Report Type:Expedited (15-DaCompany Report #PHFR2003GB04115 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Ketoacidosis Clozaril (Clozapine) PS Novartis Sector: Initial or Prolonged Infection Pharma ORAL Date:11/14/03ISR Number: 4235490-0Report Type:Expedited (15-DaCompany Report #PHFR2003GB04340 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Clozaril PS Novartis Sector: Inadequate Control Pharma ORAL 2358 DAY Clozaril SS Novartis Sector: Pharma ORAL 22-Feb-2006 08:30 AM Page: 2479 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/14/03ISR Number: 4235560-7Report Type:Expedited (15-DaCompany Report #PHBS2001NZ04304 Age:74 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - C-Reactive Protein Clozaril PS Novartis Sector: Initial or Prolonged Increased Pharma ORAL 25 mg/d Cardiomegaly Clozaril SS Novartis Sector: Chills Pharma ORAL 50 mg/d Cough Clozaril SS Novartis Sector: Malaise Pharma ORAL 37.5 mg/day Mass Valproate Sodium C Pericardial Effusion Pericarditis Pleural Effusion Pyrexia Red Blood Cell Sedimentation Rate Increased Thrombocythaemia Date:11/14/03ISR Number: 4235561-9Report Type:Expedited (15-DaCompany Report #PHHO2003CA13052 Age:56 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delirium Clozaril PS Novartis Sector: Initial or Prolonged Electroencephalogram Pharma ORAL 750 mg / day 48960MIN Other Abnormal Duralith C Saccadic Eye Movement Rivotril C Lisinopril C Clonazepam C Paxil C Haldol C Benadryl C Ativan C Date:11/14/03ISR Number: 4235562-0Report Type:Expedited (15-DaCompany Report #PHFR2003GB04313 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Clozaril PS Novartis Sector: Non-Insulin-Dependent Pharma ORAL Date:11/14/03ISR Number: 4235563-2Report Type:Expedited (15-DaCompany Report #PHNR2003AU01516 Age:24 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypocalcaemia Clozaril PS Novartis Sector: Initial or Prolonged Pharma ORAL 37.5-500mg/da y Clozaril SS Novartis Sector: Pharma 400 mg/day Solian C ORAL 200 mg, QD Sertraline C ORAL 22-Feb-2006 08:30 AM Page: 2480 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/14/03ISR Number: 4235566-8Report Type:Expedited (15-DaCompany Report #PHFR2003GB03562 Age:35 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Glucose Increased Clozaril PS Novartis Sector: Blood Thyroid Stimulating Pharma ORAL Hormone Decreased Diabetes Mellitus Hyperthyroidism Thyroxine Free Increased Date:11/14/03ISR Number: 4235571-1Report Type:Expedited (15-DaCompany Report #PHNU2003DE03537 Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Discomfort Health Leponex / Clozaril Initial or Prolonged Drug Interaction Professional (Clozapine) PS Novartis Sector: Pancreatitis Acute Pharma ORAL up to 300 mg/day Amphetamines SS ORAL Solian SS ORAL 200 mg, BID Trevilor - Slow Release SS 150 mg, BID Alcohol SS ORAL Date:11/14/03ISR Number: 4235575-9Report Type:Expedited (15-DaCompany Report #PHFR2002GB01610 Age:57 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Pressure Clozaril PS Novartis Sector: Fluctuation Pharma ORAL 300mg/day 584 DAY Dizziness Ranitidine C Electrocardiogram Qt Prolonged Hypotension Pyrexia Tachycardia Date:11/14/03ISR Number: 4235707-2Report Type:Expedited (15-DaCompany Report #C2003-2873.01 Age:88 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg Mylan PS ORAL 12.5 MG Q HS, Other ORAL Amlodipine Besylate C Carbidopa/Levodopa C Digoxin C Doxazosin Mesylate C Entacapone C Furosemide C Haloperidol C Lisinopril C Pergolide Mesylate C Quetiapine Fumarate C Tolterodine Tartrate C Warfarin Sodium C 22-Feb-2006 08:30 AM Page: 2481 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/14/03ISR Number: 4235711-4Report Type:Expedited (15-DaCompany Report #C2003-2874.01 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 250 MG/DAY, Other ORAL Date:11/14/03ISR Number: 4235718-7Report Type:Expedited (15-DaCompany Report #03-11-1411 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Level Decreased Foreign Clozapine Tablets PS ORAL 325 MG QD Initial or Prolonged Reflux Oesophagitis Literature ORAL 41 DAY Other Health Omeprazole Unknown SS 60 MG QD Professional Dibenzepin Hydrochloride C Date:11/14/03ISR Number: 4235719-9Report Type:Expedited (15-DaCompany Report #03-11-1410 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Level Decreased Foreign Clozapine Tablets PS ORAL 325 MG QD Initial or Prolonged Gastritis Literature ORAL 78 DAY Other Health Omeprazole Unknown SS 40 MG QD Professional Citalopram C Date:11/14/03ISR Number: 4236511-1Report Type:Expedited (15-DaCompany Report #03P-167-0235947-00 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Electrocardiogram Qt Foreign Epilim (Sodiuim Intervention to Prolonged Health Valproate) (Sodium Prevent Permanent Professional Valproate) PS Impairment/Damage Clozapine SS Date:11/17/03ISR Number: 4236516-0Report Type:Expedited (15-DaCompany Report #PHBS2003CA12432 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Clozaril PS Novartis Sector: Drug Level Decreased Pharma ORAL Epival SS UNKNOWN Lithium C UNKNOWN Frisium C UNKNOWN Date:11/18/03ISR Number: 4236859-0Report Type:Direct Company Report #CTU 206347 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neutrophil Count Clozapien 100 Mg Decreased Ivax PS Ivax ORAL 100 MG QID White Blood Cell Count ORAL Benztropine C Chlorpromazine C Divalproex C Famotidine C 22-Feb-2006 08:30 AM Page: 2482 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Loratadine C Losartan C Simvastatin C Date:11/18/03ISR Number: 4236892-9Report Type:Direct Company Report #CTU 206350 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neutrophil Count Clozapine 100 Mg Decreased Ivax PS Ivax ORAL 200 MG HS White Blood Cell Count ORAL Decreased Amlodipine C Levothyroxine C Date:11/18/03ISR Number: 4236933-9Report Type:Expedited (15-DaCompany Report #PHNU2003DE03979 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Leponex / Clozaril Initial or Prolonged Haemoglobin Decreased (Clozapine) PS Novartis Sector: Iron Deficiency Anaemia Pharma ORAL up to 200 mg/day Tiapridex C ORAL Date:11/18/03ISR Number: 4236934-0Report Type:Expedited (15-DaCompany Report #PHFR2003GB04364 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Accidental Exposure Clozaril PS Novartis Sector: Face Oedema Pharma ORAL 200mg/dose/ac Orthostatic Hypotension cidental 1440 MIN Date:11/18/03ISR Number: 4236935-2Report Type:Expedited (15-DaCompany Report #PHNR2002AU00642 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abortion Spontaneous Clozaril PS Novartis Sector: Complications Of Maternal Pharma 6 - 200 Exposure To Therapeutic mg/day Drugs Clozaril SS Novartis Sector: Drug Exposure During Pharma 25 - 150 Pregnancy mg/day Normal Delivery Clozaril SS Novartis Sector: Normal Newborn Pharma 25 mg/day Pregnancy Clozaril SS Novartis Sector: Pharma 50 - 150 mg/day Date:11/18/03ISR Number: 4237120-0Report Type:Expedited (15-DaCompany Report #03-11-1413 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bronchitis Health Clozapine - Ivax Initial or Prolonged Diabetes Mellitus Professional Pharmaceuticals, Other Viral Infection Inc. Tablets PS Ivax Pharamaceuticals, 22-Feb-2006 08:30 AM Page: 2483 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Inc. ORAL 25-450MG QD ORAL Trazodone C Albuterol Sulfate C Date:11/18/03ISR Number: 4237123-6Report Type:Expedited (15-DaCompany Report #03-11-1424 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 600MG QD ORAL Date:11/18/03ISR Number: 4237125-XReport Type:Expedited (15-DaCompany Report #03-11-1414 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Clozapine - Ivax Professional Pharmaceuticals, Inc Other Tablets PS Ivax Pharmaceuticals, Inc. ORAL 450-700MG QD ORAL Date:11/18/03ISR Number: 4237127-3Report Type:Expedited (15-DaCompany Report #03-10-1279 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 300MG HS ORAL Date:11/19/03ISR Number: 4237533-7Report Type:Expedited (15-DaCompany Report #03-11-1439 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Colon Cancer Health Clozapine- Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 200MG QD ORAL Date:11/19/03ISR Number: 4237535-0Report Type:Expedited (15-DaCompany Report #03-11-1425 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Throat Cancer Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 300-700MG QD ORAL 22-Feb-2006 08:30 AM Page: 2484 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/19/03ISR Number: 4237537-4Report Type:Expedited (15-DaCompany Report #03-11-1438 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Neoplasm Malignant Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc ORAL 25-650MG QD ORAL Date:11/19/03ISR Number: 4239054-4Report Type:Expedited (15-DaCompany Report #2003-03839 Age:24 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Literature Clonazepam (Watson Health Laboratories)(Clonaz Professional epam) Tablet PS Clozapine (Clozapine) SS Date:11/19/03ISR Number: 4239174-4Report Type:Expedited (15-DaCompany Report #2003040180 Age:51 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Amnesia Consumer Nardil (Phenelzine Initial or Prolonged Anxiety Sulfate) PS ORAL 30 MG Disability Difficulty In Walking (DAILY), ORAL Other Fatigue Olanzapine Glucose Tolerance (Olanzapine) SS ORAL 10 MG Impaired (DAILY), ORAL Hypersomnia Clonazepam Hypertonia (Clonazepam) SS 2 MG (DAILY) Impaired Work Ability Clozapine Muscle Rigidity (Clozapine) SS Muscle Spasms Rosiglitazone Muscle Strain Maleate Muscle Tightness (Rosiglitazone Myalgia Maleate) C Myocardial Infarction Tamsulosin Panic Disorder Hydrochloride (Tamsulosin Hydrochloride) C Date:11/20/03ISR Number: 4237991-8Report Type:Expedited (15-DaCompany Report #PHFR2003GB04368 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Choking Clozaril PS Novartis Sector: Hospitalization - Death Pharma ORAL Initial or Prolonged Foreign Body Aspiration Date:11/20/03ISR Number: 4237999-2Report Type:Expedited (15-DaCompany Report #PHHO2003CA13861 Age:29 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Clozaril PS Novartis Sector: Drug Abuser Pharma 400 mg / hs Amisulpride SS 22-Feb-2006 08:30 AM Page: 2485 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Oxcarbazepine SS Metformin SS Date:11/20/03ISR Number: 4238197-9Report Type:Expedited (15-DaCompany Report #PHEH2002US02534 Age:57 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Clozaril PS Novartis Sector: Other Arthralgia Pharma ORAL 600 mg, QD 3486 DAY Circulatory Collapse Colace C Drug Level Increased Lorazepam I Drug Toxicity Paxil I Hepatic Steatosis Osteoarthritis Pain In Extremity Sudden Cardiac Death Uterine Leiomyoma Date:11/20/03ISR Number: 4238200-6Report Type:Expedited (15-DaCompany Report #PHRM2003FR02819 Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Bronchitis Trileptal PS Novartis Sector: Other Catatonia Pharma UNKNOWN 2.4 g, daily Mental Disorder Depakote SS UNKNOWN 2 g, daily Neutropenia Leponex SS ORAL 500 mg, daily 1050 DAY Pyrexia Theralene C Temesta C Movicol C Date:11/20/03ISR Number: 4238206-7Report Type:Expedited (15-DaCompany Report #PHEH2003US10479 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Infection Clozaril PS Novartis Sector: Leukocytosis Pharma ORAL 25 mg, QD Date:11/20/03ISR Number: 4238222-5Report Type:Expedited (15-DaCompany Report #PHEH2003US10355 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Cancer Clozaril PS Novartis Sector: Mastectomy Pharma ORAL UNK, UNK Date:11/20/03ISR Number: 4238557-6Report Type:Expedited (15-DaCompany Report #PHNR2003AU01537 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiomyopathy Clozaril PS Novartis Sector: Convulsion Pharma ORAL 250 - 600 Dyspnoea mg/day 2382 DAY Ventricular Dysfunction 22-Feb-2006 08:30 AM Page: 2486 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/20/03ISR Number: 4239488-8Report Type:Expedited (15-DaCompany Report #03-11-1447 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neoplasm Malignant Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 100 725MG QD ORAL Date:11/20/03ISR Number: 4239571-7Report Type:Expedited (15-DaCompany Report #DSA_23577_2003 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Abuser Foreign Ativan PS VAR Initial or Prolonged Drug Withdrawal Syndrome Health Clozaril SS ORAL VAR PO Other Epilepsy Professional Cardura C Other Coversyl C Adalat C Lithium C Propranolol C Date:11/21/03ISR Number: 4238966-5Report Type:Expedited (15-DaCompany Report #PHFR2003GB04378 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Clozaril PS Novartis Sector: Increased Pharma ORAL 73 DAY Blood Alkaline Phosphatase Increased Diabetes Mellitus Inadequate Control Hyperpyrexia Liver Function Test Abnormal Malaise Date:11/21/03ISR Number: 4239172-0Report Type:Expedited (15-DaCompany Report #PHFR2003GB04381 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Clozaril PS Novartis Sector: Initial or Prolonged Epilepsy Pharma ORAL 2175 DAY Other Date:11/21/03ISR Number: 4239177-XReport Type:Expedited (15-DaCompany Report #PHNR2003AU01592 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Catatonia Clozaril PS Novartis Sector: Initial or Prolonged Otitis Media Pharma ORAL 13 - 675 Streptococcal Infection mg/day 1088 DAY Clozaril SS Novartis Sector: Pharma Clozaril SS Novartis Sector: Pharma 200 - 250 mg nocte 22-Feb-2006 08:30 AM Page: 2487 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/21/03ISR Number: 4239287-7Report Type:Expedited (15-DaCompany Report #PHFR2003GB04395 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Constipation Clozaril PS Novartis Sector: Diabetes Mellitus Pharma ORAL 300mg/day Diabetes Mellitus Inadequate Control Lymphocytosis Urinary Incontinence Date:11/21/03ISR Number: 4239292-0Report Type:Expedited (15-DaCompany Report #PHEH2003US10424 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Cancer Clozaril PS Novartis Sector: Fatigue Pharma ORAL 100 mg/day Malignant Breast Lump Depakote C Removal Synthroid C Moban C Klonopin C Zantac C Premarin C Date:11/21/03ISR Number: 4239299-3Report Type:Expedited (15-DaCompany Report #PHFR2003GB04396 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Body Temperature Clozaril PS Novartis Sector: Initial or Prolonged Increased Pharma ORAL Confusional State Diabetes Mellitus Non-Insulin-Dependent Disorientation Influenza Like Illness Date:11/21/03ISR Number: 4239309-3Report Type:Expedited (15-DaCompany Report #PHBS2003BR05086 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Colonoscopy Abnormal Leponex PS Novartis Sector: Diarrhoea Pharma ORAL 450 mg/d Gastritis Calcium C ORAL Gastrointestinal Disorder Vitamin B Complex C ORAL 3 tablets/d Oesophagitis Diazepam C ORAL 0.5 tablet/d Oesophagitis Ulcerative Omeprazole C ORAL Platelet Count Abnormal Platelet Count Decreased Date:11/21/03ISR Number: 4239677-2Report Type:Expedited (15-DaCompany Report #C2003-2928.01 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Constipation Health Clozapine Tablets 25 Initial or Prolonged Professional Mg Mylan PS ORAL 50 MG BID, Other ORAL 22-Feb-2006 08:30 AM Page: 2488 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/21/03ISR Number: 4239678-4Report Type:Expedited (15-DaCompany Report #C2003-2927.01 Age:76 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional 100 Mg Mylan PS ORAL 200MG/DAY, Other ORAL Date:11/21/03ISR Number: 4239690-5Report Type:Expedited (15-DaCompany Report #C2003-3001.01 Age:86 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death General Physical Health Health Clozapine Tablets 25 Deterioration Professional Mg Mylan PS Mylan ORAL 12.5 MG Q AM Multi-Organ Failure Other AND 75 MG Q PM, ORAL Acetaminophen C Carbidopa/Levodopa C Ciprofloxacin C Digoxin C Furosemide C Hyoscyamine C Lansoprazole C Levothyroxine Sodium C Lisinopril C Megestrol Acetate C Milk Of Magnesia C Mirtazapine C Morphine Sulfate Oral Concentrate C Date:11/21/03ISR Number: 4239692-9Report Type:Expedited (15-DaCompany Report #C2003-3002.01 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 25MG Q AM, Other ORAL Clozapine Tablets 100 Mg Mylan SS Mylan ORAL 100MG Q HS, ORAL Sertraline C Donepezil C Lithium Carbonate C Albuterol Sulfate C Nitroglycerin C Propoxyphene Napsylate/Apap C Glucose C Losartan C Insulin C Clopidogrel C Isosorbide Mononitrate C Pramipexole C Atorvastatin C Metoprolol C Furosemide C 22-Feb-2006 08:30 AM Page: 2489 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/21/03ISR Number: 4239693-0Report Type:Expedited (15-DaCompany Report #C2003-2938.01 Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 12.5MG Q HS, Other THEN 25MG Q HS, ORAL Levothyroxine C Morphine Sulfate Oral Concentrate C Oxandrolone C Scopolamine Transdermal C Date:11/21/03ISR Number: 4239696-6Report Type:Expedited (15-DaCompany Report #C2003-2372.01 Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Circulatory Collapse Health Clozapine Tablets Dyspnoea Professional 100 Mg Mylan PS Mylan ORAL 150MG Q AM Myocardial Infarction Other AND 450MG Q Nausea HS, ORAL Syncope Propranolol La C Vomiting Citalopram C Loratidine/Pseudoeph edrine C Zonisamide C Date:11/24/03ISR Number: 4239917-XReport Type:Expedited (15-DaCompany Report #PHFR2003GB03613 Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Clozaril PS Novartis Sector: Increased Pharma ORAL 350mg/day Aspartate Aminotransferase Increased Blood Alkaline Phosphatase Increased Blood Triglycerides Increased Liver Function Test Abnormal Date:11/24/03ISR Number: 4239946-6Report Type:Expedited (15-DaCompany Report #PHFR2003GB02814 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Glucose Increased Clozaril PS Novartis Sector: Diabetes Mellitus Pharma ORAL 100mg Glycosylated Haemoglobin mane/100mg pm Increased /275mg nocte Clozaril SS Novartis Sector: Pharma ORAL 200mg/day Lansoprazole C 30 mg, QD Zuclopenthixol C UNKNOWN Chlorpromazine C ORAL 75 mg, BID Beclometasone C 200 ug, BID 22-Feb-2006 08:30 AM Page: 2490 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Serevent C 50 ug, BID Date:11/24/03ISR Number: 4240010-0Report Type:Expedited (15-DaCompany Report #PHFR2003GB04235 Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Haemoglobin Decreased Health Clozaril PS Novartis Sector: Professional Pharma ORAL Date:11/24/03ISR Number: 4240012-4Report Type:Expedited (15-DaCompany Report #PHFR2003GB04135 Age:57 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Antinuclear Antibody Health Clozaril PS Novartis Sector: Positive Professional Pharma ORAL 275mg/day Blood Alkaline Citalopram C ORAL 20 mg, QD Phosphatase Increased Gamma-Glutamyltransferase Increased Hepatic Function Abnormal Hepatic Steatosis Date:11/24/03ISR Number: 4240028-8Report Type:Expedited (15-DaCompany Report #PHNU2003DE03753 Age:61 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other C-Reactive Protein Health Leponex / Clozaril Increased Professional (Clozapine) PS Novartis Sector: Lymphocyte Count Pharma ORAL up to Decreased 100mg/day 44640MIN Neutrophil Count Increased Platelet Count Increased Pleurisy Pyrexia Urinary Tract Infection White Blood Cell Count Increased Date:11/24/03ISR Number: 4240032-XReport Type:Expedited (15-DaCompany Report #PHNR2003AU01525 Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Upper Health Clozaril PS Novartis Sector: Initial or Prolonged Blood Alkaline Professional Pharma ORAL 12.5 - 450 Phosphatase Increased mg/day 254 DAY Blood Bilirubin Increased Clozaril SS Novartis Sector: Cholecystitis Pharma ORAL 12.5 - 200 Neutrophil Count mg/day Increased Thyroxine C Treatment Noncompliance Calcium C White Blood Cell Count Increased 22-Feb-2006 08:30 AM Page: 2491 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/24/03ISR Number: 4240247-0Report Type:Expedited (15-DaCompany Report #CA-ROCHE-351805 Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Transient Ischaemic Tamiflu PS Roche ORAL Attack Divalproex SS UNKNOWN Clozapine SS ORAL Calcium SS Roche UNKNOWN Furosemide SS UNKNOWN Amlodipine SS UNKNOWN Pulmicort SS RESPIRATORY (INHALATION) Ventolin SS UNKNOWN Slow K SS ORAL Asa SS ORAL Ranitidine SS UNKNOWN Date:11/24/03ISR Number: 4240261-5Report Type:Expedited (15-DaCompany Report #AU-ROCHE-351956 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Valium PS Roche UNKNOWN Injury Asphyxiation Clozapine SS UNKNOWN 547 DAY Alcohol SS UNKNOWN THE PATIENT TOOK '4 STUBBIES'. Venlafaxine Hydrochloride C Date:11/24/03ISR Number: 4240395-5Report Type:Expedited (15-DaCompany Report #03-11-1462 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Health Clozapine Tablets - Initial or Prolonged Head Injury Professional Ivax Hypertension Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL ORAL Date:11/24/03ISR Number: 4240397-9Report Type:Expedited (15-DaCompany Report #03-11-1440 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Abuser Health Clozapine Tablets - Initial or Prolonged Schizophrenia Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 600-700 MG QD ORAL Date:11/24/03ISR Number: 4240398-0Report Type:Expedited (15-DaCompany Report #03-11-1458 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Hospitalization - Sepsis Health Initial or Prolonged Urinary Tract Infection Professional 22-Feb-2006 08:30 AM Page: 2492 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Product Role Manufacturer Route Dose Duration Clozapine Tablets - Ivax Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 112.5 - 225 MG ORAL Date:11/24/03ISR Number: 4240400-6Report Type:Expedited (15-DaCompany Report #C2003-3023.01 Age:89 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 25 MG BID, Other ORAL Date:11/24/03ISR Number: 4241243-XReport Type:Expedited (15-DaCompany Report #03P-028-0240354-00 Age:41 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Anticonvulsant Drug Level Foreign Depakene (Valproic Intervention to Decreased Health Acid) PS ORAL 500 MG 3 IN 1 Prevent Permanent Drug Interaction Professional D PER ORAL; Impairment/Damage Grand Mal Convulsion 1000 MG 2 IN 1 D PER ORAL Clozapine SS ORAL 100 MG 1 IN 1 D PER ORAL; 150 MG 1 IN 1 D PER ORAL Eugynon SS ORAL 1 IN 1 D PER ORAL Date:11/24/03ISR Number: 4241311-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12353173 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Abilify PS Otsuka Initial or Prolonged Drug Ineffective Pharmaceutical Company, Ltd. Clozapine SS ORAL Date:11/24/03ISR Number: 4241642-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12420022 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Abilify PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL Clozapine SS Risperdal C Zoloft C 22-Feb-2006 08:30 AM Page: 2493 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/25/03ISR Number: 4240696-0Report Type:Expedited (15-DaCompany Report #PHBS2003SE12816 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - C-Reactive Protein Leponex PS Novartis Sector: Initial or Prolonged Increased Pharma UNKNOWN Confusional State Trombyl C UNKNOWN 75 mg/d Haemoglobin Decreased Salures C UNKNOWN 2.5 mg/d Heart Rate Increased Furosemide C UNKNOWN 40 mg/d Po2 Decreased Zocord C UNKNOWN 20 mg/d Pyrexia Plendil C UNKNOWN 10 mg/d Respiration Abnormal Atacand C UNKNOWN 24 mg/d Sinus Tachycardia Ergenyl - Slow Release C UNKNOWN 1200 mg/d Temesta C UNKNOWN 1.5 mg/d Trandate C UNKNOWN 100 mg/d Theralen C ORAL 1 to 1.5 ml/d Date:11/25/03ISR Number: 4240783-7Report Type:Expedited (15-DaCompany Report #PHFR2003GB03183 Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Potassium Decreased Clozaril PS Novartis Sector: Drug Level Increased Pharma ORAL 500mg/day Hypoventilation Omeprazole C ORAL 20mg/day Respiratory Arrest Simvastatin C ORAL 10mg/day Respiratory Rate Gliclazide C ORAL 80mg/day Increased Bendrofluazide C ORAL 2.5mg/day Tachycardia Metformin C ORAL 1500mg/day Sando K C ORAL 2/DAY Date:11/25/03ISR Number: 4240795-3Report Type:Expedited (15-DaCompany Report #PHNR2003AU01308 Age:49 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bundle Branch Block Clozaril PS Novartis Sector: Initial or Prolonged Electrocardiogram St Pharma ORAL 150 - 300 Other Segment Abnormal mg/day 33120MIN Electrocardiogram T Wave Inversion Emphysema Fatigue Influenza Like Illness Leukocytosis Myocarditis Neutrophilia Palpitations Pneumonitis Pyrexia Tachycardia Date:11/25/03ISR Number: 4240797-7Report Type:Expedited (15-DaCompany Report #PHFR2003GB04426 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Renal Failure Clozaril PS Novartis Sector: Initial or Prolonged Pharma ORAL 1272 DAY 22-Feb-2006 08:30 AM Page: 2494 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/25/03ISR Number: 4240812-0Report Type:Expedited (15-DaCompany Report #PHNU2003DE02103 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Vitreous Opacities Leponex / Clozaril (Clozapine) PS Novartis Sector: Pharma ORAL 100mg/day Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL up to 400mg/day Date:11/25/03ISR Number: 4240876-4Report Type:Expedited (15-DaCompany Report #PHFR2003GB04420 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Clozaril PS Novartis Sector: Drop Attacks Pharma ORAL 350mg/day Myoclonus Tachycardia Date:11/25/03ISR Number: 4240985-XReport Type:Expedited (15-DaCompany Report #PHNR2003AU01617 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abnormal Behaviour Clozaril PS Novartis Sector: Other Death Pharma ORAL UNK, UNK Fall Valproate Sodium C ORAL 1000 mg, BID Gait Disturbance Oxybutynin C ORAL 15 mg, BID Date:11/25/03ISR Number: 4241081-8Report Type:Expedited (15-DaCompany Report #PHFR2003GB04444 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anorexia Clozaril PS Novartis Sector: Blood Glucose Increased Pharma ORAL 600mg/day Confusional State Diabetes Mellitus Nausea Date:11/25/03ISR Number: 4241085-5Report Type:Expedited (15-DaCompany Report #PHFR2003IE03598 Age:55 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Adverse Drug Reaction Clozaril PS Novartis Sector: Initial or Prolonged Encephalitis Viral Pharma ORAL 12.5mg/day 2880 MIN Lower Respiratory Tract Quetiapine C ORAL 500mg/day Infection Haloperidol C ORAL 5 mg, QD Pneumonia Procyclidine C ORAL 5mg/mane/day Edronax C ORAL 6mg/day Clopixol (Decanoate) C INTRAMUSCULAR UNK, UNK 351 DAY 22-Feb-2006 08:30 AM Page: 2495 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/25/03ISR Number: 4241086-7Report Type:Expedited (15-DaCompany Report #PHHO2003CA13694 Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Constipation Clozaril (Clozapine) PS Novartis Sector: Initial or Prolonged Enterocolitis Infectious Pharma ORAL Other Pancreatitis Divalproex Sodium C Trazodone C Seroquel C Date:11/26/03ISR Number: 4241953-4Report Type:Expedited (15-DaCompany Report #PHEH2003US09261 Age:49 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukaemia Clozaril PS Novartis Sector: Leukopenia Pharma ORAL 50 mg, QD Zestoretic "Haessle" C Avandia C Abilify /Usa/ C Glynase C Glucophage "Abic" C Date:11/26/03ISR Number: 4243405-4Report Type:Expedited (15-DaCompany Report #2003113870 Age:36 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Akathisia Foreign Zeldox (Capsules) Drug Interaction Health (Ziprasidone) PS ORAL 80 MG (BID), Dyskinesia Professional ORAL Clozapine (Clozapine) SS ORAL 175 MG, ORAL Citalopram SS ORAL 40 MG, ORAL Date:11/28/03ISR Number: 4242565-9Report Type:Expedited (15-DaCompany Report #PHFR2003GB03650 Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Glucose Increased Clozaril PS Novartis Sector: Diabetes Mellitus Pharma ORAL Date:11/28/03ISR Number: 4242582-9Report Type:Expedited (15-DaCompany Report #PHRM2003FR02900 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Acute Respiratory Failure Leponex PS Novartis Sector: Hospitalization - Pulmonary Embolism Pharma ORAL 100 mg/day Initial or Prolonged Previscan C UNKNOWN Trentadil C UNKNOWN Depamide C UNKNOWN Vectarion C UNKNOWN 22-Feb-2006 08:30 AM Page: 2496 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/28/03ISR Number: 4242594-5Report Type:Expedited (15-DaCompany Report #PHNU2003DE03105 Age:53 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Pain Leponex / Clozaril Other Drug Level Above (Clozapine) PS Novartis Sector: Therapeutic Pharma ORAL 250mg/day 27360MIN Gastrointestinal Leponex / Clozaril Haemorrhage (Clozapine) SS Novartis Sector: Haematemesis Pharma ORAL 400mg/day 4320 MIN Mallory-Weiss Syndrome Leponex / Clozaril Nausea (Clozapine) SS Novartis Sector: Resuscitation Pharma ORAL 500mg/day 20160MIN Shock Haemorrhagic Leponex / Clozaril Urinary Incontinence (Clozapine) SS Novartis Sector: Pharma ORAL 25 to 125 mg/day 10080MIN Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL 450mg/day 15840MIN Concor C ORAL 2.5mg/day 208 DAY Amaryl C ORAL 2mg/day 208 DAY Slow Sodium C ORAL 2df/day 69120MIN Diazepam C ORAL 5mg/day 7200 MIN Diazepam C ORAL 3mg/day 8640 MIN Diazepam C ORAL 1mg/day 2880 MIN Bifiteral "Solvay Arzneimittel" C ORAL 23040MIN Sab Simplex C ORAL 45drp/day Diazepam C ORAL 2mg/day 4320 MIN Diazepam C ORAL 4mg/day 5760 MIN Pirenzepine C ORAL 50mg/day 56160MIN Ximovan "Aventis Pharma" I ORAL 7.5mg/day 76320MIN Date:11/28/03ISR Number: 4242598-2Report Type:Expedited (15-DaCompany Report #PHFR2003GB03150 Age:53 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abasia Clozaril PS Novartis Sector: Accidental Exposure Pharma ORAL 1x50mg Gait Disturbance Lithium Carbonate C UNKNOWN Medication Error Carbamazepine C UNKNOWN Overdose Quinine C UNKNOWN Somnolence Phyllocontin C UNKNOWN Date:11/28/03ISR Number: 4242600-8Report Type:Expedited (15-DaCompany Report #PHNU2003DE04104 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Lipase Increased Leponex / Clozaril Pharmaceutical Product (Clozapine) PS Novartis Sector: Complaint Pharma ORAL 100 mg, ONCE/SINGLE 1440 MIN Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL 200mg/day 2880 MIN Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL 50mg-50mg-125 22-Feb-2006 08:30 AM Page: 2497 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report mg/day Clozapin "Neuraxpharm" SS ORAL 200mg/day Clozapin "Neuraxpharm" SS ORAL 50 mg, BID 1440 MIN Tavor C ORAL .5 mg, TID Date:11/28/03ISR Number: 4242606-9Report Type:Expedited (15-DaCompany Report #PHNR2003AU01269 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alveolitis Clozaril PS Novartis Sector: Interstitial Lung Disease Pharma ORAL 12.5 mg, QD Clozaril SS Novartis Sector: Pharma ORAL 150 mg, QD Clozaril SS Novartis Sector: Pharma ORAL 300 mg, QD Clozaril SS Novartis Sector: Pharma ORAL 400 mg, QD Clozaril SS Novartis Sector: Pharma ORAL 600 mg, QD Clozaril SS Novartis Sector: Pharma ORAL 400 mg, QD Clozaril SS Novartis Sector: Pharma ORAL 350 mg, QD Clozaril SS Novartis Sector: Pharma ORAL 400 mg, QD Date:11/28/03ISR Number: 4242738-5Report Type:Expedited (15-DaCompany Report #PHBS2003ZA08670 Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Haemopneumothorax Leponex PS Novartis Sector: Initial or Prolonged Pneumothorax Pharma ORAL 300 mg/d White Blood Cell Count Spirulina C UNKNOWN Decreased Vitamin B C ORAL Herbal Extracts Nos C UNKNOWN Date:11/28/03ISR Number: 4242740-3Report Type:Expedited (15-DaCompany Report #PHNU2003DE04098 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Trileptal PS Novartis Sector: Phosphokinase Increased Pharma ORAL Unknown C-Reactive Protein Leponex / Clozaril Increased (Clozapine) SS ORAL Unknown Leukocytosis Leponex / Clozaril Neuroleptic Malignant (Clozapine) SS ORAL Unknown Syndrome Hypnorex C UNKNOWN Unknown Pyrexia Eunerpan C UNKNOWN Unknown Solian C UNKNOWN Unknown Saroten "Bayer Vital" C UNKNOWN Unknown 22-Feb-2006 08:30 AM Page: 2498 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/28/03ISR Number: 4242749-XReport Type:Expedited (15-DaCompany Report #PHFR2003IE03813 Age:46 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Clozaril PS Novartis Sector: Initial or Prolonged Alanine Aminotransferase Pharma ORAL 300mg/day 30240MIN Other Increased Clozaril SS Novartis Sector: Anorexia Pharma ORAL 100 mg/day Blood Alkaline Chlorpromazine SS Phosphatase Increased Eltroxin "Glaxo" C ORAL 100ug/day Blood Bilirubin Increased Valproate Sodium C UNKNOWN Blood Creatinine Increased Blood Pressure Increased Blood Urea Increased Body Temperature Increased C-Reactive Protein Increased Chills Cholecystitis Confusional State Disorientation Drug Interaction Eosinophil Count Increased Fatigue Gamma-Glutamyltransferase Increased Hepatic Function Abnormal Liver Function Test Abnormal Nausea Serum Ferritin Increased Tachycardia Vomiting White Blood Cell Count Increased Date:11/28/03ISR Number: 4242986-4Report Type:Expedited (15-DaCompany Report #PHRM2003FR02900 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Acute Respiratory Failure Leponex PS Novartis Sector: Hospitalization - Pulmonary Embolism Pharma ORAL 100 mg/day Initial or Prolonged Previscan C UNKNOWN Trentadil C UNKNOWN Depamide C UNKNOWN Vectarion C UNKNOWN Date:11/28/03ISR Number: 4242992-XReport Type:Expedited (15-DaCompany Report #PHNU2003DE04104 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Lipase Increased Leponex / Clozaril (Clozapine) PS Novartis Sector: Pharma ORAL 100 mg, ONCE/SINGLE 1440 MIN Leponex / Clozaril (Clozapine) SS Novartis Sector: 22-Feb-2006 08:30 AM Page: 2499 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pharma ORAL 200mg/day 2880 MIN Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL 50mg-50mg-125 mg/day Clozapin "Neuraxpharm" SS ORAL 200mg/day Clozapin "Neuraxpharm" SS ORAL 50 mg, BID 1440 MIN Tavor C ORAL .5 mg, TID Date:11/29/03ISR Number: 4243160-8Report Type:Expedited (15-DaCompany Report #PHNU2003DE04105 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anuria Leponex / Clozaril Other Areflexia (Clozapine) PS Novartis Sector: Asphyxia Pharma ORAL 300mg/day 1278 DAY Atrial Fibrillation Leponex / Clozaril Brain Oedema (Clozapine) SS Novartis Sector: Brain Stem Auditory Pharma ORAL 400mg/day 2880 MIN Evoked Response Abnormal Leponex / Clozaril Cardiac Arrest (Clozapine) SS Novartis Sector: Cardiac Failure Pharma ORAL 300mg/day 1440 MIN Chronic Obstructive Leponex / Clozaril Pulmonary Disease (Clozapine) SS Novartis Sector: Coma Pharma ORAL 150mg/day 1440 MIN Confusional State Uniphyllin Dizziness "Mundipharma" SS ORAL 400mg/day 5760 MIN Dyspnoea Uniphyllin Gait Disturbance "Mundipharma" SS 200mg/day 1440 MIN Gastric Haemorrhage Verahexal C ORAL 160mg/day 185 DAY Haemodynamic Instability Verahexal C ORAL 80mg/day 1440 MIN Hallucination, Auditory Pulmicort C .2 mg, TID 5760 MIN Hyperventilation Pulmicort C .2 mg, BID 1440 MIN Hypoxic Encephalopathy Infection Posture Abnormal Pulmonary Hypertension Pupil Fixed Resuscitation Somatosensory Evoked Potentials Abnormal Speech Disorder Date:12/01/03ISR Number: 4243513-8Report Type:Expedited (15-DaCompany Report #PHHO2003CA13132 Age:56 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asthenia Clozaril (Clozapine) PS Novartis Sector: Life-Threatening Blood Creatinine Pharma ORAL 225 mg / day 28800MIN Hospitalization - Increased Clozaril (Clozapine) SS Novartis Sector: Initial or Prolonged Blood Potassium Increased Pharma ORAL 25 mg / day Blood Urea Increased Prednisone C Eyelid Disorder Valproic Acid C Nephritis Interstitial Lithium Carbonate C Pyrexia Haldol C Renal Failure Cogentin C Seroquel C Tylenol C 22-Feb-2006 08:30 AM Page: 2500 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Olanzapine C Date:12/01/03ISR Number: 4243670-3Report Type:Expedited (15-DaCompany Report #PHBS2002CA08914 Age:46 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Clozaril PS Novartis Sector: Increased Pharma Dose unknown 391 DAY Aspartate Clozaril SS Novartis Sector: Aminotransferase Pharma ORAL 200 mg/d Increased Celexa C UNKNOWN 20 mg/d Constipation Diabetes Mellitus Non-Insulin-Dependent Hepatic Steatosis Weight Increased Date:12/01/03ISR Number: 4243675-2Report Type:Expedited (15-DaCompany Report #PHFR2003GB03824 Age:59 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Circulatory Collapse Clozaril PS Novartis Sector: Initial or Prolonged Drop Attacks Pharma ORAL 500mg/day 81 DAY Other Eosinophil Count Increased Loss Of Consciousness Transient Ischaemic Attack Date:12/02/03ISR Number: 4243733-2Report Type:Expedited (15-DaCompany Report #PHNU2003DE04106 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Cholesterol Leponex / Clozaril Initial or Prolonged Increased (Clozapine) PS Novartis Sector: Blood Triglycerides Pharma ORAL 12.5mg/day 2880 MIN Increased Leponex / Clozaril Electroencephalogram (Clozapine) SS Novartis Sector: Abnormal Pharma ORAL 25mg/day 7200 MIN Hypertriglyceridaemia Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL 37.5mg/day 15840MIN Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL 50mg/day 15840MIN Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL 62.5mg/day 5760 MIN Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL 50mg/day 2880 MIN Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL 25mg/day 2880 MIN 22-Feb-2006 08:30 AM Page: 2501 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/02/03ISR Number: 4243748-4Report Type:Expedited (15-DaCompany Report #PHNR2003AU01553 Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Facial Palsy Clozaril PS Novartis Sector: Muscle Contractions Pharma ORAL 12.5 - 300 Involuntary mg/day Viral Infection Date:12/02/03ISR Number: 4246074-2Report Type:Expedited (15-DaCompany Report #S03-USA-04794-01 Age:76 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Apnoea Health Levothroid Coma Professional (Levothyroxine Hyperhidrosis Sodium) PS ORAL 0.075 MG ONCE Hypotension PO Medication Error Clozapine SS 50 MG BID Respiratory Distress Prevacid Syncope (Lansoprazole) SS 30 MG ONCE Topamax (Topiramate) SS 125 MG ONCE Profentil SS 2 MG ONCE Vitamin And Mineral Senior SS 1 TABLET ONCE Luvox (Fluvoxamine Maleate) C Haldol C Visken (Pindolol) C Calcium With Vitamin D C Humibid La (Guaifenesin) C Date:12/02/03ISR Number: 4246472-7Report Type:Expedited (15-DaCompany Report #C2003-3060.01 Age:74 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 50 MG QAM AND Other 250 MG Q HS, ORAL Date:12/03/03ISR Number: 4244568-7Report Type:Expedited (15-DaCompany Report #PHHO2003CA14982 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Coma Clozaril PS Novartis Sector: Initial or Prolonged Pharma Date:12/03/03ISR Number: 4244575-4Report Type:Expedited (15-DaCompany Report #PHBS2003CH13218 Age:36 YR Gender:Female I/FU:I Outcome PT Hospitalization - Anaemia Initial or Prolonged Antinuclear Antibody Positive Arthralgia C-Reactive Protein 22-Feb-2006 08:30 AM Page: 2502 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Increased Chills Diarrhoea Disorientation Report Source Product Role Manufacturer Route Dose Duration Drug Interaction Leponex PS Novartis Sector: Drug Level Increased Pharma UNKNOWN 25 mg/d Erythema Leponex SS Novartis Sector: Gait Disturbance Pharma UNKNOWN 300 mg/d Leukocytosis Zinat SS UNKNOWN Liver Function Test Leponex SS Novartis Sector: Abnormal Pharma UNKNOWN 175 mg/d 10080MIN Myalgia Akineton C UNKNOWN 8 mg/d 30240MIN Oedema Peripheral Clopixol (Decanoate) C 40 mg/d Pneumonia Convulex "Byk Pyrexia Gulden" I UNKNOWN 1000 mg/d 30240MIN Rash Shift To The Left Somnolence Systemic Lupus Erythematosus Urinary Incontinence Urticaria Date:12/03/03ISR Number: 4244679-6Report Type:Expedited (15-DaCompany Report #PHEH2003US08492 Age:64 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Respiratory Clozaril PS Novartis Sector: Hospitalization - Distress Syndrome Pharma ORAL 50 mg/day 7200 MIN Initial or Prolonged Dyspnoea Clozaril SS Novartis Sector: Intestinal Obstruction Pharma ORAL 75 mg/day 11520MIN Pneumonia Clozaril SS Novartis Sector: Pharma ORAL 100 mg/day 4320 MIN Clozaril SS Novartis Sector: Pharma ORAL 150 mg/day 14400MIN Clozaril SS Novartis Sector: Pharma ORAL 25 mg/day 7200 MIN Multivitamins C Milk Of Magnesia C Anafranil C Avista C Metamucil "Searle" C Paxil C Seroquel C Depakote C Miralax C Date:12/03/03ISR Number: 4244693-0Report Type:Expedited (15-DaCompany Report #PHBS2003AT13165 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electroencephalogram Clozapine PS Novartis Sector: Abnormal Pharma UNKNOWN 400 mg/d Hypercholesterolaemia Clozapine SS Novartis Sector: Hyperlipidaemia Pharma UNKNOWN 300 mg/d Hypertriglyceridaemia Sertraline SS UNKNOWN 100 mg/d Psychotic Disorder Topiramate SS UNKNOWN 25 mg/d Weight Increased 22-Feb-2006 08:30 AM Page: 2503 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/03/03ISR Number: 4244694-2Report Type:Expedited (15-DaCompany Report #PHNU2003DE02382 Age:56 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bite Leponex / Clozaril Initial or Prolonged Blood Pressure Increased (Clozapine) PS Novartis Sector: Disorientation Pharma ORAL 25 mg/day 1440 MIN Drug Interaction Anafranil SS ORAL 50-175 mg/day 12960MIN Drug Level Below Anafranil SS ORAL 187.5 mg/day 36000MIN Therapeutic Quilonum - Slow Drug Level Increased Release SS ORAL 450 mg/day 2880 MIN Electroencephalogram Quilonum - Slow Abnormal Release SS ORAL 1125 mg/day 4320 MIN Enuresis Quilonum - Slow Epilepsy Release SS ORAL 225 mg/day 1440 MIN Fall Haldol "Janssen" SS ORAL 6-10 mg/day 56160MIN Grand Mal Convulsion Haldol "Janssen" SS ORAL 5 mg/day 11520MIN Hypokinesia Taxilan SS ORAL 50 mg/day 7200 MIN Myoclonus Haldol "Janssen" SS ORAL 2.5 mg/day 2880 MIN Schizoaffective Disorder Haldol "Janssen" SS ORAL 3 mg/day 10080MIN Tongue Biting Haldol "Janssen" SS ORAL 15 mg/day 10080MIN Quilonum - Slow Release SS ORAL 900 mg/day 2880 MIN Quilonum - Slow Release SS ORAL 675 mg/day 1440 MIN Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL 50 mg/day 1440 MIN Anafranil SS 225 mg/day 14400MIN Date:12/03/03ISR Number: 4244724-8Report Type:Expedited (15-DaCompany Report #PHBS2003CH13196 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - C-Reactive Protein Leponex PS Novartis Sector: Initial or Prolonged Increased Pharma UNKNOWN 300 mg/d Drug Level Increased Leponex SS Novartis Sector: Leukocytosis Pharma UNKNOWN 250 mg/d 4320 MIN Mouth Ulceration Leponex SS Novartis Sector: Pericardial Effusion Pharma UNKNOWN 200 mg/d 7200 MIN Pyrexia Leponex SS Novartis Sector: Stomatitis Pharma UNKNOWN 100 mg/d Viral Pericarditis Temesta C UNKNOWN 3 mg/d Date:12/03/03ISR Number: 4245046-1Report Type:Expedited (15-DaCompany Report #PHFR2002GB01619 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Clozaril PS Novartis Sector: Initial or Prolonged Pharma ORAL 750mg/day Procyclidine SS ORAL 15mg/day Procyclidine SS Overdose Chlorpromazine SS ORAL 600mg/day Chlorpromazine SS ORAL Overdose Zuclopenthixol C INTRAMUSCULAR 100mg/day 22-Feb-2006 08:30 AM Page: 2504 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/03/03ISR Number: 4245231-9Report Type:Expedited (15-DaCompany Report #PHFR2003GB03938 Age:80 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiac Failure Clozaril (Clozapine) PS Novartis Sector: Congestive Pharma UNKNOWN 37.5mg/day 17280MIN Chest Pain Frusemide C ORAL 60 mg/day Dry Mouth Aspirine C ORAL 75 mg/day Dyspnoea Lactulose C 10 mg, BID Orthostatic Hypotension Senna C Bisoprolol C Date:12/03/03ISR Number: 4246942-1Report Type:Expedited (15-DaCompany Report #C2003-3044.01 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 200 MG QAM Other AND 300 MG Q HS, ORAL Acetaminophen C Alprazolam C Carvedilol C Lactulose C Magnesium Hydroxide C Megestrol C Multivitamin C Prednisone C Ramipril C Spironolactone C Date:12/03/03ISR Number: 4246964-0Report Type:Expedited (15-DaCompany Report #C2003-2784.01 Age:47 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Other Clozapine Tablets 100 Mg Mylan PS Mylan ORAL 300 MG Q HS, ORAL Lamotrigine C Oxcarbazepine C Valsartan C Date:12/03/03ISR Number: 4246976-7Report Type:Expedited (15-DaCompany Report #2003119689 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Contusion Foreign Sertraline Initial or Prolonged Excoriation Health (Sertraline) PS ORAL 150 Grand Mal Convulsion Professional MG(DAILY), ORAL Clozapine (Clozapine) SS ORAL 250 MG(DAILY), ORAL Oxazepam (Oxazepam) C Metoprolol Tartrate (Metoprolol Tartrate) C Pirenzepine 22-Feb-2006 08:30 AM Page: 2505 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dihydrochloride (Pirenzepine Dihydrochloride) C Esomeprazole (Esomeprazole) C Magnosolv "Asta Medica" (Magnesium Carbonate, Magnesium Oxide) C Date:12/03/03ISR Number: 4247111-1Report Type:Direct Company Report #CTU 207422 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Pneumonia Aspiration Health Clozapine 100mg PS 100MG AM ORAL Intervention to Salivary Hypersecretion Professional Clozapine 25mg SS ORAL 750MG AM Prevent Permanent 50HS ORAL Impairment/Damage Date:12/04/03ISR Number: 4245710-4Report Type:Expedited (15-DaCompany Report #PHBS2003FI07021 Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Distension Clozapine PS Novartis Sector: Abdominal Pain Upper Pharma ORAL 500 mg/d Defaecation Urgency Loperamide SS ORAL 6 mg/d Drug Interaction Drug Level Above Therapeutic Gastroenteritis Gastrointestinal Hypomotility Gastrointestinal Necrosis General Physical Health Deterioration Haematemesis Haematochezia Haemorrhage Liver Disorder Loss Of Consciousness Megacolon Metabolic Acidosis Pneumonia Renal Disorder Shock Date:12/04/03ISR Number: 4245801-8Report Type:Expedited (15-DaCompany Report #PHFR2003GB03935 Age:67 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Clozaril PS Novartis Sector: Initial or Prolonged Kyphosis Pharma ORAL 100mg/day 77760MIN Disability Salivary Hypersecretion Somnolence 22-Feb-2006 08:30 AM Page: 2506 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/04/03ISR Number: 4245802-XReport Type:Expedited (15-DaCompany Report #PHNU2003DE04155 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bundle Branch Block Right Leponex / Clozaril Electrocardiogram Qt (Clozapine) PS Novartis Sector: Corrected Interval Pharma ORAL 400mg/day Electrocardiogram Qt Leponex / Clozaril Prolonged (Clozapine) SS Novartis Sector: Ventricular Extrasystoles Pharma ORAL 600mg/day Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL Dosage unknown Tavor C ORAL Date:12/04/03ISR Number: 4245805-5Report Type:Expedited (15-DaCompany Report #PHEH2003US10891 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Tamponade Clozaril PS Novartis Sector: Initial or Prolonged Chest Pain Pharma ORAL 500 mg, UNK 4596 DAY Drug Effect Decreased Dyspnoea Pericardial Effusion Pericarditis Pleural Effusion Polyserositis Date:12/04/03ISR Number: 4245806-7Report Type:Expedited (15-DaCompany Report #PHFR2003GB02416 Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Clozaril PS Novartis Sector: Initial or Prolonged Body Temperature Pharma ORAL 200mg/day Disability Increased Valproate Sodium C ORAL 600mg/day Other Fatigue Venlafaxine C UNKNOWN Gastroenteritis Viral Lethargy Neutrophil Count Increased Pyrexia Tachycardia White Blood Cell Count Increased Date:12/04/03ISR Number: 4245809-2Report Type:Expedited (15-DaCompany Report #PHFR2003IE03308 Age:39 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Complications Of Maternal Clozaril PS Novartis Sector: Exposure To Therapeutic Pharma ORAL Drugs Seroxat "Ciba-Geigy" C ORAL 10 ml/day Drug Exposure During Pregnancy Gestational Diabetes Pregnancy 22-Feb-2006 08:30 AM Page: 2507 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/04/03ISR Number: 4247375-4Report Type:Direct Company Report #CTU 207503 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Body Temperature Clozapine 100 Mg Hospitalization - Increased (Ivax) PS Ivax ORAL 100 MG PO HS Initial or Prolonged Influenza Like Illness Depakote C Required Nephritis Interstitial Geodon C Intervention to Pharyngolaryngeal Pain Neurontin C Prevent Permanent Red Blood Cells Urine Risperdal C Impairment/Damage Positive Cogentin C Renal Failure Acute White Blood Cell Count Increased White Blood Cells Urine Positive Date:12/05/03ISR Number: 4247395-XReport Type:Direct Company Report #CTU 207593 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Abnormal Behaviour Clozapine PS Ivax ORAL 2 TABS PO HS Intervention to Bradyphrenia Clozapine SS Ivax ORAL 2 TABS PO HS Prevent Permanent Irritability Impairment/Damage Mental Status Changes Pharmaceutical Product Complaint Restlessness Thinking Abnormal Date:12/05/03ISR Number: 4247403-6Report Type:Direct Company Report #CTU 207547 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Convulsion Clozapine 100mg&25 Intervention to Mg PS 125 MG AM 225 Prevent Permanent MG HS Impairment/Damage Fluoxetine SS 10 MG QD Date:12/08/03ISR Number: 4246726-4Report Type:Expedited (15-DaCompany Report #PHFR2003GB04250 Age:52 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other No Adverse Drug Effect Clozaril PS Novartis Sector: Pharma ORAL Date:12/08/03ISR Number: 4246759-8Report Type:Expedited (15-DaCompany Report #PHBS2003US13456 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetic Ketoacidosis Clozapine PS Novartis Sector: Pharma UNKNOWN Sertraline C UNKNOWN Divalproex Sodium C UNKNOWN Fluoxetine /N/A/ C UNKNOWN Methylphenidate C UNKNOWN 22-Feb-2006 08:30 AM Page: 2508 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/08/03ISR Number: 4246760-4Report Type:Expedited (15-DaCompany Report #PHBS2003US13457 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetic Ketoacidosis Clozapine PS Novartis Sector: Pharma UNKNOWN Sertraline C UNKNOWN Divalproex Sodium C UNKNOWN Fluoxetine /N/A/ C UNKNOWN Methylphenidate C UNKNOWN Date:12/08/03ISR Number: 4246766-5Report Type:Expedited (15-DaCompany Report #PHHO2003CA13694 Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cholelithiasis Clozaril (Clozapine) PS Novartis Sector: Initial or Prolonged Constipation Pharma ORAL Other Enterocolitis Infectious Divalproex Sodium C Lipase Increased Trazodone C Neutrophil Count Abnormal Seroquel C Pancreatitis White Blood Cell Count Abnormal Date:12/08/03ISR Number: 4246773-2Report Type:Expedited (15-DaCompany Report #PHBS2003US13458 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetic Ketoacidosis Clozapine PS Novartis Sector: Pharma UNKNOWN Sertraline C UNKNOWN Divalproex Sodium C UNKNOWN Fluoxetine /N/A/ C UNKNOWN Methylphenidate C UNKNOWN Date:12/08/03ISR Number: 4246775-6Report Type:Expedited (15-DaCompany Report #PHFR2003GB04314 Age:67 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Clozaril PS Novartis Sector: Initial or Prolonged Dizziness Pharma ORAL 350mg/day Hip Fracture Clozaril SS Novartis Sector: Orthostatic Hypotension Pharma ORAL Sedation Dothiepin C ORAL 225mg/day Bendrofluazide C ORAL 2.5mg/day Aspirine C ORAL 75mg/day Date:12/08/03ISR Number: 4246778-1Report Type:Expedited (15-DaCompany Report #PHFR2003GB04426 Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Lung Abscess Clozaril PS Novartis Sector: Initial or Prolonged Renal Failure Pharma ORAL 1272 DAY 22-Feb-2006 08:30 AM Page: 2509 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/08/03ISR Number: 4246821-XReport Type:Expedited (15-DaCompany Report #PHFR2003GB04420 Age:37 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Clozaril PS Novartis Sector: Drop Attacks Pharma ORAL 350mg/day Myoclonus Citalopram C UNKNOWN 40mg/day Petit Mal Epilepsy Spasmacol C UNKNOWN Tachycardia Oxybutynin C UNKNOWN Theophylline C UNKNOWN Date:12/08/03ISR Number: 4246826-9Report Type:Expedited (15-DaCompany Report #PHNR2003AU01592 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Catatonia Clozaril PS Novartis Sector: Initial or Prolonged Coma Pharma ORAL 525 mg/day Cough Clozaril SS Novartis Sector: Haemoglobin Decreased Pharma ORAL 13 - 675 Hypoxia mg/day 1088 DAY Malaise Clozaril SS Novartis Sector: Otitis Media Pharma Platelet Count Decreased Clozaril SS Novartis Sector: Pyrexia Pharma ORAL 200 - 250 mg Sinus Disorder nocte Streptococcal Sepsis Tachycardia Date:12/08/03ISR Number: 4247078-6Report Type:Expedited (15-DaCompany Report #PHFR2003GB03289 Age:49 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Congestive Cardiomyopathy Clozaril PS Novartis Sector: Hospitalization - Cough Pharma ORAL Initial or Prolonged Deep Vein Thrombosis Amoxicillin C 500 mg, TID Lethargy Paracetamol C 1 mg, PRN Lower Respiratory Tract Infection Productive Cough Pulmonary Embolism Pyrexia Sputum Test Date:12/08/03ISR Number: 4247079-8Report Type:Expedited (15-DaCompany Report #PHFR2001GB02135 Age:33 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatinine Clozaril PS Novartis Sector: Increased Pharma ORAL 600 mg, QD Renal Impairment Renal Neoplasm Date:12/08/03ISR Number: 4247327-4Report Type:Expedited (15-DaCompany Report #PHNR2003AU01387 Age:53 YR Gender:Male I/FU:F Outcome PT Other Condition Aggravated Ejection Fraction 22-Feb-2006 08:30 AM Page: 2510 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Decreased Electrocardiogram Qt Prolonged Ischaemic Cardiomyopathy Report Source Product Role Manufacturer Route Dose Duration Clozaril PS Novartis Sector: Pharma 325 mg nocte Clozaril SS Novartis Sector: Pharma ORAL 12.5 - 200 mg/day Clozaril SS Novartis Sector: Pharma ORAL 25 mg mane and 50 mg nocte Haloperidol C 2.5 mg, TID Olanzapine C 5 mg mane Imipramine C 5 mg mane Benztropine Mesylate C 2 mg mane Atenolol C 25 mg mane Clopidogrel C 75 mg mane Date:12/08/03ISR Number: 4247333-XReport Type:Expedited (15-DaCompany Report #PHNU2003DE01627 Age:20 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Biopsy Muscle Leponex / Clozaril Deep Vein Thrombosis (Clozapine) PS Novartis Sector: Fasciitis Pharma ORAL 300mg/day Myositis Leponex / Clozaril Pain In Extremity (Clozapine) SS Novartis Sector: Pharma ORAL 150mg/day Date:12/08/03ISR Number: 4247344-4Report Type:Expedited (15-DaCompany Report #PHNU2003DE03313 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Constipation Leponex / Clozaril Initial or Prolonged Immobile (Clozapine) PS Novartis Sector: Pharma ORAL up to 100 mg, TID Date:12/08/03ISR Number: 4247349-3Report Type:Expedited (15-DaCompany Report #PHNU2003DE04176 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Circulatory Collapse Leponex / Clozaril Eosinophilia (Clozapine) PS Novartis Sector: Pyrexia Pharma ORAL up to Urinary Tract Infection 200mg/day 20160MIN Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL up to 150mg/day Fluanxol "Bayer" C UNKNOWN Seroquel /Unk/ C ORAL 22-Feb-2006 08:30 AM Page: 2511 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/08/03ISR Number: 4248462-7Report Type:Expedited (15-DaCompany Report #C2003-3111.01 Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine Tablets 25 Professional Mg Mylan PS ORAL 75 MG, BID, Other ORAL Date:12/08/03ISR Number: 4248755-3Report Type:Expedited (15-DaCompany Report #C2003-2563.01 Age:52 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozapine Tablets Cough Professional 100 Mg Mylan PS ORAL 100 MG Q AM, Loss Of Consciousness Other 300 MG Q HS, Respiratory Arrest ORAL Bupropion Hcl C Divalproex Sodium C Risperidone C Trazadone C Date:12/08/03ISR Number: 4248757-7Report Type:Expedited (15-DaCompany Report #C2003-2428.01 Age:76 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Health Clozapine Tablets 25 Dysphagia Professional Mg Mylan PS ORAL 18.75 MG/DAY, Fall Other ORAL Hip Fracture Carbidopa/Levodopa C Selegiline C Entacapone C Hydroxyzine Pamoate C Meperidine C Date:12/08/03ISR Number: 4249110-2Report Type:Expedited (15-DaCompany Report #C2003.2785.01 Age:81 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 200 MG Q HS, Other ORAL Ceftriaxone Sodium C Divalproex Sodium C Lorazepam C Phenytoin Sodium C Tramadol C Date:12/08/03ISR Number: 4249279-XReport Type:Expedited (15-DaCompany Report #200311162BVD Age:61 YR Gender:Male I/FU:F Outcome PT Other Anaemia Condition Aggravated Conjunctivitis Drug Interaction Drug Level Above Therapeutic Psychotic Disorder 22-Feb-2006 08:30 AM Page: 2512 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tracheobronchitis Report Source Product Role Manufacturer Route Dose Duration Foreign Ciprobay Health (Ciprofloxacin Professional Hydrochloride) PS ORAL 1000 MG, Other TOTAL DAILY, ORAL Leponex (Clozapine) SS Acc C Refobacin C Leponex C Atosil C Tavor C Solian C Eisen C Espumisan C Simethicon C Lactulose C Date:12/08/03ISR Number: 4249434-9Report Type:Expedited (15-DaCompany Report #2003119646 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Dilantin Suspension Initial or Prolonged Mental Disorder Professional (Phenytoin Sodium) PS Clozapine (Clozapine) SS ORAL 725 MG (BID), ORAL Date:12/08/03ISR Number: 4249475-1Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20031104908 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Apnoea Consumer Topamax (Topiramate) Other Blood Pressure Decreased Unspecified PS ORAL 125 MG, IN 1 Cerebrovascular Accident DAY, ORAL Coma Clozapine Hyperhidrosis (Clozapine) Tablets SS ORAL 75 MG , ORAL Medication Error Prevacid Respiratory Distress (Lansoprazole) Unspecified SS 30 MG Albuterol Sulfate (Salbutamol Sulfate) Unspecified SS 2 MG Vitamins With Minerals (Vitamins With Minerals) Unspecified SS Levothroid (Levothyroxine Sodium) Unspecified SS 0.075 MG Humibid (Guaifenesin) C Haldol (Haloperidol) C Luvox (Fluvoxamine Maleate) C Acupril (Quinapril) C Visken (Pindolol) C 22-Feb-2006 08:30 AM Page: 2513 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Calcium With Vitamin D C Date:12/09/03ISR Number: 4247522-4Report Type:Expedited (15-DaCompany Report #PHNR2003AU01656 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Clozaril PS Novartis Sector: Lung Squamous Cell Pharma ORAL 25 - 500 Carcinoma Stage mg/day Unspecified Date:12/09/03ISR Number: 4247531-5Report Type:Expedited (15-DaCompany Report #PHFR2003GB04553 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Accidental Exposure Clozaril PS Novartis Sector: Haematemesis Pharma ORAL 350 mg Heart Rate Increased overdose Somnolence Chlorpromazine C 200 mg/day Nitrazepam C Date:12/09/03ISR Number: 4248621-3Report Type:Expedited (15-DaCompany Report #PHBS2003DE13394 Age:18 MON Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asthenia Clozapine PS Novartis Sector: Hospitalization - Cardiopulmonary Failure Pharma UNKNOWN Initial or Prolonged Dyspnoea Fall Loss Of Consciousness Paralysis Paralytic Gait Poisoning Date:12/10/03ISR Number: 4248889-3Report Type:Expedited (15-DaCompany Report #PHFR2003GB03916 Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Colitis Ulcerative Clozaril PS Novartis Sector: Hospitalization - Intestinal Obstruction Pharma ORAL 300mg/day 38880MIN Initial or Prolonged Lower Respiratory Tract Paroxetine C ORAL 30mg/day Infection Valproate Sodium C ORAL 1500mg/day Procyclidine C ORAL 10mg/day Diazepam C ORAL 10mg/day Senna C ORAL 1 tablet BID Haloperidol C ORAL 12mg/day Date:12/10/03ISR Number: 4249002-9Report Type:Expedited (15-DaCompany Report #PHNU2003DE04106 Age: Gender:Male I/FU:F Outcome PT Hospitalization - Anticholinergic Syndrome Initial or Prolonged Blood Cholesterol Increased Electroencephalogram 22-Feb-2006 08:30 AM Page: 2514 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Abnormal Hypertriglyceridaemia Report Source Product Role Manufacturer Route Dose Duration Health Leponex / Clozaril Professional (Clozapine) PS Novartis Sector: Pharma ORAL 12.5mg/day 2880 MIN Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL 25mg/day 7200 MIN Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL 37.5mg/day 15840MIN Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL 50mg/day 15840MIN Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL 62.5mg/day 5760 MIN Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL 50mg/day 2880 MIN Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL 25mg/day 2880 MIN Date:12/10/03ISR Number: 4249003-0Report Type:Expedited (15-DaCompany Report #PHNR2003AU01315 Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Health Clozaril PS Novartis Sector: Increased Professional Pharma 75 - 100 Drug Level Increased mg/day Eosinophil Count Clopine SS 13 - 200 Increased mg/day Hepatic Steatosis Lymphocyte Count Increased Pharmaceutical Product Complaint White Blood Cell Count Increased Date:12/10/03ISR Number: 4249004-2Report Type:Expedited (15-DaCompany Report #PHNU2003DE04242 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arrhythmia Leponex / Clozaril Initial or Prolonged Overweight (Clozapine) PS Novartis Sector: Other Sinus Tachycardia Pharma ORAL up to Somnolence 600mg/day Beta Blocking Agents C UNKNOWN Date:12/10/03ISR Number: 4249005-4Report Type:Expedited (15-DaCompany Report #PHBS2003IT13638 Age:24 YR Gender:Male I/FU:I Outcome PT Hospitalization - Blood Creatine Initial or Prolonged Phosphokinase Increased 22-Feb-2006 08:30 AM Page: 2515 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Electrocardiogram St Segment Depression Electrocardiogram T Wave Report Source Product Role Manufacturer Route Dose Duration Biphasic Leponex PS Novartis Sector: Myoglobin Blood Increased Pharma ORAL 100 mg/d Date:12/10/03ISR Number: 4250250-2Report Type:Expedited (15-DaCompany Report #03-11-1500 Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Metastatic Neoplasm Health Clozapine PS Ivax Respiratory Arrest Professional Pharmaceuticals, Other Inc. ORAL 100MG QD ORAL Date:12/10/03ISR Number: 4250252-6Report Type:Expedited (15-DaCompany Report #03-12-1504 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delusion Health Clozapine PS Ivax Initial or Prolonged Diabetes Mellitus Professional Pharmaceuticals, Other Inc. ORAL 600MG QD ORAL Date:12/10/03ISR Number: 4250255-1Report Type:Expedited (15-DaCompany Report #03-12-1505 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine PS Ivax Overweight Professional Pharmaceuticals, Other Inc. ORAL 500-600MG QD ORAL Date:12/10/03ISR Number: 4250258-7Report Type:Expedited (15-DaCompany Report #03-12-1502 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Clozapine PS Ivax Hospitalization - Myocardial Infarction Professional Pharmaceuticals, Initial or Prolonged Treatment Noncompliance Other Inc. ORAL 700MG QD ORAL Date:12/10/03ISR Number: 4250260-5Report Type:Expedited (15-DaCompany Report #03-12-1503 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dialysis Health Clozapine PS Ivax Initial or Prolonged Renal Disorder Professional Pharmaceuticals, Other Inc. ORAL 25-700MG QD ORAL Date:12/10/03ISR Number: 4250263-0Report Type:Expedited (15-DaCompany Report #03-12-1501 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pica Health Clozapine PS Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. ORAL 300MG QD ORAL 22-Feb-2006 08:30 AM Page: 2516 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/10/03ISR Number: 4250264-2Report Type:Expedited (15-DaCompany Report #03-11-1417 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pancreatic Carcinoma Health Clozapine PS Ivax Phrmaceuticals, Metastatic Professional Inc. ORAL 100-700MG QD Other ORAL Date:12/10/03ISR Number: 4250265-4Report Type:Expedited (15-DaCompany Report #C2003-3153.01 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS Mylan ORAL 300 MG/DAY, Professional ORAL Other Date:12/10/03ISR Number: 4250562-2Report Type:Expedited (15-DaCompany Report #2003GB03175 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Agranulocytosis Foreign Quetiapine PS Intervention to Health Clozaril SS ORAL 200 MG DAILY Prevent Permanent Professional PO Impairment/Damage Other Valproate Sodium C Droperidol C Lorazepam C Citalopram C Olanzapine C Lithium C Date:12/11/03ISR Number: 4249564-1Report Type:Expedited (15-DaCompany Report #PHBS2003DE13397 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Areflexia Clozapine PS Novartis Sector: Initial or Prolonged Asthenia Pharma UNKNOWN Drug Screen Positive Drug Toxicity Dyspnoea Fall Paralytic Gait Pyrexia Somnolence Date:12/11/03ISR Number: 4249570-7Report Type:Expedited (15-DaCompany Report #PHFR2003GB04245 Age:58 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Health Clozaril PS Novartis Sector: Initial or Prolonged Decreased Activity Professional Pharma ORAL 175mg Enuresis mane/200mg Hemiparesis nocte Hypersomnia Estrogen Nos SS Transient Ischaemic Omega-3 C ORAL Attack Aspirine C ORAL 75mg/day Simvastatin C ORAL 400mg/nocte Hyoscine Hydrobromide C ORAL 300ug/day 22-Feb-2006 08:30 AM Page: 2517 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Oxybutynin C ORAL 5 mg, BID Valproate Sodium C ORAL 500 mg, BID Metformin C ORAL 1 g, TID Gliclazide C ORAL 160 mg, BID Thyroxine C ORAL 100ug/day Vitamin B12 C INTRAMUSCULAR Date:12/11/03ISR Number: 4249811-6Report Type:Expedited (15-DaCompany Report #PHNU2003DE04287 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - C-Reactive Protein Leponex / Clozaril Initial or Prolonged Increased (Clozapine) PS Novartis Sector: Other Fall Pharma ORAL 550mg/day Overdose Leponex / Clozaril Pneumonia (Clozapine) SS Novartis Sector: Pharma ORAL 200mg/day Date:12/11/03ISR Number: 4250309-XReport Type:Direct Company Report #CTU 207891 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neutrophil Count Abnormal Clozapine 100 Mg Ivax PS Ivax ORAL 300 MG HS ORAL Divalproex C Docusate C Haloperidol C Psyllium C Date:12/11/03ISR Number: 4251122-XReport Type:Expedited (15-DaCompany Report #03-12-1527 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Respiratory Arrest Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmacetuicals, Inc. ORAL 25-350MG QD ORAL Date:12/11/03ISR Number: 4251123-1Report Type:Expedited (15-DaCompany Report #03-12-1525 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Aspiration Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL ORAL 22-Feb-2006 08:30 AM Page: 2518 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/12/03ISR Number: 4250328-3Report Type:Expedited (15-DaCompany Report #PHBS2003BR13729 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abscess Health Leponex PS Novartis Sector: Professional Pharma ORAL 6 tablets/d Haldol "Janssen" C UNKNOWN 5 mg/d Date:12/12/03ISR Number: 4250984-XReport Type:Expedited (15-DaCompany Report #PHNU2003DE01863 Age:47 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alpha Hydroxybutyrate Leponex / Clozaril Initial or Prolonged Dehydrogenase Increased (Clozapine) PS Novartis Sector: Apraxia Pharma ORAL Aspartate Leponex / Clozaril Aminotransferase (Clozapine) SS Novartis Sector: Increased Pharma ORAL 5000 mg, Blood Creatine ONCE/SINGLE 1440 MIN Phosphokinase Increased Blood Creatine Phosphokinase Mb Blood Lactate Dehydrogenase Increased Coma Disorientation Disturbance In Attention Fall Foot Fracture Haematoma Intentional Overdose Rhabdomyolysis Suicide Attempt Date:12/12/03ISR Number: 4250991-7Report Type:Expedited (15-DaCompany Report #PHNU2003DE03318 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alveolitis Leponex / Clozaril Pulmonary Fibrosis (Clozapine) PS Novartis Sector: Pharma ORAL 25 mg/day Saroten "Bayer Vital" C Remergil C Tafil C Date:12/12/03ISR Number: 4251594-0Report Type:Expedited (15-DaCompany Report #MK200307-0401-2 Age:56 YR Gender:Female I/FU:F Outcome PT Hospitalization - Blood Pressure Increased Initial or Prolonged Condition Aggravated Drug Interaction Potentiation Fall Grand Mal Convulsion Muscle Contractions Involuntary Myoclonus 22-Feb-2006 08:30 AM Page: 2519 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Schizoaffective Disorder Tic Report Source Product Role Manufacturer Route Dose Duration Foreign Anafranil 25mg Capsules PS 225MG Leponex SS Quilonum Slow Release SS Haldol SS Taxilan SS Date:12/15/03ISR Number: 4251322-9Report Type:Expedited (15-DaCompany Report #PHFR2003GB03610 Age:42 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Glucose Increased Health Clozaril PS Novartis Sector: Diabetes Mellitus Professional Pharma ORAL 350mg/day Date:12/15/03ISR Number: 4251325-4Report Type:Expedited (15-DaCompany Report #PHNR2003AU01624 Age:72 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abasia Clozaril PS Novartis Sector: Influenza Pharma ORAL 12 - 225 mg/day Clozaril SS Novartis Sector: Pharma ORAL 25 - 550 mg/day Clozaril SS Novartis Sector: Pharma ORAL 12.5 - 650 mg/day Coloxyl With Senna C Two bd Macrodantin C 50 mg nocte Epilim C 350 mg, BID Date:12/15/03ISR Number: 4251329-1Report Type:Expedited (15-DaCompany Report #PHFR2003IE03544 Age:39 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Duodenal Ulcer Clozaril PS Novartis Sector: Initial or Prolonged Hiatus Hernia Pharma ORAL 250mg/day Other Gliclazide C ORAL 30mg/day Metformin C ORAL 50 mg, TID Atorvastatin C ORAL 10mg/day Date:12/15/03ISR Number: 4251331-XReport Type:Expedited (15-DaCompany Report #PHHO2003CA14637 Age:48 YR Gender:Female I/FU:F Outcome PT Other Blood Glucose Increased Hyperpyrexia Lethargy Leukocytosis Neutrophil Count Increased Red Blood Cell Count Decreased 22-Feb-2006 08:30 AM Page: 2520 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Viraemia Report Source Product Role Manufacturer Route Dose Duration Clozaril PS Novartis Sector: Pharma 20160MIN Altace C Diabeta C Entrophen C Epival C Lipitor C Neurontin C Premarin C Provera C Risperdal C Date:12/15/03ISR Number: 4251433-8Report Type:Expedited (15-DaCompany Report #PHBS2003NZ13647 Age:37 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypertriglyceridaemia Clozaril PS Novartis Sector: Weight Increased Pharma ORAL 500 mg/d Valproate Sodium C UNKNOWN Date:12/15/03ISR Number: 4252027-0Report Type:Direct Company Report #CTU 208102 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Ineffective Generic Clozaril PS Pharmaceutical Product Complaint Date:12/15/03ISR Number: 4252118-4Report Type:Expedited (15-DaCompany Report #03-12-1545 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Health Clozapine- Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 100-400MG QD ORAL Date:12/15/03ISR Number: 4252122-6Report Type:Expedited (15-DaCompany Report #03-11-1372 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Health Clozapine - Ivax Required Gastric Neoplasm Professional Pharmaceuticals, Intervention to Other Inc. Tablets PS ORAL 350MG QD ORAL Prevent Permanent Chemotherapy Unknown SS Impairment/Damage Date:12/15/03ISR Number: 4252137-8Report Type:Direct Company Report #CTU 208079 Age:33 YR Gender:Male I/FU:I Outcome Life-Threatening Hospitalization - 22-Feb-2006 08:30 AM Page: 2521 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Initial or Prolonged Required Intervention to Prevent Permanent PT Report Source Product Role Manufacturer Route Dose Duration Impairment/Damage Influenza Like Illness Clozapine 100 Mg Nephritis Interstitial (Ivax) PS Ivax ORAL 100 MG PO HS Pharyngolaryngeal Pain Depakote C Renal Failure Acute Geodon C Neurontin C Risperdal C Cogentin C Date:12/15/03ISR Number: 4252163-9Report Type:Expedited (15-DaCompany Report #03-10-1287 Age:68 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aplastic Anaemia Health Clozapine - Ivax Initial or Prolonged Dyspnoea Professional Pharmaceuticals, Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 50MG 4PM ORAL Procrit C Vitamin B12 C Ferrous Sulfate C Prilosec C Aricept C Urecholine C Zocor C Megace C Metformin C Multivitamins C Calcium Carbonate C Vitamin E C Date:12/15/03ISR Number: 4252164-0Report Type:Expedited (15-DaCompany Report #03-11-1477 Age:55 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Multi-Organ Failure Health Clozapine - Ivax Pneumonia Aspiration Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 225-600MG QD ORAL Date:12/15/03ISR Number: 4252169-XReport Type:Expedited (15-DaCompany Report #03-10-1365 Age:54 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine - Ivax Other Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 600MG QD ORAL Chemotherapy C 22-Feb-2006 08:30 AM Page: 2522 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/15/03ISR Number: 4252170-6Report Type:Expedited (15-DaCompany Report #03-12-1542 Age:86 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Renal Failure Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 50-225MG QD ORAL Date:12/15/03ISR Number: 4252252-9Report Type:Expedited (15-DaCompany Report #03-12-1541 Age:74 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - C-Reactive Protein Foreign Clozapine Tablets PS ORAL 25-50MG QD Initial or Prolonged Increased Literature ORAL 20 DAY Cardiomegaly Health Chills Professional Cough Drug Toxicity Lower Respiratory Tract Infection Platelet Count Increased Pleural Effusion Pyrexia Red Blood Cell Sedimentation Rate Increased Date:12/15/03ISR Number: 4253343-9Report Type:Expedited (15-DaCompany Report #C2003-3152.01 Age:88 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 12.5MG HS Other THEN 25MG HS,ORAL Date:12/15/03ISR Number: 4253382-8Report Type:Expedited (15-DaCompany Report #C2003-3161.01 Age:92 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 200MG QD, Other ORAL Clozapine Tablets 25 Mg Mylan SS Mylan ORAL 25MG QD, ORAL Date:12/15/03ISR Number: 4253407-XReport Type:Expedited (15-DaCompany Report #03-12-1551 Age:78 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Renal Failure Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 12.5-62.5MG Q 22-Feb-2006 08:30 AM Page: 2523 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL Date:12/15/03ISR Number: 4253414-7Report Type:Expedited (15-DaCompany Report #03-12-1567 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Health Clozapine - Ivax Initial or Prolonged Coagulopathy Professional Pharmaceuticals, Other Convulsion Inc. Tablets PS Ivax Status Epilepticus Pharmaceuticals,Inc. ORAL 300MG QHS,ORAL Date:12/16/03ISR Number: 4251988-3Report Type:Expedited (15-DaCompany Report #PHNU2003DE03193 Age:54 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Health Leponex / Clozaril Increased Professional (Clozapine) PS Novartis Sector: Aspartate Pharma ORAL Aminotransferase Leponex / Clozaril Increased (Clozapine) SS Novartis Sector: Blood Alkaline Pharma ORAL Phosphatase Increased Cisplatin C 4320 MIN Gamma-Glutamyltransferase 5-Fluorouracil Increased "Biosyn" C 4320 MIN Gastric Cancer Metastases To Peritoneum Date:12/16/03ISR Number: 4252012-9Report Type:Expedited (15-DaCompany Report #PHNU2003DE03194 Age:81 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acarodermatitis Leponex / Clozaril Initial or Prolonged Decubitus Ulcer (Clozapine) PS Novartis Sector: Other Eosinophilia Pharma ORAL 12.5mg/day Escherichia Infection Leponex / Clozaril Excoriation (Clozapine) SS Novartis Sector: Generalised Erythema Pharma ORAL 75mg/day Hypersensitivity Unacid C INTRAVENOUS 1.5 g, TID 4320 MIN Leukocytoclastic Nexium Vasculitis Leukocytosis /Unk/ C UNKNOWN 20 mg, QD 98 DAY Lymphocyte Percentage Tiapride C UNKNOWN Unknown Decreased Pruritus Pseudomonas Infection Rash Rash Macular Rash Papular Rash Vesicular Skin Ulcer Staphylococcal Infection Thrombocythaemia 22-Feb-2006 08:30 AM Page: 2524 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/16/03ISR Number: 4252675-8Report Type:Expedited (15-DaCompany Report #03-12-1566 Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Health Clozapine - Ivax Myocardial Infarction Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 62.5MG QD ORAL Date:12/16/03ISR Number: 4252679-5Report Type:Expedited (15-DaCompany Report #03-12-1547 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Discomfort Health Clozapine - Ivax Initial or Prolonged Bacteraemia Professional Pharmaceuticals, Confusional State Inc. Tablets PS Ivax Dehydration Pharmaceuticals, Diarrhoea Inc. ORAL 200-400MG QD Fall ORAL Grand Mal Convulsion Hepatic Cyst Herpes Zoster Petit Mal Epilepsy Renal Cyst Staphylococcal Infection Date:12/17/03ISR Number: 4253762-0Report Type:Expedited (15-DaCompany Report #03-12-1569 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Clozapine - Iva Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 25-600MG QD ORAL Date:12/17/03ISR Number: 4253764-4Report Type:Expedited (15-DaCompany Report #03-12-1568 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Urine Health Clozapine - Ivax Initial or Prolonged Influenza Like Illness Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 50-175MG QD ORAL Date:12/17/03ISR Number: 4253765-6Report Type:Expedited (15-DaCompany Report #C2003-3173.01 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Circulatory Collapse Health Clozapine Tablets Fall Professional 100 Mg Mylan PS ORAL 100MG Q AM, Mental Status Changes Other 200MG Q PM, Sudden Death 300MG Q HS, ORAL Benztropine C Bupropion Sr C Diphenhydramine C 22-Feb-2006 08:30 AM Page: 2525 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Divalproex Sodium C Levothyroxine Sodium C Lithium C Loratadine C Risperidone C Date:12/17/03ISR Number: 4254638-5Report Type:Expedited (15-DaCompany Report #03-11-1417 Age:46 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pancreatic Carcinoma Health Clozapine - Iva Metastatic Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 150MG ORAL Date:12/18/03ISR Number: 4254299-5Report Type:Direct Company Report #CTU 208405 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diarrhoea Clozapine 100 Mg PS ORAL 100 MG TID Initial or Prolonged Hyperhidrosis ORAL Hypersensitivity Myocarditis Date:12/18/03ISR Number: 4254629-4Report Type:Expedited (15-DaCompany Report #C2003-3172.01 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hepatic Neoplasm Health Clozapine Tablets Malignant Professional 100 Mg Mylan PS ORAL 100MG TID, Pancreatic Carcinoma Other ORAL Clozapine Tablets 25 Mg Mylan SS ORAL 25 MG TID, ORAL Lithium Carbonate C Olanzapine C Date:12/18/03ISR Number: 4254642-7Report Type:Expedited (15-DaCompany Report #03-11-1477 Age:55 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Health Clozapine - Ivax Disease Progression Professional Pharmaceuticals, Dysphagia Other Inc. Tablets PS ORAL 100MG BID Dyspnoea ORAL General Physical Health Neurontin C Deterioration Ativan C Multi-Organ Failure Haldol C Pneumonia Aspiration Benadryl C Restlessness Weight Decreased 22-Feb-2006 08:30 AM Page: 2526 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/18/03ISR Number: 4254646-4Report Type:Expedited (15-DaCompany Report #03-12-1578 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 300-600MG QD ORAL Date:12/18/03ISR Number: 4254648-8Report Type:Expedited (15-DaCompany Report #03-12-1579 Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Aspiration Health Clozapine -Ivax Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 75-300MG QD ORAL Date:12/19/03ISR Number: 4254767-6Report Type:Expedited (15-DaCompany Report #PHBS2003NZ13647 Age:37 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperglycaemia Clozaril PS Novartis Sector: Hypertriglyceridaemia Pharma ORAL 500 mg/d Weight Increased Valproate Sodium C UNKNOWN Date:12/19/03ISR Number: 4254768-8Report Type:Expedited (15-DaCompany Report #PHBS2003NZ13968 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cholelithiasis Clozaril PS Novartis Sector: Gamma-Glutamyltransferase Pharma ORAL 175 mg/d 84 DAY Increased Liver Function Test Abnormal Date:12/19/03ISR Number: 4254771-8Report Type:Expedited (15-DaCompany Report #PHFR2003GB04694 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatitis C Clozaril (Clozapine) PS Novartis Sector: Initial or Prolonged Neutropenia Pharma Date:12/19/03ISR Number: 4254782-2Report Type:Expedited (15-DaCompany Report #PHBS2003CH13872 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Ascites Leponex PS Novartis Sector: Hospitalization - Colon Cancer Pharma UNKNOWN 400 mg/d Initial or Prolonged Leukopenia Seropram C UNKNOWN 40 mg/d Multi-Organ Failure Orfiril "Desitin" C UNKNOWN 1200 mg/d Peritonitis Temesta C UNKNOWN Septic Shock Stilnox C UNKNOWN 22-Feb-2006 08:30 AM Page: 2527 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/19/03ISR Number: 4254783-4Report Type:Expedited (15-DaCompany Report #PHNU2003DE04336 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypercholesterolaemia Leponex / Clozaril Hypertriglyceridaemia (Clozapine) PS Novartis Sector: Lipids Increased Pharma ORAL up to 100mg/day Date:12/19/03ISR Number: 4254789-5Report Type:Expedited (15-DaCompany Report #PHFR2003GB04696 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Clozaril PS Novartis Sector: Body Temperature Pharma ORAL 750mg/day 2024 DAY Decreased Clozaril SS Novartis Sector: Dizziness Pharma ORAL 200 mg, BID 10080MIN Drug Hypersensitivity Hallucination Nausea Orthostatic Hypotension Date:12/19/03ISR Number: 4254791-3Report Type:Expedited (15-DaCompany Report #PHHO2003CA14807 Age:59 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Clozaril PS Novartis Sector: Myocardial Ischaemia Pharma 100 mg QD Sudden Death Date:12/19/03ISR Number: 4254799-8Report Type:Expedited (15-DaCompany Report #PHNR2003AU01461 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Clozaril PS Novartis Sector: Initial or Prolonged Phosphokinase Increased Pharma 12.5 - 200 Drug Withdrawal Syndrome mg/day Rhabdomyolysis Clozaril SS Novartis Sector: Pharma ORAL 25 - 700 mg/day Clonazepam C Date:12/19/03ISR Number: 4254823-2Report Type:Expedited (15-DaCompany Report #PHFR2003GB04444 Age:49 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anorexia Clozaril PS Novartis Sector: Blood Glucose Increased Pharma ORAL 600mg/day Confusional State Diabetes Mellitus Nausea 22-Feb-2006 08:30 AM Page: 2528 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/19/03ISR Number: 4255217-6Report Type:Expedited (15-DaCompany Report #PHRM2003FR03239 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Urethral Dilation Health Leponex PS Novartis Sector: Procedure Professional Pharma ORAL 700 mg, daily Urethral Meatus Stenosis Tranxene C Urethral Stricture Tercian C Urinary Retention Date:12/19/03ISR Number: 4255218-8Report Type:Expedited (15-DaCompany Report #PHEH2003US11249 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Health Clozaril PS Novartis Sector: Initial or Prolonged Gastroenteritis Professional Pharma ORAL 400 mg, TID Other Grand Mal Convulsion Cipro "Bayer" C Hepatic Cyst Pyrexia Rash White Blood Cell Count Increased Date:12/19/03ISR Number: 4255221-8Report Type:Expedited (15-DaCompany Report #PHBS2003BR08645 Age:24 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Upper Consumer Leponex PS Novartis Sector: Asthenia Pharma ORAL 200 mg, QHS Confusional State Leponex SS Novartis Sector: Constipation Pharma ORAL 100 mg, QID Diarrhoea Leponex SS Novartis Sector: Drug Dependence Pharma ORAL 200 mg/d Eye Pain Headache Insomnia Nausea Somnolence Toothache Treatment Noncompliance Vomiting Weight Decreased Date:12/19/03ISR Number: 4255277-2Report Type:Expedited (15-DaCompany Report #PHFR2003GB03699 Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozaril PS Novartis Sector: Other Sudden Death Professional Pharma ORAL Date:12/19/03ISR Number: 4255293-0Report Type:Expedited (15-DaCompany Report #PHBS2003BR13729 Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Wound Abscess Health Leponex PS Novartis Sector: Professional Pharma ORAL 6 tablets/d Haldol "Janssen" C UNKNOWN 5 mg/d 22-Feb-2006 08:30 AM Page: 2529 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/19/03ISR Number: 4255295-4Report Type:Expedited (15-DaCompany Report #PHBS2001NZ04304 Age:74 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - C-Reactive Protein Health Clozaril PS Novartis Sector: Initial or Prolonged Increased Professional Pharma ORAL 25 mg/d Cardiomegaly Clozaril SS Novartis Sector: Chills Pharma ORAL 50 mg/d Cough Clozaril SS Novartis Sector: Malaise Pharma ORAL 37.5 mg/day Pericardial Effusion Temazepam C Pericardial Haemorrhage Valproate Sodium C Pericarditis Lactulose C Ph Body Fluid Increased Paracetamol C Platelet Count Increased Pleural Effusion Polyserositis Pyrexia Red Blood Cell Sedimentation Rate Increased Thrombocythaemia Date:12/19/03ISR Number: 4255297-8Report Type:Expedited (15-DaCompany Report #PHBS2003HR13840 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Cholesterol Health Leponex PS Novartis Sector: Increased Professional Pharma UNKNOWN 200 mg/d 365 DAY Blood Triglycerides Leponex SS Novartis Sector: Increased Pharma UNKNOWN 100 mg/d Body Mass Index Decreased Leponex SS Novartis Sector: Diabetes Mellitus Pharma UNKNOWN 50 mg/d Dry Mouth Diazepam C UNKNOWN 10 mg/d Glycosylated Haemoglobin Diazepam C UNKNOWN 25 mg/d Increased Risperidone C UNKNOWN 2 mg/d Hypercholesterolaemia Risperidone C UNKNOWN 6 mg/d Pollakiuria Weight Decreased Date:12/19/03ISR Number: 4255298-XReport Type:Expedited (15-DaCompany Report #PHBS2003DE13765 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Affect Lability Health Clozapine PS Novartis Sector: Bipolar Disorder Professional Pharma UNKNOWN 150 mg/day Crying Clozapine SS Novartis Sector: Depression Pharma UNKNOWN 25 mg/d Euphoric Mood Carbamazepine C UNKNOWN 427 DAY Fatigue Mania Psychomotor Hyperactivity Date:12/19/03ISR Number: 4255392-3Report Type:Expedited (15-DaCompany Report #C2003-3222.01 Age:61 YR Gender:Female I/FU:I Outcome Death Hospitalization - 22-Feb-2006 08:30 AM Page: 2530 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Initial or Prolonged PT Report Source Product Role Manufacturer Route Dose Duration Acute Respiratory Health Clozapine Tablets Distress Syndrome Professional 100 Mg Mylan PS Mylan ORAL 300MG Q HS Deep Vein Thrombosis Other ORAL Leukopenia Clozapine Tablets 25 Medication Error Mg SS Mylan ORAL 25MG Q HS Multi-Organ Failure ORAL Neutropenia Pneumonia Klebsiella Respiratory Failure Sepsis Date:12/19/03ISR Number: 4255399-6Report Type:Expedited (15-DaCompany Report #C2003-3230.01 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 37.5MG QD Other THEN 50MG QD ORAL Date:12/19/03ISR Number: 4255403-5Report Type:Expedited (15-DaCompany Report #C2003-2874.01 Age:56 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Clozapine Tablets Professional 100mg Mylan PS Mylan ORAL 250MG/DAY Other ORAL Date:12/19/03ISR Number: 4255404-7Report Type:Expedited (15-DaCompany Report #C2003-2826.01 Age:68 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Parkinson'S Disease Health Clozapine Tablets 25 Pneumonia Aspiration Professional Mg Mylan PS Mylan ORAL 25MG Q HS, Other ORAL Extended Phenytoin Sodium C Olmesartan Medoxomil C Quetiapine Fumarate C Temazepam C Date:12/19/03ISR Number: 4255406-0Report Type:Expedited (15-DaCompany Report #C2003-3192.01 Age:73 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Other Clozapine Tablets 25 Mg Mylan PS Mylan ORAL 25MG QHS ORAL Albuterol Sulfate C Carbidopa/Levodopa Er 50/200mg C Docusate Sodium C Donepezil Hcl 5mg C Gabapentin 300 Mg C Lorazepam C 22-Feb-2006 08:30 AM Page: 2531 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Morphine Sulfate C Multivitamins C Nitroglycerin Transdermal System C Zinc Sulfate C Date:12/19/03ISR Number: 4255407-2Report Type:Expedited (15-DaCompany Report #C2003-3191.01 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hepatic Neoplasm Health Clozapine Tablets Malignant Professional 100 Mg Mylan PS Mylan ORAL 200MG Q HS Other ORAL Date:12/19/03ISR Number: 4255497-7Report Type:Expedited (15-DaCompany Report #PHEH2003US11271 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Clozaril PS Novartis Sector: Pharma ORAL 1400 mg, QD Date:12/19/03ISR Number: 4255822-7Report Type:Direct Company Report #CTU 208485 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cholelithiasis Clozapine Ivax PS Ivax ORAL 150 MG PO HS Hospitalization - Hepatotoxicity Haldol C Initial or Prolonged Jaundice Synthroid C Lithium C Ativan C Tylenol C Date:12/22/03ISR Number: 4255700-3Report Type:Expedited (15-DaCompany Report #PHBS2003NZ13864 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cellulitis Health Leponex PS Novartis Sector: Initial or Prolonged Deep Vein Thrombosis Professional Pharma ORAL 400 mg/d Platelet Count Increased Warfarin C UNKNOWN Pulmonary Embolism Date:12/22/03ISR Number: 4256157-9Report Type:Expedited (15-DaCompany Report #PHFR2003GB04812 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Clozaril (Clozapine) PS Novartis Sector: Initial or Prolonged Confusional State Pharma Hypertension Clozaril (Clozapine) SS Novartis Sector: Medication Error Pharma 600mg Tachycardia Overdose 22-Feb-2006 08:30 AM Page: 2532 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/22/03ISR Number: 4256162-2Report Type:Expedited (15-DaCompany Report #PHNR2003AU01671 Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthma Clozaril PS Novartis Sector: Bronchospasm Pharma ORAL 12.5 - Eosinophilia 200mg/day 24480MIN Hypersensitivity Clozaril SS Novartis Sector: Pharma ORAL 25 - 375 mg/day Amisulpride C Valproate Sodium C Lithium C Topiramate C Date:12/22/03ISR Number: 4256163-4Report Type:Expedited (15-DaCompany Report #PHFR2003GB04395 Age:55 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Constipation Health Clozaril PS Novartis Sector: Diabetes Mellitus Professional Pharma ORAL 300mg/day Inadequate Control Lymphocytosis Urinary Incontinence Date:12/22/03ISR Number: 4256289-5Report Type:Expedited (15-DaCompany Report #03-12-1595 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Cancer Health Clozapine-Tablets Professional Ivax Pharmaceuticals, Inc. PS ORAL 125-200MG QD ORAL Date:12/22/03ISR Number: 4256290-1Report Type:Expedited (15-DaCompany Report #03-12-1602 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Post-Traumatic Stress Health Clozapine - Ivax Initial or Prolonged Disorder Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 150MG QD ORAL Date:12/22/03ISR Number: 4256291-3Report Type:Expedited (15-DaCompany Report #03-12-1594 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neoplasm Malignant Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 300-400MG QD ORAL 22-Feb-2006 08:30 AM Page: 2533 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/22/03ISR Number: 4256292-5Report Type:Expedited (15-DaCompany Report #03-12-1598 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 400MG QD ORAL Date:12/22/03ISR Number: 4256293-7Report Type:Expedited (15-DaCompany Report #03-12-1593 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Death Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 37.5MG QD ORAL Date:12/23/03ISR Number: 4256897-1Report Type:Expedited (15-DaCompany Report #PHBS2003NZ14135 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiomegaly Clozaril PS Novartis Sector: Sudden Cardiac Death Pharma ORAL Date:12/23/03ISR Number: 4256900-9Report Type:Expedited (15-DaCompany Report #PHNR2003AU01613 Age:22 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozaril PS Novartis Sector: Constipation Professional Pharma 13 - 650 Salivary Hypersecretion mg/day Sudden Death Date:12/23/03ISR Number: 4256933-2Report Type:Expedited (15-DaCompany Report #PHEH2003US11271 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Disorientation Health Clozaril PS Novartis Sector: Medication Error Professional Pharma ORAL 1400 mg, QD Date:12/23/03ISR Number: 4256942-3Report Type:Expedited (15-DaCompany Report #PHNR2003AU00915 Age:70 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Angina Pectoris Health Clozaril PS Novartis Sector: Back Pain Professional Pharma ORAL 250 mg, QD Cardiac Disorder Duride C Dyslipidaemia Diamicron C 40 mg, QD Electrocardiogram St-T Zocor "Merck" C 20 mg nocte Change Orudis C 200 mg, QD Fall Astrix C 100 mg, QD Hypertension Murelax C 30 mg nocte Hypotension Zoloft C 100 mg nocte Myocardial Ischaemia Anginine C SUBLINGUAL UNK, PRN Sinus Tachycardia Norvasc C 2.5 mg, UNK 1868 DAY 22-Feb-2006 08:30 AM Page: 2534 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/23/03ISR Number: 4257263-5Report Type:Expedited (15-DaCompany Report #WAES 0311CHE00033 Age:54 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Zetia PS Merck & Co., Inc ORAL 8 DAY Initial or Prolonged Phosphokinase Increased Clozapine SS ORAL Other Drug Interaction Fenofibrate SS ORAL 2 YR Myopathy Fluvastatin Sodium SS ORAL 2 YR Rhabdomyolysis Esomeprazole Magnesium C ORAL Metoclopramide Hydrochloride C ORAL Date:12/24/03ISR Number: 4257443-9Report Type:Expedited (15-DaCompany Report #PHBS2003AR14139 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Lapenax PS Novartis Sector: Prolonged Pharma ORAL 150 mg/d Date:12/24/03ISR Number: 4257472-5Report Type:Expedited (15-DaCompany Report #PHFR2003GB04564 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abnormal Behaviour Clozaril (Clozapine) PS Novartis Sector: Drowning Pharma ORAL Treatment Noncompliance Date:12/24/03ISR Number: 4257642-6Report Type:Expedited (15-DaCompany Report #PHHO2003CA13124 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiomyopathy Clozaril PS Novartis Sector: Cholestasis Pharma ORAL 300 mg/day Hepatic Congestion Paxil C ORAL 20 mg/day Hepatitis Lorazepam C 1 mg/day Pleural Adhesion Pulmonary Oedema Spleen Congestion Date:12/24/03ISR Number: 4257744-4Report Type:Expedited (15-DaCompany Report #PHEH2003US11487 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Clozaril PS Novartis Sector: Initial or Prolonged Asthma Pharma ORAL UNK, UNK Chronic Obstructive Pulmonary Disease Dyspnoea Paranoia Date:12/24/03ISR Number: 4257805-XReport Type:Expedited (15-DaCompany Report #PHNU2003DE04098 Age:39 YR Gender:Male I/FU:F Outcome PT Other Blood Creatine Phosphokinase Increased 22-Feb-2006 08:30 AM Page: 2535 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report C-Reactive Protein Increased Chills Report Source Product Role Manufacturer Route Dose Duration Hyperhidrosis Trileptal PS Novartis Sector: Leukocytosis Pharma ORAL 600mg/day Neuroleptic Malignant Leponex / Clozaril Syndrome (Clozapine) SS ORAL up to Pyrexia 400mg/day Hypnorex - Slow Release SS ORAL 1.5df/day Saroten "Bayer Vital" SS ORAL 75mg/day Eunerpan C UNKNOWN Unknown Solian C UNKNOWN Unknown Date:12/24/03ISR Number: 4257807-3Report Type:Expedited (15-DaCompany Report #PHFR2003GB04793 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Exposure Clozaril PS Novartis Sector: Initial or Prolonged Coma Pharma ORAL 500mg/error Other Convulsion Epanutin Loss Of Consciousness Tachycardia /Unk/ C UNKNOWN Antidepressants C UNKNOWN Date:12/24/03ISR Number: 4257809-7Report Type:Expedited (15-DaCompany Report #PHFR2001GB02135 Age:33 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatinine Clozaril PS Novartis Sector: Initial or Prolonged Increased Pharma 12.5mg Other Renal Cell Carcinoma Clozaril SS Novartis Sector: Stage Unspecified Pharma ORAL 600 mg, QD 1922 DAY Date:12/24/03ISR Number: 4257853-XReport Type:Expedited (15-DaCompany Report #PHFR2002GB03631 Age:31 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Triglycerides Clozaril PS Novartis Sector: Increased Pharma ORAL 550mg/day 925 DAY Diabetes Mellitus Valproate Sodium C ORAL 1200mg/day 201 DAY Zopiclone C ORAL 7.5mg/day Ranitidine C ORAL 150mg/day Date:12/24/03ISR Number: 4257861-9Report Type:Expedited (15-DaCompany Report #PHNU2003DE02974 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Leponex / Clozaril Arthropod Bite (Clozapine) PS Novartis Sector: Depressed Mood Pharma ORAL 12.5mg/day Drug Interaction Leponex / Clozaril Erythema (Clozapine) SS Novartis Sector: Psychotic Disorder Pharma ORAL up to 25mg/day Leponex / Clozaril 22-Feb-2006 08:30 AM Page: 2536 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Clozapine) SS Novartis Sector: Pharma ORAL up to 200mg/day Doxycyclin "Stada" SS ORAL 200mg/day 30240MIN Zeldox /Gfr/ C UNKNOWN 20mg/day Date:12/24/03ISR Number: 4257867-XReport Type:Expedited (15-DaCompany Report #PHEH2003US11484 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Lung Neoplasm Malignant Clozaril PS Novartis Sector: Pharma ORAL 350 mg/day 1825 DAY Date:12/24/03ISR Number: 4257869-3Report Type:Expedited (15-DaCompany Report #PHFR2003GB04802 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Ejaculation Failure Clozaril PS Novartis Sector: Erectile Dysfunction Pharma ORAL Infertility Male Date:12/24/03ISR Number: 4257870-XReport Type:Expedited (15-DaCompany Report #PHFR2003GB04030 Age:42 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Haemoglobin Decreased Clozaril PS Novartis Sector: Normochromic Normocytic Pharma ORAL UNK, UNK Anaemia Olanzapine C ORAL .5 mg, QD4SDO Occult Blood Positive Lamotrigine C ORAL Valproate Sodium C ORAL 200 mg, TID Venlafaxine C ORAL Chlorpromazine C ORAL Aspirine C ORAL Lactulose C ORAL Zuclopenthixol Decanoate C INTRAMUSCULAR Date:12/24/03ISR Number: 4257872-3Report Type:Expedited (15-DaCompany Report #PHFR2003GB04852 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Exposure Clozaril (Clozapine) PS Novartis Sector: Initial or Prolonged Convulsion Pharma 500mg Self-Medication overdose Valproate Sodium C Chlorpromazine C Propanolol C Lansoprazole C Venlafaxine C Senna C Celevac C 22-Feb-2006 08:30 AM Page: 2537 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/24/03ISR Number: 4257874-7Report Type:Expedited (15-DaCompany Report #PHEH2003US11560 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Adrenal Gland Cancer Clozaril PS Novartis Sector: Initial or Prolonged Metastatic Pharma ORAL 400 mg/day Bone Pain Colace C Chest Wall Pain Dilantin C Computerised Tomogram Megace C Abnormal Metamucil "Procter & Contusion Gamble" C Convulsion Coordination Abnormal Craniotomy Fall Hilar Lymphadenopathy Lung Neoplasm Malignant Metastases To Central Nervous System Pyrexia Date:12/24/03ISR Number: 4257875-9Report Type:Expedited (15-DaCompany Report #PHFR2003GB04897 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Haemoglobin Decreased Clozaril PS Novartis Sector: Pharma ORAL 175mg/day Date:12/26/03ISR Number: 4258304-1Report Type:Expedited (15-DaCompany Report #PHBS2003BE14284 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Triglycerides Health Leponex PS Novartis Sector: Increased Professional Pharma ORAL 200 mg, QD Feeling Abnormal Leponex SS Novartis Sector: Ketoacidosis Pharma ORAL 100 mg, BID 101 DAY Pancreatitis Acute Entumine SS ORAL 20 mg/d Entumine SS ORAL 40 mg/d Efexor C 75 mg, BID Loramet C 2 mg/d Pariet C 10 mg/d Nortrilen C 25 mg/d Date:12/26/03ISR Number: 4258381-8Report Type:Expedited (15-DaCompany Report #PHFR2003GB03882 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sperm Count Decreased Health Clozaril PS Novartis Sector: Professional Pharma ORAL 400mg/day Date:12/26/03ISR Number: 4258394-6Report Type:Expedited (15-DaCompany Report #PHNU2003DE04104 Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatic Steatosis Health Leponex / Clozaril Initial or Prolonged Lipase Increased Professional (Clozapine) PS Novartis Sector: Other Renal Cyst Pharma ORAL 100 mg, ONCE/SINGLE 1440 MIN 22-Feb-2006 08:30 AM Page: 2538 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL 200mg/day 2880 MIN Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL 50mg-50mg-125 mg/day Clozapin "Neuraxpharm" SS ORAL 200mg/day Clozapin "Neuraxpharm" SS ORAL 50 mg, BID 1440 MIN Tavor C ORAL .5 mg, TID 36000MIN Date:12/29/03ISR Number: 4261403-1Report Type:Direct Company Report #USP 042013 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Clozaril PS Sandoz TABLET Clozaril SS Sandoz TABLET Date:12/30/03ISR Number: 4259910-0Report Type:Expedited (15-DaCompany Report #PHNR2003AU01380 Age:25 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Clozaril PS Novartis Sector: Initial or Prolonged Blood Albumin Increased Pharma ORAL 12.5 - 300 Blood Alkaline mg/day Phosphatase Increased Nausea Neutrophil Count Increased Protein Total Increased Viral Infection White Blood Cell Count Increased Date:12/30/03ISR Number: 4260460-6Report Type:Expedited (15-DaCompany Report #PHEH2003US10355 Age:44 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Cancer Clozaril PS Novartis Sector: Pharma ORAL UNK, UNK Date:12/30/03ISR Number: 4261694-7Report Type:Expedited (15-DaCompany Report #C2003-3153.01 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Brain Cancer Metastatic Health Clozapine Tablets Metastases To Lung Professional 100 Mg Mylan PS Mylan ORAL 300 MG/DAY, Other ORAL 22-Feb-2006 08:30 AM Page: 2539 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/30/03ISR Number: 4261696-0Report Type:Expedited (15-DaCompany Report #03-12-1611 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 125-300MG QD ORAL Date:12/30/03ISR Number: 4261699-6Report Type:Expedited (15-DaCompany Report #03-11-1387 Age:56 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Gastrointestinal Health Clozapine - Ivax Carcinoma Professional Pharmaceuticals, Neutropenia Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 100MG QD ORAL Sinemet C Requip C Date:12/30/03ISR Number: 4261700-XReport Type:Expedited (15-DaCompany Report #03-12-1609 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Metastases To Stomach Health Clozapine - Ivax Other Oesophageal Carcinoma Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 50-250MG QD ORAL Date:12/30/03ISR Number: 4261706-0Report Type:Expedited (15-DaCompany Report #C2003-3301.01 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 300MG Q HS, Other ORAL Date:12/31/03ISR Number: 4261509-7Report Type:Expedited (15-DaCompany Report #C2003-3285.01 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Chronic Obstructive Health Clozapine Tablets Pulmonary Disease Professional 100 Mg Mylan PS Mylan ORAL 50MG Q AM AND Other 250MG Q HS, ORAL Budesonide C Ceftriaxone C Divalproex Sodium C Famotidine C Quetiapine C 22-Feb-2006 08:30 AM Page: 2540 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/31/03ISR Number: 4261511-5Report Type:Expedited (15-DaCompany Report #03-11-1396 Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Death Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 600MG QD ORAL Risperdal C Depakote C Cogentin C Date:12/31/03ISR Number: 4261515-2Report Type:Expedited (15-DaCompany Report #03-12-1621 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pneumonia Aspiration Health Clozapine Tablets - Professional Ivax Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL ORAL Date:12/31/03ISR Number: 4261518-8Report Type:Expedited (15-DaCompany Report #03-12-1627 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine Tablets - Hospitalization - Professional Ivax Initial or Prolonged Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 125MG QD ORAL Date:12/31/03ISR Number: 4262355-0Report Type:Direct Company Report #CTU 208985 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Ineffective Clozapine PS Pharmaceutical Product Loxitane C Complaint Celexa C Date:12/31/03ISR Number: 4262502-0Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20031104908 Age:76 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Apnoea Consumer Topamax (Topiramate) PS ORAL 125 MG, IN 1 Other Blood Pressure Decreased Health DAY, ORAL Coma Professional Clozapine Hyperhidrosis (Clozapine) Tablets SS ORAL 75 MG, ORAL Medication Error Humibid Respiratory Distress (Guaifenesin) C Haldol (Haloperidol) C Luvox (Fluvoxamine Maleate) C Acupril (Quinapril) C Visken (Pindolol) C 22-Feb-2006 08:30 AM Page: 2541 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Calcium With Vitamin D (Calcium With Vitamin D) C Date:01/02/04ISR Number: 4262239-8Report Type:Expedited (15-DaCompany Report #PHEH2003US11249 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Clozaril PS Novartis Sector: Initial or Prolonged Blood Glucose Increased Pharma ORAL 400 mg, TID Other Confusional State Cipro "Bayer" SS Delusional Disorder, Lipitor C Unspecified Type Singulair Gait Disturbance "Dieckmann" C Gastroenteritis Synthroid C Grand Mal Convulsion Simethicone C Hepatic Cyst Cogentin Oedema Peripheral Pain In Extremity /Unk/ C Petit Mal Epilepsy Postictal State Pyrexia Rash White Blood Cell Count Increased Date:01/02/04ISR Number: 4262242-8Report Type:Expedited (15-DaCompany Report #PHFR2003GB04553 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Exposure Clozaril PS Novartis Sector: Initial or Prolonged Haematemesis Pharma ORAL 350mg Other Heart Rate Increased Overdose Somnolence Chlorpromazine C 200 mg/day Nitrazepam C Date:01/02/04ISR Number: 4262251-9Report Type:Expedited (15-DaCompany Report #PHNR2003AU01719 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Clozaril PS Novartis Sector: Initial or Prolonged Dizziness Pharma ORAL 100 - 600 Other Fall mg/day 232 DAY Hypotension Isosorbide Dinitrate C ORAL Mental Status Changes Clopidogrel C ORAL Reflexes Abnormal Valproate Sodium C ORAL Transient Ischaemic Venlafaxine C ORAL Attack Simvastatin C ORAL Ranitidine C ORAL Date:01/02/04ISR Number: 4262297-0Report Type:Expedited (15-DaCompany Report #PHNU2003DE04484 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Fall Leponex / Clozaril Salivary Hypersecretion (Clozapine) PS Novartis Sector: Weight Increased Pharma ORAL Unknown 22-Feb-2006 08:30 AM Page: 2542 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL 800 mg/day Norvask C ORAL Unknown Tremarit C ORAL Unknown Importal C ORAL Unknown Date:01/02/04ISR Number: 4262301-XReport Type:Expedited (15-DaCompany Report #PHEH2003US11683 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Prostate Cancer Clozaril PS Novartis Sector: Pharma ORAL 375 mg, QD Date:01/02/04ISR Number: 4262392-6Report Type:Expedited (15-DaCompany Report #PHEH2003US11661 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Clozaril PS Novartis Sector: Initial or Prolonged Phosphokinase Increased Pharma ORAL UNK, UNK 17280MIN Cough Trileptal Haematocrit Decreased "Ciba-Geigy" C Myalgia Haldol "Janssen" C Pyrexia Sepsis Tachycardia White Blood Cell Count Decreased Date:01/02/04ISR Number: 4262394-XReport Type:Expedited (15-DaCompany Report #PHBS2003CH14263 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Health Leponex PS Novartis Sector: Initial or Prolonged Rhabdomyolysis Professional Pharma UNKNOWN 225 mg/d Other Lescol Forte SS UNKNOWN 80 mg/d Ezetrol SS UNKNOWN 10 mg/d 11520MIN Lipantil SS 200 mg/d Nexium C UNKNOWN 40 mg/d Paspertin C Date:01/02/04ISR Number: 4263037-1Report Type:Direct Company Report #CTU 209195 Age:24 MON Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Grand Mal Convulsion Clozapine 100 Mg X 3 Intervention to Medication Error Tab , Myers PS Myers ORAL 300 MG PO Prevent Permanent Keflex C Impairment/Damage Multivitamin C Date:01/02/04ISR Number: 4263786-5Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20031205145 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Health Haldol (Haloperidol) Initial or Prolonged Hepatitis Professional Unspecified PS ORAL 2 MG, 1 IN 4 22-Feb-2006 08:30 AM Page: 2543 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report HOUR, ORAL Clozapine (Clozapine) Tablets SS ORAL 625 MG, 1 IN 1 DAY, ORAL Prevacid (Lansoprazole) C Ferrous Suflate (Ferrous Sulfate) C Surpak (Docusate Calcium) C Escitalopram Oxalate (All Other Therapeutic Products) C Date:01/05/04ISR Number: 4263578-7Report Type:Expedited (15-DaCompany Report #PHHO2003CA16210 Age:22 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Conduction Disorder Health Clozaril PS Novartis Sector: Initial or Prolonged Electrocardiogram Qt Professional Pharma ORAL 154 DAY Disability Shortened Olanzapine C Electrocardiogram St Clopixol C Segment Elevation Hypotension Qrs Axis Abnormal Tachycardia Date:01/05/04ISR Number: 4263589-1Report Type:Expedited (15-DaCompany Report #PHFR2003GB04974 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypersensitivity Health Clozaril (Clozapine) PS Novartis Sector: Pyrexia Professional Pharma 12.5mg/day 2880 MIN Date:01/05/04ISR Number: 4264797-6Report Type:Expedited (15-DaCompany Report #C2003-3002.01 Age:72 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 25MG Q AM, Other ORAL Clozapine Tablets 100 Mg Mylan SS Mylan ORAL 100MG Q AM, ORAL Sertraline C Donepezil C Lithium Carbonate C Albuterol Sulfate C Nitroglycerin C Propozyphene Napsulate/Apap C Instant Glucose (Prn) C Losartan C Insulin C Clopidogrel C Isosorbide Mononitrate C 22-Feb-2006 08:30 AM Page: 2544 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pramipexole C Atorvastatin C Metoprolol C Furosemide C Prednisone C Lansoprazole C Ipratropium C Methylcellulose C Date:01/05/04ISR Number: 4264807-6Report Type:Expedited (15-DaCompany Report #03-12-1525 Age:59 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aspiration Health Clozapine Tablets - Initial or Prolonged Loss Of Consciousness Professional Ivax Pneumonia Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 12.5-2500MG QD ORAL Perphenazine C Valproic Acid C Clonazepam C Cogentin C Date:01/05/04ISR Number: 4264809-XReport Type:Expedited (15-DaCompany Report #03-12-1628 Age:89 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Health Clozapine Tablets - Diabetes Mellitus Professional Ivax Non-Insulin-Dependent Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 25-300MG QD ORAL Date:01/06/04ISR Number: 4263843-3Report Type:Expedited (15-DaCompany Report #PHFR2003GB04525 Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Chest Pain Clozaril PS Novartis Sector: Myocardial Infarction Pharma ORAL White Blood Cell Count Increased Date:01/06/04ISR Number: 4263858-5Report Type:Expedited (15-DaCompany Report #PHNU2003DE04106 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anticholinergic Syndrome Health Leponex / Clozaril Initial or Prolonged Blood Cholesterol Professional (Clozapine) PS Novartis Sector: Increased Pharma ORAL 12.5mg/day 2880 MIN Electroencephalogram Leponex / Clozaril Abnormal (Clozapine) SS Novartis Sector: Hypertriglyceridaemia Pharma ORAL 25mg/day 7200 MIN Leponex / Clozaril 22-Feb-2006 08:30 AM Page: 2545 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Clozapine) SS Novartis Sector: Pharma ORAL 37.5mg/day 15840MIN Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL 50mg/day 15840MIN Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL 62.5mg/day 5760 MIN Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL 50mg/day 2880 MIN Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL 25mg/day 2880 MIN Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL 75mg/day Date:01/06/04ISR Number: 4264756-3Report Type:Expedited (15-DaCompany Report #PHEH2003US11404 Age:54 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Clozaril PS Novartis Sector: Other Arteriosclerosis Pharma ORAL 100 mg, QID Bronchopneumonia Prolixin C Hyperphagia Eskalith C Nausea Seroquel Pulmonary Valve Stenosis Vomiting /Unk/ C Gabitril /Sch/ C Paxil C Cogentin /Unk/ C Benadryl "Ache" C Date:01/06/04ISR Number: 4264757-5Report Type:Expedited (15-DaCompany Report #PHBS2003CA10555 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Oxygen Saturation Health Clozaril PS Novartis Sector: Hospitalization - Abnormal Professional Pharma ORAL Initial or Prolonged Respiratory Failure Date:01/06/04ISR Number: 4264759-9Report Type:Expedited (15-DaCompany Report #PHFR2003GB03699 Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozaril PS Novartis Sector: Overdose Professional Pharma ORAL 200mg/day Sudden Death 22-Feb-2006 08:30 AM Page: 2546 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/06/04ISR Number: 4264763-0Report Type:Expedited (15-DaCompany Report #PHEH2003US10424 Age:55 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Cancer Health Clozaril PS Novartis Sector: Fatigue Professional Pharma ORAL 150 mg, QHS Malignant Breast Lump Depakote C Removal Synthroid C Mammogram Abnormal Moban C Needle Biopsy Site Klonopin C Unspecified Abnormal Zantac C Premarin C Date:01/06/04ISR Number: 4264767-8Report Type:Expedited (15-DaCompany Report #PHBS2003DK14547 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Full Blood Count Abnormal Health Leponex PS Novartis Sector: Initial or Prolonged Liver Function Test Professional Pharma ORAL Abnormal Type Iv Hypersensitivity Reaction Date:01/07/04ISR Number: 4265024-6Report Type:Expedited (15-DaCompany Report #PHFR2003GB03882 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sperm Count Decreased Health Clozaril PS Novartis Sector: Professional Pharma ORAL 400mg/day Date:01/07/04ISR Number: 4265849-7Report Type:Expedited (15-DaCompany Report #PHEH2003US11717 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dizziness Clozaril PS Novartis Sector: Initial or Prolonged Drug Toxicity Pharma ORAL UNK,UNK Mental Status Changes Phenytoin SS UNK,UNK Date:01/07/04ISR Number: 4265851-5Report Type:Expedited (15-DaCompany Report #PHBS2003CA14556 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Renal Failure Acute Health Leponex PS Novartis Sector: Initial or Prolonged Professional Pharma ORAL 125 mg/d Other Date:01/07/04ISR Number: 4265887-4Report Type:Expedited (15-DaCompany Report #04-01-0004 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozapine PS Ivax Pharma ORAL 300 MG QD Professional ORAL Other 22-Feb-2006 08:30 AM Page: 2547 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/07/04ISR Number: 4265984-3Report Type:Direct Company Report #CTU 209500 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Clozaril PS 600 Corrected Interval Prolonged Date:01/07/04ISR Number: 4267267-4Report Type:Expedited (15-DaCompany Report #04-01-0008 Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Mass Health Clozapine - Ivax Initial or Prolonged Surgery Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 50-600MG QD ORAL Date:01/07/04ISR Number: 4267269-8Report Type:Expedited (15-DaCompany Report #04-01-0007 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Respiratory Health Clozapine - Ivax Distress Syndrome Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 500-650MG QD ORAL Date:01/08/04ISR Number: 4267078-XReport Type:Expedited (15-DaCompany Report #PHEH2004US00479 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Clozaril PS Novartis Sector: Medication Error Pharma ORAL 1100 mg, QD Clozaril SS Novartis Sector: Pharma ORAL 900 mg, QD Olanzapine C Valproic Acid C Amantadine C Anticholinergics C Date:01/09/04ISR Number: 4268104-4Report Type:Expedited (15-DaCompany Report #PHFR2004GB00456 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Pressure Increased Clozaril PS Novartis Sector: Bundle Branch Block Left Pharma ORAL Dizziness Heart Rate Irregular Myocardial Infarction Overweight Sinus Tachycardia 22-Feb-2006 08:30 AM Page: 2548 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/09/04ISR Number: 4268105-6Report Type:Expedited (15-DaCompany Report #PHNU2004DE00444 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Granulocytopenia Leponex / Clozaril Lymphocytosis (Clozapine) PS Novartis Sector: Pharma ORAL 98 DAY Dipiperon /Gfr/ C Diazepam C Date:01/09/04ISR Number: 4269431-7Report Type:Expedited (15-DaCompany Report #203983 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Lymphocyte Count Foreign Mabthera(Rituximab) Initial or Prolonged Decreased Health Conc For Monocyte Count Increased Professional Mabthera(Rituximab) Neutropenia Other Conc For Infusion PS White Blood Cell Count Clozapine Decreased (Clozapine) SS ORAL ORAL Mopral (Omeprazole) SS 20 MG Zelitrex (Valaciclovir) SS ORAL ORAL Stilnox (Zolpidem Tartrate) SS ORAL ORAL Levothyrox (Levothyroxine Sodium) SS ORAL ORAL Duphalac (Lactulose) C Date:01/12/04ISR Number: 4268714-4Report Type:Expedited (15-DaCompany Report #PHBS2003DK14547 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Laboratory Test Abnormal Health Leponex PS Novartis Sector: Initial or Prolonged Liver Function Test Professional Pharma ORAL Abnormal Date:01/12/04ISR Number: 4268722-3Report Type:Expedited (15-DaCompany Report #PHEH2003US11717 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dizziness Health Clozaril PS Novartis Sector: Initial or Prolonged Drug Toxicity Professional Pharma ORAL UNK,UNK Mental Status Changes Phenytoin SS UNK,UNK Date:01/12/04ISR Number: 4268726-0Report Type:Expedited (15-DaCompany Report #PHBS2004IE00476 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Exposure Clozaril PS Novartis Sector: Initial or Prolonged Medication Error Pharma 500 mg, UNK Other 22-Feb-2006 08:30 AM Page: 2549 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/12/04ISR Number: 4268727-2Report Type:Expedited (15-DaCompany Report #PHEH2004US00479 Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Clozaril PS Novartis Sector: Other Gastric Disorder Pharma ORAL 1100 mg, QD Gastrooesophageal Reflux Clozaril SS Novartis Sector: Disease Pharma ORAL 900 mg, QD Impaired Gastric Emptying Anticholinergics SS Oesophageal Stenosis Olanzapine C Pulmonary Congestion Antihypertensives C Wheezing Prednisone C Albuterol C Symmetrel /Net/ C Valproic Acid C Amantadine C Date:01/12/04ISR Number: 4268731-4Report Type:Expedited (15-DaCompany Report #PHEH2003US09261 Age:49 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bone Marrow Transplant Health Clozaril PS Novartis Sector: Leukaemia Professional Pharma ORAL 50 mg, QD 3793 DAY Zestoretic "Haessle" C Avandia C Abilify /Usa/ C Glynase C Glucophage "Abic" C Date:01/12/04ISR Number: 4268784-3Report Type:Direct Company Report #CTU 209706 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Hypersensitivity Clozaril 25mg Neurotoxicity Novartis PS Novartis ORAL 50MG AM & HS ORAL Date:01/13/04ISR Number: 4269527-XReport Type:Expedited (15-DaCompany Report #PHBS2003CL14566 Age:10 YR Gender:Female I/FU:I Outcome PT Hospitalization - Abasia Initial or Prolonged Accidental Exposure Accidental Overdose Aggression Agitation Confusional State Depressed Level Of Consciousness Disorientation Dysarthria Glasgow Coma Scale Abnormal Hallucination, Visual Hyporeflexia 22-Feb-2006 08:30 AM Page: 2550 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hypothermia Hypotonia Irritability Report Source Product Role Manufacturer Route Dose Duration Miosis Leponex PS Novartis Sector: Respiratory Rate Pharma ORAL Increased Sinus Tachycardia Somnolence Stupor Date:01/13/04ISR Number: 4269528-1Report Type:Expedited (15-DaCompany Report #PHFR2003GB04369 Age:32 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Body Temperature Clozaril PS Novartis Sector: Hospitalization - Increased Pharma ORAL 362 DAY Initial or Prolonged Bronchopneumonia Clozaril SS Novartis Sector: Neutrophil Count Pharma ORAL 500mg/day Decreased Clozaril SS Novartis Sector: Pyrexia Pharma ORAL Rash Vesicular Risperidone C ORAL 2mg/day Varicella Fluoxetine /N/A/ C ORAL 20mg/day Date:01/13/04ISR Number: 4269529-3Report Type:Expedited (15-DaCompany Report #PHFR2003GB04395 Age:55 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Constipation Clozaril PS Novartis Sector: Lymphocytic Leukaemia Pharma ORAL 300mg/day Lymphocytosis Glibenclamide C ORAL 15mg/day Urinary Incontinence Metformin C ORAL 2g/day Perindopril C ORAL 4mg/day Lactulose C ORAL Aspirine C ORAL Date:01/13/04ISR Number: 4269545-1Report Type:Expedited (15-DaCompany Report #PHFR2003GB04340 Age:54 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Clozaril PS Novartis Sector: Inadequate Control Pharma ORAL 2358 DAY Clozaril SS Novartis Sector: Pharma ORAL Date:01/13/04ISR Number: 4269788-7Report Type:Expedited (15-DaCompany Report #04-01-0016 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 200-900MG QD ORAL 22-Feb-2006 08:30 AM Page: 2551 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/13/04ISR Number: 4269789-9Report Type:Expedited (15-DaCompany Report #04-01-0024 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukaemia Health Clozapine - Ivax White Blood Cell Count Professional Pharmaceuticals, Decreased Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 300-550MG QD ORAL Date:01/13/04ISR Number: 4269790-5Report Type:Expedited (15-DaCompany Report #C2003-3172.01 Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hepatic Neoplasm Health Clozapine Tablets Malignant Professional 100 Mg Mylan PS Mylan ORAL 100MG, TID, Pancreatic Carcinoma Other ORAL Clozapine Tablets 25 Mg Mylan SS ORAL 25 MG TID, ORAL Lithium Carbonate C Olanzapine C Date:01/13/04ISR Number: 4269791-7Report Type:Expedited (15-DaCompany Report #C2003-3001.01 Age:86 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dementia Alzheimer'S Type Health Clozapine Tablets 25 General Physical Health Professional Mg Mylan PS Mylan ORAL 12.5MG Q AM Deterioration Other AND 75MG Q PRN, ORAL Acetaminophen C Carbidopa/Levodopa C Ciprofloxacin C Digoxin C Furosemide C Hyoscyamine C Lansoprazole C Levothyroxine Sodium C Lisinopril C Megestrol Acetate C Milk Of Magnesia C Mirtazapine C Morphine Sulfate Oral Concentrate C Date:01/13/04ISR Number: 4269792-9Report Type:Expedited (15-DaCompany Report #C2003-3369-01 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 100MG BID AND Other 200MG Q HS, ORAL 22-Feb-2006 08:30 AM Page: 2552 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/14/04ISR Number: 4269931-XReport Type:Expedited (15-DaCompany Report #PHFR2003GB03699 Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Consumer Clozaril PS Novartis Sector: Overdose Pharma ORAL 200mg/day Sudden Death Date:01/14/04ISR Number: 4269935-7Report Type:Expedited (15-DaCompany Report #PHNR2004AU00450 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Cholesterol Health Clozaril PS Novartis Sector: Initial or Prolonged Increased Professional Pharma 12 - 500 Blood Glucose Increased mg/day Blood Triglycerides Clozaril SS Novartis Sector: Increased Pharma 12 - 600 Feeling Abnormal mg/day Date:01/14/04ISR Number: 4270615-2Report Type:Expedited (15-DaCompany Report #PHFR2002IE03858 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cellulitis Health Clozaril (Clozapine) PS Novartis Sector: Initial or Prolonged Deep Vein Thrombosis Professional Pharma 450mg/day Diabetes Mellitus Clozaril (Clozapine) SS Novartis Sector: Overweight Pharma ORAL 400 mg/day Thrombophlebitis Warfarin C ORAL 14 mg, QD Date:01/14/04ISR Number: 4270635-8Report Type:Expedited (15-DaCompany Report #PHNR2003AU01624 Age:72 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Balance Disorder Health Clozaril PS Novartis Sector: Convulsion Professional Pharma ORAL 12 - 225 Influenza mg/day Clozaril SS Novartis Sector: Pharma ORAL 25 - 550 mg/day Clozaril SS Novartis Sector: Pharma ORAL 12.5 - 650 mg/day Coloxyl With Senna C Two bd Macrodantin C 50 mg nocte Epilim C 350 mg, BID Date:01/14/04ISR Number: 4270878-3Report Type:Expedited (15-DaCompany Report #PHBS2004US00683 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutropenia Health Clozapine PS Novartis Sector: Initial or Prolonged White Blood Cell Count Professional Pharma ORAL 700 mg/d Other Decreased Doxorubicin SS Perphenazine C Citalopram C Cyclophosphamide C Radiotherapy C Lorazepam C 22-Feb-2006 08:30 AM Page: 2553 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Thyroxine C Contraceptives Uns C Date:01/14/04ISR Number: 4271387-8Report Type:Direct Company Report #CTU 210106 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Salivary Hypersecretion Clozapine 100 Mg PS ORAL 200 MG QD Intervention to ORAL Prevent Permanent Impairment/Damage Date:01/14/04ISR Number: 4271388-XReport Type:Direct Company Report #CTU 210105 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Orthostatic Hypotension Clozapine 100 Mg PS ORAL 150 MG QD Intervention to ORAL Prevent Permanent Impairment/Damage Date:01/14/04ISR Number: 4272501-0Report Type:Expedited (15-DaCompany Report #04-01-0026 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Lower Limb Fracture Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 100-900MG QD ORAL Date:01/14/04ISR Number: 4272580-0Report Type:Direct Company Report #CTU 210096 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neutrophil Count Clozapine 25 Mg Ivax PS Ivax ORAL 50 MG QAM Decreased ORAL Clozapine 100mg Ivac SS Ivac ORAL 100 MG HS ORAL Haloperidol C Quetiapine C Docusate C Lactulose C Psyllium C Date:01/14/04ISR Number: 4272592-7Report Type:Direct Company Report #CTU 210070 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutropenia Clozapine PS Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage 22-Feb-2006 08:30 AM Page: 2554 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/15/04ISR Number: 4272682-9Report Type:Expedited (15-DaCompany Report #04-01-0047 Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine - Ivax Hospitalization - Upper Respiratory Tract Professional Pharmaceuticals, Initial or Prolonged Infection Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 400MG QD ORAL Date:01/15/04ISR Number: 4272683-0Report Type:Expedited (15-DaCompany Report #04-01-0046 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 300MG QD ORAL Date:01/15/04ISR Number: 4272685-4Report Type:Expedited (15-DaCompany Report #03-12-1567 Age:23 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Brain Stem Infarction Health Clozapine - Ivax Hospitalization - Cerebrovascular Accident Professional Pharmaceuticals, Initial or Prolonged Coma Inc. Tablets PS Ivax Other Hypercoagulation Pharmaceuticals, Inc ORAL 300MG QD ORAL 1 YR Status Epilepticus Ranitidine 150mg C Date:01/15/04ISR Number: 4272686-6Report Type:Expedited (15-DaCompany Report #03-12-1566 Age:77 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Health Clozapine - Ivax Myocardial Infarction Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc ORAL 12.5 MG QAM ORAL Date:01/15/04ISR Number: 4272687-8Report Type:Expedited (15-DaCompany Report #04-01-0044 Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Haemoptysis Health Clozapine - Ivax Initial or Prolonged Pneumonia Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 12.5 88MG QD ORAL Date:01/15/04ISR Number: 4274176-3Report Type:Expedited (15-DaCompany Report #200410222GDDC Age:21 YR Gender:Female I/FU:I Outcome PT Other Abortion Induced Drug Exposure During 22-Feb-2006 08:30 AM Page: 2555 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pregnancy Fatigue Mood Swings Pregnancy Report Source Product Role Manufacturer Route Dose Duration Other Metronidazole PS Clozapine (Clozaril) SS ORAL 350 MG QD PO Date:01/15/04ISR Number: 4274355-5Report Type:Expedited (15-DaCompany Report #K200400007 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Qt Foreign Kemadrin(Procyclidin Initial or Prolonged Prolonged Health e) Tablet, 5mg PS 5MG, QD Multiple Drug Overdose Professional Diazepam (Diazepam) Somnolence Other 20 Mg SS 20 MG, QD Citalopram (Citalopram ) 60 Mg SS 60 MG, QD Clozapine (Clozapine) 400 Mg SS 400 MG, QD Date:01/16/04ISR Number: 4273156-1Report Type:Expedited (15-DaCompany Report #PHFR2004IE00518 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dizziness Health Clozaril (Clozapine) PS Novartis Sector: Initial or Prolonged Professional Pharma 400mg/day Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL 400mg overdose - treatment break Date:01/16/04ISR Number: 4273161-5Report Type:Expedited (15-DaCompany Report #PHNU2004DE00482 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Obsessive-Compulsive Health Leponex / Clozaril Disorder Professional (Clozapine) PS Novartis Sector: Pharma ORAL 300mg/day Date:01/16/04ISR Number: 4273192-5Report Type:Expedited (15-DaCompany Report #PHFR2004GB00499 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiomegaly Clozaril PS Novartis Sector: Overweight Pharma ORAL 525mg/day Date:01/16/04ISR Number: 4273209-8Report Type:Expedited (15-DaCompany Report #PHFR2003GB04912 Age:41 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cellulitis Clozaril PS Novartis Sector: Other Pharma ORAL 800mg/day 2032 DAY Lithium Carbonate C ORAL 400 mg/day Lactulose C ORAL 20 mg, BID Noriday C ORAL 2 tab/day Bisacodyl C 20 mg/day 22-Feb-2006 08:30 AM Page: 2556 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Diprobase C TOPICAL UNK, BID Betnevate C TOPICAL UNK, TID Date:01/19/04ISR Number: 4273736-3Report Type:Expedited (15-DaCompany Report #PHBS2004CH00714 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Megacolon Health Leponex PS Novartis Sector: Initial or Prolonged Professional Pharma UNKNOWN Fluctine SS UNKNOWN Date:01/19/04ISR Number: 4273739-9Report Type:Expedited (15-DaCompany Report #PHFR2003GB04396 Age:49 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Body Temperature Health Clozaril PS Novartis Sector: Initial or Prolonged Increased Professional Pharma ORAL Confusional State Diabetes Mellitus Non-Insulin-Dependent Disorientation Influenza Like Illness Date:01/19/04ISR Number: 4273742-9Report Type:Expedited (15-DaCompany Report #PHFR2003GB04973 Age:58 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Medication Error Consumer Clozaril PS Novartis Sector: Somnolence Pharma 300 mg Urinary Incontinence overdose 2880 MIN Date:01/19/04ISR Number: 4273745-4Report Type:Expedited (15-DaCompany Report #PHFR2004GB00467 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asthenia Health Clozaril PS Novartis Sector: Hospitalization - Hepatic Encephalopathy Professional Pharma ORAL 1579 DAY Initial or Prolonged Hepatitis Clozaril SS Novartis Sector: Other Pneumonia Pharma ORAL 350mg/day Date:01/20/04ISR Number: 4273828-9Report Type:Expedited (15-DaCompany Report #PHFR2004GB00556 Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Clozaril PS Novartis Sector: Open Wound Pharma ORAL 77760MIN Date:01/20/04ISR Number: 4273829-0Report Type:Expedited (15-DaCompany Report #PHNU2004DE00540 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Leponex / Clozaril (Clozapine) PS Novartis Sector: Pharma ORAL 400 mg/day 22-Feb-2006 08:30 AM Page: 2557 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/20/04ISR Number: 4274644-4Report Type:Expedited (15-DaCompany Report #PHEH2004US00857 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Clozaril PS Novartis Sector: Pharma ORAL 600 mg, QHS Lipitor C Abilify /Usa/ C Date:01/20/04ISR Number: 4274942-4Report Type:Expedited (15-DaCompany Report #04-01-0056 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Lymphoma Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 200-550 MG QD ORAL Date:01/20/04ISR Number: 4274943-6Report Type:Expedited (15-DaCompany Report #03-11-1393 Age:81 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asphyxia Health Clozapine - Ivax Aspiration Professional Pharmaceuticals, Dysphagia Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 37.5-175 MG QD ORAL Date:01/20/04ISR Number: 4274944-8Report Type:Expedited (15-DaCompany Report #04-01-0085 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Influenza Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 550-700 QD ORAL Date:01/20/04ISR Number: 4274945-XReport Type:Expedited (15-DaCompany Report #04-01-0072 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Oesophageal Rupture Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 450 MG QD ORAL 22-Feb-2006 08:30 AM Page: 2558 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/20/04ISR Number: 4274946-1Report Type:Expedited (15-DaCompany Report #C2003-3111.01 Age:72 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 75 MG, BID, Other ORAL Carbidopa/Levodopa C Sertraline C Gabapentin C Trimethobenzamide C Apomorphine C Date:01/20/04ISR Number: 4274947-3Report Type:Expedited (15-DaCompany Report #2004S1000071 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Chronic Obstructive Health Clozapine Tablets Pulmonary Disease Professional 100 Mg Mylan PS Mylan ORAL 100 MG QID, Other ORAL Date:01/20/04ISR Number: 4274949-7Report Type:Expedited (15-DaCompany Report #2004S1000072 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine Tablets Treatment Noncompliance Professional 100 Mg Mylan PS Mylan ORAL 200 MG/DAY, Other ORAL Levofloxacin C Quetiapine Fumerate C Simvastatin C Temazepam C Valsartan C Date:01/20/04ISR Number: 4274950-3Report Type:Expedited (15-DaCompany Report #04-01-0046 Age:49 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine- Ivax P Professional Harmaceuticals, Inc. Other Tablets PS Ivax Pharmaceruticals Inc. ORAL 300 MG QD ORAL Date:01/20/04ISR Number: 4274951-5Report Type:Expedited (15-DaCompany Report #03-11-1413 Age:37 YR Gender:Female I/FU:F Outcome PT Hospitalization - Asthma Initial or Prolonged Bronchitis Other Dehydration Diabetes Mellitus Non-Insulin-Dependent Diarrhoea Dyspnoea Exertional Nasopharyngitis Nausea 22-Feb-2006 08:30 AM Page: 2559 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Oxygen Saturation Decreased Respiratory Rate Report Source Product Role Manufacturer Route Dose Duration Increased Health Clozapine- Ivax Viral Infection Professional Pharmaceuticals, Vomiting Inc. Tablets PS Ivax Pharmaceuticals Inc. ORAL 200 MG ORAL Trazodone C Albuterol Sulfate C Date:01/20/04ISR Number: 4274952-7Report Type:Expedited (15-DaCompany Report #04-01-0058 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bronchial Obstruction Health Clozapine- Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals Inc. ORAL 300-800 MG QD ORAL Date:01/20/04ISR Number: 4274953-9Report Type:Expedited (15-DaCompany Report #04-01-0057 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine -Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 50-150 MG QD ORAL Date:01/20/04ISR Number: 4274954-0Report Type:Expedited (15-DaCompany Report #2004S1000033 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 100 MG BID Other AND 200 MG Q HS, ORAL Date:01/20/04ISR Number: 4274955-2Report Type:Expedited (15-DaCompany Report #2004S1000020 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 6.25 MG QD, Other ORAL Date:01/20/04ISR Number: 4274956-4Report Type:Expedited (15-DaCompany Report #2004S1000019 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Bacterial Health Clozapine Tablets Hospitalization - Pneumonia Viral Professional 100 Mg Mylan PS Mylan ORAL 400 MG Q HS, Initial or Prolonged Other ORAL Azithromycin C 22-Feb-2006 08:30 AM Page: 2560 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Cephalexin C Divalproex Sodium C Fluphenazine (Pm) C Levothyroxine Sodium C Lorazepam (Pm) C Pseudoephedrine (Pm) C Venlafaxine C Date:01/20/04ISR Number: 4276569-7Report Type:Expedited (15-DaCompany Report #CATIE1-0500 Age:37 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthma Study Clozapine Initial or Prolonged Blood Potassium Decreased Health (Clozapine) Other Bronchitis Professional Clozapine Colloidal Condition Aggravated Silicon Dioxide) Dehydration Capsule, 200 Mg PS Diabetes Mellitus Lexapro C Non-Insulin-Dependent Trazodone C Diarrhoea Albuterol C Nausea Respiratory Rate Increased Viral Infection Vomiting Date:01/21/04ISR Number: 4277306-2Report Type:Expedited (15-DaCompany Report #04-01-0060 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ankle Fracture Health Clozapine Tablets - Initial or Prolonged Fall Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 700 MG QD ORAL Date:01/21/04ISR Number: 4277308-6Report Type:Expedited (15-DaCompany Report #04-01-0092 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Health Clozapine Tablets - Hospitalization - Professional Ivax Initial or Prolonged Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL ORAL Date:01/21/04ISR Number: 4277310-4Report Type:Expedited (15-DaCompany Report #03-01-0100 Age:46 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Neoplasm Malignant Health Clozapine Tablets - Hospitalization - Professional Ivax Initial or Prolonged Other Pharmaceuticals, Other Inc. PS Ivax 22-Feb-2006 08:30 AM Page: 2561 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pharmaceuticals, Inc. ORAL 600MG QD ORAL Chemotherapy C Date:01/21/04ISR Number: 4277984-8Report Type:Expedited (15-DaCompany Report #A02200400080 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Health Stilnox (Zolpidem) - Initial or Prolonged Lymphocyte Count Professional Tablet - 10 Mg PS ORAL NI, UNK; ORAL Decreased Levothyrox - Neutropenia (Levothyroxine White Blood Cell Count Sodium) - Tablet - Decreased Unit Dose: Unknown SS ORAL NI UNK; ORAL Zelitrex - (Valaciclovir) - Tablet - 500 Mg SS ORAL NI UNK; ORAL Mabthera - (Rituximab) - Solution - Unit Dose; Unknown SS INTRAVENOUS NI UNK; INTRAVENOUS 73 DAY Mopral - (Meprazole) - Capsule - 20 Mg SS ORAL NI UNK; ORAL (Clozapine) - Unknwon - Unit Dose; Unknown SS ORAL NI UNK, ORAL 146 DAY Doliprane (Paracetamol) C Muxol (Ambroxol Hydrochloride) C Givalex (Hexetidine/Choline Salicylate/Chlorobut anol Hemihydrate) C Duphalac (Lactulose) C Date:01/22/04ISR Number: 4277501-2Report Type:Expedited (15-DaCompany Report #PHFR2003GB04381 Age:33 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Health Clozaril PS Novartis Sector: Initial or Prolonged Epilepsy Professional Pharma ORAL 2175 DAY Other Date:01/22/04ISR Number: 4277503-6Report Type:Expedited (15-DaCompany Report #PHFR2004GB00560 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Obsessive-Compulsive Clozaril PS Novartis Sector: Disorder Pharma ORAL 325mg/day Date:01/22/04ISR Number: 4277504-8Report Type:Expedited (15-DaCompany Report #PHFR2003GB04893 Age:54 YR Gender:Male I/FU:F Outcome PT Other Body Temperature Increased 22-Feb-2006 08:30 AM Page: 2562 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report C-Reactive Protein Increased Cough Report Source Product Role Manufacturer Route Dose Duration Lower Respiratory Tract Clozaril PS Novartis Sector: Infection Pharma ORAL 100 mg, BID Pharyngitis Movicol C ORAL Pharyngolaryngeal Pain Orphenadrine C UNKNOWN 50 mg, TID Red Blood Cell Erythromycin C 500 mg, TID 8640 MIN Sedimentation Rate Benzhexol C ORAL 2 mg, TID 8640 MIN Increased Augmentin Salivary Hypersecretion Tuberculosis /Unk/ C ORAL 625 mg, TID 8640 MIN Date:01/22/04ISR Number: 4277506-1Report Type:Expedited (15-DaCompany Report #PHBS2004CH00714 Age:17 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Health Leponex PS Novartis Sector: Initial or Prolonged Asthenia Professional Pharma UNKNOWN 100 mg/d Other Blood Pressure Leponex SS Novartis Sector: Orthostatic Abnormal Pharma UNKNOWN 300 mg/d Body Temperature Fluctine SS UNKNOWN 20 mg/d 28800MIN Increased Akineton SS UNKNOWN 2 mg/d 10080MIN Diverticulitis Akineton SS UNKNOWN 6 mg/d Dizziness Akineton SS UNKNOWN 30 mg/d Enteritis Fatigue Induration Inflammation Megacolon Muscle Rigidity Orthostatic Hypotension Pharyngolaryngeal Pain Posture Abnormal Somnolence Tachycardia Tongue Discolouration Vomiting Date:01/22/04ISR Number: 4277507-3Report Type:Expedited (15-DaCompany Report #PHFR2003GB03632 Age:29 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Health Clozaril PS Novartis Sector: Electrocardiogram Qt Professional Pharma ORAL 275 mg/day Corrected Interval Valproate Sodium SS 500 mg, BID Prolonged Venlafaxine SS 150 mg, QD Hyperglycaemia Desmopressin C Pain Metformin C 500 mg, TID Pharyngolaryngeal Pain Gliclazide C 80 mg, BID Methylcellulose C Date:01/22/04ISR Number: 4277510-3Report Type:Expedited (15-DaCompany Report #PHFR2004GB00577 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Haemoglobin Decreased Clozaril PS Novartis Sector: Pharma ORAL 22-Feb-2006 08:30 AM Page: 2563 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/22/04ISR Number: 4277511-5Report Type:Expedited (15-DaCompany Report #PHFR2003GB04378 Age:53 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Health Clozaril PS Novartis Sector: Initial or Prolonged Increased Professional Pharma ORAL 350 mg/day 87840MIN Other Blood Alkaline Dothiepin C ORAL Phosphatase Increased Metformin C ORAL Diabetes Mellitus Insulin C Diabetes Mellitus Lactulose C ORAL Inadequate Control Hyoscine C Hyperthermia Liver Function Test Abnormal Malaise Date:01/22/04ISR Number: 4278207-6Report Type:Direct Company Report #CTU 210671 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Clozaril 100 Mg Sandoz PS Sandoz ORAL 500MG PO Date:01/22/04ISR Number: 4278615-3Report Type:Direct Company Report #CTU 210742 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Medication Error Clozapine 100 Mg PS ORAL 300 MG ONCE Initial or Prolonged Mental Status Changes ORAL Required Topiramate 200 Mg SS ORAL 200 MG BID Intervention to ORAL Prevent Permanent Lorazepam C Impairment/Damage Date:01/22/04ISR Number: 4279039-5Report Type:Expedited (15-DaCompany Report #2003119646 Age:53 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Dilantin (Phenytoin Initial or Prolonged Convulsion Professional Sodium) PS Other Clozapine (Clozapine) SS ORAL 725 MG (BID), ORAL Date:01/22/04ISR Number: 4279279-5Report Type:Expedited (15-DaCompany Report #2002069039 Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Foreign Gabapentin Grand Mal Convulsion Health (Gabapentin) PS ORAL 1800 MG Loss Of Consciousness Professional DAILY, ORAL Myoclonic Epilepsy Clozapine Petit Mal Epilepsy (Clozapine) SS ORAL 800 MG, Urinary Incontinence DAILY, ORAL Venlafaxine (Venlafaxine) C Panadine Co (Codeine Phosphate, 22-Feb-2006 08:30 AM Page: 2564 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Paracetamol) C Date:01/23/04ISR Number: 4278336-7Report Type:Expedited (15-DaCompany Report #PHFR2003GB04137 Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aggression Health Clozaril PS Novartis Sector: Other Death Professional Pharma ORAL Diabetes Mellitus Insulin-Dependent Drug Level Decreased Refusal Of Treatment By Patient Date:01/23/04ISR Number: 4279166-2Report Type:Direct Company Report #CTU 210755 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neutrophil Count Clozapine 100 Mg Decreased Ivax PS Ivax ORAL 300 MG PO HS Divalproex Er [Depakote Er] C Docusate Sodium Caps [Colace] C Lithium Carbonate [Lithium Carbonate] C Paroxetine Hcl [Paxil] C Quetiapine Fumarate [Seroquel] C Ranitidine Hcl[Zantac] C Therapeutic Multiple Vitamins [Thera-M Vitamin] C Acetaminophen [Tylenol] C Alum & Mag Hydroxide [Mylanta Ii] C Chloral Hydrate [Chloral Hydrate] C Hydroxyzine Pamoate [Vistaril] C Date:01/26/04ISR Number: 4279936-0Report Type:Expedited (15-DaCompany Report #22801 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abortion Induced Foreign Metronidazole Fatigue Health (Unspecified) Mood Swings Professional (Metronidazole) PS Pregnancy Other Clozaril SS ORAL (1 IN 1 DAY (S)) ORAL 22-Feb-2006 08:30 AM Page: 2565 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/26/04ISR Number: 4280047-9Report Type:Expedited (15-DaCompany Report #04P-151-0247221-00 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Foreign Lipanthyl (Tricor) Initial or Prolonged Myopathy Health (Fenofibrate) PS ORAL 200 MG, 1 IN Required Rhabdomyolysis Professional 1 D, ORAL Intervention to Ezetrol SS 10 MG, 1 IN 1 Prevent Permanent D Impairment/Damage Lescol SS 80 MG, 1 IN 1 D Clozapine SS 80 MG, 1 IN 1 D Esomeprazole C Metoclopramide Hydrochloride C Date:01/26/04ISR Number: 4280194-1Report Type:Expedited (15-DaCompany Report #A200422 Age:49 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Balance Disorder Consumer Geodon (Ziprasidone) PS ORAL 20 MG Initial or Prolonged Dizziness (DAILY), ORAL Dyspepsia Clozapine Fatigue (Clozapine) SS (DAILY) Feeling Hot Metamucil "Procter & Insomnia Gamble" (Glucose Laryngitis Monohydrate, Nasopharyngitis Ispaghula Husk) C Visual Disturbance Vomiting Date:01/27/04ISR Number: 4279252-7Report Type:Expedited (15-DaCompany Report #PHFR2004GB00612 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiomegaly Clozaril PS Novartis Sector: Dyspnoea Pharma ORAL 450 mg/day Glucose Urine Present Myocarditis Overweight Proteinuria Tachycardia Date:01/27/04ISR Number: 4279272-2Report Type:Expedited (15-DaCompany Report #PHFR2003GB04315 Age:21 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Health Clozaril PS Novartis Sector: Professional Pharma ORAL Date:01/27/04ISR Number: 4280362-9Report Type:Expedited (15-DaCompany Report #2004S1000119 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 400 MG/DAY, Other ORAL 22-Feb-2006 08:30 AM Page: 2566 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/27/04ISR Number: 4280376-9Report Type:Expedited (15-DaCompany Report #S04-GER-00153-01 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Foreign Cipramil (Citalopram Hospitalization - Cough Health Hydrobromide) PS ORAL 40 MG QD PO Initial or Prolonged Leukopenia Professional Clozapine SS ORAL 450 MG QD PO Pyrexia Other Date:01/27/04ISR Number: 4280601-4Report Type:Expedited (15-DaCompany Report #2003119646 Age:53 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Dilantin (Phenytoin Initial or Prolonged Psychotic Disorder Professional Sodium) PS Other Clozapine (Clozapine) SS ORAL 725 MG BID ORAL Date:01/28/04ISR Number: 4280588-4Report Type:Expedited (15-DaCompany Report #04-01-0093 Age:83 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 25-37.5MG QD ORAL Date:01/28/04ISR Number: 4280589-6Report Type:Expedited (15-DaCompany Report #04-01-0097 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sleep Apnoea Syndrome Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 900MG QD ORAL Date:01/28/04ISR Number: 4280590-2Report Type:Expedited (15-DaCompany Report #04-01-0107 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Urosepsis Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 25-100MG QD ORAL 22-Feb-2006 08:30 AM Page: 2567 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/29/04ISR Number: 4281242-5Report Type:Expedited (15-DaCompany Report #PHNR2003AU00558 Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Influenza Like Illness Health Clozaril PS Novartis Sector: Initial or Prolonged Sinus Tachycardia Professional Pharma ORAL 50mg mane, Troponin Increased 250mg nocte 21600MIN Date:01/29/04ISR Number: 4281586-7Report Type:Expedited (15-DaCompany Report #PHNU2004DE00617 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Leponex / Clozaril Initial or Prolonged Drug Level Increased (Clozapine) PS Novartis Sector: Other Stupor Pharma ORAL Unknown Upper Respiratory Tract Leponex / Clozaril Infection (Clozapine) SS Novartis Sector: Pharma ORAL Unknown Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL 300mg/day Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL Unknown Doxycycline SS UNKNOWN Unknown Date:01/29/04ISR Number: 4281907-5Report Type:Expedited (15-DaCompany Report #PHBS2003CA00554 Age:27 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Complications Of Maternal Clozaril PS Novartis Sector: Other Exposure To Therapeutic Pharma ORAL Drugs Misoprostol C Hyperglycaemia Nph Insulin C Intra-Uterine Death Humalog C Maternal Drugs Affecting Foetus Date:01/29/04ISR Number: 4281947-6Report Type:Expedited (15-DaCompany Report #PHNU2004DE00454 Age:82 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Haemoglobin Decreased Health Leponex / Clozaril Initial or Prolonged Leukopenia Professional (Clozapine) PS Novartis Sector: Other Pancytopenia Pharma ORAL up to Pneumonia 300mg/day Red Blood Cell Count Zienam SS INTRAVENOUS 3 g/day 7200 MIN Decreased Marcumar C UNKNOWN Unknown Thrombocytopenia Date:01/29/04ISR Number: 4281995-6Report Type:Expedited (15-DaCompany Report #04-01-0117 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Appendicitis Perforated Health Clozapine - Ivax Initial or Prolonged Coma Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, 22-Feb-2006 08:30 AM Page: 2568 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Inc. ORAL 50-300 MG QD ORAL Date:01/29/04ISR Number: 4281996-8Report Type:Expedited (15-DaCompany Report #04-01-0100 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Upper Respiratory Tract Health Clozapine - Ivax Infection Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmacuticals, Inc ORAL 25 MG QD ORAL Date:01/29/04ISR Number: 4281997-XReport Type:Expedited (15-DaCompany Report #04-01-0115 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Other Clozapine - Ivax Pharmaceuticals, Inc. Tablets PS Ivax Pharmacuticals, Inc ORAL 300-375 MG QD ORAL Date:01/29/04ISR Number: 4281998-1Report Type:Expedited (15-DaCompany Report #04-01-0118 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Choking Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc ORAL 100-500 MG QD ORAL Date:01/29/04ISR Number: 4281999-3Report Type:Expedited (15-DaCompany Report #2004S1000144 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death General Physical Health Health Clozapine Tablets 25 Deterioration Professional Mg Mylan PS Mylan ORAL 75 MG QHS, Respiratory Disorder Other ORAL Albuterol C Cephalexin C Fluticasone Propionate/Salmetero l C Xinafoate C Ipratropium Bromide C Metronidazole C Date:01/29/04ISR Number: 4282000-8Report Type:Expedited (15-DaCompany Report #2004S1000145 Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bronchitis Health Clozapine Tablets 25 Nasopharyngitis Professional Mg Mylan PS Mylan ORAL 50 MG, QID, Other ORAL Diabetes Medications C Fluoxetine Hcl C 22-Feb-2006 08:30 AM Page: 2569 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/29/04ISR Number: 4288458-2Report Type:Expedited (15-DaCompany Report #2004S1000132 Age:88 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg Mylan PS ORAL 25MG BID, Other 12.5 QD, ORAL Controlled Release Morphone Sulfate C Docusate Sodium C Donepezil C Enalapril Maleate C Famotidine C Fentanyl Patch C Hydrocodone And Acetaminophen C Instant Release Morphone Sulfate C Lorazepam C Paroxetine C Promethazine C Propranolol C Date:01/30/04ISR Number: 4282228-7Report Type:Expedited (15-DaCompany Report #PHNU2004DE00482 Age:21 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Akathisia Health Leponex / Clozaril Obsessive Thoughts Professional (Clozapine) PS Novartis Sector: Obsessive-Compulsive Pharma ORAL 300mg/day Disorder Date:01/30/04ISR Number: 4282964-2Report Type:Expedited (15-DaCompany Report #PHBS2004NL01210 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Muscle Contractions Leponex PS Novartis Sector: Involuntary Pharma OPHTHALMIC Oxygen Saturation Decreased Sleep Apnoea Syndrome Somnolence Date:01/30/04ISR Number: 4283176-9Report Type:Expedited (15-DaCompany Report #04-01-0046 Age:49 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine Tablets Professional -Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 150 MG BID ORAL Omeprazole C Lithium Carbonate C 22-Feb-2006 08:30 AM Page: 2570 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/30/04ISR Number: 4283177-0Report Type:Expedited (15-DaCompany Report #04-01-0131 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Neoplasm Malignant Health Clozapine Tablets Professional -Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 300 MG QD ORAL Date:01/30/04ISR Number: 4283178-2Report Type:Expedited (15-DaCompany Report #04-01-0129 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Skin Infection Health Clozapine Tablets Initial or Prolonged Professional -Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals ORAL 300-750 MG QD ORAL Date:01/30/04ISR Number: 4283179-4Report Type:Expedited (15-DaCompany Report #03-12-1604 Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bowel Sounds Abnormal Health Clozapine Tablets Initial or Prolonged Confusional State Professional -Ivax Other Disorientation Other Pharmaceuticals, Fall Inc. PS Ivax Nausea Pharmaceuticals, Pneumonia Aspiration Inc. ORAL 25-75 MG QD Vomiting ORAL Elavil SS ORAL 25 MG QHS ORAL Paxil Tablets SS ORAL 20 MG ORAL Stalevo Tablets SS ORAL TID ORAL Date:01/30/04ISR Number: 4283180-0Report Type:Expedited (15-DaCompany Report #04-01-0128 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Influenza Health Clozapine Tablets Professional -Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc ORAL 500 MG QD ORAL Date:02/02/04ISR Number: 4283371-9Report Type:Expedited (15-DaCompany Report #PHBS2004IT01386 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Pancreatic Haemorrhage Leponex PS Novartis Sector: Hospitalization - Pancreatitis Necrotising Pharma ORAL 100 mg, BID Initial or Prolonged Sereupin C UNKNOWN 20 mg/d 2555 DAY Control C UNKNOWN 2.5 mg/d 2555 DAY 22-Feb-2006 08:30 AM Page: 2571 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/03/04ISR Number: 4284029-2Report Type:Expedited (15-DaCompany Report #PHNR2004AU00503 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cataplexy Clozaril PS Novartis Sector: Drug Interaction Pharma 12.5 - 600 Fall mg/day Amisulpride SS 400 mg/day Date:02/03/04ISR Number: 4284717-8Report Type:Expedited (15-DaCompany Report #C2003-3285.01 Age:56 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Chronic Obstructive Health Clozapine Tablets Pulmonary Disease Professional 100 Mg Mylan PS Mylan ORAL 50 MG QAM AND Upper Respiratory Tract Other 250 MGQHS Infection ORAL Budesonide C Ceftriaxone Intravenous C Divalproex Sodium C Famotidine C Quetiapine C Date:02/03/04ISR Number: 4284719-1Report Type:Expedited (15-DaCompany Report #2004S1000159 Age:82 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 25 MG QAM AND Other 12.5 MG Q HS ORAL Carbidopa/Levodopa C Date:02/03/04ISR Number: 4284720-8Report Type:Expedited (15-DaCompany Report #04-01-0150 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dental Treatment Health Clozapine Ivax Initial or Prolonged Endocarditis Professional Pharmaceuticals Inc PS Ivax ORAL 700 MG QD Post Procedural ORAL Complication Clonazepam C Anafranil C Seroquel C Celexa C Date:02/03/04ISR Number: 4284721-XReport Type:Expedited (15-DaCompany Report #04-01-0133 Age:67 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Breast Cancer Metastatic Health Clozapine - Ivax Metastases To Lung Professional Pharmaceuticals Inc- Other Tablets PS Ivax ORAL 500-600 MG QD ORAL 22-Feb-2006 08:30 AM Page: 2572 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/03/04ISR Number: 4284722-1Report Type:Expedited (15-DaCompany Report #04-01-0114 Age:66 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Upper Gastrointestinal Health Clozapine - Ivax Initial or Prolonged Haemorrhage Professional Pharmaceuticals, Other Inc. Tablets PS Ivax ORAL 150-500 MG QD ORAL Date:02/03/04ISR Number: 4284723-3Report Type:Expedited (15-DaCompany Report #04-01-0151 Age:66 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Health Clozapine- Ivax Pneumonia Professional Pharmaceuticals Inc PS Ivax ORAL 350-400 MG QD Other ORAL Date:02/03/04ISR Number: 4284724-5Report Type:Expedited (15-DaCompany Report #03-12-1566 Age:77 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Health Clozapine - Ivax Myocardial Infarction Professional Pharmaceuticals Inc Other Tablets PS Ivax ORAL SEE IMAGE Date:02/03/04ISR Number: 4284725-7Report Type:Expedited (15-DaCompany Report #03-12-1593 Age:79 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Death Health Clozapine - Ivax Cardiac Failure Professional Pharmaceuticals, Congestive Other Inc. Tablets PS Ivax Pharmaceuticals Cerebrovascular Accident Inc ORAL 37.5 MG QD ORAL Digoxin C Cardizem Cd C Synthroid C Aricept C Remeron C Date:02/03/04ISR Number: 4284777-4Report Type:Expedited (15-DaCompany Report #04-01-0170 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Megacolon Foreign Clozapine Tablets PS ORAL 500MG QD ORAL Hospitalization - Procedural Complication Literature Loperamide SS 6MG Initial or Prolonged Health Professional Date:02/03/04ISR Number: 4284820-2Report Type:Direct Company Report #CTU 211426 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neutrophil Count Clozapine 100 Mg Decreased Ivax PS Ivax ORAL 300 MG PO HS Divalproex Er [Depakote Er] C 22-Feb-2006 08:30 AM Page: 2573 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Docusate Sodium (Colace) C Paroxetine Hcl (Paxil) C Quetiapine Fumarate (Seroquel) C Ranitidine Hcl (Zantac) C Therapeutic Multiple Vitamins-Minerals (Thera-M Vitamin) C Acetaminophen (Tylenol) C Alum & Mag Hydroxide-Simeth Susp (Mylanta Ii) C Chloral Hydrate (Chloral Hydrate) C Hydroxyzine Pamoate (Vistaril) C Date:02/03/04ISR Number: 4285727-7Report Type:Direct Company Report #CTU 211467 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pulmonary Embolism Clozapine PS ORAL 100 MG Initial or Prolonged Ortho Evra C Other Seroquel C Cytonel C Levothyroxine C Neurontin C Lamictal C Aspirin C Zoloft C Lithium C Abilify C Date:02/04/04ISR Number: 4284875-5Report Type:Expedited (15-DaCompany Report #PHFR2003GB01609 Age:55 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Chest Pain Clozaril PS Novartis Sector: Other Convulsion Pharma ORAL 375 mg/day Electrocardiogram Abnormal Myocardial Infarction Date:02/04/04ISR Number: 4284880-9Report Type:Expedited (15-DaCompany Report #PHFR2003GB04313 Age:37 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Clozaril PS Novartis Sector: Pharma ORAL 600mg/day Haloperidol C 5 mg, BID Valproate Sodium C 500mg/day Depakote C 1000mg/day Fybogel C Senna C 22-Feb-2006 08:30 AM Page: 2574 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Aspirine C Frusemide C 40mg/day Salmeterol C 2 puffs/day Combivent /Gfr/ C Becotide C Atorvastatin C 20mg/day Apo-Indapamide C Quetiapine C 400mg/day Date:02/04/04ISR Number: 4284944-XReport Type:Expedited (15-DaCompany Report #PHEH2004US01422 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Ankle Fracture Clozaril PS Novartis Sector: Hospitalization - Fall Pharma ORAL 100mg Initial or Prolonged Myocardial Infarction am+300mg hs Nasopharyngitis Depakote C Stool Softener C Date:02/04/04ISR Number: 4285304-8Report Type:Expedited (15-DaCompany Report #PHFR2003IE04327 Age:42 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Health Clozaril PS Novartis Sector: Convulsion Professional Pharma ORAL 250mg/day Dizziness Clozaril SS Novartis Sector: Encephalopathy Pharma ORAL 300mg/day Fall Muscle Spasms Date:02/04/04ISR Number: 4285307-3Report Type:Expedited (15-DaCompany Report #PHFR2003GB03632 Age:29 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Health Clozaril PS Novartis Sector: Electrocardiogram Qt Professional Pharma ORAL 200mg/day Corrected Interval Valproate Sodium SS 500 mg, BID Prolonged Clozaril SS Novartis Sector: Hyperglycaemia Pharma ORAL 275 mg/day Pain Venlafaxine SS 150 mg, QD Pharyngolaryngeal Pain Desmopressin C Metformin C 500 mg, TID Gliclazide C 80 mg, BID Methylcellulose C Date:02/04/04ISR Number: 4285310-3Report Type:Expedited (15-DaCompany Report #PHNU2003DE04336 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypercholesterolaemia Health Leponex / Clozaril Hypertriglyceridaemia Professional (Clozapine) PS Novartis Sector: Pharma ORAL up to 100mg/day 22-Feb-2006 08:30 AM Page: 2575 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/04/04ISR Number: 4285315-2Report Type:Expedited (15-DaCompany Report #PHBS2004CH00714 Age:17 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Health Leponex PS Novartis Sector: Initial or Prolonged Asthenia Professional Pharma UNKNOWN 100 mg/d Other Blood Pressure Leponex SS Novartis Sector: Orthostatic Abnormal Pharma UNKNOWN 300 mg/d Body Temperature Fluctine SS UNKNOWN 20 mg/d 28800MIN Increased Akineton SS UNKNOWN 2 mg/d 10080MIN Diverticulitis Akineton SS UNKNOWN 6 mg/d Dizziness Akineton SS UNKNOWN 30 mg/d Enteritis Megacolon Pharyngolaryngeal Pain Posture Abnormal Somnolence Tachycardia Tongue Discolouration Vomiting Date:02/04/04ISR Number: 4285549-7Report Type:Expedited (15-DaCompany Report #04-01-0153 Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bacterial Infection Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 25-100 MG QD ORAL Date:02/04/04ISR Number: 4286693-0Report Type:Expedited (15-DaCompany Report #2004-112376-NL Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alanine Aminotransferase Mirtazapine PS DF Increased Clozapine SS ORAL DF, ORAL Aspartate Aminotransferase Increased Gamma-Glutamyltransferase Increased Liver Function Test Abnormal Date:02/04/04ISR Number: 4286809-6Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040105486 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukocytosis Health Risperdal Polycythaemia Professional (Risperidone) Unspecified PS ORAL 8 MG, IN 1 DAY, ORAL Clozapine (Clozapine) Tablets SS ORAL 400 MG, 1 IN 1 DAY, ORAL Effexor (Venlafaxine Hydrochloride) SS 150 MG, 1 IN 22-Feb-2006 08:30 AM Page: 2576 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report 1 DAY Benadryl (Diphenhydramine Hydrochloride) C Date:02/05/04ISR Number: 4286179-3Report Type:Expedited (15-DaCompany Report #PHEH2004US01335 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Lymphoma Clozaril PS Novartis Sector: Neutropenia Pharma ORAL 450 mg, QD Osteomyelitis Depakote C Renal Failure Date:02/05/04ISR Number: 4286182-3Report Type:Expedited (15-DaCompany Report #PHBS2003CA00554 Age:27 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Complications Of Maternal Clozaril PS Novartis Sector: Exposure To Therapeutic Pharma ORAL Drugs Misoprostol C Hyperglycaemia Nph Insulin C Humalog C Date:02/05/04ISR Number: 4286574-2Report Type:Expedited (15-DaCompany Report #2004S1000221 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional 25mg Mylan PS Mylan ORAL 62.5 MG QD, Other ORAL Clozapine Tablets 100 Mg Mylan SS Mylan ORAL 100 MG Q HS, ORAL Date:02/05/04ISR Number: 4286575-4Report Type:Expedited (15-DaCompany Report #2004S1000243 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional 25mg Mylan PS Mylan ORAL 75MG/DAY, Other ORAL Clozapine Tablets 100 Mg Mylan SS Mylan ORAL 200 MG/DAY, ORAL Date:02/05/04ISR Number: 4286577-8Report Type:Expedited (15-DaCompany Report #2004S1000209 Age:96 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dementia Alzheimer'S Type Other Clozapine Tablets 25mg Mylan PS Mylan ORAL 25 MG Q AM AND NOON, 50 MG Q HS, ORAL Albuterol C Nitroglycerin C 22-Feb-2006 08:30 AM Page: 2577 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/05/04ISR Number: 4286578-XReport Type:Expedited (15-DaCompany Report #2004S1000205 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine Tablets Professional 100mg Mylan PS Mylan ORAL 200 MG QAM Other AND 400MG QHS, ORAL Risperidone C Date:02/05/04ISR Number: 4286580-8Report Type:Expedited (15-DaCompany Report #2004S1000216 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional 100mg Mylan PS Mylan ORAL 400 MG Q 6PM, Other ORAL Date:02/05/04ISR Number: 4286587-0Report Type:Expedited (15-DaCompany Report #2004S1000208 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Health Clozapine Tablets Professional 100 Mg Mylan PS ORAL 600MG QD, Other ORAL Date:02/05/04ISR Number: 4286589-4Report Type:Expedited (15-DaCompany Report #04-01-0181 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Respiratory Failure Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 400-700MG QD ORAL Date:02/05/04ISR Number: 4286590-0Report Type:Expedited (15-DaCompany Report #03-12-1639 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Health Clozapine Tablets - Initial or Prolonged Dyspnoea Professional Ivax Other Lung Neoplasm Other Pharmaceuticals, Somnolence Inc. PS Ivax Pharmaceuticals, Inc. ORAL 150-550MG QD ORAL Date:02/06/04ISR Number: 4286849-7Report Type:Expedited (15-DaCompany Report #PHFR2004IE00800 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Clozaril PS Novartis Sector: Drug Level Decreased Pharma ORAL 550mg/day Phenytoin I UNKNOWN 22-Feb-2006 08:30 AM Page: 2578 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/06/04ISR Number: 4286851-5Report Type:Expedited (15-DaCompany Report #PHNU2003DE00467 Age:17 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abortion Health Leponex / Clozaril Drug Exposure During Professional (Clozapine) PS Novartis Sector: Pregnancy Pharma ORAL 25mg/day 8640 MIN Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL 12.5mg/day 17280MIN Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL up to 50mg/day Date:02/06/04ISR Number: 4286852-7Report Type:Expedited (15-DaCompany Report #PHFR2003GB03674 Age:51 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Back Pain Health Clozaril PS Novartis Sector: Initial or Prolonged Blood Glucose Increased Professional Pharma ORAL 100 mg/day 139 DAY Other Body Temperature Clozaril SS Novartis Sector: Increased Pharma ORAL 150mg/day Chest Pain Clozaril SS Novartis Sector: Diabetes Mellitus Pharma ORAL 175mg/day 95 DAY Diabetes Mellitus Trimethoprim C Inadequate Control Insulin C Diarrhoea Malaise Musculoskeletal Pain Pain Salivary Hypersecretion Urinary Tract Infection Viral Infection Weight Increased Date:02/06/04ISR Number: 4286855-2Report Type:Expedited (15-DaCompany Report #PHNU2003DE04176 Age:57 YR Gender:Female I/FU:F Outcome PT Other Alanine Aminotransferase Increased Anaemia Aspartate Aminotransferase Increased Blood Alkaline Phosphatase Increased C-Reactive Protein Increased Circulatory Collapse Eosinophilia Gamma-Glutamyltransferase Increased Haematocrit Decreased Haemoglobin Decreased Hepatic Enzyme Increased Hypotension Leukocyturia Lymphocyte Percentage 22-Feb-2006 08:30 AM Page: 2579 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Decreased Monocyte Percentage Increased Neutrophil Percentage Report Source Product Role Manufacturer Route Dose Duration Increased Health Leponex / Clozaril Platelet Count Increased Professional (Clozapine) PS Novartis Sector: Pyrexia Pharma ORAL up to Red Blood Cell Count 225mg/day 20160MIN Decreased Leponex / Clozaril Tachycardia (Clozapine) SS Novartis Sector: Urinary Tract Infection Pharma ORAL up to 200mg/day Fluanxol "Bayer" C UNKNOWN Unknown Seroquel /Unk/ C ORAL Unknown Date:02/06/04ISR Number: 4289397-3Report Type:Expedited (15-DaCompany Report #HQWYE576427JAN04 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Health Inderal (Propranolol Initial or Prolonged Treatment Noncompliance Professional Hydrochloride, Other Unspec) PS 10 MG 2 X PER 1 DAY Clozapine (Clozapine) SS ORAL 450 MG 1 X PER 1 DAY, ORAL Depakote (Valproate Semisodium) SS "ER 750 MG HS" Date:02/09/04ISR Number: 4288845-2Report Type:Expedited (15-DaCompany Report #PHFR2004GB00801 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Level Increased Clozaril PS Novartis Sector: Drug Toxicity Pharma ORAL 650mg/day Eating Disorder Lithium SS Malaise Neutrophil Count Increased Oral Intake Reduced White Blood Cell Count Increased Date:02/09/04ISR Number: 4288948-2Report Type:Expedited (15-DaCompany Report #PHEH2004US01441 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Glucose Tolerance Clozaril PS Novartis Sector: Initial or Prolonged Impaired Pharma ORAL 600 mg, QD Other Hallucination Zoloft C Paranoia Buspar C Renal Failure Trileptal "Novartis" C Synthroid C 22-Feb-2006 08:30 AM Page: 2580 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/09/04ISR Number: 4289945-3Report Type:Expedited (15-DaCompany Report #PHNU2002DE02741 Age:36 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Caesarean Section Leponex / Clozaril Initial or Prolonged Drug Exposure During (Clozapine) PS Novartis Sector: Pregnancy Pharma ORAL 100mg/day Normal Newborn Date:02/10/04ISR Number: 4289134-2Report Type:Expedited (15-DaCompany Report #PHFR2004GB00857 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypotension Clozaril PS Novartis Sector: Initial or Prolonged Medication Error Pharma ORAL Clozaril SS Novartis Sector: Pharma 250mg Date:02/10/04ISR Number: 4289135-4Report Type:Expedited (15-DaCompany Report #PHFR2004GB00854 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Colonic Stenosis Clozaril PS Novartis Sector: Initial or Prolonged Dehydration Pharma ORAL 300mg/day 586 DAY Diarrhoea Clozaril SS Novartis Sector: Overdose Pharma ORAL 900mg/overdos Renal Impairment e Date:02/10/04ISR Number: 4289136-6Report Type:Expedited (15-DaCompany Report #PHBS2004NL01540 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dialysis Leponex PS Novartis Sector: Poisoning Pharma ORAL Renal Impairment Rhabdomyolysis Date:02/10/04ISR Number: 4289327-4Report Type:Expedited (15-DaCompany Report #PHNU2003DE04484 Age:53 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Potassium Decreased Leponex / Clozaril Death (Clozapine) PS Novartis Sector: Fall Pharma ORAL up to Salivary Hypersecretion 800mg/day Weight Increased Norvask C ORAL Unknown Tremarit C ORAL 15mg/day Importal C ORAL Unknown Felodipine C ORAL Date:02/10/04ISR Number: 4289332-8Report Type:Expedited (15-DaCompany Report #PHEH2004US01319 Age:52 YR Gender:Female I/FU:F Outcome Death Hospitalization - Initial or Prolonged 22-Feb-2006 08:30 AM Page: 2581 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other PT Report Source Product Role Manufacturer Route Dose Duration Dyspnoea Clozaril PS Novartis Sector: Pulmonary Embolism Pharma ORAL 150 mg, QD Uterine Cancer Anaesthetics SS UNK, UNK Uterine Operation Zoloft C Zyprexa C Date:02/10/04ISR Number: 4290364-4Report Type:Expedited (15-DaCompany Report #PHHO2004CA01757 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Accidental Exposure Clozaril PS Novartis Sector: Medication Error Pharma ORAL 50 mg/d 2880 MIN No Adverse Drug Effect Date:02/10/04ISR Number: 4290375-9Report Type:Expedited (15-DaCompany Report #PHNU2003DE04287 Age:56 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - C-Reactive Protein Leponex / Clozaril Initial or Prolonged Increased (Clozapine) PS Novartis Sector: Other Disorientation Pharma ORAL 450mg/day Fall Leponex / Clozaril Head Injury (Clozapine) SS Novartis Sector: Overdose Pharma ORAL 200mg/day Pneumonia Haldol "Janssen" C 20 mg/day Restlessness Somnolence Date:02/10/04ISR Number: 4290393-0Report Type:Expedited (15-DaCompany Report #PHNU2004DE00702 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Leponex / Clozaril Increased (Clozapine) PS Novartis Sector: Aspartate Pharma ORAL up to Aminotransferase 900mg/day Increased Blood Creatine Phosphokinase Increased Blood Creatine Phosphokinase Mb Increased Blood Creatinine Increased Blood Lactate Dehydrogenase Increased Hepatic Enzyme Increased Myoglobin Blood Increased Myoglobinaemia 22-Feb-2006 08:30 AM Page: 2582 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/10/04ISR Number: 4290551-5Report Type:Expedited (15-DaCompany Report #04-02-0206 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Water Intoxication Health Clozapine- Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 75-125MG QD ORAL Date:02/10/04ISR Number: 4290552-7Report Type:Expedited (15-DaCompany Report #04-01-0023 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 75 MG QPM ORAL Date:02/10/04ISR Number: 4290553-9Report Type:Expedited (15-DaCompany Report #04-01-0076 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 50 MG AM ORAL Eskalith C Geodon C Date:02/10/04ISR Number: 4290554-0Report Type:Expedited (15-DaCompany Report #04-01-0172 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Health Clozapine -Ivax Initial or Prolonged Aplastic Anaemia Professional Pharmaceuticals Inc. Other Bronchitis Other Tablets PS Ivax Condition Aggravated Pharmaceuticals, Diarrhoea Inc. ORAL 100-600 MG QD Dyskinesia ORAL Pneumonia Psychotic Disorder Schizophrenia Schizophrenia, Paranoid Type Date:02/10/04ISR Number: 4290556-4Report Type:Expedited (15-DaCompany Report #04-01-0105 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Gastrointestinal Health Clozapine - Ivax Haemorrhage Professional Pharmaceuticals, Inc Other Tablets PS Ivax Pharmaceuticals, 22-Feb-2006 08:30 AM Page: 2583 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Inc. ORAL 25-30 MG QD ORAL Date:02/10/04ISR Number: 4290557-6Report Type:Expedited (15-DaCompany Report #03-12-1621 Age:56 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Aspiration Health Clozapine - Ivax Initial or Prolonged White Blood Cell Count Professional Pharmaceuticals, Other Increased Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 100 MG TID ORAL Parlodel C Effexor Xr C Sinemet C Date:02/10/04ISR Number: 4290558-8Report Type:Expedited (15-DaCompany Report #03-12-1639 Age:47 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Health Clozapine - Ivax Initial or Prolonged Impaired Self-Care Professional Pharmaceuticals, Other Lung Neoplasm Other Inc. Tablets PS Ivax Psychotic Disorder Pharmaceuticals, Respiratory Disorder Inc. ORAL 150-550 MG QD Somnolence ORAL Date:02/10/04ISR Number: 4290559-XReport Type:Expedited (15-DaCompany Report #2004S1000269 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 200 MG BID, Other ORAL Date:02/10/04ISR Number: 4293947-0Report Type:Expedited (15-DaCompany Report #04-01-0023 Age:79 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Health Clozapine - Ivax Hospitalization - Infection Professional Pharmaceuticals, Initial or Prolonged Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 75MG QPM ORAL Date:02/11/04ISR Number: 4291390-1Report Type:Expedited (15-DaCompany Report #PHFR2004GB00833 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Dental Examination Clozapine PS Novartis Sector: Abnormal Pharma ORAL 100mg/day 67680MIN Hypertension Forceval C ORAL 1 tablet Salivary Hypersecretion Paroxetine C ORAL 60mg/day Tachycardia Urinary Incontinence 22-Feb-2006 08:30 AM Page: 2584 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/11/04ISR Number: 4291415-3Report Type:Expedited (15-DaCompany Report #PHBS2003NZ13864 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cellulitis Clozaril PS Novartis Sector: Initial or Prolonged Deep Vein Thrombosis Pharma ORAL 400 mg/d Platelet Count Increased Clozaril SS Novartis Sector: Pulmonary Embolism Pharma ORAL 100 mg mane, 400 mg nocte Warfarin C UNKNOWN Date:02/11/04ISR Number: 4291417-7Report Type:Expedited (15-DaCompany Report #PHNU2004DE00776 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Retinal Vein Thrombosis Leponex / Clozaril (Clozapine) PS Novartis Sector: Pharma ORAL 75 mg/day Marcumar C Date:02/11/04ISR Number: 4291421-9Report Type:Expedited (15-DaCompany Report #PHNU2004DE00759 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Polyneuropathy Leponex / Clozaril Sensory Disturbance (Clozapine) PS Novartis Sector: Pharma ORAL 100 to 150 mg/day Antidepressants C Hypnotics And Sedatives C Date:02/12/04ISR Number: 4293031-6Report Type:Expedited (15-DaCompany Report #PHHO2004CA01622 Age:53 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiac Disorder Clozaril PS Novartis Sector: Dyspnoea Pharma Dyspnoea Exertional Date:02/12/04ISR Number: 4293646-5Report Type:Expedited (15-DaCompany Report #PHBS2003NZ13647 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Cough Health Clozaril PS Novartis Sector: Diabetes Mellitus Professional Pharma ORAL 500 mg/d Non-Insulin-Dependent Clozaril SS Novartis Sector: Dyspepsia Pharma ORAL Dyspnoea Valproate Sodium C UNKNOWN 600 mg, BID Fatigue Ranitidine C UNKNOWN Hyperglycaemia Insulin Protaphan Hypertriglyceridaemia Human C UNKNOWN Lethargy Simvastatin C UNKNOWN Metabolic Syndrome Quetiapine C UNKNOWN UNK, UNK Muscle Spasms Palpitations Weight Increased 22-Feb-2006 08:30 AM Page: 2585 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/12/04ISR Number: 4293745-8Report Type:Expedited (15-DaCompany Report #GB-GLAXOSMITHKLINE-B0321948A Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Convulsion Lamictal PS Glaxosmithkline ORAL 175MG Per day 4 MON Drug Interaction Clozaril SS ORAL 3 YR Drug Level Increased Valproic Acid C ORAL 2G Per day Mental Disorder Benztropine C ORAL 2MG Three times per day Date:02/12/04ISR Number: 4293756-2Report Type:Expedited (15-DaCompany Report #DE-GLAXOSMITHKLINE-D0043128A Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypertension Health Zantic PS Glaxosmithkline ORAL 150MG Unknown Sopor Professional Leponex SS ORAL 100MG Unknown Remergil SS ORAL 30MG Unknown Diane SS ORAL Date:02/12/04ISR Number: 4293860-9Report Type:Expedited (15-DaCompany Report #PHEH2003US11661 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Health Clozaril PS Novartis Sector: Initial or Prolonged Blood Creatine Professional Pharma ORAL UNK, UNK 17280MIN Phosphokinase Increased Trileptal Chills "Ciba-Geigy" C Cough Haldol "Janssen" C Haematocrit Decreased Hyperglycaemia Hyperhidrosis Hypoalbuminaemia Hypokalaemia Hypomagnesaemia International Normalised Ratio Increased Leukopenia Liver Function Test Abnormal Lung Neoplasm Myalgia Myocarditis Pericardial Effusion Pyrexia Rash Macular Subcutaneous Nodule Tachycardia Thrombocythaemia Date:02/12/04ISR Number: 4293964-0Report Type:Expedited (15-DaCompany Report #04-02-0212 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Health Clozapine - Ivax Initial or Prolonged Suicide Attempt Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 100-225MG QD ORAL 22-Feb-2006 08:30 AM Page: 2586 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/13/04ISR Number: 4294090-7Report Type:Expedited (15-DaCompany Report #PHNU2003DE04336 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypercholesterolaemia Health Leponex / Clozaril Hypertriglyceridaemia Professional (Clozapine) PS Novartis Sector: Pharma ORAL up to 100mg/day Date:02/13/04ISR Number: 4294151-2Report Type:Expedited (15-DaCompany Report #PHFR2003GB04852 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Health Clozaril (Clozapine) PS Novartis Sector: Initial or Prolonged Accidental Exposure Professional Pharma 500mg Convulsion overdose Hallucination Valproate Sodium C ORAL 400 mg, TID Chlorpromazine C ORAL 50 mg, QID Propanolol C ORAL 80 mg, QD Lansoprazole C ORAL 15 mg, QD Venlafaxine C ORAL 75 mg, QD Senna C Celevac C UNKNOWN 500 mg, BID Lactulose C UNKNOWN 15 ml, BID Date:02/13/04ISR Number: 4294153-6Report Type:Expedited (15-DaCompany Report #PHFR2004GB00577 Age:32 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Haemoglobin Decreased Health Clozaril PS Novartis Sector: Laboratory Test Professional Pharma ORAL 250mg/day Interference Lithium Carbonate C ORAL 800mg/day Date:02/13/04ISR Number: 4294155-XReport Type:Expedited (15-DaCompany Report #PHHO2004CA01757 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Accidental Exposure Health Clozaril PS Novartis Sector: Professional Pharma ORAL 50 mg/d 2880 MIN Date:02/13/04ISR Number: 4294546-7Report Type:Expedited (15-DaCompany Report #PHNR2004AU00627 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cytomegalovirus Infection Clozaril PS Novartis Sector: Eosinophil Count Pharma 12.5 - 175 Increased mg/day Feeling Abnormal Monocyte Count Increased Pyrexia Date:02/13/04ISR Number: 4294687-4Report Type:Expedited (15-DaCompany Report #PHBS2004CA01949 Age: Gender:Unknown I/FU:I Outcome PT Other Blood Triglycerides Increased 22-Feb-2006 08:30 AM Page: 2587 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Psychotic Disorder Report Source Product Role Manufacturer Route Dose Duration Clozaril PS Novartis Sector: Pharma ORAL 350 mg/d Date:02/13/04ISR Number: 4294691-6Report Type:Expedited (15-DaCompany Report #PHBS2004US01841 Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cogwheel Rigidity Clozapine PS Novartis Sector: Dysarthria Pharma UNKNOWN UNK, UNK Dystonia Clozapine SS Novartis Sector: Extrapyramidal Disorder Pharma UNKNOWN 150 mg/d Pleurothotonus Venlafaxine C UNKNOWN 375 mg/d Tremor Lithium C UNKNOWN 450 mg/d Aripiprazole C UNKNOWN 15 mg/d Date:02/13/04ISR Number: 4295042-3Report Type:Expedited (15-DaCompany Report #2004S1000020 Age:83 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional 25mg Mylan PS Mylan ORAL 6.25 MG QD, Other ORAL Warfarin C Losartan C Vitamin B12 C Fentanyl Transdermal System C Isosorbide Mononitrate Er C Levothyroxine C Zinc Sulfate C Dhea Sr C Vitamin C C Vitamin B Complex C Acyclovir Ointment C Lansoprazole C Acetaminophen C Betamethasone/Clotri mazole Cream C Carvedilol C Calcitonin Salmon Nasal Spray C Date:02/13/04ISR Number: 4295049-6Report Type:Expedited (15-DaCompany Report #2004S1000352 Age:78 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan Other Selegiline C Ranitidine C Sorbitol C Metoprolol C Docusate C Bromocriptine C 22-Feb-2006 08:30 AM Page: 2588 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Carbidopa/Levodopa C Diazepam C Acetaminophen C Bisacodyl C Morphine Sulfate C Date:02/13/04ISR Number: 4302396-8Report Type:Expedited (15-DaCompany Report #C2003-3173.01 Age:43 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Circulatory Collapse Health Clozapine Tablets Confusional State Professional 100 Mg Mylan PS Mylan ORAL 100MG Q AM, Fall Other 200MG Q PM, Mental Status Changes 300MG Q HS, Social Avoidant Behaviour ORAL Sudden Death Benztropine C Swelling Bupropion Sr C Diphenhydramine C Divalproex Sodium C Levothyroxine Sodium C Lithium C Loratadine C Risperidone C Haloperidol Decanoate C Risperidone M-Tab C Ibuprofen C Date:02/16/04ISR Number: 4295182-9Report Type:Expedited (15-DaCompany Report #PHBS2004IT01386 Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Amylase Increased Leponex PS Novartis Sector: Hospitalization - Blood Glucose Increased Pharma ORAL 700 mg/d 2673 DAY Initial or Prolonged Lipase Increased Sereupin C UNKNOWN 20 mg/d 2555 DAY Pancreatitis Haemorrhagic Control C UNKNOWN 2.5 mg/d 2555 DAY Pancreatitis Necrotising Date:02/16/04ISR Number: 4295188-XReport Type:Expedited (15-DaCompany Report #PHHO2004CA01959 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bronchitis Clozaril PS Novartis Sector: Initial or Prolonged Neutropenia Pharma ORAL Unspecified 612 DAY Urinary Tract Infection White Blood Cell Count Decreased Date:02/17/04ISR Number: 4296294-6Report Type:Periodic Company Report #US-GLAXOSMITHKLINE-A0429725A Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Lamotrigine PS Glaxosmithkline ORAL Neutropenia Clozapine SS ORAL 1 YR Protonix SS UNKNOWN Risperdal SS UNKNOWN Klonopin SS 22-Feb-2006 08:30 AM Page: 2589 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Cogentin C UNKNOWN Zoloft C UNKNOWN Date:02/17/04ISR Number: 4296357-5Report Type:Expedited (15-DaCompany Report #PHEH2004US01441 Age:43 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Clozaril PS Novartis Sector: Initial or Prolonged Glucose Tolerance Pharma ORAL 600 mg, QD Other Impaired Zoloft C Hallucination Buspar C Paranoia Trileptal "Novartis" C Renal Failure Synthroid C Sedation Haldol "Janssen" C Date:02/17/04ISR Number: 4296770-6Report Type:Expedited (15-DaCompany Report #PHFR2003GB05012 Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arthralgia Clozaril PS Novartis Sector: Initial or Prolonged Hyperhidrosis Pharma ORAL 12.5 mg, QD Other Hypersensitivity Clozaril SS Novartis Sector: Influenza Like Illness Pharma ORAL 225 mg/day Malaise Clozaril SS Novartis Sector: Myalgia Pharma ORAL 12.5 mg, QD 7200 MIN Pyrexia Risperidone C ORAL 6 mg/day 5760 MIN Rhinitis Risperidone C 4 mg/day 10080MIN Tachycardia Risperidone C ORAL 3 mg/day 4320 MIN Risperidone C ORAL 2 mg/day 41760MIN Date:02/17/04ISR Number: 4296793-7Report Type:Expedited (15-DaCompany Report #PHNU2003DE02762 Age:34 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Caesarean Section Leponex / Clozaril Initial or Prolonged Complications Of Maternal (Clozapine) PS Novartis Sector: Exposure To Therapeutic Pharma ORAL 100mg/day Drugs Drug Exposure During Pregnancy Pregnancy Date:02/17/04ISR Number: 4297014-1Report Type:Expedited (15-DaCompany Report #PHFR2004GB00608 Age:62 YR Gender:Male I/FU:F Outcome PT Hospitalization - Alanine Aminotransferase Initial or Prolonged Increased Blood Creatinine Increased Blood Electrolytes Abnormal Blood Urea C-Reactive Protein Increased Circulatory Collapse Eosinophil Count 22-Feb-2006 08:30 AM Page: 2590 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Increased Haemoglobin Decreased Infection Liver Function Test Report Source Product Role Manufacturer Route Dose Duration Abnormal Clozaril PS Novartis Sector: Malaise Pharma ORAL 87840MIN Nephritis Interstitial Depakote C ORAL 1250mg/day Clopidogrel C ORAL 75mg/day Diazepam C ORAL 2 mg, BID Date:02/17/04ISR Number: 4297221-8Report Type:Expedited (15-DaCompany Report #04-02-0236 Age:76 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Renal Failure Health Clozapine - Ivax Initial or Prolonged Urosepsis Professional Pharmaceutical, Inc. Other Tablets PS Ivax Pharmaceutical, Inc. ORAL 400 - 475MG QD ORAL Date:02/17/04ISR Number: 4297224-3Report Type:Expedited (15-DaCompany Report #04-02-0235 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 200 MG QD ORAL Date:02/17/04ISR Number: 4297226-7Report Type:Expedited (15-DaCompany Report #03-12-1595 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Health Clozapine - Ivax Breast Cancer Professional Pharmaceuticals, White Blood Cell Count Inc. PS Ivax Decreased Pharmaceuticals, Inc. ORAL 125-200MG QD ORAL Chemotherapy SS Date:02/17/04ISR Number: 4298998-8Report Type:Expedited (15-DaCompany Report #2004UW02283 Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bowel Sounds Abnormal Health Elavil PS ORAL 25 MG HS PO Initial or Prolonged Confusional State Professional Clozapine SS ORAL 75 MG QD PO Required Disorientation Paxil SS ORAL 20 MG PO Intervention to Fall Stalevo SS DOSAGE Prevent Permanent Nausea DECREASED Impairment/Damage Pneumonia Aspiration FROM 4 TO 3 Vomiting TABLETS 22-Feb-2006 08:30 AM Page: 2591 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/17/04ISR Number: 4300504-6Report Type:Expedited (15-DaCompany Report #200311162BVD Age:61 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Foreign Ciprobay Condition Aggravated Health (Ciprofloxacin Drug Interaction Professional Hydrochloride) PS ORAL 1000 MG, Drug Level Increased Other TOTAL DAILY, Psychotic Disorder ORAL Leponex (Clozapine) SS Acc C Refobacin C Leponex C Atosil C Tavor C Solian C Eisen C Espumisan C Simethicon C Lactulose C Date:02/18/04ISR Number: 4297222-XReport Type:Expedited (15-DaCompany Report #PHNU2004DE00755 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abortion Spontaneous Leponex / Clozaril Complications Of Maternal (Clozapine) PS Novartis Sector: Exposure To Therapeutic Pharma ORAL 300 mg/day Drugs Drug Exposure During Pregnancy Date:02/18/04ISR Number: 4297225-5Report Type:Expedited (15-DaCompany Report #PHEH2004US01788 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Catatonia Clozaril PS Novartis Sector: Initial or Prolonged Convulsion Pharma ORAL UNK, UNK Decreased Appetite Diet Refusal Gastrointestinal Tube Insertion Pneumonia Aspiration Treatment Noncompliance Date:02/18/04ISR Number: 4297294-2Report Type:Expedited (15-DaCompany Report #200411815GDDC Age:40 YR Gender:Female I/FU:I Outcome PT Death Acidosis Hospitalization - Anxiety Initial or Prolonged Blood Lactic Acid Increased Blood Potassium Increased Blood Pressure Decreased Blood Pressure Increased Body Temperature Increased Bradycardia 22-Feb-2006 08:30 AM Page: 2592 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Cardiac Arrest Dialysis Gastroenteritis Report Source Product Role Manufacturer Route Dose Duration Hepatic Haemorrhage Euglucon PS Aventis Hyperventilation Pharmaceuticals Inc. ORAL dose: 2 Hypoglycaemia TABLETS Obesity Glucophage SS ORAL Ovarian Neoplasm Leponex SS ORAL dose: 3 Pericardial Disease TABLETS Petechiae Zantac C Renal Failure Akineton C Respiratory Arrest Theralen C Shock Normorix C Date:02/18/04ISR Number: 4297564-8Report Type:Expedited (15-DaCompany Report #PHBS2004NL01963 Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Accidental Exposure Clozapine PS Novartis Sector: Coma Pharma UNKNOWN 100 mg/d Drug Toxicity Oxazepam SS UNKNOWN 10 mg/d Medication Error Norfloxacin SS UNKNOWN 400 mg/d Cisordinol C UNKNOWN 2 mg, TID Prednisolone C UNKNOWN 10 mg/d Prednisolone C UNKNOWN 5mg/d Carbamazepine C UNKNOWN 200 mg, TID Oxazepam C UNKNOWN 10 mg, TID Date:02/18/04ISR Number: 4298503-6Report Type:Expedited (15-DaCompany Report #PHBS2004NL01962 Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Accidental Exposure Clozapine PS Novartis Sector: Coma Pharma UNKNOWN 100 mg/d Drug Ineffective Lorazepam SS UNKNOWN 1 mg/d Medication Error Pimozide C UNKNOWN 6 mg/d Poisoning Lithium Carbonate C UNKNOWN 400 mg/d Acetaminophen C UNKNOWN 500 mg, TID Temazepam C UNKNOWN 10 mg/d Date:02/18/04ISR Number: 4298507-3Report Type:Expedited (15-DaCompany Report #PHBS2004IE02094 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Increased Clozapine PS Novartis Sector: Initial or Prolonged Essential Hypertension Pharma UNKNOWN 50 mg/d Norepinephrine Increased Clozapine SS Novartis Sector: Pseudophaeochromocytoma Pharma UNKNOWN 300 mg/d Tachycardia Lofepramine C UNKNOWN 210 mg/d Clopixol Depot C up to 300 mg weekly Venlafaxine C UNKNOWN 150 mg/d Venlafaxine C UNKNOWN 225 mg/d Citalopram C UNKNOWN 20 mg/d 22-Feb-2006 08:30 AM Page: 2593 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/18/04ISR Number: 4298510-3Report Type:Expedited (15-DaCompany Report #PHBS2004NL01964 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Coma Clozapine PS Novartis Sector: Pharma UNKNOWN 12.5 mg/d Clozapine SS Novartis Sector: Pharma UNKNOWN 175 mg/d Diazepam C UNKNOWN 2 mg, TID Haloperidol C UNKNOWN 10 mg, TID Ibuprofen C UNKNOWN 200 mg, TID Pantozol C UNKNOWN 40 mg/d Date:02/18/04ISR Number: 4298512-7Report Type:Expedited (15-DaCompany Report #PHNR2004AU00658 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Clozaril PS Novartis Sector: Initial or Prolonged Drug Level Increased Pharma ORAL 25 - 800 Gamma-Glutamyltransferase mg/day Increased Clozaril SS Novartis Sector: Restless Legs Syndrome Pharma ORAL 300 mg, BID Epilim C Date:02/18/04ISR Number: 4299071-5Report Type:Expedited (15-DaCompany Report #04-01-0153 Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bacterial Infection Health Clozapine - Ivax Sepsis Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 100MG QHS ORAL Sinemet C Sinemet-Cr C Date:02/18/04ISR Number: 4299082-XReport Type:Expedited (15-DaCompany Report #2004S1000119 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Health Clozapine Tablets Respiratory Arrest Professional 100 Mg Mylan PS Mylan ORAL 400MG/DAY,ORA Other L Date:02/18/04ISR Number: 4299086-7Report Type:Expedited (15-DaCompany Report #2004S1000072 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Economic Problem Health Clozapine Tablets Myocardial Infarction Professional 100 Mg Mylan PS Mylan ORAL 200 Other MG/DAY,ORAL Levofloxacin C Quetiapine Fumerate C Simvastatin C Temazepam C Valsartan C Citalopram C 22-Feb-2006 08:30 AM Page: 2594 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Diltiazem Cd C Date:02/18/04ISR Number: 4300085-7Report Type:Expedited (15-DaCompany Report #PHBS2004CA01949 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Triglycerides Foreign Clozaril (Clozapine) Increased Health Tablet PS ORAL 350 MG/D, Disease Recurrence Professional ORAL Psychotic Disorder Company Representative Other Date:02/18/04ISR Number: 4301818-6Report Type:Periodic Company Report #2003169045US Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Health Deltasone Initial or Prolonged Professional (Prednisone) Tablet PS ORAL ORAL Clozapine (Clozapine) SS Antibiotics() SS Date:02/19/04ISR Number: 4298952-6Report Type:Expedited (15-DaCompany Report #PHNR2004AU00503 Age:20 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Health Clozaril PS Novartis Sector: Cataplexy Professional Pharma 12.5 - 600 Circulatory Collapse mg/day Drug Interaction Amisulpride C 400 mg/day Electroencephalogram Abnormal Hypotonia Date:02/19/04ISR Number: 4298959-9Report Type:Expedited (15-DaCompany Report #PHEH2003US11487 Age:60 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Clozaril PS Novartis Sector: Initial or Prolonged Asthma Professional Pharma ORAL UNK, UNK Chronic Obstructive Steroids Nos SS Pulmonary Disease Dyspnoea Paranoia Psychotic Disorder Date:02/19/04ISR Number: 4299993-5Report Type:Expedited (15-DaCompany Report #04-02-0237 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatitis C Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 24-400 QD 22-Feb-2006 08:30 AM Page: 2595 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL Date:02/19/04ISR Number: 4301030-0Report Type:Expedited (15-DaCompany Report #2003GB03357 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Clozapine PS Health Professional Other Date:02/19/04ISR Number: 4301506-6Report Type:Expedited (15-DaCompany Report #S04-USA-00578-01 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Health Lexapro Initial or Prolonged Hepatitis Professional (Escitalopram) PS ORAL 10 MG QD PO Company Lexapro Representative (Escitalopram) SS ORAL 20 MG QD PO Clozapine SS 625 MG QD Haldol SS 2 MG Q4HR Prevacid (Lansoprazole) C Ferrous Sulfate C Surfax (Docusate Calcium) C Date:02/19/04ISR Number: 4301690-4Report Type:Expedited (15-DaCompany Report #2004S1000019 Age:33 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Health Clozapine Tablets Hospitalization - Myocardial Haemorrhage Professional 100 Mg Mylan PS Mylan 200 MG MG BID Initial or Prolonged Myocarditis Other Venlafaxine SS Respiratory Tract Azithromycin C Infection Cephalexin, Divalproex Sodium C Fluphenazine C Clonazepam C Benztropine C Ranitidine C Docusate Calcium C Clotrimazole C Polyethylene Glycol C Lansoprazole C Furosemide C Risperidone C Levothyroxine Sodium C Lorazepam C Pseudoephedrine C Date:02/19/04ISR Number: 4301691-6Report Type:Expedited (15-DaCompany Report #2004S1000033 Age:37 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Breast Cancer Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 100 MG BID Other AND 200 MG 22-Feb-2006 08:30 AM Page: 2596 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report QHS, ORAL Date:02/19/04ISR Number: 4301692-8Report Type:Expedited (15-DaCompany Report #04-01-0150 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bacterial Infection Health Clozapine - Ivax Initial or Prolonged Endocarditis Professional Pharmaceuticals, Post Procedural Inc. Tablets PS Ivax Pharmacuticals, Complication Inc ORAL 725 MG QD ORAL Klonopin C Anafranil C Quetiapine Fumarate C Citalopram C Date:02/20/04ISR Number: 4299934-0Report Type:Expedited (15-DaCompany Report #PHBS2004CA02237 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Choking Clozaril PS Novartis Sector: Dyspnoea Pharma ORAL 300 mg/d Logorrhoea Clozaril SS Novartis Sector: Muscle Twitching Pharma ORAL 100 mg/d Salivary Hypersecretion Zoloft C UNKNOWN Weight Increased Date:02/20/04ISR Number: 4299943-1Report Type:Expedited (15-DaCompany Report #PHBS2004NZ02076 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bundle Branch Block Right Clozaril PS Novartis Sector: Initial or Prolonged Chest Pain Pharma ORAL 450 mg/d 196 DAY Dyspnoea Clozaril SS Novartis Sector: Electrocardiogram Pharma ORAL 450 mg/d Abnormal Sleep Apnoea Syndrome Tachycardia Date:02/20/04ISR Number: 4299945-5Report Type:Expedited (15-DaCompany Report #PHFR2003GB03632 Age:29 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Clozaril PS Novartis Sector: Electrocardiogram Qt Pharma ORAL 200mg/day Corrected Interval Valproate Sodium SS 500 mg, BID Prolonged Clozaril SS Novartis Sector: Hyperglycaemia Pharma ORAL 275 mg/day Pain Venlafaxine SS 150 mg, QD Pharyngolaryngeal Pain Desmopressin C Metformin C 500 mg, TID Gliclazide C 80 mg, BID Methylcellulose C 22-Feb-2006 08:30 AM Page: 2597 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/20/04ISR Number: 4299948-0Report Type:Expedited (15-DaCompany Report #PHRM2004FR00833 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Leponex PS Novartis Sector: Initial or Prolonged Neutropenia Pharma ORAL 300 mg, daily 1045 DAY Pancytopenia Nozinan SS ORAL 75 mg, daily 1045 DAY Pyrexia Rivotril C ORAL 4 mg, daily Date:02/20/04ISR Number: 4299949-2Report Type:Expedited (15-DaCompany Report #PHFR2004GB00988 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Convulsion Clozaril PS Novartis Sector: Other Drug Interaction Pharma ORAL 900 mg, QD 934 DAY Drug Level Increased Lamictal SS Burroughs Wellcome ORAL 175 mg, QD 117 DAY Mental Disorder Valproic Acid C ORAL 2 g, QD Benztropeine C ORAL 2 mg, TID Date:02/20/04ISR Number: 4300032-8Report Type:Expedited (15-DaCompany Report #PHEH2004US01931 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Clozaril PS Novartis Sector: Pharma ORAL 400 mg, UNK Date:02/20/04ISR Number: 4300038-9Report Type:Expedited (15-DaCompany Report #PHFR2002GB01212 Age:58 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bronchopneumonia Clozaril PS Novartis Sector: Life-Threatening Cardiac Arrest Pharma ORAL 800mg/day 3344 DAY Hospitalization - Cardiac Disorder Simvastatin C ORAL 20mg/day Initial or Prolonged Cardiomegaly Aspirine C ORAL 75mg/day Congestive Cardiomyopathy Isosorbide C ORAL 10 mg, BID Electrocardiogram Ramipril C ORAL 5 mg, BID Abnormal Leukocytosis Mitral Valve Incompetence Myocardial Infarction Neutrophilia Tricuspid Valve Incompetence Date:02/20/04ISR Number: 4300049-3Report Type:Expedited (15-DaCompany Report #PHFR2003GB04012 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Depressed Level Of Clozaril PS Novartis Sector: Other Consciousness Pharma ORAL 600mg/day Epilepsy Valproate Sodium C 1g/day Sudden Death 22-Feb-2006 08:30 AM Page: 2598 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/20/04ISR Number: 4300050-XReport Type:Expedited (15-DaCompany Report #PHHO2003CA10244 Age:25 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Chest Pain Clozaril PS Novartis Sector: Circulatory Collapse Pharma ORAL 700 mg QD Depression Suicidal Clozaril SS Novartis Sector: Drug Level Increased Pharma ORAL 900 mg, QD Drug Toxicity Imipramine C 25 mg Enuresis Imipramine C 300 mg, QD Grand Mal Convulsion Loxapine C 15 mg, QD Panic Attack Buscopan C 20 mg, QD Self-Medication Epival C 1250 mg, QD Somnolence Celexa C 20 mg Sudden Death Celexa C 40 mg, QD Therapeutic Agent Ativan C 2.5 mg, QD Toxicity Date:02/20/04ISR Number: 4300166-8Report Type:Expedited (15-DaCompany Report #PHEH2004US01792 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Clozaril PS Novartis Sector: Initial or Prolonged Phosphokinase Increased Pharma ORAL UNK, UNK Blood Potassium Decreased Treatment Noncompliance Date:02/23/04ISR Number: 4301378-XReport Type:Periodic Company Report #US-GLAXOSMITHKLINE-A0425383A Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Navelbine PS Glaxosmithkline INTRAVENOUS Other Clozapine SS ORAL 150MG Per day Date:02/23/04ISR Number: 4302433-0Report Type:Expedited (15-DaCompany Report #04-02-0254 Age:86 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine - Ivax Professional Pharmaceuticals, Other Ins. Tablets PS ORAL 75-275MG QD ORAL Date:02/23/04ISR Number: 4302435-4Report Type:Expedited (15-DaCompany Report #04-01-0134 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hypothermia Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 325MG BID ORAL 22-Feb-2006 08:30 AM Page: 2599 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/23/04ISR Number: 4302436-6Report Type:Expedited (15-DaCompany Report #04-02-0251 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Circulatory Collapse Health Clozapine - Ivax Initial or Prolonged Respiratory Arrest Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 125-425MG QD ORAL Date:02/24/04ISR Number: 4302723-1Report Type:Expedited (15-DaCompany Report #PHEH2003US11271 Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Accidental Overdose Health Clozaril PS Novartis Sector: Other Amnesia Professional Pharma ORAL 1400 mg, QD Disorientation Clozaril SS Novartis Sector: Intentional Overdose Pharma ORAL 350 mg, QD Medication Error Ritalin C Klonopin C Date:02/24/04ISR Number: 4302732-2Report Type:Expedited (15-DaCompany Report #PHFR2003GB04793 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Clozaril PS Novartis Sector: Initial or Prolonged Convulsion Pharma ORAL 350mg/error Other Medication Error Epanutin Tachycardia /Unk/ C UNKNOWN Antidepressants C UNKNOWN Date:02/24/04ISR Number: 4302743-7Report Type:Expedited (15-DaCompany Report #PHBS2004FI02137 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Leponex PS Novartis Sector: Initial or Prolonged Drug Toxicity Pharma ORAL 500 mg/d Regressive Behaviour Lamictal "Wellcome" SS ORAL 150 mg/d Cipramil C ORAL 60 mg/d Stesolid C ORAL 35 mg/d Femoston Conti C UNKNOWN Magnesiamaito C ORAL 20 ml/d Senikolp C UNKNOWN Date:02/24/04ISR Number: 4303141-2Report Type:Expedited (15-DaCompany Report #FR-BRISTOL-MYERS SQUIBB COMPANY-12508727 Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anaemia Health Glucophage PS Bristol-Myers Squibb Hospitalization - General Physical Health Professional Company ORAL Initial or Prolonged Deterioration Triflucan SS ORAL Other Inflammation Novonorm SS Lung Infection Theralene SS ORAL Oesophagitis Zoloft SS ORAL Thrombocytopenia Clozapine SS ORAL Vomiting Hept-A-Myl C Peridys C Phosphalugel C 22-Feb-2006 08:30 AM Page: 2600 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Ulcar C Forlax C Ferrograd C Gaviscon C Date:02/24/04ISR Number: 4303550-1Report Type:Direct Company Report #CTU 213020 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Cough Clozapine PS ORAL 100 MG PO QAM Intervention to Pharyngitis + 300 MG PO Prevent Permanent Pyrexia QHS Impairment/Damage Date:02/24/04ISR Number: 4303637-3Report Type:Direct Company Report #CTU 213040 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Clozapine Mylan PS Drug Level Changed Pharmaceutical Product Complaint White Blood Cell Disorder Date:02/24/04ISR Number: 4303811-6Report Type:Expedited (15-DaCompany Report #C2003-3172.01 Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hepatic Neoplasm Health Clozapine Tablets Malignant Professional 100 Mg Mylan PS ORAL 100 MG, TID , Pancreatic Carcinoma Other ORAL Clozapine Tablets 25 Mg Mylan SS ORAL 25 MG TID, ORAL Date:02/24/04ISR Number: 4303817-7Report Type:Expedited (15-DaCompany Report #04-02-0259 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine -Ivax Urinary Tract Infection Professional Pharmaceuticals, Other Inc. Tablets PS ORAL UNKNOWN ORAL Date:02/24/04ISR Number: 4303820-7Report Type:Expedited (15-DaCompany Report #04-02-0257 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Clozapine - Ivax Congestive Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 600 MG QD ORAL 22-Feb-2006 08:30 AM Page: 2601 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/24/04ISR Number: 4303822-0Report Type:Expedited (15-DaCompany Report #04-02-0258 Age:88 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 25MG QD ORAL Date:02/24/04ISR Number: 4305163-4Report Type:Direct Company Report #CTU 213054 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Constipation Clozapine PS Required Dysphagia Intervention to Weight Increased Prevent Permanent Impairment/Damage Date:02/24/04ISR Number: 4307208-4Report Type:Periodic Company Report #04P-163-0249276-00 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Health Depakote Er Initial or Prolonged Professional (Divalproex Sodium) PS 750 MG, DAILY Other AT BEDTIME Clozapine SS ORAL 450 MG, DAILY AT BEDTIME,PER ORAL Propranolol SS 10 MG, 2 IN 1 D Date:02/25/04ISR Number: 4303616-6Report Type:Expedited (15-DaCompany Report #PHHO2004CA01755 Age:49 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Infarction Clozaril PS Novartis Sector: Pharma Largactil C 150 mg Ativan C 1 mg, TID and 2 mg bedtime Date:02/25/04ISR Number: 4303740-8Report Type:Expedited (15-DaCompany Report #PHNU2003DE04155 Age:65 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bundle Branch Block Right Leponex / Clozaril Electrocardiogram Qt (Clozapine) PS Novartis Sector: Corrected Interval Pharma ORAL 450mg/day 33120MIN Electrocardiogram Qt Leponex / Clozaril Corrected Interval (Clozapine) SS Novartis Sector: Prolonged Pharma ORAL 450mg/day 20160MIN Electrocardiogram Qt Leponex / Clozaril Prolonged (Clozapine) SS Novartis Sector: Myocardial Infarction Pharma ORAL 200 mg, BID Ventricular Extrasystoles Tavor C ORAL 22-Feb-2006 08:30 AM Page: 2602 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/04ISR Number: 4303746-9Report Type:Expedited (15-DaCompany Report #PHFR2004GB00626 Age:27 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chest Pain Clozaril PS Novartis Sector: Costochondritis Pharma ORAL Sedation Tachycardia Date:02/25/04ISR Number: 4303748-2Report Type:Expedited (15-DaCompany Report #PHFR2004GB01024 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Accidental Exposure Clozaril PS Novartis Sector: Pharma 300 mg accidental exposure Date:02/25/04ISR Number: 4303749-4Report Type:Expedited (15-DaCompany Report #PHFR2004GB01028 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dysphemia Clozaril PS Novartis Sector: Pharma ORAL Disulfiram C UNKNOWN Antidepressants C UNKNOWN Date:02/25/04ISR Number: 4303779-2Report Type:Expedited (15-DaCompany Report #PHFR2003GB04974 Age:43 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Eosinophilia Clozaril (Clozapine) PS Novartis Sector: Initial or Prolonged Hypersensitivity Pharma 12.5mg/day 24480MIN Other Lower Respiratory Tract Clozaril (Clozapine) SS Novartis Sector: Infection Pharma ORAL 2880 MIN Neutrophilia Venlafaxine C ORAL 37.5 mg/day Pyrexia Lithium Carbonate C ORAL 1 g/day Rash Aspirine C ORAL 75 mg/day Salbutamol C Becotide C Date:02/25/04ISR Number: 4304129-8Report Type:Expedited (15-DaCompany Report #2004S1000488 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Health Clozapine Tablets Weight Increased Professional 100 Mg Mylan PS Mylan ORAL 900 MG QD Other ORAL Date:02/25/04ISR Number: 4304131-6Report Type:Expedited (15-DaCompany Report #2004S1000145 Age:63 YR Gender:Female I/FU:F Outcome PT Death Bronchitis Nasopharyngitis Sudden Death Upper Respiratory Tract 22-Feb-2006 08:30 AM Page: 2603 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Infection Report Source Product Role Manufacturer Route Dose Duration Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 50 MG QID, Other ORAL Diabetes Medication C Fluoxetine Hcl C Date:02/25/04ISR Number: 4304133-XReport Type:Expedited (15-DaCompany Report #2004S1000132 Age:88 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dementia Health Clozapine Tabletse Professional 25 Mg Mylan PS Mylan ORAL 25 MG BID, Other 12.5 QD, ORAL Morphone Sulfate C Docusate Sodium C Donepezil C Enalapril Maleate C Famotidine C Fentanyl C Hydrocodone And Acetaminophen C Lorazepam C Paroxetine C Promethazine C Propranolol C Date:02/25/04ISR Number: 4304135-3Report Type:Expedited (15-DaCompany Report #2004S1000431 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine Tablets Polyp Professional 100 Mg Mylan PS Mylan ORAL 600 MG/DAY, Other ORAL Date:02/25/04ISR Number: 4304145-6Report Type:Expedited (15-DaCompany Report #PHEH2004US01788 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Catatonia Clozaril PS Novartis Sector: Initial or Prolonged Convulsion Pharma ORAL UNK, UNK Laboratory Test Abnormal Clozapine SS ORAL UNK, UNK 1440 MIN Medication Error Neutrophil Count Decreased Oral Intake Reduced Pneumonia Aspiration Treatment Noncompliance Date:02/25/04ISR Number: 4304150-XReport Type:Expedited (15-DaCompany Report #PHFR2004GB00772 Age:48 YR Gender:Female I/FU:F Outcome PT Hospitalization - Confusional State Initial or Prolonged Drug Toxicity 22-Feb-2006 08:30 AM Page: 2604 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Fall General Physical Health Deterioration Report Source Product Role Manufacturer Route Dose Duration Heart Rate Decreased Clozaril PS Novartis Sector: Hypotension Pharma ORAL 600mg/day 312 DAY White Blood Cell Count Depakote C UNKNOWN Decreased Lithium Carbonate I UNKNOWN Date:02/25/04ISR Number: 4304151-1Report Type:Expedited (15-DaCompany Report #PHNR2004AU00692 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Level Decreased Clozapine PS Novartis Sector: Initial or Prolonged Treatment Noncompliance Pharma ORAL 450 mg, QD Date:02/25/04ISR Number: 4304153-5Report Type:Expedited (15-DaCompany Report #2004S1000324 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Other Clozapine Tablets 100 Mg Mylan PS Mylan ORAL 350 MG QD & 400 MJG Q HS, ORAL Date:02/25/04ISR Number: 4304155-9Report Type:Expedited (15-DaCompany Report #04-01-0030 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Myocardial Health Clozapine - Ivax Infarction Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 75 MG AM ORAL Abilify C Loxapine C Atenolol C Aspirin C Sinemet C Folic Acid C Date:02/25/04ISR Number: 4304157-2Report Type:Expedited (15-DaCompany Report #04-02-0281 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Colon Cancer Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 200-600 MG QD ORAL 22-Feb-2006 08:30 AM Page: 2605 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/04ISR Number: 4304159-6Report Type:Expedited (15-DaCompany Report #04-01-0074 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Other Clozapine - Ivax Pharmaceuticals, Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 600 MG QD ORAL Date:02/25/04ISR Number: 4304160-2Report Type:Expedited (15-DaCompany Report #04-02-0283 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Gastrointestinal Health Clozapine - Ivax Hospitalization - Carcinoma Professional Pharmaceuticals, Initial or Prolonged Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 36.5-200 MG QD ORAL Date:02/25/04ISR Number: 4304161-4Report Type:Expedited (15-DaCompany Report #04-02-0273 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Neoplasm Malignant Health Clozapine - Ivax Other Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 12.5-600 MG QD ORAL Date:02/26/04ISR Number: 4304821-5Report Type:Expedited (15-DaCompany Report #PHEH2003US10891 Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiac Tamponade Health Clozaril PS Novartis Sector: Hospitalization - Chest Pain Professional Pharma ORAL 500 mg, QD 4596 DAY Initial or Prolonged Constipation Paxil C Disability Dyspnoea Depakote C Other Dyspnoea Exertional Buspar C Hyperthyroidism Ambien C Pericardial Drainage Nexium Pericardial Effusion Pericardial Excision /Usa/ C Pericarditis Pleural Effusion Polyserositis Date:02/26/04ISR Number: 4305193-2Report Type:Expedited (15-DaCompany Report #FI-GLAXOSMITHKLINE-B0323267A Age:59 YR Gender:Female I/FU:F Outcome PT Hospitalization - Abasia Initial or Prolonged Drug Interaction Drug Toxicity Somnolence 22-Feb-2006 08:30 AM Page: 2606 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Urinary Incontinence Report Source Product Role Manufacturer Route Dose Duration Consumer Lamictal PS Glaxosmithkline ORAL 150MG Per day Leponex SS ORAL 500MG Per day Cipramil C ORAL Stesolid C ORAL Femoston Conti C ORAL Milk Magnesium C Glaxosmithkline ORAL Date:02/26/04ISR Number: 4305198-1Report Type:Expedited (15-DaCompany Report #GB-GLAXOSMITHKLINE-B0323849A Age:38 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiomegaly Lithium PS Glaxosmithkline UNKNOWN Initial or Prolonged Drug Interaction Clozaril SS ORAL 400MG Per day 2 YR Drug Level Increased Date:02/26/04ISR Number: 4305492-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12420022 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutropenia Health Abilify PS Otsuka Initial or Prolonged Psychotic Disorder Professional Pharmaceutical Company, Ltd. ORAL Clozapine SS Risperdal C Zoloft C Date:02/26/04ISR Number: 4307430-7Report Type:Expedited (15-DaCompany Report #2004009242 Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anaemia Foreign Zoloft (Sertraline) PS ORAL 50 MG, ORAL Life-Threatening Diabetes Mellitus Health Fluconazole Non-Insulin-Dependent Professional (Fluconazole) SS ORAL ORAL Gastric Cancer Repaglinide Hallucination (Repaglinide) SS Lung Infection Alimemazine Psychotic Disorder (Alimemazine) SS ORAL ORAL Thrombocytopenia Metformine (Metformin Hydrochloride) SS ORAL ORAL Clozapine (Clozapine) SS ORAL ORAL Heptaminol (Heptaminol) C Domperidone (Domperidone) C Aluminum Phosphate (Aluminium Phosphate) C Sucralfate (Sucralfate) C Macrogol 4000 (Macrogol) C Ferrous Sulfate (Ferrous Sulfate) C 22-Feb-2006 08:30 AM Page: 2607 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Alginate, Bicarbonate, Aluminum Hydroxide C Date:02/26/04ISR Number: 4307543-XReport Type:Expedited (15-DaCompany Report #2004-DE-00740GD Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Food Poisoning Foreign Loperamide Hospitalization - Gastroenteritis Literature (Loperamide) PS 6 MG (NR), NR Initial or Prolonged Gastroenteritis Bacillus Clozapine Megacolon (Clozapine) SS 500 MG (NR), NR Date:02/27/04ISR Number: 4306890-5Report Type:Expedited (15-DaCompany Report #GB-GLAXOSMITHKLINE-B0323823A Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Level Increased Lithium PS Glaxosmithkline UNKNOWN Eating Disorder Clozaril SS ORAL 650MG Per day Malaise Neutrophilia White Blood Cell Count Increased Date:02/27/04ISR Number: 4306910-8Report Type:Expedited (15-DaCompany Report #PHHO2004NZ01210 Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bronchopneumonia Clozaril PS Novartis Sector: Drug Level Increased Pharma ORAL Drug Screen Positive Temazepam SS Respiratory Depression Morphine SS Paroxetine C Valproic Acid C Date:02/27/04ISR Number: 4307076-0Report Type:Expedited (15-DaCompany Report #PHBS2004IE00476 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Exposure Health Clozaril PS Novartis Sector: Initial or Prolonged Circulatory Collapse Professional Pharma 500 mg, UNK Other Medication Error Date:02/27/04ISR Number: 4307077-2Report Type:Expedited (15-DaCompany Report #PHNR2004AU00450 Age:34 YR Gender:Male I/FU:F Outcome PT Hospitalization - Blood Cholesterol Initial or Prolonged Increased Blood Glucose Increased Blood Triglycerides Increased Malaise Nausea Polydipsia 22-Feb-2006 08:30 AM Page: 2608 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Polyuria Tremor Vomiting Report Source Product Role Manufacturer Route Dose Duration Health Clozaril PS Novartis Sector: Professional Pharma 12 - 500 mg/day Clozaril SS Novartis Sector: Pharma 12 - 600 mg/day Sertraline C ORAL 200 mg, QD Esomeprazole C ORAL 20 mg, QD Date:02/27/04ISR Number: 4307078-4Report Type:Expedited (15-DaCompany Report #PHNU2003DE03979 Age:42 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Health Leponex / Clozaril Initial or Prolonged Haemoglobin Decreased Professional (Clozapine) PS Novartis Sector: Iron Deficiency Anaemia Pharma ORAL up to 200 mg/day Tiapridex C ORAL Date:02/27/04ISR Number: 4307080-2Report Type:Expedited (15-DaCompany Report #PHFR2004GB00556 Age:73 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Health Clozaril PS Novartis Sector: Open Wound Professional Pharma ORAL 77760MIN Date:02/27/04ISR Number: 4309485-2Report Type:Expedited (15-DaCompany Report #PHHO2004NZ01233 Age:18 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chest Pain Clozaril PS Novartis Sector: Depressed Mood Pharma ORAL 275 mg, QD 17280MIN Diarrhoea Olanzapine C 7.5 mg, QD 194 DAY Headache Quetiapine C 400 mg, BID Insomnia Quetiapine C Titrating Nausea down Photophobia gradually Pleuritic Pain Quetiapine C 50 mg, QD Pyrexia Rash Restlessness Sedation Tachycardia Vomiting Date:02/27/04ISR Number: 4309488-8Report Type:Expedited (15-DaCompany Report #PHRM2004FR00950 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Gastrointestinal Health Trileptal PS Novartis Sector: Hypomotility Professional Pharma ORAL Subileus Leponex SS ORAL 22-Feb-2006 08:30 AM Page: 2609 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/01/04ISR Number: 4308514-XReport Type:Expedited (15-DaCompany Report #PHEH2004US02194 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Concomitant Disease Clozaril PS Novartis Sector: Progression Pharma ORAL 300 mg, QD Death Klonopin C Cardizem C Glucotrol C Claritin C Prevacid C Lipitor C Celebrex C Zyprexa C Avandia C Depakote C Cogentin C Date:03/01/04ISR Number: 4309945-4Report Type:Expedited (15-DaCompany Report #2004S1000485 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg PS ORAL 12.5 MG QD, Other ORAL Date:03/01/04ISR Number: 4309946-6Report Type:Expedited (15-DaCompany Report #2004S1000471 Age:83 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan OPHTHALMIC 25 MG, QD, Other ORAL Clozapine Tablets 100 Mg Mylan SS Mylan ORAL 100 MG QD, ORAL Date:03/01/04ISR Number: 4309947-8Report Type:Expedited (15-DaCompany Report #2004S1000469 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 600 MG/DAY, Other ORAL Date:03/01/04ISR Number: 4309948-XReport Type:Expedited (15-DaCompany Report #2004S1000352 Age:78 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan 100 MG Q PM Other Clozapine Tablets 25 Mg Mylan SS Mylan 50 MG Q AM Selegiline C Sorbitol C Metoprolol C Docusate C Bromocriptine C 22-Feb-2006 08:30 AM Page: 2610 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Carbidopa/Levodopa C Diazepam C Acetaminophen C Bisacodyl C Morphine Sulfate C Date:03/02/04ISR Number: 4308883-0Report Type:Expedited (15-DaCompany Report #PHBS2004NO02514 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Infection Leponex PS Novartis Sector: Hospitalization - Appendicitis Perforated Pharma UNKNOWN 300 mg, QD Initial or Prolonged Cardiac Arrest Anaesthetics C Myocarditis Date:03/02/04ISR Number: 4308884-2Report Type:Expedited (15-DaCompany Report #PHFR2004GB01100 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Emotional Distress Clozaril PS Novartis Sector: Other Toxic Shock Syndrome Pharma ORAL 125mg mane & White Blood Cell Count 225mg nocte Decreased Date:03/02/04ISR Number: 4308901-XReport Type:Expedited (15-DaCompany Report #PHEH2004US02195 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Clozaril PS Novartis Sector: Neutropenia Pharma ORAL 375 mg/day Non-Hodgkin'S Lymphoma Chemotherapeutics,Ot her SS UNK, UNK Prozac C Cogentin C Ativan C Haldol "Janssen" C Date:03/02/04ISR Number: 4309094-5Report Type:Expedited (15-DaCompany Report #CA-GLAXOSMITHKLINE-A0499895A Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Lamictal PS Glaxosmithkline ORAL 100MG Twice Phosphokinase Increased per day Fall Clozaril SS UNKNOWN 25MG Twice Hypoventilation per day 8 DAY Neuroleptic Malignant Acetaminophen C Glaxosmithkline Syndrome Ativan C Neutrophilia Bromocriptine C Pleural Effusion Celebrex C Pneumonia Aspiration Clindamycin C Respiratory Acidosis Flovent C Glaxosmithkline Thrombophlebitis Furosemide C Glaxosmithkline Haloperidol C Nicotine C Glaxosmithkline Pantoloc C Salbutamol C Glaxosmithkline Cipro C Glaxosmithkline 22-Feb-2006 08:30 AM Page: 2611 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Ipratropium C Ranitidine C Glaxosmithkline Date:03/02/04ISR Number: 4309438-4Report Type:Expedited (15-DaCompany Report #PHBS2004CA02548 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Gases Abnormal Clozaril PS Novartis Sector: Eosinophil Count Pharma ORAL Increased Oxygen Saturation Abnormal Pneumonitis Date:03/02/04ISR Number: 4309441-4Report Type:Expedited (15-DaCompany Report #PHBS2004BE02545 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depressed Level Of Consumer Leponex PS Novartis Sector: Initial or Prolonged Consciousness Pharma UNKNOWN Drug Withdrawal Syndrome Leponex SS Novartis Sector: Extrapyramidal Disorder Pharma UNKNOWN 100 mg/d Gastrointestinal Disorder Leponex SS Novartis Sector: General Physical Health Pharma UNKNOWN 50 mg/d Deterioration Xanax C UNKNOWN Influenza Rivotril C UNKNOWN Insomnia Antihypertensives C UNKNOWN Tardive Dyskinesia Tremor Vomiting Date:03/02/04ISR Number: 4310980-0Report Type:Expedited (15-DaCompany Report #200301950 Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Interaction Foreign Imodium Rx Capsules Drug Level Above Literature (Loperamide Hc1 2 Mg Therapeutic Health Per Capsule) 2 Gastroenteritis Professional Mg/Capsule PS ORAL 6 MG PO Haematemesis Other Clozapine SS ORAL 500 MG DAILY Intra-Abdominal PO Haemorrhage Loss Of Consciousness Megacolon Necrotising Colitis Procedural Complication Shock Date:03/03/04ISR Number: 4310404-3Report Type:Expedited (15-DaCompany Report #PHBS2004CA01949 Age:36 YR Gender:Male I/FU:F Outcome PT Other Anaemia Blood Triglycerides Increased Myoclonus Psychotic Disorder 22-Feb-2006 08:30 AM Page: 2612 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tachycardia Report Source Product Role Manufacturer Route Dose Duration Health Clozaril PS Novartis Sector: Professional Pharma ORAL 350 mg/d Clozaril SS Novartis Sector: Pharma 350 mg/d Effexor C UNKNOWN 75 mg/d Date:03/03/04ISR Number: 4310405-5Report Type:Expedited (15-DaCompany Report #PHFR2004GB00857 Age:30 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dizziness Health Clozaril PS Novartis Sector: Initial or Prolonged Hypotension Professional Pharma ORAL Other Medication Error Clozaril SS Novartis Sector: Orthostatic Hypotension Pharma 250mg Clozaril SS Novartis Sector: Pharma ORAL 250 mg, BID Paroxetine C ORAL 30 mg/day Benzhexol C 1 mg, BID Date:03/03/04ISR Number: 4310407-9Report Type:Expedited (15-DaCompany Report #PHFR2004IE00518 Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dizziness Health Clozaril (Clozapine) PS Novartis Sector: Initial or Prolonged Medication Error Professional Pharma ORAL UNK, UNK Somnolence Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL 400mg overdose - treatment break Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL 300 mg, BID Date:03/03/04ISR Number: 4310412-2Report Type:Expedited (15-DaCompany Report #PHNR2004AU00702 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aortic Valve Incompetence Clozaril PS Novartis Sector: Echocardiogram Abnormal Pharma ORAL 12.5 - 300 mg Vomiting daily Venlafaxine C 75 mg, QD Date:03/03/04ISR Number: 4310489-4Report Type:Expedited (15-DaCompany Report #PHFR2004GB01184 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Clozaril PS Novartis Sector: Somnolence Pharma ORAL 50mg mane 175mg nocte Clozaril SS Novartis Sector: Pharma ORAL 500mg mane medication error 22-Feb-2006 08:30 AM Page: 2613 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/03/04ISR Number: 4310490-0Report Type:Expedited (15-DaCompany Report #PHFR2003GB02587 Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiomyopathy Health Clozaril PS Novartis Sector: Electrocardiogram St Professional Pharma ORAL 150mg/day Segment Elevation Clozaril SS Novartis Sector: Sinus Tachycardia Pharma ORAL 175mg/day Date:03/03/04ISR Number: 4310495-XReport Type:Expedited (15-DaCompany Report #PHBS2004HK02775 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Catecholamines Clozapine PS Novartis Sector: Initial or Prolonged Increased Pharma UNKNOWN 25 mg/d Drug Ineffective Clozapine SS Novartis Sector: Headache Pharma UNKNOWN 300 mg/d Hypertension Clozapine SS Novartis Sector: Norepinephrine Increased Pharma UNKNOWN 150 mg/d Pseudophaeochromocytoma Date:03/03/04ISR Number: 4310895-8Report Type:Expedited (15-DaCompany Report #04-03-0313 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Lung Neoplasm Malignant Health Clozapine - Ivax Professional Pharmaceuticals, Inc. Tablets PS Ivax Pharmaceuticals ORAL 325-750MG QD ORAL Date:03/03/04ISR Number: 4310898-3Report Type:Expedited (15-DaCompany Report #04-02-0312 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals ORAL 12.5-25MG QD ORAL Date:03/03/04ISR Number: 4310901-0Report Type:Expedited (15-DaCompany Report #04-02-0289 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Respiratory Arrest Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 400-800MG QD ORAL Date:03/03/04ISR Number: 4310903-4Report Type:Expedited (15-DaCompany Report #04-02-0296 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrolyte Imbalance Clozapine - Ivax Initial or Prolonged Hypersensitivity Pharmaceuticals, Inc. Tablets PS ORAL 300MG QD ORAL 22-Feb-2006 08:30 AM Page: 2614 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/03/04ISR Number: 4310906-XReport Type:Expedited (15-DaCompany Report #04-02-0298 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Health Clozapine - Ivax Choking Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals ORAL 600MG QD ORAL Date:03/03/04ISR Number: 4310907-1Report Type:Expedited (15-DaCompany Report #04-03-0300 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dehydration Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 100-750MG QD ORAL Date:03/03/04ISR Number: 4310909-5Report Type:Expedited (15-DaCompany Report #04-01-0024 Age:54 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chronic Lymphocytic Health Clozapine - Ivax Leukaemia Professional Pharmaceuticals, White Blood Cell Count Other Inc. Tablets PS Ivax Decreased Pharmaceuticals, Inc. ORAL SEE IMAGE Propranlol C Oxybutynin C Chemotherapy C Date:03/03/04ISR Number: 4310918-6Report Type:Expedited (15-DaCompany Report #04-02-0293 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Alcohol Use Health Clozapine - Ivax Completed Suicide Professional Pharmaceuticals, Treatment Noncompliance Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 200-300MG QD ORAL Alcohol C Ketamin C Date:03/03/04ISR Number: 4311586-XReport Type:Direct Company Report #CTU 213683 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anxiety Clozapine 200 Mg Drug Toxicity Ivax PS Ivax ORAL 3 X DAILY Psychotic Disorder ORAL Salivary Hypersecretion Vomiting 22-Feb-2006 08:30 AM Page: 2615 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/04/04ISR Number: 4310979-4Report Type:Expedited (15-DaCompany Report #PHHO2003CA08903 Age:27 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Autonomic Nervous System Clozaril PS Novartis Sector: Other Imbalance Pharma 25 mg / day 4320 MIN Body Temperature Zyprexa C Increased Hypertension Renal Neoplasm Tachycardia Date:03/04/04ISR Number: 4310989-7Report Type:Expedited (15-DaCompany Report #PHEH2004US02326 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dehydration Clozaril PS Novartis Sector: Initial or Prolonged Liver Function Test Pharma ORAL UNK, UNK 3650 DAY Other Abnormal Anafranil C Pneumonia Renal Failure Date:03/04/04ISR Number: 4311812-7Report Type:Expedited (15-DaCompany Report #WAES 0402USA01726 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Back Pain Zetia PS Merck & Co., Inc ORAL 12 DAY Death Clozapine SS ORAL Muscle Spasms Clozapine SS ORAL Clozapine SS ORAL Clozapine SS ORAL Albuterol Sulfate C Glucotrol C Micro-K Extencaps C Seroquel C Seroquel C Atarax C Lasix (Furosemide) C Xanax C Depakote C Monopril C Xanax C Date:03/04/04ISR Number: 4312802-0Report Type:Expedited (15-DaCompany Report #DSA_24010_2004 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Circulatory Collapse Foreign Ativan PS Initial or Prolonged Confusional State Health Clozaril SS ORAL 5000 MG ONCE Other Overdose Professional PO Other Clozaril SS ORAL 500 MG ONCE PO Temazepam SS 22-Feb-2006 08:30 AM Page: 2616 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/05/04ISR Number: 4311909-1Report Type:Expedited (15-DaCompany Report #PHEH2004US02403 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Clozaril PS Novartis Sector: Pharma ORAL 100mg am+300mg QHS Seroquel C Depakote C Celexa C Ativan C Date:03/05/04ISR Number: 4312044-9Report Type:Expedited (15-DaCompany Report #PHEH2004US02531 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sleep Apnoea Syndrome Clozaril PS Novartis Sector: Pharma ORAL 350 mg/day Date:03/05/04ISR Number: 4312464-2Report Type:Expedited (15-DaCompany Report #PHNU2003DE04242 Age:21 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Appendicectomy Health Leponex / Clozaril Initial or Prolonged Arrhythmia Professional (Clozapine) PS Novartis Sector: Other Hernia Repair Pharma ORAL 300 mg/day Incisional Hernia Leponex / Clozaril Laparotomy (Clozapine) SS Novartis Sector: Overweight Pharma ORAL 600mg/day Postoperative Ileus Beta Blocking Agents C UNKNOWN Unknown Sinus Tachycardia Somnolence Treatment Noncompliance Date:03/05/04ISR Number: 4312473-3Report Type:Expedited (15-DaCompany Report #PHFR2004GB00916 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutrophil Count Clozaril PS Novartis Sector: Increased Pharma ORAL 350mg/day Platelet Count Increased Omeprazole C ORAL 20mg/day Respiratory Tract Hyoscine C ORAL 300-600 Infection ug/day White Blood Cell Count Valproate Sodium C ORAL 800mg/day Increased Paroxetine C UNKNOWN 30mg/day Date:03/05/04ISR Number: 4312546-5Report Type:Expedited (15-DaCompany Report #PHFR2004GB01196 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Eosinophilic Myocarditis Clozaril PS Novartis Sector: Other Neutrophil Count Pharma ORAL 100mg mane/ Increased 200mg nocte White Blood Cell Count Benzhexol C ORAL 2 mg, BID Increased Risperidone C INTRAMUSCULAR 50 mg, BIW Risperdal C ORAL 2 mg, BID Depakote C ORAL 750mg/nocte 22-Feb-2006 08:30 AM Page: 2617 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/05/04ISR Number: 4312650-1Report Type:Expedited (15-DaCompany Report #2004S1000338 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pharmaceutical Product Health Clozapine Tablets Complaint Professional 100 Mg Mylan PS Mylan ORAL 500MG/DAY, Other ORAL Date:03/05/04ISR Number: 4312652-5Report Type:Expedited (15-DaCompany Report #C2003-3301.01 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Toxicity Health Clozapine Tablets Pharmaceutical Product Professional 100 Mg Mylan PS Mylan ORAL 300MG Q HS, Complaint Other ORAL Date:03/05/04ISR Number: 4312654-9Report Type:Expedited (15-DaCompany Report #04-02-0297 Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 25-125MG QD ORAL Date:03/05/04ISR Number: 4312760-9Report Type:Expedited (15-DaCompany Report #04-03-0311 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neoplasm Malignant Health Clozapine Tablets - Professional Ivax Pharmaceuticls, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 700-750MG QD ORAL Date:03/05/04ISR Number: 4312761-0Report Type:Expedited (15-DaCompany Report #04-02-0299 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Cancer Recurrent Health Clozapine Tablets - Professional Ivax Pharmaceuticls, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 175-725MG QD ORAL Date:03/05/04ISR Number: 4312763-4Report Type:Expedited (15-DaCompany Report #04-01-0134 Age:23 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hypothermia Health Clozapine Tablets - Professional Ivax Pharmaceuticls, Other Inc. PS Ivax 22-Feb-2006 08:30 AM Page: 2618 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pharmaceuticals, Inc. ORAL 325MG BID ORAL Trazodone C Lorazepam C Date:03/05/04ISR Number: 4312764-6Report Type:Expedited (15-DaCompany Report #01-12-0683 Age:20 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Alcohol Use Consumer Clozapine Tablets - Anxiety Ivax Pharmaceuticls, Diarrhoea Inc. PS Ivax Drug Toxicity Pharmaceuticals, Nausea Inc. ORAL 300MG QHS Psychotic Disorder ORAL Salivary Hypersecretion Clozapine Tablets SS ORAL 300MG QHS Vomiting ORAL Lorazepam C Date:03/05/04ISR Number: 4312765-8Report Type:Expedited (15-DaCompany Report #04-03-0320 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dehydration Health Clozapine Tablets - Initial or Prolonged Ileus Professional Ivax Pharmaceuticls, Required White Blood Cell Count Inc. PS Ivax Intervention to Increased Pharmaceuticals, Prevent Permanent Inc. ORAL 800-300MG QHS Impairment/Damage ORAL Artane SS 5MG TID Lithium Carbonate C Geodon C Prozac C Date:03/05/04ISR Number: 4312997-9Report Type:Direct Company Report #CTU 213918 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Clozapine 100 Mg Initial or Prolonged Salivary Hypersecretion Ivax PS Ivax ORAL 100 MG Q AM Syncope ORAL Clozapine 100 Mg Ivax SS Ivax ORAL 400 MG QHS ORAL Ec Asa C Folic Acid C Lactulose C Risperdal C Trazodone C Apap C Bisacodyl C Ibuprofen C Maalox C Mom C Fluvoxamine C 22-Feb-2006 08:30 AM Page: 2619 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/08/04ISR Number: 4313197-9Report Type:Expedited (15-DaCompany Report #PHNU2003DE03105 Age:53 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Pain Leponex / Clozaril Other Aspiration (Clozapine) PS Novartis Sector: Cardiomegaly Pharma ORAL 250mg/day 27360MIN Drug Level Above Pirenzepine SS ORAL 50mg/day Therapeutic Leponex / Clozaril Gastrointestinal (Clozapine) SS Novartis Sector: Haemorrhage Pharma ORAL 400mg/day 4320 MIN Gastrointestinal Motility Pirenzepine SS ORAL 25mg/day 4320 MIN Disorder Leponex / Clozaril Haematemesis (Clozapine) SS Novartis Sector: Hepatic Congestion Pharma ORAL 500mg/day Ileus Paralytic Leponex / Clozaril Mallory-Weiss Syndrome (Clozapine) SS Novartis Sector: Nausea Pharma ORAL 25 to 150 Oesophagitis mg/day 10080MIN Renal Disorder Leponex / Clozaril Respiratory Failure (Clozapine) SS Novartis Sector: Resuscitation Pharma ORAL 450mg/day 15840MIN Shock Haemorrhagic Concor C ORAL 2.5mg/day Spleen Congestion Amaryl C ORAL 2mg/day Urinary Incontinence Diazepam C ORAL 4mg/day 5760 MIN Vomiting Diazepam C ORAL 2mg/day 4320 MIN Bifiteral "Solvay Arzneimittel" C ORAL 23040MIN Diazepam C ORAL 1mg/day 2880 MIN Diazepam C ORAL 3mg/day 8640 MIN Diazepam C ORAL 5mg/day 7200 MIN Slow Sodium C ORAL 2df/day Ximovan "Aventis Pharma" I ORAL 7.5mg/day Date:03/08/04ISR Number: 4313662-4Report Type:Expedited (15-DaCompany Report #PHHO2003CA13861 Age:29 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Abuser Clozaril PS Novartis Sector: Pharma 400 mg / hs Amisulpride SS Oxcarbazepine SS Metformin SS Date:03/09/04ISR Number: 4314295-6Report Type:Expedited (15-DaCompany Report #PHNU2004DE01007 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Accidental Exposure Health Clozapine PS Novartis Sector: Drug Screen Positive Professional Pharma UNKNOWN Unknown Drug Toxicity Loss Of Consciousness 22-Feb-2006 08:30 AM Page: 2620 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/09/04ISR Number: 4314355-XReport Type:Expedited (15-DaCompany Report #PHFR2003GB01323 Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Health Clozaril PS Novartis Sector: Hospitalization - Cardiomegaly Professional Pharma ORAL 100mg/mane Initial or Prolonged Cardiomyopathy 250mg/nocte Other Dyspnoea Haloperidol SS 10mg Dyspnoea Exertional Haloperidol SS 20mg Electrocardiogram Haloperidol SS 30mg Abnormal Clonazepam SS 2mg Exercise Tolerance Clonazepam SS 6.5mg Decreased Clonazepam SS 8mg Fear Hallucination Heart Rate Increased Hyperventilation Hypoxia Mental Impairment Myocarditis Obesity Paranoia Pulmonary Embolism Pulmonary Oedema Right Ventricular Failure Sleep Apnoea Syndrome Snoring Weight Increased Date:03/10/04ISR Number: 4314699-1Report Type:Expedited (15-DaCompany Report #PHNR2004AU00503 Age:20 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Clozaril PS Novartis Sector: Cataplexy Pharma 12.5 - 600 Circulatory Collapse mg/day Electroencephalogram Clozaril SS Novartis Sector: Abnormal Pharma 500 mg/day Hypotonia Amisulpride C 400 mg/day Date:03/10/04ISR Number: 4314803-5Report Type:Expedited (15-DaCompany Report #PHEH2004US02590 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Clozaril PS Novartis Sector: Initial or Prolonged Pharma ORAL UNK,UNK Date:03/10/04ISR Number: 4314818-7Report Type:Expedited (15-DaCompany Report #PHEH2004US02533 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cellulitis Clozaril PS Novartis Sector: Initial or Prolonged Pharma ORAL 350 mg/day 22-Feb-2006 08:30 AM Page: 2621 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/10/04ISR Number: 4315066-7Report Type:Expedited (15-DaCompany Report #PHFR2004GB01266 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Colitis Ulcerative Clozapine PS Novartis Sector: Initial or Prolonged Inflammatory Bowel Pharma ORAL 38880MIN Disability Disease Paroxetine C ORAL 30mg/day Intestinal Obstruction Valproate Sodium C ORAL 1.5 g/day Procyclidine C 5 mg, BID Diazepam C ORAL 5 mg, BID Augmentin Bd C ORAL 375 mg, TID 11520MIN Haloperidol C ORAL 1mg BID + PRN 3mg up to BID Date:03/10/04ISR Number: 4315071-0Report Type:Expedited (15-DaCompany Report #PHFR2004GB00992 Age:64 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Investigation Abnormal Clozaril PS Novartis Sector: Initial or Prolonged Leukoerythroblastic Pharma ORAL Anaemia Platelet Count Decreased Red Blood Cell Count Increased Red Blood Cell Spherocytes Present White Blood Cell Count Increased Date:03/10/04ISR Number: 4315165-XReport Type:Expedited (15-DaCompany Report #04-03-0336 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neoplasm Malignant Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL ORAL Date:03/10/04ISR Number: 4315825-0Report Type:Expedited (15-DaCompany Report #S04-CAN-00872-01 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Chest Pain Foreign Celexa (Citalopram Convulsion Health Hydrobromide) PS ORAL 40 MG QD PO Drug Interaction Professional Celexa (Citalopram Drug Toxicity Other Hydrobromide) SS ORAL 20 MG QD PO Loss Of Consciousness Imipramine SS ORAL 300 MG QD PO Sudden Death Imipramine SS ORAL 25 MG QD PO Clozapine SS Epival (Valproate Semisodium) C 22-Feb-2006 08:30 AM Page: 2622 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/10/04ISR Number: 4316267-4Report Type:Periodic Company Report #HQ5049305NOV2002 Age:23 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Alkaline Health Protonix Phosphatase Increased Professional (Pantoprazole, Blood Creatine Tablet, Delayed Phosphokinase Increased Release) PS 40 MG 1 XP Jaundice Cholestatic PER 1 DAY Clozapine (Clozapine, ) SS ORAL 300 MG DAILY, ORAL Date:03/11/04ISR Number: 4315221-6Report Type:Expedited (15-DaCompany Report #PHFR2003GB02587 Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiomyopathy Clozaril PS Novartis Sector: Electrocardiogram St Pharma ORAL 150mg/day 255 DAY Segment Elevation Clozaril SS Novartis Sector: Sinus Tachycardia Pharma ORAL 175mg/day Date:03/11/04ISR Number: 4315225-3Report Type:Expedited (15-DaCompany Report #PHHO2003CA13412 Age:79 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Respiratory Arrest Clozaril PS Novartis Sector: Hospitalization - Pharma ORAL 25 mg, QD Initial or Prolonged Glyburide C Tylenol C Gabapentin C Date:03/11/04ISR Number: 4315226-5Report Type:Expedited (15-DaCompany Report #PHFR2004GB01025 Age:36 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Exposure Clozaril PS Novartis Sector: Initial or Prolonged Medication Error Pharma ORAL 14x100mg + 4 x 25mg over 2wks 20160MIN Trifluoperazine C ORAL Procyclidine C ORAL Chlorpromazine C ORAL Lithium C Sertraline C ORAL Date:03/11/04ISR Number: 4315543-9Report Type:Expedited (15-DaCompany Report #PHEH2004US02690 Age:31 YR Gender:Female I/FU:I Outcome PT Other Adrenal Insufficiency Anorexia Convulsion Diarrhoea Drug Withdrawal Syndrome Fatigue Grand Mal Convulsion Muscular Weakness 22-Feb-2006 08:30 AM Page: 2623 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Nausea Petit Mal Epilepsy Vision Blurred Report Source Product Role Manufacturer Route Dose Duration Visual Acuity Reduced Clozaril PS Novartis Sector: Vomiting Pharma ORAL 250 mg/day Weight Decreased Phenobarbital C Paxil C Date:03/11/04ISR Number: 4315549-XReport Type:Expedited (15-DaCompany Report #PHEH2004US02679 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Interaction Clozaril PS Novartis Sector: Drug Interaction Pharma ORAL 600 mg/day 3650 DAY Potentiation Celexa SS Ear, Nose And Throat Atenolol C Examination Prevacid C Sleep Apnoea Syndrome Cardura C Sudden Death Reglan /Usa/ C Zocor "Dieckmann" C Date:03/11/04ISR Number: 4315589-0Report Type:Expedited (15-DaCompany Report #PHFR2002GB02152 Age:27 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Clozaril PS Novartis Sector: Pharma ORAL 500mg/day Date:03/12/04ISR Number: 4316053-5Report Type:Expedited (15-DaCompany Report #PHNR2004AU00746 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Clozaril PS Novartis Sector: Alanine Aminotransferase Pharma ORAL 12.5 - 500 Increased mg/day Aspartate Aminotransferase Increased Blood Glucose Increased Blood Triglycerides Increased Diabetes Mellitus Hepatomegaly Nausea Date:03/12/04ISR Number: 4316054-7Report Type:Expedited (15-DaCompany Report #PHFR2004GB00938 Age:27 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - C-Reactive Protein Clozaril PS Novartis Sector: Initial or Prolonged Increased Pharma ORAL 25920MIN Haematuria Epilim C ORAL 1500 mg, QD Protein Urine Present Pyrexia Urinary Tract Infection 22-Feb-2006 08:30 AM Page: 2624 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/04ISR Number: 4316581-2Report Type:Expedited (15-DaCompany Report #2004S1000598 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional 100 Mg Mylan PS ORAL 100 GM Q AM & Other 300MG Q HS, ORAL 2 YR Date:03/12/04ISR Number: 4316582-4Report Type:Expedited (15-DaCompany Report #2004S1000606 Age:66 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Neoplasm Malignant Health Clozapine Tablets 25 Professional Mg Mylan PS Other Clozapine Tablets 100 Mg Mylan SS Mylan Date:03/12/04ISR Number: 4316583-6Report Type:Expedited (15-DaCompany Report #2004S1000607 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional 100 Mg Mylan PS Other Date:03/12/04ISR Number: 4316585-XReport Type:Expedited (15-DaCompany Report #04-01-0181 Age:53 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hypoxia Health Clozapine-Ivax Pulmonary Embolism Professional Pharmaceuticals, Respiratory Failure Other Inc. Tablets PS ORAL 300MG QHS ORAL Flovent C Atrovent C Theophylline C Toprol Xl C Date:03/12/04ISR Number: 4316586-1Report Type:Expedited (15-DaCompany Report #04-01-0125 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Myocardial Health Clozapine-Ivax Infarction Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 400-450MG QD ORAL Date:03/12/04ISR Number: 4317485-1Report Type:Expedited (15-DaCompany Report #2004UW04222 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Agranulocytosis Health Seroquel PS Intervention to Professional Clozapine SS Prevent Permanent Motrin C Impairment/Damage Vistaril C 22-Feb-2006 08:30 AM Page: 2625 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/15/04ISR Number: 4317299-2Report Type:Direct Company Report #CTU 214421 Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Grand Mal Convulsion Clozapine 100 Mg Po Intervention to Q Am, 150 Mg Po Qhs PS ORAL 100MG PO Q AM Prevent Permanent 150 MG PO Impairment/Damage QHS Valproic Acid C Date:03/15/04ISR Number: 4317718-1Report Type:Expedited (15-DaCompany Report #PHEH2004US02590 Age:80 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coma Clozaril PS Novartis Sector: Hospitalization - Pneumonia Pharma ORAL UNK,UNK Initial or Prolonged Date:03/15/04ISR Number: 4317736-3Report Type:Expedited (15-DaCompany Report #PHHO2004CH03412 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cognitive Disorder Leponex PS Novartis Sector: Initial or Prolonged Confusional State Pharma 300 mg, QD 197 DAY Dementia Alzheimer'S Type Leponex SS Novartis Sector: Depression Pharma 150 mg, QD 10080MIN Disorientation Leponex SS Novartis Sector: Dizziness Pharma 100 mg, QD 1440 MIN Fatigue Leponex SS Novartis Sector: Pharma 75 mg, QD Depakine C Seropram C Date:03/15/04ISR Number: 4317785-5Report Type:Expedited (15-DaCompany Report #PHFR2003GB04865 Age:57 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Clozaril PS Novartis Sector: Initial or Prolonged Convulsion Pharma ORAL Other Coordination Abnormal Clozaril SS Novartis Sector: Drug Level Increased Pharma ORAL 500 mg/day 195 DAY Loss Of Consciousness Clozaril SS Novartis Sector: Myoclonus Pharma ORAL 400 mg/day Transient Ischaemic Clozaril SS Novartis Sector: Attack Pharma ORAL 425 mg/day Aspirine C ORAL 75 mg/day Simvastatin C ORAL 10 mg/day Ferrous Sulphate C ORAL 600 mg/day Citalopram C ORAL 40 mg/day Citalopram C ORAL 60 mg/day Lansoprazole C ORAL 15 mg/day Date:03/15/04ISR Number: 4318407-XReport Type:Expedited (15-DaCompany Report #2004UW03376 Age:31 YR Gender:Male I/FU:F Outcome Required Intervention to 22-Feb-2006 08:30 AM Page: 2626 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Agranulocytosis Foreign Seroquel PS Leukopenia Study Clozaril SS Neutropenia Health Topamax SS Professional Lamotrigine C Other Epival C Date:03/15/04ISR Number: 4318715-2Report Type:Expedited (15-DaCompany Report #2004UW03398 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Granulocytopenia Foreign Seroquel PS ORAL 800 MG DAILY Intervention to Literature PO Prevent Permanent Health Clozaril SS Impairment/Damage Professional Other Date:03/15/04ISR Number: 4321050-XReport Type:Periodic Company Report #PHEH2003USA06782 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Health Trileptal White Blood Cell Count Professional (Oxcarbazepine) Decreased Company Tablet PS Representative Clozapine (Clozapine) SS Date:03/16/04ISR Number: 4317978-7Report Type:Expedited (15-DaCompany Report #PHNR2004AU00455 Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Clozaril PS Novartis Sector: Initial or Prolonged Blood Creatine Pharma 12.5 - 300 Other Phosphokinase Increased mg/day Fall Clozaril SS Novartis Sector: Injury Pharma 12.5 - 100 Muscle Injury mg/day Psychotic Disorder Date:03/16/04ISR Number: 4318020-4Report Type:Expedited (15-DaCompany Report #WAES 0205USA03417 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Vioxx PS Merck & Co., Inc ORAL Cardio-Respiratory Arrest Chlorpromazine SS Coma Clozapine SS Gastric Haemorrhage Naproxen SS 2 DAY Weight Decreased Naproxen SS 4 DAY Naproxen SS 4 DAY Naproxen SS Naproxen SS 1 DAY Naproxen SS 2 DAY Naproxen SS Naproxen SS 1 DAY Ascorbic Acid C 2 DAY 22-Feb-2006 08:30 AM Page: 2627 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Vitamins (Unspecified) C Oxycodone C Oxycodone C Nefazodone Hydrochloride C ORAL Chlorzoxazone C Gabapentin C ORAL Levothyroxine Sodium C Gabapentin C ORAL Folic Acid C Clonazepam C Ascorbic Acid C ORAL Date:03/16/04ISR Number: 4318611-0Report Type:Direct Company Report #CTU 214457 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Interaction Clozaril 25mg In Am White Blood Cell Count And 50mg At Bedtime PS 25MG IN AM Decreased AND 50MG AT BEDTIME Topamax C Zoloft C Inderal La C Zyprexa C Date:03/16/04ISR Number: 4319529-XReport Type:Expedited (15-DaCompany Report #S04-USA-01058-01 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Interaction Health Celexa (Citalopram Drug Level Increased Professional Hydrobromide) PS ORAL 40 MG QD PO Company Celexa (Citalopram Representative Hydrobromide) SS Clozaril (Clozapine) SS 600 MG QD Clozaril (Clozapine) SS Atenolol C Prevacid (Lansoprazole) C Cardura (Doxazosin Mesilate) C Reglan (Metoclopramide) C Zocor C Date:03/16/04ISR Number: 4319802-5Report Type:Expedited (15-DaCompany Report #2004S1000071 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Chronic Obstructive Health Clozapine Tablets Pulmonary Disease Professional 100 Mg Mylan PS Mylan ORAL 100MG QID, Other ORAL 22-Feb-2006 08:30 AM Page: 2628 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/16/04ISR Number: 4319806-2Report Type:Expedited (15-DaCompany Report #04-03-0360 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozapine PS Ivax Hypertension Professional Pharmaceuticals, Respiratory Failure Other Inc. ORAL 100MG QD ORAL Date:03/16/04ISR Number: 4319808-6Report Type:Expedited (15-DaCompany Report #04-03-0369 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine PS ORAL 500-550MG QD Professional ORAL Other Date:03/16/04ISR Number: 4319811-6Report Type:Expedited (15-DaCompany Report #04-03-0315 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Health Clozapine PS Ivax Professional Pharmaceuticals, Other Inc. ORAL 25 - 500MG QD ORAL Date:03/17/04ISR Number: 4318317-8Report Type:Expedited (15-DaCompany Report #WAES 0402USA01726 Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Back Pain Zetia PS Merck & Co., Inc ORAL 12 DAY Death Clozapine SS ORAL Hypercholesterolaemia Clozapine SS ORAL Muscle Spasms Clozapine SS ORAL Clozapine SS Clozapine SS ORAL Clozapine SS Albuterol Sulfate C Micro-K Extencaps C Seroquel C Seroquel C Atarax C Xanax C Monopril C Lasix (Furosemide) C Glucotrol C Depakote C Xanax C Date:03/17/04ISR Number: 4318604-3Report Type:Expedited (15-DaCompany Report #04-03-0378 Age:76 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Respiratory Arrest Health Clozapine Tablets - Upper Respiratory Tract Professional Ivax Infection Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 150-300 MG QD 22-Feb-2006 08:30 AM Page: 2629 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL Date:03/17/04ISR Number: 4320563-4Report Type:Expedited (15-DaCompany Report #2004UW02283 Age:73 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bowel Sounds Abnormal Health Amitriptyline PS ORAL 25 MG HS PO Initial or Prolonged Confusional State Professional Clozapine SS ORAL 75 MG QD PO Required Disorientation Paxil SS ORAL 20 MG PO Intervention to Fall Stalevo SS DOSAGE Prevent Permanent Nausea DECREASED Impairment/Damage Pneumonia Aspiration FROM 4 TO 3 Vomiting TABLETS DAILY Date:03/18/04ISR Number: 4318560-8Report Type:Expedited (15-DaCompany Report #PHEH2004US02768 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Clozaril PS Novartis Sector: Initial or Prolonged Drug Level Increased Pharma ORAL 300 mg/day 33120MIN Electrocardiogram Zyprexa C Abnormal Electrocardiogram T Wave Abnormal Hepatomegaly Hypotension Laboratory Test Abnormal Pneumonia Aspiration Splenomegaly Troponin Increased Date:03/18/04ISR Number: 4318583-9Report Type:Expedited (15-DaCompany Report #PHEH2004US02852 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Catatonia Clozaril PS Novartis Sector: Initial or Prolonged Leukopenia Pharma ORAL UNK,UNK Other Pyrexia Risperidone C Date:03/18/04ISR Number: 4318799-1Report Type:Expedited (15-DaCompany Report #GB-GLAXOSMITHKLINE-B0325878A Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aspiration Consumer Paroxetine PS Glaxosmithkline UNKNOWN Initial or Prolonged Intentional Overdose Clozaril SS ORAL 450MG Per day Respiratory Failure Zopiclone SS UNKNOWN Somnolence Rabeprazole SS UNKNOWN Date:03/18/04ISR Number: 4319495-7Report Type:Expedited (15-DaCompany Report #04-03-0310 Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 100-400MG QD 22-Feb-2006 08:30 AM Page: 2630 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL Date:03/18/04ISR Number: 4319499-4Report Type:Expedited (15-DaCompany Report #04-03-0382 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine - Ivax Respiratory Syncytial Professional Pharmaceuticals, Virus Infection Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 25-50MG QD ORAL Date:03/18/04ISR Number: 4319500-8Report Type:Expedited (15-DaCompany Report #04-03-0379 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Choking Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL ORAL Date:03/18/04ISR Number: 4319501-XReport Type:Expedited (15-DaCompany Report #04-03-0381 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Choking Health Clozapine - Ivax Injury Asphyxiation Professional Pharmaceuticals, Myocardial Infarction Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 300MG QD ORAL Date:03/18/04ISR Number: 4320859-6Report Type:Expedited (15-DaCompany Report #2004S1000652 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Health Clozapine Tablets Initial or Prolonged Diabetes Mellitus Professional 100 Mg PS ORAL 400 MG QD, Other Myocardial Infarction ORAL Platelet Count Increased Metoprolol Succinate C White Blood Cell Count Nitroglycerin Decreased Transdermal System C Ezetimibe C Insulin C Sertraline C Topiramate C Date:03/18/04ISR Number: 4320864-XReport Type:Expedited (15-DaCompany Report #04-03-0380 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine-Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax ORAL 50MG QD ORAL 22-Feb-2006 08:30 AM Page: 2631 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/18/04ISR Number: 4320867-5Report Type:Expedited (15-DaCompany Report #04-03-0398 Age:66 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sepsis Health Clozapine-Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax ORAL 50-250MG QD ORAL Date:03/18/04ISR Number: 4320963-2Report Type:Expedited (15-DaCompany Report #2004S1000650 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Neoplasm Malignant Health Clozapine Tablets Myocardial Infarction Professional 100 Mg Mylan PS Mylan ORAL 200MG Q AM & Sudden Death Other 400MG Q HS, ORAL Date:03/18/04ISR Number: 4320966-8Report Type:Expedited (15-DaCompany Report #2004S1000033 Age:37 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Breast Cancer Health Clozapine Tablets Metastases To Bone Professional 100 Mg Mylan PS Mylan ORAL 100 MG BID Other AND 200MG Q HS, ORAL Date:03/19/04ISR Number: 4319337-XReport Type:Expedited (15-DaCompany Report #PHRM2004FR00950 Age:39 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Enema Administration Trileptal PS Novartis Sector: Initial or Prolonged Gastrointestinal Pharma ORAL 2400 mg daily 115 DAY Hypomotility Leponex SS ORAL 600 mg daily Gastrointestinal Motility Disorder Subileus Date:03/19/04ISR Number: 4319347-2Report Type:Expedited (15-DaCompany Report #PHFR2004GB01355 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatinine Clozaril PS Novartis Sector: Increased Pharma Confusional State Lithium SS 800mg/day Renal Disorder Lithium SS 400mg/day Date:03/19/04ISR Number: 4319348-4Report Type:Expedited (15-DaCompany Report #PHNR2004AU00750 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Groin Pain Clozaril PS Novartis Sector: Initial or Prolonged Malignant Neoplasm Pharma ORAL 12.5 - 400 Progression mg/day Testis Cancer Vascular Stenosis 22-Feb-2006 08:30 AM Page: 2632 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/19/04ISR Number: 4319353-8Report Type:Expedited (15-DaCompany Report #PHNU2004DE01216 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypertension Leponex / Clozaril Initial or Prolonged Norepinephrine Increased (Clozapine) PS Novartis Sector: Pseudophaeochromocytoma Pharma ORAL Unknown Tachycardia Date:03/19/04ISR Number: 4319355-1Report Type:Expedited (15-DaCompany Report #PHFR2002GB03056 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anorexia Clozaril (Clozapine) PS Novartis Sector: Initial or Prolonged Cholangitis Pharma ORAL 400 mg/day 51840MIN Cholelithiasis Carbamazepine SS ORAL 500mg/day 73440MIN Chromaturia Haloperidol C ORAL 15 mg, BID Diarrhoea Modecate "Squibb" C INTRAMUSCULAR 50mg/day 36000MIN Dry Skin Modecate "Squibb" C INTRAMUSCULAR 50 mg, QW 36000MIN Dysphagia Depixol C INTRAMUSCULAR 500 mg, QW Fatigue Hepatitis Jaundice Leukopenia Liver Function Test Abnormal Nausea Neutropenia Pyrexia Rash Maculo-Papular Rash Pruritic Skin Exfoliation Tachycardia Date:03/19/04ISR Number: 4319888-8Report Type:Expedited (15-DaCompany Report #PHNU2004DE01178 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Brain Oedema Leponex / Clozaril Initial or Prolonged Grand Mal Convulsion (Clozapine) PS Novartis Sector: Other Hyponatraemia Pharma ORAL 450 mg/day Polydipsia Leponex / Clozaril Water Intoxication (Clozapine) SS Novartis Sector: Pharma ORAL 150 mg/day Haldol Decanoate C Date:03/19/04ISR Number: 4319894-3Report Type:Expedited (15-DaCompany Report #PHNR2004AU00757 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatic Failure Clozaril PS Novartis Sector: Renal Failure Pharma 200 - 800 mg/day 22-Feb-2006 08:30 AM Page: 2633 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/19/04ISR Number: 4319900-6Report Type:Expedited (15-DaCompany Report #PHNR2004AU00776 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyspnoea Clozaril PS Novartis Sector: Eosinophil Count Pharma ORAL 75 - 600 Increased mg/day Exercise Tolerance Decreased Neutrophil Count Increased Pericardial Effusion Sleep Apnoea Syndrome Weight Increased White Blood Cell Count Increased Date:03/19/04ISR Number: 4319902-XReport Type:Expedited (15-DaCompany Report #PHNU2004DE01068 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - C-Reactive Protein Leponex / Clozaril Initial or Prolonged Increased (Clozapine) PS Novartis Sector: Other Drug Interaction Pharma ORAL 50 mg/day Drug Level Increased Leponex / Clozaril General Physical (Clozapine) SS Novartis Sector: Condition Abnormal Pharma ORAL 400 mg/day Pyrexia Lamotrigine SS ORAL 100 mg/day Respiratory Failure Cipramil C ORAL 20 mg/day Urosepsis Aponal C ORAL 50 mg/day Tavor C ORAL 2 mg/day Alpha Lipoic Acid C Date:03/19/04ISR Number: 4322007-5Report Type:Expedited (15-DaCompany Report #2004-DE-01024GD(0) Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Disorder Literature Lithium Carbonate Initial or Prolonged Cogwheel Rigidity (Lithium Carbonate) PS 450 MG (IN Delusion DIVIDED Dysarthria DOSES) Gait Disturbance Clozapine Pleurothotonus (Clozapine) SS 150 MCG Therapy Non-Responder Aripiprazole Tremor (Aripiprazole) SS 15 MG Venlafaxine (Venlafaxine) C Date:03/22/04ISR Number: 4320471-9Report Type:Expedited (15-DaCompany Report #PHEH2004US02941 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Clozaril PS Novartis Sector: Initial or Prolonged B-Cell Lymphoma Pharma ORAL 400 mg/day Leukopenia Antineoplastic Lymphadenopathy Agents SS Prednisone SS Effexor C Ambien C 22-Feb-2006 08:30 AM Page: 2634 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prazosin C Date:03/22/04ISR Number: 4320478-1Report Type:Expedited (15-DaCompany Report #PHFR2004GB01028 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Clozaril PS Novartis Sector: Dysphemia Pharma ORAL 75mg mane, Myoclonus 250mg nocte Tic Disulfiram C UNKNOWN Antidepressants C UNKNOWN Cipramil C ORAL 30 mg, QD Acamprosate C ORAL 666mg/day Date:03/22/04ISR Number: 4320479-3Report Type:Expedited (15-DaCompany Report #PHNU2004DE01205 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Leponex / Clozaril Abnormal (Clozapine) PS Novartis Sector: Electrocardiogram Pharma ORAL Repolarisation Abnormality Endocarditis Date:03/22/04ISR Number: 4320488-4Report Type:Expedited (15-DaCompany Report #PHNU2004DE01213 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Distension Leponex / Clozaril Initial or Prolonged C-Reactive Protein (Clozapine) PS Novartis Sector: Increased Pharma ORAL up to 300 Concomitant Disease mg/day Aggravated Leponex / Clozaril Constipation (Clozapine) SS Novartis Sector: Gastric Disorder Pharma ORAL up to 900 Gastric Ulcer mg/day Ileus Impaired Gastric Emptying Leukocytosis Nausea Oesophagogastroscopy Pyrexia Reflux Oesophagitis Small Intestinal Stenosis Vomiting X-Ray Gastrointestinal Tract Abnormal Date:03/22/04ISR Number: 4320841-9Report Type:Expedited (15-DaCompany Report #PHEH2004US03084 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Interaction Clozaril PS Novartis Sector: Other Drug Level Increased Pharma ORAL 600 mg/day Ventricular Hypertrophy Celexa SS ORAL 40 mg/day Atenolol C 22-Feb-2006 08:30 AM Page: 2635 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prevacid C Cardura C Reglan /Usa/ C Zocor "Dieckmann" C Date:03/22/04ISR Number: 4320900-0Report Type:Expedited (15-DaCompany Report #PHBS2004NL03449 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancreatitis Leponex PS Novartis Sector: Initial or Prolonged Poisoning Pharma ORAL Date:03/22/04ISR Number: 4321058-4Report Type:Expedited (15-DaCompany Report #PHFR2004GB01099 Age:51 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acquired Immunodeficiency Clozaril PS Novartis Sector: Hospitalization - Syndrome Pharma ORAL 350mg/day 1092 DAY Initial or Prolonged Hiv Test Positive Other Leukopenia Malaise Neutropenia Platelet Count Decreased Pneumocystis Jiroveci Pneumonia Pneumonia Bacterial Sepsis Superinfection Lung Date:03/22/04ISR Number: 4321061-4Report Type:Expedited (15-DaCompany Report #PHFR2004GB01393 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Faecaloma Clozapine PS Novartis Sector: Large Intestinal Pharma ORAL 300 mg, QD Obstruction Nifedipine C ORAL 40 mg, BID Large Intestine Doxazosin C ORAL 4 mg, BID Perforation Bendrofluazide C ORAL 2.5 mg, QD Candesartan C ORAL 10 mg, QD Beclometasone C UNKNOWN 2 UNK, QD Amisulpride C ORAL 250 mg, BID Date:03/22/04ISR Number: 4321221-2Report Type:Direct Company Report #CTU 214926 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neutrophil Count Clozapine 100 Mg Decreased Ivax PS Ivax ORAL 300 MG MORNING ORAL,400 MG BEDTIME ORAL . C Atenolol C Clotrimazole Cream C Docusate C 22-Feb-2006 08:30 AM Page: 2636 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Famotidine C Simvastatin C Date:03/22/04ISR Number: 4321345-XReport Type:Direct Company Report #CTU 214937 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Obsessive-Compulsive Clozapine 100 Mg Tab Disorder (Ivax) PS ORAL 300 MG HS PO Date:03/22/04ISR Number: 4323330-0Report Type:Expedited (15-DaCompany Report #RS004307-GB Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aspiration Foreign Rabeprazole Initial or Prolonged Overdose (Rabeprazole Sodium) PS ORAL ORAL Respiratory Disorder Clozaril (Clozapine) SS ORAL 450 MG, ORAL Somnolence Zopiclone (Zopiclone) SS Paroxetine (Paroxetine) SS Date:03/23/04ISR Number: 4321196-6Report Type:Expedited (15-DaCompany Report #PHBS2004IE03684 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Accidental Exposure Clozaril PS Novartis Sector: Loss Of Consciousness Pharma ORAL 100 mg, Respiratory Depression ONCE/SINGLE 1440 MIN Antidepressants C UNKNOWN Date:03/23/04ISR Number: 4321201-7Report Type:Expedited (15-DaCompany Report #PHHO2003CA08903 Age:27 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Autonomic Nervous System Clozaril PS Novartis Sector: Other Imbalance Pharma 25 mg / day Body Temperature Zyprexa C Increased Hypertension Renal Disorder Renal Neoplasm Tachycardia Date:03/23/04ISR Number: 4322001-4Report Type:Expedited (15-DaCompany Report #PHHO2004CA01959 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bronchitis Health Clozaril PS Novartis Sector: Initial or Prolonged Leukopenia Professional Pharma ORAL Unspecified 612 DAY Neutropenia Divalproex Sodium C Urinary Tract Infection 22-Feb-2006 08:30 AM Page: 2637 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/23/04ISR Number: 4322003-8Report Type:Expedited (15-DaCompany Report #PHNU2004DE01223 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Leponex / Clozaril Phosphokinase Increased (Clozapine) PS Novartis Sector: Electromyogram Abnormal Pharma ORAL 50 mg/day Muscular Weakness Myalgia Myopathy Date:03/23/04ISR Number: 4322004-XReport Type:Expedited (15-DaCompany Report #PHNU2004DE00799 Age:55 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Leponex / Clozaril Gastric Ulcer Haemorrhage (Clozapine) PS Novartis Sector: Haemoglobin Decreased Pharma ORAL 25mg every 2 days Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL 50mg/day Asa SS ORAL Unknown Bronchoretard C UNKNOWN Unknown Valproic Acid C ORAL Unknown Date:03/23/04ISR Number: 4322006-3Report Type:Expedited (15-DaCompany Report #PHBS2003DK14547 Age:60 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Health Leponex PS Novartis Sector: Initial or Prolonged Blood Albumin Decreased Professional Pharma ORAL Blood Alkaline Leponex SS Novartis Sector: Phosphatase Increased Pharma ORAL 200 mg/d Blood Lactate Serenase C ORAL 10 to 20 mg/d Dehydrogenase Increased Rivotril C UNKNOWN Body Temperature Increased Coagulation Factor Vii Level Decreased Coagulation Factor X Level Decreased Drug Level Increased Feeling Abnormal General Physical Condition Abnormal Laboratory Test Abnormal Liver Disorder Lymphocyte Morphology Abnormal Mania Monocyte Morphology Abnormal Pneumonia Prothrombin Level Decreased 22-Feb-2006 08:30 AM Page: 2638 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/23/04ISR Number: 4322131-7Report Type:Expedited (15-DaCompany Report #PHHO2004CA01755 Age:49 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Infarction Health Clozaril PS Novartis Sector: Professional Pharma Largactil C 150 mg Ativan C 1 mg, TID and 2 mg bedtime Date:03/23/04ISR Number: 4322217-7Report Type:Expedited (15-DaCompany Report #04-03-0397 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abasia Health Clozapine - Ivax Cerebrovascular Accident Professional Pharmaceuticals, Dysphagia Other Inc. Tablets PS Ivax Pharmaceuticals Inc ORAL 900 MG QD ORAL Date:03/23/04ISR Number: 4322220-7Report Type:Expedited (15-DaCompany Report #04-03-0391 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc ORAL 500 MG QD ORAL Date:03/23/04ISR Number: 4322226-8Report Type:Expedited (15-DaCompany Report #04-02-0405 Age:83 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Health Clozapine -Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc ORAL 25-50MG QD ORAL Date:03/23/04ISR Number: 4322237-2Report Type:Expedited (15-DaCompany Report #2004S1000663 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Consumer Clozaril 100 Mg Initial or Prolonged Convulsion Health Novartis PS ORAL ORAL Other Drooling Professional Clozapine Tablets Somnolence Other 100 Mg Mylan SS Mylan ORAL 200 MG Q AM, Weight Increased 500MG Q HS, ORAL Sertraline C Divaloprex Slow Release C 22-Feb-2006 08:30 AM Page: 2639 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/23/04ISR Number: 4322238-4Report Type:Expedited (15-DaCompany Report #2004S1000692 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Cancer Metastatic Other Clozapine Tablets 100 Mg Mylan PS Mylan ORAL 200MG Q AM & 300MG Q HS, ORAL Date:03/23/04ISR Number: 4322243-8Report Type:Expedited (15-DaCompany Report #2004S1000488 Age:42 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Health Clozapine Tablets Weight Increased Professional 100 Mg Mylan PS Mylan ORAL 900 MG QD, Other ORAL Venlafaxine C Risperidone C Citalopram C Furosemide C Warfarin C Omeprazole C Potassium C Albuterol C Topiramate C Extended Phenoytoin C Lamotrigine C Oxybutynin Triamcinolone Inhaler (All For Many Years) C Date:03/23/04ISR Number: 4322244-XReport Type:Expedited (15-DaCompany Report #2004S1000431 Age:50 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Feeling Abnormal Health Clozapine Tablets Myocardial Infarction Professional 100 Mg Mylan PS Mylan ORAL 600MG/DAY, Post Procedural Other ORAL Complication Date:03/23/04ISR Number: 4322245-1Report Type:Expedited (15-DaCompany Report #04-03-0406 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Lung Neoplasm Malignant Health Clozapine-Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc ORAL 150-400MG QD ORAL Carboplatin C Paclitaxel C 22-Feb-2006 08:30 AM Page: 2640 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/24/04ISR Number: 4322584-4Report Type:Expedited (15-DaCompany Report #PHBS2004NZ02076 Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bundle Branch Block Right Health Clozaril PS Novartis Sector: Initial or Prolonged Chest Pain Professional Pharma ORAL 450 mg/d 196 DAY Dyspnoea Clozaril SS Novartis Sector: Electrocardiogram Pharma ORAL UNK, UNK Abnormal Simvastatin C UNKNOWN 40 mg, QD Sleep Apnoea Syndrome Tachycardia Treatment Noncompliance Date:03/24/04ISR Number: 4322586-8Report Type:Expedited (15-DaCompany Report #PHBS2003CA12432 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anticonvulsant Drug Level Health Clozaril PS Novartis Sector: Decreased Professional Pharma ORAL Convulsion Epival SS UNKNOWN Alesse SS ORAL Lithium C UNKNOWN Frisium C UNKNOWN Date:03/24/04ISR Number: 4322591-1Report Type:Expedited (15-DaCompany Report #PHFR2004GB00916 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Body Temperature Health Clozaril PS Novartis Sector: Increased Professional Pharma ORAL 350mg/day Influenza Like Illness Omeprazole C ORAL 20mg/day Lower Respiratory Tract Hyoscine C ORAL 300-600 Infection ug/day Mass Valproate Sodium C ORAL 800mg/day Neutrophil Count Paroxetine C UNKNOWN 30mg/day Increased Platelet Count Increased Respiratory Tract Infection White Blood Cell Count Increased Date:03/24/04ISR Number: 4322598-4Report Type:Expedited (15-DaCompany Report #PHEH2004US02941 Age:51 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Clozaril PS Novartis Sector: Hospitalization - B-Cell Lymphoma Pharma ORAL 400 mg/day Initial or Prolonged Confusional State Antineoplastic Cough Agents SS 8640 MIN Leukopenia Prednisone SS 8640 MIN Lymphadenopathy Effexor C Night Sweats Ambien C Pyrexia Prazosin C 22-Feb-2006 08:30 AM Page: 2641 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/24/04ISR Number: 4323376-2Report Type:Direct Company Report #CTU 215162 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Asthenia Clozapine 25mg Udl Blood Pressure Decreased Labs PS Udl Labs ORAL 25 MG BID PO Cardio-Respiratory Arrest Clozapine 25mg Udl Coma Labs SS Udl Labs ORAL 50 MG BID PO Nausea Date:03/25/04ISR Number: 4323382-8Report Type:Expedited (15-DaCompany Report #CA-GLAXOSMITHKLINE-A0503364A Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Wellbutrin Sr PS Glaxosmithkline 400MG Per day Drug Interaction Clozaril SS ORAL 575MG Per day Drug Level Decreased Dilantin SS Grand Mal Convulsion Clopixol C Therapeutic Response Cogentin C Decreased Fluoxetine C Lamictal C Glaxosmithkline Lamotrigine C Glaxosmithkline Lectopam C Olanzapine C Prozac C Seroquel C Zyprexa C Date:03/25/04ISR Number: 4324031-5Report Type:Expedited (15-DaCompany Report #04-03-0419 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Neoplasm Malignant Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 300-600MG QD ORAL Date:03/25/04ISR Number: 4324070-4Report Type:Expedited (15-DaCompany Report #04-02-0405 Age:83 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 25-50 MG QD ORAL Date:03/25/04ISR Number: 4324072-8Report Type:Expedited (15-DaCompany Report #03-04-0432 Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Myeloid Leukaemia Health Clozapine - Ivax Hospitalization - Leukaemia Recurrent Professional Pharmaceuticals, Initial or Prolonged Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 525MG QD ORAL Chemotherapy C 22-Feb-2006 08:30 AM Page: 2642 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/25/04ISR Number: 4324133-3Report Type:Expedited (15-DaCompany Report #2004S1000752 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Road Traffic Accident Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL SEE IMAGE Other Date:03/25/04ISR Number: 4324181-3Report Type:Expedited (15-DaCompany Report #2004S1000718 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neoplasm Malignant Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL SEE IMAGE Other Doxazosin C Vitamins C Date:03/25/04ISR Number: 4324196-5Report Type:Expedited (15-DaCompany Report #2004S1000144 Age:65 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death General Physical Health Health Clozapine Tablets 25 Deterioration Professional Mg Mylan PS Mylan ORAL 75 MG Q HS, Parkinson'S Disease Other ORAL Respiratory Disorder Albuterol C Cephalexin C Fluticasone Propionate/Salmetero l Xinafoate C Ipratropium Bromide C Metronidazole C Carbidopa/Levodopa C Date:03/26/04ISR Number: 4323634-1Report Type:Expedited (15-DaCompany Report #PHBS2004BE02545 Age:66 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Leponex PS Novartis Sector: Initial or Prolonged Blood Cortisol Increased Pharma UNKNOWN Depressed Level Of Leponex SS Novartis Sector: Consciousness Pharma UNKNOWN 100 mg/d Diarrhoea Leponex SS Novartis Sector: Drug Withdrawal Syndrome Pharma UNKNOWN 50 mg, QHS Dyskinesia Xanax C UNKNOWN Extrapyramidal Disorder Rivotril C UNKNOWN Gastrointestinal Disorder Antihypertensives C UNKNOWN Gastrointestinal Infection General Physical Health Deterioration Insomnia Pyrexia Tardive Dyskinesia Tremor Vomiting 22-Feb-2006 08:30 AM Page: 2643 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/26/04ISR Number: 4323635-3Report Type:Expedited (15-DaCompany Report #PHFR2004GB01247 Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypercholesterolaemia Clozaril PS Novartis Sector: Hyperlipidaemia Pharma ORAL 600mg/day Non-Cardiac Chest Pain Clozaril SS Novartis Sector: Weight Increased Pharma ORAL 550mg/day Multivitamins C Date:03/26/04ISR Number: 4324597-5Report Type:Expedited (15-DaCompany Report #PHNU2004DE01318 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiac Arrest Leponex / Clozaril Hospitalization - Cardiopulmonary Failure (Clozapine) PS Novartis Sector: Initial or Prolonged Diabetes Mellitus Pharma UNKNOWN Unknown Other Drug Withdrawal Syndrome Insomnia Monoparesis Obesity Oedema Resuscitation Schizophrenia Tachycardia Date:03/26/04ISR Number: 4324884-0Report Type:Expedited (15-DaCompany Report #PHFR2003GB04137 Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aggression Consumer Clozaril PS Novartis Sector: Other Death Pharma ORAL Diabetes Mellitus Insulin-Dependent Date:03/29/04ISR Number: 4325429-1Report Type:Expedited (15-DaCompany Report #PHNR2004AU00757 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatic Failure Health Clozaril PS Novartis Sector: Initial or Prolonged Pulmonary Mass Professional Pharma 200 - 800 Other Renal Failure mg/day Date:03/29/04ISR Number: 4325437-0Report Type:Expedited (15-DaCompany Report #PHNR2004AU00702 Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aortic Valve Incompetence Health Clozaril PS Novartis Sector: Diastolic Dysfunction Professional Pharma ORAL 12.5 - 300 mg Echocardiogram Abnormal daily Vomiting Venlafaxine C 75 mg, QD 22-Feb-2006 08:30 AM Page: 2644 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/29/04ISR Number: 4325821-5Report Type:Expedited (15-DaCompany Report #PHHO2003CA16212 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Abscess Health Clozaril PS Novartis Sector: Life-Threatening Acute Respiratory Professional Pharma 350 mg am + Hospitalization - Distress Syndrome hs 3298 DAY Initial or Prolonged Agranulocytosis Apo-Sulfatrim Ds SS 14400MIN Blood Creatinine Apo-Sulfatrim Ds SS UNK, BID 17280MIN Increased Lactulose C Multi-Organ Failure Ranitidine C Neutropenia Amitriptyline C Renal Failure Respiratory Failure Sepsis Septic Shock Surgery Urinary Tract Infection Vomiting White Blood Cell Count Decreased Date:03/29/04ISR Number: 4325824-0Report Type:Expedited (15-DaCompany Report #PHFR2004GB00992 Age:64 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Breast Cancer Health Clozaril PS Novartis Sector: Initial or Prolonged Haemoglobin Decreased Professional Pharma ORAL 450mg/day 1219 DAY Investigation Abnormal Thyroxine C ORAL 100ug/day Leukoerythroblastic Aspirine C ORAL 75mg/day Anaemia Lymphocyte Count Increased Malaise Nucleated Red Cells Platelet Count Decreased Red Blood Cell Spherocytes Present White Blood Cell Count Increased Date:03/29/04ISR Number: 4329928-8Report Type:Expedited (15-DaCompany Report #20040300239 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Overdose Foreign Ativan (Lorazepam) PS Initial or Prolonged Multiple Drug Overdose Health Cipramil (Citalopram Suicide Attempt Professional Hydrobromide) SS 5000 MG Other Clorazil (Clozapine) SS ORAL 500 MG PO Diazepam C Date:03/30/04ISR Number: 4326821-1Report Type:Expedited (15-DaCompany Report #PHFR2004GB01509 Age:39 YR Gender:Male I/FU:I Outcome PT Other Condition Aggravated Confusional State Electrocardiogram Abnormal 22-Feb-2006 08:30 AM Page: 2645 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Electroencephalogram Abnormal Gait Disturbance Report Source Product Role Manufacturer Route Dose Duration Wolff-Parkinson-White Clozaril PS Novartis Sector: Syndrome Pharma ORAL Date:03/30/04ISR Number: 4327165-4Report Type:Expedited (15-DaCompany Report #DE-GLAXOSMITHKLINE-D0043128A Age:82 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypertension Health Zantic PS Glaxosmithkline ORAL 150MG Unknown Initial or Prolonged Miosis Professional Leponex SS ORAL 100MG Unknown Sopor Remergil SS ORAL 30MG Unknown Diane SS ORAL Date:03/30/04ISR Number: 4327587-1Report Type:Direct Company Report #CTU 215552 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Polyserositis Clozaril PS ORAL 50 MG QAM ORAL,100 MG QHS ORAL . C Date:03/31/04ISR Number: 4327637-2Report Type:Expedited (15-DaCompany Report #PHEH2004US02852 Age:50 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Catatonia Health Clozaril PS Novartis Sector: Initial or Prolonged Eating Disorder Professional Pharma ORAL 400 mg/day 3332 DAY Leukopenia Risperidone C ORAL 2.5 mg/day Platelet Count Decreased Psychotic Disorder Pyrexia Unresponsive To Pain Stimuli Date:03/31/04ISR Number: 4328373-9Report Type:Expedited (15-DaCompany Report #PHEH2004US03355 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Ankle Operation Clozaril PS Novartis Sector: Blood Pressure Increased Pharma ORAL 250 mg/day Cholecystectomy Depakote C Constipation Zoloft C Deafness Toprol Xl C Hypertension Ferrous Sulfate C Neutropenia Ketoconazole C Neutrophil Percentage Decreased 22-Feb-2006 08:30 AM Page: 2646 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/31/04ISR Number: 4328776-2Report Type:Expedited (15-DaCompany Report #2004S1000810 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 12.5 MG QD, Other ORAL Date:03/31/04ISR Number: 4328826-3Report Type:Expedited (15-DaCompany Report #04-02-0306 Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Skin Ulcer Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 100-200MG QD ORAL Date:03/31/04ISR Number: 4328831-7Report Type:Expedited (15-DaCompany Report #04-03-0444 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Neoplasm Malignant Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 100-1200MG QD ORAL Date:03/31/04ISR Number: 4328838-XReport Type:Expedited (15-DaCompany Report #04-03-0430 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 375MG QD ORAL Date:03/31/04ISR Number: 4328887-1Report Type:Expedited (15-DaCompany Report #2004S1000119 Age:53 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Health Clozapine Tablets Respiratory Arrest Professional 100 Mg Mylan PS Mylan ORAL 400MG/DAY, Other ORAL Date:03/31/04ISR Number: 4328892-5Report Type:Expedited (15-DaCompany Report #2004S1000777 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Death Death Health Professional 22-Feb-2006 08:30 AM Page: 2647 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Product Role Manufacturer Route Dose Duration Clozapine Tablets 100 Mg Mylan PS Mylan ORAL 300 MG, BID, ORAL Atenolol C Divalproex Sodium C Trazodone C Date:03/31/04ISR Number: 4328896-2Report Type:Expedited (15-DaCompany Report #2004S1000796 Age:77 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 75 MG Q HS, Other ORAL Date:03/31/04ISR Number: 4328903-7Report Type:Expedited (15-DaCompany Report #04-03-0332 Age:82 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anaemia Health Clozapine - Ivax Hospitalization - Aspiration Professional Pharmaceuticals, Initial or Prolonged Decubitus Ulcer Other Inc. Tablets PS Ivax Dehydration Pharmaceuticals, Depression Inc. ORAL 100-275 MG QD Hyponatraemia ORAL Pneumonia Effexor C Amantadine C Date:04/01/04ISR Number: 4328651-3Report Type:Expedited (15-DaCompany Report #PHEH2004US03475 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Clozaril PS Novartis Sector: Seminoma Pharma ORAL UNK, UNK Date:04/01/04ISR Number: 4329662-4Report Type:Expedited (15-DaCompany Report #PHFR2004GB00556 Age:73 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Health Clozaril PS Novartis Sector: Open Wound Professional Pharma ORAL Clozaril SS Novartis Sector: Pharma ORAL 25mg mane & 50mg nocte Gliclazide C ORAL 80 mg, BID Acarbose C ORAL 50 mg, TID Quetiapine C ORAL 25mg/day Co-Beneldopa C ORAL 22-Feb-2006 08:30 AM Page: 2648 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/01/04ISR Number: 4330190-0Report Type:Expedited (15-DaCompany Report #04-03-0448 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Foot Fracture Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 100-650MG QD ORAL Date:04/01/04ISR Number: 4330192-4Report Type:Expedited (15-DaCompany Report #04-03-0466 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 12.5MG QD ORAL Date:04/01/04ISR Number: 4330194-8Report Type:Expedited (15-DaCompany Report #04-03-0468 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neoplasm Malignant Health Clozapine - Ivax White Blood Cell Count Professional Pharmaceuticals, Decreased Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 500MG QD ORAL Chemotherapy Unknown SS Date:04/01/04ISR Number: 4333066-8Report Type:Expedited (15-DaCompany Report #S04-USA-00578-01 Age:36 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Alkaline Health Lexapro ( Initial or Prolonged Phosphatase Increased Professional Escitalopram) PS ORAL 20 MG QD PO Hepatitis Company Clozapine SS 650 MG QD Jaundice Representative Haldol SS 2 MG Q4HR Protein Total Decreased Prevacid (Lansoprazole) C Ferrous Sulfate C Surfak (Docusate Calcium) C Date:04/02/04ISR Number: 4330144-4Report Type:Expedited (15-DaCompany Report #PHFR2004IE01604 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Loss Of Consciousness Clozaril PS Novartis Sector: Initial or Prolonged Medication Error Pharma ORAL 500mg/day Somnolence Clozaril SS Novartis Sector: Pharma ORAL 25mg/day Clozaril SS Novartis Sector: Pharma ORAL 300mg/day 22-Feb-2006 08:30 AM Page: 2649 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/02/04ISR Number: 4330148-1Report Type:Expedited (15-DaCompany Report #PHFR2004GB00992 Age:64 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Breast Cancer Clozaril PS Novartis Sector: Initial or Prolonged Haemoglobin Decreased Pharma ORAL 450mg/day 1219 DAY Investigation Abnormal Thyroxine C ORAL 100ug/day Leukoerythroblastic Aspirine C ORAL 75mg/day Anaemia Lymphocyte Count Increased Malaise Nucleated Red Cells Platelet Count Decreased Red Blood Cell Spherocytes Present White Blood Cell Count Increased Date:04/02/04ISR Number: 4330285-1Report Type:Expedited (15-DaCompany Report #PHFR2004GB00821 Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Upper Clozaril PS Novartis Sector: Initial or Prolonged Haemoptysis Pharma ORAL 275mg mane & 300mg nocte Hyoscine C ORAL 300 ug/day Date:04/02/04ISR Number: 4330288-7Report Type:Expedited (15-DaCompany Report #PHNU2004DE01376 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - General Physical Health Leponex / Clozaril Initial or Prolonged Deterioration (Clozapine) PS Novartis Sector: Migraine Pharma ORAL Unknown Pravidel SS ORAL Unknown Anti-Parkinson Agents SS UNKNOWN Unknown Date:04/02/04ISR Number: 4333621-5Report Type:Expedited (15-DaCompany Report #2004UW05737 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dizziness Health Seroquel PS 200 MG Initial or Prolonged Fall Professional TID-QID Mental Disorder Clozapine SS 200-300 NG Aripiprazole C Lorqzepam C Lexapro C Date:04/05/04ISR Number: 4331074-4Report Type:Expedited (15-DaCompany Report #PHNU2004DE01318 Age: Gender:Male I/FU:F Outcome PT Life-Threatening Cardiac Arrest Hospitalization - Cardiopulmonary Failure Initial or Prolonged Diabetes Mellitus Other Diabetic Complication 22-Feb-2006 08:30 AM Page: 2650 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Drug Withdrawal Syndrome Insomnia Monoparesis Report Source Product Role Manufacturer Route Dose Duration Obesity Leponex / Clozaril Oedema (Clozapine) PS Novartis Sector: Pulmonary Embolism Pharma ORAL between 100 - Resuscitation 300 mg/day Schizophrenia Tachycardia Date:04/05/04ISR Number: 4331172-5Report Type:Expedited (15-DaCompany Report #PHFR2004GB01551 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Clozaril (Clozapine) PS Novartis Sector: Somnolence Pharma Date:04/05/04ISR Number: 4333286-2Report Type:Expedited (15-DaCompany Report #04-03-0441 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Health Clozapine - Ivax Non-Hodgkin'S Lymphoma Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 200-500MG QD ORAL Chemotherapy SS Chemotherapy SS Date:04/05/04ISR Number: 4333289-8Report Type:Expedited (15-DaCompany Report #04-03-0469 Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine - Ivax Respiratory Arrest Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 31.5-500MG QD ORAL Date:04/05/04ISR Number: 4333291-6Report Type:Expedited (15-DaCompany Report #04-03-0474 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Choking Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 75-200MG QD ORAL Date:04/05/04ISR Number: 4333312-0Report Type:Expedited (15-DaCompany Report #FLUV00304000816 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Foreign Floxyfral 100 Initial or Prolonged Overdose Other (Fluvoxamine Psychotic Disorder Maleate) PS ORAL 100 MG QD PO Salivary Hypersecretion Clozapine Panpharma Somnolence (Clozapine) SS ORAL SEE IMAGE Lysanxia 10 Mg 22-Feb-2006 08:30 AM Page: 2651 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Prazepam) C Date:04/06/04ISR Number: 4332632-3Report Type:Expedited (15-DaCompany Report #PHNR2004AU00776 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyspnoea Health Clozaril PS Novartis Sector: Eosinophil Count Professional Pharma ORAL 75 - 600 Increased mg/day Exercise Tolerance Decreased Neutrophil Count Increased Sleep Apnoea Syndrome Weight Increased White Blood Cell Count Increased Date:04/06/04ISR Number: 4333010-3Report Type:Expedited (15-DaCompany Report #PHEH2004US02220 Age:51 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Chills Clozaril PS Novartis Sector: Hospitalization - Diabetes Mellitus Pharma ORAL 400 mg, QD Initial or Prolonged Hypertension Depakote SS 1500 mg, QD Other Myocardial Infarction Pancreatitis Acute Date:04/06/04ISR Number: 4333121-2Report Type:Expedited (15-DaCompany Report #PHFR2004GB01588 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Accidental Exposure Clozaril PS Novartis Sector: Blood Pressure Increased Pharma ORAL 100 mg Sedation overdose Tachycardia Date:04/06/04ISR Number: 4333136-4Report Type:Expedited (15-DaCompany Report #PHHO2004CA04157 Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Clozaril PS Novartis Sector: Initial or Prolonged Pancytopenia Pharma ORAL Unspecified 373 DAY Pantoloc C Topamax C Folic Acid C Motilium C Date:04/06/04ISR Number: 4333606-9Report Type:Expedited (15-DaCompany Report #2004S1000029 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sepsis Health Clozapine Tablets Hospitalization - White Blood Cell Count Professional 100 Mg Mylan PS Mylan ORAL 350MG QD, Initial or Prolonged Decreased Other ORAL 22-Feb-2006 08:30 AM Page: 2652 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/06/04ISR Number: 4335389-5Report Type:Expedited (15-DaCompany Report #2004UW06139 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blindness Other Seroquel PS Intervention to Cardiac Failure Clozaril SS Prevent Permanent Congestive Impairment/Damage Cardiomyopathy Leukocytosis Oedema Peripheral Phlebitis Date:04/08/04ISR Number: 4334641-7Report Type:Expedited (15-DaCompany Report #PHFR2004GB00545 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Clozaril PS Novartis Sector: Initial or Prolonged Drug Withdrawal Pharma ORAL 4847 DAY Convulsions Neutropenia Date:04/08/04ISR Number: 4334920-3Report Type:Expedited (15-DaCompany Report #PHFR2003GB03637 Age:27 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Clozaril PS Novartis Sector: Hospitalization - Cardiac Ventricular Pharma ORAL 700mg/day Initial or Prolonged Disorder Co-Amoxiclav C Circulatory Collapse Amlodipine C Cough Amisulpride C ORAL 100 mg/day Drug Level Increased Augmentin C INTRAVENOUS 1.2 g/day Drug Toxicity Metronidazole C INTRAVENOUS 500 mg/day Dyspnoea Hyperhidrosis Lower Respiratory Tract Infection Pulmonary Congestion Pulmonary Oedema Tachycardia Venoocclusive Liver Disease Date:04/08/04ISR Number: 4335120-3Report Type:Expedited (15-DaCompany Report #PHFR2004GB01024 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Accidental Exposure Health Clozaril PS Novartis Sector: Professional Pharma 300 mg accidental exposure Fluphenazine C INTRAMUSCULAR 200mg/day Chlorpromazine C ORAL 100mg/day Procyclidine C ORAL 5 mg, TID Carbamazepine C ORAL 100 mg, QID Gliclazide C ORAL 80mg/day 22-Feb-2006 08:30 AM Page: 2653 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/08/04ISR Number: 4335122-7Report Type:Expedited (15-DaCompany Report #PHFR2004GB01399 Age:32 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hip Fracture Clozaril PS Novartis Sector: Initial or Prolonged Osteopenia Pharma ORAL 700mg/day Upper Limb Fracture Haloperidol C ORAL 10 mg, TID Date:04/08/04ISR Number: 4335123-9Report Type:Expedited (15-DaCompany Report #PHHO2003CA06628 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Colonic Clozaril PS Novartis Sector: Pseudo-Obstruction Pharma 100 mg, TID Influenza Like Illness Detrol SS Sepsis Clozaril SS Novartis Sector: Pharma 200 mg, QHS Epival C Date:04/08/04ISR Number: 4335127-6Report Type:Expedited (15-DaCompany Report #PHNU2004DE01239 Age:63 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebral Haemorrhage Health Leponex / Clozaril Initial or Prolonged Computerised Tomogram Professional (Clozapine) PS Novartis Sector: Other Abnormal Pharma ORAL up to Epilepsy 300mg/day Solian SS ORAL 200mg/day Date:04/08/04ISR Number: 4335179-3Report Type:Expedited (15-DaCompany Report #PHBS2003BR09811 Age:27 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Health Leponex PS Novartis Sector: Confusional State Professional Pharma ORAL 600 mg/day 183 DAY Constipation Leponex SS Novartis Sector: Difficulty In Walking Pharma ORAL 100 mg, BID Drug Interaction Paroxetine SS ORAL 20 mg, QD Fatigue Tryptanol C 25 mg, QD Hypersomnia Wellbutrin C ORAL 150 mg, QD Irritability Rash Salivary Hypersecretion Somnolence Date:04/08/04ISR Number: 4335763-7Report Type:Expedited (15-DaCompany Report #04-03-0408 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Health Clozapine Tablets PS Ivax Pharmaceuticals Initial or Prolonged Professional Inc ORAL 50-300MG QD Other ORAL 22-Feb-2006 08:30 AM Page: 2654 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/08/04ISR Number: 4335769-8Report Type:Expedited (15-DaCompany Report #04-03-0418 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Gastrointestinal Health Clozapine Tablets PS Ivax Pharmaceuticals Haemorrhage Professional Inc ORAL 50-100MG QD Other ORAL Date:04/08/04ISR Number: 4335771-6Report Type:Expedited (15-DaCompany Report #04-01-0105 Age:65 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coma Health Clozapine Tablets PS Ivax Gastrointestinal Professional Pharmaceuticals, Inc ORAL 150MG QD ORAL Haemorrhage Other Haematemesis Date:04/08/04ISR Number: 4335772-8Report Type:Expedited (15-DaCompany Report #04-03-0467 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Disease Recurrence Health Clozapine Tablets PS Ivax Pharmaceuticals Initial or Prolonged Intestinal Perforation Professional Inc ORAL 400MG QD ORAL Psychotic Disorder Other Volvulus Of Bowel Date:04/08/04ISR Number: 4335773-XReport Type:Expedited (15-DaCompany Report #04-03-0492 Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Myocardial Health Clozapine Tablets PS Ivax Infarction Professional Pharmaceuticals, Inc ORAL 300-450MG QD Other ORAL Date:04/08/04ISR Number: 4335937-5Report Type:Expedited (15-DaCompany Report #2004S1000902 Age:79 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 37.5 MG, QD, Other ORAL Morphine C Lorazepam C Carbidopa/Levodopa C Docusate C Date:04/08/04ISR Number: 4335939-9Report Type:Expedited (15-DaCompany Report #2004S1000692 Age:52 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Cancer Metastatic Other Clozapine Tablets Metastases To Central 100 Mg Mylan PS Mylan ORAL 200 MG Q AM & Nervous System 400MG Q HS, ORAL Divalproex Sodium C 22-Feb-2006 08:30 AM Page: 2655 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/08/04ISR Number: 4335941-7Report Type:Expedited (15-DaCompany Report #2004S1000650 Age:57 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Health Clozapine Tablets Myocardial Infarction Professional 100 Mg Mylan PS Mylan ORAL 200MG Q AM & Sudden Death Other 400MG Q HS, ORAL Date:04/08/04ISR Number: 4337136-XReport Type:Expedited (15-DaCompany Report #HQWYE172026MAR04 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Increased Literature Serax (Oxazepam, Initial or Prolonged Bradycardia Unspec) PS 75 MG 1X PER Cold Sweat 1 DAY Coma Clozapine Drug Interaction (Clozapine) SS INCREASED IN Drug Toxicity INCREMENTS OF Hypersomnia 12.5 MG A Miosis DAY; SEE Muscular Weakness IMAGE Pallor Diazepam (Diazepam) SS 2 MG 3X PER 1 Pulse Pressure Increased DAY Salivary Hypersecretion Haloperidol C Ibuprofen C Pantozol (Pantoprazole) C Date:04/08/04ISR Number: 4337498-3Report Type:Expedited (15-DaCompany Report #2004207315FR Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsive Threshold Foreign Xanax (Alprazolam) Initial or Prolonged Lowered Health Tablet PS ORAL ORAL Depressed Level Of Professional Leponex "Novartis" Consciousness Other (Clozapine) SS Novartis ORAL 600 MG/DAY, Drug Withdrawal ORAL Convulsions Seropram (Citalopram Stress Hydrobromide) C Trismus Imovane C Date:04/09/04ISR Number: 4335338-XReport Type:Expedited (15-DaCompany Report #PHEH2004US01931 Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Circulatory Collapse Clozaril PS Novartis Sector: Overdose Pharma ORAL 400 mg, QHS Sudden Death Desipramine C ORAL 150 mg, QHS Aricept C ORAL 10 mg, QD Ditropan /Usa/ C ORAL 5 mg, TID 22-Feb-2006 08:30 AM Page: 2656 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/09/04ISR Number: 4335705-4Report Type:Expedited (15-DaCompany Report #GB-GLAXOSMITHKLINE-B0328406A Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatinine Consumer Lithium PS Glaxosmithkline UNKNOWN Increased Clozaril SS UNKNOWN Confusional State Renal Disorder Date:04/09/04ISR Number: 4336516-6Report Type:Expedited (15-DaCompany Report #04-04-0508 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL ORAL Date:04/09/04ISR Number: 4336518-XReport Type:Expedited (15-DaCompany Report #04-04-0506 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Throat Cancer Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 400-600MG QD ORAL Date:04/09/04ISR Number: 4338465-6Report Type:Expedited (15-DaCompany Report #HQWYE606305MAR04 Age:75 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Accidental Overdose Literature Serax (Oxazepam, Blood Pressure Decreased Unspec) PS ORAL 10 MG Blood Pressure Systolic (OVERDOSE Increased AMOUNT) Coma Clozapine Drug Effect Increased (Clozapine) SS ORAL 100 MG Feeling Cold (OVERDOSE Hydrocephalus AMOUNT) Leukoaraiosis Norfloxacin Loss Of Consciousness (Norfloxacin) SS ORAL 400 MG Medication Error (OVERDOSE AMUNT) Prednisolone (Prednisolone) C Carbamazepine (Carbamazepine) C Zuclopenthixol (Zuclopenthixol) C 22-Feb-2006 08:30 AM Page: 2657 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/09/04ISR Number: 4338668-0Report Type:Expedited (15-DaCompany Report #04P-167-0255629-00 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acquired Immunodeficiency Foreign Kaletra Soft Gelatin Syndrome Health Capsules Drug Ineffective Professional (Lopinavir/Ritonavir General Physical Health ) PS Deterioration Clozapine SS ORAL 350 MG, 1 IN Leukopenia 1 D, PER ORAL Neutropenia Platelet Count Decreased Pneumocystis Jiroveci Pneumonia Pneumonia Bacterial Sepsis Date:04/09/04ISR Number: 4342127-9Report Type:Periodic Company Report #03P-163-0232123-00 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Leukopenia Other Depakote (Divalproex Intervention to Sodium) (Divalproex Prevent Permanent Sodium) PS Impairment/Damage Clozapine SS ORAL 350MG-600MG DAILY, PER ORAL Date:04/09/04ISR Number: 4342137-1Report Type:Periodic Company Report #03P-163-0237507-00 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Depakote (Divalproex Professional Sodium) (Divalproex Other Sodium) PS 1500 MG Clozapine SS ORAL 400 MG, PER ORAL Risperidone SS 4 MG, 2 IN 1 D Quetiapine SS 800 MG, 1 IN 1 D Date:04/12/04ISR Number: 4336378-7Report Type:Expedited (15-DaCompany Report #PHBS2004IE03684 Age:64 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Accidental Exposure Health Clozaril PS Novartis Sector: Hospitalization - Loss Of Consciousness Professional Pharma ORAL 100 mg, Initial or Prolonged Pneumonia ONCE/SINGLE 1440 MIN Respiratory Depression Chlorpromazine C Zopitan C Date:04/12/04ISR Number: 4336379-9Report Type:Expedited (15-DaCompany Report #PHFR2004GB01677 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Haemoglobin Decreased Clozaril PS Novartis Sector: Pharma ORAL 22-Feb-2006 08:30 AM Page: 2658 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/12/04ISR Number: 4336385-4Report Type:Expedited (15-DaCompany Report #PHFR2004GB00733 Age:28 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Pressure Decreased Clozaril PS Novartis Sector: Body Temperature Pharma ORAL 4320 MIN Increased Valproate Sodium C 500mg/day Chest Pain Olanzapine C 10mg/day Diarrhoea Drug Hypersensitivity Heart Rate Irregular Hyperhidrosis Malaise Wheezing Date:04/12/04ISR Number: 4336386-6Report Type:Expedited (15-DaCompany Report #PHNR2004AU00850 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Antipsychotic Drug Level Health Clozaril PS Novartis Sector: Below Therapeutic Professional Pharma ORAL 200 mg mane + Dysarthria 200 mg nocte 792 DAY Dyskinesia Clozaril SS Novartis Sector: Extrapyramidal Disorder Pharma ORAL 200 mg mane + Gait Disturbance 300 mg nocte Somnolence Epilim C 500 mg, BID Date:04/12/04ISR Number: 4336388-XReport Type:Expedited (15-DaCompany Report #PHNU2004DE00755 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abortion Spontaneous Health Leponex / Clozaril Complications Of Maternal Professional (Clozapine) PS Novartis Sector: Exposure To Therapeutic Pharma ORAL 300 mg/day Drugs Drug Exposure During Pregnancy Pregnancy Date:04/12/04ISR Number: 4336459-8Report Type:Expedited (15-DaCompany Report #PHHO2003CA12428 Age:50 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Infarction Clozaril (Clozapine) PS Novartis Sector: Pharma ORAL 100mg am + 300mg hs 827 DAY Date:04/12/04ISR Number: 4339361-0Report Type:Expedited (15-DaCompany Report #205625 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Study Rituxan (Rituximab) White Blood Cell Count Health Conc For Solution Decreased Professional For Infusion PS INTRAVENOUS INTRAVENOUS Clozapine (Clozapine) SS ORAL 250 MG, BID, ORAL Fludarabine 22-Feb-2006 08:30 AM Page: 2659 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Fludarabine Phosphate) SS Zyprexa (Olanzapine) C Divalproex (Divalproex Sodium) C Date:04/12/04ISR Number: 4339846-7Report Type:Expedited (15-DaCompany Report #2004GB00811 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Seroquel PS Health Clozaril SS Professional Other Date:04/12/04ISR Number: 4339866-2Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20030801932 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Foreign Risperdal Initial or Prolonged Leukopenia Health (Risperidone) Other Thrombocytopenia Professional Tablets PS ORAL ORAL Tongue Neoplasm Malignant Clozapine Stage Unspecified (Clozapine) SS Date:04/13/04ISR Number: 4337254-6Report Type:Expedited (15-DaCompany Report #PHFR2004GB00801 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Level Above Clozaril PS Novartis Sector: Therapeutic Pharma ORAL 650mg/day Neutrophil Count Lithium SS Increased Oral Intake Reduced Urinary Tract Infection White Blood Cell Count Increased Date:04/13/04ISR Number: 4337766-5Report Type:Expedited (15-DaCompany Report #PHEH2004US03825 Age:81 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Parkinson'S Disease Clozaril PS Novartis Sector: Pharma ORAL 150 mg, UNK 2893 DAY Date:04/13/04ISR Number: 4337770-7Report Type:Expedited (15-DaCompany Report #PHEH2004US03832 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chemotherapy Health Clozaril PS Novartis Sector: Leukopenia Professional Pharma ORAL 450 mg/day Non-Hodgkin'S Lymphoma Chemotherapeutics,Ot Spleen Disorder her SS White Blood Cell Count Depakote C Decreased Anafranil C Dilantin C Prevacid C 22-Feb-2006 08:30 AM Page: 2660 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/13/04ISR Number: 4337818-XReport Type:Expedited (15-DaCompany Report #PHNR2004AU00855 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Colostomy Clozaril PS Novartis Sector: Initial or Prolonged Deep Vein Thrombosis Pharma ORAL 12.5 - 500 Other Gastrointestinal Necrosis mg/day General Physical Health Clozaril SS Novartis Sector: Deterioration Pharma PARENTERAL 500 mg via Pyrexia gastric tube Subcutaneous Abscess Date:04/14/04ISR Number: 4338839-3Report Type:Expedited (15-DaCompany Report #US-MERCK-0402USA01726 Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Back Pain Zetia PS Merck & Co., Inc ORAL 12 DAY Life-Threatening Death Clozapine SS ORAL Disability Hypercholesterolaemia Clozapine SS ORAL Low Density Lipoprotein Clozapine SS ORAL Increased Clozapine SS UNKNOWN Muscle Spasms Clozapine SS ORAL Zetia SS Merck & Co., Inc ORAL 12 DAY Clozapine SS UNKNOWN Albuterol Sulfate C UNKNOWN Seroquel C ORAL Seroquel C ORAL Micro-K Extencaps C ORAL Xanax C UNKNOWN Monopril C ORAL Lasix (Furosemide) C ORAL Atarax C UNKNOWN Glucotrol C UNKNOWN Depakote C ORAL Xanax C UNKNOWN Date:04/14/04ISR Number: 4340515-8Report Type:Expedited (15-DaCompany Report #DSA_24040_2004 Age:74 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Coma Literature Lorazepam PS Drug Toxicity Health Lorazepam SS ORAL 1 MG PRN PO Medication Error Professional Clozapine SS 100 MG ONCE Miosis Other Lithium Carbonate SS 400 MG Red Blood Cell Acetaminophen SS 500 MG TID Sedimentation Rate Temazepam SS 10 MG QHS Increased Pimozide C Somnolence Date:04/14/04ISR Number: 4340598-5Report Type:Expedited (15-DaCompany Report #04P-062-0256180-00 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Foreign Akineton Retard Initial or Prolonged Somnolence Health (Akineton) Suicide Attempt Professional (Biperiden) PS ORAL 68 MG, 4 MG X Tachycardia 17, ONCE, PER ORAL Leponex SS ORAL 2000 MG, 100 22-Feb-2006 08:30 AM Page: 2661 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report MG X 20, ONCE, PER ORAL Paroxetine SS ORAL 200 MG, 20 MG X 10, ONCE, PER ORAL Date:04/14/04ISR Number: 4341379-9Report Type:Expedited (15-DaCompany Report #2004S1000933 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan Other Clozapine Tablets 100 Mg Mylan SS Mylan Date:04/14/04ISR Number: 4341380-5Report Type:Expedited (15-DaCompany Report #C2003-3369.01 Age:37 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Breast Cancer Health Clozapine Tablets Metastases To Bone Professional 100 Mg Mylan PS Mylan ORAL 100MG BID AND Other 200MG Q HS ORAL Date:04/14/04ISR Number: 4341417-3Report Type:Expedited (15-DaCompany Report #FLUV00304000816 Age:20 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Foreign Floxyfral 100 Initial or Prolonged Salivary Hypersecretion Other (Fluvoxamine Somnolence Maleate) PS ORAL 100 MG QD PO Clozapine Panpharma (Clozapine) SS Panpharma ORAL SEE IMAGE Lysanxia (Prazepam) C Date:04/15/04ISR Number: 4339505-0Report Type:Expedited (15-DaCompany Report #PHFR2004IE01700 Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Clozaril PS Novartis Sector: Initial or Prolonged Overdose Pharma ORAL 550 mg, Self-Medication ONCE/SINGLE Somnolence Verbal Abuse Date:04/15/04ISR Number: 4339510-4Report Type:Expedited (15-DaCompany Report #PHFR2001GB03263 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Haemoglobin Abnormal Clozaril PS Novartis Sector: Initial or Prolonged Oesophageal Haemorrhage Pharma ORAL 400mg/day 3578 DAY Disability Oesophagitis Lansoprazole C ORAL 250mg/day Other Renal Failure Acute Atenolol C ORAL 25mg/day Vomiting Ferrous Sulphate C ORAL Ensure C ORAL Lactulose C ORAL 20ml/day 22-Feb-2006 08:30 AM Page: 2662 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/15/04ISR Number: 4339514-1Report Type:Expedited (15-DaCompany Report #PHFR2004GB01677 Age:55 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Clozaril PS Novartis Sector: Initial or Prolonged Haemoglobin Decreased Pharma ORAL Other Date:04/15/04ISR Number: 4339518-9Report Type:Expedited (15-DaCompany Report #PHNR2004AU00750 Age:25 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Groin Pain Clozaril PS Novartis Sector: Initial or Prolonged Malignant Neoplasm Pharma ORAL 12.5 - 400 Progression mg/day Testis Cancer Date:04/15/04ISR Number: 4340549-3Report Type:Expedited (15-DaCompany Report #04-04-0515 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neoplasm Malignant Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 400-750MG QD ORAL Date:04/15/04ISR Number: 4340550-XReport Type:Expedited (15-DaCompany Report #04-03-0458 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Malignant Melanoma Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 550 MG QD ORAL Date:04/15/04ISR Number: 4340552-3Report Type:Expedited (15-DaCompany Report #04-04-0533 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aneurysm Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 250-400MG QD ORAL Date:04/15/04ISR Number: 4340554-7Report Type:Expedited (15-DaCompany Report #04-02-0251 Age:50 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Circulatory Collapse Health Clozapine - Ivax Initial or Prolonged Respiratory Arrest Professional Pharmaceuticals, Skin Discolouration Other Inc. Tablets PS ORAL 400MG QHS ORAL 22-Feb-2006 08:30 AM Page: 2663 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/15/04ISR Number: 4340555-9Report Type:Expedited (15-DaCompany Report #04-04-0526 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Health Clozapine - Ivax Pancytopenia Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 300-900MG QD ORAL Date:04/16/04ISR Number: 4339764-4Report Type:Expedited (15-DaCompany Report #PHFR2004GB01731 Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Haemoglobin Decreased Clozaril PS Novartis Sector: Pharma ORAL Date:04/16/04ISR Number: 4339772-3Report Type:Expedited (15-DaCompany Report #PHFR2004GB01160 Age:49 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Body Temperature Clozaril PS Novartis Sector: Increased Pharma ORAL 50mg mane 50 Feeling Abnormal mg nocte Hypertension Clozaril SS Novartis Sector: Influenza Like Illness Pharma ORAL Obesity Chlorpromazine C ORAL 100 mg/day Pharyngolaryngeal Pain Thyroxine C ORAL 125ug/day Tachycardia Lansoprazole C ORAL Upper Respiratory Tract Zotepine C ORAL 200 mg/day Infection Date:04/16/04ISR Number: 4339822-4Report Type:Expedited (15-DaCompany Report #PHFR2004GB01699 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Clozaril PS Novartis Sector: Other Faecaloma Pharma ORAL 700mg/day Intestinal Perforation Myocardial Infarction Vomiting Date:04/19/04ISR Number: 4340854-0Report Type:Expedited (15-DaCompany Report #PHFR2003GB04802 Age:31 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Ejaculation Failure Clozaril PS Novartis Sector: Infertility Male Pharma ORAL 200 mg, QD Fluoxetine C ORAL 40 mg, QD Hyoscine Hydrobromide C ORAL 300 mg, TID Date:04/19/04ISR Number: 4341091-6Report Type:Expedited (15-DaCompany Report #PHFR2004GB01743 Age:31 YR Gender:Male I/FU:I Outcome Life-Threatening Hospitalization - 22-Feb-2006 08:30 AM Page: 2664 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Initial or Prolonged Other PT Report Source Product Role Manufacturer Route Dose Duration Cardio-Respiratory Arrest Clozaril PS Novartis Sector: Dialysis Pharma ORAL 550 mg/day Renal Failure Acute Lamotrigine SS ORAL 150 mg/day Rhabdomyolysis Lorazepam C ORAL Date:04/19/04ISR Number: 4341092-8Report Type:Expedited (15-DaCompany Report #PHBS2004FI00515 Age:55 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Level Increased Leponex PS Novartis Sector: Other Drug Toxicity Pharma UNKNOWN Valproate Sodium C UNKNOWN Date:04/19/04ISR Number: 4341093-XReport Type:Expedited (15-DaCompany Report #PHFR2004IE00800 Age:55 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anticonvulsant Drug Level Clozaril PS Novartis Sector: Decreased Pharma ORAL 550mg/day Cardiac Failure Ramipril C ORAL 10 mg, QD Congestive Frusemide C ORAL 20 mg, QD Convulsion Omeprazole C ORAL 20 mg, QD Drug Level Decreased Aspirine C ORAL 75 mg, QD Ecg Signs Of Myocardial Atorvastatin C ORAL 10 mg, Ischaemia QD/nocte Ejection Fraction Kwells C ORAL UNK, QD Decreased Venlafaxine C ORAL 75mg/day/mane Oedema Peripheral Phenytoin I UNKNOWN 100 mg, TID Pleural Effusion Ventricular Failure Date:04/19/04ISR Number: 4341106-5Report Type:Expedited (15-DaCompany Report #PHHO2004CA03403 Age:53 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Angina Pectoris Clozaril PS Novartis Sector: Arrhythmia Pharma ORAL Asthma Clozaril SS Novartis Sector: Drug Effect Decreased Pharma ORAL Dyspnoea Clozaril SS Novartis Sector: Electrocardiogram Qt Pharma Prolonged Haloperidol C Mitral Valve Incompetence Sinus Tachycardia Tachycardia Tricuspid Valve Incompetence Date:04/20/04ISR Number: 4341905-XReport Type:Expedited (15-DaCompany Report #SE-BRISTOL-MYERS SQUIBB COMPANY-12561676 Age:40 YR Gender:Female I/FU:I Outcome Death Hospitalization - 22-Feb-2006 08:30 AM Page: 2665 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Initial or Prolonged PT Report Source Product Role Manufacturer Route Dose Duration Cardiac Arrest Health Glucophage PS Bristol-Myers Squibb Lactic Acidosis Professional Company ORAL Renal Failure Leponex SS ORAL Zantac C ORAL Akineton C ORAL Theralen C ORAL Glibenclamide C ORAL Novomix C Date:04/20/04ISR Number: 4342473-9Report Type:Expedited (15-DaCompany Report #04-04-0546 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine Ivax Professional Pharmaceuticals Inc Other Tablets PS Ivax Pharmaceuticals, Inc ORAL 500MG QD ORAL Date:04/20/04ISR Number: 4342478-8Report Type:Expedited (15-DaCompany Report #04-04-0545 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Fatigue Health Clozapine Haemorrhage Professional Tablets-Ivax Neoplasm Growth Other Pharmaceuticals, Inc PS Ivax Accelerated Pharmaceuticals, Inc ORAL 750 MG QD ORAL Date:04/20/04ISR Number: 4342498-3Report Type:Expedited (15-DaCompany Report #04-03-0458 Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Malignant Melanoma Health Clozapine Ivax Neoplasm Recurrence Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc ORAL 550 MG QD ORAL Date:04/20/04ISR Number: 4342499-5Report Type:Expedited (15-DaCompany Report #04-04-0560 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Health Clozapine Ivax Initial or Prolonged Lower Limb Fracture Professional Pharmaceuticals Inc Other Tablets PS Ivax Pharmaceuticals, Inc ORAL 250-400MG QD ORAL 22-Feb-2006 08:30 AM Page: 2666 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/20/04ISR Number: 4342502-2Report Type:Expedited (15-DaCompany Report #04-04-0547 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pulmonary Embolism Health Clozapine Ivax Professional Pharmaceuticals Inc Other Tablets PS Ivax Pharmaceuticals, Inc ORAL 150-400MG QD ORAL Date:04/20/04ISR Number: 4342846-4Report Type:Direct Company Report #CTU 216974 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neutrophil Count Clozaril 100 Mg Ivax PS Ivax ORAL 300 MG HS Decreased ORAL Clotrimazole Cream C Risperidone C Lac-Hydrin Lotion C Date:04/20/04ISR Number: 4343091-9Report Type:Expedited (15-DaCompany Report #2004S1000777 Age:53 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablet 100 Professional Mg Mylan PS Mylan ORAL 300 MG, BID, Other ORAL Atenolol C Divalproex Sodium C Trazodone C Date:04/20/04ISR Number: 4343092-0Report Type:Expedited (15-DaCompany Report #2004S1000718 Age:53 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Neoplasm Malignant Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 200 MG Q AM & Other 300 MG Q HS, ORAL Doxazosin C Vitamins C Divalproex Sodium C Folic Acid C Thiamine C Multivitamin C Ziprasidone C Levofloxacin C Date:04/20/04ISR Number: 4343093-2Report Type:Expedited (15-DaCompany Report #2004S1000607 Age:42 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional 100 Mg Mylan PS ORAL 700 MG/DAY, Other ORAL Clonazepam C Levothyroxine C Aspirin C 22-Feb-2006 08:30 AM Page: 2667 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Glipizide Xl C Metformin C Date:04/20/04ISR Number: 4343095-6Report Type:Expedited (15-DaCompany Report #2004S1000431 Age:50 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine Tablets Polyp Professional 100 Mg Mylan PS ORAL 600MG/DAY, Other ORAL Date:04/20/04ISR Number: 4343096-8Report Type:Expedited (15-DaCompany Report #04-04-0509 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Health Clozapine Tablets - Corrected Interval Professional Ivax Prolonged Pharmaceuticals, Electrocardiogram Qt Inc. PS Ivax Pharmaceutcals, Prolonged Inc. ORAL 100MG HS ORAL Ditropan Xl C Lithium C Neurontin C Prevacid C Docusate Sodium C Levothyroxine C Date:04/21/04ISR Number: 4343128-7Report Type:Expedited (15-DaCompany Report #GB-GLAXOSMITHKLINE-B0329693A Age:31 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiopulmonary Failure Lamotrigine PS Glaxosmithkline ORAL 150MG per day 16 WK Hospitalization - Renal Failure Acute Clozaril SS ORAL 550MG per day 677 WK Initial or Prolonged Rhabdomyolysis Lorazepam C ORAL Other Date:04/21/04ISR Number: 4343181-0Report Type:Expedited (15-DaCompany Report #PHFR2002GB00509 Age:57 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Haemoglobin Decreased Clozaril PS Novartis Sector: Initial or Prolonged Nephrotic Syndrome Pharma ORAL 500mg/day Other Renal Transplant Clozaril SS Novartis Sector: Pharma ORAL 300mg/day Mycophenolate Sodium C UNKNOWN Date:04/21/04ISR Number: 4344661-4Report Type:Expedited (15-DaCompany Report #04-04-0559 Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Clozapine - Ivax Initial or Prolonged Fall Professional Pharmaceuticals, Head Injury Other Inc. Tablets PS Ivax Pharmaceuticals, Inc ORAL 150-400 MG QD ORAL 22-Feb-2006 08:30 AM Page: 2668 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/21/04ISR Number: 4344662-6Report Type:Expedited (15-DaCompany Report #04-04-0563 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozapine - Ivax Hospitalization - Pneumonia Professional Pharmaceuticals, Initial or Prolonged Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 25 MG QD ORAL Date:04/22/04ISR Number: 4343497-8Report Type:Expedited (15-DaCompany Report #PHEH2003US08212 Age:23 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Lung Neoplasm Clozaril PS Novartis Sector: Lymphadenectomy Pharma ORAL 300 mg/day Metastatic Neoplasm Clozaril SS Novartis Sector: Orchidectomy Pharma 250 mg, QHS Procedural Complication Depakote C Testis Cancer Date:04/22/04ISR Number: 4344004-6Report Type:Expedited (15-DaCompany Report #US-MERCK-0404USA01539 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Health Cogentin PS Merck & Co., Inc ORAL White Blood Cell Count Professional Clozapine SS ORAL Decreased Depakote SS UNKNOWN Depakote SS UNKNOWN Date:04/22/04ISR Number: 4344148-9Report Type:Expedited (15-DaCompany Report #PHBS2004NL01964 Age:44 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Coma Health Clozapine PS Novartis Sector: Therapeutic Agent Professional Pharma UNKNOWN 12.5 mg/d Toxicity Clozapine SS Novartis Sector: Pharma UNKNOWN 175 mg/d Diazepam C UNKNOWN 2 mg, TID Haloperidol C UNKNOWN 10 mg, TID Ibuprofen C UNKNOWN 200 mg, TID Pantozol C UNKNOWN 40 mg/d Date:04/22/04ISR Number: 4344163-5Report Type:Expedited (15-DaCompany Report #PHBS2004NL01963 Age:77 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Accidental Exposure Health Clozapine PS Novartis Sector: Coma Professional Pharma UNKNOWN 100 mg/d Drug Ineffective Oxazepam SS UNKNOWN 10 mg/d Drug Toxicity Norfloxacin SS UNKNOWN 400 mg/d Medication Error Cisordinol C UNKNOWN 2 mg, TID Prednisolone C UNKNOWN 10 mg/d Prednisolone C UNKNOWN 5mg/d Carbamazepine C UNKNOWN 200 mg, TID Oxazepam C UNKNOWN 10 mg, TID 22-Feb-2006 08:30 AM Page: 2669 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/22/04ISR Number: 4344173-8Report Type:Expedited (15-DaCompany Report #PHFR2000GB01804 Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alcohol Poisoning Health Clozaril PS Novartis Sector: Initial or Prolonged Diabetes Mellitus Professional Pharma ORAL 375mg/day Diabetes Mellitus Propranolol C ORAL 80mg/day Insulin-Dependent Cipramil C ORAL 30mg/day Fall Hyperglycaemia Date:04/22/04ISR Number: 4344176-3Report Type:Expedited (15-DaCompany Report #PHBS2004NL01962 Age:72 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Accidental Exposure Health Clozapine PS Novartis Sector: Coma Professional Pharma UNKNOWN 100 mg/d Drug Ineffective Lorazepam SS UNKNOWN 1 mg/d Medication Error Pimozide C UNKNOWN 6 mg/d Poisoning Lithium Carbonate C UNKNOWN 400 mg/d Acetaminophen C UNKNOWN 500 mg, TID Temazepam C UNKNOWN 10 mg/d Date:04/22/04ISR Number: 4344462-7Report Type:Expedited (15-DaCompany Report #PHFR2004GB01184 Age:27 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Accidental Overdose Clozaril PS Novartis Sector: Haemoglobin Decreased Pharma ORAL 50mg mane Hypotension 175mg nocte Medication Error Clozaril SS Novartis Sector: Somnolence Pharma ORAL 500mg mane medication error Hyoscine C ORAL 300ug nocte Date:04/22/04ISR Number: 4348017-XReport Type:Expedited (15-DaCompany Report #DSA_24010_2004 Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Multiple Drug Overdose Foreign Ativan PS Initial or Prolonged Suicide Attempt Health Cipramil SS ORAL 5000 MG ONCE Professional PO Other Clozaril SS ORAL 500 MG ONCE PO Diazepam SS Paracetamol C Temazepam C Gaviscon C Date:04/22/04ISR Number: 4348116-2Report Type:Expedited (15-DaCompany Report #PHHO2004CA03403 Age:53 YR Gender:Female I/FU:I Outcome PT Other Angina Pectoris Asthma Drug Effect Decreased Dyspnoea 22-Feb-2006 08:30 AM Page: 2670 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Electrocardiogram Qt Prolonged Mitral Valve Incompetence Report Source Product Role Manufacturer Route Dose Duration Tachycardia Foreign Clozaril (Clozapine) Tricuspid Valve Study Tablet PS Incompetence Health Haloperidol C Professional Other Date:04/22/04ISR Number: 4348145-9Report Type:Expedited (15-DaCompany Report #PHBS2004FI00515 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Level Increased Foreign Leponex (Clozapine) Other Drug Toxicity Health Tablet PS UNK, Professional Valproate Sodium C Other Date:04/22/04ISR Number: 4348153-8Report Type:Expedited (15-DaCompany Report #PHFR2003GB04802 Age:31 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Ejaculation Failure Foreign Clozaril (Clozapine) Infertility Male Health Unknown PS ORAL 200 MG QD Professional ORAL Other Fluoxetine (Fluoxetine) C Hyoscine Hydrobromide C Date:04/22/04ISR Number: 4348156-3Report Type:Expedited (15-DaCompany Report #PHFR2004GB01743 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardio-Respiratory Arrest Foreign Clozaril (Clozapine) PS ORAL 550 MG DAY Hospitalization - Renal Failure Acute Health ORAL Initial or Prolonged Rhabdomyolysis Professional Lamotrigine Other Other (Lamotrigine) SS ORAL 150 MG DAY ORAL Lorazepam C Date:04/22/04ISR Number: 4348168-XReport Type:Expedited (15-DaCompany Report #PHFR2004IE00800 Age:55 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiac Failure Foreign Clozaril (Clozapine) PS ORAL 550MG/DAY Congestive Study ORAL Convulsion Health Phenytoin Drug Level Decreased Professional (Phenytoin) C Ecg Signs Of Myocardial Other Ramipril (Ramipril) C Ischaemia Furosemide C Pleural Effusion Venlafaxine Ventricular Failure (Venlafaxine) C Omeprazole (Omeprazole) C Kwells C Aspirine C 22-Feb-2006 08:30 AM Page: 2671 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Atorvastatin C Date:04/23/04ISR Number: 4344758-9Report Type:Expedited (15-DaCompany Report #PHEH2004US02679 Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Interaction Clozaril PS Novartis Sector: Other Drug Level Increased Pharma ORAL UNK, UNK 3650 DAY Pharyngeal Reconstruction Celexa SS ORAL 40 mg, QD Sleep Apnoea Syndrome Atenolol C Sudden Death Prevacid C Uvuloplasty Cardura C Ventricular Hypertrophy Reglan /Usa/ C Zocor "Dieckmann" C Anaesthetics, Local C Date:04/23/04ISR Number: 4344760-7Report Type:Expedited (15-DaCompany Report #PHFR2004GB01670 Age:54 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cold Sweat Clozaril PS Novartis Sector: Initial or Prolonged Convulsion Pharma ORAL 600mg/day Other General Physical Health Clozaril SS Novartis Sector: Deterioration Pharma ORAL 650mg/day Hypertension Clozaril SS Novartis Sector: Loss Of Consciousness Pharma ORAL 700mg/day Obesity Fluoxetine C UNKNOWN 20mg/day Pallor Thyroxine C UNKNOWN 100ug/day Tonic Clonic Movements Tolterodine C UNKNOWN 4mg/day Haloperidol C UNKNOWN 8mg/day Lorazepam C UNKNOWN 1 mg, PRN Date:04/23/04ISR Number: 4345271-5Report Type:Expedited (15-DaCompany Report #PHBS2004DE04996 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Antinuclear Antibody Clozapine PS Novartis Sector: Initial or Prolonged Positive Pharma UNKNOWN 200 mg/d Arthralgia Clozapine SS Novartis Sector: Haemolytic Anaemia Pharma UNKNOWN 200 to 500 Muscle Injury mg/d Myalgia Clozapine SS Novartis Sector: Neuroleptic Malignant Pharma UNKNOWN 200 mg/d Syndrome Clozapine SS Novartis Sector: Pericardial Effusion Pharma UNKNOWN 50 mg/d Pleural Effusion Clozapine SS Novartis Sector: Red Blood Cell Pharma UNKNOWN 300 mg/d Sedimentation Rate Increased Skin Disorder Systemic Lupus Erythematosus 22-Feb-2006 08:30 AM Page: 2672 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/23/04ISR Number: 4345967-5Report Type:Expedited (15-DaCompany Report #2004S1001042 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Clozapine Tablets Initial or Prolonged Pharmaceutical Product Professional Ivax PS Ivax ORAL ORAL Complaint Other Clozapine Tablets Mylan SS Mylan ORAL ORAL Date:04/23/04ISR Number: 4345990-0Report Type:Expedited (15-DaCompany Report #04-02-0296 Age:49 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Hypersensitivity Health Clozapine - Ivax Initial or Prolonged Electrolyte Imbalance Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc ORAL 300MG QD ORAL Date:04/23/04ISR Number: 4345991-2Report Type:Expedited (15-DaCompany Report #04-04-0566 Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine- Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 25-37.5MG QD ORAL Date:04/23/04ISR Number: 4349086-3Report Type:Expedited (15-DaCompany Report #20040300239 Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Overdose Foreign Ativan (Lorazepam) PS Initial or Prolonged Suicide Attempt Health Cipramil (Citalopram Professional Hydrobromide) SS 5000 MG Other Clozaril (Clozapine) SS ORAL 500 MG PO Diazepam SS Paracetamol C Temazepam C Gaviscon C Date:04/26/04ISR Number: 4346840-9Report Type:Expedited (15-DaCompany Report #PHEH2004US03084 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Interaction Clozaril PS Novartis Sector: Other Drug Level Increased Pharma ORAL 600 mg/day Ventricular Hypertrophy Celexa SS ORAL 40 mg/day Atenolol C Prevacid C Cardura C Reglan /Usa/ C Zocor "Dieckmann" C 22-Feb-2006 08:30 AM Page: 2673 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/26/04ISR Number: 4346842-2Report Type:Expedited (15-DaCompany Report #PHNR2004AU00855 Age:56 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abdominal Sepsis Clozaril PS Novartis Sector: Hospitalization - Blood Albumin Decreased Pharma ORAL 12.5 - 500 Initial or Prolonged Blood Glucose Increased mg/day Other Colostomy Clozaril SS Novartis Sector: Deep Vein Thrombosis Pharma PARENTERAL 500 mg via Gastrointestinal Necrosis gastric tube Haemoglobin Decreased Protein Total Decreased Pyrexia Subcutaneous Abscess White Blood Cell Count Increased Date:04/26/04ISR Number: 4346898-7Report Type:Expedited (15-DaCompany Report #AUS/95/00010/LEX Age:22 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coma Clozaril PS Novartis Sector: Delirium Pharma 12 - 750 Extradural Haematoma mg/day Haematoma Valproate Sodium SS 20 g, Incoherent ONCE/SINGLE Multiple Drug Overdose Clozaril SS Novartis Sector: Road Traffic Accident Pharma 7.7 g, Suicide Attempt ONCE/SINGLE Clozaril SS Novartis Sector: Pharma ORAL 200 mg, QD 1440 MIN Risperidone SS 14 mg, ONCE/SINGLE Date:04/26/04ISR Number: 4347765-5Report Type:Expedited (15-DaCompany Report #04-04-0587 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Choking Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS 150-275MG QD ORAL Date:04/26/04ISR Number: 4347773-4Report Type:Expedited (15-DaCompany Report #04-04-0567 Age:71 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 300-400MG QD ORAL Date:04/26/04ISR Number: 4347775-8Report Type:Expedited (15-DaCompany Report #04-03-0311 Age:60 YR Gender:Female I/FU:F Outcome Life-Threatening Hospitalization - 22-Feb-2006 08:30 AM Page: 2674 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Initial or Prolonged Disability Other PT Report Source Product Role Manufacturer Route Dose Duration Lung Neoplasm Malignant Health Clozapine - Ivax Professional Pharmaceuticals, Inc. Tablets PS ORAL 700-750MG QD ORAL Zyprexa C Zoloft C Klonopin C Date:04/26/04ISR Number: 4347779-5Report Type:Expedited (15-DaCompany Report #04-04-0575 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Health Clozapine Tablets - Decreased Professional Ivax Other Pharmaceuticals, Inc. PS ORAL 150-250MG QD ORAL Chemotherapy C Date:04/26/04ISR Number: 4347805-3Report Type:Expedited (15-DaCompany Report #04-02-0246 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pancytopenia Health Clozapine - Ivax Required Professional Pharmaceuticals, Intervention to Other Inc. Tablets PS Ivax Phamaceuticals, Prevent Permanent Inc. ORAL 25 QHS ORAL Impairment/Damage Date:04/26/04ISR Number: 4349359-4Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040404515 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Contusion Foreign Haldol (Haloperidol) PS 2 MG Initial or Prolonged Electrocardiogram St Health Truxal Segment Depression Professional (Chlorprothixene Syncope Hydrochloride) SS SEE IMAGE Ventricular Hypertrophy Delix (Ramipril) SS SEE IMAGE Vertigo Positional Dytide H (Dyazide) Tablets SS 0.5 DOSE (S) Lasix (Furosemide) SS 40 MG Leponex (Clozapine) SS SEE IMAGE Effortil (Drops) Etilefrine Hydrochloride C Date:04/27/04ISR Number: 4347761-8Report Type:Expedited (15-DaCompany Report #200410851DE Age:55 YR Gender:Female I/FU:I Outcome PT Hospitalization - Circulatory Collapse Initial or Prolonged Contusion Dizziness Drug Interaction 22-Feb-2006 08:30 AM Page: 2675 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Ventricular Hypertrophy Report Source Product Role Manufacturer Route Dose Duration Lasix PS Aventis Pharmaceuticals Inc. Delix SS ORAL Leponex SS ORAL dose: UP TO 225MG Truxal SS Haldol SS Dytide H SS Date:04/27/04ISR Number: 4348516-0Report Type:Expedited (15-DaCompany Report #PHFR2004GB00821 Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Upper Clozaril PS Novartis Sector: Initial or Prolonged Gastrointestinal Pharma ORAL 275mg mane & Haemorrhage 300mg nocte Haematemesis Hyoscine C ORAL 300 ug/day Haemoptysis Heart Rate Increased Orthostatic Hypotension Date:04/27/04ISR Number: 4348535-4Report Type:Expedited (15-DaCompany Report #PHEH2004US01954 Age:44 YR Gender:Female I/FU:F Outcome PT Hospitalization - Abdomen Scan Initial or Prolonged Agranulocytosis Alanine Aminotransferase Increased Anaemia Atelectasis Azotaemia Blood Bilirubin Increased Blood Creatinine Increased Blood Urea Increased Computerised Tomogram Abnormal Confusional State Cough Diarrhoea Dry Mouth Febrile Neutropenia Haematochezia Haematocrit Decreased Haemoglobin Decreased Hepatic Enzyme Increased Herpes Simplex Hyperthermia Hypokalaemia Hyponatraemia Hypothyroidism Leukopenia Metabolic Acidosis Microcytosis Nausea 22-Feb-2006 08:30 AM Page: 2676 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pharyngolaryngeal Pain Pleural Effusion Polychromasia Report Source Product Role Manufacturer Route Dose Duration Rectal Haemorrhage Clozaril PS Novartis Sector: Respiratory Alkalosis Pharma ORAL UNK,UNK 43920MIN Vomiting Haldol "Janssen" C White Blood Cell Count Cogentin C Decreased Lithium C Date:04/27/04ISR Number: 4349055-3Report Type:Expedited (15-DaCompany Report #2004S1001032 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 50 MG QD & Other 175 MG QHS, ORAL Clozapine Tablets 100 Mg Mylan SS Mylan ORAL 50 MG QD & 175 MG QHS, ORAL Date:04/27/04ISR Number: 4349069-3Report Type:Expedited (15-DaCompany Report #04-04-0588 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Aspiration Health Clozapine Tablets - Initial or Prolonged Pyrexia Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 250-500 MG QD ORAL Date:04/27/04ISR Number: 4350463-5Report Type:Expedited (15-DaCompany Report #2004209948US Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Health Doxorubicin Professional Pfs(Doxorubicin Hydrochloride) Solution, Sterile PS 95 MG/M2, CYCLIC, Q28D Clozapine(Clozapine) SS ORAL 800-350 MG QD, ORAL Cytoxan (Cyclophosphamide) SS 750 MQ/M2 Q28D Oncovin(Vincristine Sulfate) SS 1.4 MG/M2, CYCLIC, Q28D Rituxan (Rituximab) SS 375 MG/M2, CYCLIC, Q28D 22-Feb-2006 08:30 AM Page: 2677 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/27/04ISR Number: 4350712-3Report Type:Expedited (15-DaCompany Report #6008400 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Glucophage (Tablets) Hospitalization - Lactic Acidosis Professional (Metformin Initial or Prolonged Renal Failure Hydrochloride) PS ORAL 3 GM, ORAL 786 DAY Leponex (Tablets) (Clozapine) SS ORAL 3 DOSAGE FORMS, ORAL Zantac (Tablets) (Ranitidine Hydrochloride) C Akineton (Biperiden Hydrochloride) C Theralen (Alimemazine Tartrate) C Glibenxlamide (Glibenclamide) C Novomix (Insulin Aspart) C Date:04/27/04ISR Number: 4353593-7Report Type:Expedited (15-DaCompany Report #2004S1000243 Age:62 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 75 MG/DAY, Other ORAL Clozapine Tablets 100 Mg Mylan SS Mylan ORAL 200 MG/DAY, ORAL Fluvoxamine C Buspirone C Venlataxine C Levothyroxine C Ziprasidone C Date:04/28/04ISR Number: 4349085-1Report Type:Expedited (15-DaCompany Report #PHFR2004GB01837 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Clozaril PS Novartis Sector: Initial or Prolonged Increased Pharma ORAL 200 mg, BID Other Circulatory Collapse Clozaril SS Novartis Sector: Drug Level Increased Pharma ORAL 200 mg Drug Toxicity medication Loss Of Consciousness error Medication Error Date:04/28/04ISR Number: 4349263-1Report Type:Expedited (15-DaCompany Report #SE-BRISTOL-MYERS SQUIBB COMPANY-12561676 Age:40 YR Gender:Female I/FU:F Outcome PT Death Alanine Aminotransferase Hospitalization - Increased Initial or Prolonged Anxiety Aspartate 22-Feb-2006 08:30 AM Page: 2678 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Aminotransferase Increased Blood Potassium Increased Blood Pressure Increased Report Source Product Role Manufacturer Route Dose Duration Blood Sodium Decreased Glucophage PS Bristol-Myers Squibb Bradycardia Company ORAL Cardiac Arrest Leponex SS ORAL Diarrhoea Stesolid SS Gastroenteritis Theralen SS ORAL Haemoglobin Decreased Glibenclamide SS ORAL Hepatic Steatosis Zantac C ORAL Hepatomegaly Akineton C ORAL Hyperventilation Novomix C Hypoglycaemia Lactic Acidosis Petechiae Renal Failure Renal Tubular Necrosis Respiratory Rate Increased Venous Stasis Vomiting Date:04/28/04ISR Number: 4349349-1Report Type:Expedited (15-DaCompany Report #PHNU2004DE00759 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Withdrawal Syndrome Leponex / Clozaril Hyperhidrosis (Clozapine) PS Novartis Sector: Memory Impairment Pharma ORAL 100 to 150 Polyneuropathy mg/day Sensory Disturbance Antidepressants C UNKNOWN Unknown Tremor Hypnotics And Sedatives C UNKNOWN Unknown Date:04/28/04ISR Number: 4349351-XReport Type:Expedited (15-DaCompany Report #PHFR2004IE01842 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyspnoea Clozaril PS Novartis Sector: Initial or Prolonged Echocardiogram Abnormal Pharma ORAL 325mg/day Palpitations Ventricular Tachycardia Date:04/28/04ISR Number: 4349352-1Report Type:Expedited (15-DaCompany Report #PHNU2004DE01563 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Disturbance In Attention Leponex / Clozaril Initial or Prolonged Drug Interaction (Clozapine) PS Novartis Sector: Drug Level Increased Pharma ORAL up to 500 Electroencephalogram mg/day Abnormal Leponex / Clozaril Grand Mal Convulsion (Clozapine) SS Novartis Sector: Pharma ORAL 350 mg/day Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL 300 mg/day Leponex / Clozaril 22-Feb-2006 08:30 AM Page: 2679 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Clozapine) SS Novartis Sector: Pharma ORAL 250 mg/day Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma up to 450 mg/day Truxal SS ORAL Unknown Truxal SS ORAL 160 mg/day Truxal SS ORAL 230 mg/day 1440 MIN Truxal SS ORAL 280 mg/day 1440 MIN Truxal SS ORAL 350 mg/day 1440 MIN Truxal SS ORAL 220 mg/day Risperdal SS ORAL 2 mg/day Risperdal SS ORAL 4 mg/day Dociton C ORAL 60 mg/day L-Thyroxin "Henning Berlin" C ORAL 125 A?g/day Date:04/28/04ISR Number: 4349354-5Report Type:Expedited (15-DaCompany Report #PHFR2004IE01700 Age:15 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Overdose Clozaril PS Novartis Sector: Initial or Prolonged Aggression Pharma ORAL 550 mg, Somnolence ONCE/SINGLE Verbal Abuse Date:04/28/04ISR Number: 4349361-2Report Type:Expedited (15-DaCompany Report #PHFR2004GB01843 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Haemoglobin Decreased Clozaril PS Novartis Sector: Pharma ORAL Date:04/28/04ISR Number: 4349363-6Report Type:Expedited (15-DaCompany Report #PHNU2004DE01567 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depressed Level Of Leponex / Clozaril Initial or Prolonged Consciousness (Clozapine) PS Novartis Sector: Drug Interaction Pharma ORAL 12.5 mg/day 1440 MIN Facial Bones Fracture Leponex / Clozaril Fall (Clozapine) SS Novartis Sector: Grand Mal Convulsion Pharma ORAL 25 mg/day 1440 MIN Risperdal SS 1 to 3 mg/day 5760 MIN Risperdal SS 4 mg/day 108 DAY Risperdal SS 5 mg/day 17280MIN Risperdal SS 6 mg/day Zyprexa SS 5 to 10 mg/day 28800MIN Zyprexa SS 15 mg/day 51840MIN Zyprexa SS 20 mg/day 83 DAY Zyprexa SS 10 mg/day Cipramil SS 20 mg/day 56160MIN Bronchoretard SS 350 mg/day Tavor C 3 to 4 mg/day 44640MIN Tavor C 2.5 to 0.5 mg/day 73440MIN Tavor C 2 to 1.5 22-Feb-2006 08:30 AM Page: 2680 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report mg/day 79200MIN Tavor C 1 mg/day 34560MIN Tavor C 0.5 mg/day 4320 MIN Ass "Hexal" C 100 mg/day Pulmicort C 0.8 mg/day Berotec C 0.4 mg/day Date:04/28/04ISR Number: 4349420-4Report Type:Expedited (15-DaCompany Report #PHBS2004PT04383 Age:46 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Leponex PS Novartis Sector: Initial or Prolonged Phosphokinase Increased Pharma ORAL 300 mg/day 382 DAY Other Dermatofibrosarcoma Biperiden Malaise Hydrochloride C ORAL 4 mg/day Muscular Weakness Lorazepam C ORAL 7.5 mg/day Myalgia Flurazepam Rhabdomyolysis Hydrochloride C ORAL 30 mg/day 375 DAY Aluminium Hydroxide C ORAL 1 g/day 76320MIN Calcium Carbonate C ORAL 1 g/day 76320MIN Zuclopenthixol Decanoate C INTRAVENOUS 388 DAY Retinol C 25920MIN Thiamine Hydrochloride C 25920MIN Riboflavin C 25920MIN Pyridoxine Hydrochloride C 25920MIN Cyanocobalamin C 25920MIN Nicotinamide C 25920MIN Date:04/28/04ISR Number: 4349427-7Report Type:Expedited (15-DaCompany Report #PHBS2004DK05379 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Leponex PS Novartis Sector: Grand Mal Convulsion Pharma ORAL Seroquel SS 800 mg, BID 587 DAY Antabus C UNKNOWN 400 mg, QW3 Buspar C UNKNOWN 10 mg, BID Zoloft C UNKNOWN 100 mg, QD Oxazepam C UNKNOWN 15 mg, QD Risperdal C UNKNOWN 3 mg, BID Egazil Duretter C UNKNOWN .6 mg, BID Nozinan C UNKNOWN 50 mg, QD Date:04/28/04ISR Number: 4349767-1Report Type:Expedited (15-DaCompany Report #04-04-0593 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Intestinal Obstruction Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 350-550MG QD ORAL 22-Feb-2006 08:30 AM Page: 2681 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/28/04ISR Number: 4349768-3Report Type:Expedited (15-DaCompany Report #04-04-0506 Age:49 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Throat Cancer Health Clozapine Tablets - Initial or Prolonged Professional Ivax Pharmaceutical, Other Inc. PS Ivax Pharmaceutical, Inc. ORAL 400-600 MG QD ORAL Date:04/28/04ISR Number: 4349923-2Report Type:Direct Company Report #CTU 217609 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asthenia Clozaril PS 400 MG DAILY 6 YR Life-Threatening Communication Disorder Prozac SS 40 MG DAILY 2 YR Convulsion Effexor Xr SS 300 MG DAILY 2 YR Fall Benadryl SS 100 MG DAILY, Memory Impairment DIVIDED 3 YR Sudden Death Lithium C Synthroid C Ddavp C Detrol La C Zantac C Flomax C Ativan C Gemifibrozil C Vitamin E C Multivitamin C Miralax C Colace C Fibercon C Lexatives C Date:04/28/04ISR Number: 4351550-8Report Type:Expedited (15-DaCompany Report #205939 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Study Rituxan (Rituximab) White Blood Cell Count Health Conc For Solution Decreased Professional For Infusion PS INTRAVENOUS 375 MG/M2, Q28D, INTRAVENOUS Clozapine (Clozapine) SS Cytoxan (Cyclophosphamide) SS 750 MG, Q28D Adriamycin (Doxorubicin Hydrochloride, Doxorubicin) SS 95 MG/M2, Q28D Oncovin (Vincristine Sulfate) SS 1.4 MG/M2, Q28D 22-Feb-2006 08:30 AM Page: 2682 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/29/04ISR Number: 4350041-8Report Type:Expedited (15-DaCompany Report #PHNU2004DE01565 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Decreased Leponex / Clozaril Initial or Prolonged Circulatory Collapse (Clozapine) PS Novartis Sector: Contusion Pharma ORAL up to 225 Dizziness mg/day Dizziness Postural Leponex / Clozaril Drug Interaction (Clozapine) SS Novartis Sector: Echocardiogram Abnormal Pharma ORAL between 100 Fall and 375 Syncope mg/day 44640MIN Ventricular Hypertrophy Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL up to 400mg/day Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL 300mg/day Truxal SS ORAL 100mg/day 2880 MIN Truxal SS ORAL 50 to 60mg/day 8640 MIN Truxal SS ORAL 40mg/day 5760 MIN Haldol "Janssen-Cilag" SS ORAL 2mg/day Delix SS ORAL 5mg/day Delix SS ORAL 3.75mg/day 5760 MIN Dytide H SS ORAL .5 DF, QD Lasix /Swe/ SS ORAL 40 mg, QD Date:04/29/04ISR Number: 4350612-9Report Type:Expedited (15-DaCompany Report #2004S1001087 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Health Clozapine Tablets 25 Hospitalization - Professional Mg Mylan PS Mylan ORAL 50 MG QHS, Initial or Prolonged Other ORAL Clozapine Tablets 100 Mg Mylan SS Mylan ORAL 500 MG QD, ORAL Date:04/29/04ISR Number: 4352787-4Report Type:Expedited (15-DaCompany Report #2004026328 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Platelet Count Decreased Consumer Geodon (Ziprasidone) PS ORAL 240 MG (TID), ORAL Clozapine (Clozapine) SS ORAL 50 MG (BID), ORAL Clonazepam (Clonazepam) C 22-Feb-2006 08:30 AM Page: 2683 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/29/04ISR Number: 4353100-9Report Type:Expedited (15-DaCompany Report #2004SE02195 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Drug Interaction Foreign Seroquel PS ORAL 800 MG BID PO Intervention to Grand Mal Convulsion Health Leponex SS ORAL 300 MG DAILY Prevent Permanent Professional PO Impairment/Damage Other Antabus C Buspar C Zoloft C Risperdal C Egazil Duretter C Nozinan C Oxazepam C Date:04/30/04ISR Number: 4350467-2Report Type:Expedited (15-DaCompany Report #PHFR2004GB00545 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Clozaril PS Novartis Sector: Initial or Prolonged Drug Withdrawal Pharma ORAL 4847 DAY Convulsions Diazepam C ORAL 15mg/day Neutropenia Date:04/30/04ISR Number: 4353676-1Report Type:Expedited (15-DaCompany Report #2004UW06257 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Conjunctivitis Bacterial Health Seroquel PS ORAL 300 MG TID PO Initial or Prolonged Dehydration Professional Clozapine SS ORAL 150 MG BID PO Hypoxia Cyanocobalamin C Mental Status Changes Ferrous Sulfate C Pneumonia Senokot C Docusate C Benzatropine C Celexa C Clozapine C Haloperidol C Date:04/30/04ISR Number: 4353678-5Report Type:Expedited (15-DaCompany Report #2004UW05737 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dizziness Health Seroquel PS 200 MG Initial or Prolonged Fall Professional TID-QID Mental Disorder Clozaril SS 200-300 MG Abilify C Ativan C Lexapro C Date:04/30/04ISR Number: 4353812-7Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040404516 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Foreign Risperdal Initial or Prolonged Facial Bones Fracture Health (Risperidone) Fall Professional Unspecified PS 1-3 MG/DAY; 4 Grand Mal Convulsion MG; 5 MG; 6 22-Feb-2006 08:30 AM Page: 2684 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report MG Leponex (Clozapine) SS 12.5 MG; 25 MG Zyprexa (Olanzapine) SS 5-10 M G Cipramil (Citalopram Hydrobromide) SS 20 MG Bronchoretard (Theophylline) SS 350 MG Ass (Unknown) (Acetylsalicylic Acid C Pulmicort (Unknown) Budesonide C Date:04/30/04ISR Number: 4353883-8Report Type:Expedited (15-DaCompany Report #04P-062-0258097-00 Age:32 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Foreign Akineton (Biperiden) Initial or Prolonged Multiple Drug Overdose Health (Biperiden) PS ORAL 50 MG OR 100 Suicide Attempt Professional MG, 25 Other TABLETS, ONCE, PER ORAL Promazine Hydrochloride SS 100 MG, 75 TABLETS, ONCE Clozapin SS 200 MG, 20 TABLETS, ONCE Date:05/03/04ISR Number: 4351334-0Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040200170 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Risperdal PS OROPHARINGEAL 1 MON Blood Bilirubin Abnormal Lorazepam C UNKNOWN Blood Creatine Clozapine I UNKNOWN Phosphokinase Increased Blood Urea Decreased Confusional State Drug Interaction Hallucination Date:05/03/04ISR Number: 4351892-6Report Type:Expedited (15-DaCompany Report #PHFR2004GB01851 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Haemoglobin Decreased Clozaril PS Novartis Sector: Pharma ORAL Date:05/03/04ISR Number: 4351894-XReport Type:Expedited (15-DaCompany Report #PHFR2004GB01730 Age:57 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Circulatory Collapse Clozaril PS Novartis Sector: Initial or Prolonged Duodenal Ulcer Pharma ORAL Amitriptyline C 50mg/day 22-Feb-2006 08:30 AM Page: 2685 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/03/04ISR Number: 4352405-5Report Type:Expedited (15-DaCompany Report #04-04-0604 Age:76 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL ORAL Date:05/03/04ISR Number: 4352408-0Report Type:Expedited (15-DaCompany Report #04-04-0602 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pulmonary Embolism Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 12.5-600MG QD ORAL Date:05/03/04ISR Number: 4353201-5Report Type:Direct Company Report #CTU 217874 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Grand Mal Convulsion Clozaril PS 400 MG BID 2 YR Initial or Prolonged Myoclonus Lopid C Glyburide C Pioglitazone C Date:05/03/04ISR Number: 4354166-2Report Type:Expedited (15-DaCompany Report #GBWYE721926APR04 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Health Efexor (Venlfaxine Inadequate Control Professional Hydrochloride, Electrocardiogram Qt Other Tablet, 0) PS ORAL 150 MG 4X PER Prolonged 1 DAY ORAL Heart Rate Increased Clozapine Pain (Clozapine) SS ORAL 275MG ORAL; Pharyngolaryngeal Pain SEE IMAGE Valproate Sodium (Valproate Sodium) SS 500 MG 2X PER 1 DAY Desmopressin C Metformin C Gliclazide C Methylcellulose C Date:05/04/04ISR Number: 4352203-2Report Type:Expedited (15-DaCompany Report #PHFR2003GB03942 Age:31 YR Gender:Male I/FU:F Outcome PT Hospitalization - Abdominal Pain Initial or Prolonged Completed Suicide Emotional Distress 22-Feb-2006 08:30 AM Page: 2686 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hypersensitivity Malaise Oedematous Pancreatitis Report Source Product Role Manufacturer Route Dose Duration Pancreatitis Acute Clozaril PS Novartis Sector: Psychotic Disorder Pharma ORAL 300mg/day 25920MIN Pyrexia Olanzapine C UNKNOWN 20mg/day 10080MIN Urticaria Olanzapine C UNKNOWN 10mg/nocte 10080MIN Date:05/04/04ISR Number: 4352204-4Report Type:Expedited (15-DaCompany Report #PHNU2004DE01602 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bundle Branch Block Right Leponex / Clozaril Conduction Disorder (Clozapine) PS Novartis Sector: Ecg Signs Of Myocardial Pharma ORAL Ischaemia Seroquel C ORAL Electrocardiogram Abnormal Electrocardiogram T Wave Inversion Date:05/04/04ISR Number: 4352207-XReport Type:Expedited (15-DaCompany Report #PHFR2004GB01860 Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Eating Disorder Clozaril PS Novartis Sector: Initial or Prolonged Fluid Intake Reduced Pharma ORAL Date:05/04/04ISR Number: 4352632-7Report Type:Expedited (15-DaCompany Report #PHEH2004US04593 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Medication Error Ritalin PS Novartis Sector: Movement Disorder Pharma 20 mg, BID Sudden Death Clozapine SS 200 mg, QHS Compazine SS Percocet SS Paxil C 50 mg, QD (50mg QAM) Ativan C 1 mg, TID Date:05/04/04ISR Number: 4352724-2Report Type:Expedited (15-DaCompany Report #04-03-0377 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Compazine PS Glaxosmithkline Clozapine SS ORAL 200MG At night Ritalin SS ORAL 20MG Twice per day Percocet SS Paxil Cr C Glaxosmithkline ORAL Ativan C ORAL 1MG Three times per day 22-Feb-2006 08:30 AM Page: 2687 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/04/04ISR Number: 4353282-9Report Type:Expedited (15-DaCompany Report #2004S1001152 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Cardiac Death Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 100MG Q HS, Other ORAL Colchicine C Allopurinol C Nifedipine Xl C Ibuprofen C Haloperidol Decanoate C Diphenhydramine C Date:05/04/04ISR Number: 4353283-0Report Type:Expedited (15-DaCompany Report #2004S1001135 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatic Neoplasm Other Clozapine Tablets Malignant 100 Mg Mylan PS Mylan ORAL 100MG Q AM AND 800MG Q PM, ORAL Date:05/04/04ISR Number: 4353407-5Report Type:Expedited (15-DaCompany Report #2004S1001162 Age:71 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death General Physical Health Health Clozapine Tablets 25 Deterioration Professional Mg Mylan PS ORAL 25 MG QHS, Other ORAL Date:05/04/04ISR Number: 4353408-7Report Type:Expedited (15-DaCompany Report #2004S1001161 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 50 MG Q AM Other AND 50 MG Q PM, ORAL Clozapine Tablets 100 Mg Mylan SS Mylan ORAL 600 MG Q PM, ORAL Date:05/04/04ISR Number: 4353409-9Report Type:Expedited (15-DaCompany Report #2004S1001154 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Overdose Other Clozapine Tablets 25 Mg Mylan PS Mylan ORAL 50 MG Q HS, ORAL Clozapine Tablets 100 Mg Mylan SS Mylan ORAL 100 MG Q 7PM & Q HS, ORAL Risperidone C Divalproex Sodium C Procycliidine C Desmopressin C 22-Feb-2006 08:30 AM Page: 2688 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/04/04ISR Number: 4355323-1Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040200170 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Foreign Risperdal Confusional State Health (Risperidone) Delirium Professional Tablets PS ORAL 4MG, 1 IN 1 Drug Interaction DAY, ORAL Hallucination Clozapine (Clozapine) Unknown SS 62.5 MG, 1 IN 1 DAY, Lorazepam (Lorazepam) C Date:05/05/04ISR Number: 4353224-6Report Type:Expedited (15-DaCompany Report #PHNU2003DE03105 Age:53 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Pain Leponex / Clozaril Other Aspiration (Clozapine) PS Novartis Sector: Cardiomegaly Pharma ORAL 250mg/day 31680MIN Drug Level Above Pirenzepine SS ORAL 50 mg/day Therapeutic Neurocil SS ORAL 100 mg/day 48960MIN Gastrointestinal Leponex / Clozaril Haemorrhage (Clozapine) SS Novartis Sector: Gastrointestinal Motility Pharma ORAL 500mg/day Disorder Leponex / Clozaril Haematemesis (Clozapine) SS Novartis Sector: Hepatic Congestion Pharma ORAL 400mg/day 15840MIN Ileus Paralytic Neurocil SS ORAL 50 mg/day 21600MIN Mallory-Weiss Syndrome Leponex / Clozaril Nausea (Clozapine) SS Novartis Sector: Oesophagitis Pharma ORAL 12.5 to 150 Renal Disorder mg/day 10080MIN Respiratory Failure Concor C ORAL 2.5mg/day Resuscitation Glimepiride C ORAL 2mg/day Shock Haemorrhagic Diazepam C ORAL 4mg/day 14400MIN Spleen Congestion Tavor C ORAL Unknown Urinary Incontinence Tavor C ORAL 0.5 mg/day 2880 MIN Vomiting Glianimon C ORAL 6 mg/day 30240MIN Glianimon C ORAL 1 mg/day 7200 MIN Glianimon C ORAL 3 mg/day 11520MIN Glianimon C UNKNOWN Unknown Tavor C ORAL 1 mg/day 38880MIN Diazepam C ORAL 1mg/day 2880 MIN Bifiteral C Solvay Arzneimittel ORAL 23040MIN Diazepam C ORAL 2mg/day 7200 MIN Slow Sodium C ORAL 2df/day Ximovan I Aventis Pharma ORAL 7.5mg/day Date:05/05/04ISR Number: 4353228-3Report Type:Expedited (15-DaCompany Report #PHNU2003DE04105 Age: Gender:Female I/FU:F Outcome PT Death Anuria Other Areflexia Asphyxia Atrial Fibrillation Brain Oedema Brain Stem Auditory 22-Feb-2006 08:30 AM Page: 2689 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Evoked Response Abnormal Cardiac Arrest Cardiac Failure Chronic Obstructive Report Source Product Role Manufacturer Route Dose Duration Pulmonary Disease Leponex / Clozaril Confusional State (Clozapine) PS Novartis Sector: Dizziness Pharma ORAL 300mg/day 1278 DAY Drug Interaction Leponex / Clozaril Drug Level Increased (Clozapine) SS Novartis Sector: Dyspnoea Pharma ORAL 400mg/day 2880 MIN Gait Disturbance Leponex / Clozaril Gastric Haemorrhage (Clozapine) SS Novartis Sector: Haemodynamic Instability Pharma ORAL 300mg/day 1440 MIN Hyperventilation Leponex / Clozaril Hypoxic Encephalopathy (Clozapine) SS Novartis Sector: Infection Pharma ORAL 150mg/day 1440 MIN Posture Abnormal Uniphyllin SS Mundipharma ORAL 400mg/day 5760 MIN Pupil Fixed Uniphyllin SS Mundipharma 200mg/day 1440 MIN Resuscitation Verahexal C ORAL 160mg/day 185 DAY Somatosensory Evoked Verahexal C ORAL 80mg/day 1440 MIN Potentials Abnormal Pulmicort C .2 mg, TID 5760 MIN Speech Disorder Pulmicort C .2 mg, BID 1440 MIN Unresponsive To Pain Stimuli Date:05/05/04ISR Number: 4353486-5Report Type:Expedited (15-DaCompany Report #PHFR2003GB04274 Age:22 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Toxicity Clozaril PS Novartis Sector: Other Hepatic Steatosis Pharma ORAL 300 mg/day Influenza Like Illness Clozaril SS Novartis Sector: Obesity Pharma ORAL 225 mg/day Splenomegaly Citalopram C ORAL 30 mg/day Hyoscine C ORAL 300ug/day Date:05/05/04ISR Number: 4353489-0Report Type:Expedited (15-DaCompany Report #PHFR2004GB00834 Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Antipsychotic Drug Level Clozaril PS Novartis Sector: Other Above Therapeutic Pharma ORAL 200mg/day Arrhythmia Chlorpromazine SS 300 mg, TID Arteritis Procyclidine SS 5 mg, QD Cardio-Respiratory Arrest Zopiclone SS 7.5mg at Carditis night Dehydration Clonazepam SS .5 mg, BID Diarrhoea Drug Interaction Myocarditis Orthostatic Hypotension Renal Impairment Date:05/05/04ISR Number: 4353510-XReport Type:Expedited (15-DaCompany Report #PHEH2004US04683 Age:51 YR Gender:Male I/FU:I Outcome PT Other Blood Cholesterol Increased 22-Feb-2006 08:30 AM Page: 2690 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Blood Creatinine Increased Blood Urea Increased Report Source Product Role Manufacturer Route Dose Duration Renal Failure Chronic Clozaril PS Novartis Sector: Urinary Incontinence Pharma ORAL 600 mg, QD Labetalol C Lipitor C Detrol C Date:05/06/04ISR Number: 4353881-4Report Type:Expedited (15-DaCompany Report #PHBS2003BR09811 Age:27 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Leponex PS Novartis Sector: Confusional State Pharma ORAL 600 mg/day 183 DAY Constipation Leponex SS Novartis Sector: Difficulty In Walking Pharma ORAL 100 mg, BID Drug Interaction Paroxetine SS ORAL 20 mg, QD Fatigue Lorazepam C UNKNOWN 1 mg, QOD Gastritis Tryptanol C 25 mg, QD Hypersomnia Wellbutrin C ORAL 150 mg, QD Increased Appetite Irritability Nightmare Physical Disability Pollakiuria Rash Salivary Hypersecretion Somnolence Date:05/06/04ISR Number: 4353903-0Report Type:Expedited (15-DaCompany Report #PHFR2004GB01691 Age:36 YR Gender:Female I/FU:F Outcome PT Hospitalization - Blood Albumin Decreased Initial or Prolonged Blood Alkaline Other Phosphatase Increased Blood Bicarbonate Increased Blood Calcium Decreased Blood Potassium Decreased Blood Sodium Decreased Blood Urea Decreased Body Temperature Increased Cardiac Failure Cough Diarrhoea Face Oedema Haematocrit Decreased Haemoglobin Decreased Lower Respiratory Tract Infection Malaise Nasopharyngitis Neutrophil Toxic Granulation Present Neutrophilia Oedema Peripheral 22-Feb-2006 08:30 AM Page: 2691 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Platelet Count Increased Protein Total Decreased Rash Report Source Product Role Manufacturer Route Dose Duration Tachycardia Clozaril PS Novartis Sector: Urinary Tract Infection Pharma ORAL 150mg morn & White Blood Cell Count 175mg night Increased Depakote C ORAL 750 mg, BID Lactulose C ORAL 15 ml nocte Fybogel C ORAL 1 tablet nocte Risperidone C ORAL 4 mg mane Risperidone C ORAL 2 mg, BID Paracetamol C Ventolin C 2 puffs BID Procyclidine C ORAL 5 mg, BID Ibuprofen C TOPICAL up to 4 times Kwells C ORAL 2 Tablets, BID Date:05/06/04ISR Number: 4354170-4Report Type:Expedited (15-DaCompany Report #PHHO2004CA03639 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anaemia Clozaril PS Novartis Sector: Other Coagulopathy Pharma 150 mg am + Hypernatraemia 400 mg hs Lung Abscess Cogentin C 2 mg, UNK Pneumonia Bacterial Clonazepam C .5 mg, TID Sudden Death Perphenazine C 8 mg, hs Imipramine C 75 mg, hs Date:05/06/04ISR Number: 4355190-6Report Type:Expedited (15-DaCompany Report #2004S1001166 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clqzapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 25MG Q HS. Other ORAL Furosemide C Potassium Chloride C Olanzapine C Enalapril C Gabapentin C Date:05/06/04ISR Number: 4355198-0Report Type:Expedited (15-DaCompany Report #2004S1001178 Age:85 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 50MG Q HS. Other ORAL 22-Feb-2006 08:30 AM Page: 2692 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/06/04ISR Number: 4355204-3Report Type:Expedited (15-DaCompany Report #2004S1001179 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death No Adverse Drug Effect Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 200 MG/DAY, Other ORAL Date:05/06/04ISR Number: 4355206-7Report Type:Expedited (15-DaCompany Report #2004S1001193 Age:83 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 50 MG QD, Other ORAL Levothyroxine C Furosemide C Pergolide C Carbidopa/Levodopa C Potassium Chloride C Date:05/06/04ISR Number: 4356317-2Report Type:Expedited (15-DaCompany Report #S04-GER-01931-01 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Foreign Cipramil (Citalopram Initial or Prolonged Facial Bones Fracture Health Hydrobromide) PS 20 MG QD Fall Professional Risperdal Grand Mal Convulsion Other (Risperidone) SS 3 MG QD Somnolence Risperdal (Risperidone) SS 4 MG QD Risperdal (Risperidone) SS 5 MG QD Risperdal (Risperidone) SS 6 MG QD Leponex (Clozapine) SS 12.5 MG QD Leponex (Clozapine) SS 25 MG QD Zyprexa (Olanzapine) SS 10 MG QD Zyprexa (Olanzapine) SS 15 MG QD Zyprexa (Olanzapine) SS 10 MG QD Zyprexa (Olanzapine) SS 20 MG QD Bronchoretard (Theophylline) SS 350 MG QD Tavor (Lorazepam) C Acetylsalicylic Acid C Pulmicord (Budesonide) C Berotec (Fenoterol Hydrobromide) C Date:05/07/04ISR Number: 4354673-2Report Type:Expedited (15-DaCompany Report #PHBS2004BR05845 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Accidental Exposure Leponex PS Novartis Sector: Confusional State Pharma ORAL 100 mg, Dysstasia ONCE/SINGLE 1440 MIN Restlessness 22-Feb-2006 08:30 AM Page: 2693 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/07/04ISR Number: 4354697-5Report Type:Expedited (15-DaCompany Report #PHFR2004GB01509 Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Clozaril PS Novartis Sector: Confusional State Pharma ORAL Electrocardiogram Abnormal Electroencephalogram Abnormal Gait Disturbance Wolff-Parkinson-White Syndrome Date:05/07/04ISR Number: 4354795-6Report Type:Expedited (15-DaCompany Report #PHHO2004CA03053 Age:53 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anaemia Clozaril (Clozapine) PS Novartis Sector: Life-Threatening Cor Pulmonale Pharma ORAL 150 mg q am + Hospitalization - Cough 300 mg q hs 1814 DAY Initial or Prolonged Cyanosis Levaquin SS 500 mg, QD Drug Ineffective Orap C ORAL 4 mg, BID Drug Interaction Risperdal C ORAL 2 mg q am + 4 Drug Level Increased mg q hs Lobar Pneumonia Colace C ORAL 100 mg q hs Non-Small Cell Lung Cancer Metastatic Pericardial Effusion Pleural Effusion Date:05/07/04ISR Number: 4354801-9Report Type:Expedited (15-DaCompany Report #PHFR2003GB01977 Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Antipsychotic Drug Level Clozaril PS Novartis Sector: Above Therapeutic Pharma ORAL 1134 DAY Blood Alcohol Increased Overdose Date:05/07/04ISR Number: 4354865-2Report Type:Expedited (15-DaCompany Report #PHBS2004GB05864 Age:32 YR Gender:Male I/FU:I Outcome PT Hospitalization - Acute Respiratory Initial or Prolonged Distress Syndrome Alanine Aminotransferase Increased Blood Creatine Phosphokinase Increased Disseminated Intravascular Coagulation Glasgow Coma Scale Abnormal Heat Stroke Hepatic Failure Hypotension International Normalised Ratio Increased 22-Feb-2006 08:30 AM Page: 2694 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Loss Of Consciousness Neutropenia Pyrexia Report Source Product Role Manufacturer Route Dose Duration Renal Tubular Necrosis Clozapine PS Novartis Sector: Respiratory Arrest Pharma UNKNOWN 200 mg, BID Rhabdomyolysis Date:05/07/04ISR Number: 4354869-XReport Type:Expedited (15-DaCompany Report #PHNU2004DE01068 Age:78 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Leponex / Clozaril Initial or Prolonged C-Reactive Protein (Clozapine) PS Novartis Sector: Other Increased Pharma ORAL 50 mg/day Cyanosis Leponex / Clozaril Drug Interaction (Clozapine) SS Novartis Sector: Drug Level Increased Pharma ORAL 400 mg/day General Physical Leponex / Clozaril Condition Abnormal (Clozapine) SS Novartis Sector: Immobile Pharma ORAL 200 mg/day Oxygen Saturation Leponex / Clozaril Decreased (Clozapine) SS Novartis Sector: Pyrexia Pharma ORAL titration Respiratory Failure Lamictal "Burroughs Somnolence Wellcome" SS ORAL 100 mg/day Tachycardia Cipramil C ORAL 20 mg/day Urinary Incontinence Aponal C ORAL 50 mg/day Urosepsis Tavor C ORAL 2 mg/day Alpha Lipoic Acid C Date:05/07/04ISR Number: 4354870-6Report Type:Expedited (15-DaCompany Report #PHFR2004IE01835 Age:53 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Glucose Fluctuation Clozaril PS Novartis Sector: Haemoglobin Decreased Pharma ORAL 600 mg/day Weight Decreased Date:05/07/04ISR Number: 4354871-8Report Type:Expedited (15-DaCompany Report #PHFR2004IE01842 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyspnoea Clozaril PS Novartis Sector: Initial or Prolonged Echocardiogram Abnormal Pharma ORAL 325mg/day Palpitations Ventricular Tachycardia Date:05/07/04ISR Number: 4354877-9Report Type:Expedited (15-DaCompany Report #PHFR2001GB03263 Age:40 YR Gender:Male I/FU:F Outcome PT Hospitalization - Haemoglobin Abnormal Initial or Prolonged Iron Deficiency Anaemia Disability Microcytic Anaemia Other Oesophageal Haemorrhage Oesophagitis Renal Failure Acute 22-Feb-2006 08:30 AM Page: 2695 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Vomiting Report Source Product Role Manufacturer Route Dose Duration Clozaril PS Novartis Sector: Pharma ORAL 400mg/day 3578 DAY Lansoprazole C ORAL 250mg/day Atenolol C ORAL 25mg/day Ferrous Sulphate C ORAL Ensure C ORAL Lactulose C ORAL 20ml/day Date:05/07/04ISR Number: 4354878-0Report Type:Expedited (15-DaCompany Report #PHFR2004GB01921 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Medication Error Clozaril PS Novartis Sector: Initial or Prolonged Sedation Pharma ORAL 100mg/day 1447 DAY Date:05/07/04ISR Number: 4355929-XReport Type:Expedited (15-DaCompany Report #04-04-0623 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Sepsis Health Clozapine Professional Tablets-Ivax Other Pharmaceuticals, Inc PS Ivax Pharmaceuticals, Inc ORAL 175-600MG QD ORAL Date:05/07/04ISR Number: 4356636-XReport Type:Expedited (15-DaCompany Report #2004UW08844 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blood Disorder Foreign Seroquel PS Intervention to Psychotic Disorder Health Clozapine SS Prevent Permanent Professional Haloperidol C Impairment/Damage Other Nozinan C Date:05/10/04ISR Number: 4355186-4Report Type:Expedited (15-DaCompany Report #PHNU2004DE01007 Age:41 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Drug Screen Positive Clozapine PS Novartis Sector: Hospitalization - Drug Toxicity Pharma ORAL Unknown Initial or Prolonged Hypothermia L-Thyroxin-Natrium C UNKNOWN Unknown Intubation Life Support Loss Of Consciousness Respiratory Failure Somnolence Sopor 22-Feb-2006 08:30 AM Page: 2696 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/10/04ISR Number: 4355192-XReport Type:Expedited (15-DaCompany Report #PHHO2004KR04979 Age:22 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Clozaril PS Novartis Sector: Hospitalization - Enterocolitis Infectious Pharma ORAL Unknown 67680MIN Initial or Prolonged Intestinal Stenosis Clozaril SS Novartis Sector: Other Oral Intake Reduced Pharma 400 mg 18720MIN Pharyngotonsillitis Magnesium Oxide C 1000 mg 38880MIN Pyrexia Ativan C 1 mg 15840MIN Haloperidol C Date:05/10/04ISR Number: 4355938-0Report Type:Expedited (15-DaCompany Report #04-04-0636 Age:67 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Clozapine-Ivax Congestive Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc ORAL 200-400MG QD ORAL Date:05/10/04ISR Number: 4357377-5Report Type:Expedited (15-DaCompany Report #DSA_24280_2004 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Foreign Tavor PS ORAL 0.5 MG QD PO Initial or Prolonged Facial Bones Fracture Health Tavor SS ORAL 1 MG QD PO Fall Professional Tavor SS ORAL 2 MG QD PO Grand Mal Convulsion Other Tavor SS ORAL 2.5 MG QD PO Tavor SS ORAL 4 MG Q DAY PO Bronchoretard SS ORAL 350 MG QD PO Cipramil SS ORAL 20 MG QD PO Leponex SS ORAL 25 MG QD PO Leponex SS ORAL 12.5 MG QD PO Risperdal SS ORAL 6 MG QD PO Risperdal SS ORAL 5 MG QD PO Risperdal SS ORAL 4 MG QD PO Risperdal SS ORAL 3 MG QD PO Zyprexa SS ORAL 10 MG Q DAY PO Zyprexa SS ORAL 20 MG QD PO Zyprexa SS ORAL 15 MG QD PO Zyprexa SS ORAL 10 MG Q DAY PO Acetylsalicylic Acid C Pulmicort C Berotec C Date:05/11/04ISR Number: 4355790-3Report Type:Expedited (15-DaCompany Report #PHFR2004GB01720 Age:53 YR Gender:Male I/FU:F Outcome PT Hospitalization - Cold Sweat Initial or Prolonged Feeling Hot Other Haematocrit Decreased Haemoglobin Decreased Hyperhidrosis Infection 22-Feb-2006 08:30 AM Page: 2697 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lymphocyte Count Decreased Monocyte Count Decreased Report Source Product Role Manufacturer Route Dose Duration Neutrophil Count Clozaril PS Novartis Sector: Decreased Pharma ORAL 3530 DAY Pancytopenia Olanzapine C UNKNOWN Platelet Count Decreased Lithium C Pyrexia Red Blood Cell Count Decreased Red Cell Distribution Width Increased White Blood Cell Count Decreased Date:05/11/04ISR Number: 4355797-6Report Type:Expedited (15-DaCompany Report #PHFR2004GB01934 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Pressure Increased Clozaril PS Novartis Sector: Convulsion Pharma ORAL 450mg/day Heart Rate Increased Clozaril SS Novartis Sector: Medication Error Pharma ORAL Extra 100mg dose given Valproate Sodium C UNKNOWN 400 mg, BID Date:05/11/04ISR Number: 4355805-2Report Type:Expedited (15-DaCompany Report #PHFR2004GB01955 Age:77 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Haemoglobin Decreased Clozaril PS Novartis Sector: Pharma ORAL Date:05/11/04ISR Number: 4355811-8Report Type:Expedited (15-DaCompany Report #PHNR2004AU00692 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Disease Progression Clozaril PS Novartis Sector: Initial or Prolonged Drug Level Decreased Pharma ORAL 450 mg, QD 280 DAY Treatment Noncompliance Date:05/11/04ISR Number: 4356125-2Report Type:Expedited (15-DaCompany Report #PHNR2004AU00698 Age:34 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asthma Clozaril PS Novartis Sector: Drug Level Increased Pharma ORAL 800 mg, QD Efexor C Topamax C Serenase C Benzotropine C UNK, PRN 22-Feb-2006 08:30 AM Page: 2698 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/11/04ISR Number: 4356128-8Report Type:Expedited (15-DaCompany Report #PHEH2004US04914 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neoplasm Malignant Clozaril PS Novartis Sector: Pharma ORAL UNK,UNK Date:05/11/04ISR Number: 4356138-0Report Type:Expedited (15-DaCompany Report #PHHO2004CA06341 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Clozaril PS Novartis Sector: Initial or Prolonged Drug Toxicity Pharma ORAL 750 mg / day 3885 DAY Dysarthria Clozaril SS Novartis Sector: Feeling Abnormal Pharma ORAL UNK, NO Grand Mal Convulsion TREATMENT 4320 MIN Clozaril SS Novartis Sector: Pharma Dose unknown Risperidone C Date:05/11/04ISR Number: 4356545-6Report Type:Expedited (15-DaCompany Report #2004S1001221 Age:92 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg Mylan PS ORAL 12.5MG QD, Other ORAL Acetaminophen C Morphine Sulfate C Digoxin C Albuterol C Furosemide C Hydroxyzine C Nystatin C Zolpidem C Lorazepam C Scopalamine Transdermal C Date:05/11/04ISR Number: 4356547-XReport Type:Expedited (15-DaCompany Report #2004S1001203 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional 100 Mg Mylan PS ORAL 50MG TID, Other ORAL Risperidone C Furosemide C Potassium Chloride C Benazepril C Amlodipine C Lansoprazole C Lactase C 22-Feb-2006 08:30 AM Page: 2699 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/11/04ISR Number: 4356549-3Report Type:Expedited (15-DaCompany Report #2004S1001032 Age:59 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 50MG QD & Other 175MG QHS, ORAL Clozapine Tablets 100 Mg Mylan SS Mylan ORAL 50MG QD & 175MG QHS, ORAL Gabapentin C Ziprasidone C Benztropine C Divalproex C Docusate C Date:05/11/04ISR Number: 4357481-1Report Type:Direct Company Report #CTU 218408 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pyrexia Clozapine (Ivax) PS Ivax NARRATIVE Initial or Prolonged Vomiting Lipitor C White Blood Cell Count Vasotec C Increased Synthroid C Oscal With D C Senokot C Zyprexa C Date:05/12/04ISR Number: 4356608-5Report Type:Expedited (15-DaCompany Report #PHRM2002FR01893 Age:28 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abortion Spontaneous Leponex PS Novartis Sector: Complications Of Maternal Pharma ORAL 250 mg, daily Exposure To Therapeutic Drugs Drug Exposure During Pregnancy Maternal Drugs Affecting Foetus Premature Separation Of Placenta Date:05/12/04ISR Number: 4357010-2Report Type:Expedited (15-DaCompany Report #PHBS2004CH06142 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Leponex PS Novartis Sector: Initial or Prolonged Hallucination, Auditory Pharma UNKNOWN 50 mg/d Medication Error Entumin SS INTRAMUSCULAR 80 mg/d Somnolence Leponex SS Novartis Sector: Pharma UNKNOWN UNK, ONCE/SINGLE 1440 MIN Tranxilium SS UNKNOWN 5 mg/d Cabaser C UNKNOWN 4 mg/d Akineton Retard C UNKNOWN 2 mg/d 22-Feb-2006 08:30 AM Page: 2700 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/12/04ISR Number: 4357012-6Report Type:Expedited (15-DaCompany Report #PHBS2004BR05845 Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Accidental Exposure Leponex PS Novartis Sector: Confusional State Pharma ORAL 100 mg, Dysstasia ONCE/SINGLE 1440 MIN Date:05/12/04ISR Number: 4358557-5Report Type:Expedited (15-DaCompany Report #04P-056-0259242-00 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Apathy Foreign Depakote (Divalproex Initial or Prolonged Confusional State Health Sodium) PS ORAL 500 MG, PER Faecal Incontinence Professional ORAL Speech Disorder Company Clozapine SS ORAL 100 MG, PER Stupor Representative ORAL Urinary Incontinence Date:05/13/04ISR Number: 4357275-7Report Type:Expedited (15-DaCompany Report #PHNR2003AU01361 Age:16 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Glucose Increased Clozaril PS Novartis Sector: Diabetes Mellitus Pharma ORAL 37.5 - 375mg 882 DAY Dizziness Thyroid Function Test Abnormal Ventricular Hypokinesia Date:05/13/04ISR Number: 4357279-4Report Type:Expedited (15-DaCompany Report #PHNR2004AU00952 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Glucose Increased Clozaril PS Novartis Sector: Blood Triglycerides Pharma 50 - 400 Increased mg/day Diabetes Mellitus Date:05/13/04ISR Number: 4357282-4Report Type:Expedited (15-DaCompany Report #PHFR2003GB02500 Age:18 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Body Temperature Clozaril PS Novartis Sector: Increased Pharma ORAL 101 DAY Electrocardiogram Abnormal Electrocardiogram St Segment Elevation Heart Rate Increased Hypertension Malaise 22-Feb-2006 08:30 AM Page: 2701 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/13/04ISR Number: 4357284-8Report Type:Expedited (15-DaCompany Report #PHNR2004AU00951 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Cholesterol Clozaril PS Novartis Sector: Increased Pharma 13 - 225 Blood Glucose Increased mg/day Blood Triglycerides Valproate Sodium C 500 mg mane + Increased 700 mg nocte Diabetes Mellitus Zocor "Dieckmann" C High Density Lipoprotein Decreased Low Density Lipoprotein Increased Date:05/13/04ISR Number: 4357289-7Report Type:Expedited (15-DaCompany Report #PHEH2004US04921 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Cancer Clozaril PS Novartis Sector: Leukopenia Pharma ORAL 600 mg/day 131 DAY Neutropenia Date:05/13/04ISR Number: 4357291-5Report Type:Expedited (15-DaCompany Report #PHFR2004GB01731 Age:61 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Clozaril PS Novartis Sector: Haematocrit Decreased Pharma ORAL 550mg/day Haemoglobin Decreased Venlafaxine C ORAL 225mg/day Clonazepam C ORAL 500 mg, BID Docusate Sodium C UNKNOWN UNK, PRN Lactulose C UNKNOWN UNK, PRN Date:05/13/04ISR Number: 4358030-4Report Type:Expedited (15-DaCompany Report #04-05-0665 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 425MG QD ORAL Date:05/13/04ISR Number: 4358031-6Report Type:Expedited (15-DaCompany Report #04-04-0522 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asterixis Health Clozapine - Ivax Initial or Prolonged Delirium Professional Pharmaceuticals, Other Encephalopathy Other Inc. Tablets PS Ivax Myoclonus Pharmaceuticals, Respiratory Failure Inc. ORAL 225-400MG QD Sedation ORAL Lithium C Prozac C Prolixin C Depakote C 22-Feb-2006 08:30 AM Page: 2702 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/13/04ISR Number: 4358033-XReport Type:Expedited (15-DaCompany Report #04-05-0649 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dizziness Health Clozapine - Ivax Initial or Prolonged Fall Professional Pharmaceuticals, Medication Error Other Inc. Tablets PS Ivax Syncope Pharmaceuticals, Inc. ORAL 300-700MG QD ORAL Risperdal C Date:05/13/04ISR Number: 4358034-1Report Type:Expedited (15-DaCompany Report #04-05-0666 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Intestinal Ischaemia Health Clozapine - Ivax Sepsis Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 600-850MG QD ORAL Date:05/13/04ISR Number: 4358036-5Report Type:Expedited (15-DaCompany Report #04-05-0635 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Meniscus Lesion Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 700-900MG QD ORAL Date:05/13/04ISR Number: 4358066-3Report Type:Expedited (15-DaCompany Report #2004S1000902 Age:79 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 37.5MG QD, Other ORAL Morphine C Lorazepam C Carbidopa/Levodopa C Docusate C Date:05/13/04ISR Number: 4358067-5Report Type:Expedited (15-DaCompany Report #2004S1001042 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - General Physical Health Health Clozapine Tablets Initial or Prolonged Deterioration Professional Mylan PS Mylan ORAL ORAL Pharmaceutical Product Other Metformin C Complaint Gemfibrozil C Treatment Noncompliance Pravastatin C Aspirin C 22-Feb-2006 08:30 AM Page: 2703 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/13/04ISR Number: 4358070-5Report Type:Expedited (15-DaCompany Report #04-02-0298 Age:56 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Health Clozapine - Ivax Choking Professional Pharmaceuticals, Fall Other Inc. Tablets PS ORAL 100MG QAM Loss Of Consciousness ORAL; 500MG Pulse Absent QHS ORAL ( Respiratory Arrest DURATION: Vomiting YEAR(S) ) Trileptal C Proscar C Florinef C Detrol La C Date:05/14/04ISR Number: 4357871-7Report Type:Expedited (15-DaCompany Report #PHNR2004AU00698 Age:34 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asthma Health Clozaril PS Novartis Sector: Other Professional Pharma ORAL 800 mg, QD Efexor C Topamax C Serenase C Benzotropine C UNK, PRN Date:05/14/04ISR Number: 4357874-2Report Type:Expedited (15-DaCompany Report #PHBS2004NL01962 Age:74 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Body Temperature Clozapine PS Novartis Sector: Increased Pharma UNKNOWN 100 mg/d Coma Lorazepam SS UNKNOWN 1 or 2.5 Feeling Abnormal mg/d Medication Error Pimozide C UNKNOWN 6 mg/d Miosis Lithium Carbonate C UNKNOWN 400 mg/d Red Blood Cell Acetaminophen C UNKNOWN 500 mg, TID Sedimentation Rate Temazepam C UNKNOWN 10 mg/d Increased Date:05/14/04ISR Number: 4357875-4Report Type:Expedited (15-DaCompany Report #PHBS2004NL01964 Age:46 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Pressure Increased Health Clozapine PS Novartis Sector: Cold Sweat Professional Pharma UNKNOWN 12.5 mg/d Coma Clozapine SS Novartis Sector: Drug Toxicity Pharma UNKNOWN 175 mg/d Heart Rate Decreased Clozapine SS Novartis Sector: Hypersomnia Pharma UNKNOWN 100 mg/d Miosis Diazepam SS UNKNOWN 2 mg, TID Muscular Weakness Oxazepam SS UNKNOWN 75 mg, QD Pallor Haloperidol C UNKNOWN 10 mg, TID Salivary Hypersecretion Ibuprofen C UNKNOWN 200 mg, TID Pantozol C UNKNOWN 40 mg/d 22-Feb-2006 08:30 AM Page: 2704 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/14/04ISR Number: 4357876-6Report Type:Expedited (15-DaCompany Report #PHBS2004NL01963 Age:75 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Pressure Decreased Health Clozapine PS Novartis Sector: Coma Professional Pharma UNKNOWN 100 mg/d Feeling Cold Oxazepam SS UNKNOWN 10 mg/d Medication Error Oxazepam SS UNKNOWN 10 mg, BID as necessary Norfloxacin SS UNKNOWN 400 mg/d Cisordinol C UNKNOWN 2 mg, TID Prednisolone C UNKNOWN 10 mg/d Prednisolone C UNKNOWN 5mg/d Carbamazepine C UNKNOWN 200 mg, TID Date:05/14/04ISR Number: 4358194-2Report Type:Expedited (15-DaCompany Report #PHFR2002GB00509 Age:57 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Haemoglobin Decreased Consumer Clozaril PS Novartis Sector: Initial or Prolonged Nephrotic Syndrome Pharma ORAL 500mg/day Other Renal Transplant Clozaril SS Novartis Sector: Pharma ORAL 300mg/day Mycophenolate Sodium C UNKNOWN Date:05/14/04ISR Number: 4358337-0Report Type:Expedited (15-DaCompany Report #PHEH2004US04965 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cerebral Disorder Clozaril PS Novartis Sector: Communication Disorder Pharma ORAL 100 mg/day Electroencephalogram Eskalith C Abnormal Benztropeine C Infection Prolixin C Leukopenia Ambien C Memory Impairment Date:05/14/04ISR Number: 4358462-4Report Type:Expedited (15-DaCompany Report #PHFR2002GB00509 Age:57 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dialysis Health Clozaril PS Novartis Sector: Initial or Prolonged Haemoglobin Decreased Professional Pharma ORAL 500mg/day Other Nephrotic Syndrome Clozaril SS Novartis Sector: Renal Transplant Pharma ORAL 300mg/day Mycophenolate Sodium C UNKNOWN Date:05/14/04ISR Number: 4358531-9Report Type:Expedited (15-DaCompany Report #PHFR2004GB01837 Age:25 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Clozaril PS Novartis Sector: Initial or Prolonged Increased Pharma ORAL 200 mg, BID Other Circulatory Collapse Clozaril SS Novartis Sector: Drug Level Increased Pharma ORAL 200 mg Drug Toxicity medication Loss Of Consciousness error Medication Error 22-Feb-2006 08:30 AM Page: 2705 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/14/04ISR Number: 4358533-2Report Type:Expedited (15-DaCompany Report #PHFR2004GB01843 Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Haemoglobin Decreased Consumer Clozaril PS Novartis Sector: Pharma ORAL Date:05/14/04ISR Number: 4358534-4Report Type:Expedited (15-DaCompany Report #PHFR2004GB01730 Age:57 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Circulatory Collapse Health Clozaril PS Novartis Sector: Initial or Prolonged Duodenal Ulcer Professional Pharma ORAL Haemoglobin Decreased Amitriptyline C 50mg/day Red Blood Cell Count Decreased Date:05/14/04ISR Number: 4358537-XReport Type:Expedited (15-DaCompany Report #PHNR2004AU00757 Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Hepatic Failure Health Clozaril PS Novartis Sector: Hospitalization - Lung Abscess Professional Pharma 200 - 800 Initial or Prolonged Pleural Effusion mg/day Pyothorax Valproate Sodium C Renal Failure Isosorbide C Atenolol C Aspirin "Bayer" C Fluoxetine C Lipitor C Date:05/14/04ISR Number: 4358541-1Report Type:Expedited (15-DaCompany Report #PHFR2004GB02040 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Haemoglobin Decreased Clozaril PS Novartis Sector: Pharma ORAL Date:05/14/04ISR Number: 4358542-3Report Type:Expedited (15-DaCompany Report #PHFR2004IE01997 Age:69 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Haemoglobin Decreased Clozaril PS Novartis Sector: Pharma ORAL Date:05/14/04ISR Number: 4358552-6Report Type:Expedited (15-DaCompany Report #PHFR2004IE01835 Age:53 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Glucose Fluctuation Clozaril PS Novartis Sector: Haemoglobin Decreased Pharma ORAL 600 mg/day Weight Decreased 22-Feb-2006 08:30 AM Page: 2706 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/14/04ISR Number: 4358553-8Report Type:Expedited (15-DaCompany Report #PHFR2004GB02026 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Haemoglobin Decreased Clozaril PS Novartis Sector: Pharma ORAL Date:05/17/04ISR Number: 4358703-3Report Type:Expedited (15-DaCompany Report #PHNR2004AU00698 Age:34 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asthma Health Clozaril PS Novartis Sector: Other Drug Level Increased Professional Pharma ORAL 800 mg, QD Drug Toxicity Efexor C Wheezing Topamax C Serenase C Benzotropine C UNK, PRN Date:05/17/04ISR Number: 4358704-5Report Type:Expedited (15-DaCompany Report #PHFR2004GB02032 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pleural Effusion Clozaril PS Novartis Sector: Pharma ORAL Date:05/17/04ISR Number: 4358721-5Report Type:Expedited (15-DaCompany Report #PHFR2004GB00954 Age:54 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Clozaril PS Novartis Sector: Hospitalization - Essential Hypertension Pharma ORAL 700mg/day Initial or Prolonged Hypertensive Heart Clomipramine C ORAL 25mg/day Disease Diazepam C ORAL 2 mg, BID Injury Temazepam C ORAL 10mg/day Joint Dislocation Date:05/17/04ISR Number: 4358898-1Report Type:Expedited (15-DaCompany Report #PHNR2004AU00776 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyspnoea Health Clozaril PS Novartis Sector: Eosinophil Count Professional Pharma ORAL 75 - 600 Increased mg/day Exercise Tolerance Decreased Neutrophil Count Increased Sleep Apnoea Syndrome Weight Increased White Blood Cell Count Increased 22-Feb-2006 08:30 AM Page: 2707 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/17/04ISR Number: 4359319-5Report Type:Direct Company Report #CTU 218752 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Clozapine By Ivax Hospitalization - 100mg & 25 Mg Initial or Prolonged Tablets PS ORAL 475 MG PO (200AM +275 MG HS) Ranitidine C Albuterol C Atorvastatin C Paroxetine C Acetaminophen C Date:05/17/04ISR Number: 4359558-3Report Type:Direct Company Report #CTU 218805 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dizziness Clozapine 100mg PS ORAL 400 MG QD Initial or Prolonged Gait Disturbance ORAL Myoclonus Tramadol 50mg SS ORAL 50MG BID ORAL Nausea Ibuprofen C Pallor Valproic Acid C Tonic Clonic Movements Propranolol C Date:05/17/04ISR Number: 4361243-9Report Type:Expedited (15-DaCompany Report #04P-167-0259625-00 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Diabetes Mellitus Foreign Valproate Sodium Intervention to Inadequate Control Health (Sodium Valproate) Prevent Permanent Electrocardiogram Qt Professional (Sodium Valproate) Impairment/Damage Prolonged (Sodium Valproate) PS 500 MG, 2 IN Hyperglycaemia 1 D ; Pain INCREASED Pharyngolaryngeal Pain DOSE Clozapine SS ORAL 275 MG, 1 IN 1 D, PER ORAL; 200 MG, 1 IN 1 D, PER ORAL Venlafaxine SS 150 MG, 4 IN 1 D Desmopressin C Metformin C Gliclazide C Methylcellulose C Date:05/18/04ISR Number: 4359797-1Report Type:Expedited (15-DaCompany Report #PHFR2004GB00834 Age:41 YR Gender:Male I/FU:F Outcome PT Death Arteritis Cardio-Respiratory Arrest Dehydration Diarrhoea Drug Interaction Drug Level Increased 22-Feb-2006 08:30 AM Page: 2708 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Myocarditis Orthostatic Hypotension Pericarditis Report Source Product Role Manufacturer Route Dose Duration Renal Impairment Consumer Procyclidine PS Glaxosmithkline UNKNOWN 5MG Four times per day Clozaril SS ORAL 200MG Per day Chlorpromazine SS Glaxosmithkline UNKNOWN 300MG Three times per day Zopiclone SS UNKNOWN 7.5MG At night Clonazepam SS UNKNOWN .5MG Per day Date:05/18/04ISR Number: 4359912-XReport Type:Expedited (15-DaCompany Report #PHHO2004CA06608 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diarrhoea Clozaril (Clozapine) PS Novartis Sector: Idiosyncratic Drug Pharma ORAL 175mg daily 74880MIN Reaction Clozaril (Clozapine) SS Novartis Sector: Orthostatic Hypotension Pharma ORAL Unspecified Pyrexia Quetiapine C Divalproex Sodium C Clonazepam C Date:05/18/04ISR Number: 4360654-5Report Type:Direct Company Report #CTU 218906 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Clozapine PS 500 MG/DAY Circulatory Collapse Depakote C Heart Rate Increased Wellchol C Sudden Death Tricor C Vomiting Niaspan C Synthroid C Date:05/19/04ISR Number: 4360079-2Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040302761 Age: Gender:Female I/FU:I Outcome PT Hospitalization - Abdominal Pain Initial or Prolonged Blood Alkaline Phosphatase Increased Blood Chloride Decreased Blood Glucose Increased Blood Potassium Decreased Blood Pressure Diastolic Decreased Chills Hepatomegaly Hyperhidrosis Internal Hernia Leukocytosis Lower Respiratory Tract Infection Neuroleptic Malignant Syndrome Oxygen Saturation Decreased 22-Feb-2006 08:30 AM Page: 2709 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Procedural Site Reaction Protein Total Increased Pyrexia Report Source Product Role Manufacturer Route Dose Duration Respiratory Rate Risperdal PS OROPHARINGEAL 1 in 4 hours Increased as needed Urinary Tract Infection Clozapine SS OROPHARINGEAL Vomiting Celexa C Ibuprofen C Norvasc C Prevacid C Spironolactone C Detrol La C Demodex C Theophylline C Singulair C Quinine Sulfate C Trazodone C Valproic Acid C Flovent C Tylenol C Vistaril C Guaifenesin C Duoneb C Duoneb C Albuterol C Date:05/19/04ISR Number: 4360125-6Report Type:Expedited (15-DaCompany Report #PHEH2004US03388 Age:55 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Clozaril PS Novartis Sector: Initial or Prolonged Dyspnoea Pharma ORAL 300 mg, QD Other Haematocrit Decreased Clozaril SS Novartis Sector: Haemoglobin Decreased Pharma ORAL 300 mg/day Neutrophil Count Depakote C Increased Prevacid C Non-Small Cell Lung Paxil C Cancer Prednisone C Platelet Count Decreased Ceftriaxone C Pneumonia Pyrexia Red Blood Cell Count Decreased White Blood Cell Count Decreased Date:05/19/04ISR Number: 4360552-7Report Type:Expedited (15-DaCompany Report #PHFR2004IE01604 Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Encephalitis Clozaril PS Novartis Sector: Initial or Prolonged Loss Of Consciousness Pharma ORAL 500mg/day Medication Error Clozaril SS Novartis Sector: Somnolence Pharma ORAL 25mg/day Clozaril SS Novartis Sector: Pharma ORAL 300mg/day 22-Feb-2006 08:30 AM Page: 2710 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/19/04ISR Number: 4360555-2Report Type:Expedited (15-DaCompany Report #PHFR2004IE01212 Age:22 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Glucose Increased Clozaril PS Novartis Sector: Diabetes Mellitus Pharma ORAL 250mg/day Enuresis Lustral C ORAL 100mg/day Iron Deficiency Anaemia Kemadrin C ORAL 5 mg, BID Weight Increased Date:05/19/04ISR Number: 4360561-8Report Type:Expedited (15-DaCompany Report #GB-ROCHE-367183 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arteritis Clonazepam PS Roche UNKNOWN Cardiopulmonary Failure Zopiclone SS UNKNOWN Diarrhoea Clozaril I ORAL Drug Interaction Chlorpromazine I UNKNOWN Drug Level Increased Procyclidine I UNKNOWN Myocarditis Orthostatic Hypotension Renal Impairment Date:05/19/04ISR Number: 4360565-5Report Type:Expedited (15-DaCompany Report #PHFR2004GB01876 Age:59 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Haemoglobin Decreased Clozaril PS Novartis Sector: Initial or Prolonged Liver Disorder Pharma ORAL 500mg Other Renal Disorder Clozaril SS Novartis Sector: Pharma 300mg nocte Date:05/19/04ISR Number: 4360581-3Report Type:Expedited (15-DaCompany Report #PHEH2004US05320 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Clozaril PS Novartis Sector: Lung Neoplasm Malignant Pharma ORAL UNK, UNK White Blood Cell Count Decreased Date:05/19/04ISR Number: 4360607-7Report Type:Expedited (15-DaCompany Report #US-MERCK-0402USA01726 Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Back Pain Zetia PS Merck & Co., Inc ORAL 10 DAY Life-Threatening Muscle Spasms Clozapine SS ORAL Disability Sudden Death Clozapine SS ORAL Clozapine SS ORAL Clozapine SS UNKNOWN Clozapine SS ORAL Zetia SS Merck & Co., Inc ORAL 10 DAY Clozapine SS UNKNOWN Albuterol C RESPIRATORY (INHALATION) Azmacort C RESPIRATORY (INHALATION) Seroquel C ORAL 22-Feb-2006 08:30 AM Page: 2711 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Seroquel C ORAL Micro-K Extencaps C ORAL Glucophage C UNKNOWN Xanax C ORAL Monopril C ORAL Lasix (Furosemide) C ORAL Atarax C UNKNOWN Glucotrol Xl C ORAL Depakote C ORAL Xanax C ORAL Date:05/19/04ISR Number: 4360764-2Report Type:Expedited (15-DaCompany Report #04-05-0667 Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Health Clozapine-Ivax Initial or Prolonged Coma Professional Pharmaceuticals, Other Inc, Tablets PS Ivax Pharmaceuticals, Inc. ORAL 500 MG QAM ORAL Plavix C Zantac C Synthroid C Allegra C Aspirin C Lanoxin C Metoprolol C Norvasc C Date:05/19/04ISR Number: 4360770-8Report Type:Expedited (15-DaCompany Report #04-05-0676 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozapine -Ivax Pneumonia Aspiration Professional Pharmaceuticals, Respiratory Failure Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 500-1100MG QD ORAL Date:05/19/04ISR Number: 4360771-XReport Type:Expedited (15-DaCompany Report #04-05-0664 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Respiratory Arrest Health Clozapine-Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 100-450MG QD ORAL 22-Feb-2006 08:30 AM Page: 2712 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/19/04ISR Number: 4360772-1Report Type:Expedited (15-DaCompany Report #04-05-0660 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Intracranial Aneurysm Health Clozapine -Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 300-600MG QD ORAL Date:05/19/04ISR Number: 4360773-3Report Type:Expedited (15-DaCompany Report #04-05-0688 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucination Health Clozapine-Ivax Initial or Prolonged Obsessive-Compulsive Professional Pharmaceuticals, Disorder Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 200-700MG QD ORAL Date:05/19/04ISR Number: 4360775-7Report Type:Expedited (15-DaCompany Report #04-05-0684 Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Neoplasm Malignant Health Clozapine -Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. OPHTHALMIC 73-375MG QD ORAL Date:05/20/04ISR Number: 4365619-5Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040302761 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Health Risperdal Initial or Prolonged Blood Alkaline Professional (Risperidone) PS ORAL 0.5 MG, ORAL Phosphatase Increased Clozapine Blood Chloride Decreased (Clozapine) Tablets SS ORAL 125 MG, 2 IN Blood Glucose Increased 1 DAY, ORAL C-Reactive Protein Celexa (Citalopram Increased Hydrobromide) C Chills Ibuprofen Hepatomegaly (Ibuprofen) C Hernia Norvasc (Amlodipine Hyperhidrosis Besilate) C Leukocytosis Prevacid Lung Infection (Lansoprazole) C Neuroleptic Malignant Spironolactone Syndrome (Spironolactone) C Pyrexia Detrol La Red Blood Cell (Tolterodine Sedimentation Rate L-Tartrate) C Increased Demodex (Torasemide) C Urinary Tract Infection Theophylline Vomiting (Theophylline) C Singulair 22-Feb-2006 08:30 AM Page: 2713 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Montelukast Sodium) C Quinine Sulfate (Quinine Sulfate) C Trazodone (Trazodone) C Valproic Acid (Valproic Acid) C Flovent (Fluticasone Propionate) C Tylenol (Paracetamol) C Vistaril (Hydroxyzine Embonate) C Guaifenesin (Guaifenesin) C Duoneb (Medihaler-Duo) C Albuterol (Salbutamol) C Date:05/21/04ISR Number: 4361348-2Report Type:Expedited (15-DaCompany Report #PHNR2004AU00919 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Clozaril PS Novartis Sector: Initial or Prolonged Fall Pharma 100 - 300 Gait Disturbance mg/day 393 DAY Date:05/21/04ISR Number: 4361385-8Report Type:Expedited (15-DaCompany Report #PHHO2004CA05480 Age:79 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Fall Clozaril (Clozapine) PS Novartis Sector: Other Neuromyopathy Pharma ORAL 72 DAY Neutropenia Posture Abnormal Salivary Hypersecretion Date:05/21/04ISR Number: 4361908-9Report Type:Periodic Company Report #03-12-1617 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Diarrhoea Thorazine PS Glaxosmithkline UNKNOWN Lethargy Clozapine SS ORAL 50MG Per day Risperdal SS UNKNOWN Depakote SS UNKNOWN Date:05/21/04ISR Number: 4364396-1Report Type:Expedited (15-DaCompany Report #04-05-0702 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Intestinal Perforation Health Clozapine -Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals , Inc. ORAL 375-475MG QD ORAL Fibercon C 22-Feb-2006 08:30 AM Page: 2714 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Colace 20omg C Date:05/21/04ISR Number: 4364397-3Report Type:Expedited (15-DaCompany Report #04-05-0703 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Health Clozapine -Ivax Hospitalization - Professional Pharmaceuticals, Initial or Prolonged Other Inc. PS Ivax Pharmaceuticals, Inc. ORAL 550-700MG QD ORAL Date:05/21/04ISR Number: 4364399-7Report Type:Expedited (15-DaCompany Report #2004S1001166 Age:49 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg Mylan PS ORAL 25MG Q HS, Other ORAL Furosemide C Potassium Chloride C Olanzapine C Enalapril C Gabapentin C Clonazepam C Lansoprazole C Citalopram C Date:05/21/04ISR Number: 4364401-2Report Type:Expedited (15-DaCompany Report #2004S1001154 Age:46 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Overdose Other Acetaminophen/Codein e 300 Mg/30 Mg PS Clozapine Tablets 25 Mg Mylan SS ORAL SEE IMAGE Risperidone C Divalproex Sodium C Procyclidine C Desmopressin C Date:05/21/04ISR Number: 4364404-8Report Type:Expedited (15-DaCompany Report #04-05-0710 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Foreign Body Trauma Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 300-350MG QD ORAL 22-Feb-2006 08:30 AM Page: 2715 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/21/04ISR Number: 4364407-3Report Type:Expedited (15-DaCompany Report #04-05-0712 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Injury Asphyxiation Health Clozapine Tablets - Intentional Self-Injury Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 25-650 MG QD ORAL Date:05/21/04ISR Number: 4364408-5Report Type:Expedited (15-DaCompany Report #2004S1001152 Age:53 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Chest Pain Health Clozapine Tablets Convulsion Professional 100 Mg Mylan PS Mylan ORAL 100MG QHS, Fall Other ORAL Sudden Cardiac Death Colchicine C Allopurinol C Nifedipine Xl C Ibuprofen C Haloperidol Decanoate C Diphenhydramine C Date:05/21/04ISR Number: 4364409-7Report Type:Expedited (15-DaCompany Report #2004S1001135 Age:56 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatic Neoplasm Other Clozapine Tablets Malignant 100 Mg Mylan PS Mylan ORAL 100MG Q AM AND 800 MG Q PM, ORAL Date:05/21/04ISR Number: 4364413-9Report Type:Expedited (15-DaCompany Report #2004S1000718 Age:53 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Neoplasm Malignant Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 200 MG Q AM & Other 300 MG Q HS, ORAL Diltiazem C Doxazosin C Vitamins C Divalproex Sodium C Folic Acid C Thiamine C Multivitamin C Zipasidone C Levofloxacin C 22-Feb-2006 08:30 AM Page: 2716 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/24/04ISR Number: 4362644-5Report Type:Expedited (15-DaCompany Report #PHFR2004IE01835 Age:53 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Glucose Fluctuation Consumer Clozaril PS Novartis Sector: Haemoglobin Decreased Pharma ORAL 600 mg/day Malaise Metformin C Weight Decreased Date:05/24/04ISR Number: 4362645-7Report Type:Expedited (15-DaCompany Report #PHNR2004AU00850 Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depressed Level Of Health Clozaril PS Novartis Sector: Initial or Prolonged Consciousness Professional Pharma ORAL 200 mg mane + Drug Withdrawal Syndrome 200 mg nocte 792 DAY Dysarthria Clozaril SS Novartis Sector: Dyskinesia Pharma ORAL 200 mg mane + Gait Disturbance 300 mg nocte Clozaril SS Novartis Sector: Pharma 12.5 - 100 mg/day Epilim C 500 mg, BID Date:05/24/04ISR Number: 4363626-XReport Type:Expedited (15-DaCompany Report #PHFR2004GB02097 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Cholesterol Clozaril PS Novartis Sector: Increased Pharma ORAL Blood Glucose Increased Hypertriglyceridaemia Lipids Increased Date:05/24/04ISR Number: 4363627-1Report Type:Expedited (15-DaCompany Report #PHNU2004DE01798 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatinine Leponex / Clozaril Increased (Clozapine) PS Novartis Sector: Pharma ORAL 350 mg/day Date:05/24/04ISR Number: 4366180-1Report Type:Expedited (15-DaCompany Report #04P-062-0258097-00 Age:32 YR Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Foreign Akineton(Biperiden) Initial or Prolonged Confusional State Health (Biperiden) PS ORAL PER ORAL Overdose Professional Promazine Suicide Attempt Other Hydrochloride SS ORAL 100 MG, 78 IN ONCE, PER ORAL Clozapin SS ORAL 200 MG, 20 TABLETS, ONCE, PER ORAL Fluphenazine SS 150 TABLETS ONCE 22-Feb-2006 08:30 AM Page: 2717 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/25/04ISR Number: 4363921-4Report Type:Expedited (15-DaCompany Report #PHHO2004CA05965 Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Drug Interaction Health Clozaril (Clozapine) PS Novartis Sector: Fracture Professional Pharma ORAL 200 mg, QHS 94 DAY Neutropenia Tazocin SS Osteomyelitis Flagyl C Suicide Attempt Percocet C ORAL 2 Tabs, BID Surgery Celexa C ORAL QD White Blood Cell Count Ritalin C ORAL Decreased Zantac C ORAL BID Risperdal C 3 mg, BID Trazodone C ORAL 50 mg, QHS Bisacodyl C ORAL Hydromorph Contin C ORAL 15 mg, BID Hydrocortisone C TOPICAL TID Sofra-Tuell C TOPICAL TID Colace C ORAL 100 mg, BID Asa C ORAL 650 mg, BID Calcium C ORAL QD Tylenol C 650 mg, Tinzaparin C SUBCUTANEOUS QD Fleet C Mom C ORAL Urojet C TOPICAL PRN Gravol C ORAL Lactulose C ORAL 30 ml, TID Multivitamins C ORAL QD Ancef C 1 g, Q8H Ancef C NO TREATMENT Keflex C 500 mg, QD Keflex C NO TREATMENT Piperacillin W/Tazobactam C 4.5 g, Q8H Date:05/25/04ISR Number: 4364330-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12400289 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Cytoxan PS Bristol-Myers Squibb Company Clozapine SS ORAL 200-900 MG/DAY Date:05/25/04ISR Number: 4368773-4Report Type:Expedited (15-DaCompany Report #2004UW08844 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Full Blood Count Foreign Seroquel PS Intervention to Decreased Health Clozapine SS Prevent Permanent Professional Celebrex SS Impairment/Damage Other Haloperidol C Nozinan C 22-Feb-2006 08:30 AM Page: 2718 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/25/04ISR Number: 4370644-4Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040501769 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Foreign Halperidol Initial or Prolonged Hallucination Health (Haloperidol) Neuroleptic Malignant Professional Unspecified PS 2.5-5MG/DAY Syndrome Clozaril (Clozapine) SS ORAL 75 MG, IN 1 Treatment Noncompliance DAY, ORAL Urinary Incontinence Amisulpride Urinary Tract Infection (Amisulpride) SS ORAL 400 MG, 2 IN 1 DAY, ORAL Sodium Valproate (Valproate Sodium) C Procyclidine (Procyclidine) C Lorazepam (Lorazepam) C Date:05/26/04ISR Number: 4364763-6Report Type:Expedited (15-DaCompany Report #PHRM2004FR01728 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutrophil Count Abnormal Leponex PS Novartis Sector: White Blood Cell Disorder Pharma ORAL 100 mg, daily Teralithe C UNKNOWN Tenormine C UNKNOWN Depamide C UNKNOWN Levothyrox C Doliprane C ORAL Date:05/26/04ISR Number: 4365525-6Report Type:Expedited (15-DaCompany Report #PHFR2004GB00801 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Level Increased Lithium PS Glaxosmithkline UNKNOWN Eating Disorder Clozaril SS ORAL 650MG Per day Malaise Neutrophilia White Blood Cell Count Increased Date:05/26/04ISR Number: 4366294-6Report Type:Direct Company Report #CTU 219570 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Diabetes Mellitus Clozapine 25 Mg Ivax PS Ivax ORAL 50 MG ORAL Intervention to Inadequate Control Clozapine 100 Mg Prevent Permanent Hyperglycaemia Ivax SS Ivax ORAL 300 MG QHS Impairment/Damage ORAL Benztropine C Docusate Na C Haloperidol C Hydroxyzine C Norvasc C Zestril C Apap C Zestril C Apap C 22-Feb-2006 08:30 AM Page: 2719 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Benadryl C Haloperidol C Maalox C Mom C Date:05/27/04ISR Number: 4366523-9Report Type:Expedited (15-DaCompany Report #GB-ROCHE-367183 Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arteritis Consumer Clonazepam PS Roche UNKNOWN Cardiopulmonary Failure Clozaril I ORAL Dehydration Chlorpromazine I UNKNOWN Diarrhoea Procyclidine I UNKNOWN Drug Interaction Zopiclone I UNKNOWN Drug Level Increased Myocarditis Orthostatic Hypotension Renal Impairment Date:05/27/04ISR Number: 4366700-7Report Type:Expedited (15-DaCompany Report #2004S1001425 Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Other Clozapine Tablets 25 Mg Mylan PS Mylan ORAL 50MG TID ORAL Date:05/27/04ISR Number: 4366701-9Report Type:Expedited (15-DaCompany Report #2004S1001481 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 500MG Q AM Other ORAL Clozapine Tablets 100 Mg Mylan SS Mylan ORAL 200MG Q AM, 400MG Q HS ORAL Benztropine C Clonazepam C Date:05/27/04ISR Number: 4366719-6Report Type:Expedited (15-DaCompany Report #2004S1000606 Age:66 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Neoplasm Malignant Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 200 MG/DAY, Other ORAL Clozapine Tablets 100 Mg Mylan SS Mylan ORAL 200 MG/DAY, ORAL Aspirin C Ferrous Sulfate C Morphine C Fentanyl C Dronabinol C Fluvoxamine C Docusate Sodium C 22-Feb-2006 08:30 AM Page: 2720 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lactulose C Date:05/27/04ISR Number: 4366738-XReport Type:Expedited (15-DaCompany Report #2004S1001179 Age:44 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death No Adverse Drug Effect Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 200MG/DAY, Other ORAL Date:05/27/04ISR Number: 4366739-1Report Type:Expedited (15-DaCompany Report #04-05-0733 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Metastatic Malignant Health Clozapine - Ivax Melanoma Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 50-75MG QD ORAL Date:05/27/04ISR Number: 4366740-8Report Type:Expedited (15-DaCompany Report #04-05-0711 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hip Fracture Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 12.5-75MG QD ORAL Date:05/27/04ISR Number: 4366745-7Report Type:Expedited (15-DaCompany Report #04-03-0441 Age:46 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Health Clozapine Tablets - Agranulocytosis Professional Ivax Fear Other Pharmaceuticals, Hodgkin'S Disease Inc. PS Ivax Pharmaceuticals, Inc. ORAL 200-500MG QD ORAL Chemotherapy Unknown SS Date:05/27/04ISR Number: 4367320-0Report Type:Expedited (15-DaCompany Report #04-05-0738 Age:55 YR Gender:Female I/FU:I Outcome PT Hospitalization - Delusion Initial or Prolonged Drug Ineffective Haemolytic Anaemia Lupus-Like Syndrome Neuroleptic Malignant Syndrome Normochromic Normocytic Anaemia Pericardial Effusion 22-Feb-2006 08:30 AM Page: 2721 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pleural Effusion Treatment Noncompliance Report Source Product Role Manufacturer Route Dose Duration Foreign Clozapine Tablets PS ORAL 200-500MG QD Literature ORAL 15 YR Health Professional Date:05/28/04ISR Number: 4366965-1Report Type:Expedited (15-DaCompany Report #PHFR2004GB01952 Age:49 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Decreased Immune Clozaril PS Novartis Sector: Other Responsiveness Pharma ORAL Dyspnoea Pneumonia Date:05/28/04ISR Number: 4366972-9Report Type:Expedited (15-DaCompany Report #PHHO2004CA06985 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Level Increased Clozaril PS Novartis Sector: Salivary Hypersecretion Pharma ORAL 600 mg, QD Haldol C 15 mg, Date:05/28/04ISR Number: 4366976-6Report Type:Expedited (15-DaCompany Report #PHFR2004IE00528 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acidosis Clozaril PS Novartis Sector: Initial or Prolonged Blood Bilirubin Increased Pharma ORAL 550mg/day 221 DAY Blood Calcium Increased Solian C ORAL 400mg/day Blood Glucose Abnormal Seroxat "Smithkline Blood Urea Increased Beecham" C ORAL 30mg/day Chest Pain Epilim C ORAL 600mg/day Circulatory Collapse Amitriptyline C ORAL 50mg/day 60480MIN Diabetic Ketoacidosis Dizziness Gamma-Glutamyltransferase Increased Haematemesis Ketosis Lipids Abnormal Neutrophilia Orthostatic Hypotension Urine Ketone Body Present Vomiting Weight Decreased White Blood Cell Count Increased Date:05/28/04ISR Number: 4367061-XReport Type:Expedited (15-DaCompany Report #PHHO2004CA06985 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Level Increased Health Clozaril PS Novartis Sector: Salivary Hypersecretion Professional Pharma ORAL 600 mg, QD 22-Feb-2006 08:30 AM Page: 2722 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Haldol C 15 mg, Date:05/28/04ISR Number: 4367137-7Report Type:Expedited (15-DaCompany Report #FR-GLAXOSMITHKLINE-B0333355A Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Deroxat PS Glaxosmithkline ORAL 20MG Per day Initial or Prolonged Aricept SS ORAL 10MG Per day Fludrocortisone Acetate SS ORAL .5UNIT Per day Leponex SS ORAL 25MG Per day Sinemet C ORAL 5UNIT per day Gutron C ORAL 15MG per day Date:05/28/04ISR Number: 4367192-4Report Type:Expedited (15-DaCompany Report #PHBS2003CA00554 Age:27 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Exposure During Health Clozaril PS Novartis Sector: Pregnancy Professional Pharma ORAL Hyperglycaemia Misoprostol C Intra-Uterine Death Nph Insulin C Humalog C Date:06/01/04ISR Number: 4367295-4Report Type:Expedited (15-DaCompany Report #PHFR2004GB01743 Age:31 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardio-Respiratory Arrest Clozaril PS Novartis Sector: Hospitalization - Renal Failure Acute Pharma ORAL 550 mg/day Initial or Prolonged Rhabdomyolysis Lamotrigine SS ORAL 150 mg/day Other Lorazepam C ORAL Date:06/01/04ISR Number: 4367308-XReport Type:Expedited (15-DaCompany Report #PHNR2004AU00984 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Clozaril PS Novartis Sector: Weight Increased Pharma 25 - 650 mg/day Clozaril SS Novartis Sector: Pharma 25 - 400 mg/day Solian C Date:06/01/04ISR Number: 4367719-2Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040504633 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Haloperidol PS OROPHARINGEAL Leukocytosis Clozaril SS OROPHARINGEAL 500 to 450 Tachycardia mg/day Thrombocythaemia Procyclidine C OROPHARINGEAL Sertraline C OROPHARINGEAL Diazepam C OROPHARINGEAL 22-Feb-2006 08:30 AM Page: 2723 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Co-Proxamol C OROPHARINGEAL Co-Proxamol C OROPHARINGEAL Diclofenac C OROPHARINGEAL Date:06/02/04ISR Number: 4367925-7Report Type:Expedited (15-DaCompany Report #PHFR2003GB02500 Age:18 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Body Temperature Health Clozaril PS Novartis Sector: Increased Professional Pharma ORAL 101 DAY Electrocardiogram Abnormal Electrocardiogram St Segment Elevation Heart Rate Increased Hypertension Malaise Date:06/02/04ISR Number: 4367926-9Report Type:Expedited (15-DaCompany Report #PHFR2004IE01835 Age:53 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Glucose Fluctuation Consumer Clozaril PS Novartis Sector: Haemoglobin Decreased Pharma ORAL 600 mg/day Malaise Metformin C Weight Decreased Date:06/02/04ISR Number: 4367935-XReport Type:Expedited (15-DaCompany Report #PHFR2004GB01934 Age:31 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Akathisia Health Clozaril PS Novartis Sector: Blood Pressure Increased Professional Pharma ORAL 300mg/day Computerised Tomogram Clozaril SS Novartis Sector: Abnormal Pharma ORAL Extra 100mg Drug Interaction dose given Drug Level Increased Clozaril SS Novartis Sector: Epilepsy Pharma ORAL 500mg/day 202 DAY Grand Mal Convulsion Fluoxetine SS ORAL 20mg/day Heart Rate Increased Valproate Sodium C UNKNOWN 400 mg, BID Medication Error Date:06/02/04ISR Number: 4367944-0Report Type:Expedited (15-DaCompany Report #PHFR2004GB02186 Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Level Increased Clozaril PS Novartis Sector: Tachycardia Pharma ORAL Date:06/02/04ISR Number: 4367946-4Report Type:Expedited (15-DaCompany Report #PHHO2004NZ07453 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Lymphopenia Clozaril PS Novartis Sector: Tachycardia Pharma ORAL 125 mg, QD 25920MIN 22-Feb-2006 08:30 AM Page: 2724 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/02/04ISR Number: 4368154-3Report Type:Expedited (15-DaCompany Report #PHEH2004US04921 Age:46 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Cancer Clozaril PS Novartis Sector: Leukopenia Pharma ORAL 600 mg/day Neutropenia Risperdal C Proscar C Cyclophosphamide C Epogen C Date:06/02/04ISR Number: 4369308-2Report Type:Expedited (15-DaCompany Report #04-05-0757 Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Colon Cancer Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc ORAL 100-225MG QD ORAL Date:06/02/04ISR Number: 4369310-0Report Type:Expedited (15-DaCompany Report #04-05-0646 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Intracranial Aneurysm Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 600MG QD ORAL Date:06/02/04ISR Number: 4369313-6Report Type:Expedited (15-DaCompany Report #04-05-0761 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc ORAL 300-450MG QD ORAL Date:06/02/04ISR Number: 4369316-1Report Type:Expedited (15-DaCompany Report #04-05-0744 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc ORAL 100-500MG QD ORAL Date:06/02/04ISR Number: 4370724-3Report Type:Direct Company Report #CTU 219981 Age: Gender:Male I/FU:I Outcome Life-Threatening Required 22-Feb-2006 08:30 AM Page: 2725 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Intervention to Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Cardiac Disorder Clozapine PS ORAL 600 MG DAILY Cardiomyopathy ORAL Dyskinesia Haloperidol C Metoprolol C Doxazosin C Diltiazem C Amantadine C Selenium C Psyllium C Date:06/02/04ISR Number: 4370726-7Report Type:Direct Company Report #CTU 219979 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Drug Level Increased Clozapine PS ORAL 50 MG DAILY Intervention to ORAL Prevent Permanent Fluvoxamine SS ORAL 100 MG BID Impairment/Damage ORAL Olanzapine C Haloperidol C Simvastatin C Date:06/02/04ISR Number: 4370730-9Report Type:Direct Company Report #CTU 219976 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Drug Level Increased Clozapine PS ORAL 700 MG DAILY Intervention to ORAL Prevent Permanent Sertraline SS ORAL 100 MG DAILY Impairment/Damage ORAL Date:06/02/04ISR Number: 4372110-9Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040504633 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Foreign Haloperidol Platelet Count Increased Health (Haloperidol) Tachycardia Professional Unspecified PS ORAL 15 MG, 2 IN 1 White Blood Cell Count DAY, ORAL Increased Clozaril (Clozapine) SS 500 TO 450 MG/DAY Procyclidine (Procyclidine) C Sertraline (Sertraline) C Diazepam (Diazepam) C Co-Proxamol (Aporex) C Diclofenac (Diclofenac) C 22-Feb-2006 08:30 AM Page: 2726 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/03/04ISR Number: 4368983-6Report Type:Expedited (15-DaCompany Report #PHFR2003GB01977 Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Antipsychotic Drug Level Clozaril PS Novartis Sector: Above Therapeutic Pharma ORAL 1134 DAY Blood Alcohol Increased Overdose Date:06/03/04ISR Number: 4370137-4Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12566568 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abnormal Behaviour Abilify Tabs 15 Mg PS Otsuka Drug Interaction Pharmaceutical Eye Movement Disorder Company, Ltd. ORAL 5 DAY Soliloquy Valium I Topamax I Clozaril I Lipitor I Inderal I Progesterone I Welchol I Date:06/03/04ISR Number: 4373768-0Report Type:Expedited (15-DaCompany Report #K200400744 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arteritis Foreign Kemadrin Cardio-Respiratory Arrest Health (Procyclidine) PS ORAL 5 MG, QID Dehydration Professional Clozapine Diarrhoea Other (Clozapine) 200mg SS ORAL 200 MG, QD, Drug Interaction ORAL Drug Level Increased Thorazine Myocarditis (Chlorpromazine Orthostatic Hypotension Hydrochloride) SS ORAL 300 MG, TID Pericarditis Zopiclone Renal Impairment (Zopiclone) SS ORAL 1.5 MG, QD AT NIGHT Clonazepam (Clonazepam) SS ORAL 0.5 MG, QD Date:06/04/04ISR Number: 4370688-2Report Type:Expedited (15-DaCompany Report #PHFR2004GB02040 Age:22 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Haemoglobin Decreased Health Clozaril PS Novartis Sector: Professional Pharma ORAL Date:06/04/04ISR Number: 4370690-0Report Type:Expedited (15-DaCompany Report #PHBS2004BE02545 Age:66 YR Gender:Female I/FU:F Outcome PT Hospitalization - Abdominal Pain Initial or Prolonged Blood Cortisol Increased Chills Depressed Level Of Consciousness 22-Feb-2006 08:30 AM Page: 2727 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Diarrhoea Drug Withdrawal Syndrome Dyskinesia Report Source Product Role Manufacturer Route Dose Duration Extrapyramidal Disorder Consumer Leponex PS Novartis Sector: Gastrointestinal Disorder Pharma UNKNOWN Hot Flush Leponex SS Novartis Sector: Hyperhidrosis Pharma UNKNOWN 150 mg/d Insomnia Leponex SS Novartis Sector: Malaise Pharma UNKNOWN 100 mg/d Myoclonus Leponex SS Novartis Sector: Osteoporosis Pharma 75 mg/d Pyrexia Leponex SS Novartis Sector: Rectal Polyp Pharma UNKNOWN 50 mg/d Restlessness Leponex SS Novartis Sector: Sedation Pharma UNKNOWN 25 mg, BID Somnolence Leponex SS Novartis Sector: Tardive Dyskinesia Pharma 25 mg /day 8640 MIN Tremor Leponex SS Novartis Sector: Vomiting Pharma 50 mg /day Xanax C UNKNOWN Xanax C UNKNOWN .5 mg, BID Rivotril C UNKNOWN 1 mg, QHS Rivotril C UNKNOWN 18720MIN Antihypertensives C UNKNOWN Aprovel C UNKNOWN 75 mg, QD Aldactazine C UNKNOWN UNK, Q48H Isoten C UNKNOWN 5 mg, QD Asaflow C UNKNOWN 160 mg, QD Trazolan C UNKNOWN 50 mg, QHS Imovane C UNKNOWN 3.75 or 7.5 mg in the evening Date:06/04/04ISR Number: 4370699-7Report Type:Expedited (15-DaCompany Report #PHNU2004DE01959 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Life Support Leponex / Clozaril Pneumonitis (Clozapine) PS Novartis Sector: Pulmonary Fibrosis Pharma ORAL Suicide Attempt Risperdal C Date:06/04/04ISR Number: 4370700-0Report Type:Expedited (15-DaCompany Report #PHFR2004GB02250 Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Fall Clozaril PS Novartis Sector: Lower Limb Fracture Pharma ORAL Date:06/04/04ISR Number: 4370701-2Report Type:Expedited (15-DaCompany Report #PHFR2004GB01588 Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Exposure Health Clozaril PS Novartis Sector: Initial or Prolonged Hypertension Professional Pharma ORAL 100 mg Other Sedation overdose Somnolence Risperidone C ORAL 2 mg, BID Tachycardia Risperidone Consta C INTRAMUSCULAR 50 mg, QW2 22-Feb-2006 08:30 AM Page: 2728 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/04/04ISR Number: 4370702-4Report Type:Expedited (15-DaCompany Report #PHFR2004GB01843 Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Health Clozaril PS Novartis Sector: Initial or Prolonged Haemoglobin Decreased Professional Pharma ORAL Other Menorrhagia Date:06/04/04ISR Number: 4371216-8Report Type:Expedited (15-DaCompany Report #PHEH2004US05908 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agranulocytosis Health Clozaril PS Novartis Sector: Other Pneumonia Professional Pharma ORAL UNK,UNK Date:06/04/04ISR Number: 4371260-0Report Type:Expedited (15-DaCompany Report #US-MERCK-0404USA01539 Age:70 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Cogentin PS Merck & Co., Inc ORAL White Blood Cell Disorder Clozapine SS ORAL Depakote SS UNKNOWN Depakote SS UNKNOWN Date:06/04/04ISR Number: 4371282-XReport Type:Expedited (15-DaCompany Report #GB-MERCK-0405GBR00189 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Vioxx PS Merck & Co., Inc ORAL Convulsion Clozapine SS ORAL Drug Interaction Clozapine SS ORAL Clozapine SS ORAL 77 DAY Clozapine SS ORAL Lithium Acetate SS UNKNOWN Tramadol Hydrochloride C UNKNOWN Date:06/04/04ISR Number: 4371361-7Report Type:Expedited (15-DaCompany Report #04-05-0750 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozapine Tablets - Myocardial Infarction Professional Ivax Pulmonary Embolism Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 150-800MG QD ORAL Date:06/04/04ISR Number: 4371366-6Report Type:Expedited (15-DaCompany Report #2004S1001503 Age:91 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozapine Tablets 25 Delirium Professional Mg Mylan PS Mylan ORAL 12.5 MG Q AM Supranuclear Palsy Other & 25 MG Q HS, ORAL 22-Feb-2006 08:30 AM Page: 2729 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Bupropion C Venlafaxine C Carbidopa/Levodopa C Atorvastatin C Clopidogrel C Entacapone C Ropinirole C Isorbide C Date:06/04/04ISR Number: 4371370-8Report Type:Expedited (15-DaCompany Report #2004S1001502 Age:84 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 50MG TID, Other THEN 25MG BIG, 50MG Q 8H & 25MG QHS, ORAL Lorazepam C Atropine C Acetaminophen C Oxycodone C Ibuprofen C Ranitidine C Date:06/04/04ISR Number: 4371373-3Report Type:Expedited (15-DaCompany Report #2004S1001494 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 100MG BID, Other ORAL Nystatin C Digoxin C Warfarin C Amlodipine C Aspirin C Folic Acid C Topiramate C Albuterol C Valproate Sodium C Date:06/04/04ISR Number: 4371375-7Report Type:Expedited (15-DaCompany Report #2004S1001493 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Health Clozapine Tablets 25 Parkinson'S Disease Professional Mg Mylan PS Mylan ORAL 25MG QD, ORAL Pneumonia Aspiration Other Levothyroxine C Carbidopa/Levodopa C Donepezil C Venlafaxine C 22-Feb-2006 08:30 AM Page: 2730 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/07/04ISR Number: 4371411-8Report Type:Expedited (15-DaCompany Report #PHFR2004GB01952 Age:49 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coronary Artery Disease Clozaril PS Novartis Sector: Other Cough Pharma ORAL 275mg/day Decreased Immune Clozaril SS Novartis Sector: Responsiveness Pharma ORAL 50mg/day Diabetes Mellitus Clozaril SS Novartis Sector: Dyspnoea Pharma ORAL 250mg/day Influenza Like Illness Human Mixtard C SUBCUTANEOUS 5mg/day Lobar Pneumonia Aspirine C ORAL 75mg/day Treatment Noncompliance Fluoxetine C ORAL 20mg/day Sulpiride C ORAL 200mg/day Amoxil "Ayerst Lab" C ORAL 250mg/day Lipitor C ORAL 20mg/day Date:06/07/04ISR Number: 4373780-1Report Type:Direct Company Report #CTU 220242 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Neutrophil Count Clozapine 25 Mg Intervention to Decreased Mylan PS Mylan ORAL 37.5 MG BID Prevent Permanent White Blood Cell Count ORAL Impairment/Damage Decreased Benztropine C Divalproex C Docusate C Haloperidol C Lorazepam C Nicotine C Piperacillin/Tazobac tam C Senna C Haloperidol Decanoate C .. C .. C Simethicone C Albuterol C Date:06/07/04ISR Number: 4374025-9Report Type:Expedited (15-DaCompany Report #PHEH2004US05859 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neoplasm Malignant Clozaril PS Novartis Sector: Pharma ORAL UNK, UNK Clozapine SS ORAL 100 mg, BID 718 DAY Date:06/08/04ISR Number: 4372531-4Report Type:Expedited (15-DaCompany Report #PHFR2004GB02026 Age:19 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Haemoglobin Decreased Health Clozaril PS Novartis Sector: Professional Pharma ORAL 22-Feb-2006 08:30 AM Page: 2731 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/08/04ISR Number: 4375234-5Report Type:Expedited (15-DaCompany Report #2004S1001523 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Lung Neoplasm Malignant Health Clozapine Tablets Hospitalization - Pain In Extremity Professional 100 Mg Mylan PS Mylan ORAL 700 MG QD Initial or Prolonged ORAL Other Clozaril Novartis SS Clonazepam C Zolpidem C Date:06/08/04ISR Number: 4375265-5Report Type:Expedited (15-DaCompany Report #2004S1001178 Age:85 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 50MG Q HS Other ORAL Fentanyl C Gentamicin Ophthalmic Drops C Megestrol Suspension C Nitroglycerin Transdermal System C Metoclopramide C Ipratropium C Albuterol C Potassium Chloride C Furosemide C Gabapentin C Paroxetine C Simvastatin C Verapamil/Trandolapr il C Bicalutamide C Date:06/08/04ISR Number: 4375267-9Report Type:Expedited (15-DaCompany Report #2004S1001161 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 50MG Q AM AND Other 50MG Q PM ORAL Clozapine Tablets 100 Mg Mylan SS Mylan ORAL 600MG Q PM ORAL Bupropion C Benztropine C Risperidone C Trazodone C Vitamin C C Acetaminophen C 22-Feb-2006 08:30 AM Page: 2732 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/08/04ISR Number: 4375315-6Report Type:Expedited (15-DaCompany Report #04-05-0664 Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc ORAL SEE IMAGE Famotidine C Senna C Ativan C Neurontin C Date:06/08/04ISR Number: 4375317-XReport Type:Expedited (15-DaCompany Report #04-05-0684 Age:63 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Non-Small Cell Lung Health Clozapine Tablets- Cancer Stage Iiia Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc ORAL 75-375 MG QD ORAL Date:06/08/04ISR Number: 4375319-3Report Type:Expedited (15-DaCompany Report #04-05-0660 Age:57 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Intracranial Aneurysm Health Clozapine Tablets- Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 500 MG QD ORAL Date:06/08/04ISR Number: 4375321-1Report Type:Expedited (15-DaCompany Report #04-06-0804 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiovascular Disorder Health Clozapine Tablets- Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 200-700 MG QD ORAL Date:06/08/04ISR Number: 4375322-3Report Type:Expedited (15-DaCompany Report #04-05-0797 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Chronic Obstructive Health Clozapine Tablets- Pulmonary Disease Professional Ivax Lung Neoplasm Malignant Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, 22-Feb-2006 08:30 AM Page: 2733 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Inc. ORAL 150 MG QD ORAL Date:06/08/04ISR Number: 4375324-7Report Type:Expedited (15-DaCompany Report #04-05-0627 Age:66 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine Tablets- Hospitalization - Professional Ivax Initial or Prolonged Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 100 MG QD ORAL Date:06/09/04ISR Number: 4374353-7Report Type:Expedited (15-DaCompany Report #PHFR2004GB01677 Age:55 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Health Clozaril PS Novartis Sector: Initial or Prolonged Haemoglobin Decreased Professional Pharma ORAL Other Humerus Fracture Occult Blood Positive Date:06/09/04ISR Number: 4374354-9Report Type:Expedited (15-DaCompany Report #PHFR2003GB02133 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Constipation Clozaril PS Novartis Sector: Initial or Prolonged Haemoglobin Decreased Pharma ORAL 200mg/mane&30 Megacolon 0mg/nocte Clozaril SS Novartis Sector: Pharma ORAL 200mg/mane&25 0mg/nocte Iron C UNKNOWN Date:06/09/04ISR Number: 4374359-8Report Type:Expedited (15-DaCompany Report #PHNR2003AU01361 Age:16 YR Gender:Male I/FU:F Outcome PT Other Anion Gap Increased Blood Alkaline Phosphatase Decreased Blood Calcium Increased Blood Glucose Increased Blood Thyroid Stimulating Hormone Increased Bradycardia Diabetes Mellitus Dizziness Electrocardiogram Abnormal Fatigue Hypotension Polydipsia Polyuria Thyroid Function Test Abnormal 22-Feb-2006 08:30 AM Page: 2734 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Thyroxine Free Increased Tricuspid Valve Incompetence Report Source Product Role Manufacturer Route Dose Duration Ventricular Dysfunction Health Clozaril PS Novartis Sector: Ventricular Hypokinesia Professional Pharma ORAL 37.5 - 375mg 882 DAY Weight Decreased Weight Increased Date:06/09/04ISR Number: 4374908-XReport Type:Expedited (15-DaCompany Report #PHFR2004GB01731 Age:61 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Clozaril PS Novartis Sector: Haematocrit Decreased Pharma ORAL 550mg/day Haemoglobin Decreased Venlafaxine C ORAL 225mg/day Red Blood Cell Count Clonazepam C ORAL 500 mg, BID Decreased Docusate Sodium C UNKNOWN UNK, PRN Lactulose C UNKNOWN UNK, PRN Date:06/09/04ISR Number: 4374909-1Report Type:Expedited (15-DaCompany Report #PHBS2004BR07080 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anorexia Leponex PS Novartis Sector: Dengue Fever Pharma ORAL 100 mg, QID Hyperhidrosis Lorax C ORAL 1.5 DF, BID Platelet Count Decreased Lexapro C ORAL 1 tablet/d Date:06/09/04ISR Number: 4374913-3Report Type:Expedited (15-DaCompany Report #PHHO2004CA05075 Age:18 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Lymphocyte Morphology Clozaril PS Novartis Sector: Initial or Prolonged Abnormal Pharma ORAL 600 mg/day Lymphocytosis Zocor C White Blood Cell Count Ferrous Gluconate C Increased Divalproex C Lorazepam C Benzoyl Peroxide C Zinc Gluconate C Date:06/09/04ISR Number: 4374922-4Report Type:Expedited (15-DaCompany Report #PHRM2004FR01954 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Balance Disorder Leponex PS Novartis Sector: Initial or Prolonged Fall Pharma ORAL 25 mg, daily Aricept SS ORAL 10 mg, daily Fludrocortisone SS ORAL 0.5 DF, daily Deroxat SS ORAL 20 mg, daily Sinemet C ORAL 5 DF, daily Gutron C ORAL 15 mg, daily 22-Feb-2006 08:30 AM Page: 2735 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/09/04ISR Number: 4375271-0Report Type:Expedited (15-DaCompany Report #04-06-0807 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypoglycaemia Health Clozapine - Ivax Initial or Prolonged Impaired Self-Care Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 400-325MG QD ORAL Date:06/09/04ISR Number: 4375272-2Report Type:Expedited (15-DaCompany Report #04-05-0703 Age:59 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Health Clozapine - Ivax Hospitalization - Professional Pharmaceuticals, Initial or Prolonged Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 700MG QD ORAL Multivitamins C Ferrous Sulfate C Calcium C Tricor C Bentyl For Spastic Colon C Date:06/09/04ISR Number: 4375273-4Report Type:Expedited (15-DaCompany Report #04-05-0711 Age:76 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hip Fracture Health Clozapine - Ivax Hospitalization - Professional Pharmaceuticals, Initial or Prolonged Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 12.5-75MG QD ORAL Date:06/09/04ISR Number: 4375274-6Report Type:Expedited (15-DaCompany Report #04-06-0803 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 400MG QD ORAL Date:06/10/04ISR Number: 4375218-7Report Type:Expedited (15-DaCompany Report #PHFR2004GB02141 Age:62 YR Gender:Female I/FU:F Outcome PT Hospitalization - Anaemia Initial or Prolonged Blood Cholesterol Other Increased Blood Triglycerides Increased Body Temperature 22-Feb-2006 08:30 AM Page: 2736 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Increased Diabetes Mellitus Diabetes Mellitus Inadequate Control Report Source Product Role Manufacturer Route Dose Duration Full Blood Count Abnormal Clozaril PS Novartis Sector: Infection Pharma ORAL Neutrophil Count Decreased Sepsis Tooth Abscess Date:06/10/04ISR Number: 4375560-XReport Type:Expedited (15-DaCompany Report #PHFR2004GB02304 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Euphoric Mood Clozaril PS Novartis Sector: Neutropenia Pharma ORAL 250mg/day Tachycardia Date:06/10/04ISR Number: 4375562-3Report Type:Expedited (15-DaCompany Report #PHRM2004FR02004 Age:0 Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Haematocrit Decreased Clozapine PS Novartis Sector: Haemoglobin Decreased Pharma ORAL 125 mg, daily Iron Deficiency Anaemia Alprazolam C ORAL 0.25 mg, Mean Cell Haemoglobin daily Decreased Mean Cell Volume Decreased Date:06/10/04ISR Number: 4375563-5Report Type:Expedited (15-DaCompany Report #PHBS2004BR06594 Age:44 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Immunology Test Abnormal Leponex PS Novartis Sector: Neutrophil Count Pharma ORAL 600 mg/d 67680MIN Increased Puran T4 C ORAL 50 mg, QD Neutrophil Percentage Vitamin B12 C ORAL 1 DF, QMO Increased Risperidone C ORAL UNK, UNK Platelet Count Increased Risperidone C ORAL 4 mg/d Red Blood Cell Count Folic Acid C ORAL 1 DF, QD Increased White Blood Cell Count Increased Date:06/10/04ISR Number: 4376454-6Report Type:Expedited (15-DaCompany Report #2004S1001563 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pancreatic Carcinoma Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL THEN 200MG Q Other AM AND 300MG Q PM, ORA Fentanyl C Codeine Sulfate C Docusate C Lansoprazole C 22-Feb-2006 08:30 AM Page: 2737 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Buspirone C Ziprasidone C Lactulose C Aluminum Hydroxide/Magnesium Hydroxide C Date:06/10/04ISR Number: 4376456-XReport Type:Expedited (15-DaCompany Report #2004S1001573 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 37.5 MG/DAY, Other ORAL Date:06/10/04ISR Number: 4376457-1Report Type:Expedited (15-DaCompany Report #04-06-0808 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Aspiration Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 12.5-300MG QD ORAL Date:06/10/04ISR Number: 4376459-5Report Type:Expedited (15-DaCompany Report #04-03-0502 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine - Ivax Sudden Death Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 500MG QD ORAL Date:06/10/04ISR Number: 4376461-3Report Type:Expedited (15-DaCompany Report #04-06-0818 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine - Ivax Hospitalization - Respiratory Failure Professional Pharmaceuticals, Initial or Prolonged Sepsis Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 100-400MG QD ORAL Date:06/10/04ISR Number: 4376490-XReport Type:Expedited (15-DaCompany Report #2004S1000752 Age:18 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Clozapine Tablets Road Traffic Accident Professional 100 Mg Mylan PS Mylan ORAL 300MG Q AM & Other 300MG Q HS, ORAL 22-Feb-2006 08:30 AM Page: 2738 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/10/04ISR Number: 4376491-1Report Type:Expedited (15-DaCompany Report #2004S1001042 Age:57 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pharmaceutical Product Health Clozapine Tablets Initial or Prolonged Complaint Professional Mylan PS Mylan ORAL 50 MG/DAY, Treatment Noncompliance Other ORAL Unevaluable Event Metformin C Gemfibrozil C Pravastatin C Aspirin C Tiagabine C Date:06/10/04ISR Number: 4376492-3Report Type:Expedited (15-DaCompany Report #2004S1001193 Age:83 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 50MG QD, Other ORAL/DECREASE D DELUSIONS Levothyroxine C Furosemide C Pergolide C Carbidopa/Levodopa C Potassium Chloride C Calcium Carbonate With Vitamin D C Date:06/10/04ISR Number: 4376494-7Report Type:Expedited (15-DaCompany Report #2004S1001538 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Other Clozapine Tablets 100 Mg Mylan PS Mylan ORAL 150MG QD, ORAL Date:06/10/04ISR Number: 4378655-XReport Type:Expedited (15-DaCompany Report #2003-109378-NL Age:59 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Circulatory Collapse Foreign Mirtazapine PS ORAL 60 MG Initial or Prolonged Coordination Abnormal Health Clozapine SS ORAL 150 MG Disorientation Professional Lithium Carbonate C Electrocardiogram T Wave Other Inversion Gait Disturbance Leukocytosis Neutrophilia Orthostatic Hypotension Pyrexia Date:06/11/04ISR Number: 4375775-0Report Type:Expedited (15-DaCompany Report #PHFR2004GB02026 Age:19 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Haemoglobin Decreased Health Clozaril PS Novartis Sector: Professional Pharma ORAL 22-Feb-2006 08:30 AM Page: 2739 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/15/04ISR Number: 4377628-0Report Type:Expedited (15-DaCompany Report #PHBS2004AT07097 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Vitreous Opacities Leponex PS Novartis Sector: Pharma UNKNOWN 25 mg/d Leponex SS Novartis Sector: Pharma UNKNOWN 100 mg/d Leponex SS Novartis Sector: Pharma UNKNOWN 12.5 mg/d Date:06/15/04ISR Number: 4377633-4Report Type:Expedited (15-DaCompany Report #PHFR2004GB02356 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Clozaril PS Novartis Sector: Agitation Pharma ORAL 150mg nocte Body Temperature and 125mg Increased mane Confusional State Risperidone SS Dizziness Drug Withdrawal Syndrome Dysphagia Hyperhidrosis Hypotension Malaise Muscle Rigidity Musculoskeletal Stiffness Neuroleptic Malignant Syndrome Pain Refusal Of Examination Restlessness Salivary Hypersecretion Tachycardia Throat Tightness Date:06/15/04ISR Number: 4379354-0Report Type:Expedited (15-DaCompany Report #04-06-0838 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Clozapine PS Ivax Health Pharmaceuticals, Professional Inc. ORAL 25-350MG QD Other ORAL Date:06/15/04ISR Number: 4379919-6Report Type:Expedited (15-DaCompany Report #04-06-0839 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 400MG QD ORAL 22-Feb-2006 08:30 AM Page: 2740 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/16/04ISR Number: 4377908-9Report Type:Expedited (15-DaCompany Report #PHFR2003GB03145 Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Clozaril PS Novartis Sector: Blood Alkaline Pharma ORAL 200mg nocte Phosphatase Increased Omeprazole C ORAL 20mg C-Reactive Protein Valproate Sodium C ORAL 1200mg Increased Hyoscine Gamma-Glutamyltransferase Hydrobromide C ORAL 300mg/day Increased Zopiclone C ORAL 7.5mg/day Liver Function Test Abnormal Vomiting Date:06/16/04ISR Number: 4377911-9Report Type:Expedited (15-DaCompany Report #PHBS2004CH07403 Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Choking Clozapine PS Novartis Sector: Hospitalization - Circulatory Collapse Pharma UNKNOWN 200 - 375 Initial or Prolonged Dyskinesia mg/d Dysphagia Clomipramine SS UNKNOWN 75 - 200 mg/d Dyspnoea Domperidone C UNKNOWN Hiccups Oesophageal Dilatation Pneumonia Aspiration Regurgitation Of Food Respiratory Distress Date:06/16/04ISR Number: 4377938-7Report Type:Expedited (15-DaCompany Report #PHRM2002FR01893 Age:26 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abortion Spontaneous Health Leponex PS Novartis Sector: Drug Exposure During Professional Pharma ORAL 225 mg, daily Pregnancy Ect (Electro Evacuation Of Retained Convulsive Therapy) SS UNKNOWN 1 DF, QMO Products Of Conception Tranxene C UNKNOWN 10 mg, daily Metrorrhagia Forlax C UNKNOWN 1 to 3 DF/day Premature Separation Of if necessary Placenta Salivary Hypersecretion Date:06/16/04ISR Number: 4378720-7Report Type:Expedited (15-DaCompany Report #PHFR2004GB02167 Age:27 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abdominal Pain Clozaril PS Novartis Sector: Hospitalization - Large Intestine Pharma ORAL UNK, UNK 47520MIN Initial or Prolonged Perforation Venlafaxine C ORAL 225 mg/day Neutrophil Count Lactulose C ORAL 10 ml, PRN Increased Platelet Count Increased White Blood Cell Count Increased 22-Feb-2006 08:30 AM Page: 2741 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/16/04ISR Number: 4380110-8Report Type:Expedited (15-DaCompany Report #2004S1001604 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death White Blood Cell Count Health Clozapine Tablets Increased Professional 100 Mg Mylan PS ORAL 700MG QD, Other ORAL Lorazepam C Dexamethasone C Promethazine C Loperamide C Clindamycin C Mirtazapine C Vitamins C Ferrous Fumarate/Ascorbic Acid/Cyanocobalamin/ Folic Acid C Famotidine C Metoprolol C Date:06/16/04ISR Number: 4380112-1Report Type:Expedited (15-DaCompany Report #2004S1001591 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg Mylan PS ORAL 75MG QD, ORAL Other Clozapine Tablets 100 Mg Mylan SS ORAL 300MG, QD, ORAL Albuterol C Albuterol/Ipratropiu m C Fluticasone/Salmeter ol C Zafirlukast C Montelukast C Valproic Acid C Date:06/16/04ISR Number: 4380115-7Report Type:Expedited (15-DaCompany Report #2004S1001203 Age:79 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional 100 Mg Mylan PS ORAL 50MG QID, Other ORAL Risperidone C Furosemide C Potassium Chlorride C Benazepril C Amlodipine C Lansoprazole C Lactase C Acetaminophen C Albuterol Solution C Bisacodyl C Carrington Moist Barrier Cream (Apply Prn) C Clonazepam C 22-Feb-2006 08:30 AM Page: 2742 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrozyzine C Levofloxacin C Methylprednisolone C Milk Of Magnesia C Polyethylene Glycol C Nystatin C Ceftriaone C Triamcinolone Cream 0.1% C Azithromycin C Date:06/16/04ISR Number: 4380117-0Report Type:Expedited (15-DaCompany Report #2004S1000902 Age:79 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg Mylan PS ORAL 37.5MG, QD, Other ORAL Morphine C Lorazepam C Carbidopa/Levodopa C Docusate C Date:06/16/04ISR Number: 4380119-4Report Type:Expedited (15-DaCompany Report #04-06-0842 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 50-100MG QD ORAL Date:06/16/04ISR Number: 4380120-0Report Type:Expedited (15-DaCompany Report #04-06-0854 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Lymphoma Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 300-400MG QD ORAL Date:06/17/04ISR Number: 4379664-7Report Type:Expedited (15-DaCompany Report #PHEH2004US06296 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Eosinophil Count Clozaril PS Novartis Sector: Initial or Prolonged Decreased Pharma ORAL 100 mg/day 89280MIN Hypoaesthesia Seroquel C Leukopenia Lymphadenopathy Lymphocyte Count Increased Neck Pain Neutropenia Pharyngolaryngeal Pain Pyrexia 22-Feb-2006 08:30 AM Page: 2743 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/17/04ISR Number: 4379666-0Report Type:Expedited (15-DaCompany Report #PHEH2004US06335 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Lung Neoplasm Malignant Clozaril PS Novartis Sector: Initial or Prolonged Pharma ORAL UNK, UNK Clozapine SS ORAL 700 mg/day Date:06/17/04ISR Number: 4380069-3Report Type:Expedited (15-DaCompany Report #US-MERCK-0402USA01726 Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Back Pain Zetia PS Merck & Co., Inc ORAL 10 DAY Life-Threatening Blood Alcohol Increased Clozapine SS ORAL Disability Cardiomegaly Clozapine SS ORAL Hepatic Congestion Clozapine SS ORAL Hepatic Steatosis Clozapine SS UNKNOWN Hepatomegaly Clozapine SS ORAL Hypercholesterolaemia Zetia SS Merck & Co., Inc ORAL 10 DAY Hyperlipidaemia Clozapine SS UNKNOWN Low Density Lipoprotein Albuterol C RESPIRATORY Increased (INHALATION) Muscle Spasms Azmacort C RESPIRATORY Sudden Cardiac Death (INHALATION) Sudden Death Seroquel C ORAL Suicidal Ideation Seroquel C ORAL Ventricular Hypertrophy Micro-K Extencaps C ORAL Glucophage C UNKNOWN Xanax C ORAL Monopril C ORAL Lasix (Furosemide) C ORAL Atarax C UNKNOWN Glucotrol Xl C ORAL Depakote C ORAL Xanax C ORAL Date:06/18/04ISR Number: 4380271-0Report Type:Expedited (15-DaCompany Report #PHRM2004FR02070 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Accidental Exposure Leponex PS Novartis Sector: Hypotension Pharma ORAL 200 mg, ONCE/SINGLE 1440 MIN Date:06/18/04ISR Number: 4380276-XReport Type:Expedited (15-DaCompany Report #PHBS2004US07626 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dystonia Clozapine PS Novartis Sector: Fall Pharma UNKNOWN 125 mg/d Gait Disturbance Dopamin C UNKNOWN Pleurothotonus 22-Feb-2006 08:30 AM Page: 2744 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/18/04ISR Number: 4380282-5Report Type:Expedited (15-DaCompany Report #PHBS2004BE02545 Age:66 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Consumer Leponex PS Novartis Sector: Initial or Prolonged Blood Cortisol Increased Pharma UNKNOWN Chills Leponex SS Novartis Sector: Depressed Level Of Pharma UNKNOWN 150 mg/d Consciousness Leponex SS Novartis Sector: Diarrhoea Pharma UNKNOWN 100 mg/d Drug Withdrawal Syndrome Leponex SS Novartis Sector: Dyskinesia Pharma UNKNOWN 75 mg/d Extrapyramidal Disorder Leponex SS Novartis Sector: Gastrointestinal Disorder Pharma UNKNOWN 50 mg/d Hot Flush Leponex SS Novartis Sector: Hyperhidrosis Pharma UNKNOWN 25 mg, BID Insomnia Leponex SS Novartis Sector: Malaise Pharma UNKNOWN 25 mg /day 7200 MIN Myoclonus Leponex SS Novartis Sector: Nausea Pharma 50 mg, QHS Osteoporosis Xanax C UNKNOWN Pyrexia Xanax C UNKNOWN .5 mg, BID Rectal Polyp Rivotril C UNKNOWN 1 mg, QHS Restlessness Rivotril C UNKNOWN 18720MIN Sedation Antihypertensives C UNKNOWN Somnolence Aprovel C UNKNOWN 75 mg, QD Tardive Dyskinesia Aldactazine C UNKNOWN UNK, Q48H Tremor Isoten C UNKNOWN 5 mg, QHS Vomiting Asaflow C UNKNOWN 160 mg, QD Trazolan C UNKNOWN 50 mg, QHS Imovane C UNKNOWN 3.75 or 7.5 mg in the evening Date:06/18/04ISR Number: 4380629-XReport Type:Expedited (15-DaCompany Report #PHRM2004FR02087 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - C-Reactive Protein Leponex PS Novartis Sector: Initial or Prolonged Increased Pharma ORAL 700 mg, daily Other Inflammation Rivotril C Pyrexia Systemic Inflammatory Response Syndrome Weight Decreased Date:06/18/04ISR Number: 4380721-XReport Type:Expedited (15-DaCompany Report #PHBS2004IE07629 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Exposure Clozaril PS Novartis Sector: Initial or Prolonged Accidental Overdose Pharma ORAL 400 mg, ONCE/SINGLE Diazepam C UNKNOWN 25 mg/d Lithium C UNKNOWN 800 mg/d Haloperidol C UNKNOWN Valproate Sodium C UNKNOWN 1250 mg, BID Kemadrin C UNKNOWN UNK, UNK 22-Feb-2006 08:30 AM Page: 2745 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/18/04ISR Number: 4380723-3Report Type:Expedited (15-DaCompany Report #PHFR2004GB02388 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Accidental Exposure Clozaril PS Novartis Sector: Overdose Pharma ORAL 150mg/ in Sedation error 1440 MIN Paroxetine C UNKNOWN Olanzapine C UNKNOWN Date:06/18/04ISR Number: 4380725-7Report Type:Expedited (15-DaCompany Report #PHNU2004DE01959 Age:22 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cough Leponex / Clozaril Dyspnoea (Clozapine) PS Novartis Sector: Life Support Pharma ORAL Malignant Histiocytosis Risperdal SS Pneumonitis Pulmonary Fibrosis Suicide Attempt Date:06/18/04ISR Number: 4381814-3Report Type:Expedited (15-DaCompany Report #2004S1001631 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 75 MG Q HS, Other ORAL Clozapine Tablets 100 Mg Mylan SS Mylang ORAL 100 MG Q HS, ORAL Date:06/18/04ISR Number: 4381820-9Report Type:Expedited (15-DaCompany Report #2004S1001645 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Other Clozapine Tablets 100 Mg Mylan PS Mylan ORAL 400 MG/DAY, ORAL Date:06/18/04ISR Number: 4381855-6Report Type:Expedited (15-DaCompany Report #04-06-0841 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Health Clozapine Tablets - Initial or Prolonged Drug Toxicity Professional Ivax Lethargy Other Pharmaceuticals, Pulmonary Embolism Inc. PS Ivax Pharmaceuticals, Inc. ORAL 125-175MG QD ORAL Coumadin SS 22-Feb-2006 08:30 AM Page: 2746 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/18/04ISR Number: 4383228-9Report Type:Expedited (15-DaCompany Report #20040300239 Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Multiple Drug Overdose Foreign Ativan (Lorazepam) PS ORAL 3 MG DAILY PO Initial or Prolonged Intentional Health Cipramil (Citalopram Suicide Attempt Professional Hydrobromide) SS ORAL 20 MG PO Other Clozaril (Clozapine) SS ORAL 5000 MG PO Clozaril (Clozapine) SS Clozaril (Clozapine) SS Diazepam SS Paracetamol C Temazepam C Gaviscon C Date:06/18/04ISR Number: 4415670-1Report Type:Periodic Company Report #US-JNJFOC-20040205928 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pulmonary Embolism Health Ortho Evra Initial or Prolonged Professional (Norelgestromin/Ethi nyl Estradiol) Patch PS TRANSDERMAL 1 DOSE(S), 3 IN 4 WEEK, TRANSDERMAL Clozapine (Clozapine) Tablets SS ORAL ORAL Seroquel (Questiapine Fumurate) Unknown C Lamotrigine (Lamotrigine) C Neurontin (Gabapentin) C Lithium (Lithium) C Cytomel (Leothyonine Sodium) C Synthroid (Levothyroxine Sodium) C Aspirin (Acetylsalicylic Acid) C Abilify (Aripiprazole) C Date:06/18/04ISR Number: 4417903-4Report Type:Periodic Company Report #US-SHR-04-023326 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Health Fludara For Professional Injection Other (Fludarabine Phosphate) Ampule PS Clozapine (Clozapine) SS ORAL 250 MG, 2X/DAY, ORAL Rituxan (Rituxan) SS Zyprexa (Olanzapine) C Divalproex Sodium (Valproate 22-Feb-2006 08:30 AM Page: 2747 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Semisodium) C Neupogen/Swe/ (Filgrastim) C Date:06/21/04ISR Number: 4381170-0Report Type:Expedited (15-DaCompany Report #PHEH2004US04965 Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cerebral Disorder Health Clozaril PS Novartis Sector: Communication Disorder Professional Pharma ORAL 100 mg/day Electroencephalogram Eskalith C Abnormal Benztropeine C Infection Prolixin C Leukocytosis Ambien C Memory Impairment Date:06/21/04ISR Number: 4384877-4Report Type:Expedited (15-DaCompany Report #04P-167-0263336-00 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Sodium Decreased Foreign Valproate Sodium Initial or Prolonged Overdose Health (Sodium Valproate) Sedation Professional (Sodium Valproate) White Blood Cell Count (Sodium Valproate) PS SEE IMAGE Increased Clozapine SS SEE IMAGE Hyoscine Hydrobromide SS SEE IMAGE Lorazepam C Venlafaxine C Date:06/21/04ISR Number: 4391075-7Report Type:Periodic Company Report #USA-2003-0010960 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Multiple Drug Overdose Health Oxycodone Multiple Drug Overdose Professional Hydrochloride PS Accidental Other Oxymorphone (Oxymorphone) SS Ethanol (Ethanol) SS Acetaminophen (Paracetamol) SS Cocaine (Cocaine) SS Methadone (Methadone) SS Diphenhydramine (Diphenhydramine) SS Caffeine (Caffeine) SS Clozapine (Clozapine) SS Date:06/22/04ISR Number: 4382274-9Report Type:Expedited (15-DaCompany Report #PHFR2004GB01474 Age:34 YR Gender:Male I/FU:F Outcome PT Other Alanine Aminotransferase Increased Aspartate Aminotransferase 22-Feb-2006 08:30 AM Page: 2748 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Increased Blood Glucose Increased Blood Lactate Dehydrogenase Increased Report Source Product Role Manufacturer Route Dose Duration Blood Triglycerides Clozaril (Clozapine) PS Novartis Sector: Increased Pharma ORAL 350mg/day Diabetes Mellitus Clozaril (Clozapine) SS Novartis Sector: Glycosylated Haemoglobin Pharma ORAL 450mg/day Increased Lansoprazole C ORAL 15mg/day Hyperglycaemia Tramadol C ORAL 50 mg, TID Nocturia Salbutamol C PRN Polydipsia Polyuria Date:06/22/04ISR Number: 4382277-4Report Type:Expedited (15-DaCompany Report #PHFR2004GB01844 Age:20 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Back Pain Clozaril PS Novartis Sector: Initial or Prolonged Blood Urine Pharma ORAL 200mg/day Other Drug Interaction Valproate Sodium SS ORAL 1 g, BID Drug Toxicity Lithium Carbonate SS ORAL 400 mg, BID Encephalopathy Clonazepam C ORAL 1 mg, QID 80640MIN Neutrophil Count Increased Proteinuria Pyelonephritis Pyrexia Renal Failure Acute Renal Impairment Sepsis Somnolence Therapeutic Agent Toxicity Urinary Tract Infection White Blood Cell Count Increased Date:06/22/04ISR Number: 4382358-5Report Type:Expedited (15-DaCompany Report #PHBS2002AU09991 Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Upper Health Clozaril PS Novartis Sector: Initial or Prolonged Blood Glucose Decreased Professional Pharma ORAL 400 mg/d 1955 DAY Hepatic Steatosis Glimepiride C UNKNOWN 5 mg, mane Influenza Like Illness Pethidine C Lipase Increased Epilim C 1200 mg, BID Pancreatitis Ditropan C 5 mg, BID Somnolence Avandia C 4 mg, mane Gemfibrozil C 60 mg, BID Date:06/22/04ISR Number: 4382990-9Report Type:Expedited (15-DaCompany Report #03-12-1567 Age:23 YR Gender:Male I/FU:F Outcome PT Life-Threatening Anaemia Hospitalization - Apallic Syndrome Initial or Prolonged Autonomic Neuropathy Other Bacteraemia 22-Feb-2006 08:30 AM Page: 2749 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Brain Stem Infarction Cerebral Infarction Cerebrovascular Accident Report Source Product Role Manufacturer Route Dose Duration Coma Health Clozapine - Ivax Convulsion Professional Pharmaceuticals, Encephalopathy Inc. Tablets PS Ivax Hypercoagulation Pharmaceuticals, Malnutrition Inc. ORAL 300MG QHS Nuclear Magnetic ORAL Resonance Imaging Brain Ranitidine C Abnormal Pneumonia Pneumonia Aspiration Respiratory Failure Urinary Tract Infection Viral Infection Date:06/22/04ISR Number: 4383453-7Report Type:Expedited (15-DaCompany Report #04-04-0526 Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pancytopenia Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 300-900 QD ORAL Date:06/22/04ISR Number: 4383455-0Report Type:Expedited (15-DaCompany Report #04-06-0872 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mania Health Clozapine ? Ivax Initial or Prolonged Professional Pharnaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 112.50-450MG ORAL Date:06/22/04ISR Number: 4383456-2Report Type:Expedited (15-DaCompany Report #04-06-0871 Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozapine ? Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 50-450MG QD ORAL Date:06/22/04ISR Number: 4384896-8Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040603232 Age:62 YR Gender:Female I/FU:I Outcome PT Hospitalization - Drug Interaction Initial or Prolonged Hyperglycaemia Hypertension 22-Feb-2006 08:30 AM Page: 2750 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hyponatraemia Myocardial Infarction Platelet Count Decreased Report Source Product Role Manufacturer Route Dose Duration Sinus Tachycardia Study Abciximab Health (Abciximab) Professional Injection PS INTRAVENOUS INTRAVENOUS Clozaril (Clozapine) SS ORAL 200 MG, 1 IN 1 DAY, ORAL Thyroxine (Levothyroxine Sodium) C Aspirin (Acetylsalicylic Acid) C Glimepiride (Glimepiride) C Hyoscine (Hyoscine) C Lantus (Insulin Glargine) C Perindopril (Perindopril) C Metformin (Metformin) C Date:06/22/04ISR Number: 4384954-8Report Type:Expedited (15-DaCompany Report #04-06-0884 Age:80 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 50-200MG QD ORAL Date:06/22/04ISR Number: 4384957-3Report Type:Expedited (15-DaCompany Report #04-06-0880 Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sepsis Health Clozapine Tablets - Hospitalization - Urinary Tract Infection Professional Ivax Initial or Prolonged Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 200 MG QD ORAL Date:06/22/04ISR Number: 4385913-1Report Type:Expedited (15-DaCompany Report #MK200406-0118-1 Age:64 YR Gender:Male I/FU:I Outcome PT Hospitalization - Choking Initial or Prolonged Circulatory Collapse Dyskinesia Dysphagia Gastrointestinal Motility Disorder 22-Feb-2006 08:30 AM Page: 2751 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hiccups Nasopharyngeal Disorder Oesophageal Dilatation Report Source Product Role Manufacturer Route Dose Duration Pneumonia Aspiration Foreign Clomipramine Capsules PS 200MG, DAILY 10 YR Clozapine SS 375MG, DAILY 10 YR Domperidone C Date:06/23/04ISR Number: 4383166-1Report Type:Expedited (15-DaCompany Report #PHEH2004US06646 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Clozapine PS Novartis Sector: Pharma UNK,UNK Date:06/23/04ISR Number: 4383180-6Report Type:Expedited (15-DaCompany Report #PHBS2004BR07756 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Arthropathy Leponex PS Novartis Sector: Hypertension Pharma ORAL 300 mg/d Thrombosis Geodon C Venous Insufficiency Folic Acid C ORAL Weight Increased Valproic Acid C ORAL 2000 mg/d Exelon C ORAL 6 mg, BID Haloperidol C UNKNOWN Date:06/23/04ISR Number: 4383389-1Report Type:Expedited (15-DaCompany Report #PHFR2004GB02437 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Overdose Health Clozaril PS Novartis Sector: Completed Suicide Professional Pharma ORAL 318 DAY Heroin SS UNKNOWN Date:06/23/04ISR Number: 4383407-0Report Type:Expedited (15-DaCompany Report #PHNU2004DE01205 Age:53 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Health Leponex / Clozaril Abnormal Professional (Clozapine) PS Novartis Sector: Electrocardiogram Pharma ORAL Unknown Repolarisation Leponex / Clozaril Abnormality (Clozapine) SS Novartis Sector: Electrocardiogram T Wave Pharma ORAL 450 mg/day Inversion Endocarditis Date:06/23/04ISR Number: 4383421-5Report Type:Expedited (15-DaCompany Report #PHFR2004GB01860 Age:61 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Eating Disorder Health Clozaril PS Novartis Sector: Initial or Prolonged Fluid Intake Reduced Professional Pharma ORAL 200 mg, BID 22-Feb-2006 08:30 AM Page: 2752 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/23/04ISR Number: 4383607-XReport Type:Expedited (15-DaCompany Report #PHNR2004AU00908 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Atrial Flutter Clozaril PS Novartis Sector: Hospitalization - Cardiac Failure Pharma 12.5 - 75 Initial or Prolonged Cellulitis mg/day 40320MIN Death Valproate Sodium SS Decreased Appetite Efexor SS Difficulty In Walking Haloperidol SS Fall Lorazepam SS Flat Affect Olanzapine SS Gait Disturbance Benztropine Mesylate SS Haemoglobin Decreased Hypotension Injury Lobar Pneumonia Lymphopenia Malaise Mycoplasma Infection Myocarditis Oxygen Saturation Decreased Peroneal Nerve Palsy Pyrexia Restlessness Rib Fracture Somnolence Tachycardia Thrombocytopenia Date:06/23/04ISR Number: 4383610-XReport Type:Expedited (15-DaCompany Report #PHEH2004US01950 Age:56 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Clozaril PS Novartis Sector: Pharma ORAL UNK, UNK Date:06/23/04ISR Number: 4383687-1Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12617403 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Antipsychotic Drug Level Cisplatin PS Bristol-Myers Squibb Above Therapeutic Company Drug Interaction Lortab C 5/500 mg Niferex C Clonazepam C Megestrol Acetate C Bristol-Myers Squibb Company Darbepoetin Alfa C Vioxx C Etoposide I Bristol-Myers Squibb Company Clozapine I ORAL 700 mg at bedtime (HS) then 600 mg HS 22-Feb-2006 08:30 AM Page: 2753 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/23/04ISR Number: 4384812-9Report Type:Expedited (15-DaCompany Report #04-06-0873 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anorexia Foreign Clozapine Tablets PS ORAL 150-300MG QD Initial or Prolonged Arthralgia Literature ORAL 43 DAY Body Temperature Health Olanzapine C Increased Professional Amitriptyline C Cardiomegaly Chest Pain Cough Dyspnoea Headache Heart Rate Increased Influenza Like Illness Malaise Nausea Pericardial Effusion Pleural Effusion Pleurisy Pleuritic Pain Red Blood Cell Sedimentation Rate Increased Respiratory Rate Increased Salivary Hypersecretion Upper Respiratory Tract Infection White Blood Cell Count Increased Date:06/23/04ISR Number: 4384833-6Report Type:Expedited (15-DaCompany Report #2004S1001538 Age:64 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional 100 Mg Mylan PS ORAL 150MG Q HS, Other ORAL Date:06/23/04ISR Number: 4384835-XReport Type:Expedited (15-DaCompany Report #2004S1001693 Age:87 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dementia Health Clozapine Tablets 25 Professional Mg Mylan PS ORAL 25 MG QD ORAL Other Paroxetine C Trazadone C Lorazepam C Lamotrigine C Olanzapine C Senna C Calcium Carbonate C Venlafaxine C Docusate C Bisacodyl C Acetaminophen C 22-Feb-2006 08:30 AM Page: 2754 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/23/04ISR Number: 4384837-3Report Type:Expedited (15-DaCompany Report #2004S1001702 Age:86 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg Mylan PS ORAL 12.5 MG QD Other ORAL Entacapone C Modafinil C Levothyroxine C Escitolapram Oxalate C Lansoprazole C Date:06/23/04ISR Number: 4384872-5Report Type:Expedited (15-DaCompany Report #04-06-0887 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cellulitis Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 400MG QD ORAL Date:06/23/04ISR Number: 4384884-1Report Type:Expedited (15-DaCompany Report #2004S1001135 Age:56 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 100MG Q AM Other AND 800MG Q PM, ORAL Date:06/23/04ISR Number: 4385008-7Report Type:Direct Company Report #CTU 221381 Age:36 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Disease Recurrence Clozapine 100mg PS Intervention to Pharmaceutical Product Prevent Permanent Complaint Impairment/Damage Psychotic Disorder Date:06/24/04ISR Number: 4383935-8Report Type:Expedited (15-DaCompany Report #PHFR2004GB02486 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyspepsia Clozapine PS Novartis Sector: Gastrooesophageal Reflux Pharma ORAL 350mg/day Disease Chlorpromazine C ORAL 100mg/day Vomiting Olanzapine C ORAL 20mg/day Date:06/24/04ISR Number: 4384031-6Report Type:Expedited (15-DaCompany Report #PHNU2004DE02147 Age:32 YR Gender:Male I/FU:I Outcome PT Other Blood Thyroid Stimulating Hormone Decreased Hyperthyroidism 22-Feb-2006 08:30 AM Page: 2755 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Thyroxine Increased Report Source Product Role Manufacturer Route Dose Duration Health Leponex / Clozaril Professional (Clozapine) PS Novartis Sector: Pharma ORAL 450 mg/day Date:06/25/04ISR Number: 4384694-5Report Type:Expedited (15-DaCompany Report #PHNR2004AU00698 Age:34 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asthma Health Clozaril PS Novartis Sector: Other Drug Level Increased Professional Pharma ORAL 800 mg, QD Drug Toxicity Topamax C Wheezing Serenase C Warfarin C Benzotropine C UNK, PRN Efexor I Date:06/25/04ISR Number: 4384697-0Report Type:Expedited (15-DaCompany Report #PHRM2004FR02147 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Leponex PS Novartis Sector: Initial or Prolonged Phosphokinase Increased Pharma ORAL Other Leukocytosis Leponex SS Novartis Sector: Medication Error Pharma ORAL 350 mg, daily Therapeutic Response Leponex SS Novartis Sector: Decreased Pharma ORAL 6 DF, daily 1440 MIN Leponex SS Novartis Sector: Pharma ORAL 350 mg, daily 8640 MIN Leponex SS Novartis Sector: Pharma ORAL Loxapac C UNKNOWN 150 mg, daily 7200 MIN Xanax C UNKNOWN 2880 MIN Risperdal C UNKNOWN 2880 MIN Mopral C UNKNOWN Date:06/25/04ISR Number: 4384953-6Report Type:Expedited (15-DaCompany Report #PHFR2004GB01876 Age:59 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Haemoglobin Decreased Health Clozaril PS Novartis Sector: Initial or Prolonged Liver Disorder Professional Pharma ORAL 500mg Other Renal Disorder Clozaril SS Novartis Sector: Pharma 300mg nocte Iron Supplements C UNKNOWN Date:06/25/04ISR Number: 4385079-8Report Type:Expedited (15-DaCompany Report #PHNU2003DE02974 Age: Gender:Female I/FU:F Outcome PT Other Anxiety Arthropod Bite Depressed Mood Drug Interaction Erythema 22-Feb-2006 08:30 AM Page: 2756 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Psychotic Disorder Report Source Product Role Manufacturer Route Dose Duration Consumer Leponex / Clozaril (Clozapine) PS Novartis Sector: Pharma ORAL 12.5mg/day Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL up to 25mg/day Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL up to 200mg/day Doxycyclin "Stada" SS ORAL 200mg/day 30240MIN Zeldox /Gfr/ C UNKNOWN 20mg/day Date:06/28/04ISR Number: 4385834-4Report Type:Expedited (15-DaCompany Report #PHBS2004SE08266 Age:82 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Circulatory Collapse Exelon PS Novartis Sector: Heart Rate Decreased Pharma UNKNOWN 3 mg/d Medication Error Clozapine SS UNKNOWN 50 mg/d Pyrexia Madopark C 400 mg/d Speech Disorder Trombyl C 75 mg/d Ebixa C 20 mg/d Aricept C Date:06/28/04ISR Number: 4388575-2Report Type:Expedited (15-DaCompany Report #2004S1000796 Age:77 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg Mylan PS ORAL 75 MG, Q HS, Other ORAL Date:06/29/04ISR Number: 4386165-9Report Type:Expedited (15-DaCompany Report #PHEH2004US06811 Age:92 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Clozaril PS Novartis Sector: Congestive Pharma ORAL 25 mg, BID Coronary Artery Atherosclerosis Date:06/29/04ISR Number: 4386175-1Report Type:Expedited (15-DaCompany Report #PHBS2004SE08234 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acidosis Leponex PS Novartis Sector: Cardiac Arrest Pharma UNKNOWN Renal Failure 22-Feb-2006 08:30 AM Page: 2757 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/29/04ISR Number: 4386861-3Report Type:Expedited (15-DaCompany Report #2004S1001799 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cervix Carcinoma Other Clozapine Tablets 100 Mg Mylan PS Mylan ORAL 400 MG QD, ORAL Date:06/29/04ISR Number: 4386864-9Report Type:Expedited (15-DaCompany Report #2004S1001785 Age:77 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Confusional State Health Clozapine Tablets 25 Mobility Decreased Professional Mg Mylan PS Mylan ORAL 50 MG QD, Parkinson'S Disease Other ORAL Donepezil C Midodrine C Clopidogrel Bisulfate C Carbidopa/Levodopa C Date:06/29/04ISR Number: 4386867-4Report Type:Expedited (15-DaCompany Report #2004S1001746 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neuroleptic Malignant Health Clozapine Tablets 25 Syndrome Professional Mg Mylan PS Mylan ORAL 150 MG QD Other ORAL Diphenhydramine C Amlodipine C Lansoprazole C Potassium C Atenolol C Halooperidol Decanoate C Levofloxacin C Date:06/29/04ISR Number: 4386869-8Report Type:Expedited (15-DaCompany Report #2004S1001503 Age:91 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 12.5 MG Q AM Other & 25 MG Q HS, ORAL Bupropion C Venlafaxine C Carbidopa/Levodopa C Atorvastatin C Clopidogrel C Entacapon C Ropinirole C Isosorbide C 22-Feb-2006 08:30 AM Page: 2758 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/29/04ISR Number: 4388072-4Report Type:Direct Company Report #CTU 221752 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyspnoea Clozapine PS ORAL 100 MG BID Oedema Peripheral ORAL Swelling Face Date:06/29/04ISR Number: 4388124-9Report Type:Expedited (15-DaCompany Report #2004S1001193 Age:83 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Health Clozapine Tablets 25 Parkinson'S Disease Professional Mg Mylan PS Mylan ORAL 50 MG QD, Other ORAL /DECREASED DELUSIONS Levothyroxine C Furosemide C Pergolide C Cabidopa/Levodopa C Potassium Chloride C Calcium Carbonate C Date:06/29/04ISR Number: 4388125-0Report Type:Expedited (15-DaCompany Report #04-06-0842 Age:47 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 75 MG BID ORAL Geodon C Seroquel C Depakote C Lithium C Wellbutrin C Date:06/29/04ISR Number: 4388126-2Report Type:Expedited (15-DaCompany Report #04-06-0896 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Scrotal Abscess Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 300-700 MG QD ORAL Date:06/29/04ISR Number: 4388127-4Report Type:Expedited (15-DaCompany Report #04-06-0895 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bronchitis Health Clozapine - Ivax Initial or Prolonged Respiratory Failure Professional Pharmaceuticals, Other Inc. Tablets PS Ivax 22-Feb-2006 08:30 AM Page: 2759 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pharmaceuticals, Inc. ORAL 700MG QD ORAL Date:06/30/04ISR Number: 4387849-9Report Type:Expedited (15-DaCompany Report #PHNR2004AU01117 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cerebral Infarction Clozaril PS Novartis Sector: Coordination Abnormal Pharma 25 - 900 Fall mg/day 3778 DAY Neutropenia Valproate Sodium C Pancytopenia White Blood Cell Count Decreased Date:06/30/04ISR Number: 4387855-4Report Type:Expedited (15-DaCompany Report #PHFR2004GB02580 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Exposure Clozaril PS Novartis Sector: Initial or Prolonged Depressed Level Of Pharma 200mg in Consciousness error Medication Error Co-Codamol C Date:06/30/04ISR Number: 4387876-1Report Type:Expedited (15-DaCompany Report #PHFR2004GB01434 Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Clozaril PS Novartis Sector: Electrocardiogram Qt Pharma ORAL Prolonged Date:07/01/04ISR Number: 4388101-8Report Type:Expedited (15-DaCompany Report #PHBS2004IE07629 Age:31 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Exposure Health Clozaril PS Novartis Sector: Initial or Prolonged Accidental Overdose Professional Pharma ORAL 400 mg, ONCE/SINGLE 1440 MIN Diazepam C UNKNOWN 25 mg/d Lithium C UNKNOWN 800 mg/d Haloperidol C UNKNOWN Valproate Sodium C UNKNOWN 1250 mg, BID Kemadrin C UNKNOWN UNK, UNK Date:07/01/04ISR Number: 4388182-1Report Type:Expedited (15-DaCompany Report #PHEH2004US03306 Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Triglycerides Clozaril PS Novartis Sector: Disability Increased Pharma ORAL 300 mg/day 1825 DAY Other Bronchitis Paroxetine C ORAL 20 mg/day 1825 DAY Cardiac Failure Aripiprazole C ORAL Congestive Pneumonia Weight Increased 22-Feb-2006 08:30 AM Page: 2760 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/01/04ISR Number: 4388443-6Report Type:Expedited (15-DaCompany Report #PHNU2004DE02265 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Distension Leponex / Clozaril Hospitalization - Abdominal Operation (Clozapine) PS Novartis Sector: Initial or Prolonged Abdominal Pain Pharma ORAL 500 mg/day Acute Abdomen Leponex / Clozaril Anorexia (Clozapine) SS Novartis Sector: Atrioventricular Block Pharma ORAL 300 mg/day 23040MIN Bowel Sounds Abnormal Akineton Retard SS ORAL 4 mg/day Cardiac Pacemaker Saroten SS Bayer Vital ORAL 30 mg/day 5760 MIN Insertion Neurocil SS ORAL 50 mg/day 11520MIN Dyspepsia Neurocil SS ORAL 50 mg/day 1440 MIN Flatulence Truxal SS ORAL 190 mg/day 1440 MIN Haematemesis Truxal SS ORAL 200 mg/day 8640 MIN Ileus Paralytic Truxal SS ORAL 50 mg/day 1440 MIN Leukocytosis Gastrozepin SS ORAL 150 mg/day 53280MIN Multi-Organ Failure Truxal SS ORAL 160 mg/day 37440MIN Nausea Truxal SS ORAL 250 mg/day 4320 MIN Pneumonia Aspiration Truxal SS ORAL 160 mg/day 2880 MIN Pyrexia Neurocil SS ORAL 75 mg/day 44640MIN Respiratory Rate Haldol SS Janssen INTRAVENOUS 10 mg/day 50400MIN Increased Saroten SS Bayer Vital ORAL 10 mg/day 1440 MIN Salivary Hypersecretion Taxilan C ORAL 200 mg/day Sepsis Xanef C ORAL 20 mg/day Somnolence Beloc Zok C ORAL 47.5 mg/day Vomiting Bifiteral "Philips" C ORAL 3 X-Ray Gastrointestinal Tablesp./day 33120MIN Tract Abnormal Unat Cor C ORAL 10 mg/day 30240MIN Adalat C ORAL 20 mg/day 1440 MIN Adalat C ORAL 40 mg/day 5760 MIN Date:07/01/04ISR Number: 4390702-8Report Type:Expedited (15-DaCompany Report #04-06-0909 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Lobar Pneumonia Health Clozapine - Ivax Initial or Prolonged Squamous Cell Carcinoma Professional Pharmaceuticals, Other Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 700 MG QD ORAL Date:07/01/04ISR Number: 4390704-1Report Type:Expedited (15-DaCompany Report #04-06-0927 Age:74 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Health Clozapine - Ivax Initial or Prolonged Hip Fracture Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 400-950 MG QD ORAL 22-Feb-2006 08:30 AM Page: 2761 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/02/04ISR Number: 4388827-6Report Type:Expedited (15-DaCompany Report #PHFR2004GB01720 Age:53 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cold Sweat Health Clozaril PS Novartis Sector: Initial or Prolonged Feeling Hot Professional Pharma ORAL 3530 DAY Other Haematocrit Decreased Olanzapine C UNKNOWN Haemoglobin Decreased Lithium C Hyperhidrosis Infection Lymphocyte Count Decreased Monocyte Count Decreased Neutrophil Count Decreased Pancytopenia Platelet Count Decreased Pyrexia Red Blood Cell Count Decreased Red Cell Distribution Width Increased White Blood Cell Count Decreased Date:07/02/04ISR Number: 4388834-3Report Type:Expedited (15-DaCompany Report #PHFR2004GB02587 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Circulatory Collapse Clozaril PS Novartis Sector: Medication Error Pharma ORAL Valproate Sodium SS ORAL Date:07/02/04ISR Number: 4388850-1Report Type:Expedited (15-DaCompany Report #PHEH2004US06646 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozapine PS Novartis Sector: Treatment Noncompliance Professional Pharma UNK,UNK Date:07/02/04ISR Number: 4388991-9Report Type:Expedited (15-DaCompany Report #PHFR2004GB02581 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyskinesia Clozaril PS Novartis Sector: Pharma ORAL Date:07/02/04ISR Number: 4389458-4Report Type:Expedited (15-DaCompany Report #PHEH2004US06746 Age:74 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Clozaril PS Novartis Sector: Hospitalization - Urosepsis Pharma ORAL 37.5 mg/day Initial or Prolonged 22-Feb-2006 08:30 AM Page: 2762 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/02/04ISR Number: 4389520-6Report Type:Expedited (15-DaCompany Report #PHFR2004GB02186 Age:63 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Level Increased Health Clozaril PS Novartis Sector: Haemoglobin Decreased Professional Pharma ORAL Lymphocyte Count Amisulpride C ORAL 50mg/nocte Decreased Venlafaxine C ORAL 150 mg, QD Tachycardia Zopiclone C ORAL 7.5mg/nocte Thiamine C ORAL 100 mg, QD Vitamin B C ORAL 1 tablet/day Date:07/02/04ISR Number: 4414486-XReport Type:Periodic Company Report #349347 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Other Klonopin (Clonazepam) PS Clozapine (Clozapine) SS ORAL 100 MG DAILY ORAL Protonix (Pantoprazole) SS Risperdal (Risperidone) SS Lamotrigine (Lamotrigine) SS Cogentin (Benztropine Mesylate) C Date:07/06/04ISR Number: 4390956-8Report Type:Expedited (15-DaCompany Report #04-06-0839 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 400MG QHS ORAL Amantadine C Date:07/06/04ISR Number: 4390957-XReport Type:Expedited (15-DaCompany Report #04-06-0921 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Choking Health Clozapine - Ivax Obstructive Airways Professional Pharmaceuticals, Disorder Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 225-475 MG QD ORAL 22-Feb-2006 08:30 AM Page: 2763 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/06/04ISR Number: 4390959-3Report Type:Expedited (15-DaCompany Report #04-05-0687 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine Tablets - Other Vaginal Cancer Professional Ivax Vulval Cancer Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 300-400MG QD ORAL Chemotherapy C Date:07/06/04ISR Number: 4393584-3Report Type:Direct Company Report #CTU 222256 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Orthostatic Hypotension Venlafaxine PS ORAL 75 MG PO QD Initial or Prolonged Syncope Clozapine SS ORAL 200 MG PO QAM 600 MG QHS Date:07/07/04ISR Number: 4393452-7Report Type:Direct Company Report #CTU 222339 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Pressure Increased Clozaril PS ORAL 200 MG PO HS Heart Rate Increased Clozaril SS ORAL 50 MG PO Q AM Lethargy Pyrexia Viral Infection Date:07/07/04ISR Number: 4395835-8Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040606404 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Foreign Risperdal Consta Asthenia Health (Risperidone) Blood Prolactin Increased Professional Microspheres PS INTRAMUSCULAR 37.5 MG, Body Temperature INTRA-MUSCULA Increased R Drug Interaction Clozapine Endocrine Disorder (Clozapine) SS 225-450MG/DAY Hypotension Iron Sulfate Lethargy (Ferrous Sulfate) C Neutrophil Count Increased Oral Intake Reduced Pharyngolaryngeal Pain Sedation Weight Decreased White Blood Cell Count Increased 22-Feb-2006 08:30 AM Page: 2764 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/08/04ISR Number: 4392024-8Report Type:Expedited (15-DaCompany Report #PHBS2004SE08522 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Balance Disorder Leponex PS Novartis Sector: Eosinophilia Pharma Eosinophilic Pneumonia Pyrexia Urinary Incontinence Date:07/08/04ISR Number: 4392028-5Report Type:Expedited (15-DaCompany Report #PHNU2004DE02263 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Level Increased Health Leponex / Clozaril Drug Toxicity Professional (Clozapine) PS Novartis Sector: Poisoning Pharma ORAL 200 mg, TID Date:07/08/04ISR Number: 4392029-7Report Type:Expedited (15-DaCompany Report #PHFR2001GB01091 Age:29 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abortion Spontaneous Clozaril PS Novartis Sector: Drug Exposure During Pharma ORAL 500 mg/day Pregnancy Date:07/08/04ISR Number: 4392055-8Report Type:Expedited (15-DaCompany Report #PHHO2004CA01622 Age:53 YR Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiac Disorder Health Clozaril PS Novartis Sector: Dyspnoea Professional Pharma Unspecified Date:07/08/04ISR Number: 4392641-5Report Type:Expedited (15-DaCompany Report #PHNR2004AU01176 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Clozaril PS Novartis Sector: Blood Alkaline Pharma 75 - 600 Phosphatase Increased mg/day 3648 DAY Blood Cholesterol Valproate Sodium SS Increased Blood Glucose Increased Gamma-Glutamyltransferase Increased Hepatitis Neutrophilia Thrombocythaemia White Blood Cell Count Increased Date:07/08/04ISR Number: 4392660-9Report Type:Expedited (15-DaCompany Report #PHNU2004DE02276 Age: Gender:Male I/FU:I Outcome PT Hospitalization - Abdominal Pain Initial or Prolonged Alanine Aminotransferase 22-Feb-2006 08:30 AM Page: 2765 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Increased Aspartate Aminotransferase Increased Report Source Product Role Manufacturer Route Dose Duration Blood Amylase Increased Leponex / Clozaril C-Reactive Protein (Clozapine) PS Novartis Sector: Increased Pharma ORAL 50mg/day 1440 MIN Gamma-Glutamyltransferase Leponex / Clozaril Increased (Clozapine) SS Novartis Sector: Hepatic Enzyme Increased Pharma ORAL 75mg/day 1440 MIN Leukocytosis Leponex / Clozaril Lipase Increased (Clozapine) SS Novartis Sector: Nausea Pharma ORAL 100mg/day 5760 MIN Pancreatitis Leponex / Clozaril Vomiting (Clozapine) SS Novartis Sector: Pharma ORAL 125mg/day 1440 MIN Pantozol C ORAL 40mg/day Date:07/08/04ISR Number: 4392683-XReport Type:Expedited (15-DaCompany Report #PHBS2004NO08833 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dystonia Leponex PS Novartis Sector: Pharma UNKNOWN Haldol SS Janssen UNKNOWN Chlorpromazine SS UNKNOWN Melleril SS UNKNOWN Nozinan SS UNKNOWN Risperdal SS UNKNOWN Serdolect SS UNKNOWN Sobril SS UNKNOWN Zyprexa SS UNKNOWN Date:07/08/04ISR Number: 4392829-3Report Type:Expedited (15-DaCompany Report #PHFR2004GB02282 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Clozaril (Clozapine) PS Novartis Sector: Circulatory Collapse Pharma 150mg/day Diarrhoea Clozaril (Clozapine) SS Novartis Sector: Fatigue Pharma ORAL 250 mg/day Gastroenteritis Viral Clozaril (Clozapine) SS Novartis Sector: Lung Infection Pharma ORAL 100 mg/day Productive Cough Flupentixol Sedation Decanoate C INTRAMUSCULAR 100 mg, BIW Tachycardia Ranitidine C Vomiting Date:07/08/04ISR Number: 4393051-7Report Type:Expedited (15-DaCompany Report #PHFR2004GB02675 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Clozaril PS Novartis Sector: Drug Level Increased Pharma UNKNOWN Myoclonus Valproate Sodium SS Sulpiride C 22-Feb-2006 08:30 AM Page: 2766 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/08/04ISR Number: 4393140-7Report Type:Expedited (15-DaCompany Report #PHHO2004CA06544 Age:65 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Clozaril PS Novartis Sector: Cellulitis Pharma ORAL 325 mg, QD 69120MIN Leukopenia Quetiapine C Pyrexia Lamotrigine C Loxapine C Date:07/08/04ISR Number: 4393145-6Report Type:Expedited (15-DaCompany Report #PHNU2004DE02275 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Amylase Increased Leponex / Clozaril Initial or Prolonged C-Reactive Protein (Clozapine) PS Novartis Sector: Increased Pharma ORAL 12.5mg/day 1440 MIN Gamma-Glutamyltransferase Leponex / Clozaril Increased (Clozapine) SS Novartis Sector: Lipase Increased Pharma ORAL 100mg/day 1440 MIN Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL 150mg/day 1440 MIN Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL 200mg/day 1440 MIN Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL 250mg/day 4320 MIN Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL 300mg/day 2880 MIN Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL 350mg/day 1440 MIN Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL 400mg/day 11520MIN Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL 450mg/day 10080MIN Atosil C ORAL 50mg/day 1440 MIN Atosil C ORAL 150mg/day 30240MIN Atosil C 100mg/day 1440 MIN Atosil C ORAL 50mg/day 1440 MIN Date:07/08/04ISR Number: 4394051-3Report Type:Expedited (15-DaCompany Report #04-06-0807 Age:56 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Health Clozapine - Ivax Initial or Prolonged Hypoglycaemia Professional Pharmaceuticals, Required Impaired Self-Care Other Inc. Tablets PS ORAL 400-325MG QD Intervention to ORAL Prevent Permanent Insulin C Impairment/Damage 22-Feb-2006 08:30 AM Page: 2767 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/08/04ISR Number: 4394052-5Report Type:Expedited (15-DaCompany Report #04-07-0948 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abscess Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 275MG QD ORAL Date:07/08/04ISR Number: 4397161-XReport Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040607414 Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspartate Foreign Haldol (Haloperidol) Aminotransferase Health Injection PS INTRAVENOUS 10 MG Decreased Professional INTRAVENOUS Blood Amylase Decreased Leponex (Clozapine) SS ORAL 500 MG, IN 1 Blood Potassium Decreased DAY, ORAL; Cardiac Pacemaker 300 MG, IN 1 Insertion DAY, ORAL Creatine Phosphokinase Taxilan (Perazine) SS ORAL 200 MG, IN 1 Decreased DAY, ORAL Drug Interaction Akineton Retard Faeces Discoloured (Biperiden Haematemesis Hydrochloride) SS ORAL 4 MG, IN 1 Ileus Paralytic DAY, ORAL Multi-Organ Failure Saroten Pneumonia Aspiration (Amitriptyline Respiratory Rate Hydrochloride) SS ORAL 10 MG, IN 1 Increased DAY, ORAL; 30 Sepsis MG, IN 1 DAY, Somnolence ORAL Neurocil (Levomeprazine Maleate) SS ORAL 50 MG, IN 1 DAY, ORAL; 75 MG, IN 1 DAY, ORAL; 50 MG, IN 1 DAY, Truxal (Chlorprothixene Hydrochloride) SS ORAL SEE IMAGE Gastrozepin (Pirenzepine Dihydrochloride) SS ORAL 150 MG, IN 1 DAY, ORAL Xanaf (Enalapril Maleate) C Beloc-Zok (Beloc-Zoc Comp) C Bifiteral (Tablets) Probucol C Unat Cor (Torasemide) C Adalat (Nifedipine) C 22-Feb-2006 08:30 AM Page: 2768 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/09/04ISR Number: 4393879-3Report Type:Expedited (15-DaCompany Report #PHFR2004GB02633 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Choking Clozaril PS Novartis Sector: Pharma ORAL Date:07/12/04ISR Number: 4394719-9Report Type:Expedited (15-DaCompany Report #PHNU2004DE02304 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chest Discomfort Health Leponex / Clozaril Hyperhidrosis Professional (Clozapine) PS Novartis Sector: Incontinence Pharma ORAL up to Loose Associations 200mg/day Lymphopenia Salivary Hypersecretion Date:07/12/04ISR Number: 4394722-9Report Type:Expedited (15-DaCompany Report #PHNU2004DE02306 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pericardial Effusion Health Leponex / Clozaril Pleural Effusion Professional (Clozapine) PS Novartis Sector: Polyserositis Pharma ORAL Date:07/12/04ISR Number: 4394724-2Report Type:Expedited (15-DaCompany Report #PHNR2004AU00952 Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Glucose Increased Health Clozaril PS Novartis Sector: Blood Triglycerides Professional Pharma 50 - 400 Increased mg/day Diabetes Mellitus Hyperglycaemia Date:07/12/04ISR Number: 4394726-6Report Type:Expedited (15-DaCompany Report #PHBS2002AU01537 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Health Clozaril PS Novartis Sector: Hyperglycaemia Professional Pharma ORAL 25 - 700 Impaired Fasting Glucose mg/day Lipid Metabolism Disorder Sertraline C UNKNOWN 50 mg/day Date:07/12/04ISR Number: 4394729-1Report Type:Expedited (15-DaCompany Report #PHBS2003BR01503 Age:42 YR Gender:Male I/FU:F Outcome PT Other Confusional State Dysphonia Erectile Dysfunction Infection Libido Decreased Motor Dysfunction Pain In Extremity Rash 22-Feb-2006 08:30 AM Page: 2769 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Throat Irritation Report Source Product Role Manufacturer Route Dose Duration Leponex PS Novartis Sector: Pharma ORAL 50 mg/d 153 DAY Leponex SS Novartis Sector: Pharma ORAL 400 mg/d Amplictil C ORAL 100 mg/d 153 DAY Date:07/12/04ISR Number: 4394731-XReport Type:Expedited (15-DaCompany Report #PHNR2004AU00951 Age:35 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Cholesterol Health Clozaril PS Novartis Sector: Increased Professional Pharma 13 - 225 Blood Glucose Increased mg/day Blood Triglycerides Valproate Sodium C 500 mg mane + Increased 700 mg nocte Fatigue High Density Lipoprotein Decreased Hyperglycaemia Low Density Lipoprotein Increased Date:07/12/04ISR Number: 4394738-2Report Type:Expedited (15-DaCompany Report #PHFR2003GB02133 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Constipation Consumer Clozaril PS Novartis Sector: Initial or Prolonged Haemoglobin Decreased Pharma ORAL 200mg/mane&30 Megacolon 0mg/nocte Clozaril SS Novartis Sector: Pharma ORAL 200mg/mane&25 0mg/nocte Iron C UNKNOWN Date:07/12/04ISR Number: 4394953-8Report Type:Expedited (15-DaCompany Report #GB-GLAXOSMITHKLINE-B0338002A Age:20 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Back Pain Lithium Carbonate PS Glaxosmithkline ORAL 400MG Twice Encephalopathy per day Haematuria Clozaril SS ORAL 200MG Per day Neutrophil Count Sodium Valproate SS ORAL 1G Twice per Increased day Proteinuria Clonazepam C ORAL 1MG Four Pyelonephritis times per day 56 DAY Pyrexia Renal Failure Acute Sepsis Somnolence Therapeutic Agent Toxicity Urinary Tract Infection White Blood Cell Count Increased 22-Feb-2006 08:30 AM Page: 2770 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/12/04ISR Number: 4395004-1Report Type:Expedited (15-DaCompany Report #PHNU2004DE01223 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Health Leponex / Clozaril Phosphokinase Increased Professional (Clozapine) PS Novartis Sector: Electromyogram Abnormal Pharma ORAL 50 mg/day Muscular Weakness Myalgia Myopathy Date:07/12/04ISR Number: 4395008-9Report Type:Expedited (15-DaCompany Report #PHFR2004GB02211 Age:21 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Pressure Diastolic Clozaril PS Novartis Sector: Increased Pharma ORAL 100-125mg/day Dizziness Clozaril SS Novartis Sector: Headache Pharma ORAL 100mg mane & Nausea 125 mg nocte Orthostatic Hypotension Clozaril SS Novartis Sector: Vasodilatation Pharma 100mg mane & 100mg nocte Clozaril SS Novartis Sector: Pharma ORAL 100 mg, BID Clozaril SS Novartis Sector: Pharma 225mg/day Quetiapine C ORAL 800mg/day Quetiapine C ORAL 400 mg/day Date:07/12/04ISR Number: 4399346-5Report Type:Expedited (15-DaCompany Report #GBWYE887608JUL04 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eosinophilia Foreign Efexor (Venlafaxine Neutrophilia Health Hydrochloride, ,0) PS White Blood Cell Count Professional Clozapine Increased Other (Clozapine, ,0) SS ORAL ORAL Date:07/12/04ISR Number: 4399395-7Report Type:Expedited (15-DaCompany Report #2004S1001879 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 100 MG Q AM, Other 200 MG Q PM ORAL Propranolol C Escitalopram C Estradiol C Lithium C Quetiapine C Clonazepam C 22-Feb-2006 08:30 AM Page: 2771 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/12/04ISR Number: 4399406-9Report Type:Expedited (15-DaCompany Report #04-06-0930 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozapine - Ivax Professional Pharmaceuticals, Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL ORAL Date:07/12/04ISR Number: 4399413-6Report Type:Expedited (15-DaCompany Report #04-07-0973 Age:67 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delusion Health Clozapine - Ivax Initial or Prolonged Paranoia Professional Pharmaceuticals, Urinary Tract Infection Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 75MG QD ORAL Date:07/12/04ISR Number: 4399414-8Report Type:Expedited (15-DaCompany Report #04-07-0966 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Nephrolithiasis Health Clozapine - Ivax Initial or Prolonged Pancreatitis Professional Pharmaceuticals, Psychotic Disorder Other Inc. Tablets PS Ivax Schizoaffective Disorder Pharmaceuticals, Schizophrenia, Catatonic Inc. ORAL 300-600MG QD Type ORAL Treatment Noncompliance Date:07/12/04ISR Number: 4399416-1Report Type:Expedited (15-DaCompany Report #04-07-0971 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Influenza Health Clozapine Tablets - Lung Disorder Professional Ivax Smoker Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 600-900 QD ORAL Date:07/12/04ISR Number: 4399417-3Report Type:Expedited (15-DaCompany Report #04-07-0964 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Neoplasm Malignant Health Clozapine Ivax Metastases To Central Professional Pharmaceuticals Inc Nervous System Other Tablets PS Ivax Pneumonia Pharmaceuticals, Weight Decreased Inc. ORAL 800 MG QD ORAL 22-Feb-2006 08:30 AM Page: 2772 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/12/04ISR Number: 4399418-5Report Type:Expedited (15-DaCompany Report #04-07-0961 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL ORAL Date:07/12/04ISR Number: 4399419-7Report Type:Expedited (15-DaCompany Report #04-07-0962 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine Tablets - Overweight Professional Ivax Smoker Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 100-600 MG QD ORAL Date:07/12/04ISR Number: 4399420-3Report Type:Expedited (15-DaCompany Report #04-07-0963 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL ORAL Date:07/12/04ISR Number: 4399421-5Report Type:Expedited (15-DaCompany Report #04-07-0965 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Death Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 200-450 MG QD ORAL Date:07/12/04ISR Number: 4399422-7Report Type:Expedited (15-DaCompany Report #04-07-0967 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Toxicity Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 400 MG BID ORAL Lithium Carbonate SS 300 MG TID 22-Feb-2006 08:30 AM Page: 2773 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Zantac C Haloperidol C Geodon C Ativan C Date:07/13/04ISR Number: 4395431-2Report Type:Expedited (15-DaCompany Report #PHBS2004TW08559 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Clozaril (Clozapine) PS Novartis Sector: Other Circulatory Collapse Pharma ORAL 500 mg/d Condition Aggravated Haloperidol C UNKNOWN 10 mg/d Hallucination, Auditory Haloperidol C UNKNOWN 15 mg/d Respiratory Arrest Ativan C UNKNOWN 1.5 mg/d Somnolence Date:07/13/04ISR Number: 4395882-6Report Type:Expedited (15-DaCompany Report #PHBS2004BR08939 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Test Abnormal Leponex PS Novartis Sector: Leukaemia Pharma ORAL 200 mg, QHS Date:07/13/04ISR Number: 4396257-6Report Type:Expedited (15-DaCompany Report #PHBS2004BE09060 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Leponex PS Novartis Sector: Phosphokinase Increased Pharma ORAL 100 mg, TID Myocarditis Anafranil C ORAL 225 mg/d Serotonin Syndrome Risperdal C UNKNOWN 2.5 mg/d Date:07/14/04ISR Number: 4396966-9Report Type:Expedited (15-DaCompany Report #PHBS2004NL03658 Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Creatine Leponex PS Novartis Sector: Hospitalization - Phosphokinase Increased Pharma ORAL 100 mg, QD Initial or Prolonged Blood Lactate Truxal C UNKNOWN 15 mg, BID Dehydrogenase Increased Oxazepam C UNKNOWN 25 mg, QID Catatonia Erythromycin C UNKNOWN Cough Pantoprazole C UNKNOWN Dialysis Dalteparin Sodium C UNKNOWN Drug Level Increased Chloramphenicol C UNKNOWN Pneumonia Primperan C Prothrombin Time Olanzapine C UNKNOWN 2.5 mg, BID Prolonged Olanzapine C UNKNOWN 5 mg, BID Pyrexia Aranesp C UNKNOWN Renal Impairment Ipratropium Bromide C UNKNOWN Rhabdomyolysis Salbutamol C UNKNOWN Lorazepam C UNKNOWN Multivitamins C UNKNOWN Dalterparine C UNKNOWN Pantoprazole I UNKNOWN 22-Feb-2006 08:30 AM Page: 2774 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/14/04ISR Number: 4396972-4Report Type:Expedited (15-DaCompany Report #PHFR2003GB04137 Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aggression Clozaril PS Novartis Sector: Other Death Pharma ORAL Diabetes Mellitus Insulin-Dependent Date:07/14/04ISR Number: 4397002-0Report Type:Expedited (15-DaCompany Report #PHEH2004US07180 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Fall Clozaril PS Novartis Sector: Hospitalization - Pneumonia Pharma 25 mg, QD Initial or Prolonged Date:07/14/04ISR Number: 4397060-3Report Type:Expedited (15-DaCompany Report #PHEH2004US05040 Age:38 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Upper Clozaril PS Novartis Sector: Initial or Prolonged Alanine Aminotransferase Pharma ORAL 200 mg/day Other Increased Seroquel C Aspartate Remeron C Aminotransferase Lo/Ovral C Increased Vitamin C C Cholelithiasis Aspirin Enteric Menorrhagia Coated K.P. C Nausea Colace C Uterine Dilation And Zantac C Curettage Lactulose C Vomiting Synthroid C Niacin C Vitamin E C Date:07/14/04ISR Number: 4397623-5Report Type:Expedited (15-DaCompany Report #2004S1001925 Age:78 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg Mylan PS ORAL 75MG Q HS Other ORAL Date:07/14/04ISR Number: 4397625-9Report Type:Expedited (15-DaCompany Report #2004S1001913 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Postoperative Thrombosis Health Clozapine Tablets Professional 100 Mg Mylan PS ORAL 100MG QAM, Other 350MG Q HS ORAL Risperidone C 22-Feb-2006 08:30 AM Page: 2775 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/14/04ISR Number: 4397626-0Report Type:Expedited (15-DaCompany Report #2004S1001693 Age:87 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dementia Health Clozapine Tablets 25 Professional Mg Mylan PS ORAL 12.5 MG BID, Other ORAL Paroxetine C Trazodone C Lorazepam C Lamotrigine C Olanzapine C Senna C Calcium Carbonate + Vitamin D C Venlafaxine Xr C Docusate C Bisacodyl C Acetaminophen C Date:07/15/04ISR Number: 4398036-2Report Type:Expedited (15-DaCompany Report #PHHO2004CA08891 Age:61 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Pain Clozaril PS Novartis Sector: Hospitalization - Agitation Pharma ORAL 12.5 mg, at Initial or Prolonged Anorexia bedtime 7200 MIN Other Asthenia Clozaril SS Novartis Sector: Cold Sweat Pharma ORAL 25 mg, at Constipation bedtime 10080MIN Death Clozaril SS Novartis Sector: Diarrhoea Pharma 12.5 mg AM + Dyspnoea 25 mg at Faecal Incontinence bedtime 10080MIN Feeling Abnormal Clozaril SS Novartis Sector: Feeling Cold Pharma ORAL 25 mg AM + Flatulence 37.5 mg at Ileus Paralytic bedtime 10080MIN Pallor Clozaril SS Novartis Sector: Salivary Hypersecretion Pharma ORAL 25 mg am + 25 Somnolence mg at bedtime 10080MIN Speech Disorder Clozaril SS Novartis Sector: Thrombocythaemia Pharma ORAL 25 mg am + 50 Urinary Incontinence mg at bedtime 10080MIN Vomiting Clozaril SS Novartis Sector: Pharma ORAL 25 mg am + 25 mg at bedtime 10080MIN Clozaril SS Novartis Sector: Pharma ORAL 25 mg at bedtime 4320 MIN Clozaril SS Novartis Sector: Pharma ORAL 12.5 mg at bedtime 17280MIN Zyprexa C 20 mg, at bedtime Zyprexa C 15 mg, at bedtime Epival C 250 mg BID + 500 mg hs Epival C HEMODIALYSIS 500 mg, UNK Rivotril C 2 mg, PRN 22-Feb-2006 08:30 AM Page: 2776 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Ativan C 2 mg, BID Date:07/15/04ISR Number: 4398038-6Report Type:Expedited (15-DaCompany Report #PHNU2004DE01213 Age:51 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Distension Health Leponex / Clozaril Initial or Prolonged C-Reactive Protein Professional (Clozapine) PS Novartis Sector: Increased Pharma ORAL up to 300 Concomitant Disease mg/day Aggravated Leponex / Clozaril Constipation (Clozapine) SS Novartis Sector: Gastric Disorder Pharma ORAL up to 900 Gastric Ulcer mg/day Ileus Ileus Paralytic Impaired Gastric Emptying Leukocytosis Nausea Oesophagogastroscopy Pyrexia Small Intestinal Stenosis Vomiting X-Ray Gastrointestinal Tract Abnormal Date:07/15/04ISR Number: 4398042-8Report Type:Expedited (15-DaCompany Report #PHHO2004CA09051 Age:44 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Cholesterol Clozaril (Clozapine) PS Novartis Sector: Increased Pharma ORAL 187.5 mg Blood Triglycerides decreased to Increased 137 mg 195 DAY High Density Lipoprotein Fluoxetine C Decreased Dextroamphetamine C Tachycardia Ativan C Weight Increased Date:07/15/04ISR Number: 4398053-2Report Type:Expedited (15-DaCompany Report #PHFR2004GB02755 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chills Clozaril PS Novartis Sector: Diarrhoea Pharma ORAL Drug Withdrawal Syndrome Clomipramine C UNKNOWN Hyperhidrosis Quetiapine C UNKNOWN Serotonin Syndrome Procyclidine C UNKNOWN Date:07/15/04ISR Number: 4398720-0Report Type:Expedited (15-DaCompany Report #PHFR2004GB02186 Age:63 YR Gender:Male I/FU:F Outcome PT Other Cough Drug Level Increased Dyspnoea Haemoglobin Decreased 22-Feb-2006 08:30 AM Page: 2777 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lymphocyte Count Decreased Mobility Decreased Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Clozaril PS Novartis Sector: Tachycardia Pharma ORAL 149 DAY Amisulpride C ORAL 50mg/nocte Venlafaxine C ORAL 150 mg, QD Zopiclone C ORAL 7.5mg/nocte Thiamine C ORAL 100 mg, QD Vitamin B C ORAL 1 tablet/day Date:07/15/04ISR Number: 4398723-6Report Type:Expedited (15-DaCompany Report #PHHO2004CA08488 Age:64 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ankle Fracture Clozaril PS Novartis Sector: Initial or Prolonged Convulsion Pharma ORAL 100 - 300 mg Disability Fall / day Other Femur Fracture Coumadin C Fibula Fracture Acetaminophen C Fracture Treatment Calcium C Tibia Fracture Chlorpromazine C Dalteparin Sodium C Folic Acid C Furosemide C Levothyroxine C Metoprolol C Multivitamins C Omeprazole C Quetiapine C Warfarin C Tylenol W/Codeine No. 3 C Metoclopramide C Morphine Sulfate C Serax C Salbutamol C Fragmin C Date:07/15/04ISR Number: 4399197-1Report Type:Direct Company Report #CTU 222873 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Clozaril 100 Mg Increased Novartis PS Novartis ORAL 3 TABLET EVERY AM ORAL Clozaril 100 Mg Novartis SS Novartis ORAL 4 TABLET EVERY PM ORAL Date:07/15/04ISR Number: 4399198-3Report Type:Direct Company Report #CTU 222874 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Clozaril 100 Mg Increased Novartis PS Novartis ORAL 3 TABLET DAILY @HS ORAL 22-Feb-2006 08:30 AM Page: 2778 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/16/04ISR Number: 4399236-8Report Type:Expedited (15-DaCompany Report #PHFR2004GB02777 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Exposure Clozaril PS Novartis Sector: Initial or Prolonged Overdose Pharma ORAL 1400 mg Self-Medication overdose Quetiapine SS Zopiclone SS Date:07/16/04ISR Number: 4399647-0Report Type:Expedited (15-DaCompany Report #PHHO2004CA01959 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bronchitis Health Clozaril PS Novartis Sector: Initial or Prolonged Leukopenia Professional Pharma ORAL Unspecified 612 DAY Neutropenia Divalproex Sodium C Urinary Tract Infection Date:07/16/04ISR Number: 4399650-0Report Type:Expedited (15-DaCompany Report #PHFR2004GB02489 Age:42 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Clozaril PS Novartis Sector: Initial or Prolonged Myocardial Infarction Pharma ORAL 550mg/day Other Obesity Diazepam C ORAL 15mg/day Weight Increased Danazol C ORAL 200mg/day Gamolenic Acid C ORAL 240mg/day Venlafaxine C ORAL 150mg/day Ibuprofen C ORAL 1600mg Frusemide C ORAL 40mg/day Beclomethasone Dipropionate C 2 puffs Date:07/16/04ISR Number: 4399651-2Report Type:Expedited (15-DaCompany Report #PHFR2004GB02437 Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Overdose Health Clozaril PS Novartis Sector: Completed Suicide Professional Pharma ORAL 250 mg/day Heroin SS UNKNOWN Amitriptyline C 100 mg nocte Date:07/16/04ISR Number: 4400529-6Report Type:Direct Company Report #CTU 222926 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Leukaemia Clozaril 100 PS TWO AM AND Platelet Count Decreased HS Red Blood Cell Count Decreased White Blood Cell Count Decreased 22-Feb-2006 08:30 AM Page: 2779 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/16/04ISR Number: 4400554-5Report Type:Direct Company Report #CTU 222937 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neutrophil Count Clozapine 100 Mg Decreased Ivax PS Ivax ORAL 100 GM 8 PM ORAL Clozapine SS ORAL 25 MG BID ORAL Risperidone C Benztropine C Haloperidol C Docusate C Date:07/16/04ISR Number: 4400561-2Report Type:Direct Company Report #CTU 222944 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Myocarditis Clozaril 50 Mg PS ORAL 750 MG 24 Intervention to Myositis HOURS ORAL Prevent Permanent Impairment/Damage Date:07/16/04ISR Number: 4402359-8Report Type:Expedited (15-DaCompany Report #04-06-0855 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dysphagia Health Clozapine Tablets - Hospitalization - Pneumonia Professional Ivax Initial or Prolonged Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 350 MG/DAY ORAL Ativan C Depakote C Zyprexa C Zoloft C Symmetrel C Date:07/19/04ISR Number: 4400686-1Report Type:Expedited (15-DaCompany Report #PHEH2004US07432 Age:69 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Neoplasm Malignant Health Clozaril PS Novartis Sector: Professional Pharma ORAL 25 mg/day Date:07/19/04ISR Number: 4401763-1Report Type:Expedited (15-DaCompany Report #PHFR2004GB02713 Age:56 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abnormal Behaviour Clozaril PS Novartis Sector: Hospitalization - Circulatory Collapse Pharma ORAL 400 mg/day Initial or Prolonged Medication Error Other Somnolence 22-Feb-2006 08:30 AM Page: 2780 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/19/04ISR Number: 4401766-7Report Type:Expedited (15-DaCompany Report #PHHO2004CA08891 Age:61 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Pain Health Clozaril PS Novartis Sector: Other Agitation Professional Pharma ORAL 12.5 mg, at Anorexia bedtime 7200 MIN Asthenia Clozaril SS Novartis Sector: Carcinoid Tumour Of The Pharma ORAL 25 mg, at Gastrointestinal Tract bedtime 10080MIN Cold Sweat Clozaril SS Novartis Sector: Constipation Pharma 12.5 mg AM + Diarrhoea 25 mg at Dyspnoea bedtime 10080MIN Faecal Incontinence Clozaril SS Novartis Sector: Feeling Abnormal Pharma ORAL 25 mg AM + Feeling Cold 37.5 mg at Flatulence bedtime 10080MIN Metastases To Liver Clozaril SS Novartis Sector: Pallor Pharma ORAL 25 mg am + 25 Salivary Hypersecretion mg at bedtime 10080MIN Somnolence Clozaril SS Novartis Sector: Speech Disorder Pharma ORAL 25 mg am + 50 Thrombocythaemia mg at bedtime 10080MIN Urinary Incontinence Clozaril SS Novartis Sector: Vomiting Pharma ORAL 25 mg am + 25 mg at bedtime 10080MIN Clozaril SS Novartis Sector: Pharma ORAL 25 mg at bedtime 4320 MIN Clozaril SS Novartis Sector: Pharma ORAL 12.5 mg at bedtime 17280MIN Zyprexa C 20 mg, at bedtime Zyprexa C 15 mg, at bedtime Epival C 250 mg BID + 500 mg hs Epival C HEMODIALYSIS 500 mg, UNK Rivotril C 2 mg, PRN Ativan C 2 mg, BID Date:07/19/04ISR Number: 4404958-6Report Type:Expedited (15-DaCompany Report #04-07-1007 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 200-500MG QD ORAL Date:07/19/04ISR Number: 4404971-9Report Type:Expedited (15-DaCompany Report #2004S1001948 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accident Health Clozapine Tablets Drowning Professional 100 Mg Mylan PS Mylan ORAL 400MG QD ORAL Other Pantoprazole C Paroxetine C 22-Feb-2006 08:30 AM Page: 2781 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Docusate Sodium C Topiramate C Oxybutynin C Clonazepam C Date:07/19/04ISR Number: 4421405-9Report Type:Periodic Company Report #2004036984 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Geodon (Im) Professional (Ziprasidone) PS INTRAMUSCULAR INTRAMUSCULAR Company Clozapine Representative (Clozapine) SS Date:07/20/04ISR Number: 4402042-9Report Type:Expedited (15-DaCompany Report #PHBS2004BR09407 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Triglycerides Leponex PS Novartis Sector: Increased Pharma ORAL 100 mg, QID Hepatic Enzyme Increased Anafranil C ORAL 50 mg, QD Date:07/20/04ISR Number: 4402043-0Report Type:Expedited (15-DaCompany Report #PHNU2004DE02190 Age:52 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chronic Obstructive Health Leponex / Clozaril Initial or Prolonged Pulmonary Disease Professional (Clozapine) PS Novartis Sector: Other Condition Aggravated Pharma ORAL up to Dizziness 600mg/day Drug Level Above Leponex / Clozaril Therapeutic (Clozapine) SS Novartis Sector: Drug Level Increased Pharma ORAL 400 mg/day Dysarthria Leponex / Clozaril Dyspnoea At Rest (Clozapine) SS Novartis Sector: General Physical Health Pharma ORAL 200 mg/day Deterioration Leponex / Clozaril Immobile (Clozapine) SS Novartis Sector: Infection Pharma ORAL Unknown Lobar Pneumonia Seroquel C ORAL 900 mg/day Pneumonia Diazepam C UNKNOWN Unknown Merigest C ORAL 1 mg/day Akineton /Aus/ C ORAL 2 mg/day Gastrozepin C ORAL 100 mg/day Ferro Sanol Comp C ORAL Unknown Nac "Ratiopharm" C ORAL 600 mg/day Date:07/20/04ISR Number: 4402339-2Report Type:Expedited (15-DaCompany Report #PHBS2004BR07080 Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anorexia Consumer Leponex PS Novartis Sector: Dengue Fever Pharma ORAL 100 mg, QID Hyperhidrosis Lorax C ORAL 1.5 DF, BID Platelet Count Decreased Lexapro C ORAL 1 tablet/d 22-Feb-2006 08:30 AM Page: 2782 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/20/04ISR Number: 4402361-6Report Type:Expedited (15-DaCompany Report #PHFR2004GB01876 Age:59 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Health Clozaril PS Novartis Sector: Initial or Prolonged Haemoglobin Decreased Professional Pharma ORAL 500mg Other Hydronephrosis Clozaril SS Novartis Sector: Joint Injury Pharma 300mg nocte Liver Disorder Iron Supplements C UNKNOWN Ureteric Obstruction Date:07/20/04ISR Number: 4402414-2Report Type:Expedited (15-DaCompany Report #PHFR2004GB02687 Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Clozaril PS Novartis Sector: Increased Pharma ORAL Blood Triglycerides Lithium C Increased Hepatic Steatosis Lipids Abnormal Liver Function Test Abnormal Date:07/21/04ISR Number: 4402902-9Report Type:Expedited (15-DaCompany Report #PHEH2004US07484 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Flatulence Clozaril PS Novartis Sector: Initial or Prolonged Gallbladder Disorder Pharma ORAL 450 mg/day 183 DAY Ileus Depakote C Nausea Synthroid C Scan Abdomen Abnormal Zyrtec C Vomiting Ranitidine C Weight Decreased Premarin /Sch/ C Sorbitol C Zelnorm /Usa/ C Aciphex C Date:07/21/04ISR Number: 4402903-0Report Type:Expedited (15-DaCompany Report #PHNR2004AU01176 Age: Gender:Female I/FU:F Outcome PT Other Anaemia Blood Alkaline Phosphatase Increased Blood Cholesterol Increased Blood Glucose Increased Gamma-Glutamyltransferase Increased Hepatitis Neutrophilia Thrombocythaemia White Blood Cell Count 22-Feb-2006 08:30 AM Page: 2783 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Increased Report Source Product Role Manufacturer Route Dose Duration Health Clozaril PS Novartis Sector: Professional Pharma 75 - 600 mg/day 3648 DAY Valproate Sodium SS Amisulpride C 400 mg, BID Lithium C ORAL 750 mg/day Thyroxin C 150mcg/mornin g Logynon Ed C 1tablet/daily Date:07/21/04ISR Number: 4403766-XReport Type:Expedited (15-DaCompany Report #PHBS2004AT07097 Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Vitreous Opacities Leponex PS Novartis Sector: Pharma UNKNOWN 25 mg/d Leponex SS Novartis Sector: Pharma UNKNOWN 100 mg/d Leponex SS Novartis Sector: Pharma UNKNOWN 12.5 mg/d Date:07/21/04ISR Number: 4407042-0Report Type:Expedited (15-DaCompany Report #2004S1001974 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Other Clozapine Tablets 100 Mg Mylan PS Mylan ORAL 200 MG QD ORAL Date:07/21/04ISR Number: 4407045-6Report Type:Expedited (15-DaCompany Report #2004S1001799 Age:41 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cervix Carcinoma Other Clozapine Tablets 100 Mg Mylan PS Mylan ORAL 400MG QD, ORAL Date:07/21/04ISR Number: 4407050-XReport Type:Expedited (15-DaCompany Report #04-07-1012 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Aspiration Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. PS Ivax Pharmaceuticals, Inc. ORAL 350-550 MG QD ORAL 22-Feb-2006 08:30 AM Page: 2784 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/21/04ISR Number: 4407051-1Report Type:Expedited (15-DaCompany Report #04-07-1008 Age:67 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine - Ivax Respiratory Disorder Professional Pharmaceuticals, Other Inc. PS Ivax Pharmaceuticals, Inc. ORAL 300 MG QD ORAL Date:07/21/04ISR Number: 4407052-3Report Type:Expedited (15-DaCompany Report #04-07-1016 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Choking Health Clozapine - Ivax Myocardial Infarction Professional Pharmaceuticals, Other Inc. PS Ivax Pharmaceuticals, Inc. ORAL ORAL Date:07/21/04ISR Number: 4407678-7Report Type:Expedited (15-DaCompany Report #2004045976 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Deafness Health Geodon (Ziprasidone) PS Other Professional Clozapine Company (Clozapine) SS Representative Date:07/22/04ISR Number: 4404431-5Report Type:Expedited (15-DaCompany Report #PHFR2004GB02489 Age:42 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Clozaril PS Novartis Sector: Initial or Prolonged Myocardial Infarction Pharma ORAL 550mg/day Other Obesity Diazepam C ORAL 15mg/day Pneumonia Danazol C ORAL 200mg/day Treatment Noncompliance Gamolenic Acid C ORAL 240mg/day Weight Increased Venlafaxine C ORAL 150mg/day Ibuprofen C ORAL 1600mg Frusemide C ORAL 40mg/day Beclomethasone Dipropionate C 2 puffs Date:07/22/04ISR Number: 4404433-9Report Type:Expedited (15-DaCompany Report #PHFR2004GB02356 Age:49 YR Gender:Male I/FU:F Outcome PT Other Aggression Agitation Body Temperature Increased Confusional State Dizziness Drug Withdrawal Syndrome Dysphagia Hyperhidrosis 22-Feb-2006 08:30 AM Page: 2785 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hypotension Malaise Muscle Rigidity Report Source Product Role Manufacturer Route Dose Duration Pain Health Clozaril PS Novartis Sector: Refusal Of Examination Professional Pharma ORAL 150mg nocte Restlessness and 125mg Salivary Hypersecretion mane Tachycardia Risperidone SS Throat Tightness Date:07/22/04ISR Number: 4404789-7Report Type:Expedited (15-DaCompany Report #PHFR2004GB02675 Age:43 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Clozaril PS Novartis Sector: Drug Level Increased Pharma UNKNOWN Myoclonus Clozaril SS Novartis Sector: Pharma ORAL 725mg/day 30240MIN Clozaril SS Novartis Sector: Pharma ORAL 700mg/day 12960MIN Clozaril SS Novartis Sector: Pharma ORAL 675mg/day Valproate Sodium SS ORAL 600 mg, BID Sulpiride C 600mg/day Citalopram C 40mg/day Folic Acid C ORAL 5mg/day Atorvastatin C ORAL Date:07/22/04ISR Number: 4407707-0Report Type:Expedited (15-DaCompany Report #04-07-1006 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Withdrawal Syndrome Health Clozapine Tablets - Initial or Prolonged Medication Error Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals,Inc. ORAL 100-900MG QD ORAL Date:07/23/04ISR Number: 4409304-XReport Type:Expedited (15-DaCompany Report #2004S1002047 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asthenia Health Clozapine Tablets 25 Fatigue Professional Mg Mylan PS Mylan ORAL 25 MG Q HS, Sleep Apnoea Syndrome Other ORAL Clozapine Tablets 100 Mg Mylan SS Mylan ORAL SEE IMAGE Lorazepam C Trazodone C Mirtazapine C Buspirone C Venlafaxine C Warfarin C 22-Feb-2006 08:30 AM Page: 2786 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/23/04ISR Number: 4409305-1Report Type:Expedited (15-DaCompany Report #2004S1002020 Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 75 MG/DAY, Other ORAL Lorazepam C Gabapentin C Carbidopa/Levodopa C Lisinopril C Atenolol C Tolcapone C Amitriptyline C Lansoprazole C Hydrocodone/Acetamin ophen C Date:07/23/04ISR Number: 4409306-3Report Type:Expedited (15-DaCompany Report #2004S1001493 Age:73 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Health Clozapine Tablets 25 Parkinson'S Disease Professional Mg Mylan PS Mylan ORAL 25 MG, QD, Pneumonia Aspiration Other ORAL Levothyroxine C Carbidopa/Levidopa C Donepezil C Venlafaxine C Date:07/23/04ISR Number: 4409341-5Report Type:Expedited (15-DaCompany Report #04-07-1042 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 12-37.5MG ORAL Date:07/26/04ISR Number: 4407458-2Report Type:Expedited (15-DaCompany Report #PHFR2003GB04137 Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aggression Clozaril PS Novartis Sector: Other Death Pharma ORAL 625mg/day Diabetes Mellitus Insulin-Dependent Date:07/26/04ISR Number: 4407848-8Report Type:Expedited (15-DaCompany Report #GB-GLAXOSMITHKLINE-B0339637A Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Nephritis Interstitial Consumer Lithium PS Glaxosmithkline UNKNOWN Therapeutic Agent Clozaril SS ORAL Toxicity Valproate Sodium C 22-Feb-2006 08:30 AM Page: 2787 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/26/04ISR Number: 4407858-0Report Type:Expedited (15-DaCompany Report #PHFR2004GB02599 Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Antinuclear Antibody Clozaril PS Novartis Sector: Initial or Prolonged Positive Pharma ORAL 150mg/day 46080MIN Other Arthralgia Lithium C ORAL 1200mg/day Blood Pressure Increased Diazepam C Chest Pain Chloral Hydrate C ORAL 10mg/day Dyspnoea Lactulose C ORAL 10md/day Eosinophil Count Senna C Increased Haloperidol C Heart Rate Increased Prednisolone C 20mg/day Immunoglobulins Increased Mixed Connective Tissue Disease Pericarditis Platelet Count Increased Pleural Effusion Pyrexia White Blood Cell Count Increased Date:07/26/04ISR Number: 4407861-0Report Type:Expedited (15-DaCompany Report #PHEH2003US10714 Age:57 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiomyopathy Clozaril PS Novartis Sector: Initial or Prolonged Chest Pain Pharma ORAL 100 mg, BID Reflux Oesophagitis Plavix C Toprol Xl C Seroquel C Lipitor C Altace C Flomax "Boehringer Ingelheim" C Imdur C Lisinopril C Date:07/26/04ISR Number: 4410654-1Report Type:Expedited (15-DaCompany Report #04P-167-0267290-00 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Back Pain Foreign Valproate Sodium Initial or Prolonged Encephalopathy Health (Sodium Valproate) PS ORAL 1 GM, 2 IN 1 Neutrophil Count Professional D, ORAL Increased Lithium Carbonate SS ORAL 400 MG, 2 IN Pyelonephritis 1 D, ORAL Renal Failure Acute Clozapine SS ORAL 200 MG, 1 IN Schizophrenia 1 D, ORAL Sepsis Clonazepam C Somnolence Therapeutic Agent Toxicity Urinary Tract Infection White Blood Cell Count Increased 22-Feb-2006 08:30 AM Page: 2788 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/26/04ISR Number: 4411021-7Report Type:Expedited (15-DaCompany Report #04-07-1043 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Lung Cancer Metastatic Health Clozapine - Ivax White Blood Cell Count Professional Pharmaceuticals, Decreased Inc. PS Ivax Pharmaceuticals ORAL 300 MG QD ORAL Chemotherapy SS Date:07/26/04ISR Number: 4411027-8Report Type:Expedited (15-DaCompany Report #04-07-1055 Age:92 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aspiration Health Clozapine - Ivax Initial or Prolonged Pneumonia Professional Pharmaceuticals, Other White Blood Cell Count Other Inc. Tablets PS Ivax Pharmaceuticals ORAL 200-300MG QD Decreased ORAL White Blood Cell Count Increased Date:07/26/04ISR Number: 4411028-XReport Type:Expedited (15-DaCompany Report #04-06-0863 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blood Cholesterol Health Clozapine - Ivax Intervention to Increased Professional Pharmaceuticals, Inc Prevent Permanent Blood Triglycerides Tablets PS Ivax Pharmaceuticals ORAL 100 MG BID Impairment/Damage Increased ORAL Eosinophilia Depakote C Hyperglycaemia Mood Stability C Hyperlipidaemia Prolixin C Prolixin Decanoate C Date:07/27/04ISR Number: 4408758-2Report Type:Expedited (15-DaCompany Report #PHEH2004US07432 Age:69 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anorexia Clozaril PS Novartis Sector: Life-Threatening Dysphagia Pharma ORAL 25 mg/day Disability Dyspnoea Lithium C 600 mg/day Other Lung Neoplasm Malignant Weight Decreased Date:07/27/04ISR Number: 4408759-4Report Type:Expedited (15-DaCompany Report #PHEH2004US07276 Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accident Clozaril PS Novartis Sector: Chest Pain Pharma ORAL 400 mg/day 1825 DAY Drug Level Increased Prevacid C Drug Toxicity Albuterol C Advair C Miralax C Seroquel I Fluvoxamine I 22-Feb-2006 08:30 AM Page: 2789 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/27/04ISR Number: 4408795-8Report Type:Expedited (15-DaCompany Report #PHEH2004US06646 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Clozaril PS Novartis Sector: Medication Error Pharma ORAL UNK,UNK Date:07/27/04ISR Number: 4408891-5Report Type:Expedited (15-DaCompany Report #PHEH2004US07911 Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Colon Cancer Clozaril PS Novartis Sector: Initial or Prolonged Leukopenia Pharma ORAL 250 mg/day Pyrexia Date:07/27/04ISR Number: 4408892-7Report Type:Expedited (15-DaCompany Report #PHBS2004BR06634 Age:59 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Myocardial Ischaemia Leponex PS Novartis Sector: Initial or Prolonged Pleural Effusion Pharma ORAL 6 tablets/d Pneumonia Depakene C UNKNOWN Thoracic Cavity Drainage Hidantal C UNKNOWN Date:07/27/04ISR Number: 4408898-8Report Type:Expedited (15-DaCompany Report #PHFR2001GB03263 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Haemoglobin Abnormal Clozaril PS Novartis Sector: Initial or Prolonged Iron Deficiency Anaemia Pharma ORAL 400mg/day 3578 DAY Disability Microcytic Anaemia Lansoprazole C ORAL 250mg/day Other Oesophageal Haemorrhage Atenolol C ORAL 25mg/day Oesophagitis Ferrous Sulphate C ORAL Polyp Ensure C ORAL Renal Failure Acute Lactulose C ORAL 20ml/day Vomiting Date:07/27/04ISR Number: 4408903-9Report Type:Expedited (15-DaCompany Report #PHBS2004BR07756 Age:51 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Arthropathy Leponex PS Novartis Sector: Hypertension Pharma ORAL 300 mg/d Thrombosis Leponex SS Novartis Sector: Venous Insufficiency Pharma ORAL 500 mg/d Weight Increased Geodon C Folic Acid C ORAL Valproic Acid C ORAL 2000 mg/d Exelon C ORAL 6 mg, BID Haloperidol C UNKNOWN Date:07/27/04ISR Number: 4409873-XReport Type:Expedited (15-DaCompany Report #04-07-1054 Age:77 YR Gender:Female I/FU:I Outcome PT Death Breast Cancer Gastrointestinal 22-Feb-2006 08:30 AM Page: 2790 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Haemorrhage Report Source Product Role Manufacturer Route Dose Duration Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals ORAL 25-300MG QD ORAL Date:07/28/04ISR Number: 4409586-4Report Type:Expedited (15-DaCompany Report #PHBS2004CA09692 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Upper Clozaril PS Novartis Sector: Initial or Prolonged Asthenia Pharma ORAL Depression Clozapine SS ORAL 275 mg/d Dizziness Puffer C UNKNOWN Gallbladder Disorder Hepatomegaly Hot Flush Myalgia Syncope Tremor Date:07/28/04ISR Number: 4412929-9Report Type:Expedited (15-DaCompany Report #2004S1002104 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Other Clozapine Tablets 100 Mg Mylan PS Mylan ORAL 50MG Q AM, 100MG 2PM , 250MG Q HS, ORAL Senna C Vitamins C Divalproex Sodium C Lorazepam 0.5 Mg C Date:07/28/04ISR Number: 4412930-5Report Type:Expedited (15-DaCompany Report #2004S1002095 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neoplasm Malignant Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 700MG Q HS Other ORAL Lorazepam C Fentanyl C Oxycodone C Hydrocodone/Acetamin ophen C Bupropion Sr C Albuterol, Fluticasone C Levothyroxine C Lactulose C Lansoprazole C 22-Feb-2006 08:30 AM Page: 2791 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/28/04ISR Number: 4413585-6Report Type:Expedited (15-DaCompany Report #DSA_24667_2004 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Upper Foreign Ativan PS Multiple Drug Overdose Health Ativan SS ORAL DF Q DAY PO Somnolence Professional Alcohol SS DF DAILY Other Clozaril SS ORAL 2000 MG ONCE PO Clozaril SS ORAL 300 MG Q DAY PO Fluoxetine SS Hyoscine SS ORAL 25 TAB ONCE PO Hyoscine SS ORAL DF Q DAY PO Procyclidine SS ORAL DF DAILY PO Procyclidine SS Date:07/29/04ISR Number: 4411085-0Report Type:Expedited (15-DaCompany Report #PHFR2003GB03655 Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Clozaril PS Novartis Sector: Diabetes Mellitus Pharma 300 mg/day Hyperglycaemia Clozaril SS Novartis Sector: Pharma ORAL 650mg/day Chlorpromazine C UNK, PRN Valproate Sodium C ORAL 500 mg, BID Propranolol C UNKNOWN 10 mg, BID Ranitidine C UNKNOWN 150 mg, BID Date:07/29/04ISR Number: 4443960-5Report Type:Periodic Company Report #US-JNJFOC-20030705539 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Health Risperdal Initial or Prolonged Syndrome Professional (Risperidone) Psychotic Disorder Tablets PS 3-9 MG DAILY Clozapine (Clozapine) SS 25 MG, 1 IN 1 DAY Cognentin (Benzatropine Mesilate) C Stelazine (Trifluoperazine Hydrochloride) C Lithium (Lithium) C Date:07/30/04ISR Number: 4412847-6Report Type:Direct Company Report #CTU 223915 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accident Clozaril PS 600 MG QHS Dyspnoea Benadryl SS 50 MG QHS Therapeutic Agent Toxicity 22-Feb-2006 08:30 AM Page: 2792 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/30/04ISR Number: 4414963-1Report Type:Expedited (15-DaCompany Report #04-07-1056 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatitis B Health Clozapine - Ivax Professional Pharmaceuticals, Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 150-1200MG QD ORAL Date:07/30/04ISR Number: 4416040-2Report Type:Expedited (15-DaCompany Report #2004048797 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acute Psychosis Health Dilantin Suspension Initial or Prolonged White Blood Cell Count Professional (Phenytoin Sodium) PS 300 MG (100 Other Decreased MG, 3 IN 1 D) Clozapine (Clozapine) SS ORAL 600 MG (600 MG, 1 IN 1 D), ORAL Clozapine (Clozapine) SS Date:08/02/04ISR Number: 4412920-2Report Type:Expedited (15-DaCompany Report #PHNU2004DE02598 Age:18 YR Gender:Male I/FU:I Outcome PT Hospitalization - Abdominal Pain Upper Initial or Prolonged Alanine Aminotransferase Increased Anaemia Aspartate Aminotransferase Increased Blood Amylase Increased Blood Bilirubin Increased Blood Glucose Increased Blood Potassium Increased Blood Pressure Increased Blood Thyroid Stimulating Hormone Increased C-Reactive Protein Increased Cold Sweat Diabetes Mellitus Drug Interaction Feeling Abnormal Haematocrit Decreased Haemoglobin Decreased Hepatic Enzyme Increased Hypothyroidism Leukocytosis Lipase Increased Lipids Increased Pancreatitis Tachycardia Tachypnoea Thrombosis 22-Feb-2006 08:30 AM Page: 2793 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Vomiting Whole Blood Transfusion Report Source Product Role Manufacturer Route Dose Duration Health Leponex / Clozaril Professional (Clozapine) PS Novartis Sector: Pharma ORAL 200 mg/day Solian SS ORAL 300 mg/day Date:08/02/04ISR Number: 4412921-4Report Type:Expedited (15-DaCompany Report #PHFR2004GB02687 Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Health Clozaril PS Novartis Sector: Increased Professional Pharma ORAL 125 mg/day Blood Bilirubin Increased Lithium C ORAL 100 mg, BIW Blood Triglycerides Omacor C 5 Caps/day Increased Disease Progression Hepatic Steatosis Hyperlipidaemia Lipids Abnormal Liver Function Test Abnormal Date:08/02/04ISR Number: 4413050-6Report Type:Expedited (15-DaCompany Report #PHFR2004GB02903 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Circulatory Collapse Clozaril PS Novartis Sector: Hypotension Pharma ORAL 100 mg in Medication Error error Date:08/02/04ISR Number: 4413244-XReport Type:Expedited (15-DaCompany Report #PHFR2004IE02946 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Clozaril PS Novartis Sector: Initial or Prolonged Circulatory Collapse Pharma ORAL 275mg/day Other Hemiparesis Lipostat C ORAL 40mg/day Insulin C Venlafaxine C ORAL 150mg/day Lantus C SUBCUTANEOUS 40iu/day Novorapid C SUBCUTANEOUS Date:08/02/04ISR Number: 4413249-9Report Type:Expedited (15-DaCompany Report #PHBS2004CH09719 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depressed Level Of Leponex PS Novartis Sector: Initial or Prolonged Consciousness Pharma UNKNOWN 100 mg, Medication Error ONCE/SINGLE Somnolence 22-Feb-2006 08:30 AM Page: 2794 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/02/04ISR Number: 4413250-5Report Type:Expedited (15-DaCompany Report #PHRM2004FR02410 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Glaucoma Leponex PS Novartis Sector: Initial or Prolonged Pharma Date:08/02/04ISR Number: 4413253-0Report Type:Expedited (15-DaCompany Report #PHBS2004BR08582 Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Infection Leponex PS Novartis Sector: Initial or Prolonged Ocular Discomfort Pharma ORAL 150 mg, BID Optic Nerve Disorder Rivotril C ORAL 2 mg/d Sinusitis Ranitidine C ORAL 150 mg/d Propranolol C ORAL 1 tablet/d Date:08/02/04ISR Number: 4413257-8Report Type:Expedited (15-DaCompany Report #PHBS2003BR09811 Age:27 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Leponex PS Novartis Sector: Confusional State Pharma ORAL 600 mg/day 183 DAY Constipation Leponex SS Novartis Sector: Difficulty In Walking Pharma ORAL 100 mg, BID Drug Interaction Paroxetine SS ORAL 20 mg, QD Fatigue Lorazepam C UNKNOWN 1 mg, QOD Gastritis Tryptanol C 25 mg, QD Hypersomnia Wellbutrin C ORAL 150 mg, QD Increased Appetite Irritability Nightmare Physical Disability Pollakiuria Rash Salivary Hypersecretion Somnolence Weight Increased Date:08/02/04ISR Number: 4415093-5Report Type:Expedited (15-DaCompany Report #04-07-1086 Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Brain Neoplasm Health Clozapine - Ivax Initial or Prolonged Professional Pharmacetuicals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 75-40MG QD ORAL Date:08/02/04ISR Number: 4415203-XReport Type:Expedited (15-DaCompany Report #04-07-1078 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Brain Cancer Metastatic Health Clozapine - Ivax Hepatic Cancer Metastatic Professional Pharmaceuticals, Lung Cancer Metastatic Other Inc. Tablets PS Ivax Pharmaceuticals, 22-Feb-2006 08:30 AM Page: 2795 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Inc. ORAL 150MG QD ORAL Date:08/02/04ISR Number: 4415205-3Report Type:Expedited (15-DaCompany Report #04-07-1074 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Brain Neoplasm Health Clozapine - Ivax Neoplasm Malignant Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 700MG QD ORAL Date:08/03/04ISR Number: 4413879-4Report Type:Expedited (15-DaCompany Report #GB/00/00598/LEX Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Liver Function Test Clozaril (Clozapine) PS Novartis Sector: Hospitalization - Abnormal Pharma ORAL 12xClozaril Initial or Prolonged Loss Of Consciousness tablets Overdose (overdose) Peroneal Nerve Palsy Clozaril (Clozapine) SS Novartis Sector: Rhabdomyolysis Pharma ORAL 600mg/day Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL 40x100mg tablets Valproate Sodium SS Anti-Parkinson Agents C Date:08/03/04ISR Number: 4414272-0Report Type:Expedited (15-DaCompany Report #PHEH2004US08289 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Clozaril PS Novartis Sector: Pharma ORAL UNK, UNK Detrol SS Date:08/03/04ISR Number: 4414273-2Report Type:Expedited (15-DaCompany Report #PHFR2004IE02730 Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Clozaril PS Novartis Sector: Initial or Prolonged Pericardial Effusion Pharma ORAL UNK, UNK 963 DAY Pericardial Rub Risperidone C ORAL 3 mg, BID Pericarditis Cipramil C ORAL 50 mg/day Weight Increased Kemadrin C ORAL 5 mg, BID Epilim C ORAL 200 mg, BID Date:08/04/04ISR Number: 4414993-XReport Type:Expedited (15-DaCompany Report #PHFR2004GB02489 Age:42 YR Gender:Female I/FU:F Outcome PT Hospitalization - Cerebrovascular Accident Initial or Prolonged Medication Error Other Myocardial Infarction Obesity Pneumonia 22-Feb-2006 08:30 AM Page: 2796 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Weight Increased Report Source Product Role Manufacturer Route Dose Duration Consumer Clozaril PS Novartis Sector: Pharma ORAL 250mg mane/300mg/no cte Diazepam C ORAL 15mg/day Danazol C ORAL 200mg/day Gamolenic Acid C ORAL 240mg/day Venlafaxine C ORAL 150mg/day Ibuprofen C ORAL 1600mg Frusemide C ORAL 40mg/day Beclomethasone Dipropionate C 2 puffs Date:08/04/04ISR Number: 4414997-7Report Type:Expedited (15-DaCompany Report #PHNU2004DE02681 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Psoriasis Health Leponex / Clozaril Professional (Clozapine) PS Novartis Sector: Pharma ORAL 500 mg/day Date:08/04/04ISR Number: 4415367-8Report Type:Expedited (15-DaCompany Report #PHEH2004US08310 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Colon Cancer Clozaril PS Novartis Sector: Pharma ORAL UNK, UNK Date:08/04/04ISR Number: 4421130-4Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040706534 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Intentional Overdose Health Tylenol 3 Multiple Drug Overdose Professional (Acetaminophen/Codei Sudden Death ne) PS ORAL ORAL Clozapine (Clozapine) Tablets SS ORAL 200 MG , 3 IN 1 DAY, ORAL Diazepam (Diazepam) C Depakote (Valproate Semisodium) C Date:08/04/04ISR Number: 4450493-9Report Type:Periodic Company Report #04-46 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Autoimmune Disorder Health Clozapine Tablets, Initial or Prolonged Thrombocytopenia Professional 100 Mg PS ORAL 700 MG/DAY/ORAL 12 YR 22-Feb-2006 08:30 AM Page: 2797 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/05/04ISR Number: 4416470-9Report Type:Expedited (15-DaCompany Report #PHBS2004GR10132 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Heart Rate Increased Health Leponex PS Novartis Sector: Hypercoagulation Professional Pharma ORAL 50 mg/d Hyperhidrosis Leponex SS Novartis Sector: Leukocytosis Pharma ORAL 75 mg/d Platelet Count Increased Leponex SS Novartis Sector: Pyrexia Pharma ORAL 125 mg/d White Blood Cell Count Leponex SS Novartis Sector: Increased Pharma ORAL 150 mg/d Leponex SS Novartis Sector: Pharma ORAL 250 mg/d 7200 MIN Leponex SS Novartis Sector: Pharma ORAL 500 mg/d 18720MIN Leponex SS Novartis Sector: Pharma 400 mg/d 2880 MIN Amoxicillin C UNKNOWN 1 g, TID Date:08/05/04ISR Number: 4416482-5Report Type:Expedited (15-DaCompany Report #PHFR2004GB02186 Age:63 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiac Failure Health Clozaril PS Novartis Sector: Cough Professional Pharma ORAL 149 DAY Drug Level Increased Amisulpride C ORAL 50mg/nocte Dyspnoea Zopiclone C ORAL 7.5mg/nocte Haemoglobin Decreased Vitamin B C ORAL 1 tablet/day Lymphocyte Count Thiamine C ORAL 100 mg, QD Decreased Venlafaxine I ORAL 150 mg, QD Mobility Decreased Oedema Peripheral Sinus Tachycardia Date:08/05/04ISR Number: 4416508-9Report Type:Expedited (15-DaCompany Report #PHFR2004GB02489 Age:42 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Consumer Clozaril PS ORAL 250mg Initial or Prolonged Myocardial Infarction mane/300mg/no Other Obesity cte Pneumonia Diazepam C ORAL 15mg/day Weight Increased Danazol C ORAL 200mg/day Gamolenic Acid C ORAL 240mg/day Venlafaxine C ORAL 150mg/day Ibuprofen C ORAL 1600mg Frusemide C ORAL 40mg/day Beclomethasone Dipropionate C 2 puffs Date:08/05/04ISR Number: 4416510-7Report Type:Expedited (15-DaCompany Report #PHFR2004GB02777 Age:28 YR Gender:Female I/FU:F Outcome PT Hospitalization - Accidental Exposure Initial or Prolonged Agitation Alanine Aminotransferase Increased 22-Feb-2006 08:30 AM Page: 2798 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dystonia Hallucination, Auditory Intentional Overdose Report Source Product Role Manufacturer Route Dose Duration Self-Injurious Ideation Health Clozaril PS Novartis Sector: Suicidal Ideation Professional Pharma ORAL 1400 mg overdose Quetiapine SS Zopiclone SS Thyroxin C ORAL 50 ug/day Quetiapine C ORAL 200mg/day Ventolin /00139501/ C 2 Pufffs PRN Date:08/05/04ISR Number: 4423932-7Report Type:Expedited (15-DaCompany Report #04P-167-0267838-00 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Circulatory Collapse Foreign Valproate Sodium Intervention to Medication Error Health (Sodium Valproate) Prevent Permanent Schizophrenia Professional (Sodium Valproate) Impairment/Damage (Sodium Valproate) PS ORAL PER ORAL Clozapine SS ORAL PER ORAL Date:08/06/04ISR Number: 4416917-8Report Type:Expedited (15-DaCompany Report #PHFR2004GB00569 Age:29 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Crohn'S Disease Clozaril PS Novartis Sector: Other Diarrhoea Pharma ORAL 350mg/day 2128 DAY Diarrhoea Haemorrhagic Clozaril SS Novartis Sector: Dizziness Pharma ORAL 300mg/day Feeling Cold Haemoglobin Decreased Inflammatory Bowel Disease Malaise Vomiting Date:08/06/04ISR Number: 4416946-4Report Type:Expedited (15-DaCompany Report #PHFR2002GB03798 Age:25 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Clozaril (Clozapine) PS Novartis Sector: Initial or Prolonged Bundle Branch Block Right Pharma ORAL 475 mg/day 504 DAY Other Dilatation Atrial Myocarditis Palpitations Supraventricular Extrasystoles Supraventricular Tachycardia 22-Feb-2006 08:30 AM Page: 2799 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/06/04ISR Number: 4416949-XReport Type:Expedited (15-DaCompany Report #PHFR2004GB00569 Age:29 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Crohn'S Disease Clozaril PS Novartis Sector: Other Diarrhoea Pharma ORAL 350mg/day 2128 DAY Diarrhoea Haemorrhagic Clozaril SS Novartis Sector: Dizziness Pharma ORAL 300mg/day Feeling Cold Haemoglobin Decreased Inflammatory Bowel Disease Malaise Vomiting Date:08/06/04ISR Number: 4418102-2Report Type:Direct Company Report #CTU 224389 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Ineffective Clozaril PS Pharmaceutical Product Complaint Date:08/06/04ISR Number: 4419184-4Report Type:Direct Company Report #CTU 224456 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Clozapine 25mg Initial or Prolonged Phosphokinase Increased (Mylan) PS Mylan ORAL 500 MG PO/DAY Required Confusional State TAPERED TO 25 Intervention to Constipation MG PO/DAY Prevent Permanent Ileus Haloperidol 10 Mg SS ORAL PO 20 MG/D Impairment/Damage Liver Function Test Clozapine C Abnormal Magnesium Hydroxide Neuroleptic Malignant (Milk Of Magnesia) C Syndrome Docusate/Senna C Pneumonia Aspiration Lovastatin C Urinary Tract Infection Ferrous Sulfate C Sorbitol C Albuterol Inhaler C Terazosin C Ranitidine C Clonazepam C Date:08/06/04ISR Number: 4422138-5Report Type:Expedited (15-DaCompany Report #C04-C-115 Age:28 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Therapeutic Agent Health Clozapine Tablets - Initial or Prolonged Toxicity Professional Ivax Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 400MG BID ORAL Lithium Carbonate - Able Laboratories SS Able Laboratories 300MG TID Zantac C Haloperidol C 22-Feb-2006 08:30 AM Page: 2800 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Haloperidol C Geodon C Geodon C Ativan C Ativan C Date:08/06/04ISR Number: 4423344-6Report Type:Expedited (15-DaCompany Report #04-07-1097 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Health Clozapine - Ivax Myocardial Infarction Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 200-250MG QD ORAL Date:08/06/04ISR Number: 4423346-XReport Type:Expedited (15-DaCompany Report #04-07-0955 Age:86 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Health Clozapine - Ivax Initial or Prolonged Congestive Professional Pharmaceuticals, Coronary Artery Disease Other Inc. Tablets PS Ivax Diabetes Mellitus Pharmaceuticals, Hypertension Inc. ORAL 50MG QD ORAL Osteomyelitis Respiratory Tract Congestion Vomiting Date:08/06/04ISR Number: 4423347-1Report Type:Expedited (15-DaCompany Report #04-05-0742 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 100 MG QAM ORAL Glyburide C Levoxyl C Date:08/06/04ISR Number: 4423350-1Report Type:Expedited (15-DaCompany Report #04-03-0311 Age:60 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Cancer Metastatic Health Clozapine - Ivax Life-Threatening Lung Squamous Cell Professional Pharmaceuticals, Hospitalization - Carcinoma Stage Inc. Tablets PS Ivax Initial or Prolonged Unspecified Pharmaceuticals, Disability Inc. ORAL 700-750MG QD Other ORAL Zyprexa C Zoloft C Klonopin C 22-Feb-2006 08:30 AM Page: 2801 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/06/04ISR Number: 4423358-6Report Type:Expedited (15-DaCompany Report #04-08-1115 Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Barium Swallow Abnormal Foreign Clozapine Tablets PS ORAL 200-375MG QD Initial or Prolonged Choking Literature ORAL 10 YR Circulatory Collapse Health Clomipramine SS 75-200MG QD Dyskinesia Professional Dysphagia Gastrooesophageal Sphincter Insufficiency Hiccups Oesophageal Dilatation Oesophageal Disorder Pneumonia Aspiration Regurgitation Of Food Respiratory Distress Date:08/06/04ISR Number: 4423407-5Report Type:Expedited (15-DaCompany Report #2004S1001913 Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cholecystectomy Health Clozapine Tablets Post Procedural Professional 100 Mg Mylan PS Mylan ORAL 100MG QAM, Complication Other 350MG Q HS Thrombosis ORAL Risperidone C Multivitamin C Date:08/06/04ISR Number: 4423420-8Report Type:Expedited (15-DaCompany Report #2004S1001925 Age:78 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 75MG Q HS Other ORAL Date:08/06/04ISR Number: 4423423-3Report Type:Expedited (15-DaCompany Report #04P-167-0268578-00 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Foreign Hytrin (Terazosin Initial or Prolonged Health Hydrochloride) Professional (Terazosin Company Hydrochloride) PS ORAL 2 MG, 1 IN 1 Representative D, PER ORAL Clozapine SS ORAL 900 MG, 1 IN 1 D, PER ORAL Date:08/06/04ISR Number: 4423425-7Report Type:Expedited (15-DaCompany Report #2004S1002144 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 50MG Q HS, Other ORAL 22-Feb-2006 08:30 AM Page: 2802 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/06/04ISR Number: 4423433-6Report Type:Expedited (15-DaCompany Report #2004S1002145 Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bone Marrow Depression Health Clozapine Tablets Cerebral Haemorrhage Professional 100 Mg Mylan PS Mylan ORAL 100MG TID, Coma Other ORAL Lamotrigine C Antibiotic C Date:08/06/04ISR Number: 4423444-0Report Type:Expedited (15-DaCompany Report #2004S1002177 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 50MG BID, Other ORAL Mirtazapine C Risperidone C Lorazepam C Temazepam C Carbamazepine C Divalproex Sodium C Clonazepam C Ziprasidone C Date:08/09/04ISR Number: 4419517-9Report Type:Periodic Company Report #03-12-1604 Age:73 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Disorientation Paxil PS Glaxosmithkline ORAL 20MG Unknown 55 DAY Initial or Prolonged Fall Stalevo SS ORAL Nausea Amitriptyline SS ORAL 23 DAY Pneumonia Aspiration Clozaril SS ORAL 3 MON Vomiting Amitriptyline C ORAL 33 DAY Date:08/09/04ISR Number: 4421038-4Report Type:Expedited (15-DaCompany Report #PHFR2004GB00916 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Body Temperature Clozaril PS Novartis Sector: Initial or Prolonged Increased Pharma ORAL 350mg/day Other Influenza Like Illness Omeprazole C ORAL 20mg/day Lower Respiratory Tract Hyoscine C ORAL 300-600 Infection ug/day Mass Valproate Sodium C ORAL 800mg/day Neutrophil Count Paroxetine C UNKNOWN 30mg/day Increased Platelet Count Increased Pneumonia Respiratory Tract Infection White Blood Cell Count Increased 22-Feb-2006 08:30 AM Page: 2803 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/09/04ISR Number: 4421041-4Report Type:Expedited (15-DaCompany Report #PHEH2004US08286 Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Cancer Clozaril PS Novartis Sector: Leukopenia Pharma ORAL 600 mg/day Date:08/09/04ISR Number: 4421212-7Report Type:Expedited (15-DaCompany Report #PHHO2004CA10973 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Level Increased Clozaril PS Novartis Sector: Pharma ORAL Dose reduced repeatedly Date:08/09/04ISR Number: 4421219-XReport Type:Expedited (15-DaCompany Report #PHBS2004CA10402 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Clozaril PS Novartis Sector: Initial or Prolonged Antipsychotic Drug Level Pharma ORAL 450 mg/d Other Above Therapeutic Clozaril SS Novartis Sector: Colitis Ischaemic Pharma unknown Disease Progression Celexa C 10 mg/d Enterocolitis Infectious Epival C 1375 mg/d Haemorrhage Seroquel C 350 mg/d Date:08/09/04ISR Number: 4421243-7Report Type:Expedited (15-DaCompany Report #PHEH2004US06296 Age:19 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Eosinophil Count Clozaril PS Novartis Sector: Initial or Prolonged Decreased Pharma ORAL 100 mg/day 89280MIN Hypoaesthesia Seroquel C Leukopenia Lymphadenopathy Lymphocyte Count Increased Neck Pain Neutropenia Pharyngolaryngeal Pain Pyrexia Viral Infection Date:08/10/04ISR Number: 4422208-1Report Type:Expedited (15-DaCompany Report #PHFR2004GB00916 Age:45 YR Gender:Male I/FU:F Outcome PT Hospitalization - Body Temperature Initial or Prolonged Increased Other Influenza Like Illness Lower Respiratory Tract Infection Mass Neutrophil Count Increased Platelet Count Increased Pneumonia 22-Feb-2006 08:30 AM Page: 2804 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Respiratory Tract Infection White Blood Cell Count Report Source Product Role Manufacturer Route Dose Duration Increased Health Clozaril PS Novartis Sector: Professional Pharma ORAL 350mg/day Omeprazole C ORAL 20mg/day Hyoscine C ORAL 300-600 ug/day Valproate Sodium C ORAL 800mg/day Paroxetine C UNKNOWN 30mg/day Date:08/10/04ISR Number: 4422486-9Report Type:Expedited (15-DaCompany Report #PHBS2004TW08559 Age:31 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Health Clozaril (Clozapine) PS Novartis Sector: Other Circulatory Collapse Professional Pharma ORAL 500 mg/d Respiratory Arrest Haloperidol C UNKNOWN 10 mg/d Somnolence Haloperidol C UNKNOWN 15 mg/d Ativan C UNKNOWN 1.5 mg/d Date:08/10/04ISR Number: 4422491-2Report Type:Expedited (15-DaCompany Report #PHBS2004FR10490 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Clozapine PS Novartis Sector: Congestive Cardiomyopathy Pharma UNKNOWN 300 mg/d Sudden Death Clorazepate SS 50 mg/d Nitrazepam SS 10 mg/d Date:08/10/04ISR Number: 4422989-7Report Type:Expedited (15-DaCompany Report #2004S1002212 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hepatic Trauma Health Clozapine Tablets Victim Of Crime Professional 100 Mg Mylan PS Mylan ORAL 300MG Q HS, Other ORAL Rofecoxib C Lorazepam C Benztropine C Tolterodine La C Lithium C Fluphenazine Injection C Date:08/10/04ISR Number: 4422990-3Report Type:Expedited (15-DaCompany Report #2004S1002207 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 750MG/DAY, Other ORAL 22-Feb-2006 08:30 AM Page: 2805 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/10/04ISR Number: 4423000-4Report Type:Expedited (15-DaCompany Report #2004S1001799 Age:41 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cervix Carcinoma Other Clozapine Tablets 100 Mg Mylan PS Mylan ORAL 400MG QD, ORAL Date:08/10/04ISR Number: 4423005-3Report Type:Expedited (15-DaCompany Report #2004S1001785 Age:77 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Confusional State Health Clozapine Tablets 25 Movement Disorder Professional Mg Mylan PS Mylan ORAL 50MG QD, ORAL Other Donepezil C Midodrine C Sertaline C Clopidogrel Bisulfate C Carbidopa / Levodopa C Quetiapine C Date:08/11/04ISR Number: 4423052-1Report Type:Expedited (15-DaCompany Report #PHFR2004GB02903 Age:31 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Circulatory Collapse Health Clozaril PS Novartis Sector: Hypotension Professional Pharma ORAL 100 mg in Medication Error error Pallor Tachycardia Date:08/11/04ISR Number: 4423411-7Report Type:Expedited (15-DaCompany Report #PHFR2004GB02388 Age:20 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Exposure Health Clozaril PS Novartis Sector: Initial or Prolonged Blood Pressure Increased Professional Pharma ORAL 150mg/ in Other Heart Rate Increased error 1440 MIN Lethargy Paroxetine C ORAL 20mg/day Overdose Olanzapine C ORAL 10mg/day Sedation Somnolence Date:08/11/04ISR Number: 4423412-9Report Type:Expedited (15-DaCompany Report #PHFR2004GB03072 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Mean Cell Volume Consumer Clozaril PS Novartis Sector: Increased Pharma ORAL Date:08/11/04ISR Number: 4423414-2Report Type:Expedited (15-DaCompany Report #PHEH2004US08509 Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mental Status Changes Clozaril PS Novartis Sector: Initial or Prolonged Pancreatic Disorder Pharma ORAL 550 mg/day 22-Feb-2006 08:30 AM Page: 2806 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/11/04ISR Number: 4423427-0Report Type:Expedited (15-DaCompany Report #PHHO2004CA08747 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Hepatitis C Clozaril (Clozapine) PS Novartis Sector: Neutropenia Pharma ORAL 179 DAY Interferon C Isotretinoin C Unk Topiramate C Unk Disulfiram C Unk Mirtazapine C Unk Ribavirin C Unk Date:08/11/04ISR Number: 4425847-7Report Type:Expedited (15-DaCompany Report #04-07-1074 Age:43 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Brain Neoplasm Health Clozapine - Ivax Other Neoplasm Malignant Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 700MG QD ORAL Date:08/12/04ISR Number: 4424149-2Report Type:Expedited (15-DaCompany Report #PHNR2004AU01314 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Cerebral Haemorrhage Clozaril PS Novartis Sector: Other Neonatal Pharma TRANSPLACENTAL Congenital Foot Epilim SS TRANSPLACENTAL Malformation Zyprexa SS TRANSPLACENTAL Convulsion Zuclopenthixol Drug Exposure During Decanoate C TRANSPLACENTAL Pregnancy Hepatosplenomegaly Neonatal Hyperammonaemia Hyperbilirubinaemia Hypoxia Liver Disorder Neonatal Apnoeic Attack Vomiting Weight Decrease Neonatal Date:08/12/04ISR Number: 4424150-9Report Type:Expedited (15-DaCompany Report #PHFR2004IE01212 Age:22 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Clozaril PS Novartis Sector: Initial or Prolonged Diabetes Mellitus Pharma ORAL 250mg/day Other Enuresis Lustral C ORAL 100mg/day Iron Deficiency Anaemia Kemadrin C ORAL 5 mg, BID Polydipsia Polyuria Weight Increased 22-Feb-2006 08:30 AM Page: 2807 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/12/04ISR Number: 4424157-1Report Type:Expedited (15-DaCompany Report #PHFR2004GB02097 Age:36 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Cholesterol Clozaril PS Novartis Sector: Increased Pharma ORAL Blood Glucose Increased Clozaril SS Novartis Sector: Diabetes Mellitus Pharma ORAL 300mg/day Hypertriglyceridaemia Metformin C UNKNOWN Lipids Increased Fish Oil C UNKNOWN Date:08/12/04ISR Number: 4425964-1Report Type:Expedited (15-DaCompany Report #04-08-1127 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 425-925MG QD ORAL Date:08/12/04ISR Number: 4425966-5Report Type:Expedited (15-DaCompany Report #04-08-1137 Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 112-5-125MG Q ORAL Date:08/12/04ISR Number: 4425968-9Report Type:Expedited (15-DaCompany Report #04-08-1138 Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Acute Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 350-475MG QD ORAL Date:08/12/04ISR Number: 4425970-7Report Type:Expedited (15-DaCompany Report #04-08-1144 Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozapine Tablets, Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 125-800MG QD ORAL 22-Feb-2006 08:30 AM Page: 2808 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/12/04ISR Number: 4425979-3Report Type:Expedited (15-DaCompany Report #2004S1002223 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 200MG BID, Other ORAL Quetiapine C Divalproex Sodium C Lorazepam C Rosiglitazone C Metoprolol C Glipizide C Date:08/12/04ISR Number: 4425982-3Report Type:Expedited (15-DaCompany Report #2004S1002225 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Clozapine Tablets 25 Drowning Professional Mg Mylan PS Mylan ORAL 50MG, BID, Other ORAL Clozapine Tablets 100mg Mylan SS Mylan ORAL 100MG Q HS, ORAL Lamotrigine C Mirtazapine C Date:08/12/04ISR Number: 4426619-XReport Type:Direct Company Report #CTU 224872 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiogenic Shock Clozapine PS ORAL 200MG PO IN Cardiomyopathy THE AM PO 400 Ischaemic Hepatitis MG PO Q PM Myocarditis Seroquel C Renal Failure Lithium C Ventricular Tachycardia Ddavp C Date:08/13/04ISR Number: 4425142-6Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040801529 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Clozaril PS OROPHARINGEAL Stress Trazodone C UNKNOWN Tachycardia Procyclidine C UNKNOWN Risperdal I OROPHARINGEAL Date:08/13/04ISR Number: 4425153-0Report Type:Expedited (15-DaCompany Report #PHNR2004AU01320 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Clozaril (Clozapine) PS Novartis Sector: Salivary Hypersecretion Pharma 0 - 250 Sleep Apnoea Syndrome mg/day 1699 DAY Weight Increased 22-Feb-2006 08:30 AM Page: 2809 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/13/04ISR Number: 4425154-2Report Type:Expedited (15-DaCompany Report #PHFR2001GB01091 Age:31 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abortion Spontaneous Clozaril PS Novartis Sector: Drug Exposure During Pharma ORAL 500 mg/day Pregnancy Folic Acid C ORAL 5mg/day Pregnancy Date:08/13/04ISR Number: 4425155-4Report Type:Expedited (15-DaCompany Report #PHFR2002GB03624 Age:33 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Health Clozaril PS Novartis Sector: Initial or Prolonged Increased Professional Pharma ORAL 450 mg/day Disability Blood Amylase Increased Lipostat C ORAL 20 mg/day Other Blood Creatinine Fenofibrate C ORAL 267 mg/day Decreased Irbesartan C ORAL 150 mg/day Hypertriglyceridaemia Neurontin C ORAL 20 mg/day Pancreatitis Insulin C Date:08/13/04ISR Number: 4425157-8Report Type:Expedited (15-DaCompany Report #PHBS2001CA01813 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Clozaril (Clozapine) PS Novartis Sector: Hospitalization - Cellulitis Pharma ORAL 500 mg/d Initial or Prolonged Leukopenia Haldol C ORAL 1 mg, QHS Other Neutropenia Quetiapine C 400 mg/d 138 DAY Pyrexia Date:08/13/04ISR Number: 4428430-2Report Type:Expedited (15-DaCompany Report #04P-167-0268683-00 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Drug Interaction Foreign Valproate Sodium Intervention to Drug Level Increased Health (Sodium Prevent Permanent Myoclonus Professional Valproate)(Sodium Impairment/Damage Valproate)(Sodium Valproate) PS Clozapine (Clozapine) SS Sulpiride C Date:08/13/04ISR Number: 4428593-9Report Type:Expedited (15-DaCompany Report #2004AP03980 Age:23 YR Gender:Male I/FU:I Outcome PT Hospitalization - Dilatation Atrial Initial or Prolonged Headache Hepatitis C Positive Mitral Valve Incompetence Myocarditis Pyrexia Red Blood Cell Sedimentation Rate Increased Tachycardia 22-Feb-2006 08:30 AM Page: 2810 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Troponin Increased Virus Serology Test Positive Report Source Product Role Manufacturer Route Dose Duration Foreign Seroquel PS ORAL 1 DAILY PO Health Clozaril SS ORAL 125 MG DAILY Professional PO Other Date:08/16/04ISR Number: 4428405-3Report Type:Expedited (15-DaCompany Report #04-08-1153 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Gallbladder Disorder Health Clozapine - Ivax Initial or Prolonged Pancreatitis Professional Pharmaceuticals, Other White Blood Cell Count Other Inc. Tablets PS Ivax Decreased Pharmaceuticals, Inc. ORAL 50-100MG QD ORAL Depakote SS Date:08/16/04ISR Number: 4429384-5Report Type:Expedited (15-DaCompany Report #2004053302 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Foreign Lipitor Rhabdomyolysis Health (Atorvastatin) PS ORAL ORAL Professional Clozapine (Clozapine) (Clozapine) SS 560 MG (560 MG, 1 IN 1 D) Date:08/16/04ISR Number: 4429694-1Report Type:Expedited (15-DaCompany Report #2004053311 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Foreign Lipitor Rhabdomyolysis Health (Atorvastatin) PS ORAL 10 MG (10 MG Professional ) ORAL Clozapine (Clozapine) (Clozapine) SS ORAL 125 MG (125 MG, 1 IN 1 D), ORAL Furosemide (Furosemide) C Levothyroxine Sodium (Levothyroxine Sodium) C Date:08/17/04ISR Number: 4427795-5Report Type:Expedited (15-DaCompany Report #PHEH2004US08830 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Neoplasm Malignant Clozaril PS Novartis Sector: Hospitalization - Pneumonia Pharma ORAL 350 mg, QD Initial or Prolonged 22-Feb-2006 08:30 AM Page: 2811 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/17/04ISR Number: 4427802-XReport Type:Expedited (15-DaCompany Report #PHFR2004IE02073 Age:49 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bacillus Infection Clozaril PS Novartis Sector: Bilirubin Urine Pharma ORAL 675mg/day Blood Bilirubin Increased Augmentin C Blood Creatinine Increased Blood Glucose Increased Blood Urea Increased Dehydration Diabetes Mellitus Dysuria Glucose Urine Present Haematuria Heart Rate Increased Malaise Pallor Protein Urine Present Pyrexia Tachycardia Urinary Tract Infection Urine Abnormality Urobilin Urine Present Vomiting White Blood Cell Count Increased Date:08/17/04ISR Number: 4431067-2Report Type:Expedited (15-DaCompany Report #2004UW16160 Age:40 YR Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Colitis Ischaemic Foreign Seroquel PS ORAL 450 MG QD PO Intervention to Haematochezia Health Seroquel SS ORAL 600 MG QD PO Prevent Permanent Professional Clozapine SS 720 NMOL/L Impairment/Damage Other Clozaril C Celexa C Epival C Date:08/18/04ISR Number: 4428416-8Report Type:Expedited (15-DaCompany Report #PHFR2004GB02947 Age:55 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Limb Discomfort Clozaril PS Novartis Sector: Initial or Prolonged Overdose Pharma ORAL 2.8g/overdose Periorbital Haematoma Clozaril SS Novartis Sector: Somnolence Pharma ORAL 200 mg, BID Clozaril SS Novartis Sector: Pharma ORAL 3-4 days supply of 200mg/bd Venlafaxine SS UNKNOWN 22-Feb-2006 08:30 AM Page: 2812 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/18/04ISR Number: 4428417-XReport Type:Expedited (15-DaCompany Report #GB/00/00598/LEX Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Circulatory Collapse Health Clozaril (Clozapine) PS Novartis Sector: Hospitalization - Hemiparesis Professional Pharma ORAL 12xClozaril Initial or Prolonged Liver Function Test tablets Abnormal (overdose) Loss Of Consciousness Clozaril (Clozapine) SS Novartis Sector: Overdose Pharma ORAL 600mg/day Peroneal Nerve Palsy Clozaril (Clozapine) SS Novartis Sector: Rhabdomyolysis Pharma ORAL 40x100mg tablets Valproate Sodium SS Anti-Parkinson Agents C Date:08/18/04ISR Number: 4428422-3Report Type:Expedited (15-DaCompany Report #PHFR2003GB04418 Age:56 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bundle Branch Block Right Clozaril PS Novartis Sector: Dizziness Pharma ORAL 350 mg/day Electrocardiogram Clozaril SS Novartis Sector: Abnormal Pharma ORAL 400 mg/day Eosinophil Count Clozaril SS Novartis Sector: Increased Pharma ORAL 250mg/day Qrs Axis Abnormal Salbutamol C 2 puffs/day Sinus Tachycardia Bricanyl C 2 puffs Ferrous Sulphate C ORAL Lorazepam C ORAL 2mg PRN Folic Acid C ORAL 5mg/day Date:08/18/04ISR Number: 4429995-7Report Type:Expedited (15-DaCompany Report #2004S1002306 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 300MG BID, Other ORAL Haloperidol C Hexavitamin C Lamotrigine C Lansoprazole C Date:08/18/04ISR Number: 4429998-2Report Type:Expedited (15-DaCompany Report #2004S1002312 Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional 100mg Mylan PS Mylan ORAL 100MG/DAY Other ORAL 22-Feb-2006 08:30 AM Page: 2813 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/18/04ISR Number: 4430230-4Report Type:Expedited (15-DaCompany Report #04-08-1168 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neoplasm Malignant Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 450MG QD ORAL Date:08/18/04ISR Number: 4430232-8Report Type:Expedited (15-DaCompany Report #04-07-1074 Age:43 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Glioblastoma Health Clozapine Tablets - Other Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 400MG HS ORAL Ativan C Ambien C Phenergan C Senna C Fentanyl C Risperdal C Lortab C Decadron C Dilantin C Date:08/18/04ISR Number: 4430233-XReport Type:Expedited (15-DaCompany Report #04-08-1172 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Upper Health Clozapine Tablets - Initial or Prolonged Abnormal Behaviour Professional Ivax Foreign Body Trauma Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 400MG QD ORAL Date:08/18/04ISR Number: 4430234-1Report Type:Expedited (15-DaCompany Report #04-08-1167 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Uterine Cancer Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 750-900MG QD ORAL 22-Feb-2006 08:30 AM Page: 2814 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/18/04ISR Number: 4430235-3Report Type:Expedited (15-DaCompany Report #04-07-0973 Age:67 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delusion Health Clozapine Tablets - Initial or Prolonged Dementia Professional Ivax Depressive Delusion Other Pharmaceuticals, Paranoia Inc. PS Ivax Urinary Tract Infection Pharmaceuticals, Inc. ORAL 50MG BID ORAL; 200MG QHS ORAL Date:08/18/04ISR Number: 4431040-4Report Type:Expedited (15-DaCompany Report #2004S1002316 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 100MG BID, Other ORAL Morphine Sulfate C Metronidazole C Potassium Chloride C Lorazepam C Memantine C Ventafaxine C Donepezil C Mirtazapine C Pantoprazole C Calcium Carbonate C Date:08/18/04ISR Number: 4431051-9Report Type:Expedited (15-DaCompany Report #2004S1002310 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 300MG Q HS, Other ORAL Rofecoxib C Benztropine Mesylate C Ciprofloxacin C Risperdal C Trazodone C Atorvastatin C Albuterol/Ipratropiu m C Date:08/19/04ISR Number: 4429309-2Report Type:Expedited (15-DaCompany Report #PHFR2004GB01955 Age:77 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Health Clozaril PS Novartis Sector: Haemoglobin Decreased Professional Pharma ORAL 22-Feb-2006 08:30 AM Page: 2815 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/19/04ISR Number: 4429312-2Report Type:Expedited (15-DaCompany Report #PHFR2004GB00559 Age:39 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cerebrovascular Accident Clozaril PS Novartis Sector: Hypotension Pharma ORAL Superior Sagittal Sinus Thrombosis Date:08/19/04ISR Number: 4429539-XReport Type:Expedited (15-DaCompany Report #04-05-0777 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Eskalith Cr PS Glaxosmithkline ORAL 450MG At Initial or Prolonged Neutrophil Count night Decreased Clozapine SS ORAL 300MG Per day 44 MON Date:08/19/04ISR Number: 4429618-7Report Type:Expedited (15-DaCompany Report #04-08-1183 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Test Abnormal Health Clozapine-Ivax Neoplasm Malignant Professional Pharmaceuticals, Pneumonia Other Inc. Tablets PS ORAL 450-600MG QD ORAL Date:08/19/04ISR Number: 4678805-1Report Type:Direct Company Report #CTU 239575 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Clozapine PS ORAL 100 MG PO TID Anger AND 300 MG PO Feeling Abnormal Q HS Memory Impairment Regressive Behaviour Date:08/20/04ISR Number: 4429903-9Report Type:Expedited (15-DaCompany Report #PHFR2004GB02230 Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Clozaril PS Novartis Sector: Initial or Prolonged Abdominal Pain Upper Pharma ORAL 400mg/day Haematemesis Omeprazole C Reflux Oesophagitis Ranitidine C Vomiting Date:08/20/04ISR Number: 4430168-2Report Type:Expedited (15-DaCompany Report #PHBS2004CA10402 Age:40 YR Gender:Male I/FU:F Outcome PT Hospitalization - Abdominal Pain Initial or Prolonged Antipsychotic Drug Level Other Above Therapeutic Colitis Ischaemic Constipation Disease Progression Enterocolitis Infectious 22-Feb-2006 08:30 AM Page: 2816 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Haemorrhage Rectal Haemorrhage Report Source Product Role Manufacturer Route Dose Duration Health Clozaril PS Novartis Sector: Professional Pharma ORAL 450 mg/d Clozaril SS Novartis Sector: Pharma unknown Celexa C 10 mg/d Epival C 1375 mg/d Seroquel C 450 mg/d Date:08/20/04ISR Number: 4430216-XReport Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040607460 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Sodium Decreased Health Risperdal PS OROPHARINGEAL Initial or Prolonged Delirium Professional Leponex SS OROPHARINGEAL Other Depressed Level Of Consciousness Disorientation Drug Level Below Therapeutic Grand Mal Convulsion Hyponatraemia Renal Failure Acute Rhabdomyolysis Treatment Noncompliance Urinary Incontinence Date:08/20/04ISR Number: 4432479-3Report Type:Expedited (15-DaCompany Report #2004S1002144 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Clozapine Tablets 25 Depression Professional Mg Mylan PS Mylan ORAL 50MG Q HS, Partner Stress Other ORAL Date:08/20/04ISR Number: 4432481-1Report Type:Expedited (15-DaCompany Report #2004S1002324 Age:88 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Other Clozapine Tablets Congestive 100 Mg Mylan PS Mylan ORAL 100MG QD, Chronic Obstructive ORAL Pulmonary Disease Lorazepam C Pneumonia Date:08/20/04ISR Number: 4432483-5Report Type:Expedited (15-DaCompany Report #2004S1002336 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 75MG QD,ORAL Other Clozapine Tablets 100mg Mylan SS Mylan ORAL 400MG HS, ORAL Simvastatin C 22-Feb-2006 08:30 AM Page: 2817 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Aripiprazole C Levothyroxine C Benztropine C Date:08/20/04ISR Number: 4432485-9Report Type:Expedited (15-DaCompany Report #2004S1002393 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Metastases To Liver Health Clozapine Tablets Neuroblastoma Professional 100 Mg Mylan PS Mylan ORAL 200MG QD, Other ORAL Acetaminophen W/Codeine C Date:08/20/04ISR Number: 4432492-6Report Type:Expedited (15-DaCompany Report #04-04-0604 Age:76 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine - Ivax Hospitalization - Respiratory Failure Professional Pharmaceuticals, Initial or Prolonged Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL ORAL Date:08/23/04ISR Number: 4430812-XReport Type:Expedited (15-DaCompany Report #PHBS2003CA00554 Age:27 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Clozaril PS Novartis Sector: Non-Insulin-Dependent Pharma ORAL Drug Exposure During Misoprostol C Pregnancy Nph Insulin C Hyperglycaemia Humalog C Intra-Uterine Death Date:08/23/04ISR Number: 4430815-5Report Type:Expedited (15-DaCompany Report #PHFR2004GB02489 Age:42 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Health Clozaril PS ORAL 250mg Initial or Prolonged Myocardial Infarction Professional mane/300mg/no Other Obesity cte Pneumonia Diazepam C ORAL 15mg/day Treatment Noncompliance Danazol C ORAL 200mg/day Weight Increased Gamolenic Acid C ORAL 240mg/day Venlafaxine C ORAL 150mg/day Ibuprofen C ORAL 1600mg Frusemide C ORAL 40mg/day Beclomethasone Dipropionate C 2 puffs Valproate Sodium C UNKNOWN Enoxaparin Sodium C UNKNOWN 22-Feb-2006 08:30 AM Page: 2818 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/23/04ISR Number: 4431123-9Report Type:Expedited (15-DaCompany Report #2004UW17337 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Apathy Foreign Crestor PS ORAL 10 MG PO Intervention to Drug Interaction Health Clozaril SS 250 MG Prevent Permanent Hypokinesia Professional Actonel C Impairment/Damage Other Calcium C Neurontin C Pantoloc C Synthroid C Tylenol C Vitamin D C Date:08/23/04ISR Number: 4433173-5Report Type:Expedited (15-DaCompany Report #2004054658 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aspartate Literature Lithium (Lithium) PS Initial or Prolonged Aminotransferase Health Clozapine Other Increased Professional (Clozapine) SS 500 MG 5 WK Blood Alkaline Verapamil Phosphatase Increased (Verapamil) C Blood Creatine Increased Bethanechol Blood Glucose Increased (Bethanechol) C Blood Osmolarity All Other Increased Therapeutic Products Blood Ph Decreased (All Other Blood Urea Increased Therapeutic Glucose Urine Present Products) C Stupor Therapeutic Response Decreased Urine Ketone Body Present Date:08/24/04ISR Number: 4431192-6Report Type:Expedited (15-DaCompany Report #PHHO2004CL11469 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Hypersensitivity Clozaril PS Novartis Sector: Interstitial Lung Disease Pharma 500 mg, QD Date:08/24/04ISR Number: 4431528-6Report Type:Expedited (15-DaCompany Report #PHBS2004NZ10840 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Confusional State Clozaril PS Novartis Sector: Convulsion Pharma ORAL 700 mg/d Disorientation Valproate Sodium C UNK, UNK Encephalopathy Quetiapine C 100 mg, BID Date:08/24/04ISR Number: 4433240-6Report Type:Expedited (15-DaCompany Report #04-08-1194 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neoplasm Malignant Health Clozapine PS Ivax Initial or Prolonged Professional Pharmaceuticals, Other Other Inc. ORAL 300MG QD ORAL 22-Feb-2006 08:30 AM Page: 2819 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/24/04ISR Number: 4433243-1Report Type:Expedited (15-DaCompany Report #04-08-1192 Age:73 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Foreign Body Aspiration Health Clozapine PS Ivax Hospitalization - Professional Pharmaceuticals, Initial or Prolonged Other Inc. OPHTHALMIC 100-300MG QD ORAL Date:08/24/04ISR Number: 4433245-5Report Type:Expedited (15-DaCompany Report #04-07-1117 Age:80 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Clozapine PS Ivax Professional Pharmaceuticals, Other Inc. ORAL 200-300 MG QD ORAL Date:08/24/04ISR Number: 4433247-9Report Type:Expedited (15-DaCompany Report #04-02-0298 Age:56 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Choking Health Clozapine PS Ivax Drug Toxicity Professional Pharmaceuticals, Fall Other Inc. ORAL 100MG QAM Foreign Body Aspiration ORAL YR Loss Of Consciousness Trileptal C Pulse Absent Proscar C Respiratory Arrest Florinef C Respiratory Distress Detrol C Vomiting Date:08/24/04ISR Number: 4433249-2Report Type:Expedited (15-DaCompany Report #04-08-1203 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine PS Ivax Professional Pharmaceuticals, Other Inc. ORAL 300MG QD ORAL Date:08/24/04ISR Number: 4433250-9Report Type:Expedited (15-DaCompany Report #2004S1002339 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Other Clozapine Tablets Mylan PS Mylan ORAL 50MG/DAY, ORAL Date:08/24/04ISR Number: 4433252-2Report Type:Expedited (15-DaCompany Report #2004S1002340 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acute Myocardial Health Clozapine Tablets Initial or Prolonged Infarction Professional 100 Mg Mylan PS Mylan ORAL 400MG QD, Other ORAL 12 MON Glyburide/Metformin C Simvastatin C 22-Feb-2006 08:30 AM Page: 2820 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Aspirin C Escitalopram C Trandolapril C Date:08/24/04ISR Number: 4433466-1Report Type:Expedited (15-DaCompany Report #S04-GER-00153-01 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Foreign Cipramil (Citalopram Hospitalization - Anxiety Health Hydrobromide) PS ORAL 40 MG QD PO Initial or Prolonged Cough Professional Clozapine SS ORAL 450 MG QD PO Delusion Other Olanzapine C Dental Caries Clozapine C Depression Risperidone C Drug Effect Decreased Leukopenia Pyrexia Weight Increased Date:08/25/04ISR Number: 4432044-8Report Type:Expedited (15-DaCompany Report #PHBS2004NZ10728 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Clozaril PS Novartis Sector: Initial or Prolonged Drug Level Increased Pharma ORAL 400 mg/d Fall Venlafaxine SS Joint Dislocation Paroxetine C Date:08/25/04ISR Number: 4432482-3Report Type:Expedited (15-DaCompany Report #PHNU2004DE02147 Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Thyroid Stimulating Leponex / Clozaril Hormone Decreased (Clozapine) PS Novartis Sector: Hyperthyroidism Pharma ORAL 450 mg/day Thyroxine Increased Date:08/25/04ISR Number: 4433544-7Report Type:Expedited (15-DaCompany Report #04-08-1208 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Suicide Attempt Health Clozapine PS Ivax Professional Pharmaceuticals, Other Inc. ORAL 150-900MG QD ORAL Date:08/25/04ISR Number: 4433545-9Report Type:Expedited (15-DaCompany Report #04-08-1204 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hepatic Neoplasm Health Clozapine PS Ivax Malignant Professional Pharmaceuticals, Other Inc. ORAL 100-550MG QD ORAL 22-Feb-2006 08:30 AM Page: 2821 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/25/04ISR Number: 4433547-2Report Type:Expedited (15-DaCompany Report #04-07-1034 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Adenocarcinoma Health Clozapine PS Ivax Metastasis Professional Pharmaceuticals, Other Inc. ORAL 25MG BID ORAL Mirapex C Date:08/26/04ISR Number: 4433607-6Report Type:Expedited (15-DaCompany Report #PHNU2004DE02306 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pericardial Effusion Leponex / Clozaril Initial or Prolonged Pleural Effusion (Clozapine) PS Novartis Sector: Other Polyserositis Pharma ORAL 75 mg/day Tachycardia Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL 250 mg/day Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL unknown small dosage Vioxx C Pantoprazol C Pipamperone C Date:08/26/04ISR Number: 4433608-8Report Type:Expedited (15-DaCompany Report #PHFR2004GB02726 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Health Clozaril PS Novartis Sector: Non-Insulin-Dependent Professional Pharma ORAL 275 mg/day Drug Ineffective Clozaril SS Novartis Sector: Drug Interaction Pharma ORAL 400 mg/day Metformin SS UNKNOWN 500 mg, TID Date:08/26/04ISR Number: 4433609-XReport Type:Expedited (15-DaCompany Report #PHNU2004DE02006 Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Leponex / Clozaril Initial or Prolonged Phosphokinase Increased (Clozapine) PS Novartis Sector: Convulsion Pharma ORAL up to 200 Hypertension mg/day 122 DAY Hyperthermia Dytide H C Hypophosphataemia Leukocytosis Neuroleptic Malignant Syndrome Rhabdomyolysis Somnolence Tachycardia Transaminases Increased 22-Feb-2006 08:30 AM Page: 2822 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/26/04ISR Number: 4433613-1Report Type:Expedited (15-DaCompany Report #PHEH2004US07552 Age:55 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dizziness Clozaril PS Novartis Sector: Initial or Prolonged Heart Rate Increased Pharma ORAL 700 mg/day Hypertrophic Obstructive Buspar C Cardiomyopathy Omeprazole C Hypotension Metoprolol C Syncope Florinef C Ventricular Hypertrophy Zocor "Dieckmann" C Date:08/26/04ISR Number: 4433617-9Report Type:Expedited (15-DaCompany Report #PHHO2004CA11767 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Panic Reaction Clozaril PS Novartis Sector: Pharma ORAL Date:08/26/04ISR Number: 4433620-9Report Type:Expedited (15-DaCompany Report #PHBS2004CH11007 Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Activities Of Daily Clozapine PS Novartis Sector: Initial or Prolonged Living Impaired Pharma UNKNOWN 600 mg/d Bradykinesia Clozapine SS Novartis Sector: Cogwheel Rigidity Pharma UNKNOWN 50 mg/d Eye Movement Disorder Valproate Sodium C UNKNOWN 2500 mg/d Mania Lithium C UNKNOWN Masked Facies Parkinson'S Disease Pre-Existing Condition Improved Rebound Effect Tremor Date:08/26/04ISR Number: 4434072-5Report Type:Expedited (15-DaCompany Report #PHFR2004GB03136 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Anaemia Clozaril PS Novartis Sector: Hospitalization - Circulatory Collapse Pharma ORAL Initial or Prolonged Gastric Ulcer Perforation Clozaril SS Novartis Sector: Other Haemoglobin Decreased Pharma ORAL 700mg/day Neutrophil Count Increased White Blood Cell Count Increased Date:08/26/04ISR Number: 4434091-9Report Type:Expedited (15-DaCompany Report #PHBS2004CA10887 Age: Gender:Male I/FU:I Outcome PT Other Asthenia Erythema Fatigue Haematocrit Decreased Headache 22-Feb-2006 08:30 AM Page: 2823 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Heart Rate Increased Hyperhidrosis Myalgia Report Source Product Role Manufacturer Route Dose Duration Nasal Congestion Clozaril PS Novartis Sector: Nasopharyngitis Pharma ORAL 12.5 mg/d Neutrophil Count Clozaril SS Novartis Sector: Increased Pharma ORAL 75 mg/d Pharyngolaryngeal Pain Inderal "Imperial Pyrexia Chemical Industries" C UNKNOWN Somnolence Seroquel C UNKNOWN 400 mg, QHS White Blood Cell Count Epival C UNKNOWN 500 mg, BID Increased Risperdal C UNKNOWN 4 mg/d Omega 3 C UNKNOWN Date:08/26/04ISR Number: 4434633-3Report Type:Expedited (15-DaCompany Report #04-07-1007 Age:46 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozapine -Ivax Cardiac Disorder Professional Pharmaceuticals, Myocardial Infarction Other Inc. Tablets PS Ivax Sudden Death Pharmaceuticals, Inc. ORAL 700MG QD ORAL Depakote C Lexapro C Ativan C Date:08/26/04ISR Number: 4434634-5Report Type:Expedited (15-DaCompany Report #04-08-1196 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Detoxification Health Clozapine - Ivax Initial or Prolonged Rehabilitation Therapy Professional Pharmaceuticals, Other Inc. Tablets PS Pharmaceuticals, Inc. ORAL 100-400MG QD ORAL Date:08/26/04ISR Number: 4434635-7Report Type:Expedited (15-DaCompany Report #04-06-0937 Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Health Clozapine -Ivax Anxiety Professional Pharmaceuticals, Circulatory Collapse Other Inc. Tablets PS Ivax Pharmaceuticals ORAL 500MG QD ORAL Coma Buspirone 15 Mg C Dyspnoea Citalopram 60 Mg C Gait Disturbance Divalproex C Pain Pallor Date:08/26/04ISR Number: 4434636-9Report Type:Expedited (15-DaCompany Report #04-08-1127 Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Clozapine -Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax 22-Feb-2006 08:30 AM Page: 2824 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pharmaceuticals, Inc. ORAL 625MG QD ORAL Date:08/26/04ISR Number: 4434655-2Report Type:Expedited (15-DaCompany Report #2004S1002223 Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 200MG, BID, Other ORAL Quetiapine C Divalproex Sodium C Lorazepam C Rosiglitazone C Metoprolol C Glipizide C Metformin C Date:08/26/04ISR Number: 4434656-4Report Type:Expedited (15-DaCompany Report #2004S1002406 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 450MG HS, Other ORAL Date:08/26/04ISR Number: 4434657-6Report Type:Expedited (15-DaCompany Report #2004S1002445 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neoplasm Malignant Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 200MG Q AM Other AND 300 MG Q HS , ORAL Date:08/26/04ISR Number: 4434682-5Report Type:Expedited (15-DaCompany Report #2004S1002396 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Other Clozapine Tablets 100 Mg Mylan PS Mylan ORAL 500MG Q HS, ORAL Date:08/26/04ISR Number: 4434683-7Report Type:Expedited (15-DaCompany Report #2004S1002400 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 50MG Q AM, Other ORAL Clozapine Tablets 100 Mg Mylan SS Mylan ORAL 100MG Q HS, ORAL 22-Feb-2006 08:30 AM Page: 2825 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/27/04ISR Number: 4435069-1Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040607460 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arrhythmia Health Risperdal PS OROPHARINGEAL Initial or Prolonged Convulsion Professional Leponex SS OROPHARINGEAL Other Delirium Depressed Level Of Consciousness Disorientation Drug Level Below Therapeutic Electroencephalogram Abnormal Hyponatraemia Rhabdomyolysis Somnolence Treatment Noncompliance Urinary Incontinence Date:08/27/04ISR Number: 4435072-1Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040805048 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Health Risperdal PS UNKNOWN Professional Clozapine SS UNKNOWN Date:08/27/04ISR Number: 4435361-0Report Type:Expedited (15-DaCompany Report #PHFR2004GB00569 Age:29 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Anaemia Health Clozaril PS Novartis Sector: Other Crohn'S Disease Professional Pharma ORAL 350mg/day 2128 DAY Diarrhoea Clozaril SS Novartis Sector: Diarrhoea Haemorrhagic Pharma ORAL 300mg/day Dizziness Feeling Cold Haemoglobin Decreased Inflammatory Bowel Disease Malaise Rectal Haemorrhage Vomiting Date:08/30/04ISR Number: 4437080-3Report Type:Expedited (15-DaCompany Report #PHHO2004CA08747 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Clozaril (Clozapine) PS Novartis Sector: Hepatitis C Pharma ORAL 179 DAY Neutropenia Interferon C Isotretinoin C Unk Topiramate C Unk Disulfiram C Unk Mirtazapine C Unk Ribavirin C Unk 22-Feb-2006 08:30 AM Page: 2826 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/30/04ISR Number: 4437168-7Report Type:Expedited (15-DaCompany Report #PHFR2004GB01699 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Empyema Health Clozaril PS Novartis Sector: Other Faecaloma Professional Pharma ORAL 700mg/day Intestinal Perforation Vomiting Date:08/30/04ISR Number: 4437169-9Report Type:Expedited (15-DaCompany Report #PHEH2004US08310 Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Health Clozaril PS Novartis Sector: Colon Cancer Professional Pharma ORAL 200 mg/day 3650 DAY Surgery Date:08/30/04ISR Number: 4437171-7Report Type:Expedited (15-DaCompany Report #PHBS2004CA11335 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Lymphadenopathy Clozaril PS Novartis Sector: Pharma ORAL Date:08/30/04ISR Number: 4437426-6Report Type:Expedited (15-DaCompany Report #PHFR2004GB02707 Age:64 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Adrenal Adenoma Clozaril PS Novartis Sector: Arrhythmia Pharma ORAL 450 mg/day Circulatory Collapse Clozaril SS Novartis Sector: Coronary Artery Pharma ORAL 400 mg/day Atherosclerosis Quetiapine SS 150mg & 50 mg Coronary Artery Disease Sinemet C Drug Level Increased Amitriptyline C 10 mg/day Gastritis Haemorrhagic Liver Disorder Myocardial Ischaemia Paralysis Pulmonary Congestion Pulmonary Oedema Salivary Hypersecretion Urinary Incontinence Date:08/30/04ISR Number: 4438946-0Report Type:Expedited (15-DaCompany Report #2004GB01905 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agitation Foreign Quetiapine PS Hospitalization - Alanine Aminotransferase Health Clozaril SS ORAL 1400 MG PO Initial or Prolonged Increased Professional Zopiclone SS Dystonia Other Thyroxine C Hallucination, Auditory Ventolin C Multiple Drug Overdose Intentional Self-Injurious Ideation Suicide Attempt 22-Feb-2006 08:30 AM Page: 2827 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/31/04ISR Number: 4437635-6Report Type:Expedited (15-DaCompany Report #PHHO2004CA11773 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ischaemic Cardiomyopathy Clozaril PS Novartis Sector: Initial or Prolonged Pharma Not reported Other Date:08/31/04ISR Number: 4437784-2Report Type:Expedited (15-DaCompany Report #PHEH2004US09247 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Lung Neoplasm Malignant Health Clozaril PS Novartis Sector: Professional Pharma UNK,UNK Date:08/31/04ISR Number: 4437785-4Report Type:Expedited (15-DaCompany Report #PHNU2004DE01798 Age: YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatinine Health Leponex / Clozaril Increased Professional (Clozapine) PS Novartis Sector: Renal Failure Pharma ORAL up to 350 mg/day Date:08/31/04ISR Number: 4437792-1Report Type:Expedited (15-DaCompany Report #PHEH2004US09257 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperkalaemia Clozaril PS Novartis Sector: Pharma ORAL 125 mg, QD Accutane C Date:08/31/04ISR Number: 4438418-3Report Type:Expedited (15-DaCompany Report #PHNU2004DE03043 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Grand Mal Convulsion Health Leponex / Clozaril Initial or Prolonged Overdose Professional (Clozapine) PS Novartis Sector: Other Pharma 500mg/day Betadorm SS 12 DF, ONCE/SINGLE Risperdal C Date:08/31/04ISR Number: 4438419-5Report Type:Expedited (15-DaCompany Report #PHHO2004CA04934 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatitis C Clozaril PS Novartis Sector: White Blood Cell Count Pharma ORAL Decreased Prozac C Clonazepam C 1 mg, UNK Lorazepam C 1 mg + 2 mg Nozinan /Net/ C 25 mg, UNK Trazodone C 100 mg, UNK Zoloft C 50 mg, UNK 22-Feb-2006 08:30 AM Page: 2828 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/31/04ISR Number: 4439160-5Report Type:Expedited (15-DaCompany Report #04-08-1221 Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Health Clozapine - Ivax Initial or Prolonged Urinary Tract Infection Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 50-75MG QD ORAL Date:08/31/04ISR Number: 4439161-7Report Type:Expedited (15-DaCompany Report #04-08-1220 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arthropod Bite Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 600-800MG QD ORAL Date:08/31/04ISR Number: 4439178-2Report Type:Expedited (15-DaCompany Report #2004S1002411 Age:87 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 18.75 MG QD, Other ORAL Potassium Chloride C Nitroglycerin C Vitamins C Aspirin C Date:08/31/04ISR Number: 4439179-4Report Type:Expedited (15-DaCompany Report #2004S1002442 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Intestinal Obstruction Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 25MG, TID, Other ORAL Clozapine Tablets 100 Mg Mylan SS Mylan ORAL 400MG, HS, ORAL Date:08/31/04ISR Number: 4440859-5Report Type:Expedited (15-DaCompany Report #04-46 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Autoimmune Disorder Health Clozapinetablets, Initial or Prolonged Thrombocytopenia Professional 100 Mg PS ORAL 700 MG/DAY/ORAL 12 YR 22-Feb-2006 08:30 AM Page: 2829 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/01/04ISR Number: 4438912-5Report Type:Expedited (15-DaCompany Report #PHHO2004CA11926 Age:21 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Creatine Clozaril PS Novartis Sector: Phosphokinase Increased Pharma ORAL 550 mg, QD 300 DAY Dehydration Risperdal SS Muscle Rigidity Valproic Acid C Neuroleptic Malignant Syndrome Tachycardia Tonsillitis Date:09/01/04ISR Number: 4438919-8Report Type:Expedited (15-DaCompany Report #PHFR2002GB03624 Age:33 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Consumer Clozaril PS Novartis Sector: Initial or Prolonged Increased Pharma ORAL 400mg/day Disability Blood Amylase Increased Clozaril SS Novartis Sector: Other Blood Creatinine Pharma ORAL 450 mg/day Decreased Lipostat C ORAL 20 mg/day Diabetes Mellitus Fenofibrate C ORAL 267 mg/day Hypertriglyceridaemia Irbesartan C ORAL 150 mg/day Liver Function Test Neurontin C ORAL 20 mg/day Abnormal Insulin C Mean Cell Volume Increased Pancreatitis Date:09/01/04ISR Number: 4438920-4Report Type:Expedited (15-DaCompany Report #PHNU2004DE02681 Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Psoriasis Health Leponex / Clozaril Professional (Clozapine) PS Novartis Sector: Pharma ORAL 400 mg/day Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL up to 600 mg/day Haldol Decanoate C INTRAMUSCULAR 1 ml, QMO Date:09/01/04ISR Number: 4439138-1Report Type:Expedited (15-DaCompany Report #PHHO2004CA09248 Age:67 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asthenia Health Clozaril (Clozapine) PS Novartis Sector: Hospitalization - Cardiac Failure Professional Pharma ORAL Unspecified Initial or Prolonged Hypotension Clozaril (Clozapine) SS Novartis Sector: Oedema Peripheral Pharma ORAL 75 mg, BID Aspirin C Furosemide C Pantoloc C Zyprexa C Vitamin B 1-6-12 C Penta-3b C Ferrous Sulphate C 22-Feb-2006 08:30 AM Page: 2830 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/01/04ISR Number: 4439509-3Report Type:Direct Company Report #CTU 226018 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Trismus Clozaril PS ORAL PO [PRIOR TO Initial or Prolonged ADMISSION] Geodon SS PO (PRIOR TO ADMISSION) Prozac SS PO (PRIOR TO ADMISSION) Date:09/01/04ISR Number: 4440384-1Report Type:Direct Company Report #CTU 226093 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Salivary Hypersecretion Clozapine 400 Mg PS ORAL 400 MG BID ORAL Date:09/02/04ISR Number: 4439739-0Report Type:Expedited (15-DaCompany Report #PHBS2004HR11446 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coma Consumer Leponex PS Novartis Sector: Life-Threatening Poisoning Pharma ORAL UNK, Hospitalization - ONCE/SINGLE 1440 MIN Initial or Prolonged Disability Date:09/02/04ISR Number: 4439745-6Report Type:Expedited (15-DaCompany Report #PHFR2003GB02133 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Constipation Health Clozaril PS Novartis Sector: Initial or Prolonged Haemoglobin Decreased Professional Pharma ORAL 200mg/mane&30 Other Megacolon 0mg/nocte Renal Disorder Clozaril SS Novartis Sector: Renal Failure Pharma ORAL 200mg/mane&25 0mg/nocte Iron C UNKNOWN Date:09/02/04ISR Number: 4439917-0Report Type:Expedited (15-DaCompany Report #PHFR2004GB03272 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Oedema Peripheral Clozapine PS Novartis Sector: Pharma ORAL 75mg mane, 225mg noct Amisulpride C ORAL 200mg/day Date:09/02/04ISR Number: 4439948-0Report Type:Expedited (15-DaCompany Report #AU-JNJFOC-20040810137 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Risperdal PS OROPHARINGEAL Pericarditis Olanzapine SS OROPHARINGEAL Tachypnoea Clozapine SS OROPHARINGEAL Clozapine SS OROPHARINGEAL 22-Feb-2006 08:30 AM Page: 2831 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/02/04ISR Number: 4440305-1Report Type:Expedited (15-DaCompany Report #04-08-1249 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pulmonary Mass Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 100-400MG QD ORAL Date:09/03/04ISR Number: 4440472-XReport Type:Expedited (15-DaCompany Report #PHBS2004IT11483 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Clozapine PS Novartis Sector: Initial or Prolonged Alanine Aminotransferase Professional Pharma UNKNOWN 300 mg/d 730 DAY Increased Clozapine SS Novartis Sector: Aspartate Pharma UNKNOWN 1000 mg/d Aminotransferase Venlafaxine SS UNKNOWN 150 mg/d 730 DAY Increased Venlafaxine SS UNKNOWN 900 mg/d Blood Cannabinoids Cannabis SS Blood Creatine Phosphokinase Increased Blood Pressure Abnormal Blood Pressure Fluctuation Coma Delirium Delusion Depression Leukocytosis Myoglobin Blood Increased Neuroleptic Malignant Syndrome Overdose Pyrexia Date:09/03/04ISR Number: 4440474-3Report Type:Expedited (15-DaCompany Report #PHEH2004US09344 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozaril PS Novartis Sector: Small Cell Lung Cancer Professional Pharma ORAL 575 mg, QHS Stage Unspecified Chemotherapeutics,Ot her SS Radiation Therapy SS Date:09/03/04ISR Number: 4440751-6Report Type:Expedited (15-DaCompany Report #PHHO2004CA08747 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozaril (Clozapine) PS Novartis Sector: Hepatitis C Professional Pharma ORAL 203 DAY Neutropenia Interferon SS White Blood Cell Count Isotretinoin C Unk Decreased Topiramate C Unk Disulfiram C Unk 22-Feb-2006 08:30 AM Page: 2832 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Mirtazapine C Unk Ribavirin C Unk Date:09/03/04ISR Number: 4440752-8Report Type:Expedited (15-DaCompany Report #PHEH2004US07465 Age:24 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accident Clozaril PS Novartis Sector: Electrocardiogram Pharma ORAL 75 mg, BID 37440MIN Abnormal Depakote C Lethargy Klonopin C Nausea Geodon C Tachycardia Abilify C Date:09/03/04ISR Number: 4441580-XReport Type:Expedited (15-DaCompany Report #2004S1002476 Age:71 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional Mylan PS Mylan ORAL 50MG/DAY,ORAL Other Date:09/03/04ISR Number: 4441581-1Report Type:Expedited (15-DaCompany Report #2004S1002505 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dysphagia Health Clozapine Tablets 25 Urinary Tract Infection Professional Mg Mylan PS Mylan ORAL 25MG HS,ORAL Other Date:09/03/04ISR Number: 4441583-5Report Type:Expedited (15-DaCompany Report #2004S1002508 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 100MG QAM, Other 300MG Q4PM & 225MG Q HS ORAL Date:09/03/04ISR Number: 4441584-7Report Type:Expedited (15-DaCompany Report #2004S1002514 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 100MG Q AM, Other 200MG Q HS, ORAL Date:09/03/04ISR Number: 4441585-9Report Type:Expedited (15-DaCompany Report #2004S1002519 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Death Death Health Professional 22-Feb-2006 08:30 AM Page: 2833 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Product Role Manufacturer Route Dose Duration Clozapine Tablets 25 Mg Mylan PS Mylan ORAL 50MG TID, ORAL Ipratropium Bromide C Glipizide C Hctz C Lactulose C Insulin Glargine C Levothyroxine C Lisinopril C Lorazepam C Lipase C Prednisolone Ophthalmic C Lansoprazole C Diclofenac Sodium C Sertraline C Date:09/03/04ISR Number: 4441751-2Report Type:Expedited (15-DaCompany Report #2004S1001221 Age:92 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 12.5MG QD, Other ORAL Acetaminophen C Morphine Sulfate C Digoxin C Albuterol C Furosemide C Hydroxyzine C Nystatin C Zolpidem C Lorazepam C Scopalamine Transdermal C Date:09/03/04ISR Number: 4441754-8Report Type:Expedited (15-DaCompany Report #2004S1002316 Age:51 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 100 MG BID, Other ORAL Morphine Sulfate C Metronidazole C Potassium Chloride C Lorazepam C Memantine C Venlafaxine C Donepezil C Mirtazapine C Pantoprazole C Calcium Carbonate With Vitamin D C Loperamide C 22-Feb-2006 08:30 AM Page: 2834 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Senna/Ducusate C Acetaminophen C Magnesium Hydroxide C Bisacodyl C Benefiber C Ceftriaxone C Levofloxacin C Cefotaxime C Dextrose C Date:09/03/04ISR Number: 4443614-5Report Type:Direct Company Report #CTU 226301 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Ineffective Clozapine - Generic PS 450 MG/DAILY 2 MON Pharmaceutical Product Complaint Date:09/03/04ISR Number: 4445300-4Report Type:Expedited (15-DaCompany Report #DSA_24862_2004 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Ativan PS Multiple Drug Overdose Health Clozapine SS Professional Movicol SS Other Zoplicone SS Date:09/03/04ISR Number: 4445324-7Report Type:Expedited (15-DaCompany Report #04P-167-0268683-00 Age:43 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Drug Interaction Foreign Valproate Sodium Intervention to Drug Level Increased Health (Sodium Valproate) Prevent Permanent Myoclonus Professional (Sodium Valproate) Impairment/Damage Schizoaffective Disorder (Sodium Valproate) PS ORAL 600 MG, 2 IN 1 D, ORAL Clozapine SS SEE IMAGE Sulpiride C Citalopram C Folic Acid C Atorvastatin C Date:09/07/04ISR Number: 4441695-6Report Type:Expedited (15-DaCompany Report #PHEH2004US09476 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Clozaril PS Novartis Sector: Pharma ORAL 800 mg/day Depakote C Date:09/07/04ISR Number: 4441697-XReport Type:Expedited (15-DaCompany Report #PHHO2004CA09248 Age:67 YR Gender:Male I/FU:F Outcome Death Hospitalization - 22-Feb-2006 08:30 AM Page: 2835 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Initial or Prolonged PT Report Source Product Role Manufacturer Route Dose Duration Asthenia Health Clozaril (Clozapine) PS Novartis Sector: Cardiac Arrest Professional Pharma ORAL Unspecified Hypotension Clozaril (Clozapine) SS Novartis Sector: Oedema Peripheral Pharma ORAL 75 mg, BID Aspirin C Furosemide C Pantoloc C Zyprexa C Vitamin B 1-6-12 C Penta-3b C Ferrous Sulphate C Date:09/07/04ISR Number: 4441698-1Report Type:Expedited (15-DaCompany Report #PHEH2004US09501 Age:74 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Parkinson'S Disease Clozaril PS Novartis Sector: Pneumonia Aspiration Pharma ORAL UNK, UNK Ditropan C Colace C Tylenol C Cinnamint C Date:09/07/04ISR Number: 4444853-XReport Type:Direct Company Report #CTU 226507 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Clozapine PS 75 MG TID Pharmaceutical Product Complaint Date:09/07/04ISR Number: 4445073-5Report Type:Expedited (15-DaCompany Report #L04-ESP-03962-24 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Citalopram PS Poisoning Literature Alcohol SS Toxicologic Test Abnormal Health Clozapine SS Professional Other Date:09/07/04ISR Number: 4445877-9Report Type:Expedited (15-DaCompany Report #GBWYE005027AUG04 Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Efexor (Venlafaxine Fall Professional Hydrochloride, Spinal Fracture Other Tablet) PS ORAL 37.5-75 MG Syncope TWICE DAILY Alcohol (Ethanol) SS ORAL Clozaril (Clozapine) SS Flecainide (Flecainide) C 22-Feb-2006 08:30 AM Page: 2836 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/08/04ISR Number: 4443530-9Report Type:Expedited (15-DaCompany Report #PHBS2004AR11774 Age:81 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chronic Lymphocytic Lapenax PS Novartis Sector: Leukaemia Pharma UNKNOWN 25 mg, QD Neutrophil Count Increased White Blood Cell Count Increased Date:09/08/04ISR Number: 4443532-2Report Type:Expedited (15-DaCompany Report #PHFR2004GB00916 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Body Temperature Clozaril PS Novartis Sector: Initial or Prolonged Increased Pharma ORAL 350mg/day Other Breath Odour Omeprazole C ORAL 20mg/day Chest X-Ray Abnormal Hyoscine C ORAL 300-600 Cough ug/day Eosinophilia Valproate Sodium C ORAL 800mg/day Influenza Like Illness Paroxetine C UNKNOWN 30mg/day Lower Respiratory Tract Infection Monocyte Count Increased Neutrophil Count Increased Platelet Count Increased Pneumonia Respiratory Tract Infection Weight Decreased White Blood Cell Count Increased Date:09/08/04ISR Number: 4443537-1Report Type:Expedited (15-DaCompany Report #PHNU2004DE03058 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Leponex / Clozaril Phosphokinase Increased (Clozapine) PS Novartis Sector: Myoglobin Blood Increased Pharma ORAL Transaminases Increased Date:09/08/04ISR Number: 4443869-7Report Type:Expedited (15-DaCompany Report #PHBS2004NZ11506 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Eczema Clozaril PS Novartis Sector: Initial or Prolonged Erythema Pharma ORAL 200 mg, QHS 1087 DAY Oedema Peripheral Insulin Protaphan Rash Human C UNKNOWN Insulin Actrapid Human C UNKNOWN Simvastatin C UNKNOWN 10 mg/d Ranitidine C UNKNOWN 150 mg, QD 22-Feb-2006 08:30 AM Page: 2837 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/08/04ISR Number: 4443871-5Report Type:Expedited (15-DaCompany Report #PHBS2004CH11673 Age:76 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diarrhoea Leponex PS Novartis Sector: Drug Interaction Pharma UNKNOWN 300 mg/d Dysphagia Nozinan SS UNKNOWN Gait Disturbance Aspirin Cardio C UNKNOWN 100 mg/d Hyperreflexia Dolprone C UNKNOWN 2000 mg/d Myoclonus Pantozol C UNKNOWN 40 mg/d Serotonin Syndrome Stilnox C UNKNOWN 10 mg/d Speech Disorder Tremor Date:09/08/04ISR Number: 4446502-3Report Type:Expedited (15-DaCompany Report #04-09-1252 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neoplasm Malignant Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 300MG QD ORAL Date:09/08/04ISR Number: 4446710-1Report Type:Expedited (15-DaCompany Report #K200401329 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Constipation Foreign Kemadrin Hospitalization - Faecaloma Health (Procyclidine) Initial or Prolonged Inadequate Diet Professional Tablet, 10mg PS ORAL 10 MG, ORAL Other Clozapine (Clozapine) 375 Mg SS ORAL 375 MG, ORAL Hyoscine Hydrobromide (Hyoscine Hydrobromide) SS Date:09/09/04ISR Number: 4444686-4Report Type:Expedited (15-DaCompany Report #PHNR2004AU01320 Age:25 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Health Clozaril PS Novartis Sector: Salivary Hypersecretion Professional Pharma 0 - 250 Sleep Apnoea Syndrome mg/day 1699 DAY Weight Increased Date:09/09/04ISR Number: 4444687-6Report Type:Expedited (15-DaCompany Report #PHFR2001GB01091 Age:31 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abortion Spontaneous Health Clozaril PS Novartis Sector: Drug Exposure During Professional Pharma ORAL 500 mg/day Pregnancy Folic Acid C ORAL 5mg/day 22-Feb-2006 08:30 AM Page: 2838 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/09/04ISR Number: 4444691-8Report Type:Expedited (15-DaCompany Report #PHFR2004GB03072 Age:66 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Folate Decreased Health Clozaril PS Novartis Sector: Initial or Prolonged Cardiac Failure Professional Pharma ORAL 3411 DAY Other Congestive Dyspnoea General Physical Health Deterioration Haemoglobin Decreased Mean Cell Volume Increased Obesity Overweight Platelet Count Decreased Vitamin B12 Decreased Date:09/09/04ISR Number: 4444776-6Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040809683 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutropenia Health Risperdal PS OROPHARINGEAL 252 DAY Initial or Prolonged Thrombocytopenia Professional Leponex SS OROPHARINGEAL 28 MON Lepticur C Noctran C Noctran C Noctran C Rivotril C Depakote C Date:09/09/04ISR Number: 4448840-7Report Type:Expedited (15-DaCompany Report #GBWYE010901SEP04 Age:55 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Amnesia Health Efexor (Venlafaxine Initial or Prolonged Limb Discomfort Professional Hydrochloride, Multiple Drug Overdose Other Tablet, 0) PS ORAL OVERDOSE ORAL Periorbital Haematoma Clozaril (Clozapine, , 0) SS ORAL 3-4 DAYS SUPPLY (1,200 TO 1,600MG) ORAL Date:09/10/04ISR Number: 4448262-9Report Type:Expedited (15-DaCompany Report #04-09-1268 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Heat Stroke Health Clozapine Tablets PS Ivax Professional Pharmaceuticals, Other Inc. ORAL 600MG QD ORAL Date:09/10/04ISR Number: 4448286-1Report Type:Expedited (15-DaCompany Report #2004S1002225 Age:27 YR Gender:Male I/FU:F Outcome PT Report Source Death Completed Suicide Health Drowning Professional 22-Feb-2006 08:30 AM Page: 2839 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Product Role Manufacturer Route Dose Duration Clozapine Tablets 25 Mg Mylan PS Mylan ORAL 50MG, BID, ORAL Clozapine Tablets 100mg Mylan SS Mylan ORAL 100MG Q HS, ORAL Lamotrigine C Benztropine C Mirtazapine C Omeprazole C Loratadine C Date:09/10/04ISR Number: 4448287-3Report Type:Expedited (15-DaCompany Report #2004S1002336 Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 75MG, QD, Other ORAL Clozapine Tablets 100mg Mylan SS Mylan ORAL 400MG HS, ORAL Simvastatin C Aripiprazole C Levothyroxine C Benztropine C Date:09/10/04ISR Number: 4448288-5Report Type:Expedited (15-DaCompany Report #2004S1002542 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 300MG/DAY, Other ORAL Date:09/10/04ISR Number: 4448289-7Report Type:Expedited (15-DaCompany Report #04-04-0553 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiovascular Disorder Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 450-600MG QD ORAL Date:09/10/04ISR Number: 4448290-3Report Type:Expedited (15-DaCompany Report #04-09-1263 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hip Fracture Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, 22-Feb-2006 08:30 AM Page: 2840 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Inc. PS Ivax Pharmaceuticals, Inc. ORAL 50-300MG QD ORAL Date:09/10/04ISR Number: 4449347-3Report Type:Expedited (15-DaCompany Report #04P-163-0271680-00 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Gallbladder Disorder Health Depakote (Divalproex Initial or Prolonged Leukopenia Professional Sodium) Divalproex Required Pancreatitis Other Sodium) PS Intervention to Clozapine SS ORAL 1 IN 1 D, Prevent Permanent ORAL Impairment/Damage Date:09/10/04ISR Number: 4449469-7Report Type:Direct Company Report #CTU 226822 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pharmaceutical Product Clozaril PS Complaint Date:09/13/04ISR Number: 4447730-3Report Type:Expedited (15-DaCompany Report #PHFR2004GB02604 Age:30 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Feelings Of Worthlessness Clozaril PS Novartis Sector: Initial or Prolonged Overdose Pharma ORAL 100mg/day Clozaril SS Novartis Sector: Pharma 14 tablets/Overd ose Date:09/13/04ISR Number: 4447755-8Report Type:Expedited (15-DaCompany Report #PHFR2003GB01809 Age:24 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Qt Health Clozaril PS Novartis Sector: Initial or Prolonged Corrected Interval Professional Pharma ORAL Other Prolonged Clozaril SS Novartis Sector: Palpitations Pharma ORAL 350mg/day 940 DAY Sinus Tachycardia Buspirone C ORAL 5 mg, BID Torsade De Pointes Hyoscine C ORAL 300ug/day Ventricular Extrasystoles Date:09/13/04ISR Number: 4448176-4Report Type:Expedited (15-DaCompany Report #PHFR2004GB02871 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Lethargy Clozaril PS Novartis Sector: Limb Discomfort Pharma ORAL 400 mg/day 257 DAY Malaise Temazepam C 20 mg/day Sensation Of Heaviness Clonazepam C 0.5mg/day Weight Increased Gaviscon C 10-20 mls qds Omeprazole C 20 mg/day 22-Feb-2006 08:30 AM Page: 2841 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/13/04ISR Number: 4448215-0Report Type:Expedited (15-DaCompany Report #PHHO2004CA10128 Age:50 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asterixis Clozaril (Clozapine) PS Novartis Sector: Other Convulsion Pharma ORAL 150 mg / day 190 DAY Granulocytopenia Epival C Leukopenia Restoril C Lung Neoplasm Malignant Rivotril C Muscle Contractions Cogentin C Involuntary Pravachol C Neutropenia Ditropan C Date:09/13/04ISR Number: 4449359-XReport Type:Expedited (15-DaCompany Report #04-09-1267 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Brain Neoplasm Malignant Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 600-800MG QD ORAL Date:09/13/04ISR Number: 4449360-6Report Type:Expedited (15-DaCompany Report #04-08-1275 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 50-400MG QD ORAL Chemotherapy C Date:09/13/04ISR Number: 4449361-8Report Type:Expedited (15-DaCompany Report #04-09-1274 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 625MG QD ORAL Date:09/13/04ISR Number: 4449384-9Report Type:Expedited (15-DaCompany Report #04-09-1273 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozapine - Ivax Chronic Obstructive Professional Pharmaceuticals, Pulmonary Disease Other Inc. Tablets PS Ivax Pharmaceuticals ORAL 75-3 MG QD Smoker ORAL 22-Feb-2006 08:30 AM Page: 2842 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/14/04ISR Number: 4448532-4Report Type:Expedited (15-DaCompany Report #PHFR2004GB02871 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other General Physical Health Clozaril PS Novartis Sector: Deterioration Pharma ORAL 400 mg/day 257 DAY Lethargy Temazepam C 20 mg/day Limb Discomfort Clonazepam C 0.5mg/day Malaise Gaviscon C 10-20 mls qds Sensation Of Heaviness Omeprazole C 20 mg/day Weight Increased Date:09/14/04ISR Number: 4448533-6Report Type:Expedited (15-DaCompany Report #PHHO2004CA10128 Age:50 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asterixis Clozaril (Clozapine) PS Novartis Sector: Other Granulocytopenia Pharma ORAL 150 mg / day 190 DAY Lung Neoplasm Malignant Epival C Neutropenia Restoril C Rivotril C Cogentin C Pravachol C Ditropan C Date:09/14/04ISR Number: 4449452-1Report Type:Expedited (15-DaCompany Report #04P-167-0271848-00 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypoaesthesia Foreign Valorpate Sodium Initial or Prolonged Liver Function Test Health (Sodium Valproate) Abnormal Professional (Sodium Valproate) Loss Of Consciousness (Sodium Valproate) PS Overdose Clozapine SS ORAL SEE IMAGE Peroneal Nerve Palsy Anti-Parkinson Rhabdomyolysis Agents C Date:09/14/04ISR Number: 4450356-9Report Type:Expedited (15-DaCompany Report #2004GB01905 Age:28 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agitation Foreign Quetiapine PS NI Hospitalization - Alanine Aminotransferase Health Clozaril SS ORAL 1400 MG PO Initial or Prolonged Increased Professional Zopiclone SS Dystonia Other Thyroxine C Hallucination, Auditory Ventolin C Multiple Drug Overdose Intentional Self-Injurious Ideation Self-Medication Suicidal Ideation Suicide Attempt 22-Feb-2006 08:30 AM Page: 2843 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/14/04ISR Number: 4450406-XReport Type:Expedited (15-DaCompany Report #GBWYE887608JUL04 Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eosinophilia Health Efexor (Venlafaxine Neutrophilia Professional Hydrochloride, 0) PS White Blood Cell Count Other Clozapine Increased (Clozapine, , 0) SS ORAL ORAL Date:09/14/04ISR Number: 4450669-0Report Type:Direct Company Report #CTU 227012 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blood Pressure Increased Clozaril 25mg Intervention to Heart Rate Increased Novartis PS Novartis ORAL INCREASING Prevent Permanent ORAL Impairment/Damage Clozaril 100mg Novartis SS Novartis INCREASING ORAL Neurontin C Lithium C Levothyroxine C Zyprexa Zydis C Cogentin C Allegra C Pepcid C Date:09/15/04ISR Number: 4450355-7Report Type:Expedited (15-DaCompany Report #04-08-1225 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozapine Tablets - Myocardial Infarction Professional Ivax Tachycardia Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 300MG QHS ORAL Date:09/15/04ISR Number: 4450409-5Report Type:Expedited (15-DaCompany Report #04-07-0955 Age:86 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Health Clozapine - Ivax Hospitalization - Dyspnoea Professional Pharmaceuticals, Initial or Prolonged Respiratory Tract Other Inc. Tablets PS Ivax Congestion Pharmaceuticals, Vomiting Inc. 50MG QD ORAL Date:09/15/04ISR Number: 4450413-7Report Type:Expedited (15-DaCompany Report #04-08-1137 Age:85 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 125MG QD ORAL 22-Feb-2006 08:30 AM Page: 2844 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Zyprexa 5mg C Ativan 0.5mg C Effexor Xr 75mg C Date:09/15/04ISR Number: 4450415-0Report Type:Expedited (15-DaCompany Report #04-09-1282 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dehydration Health Clozapine - Ivax Initial or Prolonged Infection Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 300-400MG QD ORAL Date:09/15/04ISR Number: 4450417-4Report Type:Expedited (15-DaCompany Report #04-09-1283 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - No Adverse Effect Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 100-325MG QD ORAL Date:09/15/04ISR Number: 4450419-8Report Type:Expedited (15-DaCompany Report #04-08-1204 Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Interaction Health Clozapine - Ivax Hepatic Neoplasm Professional Pharmaceuticals, Malignant Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 100-550MG QD ORAL Depakote SS ORAL 2500MG QD ORAL Terazosin SS Aspirin C Ranitidine C Atenolol C Date:09/15/04ISR Number: 4450485-XReport Type:Expedited (15-DaCompany Report #04-07-1085 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Breast Cancer Health Clozapine - Ivax Colon Cancer Professional Pharmaceuticals, Metastases To Abdominal Other Inc. Tablets PS Ivax Cavity Pharmaceuticals, Metastases To Bone Inc. ORAL 37.5-75MG QD Ovarian Cancer ORAL 22-Feb-2006 08:30 AM Page: 2845 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/16/04ISR Number: 4451289-4Report Type:Expedited (15-DaCompany Report #PHFR2004GB03438 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Clozaril PS Novartis Sector: Hospitalization - Pharma ORAL Initial or Prolonged Date:09/16/04ISR Number: 4451876-3Report Type:Expedited (15-DaCompany Report #2004S1002641 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Food Poisoning Health Clozapine Tablets Multi-Organ Failure Professional 100 Mg Mylan PS Mylan ORAL 200 MG Q HS, Other ORAL Zolpidem C Paroxetine Cr C Aripiprazole C Date:09/16/04ISR Number: 4451880-5Report Type:Expedited (15-DaCompany Report #2004S1002406 Age:51 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Food Poisoning Health Clozapine Tablets Multi-Organ Failure Professional 100mg Mylan PS Mylan ORAL 450 MG HS, Other ORAL Date:09/16/04ISR Number: 4451890-8Report Type:Expedited (15-DaCompany Report #2004S1002656 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL ORAL Other Clozapine Tablets 100 Mg Mylan SS Mylan ORAL ORAL Date:09/16/04ISR Number: 4451949-5Report Type:Expedited (15-DaCompany Report #2004S1002615 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dyspnoea Health Clozapine Tablets 25 Respiratory Arrest Professional Mg Mylan PS Mylan ORAL 25 MG Q HS, Other ORAL Clozapine Tablets 100 Mg Mylan SS Mylan ORAL 600 MG Q HS, ORAL Date:09/16/04ISR Number: 4451978-1Report Type:Expedited (15-DaCompany Report #04-09-1287 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Decubitus Ulcer Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 200-1400 MG QD ORAL 22-Feb-2006 08:30 AM Page: 2846 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/17/04ISR Number: 4452456-6Report Type:Expedited (15-DaCompany Report #PHFR2004GB03438 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Clozaril PS Novartis Sector: Hospitalization - Pharma ORAL Initial or Prolonged Date:09/17/04ISR Number: 4453161-2Report Type:Expedited (15-DaCompany Report #04-09-1292 Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Choking Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals ORAL 300-500MG QD ORAL Date:09/17/04ISR Number: 4455125-1Report Type:Expedited (15-DaCompany Report #GBR-2004-0001251 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Foreign Morphine Sulfate Electrocardiogram Qt Health (Morphine Sulfate) PS ORAL 100 MG, BID, Corrected Interval Professional ORAL Prolonged Other Clozaril (Clozapine) SS ORAL 50 MG, BID, Hypotension ORAL Pulse Abnormal Venlafaxine Tachycardia (Venlafaxine) C Treatment Noncompliance Diazepam (Diazepam) C Date:09/17/04ISR Number: 4455184-6Report Type:Expedited (15-DaCompany Report #B0344693A Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Respiratory Failure Foreign Paxil (Formulation Alanine Aminotransferase Literature Unknown) (Paroxetine Increased Health Hydrochloride) PS 20 MG/ PER Antipsychotic Drug Level Professional DAY Above Therapeutic Clozapine Aspartate (Formulation Aminotransferase Unknown) (Clozapine) SS 300 MG/ PER Increased DAY Blood Lactate Dehydrogenase Increased Body Temperature Decreased Deep Vein Thrombosis Drug Interaction Electrocardiogram T Wave Inversion Haematocrit Decreased Haemoglobin Decreased Oedema Peripheral Platelet Count Decreased Pulmonary Embolism Sinus Tachycardia 22-Feb-2006 08:30 AM Page: 2847 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/17/04ISR Number: 4473413-XReport Type:Periodic Company Report #US-JNJFOC-20040205928 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pulmonary Embolism Health Ortho Evra Initial or Prolonged Professional (Norelgestromin/Ethi nyl Estradiol) Patch PS TRANSDERMAL 1 DOSE(S), 3 IN 4 WEEK, TRANSDERMAL Clozapine (Clozapine) Tablets SS ORAL ORAL Seroquel (Quetiapine Fumurate) Unspecified C Lamotrigine (Lamotrigine) C Neurontin (Gabapentin) C Lithium (Lithium) C Cytomel (Liothyroxine Sodium) C Synthroid (Levothyroxine Sodium) C Aspirin (Acetylsalicylic Acid) C Abilify (Aripiprazole) C Date:09/20/04ISR Number: 4453320-9Report Type:Expedited (15-DaCompany Report #PHHO2004CA11767 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Panic Reaction Health Clozaril PS Novartis Sector: Professional Pharma ORAL Evening dose increased Clozaril SS Novartis Sector: Pharma ORAL Not reported Date:09/20/04ISR Number: 4453330-1Report Type:Expedited (15-DaCompany Report #PHNU2004DE03058 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Health Leponex / Clozaril Phosphokinase Increased Professional (Clozapine) PS Novartis Sector: Condition Aggravated Pharma ORAL 175 mg/day Myoglobin Blood Increased Transaminases Increased Date:09/20/04ISR Number: 4453336-2Report Type:Expedited (15-DaCompany Report #PHFR2004GB03072 Age:66 YR Gender:Female I/FU:F Outcome PT Hospitalization - Blood Folate Decreased Initial or Prolonged Cardiac Failure Other Congestive Dyspnoea 22-Feb-2006 08:30 AM Page: 2848 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report General Physical Health Deterioration Haemoglobin Decreased Report Source Product Role Manufacturer Route Dose Duration Mean Cell Volume Health Clozaril PS Novartis Sector: Increased Professional Pharma ORAL 3411 DAY Neutropenia Obesity Overweight Platelet Count Decreased Urinary Tract Infection Vitamin B12 Decreased White Blood Cell Count Decreased Date:09/20/04ISR Number: 4453337-4Report Type:Expedited (15-DaCompany Report #PHNR2004AU01411 Age:44 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Extrasystoles Clozaril PS Novartis Sector: Pharma ORAL 25 - 400 mg/day 209 DAY Date:09/20/04ISR Number: 4453586-5Report Type:Expedited (15-DaCompany Report #PHNU2004DE03058 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Health Leponex / Clozaril Phosphokinase Increased Professional (Clozapine) PS Novartis Sector: Condition Aggravated Pharma ORAL 175 mg/day Myoglobin Blood Increased Transaminases Increased Date:09/20/04ISR Number: 4453591-9Report Type:Expedited (15-DaCompany Report #PHNR2004AU01411 Age:44 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Extrasystoles Health Clozaril PS Novartis Sector: Professional Pharma ORAL 25 - 400 mg/day 209 DAY Date:09/20/04ISR Number: 4453593-2Report Type:Expedited (15-DaCompany Report #PHFR2004GB03072 Age:66 YR Gender:Female I/FU:F Outcome PT Hospitalization - Blood Folate Decreased Initial or Prolonged Cardiac Failure Other Congestive Dyspnoea General Physical Health Deterioration Haemoglobin Decreased Mean Cell Volume Increased Neutropenia Obesity Overweight Platelet Count Decreased 22-Feb-2006 08:30 AM Page: 2849 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Urinary Tract Infection Vitamin B12 Decreased White Blood Cell Count Report Source Product Role Manufacturer Route Dose Duration Decreased Health Clozaril PS Novartis Sector: Professional Pharma ORAL 3411 DAY Date:09/20/04ISR Number: 4453597-XReport Type:Expedited (15-DaCompany Report #PHHO2004CA11767 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Feeling Abnormal Health Clozaril PS Novartis Sector: Panic Reaction Professional Pharma ORAL Evening dose increased Clozaril SS Novartis Sector: Pharma ORAL Not reported Date:09/20/04ISR Number: 4453708-6Report Type:Expedited (15-DaCompany Report #PHFR2004GB02801 Age:23 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Clozapine PS Novartis Sector: Medication Error Pharma Clozapine SS Novartis Sector: Pharma ORAL 900mg/day 7200 MIN Procyclidine C ORAL 5 mg, BID Date:09/20/04ISR Number: 4453710-4Report Type:Expedited (15-DaCompany Report #PHFR2004GB02707 Age:64 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Adrenal Adenoma Health Clozaril PS Novartis Sector: Arrhythmia Professional Pharma ORAL 450 mg/day Circulatory Collapse Clozaril SS Novartis Sector: Coronary Artery Pharma ORAL 400 mg/day Atherosclerosis Sinemet C Coronary Artery Disease Amitriptyline C 10 mg/day Drug Level Increased Quetiapine I 150mg & 50 mg Gastritis Haemorrhagic Liver Disorder Myocardial Ischaemia Paralysis Pulmonary Congestion Pulmonary Oedema Salivary Hypersecretion Urinary Incontinence Date:09/20/04ISR Number: 4453720-7Report Type:Expedited (15-DaCompany Report #PHHO2004CA13010 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Circulatory Collapse Clozaril PS Novartis Sector: Life-Threatening Resuscitation Pharma Hospitalization - Initial or Prolonged 22-Feb-2006 08:30 AM Page: 2850 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/20/04ISR Number: 4453980-2Report Type:Expedited (15-DaCompany Report #PHFR2004GB03333 Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Consumer Lithium PS Glaxosmithkline UNKNOWN Increased Clozaril SS ORAL Aspartate Aminotransferase Increased Liver Function Test Abnormal Date:09/20/04ISR Number: 4454022-5Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-12698320 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Carbidopa + Levodopa PS Bristol-Myers Squibb Other Overdose Company Clozapine SS ORAL Movicol SS "3350/kcl/nah co3/nacl" Lorazepam SS Zoplicone SS Citalopram SS Date:09/20/04ISR Number: 4454753-7Report Type:Direct Company Report #CTU 227554 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Clozapine 25mg Initial or Prolonged Phosphokinase Increased (Mylan) PS Mylan ORAL SEE IMAGE Required Confusional State Haloperidol SS 20 MG/D Intervention to Constipation Clozapine C Prevent Permanent Ileus Magnesium Hydroxide Impairment/Damage Liver Function Test (Milk Of Magnesia) C Abnormal Docusate/Senna C Neuroleptic Malignant Lovastatin C Syndrome Ferrous Sulfate C Obstruction Sorbitol C Pneumonia Aspiration Albuterol C Urinary Tract Infection Terazosin C Ranitidine C Clonazepam C Date:09/20/04ISR Number: 4454798-7Report Type:Expedited (15-DaCompany Report #2004-UK-00860UK(0) Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Foreign Oramorph (0015/0122) Initial or Prolonged Electrocardiogram Qt (Morphine Sulfate) PS 100 MG BID Corrected Interval (NR, TWICE Prolonged Clozaril (Clozapine) SS ORAL 100 MG (NR, Hypotension TWICE DAILY), Pulse Abnormal PO Tachycardia Venlafaxine (Venlafaxine) C Diazepam (Diazepam) C 22-Feb-2006 08:30 AM Page: 2851 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/20/04ISR Number: 4456018-6Report Type:Expedited (15-DaCompany Report #S04-USA-06118-01 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Toxicity Health Lexapro Overdose Professional (Escitalopram) PS ORAL 30 MG QD PO Clozapine SS 300 MG Vicodin C Topamax C Depakote (Valproate Semisodium) C Lopid (Gemfibrozil) C Inderal C Doxepin C Flexeril (Cyclobenzaprine Hydrochloride) C Promethazine C Date:09/20/04ISR Number: 4456182-9Report Type:Expedited (15-DaCompany Report #04P-151-0272678-00 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anxiety Foreign Depakine (Depakene) Hospitalization - Completed Suicide Health (Sodium Initial or Prolonged Drowning Professional Valproate/Valproic Acid) PS ORAL 600 MG, 1 IN 1 D, PER ORAL Clozapine SS ORAL SEE IMAGE Fluvoxamine SS ORAL 100 MG, 1 IN 1 D, PER ORAL Lorazepam SS ORAL DOSE DECREASED, PER ORAL Date:09/20/04ISR Number: 4473459-1Report Type:Periodic Company Report #S04-USA-00560-01 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Celexa (Citalopram Professional Hydrobromide) PS ORAL 20 MG QD PO Clozapine SS 200 MG QD Date:09/21/04ISR Number: 4454673-8Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-12702239 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Metformin Hcl PS Bristol-Myers Squibb Psychotic Disorder Company ORAL Clozaril I ORAL Date:09/21/04ISR Number: 4454999-8Report Type:Expedited (15-DaCompany Report #PHBS2004HR11446 Age:44 YR Gender:Male I/FU:F Outcome Death Life-Threatening Hospitalization - 22-Feb-2006 08:30 AM Page: 2852 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Initial or Prolonged Disability PT Report Source Product Role Manufacturer Route Dose Duration Coma Consumer Leponex PS Novartis Sector: Poisoning Pharma ORAL UNK, Syncope ONCE/SINGLE 1440 MIN Victim Of Homicide Date:09/21/04ISR Number: 4455000-2Report Type:Expedited (15-DaCompany Report #PHBS2004TW12144 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Clozapine PS Novartis Sector: Convulsion Pharma UNKNOWN 400 mg/d 119 DAY Obsessive-Compulsive Clozapine SS Novartis Sector: Disorder Pharma ORAL 300 mg/d 244 DAY Restlessness Clozapine SS Novartis Sector: Therapeutic Response Pharma UNKNOWN 325 mg/d Decreased Clozapine SS Novartis Sector: Pharma UNKNOWN 300 mg//d Date:09/21/04ISR Number: 4461101-5Report Type:Direct Company Report #CTU 227737 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Clozapine 250 Mg Po Nausea Bid PS ORAL 250 MG PO BID Pharmaceutical Product Ativan C Complaint Lisinopril C Sedation Tricor C Nexium C Peri-Colace C Niaspan C Actos C Ultracet C Date:09/22/04ISR Number: 4455661-8Report Type:Expedited (15-DaCompany Report #PHRM2004FR02776 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Increased Health Leponex PS Novartis Sector: Initial or Prolonged Delirium Professional Pharma ORAL 350 mg/day Oedema Peripheral Leponex SS Novartis Sector: Tachycardia Pharma ORAL 400 mg/day Depakin Chrono C ORAL Solian C ORAL 400 drops/TID Kayexalate C Theralene C Date:09/22/04ISR Number: 4455664-3Report Type:Expedited (15-DaCompany Report #PHHO2004CA10973 Age:72 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Level Increased Health Clozaril PS Novartis Sector: Professional Pharma ORAL Dose reduced repeatedly 22-Feb-2006 08:30 AM Page: 2853 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/22/04ISR Number: 4457625-7Report Type:Expedited (15-DaCompany Report #04-07-0993 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Health Clozapine - Ivax Hospitalization - Cardiac Failure Professional Pharmaceuticals, Initial or Prolonged Congestive Other Inc. Tablets PS ORAL 600MG QD ORAL Cardiomyopathy Pneumonia Viral Infection Date:09/22/04ISR Number: 4457626-9Report Type:Expedited (15-DaCompany Report #04-09-1301 Age:67 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Aspiration Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 200-400MG QD ORAL Date:09/22/04ISR Number: 4457627-0Report Type:Expedited (15-DaCompany Report #04-09-1304 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Renal Failure Health Clozapine - Ivax Hospitalization - Professional Pharmaceuticals, Initial or Prolonged Other Inc. Tablets PS ORAL 50MG QD ORAL Date:09/22/04ISR Number: 4457628-2Report Type:Expedited (15-DaCompany Report #2004S1002703 Age:78 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg Mylan PS ORAL 25MG Q HS, Other ORAL Carbidopa/Levodopa(2 5mg/100mg Qid, 06/30 ) C Date:09/22/04ISR Number: 4457629-4Report Type:Expedited (15-DaCompany Report #2004S1002692 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dyspnoea Health Clozapine Tablets Professional 100 Mg Mylan PS ORAL 200MG Q AM Other AND 400 MG Q H, ORAL Zolpidem C Albuterol Sulfate C Methylprednisolone) C Calcium With Vitamin D C Vitamin E C Ranitidine C Metformin C Aripiprazole C Carvedilol C Paroxetine C 22-Feb-2006 08:30 AM Page: 2854 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Clopidogrel C Meclizine (Prn) C Ezetimib C Simvastatin C Metoclopramide C Oxybutynin C Pantoprazole C Docusate Sodum C Losartan/Hctz C Date:09/22/04ISR Number: 4457630-0Report Type:Expedited (15-DaCompany Report #2004S1002671 Age:67 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional 100 Mg Mylan PS ORAL 400MG, QD, Other ORAL Date:09/22/04ISR Number: 4457631-2Report Type:Expedited (15-DaCompany Report #2004S1002442 Age:58 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Health Clozapine Tablets 25 Constipation Professional Mg Mylan PS ORAL 25MG, TID, Intestinal Obstruction Other ORAL Pneumonia Aspiration Clozapine Tablets Sepsis 100 Mg Mylan SS Mylan ORAL 400MG HS, ORAL Benzotropine (Purepac) SS 2MG BID 2 WK Geodon(Pfizer) SS 160 MG QAM AND 80MG Q 5PM Bisacodyl C Magnesium Citrate C Polyehtylene Glycol C Divalproex C Date:09/22/04ISR Number: 4459298-6Report Type:Direct Company Report #CTU 227805 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Pain Upper Clozapine 100mg Cardio-Respiratory Arrest Mylan Constipation Pharmaceuticals PS Mylan Faecaloma Pharmaceuticals ORAL SEE IMAGE Gastrointestinal Motility Geodon C Disorder Benztropin C Infrequent Bowel Nitroglycerine C Movements Docusate Sodium C Intestinal Obstruction Synthroid C Pneumonia Aspiration Metamucil C Restlessness Depakote C Sepsis Bisacodyl C Skin Discolouration Aspirin C Urinary Retention Clonidine C Urine Output Increased 22-Feb-2006 08:30 AM Page: 2855 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/23/04ISR Number: 4456725-5Report Type:Expedited (15-DaCompany Report #PHBS2004SE12324 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Leponex PS Novartis Sector: Initial or Prolonged Blood Triglycerides Pharma ORAL 100 mg/d 5475 DAY Increased Cerebral Infarction Embolism Gait Disturbance Hypoaesthesia Tremor Date:09/23/04ISR Number: 4456779-6Report Type:Expedited (15-DaCompany Report #PHEH2004US10116 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Metastatic Neoplasm Clozaril PS Novartis Sector: Multi-Organ Failure Pharma ORAL UNK, UNK Respiratory Disorder Date:09/23/04ISR Number: 4456780-2Report Type:Expedited (15-DaCompany Report #PHEH2004US07743 Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Health Clozaril PS Novartis Sector: Overdose Professional Pharma ORAL 700 mg, QD Overweight Alcohol SS Klonopin C Date:09/23/04ISR Number: 4459359-1Report Type:Expedited (15-DaCompany Report #2004-04013 Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Foreign Clomipramine Initial or Prolonged Gastrointestinal Motility Literature Hydrochloride Disorder Health (Watson Oesophageal Dilatation Professional Laboratories) Pneumonia Aspiration Other (Clomipramine PS Watson Laboratories ORAL 200 MG, DAILY, ORAL Clozapine (Clozapine) SS ORAL 375 MG, DAILY, ORAL Date:09/24/04ISR Number: 4459288-3Report Type:Expedited (15-DaCompany Report #2004S1002711 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablet 25 Professional Mg Mylan PS Mylan ORAL 25 MG, BID, Other ORAL Morphine C 22-Feb-2006 08:30 AM Page: 2856 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/24/04ISR Number: 4459290-1Report Type:Expedited (15-DaCompany Report #2004S1002713 Age:86 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 50 MG, QD, Other ORAL Date:09/24/04ISR Number: 4459291-3Report Type:Expedited (15-DaCompany Report #2004S1002729 Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 75 MG, HS, Other ORAL Clozapine Tablets 100 Mg Mylan SS Mylan ORAL 100 MG, HS, ORAL Date:09/24/04ISR Number: 4459341-4Report Type:Expedited (15-DaCompany Report #2004S1002411 Age:87 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 18.75 MG QD, Other ORAL Potassium Chloride C Nitroglycerin C Vitamins C Aspirin C Date:09/24/04ISR Number: 4462064-9Report Type:Expedited (15-DaCompany Report #S04-USA-06150-01 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Health Lexapro Drug Level Increased Professional (Escitalopram) PS ORAL 20 MG QD PO Company Lexapro Representative (Escitalopram) SS ORAL 10 MG QD PO Lexapro (Escitalopram) SS ORAL 10 MG QD PO Lexapro (Escitalopram) SS ORAL 20 MG QD PO Lexapro (Escitalopram) SS ORAL 10 MG QD PO Clozaril (Clozapine) SS 500 MG QD Colace (Docusate Sodium) C Date:09/27/04ISR Number: 4459128-2Report Type:Expedited (15-DaCompany Report #PHNU2004DE02263 Age:38 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Level Increased Health Leponex / Clozaril Poisoning Professional (Clozapine) PS Novartis Sector: Pharma ORAL 200 mg, TID 900 DAY 22-Feb-2006 08:30 AM Page: 2857 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/27/04ISR Number: 4459294-9Report Type:Expedited (15-DaCompany Report #PHNU2004DE03270 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Medication Error Leponex / Clozaril Initial or Prolonged Somnolence (Clozapine) PS Novartis Sector: Pharma ORAL 225 mg/day 1440 MIN Orfiril "Desitin" C ORAL Unknown 1440 MIN Akineton /Aus/ C UNKNOWN Unknown Abilify C UNKNOWN Unknown Solian C UNKNOWN Unknown Date:09/27/04ISR Number: 4459414-6Report Type:Expedited (15-DaCompany Report #US-GLAXOSMITHKLINE-A0527175A Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Angle Closure Glaucoma Lamictal PS Glaxosmithkline Drug Interaction Clozaril SS Eye Pain Zoloft SS Iridotomy Gemfibrozil SS 600MG Twice per day Date:09/27/04ISR Number: 4459418-3Report Type:Expedited (15-DaCompany Report #GB-GLAXOSMITHKLINE-B0290333A Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Level Increased Paroxetine PS Glaxosmithkline ORAL 50MG Three Electrocardiogram Qt times per day Prolonged Clozaril SS ORAL Sinus Tachycardia Venlafaxine C UNKNOWN Chlorpromazine C Glaxosmithkline UNKNOWN Penicillin V C Glaxosmithkline UNKNOWN Paracetamol C Glaxosmithkline UNKNOWN Omeprazole C ORAL 20MG per day Phenoxymethylpenicil lin C Glaxosmithkline ORAL 250MG Twice per day Date:09/28/04ISR Number: 4461121-0Report Type:Expedited (15-DaCompany Report #PHHO2004CA13190 Age:66 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bundle Branch Block Left Clozaril PS Novartis Sector: Bundle Branch Block Right Pharma ORAL 88 DAY Date:09/28/04ISR Number: 4461241-0Report Type:Expedited (15-DaCompany Report #FR-ROCHE-381148 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Amylase Increased Valium PS Roche ORAL Initial or Prolonged Pancreatitis Leponex SS ORAL Pyrexia Leponex SS ORAL 3 DAY Leponex SS ORAL 3 DAY Leponex SS ORAL Leponex SS ORAL Leponex SS ORAL 22-Feb-2006 08:30 AM Page: 2858 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Leponex SS ORAL Date:09/28/04ISR Number: 4461356-7Report Type:Expedited (15-DaCompany Report #PHBS2004NZ12231 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Level Increased Clozaril PS Novartis Sector: Initial or Prolonged Haematocrit Decreased Pharma ORAL Haemoglobin Decreased Clozaril SS Novartis Sector: Hypochromic Anaemia Pharma ORAL 400 mg/d Leukocytosis Mean Cell Haemoglobin Decreased Mean Cell Volume Decreased Microcytic Anaemia Overdose Polychromic Red Blood Cells Present Pyrexia Red Cell Distribution Width Increased Sedation Tachycardia Date:09/28/04ISR Number: 4462195-3Report Type:Expedited (15-DaCompany Report #2004S1002336 Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg Mylan PS ORAL 75MG, QD, Other ORAL Clozapine Tabelts 100mg Mylan SS ORAL 400MG HS, ORAL Cogentin SS Bristol-Myers Squibb Abilify SS Bristol-Myers Squibb Simvastatin C Aripiprazole C Levothyroxine C Benztropine C Date:09/28/04ISR Number: 4463471-0Report Type:Expedited (15-DaCompany Report #DSA_24862_2004 Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Foreign Ativan PS Intentional Overdose Health Citalopram SS Suicide Attempt Professional Clopazine SS Other Movicol SS Sinemet SS Zoplicone SS Ativan SS ORAL 1 MG Q DAY PO Citalopram SS 40 MG Clozapine SS Movicol SS Sinemet SS Zoplicone SS 22-Feb-2006 08:30 AM Page: 2859 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/28/04ISR Number: 4464653-4Report Type:Expedited (15-DaCompany Report #2004066826 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiomyopathy Foreign Ziprasidone Other Health (Ziprasidone) PS ORAL 120 MG (60 Professional MG, 2 IN 1 D), ORAL Clozapine (Clozapine) SS Pimozide (Pimozide) C Date:09/28/04ISR Number: 4465076-4Report Type:Direct Company Report #CTU 228241 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Medication Error Clozapine 100 Mg PS Initial or Prolonged Mental Status Changes Warfarin C Trazodone C Niacin C Metoprolol C Lisinopril C Glyburide C Furosemide C Felodipine C Dosucsate C Digoxin C Combivent C Gualifenesin C Date:09/28/04ISR Number: 4466623-9Report Type:Direct Company Report #CTU 228163 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Leukopenia Clozapine 100 Mg Neutropenia Tabs Mylan PS Mylan ORAL 100 MG BID PO Date:09/29/04ISR Number: 4462157-6Report Type:Expedited (15-DaCompany Report #PHNU2004DE01318 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiac Arrest Consumer Leponex / Clozaril Hospitalization - Cardiopulmonary Failure (Clozapine) PS Novartis Sector: Initial or Prolonged Diabetes Mellitus Pharma ORAL between 100 - Other Diabetic Complication 300 mg/day Drug Withdrawal Syndrome Insomnia Monoparesis Obesity Oedema Pulmonary Embolism Resuscitation Schizophrenia Tachycardia 22-Feb-2006 08:30 AM Page: 2860 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/29/04ISR Number: 4462158-8Report Type:Expedited (15-DaCompany Report #PHBS2004CA12690 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Clozapine PS Novartis Sector: Increased Pharma UNKNOWN 200 mg/d Aspartate Citalopram C UNKNOWN 20 mg/d Aminotransferase Increased Constipation Cytolytic Hepatitis Hepatic Steatosis Liver Function Test Abnormal Weight Increased Date:09/29/04ISR Number: 4462164-3Report Type:Expedited (15-DaCompany Report #PHNU2004DE03284 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cataract Leponex / Clozaril Visual Disturbance (Clozapine) PS Novartis Sector: Pharma ORAL Unknown Date:09/29/04ISR Number: 4462172-2Report Type:Expedited (15-DaCompany Report #PHEH2004US10207 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Lung Lobectomy Clozaril PS Novartis Sector: Lung Neoplasm Malignant Pharma ORAL 300 mg, QD Date:09/29/04ISR Number: 4462173-4Report Type:Expedited (15-DaCompany Report #PHBS2004CA10887 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Clozaril PS Novartis Sector: Initial or Prolonged Blood Pressure Increased Pharma ORAL 12.5 mg/d Other Chills Clozaril SS Novartis Sector: Erythema Pharma ORAL 75 mg/d 27360MIN Fatigue Inderal C UNKNOWN Haematocrit Decreased Seroquel C UNKNOWN 400 mg, QHS Headache Epival C UNKNOWN 500 mg, BID Heart Rate Increased Risperdal C UNKNOWN 4 mg/d Hyperhidrosis Omega 3 C UNKNOWN Myalgia Haldol C UNKNOWN Nasal Congestion Lipitor C UNKNOWN Nasopharyngitis Synthroid C UNKNOWN Neutrophil Count Increased Pharyngolaryngeal Pain Pyrexia Rash Red Blood Cell Count Decreased Somnolence White Blood Cell Count Increased 22-Feb-2006 08:30 AM Page: 2861 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/29/04ISR Number: 4462320-4Report Type:Expedited (15-DaCompany Report #PHNR2004AU01449 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cataract Clozaril PS Novartis Sector: Tardive Dyskinesia Pharma ORAL 200mg/daily Modecate SS INTRAMUSCULAR 12.5mg/daily Date:09/29/04ISR Number: 4462848-7Report Type:Expedited (15-DaCompany Report #04-09-1268 Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiovascular Disorder Health Clozapine - Ivax Heart Rate Irregular Professional Pharmaceuticals, Heat Stroke Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 600 MG HS ORAL Haldol SS 5MG HS Clozapine - Ivax Pharmaceuticals, Inc. Tablets SS ORAL 300-400MG QD ORAL Date:09/29/04ISR Number: 4462851-7Report Type:Expedited (15-DaCompany Report #04-09-1336 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Decreased Activity Health Clozapine Tablets - Other Pneumonia Professional Ivax Weight Decreased Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 300-400MG QD ORAL Date:09/29/04ISR Number: 4462852-9Report Type:Expedited (15-DaCompany Report #04-09-1338 Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aortic Aneurysm Health Clozapine - Ivax Other Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 300 MG QD ORAL Date:09/29/04ISR Number: 4462855-4Report Type:Expedited (15-DaCompany Report #04-09-1339 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acidosis Health Clozapine - Ivax Hospitalization - Aspiration Professional Pharmaceuticals, Initial or Prolonged Cardiac Arrest Other Inc. Tablets PS Ivax Other Dehydration Pharmaceuticals, Gastroenteritis Inc. ORAL 500MG QHS Pneumonia ORAL Salmonellosis Cipro C 22-Feb-2006 08:30 AM Page: 2862 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/29/04ISR Number: 4462857-8Report Type:Expedited (15-DaCompany Report #04-09-1259 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Disease Progression Health Clozapine - Ivax Parkinson'S Disease Professional Pharmaceuticals, Other Inc. Tablet PS Ivax Pharmaceuticals, Inc. ORAL 18.5MG QD ORAL Date:09/29/04ISR Number: 4463814-8Report Type:Expedited (15-DaCompany Report #2004UW19849 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Foreign Seroquel PS Asthenia Health Clozaril SS Atherosclerosis Professional Orap SS Cardiac Arrest Other Carbamazepine C Hepatic Steatosis Clonazepam C Myocardial Ischaemia Flurazepam Obesity Hydrochloride C Pulmonary Congestion Kemadrin C Pulmonary Oedema Nova-Gabapentin C Pulmonary Thrombosis Topamax C Respiratory Arrest Somnolence Date:09/30/04ISR Number: 4463615-0Report Type:Expedited (15-DaCompany Report #2004S1002762 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 75MG QD, ORAL Other Lactulose C Date:09/30/04ISR Number: 4463617-4Report Type:Expedited (15-DaCompany Report #2004S1002476 Age:71 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional Mylan PS Mylan ORAL 50MG/DAY, Other ORAL Oxycodone/Acetamonop hen C Vitamins With Minerals C Celecoxib C Sertraline C Aripiprazole C Silver Sulfadiazine C Entacapone C Carbidopa/Levodopa C Lansoprazole C Aspirin C Buspirone C Acetaminophen C 22-Feb-2006 08:30 AM Page: 2863 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/30/04ISR Number: 4463618-6Report Type:Expedited (15-DaCompany Report #2004S1001523 Age:47 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Lung Neoplasm Malignant Health Clozaril Novartis PS Novartis Hospitalization - Pain In Extremity Professional Clozapine Tablets Initial or Prolonged Surgery 100mg Mylan SS Mylan ORAL 700MG QD, Other ORAL Cisplatin Bristol Myers Squibb SS Bristol Myers Squibb Etoposide Bristol Myers Squibb SS Bristol Myers Squibb Hydrocodone Bitartrate/Acetamino phen C Polysaccharide Iron Complex C Clonazepam C Rofecoxib C Megestrol Acetate C Darbepoetin Alfa C Date:09/30/04ISR Number: 4463629-0Report Type:Expedited (15-DaCompany Report #04-09-1283 Age:47 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Health Clozapine -Ivax Initial or Prolonged Professional Pharmaceuticals, Inc Other Tablets PS Ivax Pharmaceuticals ORAL 100-325MG QD ORAL Date:09/30/04ISR Number: 4466065-6Report Type:Expedited (15-DaCompany Report #2002069039 Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Foreign Gabapentin Clonic Convulsion Health (Gabapentin) PS ORAL 1800 MG Condition Aggravated Professional (DAILY), ORAL Grand Mal Convulsion Clozapine Loss Of Consciousness (Clozapine) SS ORAL ORAL Myoclonic Epilepsy Venlafaxine C Myoclonus Panadeine Co Neuralgia (Codeine Phosphate, Petit Mal Epilepsy Paracetamol) C Urinary Incontinence Date:10/01/04ISR Number: 4464021-5Report Type:Expedited (15-DaCompany Report #US-ABBOTT-04P-163-0274236-00 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Condition Aggravated Depakote PS ORAL 9 MON Drug Interaction Clozapine SS ORAL 100-550 mg 3 YR Gastric Disorder Aspirin C ORAL 4 MON Hepatic Neoplasm Terazosin C ORAL 9 MON Malignant Atenolol C ORAL 9 MON Psychiatric Symptom 22-Feb-2006 08:30 AM Page: 2864 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/01/04ISR Number: 4464273-1Report Type:Expedited (15-DaCompany Report #PHHO2004CA13010 Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozaril PS Novartis Sector: Life-Threatening Circulatory Collapse Professional Pharma ORAL 350 mg q hs Hospitalization - Resuscitation Epival C Initial or Prolonged Haldol C Date:10/01/04ISR Number: 4464274-3Report Type:Expedited (15-DaCompany Report #PHFR2004GB01934 Age:31 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Akathisia Health Clozaril PS Novartis Sector: Blood Pressure Increased Professional Pharma ORAL Cerebral Ventricle Clozaril SS Novartis Sector: Dilatation Pharma ORAL Extra 100mg Computerised Tomogram dose given Abnormal Clozaril SS Novartis Sector: Convulsion Pharma ORAL 500mg/day 202 DAY Drug Interaction Fluoxetine SS ORAL 20mg/day Drug Level Increased Valproate Sodium C UNKNOWN 400 mg, BID Epilepsy Grand Mal Convulsion Heart Rate Increased Medication Error Date:10/01/04ISR Number: 4464275-5Report Type:Expedited (15-DaCompany Report #PHFR2004GB03072 Age:66 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Folate Decreased Health Clozaril PS Novartis Sector: Initial or Prolonged Cardiac Failure Professional Pharma ORAL 3411 DAY Other Congestive Dyspnoea General Physical Health Deterioration Haemoglobin Decreased Mean Cell Volume Increased Neutropenia Obesity Overweight Platelet Count Decreased Urinary Tract Infection Vitamin B12 Decreased White Blood Cell Count Decreased Date:10/01/04ISR Number: 4464276-7Report Type:Expedited (15-DaCompany Report #PHFR2004GB03619 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Clozaril PS Novartis Sector: Prolonged Pharma ORAL 450mg/day Electrocardiogram T Wave Clozaril SS Novartis Sector: Abnormal Pharma ORAL 450mg/day Salivary Hypersecretion Amisulpride C UNKNOWN 600mg/day 22-Feb-2006 08:30 AM Page: 2865 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/01/04ISR Number: 4464281-0Report Type:Expedited (15-DaCompany Report #PHHO2004CA11926 Age:21 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Creatine Clozaril PS Novartis Sector: Phosphokinase Increased Pharma ORAL 550 mg, QD 300 DAY Dehydration Risperdal SS Muscle Rigidity Valproic Acid C Neuroleptic Malignant Syndrome Tachycardia Date:10/01/04ISR Number: 4464282-2Report Type:Expedited (15-DaCompany Report #PHNR2004AU01447 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Angina Pectoris Clozaril PS Novartis Sector: Lipids Increased Pharma ORAL 400 mg, QD Myocardial Ischaemia Gemfibrozil SS ORAL 1 g, QD Neutropenia Sertraline C ORAL Tachycardia Date:10/01/04ISR Number: 4464283-4Report Type:Expedited (15-DaCompany Report #PHHO2004CA13438 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Toxicity Clozaril PS Novartis Sector: Myoclonus Pharma Date:10/01/04ISR Number: 4465966-2Report Type:Direct Company Report #CTU 228571 Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Clozapine PS ORAL 50 MG TID Initial or Prolonged Dyspnoea ORAL Required Haemoptysis Intervention to Tachypnoea Prevent Permanent Impairment/Damage Date:10/04/04ISR Number: 4465185-XReport Type:Expedited (15-DaCompany Report #PHNU2003DE03105 Age:53 YR Gender:Male I/FU:F Outcome PT Death Abdominal Discomfort Other Abdominal Pain Adrenal Adenoma Adrenal Cortex Atrophy Anaemia Aspiration Blood Creatine Phosphokinase Increased Cardiomegaly Coronary Artery Atherosclerosis Dilatation Ventricular Drug Level Above Therapeutic 22-Feb-2006 08:30 AM Page: 2866 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Erosive Oesophagitis Gastrointestinal Disorder Gastrointestinal Report Source Product Role Manufacturer Route Dose Duration Haemorrhage Leponex / Clozaril Gastrointestinal Motility (Clozapine) PS Novartis Sector: Disorder Pharma ORAL 250mg/day 31680MIN Haematemesis Pirenzepine SS ORAL 50 mg/day Hepatic Congestion Neurocil SS ORAL 100 mg/day 48960MIN Hepatic Steatosis Leponex / Clozaril Hyperglycaemia (Clozapine) SS Novartis Sector: Hypochloraemia Pharma ORAL 500mg/day Hyponatraemia Leponex / Clozaril Ileus Paralytic (Clozapine) SS Novartis Sector: Lung Disorder Pharma ORAL 400mg/day 15840MIN Lung Hyperinflation Neurocil SS ORAL 50 mg/day 21600MIN Mallory-Weiss Syndrome Leponex / Clozaril Nausea (Clozapine) SS Novartis Sector: Oesophagitis Pharma ORAL 12.5 to 150 Renal Disorder mg/day 10080MIN Respiratory Failure Concor C ORAL 2.5mg/day Resuscitation Glimepiride C ORAL 2mg/day Shock Haemorrhagic Diazepam C ORAL 4mg/day 14400MIN Spleen Congestion Tavor C ORAL Unknown Tracheobronchitis Tavor C ORAL 0.5 mg/day 2880 MIN Urinary Incontinence Glianimon C ORAL 6 mg/day 30240MIN Vomiting Glianimon C ORAL 1 mg/day 7200 MIN Glianimon C ORAL 3 mg/day 11520MIN Glianimon C UNKNOWN Unknown Tavor C ORAL 1 mg/day 38880MIN Diazepam C ORAL 1mg/day 2880 MIN Bifiteral "Solvay Arzneimittel" C ORAL 23040MIN Diazepam C ORAL 2mg/day 7200 MIN Slow Sodium C ORAL 2df/day Ximovan "Aventis Pharma" I ORAL 7.5mg/day Date:10/04/04ISR Number: 4465566-4Report Type:Expedited (15-DaCompany Report #PHEH2004US10116 Age:53 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Metastatic Neoplasm Clozaril PS Novartis Sector: Multi-Organ Failure Pharma ORAL UNK, UNK Respiratory Disorder Date:10/04/04ISR Number: 4466940-2Report Type:Expedited (15-DaCompany Report #04-09-1362 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Metastatic Neoplasm Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals ORAL 75-375MG QD ORAL 22-Feb-2006 08:30 AM Page: 2867 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/04/04ISR Number: 4466942-6Report Type:Expedited (15-DaCompany Report #04-09-1357 Age:78 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals , Inc. ORAL 200-300MG QD ORAL Date:10/04/04ISR Number: 4466946-3Report Type:Expedited (15-DaCompany Report #04-09-1356 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc ORAL 200-300MG QD ORAL Date:10/05/04ISR Number: 4467664-8Report Type:Expedited (15-DaCompany Report #2004S1002400 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 50 MG Q AM, Other ORAL Clozapine Tablets 100 Mg Mylan SS Mylan ORAL 100 MG QHS, ORAL Date:10/05/04ISR Number: 4467671-5Report Type:Expedited (15-DaCompany Report #2004S1002505 Age:80 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asthenia Health Clozapine Tablets 25 Dysphagia Professional Mg Mylan PS Mylan ORAL 25 MG HS, Malaise Other ORAL Nausea Carbidopa Urinary Tract Infection Monohydrate C Calcitonin-Salmon C Phenazopyridine C Carbidopa/Levodopa C Date:10/05/04ISR Number: 4467673-9Report Type:Expedited (15-DaCompany Report #2004S1002641 Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Food Poisoning Health Clozapine Tablets Multi-Organ Failure Professional 100 Mg Mylan PS Mylan ORAL 200 MG Q HS, Other ORAL Zolpidem C Paroxetine Cr C Aripiprazole C 22-Feb-2006 08:30 AM Page: 2868 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/05/04ISR Number: 4467860-XReport Type:Expedited (15-DaCompany Report #04-09-1367 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiomegaly Health Clozapine - Tablets Myocardial Infarction Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 500MG QD ORAL Date:10/06/04ISR Number: 4467030-5Report Type:Expedited (15-DaCompany Report #PHEH2004US10604 Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Back Pain Clozaril PS Novartis Sector: Hospitalization - Chest Pain Pharma ORAL 100 mg/day Initial or Prolonged Fall Lexapro C Muscle Strain Seroquel C Pneumonia Klonopin C Amantadine C Plavix C Inderal-La C Detrol C Ultracet C Trazodone C Date:10/06/04ISR Number: 4468476-1Report Type:Expedited (15-DaCompany Report #04-08-1220 Age:51 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arthropod Bite Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 600-800MG QD ORAL Date:10/06/04ISR Number: 4468484-0Report Type:Expedited (15-DaCompany Report #04-08-1133 Age:69 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozapine - Ivax Hospitalization - Cardiac Failure Professional Pharmaceuticals, Initial or Prolonged Congestive Other Inc. Tablets PS Ivax Pneumonia Pharmaceuticals, Respiratory Failure Inc. ORAL 550MG QD ORAL Date:10/06/04ISR Number: 4469075-8Report Type:Direct Company Report #CTU 228994 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Feeling Abnormal Clozapine 25 Mg PS ORAL 3 TABLETS Hypersensitivity TWICE DAILY Myocarditis ORAL Restlessness Wellbutrin Sr C Cogentin C Depakote Er C 22-Feb-2006 08:30 AM Page: 2869 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/06/04ISR Number: 4470714-6Report Type:Expedited (15-DaCompany Report #2004UW20185 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Leukopenia Foreign Seroquel PS 106 DAY Intervention to Neutropenia Health Clozaril SS ORAL 575 MG DAILY Prevent Permanent Professional PO 3 YR Impairment/Damage Other Epival SS 89 DAY Date:10/06/04ISR Number: 4470717-1Report Type:Direct Company Report #CTU 228951 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Clozaril PS Pharmaceutical Product Complaint Date:10/06/04ISR Number: 4471447-2Report Type:Direct Company Report #CTU 228992 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Clozapine PS Circulatory Collapse Medication Error Mitral Valve Prolapse Date:10/07/04ISR Number: 4468202-6Report Type:Expedited (15-DaCompany Report #US-ABBOTT-04P-163-0274236-00 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Condition Aggravated Depakote PS ORAL 9 MON Gastric Disorder Clozapine SS ORAL 100-550 mg 3 YR Hepatic Neoplasm Aspirin C ORAL 4 MON Malignant Terazosin C ORAL 9 MON Psychiatric Symptom Atenolol C ORAL 9 MON Date:10/07/04ISR Number: 4468430-XReport Type:Expedited (15-DaCompany Report #PHEH2004US10379 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Clozaril PS Novartis Sector: Initial or Prolonged Congestive Pharma ORAL 800 mg, QD Other Cerebrovascular Accident Chronic Obstructive Pulmonary Disease Extrasystoles Heart Rate Increased Date:10/07/04ISR Number: 4468432-3Report Type:Expedited (15-DaCompany Report #PHFR2004GB03656 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dysphemia Clozapine PS Novartis Sector: Neutrophil Count Pharma ORAL 125mg/day Decreased Clozapine SS ORAL 125 mg, QD White Blood Cell Count Valproate Sodium C UNKNOWN 600 mg, QD Decreased 22-Feb-2006 08:30 AM Page: 2870 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/07/04ISR Number: 4468433-5Report Type:Expedited (15-DaCompany Report #PHFR2004GB03663 Age:44 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Dementia Clozapine PS Novartis Sector: Epilepsy Pharma ORAL 700 mg/day Myoclonus Diazepam C ORAL 10 mg/day Temazepam C ORAL 10 mg/day Date:10/07/04ISR Number: 4468459-1Report Type:Expedited (15-DaCompany Report #PHFR2003GB02133 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Health Clozaril PS Novartis Sector: Initial or Prolonged Constipation Professional Pharma ORAL 200mg/mane&30 Other Exfoliative Rash 0mg/nocte Glomerular Filtration Clozaril SS Novartis Sector: Rate Decreased Pharma ORAL 200mg/mane&25 Haemoglobin Decreased 0mg/nocte Hyperkalaemia Iron C UNKNOWN Megacolon Nausea Obstructive Uropathy Renal Failure Renal Failure Chronic Date:10/07/04ISR Number: 4471398-3Report Type:Expedited (15-DaCompany Report #04-10-1384 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Foreign Body Trauma Health Clozapine PS Ivax Pharmaceuticals ORAL Initial or Prolonged Professional Other Date:10/07/04ISR Number: 4471399-5Report Type:Expedited (15-DaCompany Report #04-10-1378 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dehydration Health Clozapine PS Ivax Pharmaceuticals ORAL 200MG QD ORAL Initial or Prolonged Diarrhoea Professional Gastrointestinal Disorder Other Date:10/07/04ISR Number: 4471402-2Report Type:Expedited (15-DaCompany Report #04-10-1386 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Enterococcal Infection Health Clozapine PS ORAL 900MG QD ORAL Initial or Prolonged Professional Other Date:10/07/04ISR Number: 4471407-1Report Type:Expedited (15-DaCompany Report #04-10-1383 Age:81 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bladder Operation Health Clozapine - Ivax Cardio-Respiratory Arrest Professional Pharmaceuticals, Procedural Complication Other Inc. Tablets PS Ivax 22-Feb-2006 08:30 AM Page: 2871 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pharmaceuticals, Inc. ORAL 100-200MG QD ORAL Date:10/07/04ISR Number: 4471408-3Report Type:Expedited (15-DaCompany Report #04-10-1372 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Injury Health Clozapine - Ivax Initial or Prolonged Intentional Self-Injury Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals Inc. ORAL 50-500MG QD ORAL Date:10/07/04ISR Number: 4471412-5Report Type:Expedited (15-DaCompany Report #04-10-1371 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Miosis Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 300-500MG QD ORAL Date:10/07/04ISR Number: 4471414-9Report Type:Expedited (15-DaCompany Report #04-10-1387 Age:67 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Brain Neoplasm Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 300MG QD ORAL Date:10/07/04ISR Number: 4471416-2Report Type:Expedited (15-DaCompany Report #04-10-1385 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Wound Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 350-550MG QD ORAL Date:10/07/04ISR Number: 4471464-2Report Type:Direct Company Report #CTU 229067 Age:18 YR Gender:Male I/FU:I Outcome PT Hospitalization - Drug Level Above Initial or Prolonged Therapeutic Heart Rate Increased Lethargy 22-Feb-2006 08:30 AM Page: 2872 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Neuroleptic Malignant Syndrome Pancreatitis Report Source Product Role Manufacturer Route Dose Duration Speech Disorder Clozapine (Ivax) PS Ivax ORAL SEE IMAGE Quetiapine C Lorazepam C Haldol C Date:10/07/04ISR Number: 4472341-3Report Type:Expedited (15-DaCompany Report #2004071878 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Health Geodon (Ziprasidone) PS 240 MG (2 IN Other Foreign Body Aspiration Professional 1 D) Intestinal Obstruction Benzatropine Pneumonia Aspiration Mesilate Sepsis (Benzatropine Mesilate) SS 4 MG (2 IN 1 D) Clozapine (Clozapine) SS ORAL 475 MG, ORAL Bisacodyl (Bisacodyl) C Magnesium Citrate (Magnesium Citrate) C Macrogol (Macrogol) C Valproic Acid (Valproic Acid) C Date:10/08/04ISR Number: 4469200-9Report Type:Expedited (15-DaCompany Report #PHNR2004AU01443 Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Cholesterol Clozaril PS Novartis Sector: Increased Pharma 12.5-250mg/da Blood Creatine y 27360MIN Phosphokinase Increased Risperidone C Blood Glucose Increased Blood Triglycerides Increased Chest Pain Eosinophil Count Increased Low Density Lipoprotein Decreased Lymphocyte Count Decreased Myocarditis Platelet Count Increased Somnolence Troponin Increased White Blood Cell Count Increased 22-Feb-2006 08:30 AM Page: 2873 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/08/04ISR Number: 4469205-8Report Type:Expedited (15-DaCompany Report #PHEH2004US10486 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Clozaril PS Novartis Sector: Drug Level Above Pharma ORAL 500 mg, QD Therapeutic Lexapro SS ORAL 10 mg, QD Hallucination, Auditory Lexapro SS ORAL 20 mg, QD Colace C 100 mg, QD Date:10/08/04ISR Number: 4469208-3Report Type:Expedited (15-DaCompany Report #PHFR2004GB03696 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Condition Aggravated Clozapine PS Novartis Sector: Epilepsy Pharma ORAL Valproate Sodium C Carbamazepine C Date:10/08/04ISR Number: 4469618-4Report Type:Expedited (15-DaCompany Report #GB-ABBOTT-04P-167-0271848-00 Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hemiparesis Valproate Sodium PS Initial or Prolonged Hypoaesthesia Clozapine SS ORAL Liver Function Test Clozapine SS ORAL Abnormal Clozapine SS ORAL Loss Of Consciousness Anti-Parkinson Neurological Examination Agents C Overdose Peroneal Nerve Palsy Rhabdomyolysis Unevaluable Event Date:10/08/04ISR Number: 4471116-9Report Type:Expedited (15-DaCompany Report #2004S1002393 Age:47 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Metastases To Liver Health Clozapine Tablets Neuroblastoma Professional 100 Mg Mylan PS Mylan ORAL 200MG QD ORAL Other Acetminophen W/Codeine C Lithium C Date:10/08/04ISR Number: 4471117-0Report Type:Expedited (15-DaCompany Report #2004S1002445 Age:53 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neoplasm Malignant Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 200MG Q AM Other AND 300MG Q HS ORAL Chemotherapy C Radiotherapy C Fluphenazine Deconoate C Docusate C 22-Feb-2006 08:30 AM Page: 2874 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/08/04ISR Number: 4471118-2Report Type:Expedited (15-DaCompany Report #2004S1002854 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 50MG TID ORAL Other Clozapine Tablets 100 Mg Mylan SS Mylan ORAL 100MG Q HS ORAL Albuterol C Docusate C Furosemide C Gentamicin C Oscal C Ceftriaxone C Salmeterol C Trimethoprim C Date:10/08/04ISR Number: 4473846-1Report Type:Direct Company Report #CTU 229117 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blood Creatine Clozapine PS ORAL 150 MG PO Intervention to Phosphokinase Increased DAILY Prevent Permanent Eosinophil Count Impairment/Damage Increased Date:10/10/04ISR Number: 4524936-6Report Type:Expedited (15-DaCompany Report #04-12-1691 Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Potassium Decreased Health Clozapine - Ivax Initial or Prolonged Pneumonia Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmacuticals, Inc. ORAL 300-400 QD ORAL Date:10/11/04ISR Number: 4470849-8Report Type:Expedited (15-DaCompany Report #PHEH2004US10755 Age:81 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Clozaril PS Novartis Sector: Hospitalization - Pneumonia Pharma ORAL 250 mg, QHS Initial or Prolonged Detrol C Albuterol C Catapres C Potassium Chloride C Buspar C Colace C Furosemide C Lanoxin C Pepcid C Nitro Patch C Neosporin C Glucotrol C Glucophag C Actos /Usa/ C 22-Feb-2006 08:30 AM Page: 2875 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Insulin C Ocuvite C Milk Of Magnesia C Date:10/11/04ISR Number: 4470851-6Report Type:Expedited (15-DaCompany Report #PHBS2004US13309 Age:2 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Exposure Clozapine PS Novartis Sector: Life-Threatening Coordination Abnormal Pharma ORAL A part of 100 Hospitalization - Drug Toxicity mg tab. Initial or Prolonged Hypotonia Intubation Loss Of Consciousness Muscle Rigidity Myoclonus Nystagmus Pneumonia Aspiration Respiratory Arrest Tongue Paralysis Torticollis Date:10/11/04ISR Number: 4470853-XReport Type:Expedited (15-DaCompany Report #PHBS2004US13305 Age:4 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Accidental Exposure Clozapine PS Novartis Sector: Hospitalization - Coordination Abnormal Pharma ORAL 100 mg/d Initial or Prolonged Drug Toxicity Hypotonia Loss Of Consciousness Mental Status Changes Muscle Rigidity Myoclonus Nystagmus Tongue Paralysis Torticollis Date:10/11/04ISR Number: 4470854-1Report Type:Expedited (15-DaCompany Report #PHBS2004US13306 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Accidental Exposure Clozapine PS Novartis Sector: Hospitalization - Coordination Abnormal Pharma ORAL 50 mg Initial or Prolonged Drug Toxicity (one-half of Hypotonia 100 mg tablet Loss Of Consciousness Mental Status Changes Muscle Rigidity Myoclonus Nystagmus Tongue Paralysis Torticollis 22-Feb-2006 08:30 AM Page: 2876 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/11/04ISR Number: 4470855-3Report Type:Expedited (15-DaCompany Report #PHBS2004US13308 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Accidental Exposure Clozapine PS Novartis Sector: Hospitalization - Coordination Abnormal Pharma ORAL 100 to 200 mg Initial or Prolonged Drug Toxicity Hypotonia Loss Of Consciousness Mental Status Changes Muscle Rigidity Myoclonus Nystagmus Tongue Paralysis Torticollis Date:10/11/04ISR Number: 4470856-5Report Type:Expedited (15-DaCompany Report #PHBS2004US13310 Age:5 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Accidental Exposure Clozapine PS Novartis Sector: Hospitalization - Coordination Abnormal Pharma ORAL 200 mg/d Initial or Prolonged Drug Toxicity Hypotonia Intubation Loss Of Consciousness Mental Status Changes Muscle Rigidity Myoclonus Nystagmus Respiratory Depression Tongue Paralysis Torticollis Date:10/11/04ISR Number: 4470860-7Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20041000516 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cerebral Infarction Health Haldol Decanoat PS INTRAMUSCULAR Hospitalization - Cerebrovascular Accident Professional Leponex SS OROPHARINGEAL Initial or Prolonged Paresis Truxal SS OROPHARINGEAL Disability Speech Disorder Flunitrazepam SS OROPHARINGEAL Captohexal C OROPHARINGEAL Ranitidine C Godamed C OROPHARINGEAL Beloc C OROPHARINGEAL Laxofalk C OROPHARINGEAL Date:10/12/04ISR Number: 4471493-9Report Type:Expedited (15-DaCompany Report #PHHO2004CA03053 Age:53 YR Gender:Male I/FU:F Outcome PT Death Anaemia Life-Threatening Cor Pulmonale Hospitalization - Cough Initial or Prolonged Cyanosis Drug Interaction Drug Level Increased Lobar Pneumonia 22-Feb-2006 08:30 AM Page: 2877 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Non-Small Cell Lung Cancer Metastatic Pericardial Effusion Report Source Product Role Manufacturer Route Dose Duration Pleural Effusion Health Clozaril (Clozapine) PS Novartis Sector: Professional Pharma ORAL 150 mg q am + 300 mg q hs 1814 DAY Levaquin SS 500 mg, QD Orap C ORAL 4 mg, BID Risperdal C ORAL 2 mg q am + 4 mg q hs Colace C ORAL 100 mg q hs Date:10/12/04ISR Number: 4471496-4Report Type:Expedited (15-DaCompany Report #PHEH2004US09259 Age:55 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Angle Closure Glaucoma Health Clozaril PS Novartis Sector: Initial or Prolonged Drug Interaction Professional Pharma ORAL 225 mg, UNK Other Eye Pain Lamictal "Wellcome" SS 200 mg, UNK Hypercholesterolaemia Zoloft SS 100 mg, UNK Iridotomy Gemfibrozil SS 600 mg, BID Ocular Hyperaemia Weight Increased Date:10/12/04ISR Number: 4471882-2Report Type:Expedited (15-DaCompany Report #PHBS2004CA13419 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram St Clozaril PS Novartis Sector: Segment Pharma ORAL 300 mg/d Formication Risperdal C UNKNOWN 6 mg/d Date:10/12/04ISR Number: 4472046-9Report Type:Expedited (15-DaCompany Report #04-10-1400 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozapine Tablets - Other Pancreatic Neoplasm Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 200-650 MG QD ORAL Date:10/12/04ISR Number: 4472047-0Report Type:Expedited (15-DaCompany Report #04-10-1401 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cholecystitis Infective Health Clozapine Tablets - Initial or Prolonged Pneumonia Professional Ivax Other Postoperative Infection Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 200-250 MG QD ORAL 22-Feb-2006 08:30 AM Page: 2878 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/12/04ISR Number: 4472048-2Report Type:Expedited (15-DaCompany Report #04-10-1399 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Choking Health Clozapine Tablet - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 160-300 MG QD ORAL Date:10/12/04ISR Number: 4472058-5Report Type:Expedited (15-DaCompany Report #04-06-0842 Age:47 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Health Clozapine - Ivax Myocarditis Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 75MG BID ORAL Geodon C Seroquel C Depakote C Lithium C Wellbutrin - Slow Release C Date:10/12/04ISR Number: 4472059-7Report Type:Expedited (15-DaCompany Report #04-10-1407 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Appendicitis Perforated Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 375-800MG QD ORAL Date:10/12/04ISR Number: 4474651-2Report Type:Expedited (15-DaCompany Report #2004AL000301 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Foreign Morphine So4 PS ORAL 100 MG , BID; Electrocardiogram Consumer PO Abnormal Other Clozapine (,Nul>) SS ORAL 50 MG, BID; Electrocardiogram Qt PO Corrected Interval Prolonged Hypotension Tachycardia Date:10/12/04ISR Number: 4475868-3Report Type:Expedited (15-DaCompany Report #2004070512 Age:92 YR Gender:Unknown I/FU:I Outcome PT Report Source Death Medication Error Literature Multiple Drug Overdose Health 22-Feb-2006 08:30 AM Page: 2879 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Product Role Manufacturer Route Dose Duration Gabapentin (Gabapentin) PS ORAL ORAL Clozapine (Clozapine) SS ORAL ORAL Date:10/13/04ISR Number: 4472726-5Report Type:Expedited (15-DaCompany Report #PHFR2004GB03537 Age:53 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Clozaril PS Novartis Sector: Aspartate Pharma ORAL 300mg/day 57600MIN Aminotransferase Risperidone C ORAL 1mg/day 4320 MIN Increased Risperidone C ORAL 2mg/day 14400MIN Blood Alkaline Citalopram C ORAL 30mg/day 31680MIN Phosphatase Increased Blood Creatine Phosphokinase Increased Blood Test Abnormal Cholecystitis Cholelithiasis Gamma-Glutamyltransferase Increased Malaise Myalgia Pyrexia Viral Infection Date:10/13/04ISR Number: 4472917-3Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20041002567 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Heart Rate Irregular Haldol PS UNKNOWN (5mg taken at Heat Stroke night) Clozapine SS OROPHARINGEAL Date:10/13/04ISR Number: 4473940-5Report Type:Expedited (15-DaCompany Report #2004S1002924 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 100 MG/DAY, Other ORAL Date:10/13/04ISR Number: 4473941-7Report Type:Expedited (15-DaCompany Report #2004S1002656 Age:65 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 125 MG, TID, Other ORAL Clozapine Tablets 100 Mg Mylan SS Mylan ORAL 125 MG, TID, ORAL Venlafaxine Er C 22-Feb-2006 08:30 AM Page: 2880 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Gabapentin C Lantus Insulin C Lorazepam C Galantamine C Date:10/13/04ISR Number: 4473973-9Report Type:Expedited (15-DaCompany Report #04-10-1410 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozapine - Ivax Other Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 400 MG QD ORAL Date:10/13/04ISR Number: 4474140-5Report Type:Direct Company Report #CTU 229460 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Deep Vein Thrombosis Clozapine PS Required Intervention to Prevent Permanent Impairment/Damage Date:10/13/04ISR Number: 4474316-7Report Type:Direct Company Report #CTU 229524 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Level Increased Clozapine 500 Mg PS ORAL 500 MG HS ORAL Date:10/13/04ISR Number: 4475120-6Report Type:Direct Company Report #CTU 229520 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Pressure Decreased Clozapine 25mg PS ORAL 25MG AM ORAL Clozapine 100mg SS ORAL 100MG HS ORAL Date:10/14/04ISR Number: 4473944-2Report Type:Expedited (15-DaCompany Report #PHHO2004CA14267 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Myocarditis Clozaril PS Novartis Sector: Poisoning Pharma Unknown 1440 MIN Date:10/14/04ISR Number: 4473945-4Report Type:Expedited (15-DaCompany Report #PHHO2004CA14157 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cellulitis Clozaril PS Novartis Sector: Pharma 22-Feb-2006 08:30 AM Page: 2881 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/14/04ISR Number: 4473984-3Report Type:Expedited (15-DaCompany Report #PHBS2004MX13326 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Accidental Exposure Leponex PS Novartis Sector: Diplopia Pharma ORAL 50 mg, Dizziness ONCE/SINGLE 1440 MIN Dyspnoea Captopril C ORAL Hypersomnia Vitamin A C ORAL UNK, UNK Paralysis Somnolence Date:10/14/04ISR Number: 4474512-9Report Type:Expedited (15-DaCompany Report #PHFR2004GB03462 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Macrocytic Clozaril PS Novartis Sector: Mean Cell Volume Pharma ORAL Increased Date:10/14/04ISR Number: 4474515-4Report Type:Expedited (15-DaCompany Report #PHBS2004NL13398 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Suicidal Ideation Leponex PS Novartis Sector: Suicide Attempt Pharma ORAL Anatensol SS UNKNOWN Date:10/14/04ISR Number: 4474517-8Report Type:Expedited (15-DaCompany Report #PHNU2004DE03489 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Triglycerides Leponex / Clozaril Increased (Clozapine) PS Novartis Sector: Electrocardiogram Pharma ORAL Unknown Abnormal Seroquel C UNKNOWN Unknown Electrocardiogram T Wave Ergenyl Inversion "Sanofi-Synthelabo" C ORAL Unknown Glucose Tolerance Test Abnormal Tachycardia Date:10/14/04ISR Number: 4474533-6Report Type:Expedited (15-DaCompany Report #PHEH2004US10997 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Colon Cancer Health Clozaril PS Novartis Sector: Other Colon Cancer Metastatic Professional Pharma ORAL 200 mg, QHS Pharmaceutical Product Clozapine SS ORAL 200 mg, QHS Complaint Date:10/14/04ISR Number: 4476567-4Report Type:Expedited (15-DaCompany Report #04-10-1427 Age:46 YR Gender:Male I/FU:I Outcome Death Hospitalization - 22-Feb-2006 08:30 AM Page: 2882 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Initial or Prolonged PT Report Source Product Role Manufacturer Route Dose Duration Cardio-Respiratory Arrest Health Clozapine - Ivax Pneumonia Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 300-325MG QD ORAL Date:10/14/04ISR Number: 4476568-6Report Type:Expedited (15-DaCompany Report #04-10-1428 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Health Clozapine - Ivax Hospitalization - Dyspnoea Professional Pharmaceuticals, Initial or Prolonged Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 500MG QD ORAL Date:10/15/04ISR Number: 4475285-6Report Type:Expedited (15-DaCompany Report #PHFR2004GB03254 Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dizziness Clozaril PS Novartis Sector: Initial or Prolonged Hyperhidrosis Pharma ORAL 963 DAY Medication Error Clozaril SS Novartis Sector: Pharma ORAL 150mg/mane 175mg 2880 MIN Date:10/15/04ISR Number: 4475391-6Report Type:Expedited (15-DaCompany Report #GB-ABBOTT-04P-167-0276294-00 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Valproic Acid PS ORAL Circulatory Collapse Clozapine SS ORAL Dysarthria Lamotrigine C ORAL Loss Of Consciousness Hyoscine C ORAL Sedation Codeine C ORAL Unevaluable Event Date:10/15/04ISR Number: 4475722-7Report Type:Expedited (15-DaCompany Report #PHHO2004AT14094 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatic Enzyme Increased Clozaril (Clozapine) PS Novartis Sector: Initial or Prolonged Hypokalaemia Pharma Unknown Other Psychotic Disorder Haloperidol C Respiratory Tract Risperidone C Infection Zyprexa C Seroquel C Abilify C Dominal C Melleril C Diazepam C Aquaphoril C Melperon C 22-Feb-2006 08:30 AM Page: 2883 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pantoprazole C Magnesium C Bambec C Theophylline C Aprednislon C Solian C Quetiapine C Date:10/15/04ISR Number: 4475724-0Report Type:Expedited (15-DaCompany Report #PHFR2004GB03178 Age:58 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anxiety Clozaril PS Novartis Sector: Other Blood Cholesterol Pharma ORAL 600mg/day Increased Citalopram C ORAL 40/day Coronary Artery Disease Depression Orthostatic Hypotension Date:10/15/04ISR Number: 4477460-3Report Type:Expedited (15-DaCompany Report #2004S1002442 Age:58 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Health Clozapine Tablets 25 Foreign Body Aspiration Professional Mg Mylan PS Mylan ORAL 25MG, TID, Intestinal Obstruction Other ORAL Pneumonia Aspiration Clozapine Tablets Sepsis 100 Mg Mylan SS Mylan ORAL 400MG HS, ORAL Bisacodyl C Magnesium Citrate C Polyehtylene Glycol C Divalproex C Benztropine C Geodon C Date:10/15/04ISR Number: 4477461-5Report Type:Expedited (15-DaCompany Report #2004S1002943 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chronic Obstructive Health Clozapine Tablets Initial or Prolonged Pulmonary Disease Professional 100 Mg Mylan PS Mylan ORAL 300MG Q AM Other Leukopenia Other AND 400MG HS, Pneumonia ORAL Lithium C Docusate C Calcium With Vitamin D C Levothyroxine C Loratidine C Tolterodine La C 22-Feb-2006 08:30 AM Page: 2884 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/15/04ISR Number: 4477462-7Report Type:Expedited (15-DaCompany Report #2004S1002960 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Fall Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 200MG/DAY, Other ORAL Date:10/18/04ISR Number: 4477056-3Report Type:Expedited (15-DaCompany Report #PHFR2004GB03786 Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Red Blood Cell Clozaril PS Novartis Sector: Initial or Prolonged Sedimentation Rate Pharma ORAL Increased Lithium SS Therapeutic Agent Toxicity Date:10/18/04ISR Number: 4477516-5Report Type:Expedited (15-DaCompany Report #GB-GLAXOSMITHKLINE-B0344757A Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Seroxat PS Glaxosmithkline ORAL 30MG Per day Initial or Prolonged Chlorpromazine SS Glaxosmithkline ORAL 100MG Four times per day Clonazepam SS ORAL 2MG Per day Clozaril SS ORAL Alcohol C Date:10/18/04ISR Number: 4478906-7Report Type:Expedited (15-DaCompany Report #2004S1002615 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dyspnoea Health Clozapine Tablets 25 Respiratory Arrest Professional Mg Mylan PS Mylan ORAL 25 MG Q HS, Other ORAL Clozapine Tablets 100 Mg Mylan SS Mylan ORAL 600 MG Q HS, ORAL Divalproex Sodium C Haloperidol Deconoate C Oxybutynin C Date:10/18/04ISR Number: 4478907-9Report Type:Expedited (15-DaCompany Report #2004S1002968 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 200 MG Q AM Other AND 300 MG HS, ORAL Ramipril C Furosemide C Carvedilol C Methotrexate C Digoxin C Risperidone C 22-Feb-2006 08:30 AM Page: 2885 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Iron C Folic Acid C Acetaminophen C Date:10/18/04ISR Number: 4480066-3Report Type:Expedited (15-DaCompany Report #2004075584 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Angle Closure Glaucoma Consumer Zoloft (Sertraline) PS 100 MG Drug Interaction Lamotrigine Ocular Hyperaemia (Lamotrigine) SS Clozapine (Clozapine) SS 225 MG Gemfibrozil (Gemfibrozil) C 1200 MG (600 MG, 2 IN 1 D) Date:10/18/04ISR Number: 4678694-5Report Type:Direct Company Report #CTU 237105 Age:8 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Catatonia Clozapine PS 200 MG Q PM ; Drug Withdrawal Syndrome 300 MG PM Hallucination Inappropriate Affect Therapeutic Response Unexpected With Drug Substitution Date:10/19/04ISR Number: 4478341-1Report Type:Expedited (15-DaCompany Report #IE-ABBOTT-04P-229-0276849-00 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Epilim PS UNKNOWN Clozapine SS UNKNOWN Date:10/19/04ISR Number: 4478485-4Report Type:Expedited (15-DaCompany Report #PHEH2004US08289 Age:46 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Clozaril PS Novartis Sector: Other Cardiac Arrest Pharma ORAL 500 mg, QD Circulatory Collapse Detrol SS ORAL 4 mg, QD Convulsion Synthroid C ORAL .075 mg, QD Drug Level Increased Tricor C ORAL 160 mg, QD Vomiting Niaspan C ORAL 500 mg, BID Welchol C ORAL 3 UNK, BID3SDO Date:10/19/04ISR Number: 4478487-8Report Type:Expedited (15-DaCompany Report #PHFR2004GB03462 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Macrocytic Clozaril PS Novartis Sector: Mean Cell Volume Pharma ORAL Increased 22-Feb-2006 08:30 AM Page: 2886 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/19/04ISR Number: 4478499-4Report Type:Expedited (15-DaCompany Report #PHFR2004GB03619 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Clozaril PS Novartis Sector: Corrected Interval Pharma ORAL 450mg/day Prolonged Clozaril SS Novartis Sector: Electrocardiogram Qt Pharma ORAL 450mg/day 41760MIN Prolonged Clozaril SS Novartis Sector: Electrocardiogram T Wave Pharma ORAL 500mg/day Abnormal Clozaril SS Novartis Sector: Haematuria Pharma ORAL 400mg/day Liver Function Test Amisulpride C ORAL 600mg/day Abnormal Lansoprazole C ORAL 15mg/day Obesity Maalox C ORAL 30mg/day Salivary Hypersecretion Folic Acid C ORAL 5mg/weekly Urinary Tract Infection Lactulose C ORAL 10ml/day Date:10/19/04ISR Number: 4478510-0Report Type:Expedited (15-DaCompany Report #PHEH2004US10853 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mental Disorder Clozaril PS Novartis Sector: Initial or Prolonged Stress Pharma ORAL 300 mg, QD Date:10/19/04ISR Number: 4478514-8Report Type:Expedited (15-DaCompany Report #PHRM2004FR03065 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - General Physical Health Leponex PS Novartis Sector: Initial or Prolonged Deterioration Pharma ORAL 150 mg/day Hepatosplenomegaly Lysanxia C ORAL Pericardial Rub Pericarditis Pulmonary Hypertension Urinary Retention Date:10/19/04ISR Number: 4478827-XReport Type:Expedited (15-DaCompany Report #PHBS2004CA12690 Age:46 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Clozapine PS Novartis Sector: Increased Pharma UNKNOWN 200 mg/d Aspartate Citalopram C UNKNOWN 20 mg/d Aminotransferase Increased Constipation Cytolytic Hepatitis Hepatic Steatosis Liver Function Test Abnormal Weight Increased 22-Feb-2006 08:30 AM Page: 2887 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/19/04ISR Number: 4478828-1Report Type:Expedited (15-DaCompany Report #PHEH2004US09559 Age:25 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukocytosis Clozaril PS Novartis Sector: Initial or Prolonged Malaise Pharma ORAL 500 mg, QHS Other Nausea Clozaril SS Novartis Sector: Pyrexia Pharma ORAL 12.5 mg, BID Tachycardia Clozaril SS Novartis Sector: Viral Infection Pharma ORAL 25 mg, BID Vomiting Prolixin C ORAL 10mg Qam & 20mg Qpm Seroquel C ORAL 400mg BID & 200mg QHS 14400MIN Seroquel C 400mg Qam & 300mg QPM Depakote C ORAL 500 mg, BID Depakote C 500mg Qam & 1000mgQpm Zyprexa C ORAL 10 mg, BID Prolixin Decanoate C 25mg, Q 2 weeks Date:10/19/04ISR Number: 4478829-3Report Type:Expedited (15-DaCompany Report #PHNU2004DE03515 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Lymphoma Leponex / Clozaril Initial or Prolonged (Clozapine) PS Novartis Sector: Other Pharma ORAL Unknown Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL 50 mg, BID Solian C ORAL Unknown Date:10/19/04ISR Number: 4478831-1Report Type:Expedited (15-DaCompany Report #PHBS2004CL13716 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Hypersensitivity Leponex PS Novartis Sector: Initial or Prolonged Pneumonia Primary Pharma UNKNOWN Atypical Clonazepam C UNKNOWN Clomipramine C UNKNOWN Valproic Acid C UNKNOWN Lamotrigine C UNKNOWN Olanzapine C UNKNOWN Trazodone C UNKNOWN Date:10/19/04ISR Number: 4479745-3Report Type:Expedited (15-DaCompany Report #04-10-1435 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intestinal Perforation Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 700MG QD ORAL 22-Feb-2006 08:30 AM Page: 2888 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/19/04ISR Number: 4479747-7Report Type:Expedited (15-DaCompany Report #04-10-1439 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coronary Artery Health Clozapine - Ivax Atherosclerosis Professional Pharmaceuticals, Myocardial Infarction Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 125-600MG QD ORAL Date:10/19/04ISR Number: 4480977-9Report Type:Expedited (15-DaCompany Report #04-10-1434 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Clozapine - Ivax Injury Professional Pharmaceuticals, Road Traffic Accident Other Inc. Tablets PS Ivax Pharmaceuticals, Inc ORAL 100-600MG QD ORAL Date:10/20/04ISR Number: 4479856-2Report Type:Expedited (15-DaCompany Report #PHBS2004LV13658 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Catatonia Health Leponex PS Novartis Sector: Hospitalization - Fall Professional Pharma ORAL 400 mg7d Initial or Prolonged Hypotension Haloperidol Muscle Rigidity Decanoate C once per Psychotic Disorder month Stupor Unresponsive To Pain Stimuli Date:10/21/04ISR Number: 4481263-3Report Type:Expedited (15-DaCompany Report #PHFR2004GB03786 Age:15 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Red Blood Cell Clozaril PS Novartis Sector: Initial or Prolonged Sedimentation Rate Pharma ORAL Increased Lithium SS Therapeutic Agent Toxicity Date:10/21/04ISR Number: 4481264-5Report Type:Expedited (15-DaCompany Report #PHFR2004GB03860 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Activated Partial Clozapine PS Novartis Sector: Thromboplastin Time Pharma ORAL Prolonged Antiphospholipid Antibodies Positive Systemic Lupus Erythematosus 22-Feb-2006 08:30 AM Page: 2889 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/21/04ISR Number: 4484018-9Report Type:Expedited (15-DaCompany Report #04-10-1452 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neoplasm Malignant Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 500-700MG QD ORAL Date:10/21/04ISR Number: 4484019-0Report Type:Expedited (15-DaCompany Report #04-10-1438 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Myocardial Health Clozapine - Ivax Infarction Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 500MG QD ORAL Date:10/22/04ISR Number: 4481998-2Report Type:Expedited (15-DaCompany Report #PHFR2004GB02282 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Clozaril (Clozapine) PS Novartis Sector: Circulatory Collapse Pharma ORAL 150mg/day Diarrhoea Clozaril (Clozapine) SS Novartis Sector: Fatigue Pharma ORAL 250 mg/day Gastroenteritis Viral Clozaril (Clozapine) SS Novartis Sector: Lung Infection Pharma ORAL 100 mg/day Myocarditis Flupentixol Productive Cough Decanoate C INTRAMUSCULAR 100 mg, BIW Sedation Ranitidine C Tachycardia Vomiting Date:10/22/04ISR Number: 4481999-4Report Type:Expedited (15-DaCompany Report #PHFR2004GB02476 Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Clozaril PS Novartis Sector: Other Dehydration Pharma ORAL 150mg/day Diarrhoea Clonazepam C ORAL .5 mg, BID Drug Level Increased Chlorpromazine C ORAL 100 mg, TID Hypovolaemia Myocarditis Pericarditis Ventricular Hypertrophy Date:10/22/04ISR Number: 4482666-3Report Type:Expedited (15-DaCompany Report #PHFR2004GB03887 Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Mania Clozaril PS Novartis Sector: Speech Disorder Pharma ORAL 150 mg/day 90720MIN 22-Feb-2006 08:30 AM Page: 2890 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/22/04ISR Number: 4483078-9Report Type:Expedited (15-DaCompany Report #PHHO2004NZ14677 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bundle Branch Block Right Clozaril PS Novartis Sector: Fall Pharma 300 mg/day 84 DAY Loss Of Consciousness Lithium C 1200 mg/day Date:10/22/04ISR Number: 4486341-0Report Type:Expedited (15-DaCompany Report #2004S1003016 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Chest Pain Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 50MG HS ORAL Other Clozapine Tablets 100 Mg Mylan SS Mylan ORAL 100MG HS ORAL Venlafaxine C Risperidone C Hydroxyzine Pamoate C Conjugated Estrogens C Aspirin C Gemfibrozil C Docusate C Gabapentin C Loperamide C Nitroglycerin Sublingual Tablets C Psyllium C Levetiracetam C Tolterodine La C Pantoprazole C Date:10/22/04ISR Number: 4486342-2Report Type:Expedited (15-DaCompany Report #2004S1003044 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bronchitis Health Clozapine Tablets Pneumonia Professional 100 Mg Mylan PS Mylan ORAL 300MG/DAY Other ORAL Biaxin C Promethazine Vc C Paroxetine C Date:10/22/04ISR Number: 4486343-4Report Type:Expedited (15-DaCompany Report #2004S1003023 Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pulmonary Embolism Other Clozapine Tablets 25 Thrombosis Mg Mylan PS Mylan ORAL 75MG BID ORAL Clozapine Tablets 100 Mg Mylan SS Mylan ORAL 100MG BID ORAL 22-Feb-2006 08:30 AM Page: 2891 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/22/04ISR Number: 4486345-8Report Type:Expedited (15-DaCompany Report #2004S1003019 Age:79 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 25 MG/DAY Other ORAL Date:10/22/04ISR Number: 4486346-XReport Type:Expedited (15-DaCompany Report #2004S1003021 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 300MG HS ORAL Other Date:10/25/04ISR Number: 4484563-6Report Type:Expedited (15-DaCompany Report #PHBS2004CA09692 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Upper Clozaril PS Novartis Sector: Initial or Prolonged Activities Of Daily Pharma ORAL Living Impaired Clozapine SS ORAL 275 mg/d Asthenia Puffer C UNKNOWN Depression Dizziness Drug Toxicity Gallbladder Disorder Gallbladder Oedema Hepatomegaly Hot Flush Liver Disorder Myalgia Swelling Syncope Tremor Date:10/25/04ISR Number: 4484565-XReport Type:Expedited (15-DaCompany Report #PHBS2004GB14007 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Crohn'S Disease Clozapine PS Novartis Sector: Diarrhoea Pharma UNKNOWN Clozapine SS Novartis Sector: Pharma UNKNOWN 300 mg/d Date:10/25/04ISR Number: 4488732-0Report Type:Expedited (15-DaCompany Report #2004072648 Age:76 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neuroleptic Malignant Foreign Zeldox (Capsules) Hospitalization - Syndrome Health (Ziprasidone) PS ORAL 80 MG, ORAL Initial or Prolonged Professional Clopazine Company (Clopazine) SS 12.5 MG Representative Clonazepam (Clonazepam) C Bromazepam (Bromazepam) C 22-Feb-2006 08:30 AM Page: 2892 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/26/04ISR Number: 4485454-7Report Type:Expedited (15-DaCompany Report #PHFR2004IE01997 Age:69 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Haemoglobin Decreased Clozaril PS Novartis Sector: Pharma ORAL Date:10/26/04ISR Number: 4485932-0Report Type:Expedited (15-DaCompany Report #04-10-1481 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Chronic Obstructive Health Clozapine - Ivax Pulmonary Disease Professional Pharmaceuticals, Respiratory Failure Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 25-300 MG QD ORAL Date:10/27/04ISR Number: 4486622-0Report Type:Expedited (15-DaCompany Report #PHFR2004GB03896 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Benign Prostatic Clozaril (Clozapine) PS Novartis Sector: Hyperplasia Pharma 400mg/day Diarrhoea Eosinophil Count Decreased Platelet Count Decreased Date:10/27/04ISR Number: 4486764-XReport Type:Expedited (15-DaCompany Report #US-JNJFOC-20041005104 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Infection Topamax PS UNKNOWN Neutropenia Clozapine SS OROPHARINGEAL 34 DAY Pyrexia Fluticasone C RESPIRATORY Weight Decreased (INHALATION) Olanzapine C taken at bedtime Divalproex Er C 250 mg every morning, 1000 mg at 5:00 p.m. Date:10/27/04ISR Number: 4487008-5Report Type:Expedited (15-DaCompany Report #PHNU2004DE03585 Age:35 YR Gender:Male I/FU:I Outcome PT Other Alanine Aminotransferase Increased Aspartate Aminotransferase Increased Blood Cholesterol Increased Blood Triglycerides Increased Gamma-Glutamyltransferase 22-Feb-2006 08:30 AM Page: 2893 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Increased Low Density Lipoprotein Increased Transaminases Increased Report Source Product Role Manufacturer Route Dose Duration Leponex / Clozaril (Clozapine) PS Novartis Sector: Pharma ORAL 100 mg, TID Ezetrol C ORAL 10 mg, QD Fluctin C ORAL 20 mg, QD Date:10/27/04ISR Number: 4487009-7Report Type:Expedited (15-DaCompany Report #PHNU2003DE03105 Age:53 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Pain Leponex / Clozaril Other Aspiration (Clozapine) PS Novartis Sector: Cardiomegaly Pharma ORAL 250mg/day 31680MIN Constipation Pirenzepine SS ORAL 50 mg/day Drug Level Above Neurocil SS ORAL 100 mg/day 48960MIN Therapeutic Leponex / Clozaril Flatulence (Clozapine) SS Novartis Sector: Gastrointestinal Pharma ORAL 500mg/day Haemorrhage Leponex / Clozaril Gastrointestinal Motility (Clozapine) SS Novartis Sector: Disorder Pharma ORAL 400mg/day 15840MIN Haematemesis Neurocil SS ORAL 50 mg/day 21600MIN Hepatic Congestion Leponex / Clozaril Ileus Paralytic (Clozapine) SS Novartis Sector: Mallory-Weiss Syndrome Pharma ORAL 12.5 to 150 Nausea mg/day 10080MIN Oesophagitis Concor C ORAL 2.5mg/day Renal Disorder Glimepiride C ORAL 2mg/day Respiratory Failure Diazepam C ORAL 4mg/day 14400MIN Resuscitation Tavor C ORAL Unknown Salivary Hypersecretion Tavor C ORAL 0.5 mg/day 2880 MIN Shock Haemorrhagic Glianimon C ORAL 6 mg/day 30240MIN Spleen Congestion Glianimon C ORAL 1 mg/day 7200 MIN Urinary Incontinence Glianimon C ORAL 3 mg/day 11520MIN Vomiting Glianimon C UNKNOWN Unknown Tavor C ORAL 1 mg/day 38880MIN Diazepam C ORAL 1mg/day 2880 MIN Bifiteral "Solvay Arzneimittel" C ORAL 23040MIN Diazepam C ORAL 2mg/day 7200 MIN Slow Sodium C ORAL 2df/day Ximovan "Aventis Pharma" I ORAL 7.5mg/day Date:10/27/04ISR Number: 4487016-4Report Type:Expedited (15-DaCompany Report #PHFR2004GB03923 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Arthritis Clozaril PS Novartis Sector: Pharma ORAL 22-Feb-2006 08:30 AM Page: 2894 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/27/04ISR Number: 4487020-6Report Type:Expedited (15-DaCompany Report #PHNU2004DE03584 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Cholesterol Leponex / Clozaril Increased (Clozapine) PS Novartis Sector: Blood Lactate Pharma ORAL 300 mg/day Dehydrogenase Increased Fenofibrate C 200 mg/day Blood Triglycerides Omeprazole C 20 mg/day Increased Ezetrol C 10 mg/day Gamma-Glutamyltransferase Increased High Density Lipoprotein Decreased Hyperlipidaemia Total Cholesterol/Hdl Ratio Increased Date:10/27/04ISR Number: 4487021-8Report Type:Expedited (15-DaCompany Report #PHNU2004DE03653 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Leponex / Clozaril Initial or Prolonged Grand Mal Convulsion (Clozapine) PS Novartis Sector: Pharma ORAL 300 to 400 mg/day Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL 400 to 500 mg/day 50400MIN Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL 550 to 600 mg/day 50400MIN Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL 650 mg/day 30240MIN Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL 700 mg/day 8640 MIN Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL 800 mg/day 12960MIN Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL 600 mg/day 86400MIN Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL 650 mg/day 69120MIN Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL 500 mg/day Solian SS ORAL 200 to 400 mg/day 61920MIN Solian SS ORAL 600 mg/day Hypnorex SS ORAL 600 mg/day 30240MIN Hypnorex SS ORAL 800 mg/day 11520MIN Hypnorex SS ORAL 100(?) mg/day 15840MIN Hypnorex SS ORAL 1200 mg/day 2880 MIN Hypnorex SS ORAL 1400 mg/day Tavor C ORAL 2.5 mg/day 22-Feb-2006 08:30 AM Page: 2895 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tavor C ORAL 2 to 2.5 mg/day Date:10/27/04ISR Number: 4487022-XReport Type:Expedited (15-DaCompany Report #PHFR2004GB03462 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Macrocytic Clozaril PS Novartis Sector: Mean Cell Volume Pharma ORAL Increased Date:10/27/04ISR Number: 4487023-1Report Type:Expedited (15-DaCompany Report #PHNU2004DE03515 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Lymphoma Leponex / Clozaril Hospitalization - (Clozapine) PS Novartis Sector: Initial or Prolonged Pharma ORAL 300 mg/day Solian C ORAL 300 mg/day Date:10/27/04ISR Number: 4488981-1Report Type:Expedited (15-DaCompany Report #2004S1003062 Age:69 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 50MG BID, Other THEN 75MG QD, ORAL Morphine Sulfate C Famotidine C Metoprolol C Date:10/27/04ISR Number: 4488983-5Report Type:Expedited (15-DaCompany Report #2004S1003058 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dehydration Health Clozapine Tablets PS ORAL ORAL Initial or Prolonged Nausea Professional Other Viral Infection Vomiting Date:10/27/04ISR Number: 4488985-9Report Type:Expedited (15-DaCompany Report #2004S1002703 Age:78 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 25 MG, Q HS, Other ORAL Carbidopa/Levodopa C 22-Feb-2006 08:30 AM Page: 2896 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/28/04ISR Number: 4488021-4Report Type:Expedited (15-DaCompany Report #CH-SOLVAY-00304003754 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Eosinophilia Floxyfral PS ORAL Daily dose: Initial or Prolonged Treatment Noncompliance 100 milligram(s) 37 DAY Leponex SS ORAL Daily dose: 50 milligram(s) 41 DAY Orfiril C ORAL Daily dose: 2 gram(s) Date:10/28/04ISR Number: 4488327-9Report Type:Expedited (15-DaCompany Report #PHFR2003GB02133 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Health Clozaril PS Novartis Sector: Initial or Prolonged Constipation Professional Pharma ORAL 200mg/mane&30 Other Exfoliative Rash 0mg/nocte Glomerular Filtration Clozaril SS Novartis Sector: Rate Decreased Pharma ORAL 200mg/mane&25 Haemoglobin Decreased 0mg/nocte Hyperkalaemia Iron C UNKNOWN Megacolon Nausea Obstructive Uropathy Renal Failure Renal Failure Chronic Date:10/28/04ISR Number: 4489153-7Report Type:Expedited (15-DaCompany Report #04-10-1485 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coma Health Clozapine Tablets - Hospitalization - Excoriation Professional Ivax Initial or Prolonged Fall Other Pharmaceuticals, Gait Disturbance Inc. PS Ivax Sinusitis Pharmaceuticals, Inc. ORAL ORAL Date:10/28/04ISR Number: 4489159-8Report Type:Expedited (15-DaCompany Report #04-10-1488 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bronchitis Acute Health Clozapine Tablets - Other Coma Professional Ivax Resuscitation Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL ORAL Date:10/28/04ISR Number: 4489220-8Report Type:Expedited (15-DaCompany Report #04-10-1483 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Hospitalization - Foreign Body Trauma Health Initial or Prolonged Professional 22-Feb-2006 08:30 AM Page: 2897 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Product Role Manufacturer Route Dose Duration Clozapine Tablets - Ivax Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 25-100MG QD ORAL Date:10/28/04ISR Number: 4491274-XReport Type:Expedited (15-DaCompany Report #2004PK01743 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Foreign Seroquel PS 400 TO 800 MG Initial or Prolonged Neutropenia Health Seroquel SS ORAL 400 MG DAILY Professional PO Other Leponex SS 200 TO 300 MG Leponex SS 100 TO 150 MG Leponex SS ORAL 75 MG DAILY PO Leponex SS ORAL 50 MG DAILY PO Leponex SS ORAL 25 MG DAILY PO Leponex SS ORAL 0 MG DAILY PO Leponex SS ORAL 12.5 MG DAILY PO Abilify SS ORAL 7.5 MG DAILY PO Abilify SS ORAL 15 MG DAILY PO Abilify SS ORAL 22.5 MG DAILY PO Abilify SS ORAL 30 MG DAILY PO Abilify SS ORAL 30.75 MG DAILY PO Abilify SS ORAL 0 MG DAILY PO Abilify SS ORAL 15 MG DAILY PO Abilify SS ORAL 30 MG DAILY PO Abilify SS ORAL 37.5 MG DAILY PO Madopar SS ORAL 62.5 MG DAILY PO Madopar SS ORAL 125 MG DAILY PO Madopar SS ORAL 187.5 MG DAILY PO Madopar SS ORAL 250 MG DAILY PO Madopar SS ORAL 187.5 MG DAILY PO Madopar SS ORAL 125 MG DAILY PO Madopar SS ORAL 67.5 MG DAILY PO 22-Feb-2006 08:30 AM Page: 2898 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Madopar SS ORAL 0 MG DAILY PO Madopar SS ORAL 187.5 MG DAILY PO Madopar SS ORAL 250 MG DAILY PO Sinemet-Cr SS 200 DAILY Sinemet-Cr SS 400 DAILY Sinemet-Cr SS 600 DAILY Date:10/28/04ISR Number: 4491854-1Report Type:Direct Company Report #CTU 230709 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukocytoclastic Clozapine Ivax PS Ivax ORAL 137.5MG DAILY Initial or Prolonged Vasculitis ORAL Required Divalproex Sodium C Intervention to Haloperidol C Prevent Permanent Benztropine C Impairment/Damage Lorazepam C Trazodone C Levothyroxine C Date:10/29/04ISR Number: 4491623-2Report Type:Expedited (15-DaCompany Report #S04-USA-06118-01 Age:31 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Toxicity Health Lexapro Medication Error Professional (Escitalopram) PS ORAL 30 MG QD PO Overdose Clozapine SS 300 MG Self-Medication Vicodin C Topomax C Depakote(Valproate Semisodium) C Lopid (Gemfibrozil) C Inderal C Doxepin C Flexeril (Cyclobenzaprine Hydrochloride) C Promethazine C Date:11/01/04ISR Number: 4489421-9Report Type:Expedited (15-DaCompany Report #US-ABBOTT-04P-163-0278304-00 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chills Depakene Oral Drug Withdrawal Syndrome Solution PS ORAL Dysphoria Clozapine SS ORAL 50 mg q am, Influenza Like Illness 75 mg q pm Insomnia Clozapine SS Neutropenia Pantoprazole C ORAL Pain Glibenclamide C ORAL Suicidal Ideation Pioglitazone C ORAL Metformin C ORAL Lisinopril C ORAL Levothyroxine Sodium C ORAL Furosemide C ORAL Metoprolol C ORAL 22-Feb-2006 08:30 AM Page: 2899 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Senna C ORAL Docusate C ORAL Epoetin Alfa C SUBCUTANEOUS Epoetin Alfa C Date:11/01/04ISR Number: 4489468-2Report Type:Expedited (15-DaCompany Report #PHBS2004CA14248 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dysstasia Clozaril PS Novartis Sector: Electroencephalogram Pharma ORAL 450 to 600 Abnormal mg/day Mania Clozaril SS Novartis Sector: Psychotic Disorder Pharma ORAL 400 mg/d Reflexes Abnormal Antidiabetics C UNKNOWN Speech Disorder Tic Date:11/01/04ISR Number: 4489474-8Report Type:Expedited (15-DaCompany Report #PHFR2004GB02282 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Clozaril (Clozapine) PS Novartis Sector: Hospitalization - Circulatory Collapse Pharma ORAL 150mg/day Initial or Prolonged Diarrhoea Clozaril (Clozapine) SS Novartis Sector: Fatigue Pharma ORAL 250 mg/day Gastroenteritis Viral Clozaril (Clozapine) SS Novartis Sector: Lung Infection Pharma ORAL 100 mg/day Myocarditis Flupentixol Productive Cough Decanoate C INTRAMUSCULAR 100 mg, BIW Sedation Ranitidine C Sudden Death Tachycardia Viral Infection Viral Myocarditis Vomiting Date:11/01/04ISR Number: 4489475-XReport Type:Expedited (15-DaCompany Report #PHFR2004GB03439 Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Confusional State Clozaril PS Novartis Sector: Coordination Abnormal Pharma ORAL Drug Interaction Clozaril SS Novartis Sector: Drug Level Increased Pharma ORAL 450 mg/day 84960MIN Dysarthria Xylene SS Facial Bones Fracture Peptac C ORAL 10 mls/day Fall Propranolol C ORAL 80 mg/day Hallucination, Visual Movicol C ORAL Somnolence Salbutamol C UNK, PRN Date:11/01/04ISR Number: 4489476-1Report Type:Expedited (15-DaCompany Report #PHEH2004US10755 Age:80 YR Gender:Female I/FU:F Outcome Death Hospitalization - 22-Feb-2006 08:30 AM Page: 2900 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Initial or Prolonged PT Report Source Product Role Manufacturer Route Dose Duration Cerebrovascular Accident Clozaril PS Novartis Sector: Pneumonia Pharma ORAL 250 mg, QHS Detrol C Albuterol C Catapres C Potassium Chloride C Buspar C Colace C Furosemide C Lanoxin C Pepcid C Nitro Patch C Neosporin C Glucotrol C Glucophag C Actos /Usa/ C Insulin C Ocuvite C Milk Of Magnesia C Tylenol C Ranitidine C Levothyroxine C Date:11/01/04ISR Number: 4489477-3Report Type:Expedited (15-DaCompany Report #PHFR2004GB03800 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Atrial Fibrillation Clozaril PS Novartis Sector: Hospitalization - Circulatory Collapse Pharma ORAL 30240MIN Initial or Prolonged Dizziness Faeces Discoloured Gastrointestinal Haemorrhage Haematemesis Haemoglobin Decreased Somnolence Syncope Date:11/01/04ISR Number: 4489479-7Report Type:Expedited (15-DaCompany Report #PHHO2004CA15035 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Constipation Clozaril PS Novartis Sector: Renal Failure Pharma 325 DAY Date:11/01/04ISR Number: 4489480-3Report Type:Expedited (15-DaCompany Report #PHFR2004GB03917 Age:49 YR Gender:Male I/FU:I Outcome PT Life-Threatening Blood Creatine Hospitalization - Phosphokinase Increased Initial or Prolonged Blood Creatinine Increased 22-Feb-2006 08:30 AM Page: 2901 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Blood Urea Increased Cardiomegaly Echocardiogram Abnormal Report Source Product Role Manufacturer Route Dose Duration Electrocardiogram Clozaril PS Novartis Sector: Abnormal Pharma ORAL 275 mg, QD Myocarditis Thyroxine C ORAL 25 ug, QD Pharyngolaryngeal Pain Gliclazide C ORAL 80 mg, BID Pulmonary Oedema Venlafaxine C ORAL 75 mg, QD Pyrexia Co-Amoxiclav C ORAL 625 mg, TID Renal Failure Acute Valproate Sodium C ORAL 800 mg, BID Tachycardia Thiamine C ORAL 100 mg, QD Procyclidine C ORAL 5 mg, BID Date:11/01/04ISR Number: 4489482-7Report Type:Expedited (15-DaCompany Report #PHNU2004DE03630 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arthralgia Leponex / Clozaril Initial or Prolonged Body Temperature (Clozapine) PS Novartis Sector: Increased Pharma ORAL up to 125 C-Reactive Protein mg/day 21600MIN Increased Haldol "Janssen" C ORAL 10 mg/day 41760MIN Fatigue Haldol "Janssen" C ORAL 3 mg/day 54720MIN White Blood Cell Count Akineton Increased /Aus/ C ORAL 2 mg/day 84 DAY Date:11/01/04ISR Number: 4489483-9Report Type:Expedited (15-DaCompany Report #PHNU2004DE03633 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Leponex / Clozaril Initial or Prolonged Weight Increased (Clozapine) PS Novartis Sector: Pharma ORAL 75 mg/day Quilonum - Slow Release SS ORAL up to 1150 mg/day Seroxat "Smithkline Beecham" C ORAL 40 mg/day Date:11/01/04ISR Number: 4489484-0Report Type:Expedited (15-DaCompany Report #PHBS2004CA14233 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Confusional State Clozaril PS Novartis Sector: Disorientation Pharma ORAL 300 mg/d Fall Modecate C UNKNOWN Loss Of Consciousness Depakene C UNKNOWN Nervous System Disorder Paxil C UNKNOWN Fosamax C UNKNOWN Zantac C UNKNOWN 22-Feb-2006 08:30 AM Page: 2902 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/01/04ISR Number: 4489486-4Report Type:Expedited (15-DaCompany Report #PHEH2004US11565 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Clozaril PS Novartis Sector: Initial or Prolonged Leukopenia Pharma UNK,UNK 4882 DAY Neoplasm Malignant Date:11/01/04ISR Number: 4489501-8Report Type:Expedited (15-DaCompany Report #PHEH2004US11567 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Gastric Cancer Clozaril PS Novartis Sector: Leukopenia Pharma ORAL UNK, UNK Surgery Date:11/01/04ISR Number: 4489502-XReport Type:Expedited (15-DaCompany Report #PHNU2004DE03673 Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatinine Leponex / Clozaril Initial or Prolonged Increased (Clozapine) PS Novartis Sector: Blood Immunoglobulin E Pharma ORAL 600 mg/day Increased Eosinophilia Haemoglobin Decreased Red Blood Cell Sedimentation Rate Increased Renal Failure Date:11/01/04ISR Number: 4489503-1Report Type:Expedited (15-DaCompany Report #PHFR2004GB03962 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Exposure Clozaril PS Novartis Sector: Initial or Prolonged Feeling Abnormal Pharma ORAL 50mg Other Accidental exposure 1440 MIN Date:11/01/04ISR Number: 4489504-3Report Type:Expedited (15-DaCompany Report #PHNU2004DE03639 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Leponex / Clozaril Initial or Prolonged Parotitis (Clozapine) PS Novartis Sector: Ultrasound Scan Abnormal Pharma ORAL 150 mg/day 27360MIN Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL 200 mg/day 7200 MIN Haldol "Janssen" SS ORAL 5 mg/day 17280MIN 22-Feb-2006 08:30 AM Page: 2903 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/01/04ISR Number: 4489505-5Report Type:Expedited (15-DaCompany Report #PHBS2004GB14387 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Disturbance In Attention Clozapine PS Novartis Sector: Pharma UNKNOWN Date:11/01/04ISR Number: 4489506-7Report Type:Expedited (15-DaCompany Report #PHHO2004CA14398 Age:63 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Constipation Clozaril PS Novartis Sector: Impaired Gastric Emptying Pharma ORAL 125 mg, QD 747 DAY Vomiting Kemadrin C Date:11/01/04ISR Number: 4489507-9Report Type:Expedited (15-DaCompany Report #PHEH2004US11669 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Colonic Obstruction Clozaril PS Novartis Sector: Large Intestine Pharma ORAL UNK,UNK Perforation Megacolon Date:11/01/04ISR Number: 4489508-0Report Type:Expedited (15-DaCompany Report #PHBS2004AU14436 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bowel Sounds Abnormal Clozapine PS Novartis Sector: Initial or Prolonged Bradycardia Pharma UNKNOWN 400 mg/d 2190 DAY Catatonia Clozapine SS Novartis Sector: Drug Withdrawal Syndrome Pharma UNKNOWN 175 mg/d Eating Disorder Clozapine SS Novartis Sector: Flushing Pharma UNKNOWN 225 mg/d Hyperhidrosis Hyperreflexia Impaired Self-Care Mutism Myoclonus Negativism Overdose Posturing Social Avoidant Behaviour Somnolence Staring Stupor Tachycardia Urinary Retention Waxy Flexibility White Blood Cell Count Increased Date:11/01/04ISR Number: 4489970-3Report Type:Expedited (15-DaCompany Report #PHFR2004GB03786 Age:15 YR Gender:Female I/FU:F Outcome PT Hospitalization - Red Blood Cell Initial or Prolonged Sedimentation Rate 22-Feb-2006 08:30 AM Page: 2904 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Increased Therapeutic Agent Toxicity Report Source Product Role Manufacturer Route Dose Duration Consumer Lithium PS Glaxosmithkline UNKNOWN Clozaril SS ORAL Date:11/01/04ISR Number: 4491249-0Report Type:Expedited (15-DaCompany Report #FLUV00304003754 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Level Decreased Foreign Floxyfral Initial or Prolonged Eosinophilia Health (Fluvoxamine Treatment Noncompliance Professional Maleate) PS ORAL 100 Other MILLIGRAM(S) QD ORAL Leponex (Clozapine) SS ORAL 50 MILLIGRAM(S) QD ORAL Orfiril (Valproate Sodium) C Date:11/01/04ISR Number: 4491759-6Report Type:Expedited (15-DaCompany Report #2004071878 Age:58 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Geodon (Ziprasidone) PS UNKNOWN 240 MG (2 IN Other Intestinal Obstruction Professional 1 D) UNKNOWN Pneumonia Aspiration Benzatropine Respiratory Arrest Mesilate Sepsis (Benzatropine Mesilate) SS ORAL 4 MG (2 MG, 2 IN 1 D), ORAL Clozapine (Clozapine) SS ORAL 475 MG (4 IN 1 D) ORAL Bisacodyl (Bisacodyl) C Magnesium Citrate (Magnesium Citrate) C Macrogol (Macrogol) C Valproic Acid (Valproic Acid) C Date:11/01/04ISR Number: 4492399-5Report Type:Direct Company Report #CTU 230948 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiomegaly Clozapine PS ORAL 100 MG PO QID Deep Vein Thrombosis Ibuprofen SS ORAL 60 MG PO Q6H Pulmonary Embolism Date:11/02/04ISR Number: 4490347-5Report Type:Expedited (15-DaCompany Report #PHFR2004GB03988 Age:20 YR Gender:Male I/FU:I Outcome PT Disability Myoclonus Other Nervous System Disorder 22-Feb-2006 08:30 AM Page: 2905 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Partial Seizures Report Source Product Role Manufacturer Route Dose Duration Clozapine PS Novartis Sector: Pharma ORAL 200-400 mg/day Date:11/02/04ISR Number: 4490886-7Report Type:Expedited (15-DaCompany Report #PHFR2004GB03722 Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Clozaril PS Novartis Sector: Initial or Prolonged Blood Alkaline Pharma ORAL 600mg/day Other Phosphatase Increased Blood Thyroid Stimulating Hormone Decreased Fatigue Feeling Abnormal Heart Rate Increased Hypochromic Anaemia Listless Malaise Nausea Salivary Hypersecretion Somnolence Therapeutic Response Decreased Date:11/02/04ISR Number: 4490888-0Report Type:Expedited (15-DaCompany Report #PHBS2004NZ14512 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Clozaril PS Novartis Sector: Initial or Prolonged C-Reactive Protein Pharma ORAL Increased Haloperidol - Slow Dizziness Release C UNKNOWN 150 mg, BIW Lymphocyte Count Procyclidine C UNKNOWN 5 mg, TID, Decreased prn Malaise Neutrophilia Orthostatic Hypotension Pallor Pyrexia Date:11/02/04ISR Number: 4490894-6Report Type:Expedited (15-DaCompany Report #PHFR2004GB03840 Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breathing-Related Sleep Clozaril PS Novartis Sector: Disorder Pharma ORAL 250mg/day Sleep Apnoea Syndrome Clozaril SS Novartis Sector: Snoring Pharma ORAL 225mg/day Hyoscine C ORAL 300ug/day 22-Feb-2006 08:30 AM Page: 2906 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/02/04ISR Number: 4491413-0Report Type:Expedited (15-DaCompany Report #04-09-1263 Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hip Fracture Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals ORAL 50-300MG QD ORAL Date:11/02/04ISR Number: 4491416-6Report Type:Expedited (15-DaCompany Report #04-10-1482 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Meningitis Viral Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 800MG QD ORAL Date:11/02/04ISR Number: 4491450-6Report Type:Expedited (15-DaCompany Report #04-10-1475 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 600MG QD ORAL Date:11/02/04ISR Number: 4491452-XReport Type:Expedited (15-DaCompany Report #04-10-1474 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Colostomy Infection Health Clozapine Tablets - Initial or Prolonged Self Injurious Behaviour Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 150-700MG QD ORAL Date:11/02/04ISR Number: 4491453-1Report Type:Expedited (15-DaCompany Report #04-11-1496 Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Urosepsis Health Clozapine Capsules - Initial or Prolonged Professional Ivax Other Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 50-100 MG ORAL 22-Feb-2006 08:30 AM Page: 2907 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/02/04ISR Number: 4492844-5Report Type:Direct Company Report #CTU 231052 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Myoclonus Clozapine 300 M PS ORAL 100 MG AM ORAL, 200 MG QHS ORAL Clonazepam C Olanzapine C Date:11/02/04ISR Number: 4492845-7Report Type:Direct Company Report #CTU 231053 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tachycardia Clozapine 600 Mg PS ORAL 225 MG QAM ORAL, 375 MG QHS ORAL Benztropine C Haloperidol C Inh C B6 C Date:11/03/04ISR Number: 4491607-4Report Type:Expedited (15-DaCompany Report #PHHO2004CA14980 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Nasopharyngitis Clozaril PS Novartis Sector: Parotitis Pharma Sertraline C Lithium C Date:11/03/04ISR Number: 4491906-6Report Type:Expedited (15-DaCompany Report #PHFR2004GB03722 Age:48 YR Gender:Male I/FU:F Outcome PT Hospitalization - Anxiety Initial or Prolonged Asthenia Other Blood Alkaline Phosphatase Increased Blood Thyroid Stimulating Hormone Decreased Condition Aggravated Fatigue Feeling Abnormal Heart Rate Increased Hyperhidrosis Hyperthyroidism Hypochromic Anaemia Listless Malaise Nausea Salivary Hypersecretion Schizophrenia Sedation Somnolence Tachycardia Therapeutic Response Decreased Therapy Non-Responder 22-Feb-2006 08:30 AM Page: 2908 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tremor Report Source Product Role Manufacturer Route Dose Duration Health Clozaril PS Novartis Sector: Professional Pharma ORAL 600mg/day 78 DAY Date:11/03/04ISR Number: 4491908-XReport Type:Expedited (15-DaCompany Report #PHFR2004GB03709 Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cognitive Disorder Clozaril PS Novartis Sector: Drug Ineffective Pharma ORAL 350mg/day 310 DAY Eosinophil Count Tranylcypromine C ORAL 20 mg, QD Increased Concerta C ORAL 54 mg, QD Mean Cell Haemoglobin Concentration Decreased Mean Cell Volume Increased Neutrophil Count Increased Weight Increased Date:11/03/04ISR Number: 4491909-1Report Type:Expedited (15-DaCompany Report #PHRM2004FR03235 Age:2 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Exposure Health Leponex PS Novartis Sector: Initial or Prolonged Depressed Level Of Professional Pharma ORAL 100 mg, Consciousness ONCE/SINGLE Date:11/03/04ISR Number: 4492606-9Report Type:Expedited (15-DaCompany Report #2004S1002762 Age:75 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Parkinson'S Disease Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 75MG AND 12.4 Other MG PRN AGITATION, ORAL Lactulose C Nystatin Suspension C Date:11/03/04ISR Number: 4492610-0Report Type:Expedited (15-DaCompany Report #2004S1003126 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Myocardial Health Clozapine Tablets Infarction Professional 100 Mg Mylan PS Mylan ORAL 400MG/DAY, Other ORAL Insulin C Furosemide C Potassium C Atorvastatin C Ezetimibe C 22-Feb-2006 08:30 AM Page: 2909 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/04ISR Number: 4492613-6Report Type:Expedited (15-DaCompany Report #2004S1002711 Age:49 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Renal Failure Chronic Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 25MG, BID, Other ORAL Morphine C Date:11/03/04ISR Number: 4492645-8Report Type:Expedited (15-DaCompany Report #04-11-1508 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Health Clozapine - Tablets PS Ivax Decreased Professional Pharmaceuticals, Other Inc. ORAL 700 MG QD ORAL Date:11/03/04ISR Number: 4492647-1Report Type:Expedited (15-DaCompany Report #04-09-1304 Age:56 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Post Procedural Health Clozapine - Tablets PS Ivax Hospitalization - Complication Professional Pharmaceuticals, Initial or Prolonged Pulmonary Embolism Other Inc. ORAL 150MG QHS Renal Failure ORAL Date:11/03/04ISR Number: 4493703-4Report Type:Direct Company Report #CTU 231164 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Clozaril 25mg Initial or Prolonged Grand Mal Convulsion Novartis PS Novartis ORAL 25MG BID ORAL Date:11/03/04ISR Number: 4493743-5Report Type:Direct Company Report #CTU 231219 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pharmaceutical Product Clozapine PS ~ 500 MG Q HS 1 MON Initial or Prolonged Complaint Trazadone C Prozac C Date:11/03/04ISR Number: 4494619-XReport Type:Expedited (15-DaCompany Report #2004082912 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperchlorhydria Foreign Gabapentin Mood Altered Health (Gabapentin) PS ORAL (100 MG), Neutropenia Professional ORAL Ranitinde Hydrochloride (Ranitidine Hydrochloride) SS 150 MG (150 MG, 1 IN 1 D) Clozapine (Clozapine) SS ORAL (162.5 MG), ORAL 22-Feb-2006 08:30 AM Page: 2910 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lamotrigine (Lamotrigine) SS ORAL ORAL Risperidone (Risperidone) SS ORAL (100 MG, 1 IN 1 D), ORAL Date:11/04/04ISR Number: 4492620-3Report Type:Expedited (15-DaCompany Report #PHBS2004NZ14512 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Clozaril PS Novartis Sector: Initial or Prolonged C-Reactive Protein Pharma ORAL Increased Haloperidol - Slow Dizziness Release C UNKNOWN 150 mg, BIW Lymphocyte Count Procyclidine C UNKNOWN 5 mg, TID, Decreased prn Malaise Neutrophilia Orthostatic Hypotension Pallor Pyrexia Date:11/04/04ISR Number: 4493194-3Report Type:Expedited (15-DaCompany Report #PHFR2004GB02707 Age:64 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Adrenal Adenoma Clozaril PS Novartis Sector: Arrhythmia Pharma ORAL 450 mg/day Circulatory Collapse Clozaril SS Novartis Sector: Coronary Artery Pharma ORAL 400 mg/day Atherosclerosis Sinemet C Coronary Artery Disease Amitriptyline C 10 mg/day Drug Level Increased Quetiapine I 150mg & 50 mg Gastritis Haemorrhagic Liver Disorder Myocardial Ischaemia Paralysis Pulmonary Congestion Pulmonary Oedema Salivary Hypersecretion Urinary Incontinence Date:11/04/04ISR Number: 4493195-5Report Type:Expedited (15-DaCompany Report #PHFR2004GB03072 Age:66 YR Gender:Female I/FU:F Outcome PT Hospitalization - Blood Folate Decreased Initial or Prolonged Cardiac Failure Other Congestive Dyspnoea General Physical Health Deterioration Haemoglobin Decreased Mean Cell Volume Increased Neutropenia Obesity Overweight 22-Feb-2006 08:30 AM Page: 2911 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pancytopenia Pernicious Anaemia Platelet Count Decreased Report Source Product Role Manufacturer Route Dose Duration Urinary Tract Infection Clozaril PS Novartis Sector: Vitamin B12 Decreased Pharma ORAL 3411 DAY White Blood Cell Count Decreased Date:11/04/04ISR Number: 4494405-0Report Type:Direct Company Report #CTU 231306 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Rash Mylan (Generic Clozaril) PS Mylan 400 MG/D Date:11/05/04ISR Number: 4494244-0Report Type:Expedited (15-DaCompany Report #PHBS2004DK14697 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Leponex PS Novartis Sector: Life-Threatening Cardiac Arrest Pharma ORAL 100 mg, QID Disability Ciproxin C ORAL 750 mg, BID Ciproxin C ORAL 500 mg, BID Disipal C ORAL 50 mg, QID Oxazepam C ORAL max. 15 mg 4 times daily by need Nozinan C ORAL max. 50 mg 4 times daily by need Pinex C ORAL max. 750 mg 4 times daily by nee Date:11/05/04ISR Number: 4494246-4Report Type:Expedited (15-DaCompany Report #PHBS2004NL14709 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Arrhythmia Leponex PS Novartis Sector: Cardiac Failure Pharma ORAL 425 mg/d Disorientation Oxazepam I UNKNOWN 25 mg, BID Drug Level Increased Paroxetine I ORAL 60 mg/d Myocardial Infarction Nephritis Pericarditis Renal Impairment Syncope Tachycardia Date:11/05/04ISR Number: 4494247-6Report Type:Expedited (15-DaCompany Report #PHBS2004SE14720 Age:58 YR Gender:Male I/FU:I Outcome PT Death Arteriosclerosis Hospitalization - Arthralgia Initial or Prolonged Cardiac Failure Acute Cough 22-Feb-2006 08:30 AM Page: 2912 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pneumonia Pulmonary Embolism Sudden Cardiac Death Report Source Product Role Manufacturer Route Dose Duration Leponex PS Novartis Sector: Pharma ORAL 25 mg/d since a few years Aricept C ORAL 10 mg/d Madopar Quick C ORAL Madopar Mite C ORAL Detrusitol C ORAL 2 mg/d Remeron C ORAL 30 mg/d Edronax C ORAL 4 mg/d Comtess C ORAL 200 mg/d Triobe C ORAL Losec Mups C ORAL 10 mg/d Date:11/05/04ISR Number: 4494248-8Report Type:Expedited (15-DaCompany Report #PHFR2001GB00788 Age:20 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Clozaril PS Novartis Sector: Other Pharma ORAL 250mg/day Clozaril SS Novartis Sector: Pharma ORAL 350mg/day Zopiclone C UNK, PRN Doxycycline C Date:11/05/04ISR Number: 4494249-XReport Type:Expedited (15-DaCompany Report #PHFR2004IE02073 Age:49 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bacillus Infection Clozaril PS Novartis Sector: Bilirubin Urine Pharma ORAL 675mg/day Blood Bilirubin Increased Augmentin C Blood Creatinine Increased Blood Glucose Increased Blood Urea Increased Dehydration Diabetes Mellitus Dysuria Glucose Urine Present Haematuria Heart Rate Increased Malaise Pallor Protein Urine Present Pyrexia Tachycardia Urinary Tract Infection Urine Abnormality Urobilin Urine Present Vomiting White Blood Cell Count Increased 22-Feb-2006 08:30 AM Page: 2913 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/05/04ISR Number: 4494251-8Report Type:Expedited (15-DaCompany Report #PHNU2004DE03284 Age:20 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cataract Leponex / Clozaril Visual Disturbance (Clozapine) PS Novartis Sector: Pharma ORAL 75 mg/day Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL < 75 mg/day Date:11/05/04ISR Number: 4494253-1Report Type:Expedited (15-DaCompany Report #PHBS2004GB14007 Age:29 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Crohn'S Disease Clozapine PS Novartis Sector: Diarrhoea Pharma UNKNOWN Perianal Abscess Clozapine SS Novartis Sector: Pharma UNKNOWN 300 mg/d Date:11/05/04ISR Number: 4494255-5Report Type:Expedited (15-DaCompany Report #PHBS2004NZ14330 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Lower Respiratory Tract Clozaril PS Novartis Sector: Infection Pharma ORAL Neutrophilia Paracetamol C Pyrexia Tachycardia Urinary Tract Infection Date:11/05/04ISR Number: 4494256-7Report Type:Expedited (15-DaCompany Report #PHBS2004NZ14332 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Alkaline Clozaril PS Novartis Sector: Phosphatase Increased Pharma ORAL 48960MIN Catecholamines Urine Clozaril SS Novartis Sector: Increased Pharma ORAL 100 mg, BID Electrocardiogram Qt Clozaril SS Novartis Sector: Prolonged Pharma ORAL 100 mg/d Headache Epilim C UNKNOWN 500 mg, BID Hyperhidrosis Quetiapine C UNKNOWN 400 mg, TID Pyrexia Tachycardia Date:11/05/04ISR Number: 4494259-2Report Type:Expedited (15-DaCompany Report #PHBS2004CH14715 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Insipidus Leponex PS Novartis Sector: Polydipsia Pharma UNKNOWN 350 mg/d Risperdal SS UNKNOWN 4 mg/d Tegretol C UNKNOWN 450 mg/d Temesta C UNKNOWN 6.5 mg/d Semap C ORAL 1 DF, QW2 Eltroxin C UNKNOWN 0.05 mg/d Calcium C ORAL 1 tablet/d 22-Feb-2006 08:30 AM Page: 2914 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Magnesiocard C UNKNOWN 10 mg/d Flatulex C UNKNOWN if needed Date:11/05/04ISR Number: 4494260-9Report Type:Expedited (15-DaCompany Report #PHNU2004DE03686 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypertension Health Leponex / Clozaril Medication Error Professional (Clozapine) PS Novartis Sector: Pharma ORAL 150 mg, ONCE/SINGLE 1440 MIN Fluctin C ORAL Unknown Melperone C ORAL Unknown Date:11/05/04ISR Number: 4494268-3Report Type:Expedited (15-DaCompany Report #PHNU2004DE03721 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Lactate Health Leponex / Clozaril Dehydrogenase Increased Professional (Clozapine) PS Novartis Sector: C-Reactive Protein Pharma ORAL up to Increased 425mg/day Drug Interaction Solian SS ORAL Unknown Gamma-Glutamyltransferase Increased Hepatic Enzyme Increased Transaminases Increased Date:11/05/04ISR Number: 4494957-0Report Type:Direct Company Report #CTU 231395 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutrophil Count Clozapine 25 Mg Initial or Prolonged Decreased Ivax PS Ivax ORAL 25 MG White Blood Cell Count BEDTIME Decreased ORAL Date:11/05/04ISR Number: 4496444-2Report Type:Expedited (15-DaCompany Report #2004S1003152 Age:69 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 150 MG/DAY, Other ORAL Date:11/05/04ISR Number: 4496446-6Report Type:Expedited (15-DaCompany Report #2004S1003155 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 25 MG QD, Other ORAL Morphine C Fentanyl C Iv Hydration C Haloperidol C 22-Feb-2006 08:30 AM Page: 2915 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/05/04ISR Number: 4496575-7Report Type:Expedited (15-DaCompany Report #2004S1003165 Age:81 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 12.5 MG QD, Other ORAL Date:11/05/04ISR Number: 4496576-9Report Type:Expedited (15-DaCompany Report #2004S1003175 Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anaemia Health Clozapine Tablets Impaired Healing Professional 100 Mg Mylan PS Mylan ORAL 150 MG, QD, Sepsis Other ORAL Olanzapine C Risperidone C Multivitamins With Minerals C Vitamin C C Zinc Sulfate C Pantoprazole C Acetaminophen C Hydroxyzine Hcl C Piperacillin/Tazobac trim C Date:11/05/04ISR Number: 4497180-9Report Type:Expedited (15-DaCompany Report #2004S1002924 Age:43 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Clozapine Tablets Psychotic Disorder Professional 100 Mg Mylan PS Mylan ORAL 200MG/DAY, Social Avoidant Behaviour Other ORAL Bupropion Sr C Lamotrigine C Date:11/05/04ISR Number: 4497181-0Report Type:Expedited (15-DaCompany Report #2004S1002968 Age:57 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coronary Artery Health Clozapine Tablets Atherosclerosis Professional 100 Mg Mylan PS Mylan ORAL 200MG QAM AND Other 300MG HS, ORAL Ramipril C Furosemide C Carvedilol C Methotrexate C Digoxin C Risperidone C Iron C Folic Acid C Acetaminophen C Enteric Coated Aspirin C 22-Feb-2006 08:30 AM Page: 2916 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/07/04ISR Number: 4515932-3Report Type:Expedited (15-DaCompany Report #04-11-1647 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Hypersensitivity Health Clozapine - Ivax Initial or Prolonged Osteomyelitis Professional Pharmaceuticals, Other Iinc. Tablets PS ORAL 50-500MG QD ORAL Antibiotics SS Date:11/08/04ISR Number: 4495954-1Report Type:Expedited (15-DaCompany Report #PHFR2004GB02476 Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Clozaril PS Novartis Sector: Other Dehydration Pharma ORAL 150mg/day Diarrhoea Clonazepam C ORAL .5 mg, BID Drug Level Increased Chlorpromazine C ORAL 100 mg, TID Hypovolaemia Myocarditis Pericarditis Ventricular Hypertrophy Date:11/08/04ISR Number: 4495955-3Report Type:Expedited (15-DaCompany Report #PHHO2004CA15731 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Dystonia Clozaril PS Novartis Sector: Neuroleptic Malignant Pharma ORAL Not reported 1228 DAY Syndrome Tachycardia Date:11/08/04ISR Number: 4495957-7Report Type:Expedited (15-DaCompany Report #PHHO2004CA15035 Age:58 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Constipation Clozaril PS Novartis Sector: Renal Failure Pharma 92 DAY Clozaril SS Novartis Sector: Pharma 169 DAY Risperidone C Chlorpromazine C Date:11/08/04ISR Number: 4497585-6Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20041007637 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Haemoglobin Decreased Risperdal PS OROPHARINGEAL 1.5 MG bd - Neutropenia 100 MG daily, White Blood Cell Count per source Decreased documents 21 DAY Clozapine SS OROPHARINGEAL Ranitidine SS Gabapentin SS OROPHARINGEAL Lamotrigine SS OROPHARINGEAL 22-Feb-2006 08:30 AM Page: 2917 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/08/04ISR Number: 4497694-1Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20041007713 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Health Haldol PS OROPHARINGEAL Initial or Prolonged Parotitis Professional Leponex SS OROPHARINGEAL Leponex I OROPHARINGEAL Date:11/09/04ISR Number: 4496821-XReport Type:Expedited (15-DaCompany Report #PHFR2004GB04072 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Accidental Exposure Clozaril PS Novartis Sector: Pharma ORAL Date:11/09/04ISR Number: 4496822-1Report Type:Expedited (15-DaCompany Report #PHEH2004US11931 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Clozaril PS Novartis Sector: Delusion Pharma ORAL 200 mg, BID Electrocardiogram Qt Clozaril SS Novartis Sector: Corrected Interval Pharma ORAL 175 mg, BID 44640MIN Prolonged Clozaril SS Novartis Sector: Pharma ORAL 175mg Qam & 200mg Qpm Hydrochlorothiazide C Atenolol C Depakote C Date:11/09/04ISR Number: 4496823-3Report Type:Expedited (15-DaCompany Report #PHBS2004IT14883 Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Exposure Leponex PS Novartis Sector: Initial or Prolonged Lethargy Pharma UNKNOWN 200 mg, Speech Disorder ONCE/SINGLE Date:11/09/04ISR Number: 4496870-1Report Type:Expedited (15-DaCompany Report #DE-GLAXOSMITHKLINE-D0045135A Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Health Seroxat PS Glaxosmithkline ORAL 40MG Per day 42 DAY Initial or Prolonged Hepatic Enzyme Increased Professional Leponex SS ORAL 100MG Per day 65 DAY Atehexal C ORAL 50MG Per day Gastrozepin C ORAL 50MG Per day 66 DAY Solian C UNKNOWN 150MG Unknown Bifiteral C UNKNOWN 3SP Unknown Zopiclon C UNKNOWN 3.75MG Per day Date:11/09/04ISR Number: 4496871-3Report Type:Expedited (15-DaCompany Report #DE-GLAXOSMITHKLINE-D0045136A Age:48 YR Gender:Female I/FU:I Outcome PT Hospitalization - Consciousness Fluctuating Initial or Prolonged Delirium 22-Feb-2006 08:30 AM Page: 2918 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Disorientation Drug Interaction Hallucination Report Source Product Role Manufacturer Route Dose Duration Hallucinations, Mixed Health Quilonum Retard PS Glaxosmithkline ORAL 450MG Per day Sedation Professional Leponex SS ORAL Somnolence Belladonna Herb SS ORAL 20DROP Per day 21 DAY Diazepam C ORAL Orfiril C ORAL 35 DAY Haldol C ORAL Date:11/09/04ISR Number: 4499812-8Report Type:Expedited (15-DaCompany Report #04-11-1524 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Ankle Fracture Health Clozapine - Ivax Hospitalization - Unevaluable Event Professional Pharmaceuticals, Initial or Prolonged Other Inc. Tablets PS Ivax Pharmaceuticals ORAL ORAL Date:11/09/04ISR Number: 4499813-XReport Type:Expedited (15-DaCompany Report #04-11-1520 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Health Clozapine - Ivax Initial or Prolonged White Blood Cell Count Professional Pharmaceuticals, Other Decreased Other Inc. Tablets PS Ivax Pharmaceuticals ORAL ORAL Date:11/09/04ISR Number: 4499823-2Report Type:Expedited (15-DaCompany Report #04-11-1521 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Lung Neoplasm Malignant Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 400 MG ORAL Date:11/09/04ISR Number: 4499824-4Report Type:Expedited (15-DaCompany Report #04-11-1522 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hodgkin'S Disease Health Clozapine - Ivax Initial or Prolonged White Blood Cell Count Professional Pharmaceuticals, Other Decreased Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 500 MG ORAL Date:11/09/04ISR Number: 4499826-8Report Type:Expedited (15-DaCompany Report #04-11-1527 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 250-350MG QD 22-Feb-2006 08:30 AM Page: 2919 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL Date:11/09/04ISR Number: 4499952-3Report Type:Expedited (15-DaCompany Report #2004S1003177 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Clozapine Tablets 25 Initial or Prolonged Drug Effect Increased Professional Mg Ivax PS Ivax ORAL 400 - 600 MG Other Drug Interaction Other QD, ORAL Potentiation Fluvoxamine Maleate Paranoia Tablets Mylan SS Mylan Suicidal Ideation Date:11/09/04ISR Number: 4499956-0Report Type:Expedited (15-DaCompany Report #2004S1003044 Age:51 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bronchitis Health Clozapine Tablets Cardiac Failure Professional 100 Mg Mylan PS Mylan ORAL 300 MG/QHS, Congestive Other ORAL Pneumonia Biaxin C Weight Increased Promethazine Vc C Paroxetine C Date:11/09/04ISR Number: 4499961-4Report Type:Expedited (15-DaCompany Report #2004S1003021 Age:42 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 300 MG HS, Other ORAL Temazepam C Glyburide C Metformin C Enteric Coated Aspirin C Lisinopril C Venlafaxine C Fludrocoritsone C Date:11/09/04ISR Number: 4499963-8Report Type:Expedited (15-DaCompany Report #2004S1002144 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Clozapine Tablets 25 Depression Professional Mg Mylan PS Mylan ORAL 50 MG QHS, Overdose Other ORAL Partner Stress Date:11/09/04ISR Number: 4499971-7Report Type:Expedited (15-DaCompany Report #04-08-1275 Age:54 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, 22-Feb-2006 08:30 AM Page: 2920 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Inc. ORAL 50-400MG QD ORAL Chemotherapy Unknown SS Date:11/09/04ISR Number: 4499977-8Report Type:Expedited (15-DaCompany Report #04-11-1525 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Aspiration Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 100-200MG QD ORAL Date:11/10/04ISR Number: 4497129-9Report Type:Expedited (15-DaCompany Report #PHFR2004GB03519 Age:62 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Clozaril PS Novartis Sector: Initial or Prolonged Brain Scan Abnormal Pharma ORAL 350mg/day Other Cerebrovascular Disorder Condition Aggravated Demyelination Extrapyramidal Disorder General Physical Health Deterioration Hemiparesis Hypertonia Immobile Incontinence Infarction Muscle Rigidity Neurological Symptom Parkinsonism Speech Disorder Vasculitis Date:11/10/04ISR Number: 4499987-0Report Type:Expedited (15-DaCompany Report #04-11-1528 Age:69 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ankle Fracture Health Clozapine - Ivax Initial or Prolonged Arrhythmia Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 25MG QD ORAL Date:11/10/04ISR Number: 4499997-3Report Type:Expedited (15-DaCompany Report #04-11-1552 Age:17 YR Gender:Female I/FU:I Outcome PT Hospitalization - Appendicitis Initial or Prolonged C-Reactive Protein Increased Chest Pain Coxsackie Virus Serology Test Positive 22-Feb-2006 08:30 AM Page: 2921 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Diarrhoea Electrocardiogram T Wave Amplitude Decreased Report Source Product Role Manufacturer Route Dose Duration Electrocardiogram T Wave Foreign Clozapine Tablets PS ORAL ORAL Inversion Literature Valproate Sodium C Enterocolitis Health Clopenthixol C Enterovirus Serology Test Professional Positive Eosinophilia Gamma-Glutamyltransferase Increased Leukocytosis Normochromic Normocytic Anaemia Oppositional Defiant Disorder Pericardial Effusion Pyrexia Shift To The Left Thrombocythaemia Troponin T Increased Date:11/12/04ISR Number: 4499692-0Report Type:Expedited (15-DaCompany Report #PHBS2004NL15029 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiac Failure Leponex PS Novartis Sector: Hospitalization - Pharma ORAL Initial or Prolonged Glimepiride C Oxazepam C Isosorbide Dinitrate C Furosemide C Metformin C Ipratropium Bromide W/Salbutamol C Date:11/12/04ISR Number: 4500126-8Report Type:Expedited (15-DaCompany Report #PHNU2004DE01216 Age:58 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypertension Health Leponex / Clozaril Initial or Prolonged Norepinephrine Increased Professional (Clozapine) PS Novartis Sector: Pseudophaeochromocytoma Pharma ORAL 300 mg/day Tachycardia Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL 175 mg/day Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL 100 mg/day Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL Unknown 22-Feb-2006 08:30 AM Page: 2922 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/15/04ISR Number: 4500586-2Report Type:Expedited (15-DaCompany Report #FR-ABBOTT-04P-056-0279959-00 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Distension Depakote PS ORAL Important Gastrointestinal dose regimen Obstruction Clozapine SS ORAL Important Overdose dose regimen Other Psychotherapeutic Drugs C Important dose regimen Date:11/15/04ISR Number: 4500699-5Report Type:Expedited (15-DaCompany Report #PHEH2004US11963 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Clozaril PS Novartis Sector: Increased Pharma ORAL 450 mg, QD Aspartate Aminotransferase Increased Blood Alkaline Phosphatase Hepatic Enzyme Increased Date:11/15/04ISR Number: 4500701-0Report Type:Expedited (15-DaCompany Report #PHNU2004DE03793 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Ineffective Leponex / Clozaril Pleurothotonus (Clozapine) PS Novartis Sector: Pharma ORAL 12.5 mg/day 2880 MIN Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL 25 mg/day 1440 MIN Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL 50 mg/day 4320 MIN Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL 100 mg/day 2880 MIN Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL 150 mg/day 1440 MIN Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL 200 mg/day 1440 MIN Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL 400 mg/day 7200 MIN Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL 300 mg/day 1440 MIN Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL 250 mg/day 1440 MIN Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL 200 mg/day 1440 MIN 22-Feb-2006 08:30 AM Page: 2923 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL 150 mg/day 1440 MIN Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL 100 mg/day 5760 MIN Neurocil SS ORAL 350 mg/day 50400MIN Neurocil SS ORAL 250 mg/day 1440 MIN Neurocil SS ORAL 200 mg/day 1440 MIN Neurocil SS 125 mg/day 1440 MIN Neurocil SS ORAL 75 mg/day 1440 MIN Neurocil SS ORAL 50 mg/day 1440 MIN Gastrozepin C ORAL 25 mg/day 2880 MIN Gastrozepin C ORAL 50 mg/day 43200MIN Gastrozepin C ORAL 75 mg/day Date:11/15/04ISR Number: 4501186-0Report Type:Expedited (15-DaCompany Report #PHFR2004GB04189 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Lower Respiratory Tract Clozaril PS Novartis Sector: Initial or Prolonged Infection Pharma ORAL White Blood Cell Count Decreased Date:11/15/04ISR Number: 4501703-0Report Type:Direct Company Report #CTU 231937 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abnormal Behaviour Fazaclo 700 Mg Daily PS ORAL PO Aggression Luvox C Pharmaceutical Product Complaint Date:11/15/04ISR Number: 4501861-8Report Type:Direct Company Report #CTU 231969 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neutrophil Count Clozapine 100 Mg Decreased Ivax PS Ivax ORAL 300 MG BID ORAL Quetiapine C Eskalith Cr C Date:11/15/04ISR Number: 4503875-0Report Type:Expedited (15-DaCompany Report #2004086750 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukaemia Foreign Ziprasidone (Caps) Initial or Prolonged Health (Ziprasidone) PS ORAL 80 MG (1 IN 1 Other Professional D), ORAL Clozapine (Clozapine) SS 22-Feb-2006 08:30 AM Page: 2924 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/15/04ISR Number: 4503984-6Report Type:Expedited (15-DaCompany Report #03-11-1439 Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Colon Cancer Health Clozapine - Ivax Hospitalization - Professional Pharmaceuticals, Initial or Prolonged Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 200MG QD ORAL Date:11/15/04ISR Number: 4503985-8Report Type:Expedited (15-DaCompany Report #04-08-1203 Age:53 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc ORAL 100MG TID ORAL Depakote C Prolixin C Cogentin C Lotensin C Norvasc C Colace C Visken C Prilosec C Centrum Tablets C Vitamin C C Prolixin C Mylanta C Milk Of Magnesia C Lotrimin Cr C Docusate Sodium C Pindolol Tablets C Date:11/15/04ISR Number: 4503993-7Report Type:Expedited (15-DaCompany Report #2004S1003058 Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dehydration Health Clozapine Tablets 25 Initial or Prolonged Diarrhoea Professional Mg PS ORAL 75 MG QD THEN Other Nausea 50MG QD, ORAL Viral Infection Clonazepam C Vomiting Divalproex Sodium C Date:11/15/04ISR Number: 4504004-XReport Type:Expedited (15-DaCompany Report #2004S1002854 Age:83 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Apnoea Health Clozapine Tablets 25 Pneumonia Professional Mg Mylan PS Mylan ORAL 50MG, TID, Other ORAL Clozapine Tablets 100 Mg Mylan SS Mylan ORAL 100MG Q HS , ORAL Albuterol C Docusate C Furosemide C 22-Feb-2006 08:30 AM Page: 2925 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Gentamicin C Oscal C Ceftriaxone C Salmeterol C Trimethoprim C Date:11/15/04ISR Number: 4504011-7Report Type:Expedited (15-DaCompany Report #04-11-1561 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Breast Cancer Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 250-600MG QD ORAL Date:11/15/04ISR Number: 4504016-6Report Type:Expedited (15-DaCompany Report #04-11-1566 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cellulitis Health Clozapine-Ivax Initial or Prolonged Sepsis Professional Pharmaceuticals, Inc Other Tablets PS Ivax Pharmaceuticals, Inc ORAL 150MG QD ORAL Date:11/15/04ISR Number: 4504018-XReport Type:Expedited (15-DaCompany Report #04-11-1551 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Granulocytopenia Literature Clozapine Tablets PS ORAL 900-300MG QD Initial or Prolonged Neutropenia Health ORAL Other Therapy Non-Responder Professional Phenytoin SS 400 MG QD 3 MON Benztropine Mesylate C Risperidone C Date:11/15/04ISR Number: 4504041-5Report Type:Expedited (15-DaCompany Report #04-11-1570 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 500MG QD ORAL Date:11/15/04ISR Number: 4504045-2Report Type:Expedited (15-DaCompany Report #04-08-1210 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Health Clozapine - Ivax Other Delusion Professional Pharmaceuticals, Drug Level Increased Other Inc. Tablets PS ORAL 350 QD ORAL Paranoia Abilify SS 30 MG QD Treatment Noncompliance Lexapro C Klonopin C 22-Feb-2006 08:30 AM Page: 2926 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/15/04ISR Number: 4504046-4Report Type:Expedited (15-DaCompany Report #2004S1003239 Age:93 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Renal Failure Health Clozapine Tablets 25 Professional Mg Mylan PS ORAL ORAL Other Date:11/16/04ISR Number: 4502367-2Report Type:Expedited (15-DaCompany Report #PHHO2004CA11926 Age:21 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Creatine Clozaril PS Novartis Sector: Phosphokinase Increased Pharma ORAL 550 mg, QD 301 DAY Dehydration Risperdal SS 20160MIN Muscle Rigidity Valproic Acid C Neuroleptic Malignant Ativan C Syndrome Tachycardia Date:11/16/04ISR Number: 4502368-4Report Type:Expedited (15-DaCompany Report #PHFR2004GB03786 Age:15 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Clozaril PS Novartis Sector: Initial or Prolonged Blood Potassium Decreased Professional Pharma ORAL 200mg/day 97920MIN Other Blood Urea Decreased Lithium SS ORAL 1400mg/day C-Reactive Protein Clonazepam SS ORAL 2mg/day 67680MIN Increased Fatigue Grand Mal Convulsion Hypotension Malaise Mycoplasma Infection Mycoplasma Serology Positive Nausea Neutrophil Count Decreased Psychotic Disorder Pyrexia Red Blood Cell Sedimentation Rate Increased Therapeutic Agent Toxicity Viral Infection White Blood Cell Count Decreased Date:11/16/04ISR Number: 4502897-3Report Type:Direct Company Report #CTU 232023 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sedation Clozapine PS Sensory Disturbance Somnolence 22-Feb-2006 08:30 AM Page: 2927 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/16/04ISR Number: 4504232-3Report Type:Expedited (15-DaCompany Report #04-11-1576 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Neoplasm Malignant Health Clozapine Tablets PS Ivax Professional Pharmaceuticals, Other Inc. ORAL 250-900MG QD ORAL Date:11/16/04ISR Number: 4504237-2Report Type:Expedited (15-DaCompany Report #04-11-1571 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Literature Clozapine Tablets PS ORAL 200MG QD ORAL 2 YR Constipation Health Citalopram C Cytolytic Hepatitis Professional Hepatic Steatosis Psychotic Disorder Suicidal Ideation Weight Increased Date:11/16/04ISR Number: 4504242-6Report Type:Expedited (15-DaCompany Report #2004S1003273 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Myocardial Health Clozapine Tablets 25 Infarction Professional Mg Mylan PS Mylan ORAL 375 MG QD Other ORAL Clozapine Tablets 100 Mg Mylan SS Mylan ORAL 375MG QD ORAL Divalproex Sodium C Benztropine C Date:11/17/04ISR Number: 4503482-XReport Type:Expedited (15-DaCompany Report #PHEH2004US12292 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Choking Clozaril PS Novartis Sector: Hospitalization - Injury Asphyxiation Pharma ORAL 600 mg/day Initial or Prolonged Date:11/17/04ISR Number: 4503484-3Report Type:Expedited (15-DaCompany Report #PHEH2004US12142 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chronic Obstructive Clozaril PS Novartis Sector: Initial or Prolonged Pulmonary Disease Pharma ORAL 200 mg/day 3650 DAY Other Convulsion Drug Ineffective Pneumonia Schizophrenia, Paranoid Type 22-Feb-2006 08:30 AM Page: 2928 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/17/04ISR Number: 4503485-5Report Type:Expedited (15-DaCompany Report #PHEH2004US09257 Age:19 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperkalaemia Health Clozaril PS Novartis Sector: Professional Pharma ORAL 125 mg, QD Accutane SS ORAL 40 mg, QD Date:11/17/04ISR Number: 4524619-2Report Type:Periodic Company Report #C2003-2157.01 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Haematoma Health Clozapine Tablets PS Somnolence Professional Other Date:11/17/04ISR Number: 4524620-9Report Type:Periodic Company Report #2004S1000256 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Health Clozapine Tablets PS Decreased Professional Date:11/17/04ISR Number: 4524621-0Report Type:Periodic Company Report #2004S1000286 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Deep Vein Thrombosis Health Clozapine Tablets PS Professional Date:11/17/04ISR Number: 4524622-2Report Type:Periodic Company Report #2004S1000772 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Liver Function Test Health Clozapine Tablets PS ORAL ORAL Abnormal Professional Other Date:11/17/04ISR Number: 4524623-4Report Type:Periodic Company Report #2004S1000874 Age:32 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Glucose Increased Health Clozapine Tablets PS Sedation Professional Weight Increased Other Date:11/17/04ISR Number: 4524624-6Report Type:Periodic Company Report #2004S1001000 Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Liver Function Test Health Clozapine Tablets PS ORAL ORAL Abnormal Professional Clozapine Tablets Other Ivax SS ORAL ORAL 22-Feb-2006 08:30 AM Page: 2929 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/17/04ISR Number: 4524625-8Report Type:Periodic Company Report #2004S1001033 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozapine Tablets Professional Mylan PS Mylan Other Date:11/17/04ISR Number: 4524626-XReport Type:Periodic Company Report #2004S1001123 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Salivary Hypersecretion Health Clozapine Tablets PS ORAL 375 MG QD, Professional ORAL Other Date:11/17/04ISR Number: 4524627-1Report Type:Periodic Company Report #2004S1001190 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Health Clozapine Tablets PS Professional Other Date:11/17/04ISR Number: 4524628-3Report Type:Periodic Company Report #C2003-1107.01 Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Salivary Hypersecretion Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 50 MG Q AM Other AND Q HS, ORAL Clozapine Tablets 100 Mg Mylan SS ORAL 100MG Q AM, 200MG Q HS, ORAL Quetiapine Fumarate C Benztropine C Date:11/17/04ISR Number: 4524629-5Report Type:Periodic Company Report #C2003-1184.01 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 25MG QD, THEN Other 25MG BID, THEN 25MG TID, THEN 25MG QID, Date:11/17/04ISR Number: 4524630-1Report Type:Periodic Company Report #C2003-1231.01 Age:73 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 12.5MG HS, Other THEN 50MG HS, 22-Feb-2006 08:30 AM Page: 2930 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report THEN 75MGT HS, ORAL Dipyridamole/Aspirin C Carbidopa/Levodopa C Carbidopa/Levodopa Cr C Levothyroxine C Date:11/17/04ISR Number: 4524631-3Report Type:Periodic Company Report #C2003-1238.01 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eosinophilia Health Clozapine Tablets 25 White Blood Cell Count Professional Mg Mylan PS Mylan ORAL SEE IMAGE Decreased Clozapine Tablets 25 Mg Mylan SS Mylan ORAL SEE IMAGE Levothyroxine C Date:11/17/04ISR Number: 4524632-5Report Type:Periodic Company Report #C2003-1456.01 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Health Clozapine Tablets 25 Decreased Professional Mg Mylan PS Mylan ORAL 50MG Q HS, ORAL Clozapine Tablets 100 Mg Mylan SS Mylan ORAL 100MG Q AM, 200 MG Q HS, ORAL Lithium Carbonate C Date:11/17/04ISR Number: 4524633-7Report Type:Periodic Company Report #C2003-1499.01 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 25MG Q HS Other ORAL Clozapine Tablets 25 Mg Mylan SS Mylan ORAL 100 MG BID, ORAL Celecoxib C Divalproex Sodium C Glycopyrrolate C Hydroxychloroquine Sulfate C Omeprazole C Oxybutynin Chloride C Ranitidine C Ziprasidone C Date:11/17/04ISR Number: 4524634-9Report Type:Periodic Company Report #C2003-1510.01 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukocytosis Health Clozapine Tablets 25 Professional Mg PS Trazadone C 22-Feb-2006 08:30 AM Page: 2931 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lorazepam C Divalproex Sodium C Date:11/17/04ISR Number: 4524635-0Report Type:Periodic Company Report #C2003-1514.01 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan Other Zyprexa Tablets Eli Lilly SS ORAL 50MG Q HS, ORAL Date:11/17/04ISR Number: 4524636-2Report Type:Periodic Company Report #C2003-1870.01 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozapine Tablets 25 Neutrophil Count Professional Mg Mylan PS Mylan ORAL 25MG Q HS, Decreased Other ORAL Clozapine Tablets 100 Mg Mylan SS Mylan ORAL 200MG Q HS, ORAL Lithium C Lorazepam C Bupropion C Date:11/17/04ISR Number: 4524637-4Report Type:Periodic Company Report #C2003-1957.01 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozapine Tablets 25 Neutropenia Professional Mg Mylan PS Mylan ORAL 50MG BID, Other ORAL Haloperidol Injection C Lorazepam Injection C Oxcarbazepine C Date:11/17/04ISR Number: 4524638-6Report Type:Periodic Company Report #C2003-2035.01 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 50MG BID, Other ORAL Clozapine Tablets 100 Mg Mylan SS Mylan ORAL 200MG, Q HS, ORAL Date:11/17/04ISR Number: 4524639-8Report Type:Periodic Company Report #C2003-2091.01 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Other Neutrophil Count Health Decreased Professional 22-Feb-2006 08:30 AM Page: 2932 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Product Role Manufacturer Route Dose Duration Clozapine Tablets 25 Mg Mylan PS ORAL 50 MG BID, ORAL Clozapine Tablets 100 Mg Mylan SS ORAL 100MG, BID, ORAL Haloperidol C Divalproex C Omeprazole C Topiramate C Date:11/17/04ISR Number: 4524640-4Report Type:Periodic Company Report #C2003-2140.01 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 50 MG QD, Other ORAL Lorazepam C Chlorpromazine C Lithium C Haloperidol C Clonazepam C Date:11/17/04ISR Number: 4524641-6Report Type:Periodic Company Report #C2003-2141.01 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neutropenia Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 12.5MG Q PM, Other THEN 25MG QD, THEN 37.5MG Q PM, THEN50MG Q PM, THEN Albuterol Inhaler C Divalproex Sodium Dr C Lorazepam C Omeprazole C Trazodone C Paroxetine C Haloperidol Injection C Benztropine C Date:11/17/04ISR Number: 4524642-8Report Type:Periodic Company Report #C2003-2217.01 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 50MG Q PM, Other ORAL Clozapine Tablets 100 Mg Mylan SS Mylan ORAL 100MG Q AM, ORAL Clonazepam C 22-Feb-2006 08:30 AM Page: 2933 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Fluoxetine C Clomipramine C Date:11/17/04ISR Number: 4524643-XReport Type:Periodic Company Report #C2003-2240.01 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Literature Provigil Cephalon PS ORAL 100MG QD, Drug Interaction Other THEN 300MG Fall QD, ORAL Gait Disturbance Clozapine Tablets 25 Hypoxia Mg SS ORAL 25MG QHS AND TITRATED, ORAL Clozapine Tablets 100 Mg SS ORAL 100MG QD, TITRATED TO 400MG QD, THEN 450 MG QD, THEN Haloperidol C Quetiapine C Divalproex C Benztropine C Lorazepam C Levothyroxine C Furosemide C Potassium C Docusate Sodium C Date:11/17/04ISR Number: 4524644-1Report Type:Periodic Company Report #C2003-2316.01 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Health Clozapine Tablets Professional 25mg Mylan PS Mylan ORAL ORAL Other Trifluoperazine C Risperidone C Naproxen C Date:11/17/04ISR Number: 4524645-3Report Type:Periodic Company Report #C2003-2380.01 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 50MG Q HS, Other ORAL Clozapine Tablets 100 Mg Mylan SS Mylan ORAL 200MG Q HS, ORAL Augmentin 875mg Glaxosmithkline SS Glaxosmithkline ORAL 875MG BID, ORAL Divalproex Sodium C Levothyroxine C Potassium C Furosemide C 22-Feb-2006 08:30 AM Page: 2934 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/17/04ISR Number: 4524646-5Report Type:Periodic Company Report #C2003-2426.01 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 50MG Q HS, Other ORAL Clozapine Tablets 100 Mg Mylan SS Mylan ORAL 400MG HS, ORAL Olanzapine C Date:11/17/04ISR Number: 4524647-7Report Type:Periodic Company Report #C2003-2656.01 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neutropenia Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 50MG Q HS, Other ORAL Clozapine Tablets 100 Mg Mylan SS Mylan ORAL 200MG BID, ORAL Olanzapine C Divalproex Sodium C Benztropine Mesylate C Date:11/17/04ISR Number: 4524648-9Report Type:Periodic Company Report #C2003-2796.01 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozapine Tablets 25 Neutropenia Professional Mg Mylan PS Mylan ORAL 25MG HS, THEN Other 25MG BID, ORAL Acetaminophen C Carbidopa/Levodopa C Clonazepam C Entacapone C Esomeprazole Magnesium C Ferrous Sulfate C Haloperidol C Meperidine C Milk Of Magnesia C Multivitamin With Minerals C Ropinirole C Trihexyphenidyl C Date:11/17/04ISR Number: 4524815-4Report Type:Periodic Company Report #C2003-2846.01 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Health Clozapine Tablets 25 Enuresis Professional Mg Mylan PS Mylan ORAL 25MG QD, ORAL White Blood Cell Count Other Clozapine Tablets Decreased 100 Mg Mylan SS Mylan ORAL 200MG QD, ORAL Metronidazole SS 22-Feb-2006 08:30 AM Page: 2935 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Cipro Bayer SS Divalproex Sodium C Gabapentin C Hyoscyamine C Mesalamine C Tolterodine La C Date:11/17/04ISR Number: 4524817-8Report Type:Periodic Company Report #C2003-2848.01 Age:8 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dry Skin Health Clozapine Tablets 25 Exfoliative Rash Professional Mg Mylan PS Mylan ORAL 50MG BID, Photosensitivity Reaction Other ORAL Rash Erythematous Clozapine Tablets Rash Generalised 100 Mg Mylan SS Mylan ORAL 150 MG BID Rash Macular THEN 100MG Rash Pruritic BID, ORAL Divalproex Sodium C Guanfacine Hcl C Lithium Carbonate C Senna Concentrate C Docusate C Date:11/17/04ISR Number: 4524822-1Report Type:Periodic Company Report #C2003-2954.01 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 50MG Q HS, Other ORAL Clozapine Tablets 100 Mg Mylan SS Mylan ORAL 700MG Q HS, ORAL Desmorpressin Acetate C Divalproex Sodium C Hydrochlorothiazide C Isosorbide C Metoprolol C Pantroprazole Sodium C Ramipril C Date:11/17/04ISR Number: 4524853-1Report Type:Periodic Company Report #C2003-3078.01 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Health Clozapine Tablets 25 Decreased Professional Mg PS ORAL 25MG Q HS, Other ORAL Clozapine Tablets 100 Mg SS ORAL 200MG Q HS, ORAL Benztropine Mesylate C 22-Feb-2006 08:30 AM Page: 2936 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/17/04ISR Number: 4524856-7Report Type:Periodic Company Report #C2003-3198.01 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Other Clozapine Tablets 25 Mg Mylan PS Mylan ORAL 50MG BID, ORAL Albuterol C Calcitronin Salmon Nasal Spray C Methylphenidate C Multivitamin With Minerals C Nystatin Cream C Potassium Chloride C Trazodone C Venlafaxine C Date:11/17/04ISR Number: 4524858-0Report Type:Periodic Company Report #C2003-3289.01 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Influenza Like Illness Health Clozapine Tablets 25 Leukopenia Professional Mg Mylan PS Mylan ORAL 25MG BID, Malaise Other ORAL Clozapine Tablets 100 Mg Mylan SS Mylan ORAL 100MG Q HS, ORAL Date:11/17/04ISR Number: 4524862-2Report Type:Periodic Company Report #2004S1000031 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Antipsychotic Drug Level Health Clozapine Tablets 25 Below Therapeutic Professional Mg Mylan PS Mylan ORAL 25MG QD, ORAL Clozapine Tablets 100 Mg Mylan SS Mylan ORAL 300MG QD, ORAL Benztropine Mesylate C Polyethylene Glycol-Electrolyte Solution C Date:11/17/04ISR Number: 4524867-1Report Type:Periodic Company Report #2004S1000070 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 25MG Q HS, Other ORAL Clozapine Tablets 100 Mg Mylan SS Mylan ORAL 200MG, Q HS, ORAL 22-Feb-2006 08:30 AM Page: 2937 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/17/04ISR Number: 4524875-0Report Type:Periodic Company Report #2004S1000142 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Health Clozapine Tablets 25 Leukopenia Professional Mg Mylan PS Mylan ORAL 25MG QD, ORAL Other Ferrous Sultate C Propranolol C Date:11/17/04ISR Number: 4524878-6Report Type:Periodic Company Report #2004S1000245 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Consumer Clozapine Tablets 25 Mg Mylan PS Mylan ORAL 50MG HS, ORAL Clozapine Tablets 100 Mg Mylan SS Mylan ORAL 200MG HS, ORAL Gabapentin C Date:11/17/04ISR Number: 4524880-4Report Type:Periodic Company Report #2004S1000247 Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 50MG QD, ORAL Other Clozapine Tablets 100 Mg Mylan SS Mylan ORAL 300MG Q HS, ORAL Bupropion Hcl C Divalproex Sodium C Escitalopram Oxalate C Gabapentin C Lorazepam C Risperidone C Date:11/17/04ISR Number: 4524881-6Report Type:Periodic Company Report #2004S1000257 Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Health Clozapine Tablets 25 White Blood Cell Count Professional Mg Mylan PS Mylan ORAL 125MG QD, Decreased Other ORAL Amphetamine/Dextroam phetamine Salts C Carbamazepine C Oxybutrin Xl C Oxcarbazepine C Benztropine Hydrochloride C Bupropion Hydrochloride C 22-Feb-2006 08:30 AM Page: 2938 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/17/04ISR Number: 4524883-XReport Type:Periodic Company Report #2004S1000411 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozapine Tablets 25 Neutropenia Professional Mg Mylan PS Mylan ORAL 50MG Q, HS, Other ORAL Clozapine Tablets 100 Mg Mylan SS Mylan ORAL 400MG Q, HS, ORAL Date:11/17/04ISR Number: 4524884-1Report Type:Periodic Company Report #2004S1000541 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 25NG Q, HS, Other THEN 50MG QD, ORAL Clozapine Tablets 100 Mg Mylan SS Mylan ORAL 100MG Q, HS, ORAL Date:11/17/04ISR Number: 4524886-5Report Type:Periodic Company Report #2004S1000548 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 50MG BID, Other THEN ORAL Clozapine Tablets 100 Mg Mylan SS Mylan ORAL 200 MG BID THEN ORAL Escitalopram Oxalate C Levetiraetam C Simvastatin C Orlistat C Levothyroxine Sodium C Date:11/17/04ISR Number: 4524887-7Report Type:Periodic Company Report #2004S1000666 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozapine Tablets 25 Neutrophil Count Professional Mg Mylan PS Mylan ORAL 25MG, BID, Decreased Other ORAL Date:11/17/04ISR Number: 4524888-9Report Type:Periodic Company Report #2004S1000904 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 50MG Q, HS, Other ORAL Clozapine Tablets 100 Mg Mylan SS Mylan ORAL 700MG Q HS, ORAL Metformin C 22-Feb-2006 08:30 AM Page: 2939 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Glipizide Xl C Haloperidol C Divalproex Sodium C Benztropine C Insulin C Pantoprazole C Date:11/17/04ISR Number: 4524889-0Report Type:Periodic Company Report #2004S1000927 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozapine Tablets 25 Neutropenia Professional Mg Mylan PS Mylan ORAL 50MG, QD, Other ORAL Clozapine Tablets 100 Mg Mylan SS Mylan ORAL 400MG, QD, ORAL Date:11/17/04ISR Number: 4524891-9Report Type:Periodic Company Report #2004S1000931 Age:71 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 50MG Q, HS, Other ORAL; YEARS Quetiapine C Rofecoxib C Zinc Sulfate C Vitamin C C Vitamin E C Date:11/17/04ISR Number: 4524892-0Report Type:Periodic Company Report #2004S1001057 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 50 MG Q AM, Other ORAL Clozapine Tablets 100 Mg Mylan SS Mylan ORAL 100MG Q AM, 300MG Q, HS, ORAL Date:11/17/04ISR Number: 4524893-2Report Type:Periodic Company Report #2004S1001215 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 12.5MG, QD, Other THEN 37.5MG QD, THEN 50MG QD, THEN 75MG QD, ORAL Clonazepam C Oxcarbazepine C Modafinil C Escitalopram C 22-Feb-2006 08:30 AM Page: 2940 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/17/04ISR Number: 4524895-6Report Type:Periodic Company Report #2004S1001238 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 50MG BID, Other ORAL Clozapine Tablets 100mg Mylan SS Mylan ORAL 300 MG Q HS, ORAL Pindolol C Aspirin C Conjugated Estrogens C Atorvastatin C Niacin Extended-Release C Date:11/17/04ISR Number: 4524897-XReport Type:Periodic Company Report #2004S1001256 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Platelet Count Decreased Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 12.5MG QD, Other THEN 25MG BID, ORAL Ziprasidone C Date:11/17/04ISR Number: 4524904-4Report Type:Periodic Company Report #C2003-0117.01 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Health Clozapine Tablets Decreased Professional 100 Mg Mylan PS Mylan ORAL SEE IMAGE Other Diphenhydramine C Docusate Sodium C Hydroxyzine Pamoate C Date:11/17/04ISR Number: 4524914-7Report Type:Periodic Company Report #C2003-0660.02 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sedation Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 250 MG Q HS, ORAL Topiramate C Lamotrigine C Levothyroxine C Bupropion Sr C Methylphenidate C Escitalopram C Date:11/17/04ISR Number: 4524918-4Report Type:Periodic Company Report #C2003-1134.01 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Health Clozapine Tablets Leukopenia Professional 100 Mg Mylan PS Mylan ORAL 300 Q AM, 400 Other Q PRN, ORAL 22-Feb-2006 08:30 AM Page: 2941 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Macrobid Proctor & Gamble SS ORAL 100MG, QD, ORAL Nitrofurantoin C Phenobarbital C Date:11/17/04ISR Number: 4524924-XReport Type:Periodic Company Report #C2003-1135.01 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Health Clozapine Tablets Neutrophil Count Professional 100 Mg Mylan PS Mylan ORAL 100MG BID, Decreased Other ORAL White Blood Cell Count Trileptal Novartis SS Decreased Citalopram C Haloperidol C Oxcarbazepine C Divalproex C Date:11/17/04ISR Number: 4524928-7Report Type:Periodic Company Report #C2003-1160.01 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Health Clozapine Tablets Phosphokinase Increased Professional 100 Mg Mylan PS Mylan ORAL 200MG Q HS, Pneumonia Other ORAL Valproic Acid C Date:11/17/04ISR Number: 4524930-5Report Type:Periodic Company Report #C2003-1164.01 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 200MG Q HS, Other ORAL Olanzapine C Tolterodine Tartrate La C Date:11/17/04ISR Number: 4524932-9Report Type:Periodic Company Report #C2003-1276.01 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 200MG Q HS, Other ORAL Chemotherapy C Date:11/17/04ISR Number: 4524933-0Report Type:Periodic Company Report #C2003-1324.01 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyspnoea Health Clozapine Tablets Initial or Prolonged Liver Function Test Professional 100 Mg Mylan PS Mylan ORAL 100MG Q AM, Other Abnormal 200 MG Q HS, Pneumonia ORAL 22-Feb-2006 08:30 AM Page: 2942 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Fluphenazine C Fluphenazine Deconoate C Trazodone C Venlafaxine Er C Azithromycin C Date:11/17/04ISR Number: 4524961-5Report Type:Periodic Company Report #C2003-1369.01 Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Health Clozapine Tablets Initial or Prolonged Neutropenia Professional 100 Mg Mylan PS Mylan ORAL 100 MG Q AM, Other Other 200MG Q HS, ORAL Diclofenac Potassium C Divalproex Sodium Er C Docusate Sodium C Furosemide C Gabapentin C Glipizide Xl C Isosorbide Mononitrate C Levothyroxine C Misoprostol C Multivitamin C Phenytoin C Pioglitazone C Potassium Chloride C Ramipril C Date:11/17/04ISR Number: 4524962-7Report Type:Periodic Company Report #C2003-1656.01 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutrophil Count Health Clozapine Tablets Decreased Professional 100 Mg Mylan PS Mylan ORAL 100MG Q AM, Other 100MG Q HS, ORAL Albuterol Sulfate C Divalproex Sodium C Docusate Sodium C Levothyroxine Sodium C Olanzapine C Topiramate C Valdecoxib C Clonazepam C Senna C Desmopressin Nasal Spray C Lorazepam C Date:11/17/04ISR Number: 4524964-0Report Type:Periodic Company Report #C2003-1434.01 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Health Clozapine Tablets Increased Professional 100 Mg Mylan PS Mylan ORAL 100MG QAM, 22-Feb-2006 08:30 AM Page: 2943 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report 200MG AT 2PM, 300MG QHS, ORAL Date:11/17/04ISR Number: 4524969-XReport Type:Periodic Company Report #C2003-1439.01 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Consumer Clozapine Tablets Health 100 Mg Mylan PS Mylan ORAL 200MG Q AM, Professional 200MG Q HS, Other ORAL Chemotherapy C Date:11/17/04ISR Number: 4524970-6Report Type:Periodic Company Report #C2003-1512.01 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 200 Q AM, 300 Other Q PM, ORAL Copegus 600mg Schering SS Schernig ORAL 600 MG BID, ORAL Pegasys 180mcg Schering SS Schering SUBCUTANEOUS 180MCG, WEEKLY, SQ Date:11/17/04ISR Number: 4524972-XReport Type:Periodic Company Report #C2003-1530.01 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozapine Tablets Neutropenia Professional 100 Mg Mylan PS Mylan ORAL STARTED AT Other 25MG Q HS, TITRATED TO 500MG Q HS, ORAL Acetaminophen C Atorvastatin C Clopidogrel C Dimenhydranate C Guaifenesin C Levothyroxine C Multivitamin C Pneumococcal Vaccine C Ranitidine C Tetanus/Diptheria C Calcium With Vitamin D C Date:11/17/04ISR Number: 4524973-1Report Type:Periodic Company Report #C2003-1532.01 Age:25 YR Gender:Female I/FU:I Outcome PT Other Neutropenia Vaginal Infection White Blood Cell Count 22-Feb-2006 08:30 AM Page: 2944 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Decreased Report Source Product Role Manufacturer Route Dose Duration Health Clozapine Tablets Professional 100 Mg Mylan PS ORAL 100MG Q HS, Other THE 200MG Q HS, THEN 300MG Q HS, ORAL Divalproex Sodium C Docusate Calcium C Sulfamethoxazole/Tri methoprim C Date:11/17/04ISR Number: 4524975-5Report Type:Periodic Company Report #C2003-1537.01 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dry Mouth Health Clozapine Tablets Dysarthria Professional 100 Mg Mylan PS Mylan ORAL 300MG Q HS, Swollen Tongue ORAL Clonazepam C Gabapentin C Quetiapine Fumarate C Zolpidem Tartrate C Date:11/17/04ISR Number: 4524982-2Report Type:Periodic Company Report #C2003-1631.01 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozapine Tablets Professional 100 Mg Myaln PS Mylan ORAL 700MG QD, Other THEN 200MG TID, ORAL Clozapine Tablets 100 Mg Ivax SS Ivax ORAL 700 MG QD, THEN 200MG TID, ORAL Divalproex Sodium C Docusate Sodium C Heparin Sodium C Nicotine Patch C Oxycodone And Acetaminophen C Date:11/17/04ISR Number: 4524986-XReport Type:Periodic Company Report #C2003-1650.1 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 100MG Q AM Other AND 300MG Q HS, ORAL Peginterferon Alfa-2a C Ribavirin C 22-Feb-2006 08:30 AM Page: 2945 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/17/04ISR Number: 4524988-3Report Type:Periodic Company Report #C2003-1659.01 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Enuresis Health Clozapine Tablet 100 Professional Mg Mylan PS Mylan ORAL 600MG/DAY, ORAL Diphenhydramine C Doxazosin C Date:11/17/04ISR Number: 4524989-5Report Type:Periodic Company Report #C2003-1682.01 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Mastocytosis Health Clozapine Tablet 100 Professional Mg Mylan PS Mylan ORAL 300MG Q HS, ORAL Lamotrigine C Sertraline Hcl C Date:11/17/04ISR Number: 4524992-5Report Type:Periodic Company Report #C2003-1688.01 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozapine Tablet 100 Professional Mg Mylan PS Mylan ORAL 400MG Q HS, Other ORAL Benztropine C Citalopram Hydrobromide C Divalproex Sodium C Glyburide C Levothyroxine Sodium C Metformin C Date:11/17/04ISR Number: 4524993-7Report Type:Periodic Company Report #C2003-1693.01 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Health Clozapine Tablet 100 Professional Mg Mylan PS Mylan ORAL 400MG QD, Other ORAL Fluphenazine Deconoate C Date:11/17/04ISR Number: 4524995-0Report Type:Periodic Company Report #C2003-1735.01 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Antipsychotic Drug Level Health Clozapine Tablets Below Therapeutic Professional 100 Mg Mylan PS Mylan ORAL 400MG Q HS, Drooling ORAL Fatigue Aspirin C Urinary Incontinence Docusate Sodium C Glycopyrrolate C Multivitamin C 22-Feb-2006 08:30 AM Page: 2946 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/17/04ISR Number: 4524998-6Report Type:Periodic Company Report #C2003-1745.01 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Health Clozapine Tablet 100 Neutropenia Professional Mg Mylan PS Mylan ORAL 200MG HS, Weight Increased Other THEN 150MG HS, THEN HOLD, ORAL Metformin C Olanzapine C Docusate Sodium C Medroxyprogesterone C Date:11/17/04ISR Number: 4525001-4Report Type:Periodic Company Report #C2003-1757.01 Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozapine Tablet 100 Professional Mg Mylan PS Mylan ORAL SEE IMAGE Other Amlodipine C Aspirin C Cimetidine C Docusate Sodium C Doxazosin Mesylate C Folic Acid C Hydrochlorothiazide C Ipratropium Bromide C Albuterol Sulfate C Lactulose C Levofloxacin C Lisinopril C Metoclopramide C Polycarbophil C Potassium Chloride C Risperidone C Thiamine C Date:11/17/04ISR Number: 4525002-6Report Type:Periodic Company Report #C2003-1877.01 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutrophil Count Health Clozapine Tablet 100 Decreased Professional Mg Mylan PS Mylan ORAL 300MG BID, Other ORAL Docusate Sodium C Folic Acid C Topiramate C Valproic Acid C Atenolol C Ferrous Gluconate C Date:11/17/04ISR Number: 4525004-XReport Type:Periodic Company Report #C2003-1892.01 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Health Clozapine Tablet 100 Professional Mg Mylan PS Mylan ORAL 200MG Q AM Other AND 400MG HS, 22-Feb-2006 08:30 AM Page: 2947 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL Aripiprazole C Valproic Acid C Date:11/17/04ISR Number: 4525005-1Report Type:Periodic Company Report #C2003-1951.01 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozapine Tablet 100 Professional Mg Mylan PS Mylan ORAL 350MG Q HS, Other THEN 400MG Q HS, ORAL Effexor Er C Quetiapine C Gabapentin C Trazodone C Lorazepam C Date:11/17/04ISR Number: 4525008-7Report Type:Periodic Company Report #C2003-2183.01 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 200MG Q AM, Other 200MG Q HS, ORAL Divalproex C Escitalopram C Date:11/17/04ISR Number: 4525010-5Report Type:Periodic Company Report #C2003-2272.01 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 300 Q AM, 200 Other Q NOON, 300 Q PM, ORAL Divalproex Sodium C Lithium C Date:11/17/04ISR Number: 4525011-7Report Type:Periodic Company Report #C2003-2363.01 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 100 Q AM, 200 Other Q PM, ORAL Divalproex Sodium C Trifluoperazine C Atorvastatin C Date:11/17/04ISR Number: 4525012-9Report Type:Periodic Company Report #C2003-2364.01 Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Other White Blood Cell Count Health Decreased Professional 22-Feb-2006 08:30 AM Page: 2948 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Product Role Manufacturer Route Dose Duration Clozapine Tablets 100 Mg Mylan PS Mylan ORAL 800 MG Q HS, ORAL Lithium Carbonate C Venlafaxine Er C Clonazepam C Levothyroxine C Oxybutynin C Date:11/17/04ISR Number: 4525014-2Report Type:Periodic Company Report #C2003-2657.01 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 100MG Q AM Other AND 200MG Q HS, ORAL Calcium/Vitamin D C Docusate Sodium C Hydrochlorothiazide C Imipramine C Iron Supplement C Olanzapine C Senna C Date:11/17/04ISR Number: 4525015-4Report Type:Periodic Company Report #C2003-2658.01 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 600MG Q HS, Other ORAL Ibuprofen C Date:11/17/04ISR Number: 4525017-8Report Type:Periodic Company Report #C2003-2672.01 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 100MG HS, Other ORAL Benztropine C Docusate Sodium C Lamotrigine C Lansoprazole C Venlafaxine C Date:11/17/04ISR Number: 4525018-XReport Type:Periodic Company Report #C2003-2748.01 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 100MG Q AM & Other 300MG Q HS, 22-Feb-2006 08:30 AM Page: 2949 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL Risperidone C Date:11/17/04ISR Number: 4525022-1Report Type:Periodic Company Report #C2003-2798.01 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 350MG QD, Other THEN 200MG HS, ORAL Amlodipine C Aspirin C Clonazepam C Divalproex Sodium Er C Docusate Sodium C Hydrochlorothiazide C Multivitamin C Zolpidem Tarrate C Date:11/17/04ISR Number: 4525032-4Report Type:Periodic Company Report #C2003-2836.01 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Health Clozapine Tablets Decreased Professional 100 Mg Mylan PS Mylan ORAL 400MG, QD, Other ORAL Date:11/17/04ISR Number: 4525040-3Report Type:Periodic Company Report #C2003-2841.01 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Health Clozapine Tablets Initial or Prolonged Professional 100 Mg Mylan PS Mylan ORAL 200MG Q AM Other Other AND 300MG Q HS, ORAL Alprazolam C Atenolol C Conjugated Estrogens C Oxcarbazepine C Sertraline C Date:11/17/04ISR Number: 4525042-7Report Type:Periodic Company Report #C2003-2845.01 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 600MG, HS, Other ORAL Date:11/17/04ISR Number: 4525044-0Report Type:Periodic Company Report #C2003-2847.01 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Haematocrit Decreased Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 150MG QD, ORAL 22-Feb-2006 08:30 AM Page: 2950 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Aspirin (Qd) C Vitamin B12 C Unknown Stool Softeners C Magnesium C Aluminum C Date:11/17/04ISR Number: 4525046-4Report Type:Periodic Company Report #C2003-2864.01 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Ineffective Health Clozapine Tablets Leukopenia Professional 100 Mg Mylan PS Mylan ORAL 300MG QD, Other ORAL Benztropine Mesylate C Citalopram Hydrobromide C Haloperidol Lactate C Lorazepam C Date:11/17/04ISR Number: 4525047-6Report Type:Periodic Company Report #C2003-2913.01 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Health Clozapine Tablets Neutrophil Count Professional 100 Mg Mylan PS Mylan ORAL 800MG Q HS, Decreased Other ORAL Divalproex Sodium C Fluvoxamine C Risperidone C Date:11/17/04ISR Number: 4525051-8Report Type:Periodic Company Report #C2003-2978.01 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Health Clozapine Tablets Leukopenia Professional 100 Mg Mylan PS Mylan ORAL 200MG Q AM Pyrexia Other AND 300MG Q HS, ORAL Lorazepam C Quetiapine Fumarate C Fluphenazine C Date:11/17/04ISR Number: 4525057-9Report Type:Periodic Company Report #C2003-2982.01 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyspnoea Consumer Clozapine Tablets Nausea Health 100 Mg Mylan PS Mylan ORAL 600MG QD, Paraesthesia Professional ORAL Other Risperidone C Glimepiride C Metformin C Pioglitazone C Oxybutynin Chloride C Paroxetine C 22-Feb-2006 08:30 AM Page: 2951 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/17/04ISR Number: 4525060-9Report Type:Periodic Company Report #C2003-2984.01 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Other Clozapine Tablets 100 Mg Mylan PS Mylan ORAL 300MG Q HS, ORAL Aripiprazole C Divalproex Sodium C Gemfibrozil C Hydrochlorothiazide C Insulin C Lisinopril C Metformin C Rosiglitazone Maleate C Trazodone C Venlafaxine Xr C Clonazepam C Haloperidol C Lorazepam C Pneumococcal Polysaccharide Vaccine C Insulin Lispro C Date:11/17/04ISR Number: 4525085-3Report Type:Periodic Company Report #C2003-3030.01 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombocytopenia Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 650MG QD THEN 500MG, ORAL Clonazepam C Sertraline C Haloperidol C Benztropine C Diltiazem C Enalapril Maleate C Albuterol C Vitamin E C Prednisone C Date:11/17/04ISR Number: 4525094-4Report Type:Periodic Company Report #C2003-3076.01 Age:78 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 150MG QD, Other THEN 100MG, ORAL Fluoxetine C Ranitidine C Doxepin C Buffered Aspirin C Vitamin E C Diphenhydramine C 22-Feb-2006 08:30 AM Page: 2952 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/17/04ISR Number: 4525099-3Report Type:Periodic Company Report #C2003-3130.01 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Health Clozapine Tablets White Blood Cell Count Professional 100 Mg Mylan PS ORAL 200MG Q AM, Decreased Other 300MG Q PM, ORAL Divalproex 500mg (1000mg Q Am, 1500mg Q Hs) C Date:11/17/04ISR Number: 4525100-7Report Type:Periodic Company Report #C2003-3186.01 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozapine Tablets Neutropenia Professional 100 Mg Mylan PS Mylan ORAL 600MG, QD, Other ORAL Propranolol Hydrochloride C Benztropine Mesylate C Oxcarbazepine C Levothyroxine C Haloperidol Deconate Injection C Date:11/17/04ISR Number: 4525114-7Report Type:Periodic Company Report #C2003-3244.01 Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozapine Tablets Neutropenia Professional 100 Mg Mylan PS Mylan ORAL 300MG QD, Other THEN 250MG, QD, ORAL Escitalopram Oxalate C Quetiapine Fumarate C Risperidone C Cefuroxime Axetil C Date:11/17/04ISR Number: 4525117-2Report Type:Periodic Company Report #C2003-3308.01 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Consumer Clozapine Tablets 100 Mg Mylan PS Mylan ORAL 300MG Q AM AND 400MG Q HS, ORAL Insulin C Metoprolol Succinate C Other Unknown Medications C 22-Feb-2006 08:30 AM Page: 2953 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/17/04ISR Number: 4525121-4Report Type:Periodic Company Report #C2003-3344.01 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 200MG QD, Other ORAL Quetiapine C Date:11/17/04ISR Number: 4525124-XReport Type:Periodic Company Report #C2003-3359.01 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Health Clozapine Tablets Leukopenia Professional 100 Mg Mylan PS Mylan ORAL 600MG Q HS, Other ORAL Benztropine C Divalproex Sodium C Lorazepam C Quetiapine C Sertraline C Date:11/17/04ISR Number: 4525128-7Report Type:Periodic Company Report #C2003-3362.01 Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 100MG HS, Other ORAL Fentanyl Transdermal C Ferrous Sulfate C Hydrocodone/Acetamin ophen C Lactulose C Levetiracetam C Levothyroxine Sodium C Vitamin E C Date:11/17/04ISR Number: 4525134-2Report Type:Periodic Company Report #C2003-3384.01 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL ORAL Other Date:11/17/04ISR Number: 4525137-8Report Type:Periodic Company Report #2004S1000122 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozapine Tablets Neutrophil Count Professional 100 Mg Mylan PS Mylan ORAL 400MG HS, Decreased Other ORAL Albuterol C Depakote C Diphenhydramine C Docusate Sodium C Lisinopril C 22-Feb-2006 08:30 AM Page: 2954 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lorazepam C Quetiapine Fumerate C Ranitidine C Risperidone C Date:11/17/04ISR Number: 4525141-XReport Type:Periodic Company Report #2004S1000141 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 200MG BID, Other ORAL Iron C Levothyroxine Sodium C Vitamins C Date:11/17/04ISR Number: 4525148-2Report Type:Periodic Company Report #2004S1000152 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozapine Tablets Professional 100 Mg Mylan PS ORAL 600MG HS, Other ORAL Benztropine C Date:11/17/04ISR Number: 4525153-6Report Type:Periodic Company Report #2004S1000272 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 100MG TID, Other ORAL Ipratropium Bromide/Albuterol Sulfate C Date:11/17/04ISR Number: 4525157-3Report Type:Periodic Company Report #2004S1000285 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Health Clozapine Tablets Weight Decreased Professional 100 Mg Mylan PS Mylan ORAL 200MG TID, ORAL YR Aripirazole C Chlordiazepoxide Hydrochloride C Nortriptyline C Date:11/17/04ISR Number: 4525161-5Report Type:Periodic Company Report #2004S1000405 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Health Clozapine Tablets White Blood Cell Count Professional 100 Mg Mylan PS Mylan ORAL 100MG BID, Decreased Other ORAL Aripiprazole C 22-Feb-2006 08:30 AM Page: 2955 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Oxcarbazepine C Levothyroxine C Quetiapine Fumarate C Date:11/17/04ISR Number: 4525167-6Report Type:Periodic Company Report #2004S1000409 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 300MG Q HS, Other ORAL Trazodone Hydrochloride C Bupropion Hydrochloride Sr C Alprazolam C Date:11/17/04ISR Number: 4525175-5Report Type:Periodic Company Report #2004S1000472 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 200MG BID, Other ORAL Quetiapine Fumarate C Date:11/17/04ISR Number: 4525200-1Report Type:Periodic Company Report #2004S1000487 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 200 MG Q AM, Other 300MG Q HS ORAL Risperidone C Lorazepam C Procyclidine Hydrochloride C Levothyroxine Sodium C Docusate Sodium C Desmopressin C Date:11/17/04ISR Number: 4525207-4Report Type:Periodic Company Report #2004S1000496 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 400MG Q HS, Other ORAL Carbamazepine C Aripirazole C Ethinyl Estradiol/Norethindr one C Topiramate C Fluconazole C 22-Feb-2006 08:30 AM Page: 2956 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/17/04ISR Number: 4525215-3Report Type:Periodic Company Report #2004S1000503 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Health Clozapine Tablets Drug Effect Decreased Professional 100 Mg Mylan PS Mylan ORAL 200MG QD, Paraesthesia Other THEN 300MG Pruritus QD, ORAL Salivary Hypersecretion Benztropine Mesylate Tachycardia Tablets 2mg SS ORAL 6MG QD, THEN 2MG QD, ORAL Fluoxetine Hydrochloride C Date:11/17/04ISR Number: 4525228-1Report Type:Periodic Company Report #2004S1000535 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 400MG QD, Other ORAL Divalproex Sodium C Sertraline C Loratadine C Gemfibrozil C Lorazepam C Desmopressin C Docusate Sodium C Cetirizine C Fluticasone Nasal Spray C Date:11/17/04ISR Number: 4525248-7Report Type:Periodic Company Report #2004S1000608 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Clozapine Tablets Professional 100 Mg PS ORAL 400MG BID, THEN UNK, ORAL Tolterodine C Benztropine C Fluoxetine C Lansoprazole C Haloperidol C Date:11/17/04ISR Number: 4525257-8Report Type:Periodic Company Report #2004S1000704 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eosinophil Percentage Health Clozapine Tablets Abnormal Professional 100 Mg Mylan PS Mylan ORAL 600MG QD, ORAL Paroxetine Hydrochloride C Lithium Carbonate Slow-Release C 22-Feb-2006 08:30 AM Page: 2957 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/17/04ISR Number: 4525292-XReport Type:Periodic Company Report #2004S1000880 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Gait Disturbance Health Clozapine Tablets Pruritus Professional 100 Mg PS ORAL 100MG Q HS, Psychotic Disorder Other ORAL Divalproex Sodium C Olanzapine C Date:11/17/04ISR Number: 4525301-8Report Type:Periodic Company Report #2004S1000909 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drooling Health Clozapine Tablets Dysphagia Professional 100 Mg PS ORAL 300MG QD, Hypersomnia ORAL Divaloproex Sodium C Levothyroxine Sodium C Docusate Sodium C Date:11/17/04ISR Number: 4525309-2Report Type:Periodic Company Report #2004S1001021 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Health Clozapine Tablets White Blood Cell Count Professional 100 Mg Mylan PS Mylan ORAL 600MG QD, Decreased Other THEN 500MG QD, ORAL Gabapentin C Divalproex Sodium C Date:11/17/04ISR Number: 4525312-2Report Type:Periodic Company Report #2004S1001060 Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 400MG Q HS, Other TITRATED TO 500MG ORAL Risperidone C Mixed Amphetamine Salts Xr C Nortriptyline Hydrochloride C Divaloprex Sodium C Lansoprazole C Desmopressin C Date:11/17/04ISR Number: 4525314-6Report Type:Periodic Company Report #2004S1001085 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 300MG QD, Other ORAL Cyclobenzaprine Hydrochloride C 22-Feb-2006 08:30 AM Page: 2958 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dantrolene Sodium C Diazepam C Fluoxetine Hydrochloride C Nitrofurantoin C Penicillin C Vitamins C Date:11/17/04ISR Number: 4525318-3Report Type:Periodic Company Report #2004S1001156 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Grand Mal Convulsion Health Clozapine Tablets Heart Rate Increased Professional 100 Mg PS ORAL 450MG QD, Petit Mal Epilepsy Other THEN UNK, TITRATED TO 200MG QD, ORAL Haloperidol Lactate C Benztropine Mesylate C Fluoxetine Hydrochloride C Clonazepam C Date:11/17/04ISR Number: 4525329-8Report Type:Periodic Company Report #2004S1001251 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Clozapine Tablets Drug Ineffective Professional 100 Mg PS ORAL 300-400MG QD, ORAL Date:11/17/04ISR Number: 4525334-1Report Type:Periodic Company Report #2004S1001252 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Other Clozapine Tablets 100 Mg Mylan PS Mylan ORAL 300MG QD, ORAL Lithium Carbonate C Lamotrigine C Propranolol Hydrochloride C Omeprazole C Trazodone Hydrochloride C Date:11/17/04ISR Number: 4525357-2Report Type:Periodic Company Report #2004S1001282 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombocytopenia Health Clozapine Tablets Professional 100 Mg PS ORAL 500 MG, QD, Other ORAL Cimetidine C Divalproex Sodium C 22-Feb-2006 08:30 AM Page: 2959 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/17/04ISR Number: 4525359-6Report Type:Periodic Company Report #C2002-0151.01 Age:52 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 900 MG, QD, ORAL Carbamazepine C Lithium C Benztropine C Mesylate C Trazodone Hcl C Lamotrigine C Date:11/17/04ISR Number: 4525363-8Report Type:Periodic Company Report #C2002-1762.01 Age:51 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutrophil Count Health Clozapine Tablets Decreased Professional 100 Mg Mylan PS Mylan ORAL 100MG TID, White Blood Cell Count Other ORAL Decreased Clozapine Tablets 25 Mg Mylan SS Mylan ORAL 75 MG TID, ORAL Acetaminophen C Calcium C Divalproate Sodium C Gabapentin C Oxybutynin C Diphenhydramine C Date:11/17/04ISR Number: 4525367-5Report Type:Periodic Company Report #C2002-2912.01 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozapine Tablets Neutrophil Count Professional 100 Mg Mylan PS Mylan ORAL 500MG QD, Decreased Other ORAL Interferon SS Date:11/18/04ISR Number: 4505466-4Report Type:Direct Company Report #CTU 232420 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cholecystitis Clozaril 100mg Initial or Prolonged Hepatitis Novartis PS Novartis TWO DAILY Required Prilosec C Intervention to Omeprazole C Prevent Permanent Seroquel C Impairment/Damage Quetiapine Fumarate C Abilify C Aripiprazole C Imitrex C Sumatriptan Succinate C Hydrocodone Gf C Hydrocodone-Guaifene sin C Clozaril C 22-Feb-2006 08:30 AM Page: 2960 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Clozapine C Synthroid C Levothyroxine Sodium C Imitrex C Sumatriptan Succinate C Phenergan Tab C Promethazine Hcl C Cipro Tab C Ciprofloxacin Hcl C Date:11/18/04ISR Number: 4505484-6Report Type:Expedited (15-DaCompany Report #04-11-1583 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 100MG QD ORAL Date:11/18/04ISR Number: 4505486-XReport Type:Expedited (15-DaCompany Report #04-11-1589 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Clozapine - Ivax Gun Shot Wound Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 600MG QD ORAL Date:11/19/04ISR Number: 4505184-2Report Type:Expedited (15-DaCompany Report #PHFR2003GB03397 Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cushingoid Clozaril PS Novartis Sector: Initial or Prolonged Electrocardiogram Qt Pharma ORAL 300 mg/day 31680MIN Other Corrected Interval Clozaril SS Novartis Sector: Prolonged Pharma ORAL Eosinophilia Sertraline C ORAL 100 mg/day Influenza Like Illness Lactulose C ORAL 10 mg/day Night Sweats Ampicillin C ORAL 14400MIN Pain Pyrexia Qrs Axis Abnormal Sinus Bradycardia White Blood Cell Count Increased Date:11/19/04ISR Number: 4505185-4Report Type:Expedited (15-DaCompany Report #PHFR2004GB02615 Age:33 YR Gender:Male I/FU:F Outcome PT Death Abnormal Behaviour Other Depressed Level Of Consciousness Drug Level Increased 22-Feb-2006 08:30 AM Page: 2961 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dyspnoea Hallucination, Auditory Inappropriate Affect Report Source Product Role Manufacturer Route Dose Duration Logorrhoea Clozaril PS Novartis Sector: Mass Pharma ORAL 675 mg/day Psychotic Disorder Hyoscine C UNKNOWN Sedation Haloperidol C UNKNOWN Lorazepam I UNKNOWN Date:11/19/04ISR Number: 4505186-6Report Type:Expedited (15-DaCompany Report #PHFR2004GB03722 Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Health Clozaril PS Novartis Sector: Initial or Prolonged Asthenia Professional Pharma ORAL 600mg/day 78 DAY Other Blood Alkaline Phosphatase Increased Blood Thyroid Stimulating Hormone Decreased Fatigue Feeling Abnormal Heart Rate Increased Hyperhidrosis Hypochromic Anaemia Listless Malaise Nausea Salivary Hypersecretion Sedation Somnolence Tachycardia Therapeutic Response Decreased Tremor Date:11/19/04ISR Number: 4505973-4Report Type:Expedited (15-DaCompany Report #PHHO2004CA15731 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Dystonia Health Clozaril PS Novartis Sector: Neuroleptic Malignant Professional Pharma ORAL Not reported Syndrome Ativan C Tachycardia Haldol C Oxybutynin C Domperidone C Gemfibrozil C Date:11/19/04ISR Number: 4506072-8Report Type:Expedited (15-DaCompany Report #PHEH2004US09501 Age:74 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Brain Neoplasm Clozaril PS Novartis Sector: Parkinson'S Disease Pharma ORAL UNK, UNK Pneumonia Aspiration Ditropan C Colace C Tylenol C Cinnamint C 22-Feb-2006 08:30 AM Page: 2962 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/19/04ISR Number: 4506073-XReport Type:Expedited (15-DaCompany Report #PHFR2001GB00788 Age:20 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Health Clozaril PS Novartis Sector: Other Loss Of Consciousness Professional Pharma ORAL 250mg/day Clozaril SS Novartis Sector: Pharma ORAL 350mg/day Valproate Sodium SS Zopiclone C UNK, PRN Doxycycline C Date:11/19/04ISR Number: 4507258-9Report Type:Expedited (15-DaCompany Report #2004S1002508 Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 100 MG QAM, Other 300 MG Q4PM & 25 MG Q HS ORAL Clozapine Tablets 100 Mg Mylan SS Mylan Date:11/19/04ISR Number: 4507263-2Report Type:Expedited (15-DaCompany Report #2004S1003282 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Areflexia Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 12.5 MG TID, Other ORAL Morphine C Atropine Ophthalmic C Fentanyl C Levothyroxine C Multivitamins C Atenolol C Mirtazapine C Donepezil C Date:11/19/04ISR Number: 4507365-0Report Type:Expedited (15-DaCompany Report #04-11-1580 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Health Clozapine - Ivax Initial or Prolonged Alcoholism Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 600MG QD ORAL Date:11/19/04ISR Number: 4507366-2Report Type:Expedited (15-DaCompany Report #04-11-1595 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neoplasm Malignant Health Clozapine - Ivax Initial or Prolonged Tracheal Obstruction Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals ORAL 750MG QD ORAL Chemotherapy C 22-Feb-2006 08:30 AM Page: 2963 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/19/04ISR Number: 4507367-4Report Type:Expedited (15-DaCompany Report #04-08-1247 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Neoplasm Malignant Health Clozapine - Ivax Pneumonia Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. 250-650MG QD ORAL Date:11/19/04ISR Number: 4507368-6Report Type:Expedited (15-DaCompany Report #04-11-1603 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dehydration Health Clozapine - Ivax Initial or Prolonged Infection Professional Pharmaceuticals, Therapeutic Agent Other Inc. Tablets PS Ivax Toxicity Pharmaceuticals, Urinary Tract Infection Inc. ORAL 25-250MG QD ORAL Lithium Unknown SS Date:11/19/04ISR Number: 4507369-8Report Type:Expedited (15-DaCompany Report #04-11-1601 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Gastroenteritis Health Clozapine - Ivax Initial or Prolonged Hypoglycaemia Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 300-800 MG QD ORAL Insulin C Date:11/19/04ISR Number: 4512877-XReport Type:Direct Company Report #CTU 232509 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Clozapine (Ivax) 25 Initial or Prolonged Mg PS Ivax ORAL 5 MG PO BID Benztropine C Chloral Hydrate C Clonazepam C Diphenhydramine C Donepezil C Prolixin C Gabapentin C Gemfibrozil C Propranolol C Risperidal C Zolpidem C 22-Feb-2006 08:30 AM Page: 2964 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/19/04ISR Number: 4678659-3Report Type:Direct Company Report #CTU 239849 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Ineffective Clozapine PS 500 MG HS Therapeutic Response Unexpected With Drug Substitution Date:11/22/04ISR Number: 4506519-7Report Type:Expedited (15-DaCompany Report #PHHO2004CA15731 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Dystonia Clozaril PS Novartis Sector: Neuroleptic Malignant Pharma ORAL Not reported Syndrome Ativan C Tachycardia Haldol C Oxybutynin C Domperidone C Gemfibrozil C Date:11/22/04ISR Number: 4506520-3Report Type:Expedited (15-DaCompany Report #PHHO2004CA11931 Age:43 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Embolism Clozaril PS Novartis Sector: Pharma ORAL 100 mg, QD 2399 DAY Date:11/22/04ISR Number: 4506595-1Report Type:Expedited (15-DaCompany Report #PHRM2004FR03124 Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Pain Leponex PS Novartis Sector: Other Abdominal Rigidity Pharma ORAL 500 mg/day 119 DAY Balance Disorder Depakote SS ORAL 2.5 g daily 127 DAY Constipation Clopixol C ORAL 250 mg daily 2880 MIN Dysphagia Loxapac C ORAL 100 mg daily 12960MIN Faecaloma Intestinal Obstruction Speech Disorder Date:11/22/04ISR Number: 4507697-6Report Type:Expedited (15-DaCompany Report #04-11-1596 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Breast Cancer Female Health Clozapine - Ivax Metastases To Bone Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 200-400MG QD ORAL 22-Feb-2006 08:30 AM Page: 2965 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/22/04ISR Number: 4509039-9Report Type:Direct Company Report #CTU 232543 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Clonic Convulsion Clozapine (Ivax) PS Ivax 400 MG Q AM Initial or Prolonged AND 600 MG HS Date:11/23/04ISR Number: 4507664-2Report Type:Expedited (15-DaCompany Report #AU-ABBOTT-04P-008-0280805-00 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Ileus Paralytic Valproate Sodium PS ORAL Clozapine SS ORAL Citalopram Hydrobromide SS ORAL Date:11/23/04ISR Number: 4507733-7Report Type:Expedited (15-DaCompany Report #PHFR2003GB02133 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Clozaril PS Novartis Sector: Initial or Prolonged Constipation Pharma ORAL 400mg/day Other Convulsion Clozaril SS Novartis Sector: Exfoliative Rash Pharma ORAL 200mg/mane&30 Glomerular Filtration 0mg/nocte Rate Decreased Clozaril SS Novartis Sector: Haemodialysis Pharma ORAL 200mg/mane&25 Haemoglobin Decreased 0mg/nocte Hyperkalaemia Iron C UNKNOWN Megacolon Nausea Obstructive Uropathy Renal Failure Chronic Date:11/23/04ISR Number: 4510661-4Report Type:Expedited (15-DaCompany Report #2004S1003377 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 25 MG QD, Other ORAL Date:11/23/04ISR Number: 4510665-1Report Type:Expedited (15-DaCompany Report #2004S1001032 Age:59 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 50MG QD & Other 175MG QHS, ORAL Clozapine Tablets 100 Mg Mylan SS Mylan ORAL 50MG QD & 175MG QHS, ORAL Gabapentin C Ziprasidone C Benztropine C Divalproex Er 500 Mg C 22-Feb-2006 08:30 AM Page: 2966 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Docusate 100 Mg C Date:11/23/04ISR Number: 4510682-1Report Type:Expedited (15-DaCompany Report #04-11-1616 Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asthenia Health Clozapine - Ivax Fall Professional Pharmaceuticals, General Physical Health Other Inc. Tablets PS Ivax Deterioration Pharmaceuticals, Hip Fracture Inc. ORAL 700MG QD ORAL Date:11/23/04ISR Number: 4510684-5Report Type:Expedited (15-DaCompany Report #04-11-1614 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Health Clozapine - Ivax Decreased Professional Pharmaceuticals, Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 100-500MG QD ORAL Date:11/23/04ISR Number: 4510685-7Report Type:Expedited (15-DaCompany Report #04-11-1623 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Clozapine - Ivax Initial or Prolonged Spinal Fracture Professional Pharmaceuticals, Other White Blood Cell Count Other Inc. Tablets PS Ivax Decreased Pharmaceuticals, Inc. ORAL 400-600MG QD ORAL Date:11/23/04ISR Number: 4510686-9Report Type:Expedited (15-DaCompany Report #04-11-1617 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Health Clozapine - Ivax Neutrophil Count Professional Pharmaceuticals, Decreased Inc. Tablets PS Ivax White Blood Cell Count Pharmaceuticals, Decreased Inc. ORAL 25-600MG QD ORAL Chemotherapy Unknown SS Date:11/24/04ISR Number: 4509674-8Report Type:Expedited (15-DaCompany Report #PHRM2004FR03065 Age:30 YR Gender:Male I/FU:F Outcome PT Hospitalization - Ascites Initial or Prolonged Bladder Disorder Other Bladder Diverticulum Bladder Stenosis Blood Alkaline 22-Feb-2006 08:30 AM Page: 2967 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Phosphatase Increased Blood Lactate Dehydrogenase Increased C-Reactive Protein Report Source Product Role Manufacturer Route Dose Duration Increased Leponex PS Novartis Sector: Calculus Urinary Pharma ORAL 150 mg/day Cardiomegaly Lysanxia SS ORAL 50 MG DAILY Chest X-Ray Abnormal Cor Pulmonale Enuresis Gamma-Glutamyltransferase Increased General Physical Health Deterioration Haemoglobin Decreased Hepatosplenomegaly Inflammation Lymphopenia Malaise Mediastinal Disorder Nitrite Urine Present Normochromic Normocytic Anaemia Oedema Peripheral Pericardial Rub Pericarditis Pleural Effusion Pollakiuria Prostate Infection Prostatic Disorder Pulmonary Embolism Pulmonary Hypertension Red Blood Cell Sedimentation Rate Increased Sarcoidosis Surgery Thrombocytopenia Urinary Retention Weight Decreased Date:11/24/04ISR Number: 4509675-XReport Type:Expedited (15-DaCompany Report #PHRM2004FR03235 Age:2 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Exposure Leponex PS Novartis Sector: Initial or Prolonged Loss Of Consciousness Pharma ORAL 100 mg, ONCE/SINGLE Date:11/24/04ISR Number: 4509723-7Report Type:Expedited (15-DaCompany Report #PHEH2004US12476 Age:22 YR Gender:Female I/FU:I Outcome PT Other Abdominal Pain Upper Cholecystectomy Cholecystitis Acute Diarrhoea Drug Toxicity Hepatocellular Damage Influenza Like Illness 22-Feb-2006 08:30 AM Page: 2968 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Nausea Pyrexia Vomiting Report Source Product Role Manufacturer Route Dose Duration Clozaril PS Novartis Sector: Pharma ORAL 100 mg/day Prilosec C Imitrex "Cerenex" C Seroquel C Date:11/24/04ISR Number: 4509730-4Report Type:Expedited (15-DaCompany Report #PHNU2004DE03909 Age:0 Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hydrocephalus Leponex / Clozaril Intraventricular (Clozapine) PS Novartis Sector: Haemorrhage Pharma ORAL Unknown Ventriculo-Vascular Shunt Date:11/24/04ISR Number: 4509731-6Report Type:Expedited (15-DaCompany Report #PHFR2004GB04286 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pyelonephritis Clozapine PS Novartis Sector: Other Sepsis Pharma ORAL 350mg/day Tolbutamide C ORAL 500 mg, TID Date:11/24/04ISR Number: 4509736-5Report Type:Expedited (15-DaCompany Report #PHFR2004GB04297 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Medication Error Clozaril PS Novartis Sector: Initial or Prolonged Poisoning Pharma 1354 DAY Sedation Clozaril SS Novartis Sector: Pharma 300mg once Date:11/24/04ISR Number: 4509737-7Report Type:Expedited (15-DaCompany Report #PHNR2004AU01650 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arthralgia Clozaril PS Novartis Sector: Initial or Prolonged Feeling Hot And Cold Pharma ORAL 25 - 900 Headache mg/day 1145 DAY Lethargy Clozaril SS Novartis Sector: Musculoskeletal Stiffness Pharma ORAL 600 mg, QD Myalgia Antidepressants C Salivary Hypersecretion Tongue Biting Date:11/24/04ISR Number: 4509745-6Report Type:Expedited (15-DaCompany Report #PHBS2004CA15688 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Accidental Exposure Clozaril PS Novartis Sector: Vomiting Pharma ORAL 200 mg, ONCE/SINGLE 1440 MIN Zyprexa C ORAL 27.5 mg/d 22-Feb-2006 08:30 AM Page: 2969 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Carbolith C ORAL 900 mg/d Listentil C ORAL 50 mg, QHS Temazepam C ORAL 30 mg, PRN Celexa C ORAL 0.25 tablet in the morning Epival C ORAL 3 tablets/d Lipidil C UNKNOWN 160 mg/d Pantoloc C ORAL 40 mg, QD Colace C ORAL 100 mg/d Ativan C UNKNOWN UNK, PRN Chlorpromazine C UNKNOWN UNK, PRN Date:11/24/04ISR Number: 4510009-5Report Type:Expedited (15-DaCompany Report #AU-ABBOTT-04P-008-0280799-00 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Ejection Fraction Valproate Sodium PS ORAL Decreased Clozapine SS ORAL 18 DAY Myocarditis Olanzapine C UNKNOWN Platelet Count Decreased Pyrexia Tachycardia Troponin Increased Date:11/24/04ISR Number: 4510587-6Report Type:Expedited (15-DaCompany Report #AU-ABBOTT-04P-008-0280885-00 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Epilim PS UNKNOWN Increased Clozapine SS ORAL Leukocytosis Olanzapine SS UNKNOWN Sinus Tachycardia Olanzapine SS UNKNOWN Fluoxetine Hydrochloride SS UNKNOWN Date:11/24/04ISR Number: 4510612-2Report Type:Expedited (15-DaCompany Report #AU-ABBOTT-04P-008-0280887-00 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Valproate Sodium PS Blood Cholesterol Clozapine SS ORAL 10 YR Increased Amisulpride C Blood Glucose Increased Lithium Carbonate C Hepatitis Levothyroxine Sodium C Neutrophilia Eugynon C Thrombocythaemia White Blood Cell Count Increased Date:11/26/04ISR Number: 4514923-6Report Type:Expedited (15-DaCompany Report #2004066826 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Treatment Noncompliance Foreign Ziprasidone (Caps) Other Health (Ziprasidone) PS ORAL 120 MG (60 Professional MG, 2 IN 1 22-Feb-2006 08:30 AM Page: 2970 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report D), ORAL Clozapine (Clozapine) SS Pimozide (Pimozide) SS Date:11/26/04ISR Number: 4527145-XReport Type:Periodic Company Report #04P-163-0271125-00 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Health Depakote Er 500mg Initial or Prolonged Drug Level Increased Professional (Depakote Er) Pancreatitis Other (Divalproex Sodiu) Pyrexia (Divalproex Sodium) PS ORAL 500 MG , 4 IN 1 D, PER ORAL Clozapine (Clozapine) SS ORAL 25 MG, 3 IN 1 D, PER ORAL Date:11/28/04ISR Number: 4511171-0Report Type:Expedited (15-DaCompany Report #PHHO2004CA11773 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ischaemic Cardiomyopathy Clozaril PS Novartis Sector: Initial or Prolonged Pharma Not reported Other Date:11/28/04ISR Number: 4511175-8Report Type:Expedited (15-DaCompany Report #PHBS2004MX13326 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Accidental Exposure Leponex PS Novartis Sector: Diplopia Pharma ORAL 50 mg, Dizziness ONCE/SINGLE 1440 MIN Dyspnoea Captopril C ORAL Paralysis Vitamin A C ORAL UNK, UNK Somnolence Date:11/28/04ISR Number: 4511176-XReport Type:Expedited (15-DaCompany Report #PHHO2004CA14980 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Infectious Mononucleosis Clozaril PS Novartis Sector: Mumps Pharma Nasopharyngitis Sertraline C Parotitis Lithium C Date:11/28/04ISR Number: 4511178-3Report Type:Expedited (15-DaCompany Report #PHHO2004CA14157 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cellulitis Health Clozaril PS Novartis Sector: Professional Pharma 22-Feb-2006 08:30 AM Page: 2971 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/28/04ISR Number: 4511182-5Report Type:Expedited (15-DaCompany Report #PHBS2004SE12324 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Leponex PS Novartis Sector: Initial or Prolonged Blood Triglycerides Pharma ORAL 100 mg/d 5475 DAY Increased Cerebral Infarction Hypoaesthesia Tremor Date:11/28/04ISR Number: 4511185-0Report Type:Expedited (15-DaCompany Report #PHHO2004CA11931 Age:43 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Embolism Clozaril PS Novartis Sector: Pharma ORAL 100 mg, QD 2399 DAY Date:11/28/04ISR Number: 4511188-6Report Type:Expedited (15-DaCompany Report #PHHO2004CA14267 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Myocarditis Clozaril PS Novartis Sector: Poisoning Pharma Unknown 1440 MIN Date:11/29/04ISR Number: 4511677-4Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-12768065 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Health Abilify PS Otsuka Initial or Prolonged Phosphokinase Increased Professional Pharmaceutical Disturbance In Attention Company, Ltd. ORAL Increased to Hallucination 30 mg/day Muscle Rigidity after one Schizophrenia week. Social Avoidant Behaviour Clozapine SS Tardive Dyskinesia Quetiapine SS Date:11/29/04ISR Number: 4514178-2Report Type:Expedited (15-DaCompany Report #04-11-1593 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Disorder Health Clozapine - Ivax Initial or Prolonged Convulsion Professional Pharmaceuticals, Inc PS Ivax Coordination Abnormal Other Pharmaceuticals, Inc ORAL 250-400 MG QD Drug Toxicity ORAL Dilantin SS Date:11/29/04ISR Number: 4514184-8Report Type:Expedited (15-DaCompany Report #04-10-1449 Age:61 YR Gender:Male I/FU:I Outcome PT Death Anaemia Other Cardiac Failure Congestive Disseminated Intravascular Coagulation 22-Feb-2006 08:30 AM Page: 2972 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Leukocytosis Pneumonia Report Source Product Role Manufacturer Route Dose Duration Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablet PS Ivax Pharmaceuticals, Inc. ORAL 250 MG QHS ORAL Bisacodyl C Milk Of Magnesia C Promethazine C Acetaminophen C Ativan C Urecholine C Amantadine C Aricept C Aspirin C Depakote C Synthroid C Levaquin C Zithromax C Albuterol Sulfate C Miralax C Namenda C Date:11/29/04ISR Number: 4514186-1Report Type:Expedited (15-DaCompany Report #04-11-1635 Age:86 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Clozapine Tablets - Congestive Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 25 MG QD ORAL Date:11/29/04ISR Number: 4514187-3Report Type:Expedited (15-DaCompany Report #04-11-1634 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Health Clozapine Tablets - Emphysema Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 625 MG QD ORAL Date:11/29/04ISR Number: 4514189-7Report Type:Expedited (15-DaCompany Report #04-11-1637 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dehydration Health Clozapine Tablets - Initial or Prolonged Weight Decreased Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, 22-Feb-2006 08:30 AM Page: 2973 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Inc. ORAL 50-125 MG QD ORAL Date:11/29/04ISR Number: 4514906-6Report Type:Direct Company Report #CTU 233130 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bronchitis Clozapine Ivax PS Ivax Cardio-Respiratory Arrest Chronic Obstructive Pulmonary Disease Coma Dyspnoea Oxygen Saturation Decreased Pulmonary Embolism Sleep Apnoea Syndrome Date:11/30/04ISR Number: 4513754-0Report Type:Expedited (15-DaCompany Report #AU-BRISTOL-MYERS SQUIBB COMPANY-12776902 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Drooling Modecate PS Apothecon Dyskinesia Clozapine SS Paraesthesia Oral Risperdal SS Speech Disorder Date:11/30/04ISR Number: 4514030-2Report Type:Expedited (15-DaCompany Report #PHBS2004NZ15754 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Clozaril PS Novartis Sector: Blood Creatine Pharma ORAL Phosphokinase Increased Circulatory Collapse Myocardial Infarction Pyrexia Troponin I Increased Date:11/30/04ISR Number: 4515258-8Report Type:Direct Company Report #CTU 233221 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Ineffective Clozaril PS 325 MG BID Pharmaceutical Product Vitamin E C Complaint Hctz C Atenolol C Depakote C Ranitidine C Haloperidol C Benzropine C 22-Feb-2006 08:30 AM Page: 2974 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/30/04ISR Number: 4515709-9Report Type:Expedited (15-DaCompany Report #2004S1002729 Age:63 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 75 MG HS, Other ORAL Clozapine Tablets 100 Mg Mylan SS Mylan ORAL 100 MG HS, ORAL Date:11/30/04ISR Number: 4515711-7Report Type:Expedited (15-DaCompany Report #2004S1002656 Age:65 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapien Tablets 25 Professional Mg Mylan PS Mylan ORAL 125 MG TID, Other ORAL Clozapine Tablets 100 Mg Mylan SS Mylan ORAL 125 MG TID ORAL Venlafaxine Er C Lorazepam C Galantamine C Date:11/30/04ISR Number: 4518098-9Report Type:Expedited (15-DaCompany Report #GBWYE229924NOV04 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Exposure Health Advil (Ibuprofen Initial or Prolonged Blood Pressure Decreased Professional Tablet) PS Multiple Drug Overdose Other Alcohol (Ethanol) SS Intentional Clozaril (Clozapine) SS ORAL 2 DAY Somnolence White Blood Cell Count Increased Date:12/01/04ISR Number: 4515056-5Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12770947 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Abilify PS Otsuka Other Death Pharmaceutical Delusion Company, Ltd. Drug Level Increased Clozapine SS ORAL Paranoia Lexapro C ORAL Treatment Noncompliance Klonopin C White Blood Cell Count Increased Date:12/01/04ISR Number: 4515110-8Report Type:Expedited (15-DaCompany Report #PHBS2004NZ14512 Age:39 YR Gender:Female I/FU:F Outcome PT Hospitalization - Blood Glucose Increased Initial or Prolonged C-Reactive Protein Increased Dizziness 22-Feb-2006 08:30 AM Page: 2975 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lymphocyte Count Decreased Malaise Report Source Product Role Manufacturer Route Dose Duration Neutrophilia Clozaril PS Novartis Sector: Orthostatic Hypotension Pharma ORAL 23040MIN Pallor Haloperidol - Slow Platelet Count Increased Release C UNKNOWN 150 mg, BIW Pyrexia Procyclidine C UNKNOWN 5 mg, TID, prn Date:12/01/04ISR Number: 4515111-XReport Type:Expedited (15-DaCompany Report #PHNU2004DE03920 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Myositis Leponex / Clozaril Red Blood Cell (Clozapine) PS Novartis Sector: Sedimentation Rate Pharma ORAL Unknown Increased Valproic Acid C ORAL Unknown Torticollis Trileptal "Novartis" C ORAL Unknown Date:12/01/04ISR Number: 4515935-9Report Type:Expedited (15-DaCompany Report #2004S1003417 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Choking Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 200MG BID, Other ORAL Multivitamins C Atorvastatin C Glycerin C Date:12/01/04ISR Number: 4516140-2Report Type:Direct Company Report #USP 56973 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Pletal PS TABLET Nervous System Disorder Clozaril SS TABLET Date:12/01/04ISR Number: 4519036-5Report Type:Expedited (15-DaCompany Report #2004GB02737 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Quetiapine PS ORAL 250 MG PO Initial or Prolonged Phosphokinase Increased Health Clozapine SS Condition Aggravated Professional Abilify SS ORAL 15 MG HS PO Disturbance In Attention Other Abilify SS ORAL 30 MG HS PO Hallucination Mental Impairment Muscle Rigidity Social Avoidant Behaviour Tardive Dyskinesia 22-Feb-2006 08:30 AM Page: 2976 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/01/04ISR Number: 4519782-3Report Type:Direct Company Report #CTU 233315 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Clozapine 100mg PS ORAL 1 Q HS PO Initial or Prolonged Pharmaceutical Product Complaint Psychotic Disorder Date:12/02/04ISR Number: 4516316-4Report Type:Expedited (15-DaCompany Report #PHFR2004GB03923 Age:59 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Arthritis Clozaril PS Novartis Sector: Other Pharma ORAL UNK, UNK Citalopram C Bendrofluazide C ORAL Rofecoxib C ORAL Date:12/02/04ISR Number: 4516400-5Report Type:Expedited (15-DaCompany Report #PHNU2004DE03686 Age:62 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Fatigue Leponex / Clozaril Hypertension (Clozapine) PS Novartis Sector: Medication Error Pharma ORAL 150 mg, ONCE/SINGLE 1440 MIN Fluctin C ORAL 20 mg/day Melperone C ORAL 25 mg/day Asa C ORAL 300 mg, QD Trimipramine C ORAL 75 mg/day Date:12/02/04ISR Number: 4516459-5Report Type:Expedited (15-DaCompany Report #PHNU2004DE03934 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Photophobia Leponex / Clozaril Scintillating Scotoma (Clozapine) PS Novartis Sector: Visual Field Tests Pharma ORAL Unknown Abnormal Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL 75 mg, QD Date:12/02/04ISR Number: 4517018-0Report Type:Expedited (15-DaCompany Report #PHBS2004BR15790 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bundle Branch Block Leponex PS Novartis Sector: Electrocardiogram Pharma ORAL 400 mg/d Repolarisation Haloperidol C ORAL 10 mg/d Abnormality 22-Feb-2006 08:30 AM Page: 2977 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/02/04ISR Number: 4517670-XReport Type:Direct Company Report #CTU 233503 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Pressure Systolic Clozapine 25mg And Increased 100mg Ivax PS Ivax ORAL P.O. Cardio-Respiratory Arrest TITRATION Excoriation (STANDARD) Fall Depakote Er C Pulse Absent Risperidal C Swelling Clonazepam C Hctz C Clonidine C Zyprexa C Date:12/02/04ISR Number: 4517672-3Report Type:Direct Company Report #CTU 233499 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Body Temperature Clozapine 100 Mg Increased Tablet Ivax PS Ivax ORAL 100 MG AM, Coma 200 MG HS PO Cough Hctz C Diabetes Mellitus Lisinopril C Inadequate Control Metformin C Respiratory Tract Amaryl C Congestion Z-Pak C Wheezing Clozapine C Date:12/03/04ISR Number: 4518317-9Report Type:Expedited (15-DaCompany Report #FR-ABBOTT-04P-056-0279959-00 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Distension Depakote Tablets PS ORAL Important Balance Disorder dose Catatonia regimen/1000 Depression mg to 2000 mg Dysphagia Depakote Tablets SS ORAL Gastrointestinal Depakote Tablets SS ORAL Obstruction Clozapine SS ORAL Important Overdose dose regimen 118 DAY Sedation Loxapine Succinate C ORAL 7 MON Speech Disorder Amitriptyline Hydrochloride C ORAL 60 DAY Trihexyphenidyl Hydrochloride C ORAL 101 DAY Clonazepam C ORAL 22 DAY Clonazepam C ORAL 22 DAY Zuclopenthixol Hydrochloride C ORAL Zuclopenthixol Hydrochloride C ORAL Valpromide C Lithium C Hydroxyzine C Paroxetine C Haloperidol C Levomepromazine C Olanzapine C Acepromazine C 22-Feb-2006 08:30 AM Page: 2978 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Aceprometazine C Oxazepam C Carbamazepine C Amisulpride C Zuclopenthixol C Imipramine C Clorazepate Dipotassium C Diazepam C Date:12/03/04ISR Number: 4518387-8Report Type:Expedited (15-DaCompany Report #PHNR2004AU01680 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Cholesterol Clozaril PS Novartis Sector: Other Increased Pharma 25 - 750 Diabetes Mellitus mg/day Non-Insulin-Dependent Myocardial Infarction Obesity Date:12/03/04ISR Number: 4518403-3Report Type:Expedited (15-DaCompany Report #PHFR2003GB03514 Age:22 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Pain Clozaril PS Novartis Sector: Hospitalization - Asthenia Pharma ORAL 900mg/day Initial or Prolonged Bradycardia Amisulpride C ORAL 400mg/day Other Circulatory Collapse Omeprazole C ORAL 20mg/day Colon Gangrene Laxatives C UNKNOWN Colonic Haemorrhage Constipation Crying Dyspnoea Faecaloma General Physical Health Deterioration Intestinal Infarction Intestinal Ischaemia Loss Of Consciousness Pyrexia Urinary Tract Infection Vomiting Date:12/03/04ISR Number: 4518422-7Report Type:Expedited (15-DaCompany Report #PHEH2004US12691 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Metastases To Liver Clozaril PS Novartis Sector: Hospitalization - Metastases To Lung Pharma ORAL UNK,UNK Initial or Prolonged Pancreatic Carcinoma Metastatic 22-Feb-2006 08:30 AM Page: 2979 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/03/04ISR Number: 4518424-0Report Type:Expedited (15-DaCompany Report #PHNU2004DE03948 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Toxicity Leponex / Clozaril (Clozapine) PS Novartis Sector: Pharma Unknown Date:12/03/04ISR Number: 4518620-2Report Type:Expedited (15-DaCompany Report #PHRM2004FR03405 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Leponex PS Novartis Sector: Initial or Prolonged Blood Ketone Body Pharma ORAL UNK, UNK 1148 DAY Increased Tercian SS Diabetes Mellitus Nozinan SS Diabetes Mellitus Imovane C ORAL 7.5 mg, QD Non-Insulin-Dependent Clopixol C Glycosylated Haemoglobin Laroxyl C Increased Magne B6 C Hypercholesterolaemia Hyperglycaemia Hyperthermia Lung Disorder Pneumonia Legionella Polydipsia Polyuria Urine Ketone Body Present Weight Increased Date:12/03/04ISR Number: 4518943-7Report Type:Direct Company Report #CTU 233603 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Effect Decreased Clozapine PS MED RECORD Initial or Prolonged Pharmaceutical Product NOT AVAILABLE Complaint ~ 500 MG Q HO 1 MON Trazodone C Prozac C Date:12/03/04ISR Number: 4519590-3Report Type:Expedited (15-DaCompany Report #M2004-1803 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Foreign Caridopa/Levodopa PS Multiple Drug Overdose Other Lorazepam SS 1MG Denzapine (Clozapine) SS ORAL ORAL Movicol (Potassium Chloride/Macrogol/So dium Bicarbonate/Sodium Chloride) SS 2 SACHETS Zopiclone (Zopiclone) SS 3.75 MG Citalopram (Citalopram) SS 40 MG 22-Feb-2006 08:30 AM Page: 2980 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/03/04ISR Number: 4519635-0Report Type:Expedited (15-DaCompany Report #2004S1002316 Age:51 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 100MG BID, Other ORAL Morphine Sulfate C Metronidazole C Potassium Chloride C Lorazepam C Memantine C Venlafaxine C Donepezil C Mirtazapine C Pantoprazole C Calcium Carbonate With Vitamin D C Loperamide C Senna/Ducusate C Acetaminophen C Magnesium Hydroxide C Bisacodyl C Benefiber C Ceftriaxone C Levofloxacin C Cefotaxime C Dextrose C Date:12/03/04ISR Number: 4519636-2Report Type:Expedited (15-DaCompany Report #2004S1003441 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 100MG TID, Other 300MG HS, ORAL Date:12/03/04ISR Number: 4519638-6Report Type:Expedited (15-DaCompany Report #04-11-1632 Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Glucose Decreased Health Clozapine - Ivax Hospitalization - Coma Professional Pharmaceuticals, Initial or Prolonged Eating Disorder Other Inc. Tablets PS ORAL 100MG QD ORAL Lethargy Insulin C Date:12/03/04ISR Number: 4519641-6Report Type:Expedited (15-DaCompany Report #2004S1003463 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 100MG QAM AND Other 200MG HS, ORAL 22-Feb-2006 08:30 AM Page: 2981 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/03/04ISR Number: 4519643-XReport Type:Expedited (15-DaCompany Report #2004S1003155 Age:83 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dementia Health Clozapine Tablets Professional 25mg Mylan PS Mylan ORAL 25MG, QD, Other ORAL Morphine C Fentanyl C Iv Hydration C Haloperidol C Date:12/03/04ISR Number: 4519644-1Report Type:Expedited (15-DaCompany Report #2004S1003451 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Appendicectomy Health Clozapine Tablets 25 Hospitalization - Aspiration Professional Mg Mylan PS Mylan ORAL 50MG BID, Initial or Prolonged Post Procedural Other ORAL Complication Clozapine Tablets Vomiting 100 Mg Mylan SS Mylan ORAL 500MG HS, ORAL Atorvastatin C Niacin C Aspirin C Darbepoetin Alpha C Date:12/03/04ISR Number: 4519645-3Report Type:Expedited (15-DaCompany Report #2004S1003023 Age:71 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asthenia Other Clozapine Tablets 25 Pulmonary Embolism Mg Mylan PS Mylan ORAL 75MG, BID, Thrombosis ORAL Clozapine Tablets 100 Mg Mylan SS Mylan ORAL 100MG, BID ORAL Date:12/03/04ISR Number: 4520393-4Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20041106283 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Exposure Foreign Ibuprofen Initial or Prolonged Blood Pressure Decreased Health (Ibuprofen) PS Multiple Drug Overdose Professional Clozaril ( Somnolence Clozapine) SS ORAL ORAL White Blood Cell Count Alcohol (Ethanol) SS Increased Date:12/03/04ISR Number: 4521072-XReport Type:Expedited (15-DaCompany Report #NLWYE245730NOV04 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Foreign Efexor (Venlafaxine Initial or Prolonged Ileus Paralytic Consumer Hydrochloride, Other Other Tablet, 0) PS 75 MG 1X PER 1 DAY Leponex (Clozapine, 22-Feb-2006 08:30 AM Page: 2982 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report , 0) SS 50 MG 3X PER 1 DAY Nozinan (Levomepromazine) C Date:12/06/04ISR Number: 4519395-3Report Type:Expedited (15-DaCompany Report #04-11-1663 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Colorectal Cancer Health Clozapine Tablets - Metastases To Liver Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 50-400MG QD ORAL Date:12/06/04ISR Number: 4519396-5Report Type:Expedited (15-DaCompany Report #04-12-1678 Age:73 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, I Nc. ORAL 500MG QD ORAL Date:12/06/04ISR Number: 4519397-7Report Type:Expedited (15-DaCompany Report #04-12-1675 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 225-325 MG QD ORAL Date:12/06/04ISR Number: 4519398-9Report Type:Expedited (15-DaCompany Report #04-12-1674 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypercalcaemia Health Clozapine Tablets - Initial or Prolonged Mental Status Changes Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 425-525MG QD ORAL Date:12/06/04ISR Number: 4519399-0Report Type:Expedited (15-DaCompany Report #04-11-1662 Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Death Myocardial Infarction Health Professional 22-Feb-2006 08:30 AM Page: 2983 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Product Role Manufacturer Route Dose Duration Clozapine Tablets - Ivax Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 300-700MG QD ORAL Date:12/06/04ISR Number: 4519663-5Report Type:Expedited (15-DaCompany Report #PHFR2004GB03700 Age:41 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Pain Clozapine PS Novartis Sector: Hospitalization - Cardiac Arrest Pharma ORAL UNK, UNK Initial or Prolonged Fracture Becotide C UNKNOWN 2 puffs, QID Other Movement Disorder Movicol C UNKNOWN 2 sachets 250 Myocarditis ml/QD Salbutamol C 2 puffs/QID Valproate Sodium C UNKNOWN 400 mg, BID Olanzapine C UNKNOWN 20mg/day Citalopram C UNKNOWN 40 mg, QD Valproate Sodium C UNKNOWN 200mg bd + 400mg bd Lactulose C UNKNOWN 20 ml, QD Sodium Amytal C UNKNOWN 120 mg, QD Date:12/06/04ISR Number: 4519682-9Report Type:Expedited (15-DaCompany Report #PHBS2004CA15688 Age:55 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Accidental Exposure Clozaril PS Novartis Sector: Alcohol Use Pharma ORAL 200 mg, Fatigue ONCE/SINGLE 1440 MIN Hypokinesia Apo-Flurazepam C ORAL 300 mg, QHS Medication Error Docusate Sodium C ORAL 100 mg, QD Psychomotor Retardation Uremol C 2 or 3 times Somnolence per day Vomiting Zyprexa C ORAL 27.5 mg/d White Blood Cell Count Histantil C ORAL 50 mg, QHS Decreased Celexa C ORAL 5 mg in the morning Lipidil C UNKNOWN 160 mg/d Colace C ORAL 100 mg/d Chlorpromazine C UNKNOWN UNK, PRN Ativan C UNKNOWN UNK, PRN Pantoloc C ORAL 40 mg, QD Epival C ORAL 3 tablets/d Temazepam C ORAL 30 mg, PRN Carbolith C ORAL 900 mg/d 29 Vitamins+Minerals C Celestoderm C UNK, BID Lorazepam C 2 mg every 4 - 6 hours 22-Feb-2006 08:30 AM Page: 2984 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/06/04ISR Number: 4519684-2Report Type:Expedited (15-DaCompany Report #PHFR2004GB04104 Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Infection Clozaril PS Novartis Sector: Initial or Prolonged Rash Pharma ORAL UNK, UNK 251 DAY Sepsis Clozaril SS Novartis Sector: Pharma ORAL 10080MIN Valproate Sodium C ORAL 300mg/day Propanolol C 20mg/day Date:12/06/04ISR Number: 4519686-6Report Type:Expedited (15-DaCompany Report #PHBS2004CA15856 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Cancer Female Clozaril PS Novartis Sector: Radical Mastectomy Pharma ORAL 200 mg/d Date:12/06/04ISR Number: 4519698-2Report Type:Expedited (15-DaCompany Report #PHHO2004CA16639 Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Clozaril PS Novartis Sector: Csf Test Abnormal Pharma 1503 DAY Fall Pyrexia White Blood Cell Count Increased Date:12/06/04ISR Number: 4520880-9Report Type:Expedited (15-DaCompany Report #GBWYE247601DEC04 Age:24 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Metabolic Acidosis Health Efexor (Venlafazine Initial or Prolonged Overdose Professional Hydrochloride, Somnolence Tablet, 0) PS 600MG Acamprosate (Acamprosate) SS 7900MG Clozaril (Clozapine) SS SIX TIMES 450MG Lamotrigine (Lamotrigine) SS 1200MG Metformin (Metformin) SS 800MG Sulprid (Sulpiride) SS 6400MG Zopiclone (Zopiclone) SS 60MG Atenolol (Atenolol) C Date:12/06/04ISR Number: 4520935-9Report Type:Expedited (15-DaCompany Report #M2004-1803 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Foreign Carbidopa/Levodopa PS Multiple Drug Overdose Other Lorazepam SS 1 MG Denzapine (Clozapine) SS 400 MG Movicol (Potassium 22-Feb-2006 08:30 AM Page: 2985 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Chloride/Sodium Bicarbonate/Sodium Chloride) SS 2 SACHETS Zopiclone (Zopiclone) SS 3.75 MG Citalopram (Citalopram) SS 40 MG Date:12/06/04ISR Number: 4520992-XReport Type:Expedited (15-DaCompany Report #2004086750 Age:31 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acute Myeloid Leukaemia Foreign Ziprasidone (Caps) Initial or Prolonged Anaemia Health (Ziprasidone) PS ORAL 80 MG (1 IN 1 Other Leukopenia Professional D), ORAL Clozapine (Clozapine) (Clozapine) SS Date:12/07/04ISR Number: 4519847-6Report Type:Expedited (15-DaCompany Report #PHBS2004NZ16033 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Urea Increased Clozaril PS Novartis Sector: Dialysis Pharma ORAL 450 mg, QD Hypercalcaemia Renal Failure Acute Date:12/07/04ISR Number: 4519850-6Report Type:Expedited (15-DaCompany Report #PHEH2004US11567 Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Gastric Cancer Clozaril PS Novartis Sector: Leukopenia Pharma ORAL 800 mg, QD Lymphoma Valium C ORAL 5 mg, Q6H Surgery White Blood Cell Count Decreased Date:12/07/04ISR Number: 4519852-XReport Type:Expedited (15-DaCompany Report #PHEH2004US12871 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Medication Error Clozaril PS Novartis Sector: Initial or Prolonged Neurological Symptom Pharma ORAL 100 mg, twice Pletal SS ORAL 100 mg, BID Date:12/07/04ISR Number: 4519853-1Report Type:Expedited (15-DaCompany Report #PHEH2004US12824 Age:81 YR Gender:Male I/FU:I Outcome PT Other Electroencephalogram Abnormal Haemoglobin Decreased Mean Cell Haemoglobin Concentration Decreased Mean Cell Haemoglobin 22-Feb-2006 08:30 AM Page: 2986 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Decreased Mean Cell Volume Decreased Neoplasm Malignant Report Source Product Role Manufacturer Route Dose Duration Nervous System Disorder Clozaril PS Novartis Sector: Prostatic Disorder Pharma ORAL 50mg Qam, Red Blood Cell 100mg Qpm Abnormality Trazodone C 50 mg, QD Aricept C 10 mg, QD Date:12/07/04ISR Number: 4519855-5Report Type:Expedited (15-DaCompany Report #PHFR2004GB03709 Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cognitive Disorder Clozaril PS Novartis Sector: Drug Ineffective Pharma ORAL 350mg/day 310 DAY Eosinophil Count Tranylcypromine C ORAL 20 mg, QD Increased Concerta C ORAL 54 mg, QD Mean Cell Haemoglobin Concentration Decreased Mean Cell Volume Increased Neutrophil Count Increased Weight Increased Date:12/07/04ISR Number: 4519903-2Report Type:Expedited (15-DaCompany Report #PHFR2004GB04392 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiac Flutter Clozaril PS Novartis Sector: Pharma ORAL Date:12/07/04ISR Number: 4519907-XReport Type:Expedited (15-DaCompany Report #PHNU2004DE03954 Age:11 MON Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Exposure Leponex / Clozaril Initial or Prolonged Fatigue (Clozapine) PS Novartis Sector: Miosis Pharma ORAL 25 or 50 mg 1440 MIN Movement Disorder Somnolence Tachycardia Date:12/07/04ISR Number: 4519928-7Report Type:Expedited (15-DaCompany Report #GB-ROCHE-387448 Age:15 YR Gender:Female I/FU:I Outcome PT Hospitalization - Agitation Initial or Prolonged Blood Potassium Decreased Blood Pressure Decreased Blood Urea Decreased Fatigue Grand Mal Convulsion Malaise Mycoplasma Infection Psychotic Disorder Therapeutic Agent 22-Feb-2006 08:30 AM Page: 2987 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Toxicity Viral Infection Report Source Product Role Manufacturer Route Dose Duration Clonazepam PS Roche ORAL 47 DAY Clozaril SS ORAL 68 DAY Lithium SS ORAL Date:12/07/04ISR Number: 4520225-4Report Type:Expedited (15-DaCompany Report #PHBS2004PL16325 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Depressed Level Of Clozapine PS Novartis Sector: Consciousness Pharma UNKNOWN 75 mg, Drug Toxicity ONCE/SINGLE Date:12/07/04ISR Number: 4520233-3Report Type:Expedited (15-DaCompany Report #PHBS2004PL16334 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Depressed Level Of Clozapine PS Novartis Sector: Hospitalization - Consciousness Pharma UNKNOWN 750 mg, Initial or Prolonged Drug Toxicity ONCE/SINGLE Pneumonia Salivary Hypersecretion Tachycardia Date:12/07/04ISR Number: 4520235-7Report Type:Expedited (15-DaCompany Report #PHBS2004PL16339 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Clozapine PS Novartis Sector: Life-Threatening Central Nervous System Pharma UNKNOWN 800 mg, Lesion ONCE/SINGLE Depressed Level Of Consciousness Drug Toxicity Pneumonia Respiratory Failure Shock Date:12/07/04ISR Number: 4520236-9Report Type:Expedited (15-DaCompany Report #PHFR2004GB04407 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Renal Cell Carcinoma Clozaril PS Novartis Sector: Stage Unspecified Pharma Olanzapine C Date:12/07/04ISR Number: 4520237-0Report Type:Expedited (15-DaCompany Report #PHBS2004FI14982 Age:18 YR Gender:Male I/FU:F Outcome PT Hospitalization - Acidosis Initial or Prolonged Blood Glucose Increased C-Reactive Protein Increased 22-Feb-2006 08:30 AM Page: 2988 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Cyanosis Drug Toxicity Electrocardiogram Qt Report Source Product Role Manufacturer Route Dose Duration Prolonged Leponex PS Novartis Sector: Hypokalaemia Pharma ORAL 200 mg/d Loss Of Consciousness Charcoal, Activated SS Muscle Twitching Lorazepam SS UNKNOWN Pneumonia Aspiration Leponex SS Novartis Sector: Respiratory Rate Pharma ORAL UNK, Increased ONCE/SINGLE Restlessness Alcohol SS Sinus Tachycardia Benzodiazepines C UNKNOWN Tachycardia Ethanol C UNKNOWN Vomiting Date:12/07/04ISR Number: 4520860-3Report Type:Expedited (15-DaCompany Report #04-12-1686 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. PS Ivax Pharmaceuticals, Inc. ORAL 500-700MG QD ORAL Date:12/07/04ISR Number: 4520861-5Report Type:Expedited (15-DaCompany Report #04-11-1659 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Clozapine - Ivax Congestive Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 300-700MG QD ORAL Date:12/07/04ISR Number: 4520863-9Report Type:Expedited (15-DaCompany Report #04-12-1681 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Peritonitis Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 100-700 MG QD ORAL Date:12/07/04ISR Number: 4520892-5Report Type:Expedited (15-DaCompany Report #2004S1003239 Age:93 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Renal Failure Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL ORAL Other 22-Feb-2006 08:30 AM Page: 2989 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/07/04ISR Number: 4520894-9Report Type:Expedited (15-DaCompany Report #2004S1003273 Age:58 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Myocardial Health Clozapine Tablets 25 Infarction Professional Mg Mylan PS Mylan ORAL 375MG, QD, Other ORAL Clozapine Tablets 100 Mg Mylan SS Mylan ORAL 375 MG, QD, ORAL Divalproex Sodium C Benztropine C Date:12/07/04ISR Number: 4520895-0Report Type:Expedited (15-DaCompany Report #2004S1003480 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dialysis Health Clozapine Tablets Hydronephrosis Professional 100 Mg Mylan PS Mylan ORAL 800MG/DAY, Hypertension Other ORAL Neuroleptic Malignant Antibiotics C Syndrome Pneumonia Post Procedural Complication Renal Failure Urinary Tract Infection Date:12/07/04ISR Number: 4520896-2Report Type:Expedited (15-DaCompany Report #2004S1003483 Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 500MG QHS, Other ORAL Date:12/07/04ISR Number: 4520897-4Report Type:Expedited (15-DaCompany Report #04-12-1680 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine - Tablets Professional Ivax Other Pharmaceuticals, Inc. Ta PS Ivax Pharmaceuticals, Inc ORAL 500MG, QD ORAL Date:12/07/04ISR Number: 4520900-1Report Type:Expedited (15-DaCompany Report #04-12-1679 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine - Tablets Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 100-500MG QD ORAL 22-Feb-2006 08:30 AM Page: 2990 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/07/04ISR Number: 4521936-7Report Type:Direct Company Report #CTU 233775 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leprosy Clozaril PS Lupus-Like Syndrome Skin Disorder White Blood Cell Count Increased Date:12/07/04ISR Number: 4521941-0Report Type:Direct Company Report #CTU 233747 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Clozapine (Ivax Hospitalization - Body Temperature 0712-4360-10) PS Ivax ORAL 375MG PO BID Initial or Prolonged Increased Date:12/07/04ISR Number: 4523021-7Report Type:Direct Company Report #CTU 233825 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neutrophil Count Clozapine 100 Mg Decreased Ivax PS Ivax ORAL 100 MG HS ORAL Divaproex Er C Levothyroxine C Perphenazine C Olanzapine C Date:12/08/04ISR Number: 4520932-3Report Type:Expedited (15-DaCompany Report #PHFR2004GB04410 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depressed Level Of Clozaril PS Novartis Sector: Initial or Prolonged Consciousness Pharma 200 mg once Medication Error Somnolence Tachycardia Date:12/08/04ISR Number: 4520933-5Report Type:Expedited (15-DaCompany Report #PHFR2004GB04411 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Atrial Flutter Clozaril PS Novartis Sector: Dizziness Pharma Infection Syncope Tachycardia Date:12/08/04ISR Number: 4520934-7Report Type:Expedited (15-DaCompany Report #PHBS2004PL16341 Age:41 YR Gender:Male I/FU:I Outcome PT Death Brain Stem Syndrome Life-Threatening Cardiac Arrest Depressed Level Of 22-Feb-2006 08:30 AM Page: 2991 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Consciousness Disseminated Intravascular Coagulation Drug Toxicity Report Source Product Role Manufacturer Route Dose Duration Multi-Organ Failure Clozapine PS Novartis Sector: Pneumonia Pharma UNKNOWN 900 mg, QD Respiratory Failure Benzodiazepines C UNKNOWN Shock Date:12/08/04ISR Number: 4520941-4Report Type:Expedited (15-DaCompany Report #PHNU2004DE03721 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Lactate Leponex / Clozaril Dehydrogenase Increased (Clozapine) PS Novartis Sector: C-Reactive Protein Pharma ORAL up to Increased 425mg/day Gamma-Glutamyltransferase Solian SS ORAL Unknown Increased Hepatic Enzyme Increased Hepatitis C Transaminases Increased Date:12/08/04ISR Number: 4521308-5Report Type:Expedited (15-DaCompany Report #PHBS2004PL16328 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Atrioventricular Block Clozapine PS Novartis Sector: Life-Threatening Cardiac Arrest Pharma UNKNOWN 3000 mg, Depressed Level Of ONCE/SINGLE Consciousness Drug Toxicity Shock Date:12/08/04ISR Number: 4521309-7Report Type:Expedited (15-DaCompany Report #PHFR2003GB03514 Age:22 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Pain Clozaril PS Novartis Sector: Hospitalization - Asthenia Pharma ORAL 900mg/day Initial or Prolonged Bradycardia Amisulpride C ORAL 400mg/day Other Circulatory Collapse Omeprazole C ORAL 20mg/day Colon Gangrene Laxatives C UNKNOWN Colonic Haemorrhage Constipation Crying Dyspnoea Electromechanical Dissociation Faecaloma General Physical Health Deterioration Haemorrhage Intestinal Infarction Intestinal Ischaemia Pyrexia Urinary Tract Infection Vomiting 22-Feb-2006 08:30 AM Page: 2992 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/08/04ISR Number: 4522987-9Report Type:Expedited (15-DaCompany Report #04P-056-0279959-00 Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Distension Foreign Depakote Balance Disorder Health Catatonia Professional (Depakote) PS ORAL 500 MG, ORAL Depression Other Clozapine SS ORAL 100 MG, ORAL Dysphagia Loxapine Succinate C Gastrointestinal Amitriptyline Obstruction Hydrochloride C Overdose Trihexyphenidyl Sedation Hydrochloride C Speech Disorder Clonazepam C Vomiting Zuclopenthixol Hydrochloride C Valpromide C Lithium C Hydroxyzine C Paroxetine C Haloperidol C Levomepromazine C Olanzapine C Acepromazine C Acepromethazine C Oxazepam C Carbamazepine C Amisulpride C ............ C Imipramine C Clorazepate Dipotassium C Diazepam C Date:12/09/04ISR Number: 4521872-6Report Type:Expedited (15-DaCompany Report #PHBS2004US16186 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Qt Clozapine PS Novartis Sector: Initial or Prolonged Corrected Interval Pharma UNKNOWN 25 mg, QD Prolonged Clozapine SS Novartis Sector: Electrocardiogram Qt Pharma UNKNOWN 150 mg, QD Prolonged Heart Rate Increased Tachycardia Date:12/09/04ISR Number: 4521873-8Report Type:Expedited (15-DaCompany Report #PHFR2004GB03974 Age:53 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Full Blood Count Clozaril PS Novartis Sector: Initial or Prolonged Decreased Pharma ORAL 350mg/day Other Nausea Oesophageal Carcinoma Regurgitation Of Food Throat Cancer Vomiting 22-Feb-2006 08:30 AM Page: 2993 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/09/04ISR Number: 4521875-1Report Type:Expedited (15-DaCompany Report #PHFR2004GB04210 Age:25 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Clozaril PS Novartis Sector: Phosphokinase Increased Pharma ORAL UNK, UNK 116 DAY Blood Potassium Increased Clozaril SS Novartis Sector: Qrs Axis Abnormal Pharma ORAL 275mg/day 11520MIN Sinus Tachycardia Clozaril SS Novartis Sector: Tachycardia Pharma ORAL UNK, UNK 15840MIN Valproate Semisodium C ORAL Hyoscine Hydrobromide C 300ug/day Fluticasone C 500ug/day Date:12/09/04ISR Number: 4521902-1Report Type:Expedited (15-DaCompany Report #PHBS2003BR01504 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatitis C Leponex PS Novartis Sector: Lymphocyte Count Pharma ORAL Decreased Interferon SS UNKNOWN Monocyte Count Decreased Ribavirin SS UNKNOWN Platelet Count Decreased Cipramil C ORAL 1 tablet/d Date:12/09/04ISR Number: 4521909-4Report Type:Expedited (15-DaCompany Report #PHFR2004GB04429 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chorea Clozaril PS Novartis Sector: Obsessive-Compulsive Pharma ORAL Disorder Date:12/09/04ISR Number: 4521911-2Report Type:Expedited (15-DaCompany Report #PHBS2003BR01503 Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Confusional State Leponex PS Novartis Sector: Dysphonia Pharma ORAL 50 mg/d 152 DAY Erectile Dysfunction Leponex SS Novartis Sector: Infection Pharma ORAL 400 mg/d Libido Decreased Amplictil C ORAL 100 mg/d 152 DAY Motor Dysfunction Pain In Extremity Rash Throat Irritation Date:12/09/04ISR Number: 4522388-3Report Type:Expedited (15-DaCompany Report #PHHO2004CA15731 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Dystonia Clozaril PS Novartis Sector: Neuroleptic Malignant Pharma ORAL Not reported Syndrome Ativan C Tachycardia Haldol C Oxybutynin C Domperidone C Gemfibrozil C 22-Feb-2006 08:30 AM Page: 2994 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/09/04ISR Number: 4522569-9Report Type:Expedited (15-DaCompany Report #PHFR2004GB04443 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Clozaril PS Novartis Sector: Corrected Interval Pharma Prolonged Tremor Date:12/09/04ISR Number: 4522570-5Report Type:Expedited (15-DaCompany Report #PHHO2004CA11773 Age:53 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ischaemic Cardiomyopathy Clozaril PS Novartis Sector: Initial or Prolonged Leukopenia Pharma UNK, UNK Other Myocardial Infarction Clozaril SS Novartis Sector: Pharma Zoloft C Lipitor C Metoprolol C Colace C Plavix C Epival C Loxapac C Date:12/09/04ISR Number: 4524816-6Report Type:Direct Company Report #CTU 233968 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Faecaloma Clozapine 25mg Initial or Prolonged Ivax PS Ivax ORAL 50MG QAM ORAL Clozapine 100mg Ivax SS Ivax ORAL 300 MG QHS ORAL Depakote C Docusate Na C Folic Acid C Fluvoxamine C Trazodone C Bisacodyl C Ibuprofen C Maalox C Omeprazole C Apap C Docusate Na C Lorazepam C Mom C Date:12/10/04ISR Number: 4523038-2Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12777728 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Level Above Abilify PS Otsuka Therapeutic Pharmaceutical Company, Ltd. ORAL Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL 22-Feb-2006 08:30 AM Page: 2995 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Clozaril SS Started at 400 mg/day, decreased to 300 mg/day when Date:12/10/04ISR Number: 4523105-3Report Type:Expedited (15-DaCompany Report #PHBS2004FI14982 Age:18 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cyanosis Leponex PS Novartis Sector: Initial or Prolonged Drug Toxicity Pharma ORAL 200 mg/d Electrocardiogram Qt Charcoal, Activated SS Prolonged Lorazepam SS UNKNOWN Hypokalaemia Leponex SS Novartis Sector: Loss Of Consciousness Pharma ORAL UNK, Pneumonia Aspiration ONCE/SINGLE Restlessness Alcohol SS Tachycardia Benzodiazepines C UNKNOWN Vomiting Ethanol C UNKNOWN Date:12/10/04ISR Number: 4523858-4Report Type:Expedited (15-DaCompany Report #PHBS2004NZ14512 Age:39 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Clozaril PS Novartis Sector: Initial or Prolonged C-Reactive Protein Pharma ORAL 23040MIN Increased Haloperidol - Slow Dizziness Release C UNKNOWN 150 mg, BIW Lymphocyte Count Procyclidine C UNKNOWN 5 mg, TID, Decreased prn Malaise Neutrophilia Orthostatic Hypotension Pallor Platelet Count Increased Pyrexia Date:12/10/04ISR Number: 4523873-0Report Type:Expedited (15-DaCompany Report #IE-BRISTOL-MYERS SQUIBB COMPANY-12783494 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Metabolic Acidosis Metformin Hcl PS Bristol-Myers Squibb Initial or Prolonged Overdose Company ORAL Somnolence Atenolol SS Geneva Suicide Attempt Pharmaceuticals Technology, Corp. ORAL Acamprosate SS ORAL Zopiclone SS ORAL Sulpirid SS ORAL Venlafaxine Hcl SS ORAL Lamotrigine SS ORAL Clozaril SS ORAL 22-Feb-2006 08:30 AM Page: 2996 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/10/04ISR Number: 4524920-2Report Type:Expedited (15-DaCompany Report #2004S1002762 Age:75 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Parkinson'S Disease Health Clozapine Tablets 25 Pneumonia Professional Mg Mylan PS Mylan ORAL 37.5 MG QD Other AND 12.5 MG PRN AGITATION, ORAL Lactulose C Nystatin C Carbidopa/Levodopa C Date:12/10/04ISR Number: 4524940-8Report Type:Expedited (15-DaCompany Report #04-05-0757 Age:82 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Colon Cancer Health Clozapine - Ivax Hospitalization - Professional Pharmaceuticals, Initial or Prolonged Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 100-225 MG QD ORAL Date:12/10/04ISR Number: 4524943-3Report Type:Expedited (15-DaCompany Report #04-10-1485 Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Pressure Systolic Health Clozapine - Ivax Hospitalization - Increased Professional Pharmaceuticals, Initial or Prolonged Cardio-Respiratory Arrest Other Inc. Tablets PS Ivax Coma Pharmaceuticals, Excoriation Inc. ORAL 150 MG QD Fall ORAL Gait Disturbance Depakote C Pulse Absent Risperdal C Sinusitis Clonazepam C Skin Laceration Hydrochlorothiazide C Therapy Non-Responder Clonidine C Zyprexa C Date:12/10/04ISR Number: 4525000-2Report Type:Expedited (15-DaCompany Report #2004S1002316 Age:51 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Huntington'S Chorea Health Clozapine Tablets Pneumonia Professional 100 Mg Mylan PS Mylan ORAL 100MG BID Other ORAL Morphine Sulfate C Metronidazole C Potassium Chloride C Lorazepam C Memantine C Venlafaxine C Donepezil C Mirtazapine C Pantoprazole C Calcium Carbonate 22-Feb-2006 08:30 AM Page: 2997 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report With Vitamin D C Loperamide C Senna/Docusate C Acetaminophen C Magnesium Hydroxide C Bisacodyl C Benefiber C Ceftriaxone C Levofloxacin C Cefotaxime C Dextrose 5% Normal Saline Solution C Date:12/10/04ISR Number: 4525003-8Report Type:Expedited (15-DaCompany Report #2004S1003511 Age:95 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional 25mg Mylan PS Mylan ORAL 12.5MG HS Other ORAL Carbidopa/Levodopa C Prednisone C Date:12/10/04ISR Number: 4525021-XReport Type:Expedited (15-DaCompany Report #04-12-1690 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pancreatic Carcinoma Health Clozapine-Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 100-550MG QD ORAL Date:12/10/04ISR Number: 4525023-3Report Type:Expedited (15-DaCompany Report #04-10-1488 Age:51 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coma Health Clozapine - Ivax Other General Physical Health Professional Pharmaceuticals, Deterioration Other Inc. Tablets PS Ivax Respiratory Failure Pharmaceuticals, Inc ORAL 300 MG QHS Wheezing ORAL Zithromax Z-Pack SS Hydrochlorothiazide C Lisinopril C Metformin C Amaryl C Date:12/13/04ISR Number: 4525399-7Report Type:Expedited (15-DaCompany Report #PHFR2004GB03786 Age:15 YR Gender:Female I/FU:F Outcome PT Hospitalization - Agitation Initial or Prolonged Blood Potassium Decreased Blood Pressure Decreased Blood Urea Decreased C-Reactive Protein 22-Feb-2006 08:30 AM Page: 2998 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Increased Fatigue Grand Mal Convulsion Malaise Report Source Product Role Manufacturer Route Dose Duration Mycoplasma Infection Lithium PS Glaxosmithkline UNKNOWN 1400MG per Neutrophil Count day Decreased Clozaril SS ORAL 200MG per day 68 DAY Platelet Count Increased Clonazepam SS ORAL 2MG per day 47 DAY Psychotic Disorder Pyrexia Rebound Effect Red Blood Cell Sedimentation Rate Increased Therapeutic Agent Toxicity Viral Infection White Blood Cell Count Decreased Date:12/13/04ISR Number: 4525889-7Report Type:Expedited (15-DaCompany Report #PHBS2004CH16569 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abdominal Pain Upper Clozapine PS Novartis Sector: Appendicectomy Pharma Appendicitis Clopenthixol C UNKNOWN 5 mg/d C-Reactive Protein Valproate Sodium C 1500 mg/d Increased Chest Pain Diarrhoea Electrocardiogram T Wave Inversion Enterocolitis Eosinophilia Epigastric Discomfort Gamma-Glutamyltransferase Increased Leukocytosis Nausea Normochromic Normocytic Anaemia Pericardial Effusion Pericarditis Polyserositis Pyrexia Thrombocythaemia Troponin Increased Vomiting Date:12/13/04ISR Number: 4525924-6Report Type:Expedited (15-DaCompany Report #PHHO2004CA08705 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiomegaly Clozaril PS Novartis Sector: Other Drug Interaction Pharma ORAL Not reported Drug Toxicity Dextromethorphan SS Paroxetine SS Flurazepam SS 22-Feb-2006 08:30 AM Page: 2999 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/13/04ISR Number: 4526737-1Report Type:Expedited (15-DaCompany Report #2004102386 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anticonvulsant Toxicity Health Dilantin Suspension Initial or Prolonged Cardiac Disorder Professional (Phenytoin Sodium) PS Convulsion Clozapine Coordination Abnormal (Clozapine) SS ORAL (1 D), ORAL Treatment Noncompliance Date:12/14/04ISR Number: 4526957-6Report Type:Expedited (15-DaCompany Report #2004S1003517 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 450MG BID, Other ORAL Date:12/14/04ISR Number: 4526958-8Report Type:Expedited (15-DaCompany Report #2004S1003282 Age:83 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Areflexia Health Clozapine Tablets 25 Dysphagia Professional Mg Mylan PS Mylan ORAL 12.5 MG TID, Other ORAL Morphine C Atropine Ophthalmic C Fentanyl C Sorbitol C Levothyroxine C Multivitamins C Atenolol C Mirtazapine C Donepezil C Gatifloxacin C Docusate Sodium C Acteaminophen C Date:12/15/04ISR Number: 4527212-0Report Type:Expedited (15-DaCompany Report #PHRM2004FR03124 Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Distension Leponex PS Novartis Sector: Other Abdominal Pain Pharma ORAL 400 mg, daily 122 DAY Abdominal Rigidity Artane SS ORAL 15 mg, daily 101 DAY Balance Disorder Depakote SS ORAL 2.5 g daily 127 DAY Constipation Clopixol SS ORAL 200 mg, daily 101 DAY Dysphagia Loxapac SS ORAL 300 mg, daily 12960MIN Faecaloma Rivotril C ORAL 4 mg, daily 14400MIN Intestinal Obstruction Daflon C Salivary Hypersecretion Fucidine C Speech Disorder Vomiting 22-Feb-2006 08:30 AM Page: 3000 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/15/04ISR Number: 4527582-3Report Type:Expedited (15-DaCompany Report #PHBS2003CA00554 Age:27 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Exposure During Clozaril PS Novartis Sector: Pregnancy Pharma ORAL Gestational Diabetes Misoprostol C Hyperglycaemia Nph Insulin C Intra-Uterine Death Humalog C Date:12/15/04ISR Number: 4527599-9Report Type:Expedited (15-DaCompany Report #PHFR2004GB04499 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Atrioventricular Block Clozaril PS Novartis Sector: Complete Pharma ORAL 500mg/day Bradycardia Venlafaxine C 75mg/day Date:12/15/04ISR Number: 4527613-0Report Type:Expedited (15-DaCompany Report #PHNR2004AU01714 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Cholesterol Clozaril PS Novartis Sector: Increased Pharma ORAL From ? to Blood Glucose Increased 250-300 mg, day Clozaril SS Novartis Sector: Pharma ORAL 100 mg, day Date:12/15/04ISR Number: 4530457-7Report Type:Expedited (15-DaCompany Report #04-12-1708 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozapine - Ivax Chest Pain Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 300MG QD ORAL Date:12/15/04ISR Number: 4530458-9Report Type:Expedited (15-DaCompany Report #04-12-1675 Age:58 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Valve Disease Health Clozapine - Ivax Myocardial Infarction Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 225-325MG QD ORAL Date:12/15/04ISR Number: 4530460-7Report Type:Expedited (15-DaCompany Report #04-12-1709 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozapine - Ivax Choking Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 450-500MG QD ORAL 22-Feb-2006 08:30 AM Page: 3001 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/15/04ISR Number: 4530461-9Report Type:Expedited (15-DaCompany Report #04-12-1716 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 400-450MG QD ORAL Date:12/15/04ISR Number: 4531123-4Report Type:Expedited (15-DaCompany Report #S04-IRL-07963-01 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Metabolic Acidosis Foreign Acamprosate PS ORAL 7900 MG ONCE Initial or Prolonged Multiple Drug Overdose Health PO Intentional Professional Metformin SS ORAL 800 MG ONCE Somnolence Other PO Clozaril (Clozapine) SS ORAL 2730 MG ONCE PO Zopiclone SS ORAL 60 MG ONCE PO Sulprid (Sulpiride) SS ORAL 6400 MG ONCE PO Venlafaxine SS ORAL 600 MG ONCE PO Lamotrigine SS ORAL 1200 MG ONCE PO Atenolol SS ORAL 100 MG ONCE PO Date:12/16/04ISR Number: 4528560-0Report Type:Expedited (15-DaCompany Report #PHBS2004PL16651 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Caesarean Section Clozapine PS Novartis Sector: Initial or Prolonged Drug Exposure During Pharma UNKNOWN 200 mg/d Pregnancy Premature Labour Date:12/16/04ISR Number: 4528561-2Report Type:Expedited (15-DaCompany Report #PHNU2004DE04173 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mental Disorder Leponex / Clozaril Initial or Prolonged Pyrexia (Clozapine) PS Novartis Sector: Urinary Tract Infection Pharma ORAL Unknown Urosepsis Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL Unknown Date:12/16/04ISR Number: 4528576-4Report Type:Expedited (15-DaCompany Report #PHBS2004PL16652 Age: Gender:Male I/FU:I Outcome PT Congenital Anomaly Arrhythmia Cardiac Disorder Coma Neonatal Congenital Central Nervous System Anomaly 22-Feb-2006 08:30 AM Page: 3002 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Congenital Floppy Infant Convulsion Convulsion Neonatal Report Source Product Role Manufacturer Route Dose Duration Developmental Delay Clozapine PS Novartis Sector: Dyspnoea Pharma TRANSPLACENTAL Foetal Malposition Hernia Congenital Hypersomnia Hypotonia Hypoxic Encephalopathy Microgenia Myocarditis Neonatal Apnoeic Attack Neonatal Asphyxia Neonatal Respiratory Depression Opisthotonus Physical Testicle Examination Abnormal Date:12/16/04ISR Number: 4528578-8Report Type:Expedited (15-DaCompany Report #PHBS2004KR14676 Age:32 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alopecia Clozaril PS Novartis Sector: Pharma ORAL UNK, UNK Date:12/16/04ISR Number: 4528583-1Report Type:Expedited (15-DaCompany Report #PHNU2004DE04118 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Leponex / Clozaril Ovarian Cancer (Clozapine) PS Novartis Sector: Pharma ORAL Unknown Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL 250 mg/day Antineoplastic Agents C UNKNOWN Unknown Date:12/16/04ISR Number: 4528584-3Report Type:Expedited (15-DaCompany Report #PHFR2004GB04505 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Carotid Artery Disease Clozapine PS Novartis Sector: Pharma Date:12/16/04ISR Number: 4528587-9Report Type:Expedited (15-DaCompany Report #PHRM2004FR03629 Age:38 YR Gender:Female I/FU:I Outcome PT Hospitalization - Antipsychotic Drug Level Initial or Prolonged Above Therapeutic Blood Alkaline Phosphatase Increased Delusion Electrocardiogram Qt 22-Feb-2006 08:30 AM Page: 3003 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prolonged Gamma-Glutamyltransferase Increased Psychotic Disorder Report Source Product Role Manufacturer Route Dose Duration Therapeutic Response Leponex PS Novartis Sector: Decreased Pharma ORAL 350 mg/day Date:12/16/04ISR Number: 4528615-0Report Type:Expedited (15-DaCompany Report #PHHO2004NZ17489 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Ineffective Clozaril (Clozapine) PS Novartis Sector: Hyperhidrosis Pharma 200 DAY Skin Odour Abnormal Weight Increased Date:12/16/04ISR Number: 4529428-6Report Type:Expedited (15-DaCompany Report #2004S1003126 Age:54 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Myocardial Health Clozapine Tablets Infarction Professional 100 Mg Mylan PS Mylan ORAL 100 MG TID Other AND 200MG Q HS, THEN 100MG, QID; ORAL Insulin C Furosemide C Potassium C Atorvastatin C Ezetimibe C Date:12/16/04ISR Number: 4529438-9Report Type:Expedited (15-DaCompany Report #2004S1003558 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neoplasm Malignant Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 300 MG TID; Other ORAL Acetaminphen/Tramado l C Topiramate C Fosinopril/Hctz C Estradiol C Clonazepam C Ziprasidone C Oxycodone C Dexamethasone C Date:12/16/04ISR Number: 4529510-3Report Type:Expedited (15-DaCompany Report #04-12-1729 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cellulitis Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax-Pharmaceuticals , Inc. ORAL 300-550MG QD ORAL 22-Feb-2006 08:30 AM Page: 3004 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/16/04ISR Number: 4529512-7Report Type:Expedited (15-DaCompany Report #04-12-1706 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Macrocytic Health Clozapine - Ivax Neutrophil Count Professional Pharmaceuticals, Increased Other Inc. Tablets PS Ivax Pain Pharmaceuticals, Pharyngitis Inc. ORAL 75MG QD ORAL Productive Cough Depakote SS Pyrexia Klonopin C Respiratory Tract Congestion Sedation White Blood Cell Count Increased Date:12/16/04ISR Number: 4529515-2Report Type:Expedited (15-DaCompany Report #04-12-1730 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Ovarian Cyst Health Clozapine - Ivax Professional Pharmaceuticals, Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL ORAL Clozaril SS ORAL ORAL Date:12/16/04ISR Number: 4529518-8Report Type:Expedited (15-DaCompany Report #2004S1003562 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asthma Health Clozapine Tablets Feeling Abnormal Professional 100 Mg Mylan PS Mylan ORAL 200MG QAM AND Loss Of Consciousness Other 400MG HS, Pneumonia ORAL 2 YR Refusal Of Treatment By Clonazepam C Patient Levothyroxine C Therapy Non-Responder Desmopressin Acetate C Oxcarbazeprine C Paroxetine C Anti-Asthmatics C Date:12/16/04ISR Number: 4529520-6Report Type:Expedited (15-DaCompany Report #04-12-1736 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Health Clozapine - Ivax Other Nasopharyngitis Professional Pharmaceuticals, Respiratory Disorder Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 300MG QD ORAL 22-Feb-2006 08:30 AM Page: 3005 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/16/04ISR Number: 4687571-5Report Type:Direct Company Report #CTU 242960 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Ineffective Clozapine PS 750 MG / Q Psychotic Disorder WITH DINNER Therapeutic Response Unexpected With Drug Substitution Date:12/17/04ISR Number: 4530128-7Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20041002567 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Heart Rate Irregular Haldol PS UNKNOWN (5mg taken at Heat Stroke night) Clozapine SS OROPHARINGEAL Date:12/17/04ISR Number: 4531418-4Report Type:Expedited (15-DaCompany Report #2004S1003377 Age:75 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg Mylan PS ORAL 25MG QD, ORAL Other Date:12/20/04ISR Number: 4531643-2Report Type:Expedited (15-DaCompany Report #PHEH2004US13358 Age:81 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dementia Clozaril PS Novartis Sector: Dementia Alzheimer'S Type Pharma UNK, UNK Dysphagia Date:12/20/04ISR Number: 4531644-4Report Type:Expedited (15-DaCompany Report #PHFR2004GB01275 Age:48 YR Gender:Male I/FU:F Outcome PT Other Agitation Anxiety Blood Cholesterol Increased Blood Glucose Increased Blood Lactate Dehydrogenase Decreased Blood Triglycerides Increased Blood Urea Increased C-Reactive Protein Increased Confusional State Delirium Drug Level Increased Dyspnoea Haemoglobin Decreased Hallucination, Visual Hyperhidrosis Incontinence 22-Feb-2006 08:30 AM Page: 3006 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Influenza Like Illness Lower Respiratory Tract Infection Report Source Product Role Manufacturer Route Dose Duration Malaise Clozaril PS Novartis Sector: Nightmare Pharma 275mg/day Red Blood Cell Count Clozaril SS Novartis Sector: Decreased Pharma ORAL 100mg Restlessness mane/200mg Salivary Hypersecretion nocte Tachycardia Clozaril SS Novartis Sector: Weight Decreased Pharma ORAL 400mg/day White Blood Cell Count Carbamazepine C ORAL 400mg/day Increased Chlorpromazine C ORAL 300mg/day Trazodone C UNKNOWN 200mg/day Date:12/20/04ISR Number: 4532791-3Report Type:Expedited (15-DaCompany Report #04-12-1735 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals , Inc. ORAL 250-450 MG QD ORAL Chemotherapy SS Date:12/20/04ISR Number: 4532793-7Report Type:Expedited (15-DaCompany Report #04-10-1484 Age:56 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abasia Health Clozapine Tablets - Facial Palsy Professional Ivax Lipoma Other Pharmaceuticals, Malaise Inc. PS Ivax Pharyngitis Pharmaceuticals, Wheezing Inc. ORAL 700MG QD ORAL Clozapine SS Cogentin C Ativan C Aspirin C Synthroid C Zocor C Zetia C Date:12/20/04ISR Number: 4532795-0Report Type:Expedited (15-DaCompany Report #04-12-1751 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 400MG QD ORAL 22-Feb-2006 08:30 AM Page: 3007 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/20/04ISR Number: 4536811-1Report Type:Expedited (15-DaCompany Report #2004GB02876 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Metabolic Acidosis Foreign Atenolol PS ORAL 100 MG ONCE Initial or Prolonged Overdose Health PO Somnolence Professional Metformin SS ORAL 800 MG ONCE Suicide Attempt Other PO Acamprostate SS ORAL 7900 MG ONCE PO Clozaril SS ORAL 2700 MG ONCE PO Zopiclone SS ORAL 60 MG ONCE PO Sulprid SS ORAL 6400 MG ONCE PO Venlafaxine SS ORAL 600 MG ONCE PO Lamotrigine SS ORAL 1200 MG ONCE PO Date:12/20/04ISR Number: 4554359-5Report Type:Periodic Company Report #04-07-1052 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Health Clozapine Tablets - Drug Ineffective Professional Ivax Drug Level Increased Other Pharmaceuticals, Hyperlipidaemia Inc. PS Ivax Weight Increased Pharmaceuticals, Inc. ORAL 300-600 MG QD ORAL Risperdal Unknown SS 4MG BID Trazodone C Effexor Xr C Neurontin C Date:12/21/04ISR Number: 4532659-2Report Type:Expedited (15-DaCompany Report #PHHO2004NZ13155 Age:58 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aplastic Anaemia Clozaril PS Novartis Sector: Bone Marrow Disorder Pharma ORAL 3796 DAY Colorectal Cancer Metastatic Neutropenia Date:12/21/04ISR Number: 4532806-2Report Type:Expedited (15-DaCompany Report #PHBS2004CL16737 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Testicular Embryonal Leponex PS Novartis Sector: Carcinoma Pharma ORAL 22-Feb-2006 08:30 AM Page: 3008 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/21/04ISR Number: 4532839-6Report Type:Expedited (15-DaCompany Report #PHBS2004KR16686 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Haemoglobin Decreased Clozaril PS Novartis Sector: Platelet Count Increased Pharma ORAL 300 mg/d 141 DAY Vaginal Haemorrhage Topiramate C UNKNOWN 50 mg/d 127 DAY Date:12/21/04ISR Number: 4532864-5Report Type:Expedited (15-DaCompany Report #PHEH2004US12476 Age:22 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Upper Clozaril PS Novartis Sector: Alanine Aminotransferase Pharma ORAL 200 mg, QD Increased Abilify C 5 mg, QHS Aspartate Levaquin C 750 mg, QD Aminotransferase Hydrocodone C 10 ml, PRN Increased Imitrex "Cerenex" C 25 mg, UNK Blood Alkaline Seroquel C 200 mg, QHS Phosphatase Increased Prilosec C 40 mg, QD Cholecystectomy Frovatriptan C UNK mg, PRN Cholecystitis Acute Synthroid C Diarrhoea Drug Toxicity Hepatic Necrosis Hepatitis Influenza Like Illness Nausea Pyrexia Vomiting Date:12/21/04ISR Number: 4532904-3Report Type:Expedited (15-DaCompany Report #PHFR2003GB02133 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Clozaril PS Novartis Sector: Initial or Prolonged Constipation Pharma ORAL 200mg/mane&30 Other Convulsion 0mg/nocte Exfoliative Rash Clozaril SS Novartis Sector: Glomerular Filtration Pharma ORAL 200mg/mane&25 Rate Decreased 0mg/nocte Haemoglobin Decreased Clozaril SS Novartis Sector: Hyperkalaemia Pharma ORAL 400mg/day Megacolon Iron C UNKNOWN Nausea Obstructive Uropathy Renal Failure Chronic Date:12/21/04ISR Number: 4532906-7Report Type:Expedited (15-DaCompany Report #PHFR2004GB02341 Age:50 YR Gender:Male I/FU:F Outcome PT Death Blood Creatinine Other Increased Blood Potassium Increased Blood Urea Increased Bone Marrow Disorder Diabetes Mellitus Kidney Infection 22-Feb-2006 08:30 AM Page: 3009 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Rash Renal Abscess Renal Failure Acute Report Source Product Role Manufacturer Route Dose Duration Renal Papillary Necrosis Clozaril PS Novartis Sector: Sepsis Pharma ORAL 350mg/day Clozaril SS Novartis Sector: Pharma 450mg/day Date:12/21/04ISR Number: 4532924-9Report Type:Expedited (15-DaCompany Report #PHNR2004AU01680 Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Cholesterol Clozaril PS Novartis Sector: Other Increased Pharma 25 - 725 Diabetes Mellitus mg/day Non-Insulin-Dependent Desmopressin C 2 tablets/day Myocardial Infarction Diaformin C 1 tablet Obesity twice daily Jezil C Date:12/21/04ISR Number: 4533283-8Report Type:Expedited (15-DaCompany Report #PHBS2004US16877 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Clozapine PS Novartis Sector: Obstructive Uropathy Pharma Renal Failure Acute Lithium SS White Blood Cell Count Divalproex Sodium SS Decreased Date:12/21/04ISR Number: 4533291-7Report Type:Expedited (15-DaCompany Report #PHNR2004AU00450 Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Cholesterol Clozaril PS Novartis Sector: Initial or Prolonged Increased Pharma 12 - 500 Blood Glucose Increased mg/day Blood Triglycerides Clozaril SS Novartis Sector: Increased Pharma 12 - 600 Malaise mg/day 2410 DAY Nausea Sertraline C ORAL 200 mg, QD Polydipsia Esomeprazole C ORAL 20 mg, QD Polyuria Tremor Vomiting Weight Increased Date:12/21/04ISR Number: 4533292-9Report Type:Expedited (15-DaCompany Report #PHNU2004DE03934 Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Photophobia Leponex / Clozaril Scintillating Scotoma (Clozapine) PS Novartis Sector: Visual Field Tests Pharma ORAL 75 mg, QD Abnormal Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL 75 mg, QD 22-Feb-2006 08:30 AM Page: 3010 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/21/04ISR Number: 4533746-5Report Type:Expedited (15-DaCompany Report #PHBS2004US16868 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Hypersensitivity Clozapine PS Novartis Sector: Granulocytopenia Pharma Infection Divalproex Sodium SS Leukopenia Lithium C Psychotic Disorder Date:12/21/04ISR Number: 4533747-7Report Type:Expedited (15-DaCompany Report #PHEH2004US13326 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depressed Level Of Clozaril PS Novartis Sector: Initial or Prolonged Consciousness Pharma ORAL 400 mg, QD Drooling Alprazolam SS 0.25 mg, TID 8640 MIN Hernia Repair Temazepam SS 15 mg, QD 8640 MIN Medication Error Depakote C Sedation Olanzapine C Date:12/21/04ISR Number: 4533748-9Report Type:Expedited (15-DaCompany Report #PHEH2004US13358 Age:81 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dementia Clozaril PS Novartis Sector: Dementia Alzheimer'S Type Pharma UNK, UNK Dysphagia Date:12/21/04ISR Number: 4533945-2Report Type:Expedited (15-DaCompany Report #2004S1003019 Age:79 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 25 MG/DAY, Other ORAL Date:12/21/04ISR Number: 4533947-6Report Type:Expedited (15-DaCompany Report #2004S1003239 Age:93 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Renal Failure Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL ORAL Other Date:12/21/04ISR Number: 4533949-XReport Type:Expedited (15-DaCompany Report #2004S1003599 Age:88 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 100 MG BID, Other ORAL Triamterene/Hctz C Metformin C Acarbose C Fosinopril C Fluoxetine C 22-Feb-2006 08:30 AM Page: 3011 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Insulin Lispro C Date:12/21/04ISR Number: 4533950-6Report Type:Expedited (15-DaCompany Report #04-12-1764 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 50-300MG QD ORAL Taxol SS Carboplat SS Date:12/21/04ISR Number: 4533951-8Report Type:Expedited (15-DaCompany Report #04-12-1762 Age:71 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 15-200 MG QD ORAL Date:12/21/04ISR Number: 4533952-XReport Type:Expedited (15-DaCompany Report #04-12-1758 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delusion Health Clozapine - Ivax Initial or Prolonged Overdose Professional Pharmaceuticals, Subcutaneous Abscess Other Inc. Tablets PS Ivax Suicide Attempt Pharmaceuticals, Weight Decreased Inc. ORAL ORAL Date:12/21/04ISR Number: 4534626-1Report Type:Expedited (15-DaCompany Report #04-12-1767 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Lower Limb Fracture Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 250-400 QD ORAL Date:12/22/04ISR Number: 4535346-XReport Type:Expedited (15-DaCompany Report #US-JNJFOC-20041204675 Age: Gender:Female I/FU:I Outcome PT Death Bronchitis Bronchitis Acute Coma Drug Ineffective Drug Interaction 22-Feb-2006 08:30 AM Page: 3012 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Respiratory Failure Report Source Product Role Manufacturer Route Dose Duration Haldol PS UNKNOWN Clozapine SS OROPHARINGEAL Hydrochlorothiazide C OROPHARINGEAL Lisinopril C OROPHARINGEAL Metformin C OROPHARINGEAL Amaryl C OROPHARINGEAL Date:12/23/04ISR Number: 4535862-0Report Type:Expedited (15-DaCompany Report #PHNU2004DE03948 Age:1 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Toxicity Leponex / Clozaril Initial or Prolonged (Clozapine) PS Novartis Sector: Other Pharma Unknown Date:12/23/04ISR Number: 4536567-2Report Type:Expedited (15-DaCompany Report #GB-ABBOTT-04P-167-0283868-00 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Valproate Sodium PS UNKNOWN Clozapine SS ORAL Clozapine SS ORAL Doxycycline C UNKNOWN Zopiclone C UNKNOWN Date:12/23/04ISR Number: 4537166-9Report Type:Expedited (15-DaCompany Report #PHNU2004DE04255 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other B-Cell Lymphoma Leponex / Clozaril (Clozapine) PS Novartis Sector: Pharma ORAL Low dosage Date:12/23/04ISR Number: 4537218-3Report Type:Expedited (15-DaCompany Report #PHFR2004GB04569 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Clozapine PS Novartis Sector: Diarrhoea Pharma 125 mg, BID Haematochezia Neutrophil Count Decreased White Blood Cell Count Decreased Date:12/23/04ISR Number: 4537243-2Report Type:Expedited (15-DaCompany Report #PHFR2004GB00550 Age:27 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Haematemesis Clozaril (Clozapine) PS Novartis Sector: Initial or Prolonged Peptic Ulcer Pharma 400 mg/day 790 DAY Other Stomach Discomfort 22-Feb-2006 08:30 AM Page: 3013 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/23/04ISR Number: 4537247-XReport Type:Expedited (15-DaCompany Report #PHEH2004US12742 Age:46 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiac Arrest Clozaril PS Novartis Sector: Hospitalization - Cardiac Pacemaker Pharma ORAL 450 mg, QD 3650 DAY Initial or Prolonged Malfunction Ativan C Other Cardiomyopathy Topamax C Hypersensitivity Myocarditis Ventricular Fibrillation Date:12/23/04ISR Number: 4537249-3Report Type:Expedited (15-DaCompany Report #PHNU2004DE02249 Age: Gender:Female I/FU:F Outcome PT Life-Threatening Abdominal Pain Hospitalization - Acute Abdomen Initial or Prolonged Alanine Aminotransferase Increased Anaemia Aspartate Aminotransferase Increased Biopsy Kidney Blood Alkaline Phosphatase Increased Blood Cholesterol Increased Blood Creatinine Increased Blood Glucose Increased Blood Lactate Dehydrogenase Increased Blood Ph Decreased Blood Triglycerides Increased Blood Urea Increased Body Temperature Increased C-Reactive Protein Increased Catheterisation Venous Cholestasis Diabetes Mellitus Insulin-Dependent Diabetic Ketoacidosis Disturbance In Attention Gamma-Glutamyltransferase Increased Glomerulonephritis Acute Haematuria Haemodialysis Hypernatraemia Hypertension Hyperuricaemia Infection Kussmaul Respiration Lipase Increased Nephritis Interstitial Oedema 22-Feb-2006 08:30 AM Page: 3014 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Oliguria Pancreatitis Acute Peritonitis Report Source Product Role Manufacturer Route Dose Duration Proteinuria Leponex / Clozaril Renal Failure Acute (Clozapine) PS Novartis Sector: Renal Tubular Necrosis Pharma ORAL 50 to Weight Increased 600mg/day White Blood Cell Count Leponex / Clozaril Increased (Clozapine) SS Novartis Sector: Pharma ORAL 150mg/day Tavor SS ORAL 1 to 2 mg/day Solian SS ORAL 300mg/day Benperidol C UNKNOWN Risperdal C UNKNOWN Lyogen C UNKNOWN Akineton /Aus/ C UNKNOWN Haldol C UNKNOWN Biperiden C UNKNOWN Fluanxol "Bayer" C UNKNOWN Pipamperone C UNKNOWN Date:12/23/04ISR Number: 4537253-5Report Type:Expedited (15-DaCompany Report #PHFR2004GB03974 Age:53 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Full Blood Count Clozaril PS Novartis Sector: Initial or Prolonged Decreased Pharma ORAL 350mg/day Other Haemoglobin Decreased Nausea Oesophageal Carcinoma Regurgitation Of Food Throat Cancer Vomiting Date:12/23/04ISR Number: 4537257-2Report Type:Expedited (15-DaCompany Report #PHEH2004US13594 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Clozaril PS Novartis Sector: Pharma ORAL 350 mg, QD Date:12/23/04ISR Number: 4537275-4Report Type:Expedited (15-DaCompany Report #PHFR2004GB03519 Age:62 YR Gender:Male I/FU:F Outcome PT Death Asthenia Hospitalization - Brain Scan Abnormal Initial or Prolonged Cerebrovascular Disorder Other Condition Aggravated Demyelination Extrapyramidal Disorder General Physical Health Deterioration Hemiparesis Hypertonia Immobile Incontinence Infarction 22-Feb-2006 08:30 AM Page: 3015 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Muscle Rigidity Neurological Symptom Parkinsonism Report Source Product Role Manufacturer Route Dose Duration Speech Disorder Clozaril PS Novartis Sector: Vasculitis Pharma ORAL 350mg/day Date:12/23/04ISR Number: 4537372-3Report Type:Expedited (15-DaCompany Report #US-ABBOTT-04P-163-0283999-00 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bronchitis Depakote PS Other Coma Depakote SS Diabetes Mellitus Clozapine SS ORAL 18 DAY Inadequate Control Hydrochlorothiazide C ORAL 34 DAY Headache Lisinopril C ORAL 34 DAY Nausea Metformin C ORAL 34 DAY Respiratory Failure Glimepiride C ORAL 13 DAY Therapeutic Response Ziprasidone Decreased Hydrochloride C Haldol C Date:12/23/04ISR Number: 4538484-0Report Type:Direct Company Report #CTU 235067 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Clozapine 800 Mg/Day PS SEE IMAGE Blood Creatinine Abilify 15 Mg/Day SS 15 MG /DAY Increased Haldol Prn SS Blood Gases Abnormal Geodon X 1 SS SEE IMAGE Cholinergic Syndrome Dialysis Diarrhoea Electrolyte Imbalance Hallucination Incoherent Lethargy Neuroleptic Malignant Syndrome Urinary Retention Date:12/27/04ISR Number: 4538443-8Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20041204999 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombocytopenia Risperdal Consta PS INTRAMUSCULAR Leponex SS OROPHARINGEAL Ergenyl C OROPHARINGEAL Ximovan C Date:12/27/04ISR Number: 4538508-0Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20041005104 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Topamax PS UNKNOWN Pyrexia Clozapine SS OROPHARINGEAL 34 DAY Weight Decreased Fluticasone C RESPIRATORY (INHALATION) 22-Feb-2006 08:30 AM Page: 3016 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Olanzapine C taken at bedtime Divalproex Er C 250 mg every morning, 1000 mg at 5:00 p.m. Date:12/27/04ISR Number: 4539505-1Report Type:Direct Company Report #CTU 235126 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Platelet Count Decreased Clozapine 100 Mg Intervention to Tabs Ivax PS Ivax ORAL 200 MG PO BID Prevent Permanent Impairment/Damage Date:12/27/04ISR Number: 4541740-3Report Type:Expedited (15-DaCompany Report #2004GB03164 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Loss Of Consciousness Foreign Quetiapine PS ORAL 750 MG DAILY Intervention to Sinus Tachycardia Health PO Prevent Permanent Professional Clozaril SS ORAL 300 MG DAILY Impairment/Damage Other PO Citalopram C Date:12/28/04ISR Number: 4539388-XReport Type:Expedited (15-DaCompany Report #PHFR2003GB04210 Age:31 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Alanine Aminotransferase Clozaril PS Novartis Sector: Other Increased Pharma ORAL 350mg/day Blood Cholesterol Citalopram C ORAL 20 mg, QD Increased Lansoprazole C ORAL 15mg/nocte Blood Glucose Increased Flupentixol C ORAL 3 mg, PRN Blood Triglycerides Paracetamol C ORAL 1 g, PRN Increased Diabetes Mellitus Gamma-Glutamyltransferase Increased Glycosylated Haemoglobin Increased Hepatic Steatosis Weight Increased Date:12/28/04ISR Number: 4539430-6Report Type:Expedited (15-DaCompany Report #PHEH2004US13594 Age:19 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Clozaril PS Novartis Sector: Fall Pharma ORAL 350 mg, QD Myocardial Infarction 22-Feb-2006 08:30 AM Page: 3017 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/28/04ISR Number: 4540415-4Report Type:Expedited (15-DaCompany Report #04-12-1791 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Choking Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 400MG QD ORAL Date:12/28/04ISR Number: 4540417-8Report Type:Expedited (15-DaCompany Report #04-12-1765 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 400-1500MG QD ORAL Date:12/28/04ISR Number: 4540419-1Report Type:Expedited (15-DaCompany Report #04-12-1795 Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Respiratory Disorder Health Clozapine Tablets - Hospitalization - Professional Ivax Initial or Prolonged Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 175MG QD ORAL Date:12/28/04ISR Number: 4540421-XReport Type:Expedited (15-DaCompany Report #04-12-1764 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 50-30 QD ORAL Taxol SS Carboplat SS Date:12/28/04ISR Number: 4540429-4Report Type:Expedited (15-DaCompany Report #04-12-1796 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Colon Cancer Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 600MG QD ORAL 22-Feb-2006 08:30 AM Page: 3018 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/28/04ISR Number: 4540433-6Report Type:Expedited (15-DaCompany Report #2004S1003511 Age:95 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Health Clozapine Tablets 25 Pathogen Resistance Professional Mg Mylan PS Mylan ORAL 12.5MG HS, Pneumonia Other ORAL Carbidopa/Levodopa C Prednisone C Date:12/28/04ISR Number: 4540438-5Report Type:Expedited (15-DaCompany Report #2004S1003463 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 100 MG QAM Other AND 200 MG HS, ORAL Date:12/28/04ISR Number: 4540476-2Report Type:Expedited (15-DaCompany Report #2004S1003678 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Injury Asphyxiation Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 450 MG BID, Other ORAL Venlafaxine C Donepezil C Date:12/28/04ISR Number: 4540493-2Report Type:Expedited (15-DaCompany Report #2004S1003635 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 50MG BID AND Other 100MG QHS, ORAL Divalproex C Fluoxetine C Risperidone C Cefpodoxime C Date:12/28/04ISR Number: 4540494-4Report Type:Expedited (15-DaCompany Report #2004S1003649 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 200MG HS, Other ORAL Date:12/29/04ISR Number: 4540604-9Report Type:Expedited (15-DaCompany Report #PHNU2004DE04279 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Lymphopenia Leponex / Clozaril (Clozapine) PS Novartis Sector: Pharma ORAL UNK, UNK 22-Feb-2006 08:30 AM Page: 3019 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Ciatyl-Z SS UNK, UNK 4320 MIN Date:12/29/04ISR Number: 4540605-0Report Type:Expedited (15-DaCompany Report #PHNR2004AU01714 Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Cholesterol Clozaril PS Novartis Sector: Increased Pharma ORAL 75 - 250 Blood Glucose Increased mg/day Liver Function Test Clozaril SS Novartis Sector: Abnormal Pharma ORAL 100 mg/day Date:12/29/04ISR Number: 4540669-4Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-12799631 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Abilify PS Otsuka Initial or Prolonged Phosphokinase Increased Pharmaceutical Disturbance In Attention Company, Ltd. 15 then 30 mg Hallucination nocte after Muscle Rigidity one week Schizophrenia Clozapine SS UNKNOWN Social Avoidant Behaviour Quetiapine SS UNKNOWN Tardive Dyskinesia Date:12/29/04ISR Number: 4542379-6Report Type:Expedited (15-DaCompany Report #04-12-1770 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neoplasm Malignant Health Clozapine - Ivax Initial or Prolonged Renal Failure Acute Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 125-325MG QD ORAL Date:12/29/04ISR Number: 4542380-2Report Type:Expedited (15-DaCompany Report #04-12-1727 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aggression Health Clozapine - Ivax Hospitalization - Diarrhoea Professional Pharmaceuticals, Initial or Prolonged Neuroleptic Malignant Inc. Tablets PS Ivax Syndrome Pharmaceuticals, Renal Cell Carcinoma Inc. ORAL 800MG QD ORAL Stage Unspecified Geodon C Respiratory Failure Abilify C Haldol C Date:12/29/04ISR Number: 4542382-6Report Type:Expedited (15-DaCompany Report #2004S1003718 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 500MG Q AM, Other ORAL 22-Feb-2006 08:30 AM Page: 3020 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/29/04ISR Number: 4542384-XReport Type:Expedited (15-DaCompany Report #2004S1003740 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Haemorrhage Health Clozapine Tablets Vomiting Professional 100 Mg Mylan PS Mylan ORAL 400MG QD, Other ORAL Clonazepam C Temazepam C Oxcarbabazpine C Date:12/29/04ISR Number: 4542387-5Report Type:Expedited (15-DaCompany Report #04-12-1775 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hodgkin'S Disease Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 200-500MG QD ORAL Date:12/29/04ISR Number: 4542388-7Report Type:Expedited (15-DaCompany Report #04-10-1374 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Health Clozapine- Ivax Initial or Prolonged Anaemia Professional Pharmaceuticals, Other Anxiety Other Inc. Tablets PS Ivax Drug Level Increased Pharmaceuticalsl, Metastases To Bone Inc. ORAL 300-75MG QD Metastases To Liver ORAL Neutropenia Vincristine SS Therapeutic Agent Cytoxan SS Toxicity Adriamycin SS Thrombocytopenia Etoposide SS Tremor Cisplatin SS Undifferentiated Sarcoma Ifosfamide SS White Blood Cell Count Decreased Date:12/29/04ISR Number: 4543232-4Report Type:Expedited (15-DaCompany Report #2004GB02737 Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Quetiapine PS ORAL 350 MG DAILY Initial or Prolonged Phosphokinase Increased Health PO Condition Aggravated Professional Clozapine SS Disturbance In Attention Other Abilify SS 15-30MG NOCTE Hallucination Abilify SS ORAL 30 MG HS PO Muscle Rigidity Social Avoidant Behaviour Tardive Dyskinesia 22-Feb-2006 08:30 AM Page: 3021 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/30/04ISR Number: 4541601-XReport Type:Expedited (15-DaCompany Report #PHFR2004GB04465 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Distension Clozaril PS Novartis Sector: Initial or Prolonged Blood Pressure Increased Pharma ORAL C-Reactive Protein Hyoscine SS UNKNOWN Increased Antibiotics C UNKNOWN Drug Interaction Ileus Paralytic Vomiting Date:12/30/04ISR Number: 4541605-7Report Type:Expedited (15-DaCompany Report #PHFR2004GB04323 Age:73 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Confusional State Clozaril PS Novartis Sector: Crepitations Pharma ORAL UNK, UNK Diarrhoea Co-Amoxiclav SS ORAL 375mg/day 7200 MIN Pleurothotonus Clozaril SS Novartis Sector: Pneumonia Pharma ORAL 175mg/day Pyrexia Clozaril SS Novartis Sector: Somnolence Pharma UNK, UNK Upper Respiratory Tract Bendrofluazide C ORAL 2.5mg/day Infection Ranitidine C ORAL UNK, UNK Urinary Tract Infection Procyclidine C ORAL 2.5mg/day Vomiting Date:12/30/04ISR Number: 4541613-6Report Type:Expedited (15-DaCompany Report #PHEH2004US12824 Age:81 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Clozaril PS Novartis Sector: Initial or Prolonged Anxiety Pharma ORAL 50mg Qam, Other Electroencephalogram 100mg Qpm Abnormal Trazodone C 50 mg, QD Haemoglobin Decreased Aricept C 10 mg, QD Mean Cell Haemoglobin Aricept C 5 mg, QD Concentration Decreased Xenaderm C Mean Cell Haemoglobin Peridex C 0.5 ml, BID Decreased Aspirin C Mean Cell Volume Mycostatin C Decreased Decadron Neoplasm Malignant Nervous System Disorder /Can/ C Prostatic Disorder Metamucil C Red Blood Cell Abnormality Date:12/30/04ISR Number: 4541619-7Report Type:Expedited (15-DaCompany Report #PHFR2004GB04622 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Triglycerides Clozaril PS Novartis Sector: Increased Pharma ORAL 22-Feb-2006 08:30 AM Page: 3022 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/30/04ISR Number: 4541814-7Report Type:Expedited (15-DaCompany Report #PHRM2004FR03762 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - General Physical Health Leponex PS Novartis Sector: Initial or Prolonged Deterioration Pharma Mitochondrial Toxicity Antivirals For Pancreatitis Systemic Use SS Date:12/30/04ISR Number: 4541823-8Report Type:Expedited (15-DaCompany Report #PHEH2004US13595 Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Myocardial Infarction Clozaril PS Novartis Sector: Vomiting Pharma ORAL 550 mg, QD Weight Decreased Date:12/30/04ISR Number: 4541904-9Report Type:Expedited (15-DaCompany Report #PHFR2003GB02689 Age:22 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dysphemia Clozaril PS Novartis Sector: Haemorrhage Pharma ORAL 715 DAY Menorrhagia Salivary Hypersecretion Weight Increased Date:12/30/04ISR Number: 4541906-2Report Type:Expedited (15-DaCompany Report #PHFR2003GB03674 Age:51 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Back Pain Clozaril PS Novartis Sector: Initial or Prolonged Blood Glucose Increased Pharma ORAL 175mg/day 95 DAY Other Body Temperature Clozaril SS Novartis Sector: Increased Pharma ORAL UNK, UNK Chest Pain Clozaril SS Novartis Sector: Diabetes Mellitus Pharma ORAL 150mg/day Diarrhoea Trimethoprim C Drug Withdrawal Syndrome Insulin C Dyspnoea Malaise Musculoskeletal Pain Pain Salivary Hypersecretion Urinary Tract Infection Viral Infection Weight Increased Date:12/30/04ISR Number: 4541912-8Report Type:Expedited (15-DaCompany Report #PHFR2004GB04429 Age:25 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Chorea Clozaril PS Novartis Sector: Other Movement Disorder Pharma ORAL 300mg/day Obsessive-Compulsive Cipramil C Disorder 22-Feb-2006 08:30 AM Page: 3023 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/30/04ISR Number: 4542428-5Report Type:Expedited (15-DaCompany Report #US-ABBOTT-04P-163-0284497-00 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Macrocytic Depakote PS Nasal Congestion Depakote SS Pain Clozapine SS ORAL Pharyngitis Clonazepam C Productive Cough Pyrexia Sedation Date:12/30/04ISR Number: 4543189-6Report Type:Expedited (15-DaCompany Report #04-12-1706 Age:31 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Macrocytic Health Clozapine - Ivax Drug Level Increased Professional Pharmaceuticals, Neutrophil Count Other Inc. Tablets PS Ivax Increased Pharmaceuticals, Pain Inc. ORAL 75MG QD, ORAL Pharyngitis Depakote SS Sedation Klonopin C Date:12/30/04ISR Number: 4543194-XReport Type:Expedited (15-DaCompany Report #04-12-1737 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Large Intestine Health Clozapine - Ivax Perforation Professional Pharmaceuticals, Megacolon Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 500MG QD, ORAL Prilosec C Oxybutynin C Clonazepam C Date:12/30/04ISR Number: 4543197-5Report Type:Expedited (15-DaCompany Report #04-12-1807 Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 25-300MG QD, ORAL Date:12/30/04ISR Number: 4543200-2Report Type:Expedited (15-DaCompany Report #04-12-1808 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Choking Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 650-700MG QD 22-Feb-2006 08:30 AM Page: 3024 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL Date:12/30/04ISR Number: 4544609-3Report Type:Expedited (15-DaCompany Report #2004114755 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Geodon (Ziprasidone) PS Initial or Prolonged Psychotic Disorder Professional Clozapine Therapy Non-Responder (Clozapine) SS ORAL 225 MG, ORAL Topiramate (Topiramate) C Benzatropine Mesilate (Benzatropine Mesilate) C Date:12/30/04ISR Number: 4549206-1Report Type:Periodic Company Report #04-05-0706 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Health Clozapine Tablets - Initial or Prolonged Drug Ineffective Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 400-900MG QD ORAL Date:12/30/04ISR Number: 4549207-3Report Type:Periodic Company Report #04-05-0707 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 500MG QD ORAL Date:12/30/04ISR Number: 4549208-5Report Type:Periodic Company Report #04-05-0713 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pre-Existing Disease Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 400MG QD ORAL Date:12/30/04ISR Number: 4549209-7Report Type:Periodic Company Report #04-05-0715 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Unevaluable Event Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, 22-Feb-2006 08:30 AM Page: 3025 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Inc. PS Ivax Pharmaceuticals, Inc. ORAL ORAL Date:12/30/04ISR Number: 4549210-3Report Type:Periodic Company Report #04-05-0716 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 450MG QD ORAL Lexapro C Topamax C Trazodone C Date:12/30/04ISR Number: 4549211-5Report Type:Periodic Company Report #04-05-0717 Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pre-Existing Disease Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL ORAL Date:12/30/04ISR Number: 4549212-7Report Type:Periodic Company Report #04-05-0718 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Health Clozapine Tablets - Initial or Prolonged Irritability Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 300-550MG QD ORAL Date:12/30/04ISR Number: 4549213-9Report Type:Periodic Company Report #04-05-0720 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Hypertension Health Clozapine Tablets - Intervention to Professional Ivax Prevent Permanent Pharmaceuticals, Impairment/Damage Inc. PS Ivax Pharmaceuticals, Inc. ORAL 25-300MG BID ORAL Seroquel C Klonopin C 22-Feb-2006 08:30 AM Page: 3026 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/30/04ISR Number: 4549216-4Report Type:Periodic Company Report #04-05-0722 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 150MG QD ORAL Valproic Acid C Levodopa-Carbidopa C Paroxetine C Date:12/30/04ISR Number: 4549217-6Report Type:Periodic Company Report #04-05-0724 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Unevaluable Event Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 250-375MG QD ORAL Date:12/30/04ISR Number: 4549219-XReport Type:Periodic Company Report #04-05-0725 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychiatric Symptom Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 150-450MG QD ORAL Date:12/30/04ISR Number: 4549220-6Report Type:Periodic Company Report #04-05-0726 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective For Health Clozapine Tablets - Initial or Prolonged Unapproved Indication Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 300-600MG QD ORAL Date:12/30/04ISR Number: 4549221-8Report Type:Periodic Company Report #04-05-0727 Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death General Physical Health Health Clozapine Tablets - Deterioration Professional Ivax Other Pharmaceuticals, Inc. PS Ivax 22-Feb-2006 08:30 AM Page: 3027 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pharmaceuticals, Inc. ORAL 50-75MG QD ORAL Date:12/30/04ISR Number: 4549222-XReport Type:Periodic Company Report #04-05-0728 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychiatric Symptom Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 25-600MG QD ORAL Date:12/30/04ISR Number: 4549223-1Report Type:Periodic Company Report #04-05-0735 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 300-400MG QD ORAL Date:12/30/04ISR Number: 4549224-3Report Type:Periodic Company Report #04-05-0736 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Unevaluable Event Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 500MG QD ORAL Date:12/30/04ISR Number: 4549225-5Report Type:Periodic Company Report #04-05-0737 Age:81 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Failure To Thrive Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 25MG QD ORAL Date:12/30/04ISR Number: 4549226-7Report Type:Periodic Company Report #04-05-0741 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychiatric Symptom Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, 22-Feb-2006 08:30 AM Page: 3028 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Inc. PS Ivax Pharmaceuticals, Inc. ORAL 100MG QD ORAL Date:12/30/04ISR Number: 4549228-0Report Type:Periodic Company Report #04-05-0743 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 100MG QAM ORAL; 200MG HS ORAL Risperdal C Ativan C Ditropan Xl C Exelon C Date:12/30/04ISR Number: 4549229-2Report Type:Periodic Company Report #04-05-0747 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Paranoia Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 125-200MG QD ORAL Date:12/30/04ISR Number: 4549231-0Report Type:Periodic Company Report #04-05-0748 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Treatment Noncompliance Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 50-400MG QD ORAL Date:12/30/04ISR Number: 4549233-4Report Type:Periodic Company Report #04-05-0751 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Treatment Noncompliance Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 400MG QD ORAL 22-Feb-2006 08:30 AM Page: 3029 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/30/04ISR Number: 4549235-8Report Type:Periodic Company Report #04-05-0752 Age:76 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Unevaluable Event Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 25MG BID ORAL Zoloft C Zyprexa C Date:12/30/04ISR Number: 4549237-1Report Type:Periodic Company Report #04-05-0753 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Unevaluable Event Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 25-200MG QD ORAL Date:12/30/04ISR Number: 4549240-1Report Type:Periodic Company Report #04-05-0758 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pre-Existing Disease Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 12.5-525MG QD ORAL Date:12/30/04ISR Number: 4549242-5Report Type:Periodic Company Report #04-05-0759 Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Health Clozapine Tablets - Initial or Prolonged Pyrexia Professional Ivax Other Urinary Tract Infection Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 150-300MG QD ORAL Date:12/30/04ISR Number: 4549243-7Report Type:Periodic Company Report #04-05-0760 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Unevaluable Event Health Clozapine Tablets - Professional Ivax Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, 22-Feb-2006 08:30 AM Page: 3030 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Inc. ORAL 300-350MG QD ORAL Date:12/30/04ISR Number: 4549245-0Report Type:Periodic Company Report #04-05-0762 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychiatric Evaluation Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 200-300MG QD ORAL Date:12/30/04ISR Number: 4549246-2Report Type:Periodic Company Report #04-05-0763 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Intentional Overdose Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 200MG TID ORAL Tylenol W/Codeine No. 3 SS 2Q4H PRN Diazepam C Depakote C Date:12/30/04ISR Number: 4549248-6Report Type:Periodic Company Report #04-05-0764 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective For Health Clozapine Tablets - Initial or Prolonged Unapproved Indication Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 400-500MG QD ORAL Date:12/30/04ISR Number: 4549249-8Report Type:Periodic Company Report #04-05-0765 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 500-700MG QD ORAL 22-Feb-2006 08:30 AM Page: 3031 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/30/04ISR Number: 4549250-4Report Type:Periodic Company Report #04-05-0766 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Treatment Noncompliance Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 300-500MG QD ORAL Date:12/30/04ISR Number: 4549252-8Report Type:Periodic Company Report #04-05-0767 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Treatment Noncompliance Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 200-800MG QD ORAL Date:12/30/04ISR Number: 4549253-XReport Type:Periodic Company Report #04-05-0768 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pericardial Effusion Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL ORAL Date:12/30/04ISR Number: 4549254-1Report Type:Periodic Company Report #04-05-0772 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Treatment Noncompliance Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 500-700MG QD ORAL Date:12/30/04ISR Number: 4549255-3Report Type:Periodic Company Report #04-05-0776 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 150-600MG QD ORAL 22-Feb-2006 08:30 AM Page: 3032 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Oxycontin C Date:12/30/04ISR Number: 4549256-5Report Type:Periodic Company Report #04-05-0777 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Health Clozapine Tablets - Initial or Prolonged Neutrophil Count Professional Ivax Other Decreased Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 300MG QD ORAL Eskalith SS 450MG QHS Date:12/30/04ISR Number: 4549257-7Report Type:Periodic Company Report #04-05-0778 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Unevaluable Event Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 325MG BID ORAL Citalopram C Ibuprofen C L-Thyroxin C Gemfibrozil C Fish Oil C Divalproex Sodium C Multivitamins C Docusate Calcium C Milk Of Magnesia C Clotrimazole Cream C Erythromycin C Tetrahydrozoline C Date:12/30/04ISR Number: 4549258-9Report Type:Periodic Company Report #04-05-0779 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Treatment Noncompliance Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 200-400MG QD ORAL Date:12/30/04ISR Number: 4549259-0Report Type:Periodic Company Report #04-05-0780 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective For Health Clozapine Tablets - Initial or Prolonged Unapproved Indication Professional Ivax Other Pharmaceuticals, 22-Feb-2006 08:30 AM Page: 3033 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Inc. PS Ivax Pharmaceuticals, Inc. ORAL 200-300MG QD ORAL Date:12/30/04ISR Number: 4549261-9Report Type:Periodic Company Report #04-05-0782 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Treatment Noncompliance Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 400-600MG QD ORAL Date:12/30/04ISR Number: 4549262-0Report Type:Periodic Company Report #04-05-0783 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pre-Existing Disease Health Clozapine-Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc.Tablets PS Ivax Pharmaceuticals, Inc. ORAL 25-800MG QD ORAL Date:12/30/04ISR Number: 4549263-2Report Type:Periodic Company Report #04-05-0785 Age:78 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Unevaluable Event Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 300MG QD ORAL Date:12/30/04ISR Number: 4549264-4Report Type:Periodic Company Report #04-05-0786 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutrophil Count Health Clozapine Tablets - Decreased Professional Ivax Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 300MG HS ORAL 7 MON Risperdal C Depakote C Restoril C Ativan C 22-Feb-2006 08:30 AM Page: 3034 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/30/04ISR Number: 4549265-6Report Type:Periodic Company Report #04-06-0789 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Treatment Noncompliance Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 450MG QD ORAL Date:12/30/04ISR Number: 4549266-8Report Type:Periodic Company Report #04-06-0791 Age:69 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Oedema Peripheral Health Clozapine Tablets - Hospitalization - Unevaluable Event Professional Ivax Initial or Prolonged Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 400-125MG QD ORAL Date:12/30/04ISR Number: 4549267-XReport Type:Periodic Company Report #04-06-0792 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pre-Existing Disease Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 50MG QD ORAL Date:12/30/04ISR Number: 4549269-3Report Type:Periodic Company Report #04-06-0793 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Health Clozapine Tablets - Required Professional Ivax Intervention to Other Pharmaceuticals, Prevent Permanent Inc. PS Ivax Impairment/Damage Pharmaceuticals, Inc. ORAL 125MG QHS ORAL Promethazine Tablets C Lamictal Tablets C Dilantin Capsules C Docusate Sodium Capsules C Senna S C Dilantin Chewable Tablets C Seroquel Tablets C Phenergan Tablets C Abilify Tablets C Zoloft C Hydroxyzine C Tizanidine 22-Feb-2006 08:30 AM Page: 3035 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride C Ibuprofen Tablets C Vistaril C Date:12/30/04ISR Number: 4549272-3Report Type:Periodic Company Report #04-06-0795 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Treatment Noncompliance Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 250-600MG QD ORAL Date:12/30/04ISR Number: 4549277-2Report Type:Periodic Company Report #04-06-0801 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Grand Mal Convulsion Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 100MG TID ORAL Thorazine C Depakote C Cogentin C Date:12/30/04ISR Number: 4549279-6Report Type:Periodic Company Report #04-06-0811 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Paranoia Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 100-400MG QD ORAL Date:12/30/04ISR Number: 4549280-2Report Type:Periodic Company Report #04-06-0812 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Treatment Noncompliance Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 150-500MG QD ORAL 22-Feb-2006 08:30 AM Page: 3036 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/30/04ISR Number: 4549281-4Report Type:Periodic Company Report #04-06-0813 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Treatment Noncompliance Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 700MG QD ORAL Date:12/30/04ISR Number: 4549282-6Report Type:Periodic Company Report #04-06-0814 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Health Clozapine - Ivax Initial or Prolonged White Blood Cell Count Professional Pharmaceuticals, Required Decreased Other Inc. Tablets PS Ivax Intervention to Pharmaceuticals, Prevent Permanent Inc. ORAL 350MG QD ORAL Impairment/Damage Zithromax C Augmentin C Omnicef C Date:12/30/04ISR Number: 4549283-8Report Type:Periodic Company Report #04-06-0820 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 325-600MG QD ORAL Date:12/30/04ISR Number: 4549284-XReport Type:Periodic Company Report #04-06-0821 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychiatric Symptom Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL ORAL Date:12/30/04ISR Number: 4549285-1Report Type:Periodic Company Report #04-06-0822 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Treatment Noncompliance Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL ORAL 22-Feb-2006 08:30 AM Page: 3037 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/30/04ISR Number: 4549286-3Report Type:Periodic Company Report #04-06-0823 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Treatment Noncompliance Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 900MG QD ORAL Date:12/30/04ISR Number: 4549287-5Report Type:Periodic Company Report #04-06-0824 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 100-750MG QD ORAL Date:12/30/04ISR Number: 4549288-7Report Type:Periodic Company Report #04-06-0832 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Health Clozapine - Ivax Required Professional Pharmaceuticals, Intervention to Other Inc. Tablets PS Ivax Prevent Permanent Pharmaceuticals, Impairment/Damage Inc. ORAL SEE IMAGE Haldol Tablets C Geodon Tablets C Seroquel Tablets C Cogentin C Wellbutrin Tablets Sr C Quetiapine Fumarate C Pantoprazole C Docusate Sodium C Ferrous Sulfate C Folic Acid C Multivitamins C Date:12/30/04ISR Number: 4549289-9Report Type:Periodic Company Report #04-06-0833 Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Unevaluable Event Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 75MG QD ORAL 22-Feb-2006 08:30 AM Page: 3038 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/30/04ISR Number: 4549290-5Report Type:Periodic Company Report #04-06-0836 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 300-600MG QD ORAL Date:12/30/04ISR Number: 4549291-7Report Type:Periodic Company Report #04-06-0846 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 750MG QD ORAL Date:12/30/04ISR Number: 4549292-9Report Type:Periodic Company Report #04-06-0847 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychiatric Evaluation Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 25-900MG QD ORAL Date:12/30/04ISR Number: 4549293-0Report Type:Periodic Company Report #04-06-0848 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hospitalisation Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 250MG QD ORAL Date:12/30/04ISR Number: 4549295-4Report Type:Periodic Company Report #04-06-0849 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drooling Health Clozapine - Ivax Initial or Prolonged Treatment Noncompliance Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 600-550MG ORAL 22-Feb-2006 08:30 AM Page: 3039 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/30/04ISR Number: 4549297-8Report Type:Periodic Company Report #04-06-0850 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 500-700MG QD ORAL Date:12/30/04ISR Number: 4549302-9Report Type:Periodic Company Report #04-06-0852 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Health Clozapine - Ivax Required Professional Pharmaceuticals, Intervention to Other Inc. Tablets PS Ivax Prevent Permanent Pharmaceuticals, Impairment/Damage Inc. ORAL 750MG QD ORAL Pegasys Injectable Solution SS INTRAMUSCULAR 180MCG QW INTRAMUSCULAR Ribavirin SS ORAL SEE IMAGE Abilify C Date:12/30/04ISR Number: 4549304-2Report Type:Periodic Company Report #04-06-0856 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 150-700MG QD ORAL Date:12/30/04ISR Number: 4549305-4Report Type:Periodic Company Report #04-06-0857 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Procedural Complication Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL ORAL Date:12/30/04ISR Number: 4549308-XReport Type:Periodic Company Report #04-06-0858 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pre-Existing Disease Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 12.5-37.5MG Q ORAL 22-Feb-2006 08:30 AM Page: 3040 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/30/04ISR Number: 4549312-1Report Type:Periodic Company Report #04-06-0859 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Health Clozapine Tablets - Initial or Prolonged Hallucination, Auditory Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 100-400MG QD ORAL Date:12/30/04ISR Number: 4549313-3Report Type:Periodic Company Report #04-06-0860 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperglycaemia Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 300MG QD ORAL Date:12/30/04ISR Number: 4549314-5Report Type:Periodic Company Report #04-06-0862 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Suicidal Ideation Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 150 MG QAM ORAL Date:12/30/04ISR Number: 4549316-9Report Type:Periodic Company Report #04-06-0874 Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozapine Tablets - Other Urinary Tract Infection Professional Ivax Required Other Pharmaceuticals, Intervention to Inc. PS Ivax Prevent Permanent Pharmaceuticals, Impairment/Damage Inc. ORAL 450MG QD ORAL Date:12/30/04ISR Number: 4549317-0Report Type:Periodic Company Report #04-06-0875 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucination, Auditory Health Clozapine Tablets - Initial or Prolonged Hallucination, Visual Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 450-800MG QD ORAL 22-Feb-2006 08:30 AM Page: 3041 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/30/04ISR Number: 4549318-2Report Type:Periodic Company Report #04-06-0876 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Paranoia Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 450-600MG QD ORAL Date:12/30/04ISR Number: 4549319-4Report Type:Periodic Company Report #04-06-0885 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Unevaluable Event Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 150-200MG QD ORAL Date:12/30/04ISR Number: 4549321-2Report Type:Periodic Company Report #04-06-0891 Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Treatment Noncompliance Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 25-150MG QD ORAL Date:12/30/04ISR Number: 4549322-4Report Type:Periodic Company Report #04-06-0892 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 150-500MG QD ORAL Date:12/30/04ISR Number: 4549323-6Report Type:Periodic Company Report #04-06-0911 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hospitalisation Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 150-700MG QD 22-Feb-2006 08:30 AM Page: 3042 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL Date:12/30/04ISR Number: 4549324-8Report Type:Periodic Company Report #04-06-0912 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 12.5-200MG QD ORAL Date:12/30/04ISR Number: 4549325-XReport Type:Periodic Company Report #04-06-0913 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Unevaluable Event Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 100MG QD ORAL Date:12/30/04ISR Number: 4549327-3Report Type:Periodic Company Report #04-06-0914 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Incision Site Health Clozapine Tablets - Initial or Prolonged Complication Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 25-400MG QD ORAL Date:12/30/04ISR Number: 4549331-5Report Type:Periodic Company Report #04-06-0915 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Treatment Noncompliance Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL ORAL Date:12/30/04ISR Number: 4549335-2Report Type:Periodic Company Report #04-06-0916 Age:67 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Health Clozapine Tablets - Required Professional Ivax Intervention to Other Pharmaceuticals, Prevent Permanent Inc. PS Ivax Impairment/Damage Pharmaceuticals, 22-Feb-2006 08:30 AM Page: 3043 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Inc. ORAL 200MG BID ORAL Depakote C Clonazepam C Seizure Disorder C Date:12/30/04ISR Number: 4549337-6Report Type:Periodic Company Report #04-06-0926 Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Unevaluable Event Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 300MG QD ORAL Date:12/30/04ISR Number: 4549340-6Report Type:Periodic Company Report #04-06-0928 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Treatment Noncompliance Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 300-700MG QD ORAL Date:12/30/04ISR Number: 4549341-8Report Type:Periodic Company Report #04-06-0933 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pre-Existing Disease Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 225-450MG QD ORAL Date:12/30/04ISR Number: 4549343-1Report Type:Periodic Company Report #04-06-0934 Age:67 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intestinal Obstruction Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 100-400MG QD ORAL 22-Feb-2006 08:30 AM Page: 3044 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/30/04ISR Number: 4549344-3Report Type:Periodic Company Report #04-06-0935 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychiatric Symptom Health Clozapine - Ivax Initial or Prolonged White Blood Cell Count Professional Pharmaceuticals, Decreased Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL ORAL Date:12/30/04ISR Number: 4549345-5Report Type:Periodic Company Report #04-06-0936 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Unevaluable Event Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 125-250MG QD ORAL Date:12/30/04ISR Number: 4549346-7Report Type:Periodic Company Report #04-06-0939 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 250MG QD ORAL Date:12/30/04ISR Number: 4549362-5Report Type:Periodic Company Report #04-06-0954 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Toxicity Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 300MG HS ORAL Lexapro Tablets SS ORAL 30MG AM ORAL Date:12/30/04ISR Number: 4549364-9Report Type:Periodic Company Report #04-06-0987 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychiatric Symptom Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 100MG QD ORAL 22-Feb-2006 08:30 AM Page: 3045 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/30/04ISR Number: 4549366-2Report Type:Periodic Company Report #04-07-0950 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death No Adverse Drug Effect Health Clozapine - Ivax Professional Pharmaceuticals, Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 575MG QD ORAL Depakote Er C Klonopin C Remeron C Date:12/30/04ISR Number: 4549369-8Report Type:Periodic Company Report #04-07-0951 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Pain Health Clozapine - Ivax Unevaluable Event Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals ORAL 300-400MG QD ORAL Date:12/30/04ISR Number: 4549371-6Report Type:Periodic Company Report #04-07-0952 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Clozapine - Ivax Initial or Prolonged Mental Disorder Professional Pharmaceuticals, Other Other Inc. Tablets PS Ivax Required Pharmaceuticals, Intervention to Inc. ORAL 100MG QD ORAL Prevent Permanent Divalproex Sodium C Impairment/Damage Date:12/30/04ISR Number: 4549372-8Report Type:Periodic Company Report #04-07-0953 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Unevaluable Event Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 150MG QPM ORAL Date:12/30/04ISR Number: 4549373-XReport Type:Periodic Company Report #04-07-0958 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Normal Labour Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 350-450MG QD ORAL 22-Feb-2006 08:30 AM Page: 3046 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/30/04ISR Number: 4549386-8Report Type:Periodic Company Report #04-07-0959 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucination, Auditory Health Clozapine - Ivax Initial or Prolonged Treatment Noncompliance Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 400-475MG QD ORAL Date:12/30/04ISR Number: 4549387-XReport Type:Periodic Company Report #04-07-0972 Age:77 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pre-Existing Disease Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 12.5MG QD ORAL Date:12/30/04ISR Number: 4549390-XReport Type:Periodic Company Report #04-07-0975 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 250-300MG QD ORAL Date:12/30/04ISR Number: 4549391-1Report Type:Periodic Company Report #04-07-0976 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 75-100MG QD ORAL Date:12/30/04ISR Number: 4549392-3Report Type:Periodic Company Report #04-07-0978 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Treatment Noncompliance Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 175-600MG QD ORAL 22-Feb-2006 08:30 AM Page: 3047 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/30/04ISR Number: 4549393-5Report Type:Periodic Company Report #04-07-0979 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 50MG BID ORAL Date:12/30/04ISR Number: 4549394-7Report Type:Periodic Company Report #04-07-0981 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hospitalisation Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 150MG QD ORAL Zyprexa C Date:12/30/04ISR Number: 4549396-0Report Type:Periodic Company Report #04-07-0983 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective For Health Clozapine - Ivax Initial or Prolonged Unapproved Indication Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 25-600MG QD ORAL Date:12/30/04ISR Number: 4549397-2Report Type:Periodic Company Report #04-07-0986 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Health Clozapine - Ivax Initial or Prolonged Anaemia Professional Pharmaceuticals, Other Pharyngitis Inc. Tablets PS Ivax Pneumonia Pharmaceuticals, Pyrexia Inc. ORAL 200 MG QD ORAL Risperdal C Xanax C Date:12/30/04ISR Number: 4549399-6Report Type:Periodic Company Report #04-07-0989 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intestinal Obstruction Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 200MG QD ORAL 22-Feb-2006 08:30 AM Page: 3048 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/30/04ISR Number: 4549905-1Report Type:Periodic Company Report #04-05-0638 Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Health Clozapine Tablets - Initial or Prolonged Pre-Existing Disease Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 125-800MG QD ORAL Date:12/30/04ISR Number: 4549906-3Report Type:Periodic Company Report #04-05-0639 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 400-500MG QD ORAL Date:12/30/04ISR Number: 4549907-5Report Type:Periodic Company Report #04-05-0640 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychiatric Evaluation Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 350MG QD ORAL Date:12/30/04ISR Number: 4549908-7Report Type:Periodic Company Report #04-05-0641 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Health Clozapine Tablets - Required Professional Ivax Intervention to Other Pharmaceuticals, Prevent Permanent Inc. PS Ivax Impairment/Damage Pharmaceuticals, Inc. ORAL SEE IMAGE Trileptal C Neurontin C Ativan C Levoxyl C Cytomel C Omega C Multivitamins C Seroquel C 22-Feb-2006 08:30 AM Page: 3049 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/30/04ISR Number: 4549909-9Report Type:Periodic Company Report #04-05-0644 Age:67 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Unevaluable Event Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 37.5MG HS ORAL Sinemet C Lescol C Zoloft C Labetalol C Prilosec C Imdur C Lasix C Flomax C Date:12/30/04ISR Number: 4549910-5Report Type:Periodic Company Report #04-05-0645 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 100-400MG QD ORAL Date:12/30/04ISR Number: 4549911-7Report Type:Periodic Company Report #04-05-0647 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 75-400MG QD ORAL Date:12/30/04ISR Number: 4549912-9Report Type:Periodic Company Report #04-05-0657 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Treatment Noncompliance Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 450MG QD ORAL 22-Feb-2006 08:30 AM Page: 3050 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/30/04ISR Number: 4549913-0Report Type:Periodic Company Report #04-05-0658 Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Unevaluable Event Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceticals, Inc. ORAL ORAL Date:12/30/04ISR Number: 4549914-2Report Type:Periodic Company Report #04-05-0659 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 25-500 MG QD ORAL Date:12/30/04ISR Number: 4549915-4Report Type:Periodic Company Report #04-05-0661 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Treatment Noncompliance Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 200-500MG QD ORAL Date:12/30/04ISR Number: 4549916-6Report Type:Periodic Company Report #04-05-0662 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Unevaluable Event Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 300-700 MG QD ORAL Date:12/30/04ISR Number: 4549917-8Report Type:Periodic Company Report #04-050668 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychiatric Symptom Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 700 MG QD ORAL 22-Feb-2006 08:30 AM Page: 3051 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/30/04ISR Number: 4549918-XReport Type:Periodic Company Report #04-05-0669 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Suicidal Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 150-475 MG QD ORAL Date:12/30/04ISR Number: 4549919-1Report Type:Periodic Company Report #04-05-0670 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Unevaluable Event Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 200-275 MG QD ORAL Date:12/30/04ISR Number: 4549920-8Report Type:Periodic Company Report #04-05-0671 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Unevaluable Event Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 300-500 MG QD ORAL Date:12/30/04ISR Number: 4549921-XReport Type:Periodic Company Report #04-05-0672 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pre-Existing Disease Health Clozapine - Ivax Initial or Prolonged Psychiatric Symptom Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 300-500 MG QD ORAL Date:12/30/04ISR Number: 4549922-1Report Type:Periodic Company Report #04-05-0673 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Health Clozapine - Ivax Initial or Prolonged Paranoia Professional Pharmaceuticals, Suicidal Ideation Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 150-900 MG QD ORAL 22-Feb-2006 08:30 AM Page: 3052 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/30/04ISR Number: 4549923-3Report Type:Periodic Company Report #04-05-0674 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Diarrhoea Health Clozapine - Ivax Hospitalization - Hypotension Professional Pharmaceuticals, Initial or Prolonged Oxygen Saturation Other Inc. Tablets PS Ivax Required Abnormal Pharmaceuticals, Intervention to Pharyngolaryngeal Pain Inc. ORAL SEE IMAGE Prevent Permanent Pyrexia Haldol C Impairment/Damage Respiratory Rate Valproic Acid C Increased Fluvoxamine C Tachycardia Date:12/30/04ISR Number: 4549924-5Report Type:Periodic Company Report #04-05-0685 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL ORAL Chemotherapy SS Date:12/30/04ISR Number: 4549925-7Report Type:Periodic Company Report #04-05-0686 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 500MG QD ORAL Date:12/30/04ISR Number: 4549926-9Report Type:Periodic Company Report #04-05-0689 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 50MG AM ORAL; 75MG HS ORAL Fluvoxamine SS ORAL 50MG AM ORAL; 100MG HS ORAL Haloperidol C Luvox C Doxycycline C Benztropine Mesylate C Date:12/30/04ISR Number: 4549927-0Report Type:Periodic Company Report #04-05-0690 Age:43 YR Gender: I/FU:I Outcome PT Report Source Hospitalization - Agitation Health Initial or Prolonged Treatment Noncompliance Professional 22-Feb-2006 08:30 AM Page: 3053 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Product Role Manufacturer Route Dose Duration Clozapine - Ivax Pharmaceuticals, Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 500-600MG QD ORAL Date:12/30/04ISR Number: 4549928-2Report Type:Periodic Company Report #04-05-0694 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 200MG AM ORAL Seroquel C Depakote C Ditropan C Risperdal C Levoxyl C Albuterol Sulfate C Atrovent C Serevent C Flovent C Zestril C Premarin C Provera C Date:12/30/04ISR Number: 4549929-4Report Type:Periodic Company Report #04-05-0695 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 100MG AM ORAL; 200MG HS ORAL Valproic Acid C Date:12/30/04ISR Number: 4549930-0Report Type:Periodic Company Report #04-05-0698 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Unevaluable Event Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 750MG QD ORAL Depakote C Celexa C Ativan C Pepcid C 22-Feb-2006 08:30 AM Page: 3054 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/30/04ISR Number: 4549931-2Report Type:Periodic Company Report #04-05-0699 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pre-Existing Disease Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 100-400MG QD ORAL Date:12/30/04ISR Number: 4549932-4Report Type:Periodic Company Report #04-05-0700 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Unevaluable Event Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 650MG QHS ORAL Loxitane C Trileptal C Restoril C Midodrine C Date:12/30/04ISR Number: 4549933-6Report Type:Periodic Company Report #04-05-0704 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alcoholism Health Clozapine - Ivax Initial or Prolonged Treatment Noncompliance Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 900MG QD ORAL Date:12/30/04ISR Number: 4549934-8Report Type:Periodic Company Report #04-05-0705 Age:67 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Clozapine - Ivax Initial or Prolonged Delusion Professional Pharmaceuticals, Insomnia Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 75-300MG QD ORAL Date:12/30/04ISR Number: 4553693-2Report Type:Periodic Company Report #04-07-1060 Age:66 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective For Health Clozapine Tablets - Initial or Prolonged Unapproved Indication Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 150-375MG QD ORAL 22-Feb-2006 08:30 AM Page: 3055 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/30/04ISR Number: 4553694-4Report Type:Periodic Company Report #04-07-1061 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychiatric Symptom Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 900MG QD ORAL Date:12/30/04ISR Number: 4553695-6Report Type:Periodic Company Report #04-07-1062 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 250MG QD ORAL Date:12/30/04ISR Number: 4553696-8Report Type:Periodic Company Report #04-07-1063 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Thrombocytopenia Health Clozapine Tablets - Hospitalization - Professional Ivax Initial or Prolonged Pharmaceuticals, Other Inc. PS Ivax Pharmaceuticals, Inc. ORAL 500MG AM ORAL Levothyroxine C Haloperidol C Lithobid C Metformin C Benztropine Mesylate C Niacin C Date:12/30/04ISR Number: 4553697-XReport Type:Periodic Company Report #04-07-1064 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozapine Tablets - Neutropenia Professional Ivax Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 525MG QD ORAL Imuran SS Date:12/30/04ISR Number: 4553698-1Report Type:Periodic Company Report #04-07-1066 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Cardiac Death Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, 22-Feb-2006 08:30 AM Page: 3056 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Inc. PS Ivax Pharmaceuticals, Inc. ORAL 400MG QD ORAL Lexapro C Risperdal C Ativan C Date:12/30/04ISR Number: 4553699-3Report Type:Periodic Company Report #04-07-1067 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Treatment Noncompliance Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 200-400MG QD ORAL Date:12/30/04ISR Number: 4553700-7Report Type:Periodic Company Report #04-07-1068 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 500MG QD ORAL Date:12/30/04ISR Number: 4553701-9Report Type:Periodic Company Report #04-07-1069 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Unevaluable Event Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 400-600MG QD ORAL Date:12/30/04ISR Number: 4553702-0Report Type:Periodic Company Report #04-07-1070 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Tardive Dyskinesia Health Clozapine Tablets - Initial or Prolonged Treatment Noncompliance Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 75-400MG QD ORAL 22-Feb-2006 08:30 AM Page: 3057 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/30/04ISR Number: 4553711-1Report Type:Periodic Company Report #04-07-1071 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pre-Existing Disease Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 400MG QD ORAL Date:12/30/04ISR Number: 4553712-3Report Type:Periodic Company Report #04-07-1072 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozapine Tablets - Professional Ivax Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 300-700MG QD ORAL Date:12/30/04ISR Number: 4553713-5Report Type:Periodic Company Report #04-07-1075 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pre-Existing Disease Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 300MG QHS ORAL Proloxin Decanoate C Cogentin C Celexa C Prevacid C Benztropine Mesylate C Ditropan C Advair C Hydrochlorothiazide C Singulair C Date:12/30/04ISR Number: 4553714-7Report Type:Periodic Company Report #04-07-1077 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Treatment Noncompliance Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 300-450MG QD ORAL Abilify C Paroxetine C Metformin C 22-Feb-2006 08:30 AM Page: 3058 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/30/04ISR Number: 4553715-9Report Type:Periodic Company Report #04-07-1079 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucination Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 50-175MG QD ORAL Date:12/30/04ISR Number: 4553716-0Report Type:Periodic Company Report #04-07-1082 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 600MG QD ORAL Albuterol Sulfate C Avandia C Cardizem C Diovan C Flovent C Glucophage C Lasix C Prolixin Decanoate C Senokot C Seroquel C Trileptal C Tylenol C Singulair C ... C ... C Date:12/30/04ISR Number: 4554198-5Report Type:Periodic Company Report #04-06-0893 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 450MG HS ORAL Date:12/30/04ISR Number: 4554199-7Report Type:Periodic Company Report #04-06-0894 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Health Clozapine Tablets - Initial or Prolonged Panic Attack Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 800MG QD ORAL 22-Feb-2006 08:30 AM Page: 3059 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Abilify C Senna S C Seroquel C Lexapro C Benztropine Mesylate C Date:12/30/04ISR Number: 4554204-8Report Type:Periodic Company Report #04-06-0897 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Health Clozapine Tablets - Initial or Prolonged Pneumonia Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 400-800MG QD ORAL Date:12/30/04ISR Number: 4554205-XReport Type:Periodic Company Report #04-06-0898 Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Decreased Appetite Health Clozapine Tablets - Initial or Prolonged Treatment Noncompliance Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceutical, Inc. ORAL 250MG QD ORAL Date:12/30/04ISR Number: 4554206-1Report Type:Periodic Company Report #04-06-0899 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Treatment Noncompliance Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 600MG QD ORAL Date:12/30/04ISR Number: 4554207-3Report Type:Periodic Company Report #04-06-0900 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Treatment Noncompliance Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 200-700MG QD ORAL 22-Feb-2006 08:30 AM Page: 3060 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/30/04ISR Number: 4554210-3Report Type:Periodic Company Report #04-06-0902 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 100MG QD ORAL Date:12/30/04ISR Number: 4554211-5Report Type:Periodic Company Report #04-06-0906 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychiatric Symptom Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 600-650MG QD ORAL Date:12/30/04ISR Number: 4554212-7Report Type:Periodic Company Report #04-06-0907 Age:81 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Unevaluable Event Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 150MG QD ORAL Furosemide C Clonazepam C Mirtazapine C Date:12/30/04ISR Number: 4554213-9Report Type:Periodic Company Report #04-06-0908 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychiatric Symptom Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 400MG QD ORAL Date:12/30/04ISR Number: 4554227-9Report Type:Periodic Company Report #04-07-0990 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Leukopenia Health Clozapine - Ivax Intervention to Platelet Count Decreased Professional Pharmaceuticals, Prevent Permanent Other Inc. Tablets PS Ivax Impairment/Damage Pharmaceuticals, Inc. ORAL 100-875MG QD ORAL 22-Feb-2006 08:30 AM Page: 3061 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lamictal C Depakote C Date:12/30/04ISR Number: 4554228-0Report Type:Periodic Company Report #04-07-0992 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Health Clozapine - Ivax Initial or Prolonged Salivary Hypersecretion Professional Pharmaceuticals, Sedation Other Inc. Tablets PS Ivax Urinary Incontinence Pharmaceuticals, Inc. ORAL 900MG QD ORAL Loxitane C Depakote C Ativan C Date:12/30/04ISR Number: 4554233-4Report Type:Periodic Company Report #04-07-0994 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Health Clozapine - Ivax Initial or Prolonged Neutropenia Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 50-350MG QD ORAL Paxil Cr C Depakote C Haldol C Desmopressin Nasal Solution C Date:12/30/04ISR Number: 4554234-6Report Type:Periodic Company Report #04-07-0998 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hospitalisation Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 150-200MG QD ORAL Date:12/30/04ISR Number: 4554235-8Report Type:Periodic Company Report #04-07-1000 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Clozapine - Ivax Professional Pharmaceuticals, Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 400-700MG QD ORAL 22-Feb-2006 08:30 AM Page: 3062 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/30/04ISR Number: 4554236-XReport Type:Periodic Company Report #04-07-1001 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death No Adverse Drug Effect Health Clozapine - Ivax Road Traffic Accident Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 300MG QHS ORAL Amaryl C Metoclopramide C Altace C Tricor C Sonata C Paxil C Risperdal C Depakote C Percocet C Date:12/30/04ISR Number: 4554237-1Report Type:Periodic Company Report #04-07-1002 Age:92 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 25-50MG QD ORAL Date:12/30/04ISR Number: 4554238-3Report Type:Periodic Company Report #04-07-1003 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intestinal Obstruction Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 100-500MG QD ORAL Date:12/30/04ISR Number: 4554241-3Report Type:Periodic Company Report #04-07-1010 Age:44 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Treatment Noncompliance Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 400-500MG QD ORAL 22-Feb-2006 08:30 AM Page: 3063 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/30/04ISR Number: 4554242-5Report Type:Periodic Company Report #04-07-1011 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 25-300MG QD ORAL Date:12/30/04ISR Number: 4554297-8Report Type:Periodic Company Report #04-07-1013 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Health Clozapine Tablets - Initial or Prolonged Rash Macular Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 150-450 MG QD ORAL Date:12/30/04ISR Number: 4554300-5Report Type:Periodic Company Report #04-07-1017 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Clozapine Tablets - Initial or Prolonged Psychotic Disorder Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 150-400MG QD ORAL Date:12/30/04ISR Number: 4554313-3Report Type:Periodic Company Report #04-07-1018 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Back Pain Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 150-475MG QD ORAL Date:12/30/04ISR Number: 4554320-0Report Type:Periodic Company Report #04-07-1021 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Surgery Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS ORAL 37.5-50MG QD ORAL 22-Feb-2006 08:30 AM Page: 3064 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/30/04ISR Number: 4554322-4Report Type:Periodic Company Report #04-07-1022 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychiatric Symptom Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 200MG QD ORAL Date:12/30/04ISR Number: 4554328-5Report Type:Periodic Company Report #04-07-1023 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 500MG QD ORAL Date:12/30/04ISR Number: 4554335-2Report Type:Periodic Company Report #04-07-1026 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Disorientation Health Clozapine Tablets - Initial or Prolonged Dizziness Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 250 MG QD ORAL Lithium Unknown SS Date:12/30/04ISR Number: 4554336-4Report Type:Periodic Company Report #04-07-1027 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Sepsis Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 400-700MG QD ORAL Date:12/30/04ISR Number: 4554337-6Report Type:Periodic Company Report #04-07-1028 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Other Pharmaceuticals, Required Inc. PS Ivax Intervention to Pharmaceuticals, Prevent Permanent Inc. ORAL 100-500MG QD Impairment/Damage ORAL 22-Feb-2006 08:30 AM Page: 3065 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/30/04ISR Number: 4554339-XReport Type:Periodic Company Report #04-07-1029 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychiatric Evaluation Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 100-400MG QD ORAL Date:12/30/04ISR Number: 4554344-3Report Type:Periodic Company Report #04-07-1030 Age:67 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delusion Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 325MG QD ORAL Date:12/30/04ISR Number: 4554346-7Report Type:Periodic Company Report #04-07-1031 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Suicidal Ideation Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 225-600MG QD ORAL Date:12/30/04ISR Number: 4554348-0Report Type:Periodic Company Report #04-07-1032 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychiatric Symptom Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 200-600MG QD ORAL Date:12/30/04ISR Number: 4554351-0Report Type:Periodic Company Report #04-07-1033 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective For Health Clozapine Tablets - Initial or Prolonged Unapproved Indication Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 12.5-88MG QD ORAL 22-Feb-2006 08:30 AM Page: 3066 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/30/04ISR Number: 4554352-2Report Type:Periodic Company Report #04-07-1044 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 250MG HS ORAL Seroquel C Date:12/30/04ISR Number: 4554355-8Report Type:Periodic Company Report #04-07-1050 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Health Clozapine Tablets - Initial or Prolonged Musculoskeletal Chest Professional Ivax Pain Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 300-450MG QD ORAL Date:12/30/04ISR Number: 4554363-7Report Type:Periodic Company Report #04-07-1053 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Consumer Clozapine Tablets - Initial or Prolonged Anaemia Ivax Other Diarrhoea Pharmaceuticals, Pneumonia Inc. PS Ivax Pyrexia Pharmaceuticals, Somnolence Inc. ORAL 25-50MG QD White Blood Cell Count ORAL Increased Lithobid C Cogentin C Risperdal C Synthroid C Prilosec C Date:12/30/04ISR Number: 4554366-2Report Type:Periodic Company Report #04-07-1058 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Clozapine Tablets - Professional Ivax Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 200 MG BID ORAL 22-Feb-2006 08:30 AM Page: 3067 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/30/04ISR Number: 4554370-4Report Type:Periodic Company Report #04-07-1059 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pulmonary Embolism Health Clozapine Tablets - Initial or Prolonged Professional Ivax Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 250-500MG QD ORAL Date:01/03/05ISR Number: 4543051-9Report Type:Expedited (15-DaCompany Report #PHHO2004CA18165 Age:56 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Distension Clozaril PS Novartis Sector: Initial or Prolonged Colitis Ischaemic Pharma 50 mg, QHS Constipation Clozaril SS Novartis Sector: Rectal Haemorrhage Pharma 100mg daily dose Efexor Xr C Lipitor C Pantoloc C Pariet C Asa C Glyburide C Altace C Docusate C Ativan C Domperidone C Ovol C Loxapine C Seroquel C Zopiclone C Bisacodyl C Tylenol C Novogesic C Fleet Enema C Date:01/03/05ISR Number: 4543485-2Report Type:Expedited (15-DaCompany Report #GB-GLAXOSMITHKLINE-B0362676A Age:36 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Overdose Paracetamol PS Glaxosmithkline ORAL 500MG Single Initial or Prolonged Liver Function Test dose Abnormal Clozaril SS ORAL 450MG per day Multiple Drug Overdose Nausea Suicide Attempt Vomiting Date:01/03/05ISR Number: 4543867-9Report Type:Expedited (15-DaCompany Report #PHFR2003GB04442 Age:24 YR Gender:Male I/FU:I Outcome PT Hospitalization - Electrocardiogram Qt Initial or Prolonged Corrected Interval Other Prolonged 22-Feb-2006 08:30 AM Page: 3068 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Multiple Drug Overdose Somnolence Report Source Product Role Manufacturer Route Dose Duration Foreign Clozaril (Clozapine) PS ORAL SEE IMAGE, Study ORAL Health Diazepam (Ngx) Professional (Diazepam) SS SEE IMAGE Other Citalopram (Ngx) (Citalopram) SS SEE IMAGE Procyclidine (Procyclidine) SS SEE IMAGE Date:01/03/05ISR Number: 4543922-3Report Type:Expedited (15-DaCompany Report #PHFR2004GB00738 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Circulatory Collapse Foreign Clozaril (Clozapine) PS ORAL SEE IMAGE Initial or Prolonged Confusional State Study Lorazepam (Ngx) Multiple Drug Overdose Health (Lorazepam) SS ORAL SEE IMAGE Intentional Professional Temazepam (Ngx) Suicide Attempt Other (Temazepam) SS OVERDOSE Treatment Noncompliance Diazepam (Ngx) (Diazepam) SS OVERDOSE Cipramil (Citalopram Hydrobromide) SS ORAL SEE IMAGE Gaviscon(Sodium Alginate, Sodium Bicarbonate) C Date:01/03/05ISR Number: 4544089-8Report Type:Expedited (15-DaCompany Report #PHFR2003GB03546 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Abuser Foreign Clozaril (Clozapine) PS ORAL SEE IMAGE, Initial or Prolonged Drug Withdrawal Syndrome Study ORAL Epilepsy Health Lorazepam (Ngx) Professional (Lorazepam) SS SEE IMAGE Other Cardura (Doxazosin Mesilate) C Coversyl (Perindopril) C Adalat (Nifedipine) C Lithium (Lithium) C Priadel (Lithium Carbonate) C Propanolol (Propranolol) C Date:01/03/05ISR Number: 4544091-6Report Type:Expedited (15-DaCompany Report #PHFR2003GB03129 Age:28 YR Gender:Male I/FU:I Outcome PT Life-Threatening Cardio-Respiratory Arrest Hospitalization - Drug Interaction Initial or Prolonged Hyperthermia Malignant Other Medication Error Neuroleptic Malignant Syndrome 22-Feb-2006 08:30 AM Page: 3069 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Neutrophil Count Increased Rhabdomyolysis Report Source Product Role Manufacturer Route Dose Duration Supraventricular Foreign Clozaril (Clozapine) PS ORAL SEE IMAGE, Tachycardia Study ORAL Therapy Non-Responder Health Lorazepam (Ngx) Professional (Lorazepam) SS SEE IMAGE Other Amisulpride (Amisulpride) C Date:01/03/05ISR Number: 4546341-9Report Type:Expedited (15-DaCompany Report #2004116594 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bronchitis Acute Health Geodon (Ziprasidone) PS Hospitalization - Coma Professional Haloperidol Initial or Prolonged Diabetes Mellitus (Haloperidol) SS Other Inadequate Control Valproate Semisodium Headache (Valproate Mania Semisodium) SS Psychotic Disorder Clozapine Respiratory Failure (Clozapine) SS ORAL 300 MG, ORAL Resuscitation Glimepiride Therapeutic Response (Glimepiride) C Decreased Azithromycin Wheezing (Azithromycin) C Hydrochlorothiazide (Hydrochlorothiazide ) C Lisinopril (Lisinopril) C Metformin (Metformin) C Date:01/03/05ISR Number: 4546630-8Report Type:Expedited (15-DaCompany Report #2004102386 Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Disorder Health Dilantin Suspension Initial or Prolonged Condition Aggravated Professional (Phenytoin Sodium) PS Convulsion Clozapine Coordination Abnormal (Clozapine) SS ORAL 250 MG (1 D), Pre-Existing Disease ORAL Therapeutic Agent Risperidone Toxicity (Risperidone) C Disulfiram (Disulfiram) C Date:01/04/05ISR Number: 4543844-8Report Type:Expedited (15-DaCompany Report #PHRM2004FR03065 Age:37 YR Gender:Male I/FU:F Outcome PT Hospitalization - Ascites Initial or Prolonged Bladder Disorder Other Bladder Diverticulum Bladder Stenosis Blood Alkaline Phosphatase Increased 22-Feb-2006 08:30 AM Page: 3070 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Blood Lactate Dehydrogenase Increased C-Reactive Protein Report Source Product Role Manufacturer Route Dose Duration Increased Leponex PS Novartis Sector: Calculus Urinary Pharma ORAL UNK, UNK Cardiomegaly Lysanxia SS ORAL 50 MG DAILY Chest X-Ray Abnormal Oflocet SS ORAL Enuresis Gamma-Glutamyltransferase Increased General Physical Health Deterioration Haemoglobin Decreased Hepatosplenomegaly Inflammation Lymphopenia Malaise Mediastinal Disorder Nitrite Urine Present Normochromic Normocytic Anaemia Oedema Peripheral Pericardial Rub Pericarditis Pleural Effusion Pollakiuria Prostate Infection Prostatic Disorder Proteus Infection Pulmonary Embolism Pulmonary Hypertension Red Blood Cell Sedimentation Rate Increased Surgery Thrombocytopenia Urinary Retention Weight Decreased Date:01/04/05ISR Number: 4544172-7Report Type:Expedited (15-DaCompany Report #PHNU2004DE03948 Age:1 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Leponex / Clozaril Initial or Prolonged Drug Toxicity (Clozapine) PS Novartis Sector: Other Infection Pharma 100 mg Respiratory Tract Chloral Hydrate SS Infection Sinus Tachycardia Somnolence Date:01/04/05ISR Number: 4544180-6Report Type:Expedited (15-DaCompany Report #PHBS2004CH17454 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Leponex PS Novartis Sector: Initial or Prolonged Myocardial Infarction Pharma UNKNOWN 275 mg/d Aspirin Cardio C Selipran C 22-Feb-2006 08:30 AM Page: 3071 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Plavix C Antihypertensives C Date:01/04/05ISR Number: 4544182-XReport Type:Expedited (15-DaCompany Report #PHBS2005BR00455 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chest Pain Leponex PS Novartis Sector: Delirium Pharma ORAL 100 mg, BID Medication Error Leponex SS Novartis Sector: Pharma ORAL 500 mg, QD 1440 MIN Date:01/04/05ISR Number: 4544537-3Report Type:Expedited (15-DaCompany Report #04-12-1813 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Lung Neoplasm Malignant Health Clozapine - Ivax White Blood Cell Count Professional Pharmaceuticals, Decreased Other Inc. Orals PS Ivax Pharmaceuticals, Inc. ORAL 500 MG ORAL Chemotherapy C Date:01/04/05ISR Number: 4544539-7Report Type:Expedited (15-DaCompany Report #04-12-1814 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Consumer Clozapine - Ivax Other Health Pharmaceuticals, Professional Inc. Orals PS Ivax Other Pharmaceuticals, Inc. ORAL 200 MG ORAL Date:01/04/05ISR Number: 4544549-XReport Type:Expedited (15-DaCompany Report #04-12-1804 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Cancer Metastatic Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 500-400MG QD ORAL Date:01/04/05ISR Number: 4544551-8Report Type:Expedited (15-DaCompany Report #04-12-1682 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 37.5MG QD ORAL 22-Feb-2006 08:30 AM Page: 3072 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/04/05ISR Number: 4544555-5Report Type:Expedited (15-DaCompany Report #04-12-1809 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine - Ivax Other Professional Pharmaceuticals, Other Inc. Capsules PS Ivax Pharmaceuticals, Inc. ORAL 150 MG ORAL Date:01/04/05ISR Number: 4544558-0Report Type:Expedited (15-DaCompany Report #04-12-1810 Age:73 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiopulmonary Failure Health Clozapine - Ivax Other Professional Pharmaceuticals, Other Inc. Orals PS Ivax Pharmaceuticals, Inc. ORAL 125 MG ORAL Date:01/04/05ISR Number: 4544561-0Report Type:Expedited (15-DaCompany Report #2004S1003749 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 100MG Q 4PM Other & 200MG HS, ORAL Acetaminophen C Aspirin C Bisacody C Glycerin C Ferrous Sulfate C Fleet Phospho-Soda C Glyburide C Levothyroxine C Lithium Carbonate C Metformin C Magnesium Hydroxide C Insulin R (Prn) C Sodium Polystyrene Sulfonate C Insulin 70/30 C Ranitidine C Date:01/05/05ISR Number: 4544541-5Report Type:Expedited (15-DaCompany Report #PHBS2003BR01503 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Confusional State Leponex PS Novartis Sector: Dysphonia Pharma ORAL 50 mg/d 152 DAY Erectile Dysfunction Leponex SS Novartis Sector: Infection Pharma ORAL 450 mg/d Libido Decreased Amplictil C ORAL 100 mg/d 152 DAY Motor Dysfunction Pain In Extremity Rash Throat Irritation 22-Feb-2006 08:30 AM Page: 3073 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/05/05ISR Number: 4544543-9Report Type:Expedited (15-DaCompany Report #PHBS2004FI15975 Age:44 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Leponex PS Novartis Sector: Hospitalization - C-Reactive Protein Pharma ORAL 73 DAY Initial or Prolonged Increased Novomix C Fungal Skin Infection Laxoberon C ORAL Localised Oedema Levolac C ORAL Lymphadenopathy Neutropenia Platelet Count Increased Pyrexia Urosepsis White Blood Cell Count Decreased Date:01/05/05ISR Number: 4545271-6Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20030805071 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiac Arrest Risperdal PS OROPHARINGEAL Hospitalization - Circulatory Collapse Clozapine SS OROPHARINGEAL Initial or Prolonged Dyspnoea Disability Intracardiac Thrombus Other Myocardial Infarction Ventricular Fibrillation Date:01/05/05ISR Number: 4546128-7Report Type:Direct Company Report #CTU 235721 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pharmaceutical Product Fazaclo PS Alamo Complaint Pharmaceuticals Date:01/05/05ISR Number: 4546688-6Report Type:Expedited (15-DaCompany Report #05-01-0003 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Appendicectomy Health Clozapine Tablets - Initial or Prolonged Incision Site Abscess Professional Ivax Post Procedural Other Pharmaceuticals, Complication Inc. PS Ivax Pharmaceutical, Inc. ORAL 300MG QD ORAL Date:01/05/05ISR Number: 4546690-4Report Type:Expedited (15-DaCompany Report #05-01-0010 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Renal Failure Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 600-800MG QD ORAL 22-Feb-2006 08:30 AM Page: 3074 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/05/05ISR Number: 4546691-6Report Type:Expedited (15-DaCompany Report #05-01-0011 Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Clozapine Tablets - Gun Shot Wound Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 50-250MG QD ORAL Date:01/05/05ISR Number: 4546693-XReport Type:Expedited (15-DaCompany Report #05-01-0004 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Neoplasm Malignant Health Clozapine Tablets - Other Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 725MG QD ORAL Date:01/05/05ISR Number: 4546694-1Report Type:Expedited (15-DaCompany Report #05-01-0002 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Intestinal Ischaemia Health Clozapine Tablets - Other Pneumonia Professional Ivax Other Pharmaceuticals, Inc. PS Vax Pharmaceuticals, Inc. ORAL 300-700MG QD ORAL Date:01/05/05ISR Number: 4546703-XReport Type:Expedited (15-DaCompany Report #2004S1003763 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accident Health Clozapine Tablets Choking Professional 100 Mg Mylan PS Mylan ORAL 425MG BID, Other ORAL Venlafaxine C Date:01/07/05ISR Number: 4547052-6Report Type:Expedited (15-DaCompany Report #PHFR2005GB00442 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Amnesia Clozapine PS Novartis Sector: Other Decreased Interest Pharma ORAL 600 mg/day Disorientation Procyclidine C ORAL Disturbance In Attention Epilim C ORAL 500 mg/day Drug Toxicity Eating Disorder Incontinence Respiratory Disorder Somnolence Weight Increased 22-Feb-2006 08:30 AM Page: 3075 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/07/05ISR Number: 4547053-8Report Type:Expedited (15-DaCompany Report #PHFR2004GB04702 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Liver Disorder Clozaril PS Novartis Sector: Pancreatitis Pharma Date:01/07/05ISR Number: 4547054-XReport Type:Expedited (15-DaCompany Report #PHFR2004GB04710 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Cholesterol Clozaril PS Novartis Sector: Increased Pharma ORAL 591 DAY Hyperlipidaemia Date:01/07/05ISR Number: 4547055-1Report Type:Expedited (15-DaCompany Report #PHBS2005CH00492 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Dreams Leponex PS Novartis Sector: Initial or Prolonged Agitation Pharma ORAL 250 mg/day 173 DAY Anxiety Leponex SS Novartis Sector: Depressed Level Of Pharma 50 mg/day Consciousness Floxyfral SS ORAL 100 mg/day 173 DAY Diarrhoea Floxyfral SS ORAL 300 mg/day 31680MIN Dizziness Drug Level Above Therapeutic Hyperhidrosis Hyperreflexia Nightmare Serotonin Syndrome Somnolence Date:01/07/05ISR Number: 4547056-3Report Type:Expedited (15-DaCompany Report #PHNU2004DE03793 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Ineffective Leponex / Clozaril Pleurothotonus (Clozapine) PS Novartis Sector: Pharma ORAL 12.5 mg/day 2880 MIN Ect (Electro Convulsive Therapy) SS Neurocil SS ORAL 350 mg/day 50400MIN Neurocil SS ORAL 250 mg/day 1440 MIN Neurocil SS ORAL 200 mg/day 1440 MIN Neurocil SS 125 mg/day 1440 MIN Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL 25 mg/day 1440 MIN Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL 100 mg/day 2880 MIN Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL 200 mg/day 1440 MIN Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL 100 mg/day 5760 MIN 22-Feb-2006 08:30 AM Page: 3076 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL 150 mg/day 1440 MIN Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL 200 mg/day 1440 MIN Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL 250 mg/day 1440 MIN Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL 300 mg/day 1440 MIN Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL 400 mg/day 7200 MIN Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL 150 mg/day 1440 MIN Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL 50 mg/day 4320 MIN Neurocil SS ORAL 75 mg/day 1440 MIN Neurocil SS ORAL 50 mg/day 1440 MIN Gastrozepin C ORAL 25 mg/day 2880 MIN Gastrozepin C ORAL 50 mg/day 43200MIN Gastrozepin C ORAL 75 mg/day Date:01/07/05ISR Number: 4547057-5Report Type:Expedited (15-DaCompany Report #PHNU2004DE04328 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Leponex / Clozaril Initial or Prolonged Blood Creatine (Clozapine) PS Novartis Sector: Other Phosphokinase Increased Pharma Unknown Electrocardiogram Abnormal Electrocardiogram T Wave Inversion Myoglobinuria Rhabdomyolysis Date:01/07/05ISR Number: 4547290-2Report Type:Expedited (15-DaCompany Report #PHEH2004US12824 Age:81 YR Gender:Male I/FU:F Outcome PT Hospitalization - Agitation Initial or Prolonged Anxiety Other Dementia Alzheimer'S Type Electroencephalogram Abnormal Haemoglobin Decreased Mean Cell Haemoglobin Concentration Decreased Mean Cell Volume Decreased Prostatic Disorder Red Blood Cell Abnormality Red Cell Distribution 22-Feb-2006 08:30 AM Page: 3077 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Width Increased Report Source Product Role Manufacturer Route Dose Duration Clozaril PS Novartis Sector: Pharma ORAL 150 mg, QD Trazodone C 50 mg, QD Aricept C 10 mg, QD Aricept C 5 mg, QD Xenaderm C Peridex C 0.5 ml, BID Aspirin C Mycostatin C Decadron /Can/ C Metamucil C Date:01/07/05ISR Number: 4547305-1Report Type:Expedited (15-DaCompany Report #PHEH2005US00480 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cough Clozaril PS Novartis Sector: Initial or Prolonged Lung Infiltration Pharma ORAL 225 mg, QD 34560MIN Pneumonia Viral Pyrexia White Blood Cell Count Increased Date:01/07/05ISR Number: 4547315-4Report Type:Expedited (15-DaCompany Report #PHEH2005US00537 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Clozaril PS Novartis Sector: Pharma ORAL 25 mg, QD Clozaril SS Novartis Sector: Pharma ORAL 25 mg, QD Clozaril SS Novartis Sector: Pharma ORAL 12.5 mg, QD Sinemet C ORAL 25/100, QID2SDO Namenda C 10 mg, BID Vitamin B12 C 1000 mg, QD Vitamin E C 400 UNK, QD Trazodone C 25 mg, PRN Oxycodone C ORAL UNK, PRN Date:01/10/05ISR Number: 4551224-4Report Type:Expedited (15-DaCompany Report #04-12-1767 Age:57 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abasia Health Clozapine Tablets - Initial or Prolonged Delusion Professional Ivax Dizziness Other Pharmaceuticals, Fall Inc. PS Ivax Limb Injury Pharmaceuticals, Lower Limb Fracture Inc. ORAL 500-600MG QD ORAL Abilify SS 200MG QAM 22-Feb-2006 08:30 AM Page: 3078 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Neurontin C Eskalith C Date:01/10/05ISR Number: 4551340-7Report Type:Expedited (15-DaCompany Report #05-01-0014 Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 50-300MG QD, ORAL Date:01/10/05ISR Number: 4551344-4Report Type:Expedited (15-DaCompany Report #04-12-1765 Age:55 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 700MG QD ORAL Date:01/10/05ISR Number: 4551346-8Report Type:Expedited (15-DaCompany Report #04-12-1761 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hepatic Neoplasm Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 200-300MG QD ORAL Date:01/10/05ISR Number: 4551491-7Report Type:Expedited (15-DaCompany Report #2004S1003786 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Aspiration Health Clozapine Tablets 25 Respiratory Failure Professional Mg Mylan PS Mylan ORAL 12.5 MG HS, Other ORAL Antibiotic C Steroid C Diabetic Medication C Date:01/10/05ISR Number: 4551922-2Report Type:Expedited (15-DaCompany Report #05-01-0017 Age:55 YR Gender:Male I/FU:I Outcome PT Hospitalization - Catatonia Initial or Prolonged Communication Disorder Drug Withdrawal Syndrome Flushing General Physical Health Deterioration 22-Feb-2006 08:30 AM Page: 3079 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hallucination, Auditory Oral Intake Reduced Somnolence Report Source Product Role Manufacturer Route Dose Duration Treatment Noncompliance Foreign Clozapine Tablets PS 400-175MG QD Urinary Retention Literature Health Professional Date:01/11/05ISR Number: 4549173-0Report Type:Expedited (15-DaCompany Report #PHBS2004CA17174 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Albumin Decreased Clozaril PS Novartis Sector: Blood Bilirubin Increased Pharma ORAL UNK, UNK 41760MIN Blood Creatinine Valproic Acid C Increased Inderal C Cholestasis Ramipril C Diarrhoea Benzodiazepines C Glomerular Filtration Rate Decreased Hepatic Enzyme Increased Nausea Vomiting Date:01/11/05ISR Number: 4549174-2Report Type:Expedited (15-DaCompany Report #PHNR2004AU01573 Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Clozaril PS Novartis Sector: Hospitalization - Cardiomegaly Pharma 35 - 300 Initial or Prolonged Depression daily Mental Disorder Clozaril SS Novartis Sector: Sleep Apnoea Syndrome Pharma 550 mg daily Sudden Death Lorazepam C Toxicologic Test Abnormal Valproate Sodium C Olanzapine C 10 mg daily Valium C Date:01/11/05ISR Number: 4549175-4Report Type:Expedited (15-DaCompany Report #PHRM2005FR00473 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradycardia Leponex PS Novartis Sector: Initial or Prolonged Chest Pain Pharma ORAL 8640 MIN Ecg Signs Of Myocardial Ischaemia Lung Disorder Neutropenia Pyrexia Rash Maculo-Papular Ventricular Dyskinesia 22-Feb-2006 08:30 AM Page: 3080 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/11/05ISR Number: 4549176-6Report Type:Expedited (15-DaCompany Report #PHBS2004NZ14512 Age:39 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Clozaril PS Novartis Sector: Initial or Prolonged C-Reactive Protein Pharma ORAL 125 mg, BID Increased Clozaril SS Novartis Sector: Dizziness Pharma ORAL 23040MIN Eosinophil Count Haloperidol - Slow Increased Release C UNKNOWN 150 mg, BIW Haematocrit Decreased Procyclidine C UNKNOWN 5 mg, TID, Haemoglobin Decreased prn Lymphocyte Count Decreased Malaise Neutrophil Count Increased Neutrophilia Orthostatic Hypotension Pallor Platelet Count Increased Pyrexia White Blood Cell Count Increased Date:01/12/05ISR Number: 4549940-3Report Type:Expedited (15-DaCompany Report #PHEH2004US10256 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Choking Clozaril PS Novartis Sector: Initial or Prolonged Dysphagia Pharma ORAL UNK,UNK Dyspnoea Clozaril SS Novartis Sector: Gastrooesophageal Reflux Pharma ORAL UNK,UNK Disease Clozaril SS Novartis Sector: Laryngospasm Pharma ORAL UNK,UNK Salivary Hypersecretion Clozaril SS Novartis Sector: Weight Decreased Pharma ORAL 200mg Qpm,500mg Qhs Metformin C Provigil C Depakote C Wellbutrin C Date:01/12/05ISR Number: 4549941-5Report Type:Expedited (15-DaCompany Report #PHFR2005GB00451 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Clozaril PS Novartis Sector: Initial or Prolonged Abnormal Pharma ORAL 450mg/day Other Blood Alkaline Paracetamol SS UNKNOWN Overdose 32 Phosphatase Increased x 500 mg Intentional Overdose Liver Function Test Abnormal Nausea Suicide Attempt Vomiting 22-Feb-2006 08:30 AM Page: 3081 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/12/05ISR Number: 4549942-7Report Type:Expedited (15-DaCompany Report #PHBS2005NZ00543 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Health Leponex PS Novartis Sector: Initial or Prolonged Drug Abuser Professional Pharma ORAL 300 mg/d Drug Level Decreased Leponex SS Novartis Sector: Social Problem Pharma ORAL 325 mg/d Leponex SS Novartis Sector: Pharma ORAL 350 mg/d 4320 MIN Leponex SS Novartis Sector: Pharma ORAL 375 mg/d 2880 MIN Leponex SS Novartis Sector: Pharma ORAL 400 mg/d Marijuana SS UNKNOWN Omeprazole C UNKNOWN 20 mg/d Prednisolone C UNKNOWN 5 mg/d Clonazepam I UNKNOWN Date:01/12/05ISR Number: 4549943-9Report Type:Expedited (15-DaCompany Report #PHNU2004DE04328 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Health Leponex / Clozaril Initial or Prolonged Blood Creatine Professional (Clozapine) PS Novartis Sector: Other Phosphokinase Increased Pharma ORAL 200 mg, TID Blood Creatine Leponex / Clozaril Phosphokinase Mb (Clozapine) SS Novartis Sector: Increased Pharma ORAL Convulsion Electrocardiogram Abnormal Electrocardiogram T Wave Inversion Myoglobinuria Rhabdomyolysis Date:01/12/05ISR Number: 4552978-3Report Type:Direct Company Report #CTU 236465 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Psychotic Disorder Clozaril PS 275 BID Date:01/12/05ISR Number: 4553424-6Report Type:Expedited (15-DaCompany Report #S04-GER-08303-01 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Depressed Mood Foreign Cipramil Drug Interaction Health (Citalopram Drug Level Increased Professional Hydrobromide) PS ORAL 40 MG QD PO Embolism Other Cipramil (Citalopram Hydrobromide) SS ORAL 20 MG QD PO Clozapine SS 350 MG QD 22-Feb-2006 08:30 AM Page: 3082 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/13/05ISR Number: 4551227-XReport Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-12819793 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Metformin Hcl PS Bristol-Myers Squibb Initial or Prolonged Inadequate Control Company Diarrhoea Clozaril I ORAL 24 DAY Drug Interaction Thirst Date:01/13/05ISR Number: 4551916-7Report Type:Expedited (15-DaCompany Report #05-01-0016 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alcoholism Health Clozapine Tablets - Initial or Prolonged Drug Abuser Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 200-250MG QD ORAL Date:01/13/05ISR Number: 4551918-0Report Type:Expedited (15-DaCompany Report #04-12-1727 Age:49 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aggression Health Clozapine Tablets - Hospitalization - Congestive Cardiomyopathy Professional Ivax Initial or Prolonged Hepatosplenomegaly Pharmaceuticals, Neuroleptic Malignant Inc. PS Ivax Syndrome Pharmaceuticals, Pneumonia Inc. ORAL 800MG QD ORAL Pulmonary Congestion Geodon C Renal Cell Carcinoma Abilify C Stage Unspecified Haldol C Respiratory Failure Date:01/13/05ISR Number: 4551920-9Report Type:Expedited (15-DaCompany Report #05-01-0044 Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Urinary Tract Infection Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 375MG QD ORAL Date:01/13/05ISR Number: 4551923-4Report Type:Expedited (15-DaCompany Report #05-01-0041 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alcohol Rehabilitation Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 25-700MG QD 22-Feb-2006 08:30 AM Page: 3083 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL Date:01/13/05ISR Number: 4551925-8Report Type:Expedited (15-DaCompany Report #05-01-0038 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Clostridial Infection Health Clozapine Tablets - Initial or Prolonged Pneumonia Professional Ivax Other Sputum Retention Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 25MG QD ORAL Date:01/13/05ISR Number: 4551928-3Report Type:Expedited (15-DaCompany Report #05-01-0039 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukaemia Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 24-400MG QD ORAL Chemotherapy For Leukemia C Date:01/13/05ISR Number: 4551931-3Report Type:Expedited (15-DaCompany Report #04-11-1617 Age:42 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Health Clozapine Tablets - Psychotic Disorder Professional Ivax Refusal Of Treatment By Pharmaceuticals, Patient Inc. PS Ivax White Blood Cell Count Pharmaceuticals, Decreased Inc. ORAL 25-600MG QD ORAL Chemotherapy SS Date:01/13/05ISR Number: 4551933-7Report Type:Expedited (15-DaCompany Report #2004S1003558 Age:51 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lymphocytic Leukaemia Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 300 MG TID, Other ORAL Acetaminophen/Tramad ol C Topiramate C Fosinopril/Hctz C Estradiol C Clonazepam C Ziprasidone C Oxycodone C Dexamethasone C 22-Feb-2006 08:30 AM Page: 3084 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/13/05ISR Number: 4551940-4Report Type:Expedited (15-DaCompany Report #2004S1003126 Age:54 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Myocardial Health Clozapine Tablets Infarction Professional 100 Mg Mylan PS Mylan ORAL 100MG TID AND Other 200 MG Q HS, THEN 100MG QID, ORAL Insulin C Furosemide C Potassium C Atorvastatin C Ezetimibe C Date:01/13/05ISR Number: 4553003-0Report Type:Expedited (15-DaCompany Report #002 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Distension Health Fazaclo Odt PS Alamo Pharmaceutical ORAL 300 MG PO, HS Cyanosis Professional Fluoxetine C Gallbladder Operation Alprazolam C Respiratory Arrest Disiprimine C Vomiting Phentermine C Lithium C Wellbutrin C Clozaril C Zyprexa C Neurontin C Trazadone C Effexor C Paxil C Klonopin C Date:01/13/05ISR Number: 4553208-9Report Type:Expedited (15-DaCompany Report #2005003898 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Death Consumer Accupril (Quinapril Life-Threatening Antipsychotic Drug Level Hydrochloride) PS 20 MG ( 1 D), Other Above Therapeutic Hydrochlorothiazide Convulsion (Hydrochlorothiazide Drug Interaction ) Drug Toxicity (Hydrochlorothiazide Hypertension ) SS 12.5 MG (12.5 Pulmonary Congestion MG, 1 IN 1 D), Clozapine (Clozapine) SS 400 MG (1 D) Valproate Semisodium (Valproate Semisodium) C Piroxicam (Piroxicam) C Oxybutynin (Oxybutynin) C Bisacodyl (Bisacodyl) C Baclofen (Baclofen) C 22-Feb-2006 08:30 AM Page: 3085 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/14/05ISR Number: 4552660-2Report Type:Expedited (15-DaCompany Report #PHEH2004US11328 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abdominal Distension Clozaril PS Novartis Sector: Hospitalization - Abdominal Pain Pharma ORAL 700 mg, QD Initial or Prolonged Constipation Clozaril SS Novartis Sector: Disability Convulsion Pharma ORAL 50 mg, QD 1440 MIN Depressed Level Of Consciousness Pneumatosis Intestinalis Pneumoperitoneum Date:01/14/05ISR Number: 4552673-0Report Type:Expedited (15-DaCompany Report #PHNU2005DE00536 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Accidental Exposure Leponex / Clozaril Hospitalization - General Physical Health (Clozapine) PS Novartis Sector: Initial or Prolonged Deterioration Pharma ORAL Date:01/14/05ISR Number: 4552678-XReport Type:Expedited (15-DaCompany Report #PHFR2004GB03696 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Epilepsy Clozapine PS Novartis Sector: Sudden Death Pharma ORAL Tongue Biting Carbamazepine SS Valproate Sodium C Date:01/14/05ISR Number: 4552903-5Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050100927 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pulmonary Hypertension Oflocet PS OROPHARINGEAL Initial or Prolonged Leponex SS OROPHARINGEAL Humalog C Elisor C Avlocardyl C Tardyferon C Triatec C Lasilix C Previscan C Vitamins B1 & B6 C Date:01/14/05ISR Number: 4553060-1Report Type:Expedited (15-DaCompany Report #PHBS2005NL00847 Age:90 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cheyne-Stokes Respiration Leponex PS Novartis Sector: Coma Pharma ORAL 12.5 mg/day Hypotension Fenoterol Loss Of Consciousness Hydrobromide Somnolence W/Ipratropium Bromide C Fluticasone C Hypromellose C Acetylsalicylic Acid C 22-Feb-2006 08:30 AM Page: 3086 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Colecalciferol C Levodopa Benserazide Hydrochlo C Magnesium Oxide C Pantoprazole C Temazepam C Date:01/14/05ISR Number: 4553126-6Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20041204999 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Thrombocytopenia Risperdal Consta PS INTRAMUSCULAR Initial or Prolonged Leponex SS OROPHARINGEAL Other Ergenyl Chrono SS OROPHARINGEAL Ergenyl Chrono SS OROPHARINGEAL Ximovan C Date:01/14/05ISR Number: 4554802-1Report Type:Expedited (15-DaCompany Report #PHFR2003GB02848 Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Clozaril(Clozpine) Initial or Prolonged Phosphokinase Increased Study Unknown PS 75 MG/DAY Blood Sodium Increased Health Lorazepam (Ngx) Blood Urea Increased Professional (Lorazepam) SS INTRAMUSCULAR INTRAMUSCULAR Dehydration Other Fluid/Electrolyte Neuroleptic Malignant Replacement Therapy Syndrome (Fluid/Electrolyte Urinary Tract Infection Replacement Therapy) SS Date:01/14/05ISR Number: 4556725-0Report Type:Expedited (15-DaCompany Report #002 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Distension Health Fazaclo 100mg Odt, Gallbladder Disorder Professional Cima Labs For Alamo Respiratory Arrest Pharmaceutical PS Alamo Pharmaceutical 30MG,. PO, HS Vomiting Fluoxetine C Alprazolam C Disiprimine C Phentermine C Lithium C Wellbutrin C Clozaril C Zyprexa C Neurontin C Trazadone C Effexor C Paxil C Klonopin C Date:01/14/05ISR Number: 4568858-3Report Type:Direct Company Report #CTU 236880 Age:28 YR Gender:Male I/FU:I Outcome PT Other Condition Aggravated Pharmaceutical Product 22-Feb-2006 08:30 AM Page: 3087 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Complaint Report Source Product Role Manufacturer Route Dose Duration Clozapine 450 Mg Qd PS ORAL 450 MG QD PO Date:01/18/05ISR Number: 4554008-6Report Type:Expedited (15-DaCompany Report #PHBS2004NZ11506 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chillblains Clozaril PS Novartis Sector: Initial or Prolonged Eczema Pharma ORAL 200 mg, QHS Erythema Insulin Protaphan Oedema Peripheral Human C UNKNOWN Rash Insulin Actrapid Skin Ulcer Human C UNKNOWN Simvastatin C UNKNOWN 10 mg/d Ranitidine C UNKNOWN 150 mg, QD Antiasthmatics,Inhal ants C Date:01/18/05ISR Number: 4554229-2Report Type:Expedited (15-DaCompany Report #PHBS2005CA00897 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pilonidal Cyst Clozaril PS Novartis Sector: Surgery Pharma ORAL 300 mg/d Date:01/18/05ISR Number: 4554649-6Report Type:Expedited (15-DaCompany Report #PHEH2005US00819 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Clozaril PS Novartis Sector: Initial or Prolonged Nasopharyngitis Pharma ORAL 350 mg, QHS Neutropenia Depakote SS White Blood Cell Count Abilify C Decreased Lexapro C Date:01/18/05ISR Number: 4555349-9Report Type:Direct Company Report #CTU 237040 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pyrexia Clozapine 199 Mg PS ORAL 650 MG PO Tachycardia ORAL Tremor Date:01/18/05ISR Number: 4555350-5Report Type:Direct Company Report #CTU 237039 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Salivary Hypersecretion Clozapine 100 Mg PS ORAL 650 MG QD ORAL 22-Feb-2006 08:30 AM Page: 3088 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/18/05ISR Number: 4555534-6Report Type:Direct Company Report #CTU 236937 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pharmaceutical Product Clozapine Generic PS ORAL 500 MG PO Complaint Psychotic Disorder Date:01/18/05ISR Number: 4555599-1Report Type:Expedited (15-DaCompany Report #PHFR2003GB01536 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cerebrovascular Accident Foreign Clozaril (Clozapine) PS ORAL SEE IMAGE Circulatory Collapse Study Diazepam (Ngx) Drug Interaction Health (Diazepam) SS 1 MG, BID Hypotension Professional Digoxin (Digoxin) C Rash Other Venlafaxine Somnolence (Venlafaxine) C Transient Ischaemic Zopiclone Attack (Zopiclone) C Co-Danthrusate (Dantron, Docusate Sodium) C Simple Linctus (Amaranth, Anise Water, Chloroform Spirit, Citric Acid, Monohydrate Syr) C Aspirine (Acetylsalicylic Acid) C Date:01/18/05ISR Number: 4555669-8Report Type:Expedited (15-DaCompany Report #2005S1000021 Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 25 MG, BID, Other ORAL Date:01/18/05ISR Number: 4555672-8Report Type:Expedited (15-DaCompany Report #2004S1003417 Age:56 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Choking Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 200 MG BID, Other ORAL Multivitamins C Atorvastatin C Glycerin C Date:01/18/05ISR Number: 4555675-3Report Type:Expedited (15-DaCompany Report #2004S1003649 Age:55 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tabletes Professional 100 Mg Mylan PS Mylan ORAL 200 MG HS, Other ORAL 22-Feb-2006 08:30 AM Page: 3089 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Metformin C Celecoxib C Temazepam C Lisinopril C Fenofibrate C Date:01/19/05ISR Number: 4555539-5Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-12768065 Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Abilify PS Otsuka Initial or Prolonged Phosphokinase Increased Pharmaceutical Disturbance In Attention Company, Ltd. ORAL Increased to Hallucination 30 mg/day Muscle Rigidity after one Schizophrenia week. Social Avoidant Behaviour Clozapine SS Tardive Dyskinesia Quetiapine SS Date:01/19/05ISR Number: 4555851-XReport Type:Expedited (15-DaCompany Report #PHEH2004US04593 Age:72 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Abuser Ritalin PS Novartis Sector: Movement Disorder Pharma 20 mg, BID Overdose Clozapine SS 200 mg, QHS Sudden Death Compazine SS Percocet SS Paxil C 50 mg, QD (50mg QAM) Ativan C 1 mg, TID Date:01/19/05ISR Number: 4559494-3Report Type:Expedited (15-DaCompany Report #2004053302 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Asthenia Foreign Lipitor Hospitalization - Blood Creatine Health (Atorvastatin) PS ORAL ORAL Initial or Prolonged Phosphokinase Increased Professional Clozapine Other Difficulty In Walking (Clozapine) Drug Interaction (Clozapine) SS 560 MG (560 Lethargy MG, 1 IN 1 D) Musculoskeletal Stiffness Pain Rhabdomyolysis Sedation Date:01/19/05ISR Number: 4697953-3Report Type:Direct Company Report #CTU 237130 Age: Gender:Male I/FU:I Outcome PT Other Activities Of Daily Living Impaired Anxiety Depression Paranoia Therapeutic Response 22-Feb-2006 08:30 AM Page: 3090 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Unexpected With Drug Substitution Report Source Product Role Manufacturer Route Dose Duration Clozapine (Titrated Up To 300mg Bid PS ORAL 300MG BID ORALLY Risperdal C Cogentin C Klonopin C Date:01/19/05ISR Number: 4697994-6Report Type:Direct Company Report #CTU 237123 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abnormal Behaviour Clozapine 100 Mg PS TWO AM 7 Q Delusion HS Drug Ineffective Geodon C Hallucination, Auditory Cogentin C Impaired Self-Care Memory Impairment Therapeutic Response Unexpected With Drug Substitution Date:01/20/05ISR Number: 4556434-8Report Type:Expedited (15-DaCompany Report #PHEH2004US13379 Age:69 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Clozaril PS Novartis Sector: Hospitalization - Respiratory Failure Pharma ORAL 100 mg, BID Initial or Prolonged Date:01/20/05ISR Number: 4556914-5Report Type:Expedited (15-DaCompany Report #PHBS2004CA14248 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dysstasia Clozaril PS Novartis Sector: Electroencephalogram Pharma ORAL 450 to 600 Abnormal mg/day Mania Clozaril SS Novartis Sector: Psychotic Disorder Pharma ORAL 400 mg/d Reflexes Abnormal Antidiabetics C UNKNOWN Speech Disorder Tic Date:01/20/05ISR Number: 4556916-9Report Type:Expedited (15-DaCompany Report #PHHO2005CA00593 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coma Clozaril PS Novartis Sector: Hospitalization - Encephalopathy Pharma 500mg daily Initial or Prolonged Hepatitis dose 270 DAY Other Intubation Ezetrol SS Paxil C Topamax C Histantil C 50 mg, QHS Dalmane C 30 mg, QHS 22-Feb-2006 08:30 AM Page: 3091 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Aas C 80 mg, QD Loxapac C 25 mg, QD Avandia C 4 mg, QD Glucophage C Altace C 5 mg, QD Date:01/21/05ISR Number: 4558158-XReport Type:Expedited (15-DaCompany Report #PHEH2004US13595 Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Vomiting Clozaril PS Novartis Sector: Weight Decreased Pharma ORAL 550 mg, QD Date:01/21/05ISR Number: 4558159-1Report Type:Expedited (15-DaCompany Report #PHEH2005US00968 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Crohn'S Disease Clozaril PS Novartis Sector: Initial or Prolonged Leukopenia Pharma ORAL 100 mg, BID Neutropenia Date:01/21/05ISR Number: 4558167-0Report Type:Expedited (15-DaCompany Report #PHEH2005US00992 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Clozaril PS Novartis Sector: Pharma ORAL Date:01/21/05ISR Number: 4558168-2Report Type:Expedited (15-DaCompany Report #PHNR2003AU00976 Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Ketoacidosis Clozaril PS Novartis Sector: Initial or Prolonged Hyperglycaemia Pharma ORAL Hypoxia Clozaril SS Novartis Sector: Lethargy Pharma ORAL 12.5-275 mg, Liver Function Test daily 826 DAY Abnormal Panadol C Nausea Polydipsia Polyuria Date:01/21/05ISR Number: 4558173-6Report Type:Expedited (15-DaCompany Report #PHNR2005AU00467 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intestinal Perforation Clozaril PS Novartis Sector: Initial or Prolonged Leukocytosis Pharma ORAL 12.5 - 275 Neutrophilia mg/day 303 DAY 22-Feb-2006 08:30 AM Page: 3092 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/21/05ISR Number: 4558174-8Report Type:Expedited (15-DaCompany Report #PHNR2005AU00468 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiac Disorder Clozaril PS Novartis Sector: Troponin Increased Pharma 12.5 - 150 mg, daily 31680MIN Date:01/21/05ISR Number: 4558411-XReport Type:Expedited (15-DaCompany Report #PHHO2003CA03752 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Lymphoma Clozaril PS Novartis Sector: Pharma ORAL Date:01/21/05ISR Number: 4561252-0Report Type:Expedited (15-DaCompany Report #T04-SWI-08295-01 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acoustic Neuroma Foreign Cipralex Initial or Prolonged Antipsychotic Drug Level Study (Escitalopram) PS ORAL 10 MG QD PO Above Therapeutic Health Leponex (Clozapine) SS ORAL 300 MG QD PO Encopresis Professional Leponex (Clozapine) SS ORAL 275 MG QD PO Enuresis Other Leponex (Clozapine) SS ORAL 287.5 MG QD Hypertonic Bladder PO Incontinence Orfiril (Valproate Therapy Non-Responder Sodium) C Urinary Tract Infection Magnesiocard (Magnesium Aspartate Hydrochloride) C Date:01/21/05ISR Number: 4562772-5Report Type:Expedited (15-DaCompany Report #PHFR2003GB01536 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cerebrovascular Accident Foreign Clozaril (Clozapine) PS ORAL SEE IMAGE Circulatory Collapse Study Diazepam (Ngx) Drug Interaction Health (Diazepam) SS 1 MG, BID Hypotension Professional Digoxin (Digoxin) C Rash Other Venlafaxine Somnolence (Venlafaxine) C Transient Ischaemic Zopiclone Attack (Zopiclone) C Co-Danthrusate (Dantron, Docusate Sodium) C Simple Linctus (Amaranth, Anise Water, Chloroform Spirit, Citric Acid Monohydrate, Syr) C Aspirine (Acetylsalicylic Acid) C 22-Feb-2006 08:30 AM Page: 3093 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/21/05ISR Number: 4562957-8Report Type:Expedited (15-DaCompany Report #2004053311 Age:65 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Foreign Atorvastatin Initial or Prolonged Convulsion Health Other Drug Toxicity Professional (Atorvastatin) PS ORAL 10 MG (10 MG, Muscle Disorder 1 IN 1 D), Rhabdomyolysis ORAL Clozapine (Clozapine) SS ORAL 125 MG (125 MG, 1 IN 1 D), ORAL Furosemide (Furosemide) C Levothyroxine Sodium (Levothyroxine Sodium) C Date:01/24/05ISR Number: 4559334-2Report Type:Expedited (15-DaCompany Report #PHFR2005GB00574 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Exposure Clozaril PS Novartis Sector: Initial or Prolonged Confusional State Pharma ORAL 225 mg Salivary Hypersecretion overdose Somnolence Date:01/24/05ISR Number: 4559346-9Report Type:Expedited (15-DaCompany Report #PHHO2004CA18078 Age:47 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Clozaril PS Novartis Sector: Hyperglycaemia Pharma ORAL up to 300mg Lethargy daily 176 DAY Sleep Walking Clopixol C Somnolence Seroquel C Celexa C Epival C Date:01/24/05ISR Number: 4559944-2Report Type:Expedited (15-DaCompany Report #2005S1000087 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebral Haemorrhage Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 200MG TID, Other ORAL Fluvoxamine Maleate C Amlodipine C Divalproex Er C Lovastatin C 22-Feb-2006 08:30 AM Page: 3094 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/24/05ISR Number: 4559945-4Report Type:Expedited (15-DaCompany Report #C04-C-115 Age:28 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Therapeutic Agent Health Lithium Carbonate Initial or Prolonged Toxicity Professional Capsules Usp 300 Mg PS 300 MG TID Other Clozapine - Ivax Pharmaceuticals, Inc. SS Ivax Pharmaceuticals, Inc. ORAL 400 MG BID ORAL Zantac C Haloperidol C Geodon C Ativan C Date:01/24/05ISR Number: 4560011-2Report Type:Expedited (15-DaCompany Report #04-12-1735 Age:56 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Health Clozapine-Ivax Breast Cancer Professional Pharmaceuticals, Neutropenia Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 250-450 MG QD ORAL Chemotherapy SS Date:01/24/05ISR Number: 4560014-8Report Type:Expedited (15-DaCompany Report #2005S1000054 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Fall Health Clozapine Tablets 25 Hip Fracture Professional Mg Mylan PS Mylan ORAL 150 MG QAM, Other AND 125 MG QHS, ORAL Clozapine Tablets 100 Mg Mylan SS Mylan ORAL 150 MG QAM AND 125 MG QHS ORAL Date:01/25/05ISR Number: 4560198-1Report Type:Expedited (15-DaCompany Report #PHRM2004FR03629 Age:38 YR Gender:Female I/FU:F Outcome PT Hospitalization - Antipsychotic Drug Level Initial or Prolonged Above Therapeutic Anxiety Blood Alkaline Phosphatase Increased Delirium Electrocardiogram Qt Prolonged Gamma-Glutamyltransferase Increased Hallucination Psychotic Disorder Therapeutic Response 22-Feb-2006 08:30 AM Page: 3095 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Decreased Report Source Product Role Manufacturer Route Dose Duration Leponex PS Novartis Sector: Pharma ORAL 350 mg/day Ditropan C ORAL Seropram C Duphalac C ORAL Lansoyl C ORAL Xanax C ORAL Date:01/25/05ISR Number: 4560200-7Report Type:Expedited (15-DaCompany Report #PHNU2004DE03954 Age:11 MON Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Exposure Leponex / Clozaril Initial or Prolonged Agitation (Clozapine) PS Novartis Sector: Other Depressed Level Of Pharma ORAL 25 to 50 mg 1440 MIN Consciousness Eyelid Ptosis Fatigue Granulocytopenia Hypotonia Increased Appetite Infection Miosis Movement Disorder Pyrexia Somnolence Tachycardia Date:01/25/05ISR Number: 4560755-2Report Type:Direct Company Report #CTU 237838 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Leukopenia Clozapine 200 Mg Required Am 300mg Hs Mylan PS Mylan ORAL 200MG/300MG Intervention to AM/HS ORAL Prevent Permanent Impairment/Damage Date:01/25/05ISR Number: 4562051-6Report Type:Expedited (15-DaCompany Report #2004S1003678 Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asphyxia Health Clozapine Tablets Choking Professional 100 Mg Mylan PS Mylan ORAL 425 MG BID Other ORAL Venlafaxine C Donepezil C Date:01/25/05ISR Number: 4562052-8Report Type:Expedited (15-DaCompany Report #2004S1003718 Age:51 YR Gender:Male I/FU:F Outcome PT Report Source Death Death Health Professional 22-Feb-2006 08:30 AM Page: 3096 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Product Role Manufacturer Route Dose Duration Clozapine Tablets 100 Mg Mylan PS Mylan ORAL 500 MG Q AM, ORAL Date:01/25/05ISR Number: 4565351-9Report Type:Direct Company Report #CTU 237758 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Level Increased Clozapine 100mg PS ORAL 100MG BID ORAL Date:01/25/05ISR Number: 4569033-9Report Type:Direct Company Report #CTU 237881 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abnormal Sleep-Related Clozapine PS 400MG ONCE Event DAILY AT 8PM Dyspnoea Ativan C Heart Rate Increased Loss Of Consciousness Sleep Apnoea Syndrome Date:01/26/05ISR Number: 4560799-0Report Type:Expedited (15-DaCompany Report #PHNU2003DE03515 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Bradycardia Clozapine PS Novartis Sector: Hospitalization - Circulatory Collapse Pharma ORAL Unknown 1440 MIN Initial or Prolonged Coordination Abnormal Elcrit SS Dysarthria Hypotension Intentional Overdose Nausea Somnolence Victim Of Crime Date:01/26/05ISR Number: 4560810-7Report Type:Expedited (15-DaCompany Report #PHNU2003DE03515 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Bradycardia Clozapine PS Novartis Sector: Hospitalization - Circulatory Collapse Pharma ORAL Unknown 1440 MIN Initial or Prolonged Coordination Abnormal Elcrit SS Dysarthria Hypotension Intentional Overdose Nausea Somnolence Victim Of Crime 22-Feb-2006 08:30 AM Page: 3097 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/26/05ISR Number: 4560811-9Report Type:Expedited (15-DaCompany Report #PHFR2005GB00616 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Clozaril PS Novartis Sector: Prolonged Pharma ORAL 300mg/day Eosinophil Count Diazepam C UNKNOWN Increased Citalopram C UNKNOWN 40mg/day Tachycardia Hyoscine C UNKNOWN 300 ug, TID Date:01/26/05ISR Number: 4560812-0Report Type:Expedited (15-DaCompany Report #PHBS2005SE01249 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bronchitis Leponex PS Novartis Sector: Cardiomegaly Pharma ORAL 600 mg/d Cardiopulmonary Failure Cisordinol SS ORAL 5 mg/d Coronary Artery Cipralex SS ORAL 20 mg/d Atherosclerosis Atarax C ORAL Myocardial Ischaemia Akineton C ORAL 2 mg/d Stesolid C ORAL Date:01/26/05ISR Number: 4560817-XReport Type:Expedited (15-DaCompany Report #PHNU2005DE00536 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Accidental Exposure Leponex / Clozaril Hospitalization - General Physical Health (Clozapine) PS Novartis Sector: Initial or Prolonged Deterioration Pharma ORAL Elcrit SS Date:01/26/05ISR Number: 4560825-9Report Type:Expedited (15-DaCompany Report #PHNU2005DE00539 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Accidental Exposure Leponex / Clozaril Circulatory Collapse (Clozapine) PS Novartis Sector: Pharma ORAL Unknown 1440 MIN Date:01/26/05ISR Number: 4563016-0Report Type:Expedited (15-DaCompany Report #05-01-0089 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 250-800MG QD ORAL Date:01/26/05ISR Number: 4563017-2Report Type:Expedited (15-DaCompany Report #05-01-0091 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax 22-Feb-2006 08:30 AM Page: 3098 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pharmaceuticals, Inc ORAL 500MG QD ORAL Date:01/26/05ISR Number: 4563018-4Report Type:Expedited (15-DaCompany Report #04-12-1772 Age:74 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abasia Health Clozapine - Ivax Initial or Prolonged Aggression Professional Pharmaceuticals, Confusional State Other Inc. Tablets PS Ivax Drug Abuser Pharmaceuticals, Oral Intake Reduced Inc. ORAL 50-300MG QD Paranoia ORAL Date:01/26/05ISR Number: 4563019-6Report Type:Expedited (15-DaCompany Report #05-01-0082 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Urosepsis Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceutcials, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 250MG HS ORAL Date:01/26/05ISR Number: 4563020-2Report Type:Expedited (15-DaCompany Report #05-01-0084 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bacterial Infection Health Clozapine - Ivax Initial or Prolonged Blood Culture Positive Professional Pharmaceuticals, Dehydration Other Inc. Tablets PS Ivax Diabetes Insipidus Pharmaceuticals, Erythema Inc. ORAL 600MG QD ORAL Small Intestinal Geodon C Obstruction Seroquel C Volvulus Of Bowel Zoloft C Ddavp C Prevacid C Hydroxyzine C Date:01/26/05ISR Number: 4563021-4Report Type:Expedited (15-DaCompany Report #05-01-0078 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Health Clozapine - Ivax Decreased Professional Pharmaceuticals, Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 250-525MG QD ORAL Date:01/26/05ISR Number: 4563022-6Report Type:Expedited (15-DaCompany Report #05-01-0096 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ankle Fracture Health Clozapine - Ivax Initial or Prolonged Fall Professional Pharmaceuticals, Foot Fracture Other Inc. Tablets PS Ivax 22-Feb-2006 08:30 AM Page: 3099 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pharmaceuticals, Inc. ORAL 400MG QD ORAL Date:01/26/05ISR Number: 4563034-2Report Type:Expedited (15-DaCompany Report #2005S1000128 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Overdose Health Clozapine Tablets Medication Error Professional 100 Mg Mylan PS Mylan ORAL 100 MG QAM Other AND 200 MG QHS, ORAL Date:01/26/05ISR Number: 4563035-4Report Type:Expedited (15-DaCompany Report #04-11-1659 Age:46 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asthma Health Clozapine - Ivax Cardiac Failure Professional Pharmaceuticals, Congestive Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 300 MG QD ORAL Celexa C Lithium Carbonate C Date:01/26/05ISR Number: 4563036-6Report Type:Expedited (15-DaCompany Report #05-01-0059 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Respiratory Failure Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 300MG QD ORAL Date:01/26/05ISR Number: 4563038-XReport Type:Expedited (15-DaCompany Report #05-01-0081 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hip Fracture Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 200MG QD ORAL Date:01/26/05ISR Number: 4563039-1Report Type:Expedited (15-DaCompany Report #05-01-0085 Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Decubitus Ulcer Health Clozapine - Ivax Initial or Prolonged Infected Skin Ulcer Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 25-50MG QD ORAL 22-Feb-2006 08:30 AM Page: 3100 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/26/05ISR Number: 4565123-5Report Type:Direct Company Report #CTU 237988 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Clozapine PS 375-500 MG Initial or Prolonged Agitation Zyprexa C Condition Aggravated Depakote C Delusion Lorazepam C Amantadine C Cogentin C Date:01/26/05ISR Number: 4565124-7Report Type:Direct Company Report #CTU 237989 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Clozaril 100 Mg PS 2 1/4 D Initial or Prolonged Fear Lamictil C Obsessive Thoughts Zoloft C Gemfibrizol C Date:01/26/05ISR Number: 4565128-4Report Type:Direct Company Report #CTU 237990 Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abnormal Behaviour Clozapine From Brand Agitation Name PS 225WAS ON Drug Dependence BRAND NAME Irritability FROM 1993 Paranoia [GENERIC FROM Pharmaceutical Product ~4/2000 & WAS Complaint Lithium C Lorazepam C Date:01/27/05ISR Number: 4562423-XReport Type:Expedited (15-DaCompany Report #PHFR2004GB03519 Age:62 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asthenia Clozaril PS Novartis Sector: Hospitalization - Brain Scan Abnormal Pharma ORAL 350mg/day Initial or Prolonged Cerebrovascular Disorder Other Condition Aggravated Demyelination Extrapyramidal Disorder General Physical Health Deterioration Hemiparesis Hypertonia Immobile Incontinence Infarction Muscle Rigidity Neurological Symptom Parkinsonism Speech Disorder Vasculitis 22-Feb-2006 08:30 AM Page: 3101 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/27/05ISR Number: 4562424-1Report Type:Expedited (15-DaCompany Report #PHEH2005US00992 Age:55 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Clozaril PS Novartis Sector: Pharma ORAL UNK, UNK Date:01/27/05ISR Number: 4563959-8Report Type:Expedited (15-DaCompany Report #2005S1000155 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Multi-Organ Failure Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 25MG AM AND Other 75MG HS, ORAL Atorvastatin C Valproic Acid C Date:01/27/05ISR Number: 4563967-7Report Type:Expedited (15-DaCompany Report #2005S1000153 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neoplasm Malignant Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 25 MG BID, Other ORAL Clozapine Tablets 100mg Mylan SS Mylan ORAL 100MG BID, ORAL Morphine Sulfate C Fentanyl C Ceftriaxone Sodium C Metformin C Repaglinide C Metoprolol C Glipizide C Imipramine C Carbidopa/Levodopa C Rivastigmine Tartrate C Acetaminophen C Date:01/27/05ISR Number: 4563976-8Report Type:Expedited (15-DaCompany Report #05-01-0095 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Appendicectomy Health Clozapine Tablets - Initial or Prolonged Colectomy Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 200-400MG QD ORAL Date:01/27/05ISR Number: 4565159-4Report Type:Direct Company Report #CTU 238302 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hypotension Clozapine PS ORAL 300 MG PO Tachycardia 22-Feb-2006 08:30 AM Page: 3102 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/27/05ISR Number: 4567339-0Report Type:Expedited (15-DaCompany Report #S05-SWE-00274-01 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bronchial Oedema Foreign Cipralex Bronchitis Health (Escitalopram) PS ORAL 20 MG QD PO Cardiomegaly Professional Cisordinol - Slow Cardiopulmonary Failure Other Release Coronary Artery (Zuclopenthixol Atherosclerosis Decanoate) SS ORAL 5 MG QD PO Lung Disorder Leponex (Clozapine) SS ORAL 100 MG Q4HR Sudden Death PO Tracheal Oedema Atarax (Hydroxyzine Hydrochloride) C Akineton (Biperiden Hydrochloride) C Stesolid (Diazepam) C Date:01/27/05ISR Number: 4697006-4Report Type:Direct Company Report #CTU 238239 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Psychotic Disorder Clozapine PS 100 AM , 300 Hospitalization - Therapeutic Response HS Initial or Prolonged Unexpected With Drug Disability Substitution Date:01/27/05ISR Number: 4697009-XReport Type:Direct Company Report #CTU 238232 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Clozaril PS 450 MG DAILY Paranoia Therapeutic Response Unexpected With Drug Substitution Date:01/27/05ISR Number: 4697012-XReport Type:Direct Company Report #CTU 238230 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Irritability Clozaril PS Mania Speech Disorder Tangentiality Therapeutic Response Unexpected With Drug Substitution Date:01/28/05ISR Number: 4563485-6Report Type:Expedited (15-DaCompany Report #PHFR2005GB00486 Age:34 YR Gender:Male I/FU:F Outcome PT Death Abdominal Pain Hospitalization - Ileus Paralytic Initial or Prolonged Infection Other Intestinal Obstruction Laparotomy 22-Feb-2006 08:30 AM Page: 3103 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Neutrophil Count Increased Pyrexia Report Source Product Role Manufacturer Route Dose Duration White Blood Cell Count Clozaril PS Novartis Sector: Increased Pharma ORAL Date:01/28/05ISR Number: 4563487-XReport Type:Expedited (15-DaCompany Report #PHFR2005GB00622 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Abuser Clozaril PS Novartis Sector: Pulmonary Embolism Pharma ORAL Methadone SS UNKNOWN Clozapine SS Atenolol C UNKNOWN 5mg/day Lansoprazole C UNKNOWN 15mg/day Buspirone C ORAL 15mg/day Thiamine C UNKNOWN 150mg/day Paroxetine C UNKNOWN 40mg/day Date:01/28/05ISR Number: 4563621-1Report Type:Expedited (15-DaCompany Report #PHBS2005FI01294 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Leponex PS Novartis Sector: Initial or Prolonged Leukopenia Pharma ORAL Peritonitis Leponex SS Novartis Sector: Surgery Pharma ORAL 350 mg/d 85 DAY Ulcer Leponex SS Novartis Sector: Wound Infection Pharma ORAL 600 mg/d 69120MIN Temesta C UNKNOWN 1.5 mg/d Cipramil C UNKNOWN 40 mg/d Date:01/28/05ISR Number: 4563623-5Report Type:Expedited (15-DaCompany Report #PHFR2005GB00625 Age:32 Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Clozaril PS Novartis Sector: Life-Threatening Pulmonary Embolism Pharma ORAL UNK, UNK Other Trazodone C ORAL 150 mg, QD Citalopram C ORAL 40 mg, QD Pirenzepine C 100mg/day 31680MIN Thyroxine C ORAL 100 ug, BID Clonazepam C ORAL UNK, UNK Beclometasone C UNKNOWN 100 ug, BID Quetiapine C UNKNOWN 133 DAY Aripiprazole C UNKNOWN 106 DAY Date:01/28/05ISR Number: 4563624-7Report Type:Expedited (15-DaCompany Report #PHHO2005CA01219 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Cholesterol Clozaril PS Novartis Sector: Increased Pharma Unknown 21600MIN Diabetes Mellitus Drug Ineffective 22-Feb-2006 08:30 AM Page: 3104 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/28/05ISR Number: 4563626-0Report Type:Expedited (15-DaCompany Report #PHRM2005FR00473 Age:58 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradycardia Leponex PS Novartis Sector: Initial or Prolonged Chest Pain Pharma ORAL 8640 MIN Ecg Signs Of Myocardial Clozapine SS Ischaemia Lung Disorder Neutropenia Pyrexia Rash Maculo-Papular Ventricular Dyskinesia Date:01/28/05ISR Number: 4563627-2Report Type:Expedited (15-DaCompany Report #PHNU2004DE02637 Age:81 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Operation Leponex / Clozaril Hospitalization - Angiopathy (Clozapine) PS Novartis Sector: Initial or Prolonged Artificial Anus Pharma ORAL Unknown Constipation Dry Mouth Dysphagia Erythema Gastrointestinal Infection Ileus Date:01/28/05ISR Number: 4563835-0Report Type:Expedited (15-DaCompany Report #PHBS2005PH01508 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Gastrointestinal Leponex PS Novartis Sector: Hospitalization - Haemorrhage Pharma 100 mg/d 221 DAY Initial or Prolonged Haemoglobin Decreased Levomepromazine C 50 mg, QHS 221 DAY Loss Of Consciousness Date:01/28/05ISR Number: 4567799-5Report Type:Expedited (15-DaCompany Report #2005S1000179 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Appendicitis Perforated Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 100 MG QAM Other AND 100 MG QHS, ORAL Date:01/28/05ISR Number: 4567801-0Report Type:Expedited (15-DaCompany Report #2004S1003282 Age:83 YR Gender:Female I/FU:F Outcome PT Death Abnormal Behaviour Aggression Areflexia Coma Dyspnoea Lethargy Oral Intake Reduced 22-Feb-2006 08:30 AM Page: 3105 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pulse Absent Report Source Product Role Manufacturer Route Dose Duration Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 125 MG TID, Other ORAL Morphine C Atropine Ophthalmic C Fentanyl C Sorbitol C Levothyroxine C Atenolol C Mirtazapine C Donepezil C Gatifloxacin C Docusate Sodium C Acetaminophen C Lactulose C Multivitamin C Date:01/28/05ISR Number: 4575381-9Report Type:Direct Company Report #CTU 238570 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dysphonia Clozaril 25 Mg Up Self-Injurious Ideation To 5 / Day PS PO 25 MG UP TO 5 X DAY Date:01/28/05ISR Number: 4695311-9Report Type:Direct Company Report #CTU 238520 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration No Adverse Effect Clozaril 60mg Qpm, 50mg Q Hs PS 5 YR Date:01/31/05ISR Number: 4564999-5Report Type:Expedited (15-DaCompany Report #PHFR2004GB00456 Age:54 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Pressure Increased Clozaril PS Novartis Sector: Other Bundle Branch Block Left Pharma ORAL 375mg/day Circulatory Collapse Dizziness Electrocardiogram Abnormal Heart Rate Irregular Myocardial Infarction Overweight Sinus Tachycardia Date:01/31/05ISR Number: 4565002-3Report Type:Expedited (15-DaCompany Report #PHFR2005GB00679 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Clozaril PS Novartis Sector: Fall Pharma ORAL 500mg/day Head Injury 22-Feb-2006 08:30 AM Page: 3106 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/31/05ISR Number: 4565839-0Report Type:Expedited (15-DaCompany Report #DE-ABBOTT-04P-062-0267893-00 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Ergenyl Chrono Initial or Prolonged General Physical Health Tablets PS ORAL 1 YR Other Deterioration Clozapine SS 15 YR Necrosis Bezafibrate C ORAL Pancreatitis Acute Pneumonia Aspiration Respiratory Failure Date:02/01/05ISR Number: 4566352-7Report Type:Expedited (15-DaCompany Report #PHEH2005US01340 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Clozaril PS Novartis Sector: Other Drug Interaction Pharma ORAL 450 mg, QD Drug Toxicity Clozaril SS Novartis Sector: Pharma ORAL 425 mg, QD 60480MIN Clozaril SS Novartis Sector: Pharma ORAL 400 mg, QD Hydrochloorthiazide SS ORAL 25 mg, QD Accupril SS ORAL 20 mg, QD Depakote C 2250 mg, QD Oxybutynin C 5 mg, QD Bisacodyl C 5 mg, QD Baclofen C 10 mg, QD Miralax C 34560MIN Date:02/01/05ISR Number: 4566353-9Report Type:Expedited (15-DaCompany Report #PHFR2005GB00667 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Cholesterol Clozaril PS Novartis Sector: Increased Pharma UNKNOWN Date:02/01/05ISR Number: 4566355-2Report Type:Expedited (15-DaCompany Report #PHFR2004IE02736 Age:30 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Glucose Increased Clozaril PS Novartis Sector: Hypercholesterolaemia Pharma ORAL 75 mg/day 3939 DAY Thirst Date:02/01/05ISR Number: 4566362-XReport Type:Expedited (15-DaCompany Report #PHHO2005CA00593 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coma Clozaril PS Novartis Sector: Hospitalization - Encephalopathy Pharma 500mg daily Initial or Prolonged General Physical Health dose 270 DAY Other Deterioration Ezetrol SS Hepatitis Paxil C Intubation Topamax C Histantil C 50 mg, QHS Dalmane C 30 mg, QHS Aas C 80 mg, QD 22-Feb-2006 08:30 AM Page: 3107 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Loxapac C 25 mg, QD Avandia C 4 mg, QD Glucophage C Altace C 5 mg, QD Date:02/01/05ISR Number: 4566363-1Report Type:Expedited (15-DaCompany Report #PHNU2005DE00589 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Interaction Leponex / Clozaril Drug Level Increased (Clozapine) PS Novartis Sector: Sudden Death Pharma ORAL UNK, UNK Cipramil SS ORAL UNK, UNK Cipramil SS ORAL UNK, UNK Date:02/01/05ISR Number: 4566364-3Report Type:Expedited (15-DaCompany Report #PHNR2004AU01644 Age:41 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Albumin Decreased Clozaril PS Novartis Sector: Blood Calcium Decreased Pharma 12 - 500 mg Blood Cholesterol daily 1582 DAY Decreased Epilim SS Blood Creatinine Clozaril SS Novartis Sector: Increased Pharma 50 - 757 Blood Glucose Fluctuation mg/day Blood Phosphorus Topamax C Increased Efexor Xr C Blood Sodium Decreased Cephalexin C Blood Urea Increased Blood Uric Acid Increased Convulsion Gamma-Glutamyltransferase Increased Haematocrit Decreased Haemoglobin Decreased Incontinence Mean Cell Volume Increased Metabolic Disorder Red Blood Cell Count Decreased Thrombocytopenia Date:02/01/05ISR Number: 4566681-7Report Type:Expedited (15-DaCompany Report #PHFR2004IE04416 Age:22 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Apathy Clozaril PS Novartis Sector: Other Blood Cortisol Increased Pharma ORAL 400mg/day Hypersomnia Venlafaxine C ORAL 225mg/day Weight Increased 22-Feb-2006 08:30 AM Page: 3108 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/01/05ISR Number: 4566696-9Report Type:Expedited (15-DaCompany Report #PHNU2005DE00626 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acidosis Leponex / Clozaril Initial or Prolonged Blood Glucose Increased (Clozapine) PS Novartis Sector: Other Blood Ph Decreased Pharma ORAL Diabetes Mellitus Insulin SS UNK, UNK Inadequate Control Date:02/01/05ISR Number: 4566698-2Report Type:Expedited (15-DaCompany Report #PHBS2005HR01494 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Leponex PS Novartis Sector: Initial or Prolonged Amimia Pharma ORAL 25 mg/d 18720MIN Mental Impairment Eglonyl C UNKNOWN 200 mg/d Psychiatric Symptom Anafranil C UNKNOWN 25 mg/d Apaurin C UNKNOWN 10 mg/d Akineton C UNKNOWN Date:02/01/05ISR Number: 4566700-8Report Type:Expedited (15-DaCompany Report #PHNR2005AU00467 Age:33 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intestinal Perforation Clozaril PS Novartis Sector: Initial or Prolonged Leukocytosis Pharma ORAL 12.5 - 275 Neutrophilia mg/day 303 DAY Clozaril SS Novartis Sector: Pharma ORAL 25 mg, QD Date:02/01/05ISR Number: 4570156-9Report Type:Expedited (15-DaCompany Report #05-01-0118 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine PS Ivax Upper Respiratory Tract Professional Pharmaceuticals, Infection Other Inc. ORAL 500-600MG QD ORAL Date:02/01/05ISR Number: 4570157-0Report Type:Expedited (15-DaCompany Report #04-11-1516 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine PS Ivax Hospitalization - Professional Pharmaceuticals, Initial or Prolonged Other Inc. ORAL 25G QD ORAL Date:02/01/05ISR Number: 4570158-2Report Type:Expedited (15-DaCompany Report #05-01-0125 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 12.5-400MG QD 22-Feb-2006 08:30 AM Page: 3109 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL Date:02/01/05ISR Number: 4570159-4Report Type:Expedited (15-DaCompany Report #05-01-0136 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Thermal Burn Health Clozapine PS Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. ORAL 375-725MG QD ORAL Date:02/01/05ISR Number: 4570160-0Report Type:Expedited (15-DaCompany Report #04-12-1706 Age:32 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Macrocytic Health Clozapine PS Ivax Ear Pain Professional Pharnmaceuticals, Malaise Other Inc. ORAL 75MG QD ORAL Pain Depakote SS Pharyngitis Klonopin SS Productive Cough Prozac C Sedation Tachycardia Date:02/01/05ISR Number: 4570161-2Report Type:Expedited (15-DaCompany Report #2005S1000221 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiopulmonary Failure Health Clozapine PS Mylan ORAL 100 MG QID, Professional ORAL Other Insulin Sliding Scale C Ranitidine C Sertraline C Divalproex C Monobasic Sodium Phosphate C Furosemide C Digoxin C Levothyroxine C Lisinopril C Multivitamin C Acetaminophen C Bisacodyl C Sodium Biphosphate C Sorbitol C Insulin 70/30 C Date:02/01/05ISR Number: 4570163-6Report Type:Expedited (15-DaCompany Report #2005S1000207 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 600 MG Q HS, Other ORAL Glipizide Xl C 22-Feb-2006 08:30 AM Page: 3110 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/01/05ISR Number: 4576067-7Report Type:Direct Company Report #CTU 238773 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiomyopathy Clozapine Unknown Hypertrophy Unknown PS Date:02/02/05ISR Number: 4567900-3Report Type:Expedited (15-DaCompany Report #PHEH2004US10114 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Clozaril PS Novartis Sector: Initial or Prolonged Phosphokinase Increased Pharma ORAL 600 mg, QD Other Clostridium Colitis Clozaril SS Novartis Sector: Confusional State Pharma ORAL 200 mg, BID Dehydration Zyprexa C 10 mg, BID Intubation Seroquel C ORAL 25 mg, QD 237 DAY Loss Of Consciousness Seroquel C ORAL 200 mg, BID Muscle Rigidity Depakote C 1500 mg, QD Neuroleptic Malignant Allopurinol C ORAL 100 mg, QD Syndrome Metoprolol C ORAL 50 mg, QD Pneumonia Aspiration Colace C 100 mg, QD Psychotic Disorder Synthroid C 50 mg, UNK Renal Failure Acute Respiratory Failure Rhabdomyolysis Tachycardia Date:02/02/05ISR Number: 4567901-5Report Type:Expedited (15-DaCompany Report #PHEH2005US01333 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Clozaril PS Novartis Sector: Initial or Prolonged Upper Gastrointestinal Pharma ORAL 300 mg, QD Haemorrhage Risperdal C White Blood Cell Count Decreased Date:02/02/05ISR Number: 4567906-4Report Type:Expedited (15-DaCompany Report #PHFR2004GB03974 Age:53 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Full Blood Count Clozaril PS Novartis Sector: Initial or Prolonged Decreased Pharma ORAL UNK, UNK Other Haemoglobin Decreased Nausea Oesophageal Carcinoma Regurgitation Of Food Throat Cancer Vomiting Date:02/02/05ISR Number: 4567908-8Report Type:Expedited (15-DaCompany Report #PHNU2005DE00667 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Brain Oedema Leponex / Clozaril Hyponatraemia (Clozapine) PS Novartis Sector: Pharma ORAL Unknown 22-Feb-2006 08:30 AM Page: 3111 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Atosil C Unknown Tavor C Unknown Date:02/02/05ISR Number: 4568242-2Report Type:Expedited (15-DaCompany Report #PHHO2004CA11524 Age:53 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Clozaril PS Novartis Sector: Cardiac Arrest Pharma ORAL 450 mg, QD Drug Toxicity Lithium Carbonate C Dyspnoea Zopiclone C Loss Of Consciousness Pallor Syncope Date:02/02/05ISR Number: 4568245-8Report Type:Expedited (15-DaCompany Report #PHNU2004DE04255 Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other B-Cell Lymphoma Leponex / Clozaril (Clozapine) PS Novartis Sector: Pharma ORAL 50 mg/day Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL 25 mg/day Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL 400 mg/day Date:02/02/05ISR Number: 4569089-3Report Type:Expedited (15-DaCompany Report #05-01-0119 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypercalcaemia Health Clozapine - Ivax Initial or Prolonged Renal Failure Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 50-300MG QD ORAL Date:02/02/05ISR Number: 4569090-XReport Type:Expedited (15-DaCompany Report #05-01-0137 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. 200-300MG QD ORAL 22-Feb-2006 08:30 AM Page: 3112 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/02/05ISR Number: 4569091-1Report Type:Expedited (15-DaCompany Report #04-11-1634 Age:50 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Health Clozapine -Ivax Emphysema Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 600MG QD ORAL Colace C Altace C Lasix C Lanoxin C Date:02/03/05ISR Number: 4568988-6Report Type:Expedited (15-DaCompany Report #PHFR2005GB00725 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Disorder Clozaril PS Novartis Sector: Initial or Prolonged Pharma ORAL 400mg/day Date:02/03/05ISR Number: 4569445-3Report Type:Expedited (15-DaCompany Report #PHNU2005DE00809 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Leponex / Clozaril Drug Level Increased (Clozapine) PS Novartis Sector: Pharma ORAL 700 mg/day Fluanxol "Fisons" C 0.6 ml/day Truxal C Date:02/03/05ISR Number: 4569456-8Report Type:Expedited (15-DaCompany Report #PHFR2005GB00727 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chest Pain Clozaril PS Novartis Sector: Ecg P Wave Inverted Pharma ORAL 100 mg, BID 21600MIN Eosinophil Count Olanzapine C ORAL 20mg/day Increased Hypothermia Mean Cell Volume Abnormal Monocyte Count Increased Tachycardia Date:02/03/05ISR Number: 4569457-XReport Type:Expedited (15-DaCompany Report #PHFR2005GB00730 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Clozaril PS Novartis Sector: Initial or Prolonged Malaise Pharma ORAL 25 x 100mg Nausea Overdose 22-Feb-2006 08:30 AM Page: 3113 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/04/05ISR Number: 4570540-3Report Type:Expedited (15-DaCompany Report #PHEH2005US01478 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Parkinson'S Disease Clozaril PS Novartis Sector: Pharma ORAL 25 mg, QD Clozapine SS 25 mg, QD Date:02/04/05ISR Number: 4570542-7Report Type:Expedited (15-DaCompany Report #PHEH2005US01533 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Choking Clozaril PS Novartis Sector: Pharma ORAL 450 mg, QD Paxil C Klonopin C Seroquel C Verapamil C Keppra C Trileptal C Date:02/04/05ISR Number: 4570543-9Report Type:Expedited (15-DaCompany Report #PHHO2004CA16635 Age:63 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Balance Disorder Clozaril (Clozapine) PS Novartis Sector: Decreased Appetite Pharma ORAL 600 mg / day Fall Neurontin C Infarction Largactil C Vitamin B Complex C Colace C Senokot C Omega C Date:02/04/05ISR Number: 4570554-3Report Type:Expedited (15-DaCompany Report #PHHO2005NZ01676 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Tamponade Clozaril (Clozapine) PS Novartis Sector: Initial or Prolonged Pericardial Drainage Pharma Not reported Pericardial Effusion Date:02/04/05ISR Number: 4570555-5Report Type:Expedited (15-DaCompany Report #PHNU2005DE00743 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperthermia Malignant Leponex / Clozaril (Clozapine) PS Novartis Sector: Pharma ORAL Unknown Date:02/04/05ISR Number: 4588371-7Report Type:Direct Company Report #CTU 240612 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ileus Clozapine 100mg Initial or Prolonged Nausea Tablets PS ORAL 300MG PO BID Vomiting Benztropine C 22-Feb-2006 08:30 AM Page: 3114 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Divalproex C Fosinopril C Glyburide C Haldol C Levothyroxine C Metformin C Date:02/04/05ISR Number: 4598014-4Report Type:Periodic Company Report #PHEH2004US08129 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Health Clozaril (Clozapine) Initial or Prolonged Phosphokinase Increased Professional Tablet PS 300 MG/DAY, Blood Pressure Decreased ORAL Dizziness Prolixin Fall (Fluphenazine Heart Rate Increased Hydrochloride) SS Atenolol (Atenolol) C Calcium (Calcium) C Depakote (Valproate Semisodium) C Paxil (Paroxetine Hydrochloride) C Date:02/04/05ISR Number: 4598015-6Report Type:Periodic Company Report #PHEH2004US08217 Age:81 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) Professional Tablet PS ORAL 37.5 MG/DAY, ORAL Date:02/04/05ISR Number: 4598016-8Report Type:Periodic Company Report #PHEH2004US08605 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Health Clozaril(Clozapine) Initial or Prolonged Professional Tablet PS ORAL 400 MG, TID, ORAL Date:02/04/05ISR Number: 4598017-XReport Type:Periodic Company Report #PHEH2004US09241 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arthralgia Health Clozaril (Clozapine) Initial or Prolonged Muscle Rigidity Professional Tablet PS ORAL 125 MG, QD, Neuroleptic Malignant ORAL Syndrome Risperdal Pyrexia (Risperidone) C Geodon (Ziprasidone Hydrochloride) C Gabitril (Tiagabine Hydrochloride) C Depakote (Valproate Semisodium) C 22-Feb-2006 08:30 AM Page: 3115 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/04/05ISR Number: 4598018-1Report Type:Periodic Company Report #PHEH2004US09283 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anorexia Health Clozaril (Clozapine) Initial or Prolonged Infection Professional Tablet PS 300 MG, QD, Pancreatitis OCCLUSIVE Pneumonia Depakote (Valproate Semisodium) C Buspar (Buspirone Hydrochloride) C Date:02/04/05ISR Number: 4598019-3Report Type:Periodic Company Report #PHEH2004US09422 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukocytosis Health Clozaril (Clozapine) Initial or Prolonged Psychotic Disorder Professional Tablet PS ORAL 100 MG, BID, ORAL Aricept (Donepezil Hydrochloride) C Ativan (Lorazepam) C Nasonex (Mometasone Furoate) C Singulair "Dieckmann" (Montelukast Sodium) C Darvocet-N (Dextropropoxyphene Napsilate, Paracetamol) C Risperdal (Risperidone) C Geodon (Ziprasidone Hydrochloride) C Vitamins (No Ingredients/Substanc es) C Date:02/04/05ISR Number: 4598020-XReport Type:Periodic Company Report #PHEH2004US09484 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) Professional Tablet PS ORAL 25 MG/DAY, ORAL Date:02/04/05ISR Number: 4598021-1Report Type:Periodic Company Report #PHEH2004US09512 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Accidental Exposure Health Clozaril(Clozapine) Asthenia Professional Tablet PS ORAL ORAL Hypotension Tachycardia 22-Feb-2006 08:30 AM Page: 3116 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/04/05ISR Number: 4598022-3Report Type:Periodic Company Report #PHEH2004US09717 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Health Clozaril (Clozapine) Increased Professional Tablet PS ORAL ORAL Aspartate Depakene (Valproate Aminotransferase Sodium) C Increased Seroquel (Quetiapine Blood Creatine Fumarate) C Phosphokinase Increased Date:02/04/05ISR Number: 4598023-5Report Type:Periodic Company Report #PHEH2004US09736 Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agranulocytosis Health Clozaril (Clozapine) Hospitalization - Anorexia Professional Tablet PS ORAL ORAL Initial or Prolonged Asthenia Clozaril (Clozapine) Other Leukocytosis Tablet SS 12.5MG BID & Pyrexia 25MG QHS Stomatitis Abilify (Aripiprazole) C Labetalol (Labetalol) C Thioridazine (Thioridazine) C Lithium (Lithium) C Date:02/04/05ISR Number: 4598024-7Report Type:Periodic Company Report #PHEH2002US09380 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest X-Ray Abnormal Health Clozaril(Clozapine) Initial or Prolonged Cough Professional Tablet PS ORAL 200 MG, ORAL Fatigue Olanzapine Leukopenia (Olanzapine) C Prostatic Disorder Pyrexia Viral Infection Date:02/04/05ISR Number: 4598025-9Report Type:Periodic Company Report #PHEH2003US02727 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyskinesia Health Clozaril(Clozapine) Tardive Dyskinesia Professional Tablet PS ORAL 500 MG, QD, Company ORAL Representative Risperdal /Swe/(Risperidone) C Vitamin E (Tocopherol) C Zyprexa (Olanzapine) C Zoloft /Usa/(Sertraline Hydrochloride) C Vioxx /Usa/(Rofecoxib) C 22-Feb-2006 08:30 AM Page: 3117 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Darvocet-N (Dextropropoxyphene Napsilate, Paracetamol) C Date:02/04/05ISR Number: 4598026-0Report Type:Periodic Company Report #PHEH2003US10185 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Health Clozaril(Clozapine) Initial or Prolonged Professional Tablet PS ORAL 300 MG, QD, ORAL Depakote (Valproate Semisodium) C Risperdal (Risperidone) C Celexa (Citalopram Hydrobromide) C Buspar (Buspirone Hydrochloride) C Date:02/04/05ISR Number: 4598027-2Report Type:Periodic Company Report #PHEH2003US10193 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Clozaril(Clozapine) Initial or Prolonged Suture Insertion Professional Tablet PS ORAL 500 MG, QD, ORAL Date:02/04/05ISR Number: 4598028-4Report Type:Periodic Company Report #PHEH2003US10197 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril(Clozapine) Professional Tablet PS ORAL ORAL Date:02/04/05ISR Number: 4598029-6Report Type:Periodic Company Report #PHEH2003US10253 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypertension Health Clozaril(Clozapine) Professional Tablet PS ORAL ORAL Seroquel (Quetiapine Fumarate) C Risperdal (Risperidone) C Depakote (Valproate Semisodium) C Date:02/04/05ISR Number: 4598030-2Report Type:Periodic Company Report #PHEH2003US10266 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Colostomy Health Clozaril(Clozapine) Constipation Professional Tablet PS ORAL ORAL Intestinal Obstruction 22-Feb-2006 08:30 AM Page: 3118 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/04/05ISR Number: 4598031-4Report Type:Periodic Company Report #PHEH2003US10353 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pulmonary Embolism Health Clozaril(Clozapine) Initial or Prolonged Professional Tablet PS ORAL 300 MG/DAY, ORAL Depo Provera (Medroxyprogesterone Acetate) C Date:02/04/05ISR Number: 4598032-6Report Type:Periodic Company Report #PHEH2003US10376 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neuroleptic Malignant Health Clozaril(Clozapine) Syndrome Professional Tablet PS ORAL ORAL Date:02/04/05ISR Number: 4598033-8Report Type:Periodic Company Report #PHEH2003US10411 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Health Clozaril(Clozapine) Other Death Professional Tablet PS ORAL 400 MG/DAY, Respiratory Arrest ORAL Date:02/04/05ISR Number: 4598051-XReport Type:Periodic Company Report #PHEH2004US01784 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Health Clozaril (Clozapine) Initial or Prolonged Intentional Misuse Professional Tablet PS ORAL ORAL Overdose Somnolence Date:02/04/05ISR Number: 4598052-1Report Type:Periodic Company Report #PHEH2004US01789 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Health Clozaril Initial or Prolonged Therapeutic Response Professional (Clozapine)Tablet PS ORAL ORAL Unexpected Date:02/04/05ISR Number: 4598053-3Report Type:Periodic Company Report #PHEH2004US01795 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutrophil Count Health Clozaril (Clozapine) Initial or Prolonged Decreased Professional Tablet PS ORAL ORAL Pneumonia Aspiration Topamax (Topiramate) SS Psychotic Disorder 22-Feb-2006 08:30 AM Page: 3119 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/04/05ISR Number: 4598069-7Report Type:Periodic Company Report #PHEH2004US01798 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Vomiting Health Clozaril (Clozapine) Initial or Prolonged Professional Tablet PS Date:02/04/05ISR Number: 4598075-2Report Type:Periodic Company Report #PHEH2004US01806 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Glucose Increased Health Clozaril (Clozapine) Weight Increased Professional Tablet PS ORAL 375 MG/DAY, ORAL Paxil (Paroxetine Hydrochloride) C Geodon (Ziprasidone Hydrochloride) C Ativan (Lorazepam) C Date:02/04/05ISR Number: 4598077-6Report Type:Periodic Company Report #PHEH2004US01850 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Health Clozaril (Clozapine) Initial or Prolonged Treatment Noncompliance Professional Tablet PS ORAL ORAL Date:02/04/05ISR Number: 4598097-1Report Type:Periodic Company Report #PHEH2004US01852 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Negative Thoughts Health Clozaril (Clozapine) Initial or Prolonged Treatment Noncompliance Professional Tablet PS ORAL ORAL Date:02/04/05ISR Number: 4598098-3Report Type:Periodic Company Report #PHEH2004US01854 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Health Clozaril (Clozapine) Initial or Prolonged Professional Tablet PS ORAL ORAL Date:02/04/05ISR Number: 4598100-9Report Type:Periodic Company Report #PHEH2004US02008 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Delusion Clozaril (Clozapine) Hallucination Tablet PS ORAL 300 MG/DAY, Paranoia ORAL Lipitor (Atorvastatin) C Paxil (Paroxetine Hydrochloride) C 22-Feb-2006 08:30 AM Page: 3120 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/04/05ISR Number: 4598102-2Report Type:Periodic Company Report #PHEH2004US02128 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucinations, Mixed Consumer Clozaril (Clozapine) Initial or Prolonged Tablet PS ORAL ORAL Date:02/04/05ISR Number: 4598104-6Report Type:Periodic Company Report #PHEH2004US02175 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - C-Reactive Protein Health Clozaril (Clozapine) Initial or Prolonged Increased Professional Tablet PS ORAL 125 MG, BID, Leukocytosis ORAL Pyrexia Risperdal (Risperidone) C Celexa (Citalopram Hydrobromide) C Amlodipine (Amlodipine) C Spironolactone (Spironolactone) C Deseril (Methysergide) C Combivent (Ipratropium Bromide, Salbutamol Sulfate) C Singulair "Dieckmann" (Montelukast Sodium) C Date:02/04/05ISR Number: 4598121-6Report Type:Periodic Company Report #PHEH2004US02219 Age:66 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Clozaril (Clozapine) Leukopenia Professional Tablet PS ORAL 300 MG, QHS, Tonic Clonic Movements ORAL Celexa (Citalopram Hydrobromide) C Date:02/04/05ISR Number: 4598126-5Report Type:Periodic Company Report #PHEH2004US02247 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Consumer Clozaril (Clozapine) Tablet PS ORAL ORAL Date:02/04/05ISR Number: 4598128-9Report Type:Periodic Company Report #PHEH2004US02290 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Clozaril (Clozapine) Initial or Prolonged Feeling Abnormal Professional Tablet PS ORAL 400 MG, QD, Gaze Palsy ORAL Staring 22-Feb-2006 08:30 AM Page: 3121 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/04/05ISR Number: 4598130-7Report Type:Periodic Company Report #PHEH2004US02312 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Arrest Health Clozaril (Clozapine) Initial or Prolonged Convulsion Professional Tablet PS ORAL 400 MG/DAY, Hypoxia ORAL Intubation Vasotec (Enalapril Lethargy Maleate) C Mental Status Changes Aspirin "Bayer" (Acetylsalicylic Acid) C Glucotrol (Glipizide) C Date:02/04/05ISR Number: 4598132-0Report Type:Periodic Company Report #PHEH2004US02480 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coma Consumer Clozaril (Clozapine) Overdose Tablet PS ORAL ORAL Date:02/04/05ISR Number: 4598137-XReport Type:Periodic Company Report #PHEH2004US02495 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) Other Dysphagia Professional Tablet PS ORAL 62.5 MG/DAY, ORAL Aricept (Donepezil Hydrochloride) C Dilantin (Phenytoin Sodium) C Duragesic (Fentanyl) C Lasix /Sch /(Furosemide, Furosemide Sodium) C Lisinopril Carbonate (Lithium Carbonate) C Potassium Chloride (Potassium Chloride) C Lantus (Insulin Glargine) C Date:02/04/05ISR Number: 4598143-5Report Type:Periodic Company Report #PHEH2004US02552 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Health Clozaril (Clozapine) Headache Professional Tablet PS ORAL 300 MG/DAY ; Urinary Retention 275 MG/DAY : ORAL Lithium (Lithium) C Doxazosin (Doxazosin) C Gabitril (Tiagabine Hydrochloride) C Citrucel (Methylcellulose) C 22-Feb-2006 08:30 AM Page: 3122 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/04/05ISR Number: 4598144-7Report Type:Periodic Company Report #PHEH2004US02709 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Clozaril (Clozapine) Tablet PS ORAL 600 MG/DAY, ORAL Date:02/04/05ISR Number: 4598146-0Report Type:Periodic Company Report #PHEH2004US02750 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Health Clozaril (Clozapine) Orthostatic Hypotension Professional Tablet PS ORAL SEE IMAGE Overdose Geodon (Ziprasidone Sedation Hydrochloride) C Date:02/04/05ISR Number: 4598148-4Report Type:Periodic Company Report #PHEH2004US02766 Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthma Health Clozaril (Clozapine) Tachycardia Professional Tablet PS ORAL 200 MG/DAY ; 300 MG : QD, ORAL Depakote (Valproate Semisodium) C Risperdal (Risperidone) C Ativan (Lorazepam) C Albuterol (Salbutamol) C Serevent (Salmeterol Xinafoate) C Date:02/04/05ISR Number: 4598151-4Report Type:Periodic Company Report #PHEH2004US02793 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Health Clozaril (Clozapine) Initial or Prolonged Convulsion Professional Tablet PS ORAL ORAL 1095 DAY Neutropenia Clozaril (Clozapine) Pneumonia Tablet SS ORAL ORAL Psychotic Disorder Coumadin "Boots" (Warfarin Sodium) C Hydrochlorothiazide (Hydrochlorothiazide ) C Ativan (Lorazepam) C Depakote (Valproate Semisodium) C Date:02/04/05ISR Number: 4598153-8Report Type:Periodic Company Report #PHEH2004US03107 Age:73 YR Gender:Female I/FU:I Outcome PT Hospitalization - Infection Initial or Prolonged White Blood Cell Count 22-Feb-2006 08:30 AM Page: 3123 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Increased Report Source Product Role Manufacturer Route Dose Duration Health Clozaril (Clozapine) Professional Tablet PS 300 MG, QD Date:02/04/05ISR Number: 4598158-7Report Type:Periodic Company Report #PHEH2004US03280 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Health Clozaril (Clozapine) Myocardial Infarction Professional Tablet PS ORAL ORAL Date:02/04/05ISR Number: 4598161-7Report Type:Periodic Company Report #PHEH2004US03315 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Consumer Clozaril (Clozapine) Initial or Prolonged Diarrhoea Tablet PS ORAL Haematemesis Clozaril (Clozapine) Sepsis Tablet SS Prozac (Fluoxetine Hydrochloride) C Risperdal (Risperidone) C Date:02/04/05ISR Number: 4598164-2Report Type:Periodic Company Report #PHEH2004US03567 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Ineffective Health Clozaril (Clozapine) Eye Disorder Professional Tablet PS ORAL 200 MG/DAY, Hallucination ORAL Increased Upper Airway Lithium (Lithium) C Secretion Ocular Hyperaemia Date:02/04/05ISR Number: 4598169-1Report Type:Periodic Company Report #PHEH2004US03594 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozaril (Clozapine) Other Chest Pain Professional Tablet PS ORAL 100 MG/DAY, Convulsion ORAL Death Haldol "Janssen" Fall (Haloperidol) C Loss Of Consciousness Procardia (Nifedipine) C Allopurinol (Allopurinol) C Atenolol (Atenolol) C Colchicine (Colchicine) C 22-Feb-2006 08:30 AM Page: 3124 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/04/05ISR Number: 4598173-3Report Type:Periodic Company Report #PHEH2004US03715 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Health Clozaril (Clozapine) Professional Tablet PS Date:02/04/05ISR Number: 4598206-4Report Type:Periodic Company Report #PHEH2004US04432 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Clozaril (Clozapine) Dyskinesia Professional Tablet PS ORAL 400 MG/DAY ; Postictal State 200 MG/DAY : Tonic Clonic Movements ORAL Date:02/04/05ISR Number: 4598208-8Report Type:Periodic Company Report #PHEH2004US04521 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Clozaril (Clozapine) Initial or Prolonged Rhabdomyolysis Professional Tablet PS ORAL 300 MG, BID, ORAL Seroquel (Quetiapine Fumarate) C Date:02/04/05ISR Number: 4598229-5Report Type:Periodic Company Report #PHEH2004US04602 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Distension Health Clozaril (Clozapine) Intestinal Obstruction Professional Tablet PS ORAL 400 MG, BID, Vomiting ORAL Date:02/04/05ISR Number: 4598231-3Report Type:Periodic Company Report #PHEH2004US04840 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) Hospitalization - Pneumonia Professional Tablet PS ORAL 500 MG/DAY, Initial or Prolonged ORAL Albuterol (Salbutamol) C Combivent (Ipratropium Bromide, Salbutamol Sulfate) C Date:02/04/05ISR Number: 4598232-5Report Type:Periodic Company Report #PHEH2004US04843 Age:80 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) Professional Tablet PS ORAL 275 MG/DAY, ORAL 22-Feb-2006 08:30 AM Page: 3125 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/04/05ISR Number: 4598234-9Report Type:Periodic Company Report #PHEH2004US05086 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) Other Visual Disturbance Professional Tablet PS ORAL 300 MG/DAY, ORAL Neurontin (Gabapentin) C Synthroid (Levothyroxine Sodium) C Cogentin (Benzatropine Sulfate) C Zantac (Ranitidine Hydrochloride) C Primidone (Primidone) C Date:02/04/05ISR Number: 4598236-2Report Type:Periodic Company Report #PHEH2004US05186 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Depression Health Clozaril (Clozapine) Disorientation Professional Tablet PS ORAL 50 MG, QD, Thinking Abnormal ORAL Date:02/04/05ISR Number: 4598271-4Report Type:Periodic Company Report #PHEH2004US05220 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Clozaril (Clozapine) Initial or Prolonged Dysphemia Professional Tablet PS ORAL 450 MG ; 350 Paranoia MG : QD, ORAL Seroquel (Quetiapine Fumarate) C Lithium (Lithium) C Date:02/04/05ISR Number: 4598273-8Report Type:Periodic Company Report #PHEH2004US05437 Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Clozaril (Clozapine) Feeling Abnormal Professional Tablet PS ORAL 100 MG, TID ; Sedation 75MG Somnolence BID+100MG, HS : ORAL Geodon (Ziprasisone Hydrochloride) SS 60 MG ; 40 MG Klonopin (Clonazepam) C Lithobid (Lithium Carbonate) C Cogentin (Benzatropine Mesilate) C Lexapro 22-Feb-2006 08:30 AM Page: 3126 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Escitalopram Oxalate) C Date:02/04/05ISR Number: 4598274-XReport Type:Periodic Company Report #PHEH2004US05605 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiac Failure Health Clozaril (Clozapine) Congestive Professional Tablet PS ORAL 75 MG/DAY, Carditis ORAL Dyspnoea Clozaril (Clozapine) Heart Rate Increased Tablet SS ORAL ORAL Leukocytosis Oedema Peripheral Date:02/04/05ISR Number: 4598275-1Report Type:Periodic Company Report #PHEH2004US05780 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Health Clozaril (Clozapine) Initial or Prolonged Professional Tablet PS ORAL 100 MG/DAY, ORAL Date:02/04/05ISR Number: 4598276-3Report Type:Periodic Company Report #PHEH2004US05788 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pericardial Effusion Health Clozaril (Clozapine) Initial or Prolonged Pericarditis Professional Tablet PS ORAL ORAL Date:02/04/05ISR Number: 4598292-1Report Type:Periodic Company Report #PHEH2004US06227 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Cholesterol Health Clozaril Initial or Prolonged Increased Professional (Clozapine)Tablet PS ORAL 100 MG, TID, Confusional State ORAL Drooling .... C Gastrooesophageal Reflux Risperdal Disease (Risperidone) C Lexapro (Escitalopram Oxalate) C Ativan (Lorazepam) C Protonix "Pharmacia" (Pantoprazole) C Pravachol (Pravastatin Sodium) C Colace (Docusate Sodium) C Date:02/04/05ISR Number: 4598297-0Report Type:Periodic Company Report #PHEH2004US06287 Age:26 YR Gender:Male I/FU:I Outcome PT Hospitalization - Alanine Aminotransferase Initial or Prolonged Increased 22-Feb-2006 08:30 AM Page: 3127 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Aspartate Aminotransferase Increased Report Source Product Role Manufacturer Route Dose Duration Blood Creatine Health Clozaril (Clozapine) Phosphokinase Increased Professional Tablet PS ORAL SEE IMAGE Haldol "Janssen" (Haloperidol) C Janssen Date:02/04/05ISR Number: 4598300-8Report Type:Periodic Company Report #PHEH2004US06329 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Health Clozaril Initial or Prolonged Blood Creatine Professional (Clozapine)Tablet PS ORAL 300 MG/DAY ; Phosphokinase Increased 200 MG/DAY Dehydration : ORAL Hypertension Depakote (Valproate Hypoaesthesia Semisodium) C Memory Impairment Mental Impairment Neuroleptic Malignant Syndrome Sepsis Urinary Tract Infection Date:02/04/05ISR Number: 4598304-5Report Type:Periodic Company Report #PHEH2004US06394 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Disorientation Consumer Clozaril Initial or Prolonged (Clozapine)Tablet PS ORAL ORAL Geodon (Ziprasidone Hydrochloride) SS ORAL ORAL Date:02/04/05ISR Number: 4598306-9Report Type:Periodic Company Report #PHEH2004US06516 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Disease Progression Health Clozaril Initial or Prolonged Leukopenia Professional (Clozapine)Tablet PS ORAL ORAL Clozaril (Clozapine) Tablet SS ORAL 225 MG, QD, ORAL Date:02/04/05ISR Number: 4598311-2Report Type:Periodic Company Report #PHEH2004US06629 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Health Clozaril Initial or Prolonged Phosphokinase Increased Professional (Clozapine)Tablet PS ORAL 300 MG/DAY, Infection ORAL Neuroleptic Malignant Haldol "Janssen" Syndrome (Haloperidol) SS ORAL 2 MG/KG, ORAL Rhabdomyolysis Depakote (Valproate Semisodium) C 22-Feb-2006 08:30 AM Page: 3128 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/04/05ISR Number: 4598316-1Report Type:Periodic Company Report #PHEH2004US06676 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Clozaril Initial or Prolonged Electroencephalogram Professional (Clozapine)Tablet PS ORAL 200 MG/DAY, ORAL Date:02/04/05ISR Number: 4598324-0Report Type:Periodic Company Report #PHEH2004US06696 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypotension Health Clozaril Stomach Discomfort Professional (Clozapine)Tablet PS ORAL 800 MG/DAY, Thinking Abnormal ORAL White Blood Cell Count Cogentin Decreased (Benzatropine Mesilate) C Date:02/04/05ISR Number: 4598326-4Report Type:Periodic Company Report #PHEH2004US07504 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Health Clozaril Professional (Clozapine)Tablet PS ORAL 400 MG/DAY, ORAL Ziprasidone (Ziprasidone) C Buspirone (Busiprone) C Fluoxetine (Fluoxetine) C Date:02/04/05ISR Number: 4598328-8Report Type:Periodic Company Report #PHEH2004US07744 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Confusional State Health Clozaril Sedation Professional (Clozapine)Tablet PS ORAL ORAL Abilify (Aripiprazole) SS Haldol "Janssen" (Haloperidol) C Date:02/04/05ISR Number: 4598414-2Report Type:Periodic Company Report #PHEH2003US10478 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Confusional State Health Clozaril (Clozapine) Grand Mal Convulsion Professional Tablet PS ORAL SEE IMAGE 365 DAY Levaquinn (Levolfoxacin) C Colace (Docusate Sodium) C Flagyl (Metronidazole) C 22-Feb-2006 08:30 AM Page: 3129 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/04/05ISR Number: 4598416-6Report Type:Periodic Company Report #PHEH2003US10708 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) Professional Tablet PS ORAL 600 MG, QD, ORAL Paxil (Paroxetine Hdyrochloride) C Klonopin (Clonazepam) C Date:02/04/05ISR Number: 4598418-XReport Type:Periodic Company Report #PHEH2003US10716 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiomyopathy Health Clozaril (Clozapine) Initial or Prolonged Dyspnoea Exertional Professional Tablet PS ORAL 100 MG/DAY, Echocardiogram Abnormal ORAL Hypertension Neurontin (Gabapentin) C Seroque (Quetiapine Fumarate) C Date:02/04/05ISR Number: 4598419-1Report Type:Periodic Company Report #PHEH2003US10734 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Health Clozaril (Clozapine) Increased Professional Tablet PS ORAL 450 MG, QD, Aspartate ORAL Aminotransferase Insulin (Insulin)1 C Increased Zyprexa (Olanzapine) C Prolixin (Fluphenazine Hydrochloride) C Date:02/04/05ISR Number: 4598472-5Report Type:Periodic Company Report #PHEH2003US10819 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Consumer Clozaril (Clozapine) Tablet PS ORAL ORAL Date:02/04/05ISR Number: 4598474-9Report Type:Periodic Company Report #PHEH2003US11095 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypertension Health Clozaril (Clozapine) Professional Tablet PS ORAL 200 MG, BID, ORAL Seroquel (Quetiapine Fumarate) C Celexa (Citalopram Hydrobromide) C Depakote (Valproate Semisodium) C 22-Feb-2006 08:30 AM Page: 3130 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/04/05ISR Number: 4598477-4Report Type:Periodic Company Report #PHEH2003US11186 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychiatric Evaluation Health Clozaril (Clozapine) Initial or Prolonged Professional Tablet PS ORAL ORAL Date:02/04/05ISR Number: 4598478-6Report Type:Periodic Company Report #PHEH2003US11292 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Respiratory Depression Health Clozaril (Clozapine) Initial or Prolonged Professional Tablet PS ORAL 100 MG, QID, ORAL Date:02/04/05ISR Number: 4598480-4Report Type:Periodic Company Report #PHEH2003US11682 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypertension Health Clozaril (Clozapine) Professional Tablet PS ORAL 25 MG, BID, ORAL Prozac (Fluoxetine Hydrochloride) C Depakote (Valproate Semisodium) C Synthroid (Levothyroxine Sodium) C Date:02/04/05ISR Number: 4598482-8Report Type:Periodic Company Report #PHEH2004US00444 Age:87 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) Professional Tablet PS ORAL 12.5MG PM + 18.75MG HS, ORAL Klonopin (Clonazepam) C Ritalin (Methylphenidate Hydrochloride) C Aldactone (Spironolactone) C Potassium Chloride (Potassium Chloride) C Protonix (Pantoprazole) C Asa (Acetylsalicylic Acid) C Lexapro (Ecitalopram) C 22-Feb-2006 08:30 AM Page: 3131 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/04/05ISR Number: 4598486-5Report Type:Periodic Company Report #PHEH2004US00445 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Polydipsia Health Clozaril (Clozapine) Initial or Prolonged Professional Tablet PS ORAL 200 -600 MG, QD, ORAL Risperdal/Swe (Risperidone) C Nexium /Usa/ (Esomeprazole Magnesium) C Flovent (Fluticasone Propionate) C Atrovent (Ipratropium Bromide) C Date:02/04/05ISR Number: 4598488-9Report Type:Periodic Company Report #PHEH2004US00623 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Clozaril (Clozapine) Professional Tablet PS ORAL ORAL Date:02/04/05ISR Number: 4598490-7Report Type:Periodic Company Report #PHEH2004US00853 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Health Clozaril (Clozapine) Initial or Prolonged Delirium Professional Tablet PS ORAL 525, QD, ORAL Dysarthria Cogentin Pyrexia (Benzatropine Mesilate) C Reglan (Metoclopramide Hydrochloride) C Protonix "Pharmacia" (Pantoprazole) C Cozaar (Losartan Potassium) C Date:02/04/05ISR Number: 4598494-4Report Type:Periodic Company Report #PHEH2004US01024 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Muscle Disorder Clozaril (Clozapine) Overdose Tablet PS ORAL 300 MG, QD, ORAL Abilify (Aripiprazole) C Neurontin (Gabapentin) C Lexapro (Escitalopram) C Prolixin (Fluphenazine Hydrochloride) C 22-Feb-2006 08:30 AM Page: 3132 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/04/05ISR Number: 4598499-3Report Type:Periodic Company Report #PHEH2004US01457 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukocytosis Health Clozaril (Clozapine) Leukopenia Professional Tablet PS ORAL 125 MG/DAY, ORAL Date:02/04/05ISR Number: 4598500-7Report Type:Periodic Company Report #PHEH2004US01531 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ammonia Increased Health Clozaril (Clozapine) Initial or Prolonged Cardiomyopathy Professional Tablet PS ORAL ORAL Other Depression Depakote (Valproate Echocardiogram Abnormal Semisodium) C Ventricular Hypertrophy Atenolol (Atenolol) C Haldol "Janssen" (Haloperidol) C Lithium (Lithium) C Oral Blood Glucose Lowering Drugs (No Ingredients/Substanc es) C Date:02/04/05ISR Number: 4598501-9Report Type:Periodic Company Report #PHEH2004US01532 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Health Clozaril (Clozapine) Initial or Prolonged Cellulitis Professional Tablet PS ORAL ORAL Other Date:02/04/05ISR Number: 4598502-0Report Type:Periodic Company Report #PHEH2004US01545 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Constipation Health Clozaril (Clozapine) Initial or Prolonged Professional Tablet PS ORAL ORAL Date:02/04/05ISR Number: 4598504-4Report Type:Periodic Company Report #PHEH2004US01699 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anger Health Clozaril (Clozapine) Hallucination, Auditory Professional Tablet PS ORAL 200 MG, QD, ORAL Date:02/04/05ISR Number: 4598505-6Report Type:Periodic Company Report #PHEH2004US01716 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Health Clozaril (Clozapine) Initial or Prolonged Neutropenia Professional Tablet PS ORAL ORAL Ativan (Lorazepam) C 22-Feb-2006 08:30 AM Page: 3133 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/04/05ISR Number: 4598508-1Report Type:Periodic Company Report #PHEH2004US10973 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Grand Mal Convulsion Health Clozaril(Clozapine) Initial or Prolonged Professional Tablet PS ORAL 700 MG, QD, ORAL; SEE IMAGE Propanol (Propanolol) C Abilify (Aripiprazole) C Date:02/04/05ISR Number: 4598510-XReport Type:Periodic Company Report #PHEH2004US11069 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Leukopenia Health Clozaril (Clozapine) Hospitalization - Mental Disorder Professional Tablet PS ORAL 200 MG, QHS, Initial or Prolonged Neutropenia ORAL Tachycardia Date:02/04/05ISR Number: 4598514-7Report Type:Periodic Company Report #PHEH2004US11115 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hallucination, Auditory Health Clozaril (Clozapine) Professional Tablet PS ORAL 75MG QAM, 75 MG QPM, 150 MGQHS, ORAL Clozapine Tablet SS ORAL 75 MG QAM,75 MG QPM,150 MGQHS,ORAL Eskalith (Lithium Carbonate) C Date:02/04/05ISR Number: 4598521-4Report Type:Periodic Company Report #PHEH2004US11135 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Clozaril (Clozapine) Initial or Prolonged Professional Tablet PS ORAL 100MG QAM & 400MG QPM, ORAL Date:02/04/05ISR Number: 4598527-5Report Type:Periodic Company Report #PHEH2004US11475 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) Professional Tablet PS ORAL 375 MG/DAY, ORAL 22-Feb-2006 08:30 AM Page: 3134 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/04/05ISR Number: 4598533-0Report Type:Periodic Company Report #PHEH2004US11500 Age:88 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril(Clozapine) Professional Tablet PS ORAL 100 MG/DAY ORAL Demadex (Torasemide) C Ditropan (Oxybutynin) C Potassium (Potassium) C Multivitamins W/Minerals (Minerals Nos, Vitamins Nos) C Date:02/04/05ISR Number: 4598557-3Report Type:Periodic Company Report #PHEH2004US11547 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Grand Mal Convulsion Health Clozaril (Clozapine) Initial or Prolonged Professional Tablet PS ORAL 150 MG/DAY, ORAL 21 DAY Date:02/04/05ISR Number: 4598569-XReport Type:Periodic Company Report #PHEH2004US11570 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Myoclonus Health Clozaril (Clozapine) Initial or Prolonged Psychotic Disorder Professional Tablet PS ORAL 500 MG, QD, Tic ORAL; SEE IMAGE Vistaril (Hydroxyzine Embonate) C Tofranil (Imipramine Hydrochloride) C Geodon C Date:02/04/05ISR Number: 4598573-1Report Type:Periodic Company Report #PHEH2004US11590 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pulmonary Embolism Health Clozaril (Clozapine) Initial or Prolonged Professional Tablet PS ORAL 750 MG, QD, ORAL Valproic Acid (Valproic Acid) C Topamax (Topiramate) C Amantadine (Amantadine) C Date:02/04/05ISR Number: 4600951-9Report Type:Periodic Company Report #PHEH2004US09767 Age:51 YR Gender:Male I/FU:I Outcome Death Hospitalization - 22-Feb-2006 08:30 AM Page: 3135 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Initial or Prolonged PT Report Source Product Role Manufacturer Route Dose Duration Acute Respiratory Health Clozaril (Clozapine) Distress Syndrome Professional Tablet PS ORAL 300 MG, TID, Delirium ORAL Dyspnoea Iron (Iron) C Hyperhidrosis Docusate (Docusate) C Intestinal Obstruction Haldol Decanoate Leukocytosis (Haloperidol Pulmonary Embolism Decanote) C Renal Failure Synthroid Respiratory Distress (Levothyroxine Vomiting Sodium) C Depakote (Valproate Semisodium) C Cogentin (Benzatropine Mesilate) C Asa (Acetylsalicylic Acid) C Date:02/04/05ISR Number: 4600952-0Report Type:Periodic Company Report #PHEH2004US09926 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pancreatitis Health Clozaril (Clozapine) Professional Tablet PS ORAL 400 MG/DAY, ORAL Date:02/04/05ISR Number: 4600953-2Report Type:Periodic Company Report #PHEH2004US10144 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Health Clozaril (Clozapine) Initial or Prolonged Syndrome Professional Tablet PS ORAL 700 MG ; 200 Other Pneumonia MG : BID, ORAL Date:02/04/05ISR Number: 4600954-4Report Type:Periodic Company Report #PHEH2004US10150 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) Professional Tablet PS ORAL 700 MG, QD, ORAL Bupropion (Bupropion) C Fluoxetine (Fluoxetine) C Date:02/04/05ISR Number: 4600955-6Report Type:Periodic Company Report #PHEH2004US10191 Age:44 YR Gender:Male I/FU:I Outcome PT Other Alanine Aminotransferase Increased 22-Feb-2006 08:30 AM Page: 3136 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Aspartate Aminotransferase Increased Report Source Product Role Manufacturer Route Dose Duration Biopsy Liver Abnormal Health Clozaril (Clozapine) Hepatic Enzyme Increased Professional Tablet PS ORAL 425 MG, QD, Hepatic Fibrosis ORAL Hepatitis Metformin (Metformin) SS Date:02/04/05ISR Number: 4600956-8Report Type:Periodic Company Report #PHEH2004US10212 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Health Clozaril (Clozapine) Initial or Prolonged Leukopenia Professional Tablet PS ORAL ORAL Pneumonia Effexor (Venlafaxine Pyrexia Hydrochloride) C Seroquel (Quetiapine Fumarate) C Date:02/04/05ISR Number: 4600967-2Report Type:Periodic Company Report #PHEH2004US10242 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiomyopathy Health Clozaril (Clozapine) Professional Tablet PS ORAL 350 MG, QD, ORAL Date:02/04/05ISR Number: 4600970-2Report Type:Periodic Company Report #PHEH2004US10411 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Health Clozaril (Clozapine) Initial or Prolonged Convulsion Professional Tablet PS ORAL 200 MG, QD, Fall ORAL Glucophage "Abic" (Metformin Hydrochloride) C Insulin (Insulin) C Monopril (Fosinopril Sodium) C Date:02/04/05ISR Number: 4600972-6Report Type:Periodic Company Report #PHEH2004US10441 Age:15 YR Gender:Male I/FU:I Outcome PT Hospitalization - Cardiac Enzymes Increased Initial or Prolonged Cardiac Failure Congestive Cardiac Function Test Abnormal Cardiomyopathy Cd4 Lymphocytes Decreased Chest Pain Dyspnoea Endocarditis Eosinophilic Myocarditis 22-Feb-2006 08:30 AM Page: 3137 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Haemoptysis Leukocytosis Nausea Report Source Product Role Manufacturer Route Dose Duration Neutrophil Count Health Clozaril (Clozapine) Increased Professional Tablet PS ORAL 50 MG, TID , Pyrexia ORAL Tachypnoea Clozapine (Clozapine) SS ORAL 50 MG, TID, ORAL Clozapine (Clozapine) SS 50 MG, ONCE/SINGLE Date:02/04/05ISR Number: 4600975-1Report Type:Periodic Company Report #PHEH2004US10786 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delusion Health Clozaril (Clozapine) Initial or Prolonged Professional Tablet PS ORAL 250 MG, QHS, ORAL Lithium (Lithium) C Geodon (Zipradisone Hydrochloride) C Date:02/04/05ISR Number: 4601425-1Report Type:Periodic Company Report #04-10-1484 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Unevaluable Event Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 700 MG QD ORAL Clozapine SS Date:02/04/05ISR Number: 4601426-3Report Type:Periodic Company Report #04-10-1484 Age:56 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lipoma Health Clozapine - Ivax Pharyngitis Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 700 MG QD ORAL Clozapine SS Cogentin C Ativan 0.5mg C Ativan 1mg C Aspirin C Synthroid C Zocor C Zetia C Date:02/04/05ISR Number: 4706153-XReport Type:Direct Company Report #CTU 239347 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Convulsion Clozaril PS 22-Feb-2006 08:30 AM Page: 3138 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/04/05ISR Number: 4706154-1Report Type:Direct Company Report #CTU 239349 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Clozapine 100mg Tabs PS ONE Q AM 7 Q Initial or Prolonged Delusion HS Drug Ineffective Crestor C Drug Level Changed Cogentin C Hallucination, Auditory Impaired Self-Care Memory Impairment Therapeutic Response Unexpected With Drug Substitution Date:02/04/05ISR Number: 4706156-5Report Type:Direct Company Report #CTU 239352 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Drug Ineffective Clozapine PS 350 MG Q HS Disability Psychotic Disorder Zyprexa C Pyromania Lorazepam C Sedation Depakote C Date:02/07/05ISR Number: 4571752-5Report Type:Expedited (15-DaCompany Report #US-MERCK-0412USA00446 Age:66 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Zocor PS Merck & Co., Inc ORAL 28 DAY Initial or Prolonged Diarrhoea Clozapine SS ORAL Disability Feeling Abnormal Clozapine SS UNKNOWN Malaise Synthroid C UNKNOWN Muscular Weakness Pyrexia Tachycardia Date:02/07/05ISR Number: 4571861-0Report Type:Expedited (15-DaCompany Report #PHEH2004US12824 Age:81 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Clozaril PS Novartis Sector: Hospitalization - Anxiety Pharma ORAL 150 mg, QD Initial or Prolonged Coma Trazodone C 50 mg, QD Other Death Aricept C 10 mg, QD Dementia Alzheimer'S Type Aricept C 5 mg, QD Electroencephalogram Xenaderm C Abnormal Peridex C 0.5 ml, BID Haemoglobin Decreased Aspirin C Prostatic Disorder Mycostatin C Red Blood Cell Decadron Abnormality Red Cell Distribution /Can/ C Width Increased Metamucil C 22-Feb-2006 08:30 AM Page: 3139 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/07/05ISR Number: 4571862-2Report Type:Expedited (15-DaCompany Report #PHBS2005HR01774 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pseudomonas Infection Leponex PS Novartis Sector: Initial or Prolonged Pyrexia Pharma ORAL Other Date:02/07/05ISR Number: 4571864-6Report Type:Expedited (15-DaCompany Report #PHRM2005FR00692 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Leponex PS Novartis Sector: Phosphokinase Increased Pharma ORAL 600 mg per Convulsion day Electrocardiogram Qt Atarax Prolonged /Can/ C UNK, PRN Seresta C Date:02/07/05ISR Number: 4575886-0Report Type:Expedited (15-DaCompany Report #04-05-0698 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Health Clozapine - Ivax Drug Interaction Professional Pharmaceuticals, Drug Level Increased Other Inc. Tablets PS Ivax Sudden Death Pharmaceuticals, Inc. ORAL 750 MG QD ORAL Celexa SS ORAL 60 MG QD ORAL Depakote C Ativan C Pepcid C Date:02/07/05ISR Number: 4575904-XReport Type:Expedited (15-DaCompany Report #2005S1000238 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Clozapine PS Mylan ORAL 300 MG HS, Professional ORAL Other Escitalopram C Metoprolol Tartrate C Quetiapine C Topiramate C Simvastatin C Multivitamins C Iron C Date:02/07/05ISR Number: 4575909-9Report Type:Expedited (15-DaCompany Report #2005S1000247 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Clozapine PS Mylan ORAL 400 MG QHS, Congestive Professional ORAL Other Furosemide C Valsartan C Atenolol C 22-Feb-2006 08:30 AM Page: 3140 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Esomeprazole C Sertraline C Lithium C Date:02/07/05ISR Number: 4575914-2Report Type:Expedited (15-DaCompany Report #2005S1000268 Age:66 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pharmaceutical Product Health Clozapine Tablets Complaint Professional 100 Mg Mylan PS Mylan ORAL 200 MG GAM Pneumonia Other AND 300MG QHS, ORAL Heparin C Loxapine C Metronidazole C Divaloproex C Vancomycin C Acetaminophen C Fluticasone C Calcium C Buspirone C Clonazepam C Montelukast C Date:02/07/05ISR Number: 4578843-3Report Type:Direct Company Report #CTU 239449 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Paranoia Clozaril 100mg PS ORAL 2 1/4 PO QD Initial or Prolonged Lamictal C Zoloft C Gemfibrozil C Date:02/07/05ISR Number: 4699722-7Report Type:Direct Company Report #CTU 239409 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Delusion Clozaril PS 100 MG BID Depression Pharmaceutical Product Complaint Date:02/07/05ISR Number: 4700377-3Report Type:Direct Company Report #CTU 239497 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Clozapine PS ORAL TOTAL 800MG Required Drug Ineffective PO 200MG AM & Intervention to Insomnia NOON , 400MG Prevent Permanent Paranoia HS Impairment/Damage Persecutory Delusion Ativan C Therapeutic Response Unexpected With Drug Substitution Thinking Abnormal Verbal Abuse 22-Feb-2006 08:30 AM Page: 3141 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/08/05ISR Number: 4573229-XReport Type:Periodic Company Report #2004S1001938 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Paxil PS Glaxosmithkline ORAL 20MG Three times per day Clozapine SS ORAL 100MG Four times per day No Concurrent Medication C Date:02/08/05ISR Number: 4574180-1Report Type:Expedited (15-DaCompany Report #PHBS2005GB01833 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Caesarean Section Clozapine PS Novartis Sector: Drug Exposure During Pharma UNKNOWN 100 mg/d Pregnancy Methyldopate Normal Newborn Hydrochloride C UNKNOWN 1500 mg/d Pregnancy Induced Hypertension Date:02/08/05ISR Number: 4574181-3Report Type:Expedited (15-DaCompany Report #PHBS2005FI01893 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Granulocytopenia Leponex PS Novartis Sector: Initial or Prolonged Spleen Disorder Pharma ORAL 550 mg/d Date:02/08/05ISR Number: 4574186-2Report Type:Expedited (15-DaCompany Report #PHNU2005DE00774 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Angina Pectoris Leponex / Clozaril Initial or Prolonged Blood Pressure Decreased (Clozapine) PS Novartis Sector: Other Blood Pressure Increased Pharma ORAL 75 to 100 Diarrhoea Infectious mg/day 5760 MIN Drug Interaction Leponex / Clozaril Gastrointestinal (Clozapine) SS Novartis Sector: Infection Pharma ORAL 125 mg/day 10080MIN Hyperhidrosis Leponex / Clozaril Loss Of Consciousness (Clozapine) SS Novartis Sector: Syncope Pharma ORAL Unknown Tachycardia Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL 12.5 to 50 mg/day 7200 MIN Stangyl SS ORAL Unknown 37440MIN Lasix SS ORAL 40 mg/day 4320 MIN Delix SS ORAL 1.25 mg/day 7200 MIN Delix SS ORAL 2.5 mg/day 4320 MIN Lasix SS ORAL 20 mg/day 11520MIN Micardis SS ORAL Unknown Trevilor C ORAL 150 mg/day 8640 MIN Trevilor C ORAL 37.5 to 75 mg/day 213 DAY Trevilor C ORAL Unknown 22-Feb-2006 08:30 AM Page: 3142 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/08/05ISR Number: 4576910-1Report Type:Expedited (15-DaCompany Report #05-02-0144 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Therapeutic Agent Health Clozapine - Ivax Initial or Prolonged Toxicity Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 50-550MG QD ORAL Lithium SS Date:02/08/05ISR Number: 4576913-7Report Type:Expedited (15-DaCompany Report #05-02-0149 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Therapeutic Agent Health Clozapine - Ivax Initial or Prolonged Toxicity Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 400-500MG QD ORAL Lithium SS Date:02/08/05ISR Number: 4576915-0Report Type:Expedited (15-DaCompany Report #05-01-0148 Age:80 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine Tablets - Respiratory Failure Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 25-100MG QD ORAL Date:02/08/05ISR Number: 4577024-7Report Type:Expedited (15-DaCompany Report #2004S1003718 Age:51 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional 100 Mg Mylan PS ORAL 500MG Q AM, Other ORAL Date:02/08/05ISR Number: 4577087-9Report Type:Expedited (15-DaCompany Report #05-01-0147 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Alcohol Use Health Clozapine Tablets - Brain Oedema Professional Ivax Suicide Attempt Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals Inc. ORAL 100-325MG QD ORAL Atropine SS OPHTHALMIC OPHTHALMIC Ethanol SS 22-Feb-2006 08:30 AM Page: 3143 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/08/05ISR Number: 4577094-6Report Type:Expedited (15-DaCompany Report #04-12-1682 Age:75 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 37.5MG QD ORAL Date:02/08/05ISR Number: 4577099-5Report Type:Expedited (15-DaCompany Report #2005S1000296 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Culture Positive Health Clozapine Tablets Hospitalization - Brain Oedema Professional 100 Mg Mylan PS Mylan ORAL 550MG QD, Initial or Prolonged Cryptococcosis Other ORAL Disseminated Sertraline C Intravascular Coagulation Modafinil C Encephalitis Pancreatitis Acute Respiratory Tract Infection Septic Shock Streptococcal Infection Virus Serology Test Positive Date:02/08/05ISR Number: 4577100-9Report Type:Expedited (15-DaCompany Report #2004S1003599 Age:88 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional 100 Mg Mylan PS Myilan ORAL 100MG BID, Other ORAL Triamterene/Hctz C Metformin C Acarbose C Fosinopril C Fluoxetine C Aspirin C Insulin Lispro C Atorvastatin C Date:02/08/05ISR Number: 4577103-4Report Type:Expedited (15-DaCompany Report #2004S1002324 Age:88 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Other Clozapine Tablets Congestive 100 Mg Mylan PS Mylan ORAL 100MG QD, Chronic Obstructive ORAL Pulmonary Disease Lorazepam C Pneumonia 22-Feb-2006 08:30 AM Page: 3144 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/08/05ISR Number: 4577109-5Report Type:Expedited (15-DaCompany Report #2005S1000087 Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebral Haemorrhage Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 300MG BID, Other ORAL Fluvoxamine Maleate C Amlodipine C Divalproex Er C Lovastatin C Date:02/08/05ISR Number: 4577115-0Report Type:Expedited (15-DaCompany Report #2004S1003782 Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Oropharyngeal Cancer Health Clozapine Tablets Stage Unspecified Professional 100 Mg Mylan PS Mylan ORAL 200MG Q AM & Other 500MG Q HS, ORAL Omeprazole C Fentanyl Patch C Dexamethaxone C Potassium Chloride Elixir C Valproic Acid C Hyoscyamine C Lorazepam C Date:02/08/05ISR Number: 4577401-4Report Type:Expedited (15-DaCompany Report #S05-SWE-00274-01 Age:36 YR Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bronchitis Foreign Cipralex Cardiomegaly Health (Escitalopram) PS ORAL 20 MG QD PO Cardiopulmonary Failure Professional Cisordinol - Slow Coronary Artery Disease Other Release Lung Disorder (Zuclopenthixol Sudden Death Decanoate) SS ORAL 5 MG QD PO Leponex (Clozapine) SS ORAL 100 MG Q4HR PO Atarax (Hydroxyzine Hydrochloride0 C Akineton (Biperiden Hydrochloride) C Stesolid (Diazepam) C Date:02/08/05ISR Number: 4703591-6Report Type:Direct Company Report #CTU 239649 Age:45 YR Gender:Female I/FU:I Outcome PT Other Anxiety Depressed Mood Feeling Of Despair Hypersomnia Partner Stress 22-Feb-2006 08:30 AM Page: 3145 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Self-Injurious Ideation Therapeutic Response Unexpected With Drug Report Source Product Role Manufacturer Route Dose Duration Substitution Clozapine PS Geodon C Wellbutrin Sr C Date:02/09/05ISR Number: 4575367-4Report Type:Expedited (15-DaCompany Report #PHBS2005FI01962 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death White Blood Cell Count Leponex PS Novartis Sector: Decreased Pharma ORAL Date:02/09/05ISR Number: 4576028-8Report Type:Expedited (15-DaCompany Report #PHNU2005DE00866 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Catecholamines Urine Leponex / Clozaril Increased (Clozapine) PS Novartis Sector: Hypertensive Crisis Pharma ORAL Unknown Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL 700 mg/day Propranolol C ORAL 100 mg/day Tavor C ORAL Unknown Delix C ORAL 7.5 mg/day Date:02/09/05ISR Number: 4576032-XReport Type:Expedited (15-DaCompany Report #PHBS2005HR01774 Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Antinuclear Antibody Leponex PS Novartis Sector: Hospitalization - Positive Pharma ORAL 200 mg/d 11520MIN Initial or Prolonged Coma Leponex SS Novartis Sector: Disability Diarrhoea Pharma ORAL 100 mg/d Other Dysphagia Haloperidol C UNKNOWN Life Support Clopixol C UNKNOWN Lupus-Like Syndrome Diazepam C UNKNOWN Pseudomonas Infection Pyrexia Red Blood Cell Sedimentation Rate Increased Respiratory Depression Tracheostomy Vasculitis White Blood Cell Count Increased Date:02/09/05ISR Number: 4577260-XReport Type:Expedited (15-DaCompany Report #05-02-0167 Age:74 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Catheter Related Health Clozapine- Ivax Initial or Prolonged Complication Professional Pharmaceuticals, Haemorrhage Other Inc. Tablets PS Ivax 22-Feb-2006 08:30 AM Page: 3146 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pharmaceuticals, Inc. ORAL 50 MG QD ORAL Date:02/09/05ISR Number: 4577261-1Report Type:Expedited (15-DaCompany Report #05-01-0145 Age:67 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Health Clozapine Ivax Other Enuresis Professional Pharmaceuticals Inc General Physical Health Other Tablets PS Ivax Pharmaceuticals Deterioration Inc. ORAL 500MG QD ORAL Hypertension Mass Pneumonia Post Procedural Complication Renal Failure Sepsis Urinary Tract Infection Date:02/09/05ISR Number: 4578799-3Report Type:Direct Company Report #CTU 239997 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Clozapine PS 100 MG DAILY Initial or Prolonged Pharmaceutical Product Complaint Unevaluable Event Date:02/09/05ISR Number: 4579223-7Report Type:Direct Company Report #CTU 240000 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Constipation Clozapine 400 Mg PS 400 MG HS Ileus Paralytic Benztropine 2 Mg SS 2 MG TID Vomiting Date:02/09/05ISR Number: 4700265-2Report Type:Direct Company Report #CTU 239834 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hallucination, Visual Clozaril (Generic) PS Insomnia Mood Altered Visual Disturbance Date:02/09/05ISR Number: 4700839-9Report Type:Direct Company Report #CTU 239816 Age: Gender:Male I/FU:I Outcome PT Other Abnormal Behaviour Activities Of Daily Living Impaired Affect Lability Aggression Impaired Self-Care Mood Altered 22-Feb-2006 08:30 AM Page: 3147 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Staring Therapeutic Response Unexpected With Drug Report Source Product Role Manufacturer Route Dose Duration Substitution Clozapine Generic PS 450 MGS/D Depakote C Zoloft C Date:02/10/05ISR Number: 4576667-4Report Type:Expedited (15-DaCompany Report #PHFR2004GB04410 Age:80 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Overdose Clozaril PS Novartis Sector: Initial or Prolonged Cardiovascular Disorder Pharma ORAL 200mg once Other Depressed Level Of Phenobarbitone C ORAL 15 mg, BID Consciousness Benzhexol C ORAL 5 mg, BID Medication Error Diazepam C ORAL 5 mg, TID Somnolence Fluphenazine C INTRAMUSCULAR 25 mg PRN Tachycardia Date:02/10/05ISR Number: 4577146-0Report Type:Expedited (15-DaCompany Report #PHEH2004US12824 Age:81 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Clozaril PS Novartis Sector: Hospitalization - Anxiety Pharma ORAL 150 mg, QD Initial or Prolonged Coma Trazodone C 50 mg, QD Other Dementia Alzheimer'S Type Aricept C 10 mg, QD Electroencephalogram Aricept C 5 mg, QD Abnormal Xenaderm C Haemoglobin Decreased Peridex C 0.5 ml, BID Prostatic Disorder Aspirin C Red Blood Cell Mycostatin C Abnormality Decadron /Can/ C Metamucil C Date:02/10/05ISR Number: 4577685-2Report Type:Expedited (15-DaCompany Report #US-MERCK-0502USA00822 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Toxicity Vioxx PS Merck & Co., Inc UNKNOWN Hepatic Steatosis Clozaril SS UNKNOWN Portal Triaditis Lorazepam C UNKNOWN Uterine Leiomyoma Paxil C UNKNOWN Date:02/10/05ISR Number: 4579522-9Report Type:Expedited (15-DaCompany Report #2005S1000307 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 50 MG HS, Other ORAL Clozapine Tablets 100 Mg Mylan SS Mylan ORAL 700 MG HS, ORAL 22-Feb-2006 08:30 AM Page: 3148 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/10/05ISR Number: 4579523-0Report Type:Expedited (15-DaCompany Report #2005S1000342 Age:78 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Failure To Thrive Health Clozapine Tablets Pneumonia Aspiration Professional 100 Mg Mylan PS Mylan ORAL 100MG, BID, Other ORAL Date:02/10/05ISR Number: 4579524-2Report Type:Expedited (15-DaCompany Report #2005S1000305 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Circulatory Collapse Health Clozapine Tablets 25 Dyspnoea Professional Mg Mylan PS Mylan ORAL 50 MG HS, Other ORAL Clozapine Tablets 100 Mg Mylan SS Mylan ORAL 100 MG QAM AND 200 MG HS, ORAL Risperidone C Benztropine Mesylate C Methscopolamine C Date:02/10/05ISR Number: 4579526-6Report Type:Expedited (15-DaCompany Report #2005S1000155 Age:53 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Multi-Organ Failure Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 25 MG AM AND Other 75 MG HS, ORAL Atorvastatin C Valproic Acid C Vitamin B12 C Potassium Chloride C Omeprazole C Calcium With Vitamin D C Multivitamin C Lorazepam C Folic Acid C Date:02/10/05ISR Number: 4579529-1Report Type:Expedited (15-DaCompany Report #2005S1000021 Age:72 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg Mylan PS ORAL 25MG BID, Other ORAL Date:02/10/05ISR Number: 4579530-8Report Type:Expedited (15-DaCompany Report #2004S1003556 Age:66 YR Gender:Female I/FU:I Outcome Other Required Intervention to Prevent Permanent 22-Feb-2006 08:30 AM Page: 3149 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Diverticulitis Health Clozapine Tablets Malaise Professional 100 Mg Mylan PS ORAL 300MG QD THEN Pyrexia Other 100MG QD, Red Blood Cell ORAL Sedimentation Rate Zocor Tablets 20 Mg Increased Merck SS Merck ORAL 20MG HS, ORAL Tachycardia Levothyroxine C Date:02/10/05ISR Number: 4579728-9Report Type:Direct Company Report #CTU 240111 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Weight Increased Clozapine 100mg PS ORAL 400MG DAILY ORAL Date:02/10/05ISR Number: 4602167-9Report Type:Periodic Company Report #04-10-1484 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Unevaluable Event Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 700MG QD ORAL Clozapine SS Date:02/11/05ISR Number: 4578150-9Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050200946 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arrhythmia Risperdal PS OROPHARINGEAL Initial or Prolonged Cardiac Failure Clozapine SS OROPHARINGEAL Congestive Clozapine SS OROPHARINGEAL (drug was Cold Sweat stopped on Fall 25-Oct-04 and Sedation restarted on 09-Nov-04.) Seroquel C Date:02/11/05ISR Number: 4578197-2Report Type:Expedited (15-DaCompany Report #PHNU2005DE00777 Age: Gender:Male I/FU:I Outcome PT Disability Alanine Aminotransferase Increased Drug Interaction Gamma-Glutamyltransferase Increased Hepatocellular Damage Hepatomegaly Hyperlipidaemia Lipids Increased Liver Disorder 22-Feb-2006 08:30 AM Page: 3150 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Metabolic Syndrome Transaminases Increased Ultrasound Scan Abnormal Report Source Product Role Manufacturer Route Dose Duration Weight Increased Leponex / Clozaril (Clozapine) PS Novartis Sector: Pharma ORAL Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL 25 to 225 mg 12960MIN Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL 25 to 300 mg 28800MIN Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL 350 to 400 mg 18720MIN Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma UNK, UNK Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma up to 550 mg/day Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma up to 550 mg/day Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma up to 550 mg/day Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma up to 550 mg/day Truxal SS 25920MIN Truxal SS Truxal SS 12960MIN Truxal SS 7200 MIN Dipiperon C 5760 MIN Dipiperon C 47520MIN Dipiperon C Risperdal C to 4 mg Risperdal C to 6 mg 37440MIN Risperdal C 12960MIN Glucophage C Pravasin C 18720MIN Seroquel C Date:02/11/05ISR Number: 4578198-4Report Type:Expedited (15-DaCompany Report #PHBS2005CN01928 Age:55 YR Gender:Female I/FU:I Outcome PT Other Alanine Aminotransferase Increased Blood Alkaline Phosphatase Increased Blood Bilirubin Increased Blood Creatine Phosphokinase Increased Blood Lactate 22-Feb-2006 08:30 AM Page: 3151 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dehydrogenase Increased Eosinophilia Hepatic Enzyme Increased Hepatitis Toxic Report Source Product Role Manufacturer Route Dose Duration Lymphocyte Count Clozapine PS Novartis Sector: Decreased Pharma UNKNOWN 25 mg/d Neutrophilia Clozapine SS Novartis Sector: Pyrexia Pharma UNKNOWN 200 mg/d Urticaria Date:02/11/05ISR Number: 4578473-3Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050200811 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrial Fibrillation Risperdal PS Initial or Prolonged Body Temperature Euthyrox SS Other Increased Akineton Ret SS C-Reactive Protein Leponex SS Increased Leponex SS Cardiac Failure Chronic Leponex SS Malaise Leponex SS Myocarditis Leponex SS Leponex SS Zyprexa SS Zyprexa SS Zyprexa SS Zyprexa SS Zyprexa SS Tavor SS Tavor SS Tavor SS Tavor SS Date:02/11/05ISR Number: 4578699-9Report Type:Expedited (15-DaCompany Report #PHBS2004CA14248 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Difficulty In Walking Clozaril PS Novartis Sector: Dysstasia Pharma ORAL 150 mg/d Electroencephalogram Clozaril SS Novartis Sector: Abnormal Pharma ORAL 450 to 600 Mania mg/day Psychotic Disorder Clozaril SS Novartis Sector: Reflexes Abnormal Pharma ORAL 400 mg/d Speech Disorder Antidiabetics C UNKNOWN Tic Date:02/11/05ISR Number: 4578704-XReport Type:Expedited (15-DaCompany Report #PHBS2005NZ01941 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - C-Reactive Protein Clozaril PS Novartis Sector: Initial or Prolonged Increased Pharma ORAL 100 mg/d Chest Pain Clozaril SS Novartis Sector: Pleurisy Viral Pharma ORAL 100 mg/d 23040MIN Pyrexia Thrombocytopenia 22-Feb-2006 08:30 AM Page: 3152 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/11/05ISR Number: 4578706-3Report Type:Expedited (15-DaCompany Report #PHFR2003GB01758 Age:27 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Arthritis Clozaril PS Novartis Sector: Confusional State Pharma ORAL 800mg/day Constipation Sulpiride SS ORAL 1200mg/day Diabetes Mellitus Procyclidine C UNKNOWN Influenza Like Illness Hyoscine C ORAL 300ug/day Lethargy Glipizide C UNKNOWN Protein Urine Tremor Weight Decreased Date:02/11/05ISR Number: 4578707-5Report Type:Expedited (15-DaCompany Report #PHHO2005CA02039 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chest Pain Clozaril PS Novartis Sector: Dyspnoea Pharma Myocarditis Seroquel C Pericarditis Lithium C Tachycardia Thyroid Disorder Date:02/11/05ISR Number: 4582393-8Report Type:Direct Company Report #CTU 240186 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypertension Clozapine Dose Not Pharmaceutical Product Specified PS ORAL PO Complaint Tachycardia Date:02/14/05ISR Number: 4579638-7Report Type:Expedited (15-DaCompany Report #IE-BRISTOL-MYERS SQUIBB COMPANY-12783494 Age:25 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Metformin Hcl PS Bristol-Myers Squibb Initial or Prolonged Intentional Overdose Company ORAL 1000 mg BID Other Metabolic Acidosis regular dose, Somnolence attempted Suicide Attempt suicide by taking 4 Atenolol SS Sandoz Inc. (Geneva Pharm Tech) ORAL Acamprosate SS ORAL 666 mg TID regular dose, attempted suicide by taking 4 Zopiclone SS ORAL Sulpirid SS ORAL Venlafaxine Hcl SS ORAL Lamotrigine SS ORAL Clozaril SS ORAL 22-Feb-2006 08:30 AM Page: 3153 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/14/05ISR Number: 4579703-4Report Type:Expedited (15-DaCompany Report #PHNU2005SI00925 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Dyspnoea Leponex / Clozaril Hospitalization - Leukopenia (Clozapine) PS Novartis Sector: Initial or Prolonged Pyrexia Pharma ORAL 350 mg/day Sepsis Lamictal Surgery "Glaxosmithkline" C ORAL 100 mg, BID Fluanxol C ORAL 20 mg/day Date:02/14/05ISR Number: 4579712-5Report Type:Expedited (15-DaCompany Report #PHBS2005PH01508 Age:42 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Gastrointestinal Leponex PS Novartis Sector: Hospitalization - Haemorrhage Pharma 100 mg/d 221 DAY Initial or Prolonged Haemoglobin Decreased Levomepromazine C 50 mg, QHS 221 DAY Loss Of Consciousness Oesophageal Candidiasis Date:02/15/05ISR Number: 4582861-9Report Type:Expedited (15-DaCompany Report #PHFR2005GB00606 Age:48 Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Clozaril PS Novartis Sector: Initial or Prolonged Dystonia Pharma ORAL 550mg/day Overdose Clozaril SS Novartis Sector: Pharma ORAL 20 Clozaril tablets Mirtazapine C ORAL 15 mg/say Omeprazole C ORAL 20 mg/day Morphine Sulfate C 180 mg/day Desloratadine C ORAL 5 mg/day Date:02/15/05ISR Number: 4582925-XReport Type:Expedited (15-DaCompany Report #PHFR2004GB04436 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Clozaril PS Novartis Sector: Initial or Prolonged Drug Level Decreased Pharma UNK, UNK Drug Level Increased Andrews Liver Salt SS ORAL Feeling Abnormal Frusemide C Oedema Peripheral Overdose Treatment Noncompliance Date:02/15/05ISR Number: 4584760-5Report Type:Expedited (15-DaCompany Report #2005S1000365 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 300MG BID, Other ORAL 22-Feb-2006 08:30 AM Page: 3154 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/15/05ISR Number: 4584781-2Report Type:Expedited (15-DaCompany Report #2005S1000364 Age:86 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 75MG HS, ORAL Other Clozapine Tablets 100 Mg Mylan SS Mylan ORAL 100MG HS, ORAL Fentanyl C Morphine Sulfate C Levothyroxine C Quetiapine C Zinc C Vitamin E C Calciton-Salmon C Sennosides C Carbidopa/Levodopa C Aspriin (Enteric Coated) C Mirtazapine C Ibuprofen (Prn) C Date:02/15/05ISR Number: 4587323-0Report Type:Expedited (15-DaCompany Report #2005AP00868 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Angioneurotic Oedema Foreign Atenolol PS 25 MG DAILY Intervention to Dry Skin Health Risperidone SS 2 MG DAILY Prevent Permanent Erythema Professional Fluvoxamine Maleate SS 100 MG DAILY Impairment/Damage Skin Fissures Other Clozapine SS 50 MG DAILY Swollen Tongue Zolpidem Tartrate SS 100 MG DAILY Date:02/15/05ISR Number: 4587507-1Report Type:Expedited (15-DaCompany Report #2005S1000354 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bronchitis Acute Health Clozapine Tablets 25 Hospitalization - Dysphagia Professional Mg Mylan PS Mylan ORAL 50 MG QD, Initial or Prolonged Influenza Other ORAL Leukopenia Clozapine Tablets Pneumonia Aspiration 100 Mg Mylan SS Mylan ORAL 300 MG QD, Sepsis ORAL Quetiapine C Risperidone C Clonazepam C Date:02/15/05ISR Number: 4587508-3Report Type:Expedited (15-DaCompany Report #2005S1000357 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pulmonary Embolism Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 200 MG BID, Other ORAL 22-Feb-2006 08:30 AM Page: 3155 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/16/05ISR Number: 4585802-3Report Type:Expedited (15-DaCompany Report #05-01-0059 Age:55 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Respiratory Failure Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 300MG QD ORAL Levaquin C Advair C Date:02/16/05ISR Number: 4585803-5Report Type:Expedited (15-DaCompany Report #05-01-0106 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine Tablets Professional -Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 150-350MG QD ORAL Date:02/16/05ISR Number: 4585804-7Report Type:Expedited (15-DaCompany Report #05-02-0179 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 500 MG QD ORAL Date:02/16/05ISR Number: 4588797-1Report Type:Expedited (15-DaCompany Report #004 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Health Fazaclo PS Alamo Initial or Prolonged Professional Pharmaceuticals Company Representative Date:02/16/05ISR Number: 4589232-XReport Type:Direct Company Report #CTU 240557 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Pharmaceutical Product Clozapine-Ivax PS Ivax ORAL 400 MG PO Other Complaint BEDTIME Psychotic Disorder Thinking Abnormal 22-Feb-2006 08:30 AM Page: 3156 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/17/05ISR Number: 4584717-4Report Type:Expedited (15-DaCompany Report #PHFR2003GB04210 Age:31 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Alanine Aminotransferase Clozaril PS Novartis Sector: Other Increased Pharma ORAL 350mg/day Blood Cholesterol Citalopram C ORAL 20 mg, QD Increased Lansoprazole C ORAL 15mg/nocte Blood Glucose Increased Flupentixol C ORAL 3 mg, PRN Blood Triglycerides Paracetamol C ORAL 1 g, PRN Increased Diabetes Mellitus Gamma-Glutamyltransferase Increased Glycosylated Haemoglobin Increased Hepatic Steatosis Weight Increased Date:02/17/05ISR Number: 4585487-6Report Type:Expedited (15-DaCompany Report #PHEH2005US01885 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Toxicity Clozapine PS Novartis Sector: Pharma Tofranil SS Amitriptyline SS Date:02/17/05ISR Number: 4585979-XReport Type:Expedited (15-DaCompany Report #DE-ABBOTT-05P-062-0290018-00 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrial Fibrillation Akineton Retard PS ORAL 26 DAY Initial or Prolonged Body Temperature Levothyroxine Sodium SS ORAL 49 DAY Increased Risperidone SS ORAL 31 DAY C-Reactive Protein Leponex SS ORAL Increased Leponex SS ORAL Cardiac Failure Leponex SS ORAL Fatigue Leponex SS ORAL Myocarditis Leponex SS ORAL Leponex SS ORAL Olanzapine SS ORAL 41 DAY Olanzapine SS ORAL 41 DAY Olanzapine SS ORAL 41 DAY Olanzapine SS ORAL 41 DAY Olanzapine SS ORAL 41 DAY Lorazepam SS ORAL Lorazepam SS ORAL Lorazepam SS ORAL Lorazepam SS ORAL Date:02/17/05ISR Number: 4588009-9Report Type:Expedited (15-DaCompany Report #2005S1000399 Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Parkinson'S Disease Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 25 MG BID Other ORAL Carbidopa/Levodopa C 22-Feb-2006 08:30 AM Page: 3157 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pramipexole C Date:02/17/05ISR Number: 4588010-5Report Type:Expedited (15-DaCompany Report #2004S1003441 Age:57 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coma Health Clozapine Tablets Hospitalization - Pneumonia Professional 100 Mg Mylan PS Mylan ORAL 100 MG TID, Initial or Prolonged White Blood Cell Count Other 300 MG HS, Increased ORAL Divalproex Sodium C Benztropine C Date:02/17/05ISR Number: 4588012-9Report Type:Expedited (15-DaCompany Report #2005S1000406 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Circulatory Collapse Health Clozapine Tablets Hospitalization - Sudden Death Professional 100 Mg Mylan PS Mylan ORAL 200 MG HS, Initial or Prolonged Urinary Tract Infection Other ORAL Glipizide C Benazepril C Tamsulosin C Lansoprazole C Date:02/17/05ISR Number: 4588013-0Report Type:Expedited (15-DaCompany Report #2004S1002711 Age:49 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Renal Failure Chronic Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 25 MG, BID, Other ORAL Morphine-Sulfate C Sertraline C Albuterol Nebulizer C Divalproex Sodium C Fentanyl C Furosemide C Potassium Chloride C Sorbitol C Darbepoetin Alfa C Ziprasidone C Oxycodone C Metoprolol C Lorazepam C Diphenoxylate/Atropi ne Sulfate C Bisacodyl C Date:02/17/05ISR Number: 4588014-2Report Type:Expedited (15-DaCompany Report #2005S1000128 Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Overdose Health Clozapine Tablets Medication Error Professional 100 Mg Mylan PS Mylan ORAL 200 MG HS, Other ORAL 22-Feb-2006 08:30 AM Page: 3158 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/17/05ISR Number: 4588015-4Report Type:Expedited (15-DaCompany Report #2004S1003562 Age:27 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asthma Health Clozapine Tablets Feeling Abnormal Professional 100 Mg Mylan PS Mylan ORAL 200 MG QAM Loss Of Consciousness Other AND 400 MG Pneumonia HS, ORAL 2 YR Refusal Of Treatment By Clonazepam C Patient Levothyroxine C Desmopressin Acetate C Oxcarbazepine C Paroxetine C Anti-Asthmatics C Date:02/17/05ISR Number: 4588016-6Report Type:Expedited (15-DaCompany Report #2005S1000153 Age:75 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neoplasm Malignant Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 25MG BID, Other ORAL Morphine Sulfate Injection C Fentanyl Transdermal System C Ceftriaxone Sodum C Metformin Xr C Repaglinide C Metoprolol C Iomipramine C Carbidopa/Levodopa C Rivastigmine Tartrate C Acetaminophen C Magnesium Sulfate Injection C Lactulose C Date:02/17/05ISR Number: 4588020-8Report Type:Expedited (15-DaCompany Report #05-02-0205 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Choking Health Clozapine Tablets - Professional Ivax Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 350-500 MG QD ORAL Date:02/17/05ISR Number: 4588021-XReport Type:Expedited (15-DaCompany Report #05-02-0211 Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax 22-Feb-2006 08:30 AM Page: 3159 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pharmaceuticals, Inc. ORAL 100-200 MG QD ORAL Date:02/17/05ISR Number: 4589716-4Report Type:Expedited (15-DaCompany Report #004 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pharmaceutical Product Health Fazaclo PS Alamo Initial or Prolonged Complaint Professional Pharmaceuticals Psychotic Disorder Company Representative Date:02/17/05ISR Number: 4590258-0Report Type:Expedited (15-DaCompany Report #6012941 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrial Fibrillation Foreign Euthyrox Initial or Prolonged C-Reactive Protein Health Increased Professional (Levothyroxine Cardiac Failure Other Sodium) PS ORAL 100 MG ORAL 50 DAY Myocarditis Risperdal (Risperidone) SS 4 MG Akineton Ret (Biperiden Hydrochloride) SS ORAL 1 DOSE FORMS ORAL 26 DAY Leponex (Clozapine) SS SEE IMAGE 1 DAY Zyprexa (Olanzapine) SS SEE IMAGE 15 DAY Tavor (Lorazepam) SS SEE IMAGE 21 DAY Date:02/17/05ISR Number: 4590298-1Report Type:Expedited (15-DaCompany Report #2005AP01006 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Foreign Bupivacaine Initial or Prolonged Respiratory Depression Health Hydrochloride PS Sedation Professional Fentanyl SS Other Clozaril SS ORAL 300 MG DAILY PO Date:02/17/05ISR Number: 4590361-5Report Type:Expedited (15-DaCompany Report #MK200502-0131-1 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Toxicity Health Tofranil Tablets Professional (Strength Unk) PS Company Clozapine Tablets SS ORAL 50-400 MG QD Representative PO Amitriptyline SS Luvox C 22-Feb-2006 08:30 AM Page: 3160 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/18/05ISR Number: 4586418-5Report Type:Expedited (15-DaCompany Report #PHEH2005US01966 Age:86 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Parkinson'S Disease Clozaril PS Novartis Sector: Pharma ORAL 25 mg, QHS for one week Sinemet C Seroquel C Date:02/18/05ISR Number: 4586420-3Report Type:Expedited (15-DaCompany Report #PHHO2005CA02278 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatic Function Abnormal Clozaril (Clozapine) PS Novartis Sector: Psychomotor Retardation Pharma ORAL 200 mg/BID + 200 mg hs 46080MIN Xanax C Celexa C Zyprexa C Wellbutrin Sr C Kemadrin C Date:02/18/05ISR Number: 4586682-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12806493 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Taxol PS Bristol-Myers Squibb Company Carboplatin SS Bristol-Myers Squibb Company Clozapine SS ORAL dose: 50 - 300 mg Date:02/18/05ISR Number: 4586721-9Report Type:Expedited (15-DaCompany Report #PHNU2004DE03043 Age:27 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Grand Mal Convulsion Betadorm PS 12 DF, Initial or Prolonged Overdose ONCE/SINGLE Other Clozapine SS 500mg/day Risperdal C Date:02/18/05ISR Number: 4587035-3Report Type:Expedited (15-DaCompany Report #PHBS2005NZ02123 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Clozaril PS Novartis Sector: Initial or Prolonged Phosphokinase Increased Pharma ORAL 700 mg/day 894 DAY Dysstasia Antihistaminics C Muscle Rigidity Chlorpromazine C Neuroleptic Malignant Syndrome Pneumonia Aspiration Pyrexia 22-Feb-2006 08:30 AM Page: 3161 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/18/05ISR Number: 4587040-7Report Type:Expedited (15-DaCompany Report #PHFR2004GB00456 Age:54 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Pressure Increased Clozaril PS Novartis Sector: Other Bundle Branch Block Left Pharma ORAL UNK, UNK 2303 DAY Cardiac Arrest Hyoscine Circulatory Collapse Hydrobromide SS ORAL 900mg/day Dizziness Electrocardiogram Abnormal Heart Rate Irregular Myocardial Infarction Overweight Sinus Tachycardia Date:02/18/05ISR Number: 4587245-5Report Type:Expedited (15-DaCompany Report #PHFR2003GB04965 Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Feeling Abnormal Lamivudine PS Glaxosmithkline UNKNOWN Initial or Prolonged Haemoglobin Decreased Clozaril SS ORAL 350MG Per day Mean Cell Volume Stavudine SS UNKNOWN Increased Saquinavir SS UNKNOWN Neutrophil Count Sodium Valproate C ORAL 1000MG Per Decreased day 92 WK Platelet Count Decreased Pneumonia Pyrexia Thrombocytopenia White Blood Cell Count Decreased Date:02/18/05ISR Number: 4588631-XReport Type:Expedited (15-DaCompany Report #05-01-0094 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Toxicity Health Clozapine - Ivax Initial or Prolonged Eating Disorder Professional Pharmaceuticals, Other Neutrophil Count Other Inc. Tablets PS Ivac Increased Pharmaceuticals, Pneumonia Inc. ORAL 300MG QD ORAL Weight Decreased Lipitor C Zantac C Synthroid C Date:02/18/05ISR Number: 4588637-0Report Type:Expedited (15-DaCompany Report #05-02-0215 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Ankle Fracture Health Clozapine - Ivax Hospitalization - Post Procedural Professional Pharmaceuticals, Initial or Prolonged Complication Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 400 MG QD ORAL 22-Feb-2006 08:30 AM Page: 3162 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/19/05ISR Number: 4587913-5Report Type:Expedited (15-DaCompany Report #PHNU2005DE00926 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Leponex / Clozaril Initial or Prolonged Delirium (Clozapine) PS Novartis Sector: Other Leukocytosis Pharma ORAL low dosages Memory Impairment Zoplicone SS ORAL Personality Change Fluoxetine SS ORAL Social Avoidant Behaviour Date:02/19/05ISR Number: 4587922-6Report Type:Expedited (15-DaCompany Report #PHEH2005US01885 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Toxicity Tofranil PS Clozapine SS Amitriptyline SS Date:02/21/05ISR Number: 4588144-5Report Type:Expedited (15-DaCompany Report #PHFR2005GB00654 Age:22 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Cognitive Disorder Clozaril PS Novartis Sector: Other Memory Impairment Pharma ORAL Speech Disorder Venlafaxine C ORAL 150 mg, BID Hyoscine Hydrobromide C ORAL 300 mg, BID Hyoscine Hydrobromide C ORAL 300 mg, BID Date:02/21/05ISR Number: 4588146-9Report Type:Expedited (15-DaCompany Report #PHBS2005IE02398 Age:66 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Exposure Clozaril PS Novartis Sector: Initial or Prolonged Pharma UNKNOWN UNK, UNK 1440 MIN Date:02/22/05ISR Number: 4588468-1Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-12855300 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Feeling Abnormal Stavudine PS Bristol-Myers Squibb Initial or Prolonged Haemoglobin Decreased Company Other Mean Cell Volume Clozaril SS ORAL 01-Jun-2004 Increased temporarily Neutrophil Count with-held Decreased then Platelet Count Decreased restarted. Pneumonia Lamivudine SS Pyrexia Saquinavir SS White Blood Cell Count Sodium Valproate C ORAL Decreased 22-Feb-2006 08:30 AM Page: 3163 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/22/05ISR Number: 4588622-9Report Type:Expedited (15-DaCompany Report #PHBS2005DE02352 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Clozapine PS Novartis Sector: Disturbance In Attention Pharma UNKNOWN 250 mg/d Libido Decreased Lorazepam SS UNKNOWN 1 mg/d Weight Increased Haloperidol SS Zotepine SS Risperidone SS UNKNOWN 6 mg/d Date:02/22/05ISR Number: 4588623-0Report Type:Expedited (15-DaCompany Report #PHEH2005US02144 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Clozaril PS Novartis Sector: Initial or Prolonged Cardiac Failure Pharma ORAL Unk, Unk Other Congestive Clozaril SS Novartis Sector: Cardiac Myxoma Pharma ORAL 12.5 mg, QD Dehydration Lithobid C Nausea Zoloft C Vomiting Antihypertensive Drugs C Date:02/22/05ISR Number: 4588625-4Report Type:Expedited (15-DaCompany Report #PHEH2005US02200 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Level Increased Clozaril PS Novartis Sector: Drug Toxicity Pharma ORAL 400 mg, QD Pulmonary Oedema Abilify C 30 mg, QD Lamotrigine C 100 mg, QHS Artane C UNK mg, QD Depakote C 1500 mg, QD Risperdal I 3 mg, QD Klonopin I 1 mg, QD Paxil I 215 mg, QD Date:02/22/05ISR Number: 4588645-XReport Type:Expedited (15-DaCompany Report #PHRM2005FR00841 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Lung Disorder Leponex PS Novartis Sector: Neutropenia Pharma ORAL 150 mg daily 87 DAY Imovane C Deroxat C Rivotril C Lithium C Praxinor C Date:02/22/05ISR Number: 4588647-3Report Type:Expedited (15-DaCompany Report #PHFR2002GB00857 Age:56 YR Gender:Male I/FU:F Outcome PT Hospitalization - Agitation Initial or Prolonged Blood Pressure Increased Contusion Convulsion 22-Feb-2006 08:30 AM Page: 3164 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Head Injury Heart Rate Increased Mental Disorder Report Source Product Role Manufacturer Route Dose Duration Neutrophil Count Clozaril PS Novartis Sector: Increased Pharma ORAL 500mg/day Overdose Clozaril SS Novartis Sector: Road Traffic Accident Pharma ORAL 350mg/day Date:02/22/05ISR Number: 4588648-5Report Type:Expedited (15-DaCompany Report #PHNR2004AU01714 Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alcohol Use Clozaril PS Novartis Sector: Blood Cholesterol Pharma ORAL 75 - 250 Increased mg/day Blood Glucose Increased Clozaril SS Novartis Sector: Liver Function Test Pharma ORAL 100 mg/day Abnormal Date:02/22/05ISR Number: 4588649-7Report Type:Expedited (15-DaCompany Report #PHRM2005FR00847 Age:0 DY Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Antipsychotic Drug Level Leponex PS Novartis Sector: Hospitalization - Above Therapeutic Pharma TRANSPLACENTAL UNK, UNK Initial or Prolonged Apgar Score Low Depamide SS TRANSPLACENTAL UNK, UNK Drug Exposure During Depamide SS TRANSPLACENTAL Pregnancy Valium SS TRANSPLACENTAL UNK, UNK Hypotonia Neonatal Ixel C TRANSPLACENTAL Life Support Imovane C TRANSPLACENTAL 2880 MIN Neonatal Respiratory Theralene C TRANSPLACENTAL 2880 MIN Distress Syndrome Temesta I TRANSPLACENTAL UNK, UNK Somnolence Neonatal Temesta I TRANSPLACENTAL UNK, UNK 33120MIN Vomiting Neonatal Largactil I TRANSPLACENTAL 1440 MIN Lexomil I TRANSPLACENTAL 1440 MIN Date:02/22/05ISR Number: 4590988-0Report Type:Direct Company Report #CTU 240994 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Valproic Acid PS ORAL 1.5 GRAMS BID Initial or Prolonged Increased ORAL Clozapine SS ORAL 300 MG BID ORAL Date:02/22/05ISR Number: 4591012-6Report Type:Direct Company Report #CTU 240941 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Level Changed Clozaril 100 Mg Pharmaceutical Product Tablet PS ORAL 2 TABS AM/ 5 Complaint PM TAKEN PO/DAILY GROUP/INDIVID UAL RESERVES 22-Feb-2006 08:30 AM Page: 3165 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/22/05ISR Number: 4591304-0Report Type:Expedited (15-DaCompany Report #2005S1000207 Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 600 MG Q HS, Other ORAL Glipizide Xl C Date:02/22/05ISR Number: 4591315-5Report Type:Expedited (15-DaCompany Report #2005S1000462 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 600MG, QD, Other ORAL Date:02/22/05ISR Number: 4591353-2Report Type:Expedited (15-DaCompany Report #2005S1000460 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatinine Health Clozapine Tablets Initial or Prolonged Increased Professional 100 Mg Mylan PS ORAL 100MG GAM AND Other Confusional State Other 200MG HS, Diabetic Ketoacidosis ORAL Pneumonia Streptococcal Atenolol C Sepsis Paroxetine C White Blood Cell Count Quetiapine C Decreased Gemfibrozil C Date:02/22/05ISR Number: 4591358-1Report Type:Expedited (15-DaCompany Report #2005S1000440 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional 100 Mg Mylan PS ORAL 20MG GRAM AND Other 400MG HS, ORAL Celecoxib C Aspirin C Atenolol C Atorvastatin C Tamsulosin C Triamterene/Hctz C Valsartan C Divalproex C Date:02/22/05ISR Number: 4591368-4Report Type:Expedited (15-DaCompany Report #2005UW02051 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Toxicity Health Amitriptyline PS Professional Clozapine SS ORAL 400 MG QD PO Imipramine SS 22-Feb-2006 08:30 AM Page: 3166 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/22/05ISR Number: 4594114-3Report Type:Expedited (15-DaCompany Report #S04-IRL-07963-01 Age:25 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Foreign Acamprosate PS ORAL 7992 MG ONCE Initial or Prolonged Metabolic Acidosis Health PO Multiple Drug Overdose Professional Acamprosate SS ORAL 666 MG TID PO Intentional Other Metformin SS ORAL 8000 MG ONCE Schizophrenia PO Sedation Metformin SS ORAL 1000 MG BID Somnolence PO Suicide Attempt Zopiclone SS ORAL 60 MG ONCE PO Zopiclone SS Sulprid (Sulpiride) SS ORAL 6400 MG ONCE PO Sulprid (Sulpiride) SS Venlafaxine SS ORAL 600 MG ONCE PO Venlafaxine SS Lamotrigine SS ORAL 1200 MG ONCE PO Lamotrigine SS Atenolol SS ORAL 100 MG ONCE PO Atenolol SS Clozaril (Clozapine) SS ORAL 2700 MG ONCE PO Clozaril (Clozapine) SS Date:02/23/05ISR Number: 4589310-5Report Type:Expedited (15-DaCompany Report #PHBS2005BE02537 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Leponex PS Novartis Sector: Initial or Prolonged Dyslipidaemia Pharma ORAL 100 mg, BID Date:02/23/05ISR Number: 4589312-9Report Type:Expedited (15-DaCompany Report #PHRM2005FR00851 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Leponex PS Novartis Sector: Initial or Prolonged Drug Exposure During Pharma ORAL 200 mg/day Pregnancy Leponex SS Novartis Sector: Hospitalisation Pharma ORAL 300 mg/day Insomnia Leponex SS Novartis Sector: Mania Pharma ORAL 400 mg/day Depamide SS ORAL Depamide SS ORAL 900 mg/day 14400MIN Depamide SS ORAL 1200 mg/day Valium SS ORAL 30 to 50 mg/day Temesta C ORAL Temesta C ORAL 33120MIN Ixel C ORAL Largactil C UNKNOWN 1440 MIN Lexomil C ORAL 1440 MIN Imovane C ORAL 2880 MIN Theralene C ORAL 50 drops/day 2880 MIN 22-Feb-2006 08:30 AM Page: 3167 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/23/05ISR Number: 4589591-8Report Type:Expedited (15-DaCompany Report #CH-MERCK-0311CHE00033 Age:54 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Zetia PS Merck & Co., Inc ORAL 8 DAY Initial or Prolonged Phosphokinase Increased Fluvastatin Sodium SS ORAL 2 YR Other Drug Interaction Fenofibrate SS ORAL 2 YR Myopathy Clozapine SS ORAL Rhabdomyolysis Esomeprazole Magnesium C ORAL Metoclopramide Hydrochloride C ORAL Date:02/23/05ISR Number: 4591435-5Report Type:Direct Company Report #CTU 241125 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Citalopram PS 60 MG/DAY Drug Level Increased Clozapine SS 350 MG 1 DAY Sudden Death Depakote SS 1000 MG/DAY Date:02/23/05ISR Number: 4591582-8Report Type:Expedited (15-DaCompany Report #05-01-0078 Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatitis C Health Clozapine - Ivax White Blood Cell Count Professional Pharmaceuticals, Decreased Inc. Tablets PS ORAL 500 MG QD ORAL Peg-Intron SS SUBCUTANEOUS 80MCG 0.5ML SUBCUTANEOUS Rebetol SS ORAL 200 MG TID ORAL Seroquel C Paxil Cr C Date:02/23/05ISR Number: 4591584-1Report Type:Expedited (15-DaCompany Report #05-01-0091 Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Fall Health Clozapine Ivax Myocardial Infarction Professional Pharmaceuticals Inc Other Tablets PS ORAL 400 MG QHS ORAL Risperdal C Zoloft C Topamax C Enalapril C Lipitor C Lasix C Date:02/23/05ISR Number: 4591586-5Report Type:Expedited (15-DaCompany Report #05-02-0238 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coma Health Clozapine Ivax Other Myocardial Infarction Professional Pharmaceuticals Inc Respiratory Failure Other Tablets PS ORAL 700-900 MG QD 22-Feb-2006 08:30 AM Page: 3168 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL Date:02/23/05ISR Number: 4594423-8Report Type:Expedited (15-DaCompany Report #S05-USA-00802-01 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Health Celexa (Citalopram Drug Interaction Professional Hydrobromide) PS ORAL 60 MG QD PO Drug Toxicity Clozapine SS ORAL 750 MG QD PO Sudden Death Depakote (Valproate White Blood Cell Count Semisodium) C Increased Ativan (Lorazepam) C Pepcid (Famotidine C Date:02/23/05ISR Number: 4595355-1Report Type:Expedited (15-DaCompany Report #2004GB02876 Age:25 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Foreign Atenolol PS ORAL 100 MG ONCE Initial or Prolonged Metabolic Acidosis Health PO Multiple Drug Overdose Professional Metformin SS ORAL 8000 MG ONCE Intentional Other PO Schizophrenia Campral SS ORAL 7992 MG ONCE Sedation PO Somnolence Clozaril SS ORAL 2700 MG ONCE Suicide Attempt PO Zopiclone SS ORAL 60 MG ONCE PO Sulprid SS ORAL 6400 MG ONCE PO Venlafaxine SS ORAL 600 MG ONCE PO Lamotrigine SS ORAL 1200 MG ONCE PO Date:02/23/05ISR Number: 4595661-0Report Type:Direct Company Report #CTU 241223 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Chest Pain Clozapine PS 600 MG HS 1 MON Electrocardiogram Change Myocarditis Date:02/24/05ISR Number: 4590152-5Report Type:Expedited (15-DaCompany Report #PHEH2005US02346 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Clozaril PS Novartis Sector: Other Neoplasm Malignant Pharma ORAL 100mg Qam & Syncope 500mg Qpm Date:02/24/05ISR Number: 4590159-8Report Type:Expedited (15-DaCompany Report #PHHO2005CA02039 Age:23 YR Gender:Male I/FU:F Outcome PT Other Chest Pain Dyspnoea Myocarditis 22-Feb-2006 08:30 AM Page: 3169 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pericarditis Tachycardia Thyroid Disorder Report Source Product Role Manufacturer Route Dose Duration Clozaril PS Novartis Sector: Pharma ORAL 350 mg hs Seroquel C Lithium C Date:02/24/05ISR Number: 4590422-0Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050204139 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Haldol PS 583 DAY Clozapine SS OROPHARINGEAL 443 DAY Ativan C Lithium Carbonate C Date:02/24/05ISR Number: 4595049-2Report Type:Expedited (15-DaCompany Report #05-02-0262 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Health Clozapine Tablets - Initial or Prolonged Fall Professional Ivax Hip Fracture Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 50 MG QD ORAL Date:02/24/05ISR Number: 4595053-4Report Type:Expedited (15-DaCompany Report #05-01-0119 Age:44 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypercalcaemia Health Clozapine Tablets - Initial or Prolonged Renal Failure Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 250 MG QD ORAL Date:02/24/05ISR Number: 4595058-3Report Type:Expedited (15-DaCompany Report #05-02-0252 Age:67 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Colon Cancer Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 250 MG QD ORAL Chemotherapy C 22-Feb-2006 08:30 AM Page: 3170 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/24/05ISR Number: 4595064-9Report Type:Expedited (15-DaCompany Report #05-02-0254 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Health Clozapine Tablets - Initial or Prolonged Dehydration Professional Ivax Meningitis Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 400-600 MG QD ORAL Date:02/24/05ISR Number: 4595066-2Report Type:Expedited (15-DaCompany Report #05-02-0237 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 500 MG QD ORAL Date:02/24/05ISR Number: 4595071-6Report Type:Expedited (15-DaCompany Report #05-02-0253 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Gallbladder Disorder Health Clozapine Tablets - Initial or Prolonged Small Intestinal Professional Ivax Obstruction Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 25-500MG QD ORAL Date:02/24/05ISR Number: 4595148-5Report Type:Expedited (15-DaCompany Report #05-02-0239 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Choking Health Clozapine Tablets - Foreign Body Trauma Professional Ivax Obstructive Airways Other Pharmaceuticals, Disorder Inc. PS Ivax Pharmaceuticals, Inc. ORAL 300-600MG QD ORAL Date:02/24/05ISR Number: 4595152-7Report Type:Expedited (15-DaCompany Report #05-02-0249 Age:81 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Infection Health Clozapine Tablets - Initial or Prolonged Urinary Tract Infection Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 175-225MG QD 22-Feb-2006 08:30 AM Page: 3171 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL Atrovent C Albuterol Sulfate C Date:02/24/05ISR Number: 4595156-4Report Type:Expedited (15-DaCompany Report #2005S1000492 Age:76 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional 100 Mg Mylan PS ORAL 100MG QHS, Other ORAL Oxycodone/Apap C Morphine Sulfate C Magestrol Acetate C Haloperidol C Risperidone C Clonazepam C Date:02/24/05ISR Number: 4604787-4Report Type:Periodic Company Report #041-163-0276180-00 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Toxicity Health Vicodin Fat Tissue Increased Professional (Hydrocodone/Acetami Unevaluable Event Other nophen) (Hydrocodone/Acetami nophen) PS Lexapro Film-Coated Tablets (Escitalopram) (Escitalopram) SS ORAL 30 MG, 1 IN 1 D, PER ORAL Clozapine SS 300 MG, 1 IN 1 D Topiramate C Valproate Semisodium C Cyclobenzaprine Hydrochloride C Promethazine C Doxepin C Propranolol Hydrochloride C Gemfibrozil C Over The Counter Medications C Date:02/25/05ISR Number: 4590811-4Report Type:Expedited (15-DaCompany Report #PHNU2005DE01009 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Leponex / Clozaril Initial or Prolonged Electroencephalogram (Clozapine) PS Novartis Sector: Abnormal Pharma ORAL 25 to Grand Mal Convulsion 250mg/day 15840MIN Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL 400 mg, QD 1440 MIN Leponex / Clozaril (Clozapine) SS Novartis Sector: 22-Feb-2006 08:30 AM Page: 3172 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pharma ORAL 575mg/day 1440 MIN Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL 600mg/day 8640 MIN Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL 300 to 575 mg/day 23040MIN Risperdal SS ORAL 2 to 6mg/day 90720MIN Risperdal SS ORAL 5 to 4 mg/day 11520MIN Risperdal SS ORAL 3mg/day Truxal SS UNKNOWN 180 to 260mg/day 31680MIN Truxal SS UNKNOWN 300mg/day 86400MIN Date:02/25/05ISR Number: 4590851-5Report Type:Expedited (15-DaCompany Report #PHEH2005US02284 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukocytosis Clozaril PS Novartis Sector: Initial or Prolonged Leukopenia Pharma ORAL 700 mg, QD Other Lymphoma Psychotic Disorder Date:02/25/05ISR Number: 4590852-7Report Type:Expedited (15-DaCompany Report #PHFR2004GB04443 Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Clozaril PS Novartis Sector: Corrected Interval Pharma ORAL 100mg/day Prolonged Tremor Date:02/25/05ISR Number: 4590853-9Report Type:Expedited (15-DaCompany Report #PHHO2005CA01914 Age:54 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Alkaline Clozaril PS Novartis Sector: Initial or Prolonged Phosphatase Increased Pharma ORAL titrated to Diarrhoea 150mg 46080MIN Eosinophil Count Epival C Increased Haldol C Gastritis Cogentin C Viral Infection Date:02/25/05ISR Number: 4590854-0Report Type:Expedited (15-DaCompany Report #PHBS2005PH01508 Age:42 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Disease Recurrence Leponex PS Novartis Sector: Hospitalization - Gastrointestinal Pharma 100 mg/d 222 DAY Initial or Prolonged Haemorrhage Levomepromazine C 50 mg, QHS 221 DAY Haematemesis Haemoglobin Decreased Loss Of Consciousness Oesophageal Candidiasis 22-Feb-2006 08:30 AM Page: 3173 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/05ISR Number: 4591403-3Report Type:Expedited (15-DaCompany Report #PHEH2004US13594 Age:19 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Clozaril PS Novartis Sector: Convulsion Pharma ORAL 350 mg, QD Fall Depakote C Intubation Amoxicillin C Myocardial Infarction Nasocort C Resuscitation Salbutamol C Date:02/25/05ISR Number: 4591405-7Report Type:Expedited (15-DaCompany Report #PHEH2005US01811 Age:86 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Chronic Obstructive Clozaril PS Novartis Sector: Pulmonary Disease Pharma 25 mg, QD Date:02/25/05ISR Number: 4591408-2Report Type:Expedited (15-DaCompany Report #PHNR2004AU01654 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Cholesterol Clozaril PS Novartis Sector: Increased Pharma 12.5 - 400 Blood Triglycerides mg, daily 589 DAY Increased Hyperlipidaemia Weight Increased Date:02/25/05ISR Number: 4591409-4Report Type:Expedited (15-DaCompany Report #PHFR2004GB00456 Age:54 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Pressure Increased Clozaril PS Novartis Sector: Other Bundle Branch Block Left Pharma ORAL UNK, UNK 2303 DAY Cardiac Arrest Hyoscine Circulatory Collapse Hydrobromide SS ORAL 900mg/day Dizziness Electrocardiogram Abnormal Heart Rate Irregular Hypertensive Heart Disease Overweight Sinus Tachycardia Date:02/25/05ISR Number: 4591417-3Report Type:Expedited (15-DaCompany Report #PHNU2002DE01127 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Leponex / Clozaril Initial or Prolonged Cardiomegaly (Clozapine) PS Novartis Sector: Other Electrocardiogram Pharma ORAL up to Abnormal 100mg/day 20160MIN Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL 300mg/day Tavor C ORAL 6mg/day 22-Feb-2006 08:30 AM Page: 3174 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Haldol "Janssen-Cilag" C ORAL 20 mg, QD 40320MIN Date:02/25/05ISR Number: 4591482-3Report Type:Expedited (15-DaCompany Report #US-ABBOTT-04P-163-0284497-00 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Macrocytic Depakote PS Drug Level Increased Depakote SS Ear Pain Clozapine SS ORAL Eosinophil Count Clozapine SS ORAL Increased Clonazepam SS Lymphocyte Count Increased Malaise Mean Cell Volume Increased Monocyte Count Increased Nasal Congestion Neutrophil Count Increased Pain Pharyngitis Productive Cough Pyrexia Sedation Tachycardia White Blood Cell Count Increased Date:02/25/05ISR Number: 4595175-8Report Type:Expedited (15-DaCompany Report #2005BL000950 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Brain Oedema Health Atropine Sulfate Intentional Misuse Professional Ophthalmic Solution PS Usp OPHTHALMIC OPHTHALMIC Suicide Attempt Other Clozapine SS ORAL 100 MILLIGRAMS; DAILY; ORAL Topamax C Lexapro C Date:02/28/05ISR Number: 4592280-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12766077 Age:42 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Aripiprazole PS Otsuka Initial or Prolonged Treatment Noncompliance Pharmaceutical Company, Ltd. Clozapine SS ORAL 50-600 mg/day, stopped and restarted. The patient 22-Feb-2006 08:30 AM Page: 3175 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/28/05ISR Number: 4592340-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12793386 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Platelet Count Increased Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL Dose ranged from 15 to 30 mg/day. 17 DAY Clozapine SS ORAL Dose ranged from 25 mg/twice daily up to 400 mg/day, Clozapine SS ORAL Dose ranged from 25 mg/twice daily up to 400 mg/day, Zyprexa SS ORAL Dose ranged from 10 to 20 mg/day 28 DAY Losartan C Docusate Sodium C Ferrous Sulfate C Trazodone Hcl C Apothecon Chlorpromazine C Venlafaxine Hcl C Mirtazapine C Date:02/28/05ISR Number: 4592351-5Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12797148 Age:49 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neuroleptic Malignant Abilify PS Otsuka Hospitalization - Syndrome Pharmaceutical Initial or Prolonged Renal Failure Company, Ltd. ORAL Interrupted Other Respiratory Distress on 06-Nov-2004 when the patient was Haldol SS Clozaril SS Interrupted on 06-Nov-2004 when the patient was Pavulon C 1 DAY Diprivan C 1 DAY Geodon C 1 DAY Dantrium C 1 DAY Date:02/28/05ISR Number: 4592407-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12825915 Age:57 YR Gender:Female I/FU:I Outcome PT Hospitalization - Delusion Initial or Prolonged Dizziness Fall Lower Limb Fracture 22-Feb-2006 08:30 AM Page: 3176 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report White Blood Cell Count Increased Report Source Product Role Manufacturer Route Dose Duration Abilify PS Otsuka Pharmaceutical Company, Ltd. Clozapine SS ORAL Neurontin C Eskalith C Date:02/28/05ISR Number: 4592798-7Report Type:Expedited (15-DaCompany Report #PHNR2003AU00572 Age:37 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Upper Clozaril PS Novartis Sector: Anaemia Pharma ORAL 12-650mg,day Gastroenteritis Solian C Gastrointestinal Haemorrhage Malaise Nausea Vomiting Date:02/28/05ISR Number: 4592922-6Report Type:Expedited (15-DaCompany Report #04-11-1603 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dehydration Lithium PS Glaxosmithkline UNKNOWN Initial or Prolonged Infection Clozapine SS ORAL Therapeutic Agent Toxicity Urinary Tract Infection Date:02/28/05ISR Number: 4596286-3Report Type:Expedited (15-DaCompany Report #05-02-0276 Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Neoplasm Malignant Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 375 MG QD ORAL Date:02/28/05ISR Number: 4596431-XReport Type:Expedited (15-DaCompany Report #2005017952 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Foreign Zeldox (Capsules) Initial or Prolonged Bradycardia Health (Ziprasidone) PS ORAL 200 MG (2 IN Condition Aggravated Professional 1 D), ORAL Dizziness Company Clozapine Schizophrenia Representative (Clozapine) SS Suicidal Ideation Buspirone C 22-Feb-2006 08:30 AM Page: 3177 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/28/05ISR Number: 4597410-9Report Type:Direct Company Report #CTU 241490 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Clozapine PS Pharmaceutical Product Complaint Psychotic Disorder Date:03/01/05ISR Number: 4593801-0Report Type:Expedited (15-DaCompany Report #DE-BRISTOL-MYERS SQUIBB COMPANY-12452827 Age:50 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Karvea Tabs 300 Mg PS Bristol-Myers Squibb Initial or Prolonged Drug Level Decreased Company ORAL stopped Psychotic Disorder 28-Mar-2003; began Coaprovel Jun-2003 - Dipiperon C ORAL Dose Value: 80-160 mg Allopurinol C ORAL Coaprovel Tabs I Bristol-Myers Squibb Company ORAL Leponex I Dose Value: 350-500 mg. Duration of therapy: for more than 10 Date:03/01/05ISR Number: 4593806-XReport Type:Expedited (15-DaCompany Report #PHBS2005NZ02792 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neuropathy Clozaril PS Novartis Sector: Paralysis Pharma ORAL 300 mg/d Sensory Loss Simvastatin C Date:03/01/05ISR Number: 4594076-9Report Type:Expedited (15-DaCompany Report #DE-BRISTOL-MYERS SQUIBB COMPANY-12874905 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Glucophage PS Bristol-Myers Squibb Initial or Prolonged Delirium Company Disorientation Hypnorex I Drug Interaction Convulex I Restlessness Ciatyl-Z I Novonorm I Haldol I 15mg 15-Oct-2003 to 28-Oct-2003, 20mg Leponex I Tavor I 22-Feb-2006 08:30 AM Page: 3178 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/01/05ISR Number: 4594761-9Report Type:Expedited (15-DaCompany Report #PHBS2004BE02545 Age:66 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Leponex PS Novartis Sector: Initial or Prolonged Blood Cortisol Increased Pharma UNKNOWN 75 mg/d Body Temperature Leponex SS Novartis Sector: Decreased Pharma UNKNOWN 50 mg/d Depressed Level Of Leponex SS Novartis Sector: Consciousness Pharma UNKNOWN 25 mg /day 7200 MIN Diarrhoea Leponex SS Novartis Sector: Drug Withdrawal Syndrome Pharma 50 mg, QHS Dyskinesia Leponex SS Novartis Sector: Extrapyramidal Disorder Pharma UNKNOWN 25 mg, BID Facial Spasm Leponex SS Novartis Sector: Gastrointestinal Disorder Pharma UNKNOWN Hot Flush Leponex SS Novartis Sector: Hyperhidrosis Pharma UNKNOWN 100 mg/d Influenza Leponex SS Novartis Sector: Insomnia Pharma UNKNOWN 150 mg/d Malaise Artane C UNKNOWN Myoclonus Aprovel C UNKNOWN 75 mg, QD Nausea Aldactazine C UNKNOWN UNK, Q48H Osteoporosis Isoten C UNKNOWN 5 mg, QHS Pyrexia Asaflow C UNKNOWN 160 mg, QD Rectal Polyp Trazolan C UNKNOWN 50 mg, QHS Restlessness Imovane C UNKNOWN 3.75 or 7.5 Sedation mg in the Somnolence evening Stress Xanax C UNKNOWN .5 mg, BID Tardive Dyskinesia Xanax C UNKNOWN Tremor Rivotril C UNKNOWN 18720MIN Vomiting Rivotril C UNKNOWN 1 mg, QHS Antihypertensives C UNKNOWN Date:03/01/05ISR Number: 4594763-2Report Type:Expedited (15-DaCompany Report #PHBS2005CL02968 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Cancer Female Leponex PS Novartis Sector: Pharma ORAL Date:03/01/05ISR Number: 4594766-8Report Type:Expedited (15-DaCompany Report #PHBS2005YU02987 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Faecal Incontinence Leponex PS Novartis Sector: Urinary Incontinence Pharma ORAL 100 mg/day 12960MIN Haloperidol C Date:03/01/05ISR Number: 4597013-6Report Type:Expedited (15-DaCompany Report #2005S1000305 Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Circulatory Collapse Health Clozapine PS Mylan ORAL 50MG, HS, Pneumonia Professional ORAL Other Clozapine SS Mylan ORAL 100MG QAM AND 200MG HS, ORAL 22-Feb-2006 08:30 AM Page: 3179 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Risperidone C Benztropine Mesylate C Methscopolamine C Date:03/01/05ISR Number: 4597014-8Report Type:Expedited (15-DaCompany Report #2005S1000021 Age:72 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 25MG BID, Other ORAL Date:03/01/05ISR Number: 4597016-1Report Type:Expedited (15-DaCompany Report #2005S1000268 Age:66 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Distension Health Clozapine Ablets 100 Bacteraemia Professional Mg Mylan PS Mylan ORAL 200MG QAM AND Cardiac Arrest Other 300MG QHS, Confusional State ORAL Hyponatraemia Heparin C Inappropriate Loxapine C Antidiuretic Hormone Metronidazole C Secretion Divaloproex C Infection Vancomycin C Lung Disorder Acetaminophen C Pathogen Resistance Fluticasone C Pneumonia Calcium C Respiratory Arrest Buspirone C Clonazepam C Montelukast C Piperacillin Sodium/Tazobactam Sodium C Fluticasone/Salmeter ol Inhaler C Lansoprazole C Calcium Citrate C Multivitamins C Albuterol C Ipratropium C Levofloxacin C Date:03/01/05ISR Number: 4597023-9Report Type:Expedited (15-DaCompany Report #05-02-0261 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cellulitis Health Clozapine PS Ivan Initial or Prolonged Professional Pharmaceuticals, Other Inc, ORAL 100-150MG QD ORAL 22-Feb-2006 08:30 AM Page: 3180 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/01/05ISR Number: 4597029-XReport Type:Expedited (15-DaCompany Report #05-02-0292 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ankle Fracture Health Clozapine -Ivax Initial or Prolonged Fall Professional Pharmaceuticals Inc Pleural Effusion Other Tablets PS Ivax Pulmonary Oedema Pharmaceuticals, Inc. ORAL 300-600MG QD ORAL Date:03/01/05ISR Number: 4597030-6Report Type:Expedited (15-DaCompany Report #05-02-0284 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Toxicity Health Clozapine -Ivax Initial or Prolonged Liver Transplant Professional Pharmaceuticals Inc Other Tablets PS Ivax Pharmaceuticals, Inc. ORAL 400MG QD ORAL Tylenol SS Date:03/01/05ISR Number: 4597036-7Report Type:Expedited (15-DaCompany Report #2004S1003740 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Haematemesis Health Clozapine Tablets Pelvic Mass Professional 100 Mg Mylan PS Mylan ORAL 400MG, QD, Other ORAL Date:03/01/05ISR Number: 4597044-6Report Type:Expedited (15-DaCompany Report #2005S1000572 Age:67 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agranulocytosis Health Clozapine Tablets 25 Hospitalization - Jaundice Cholestatic Professional Mg Mylan PS Mylan ORAL 50MG, QAM, Initial or Prolonged Other ORAL Clozapine Tablets 100 Mg Mylan SS Mylan ORAL 100MG QAM AND 200MG HS, ORAL Sennosides C Zolpidem C Triamcinolone Acetonide C Cetirizine C Diphenhydramine C Hydrocortisone C Furosemide C Perpherazine C Viscous Lidocaine/Diphenhydr amine/Aluminum/Magne sium Hydroxide C Aluminum/Magnesium Hydroxide C Terbinifine C Pantoprazole C Gatifloxacin C 22-Feb-2006 08:30 AM Page: 3181 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Acetaminophen C Trazodone C Tamsulosin C Diclofenac C Baclofen C Date:03/01/05ISR Number: 4597047-1Report Type:Expedited (15-DaCompany Report #2005S1000364 Age:86 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 75MG, HS, Other ORAL Clozapine Tablets 100 Mg Mylan SS Mylan ORAL 100MG, HS, ORAL Fentanyl C Morphine Sulfate C Levothyroxine C Quetiapine C Zinc C Vitamin E C Calcium-Salmon C Sennosides C Carbidopa/Levodopa C Aspirin (Enteric Coated) C Mirtazapine C Ibuprofen C Date:03/01/05ISR Number: 4597049-5Report Type:Expedited (15-DaCompany Report #2005S1000357 Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pulmonary Embolism Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 200MG, BID, Other ORAL Date:03/02/05ISR Number: 4596555-7Report Type:Expedited (15-DaCompany Report #PHNU2004DE04313 Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiovascular Disorder Leponex / Clozaril Initial or Prolonged Constipation (Clozapine) PS Novartis Sector: Drug Interaction Pharma ORAL Inhibition Leponex / Clozaril Drug Level Increased (Clozapine) SS Novartis Sector: Tremor Pharma ORAL UNK, UNK Taxilan SS 75 mg, QID 17280MIN Melperone C Date:03/02/05ISR Number: 4597153-1Report Type:Expedited (15-DaCompany Report #04-12-1732 Age:46 YR Gender:Female I/FU:I Outcome Death Hospitalization - 22-Feb-2006 08:30 AM Page: 3182 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Initial or Prolonged PT Report Source Product Role Manufacturer Route Dose Duration Anoxic Encephalopathy Health Clozapine PS Ivax Cardiac Arrest Professional Pharmaceuticals, Coma Other Inc. ORAL 100MG TID Convulsion ORAL Cough Aricept C Electrocardiogram Qt Neurontin C Prolonged Clonazepam C Pneumonia Dilantin C Remeron C Date:03/02/05ISR Number: 4597154-3Report Type:Expedited (15-DaCompany Report #05-02-0283 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Qt Literature Clozapine PS ORAL 25-150MG ORAL 14 DAY Initial or Prolonged Corrected Interval Health Other Prolonged Professional Tachycardia Date:03/02/05ISR Number: 4597155-5Report Type:Expedited (15-DaCompany Report #05-02-0295 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 350-600MG QD ORAL Date:03/02/05ISR Number: 4610886-3Report Type:Periodic Company Report #2004-122502-NL Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Leukopenia Health Remeron Soltab PS ORAL 30 MG QD ORAL Intervention to Neutropenia Professional Remeron Soltab SS ORAL 60 MG QD ORAL Prevent Permanent Remeron Soltab SS ORAL 30 MG QD ORAL Impairment/Damage Clozapine SS ORAL 700 MG QD ORAL Clozapine SS ORAL 600 MG QD ORAL Clozapine SS ORAL 500 MG QD ORAL Multivitamins C Venlafaxine Hydrochloride C Ferrous Sulfate C Hydrochlorothiazide C 22-Feb-2006 08:30 AM Page: 3183 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/02/05ISR Number: 4695401-0Report Type:Direct Company Report #CTU 241802 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Aggression Clozapine PS ORAL 200 MG PO BID Dizziness Therapeutic Response Unexpected With Drug Substitution Date:03/02/05ISR Number: 4695402-2Report Type:Direct Company Report #CTU 241805 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dizziness Clozapine PS ORAL 100 MG PO AM, Feeling Abnormal 150 MG PO Hallucination, Auditory QHS Restlessness Date:03/03/05ISR Number: 4597532-2Report Type:Expedited (15-DaCompany Report #PHEH2004US13595 Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Catatonia Clozaril PS Novartis Sector: Chronic Obstructive Pharma ORAL 550 mg, QD Pulmonary Disease Constipation Convulsion Heart Rate Increased Mutism Staring Vomiting Weight Decreased Date:03/03/05ISR Number: 4597536-XReport Type:Expedited (15-DaCompany Report #PHFR2004GB04682 Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Clozaril PS Novartis Sector: Ventricular Hypertrophy Pharma ORAL Weight Increased Clozaril SS Novartis Sector: Pharma ORAL 400mg/day Date:03/03/05ISR Number: 4597537-1Report Type:Expedited (15-DaCompany Report #PHFR2005GB01006 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Chest Pain Clozaril PS Novartis Sector: Pharma ORAL 550 mg/day Date:03/03/05ISR Number: 4597540-1Report Type:Expedited (15-DaCompany Report #PHBS2005BR02969 Age:29 YR Gender:Male I/FU:I Outcome PT Other Agitation Asthenia Confusional State 22-Feb-2006 08:30 AM Page: 3184 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Delirium Depressed Mood Dizziness Report Source Product Role Manufacturer Route Dose Duration Eating Disorder Leponex PS Novartis Sector: Ejaculation Failure Pharma ORAL 50 mg/d Hallucination Anafranil SS ORAL 10 mg/d Increased Appetite Anafranil SS ORAL 25 mg/d Somnolence Anafranil SS ORAL 37.5 mg/d Weight Decreased Anafranil SS ORAL Geodon C ORAL Melleril C UNKNOWN Pamelor C UNKNOWN Luvox C UNKNOWN Zyprexa C UNKNOWN Date:03/03/05ISR Number: 4597625-XReport Type:Expedited (15-DaCompany Report #DE-BRISTOL-MYERS SQUIBB COMPANY-12870275 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Abilify PS Otsuka Pharmaceutical Company, Ltd. Clozapine SS Date:03/03/05ISR Number: 4599366-1Report Type:Expedited (15-DaCompany Report #2005S1000054 Age:75 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Fall Health Clozapine Tablets 25 Hip Fracture Professional Mg Mylan PS Mylan ORAL 150MG QAM, Pharmaceutical Product Other AND 125 MG Complaint QHS, ORAL Unevaluable Event Clozapine Tablets 100 Mg Mylan SS Mylan ORAL 150MG QAM AND 125MG QHS, ORAL Date:03/03/05ISR Number: 4599368-5Report Type:Expedited (15-DaCompany Report #2005S1000128 Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Multiple Drug Overdose Health Clozapine Tablets Accidental Professional 100 Mg Mylan PS Mylan ORAL 200MG HS, Self-Medication Other ORAL Fluvoxamine C Loratidine C Lorazepam C Quetiapine C Montelukast C Fluticasone/Salmeter ol C 22-Feb-2006 08:30 AM Page: 3185 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/03/05ISR Number: 4599369-7Report Type:Expedited (15-DaCompany Report #2005S1000153 Age:75 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neoplasm Malignant Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 25MG, BID, Other ORAL Clozapine Tablets 100mg Mylan SS Mylan ORAL 100MG BID, ORAL Morphine Sulfate Injection C Fentanyl Transdermal System C Ceftriaxone Sodium C Metformin Xr C Repaglinide C Metoprolol C Glipizide Er C Imipramine C Carbidopa/Levodopa C Rivastigmine Tartrate C Acetaminophen C Magnesium Sulfate Injection C Lactulose C Date:03/03/05ISR Number: 4599370-3Report Type:Expedited (15-DaCompany Report #2005S1000365 Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozapine Tablets Coma Professional (100 Mg) PS ORAL 300 MG; BID; Loss Of Consciousness Other PO Pupil Fixed Clonazepam C Skin Discolouration Fluphenazine C Hydrochloride C Fluphenazine Decanoate C Lansoprazole C Metoclopramide C Lisinopril C Date:03/03/05ISR Number: 4599371-5Report Type:Expedited (15-DaCompany Report #2005S1000589 Age:66 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets 25 Professional Mg Mylan PS Mylan ORAL 25 MG QAM & Other 37.5 MG HS, ORAL Calcitonin-Salmon C Lorazepam C Hydrocodone Bitartrate/Acetamino phen C Phenytoin C Lansoprazole C Paroxetine C 22-Feb-2006 08:30 AM Page: 3186 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Midodrine C Selegiline C Carbidopa/Levodopa C Date:03/03/05ISR Number: 4599372-7Report Type:Expedited (15-DaCompany Report #2005S1000629 Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 50MG QAM AND Other 250 MG HS, ORAL Date:03/03/05ISR Number: 4599757-9Report Type:Expedited (15-DaCompany Report #2005S1000653 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Intracranial Aneurysm Health Clozapine Tablets Professional 100 Mg Mylan PS Mylan ORAL 400 MG HS, Other ORAL Mirtazapine C Fluphenazine Decanoate C Date:03/04/05ISR Number: 4598759-6Report Type:Expedited (15-DaCompany Report #PHFR2005GB01028 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Exposure Clozaril PS Novartis Sector: Initial or Prolonged Dyspnoea Pharma ORAL 250 mg, ONCE/SINGLE Date:03/04/05ISR Number: 4598763-8Report Type:Expedited (15-DaCompany Report #PHHO2003CA03752 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Axillary Mass Clozaril PS Novartis Sector: Lymphoma Pharma ORAL 600 mg, QD Lorazepam C Date:03/04/05ISR Number: 4598829-2Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12770947 Age:44 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Abilify PS Otsuka Other Death Pharmaceutical Delusion Company, Ltd. ORAL Drug Level Increased Clozapine SS ORAL Fear Lexapro C ORAL Paranoia Klonopin C Treatment Noncompliance Benztropine C White Blood Cell Count Lisinopril C Increased Humulin C Metformin Hcl C Bristol-Myers Squibb Company Levoxyl C 22-Feb-2006 08:30 AM Page: 3187 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Ortho-Novum C Nitroglycerine C Atenolol C Sandoz Inc. (Geneva Pharm Tech) Date:03/04/05ISR Number: 4600457-7Report Type:Expedited (15-DaCompany Report #05-02-0314 Age:1 DY Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Caesarean Section Foreign Clozapine PS TRANSPLACENTAL 200MG QD 28 WK Initial or Prolonged Chest X-Ray Abnormal Literature Congenital Anomaly Coma Neonatal Health Other Congenital Anomaly Professional Congenital Central Other Nervous System Anomaly Congenital Floppy Infant Convulsion Neonatal Developmental Delay Drug Exposure During Pregnancy Encephalopathy Neonatal Foetal Arrhythmia Foetal Disorder Heart Disease Congenital Hernia Congenital Microgenia Myocarditis Neonatal Apnoeic Attack Neonatal Disorder Neonatal Respiratory Failure Opisthotonus Physical Testicle Examination Abnormal Premature Baby Trismus Date:03/04/05ISR Number: 4600786-7Report Type:Expedited (15-DaCompany Report #05-02-0275 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dehydration Health Clozapine Ivax Initial or Prolonged Failure To Thrive Professional Pharmaceuticals, Oral Intake Reduced Other Inc. Tablets PS ORAL 100-525MG QD ORAL Date:03/07/05ISR Number: 4599992-XReport Type:Expedited (15-DaCompany Report #PHHO2005CA03462 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pancytopenia Clozaril PS Novartis Sector: Pharma Metamucil C Multivitamins C Lactaid C Lamotrigine C 150 mg, UNK Clonazepam C 10 mg, UNK 22-Feb-2006 08:30 AM Page: 3188 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/07/05ISR Number: 4599995-5Report Type:Expedited (15-DaCompany Report #PHBS2005BR02969 Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Leponex PS Novartis Sector: Asthenia Pharma ORAL 50 mg/d Confusional State Anafranil SS ORAL 10 mg/d Delirium Anafranil SS ORAL 25 mg/d Depressed Mood Anafranil SS ORAL 37.5 mg/d Dizziness Anafranil SS ORAL Eating Disorder Geodon C ORAL Ejaculation Failure Melleril C UNKNOWN Hallucination Pamelor C UNKNOWN Increased Appetite Luvox C UNKNOWN Somnolence Zyprexa C UNKNOWN Weight Decreased Date:03/07/05ISR Number: 4600004-XReport Type:Expedited (15-DaCompany Report #PHNU2003DE03552 Age:61 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Leponex / Clozaril Initial or Prolonged Increased (Clozapine) PS Novartis Sector: Other Aspartate Pharma ORAL Aminotransferase Leponex / Clozaril Increased (Clozapine) SS Novartis Sector: Blood Glucose Increased Pharma ORAL 400 mg, BID C-Reactive Protein Leponex / Clozaril Increased (Clozapine) SS Novartis Sector: Conjunctivitis Pharma ORAL 300 mg, BID Drug Interaction Ciprobay SS ORAL 500 mg, BID 10080MIN Drug Level Increased Solian C ORAL 300 mg, BID Haematocrit Decreased Atosil C ORAL 50 mg, TID Haemoglobin Decreased Tavor C ORAL 1 mg, BID Leukocytosis Iron C UNKNOWN Lymphocyte Percentage Espumisan C ORAL Decreased Simethicone C ORAL Neutrophil Percentage Lactulose C ORAL Increased Platelet Count Decreased Pneumonia Psychotic Disorder Red Blood Cell Count Decreased Tracheobronchitis White Blood Cell Count Increased Date:03/07/05ISR Number: 4600016-6Report Type:Expedited (15-DaCompany Report #PHNU2005DE01148 Age:33 YR Gender:Male I/FU:I Outcome PT Life-Threatening Agitation Hospitalization - Blood Creatinine Initial or Prolonged Increased Blood Immunoglobulin E Increased Blood Urea Increased Bronchospasm Diarrhoea 22-Feb-2006 08:30 AM Page: 3189 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Eosinophilia Hypersensitivity Infection Report Source Product Role Manufacturer Route Dose Duration Intubation Leponex / Clozaril Nephritis Interstitial (Clozapine) PS Novartis Sector: Pyrexia Pharma ORAL 12.5 to 100 Renal Failure Acute mg 10080MIN Renal Function Test Leponex / Clozaril Abnormal (Clozapine) SS Novartis Sector: Respiratory Failure Pharma ORAL 200 mg/day 21600MIN Sepsis Risperdal C ORAL 4 to 6 mg 37440MIN Tavor C ORAL 3 mg/day 37440MIN Convulex "Byk Gulden" C ORAL 600-1200 mg 30240MIN Date:03/07/05ISR Number: 4600146-9Report Type:Expedited (15-DaCompany Report #05-03-0327 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Health Clozapine Tablets PS Ivax Initial or Prolonged Hip Fracture Professional Pharmaceuticals, Inc ORAL 350-900MG QD Other ORAL Date:03/07/05ISR Number: 4600151-2Report Type:Expedited (15-DaCompany Report #05-02-0322 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Encephalopathy Health Clozapine Tablets PS Ivax Pharmaceuticals Initial or Prolonged Ileus Paralytic Professional Inc ORAL 25MG QD ORAL Other Date:03/07/05ISR Number: 4600240-2Report Type:Expedited (15-DaCompany Report #05-02-0144 Age:57 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Lithium PS Glaxosmithkline ORAL 1800MG per Initial or Prolonged Therapeutic Agent day 28 DAY Toxicity Clozapine SS ORAL 550MG Per day Effexor Xr C ORAL Depakote C ORAL 3000MG Per day Date:03/07/05ISR Number: 4600999-4Report Type:Direct Company Report #CTU 242155 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Granulocytosis Clozaril PS ORAL PO Hospitalization - Initial or Prolonged Other Required Intervention to Prevent Permanent Impairment/Damage 22-Feb-2006 08:30 AM Page: 3190 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/07/05ISR Number: 4602650-6Report Type:Expedited (15-DaCompany Report #S05-SWE-00274-01 Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bronchitis Chronic Foreign Cipralex Cardiomegaly Health (Escitalopram) PS ORAL 20 MG QD PO Cardiopulmonary Failure Professional Cisordinol - Slow Coronary Artery Other Release Atherosclerosis (Zuclopenthixol Dilatation Atrial Decanoate) SS ORAL 5 MG QD PO Dilatation Ventricular Leponex (Clozapine) SS ORAL 100 MG Q4HR Lung Hyperinflation PO Mucous Membrane Disorder Atarax (Hydroxyzine Hydrochloride) C Akineton (Biperiden Hydrochloride) C Stesolid (Diazepam) C Date:03/07/05ISR Number: 4602670-1Report Type:Expedited (15-DaCompany Report #2005017952 Age:31 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Foreign Zeldox (Capsules) Initial or Prolonged Bradycardia Health (Ziprasidone) PS ORAL 200 MG (2 IN Disease Recurrence Professional 1 D), ORAL Dizziness Company Clozapine Psychotic Disorder Representative (Clozapine) SS Suicidal Ideation Buspirone (Buspirone) C Date:03/08/05ISR Number: 4601437-8Report Type:Expedited (15-DaCompany Report #05-02-0176 Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Nicoderm PS Glaxosmithkline TRANSDERMAL Initial or Prolonged Delirium Clozapine SS Date:03/08/05ISR Number: 4601559-1Report Type:Expedited (15-DaCompany Report #PHFR2004GB04710 Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Cholesterol Clozaril PS Novartis Sector: Increased Pharma ORAL 591 DAY Blood Triglycerides Depakote C ORAL 500 mg, BID Increased Diazepam C ORAL 2 mg, BID Hyperlipidaemia Aripiprazole C ORAL 30 mg, QD Senna C Procyclidine C ORAL Date:03/08/05ISR Number: 4601645-6Report Type:Expedited (15-DaCompany Report #DE-GLAXOSMITHKLINE-D0045037A Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Quilonum Retard PS Glaxosmithkline ORAL 1150MG per Initial or Prolonged Weight Increased day 4 YR Leponex SS ORAL 75MG per day 4 YR Seroxat C Glaxosmithkline ORAL 40MG per day Lamictal C Glaxosmithkline UNKNOWN 22-Feb-2006 08:30 AM Page: 3191 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Zeldox C UNKNOWN Date:03/08/05ISR Number: 4601646-8Report Type:Expedited (15-DaCompany Report #DE-GLAXOSMITHKLINE-D0045136A Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Consciousness Fluctuating Quilonum Retard PS Glaxosmithkline ORAL 450MG Per day Initial or Prolonged Delirium Leponex SS ORAL Disorientation Belladonna Herb SS ORAL 20DROP Per Drug Interaction day 21 DAY Hallucination Diazepam C ORAL Hallucinations, Mixed Orfiril C ORAL 35 DAY Sedation Haldol C ORAL Somnolence Date:03/08/05ISR Number: 4601650-XReport Type:Expedited (15-DaCompany Report #2005003866 Age:61 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Decreased Quilonum Retard PS Glaxosmithkline ORAL 450MG Twice Initial or Prolonged Bowel Sounds Abnormal per day Convulsion Leponex SS ORAL 25MG per day Myalgia Myoclonus Somnolence Date:03/08/05ISR Number: 4602623-3Report Type:Expedited (15-DaCompany Report #05-02-0212 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Health Clozapine Tablets - Initial or Prolonged Decubitus Ulcer Professional Ivax Gastrointestinal Other Pharmaceuticals, Haemorrhage Inc. PS Ivax Mental Disorder Pharmaceuticals, Sepsis Inc. ORAL 250 MG BID ORAL Depakote SS 750 MG QD Hydrochlorothiazide C Zocor C Glyburide C Metformin C Labetalol C Norvasc C Vitamin C C Folic Acid C Prevacid C Aspirin C Ferrous Sulfate C Date:03/08/05ISR Number: 4602625-7Report Type:Expedited (15-DaCompany Report #05-02-0168 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bacterial Infection Health Clozapine Tablets - Hospitalization - Pneumonia Professional Ivax Initial or Prolonged Respiratory Failure Other Pharmaceuticals, 22-Feb-2006 08:30 AM Page: 3192 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Inc. PS Ivax Pharmaceuticals, Inc. ORAL 300 MG HS ORAL Risperdal C Depakote C Celexa C Date:03/08/05ISR Number: 4602627-0Report Type:Expedited (15-DaCompany Report #05-03-0330 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drooling Health Clozapine Tablets - Initial or Prolonged Drug Ineffective Professional Ivax Other Hypotension Other Pharmaceuticals, Pneumonia Aspiration Inc. PS Ivax Sedation Pharmaceuticals, Inc. ORAL 25-300MG QD ORAL Date:03/08/05ISR Number: 4602630-0Report Type:Expedited (15-DaCompany Report #05-02-0190 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 600MG QD ORAL Seroquel C Luvox C Ativan C Surpak C Protonix C Date:03/09/05ISR Number: 4602892-XReport Type:Expedited (15-DaCompany Report #FR-GLAXOSMITHKLINE-B0373429A Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Deroxat PS Glaxosmithkline ORAL 20MG Per day 8 MON Pyrexia Theralene SS ORAL 20MG Per day 8 MON Leponex SS ORAL 450MG Per day 8 MON Smecta C Movicol C Date:03/09/05ISR Number: 4602978-XReport Type:Expedited (15-DaCompany Report #PHFR2002IE01691 Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Folate Decreased Clozaril PS Novartis Sector: Initial or Prolonged Gastrointestinal Pharma ORAL 650mg/day Haemorrhage Aspirine SS ORAL Haemoglobin Decreased Andrews Liver Salt SS Haemorrhoids Hypochromic Anaemia Serum Ferritin Decreased Vitamin B12 Decreased 22-Feb-2006 08:30 AM Page: 3193 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/09/05ISR Number: 4602997-3Report Type:Expedited (15-DaCompany Report #PHFR2005GB00457 Age:58 YR Gender:Not SpecifiI/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Grand Mal Convulsion Clozaril PS Novartis Sector: Haematemesis Pharma ORAL 650mg/day 4559 DAY Pyrexia Hydroxyzine C ORAL 25mg/day Rash Erythematous Valproate Sodium C UNK, UNK Date:03/09/05ISR Number: 4603007-4Report Type:Expedited (15-DaCompany Report #PHFR2005GB00574 Age:49 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Exposure Clozaril PS Novartis Sector: Initial or Prolonged Confusional State Pharma ORAL 200mg once Salivary Hypersecretion Somnolence Date:03/09/05ISR Number: 4603020-7Report Type:Expedited (15-DaCompany Report #PHFR2005GB01052 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrial Flutter Clozaril PS Novartis Sector: Initial or Prolonged Blood Pressure Pharma 25920MIN Fluctuation C-Reactive Protein Increased Incontinence Pyrexia Somnolence Tachycardia Date:03/09/05ISR Number: 4603022-0Report Type:Expedited (15-DaCompany Report #PHHO2005CA03462 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pancytopenia Clozaril PS Novartis Sector: Pharma 350mg am, 550mg hs Metamucil C Multivitamins C Lactaid C Lamotrigine C 150 mg, UNK Clonazepam C 10 mg, UNK Date:03/09/05ISR Number: 4603054-2Report Type:Expedited (15-DaCompany Report #PHEH2005US02626 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Band Neutrophil Count Clozaril PS Novartis Sector: Initial or Prolonged Increased Pharma ORAL 150 mg, QD Diarrhoea Eosinophil Count Increased Leukocytosis Multi-Organ Disorder Nausea Vomiting 22-Feb-2006 08:30 AM Page: 3194 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/09/05ISR Number: 4603964-6Report Type:Expedited (15-DaCompany Report #05-03-0348 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 12.5-300MG QD ORAL Date:03/10/05ISR Number: 4604100-2Report Type:Expedited (15-DaCompany Report #PHFR2002GB04377 Age:61 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chronic Lymphocytic Clozaril PS Novartis Sector: Leukaemia Pharma ORAL UNK, UNK Lymphocyte Count Lansoprazole C Increased White Blood Cell Count Increased Date:03/10/05ISR Number: 4604102-6Report Type:Expedited (15-DaCompany Report #PHFR2005GB00663 Age:67 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Clozaril PS Novartis Sector: Blood Glucose Increased Pharma ORAL 225mg/day 24480MIN Dehydration Valproate Sodium C UNKNOWN 400 mg/day Heart Rate Increased Metformin C ORAL 500 mg/day Hernia Obstructive Lymphocyte Count Decreased Neutrophil Count Increased Salivary Hypersecretion Sedation Somnolence Tachycardia Urinary Incontinence White Blood Cell Count Increased Date:03/10/05ISR Number: 4604103-8Report Type:Expedited (15-DaCompany Report #PHFR2005GB01006 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Chest Pain Clozaril PS Novartis Sector: Sudden Death Pharma ORAL 550 mg/day Date:03/10/05ISR Number: 4604105-1Report Type:Expedited (15-DaCompany Report #PHBS2005DK03339 Age:31 YR Gender:Female I/FU:I Outcome PT Death Cardiac Arrest Other Haemorrhagic Ovarian Cyst Ovarian Cyst Pulmonary Embolism 22-Feb-2006 08:30 AM Page: 3195 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pulmonary Haemorrhage Pulmonary Oedema Respiratory Distress Report Source Product Role Manufacturer Route Dose Duration Resuscitation Leponex PS Novartis Sector: Pharma ORAL Gestodene SS UNKNOWN Ethylestradiol SS UNKNOWN Durascan SS ORAL 1 DF, QD Zyprexa C UNKNOWN Orap C UNKNOWN Rivotril C UNKNOWN Lysantin C UNKNOWN Pamol C UNKNOWN Date:03/10/05ISR Number: 4604301-3Report Type:Expedited (15-DaCompany Report #05-03-0355 Age:96 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Clozapine PS Ivax Congestive Professional Pharmaceuticals, Other Inc. ORAL 12.5-87.5MG Q ORAL Date:03/10/05ISR Number: 4604957-5Report Type:Direct Company Report #CTU 242611 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Clozapine Tablets Initial or Prolonged Usp PS ORAL 400 MG BID ORAL Amitriptyline C Olanzapine C Theophylline C Lorazepam C Montelukast C Tinatidine C Fluticasone C Albuterol C Date:03/10/05ISR Number: 4615808-7Report Type:Periodic Company Report #003 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Agranulocytosis Health Fazaclo PS Alamo Intervention to Professional Pharmaceuticals ORAL 600 MG PER Prevent Permanent DAY PO Impairment/Damage Cogentin C Risperdal C Keppra C Vasotec C Ativan C PRN Benadryl C PRN Tylenol C PRN 22-Feb-2006 08:30 AM Page: 3196 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/11/05ISR Number: 4604930-7Report Type:Expedited (15-DaCompany Report #PHBS2001NL09017 Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Ketoacidosis Clozapine PS Novartis Sector: Initial or Prolonged Disseminated Pharma 450 mg/d Intravascular Coagulation Valproic Acid (Ngx) SS 500 mg, BID Drug Interaction Hyperammonaemia Hyperglycaemia Hypotension Loss Of Consciousness Pyrexia Respiratory Distress Tachypnoea Date:03/11/05ISR Number: 4606004-8Report Type:Expedited (15-DaCompany Report #PHFR2003IE02073 Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agitation Clozaril PS Novartis Sector: Hospitalization - Aspartate Pharma ORAL 300 mg/day 25920MIN Initial or Prolonged Aminotransferase Valproate Sodium C ORAL 1000 mg/day 18720MIN Other Increased Clonazepam C ORAL 1.5 mg/day 20160MIN Blindness Kwells C ORAL 4 tab/day 4320 MIN Blood Bilirubin Increased Blood Lactate Dehydrogenase Increased Blood Potassium Increased Blood Sodium Decreased Blood Urea Increased Brain Hypoxia Cardiac Arrest Cardiomyopathy Convulsion Depressed Level Of Consciousness Diabetes Mellitus Disorientation Faecal Incontinence Hepatic Failure Hyperhidrosis Hyperthermia Hypotension Myocarditis Pain Tachycardia Urinary Incontinence Date:03/11/05ISR Number: 4606006-1Report Type:Expedited (15-DaCompany Report #PHEH2005US02953 Age:74 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Clozaril PS Novartis Sector: Congestive Pharma ORAL 225 mg, QD Chronic Obstructive Pulmonary Disease Influenza 22-Feb-2006 08:30 AM Page: 3197 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/11/05ISR Number: 4606007-3Report Type:Expedited (15-DaCompany Report #PHFR2002GB00857 Age:56 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Clozaril PS Novartis Sector: Initial or Prolonged Blood Pressure Increased Pharma ORAL 100mg mane, Contusion 400mg nocte Convulsion Clozaril SS Novartis Sector: Diarrhoea Pharma ORAL 500mg mane, Head Injury 400mg nocte Heart Rate Increased Clozaril SS Novartis Sector: Malaise Pharma ORAL 350mg/day Mental Disorder Amisulpride C ORAL 400mg/nocte Neutrophil Count Increased Overdose Road Traffic Accident Treatment Noncompliance Vomiting Date:03/11/05ISR Number: 4606016-4Report Type:Expedited (15-DaCompany Report #PHFR2005GB00505 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebellar Infarction Clozaril PS Novartis Sector: Initial or Prolonged Hyperlipidaemia Pharma ORAL 700 mg/day Hypertension Amisulpride C 600mg/day Overweight Pravastatin C ORAL Posture Abnormal Bendrofluazide C ORAL 2.5mg/day Date:03/11/05ISR Number: 4606033-4Report Type:Expedited (15-DaCompany Report #PHFR2005GB01129 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Medication Error Clozaril PS Novartis Sector: Overdose Pharma ORAL overdose of unknown amount Alcohol SS Date:03/11/05ISR Number: 4606035-8Report Type:Expedited (15-DaCompany Report #PHHO2005CA01059 Age:40 YR Gender:Male I/FU:F Outcome PT Hospitalization - Acute Prerenal Failure Initial or Prolonged Amyloidosis Aspartate Aminotransferase Increased Blood Alkaline Phosphatase Increased Blood Creatinine Increased Diarrhoea Hypovolaemia Jaundice Cholestatic Kidney Enlargement Lower Respiratory Tract Infection 22-Feb-2006 08:30 AM Page: 3198 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Steatorrhoea Vomiting Report Source Product Role Manufacturer Route Dose Duration Clozaril PS Novartis Sector: Pharma ORAL 25 mg hs to 225 mg daily 56160MIN Carbamazepine C Divalproex Sodium C Olanzapine C Propranolol C Felodipine C Ramipril C Hydrochlorothiazide C Date:03/11/05ISR Number: 4606055-3Report Type:Expedited (15-DaCompany Report #PHRM2005FR00692 Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Leponex PS Novartis Sector: Initial or Prolonged Phosphokinase Increased Pharma ORAL 550 mg daily 93 DAY Convulsion Atarax Electrocardiogram Qt Prolonged /Can/ C UNK, PRN Malaise Seresta C Myoglobin Blood Increased Rhabdomyolysis Tachycardia Date:03/11/05ISR Number: 4606059-0Report Type:Expedited (15-DaCompany Report #PHFR2005GB01100 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Pressure Increased Clozaril (Clozapine) PS Novartis Sector: Electrocardiogram St Pharma ORAL Segment Elevation Electrocardiogram T Wave Inversion Hypotension Tachycardia Date:03/11/05ISR Number: 4606077-2Report Type:Expedited (15-DaCompany Report #PHNU2005DE01152 Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cholecystectomy Leponex / Clozaril Initial or Prolonged Cholecystitis (Clozapine) PS Novartis Sector: Cholelithiasis Pharma ORAL up to 150 Eosinophilia mg/day 43200MIN Hepatic Enzyme Increased Tavor C ORAL 6 mg/day 23040MIN Pyrexia Beloc Zok C ORAL 47.5 mg, QD 28800MIN Date:03/11/05ISR Number: 4606283-7Report Type:Expedited (15-DaCompany Report #GB-ABBOTT-05P-167-0292835-00 Age:18 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cognitive Disorder Valproate Sodium PS Grand Mal Convulsion Clozapine SS ORAL 39 DAY 22-Feb-2006 08:30 AM Page: 3199 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Citalopram C ORAL Lorazepam C ORAL Zopiclone C ORAL Date:03/11/05ISR Number: 4606694-XReport Type:Expedited (15-DaCompany Report #2005S1000462 Age:53 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional (100 Mg) PS ORAL 600 MG; QD; Other PO Date:03/11/05ISR Number: 4606696-3Report Type:Expedited (15-DaCompany Report #2005S1000399 Age:82 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional (25 Mg) PS ORAL 25 MG; BID; Other PO Sinemet C Mirapex C Date:03/11/05ISR Number: 4606708-7Report Type:Expedited (15-DaCompany Report #05-03-0360 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Colitis Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. PS Ivax Pharmaceuticals, Inc. ORAL 25-700MG QD ORAL Date:03/11/05ISR Number: 4606709-9Report Type:Expedited (15-DaCompany Report #2005S1000827 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Parkinson'S Disease Health Clozapine Tablets Professional (25 Mg) PS ORAL 75 MG;HS;PO Other Lorazepam C Morphine C Paracetamol C Date:03/11/05ISR Number: 4606710-5Report Type:Expedited (15-DaCompany Report #2005S1000820 Age:74 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional (100 Mg) PS ORAL 100 MG;QID;PO Other Clonazepam C Hytrin C 22-Feb-2006 08:30 AM Page: 3200 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/11/05ISR Number: 4606711-7Report Type:Expedited (15-DaCompany Report #2005S1000809 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional (25 Mg) PS ORAL 50 MG;QAM;PO Other Clozapine Tablets (100 Mg) SS ORAL 100 MG;HS;PO Effexor-Xr C Lorazepam C Buspar C Amoxapine C Advair C Combivent C Ritalin C Flexeril C Premarin C Pepcid C Clucophage C Date:03/11/05ISR Number: 4606712-9Report Type:Expedited (15-DaCompany Report #2005S1000790 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine Tablets Professional (100 Mg) PS ORAL SEE IMAGE Other Chlordiazepoxide C Benztrone C Depakote C Protonix C Diclofenac C Busipirone C Risperdal C Zoloft C Lipitor C Lorazepam C Date:03/11/05ISR Number: 4607287-0Report Type:Direct Company Report #CTU 242844 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Clozaril PS 25 MG BID Myocarditis Respiratory Arrest Date:03/11/05ISR Number: 4608221-XReport Type:Expedited (15-DaCompany Report #200311162BVD Age:61 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Foreign Ciprobay Conjunctivitis Health (Ciprofloxacin Drug Interaction Professional Hydrochloride) PS ORAL 1000 MG, Drug Level Increased Other TOTAL DAILY, Psychotic Disorder ORAL Tracheobronchitis Leponex SS Acc C Refobacin C Atosil C Tavor C 22-Feb-2006 08:30 AM Page: 3201 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Solian C Eisen C Espumisan C Simethicon C Lactulose C Date:03/11/05ISR Number: 4688530-9Report Type:Direct Company Report #CTU 242714 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Clozapine 300 Mg Po Drug Effect Decreased Bid PS Nausea Date:03/11/05ISR Number: 4693380-3Report Type:Direct Company Report #CTU 242692 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abnormal Behaviour Clozapine PS ORAL 400MG BID PO Delusional Perception Exelon C Drug Ineffective Klonopin C Hallucination, Auditory Depakote C Insomnia Abilify C Irritability Halcion C Pharmaceutical Product Complaint Speech Disorder Thinking Abnormal Date:03/14/05ISR Number: 4606877-9Report Type:Expedited (15-DaCompany Report #PHBS2005NZ03421 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Constipation Clozaril PS Novartis Sector: Hospitalization - Faecaloma Pharma ORAL 550 mg/d 2291 DAY Initial or Prolonged Foreign Body Aspiration Amitriptyline C 10 mg/d Intestinal Ischaemia Benztropine Mesylate C 2 mg/d Intestinal Resection Obstructive Airways Disorder Pulmonary Embolism Date:03/14/05ISR Number: 4606888-3Report Type:Expedited (15-DaCompany Report #PHEH2005US01533 Age:57 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Choking Clozaril PS Novartis Sector: Pharma ORAL 450 mg, QD Hep-B-Vax SS Paxil C 30 mg, QD Klonopin C 1.5 mg, QD Seroquel C Verapamil C Keppra C 1500 mg, BID Trileptal C 600 mg, BID Aspirin C 22-Feb-2006 08:30 AM Page: 3202 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/14/05ISR Number: 4606889-5Report Type:Expedited (15-DaCompany Report #PHEH2005US01966 Age:86 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cachexia Clozaril PS Novartis Sector: Disease Progression Pharma ORAL 25 mg, QHS Parkinson'S Disease for one week Sinemet C Seroquel C Date:03/14/05ISR Number: 4606890-1Report Type:Expedited (15-DaCompany Report #PHFR2005GB00727 Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chest Pain Clozaril PS Novartis Sector: Ecg P Wave Inverted Pharma ORAL 100 mg, BID 21600MIN Eosinophil Count Olanzapine C ORAL 20mg/day Increased Valproate Sodium C ORAL 1500mg/day Hypothermia Mean Cell Volume Abnormal Monocyte Count Increased Tachycardia Date:03/14/05ISR Number: 4606900-1Report Type:Expedited (15-DaCompany Report #PHFR2003GB02133 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Clozaril PS Novartis Sector: Initial or Prolonged Constipation Pharma ORAL 200mg/mane&30 Other Convulsion 0mg/nocte Exfoliative Rash Clozaril SS Novartis Sector: Glomerular Filtration Pharma ORAL 200mg/mane&25 Rate Decreased 0mg/nocte Haemodialysis Clozaril SS Novartis Sector: Haemoglobin Decreased Pharma ORAL 400mg/day Hyperkalaemia Iron C UNKNOWN Megacolon Nausea Obstructive Uropathy Post Procedural Complication Renal Failure Chronic Date:03/14/05ISR Number: 4606901-3Report Type:Expedited (15-DaCompany Report #PHBS2005CL02968 Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Cancer Female Leponex PS Novartis Sector: Pharma ORAL 100 mg / day Leponex SS Novartis Sector: Pharma ORAL 125 mg / day Date:03/14/05ISR Number: 4606904-9Report Type:Expedited (15-DaCompany Report #PHNU2005DE01200 Age: Gender:Female I/FU:I Outcome PT Hospitalization - Alanine Aminotransferase Initial or Prolonged Increased 22-Feb-2006 08:30 AM Page: 3203 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Arthralgia Aspartate Aminotransferase Report Source Product Role Manufacturer Route Dose Duration Increased Leponex / Clozaril Body Temperature (Clozapine) PS Novartis Sector: Increased Pharma ORAL 12.5 to 225 C-Reactive Protein mg 31680MIN Increased Leponex / Clozaril Fatigue (Clozapine) SS Novartis Sector: Leukocytosis Pharma 33120MIN Pain Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL 7200 MIN Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL 8640 MIN Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL 20160MIN Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL 2880 MIN Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL UNK, UNK 8640 MIN Zoloft C ORAL 21600MIN Beloc Zok C Date:03/14/05ISR Number: 4606962-1Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20041007637 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Risperdal PS OROPHARINGEAL 1.5 MG bd per source documents 21 DAY Risperdal SS OROPHARINGEAL 100 MG per source documents 21 DAY Clozapine SS OROPHARINGEAL Ranitidine SS Gabapentin SS OROPHARINGEAL Lamotrigine SS OROPHARINGEAL 25-50 MG Date:03/14/05ISR Number: 4607559-XReport Type:Expedited (15-DaCompany Report #PHFR2005IE01089 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Venous Occlusion Clozaril PS Novartis Sector: Initial or Prolonged Pharma ORAL 125mg/day Date:03/14/05ISR Number: 4607603-XReport Type:Expedited (15-DaCompany Report #PHFR2005GB01129 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Clozaril PS Novartis Sector: Pharma ORAL overdose of unknown amount 22-Feb-2006 08:30 AM Page: 3204 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Alcohol SS Date:03/15/05ISR Number: 4608578-XReport Type:Expedited (15-DaCompany Report #GXKR2005US00686 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Clozapine PS Novartis Sector: Initial or Prolonged Increased Pharma 175 mg Ascites Divalproex Sodium Aspartate (Ngx) SS 1000 mg, BID Aminotransferase Lithium Carbonate C 1200 mg/d Increased Perphenazine C 32 mg/d Asterixis Biperiden C 6 mg/d Drug Interaction Albuterol Sulfate C 2 puffs, QID Hepatic Encephalopathy Selegiline C 10 mg/d Hepatic Failure Lorazepam C 0.5 mg, Q2H Hepatotoxicity Propranolol C 20 mg/d Hyperbilirubinaemia Hypertension Hyperthermia Liver Tenderness Sedation Tachycardia Date:03/15/05ISR Number: 4608806-0Report Type:Expedited (15-DaCompany Report #PHBS2005DE03547 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akinesia Clozapine PS Novartis Sector: Initial or Prolonged Aphasia Pharma UNKNOWN 12.5 mg/d C-Reactive Protein Clozapine SS Novartis Sector: Increased Pharma UNKNOWN 150 mg/d Drug Level Increased Clozapine SS Novartis Sector: Drug Toxicity Pharma UNKNOWN 200 mg/d Escherichia Infection Clozapine SS Novartis Sector: Escherichia Urinary Tract Pharma UNKNOWN 100 mg, QHS Infection Clozapine SS Novartis Sector: Incoherent Pharma UNKNOWN 200 mg/d Pyrexia Mirtazapine C UNKNOWN 30 mg/d Speech Disorder Mirtazapine C UNKNOWN 15 mg/d Urinary Tract Infection Date:03/15/05ISR Number: 4608809-6Report Type:Expedited (15-DaCompany Report #PHBS2005US03546 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Breast Cancer In Situ Clozapine PS Novartis Sector: Initial or Prolonged Colonoscopy Pharma UNKNOWN 500 mg/d Other Drug Level Decreased Clozapine SS Novartis Sector: Faecal Incontinence Pharma UNKNOWN 25 mg/d Faecaloma Clozapine SS Novartis Sector: Leukopenia Pharma UNKNOWN 800 mg/d Malignant Breast Lump Olanzapine C UNKNOWN 10 mg/d Removal Benazepril C UNKNOWN 20 mg/d Medical Diet Haloperidol C UNKNOWN 150 mg, TIW Neutropenia Haloperidol Decanoate C UNKNOWN 150 mg, TIW Tamoxifen Citrate C UNKNOWN 20 mg/d 22-Feb-2006 08:30 AM Page: 3205 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/15/05ISR Number: 4608813-8Report Type:Expedited (15-DaCompany Report #PHFR2004GB02625 Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Clozaril PS Novartis Sector: Blood Creatine Pharma ORAL 36000MIN Phosphokinase Increased Clozaril SS Novartis Sector: Blood Glucose Increased Pharma ORAL 250 mg/day C-Reactive Protein Valproate Sodium C ORAL 1400 mg/day Increased Valproate Sodium C ORAL 800 mg, BID Circulatory Collapse Clonazepam C ORAL 1 mg, BID Constipation Lactulose C ORAL Diabetes Mellitus Metformin C ORAL 1500 mg/day Diarrhoea Oxybutynin C ORAL 10 mg/day Difficulty In Walking Omeprazole C ORAL 10 mg/day Disorientation Enalapril C ORAL 7.5 mg/day Dizziness Dysarthria Faecal Incontinence Gastroenteritis Viral Glycosuria Grand Mal Convulsion Hypertension Infection Labile Blood Pressure Oxygen Saturation Decreased Pyrexia Syncope Syncope Vasovagal Tachycardia Urinary Tract Infection White Blood Cell Count Increased Date:03/15/05ISR Number: 4608814-XReport Type:Expedited (15-DaCompany Report #PHNU2005DE01197 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Leponex / Clozaril Initial or Prolonged Increased (Clozapine) PS Novartis Sector: Other Electroencephalogram Pharma ORAL Abnormal Leponex / Clozaril Gamma-Glutamyltransferase (Clozapine) SS Novartis Sector: Increased Pharma ORAL 300 to 450 mg 46080MIN Glutamate Dehydrogenase Leponex / Clozaril Increased (Clozapine) SS Novartis Sector: Hepatic Enzyme Increased Pharma ORAL 44640MIN Hypotonia Leponex / Clozaril Speech Disorder (Clozapine) SS Novartis Sector: Tremor Pharma ORAL 12960MIN Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL Trevilor C 22-Feb-2006 08:30 AM Page: 3206 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/15/05ISR Number: 4608819-9Report Type:Expedited (15-DaCompany Report #PHNU2005DE01272 Age:3.5 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Exposure Leponex / Clozaril Initial or Prolonged Pallor (Clozapine) PS Novartis Sector: Somnolence Pharma ORAL 25 mg, ONCE/SINGLE 1440 MIN Date:03/16/05ISR Number: 4610277-5Report Type:Expedited (15-DaCompany Report #PHHO2005CA02039 Age:23 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chest Pain Clozaril PS Novartis Sector: Dyspnoea Pharma ORAL 350 mg hs Pericarditis Seroquel C Tachycardia Lithium C Thyroid Disorder Date:03/16/05ISR Number: 4610279-9Report Type:Expedited (15-DaCompany Report #PHHO2005CA04265 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Decreased Clozaril PS Novartis Sector: Initial or Prolonged Cardiac Disorder Pharma ORAL 1721 DAY Date:03/16/05ISR Number: 4610280-5Report Type:Expedited (15-DaCompany Report #PHHO2005CA04305 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pernicious Anaemia Clozaril PS Novartis Sector: Pharma ORAL Date:03/16/05ISR Number: 4610549-4Report Type:Expedited (15-DaCompany Report #05-03-0400 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceutical, Inc. Other Tablets PS Ivax Pharmaceutical, Inc. ORAL 200-500 MG QD ORAL Date:03/16/05ISR Number: 4610552-4Report Type:Expedited (15-DaCompany Report #05-03-0387 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Tracheostomy Malfunction Health Clozapine - Ivax Professional Pharmaceutical, Inc. Other Tablets PS Ivax Pharmaceutical, Inc. ORAL 230-350MG QD ORAL 22-Feb-2006 08:30 AM Page: 3207 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/16/05ISR Number: 4610553-6Report Type:Expedited (15-DaCompany Report #05-03-0359 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozapine - Ivax Professional Pharmaceutical, Inc. Other Tablets PS Ivax Pharmaceutical, Inc. ORAL 600 MG QD ORAL Date:03/16/05ISR Number: 4610560-3Report Type:Expedited (15-DaCompany Report #04-12-1823 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozapine - Ivax Circulatory Collapse Professional Pharmaceutical, Inc. Dizziness Other Tablets PS Ivax Pharmaceutical, Inc. ORAL 450 MG BID ORAL Lipitor C Glucovance C Micronor C Oxazepam C Date:03/16/05ISR Number: 4610564-0Report Type:Expedited (15-DaCompany Report #05-03-0338 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine - Ivax Other Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 300-900MG QD ORAL Date:03/16/05ISR Number: 4610575-5Report Type:Expedited (15-DaCompany Report #2005S1000880 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozapine Tablets Chronic Obstructive Professional (100 Mg) PS ORAL 100 MG; QD; Pulmonary Disease Other PO Pharmaceutical Product Lithium C Complaint Oxygen C Date:03/16/05ISR Number: 4610584-6Report Type:Expedited (15-DaCompany Report #2005S1000406 Age:70 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aortic Aneurysm Rupture Health Clozapine Tablets Circulatory Collapse Professional (100 Mg) PS ORAL 200 MG; HS; Sudden Death Other PO Urinary Tract Infection Glucotrol C Lotensin C Flomax C Prevacid C 22-Feb-2006 08:30 AM Page: 3208 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/16/05ISR Number: 4610587-1Report Type:Expedited (15-DaCompany Report #2005S1000207 Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional (100 Mg) PS ORAL 600 MG; HS; Other PO Glipizide Xl C Date:03/16/05ISR Number: 4610588-3Report Type:Expedited (15-DaCompany Report #05-03-0377 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 125-325MG QD ORAL Date:03/16/05ISR Number: 4610592-5Report Type:Expedited (15-DaCompany Report #05-03-0382 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drooling Health Clozapine - Ivax Initial or Prolonged Pneumonia Aspiration Professional Pharmaceuticals, Other Other Inc. - Tablets PS Ivax Pharmaceuticals, Inc. ORAL 50-200 MG QD ORAL Date:03/16/05ISR Number: 4610597-4Report Type:Expedited (15-DaCompany Report #05-03-0381 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Health Clozapine Tablets - Lung Neoplasm Malignant Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 400-700 MG QD ORAL Date:03/16/05ISR Number: 4610600-1Report Type:Expedited (15-DaCompany Report #05-03-0361 Age:81 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Clozapine Tablets - Pneumonia Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 12.5-250MG QD ORAL 22-Feb-2006 08:30 AM Page: 3209 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/16/05ISR Number: 4610606-2Report Type:Expedited (15-DaCompany Report #2005S1000179 Age:52 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Appendicitis Perforated Health Clozapine Tablets Professional (100 Mg) PS ORAL SEE IMAGE Other Date:03/16/05ISR Number: 4611563-5Report Type:Direct Company Report #CTU 243444 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Test Abnormal Clozaril 100 Mg PS ORAL 2 AM / 5 PM Pharmaceutical Product TAKEN PO Complaint Date:03/16/05ISR Number: 4612196-7Report Type:Expedited (15-DaCompany Report #S05-USA-01285-01 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intestinal Obstruction Health Lexapro Initial or Prolonged White Blood Cell Count Professional (Escitalopram) PS ORAL 10 MG QAM PO Increased Clozapine SS ORAL 575 MG QD PO Benztropine SS 1 MG QAM Benzrtopine SS 2 MG QHS Clonazepam SS 1 MG PRN Date:03/16/05ISR Number: 4612522-9Report Type:Direct Company Report #CTU 243306 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Test Abnormal Clozaril PS ORAL 2 AM / 5 PM Pharmaceutical Product TAKEN P.O. Complaint DAILY GROUP/ 1X WK INDIV RESIDES RRP Date:03/16/05ISR Number: 4613343-3Report Type:Expedited (15-DaCompany Report #2005042029 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperchlorhydria Foreign Gabapentin Mood Altered Health (Gabapentin) PS ORAL 100 MG (100 Neutropenia Professional MG, 1 IN 1 D),ORAL Clozapine (Clozapine) SS ORAL ORAL Ranitidine Hydrochloride (Ranitidine Hydrochloride) SS 150 MG (150 MG, 1 IN 1 D) Risperidone (Risperidone) SS ORAL 3 MG (1.5 MG, 2 IN 1 D),ORAL Lamotrigine (Lamotrigine) SS ORAL ORAL 22-Feb-2006 08:30 AM Page: 3210 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/17/05ISR Number: 4610952-2Report Type:Expedited (15-DaCompany Report #GXKR2005DK00721 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Leponex PS Novartis Sector: Hospitalization - Dyspnoea Pharma ORAL UNK, UNK 730 DAY Initial or Prolonged Ovarian Cyst Gestonette (Ngx) SS ORAL 1 Tablet 87840MIN Pulmonary Congestion Orap C UNKNOWN Pulmonary Thrombosis Rivotril C UNKNOWN Zyprexa C UNKNOWN Date:03/17/05ISR Number: 4611156-XReport Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050301645 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Brain Oedema Risperdal Consta PS INTRAMUSCULAR Cardiac Arrest Risperdal C OROPHARINGEAL Coma Leponex I OROPHARINGEAL Drug Interaction Hypoxic Encephalopathy Pulmonary Embolism Date:03/17/05ISR Number: 4611357-0Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12888863 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Overdose Buspar PS Bristol-Myers Squibb Other Drug Toxicity Company Duration: >1 year 1 YR Clozapine SS ORAL Dosage: 50-400mg daily Imipramine SS Amitriptyline SS Luvox SS Date:03/17/05ISR Number: 4611453-8Report Type:Expedited (15-DaCompany Report #PHEH2005US02953 Age:74 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Clozaril PS Novartis Sector: Congestive Pharma Chronic Obstructive Pulmonary Disease Influenza Pneumonia Date:03/17/05ISR Number: 4611456-3Report Type:Expedited (15-DaCompany Report #PHFR2005IE01089 Age:65 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Deep Vein Thrombosis Clozaril PS Novartis Sector: Initial or Prolonged Venous Occlusion Pharma ORAL UNK, UNK 44640MIN 22-Feb-2006 08:30 AM Page: 3211 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/17/05ISR Number: 4615396-5Report Type:Expedited (15-DaCompany Report #2004070512 Age:92 YR Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Medication Error Literature Gabapentin Multiple Drug Overdose Health (Gabapentin) PS ORAL ORAL Accidental Professional Clozapine (Clozapine) SS ORAL ORAL Date:03/17/05ISR Number: 4615777-XReport Type:Expedited (15-DaCompany Report #2005S1000365 Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozapine Tablets Professional (100 Mg) PS ORAL 300 MG; BID; Other PO Clonazepam C Fluphenazine C Hydrochloride C Fluphenazine Decanoate C Lansoprazole C Metoclopramide C Lisinopril C Date:03/17/05ISR Number: 4615779-3Report Type:Expedited (15-DaCompany Report #2005S1000948 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Influenza Health Clozapine Tablets Professional (100 Mg) PS ORAL 150 MG; BID; Other PO Paracetamol C Salbutamol C Fluticasone Propionate C Potassium C Levothyroxine Sodium C Vitamin Nos C Haloperidol C Lorazepam C Metformin C Date:03/17/05ISR Number: 4615780-XReport Type:Expedited (15-DaCompany Report #2005S1000926 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aneurysm Health Clozapine Tablets Feeling Abnormal Professional (100 Mg) PS ORAL 300 MG; HS; Headache Other PO Bupropion Hydrochloride C Paroxetine C 22-Feb-2006 08:30 AM Page: 3212 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/17/05ISR Number: 4615781-1Report Type:Expedited (15-DaCompany Report #2005S1000924 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Health Clozapine Tablets Professional (100 Mg) PS ORAL 600 MG; HS; Other PO Tiagabine Hydrochloride C Paroxetine C Date:03/17/05ISR Number: 4615782-3Report Type:Expedited (15-DaCompany Report #2005S1000940 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional (25 Mg) PS ORAL 25 MG; TID; Other PO Clozapine Tablets (100 Mg) SS ORAL 100 MG; TID; PO Date:03/17/05ISR Number: 4615785-9Report Type:Expedited (15-DaCompany Report #2005S1000460 Age:54 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Creatinine Health Clozapine Tablets Hospitalization - Increased Professional (100 Mg) PS ORAL SEE IMAGE Initial or Prolonged Confusional State Company Atenolol C Required Diabetic Ketoacidosis Representative Paroxetine C Intervention to Multi-Organ Failure Other Hydrochloride Cr C Prevent Permanent Pneumonia Streptococcal Quetiapine C Impairment/Damage Sepsis Gemfibrozil C White Blood Cell Count Decreased Date:03/17/05ISR Number: 4615787-2Report Type:Expedited (15-DaCompany Report #2005S1000572 Age:67 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agranulocytosis Health Clozapine Tablets Jaundice Cholestatic Professional (25 Mg) PS ORAL 50 MG; QAM; White Blood Cell Count Other PO Abnormal Clozapine Tablets (100 Mg) SS ORAL 100 MG; QAM; PO; 200 MG; HS; PO Senna Fruit C Zolpidem Tartrate C Triamcinolone Acetonide C Cetirizine C Hydrochloride C Diphenhydramine C Hydrocortisone C Furosemide C Perphenazine C Clark'S Solution C Maalox C 22-Feb-2006 08:30 AM Page: 3213 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lamisil C Protonix Wyeth-Ayerst C Wyeth-Ayerst Tequin C Acetaminophen C Trazodone C Flomax Boehringer Ingelheim C Boehringer Ingelheim Diclofenac C Baclofen C Date:03/17/05ISR Number: 4615792-6Report Type:Expedited (15-DaCompany Report #2005S1000950 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Overdose Health Clozapine Tablets Drug Abuser Professional (100 Mg) PS ORAL 150 MG; QAM; Other PO Clonazepam C Clomipramine C Hydrochloride C Trazodone C Date:03/17/05ISR Number: 4615794-XReport Type:Expedited (15-DaCompany Report #2005S1000985 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional (100 Mg) PS ORAL 400 MG; QAM; Other PO; 500 MG; HS; PO Clomipramine C Olanzapine C Lorazepam C Date:03/17/05ISR Number: 4615796-3Report Type:Expedited (15-DaCompany Report #2005S1000947 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional (100 Mg) PS ORAL 300 MG; QAM; Other PO; 400 MG; HS; PO Date:03/17/05ISR Number: 4615797-5Report Type:Expedited (15-DaCompany Report #2005S1000914 Age:77 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional (25 Mg) PS ORAL 25 MG; HS; PO Other Atorvastatin C Alfuzosin Hydrochloride C Dutasteride C Lisinopril C Rosiglitazone Maleate C 22-Feb-2006 08:30 AM Page: 3214 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Galantamine Hydrobromide C Amantadine Hydrochloride C Date:03/18/05ISR Number: 4612529-1Report Type:Expedited (15-DaCompany Report #PHFR2005GB00725 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Disorder Clozaril PS Novartis Sector: Initial or Prolonged Tachycardia Pharma ORAL 400mg/day Date:03/18/05ISR Number: 4612530-8Report Type:Expedited (15-DaCompany Report #PHFR2005GB01052 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrial Flutter Clozaril PS Novartis Sector: Initial or Prolonged Blood Creatine Pharma 25920MIN Phosphokinase Increased Hyoscine SS ORAL 300ug/day 4320 MIN Blood Pressure Fluctuation C-Reactive Protein Increased Incontinence Muscle Rigidity Pyrexia Somnolence Tachycardia Date:03/18/05ISR Number: 4612788-5Report Type:Expedited (15-DaCompany Report #PHBS1999BR11502 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Basophil Count Increased Leponex PS Novartis Sector: Eosinophilia Pharma Lymphocyte Count Increased Monocyte Count Increased Neutrophil Count Increased Date:03/18/05ISR Number: 4612789-7Report Type:Expedited (15-DaCompany Report #PHBS2005BE02661 Age:34 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Epilepsy Leponex PS Novartis Sector: Initial or Prolonged Lymphopenia Pharma ORAL 500 mg/d Leponex SS Novartis Sector: Pharma ORAL 300 mg/d 20160MIN Leponex SS Novartis Sector: Pharma ORAL 200 mg/d Xanax SS 1 mg/d Xanax SS 0.5 mg/d 22-Feb-2006 08:30 AM Page: 3215 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/18/05ISR Number: 4612790-3Report Type:Expedited (15-DaCompany Report #PHBS2005BR03829 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Leponex PS Novartis Sector: Hunger Pharma ORAL 25 mg, UNK 183 DAY Loss Of Consciousness Leponex SS Novartis Sector: Pharma ORAL 300 mg, QHS Synthroid C ORAL 75 ug, QD Rivotril C ORAL UNK, BID Date:03/18/05ISR Number: 4612791-5Report Type:Expedited (15-DaCompany Report #PHBS2005IT03824 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Abuser Leponex PS Novartis Sector: Epilepsy Pharma ORAL 300 mg, BID Date:03/21/05ISR Number: 4614012-6Report Type:Expedited (15-DaCompany Report #FR-ROCHE-398066 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Apgar Score Low Valium PS Roche Caesarean Section Leponex SS Drug Exposure During Leponex SS Pregnancy Leponex SS Drug Level Increased Depamide SS Hypotonia Depamide SS 1 DAY Neonatal Disorder Depamide SS Respiratory Failure Somnolence Vomiting Date:03/21/05ISR Number: 4614032-1Report Type:Expedited (15-DaCompany Report #PHBS2005SE03928 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiac Failure Leponex PS Novartis Sector: Pharma UNKNOWN Date:03/21/05ISR Number: 4619099-2Report Type:Periodic Company Report #2004-12-1181 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypotension Health Peg-Intron Initial or Prolonged Neutropenia Professional (Peginterferon Other Somnolence Alfa-2b) Injectable Powder PS SUBCUTANEOUS 120 MCG QWK SUBCUTANEOUS Rebetol (Ribavirin) Capsules SS ORAL ORAL Clozapine Tablets SS ORAL 25-400 MG QD ORAL Depakote C 22-Feb-2006 08:30 AM Page: 3216 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/21/05ISR Number: 4620733-1Report Type:Periodic Company Report #2004-06-2085 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Health Peg-Intron Professional (Peginterferon Other Alfa-2b) Injectable Powder PS SUBCUTANEOUS SUBCUTANEOUS Clozapine Tablets SS ORAL 750 MG QD ORAL Date:03/22/05ISR Number: 4614769-4Report Type:Expedited (15-DaCompany Report #AU-BRISTOL-MYERS SQUIBB COMPANY-12899258 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Body Temperature Abilify PS Otsuka Initial or Prolonged Increased Pharmaceutical Hyperhidrosis Company, Ltd. ORAL Loss Of Consciousness Clozaril SS ORAL progr. decr. Neuroleptic Malignant from 550 mg Syndrome on Psychotic Disorder 27-Jan-2004 Rebound Effect to 200 mg; Valium C Date:03/22/05ISR Number: 4614859-6Report Type:Expedited (15-DaCompany Report #PHEH2005US03325 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Clozaril PS Novartis Sector: Hospitalization - Pharma ORAL 600 mg, QD Initial or Prolonged Date:03/22/05ISR Number: 4617464-0Report Type:Expedited (15-DaCompany Report #2005S1001094 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional (100 Mg) PS ORAL SEE IMAGE, PO Other Levothyroxine Sodium C Ranitidine C Hydrochloride C Acetylsalicylic Acid C Furosemide C Potassium Chloride C Clonazepam C Vitamins Nos C Lamotrigine C Date:03/22/05ISR Number: 4617465-2Report Type:Expedited (15-DaCompany Report #2005S1001035 Age:84 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional (25 Mg) PS ORAL 12.5 MG.; QD; Other PO Coreg C Luvox C 22-Feb-2006 08:30 AM Page: 3217 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Benzonatate C Levaquin C Trazodone C Furosemide C Prevacid C Plavix C Avelox C Guaifenesin/Dextrome thorphan C Date:03/22/05ISR Number: 4617508-6Report Type:Expedited (15-DaCompany Report #2005S1001025 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional (25 Mg) PS ORAL 50 MG; HS; PO Other Paracetamol C Morphine C Atenolol C Mirtazapine C Trazodone C Pantoprazole Sodium C Docusate Sodium C Date:03/22/05ISR Number: 4617510-4Report Type:Expedited (15-DaCompany Report #2005S1000589 Age:67 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional (25 Mg) PS ORAL 25 MG; QAM; Other PO; 37.5 MG; HS; PO Calcitonin, Salmon C Lorazepam C Paracetamol/Hydrocod one Bitartrate C Phenytoin Sodium C Lansoprazole C Paroxetine Hydrochloride C Midodrine Hydrochloride C Selegiline C Levodopa/Carbidopa C Morphine 20mg/Ml Solution C Ibuprofen C Date:03/22/05ISR Number: 4617512-8Report Type:Expedited (15-DaCompany Report #2005S1000238 Age:38 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Clozapine Tablets Professional (100 Mg) PS ORAL 300 MG; HS; Other PO Lexapro C Lopressor C Seroquel C 22-Feb-2006 08:30 AM Page: 3218 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Topamax C Zocor "Merck" C Multivitamins And Iron C Date:03/22/05ISR Number: 4621224-4Report Type:Direct Company Report #CTU 243928 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asthma Clozapine PS ORAL 150 MG PO BID Body Temperature Increased Bronchitis Dysarthria Dysphagia Influenza Pneumonia Aspiration Date:03/23/05ISR Number: 4617203-3Report Type:Expedited (15-DaCompany Report #PHBS2005SE03930 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Leponex PS Novartis Sector: Hypernatraemia Pharma UNKNOWN Renal Failure Date:03/23/05ISR Number: 4617205-7Report Type:Expedited (15-DaCompany Report #PHNU2005DE01429 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Leponex / Clozaril Dyspnoea (Clozapine) PS Novartis Sector: Pharma ORAL Nebilet SS Abilify SS Date:03/23/05ISR Number: 4617208-2Report Type:Expedited (15-DaCompany Report #PHRM2005FR01101 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Bronchial Leponex PS Novartis Sector: Inflammation Pharma ORAL 600 mg/day Pulmonary Oedema Lepticur SS ORAL 30 mg/day Theralene SS ORAL 40 drops/day Rivotril SS ORAL 35 mg/day Tercian SS ORAL 150 mg, TID Duphalac C ORAL 2 DF, TID Transipeg C ORAL Date:03/23/05ISR Number: 4617212-4Report Type:Expedited (15-DaCompany Report #PHHO2005CA04265 Age:46 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Decreased Clozaril PS Novartis Sector: Initial or Prolonged Cardiomyopathy Pharma ORAL 1721 DAY 22-Feb-2006 08:30 AM Page: 3219 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/23/05ISR Number: 4617220-3Report Type:Expedited (15-DaCompany Report #PHHO2004CA07763 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delirium Clozaril PS Novartis Sector: Initial or Prolonged Pneumonia Pharma ORAL 800 mg daily Pyrexia Tooth Disorder Date:03/23/05ISR Number: 4617230-6Report Type:Expedited (15-DaCompany Report #GXKR2005DK00721 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Leponex PS Novartis Sector: Dyspnoea Pharma ORAL UNK, UNK 730 DAY Ovarian Cyst Gestonette (Ngx) SS ORAL 75A?g Pulmonary Congestion gestoden/20A? Pulmonary Embolism g ethinylestrad iol 87840MIN Orap C UNKNOWN Rivotril C UNKNOWN Zyprexa C UNKNOWN Date:03/23/05ISR Number: 4617299-9Report Type:Expedited (15-DaCompany Report #05-01-0119 Age:44 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dizziness Health Clozapine Tablets - Initial or Prolonged Fall Professional Iax Pharmaceuticals, Hypercalcaemia Other Inc. PS Ivax Renal Failure Pharmaceuticals, Thinking Abnormal Inc. ORAL 250MG QD ORAL Abilify SS 15MG AM Lamictal C Colace C Date:03/23/05ISR Number: 4617304-XReport Type:Expedited (15-DaCompany Report #05-01-0125 Age:43 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukaemia Health Clozapine Tablets - Neutropenia Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 12.5-400MG QD ORAL Date:03/23/05ISR Number: 4617306-3Report Type:Expedited (15-DaCompany Report #05-03-0427 Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Neoplasm Malignant Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, 22-Feb-2006 08:30 AM Page: 3220 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Inc. ORAL 375-450MG QD ORAL Date:03/23/05ISR Number: 4617379-8Report Type:Expedited (15-DaCompany Report #05-03-0458 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Abuser Health Clozapine Tablets - Initial or Prolonged Psychotic Disorder Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 75-400MG QD ORAL Date:03/23/05ISR Number: 4617388-9Report Type:Expedited (15-DaCompany Report #US-ABBOTT-05P-163-0294050-00 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Depakote PS Initial or Prolonged Decubitus Ulcer Clozapine SS ORAL 3 YR Gastrointestinal Hydrochlorothiazide C Haemorrhage Simvastatin C Psychiatric Symptom Glibenclamide C Sepsis Metformin C Labetalol C Amlodipine Besilate C Ascorbic Acid C Folic Acid C Lansoprazole C Acetylsalicylic Acid C Ferrous Sulfate C Date:03/23/05ISR Number: 4617390-7Report Type:Expedited (15-DaCompany Report #05-03-0457 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pulmonary Mass Health Clozapine Tablets - Initial or Prolonged Scar Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL ORAL Date:03/23/05ISR Number: 4617391-9Report Type:Expedited (15-DaCompany Report #05-03-0464 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sepsis Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 500-650MG QD ORAL 22-Feb-2006 08:30 AM Page: 3221 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/23/05ISR Number: 4617432-9Report Type:Expedited (15-DaCompany Report #05-03-0459 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 200MG QD ORAL Date:03/24/05ISR Number: 4617768-1Report Type:Expedited (15-DaCompany Report #05-02-0176 Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Nicoderm PS Glaxosmithkline TRANSDERMAL Initial or Prolonged Delirium Clozapine SS Effexor Xr C Vitamin E C Lopid C Abilify C Date:03/24/05ISR Number: 4618358-7Report Type:Expedited (15-DaCompany Report #US-MERCK-0503USA03019 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Constipation Cogentin PS Merck & Co., Inc ORAL Initial or Prolonged Intestinal Obstruction Cogentin SS Merck & Co., Inc ORAL Clozapine SS ORAL Clonazepam SS ORAL Lexapro SS ORAL Date:03/24/05ISR Number: 4622295-1Report Type:Direct Company Report #CTU 244170 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Life Support Clozapine PS ADMINISTERED Hospitalization - Medication Error DAILY Initial or Prolonged Neutrophil Count Required Decreased Intervention to Pyrexia Prevent Permanent White Blood Cell Count Impairment/Damage Decreased Date:03/25/05ISR Number: 4619483-7Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050301645 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asthenia Risperdal Consta PS INTRAMUSCULAR Brain Oedema Risperdal Consta SS INTRAMUSCULAR Cardiac Arrest Risperdal C OROPHARINGEAL Cardio-Respiratory Arrest Leponex I OROPHARINGEAL Coma Drug Interaction Hyporeflexia Hypoxic Encephalopathy Pulmonary Embolism Respiratory Arrest 22-Feb-2006 08:30 AM Page: 3222 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/25/05ISR Number: 4620644-1Report Type:Expedited (15-DaCompany Report #2005S1001108 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional (25 Mg) PS ORAL HS; PO Other Date:03/25/05ISR Number: 4620646-5Report Type:Expedited (15-DaCompany Report #2005S1001107 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine Tablets Renal Failure Professional (100 Mg) PS ORAL 400 MG; HS; Other PO Glimepiride C Trazodone C Benzatropine Mesilate C Docusate Sodium C Sertraline C Valproic Acid C Date:03/25/05ISR Number: 4620647-7Report Type:Expedited (15-DaCompany Report #2005S1001103 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Laryngeal Cancer Health Clozapine Tablets Professional (100 Mg) PS ORAL SEE IMAGE, PO Other Glycopyrronium Bromide C Risperidone C Nicotine C Lorazepam C Senna C Paracetamol C Pseudoephedrine Hydrochloride C Date:03/25/05ISR Number: 4620648-9Report Type:Expedited (15-DaCompany Report #A01200501404 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Angioneurotic Oedema Foreign Stilnox Dry Skin Health (Zolpidem) PS ORAL 100 MG ORAL 2 DAY Overdose Professional Risperidone SS ORAL 2 MG ORAL Other Fluvoxamine Maleate SS ORAL 50 MG ORAL 1 DAY Clozapine SS Date:03/25/05ISR Number: 4620649-0Report Type:Expedited (15-DaCompany Report #2005S1000653 Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Intracranial Aneurysm Health Clozapine Tablets Myocardial Infarction Professional (100 Mg) PS ORAL 400 MG; HS; Other PO Prolixin Decanoate SS SEE IMAGE Mirtazapine C 22-Feb-2006 08:30 AM Page: 3223 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/25/05ISR Number: 4620650-7Report Type:Expedited (15-DaCompany Report #2005S1000492 Age:76 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death General Physical Health Health Clozapine Tablets Deterioration Professional (100 Mg) PS ORAL 100 MG; HS; Oral Intake Reduced Other PO Pneumonia Aspiration Percocet C Weight Decreased Morphine C Megace C Haldol C Risperdal C Klonopin C Pantoprazole C Potassium Chloride C Lorazepam C Furosemide C Date:03/25/05ISR Number: 4620652-0Report Type:Expedited (15-DaCompany Report #2005S1000357 Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pulmonary Embolism Health Clozapine Tablets Professional (100 Mg) PS ORAL 200 MG; BID; Other PO Date:03/25/05ISR Number: 4620704-5Report Type:Expedited (15-DaCompany Report #2005S1001192 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Alcohol Poisoning Health Clozapine Tablets Coronary Artery Occlusion Professional (100 Mg) PS ORAL 100 MG; HS; Myocardial Infarction Other PO Valproate Semisodium C Quetiapine C Lorazepam C Date:03/28/05ISR Number: 4620115-2Report Type:Expedited (15-DaCompany Report #200512168US Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Lovenox PS Aventis Hospitalization - Deep Vein Thrombosis Pharmaceuticals Inc. dose: UNK Initial or Prolonged Clozapine SS ORAL Date:03/28/05ISR Number: 4621495-4Report Type:Expedited (15-DaCompany Report #2005-126683-NL Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Alcohol Use Mirtazapine PS DF Cardiac Arrest Clozapine SS SCHIZOPHRENIA Feeling Abnormal NOS Overdose Alcohol SS DF Suicidal Ideation 22-Feb-2006 08:30 AM Page: 3224 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/28/05ISR Number: 4621580-7Report Type:Expedited (15-DaCompany Report #7929 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Interaction Foreign Fluphenazine PS 6 MG 17 DAY Thrombocytopenia Literature Clozapine SS 37.5 MG Health Diazepam C Professional Other Date:03/29/05ISR Number: 4621678-3Report Type:Expedited (15-DaCompany Report #PHFR2005GB01294 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Cholesterol Clozaril PS Novartis Sector: Increased Pharma ORAL Blood Triglycerides Increased Hepatic Steatosis Date:03/29/05ISR Number: 4621680-1Report Type:Expedited (15-DaCompany Report #PHNR2005AU00665 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Cholesterol Clozaril PS Novartis Sector: Increased Pharma ORAL 700 mg, QD Blood Triglycerides Increased Date:03/29/05ISR Number: 4621681-3Report Type:Expedited (15-DaCompany Report #PHBS2005BR04185 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Full Blood Count Leponex PS Novartis Sector: Decreased Pharma UNKNOWN Infection Date:03/29/05ISR Number: 4621682-5Report Type:Expedited (15-DaCompany Report #PHRM2005FR01096 Age:1 DY Gender:Male I/FU:I Outcome PT Congenital Anomaly Congenital Hand Other Malformation Congenital Pyelocaliectasis Cryptorchism Developmental Coordination Disorder Drug Exposure During Pregnancy Drug Withdrawal Syndrome Neonatal High Arched Palate Hypotonia Neonatal Neonatal Disorder Neonatal Tachypnoea Talipes Torticollis 22-Feb-2006 08:30 AM Page: 3225 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tremor Neonatal Report Source Product Role Manufacturer Route Dose Duration Leponex PS Novartis Sector: Pharma TRANSPLACENTAL Zoloft SS TRANSPLACENTAL Tranxene SS TRANSPLACENTAL Insulin C TRANSPLACENTAL Date:03/29/05ISR Number: 4622080-0Report Type:Expedited (15-DaCompany Report #05-03-0422 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiopulmonary Failure Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 300-700MG QD ORAL Date:03/29/05ISR Number: 4622084-8Report Type:Expedited (15-DaCompany Report #2005S1001214 Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional (100mg) PS ORAL PO Other Date:03/29/05ISR Number: 4622091-5Report Type:Expedited (15-DaCompany Report #2005S1001229 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional (100 Mg) PS ORAL 400 MG; HS; Other PO Date:03/29/05ISR Number: 4622096-4Report Type:Expedited (15-DaCompany Report #2005S1000364 Age:86 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Health Clozapine Tablets Professional (25 Mg) PS ORAL 75 MG; HS; PO Other Clozapine Tablets (100 Mg) SS ORAL 100 MG; HS; PO Fentanyl C Morphine Sulfate C Levothyroxine Sodium C Quetiapine Fumarate C Zinc C Tocopherol C Calcitonin, Salmon C Senna Fruit C Levodopa/ Carbidopa C Acetylsalicylic Acid C Mirtazapine C Ibuprofen C 22-Feb-2006 08:30 AM Page: 3226 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/29/05ISR Number: 4622098-8Report Type:Expedited (15-DaCompany Report #2005S1000985 Age:57 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Fall Health Clozapine Tablets Pneumothorax Professional (100 Mg) PS ORAL 400 MG; QAM; Rib Fracture Other PO Clozapine Tablets SS ORAL 500 MG; HS; PO Clomipramine C Olanzapine C Lorazepam C Date:03/29/05ISR Number: 4622100-3Report Type:Expedited (15-DaCompany Report #2005S1001202 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional (100 Mg) PS ORAL 300 MG; QAM; Other PO Clozapine Tablets SS ORAL 500 MG; HS; PO Omeprazole C Ranitidine Hydrochloride C Docusate Sodium C Fluoxetine Hydrochloride C Olanzapine C Risperidone C Benzatropine Mesilate C Date:03/29/05ISR Number: 4622991-6Report Type:Expedited (15-DaCompany Report #9402 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Health Clozapine PS ORAL 325 MG NOCTE, Hospitalization - Constipation Professional PO 1 YR Initial or Prolonged Loss Of Consciousness Amiodarone SS ORAL 200 GM AMNE , Rectal Prolapse PO 4 WK Digoxin SS ORAL 125 MICROGRAM MANE, PO 3 DAY Perindopril SS ORAL 4 MG NOCTE, PO Benztropine Mesylate SS ORAL PO Aspirin SS 100 MG ALT_DAYS Doxepin SS 100 MG NOCTE Date:03/30/05ISR Number: 4622948-5Report Type:Expedited (15-DaCompany Report #PHFR2005GB00623 Age:41 YR Gender:Male I/FU:F Outcome PT Death Abdominal Pain Other Arrhythmia Balance Disorder Circulatory Collapse Coma 22-Feb-2006 08:30 AM Page: 3227 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Constipation Depressed Level Of Consciousness Report Source Product Role Manufacturer Route Dose Duration Hypotension Clozaril PS Novartis Sector: Myocardial Infarction Pharma ORAL UNK, UNK Pallor Clozaril SS Novartis Sector: Vomiting Pharma ORAL 500mg/day Atorvastatin C ORAL Acetylsalicylic Acid C ORAL UNK, UNK Pirenzepine C ORAL 75mg/day Metoclopramide Hydrochloride C ORAL 30mg/day Omeprazole C ORAL 20mg/day Date:03/30/05ISR Number: 4622960-6Report Type:Expedited (15-DaCompany Report #PHBS2005DK03339 Age:31 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Leponex PS Novartis Sector: Other Ovarian Cyst Pharma ORAL Pulmonary Embolism Gestodene SS UNKNOWN Pulmonary Haemorrhage Ethylestradiol SS UNKNOWN Pulmonary Oedema Durascan SS ORAL 1 DF, QD Respiratory Distress Zyprexa C UNKNOWN Resuscitation Orap C UNKNOWN Rivotril C UNKNOWN Lysantin C UNKNOWN Pamol C UNKNOWN Date:03/30/05ISR Number: 4622962-XReport Type:Expedited (15-DaCompany Report #PHNR2005AU00572 Age:67 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Clozaril PS Novartis Sector: Initial or Prolonged Drug Level Increased Pharma 12 - 700 mg/day 1705 DAY Clozaril SS Novartis Sector: Pharma 12 mg, QD Lithium SS Celebrex SS Sertraline SS Date:03/30/05ISR Number: 4622963-1Report Type:Expedited (15-DaCompany Report #PHRM2005FR01132 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Multiple Sclerosis Leponex PS Novartis Sector: Pharma ORAL 500 mg daily Date:03/30/05ISR Number: 4622964-3Report Type:Expedited (15-DaCompany Report #PHNR2005AU00667 Age:26 YR Gender:Female I/FU:I Outcome PT Other Amenorrhoea Drug Interaction Galactorrhoea Hyperprolactinaemia 22-Feb-2006 08:30 AM Page: 3228 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Oligomenorrhoea Report Source Product Role Manufacturer Route Dose Duration Clozaril PS Novartis Sector: Pharma UNK, UNK Solian SS Date:03/30/05ISR Number: 4624334-0Report Type:Direct Company Report #CTU 244828 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Level Fluctuating Clozaril 100 Mg PS ORAL 2 AM/5 PM Pharmaceutical Product TAKEN PO Complaint Date:03/30/05ISR Number: 4624374-1Report Type:Direct Company Report #CTU 244815 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coma Clozapine PS ADMINISTERED Hospitalization - Neutrophil Count DAILY Initial or Prolonged Decreased Required Pharmaceutical Product Intervention to Complaint Prevent Permanent Pyrexia Impairment/Damage White Blood Cell Count Decreased Date:03/30/05ISR Number: 4631789-4Report Type:Periodic Company Report #04P-163-0268091-00 Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Urine Present Health Valproic Acid Initial or Prolonged Thrombocytopenia Professional (Depakene) (Valproic Other Acid) PS ORAL PER ORAL Clozapine SS ORAL 100-500 MG DAILY, PER ORAL Levothyroxine C Haloperidol C Lithium Carbonate C Metformin C Benzatropine C Nicotinic Acid C Date:03/31/05ISR Number: 4623935-3Report Type:Expedited (15-DaCompany Report #FR-ROCHE-399277 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abnormal Behaviour Rivotril PS Roche ORAL Blood Ethanol Increased Leponex SS ORAL STRENGTH Foreign Body Aspiration REPORTED AS Hepatic Congestion 100. Pulmonary Oedema Tercian SS ORAL Respiratory Depression Theralene SS ORAL Lepticur SS ORAL Duphalac C 22-Feb-2006 08:30 AM Page: 3229 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Transipeg C Date:03/31/05ISR Number: 4624025-6Report Type:Expedited (15-DaCompany Report #PHBS2005DE02352 Age:27 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Clozapine PS Novartis Sector: Disturbance In Attention Pharma UNKNOWN 250 mg/d Fatigue Lorazepam SS UNKNOWN 1 mg/d Increased Appetite Haloperidol SS Libido Decreased Zotepine SS Salivary Hypersecretion Risperidone SS UNKNOWN 6 mg/d Weight Increased Date:03/31/05ISR Number: 4624026-8Report Type:Expedited (15-DaCompany Report #PHEH2005US03638 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Lung Neoplasm Malignant Clozaril PS Novartis Sector: Pharma ORAL UNK, QD Clozapine SS ORAL 500 mg, QD Chemotherapeutics,Ot her C Date:03/31/05ISR Number: 4624027-XReport Type:Expedited (15-DaCompany Report #PHFR2005GB00725 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Alkaline Clozaril PS Novartis Sector: Initial or Prolonged Phosphatase Increased Pharma ORAL UNK, UNK Blood Creatine Hyoscine Phosphokinase Increased Hydrobromide C ORAL 300 ug, BID Blood Glucose Increased Zopiclone C ORAL 7.5mg/day Blood Pressure Increased Cardiac Disorder Diplopia Dizziness Dyspepsia Non-Cardiac Chest Pain Palpitations Tachycardia Weight Increased Date:03/31/05ISR Number: 4624029-3Report Type:Expedited (15-DaCompany Report #PHBS2004CL16737 Age:22 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Testicular Embryonal Leponex PS Novartis Sector: Carcinoma Pharma ORAL Date:03/31/05ISR Number: 4624039-6Report Type:Expedited (15-DaCompany Report #PHHO2005NZ03470 Age:44 YR Gender:Male I/FU:F Outcome PT Hospitalization - Abdominal Distension Initial or Prolonged Abdominal Pain 22-Feb-2006 08:30 AM Page: 3230 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Colonic Pseudo-Obstruction Intestinal Infarction Report Source Product Role Manufacturer Route Dose Duration Megacolon Clozaril PS Novartis Sector: Neutropenia Pharma ORAL Not reported 502 DAY Vomiting Valproate Sodium C Omeprazole C Metoprolol C Simvastatin C Bezafibrate C Ibuprofen C Date:03/31/05ISR Number: 4624040-2Report Type:Expedited (15-DaCompany Report #PHBS2005PH04243 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Leponex PS Novartis Sector: Hospitalization - Pyrexia Pharma ORAL 25 mg/d Initial or Prolonged Epival C UNKNOWN 250 mg/d Date:04/01/05ISR Number: 4625239-1Report Type:Expedited (15-DaCompany Report #US-ROCHE-399151 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Constipation Klonopin PS Roche ORAL 1MG AT Initial or Prolonged Intestinal Obstruction BEDTIME AS NEEDED. Clozapine SS ORAL Benzatropine SS UNKNOWN 1 MG TAKEN IN THE MORNING AND 2 MG TAKEN AN BEDTIME. Lexapro SS ORAL TAKEN IN THE MORNING. Date:04/01/05ISR Number: 4625473-0Report Type:Expedited (15-DaCompany Report #PHEH2005US03325 Age:56 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Clozaril PS Novartis Sector: Cardio-Respiratory Arrest Pharma 600 mg, QD Pneumonia Uroxatral C ORAL 10 mg, PRN Vomiting Klonopin C ORAL 1 mg, BID Buspar C ORAL 15 mg, TID Cogentin C ORAL 4 mg, BID Risperdal C ORAL 2 mg, BID Date:04/01/05ISR Number: 4625474-2Report Type:Expedited (15-DaCompany Report #PHFR2005GB01290 Age:41 YR Gender:Male I/FU:I Outcome PT Hospitalization - Colectomy Initial or Prolonged Constipation Faecaloma Intestinal Functional Disorder 22-Feb-2006 08:30 AM Page: 3231 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Platelet Count Decreased Stupor Report Source Product Role Manufacturer Route Dose Duration Clozaril PS Novartis Sector: Pharma ORAL 4048 DAY Clozaril SS Novartis Sector: Pharma ORAL 100mg/day Date:04/01/05ISR Number: 4625475-4Report Type:Expedited (15-DaCompany Report #PHHO2005CA02703 Age:56 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Bronchospasm Clozaril (Clozapine) PS Novartis Sector: Hospitalization - Depressed Level Of Pharma UNK, UNK 17280MIN Initial or Prolonged Consciousness Crestor SS Other General Physical Health Rivotril C Deterioration Anafranil C Oxygen Saturation Monocor C Abnormal Seroquel C Respiratory Distress Tachycardia Date:04/01/05ISR Number: 4627682-3Report Type:Expedited (15-DaCompany Report #2005S1000207 Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Toxicity Health Clozapine Tablets Professional (100 Mg) PS ORAL 600 MG; HS; Other PO Glipizide Xl C Date:04/01/05ISR Number: 4627683-5Report Type:Expedited (15-DaCompany Report #2005S1000354 Age:58 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asthma Health Clozapine Tablets Hospitalization - Bronchitis Acute Professional (25 Mg) PS ORAL 12.5 MG; QD; Initial or Prolonged Dysarthria Other PO; 50 MG; Dysphagia QD; PO Infection Clozapine Tablets Influenza (100 Mg) SS ORAL 100 MG; QD; Leukopenia PO Pneumonia Aspiration Quetiapine C Refusal Of Treatment By Risperidone C Relative Clonazepam C Respiratory Tract Acetylsalicylic Acid C Congestion Multivitamins C Sepsis Docusate Sodium C White Blood Cell Count Terazosin Decreased Hydrochloride C Oxybutynin C Lorazepam C 22-Feb-2006 08:30 AM Page: 3232 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/01/05ISR Number: 4627685-9Report Type:Expedited (15-DaCompany Report #2005S1000914 Age:77 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional (25 Mg) PS ORAL 25 MG; HS; PO Other Atorvastatin C Alfuzosin Hydrochloride C Dutasteride C Lisinopril C Rosiglitazone Maleate C Ascorbic Acid C Galantamine Hydrobromide C Amantadine Hydrochloride C Tocopherol C Pseudoephedrine Sulfate/Loratadine C Multivitamins, Plain C Tolterodne L-Tartrate C Zafirlukast C Date:04/01/05ISR Number: 4627948-7Report Type:Expedited (15-DaCompany Report #05-03-0470 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Neoplasm Malignant Health Clozapine Tablets - Hospitalization - Metastases To Spine Professional Ivax Initial or Prolonged Pneumonia Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc ORAL 700MG QD ORAL Date:04/01/05ISR Number: 4627976-1Report Type:Expedited (15-DaCompany Report #2005S1001360 Age:81 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death General Physical Health Other Clozapine Tablets Deterioration (100 Mg) PS ORAL 100 MG; BID; Prostate Cancer PO L.Evodopa/Carbidopa C Ropinirole C Hydrochloride C Rabeprazole Sodium C Ascorbic Acid C Cyanocobalamin C Date:04/01/05ISR Number: 4627980-3Report Type:Expedited (15-DaCompany Report #2005S1001328 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional (100 Mg) PS ORAL SEE IMAGE, PO Other Tiotropium Bromide C Lansoprazole C Docusate Sodium C 22-Feb-2006 08:30 AM Page: 3233 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Salmeterol Xinafoate C Escitalopram C Date:04/01/05ISR Number: 4627984-0Report Type:Expedited (15-DaCompany Report #2005S1001338 Age:79 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Renal Failure Health Clozapine Tablets Professional (25 Mg) PS ORAL 100 MG; Q8H; Other PO Levodopa/Carbidopa C Metoprolol Succinate C Flecainide Acetate C Montelukast Sodium C Finasteride C Atorvastatin C Date:04/01/05ISR Number: 4627986-4Report Type:Expedited (15-DaCompany Report #2005S1001349 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets PS ORAL PO Professional Other Date:04/01/05ISR Number: 4627988-8Report Type:Expedited (15-DaCompany Report #2005S1000940 Age:56 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozapine Tablets Gastrointestinal Professional (25 Mg) PS ORAL 25 MG; TID; Haemorrhage Other PO Clozapine Tablets (100 Mg) SS ORAL 100 MG; TID; PO Date:04/01/05ISR Number: 4627989-XReport Type:Expedited (15-DaCompany Report #2005S1001288 Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Chest X-Ray Abnormal Health Clozapine Tablets Dyspnoea Professional (25 Mg) PS ORAL 50 MG; HS; PO Other Clozapine Tablets (100 Mg) SS ORAL 400 MG; HS; PO Escitalopram C Lansoprazole C Psyllium Hydrophilic C Mucilloid C Valproate Semisodium C Benzatropine Mesilate C Ascorbic Acid/Tocopherol/Reti nol C Macrogol C Ziprasidone 22-Feb-2006 08:30 AM Page: 3234 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride C Date:04/01/05ISR Number: 4627990-6Report Type:Expedited (15-DaCompany Report #2005S1001294 Age:79 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Parkinson'S Disease Health Clozapine Tablets Professional (25 Mg) PS ORAL 25 MG; HS; PO Other Furosemide C Glipizide C Valsartan C Levodopa/Carbidopa C Date:04/01/05ISR Number: 4627993-1Report Type:Expedited (15-DaCompany Report #2005S1001323 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional (100 Mg) PS Other Date:04/01/05ISR Number: 4627994-3Report Type:Expedited (15-DaCompany Report #2005S1000440 Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional (100 Mg) PS ORAL SEE IMAGE, PO Other Celecoxib C Acetylsalicylic Acid C Atenolol C Atorvastatin C Tamsulosin C Hydrochloride C Hydrochlorothiazide/ Triamterene C Valsartan C Valproate Semisodium C Date:04/01/05ISR Number: 4628018-4Report Type:Expedited (15-DaCompany Report #05-03-0496 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Neoplasm Malignant Health Clozapine Tablets - Other Medication Error Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 175-200MG QD ORAL Date:04/01/05ISR Number: 4628019-6Report Type:Expedited (15-DaCompany Report #05-03-0497 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Infection Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, 22-Feb-2006 08:30 AM Page: 3235 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Inc. PS Ivax Pharmaceuticals, Inc. ORAL 100-500MG QD ORAL Date:04/01/05ISR Number: 4628026-3Report Type:Expedited (15-DaCompany Report #05-03-0481 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Colon Cancer Metastatic Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 350-400MG QD ORAL Date:04/01/05ISR Number: 4628027-5Report Type:Expedited (15-DaCompany Report #05-03-0476 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 200MG QD ORAL Date:04/01/05ISR Number: 4628043-3Report Type:Expedited (15-DaCompany Report #05-03-0469 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Colitis Ischaemic Health Clozapine Tablets - Initial or Prolonged Convulsion Professional Ivax Superior Sagittal Sinus Other Pharmaceuticals, Thrombosis Inc. PS Ivax Pharmaceuticals, Inc. ORAL 25-750MG QD ORAL Haldol C Cogentin C Depakote C Ativan C Abilify C Perdiem C Date:04/01/05ISR Number: 4628149-9Report Type:Expedited (15-DaCompany Report #05-03-0506 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 400-500MG QD ORAL 22-Feb-2006 08:30 AM Page: 3236 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/01/05ISR Number: 4628151-7Report Type:Expedited (15-DaCompany Report #05-03-0505 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Haemorrhage Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 50-400MG QD ORAL Date:04/01/05ISR Number: 4628153-0Report Type:Expedited (15-DaCompany Report #05-03-0461 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebral Infarction Health Clozapine - Ivax Hospitalization - Depressed Level Of Professional Pharmaceuticals, Initial or Prolonged Consciousness Other Inc. Tablets PS Ivax Grand Mal Convulsion Pharmaceuticals, Hyperchloraemia Inc. ORAL 100MG BID Hypernatraemia ORAL Pneumonitis Fluvoxamine C Seroquel C Gabapentin C Luvox C Topamax C Metoprolol C Prevacid C Trazodone C Date:04/01/05ISR Number: 4628155-4Report Type:Expedited (15-DaCompany Report #05-02-0478 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Chronic Myeloid Leukaemia Health Clozapine - Ivax Hospitalization - Pneumonia Professional Pharmaceuticals, Initial or Prolonged Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 275MG QD ORAL Depakote SS 750MG TID Dilantin C Neurontin C Toprol Xl C Date:04/01/05ISR Number: 4628157-8Report Type:Expedited (15-DaCompany Report #05-03-0529 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Small Cell Carcinoma Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 600-800MG QD ORAL 22-Feb-2006 08:30 AM Page: 3237 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/01/05ISR Number: 4632135-2Report Type:Periodic Company Report #04P-163-0256643-00 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Agranulocytosis Health Depakote(Divalproex Intervention to Professional Sodium) (Divalproex Prevent Permanent Company Sodium) PS 1500 MG, 1 IN Impairment/Damage Representative 1 D Clozapine SS Date:04/01/05ISR Number: 4632137-6Report Type:Periodic Company Report #04P-163-0257368-00 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Neutropenia Health Depakote Intervention to Professional 250mg(Depakote) Prevent Permanent Other (Divalproex Sodium) Impairment/Damage (Divalproex Sodium) PS 250 MG @ 9AM/500 MG G HS Clozapine SS ORAL 100 MG, 1 IN 1 D, ORAL Benzatropine Mesilate SS Date:04/01/05ISR Number: 4632333-8Report Type:Periodic Company Report #04P-163-0262787-00 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Thrombocytopenia Health Depakote (Divalproex Initial or Prolonged Professional Sodium) (Divalproex Other Sodium) PS ORAL 1000 MG, 1 IN 1 D, PER ORAL Clozapine SS ORAL 500 MG, 1 IN 1 D, PER ORAL Tagamet C Date:04/04/05ISR Number: 4625983-6Report Type:Expedited (15-DaCompany Report #PHNU2005SI00925 Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abscess Leponex / Clozaril Hospitalization - Agranulocytosis (Clozapine) PS Novartis Sector: Initial or Prolonged Dyspnoea Pharma ORAL 350 mg/day Leukopenia Lamictal Pyrexia "Glaxosmithkline" C ORAL 100 mg, BID Sepsis Fluanxol C ORAL 20 mg/day Date:04/04/05ISR Number: 4626169-1Report Type:Expedited (15-DaCompany Report #PHBS2005CA04559 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tachycardia Clozaril (Clozapine) PS Novartis Sector: Ventricular Hypokinesia Pharma UNKNOWN 550 mg/d 22-Feb-2006 08:30 AM Page: 3238 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/05/05ISR Number: 4626771-7Report Type:Expedited (15-DaCompany Report #PHFR2005GB01285 Age:58 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Glucose Increased Clozaril PS Novartis Sector: Hospitalization - Cardiac Arrest Pharma ORAL 200mg/day Initial or Prolonged Cardiac Failure Other Cholelithiasis Circulatory Collapse Diabetes Mellitus Malaise Pancreatitis Date:04/05/05ISR Number: 4626803-6Report Type:Expedited (15-DaCompany Report #PHHO2005CA02703 Age:56 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Bronchospasm Clozaril (Clozapine) PS Novartis Sector: Hospitalization - Depressed Level Of Pharma UNK, UNK 17280MIN Initial or Prolonged Consciousness Crestor SS Other General Physical Health Rivotril C Deterioration Anafranil C Oxygen Saturation Monocor C Abnormal Seroquel C Respiratory Distress Tachycardia Date:04/05/05ISR Number: 4626806-1Report Type:Expedited (15-DaCompany Report #GXKR2005US00708 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Clozapine PS Novartis Sector: Initial or Prolonged Drug Interaction Pharma UNK, UNK 2007 DAY Other Dyspepsia Sulfamethoxazole+Tri Fatigue methoprim (Ngx) SS Neutropenia Paranoia Thrombocytopenia Date:04/05/05ISR Number: 4626940-6Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050306353 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Overdose Tylenol PS Initial or Prolonged Drug Toxicity Tylenol SS Liver Disorder Clozapine SS OROPHARINGEAL Date:04/05/05ISR Number: 4627068-1Report Type:Expedited (15-DaCompany Report #PHNU2004DE03555 Age:25 YR Gender:Male I/FU:F Outcome PT Other Alcoholism Blood Pressure Increased Eosinophil Percentage Increased Gamma-Glutamyltransferase Increased Salivary Hypersecretion 22-Feb-2006 08:30 AM Page: 3239 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Somnolence Tachycardia Weight Increased Report Source Product Role Manufacturer Route Dose Duration Leponex / Clozaril (Clozapine) PS Novartis Sector: Pharma ORAL up to 900 mg/day Date:04/05/05ISR Number: 4627343-0Report Type:Expedited (15-DaCompany Report #2005S1000950 Age:18 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Overdose Health Clozapine Tablets Drug Effect Decreased Professional (100 Mg) PS ORAL 150 MG , QAM; Mental Status Changes Other PO Clonazepam C Clomipramine C Hydrochloride C Trazodone C Minocycline C Date:04/05/05ISR Number: 4627347-8Report Type:Expedited (15-DaCompany Report #2005S1000947 Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Glioblastoma Health Clozapine Tablets Lung Cancer Metastatic Professional (100 Mg) PS ORAL SEE IMAGE Other Date:04/05/05ISR Number: 4627349-1Report Type:Expedited (15-DaCompany Report #2005S1000589 Age:67 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Parkinson'S Disease Health Clozapine Tablets Professional (25mg) PS ORAL SEE IMAGE Other Calcitonin, Salmon C Lorazepam C Paracetamol/Hydrocod one C Bitartrate C Phenytoin Sodium C Lansoprazole C Paroxetine Hydrochloride C Midodrine Hydrochloride C Selegiline C Levodopa /Carbidopa C Morphine 20 Mg/Ml Solution C Ibuprofen C 22-Feb-2006 08:30 AM Page: 3240 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/05/05ISR Number: 4627351-XReport Type:Expedited (15-DaCompany Report #2005S1000572 Age:67 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agranulocytosis Health Clozapine Tablets Jaundice Cholestatic Professional (25 Mg) PS ORAL 50 MG, QAM ; Septic Necrosis Other PO, Clozapine Tablets (100 Mg) SS SE IMAGE Senna Fruit C Zolpidem Tartrate C Triamcinolone Acetonide C Cetirizine C Hydrochloride C Diphenhydramine C Hydrocortisone C Furosemide C Perphenazine C Clark'S Solution C Magnesium Hydroxide/Aluminium Hydroxide Gel C Terbinafine Hydrochloride C Pantoprazole C Gatifloxacin C Paracetamol C Trazodone C Tamsulosin Hydrochloride C Diclofenac C Baclofen C Date:04/05/05ISR Number: 4627354-5Report Type:Expedited (15-DaCompany Report #2005S1001447 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional (100 Mg) PS ORAL 400 MG; BID; Other PO Clozapine Tablets (25 Mg) SS ORAL 50 MG;Q24; PO Bupropion Hydrochloride C Clonazepam C Fexofenadine C Hydrochloride C Docusate Sodum C Lansoprazole C Metoclopramide Hydrochloride C Date:04/05/05ISR Number: 4627356-9Report Type:Expedited (15-DaCompany Report #2005S1001377 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets ( Professional 25 Mg) PS ORAL 75 MG; BID; Other PO 22-Feb-2006 08:30 AM Page: 3241 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Clozapine Tablets (100 Mg) SS ORAL 200 MG ; BID; PO Date:04/05/05ISR Number: 4628053-6Report Type:Direct Company Report #CTU 245325 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Drooling Clozapine Bid PS 200 MG BID Pharmaceutical Product Complaint Date:04/05/05ISR Number: 4628990-2Report Type:Direct Company Report #CTU 245300 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Abilify PS DAILY Drug Interaction Zoloft SS DAILY Paradoxical Drug Reaction Clozaril SS Suicidal Ideation Date:04/06/05ISR Number: 4628143-8Report Type:Expedited (15-DaCompany Report #PHBS2005DE03547 Age:51 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akinesia Clozapine PS Novartis Sector: Initial or Prolonged Aphasia Pharma UNKNOWN 12.5 mg/d C-Reactive Protein Clozapine SS Novartis Sector: Increased Pharma UNKNOWN 150 mg/d Drug Interaction Clozapine SS Novartis Sector: Drug Level Increased Pharma UNKNOWN 200 mg/d Escherichia Infection Clozapine SS Novartis Sector: Gait Disturbance Pharma UNKNOWN 100 mg, QHS Pyrexia Clozapine SS Novartis Sector: Speech Disorder Pharma UNKNOWN 200 mg/d Urinary Tract Infection Mirtazapine (Ngx) SS UNKNOWN 30-15 mg/d Mirtazapine (Ngx) SS UNKNOWN 15 mg/d Date:04/06/05ISR Number: 4628269-9Report Type:Expedited (15-DaCompany Report #PHEH2005US01691 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Feeling Abnormal Clozaril PS Novartis Sector: Initial or Prolonged Leukopenia Pharma ORAL 350 mg, QD Neutropenia Pancytopenia Pharyngolaryngeal Pain Psychotic Disorder Pyrexia Date:04/06/05ISR Number: 4631032-6Report Type:Direct Company Report #CTU 245485 Age:43 YR Gender:Male I/FU:I Outcome PT Other Anxiety Condition Aggravated 22-Feb-2006 08:30 AM Page: 3242 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Irritability Obsessive-Compulsive Disorder Report Source Product Role Manufacturer Route Dose Duration Paranoia Clozapine PS Pharmaceutical Product Depakote C Complaint Ativan C Date:04/06/05ISR Number: 4631116-2Report Type:Direct Company Report #CTU 245516 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Clozapine PS ORAL 300 MG BID PO 4 WK Pharmaceutical Product Complaint Date:04/07/05ISR Number: 4631616-5Report Type:Expedited (15-DaCompany Report #2005SE01927 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Abdomen Health Seroquel PS ORAL 300 MG BID PO Cardio-Respiratory Arrest Professional Clozapine SS ORAL 100 MG QID PO Epistaxis Other Valproic Acid C Hypotension Fluphenazine C Thrombocytopenia Date:04/08/05ISR Number: 4629917-XReport Type:Expedited (15-DaCompany Report #PHBS2005YU04715 Age:67 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cough Leponex PS Novartis Sector: Increased Bronchial Pharma ORAL 100 mg, TID Secretion Rhonchi Date:04/08/05ISR Number: 4629927-2Report Type:Expedited (15-DaCompany Report #PHNU2005DE01469 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - General Physical Health Leponex / Clozaril Initial or Prolonged Deterioration (Clozapine) PS Novartis Sector: Other Haemoglobin Decreased Pharma ORAL Date:04/08/05ISR Number: 4630329-3Report Type:Expedited (15-DaCompany Report #PHFR2005GB01429 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatinine Clozapine PS Novartis Sector: Increased Pharma Creatinine Renal Clearance Decreased Renal Impairment 22-Feb-2006 08:30 AM Page: 3243 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/08/05ISR Number: 4630337-2Report Type:Expedited (15-DaCompany Report #PHFR2005GB01429 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatinine Clozapine PS Novartis Sector: Increased Pharma Creatinine Renal Clearance Decreased Renal Impairment Date:04/08/05ISR Number: 4632525-8Report Type:Expedited (15-DaCompany Report #PHBS2005DEU03547 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akinesia Foreign Clozapine Initial or Prolonged Aphasia Literature (Clozapine) PS 12.5 MG/D, Drug Interaction Health UNKNOWN (SEE Drug Toxicity Professional IMAGE) Escherichia Urinary Tract Other Mirtazapine SS 30 5MG/D, Infection UNKNOWN (SEE Gait Disturbance IMAGE) Incoherent Therapy Non-Responder Date:04/08/05ISR Number: 4632606-9Report Type:Expedited (15-DaCompany Report #05-04-0535 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL ORAL Date:04/08/05ISR Number: 4632607-0Report Type:Expedited (15-DaCompany Report #05-04-0542 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mania Health Clozapine - Ivax Initial or Prolonged Stress Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL ORAL Date:04/08/05ISR Number: 4632608-2Report Type:Expedited (15-DaCompany Report #05-02-0218 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Atherosclerosis Health Clozapine - Ivax Congestive Cardiomyopathy Professional Pharmaceuticals, Emphysema Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 200MG BID ORAL Warfarin Sodium C 22-Feb-2006 08:30 AM Page: 3244 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/08/05ISR Number: 4632610-0Report Type:Expedited (15-DaCompany Report #2005S1001490 Age:69 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional (100 Mg) PS ORAL 300 MG; HS; Other PO Citalopram Hydrobromide C Lisinopril C Date:04/08/05ISR Number: 4632611-2Report Type:Expedited (15-DaCompany Report #2005S1001504 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Neoplasm Malignant Health Clozapine Tablets Professional (25 Mg) PS ORAL 75 MG; BID; Other PO Clonazapine Tablets (100 Mg) SS ORAL 200 MG; HS; PO Date:04/08/05ISR Number: 4632612-4Report Type:Expedited (15-DaCompany Report #2005S1001515 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Health Clozapine Tablets Haemorrhoid Operation Professional (100 Mg) PS ORAL SEE IMAGE Other Lithium C Date:04/08/05ISR Number: 4632615-XReport Type:Expedited (15-DaCompany Report #2005S1001481 Age:78 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional (100 Mg) PS ORAL 200 MG; HS; Other PO Clozapine Tablet (25 Mg) SS ORAL SEE IMAGE Date:04/08/05ISR Number: 4633450-9Report Type:Expedited (15-DaCompany Report #2005UW02051 Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Toxicity Health Amitriptyline PS Other Intentional Misuse Professional Clozapine SS ORAL 400 MG QD PO Medication Error Imipramine SS Multiple Drug Overdose Luvox C Accidental Buspar C Schizoaffective Disorder Self-Medication 22-Feb-2006 08:30 AM Page: 3245 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/11/05ISR Number: 4631940-6Report Type:Expedited (15-DaCompany Report #PHRM2005FR01227 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Antipsychotic Drug Level Leponex PS Novartis Sector: Above Therapeutic Pharma ORAL 400 mg/day Pneumonia Aspiration Theralene C ORAL Vomiting Date:04/11/05ISR Number: 4632052-8Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12915138 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dizziness Abilify PS Otsuka Initial or Prolonged Fall Pharmaceutical Hypercalcaemia Company, Ltd. Psychiatric Symptom Clozapine SS ORAL Renal Failure Lamictal C ORAL Colace C ORAL Date:04/11/05ISR Number: 4632329-6Report Type:Expedited (15-DaCompany Report #PHFR2005GB01028 Age:60 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Exposure Clozaril PS Novartis Sector: Initial or Prolonged Dyspnoea Pharma ORAL 250 mg, Hypersensitivity ONCE/SINGLE Swelling Face Procyclidine C ORAL 5 g, TID Oxybutynin C 5 mg, BID Trimethoprim C ORAL 100 mg, UNK Valproate Sodium C ORAL Sertraline C Promazine C ORAL Quinine Sulphate C ORAL Clopixol /00876701/ C INTRAMUSCULAR Hyoscine Hydrobromide C Date:04/11/05ISR Number: 4632335-1Report Type:Expedited (15-DaCompany Report #PHHO2005NZ01676 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Tamponade Clozaril (Clozapine) PS Novartis Sector: Initial or Prolonged Myocarditis Pharma ORAL 500 mg, QD 3390 DAY Pericardial Drainage Antibiotics C Pericardial Effusion Pleural Effusion Date:04/11/05ISR Number: 4632336-3Report Type:Expedited (15-DaCompany Report #PHBS2005AU04861 Age:16 YR Gender:Female I/FU:I Outcome PT Hospitalization - Autoimmune Thyroiditis Initial or Prolonged Blood Prolactin Increased Coeliac Disease Goitre 22-Feb-2006 08:30 AM Page: 3246 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hypothyroidism Menorrhagia Nausea Report Source Product Role Manufacturer Route Dose Duration Pituitary Tumour Benign Clozapine PS Novartis Sector: Tremor Pharma UNKNOWN 225 mg/d Visual Field Defect Cabergoline C UNKNOWN 0.5 mg, QW Vomiting Cabergoline C UNKNOWN 0.5 mg, BIW Weight Decreased Thyroxine C UNKNOWN 250 mg/d Temazepam C UNKNOWN Levonorgestrel W/Ethinylestradiol C UNKNOWN Norethisterone C UNKNOWN Warfarin C UNKNOWN Lisinopril C UNKNOWN 5 mg/d Date:04/11/05ISR Number: 4632507-6Report Type:Expedited (15-DaCompany Report #05-02-0216 Age:76 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Health Clozapine - Ivax Initial or Prolonged Staphylococcal Infection Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 25-250MG QD ORAL Losartan C Lasix C Prevacid C Date:04/11/05ISR Number: 4632508-8Report Type:Expedited (15-DaCompany Report #05-01-0092 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiomegaly Health Clozapine - Ivax Cardiomyopathy Professional Pharmaceuticals, Sudden Cardiac Death Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 100MG BID ORAL Lorazepam Tablets C Zoloft Tablets C Allegra Tablets 180 Mg C Benztropine Mesylate Tablets C Clonazepam Tablets C Fluoxetine Capsules C Claritin Tablets C Seroquel Tablets C Zyprexa Tablets C Trileptal Tablets C Tobradex Ophtalmic C Prednisolone Ophthalmic C Penicillin V-K Tablets C Clarinex Tablets C 22-Feb-2006 08:30 AM Page: 3247 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/11/05ISR Number: 4632509-XReport Type:Expedited (15-DaCompany Report #05-04-0564 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Influenza Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 37.5MG QD ORAL Date:04/11/05ISR Number: 4632510-6Report Type:Expedited (15-DaCompany Report #05-03-0382 Age:46 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Clozapine - Ivax Initial or Prolonged Drooling Professional Pharmaceuticals, Other Dysphagia Other Inc. Tablets PS Ivax Gastric Stenosis Pharmaceuticals, Pneumonia Aspiration Inc. ORAL 50-20MG QD Post Procedural ORAL Complication Geodon C Zoloft 200 Mg C Nexium 40 Mg C Date:04/11/05ISR Number: 4632511-8Report Type:Expedited (15-DaCompany Report #05-02-0252 Age:67 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Colorectal Cancer Stage Health Clozapine -Ivax Initial or Prolonged Iii Professional Pharmaceuticals, Other White Blood Cell Count Other Inc. Tablets PS Ivax Decreased Pharmaceuticals, Inc. ORAL 25MG QD ORAL Chemotherapy C Paxil C Date:04/11/05ISR Number: 4632513-1Report Type:Expedited (15-DaCompany Report #05-04-0556 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dysphagia Other Clozapine - Ivax Other Pneumonia Aspiration Pharmaceuticals, Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 62.5MG QD ORAL Date:04/11/05ISR Number: 4632514-3Report Type:Expedited (15-DaCompany Report #05-04-0552 Age:69 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 200MG QD ORAL 22-Feb-2006 08:30 AM Page: 3248 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/12/05ISR Number: 4632781-6Report Type:Expedited (15-DaCompany Report #PHBS2005AU04873 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Adverse Drug Reaction Clozapine PS Novartis Sector: Initial or Prolonged Alanine Aminotransferase Pharma UNKNOWN 12.5 mg/d Increased Clozapine SS Novartis Sector: C-Reactive Protein Pharma UNKNOWN 150 mg/d Increased Temazepam C UNKNOWN 10-20 mg as Cholangitis required Cholelithiasis Circadian Rhythm Sleep Disorder Gamma-Glutamyltransferase Increased Neutrophilia Pyrexia Sinus Tachycardia Date:04/12/05ISR Number: 4632782-8Report Type:Expedited (15-DaCompany Report #PHFR2005GB00505 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebellar Infarction Clozaril PS Novartis Sector: Initial or Prolonged Hyperlipidaemia Pharma ORAL 700 mg/day Hypertension Amisulpride C 600mg/day Overweight Pravastatin C ORAL Posture Abnormal Bendrofluazide C ORAL 2.5mg/day Date:04/12/05ISR Number: 4632783-XReport Type:Expedited (15-DaCompany Report #PHBS2005ES04938 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Colitis Leponex PS Novartis Sector: Initial or Prolonged Diarrhoea Pharma ORAL Other Syncope Zyprexa C UNKNOWN Weight Decreased Date:04/12/05ISR Number: 4632784-1Report Type:Expedited (15-DaCompany Report #PHRM2005FR01132 Age:21 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Multiple Sclerosis Leponex PS Novartis Sector: Optic Neuritis Pharma ORAL 575 mg daily Retrobulbar Date:04/12/05ISR Number: 4633246-8Report Type:Direct Company Report #CTU 245944 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Clozapine PS Insomnia Paranoia Pharmaceutical Product Complaint Restlessness 22-Feb-2006 08:30 AM Page: 3249 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/12/05ISR Number: 4633437-6Report Type:Expedited (15-DaCompany Report #HQWYE650604APR05 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Health Efexor Xr White Blood Cell Count Professional (Venlafaxine Decreased Other Hydrochloride, Capsule, Extended Release) PS ORAL 150 MG 1 X PER 1 DAY; ORAL 25 DAY Clozaril (Clozapine) SS ORAL 300 MG1X PER DAY 149 DAY Lamictal (Lamotrigene) SS ORAL 25 MG 1X PER DAY Date:04/12/05ISR Number: 4633888-XReport Type:Expedited (15-DaCompany Report #2005S1001108 Age:79 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional (25 Mg) PS ORAL 12.5 MG ; HS Other ; PO Date:04/12/05ISR Number: 4633910-0Report Type:Expedited (15-DaCompany Report #2005S1001573 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional (25 Mg) PS ORAL 75 MG; HS; PO Other Date:04/12/05ISR Number: 4633912-4Report Type:Expedited (15-DaCompany Report #2005S1001608 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Health Clozapine Tablets Professional (100 Mg) PS ORAL 100 MG; BID; Other PO Date:04/12/05ISR Number: 4633914-8Report Type:Expedited (15-DaCompany Report #2005S1001715 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional (25 Mg) PS ORAL 25 MG; BID; Other PO Clozapine Tablets (100 Mcg) SS ORAL 100 MG;BID;PO; SEE IMAGE Risperidone C Famotidine C Captopril C Valproate Sodium C Insulin C 22-Feb-2006 08:30 AM Page: 3250 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/12/05ISR Number: 4633919-7Report Type:Direct Company Report #CTU 245876 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Level Fluctuating Clozaril 100 Mg PS 2 AM/5 PM Pharmaceutical Product TAKEN PO Complaint Date:04/12/05ISR Number: 4633965-3Report Type:Expedited (15-DaCompany Report #2005S1001568 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death General Physical Health Health Clozapine Tablets Deterioration Professional (25 Mg) PS ORAL 25 MG; QD; PO Sepsis Other Clozapine Tablets (100 Mg) SS ORAL 150 MG; HS; PO Lisinopril C Estrogens Conjugated C Calcitonin, Salmon C Multivitamins, Plain C Vitamin E C Mometasone Furoate C Trazodone C Loxapine C Isosorbide Mononitrate C Docusate Sodium C Valproate Semisodium C Salmeterol Xinafoate C Calcium/Vitamin D Nos C Glyceryl Trinitrate C Fluticasone Propionate C Ipratropium Bromide/Salbutamol Sulfate C Magnesium Hydroxide/Aluminium Hydroxide Gel C Dried/Simeticone C Paracetamol C Date:04/12/05ISR Number: 4633966-5Report Type:Expedited (15-DaCompany Report #2005S1000087 Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebral Haemorrhage Other Clozapine Tablets (100 Mg) PS ORAL 300 MG; BID; PO Fluvoxamine Maleate C Amlodipine Besilate C Valproate Semisodium C Lovastatin C 22-Feb-2006 08:30 AM Page: 3251 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/12/05ISR Number: 4633973-2Report Type:Expedited (15-DaCompany Report #2005S1000827 Age:83 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Hospitalization - Professional (25 Mg) PS ORAL 75 MG; HS; PO Initial or Prolonged Other Lorazepam C Morphine C Paracetamol C Date:04/12/05ISR Number: 4633975-6Report Type:Expedited (15-DaCompany Report #2005S1001094 Age:66 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional (100 Mg) PS ORAL 300 MG; QAM; Other PO; 500 MG; HS; PO Levothyroxine Sodium C Ranitidine C Hydrochloride C Acetylsalicylic Acid C Furosemide C Potassium Chloride C Clonazepam C Vitamins Nos C Lamotrigine C Docusate Sodium C Date:04/12/05ISR Number: 4634907-7Report Type:Expedited (15-DaCompany Report #S05-FRA-01403-01 Age:78 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Iron Decreased Foreign Ebixa (Memantine) PS ORAL 20 MG QD PO Initial or Prolonged C-Reactive Protein Health Depakine (Valproate Increased Professional Sodium) SS ORAL 2 G QD PO Inflammation Other Verapamil SS ORAL 240 MG QD PO Normochromic Normocytic Athymil (Mianserin Anaemia Hydrochloride) SS ORAL 30 MG QD PO Serum Ferritin Increased Plavix (Clopidogren Sulfate) SS ORAL 1 UNK QD PO Clozapine SS ORAL 50 MG QD PO Augmentin C Date:04/13/05ISR Number: 4633785-XReport Type:Expedited (15-DaCompany Report #PHHO2005CA04305 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pernicious Anaemia Clozaril PS Novartis Sector: Pharma ORAL Date:04/13/05ISR Number: 4633957-4Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040603232 Age:62 YR Gender:Female I/FU:I Outcome PT Hospitalization - Drug Interaction Initial or Prolonged Hyperglycaemia Hypertension 22-Feb-2006 08:30 AM Page: 3252 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hyponatraemia Myocardial Infarction Platelet Count Decreased Report Source Product Role Manufacturer Route Dose Duration Sinus Tachycardia Abciximab PS INTRAVENOUS Clozaril SS OROPHARINGEAL Throxine C OROPHARINGEAL Aspirin C OROPHARINGEAL Glimepiride C OROPHARINGEAL Hyoscine C OROPHARINGEAL Lantus C SUBCUTANEOUS Perindopril C OROPHARINGEAL Metformin C OROPHARINGEAL Date:04/13/05ISR Number: 4635424-0Report Type:Expedited (15-DaCompany Report #05-03-0461 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebral Infarction Health Clozapine Tablets - Hospitalization - Depressed Level Of Professional Ivax Initial or Prolonged Consciousness Other Pharmaceuticals, Grand Mal Convulsion Inc. PS Ivax Hyperchloraemia Pharmaceuticals, Hypernatraemia Inc. ORAL 100MG BID Pneumonitis ORAL Pyrexia Fluvoxamine C Seroquel C Neuropsychotic Dysfunction C Gabapentin C Luvox C Topamax C Metoprolol C Prevacid C Trazodone C Keppra C Date:04/13/05ISR Number: 4635426-4Report Type:Expedited (15-DaCompany Report #04-11-1631 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Health Clozapine Tablets - Cardiomegaly Professional Ivax Hypothyroidism Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 500MG QD ORAL Zyprexa SS ORAL 7.5MG BID ORAL/MONTHS Levothyroxine C Diazepam C Date:04/13/05ISR Number: 4635428-8Report Type:Expedited (15-DaCompany Report #05-04-0596 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neoplasm Malignant Health Clozapine Tablets - White Blood Cell Count Professional Ivax Decreased Other Pharmaceuticals, 22-Feb-2006 08:30 AM Page: 3253 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Inc. PS Ivax Pharmaceuticals, Inc. ORAL 600MG QD ORAL Chemotherapy SS Date:04/13/05ISR Number: 4635434-3Report Type:Expedited (15-DaCompany Report #05-04-0565 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Abscess Health Clozapine Tablets - Other Pulmonary Mass Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 25-200 QD ORAL Date:04/13/05ISR Number: 4635437-9Report Type:Expedited (15-DaCompany Report #05-04-0557 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrolyte Imbalance Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 200MG QHS ORAL Date:04/13/05ISR Number: 4635439-2Report Type:Expedited (15-DaCompany Report #05-04-0553 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neoplasm Malignant Health Clozapine Tablets - White Blood Cell Count Professional Ivax Decreased Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 125-600MG QD ORAL Chemotherapy For Cancer C Date:04/14/05ISR Number: 4635235-6Report Type:Expedited (15-DaCompany Report #PHBS2005US05072 Age:27 YR Gender:Male I/FU:I Outcome PT Death Blood Cholesterol Hospitalization - Increased Initial or Prolonged Blood Triglycerides Other Increased Body Mass Index Increased Circulatory Collapse Diabetes Mellitus Insulin-Dependent Diabetes Mellitus Non-Insulin-Dependent Difficulty In Walking 22-Feb-2006 08:30 AM Page: 3254 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hypertension Low Density Lipoprotein Increased Report Source Product Role Manufacturer Route Dose Duration Metabolic Syndrome Clozapine PS Novartis Sector: Salivary Hypersecretion Pharma UNKNOWN 400 mg/d Sedation Clozapine SS Novartis Sector: Sleep Disorder Pharma UNKNOWN 200 mg/d Snoring Clozapine SS Novartis Sector: Weight Increased Pharma UNKNOWN 300 mg/d Ziprasidone C Aripiprazole C Olanzapine C Risperidone C 3 mg, BID Quetiapine C UNKNOWN 800 mg/d Haloperidol C UNKNOWN 5 mg/d Lamotrigine C UNKNOWN 200 mg/d Date:04/14/05ISR Number: 4635236-8Report Type:Expedited (15-DaCompany Report #PHNR2005AU00743 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Pulmonary Oedema Clozapine PS Novartis Sector: Blood Creatine Pharma 161 DAY Phosphokinase Increased Cardiomegaly Cardiomyopathy Eosinophil Count Increased Obesity Restrictive Cardiomyopathy Date:04/14/05ISR Number: 4635238-1Report Type:Expedited (15-DaCompany Report #PHBS2003NZ09807 Age:21 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hodgkin'S Disease Clozaril PS Novartis Sector: Lymphopenia Pharma ORAL 350 mg/day Clozaril SS Novartis Sector: Pharma ORAL 300 mg nocte Date:04/14/05ISR Number: 4635244-7Report Type:Expedited (15-DaCompany Report #PHFR2005GB00730 Age:53 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Clozaril PS Novartis Sector: Initial or Prolonged Malaise Pharma ORAL 12 x 50mg Nausea overdose Overdose Clozaril SS Novartis Sector: Pharma ORAL 150mg + 350mg Topiramate SS ORAL 2 x 150mg Topiramate SS ORAL 9 x 150mg overdose Pirenzepine SS 6 x 50mg overdose Pirenzepine SS 100 mg nocte Pirenzepine SS Topiramate SS 200 mg, BID 22-Feb-2006 08:30 AM Page: 3255 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lactulose C ORAL 20 ml/day Amlodipine C 55 mg, QD Amlodipine C ORAL 5 mg/day Femoston "Eurimpharm" C 10 mg/day Senna C ORAL Date:04/14/05ISR Number: 4635245-9Report Type:Expedited (15-DaCompany Report #PHFR2005GB01431 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypotension Clozaril PS Novartis Sector: Initial or Prolonged Medication Error Pharma ORAL 250mg/am 300mg/pm Clozaril SS Novartis Sector: Pharma ORAL 600mg/pm once Lamotrigine C Date:04/14/05ISR Number: 4635252-6Report Type:Expedited (15-DaCompany Report #PHFR2005GB01431 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypotension Clozaril PS Novartis Sector: Initial or Prolonged Medication Error Pharma ORAL 250mg/am 300mg/pm Clozaril SS Novartis Sector: Pharma ORAL 600mg/pm once Lamotrigine C Date:04/14/05ISR Number: 4635949-8Report Type:Expedited (15-DaCompany Report #2005S1001192 Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Alcohol Poisoning Health Clozapine Tablets Coronary Artery Occlusion Professional (100 Mg) PS ORAL 100 MG; HS; Endocrine Disorder Other PO Myocardial Infarction Valproate Sodium C Quetiapine C Lorazepam C Date:04/14/05ISR Number: 4635950-4Report Type:Expedited (15-DaCompany Report #2005S1001682 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional (100 Mg) PS ORAL SEE IMAGE Other Vitamins Nos C Date:04/14/05ISR Number: 4635953-XReport Type:Expedited (15-DaCompany Report #2005S1001759 Age:81 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Aspiration Health Clozapine Tablets Professional (25 Mg) PS ORAL 12.5 MG; QD; Other PO 22-Feb-2006 08:30 AM Page: 3256 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/15/05ISR Number: 4635842-0Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040603232 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperglycaemia Abciximab PS INTRAVENOUS Initial or Prolonged Hypertension Clozaril SS OROPHARINGEAL Hyponatraemia Throxine C OROPHARINGEAL Myocardial Infarction Aspirin C OROPHARINGEAL Platelet Count Decreased Glimepiride C OROPHARINGEAL Sinus Tachycardia Hyoscine C OROPHARINGEAL Lantus C SUBCUTANEOUS Perindopril C OROPHARINGEAL Metformin C OROPHARINGEAL Date:04/15/05ISR Number: 4636129-2Report Type:Expedited (15-DaCompany Report #PHFR2005GB01374 Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Asthenia Clozaril PS Novartis Sector: Other Difficulty In Walking Pharma ORAL 200 mg/day Dizziness Date:04/15/05ISR Number: 4636136-XReport Type:Expedited (15-DaCompany Report #PHFR2005GB01432 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Aspiration Clozaril PS Novartis Sector: Initial or Prolonged Pharma ORAL 2906 DAY Date:04/15/05ISR Number: 4636175-9Report Type:Expedited (15-DaCompany Report #PHFR2005GB01432 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Aspiration Clozaril PS Novartis Sector: Initial or Prolonged Pharma ORAL 2906 DAY Date:04/15/05ISR Number: 4636999-8Report Type:Expedited (15-DaCompany Report #2005S1000940 Age:56 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozapine Tablets Gastrointestinal Professional (25 Mg) PS ORAL 25 MG; TID; Haemorrhage Other PO Clozapine Tablets (100 Mg) SS ORAL 100 MG; TID; PO Date:04/15/05ISR Number: 4640137-5Report Type:Direct Company Report #CTU 246278 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Faecaloma Clozaril 100 Mg Stool Analysis Abnormal (Novartis) PS Novartis 100 MG QID 22-Feb-2006 08:30 AM Page: 3257 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/18/05ISR Number: 4637327-4Report Type:Expedited (15-DaCompany Report #PHFR2005GB00916 Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Distension Clozaril PS Novartis Sector: Hospitalization - Constipation Pharma ORAL Initial or Prolonged Eating Disorder Clozaril SS Novartis Sector: Intestinal Infarction Pharma ORAL 500mg/day Intestinal Ischaemia Amisulpride SS UNKNOWN Intestinal Perforation Zopiclone C 7.5 mg nocte Malaise Lorazepam C 1 mg nocte Peritonitis Movicol C 2 daily Weight Decreased Sodium Bicarbonate C 10 mg, BID Zispin C 30 mg Date:04/18/05ISR Number: 4637863-0Report Type:Expedited (15-DaCompany Report #PHFR2005GB01105 Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Autoimmune Disorder Clozaril PS Novartis Sector: Initial or Prolonged Blood Creatinine Pharma ORAL UNK, UNK Other Increased Valproate Sodium C ORAL 1000 mg, BID Blood Urea Increased C-Reactive Protein Increased Confusional State Constipation Convulsion Delirium Enuresis Haemoglobin Decreased Hyperpyrexia Lymphocyte Count Decreased Malaise Pericardial Effusion Pericarditis Peritonitis Renal Failure Salivary Hypersecretion Sedation Tachycardia Vomiting Date:04/18/05ISR Number: 4637874-5Report Type:Expedited (15-DaCompany Report #PHFR2005GB01105 Age:26 YR Gender:Male I/FU:F Outcome PT Hospitalization - Autoimmune Disorder Initial or Prolonged Blood Creatinine Other Increased Blood Urea Increased C-Reactive Protein Increased Confusional State Constipation Convulsion Delirium Enuresis Haemoglobin Decreased 22-Feb-2006 08:30 AM Page: 3258 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hyperpyrexia Lymphocyte Count Decreased Report Source Product Role Manufacturer Route Dose Duration Malaise Clozaril PS Novartis Sector: Pericardial Effusion Pharma ORAL UNK, UNK Pericarditis Valproate Sodium C ORAL 1000 mg, BID Peritonitis Renal Failure Salivary Hypersecretion Sedation Tachycardia Vomiting Date:04/18/05ISR Number: 4637876-9Report Type:Expedited (15-DaCompany Report #PHHO2005CA04305 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pernicious Anaemia Clozaril PS Novartis Sector: Pharma ORAL 75mg to 100mg Date:04/18/05ISR Number: 4638874-1Report Type:Direct Company Report #CTU 246442 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chills Clozapine PS Pyrexia Date:04/18/05ISR Number: 4639191-6Report Type:Expedited (15-DaCompany Report #2005SE01927 Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Distension Foreign Seroquel PS ORAL 300 MG BID PO Acute Abdomen Health Clozapine SS ORAL 100 MG QID PO Cardio-Respiratory Arrest Professional Valproic Acid C Epistaxis Other Fluphenazine C Hypotension Thrombocytopenia Date:04/18/05ISR Number: 4639355-1Report Type:Expedited (15-DaCompany Report #CHPA2005US01069 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Health Private Label (Nch) Initial or Prolonged Delirium Professional (Nicotine) Trans-Therapeutic-Sy stem PS TRANSDERMAL 21 MG, TRANSDERMAL Clozapine (Clozapine) Tablet SS ORAL 300-400MG QD, ORAL Effexor-Xr (Venlafaxine Hydrochloride) C Vitamin E (Tocopherol) C Lopid (Gemfibrozil) C Abilify 22-Feb-2006 08:30 AM Page: 3259 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Aripiprazole) C Date:04/18/05ISR Number: 4639452-0Report Type:Expedited (15-DaCompany Report #05-04-0617 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neoplasm Malignant Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 500MG QD ORAL Date:04/18/05ISR Number: 4639463-5Report Type:Expedited (15-DaCompany Report #05-03-0427 Age:64 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Neoplasm Malignant Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 375-450MG QD ORAL Date:04/18/05ISR Number: 4639534-3Report Type:Expedited (15-DaCompany Report #05-04-0611 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiomegaly Consumer Clozapine - Ivax Initial or Prolonged Dehydration Health Pharmaceuticals, Other Delusion Professional Inc. Tablets PS ORAL 300MG QD ORAL Diarrhoea Zyprexa C Ear Infection Zoloft C Eating Disorder Depakote C Enterococcal Infection Pericardial Effusion Pleural Effusion Scar Treatment Noncompliance Date:04/18/05ISR Number: 4639536-7Report Type:Expedited (15-DaCompany Report #05-04-0608 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Foot Fracture Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 25-200MG QD ORAL Date:04/18/05ISR Number: 4639897-9Report Type:Expedited (15-DaCompany Report #2005056051 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Influenza Foreign Xanax Initial or Prolonged Leukocytosis Health (Alprazolam) PS ORAL 2 MG (0.5 MG, Professional 4 IN 1 D), Other ORAL Nadroparin Calcium (Nadroparin Calcium) SS SUBCUTANEOUS 1 DOSAGE FORM (1 IN 1 D), SUBCUTANEOUS Clozapine 22-Feb-2006 08:30 AM Page: 3260 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Clozapine) SS ORAL 150 MG (25 MG, 6 IN 1 D), ORAL Lansoprazole (Lansoprazole) SS ORAL 1 DOSAGE FORM (1 IN 1 D), ORAL Domperidone (Domperidone) SS ORAL 60 MG (10 MG, 6 IN 1 D), ORAL Clonazepam (Clonazepam) SS ORAL 2.5 MG/ML, ORAL Gaviscon (Sodium Alginate, Sodium Bicarbonate) C Clorazepine Dipotassium (Clorazepate Dipotassium) C Macrogol (Macrogol) C Salactol (Lactic Acid) C Date:04/19/05ISR Number: 4638673-0Report Type:Expedited (15-DaCompany Report #PHFR2004GB02625 Age:48 YR Gender:Female I/FU:F Outcome PT Other Abdominal Pain Blood Creatine Phosphokinase Increased Blood Glucose Increased C-Reactive Protein Increased Circulatory Collapse Cognitive Disorder Constipation Diabetes Mellitus Diarrhoea Difficulty In Walking Disorientation Dizziness Dysarthria Faecal Incontinence Gait Disturbance Gastroenteritis Viral Glycosuria Grand Mal Convulsion Hypertension Infection Labile Blood Pressure Oxygen Saturation Decreased Pyrexia Sinus Tachycardia Syncope Syncope Vasovagal Tachycardia Urinary Tract Infection White Blood Cell Count 22-Feb-2006 08:30 AM Page: 3261 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Increased Report Source Product Role Manufacturer Route Dose Duration Clozaril PS Novartis Sector: Pharma ORAL 36000MIN Clozaril SS Novartis Sector: Pharma ORAL 250 mg/day Valproate Sodium C ORAL 1400 mg/day Valproate Sodium C ORAL 800 mg, BID Clonazepam C ORAL 1 mg, BID Lactulose C ORAL Metformin C ORAL 1500 mg/day Oxybutynin C ORAL 10 mg/day Omeprazole C ORAL 10 mg/day Enalapril C ORAL 7.5 mg/day Date:04/19/05ISR Number: 4638675-4Report Type:Expedited (15-DaCompany Report #PHFR2005GB01294 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Cholesterol Clozaril PS Novartis Sector: Increased Pharma ORAL Blood Triglycerides Increased Hepatic Steatosis Date:04/19/05ISR Number: 4639106-0Report Type:Expedited (15-DaCompany Report #PHBS2004IT11483 Age:19 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Clozapine PS Novartis Sector: Initial or Prolonged Alanine Aminotransferase Pharma UNKNOWN 300 mg/d 730 DAY Increased Clozapine SS Novartis Sector: Aspartate Pharma UNKNOWN 1000 mg/d Aminotransferase Venlafaxine (Ngx) SS UNKNOWN 150 mg/d 730 DAY Increased Venlafaxine (Ngx) SS UNKNOWN 900 mg/d Blood Cannabinoids Cannabis SS Blood Creatine Phosphokinase Increased Blood Pressure Abnormal Coma Delirium Leukocytosis Myoglobin Blood Increased Neuroleptic Malignant Syndrome Overdose Pyrexia Date:04/19/05ISR Number: 4639122-9Report Type:Expedited (15-DaCompany Report #PHFR2001GB03506 Age:34 YR Gender:Male I/FU:F Outcome PT Death Colitis Ulcerative Hospitalization - Intestinal Ischaemia Initial or Prolonged Intestinal Obstruction Multi-Organ Failure Necrotising Colitis 22-Feb-2006 08:30 AM Page: 3262 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sepsis Report Source Product Role Manufacturer Route Dose Duration Clozaril PS Novartis Sector: Pharma ORAL 12.5mg/day Clozaril SS Novartis Sector: Pharma ORAL 200mg/day 5760 MIN Diazepam C ORAL 4mg/day 67680MIN Olanzapine C ORAL 20mg/day reducing to zero 100 DAY Lansoprazole C ORAL 30mg/day 37440MIN Date:04/19/05ISR Number: 4639124-2Report Type:Expedited (15-DaCompany Report #PHFR2005GB01477 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Medication Error Clozaril PS Novartis Sector: Initial or Prolonged Sedation Pharma Somnolence Clozaril SS Novartis Sector: Pharma UNK, UNK Date:04/19/05ISR Number: 4639128-XReport Type:Expedited (15-DaCompany Report #PHFR2005GB01482 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Myeloproliferative Clozaril PS Novartis Sector: Disorder Pharma UNK, UNK Thrombocythaemia Citalopram C ORAL Thrombocytopenia Amisulpride C ORAL Date:04/19/05ISR Number: 4639129-1Report Type:Expedited (15-DaCompany Report #PHNU2005DE01641 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cholecystitis Leponex / Clozaril Lipase Increased (Clozapine) PS Novartis Sector: Ultrasound Scan Abnormal Pharma ORAL UNK, UNK Ergenyl Chrono C Date:04/19/05ISR Number: 4639146-1Report Type:Expedited (15-DaCompany Report #PHNU2005DE01654 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Exposure Leponex / Clozaril Initial or Prolonged Depressed Level Of (Clozapine) PS Novartis Sector: Other Consciousness Pharma ORAL Poisoning Cipralex C Somnolence Unresponsive To Verbal Stimuli 22-Feb-2006 08:30 AM Page: 3263 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/19/05ISR Number: 4641040-7Report Type:Direct Company Report #CTU 246487 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abnormal Behaviour Clozapine PS 400 MG QHS Decreased Activity Impaired Self-Care Paranoia Date:04/19/05ISR Number: 4641234-0Report Type:Direct Company Report #CTU 246593 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Neutrophil Count Clozapine PS 100 MG QAM - Intervention to Decreased 500 MG HS Prevent Permanent Impairment/Damage Date:04/19/05ISR Number: 4641235-2Report Type:Direct Company Report #CTU 246594 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Delusion Clozapine PS ORAL 900 MG / DAY Drug Effect Decreased PO Pharmaceutical Product Complaint Tremor Date:04/19/05ISR Number: 4641236-4Report Type:Direct Company Report #CTU 246595 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Paranoia Clozapine PS 50 MG QAM - 500 MG HS Date:04/20/05ISR Number: 4640356-8Report Type:Periodic Company Report #04-07-1026 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Disorientation Lithium PS Glaxosmithkline ORAL Initial or Prolonged Dizziness Clozapine SS ORAL 250MG Per day Date:04/20/05ISR Number: 4640372-6Report Type:Periodic Company Report #05-02-0149 Age:53 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Therapeutic Agent Lithium PS Glaxosmithkline UNKNOWN Initial or Prolonged Toxicity Clozapine SS ORAL Date:04/21/05ISR Number: 4641077-8Report Type:Expedited (15-DaCompany Report #PHEH2005US02626 Age:35 YR Gender:Female I/FU:F Outcome PT Hospitalization - Abdominal Pain Initial or Prolonged Antipsychotic Drug Level Other Increased 22-Feb-2006 08:30 AM Page: 3264 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Bacteria Stool Identified Band Neutrophil Count Increased Report Source Product Role Manufacturer Route Dose Duration Blood Chloride Decreased Clozaril PS Novartis Sector: Blood Glucose Increased Pharma ORAL 150 mg, BID 20160MIN Blood Potassium Decreased Depakote C ORAL 500 mg, BID Blood Sodium Decreased Zoloft C ORAL 150 mg, QD Diarrhoea Infectious Motrin C Enterococcal Infection Imodium C Eosinophil Count Ativan I UNK, PRN Increased Hepatomegaly Hypovolaemia Leukocytosis Lymphocyte Count Decreased Nausea Neutrophil Count Increased Pericardial Effusion Pericardial Fibrosis Pleural Effusion Pyrexia Urinary Tract Infection Vomiting Date:04/21/05ISR Number: 4641111-5Report Type:Expedited (15-DaCompany Report #PHFR2002GB04377 Age:61 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chronic Lymphocytic Clozaril PS Novartis Sector: Leukaemia Pharma ORAL 35mg/day Drug Level Below Lansoprazole C Therapeutic Drug Level Decreased Lymphocyte Count Increased Overweight White Blood Cell Count Increased Date:04/21/05ISR Number: 4641112-7Report Type:Expedited (15-DaCompany Report #PHNR2005AU00760 Age:30 YR Gender:Male I/FU:I Outcome PT Hospitalization - Blood Cholesterol Initial or Prolonged Increased Other Blood Creatine Phosphokinase Mb Increased Blood Pressure Decreased Blood Triglycerides Increased Cardiomegaly Cardiomyopathy Dilatation Atrial Dilatation Ventricular Eosinophilia Fatigue 22-Feb-2006 08:30 AM Page: 3265 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Low Density Lipoprotein Increased Neutrophil Count Report Source Product Role Manufacturer Route Dose Duration Increased Clozaril PS Novartis Sector: Red Blood Cell Pharma 12.5 -200 mg, Sedimentation Rate daily Increased Troponin Increased Ventricular Dysfunction Date:04/21/05ISR Number: 4641446-6Report Type:Expedited (15-DaCompany Report #PHBS2005CA04559 Age:23 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram T Wave Clozaril (Clozapine) PS Novartis Sector: Abnormal Pharma ORAL 600 mg/d Tachycardia Clozaril (Clozapine) SS Novartis Sector: Ventricular Hypokinesia Pharma ORAL 550 mg/d Buspirone C Rivotril C Ativan C Date:04/21/05ISR Number: 4641447-8Report Type:Expedited (15-DaCompany Report #PHBS2005YU05474 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Anxiety Leponex PS Novartis Sector: Confusional State Pharma ORAL 25 mg/d Hypertonia Lorazepam C Hypokinesia Hypotension Salivary Hypersecretion Date:04/21/05ISR Number: 4642142-1Report Type:Expedited (15-DaCompany Report #2005S1002016 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional (100 Mg) PS Other Date:04/21/05ISR Number: 4642144-5Report Type:Expedited (15-DaCompany Report #2005S1002015 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional (25 Mg) PS ORAL SEE IMAGE, PO Other Glibenclamide C Levofloxacin C Rosiglitazone Maleate C Potassium C Furosemide C Levothyroxine Sodium C Repaglinide C 22-Feb-2006 08:30 AM Page: 3266 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/21/05ISR Number: 4642148-2Report Type:Expedited (15-DaCompany Report #2005S1001906 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional (25 Mg) PS 25 MG Other Clozapine Tablets (100 Mg) SS 100 MG Date:04/21/05ISR Number: 4642151-2Report Type:Expedited (15-DaCompany Report #2005S1001890 Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional (25 Mg) PS ORAL 75 MG; HS; PO Other Date:04/21/05ISR Number: 4642161-5Report Type:Expedited (15-DaCompany Report #2005SI000629 Age:71 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional (100 Mg) PS ORAL 50 MG QAM PO; Other 250 MG HS PO Date:04/21/05ISR Number: 4642183-4Report Type:Expedited (15-DaCompany Report #2005S1000926 Age:51 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aneurysm Health Clozapine Tablets Headache Professional (100 Mg) PS ORAL 300 MG; HS; Malaise Other PO Bupropion Hydrochloride C Paroxetine C Diltiazem Hydrochloride C Date:04/21/05ISR Number: 4642186-XReport Type:Expedited (15-DaCompany Report #2005S1000924 Age:46 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Health Clozapine Tablets Professional (100 Mg) PS ORAL 500 MG; HS; Other PO Buspar SS ORAL BID; PO Paxil SS 30 MG; BID Tiagabine Hydrochloride C Date:04/21/05ISR Number: 4642189-5Report Type:Expedited (15-DaCompany Report #2005S1000653 Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Intracranial Aneurysm Health Clozapine Tablets Myocardial Infarction Professional (100 Mg) PS ORAL 400 MG; HS; Other PO 22-Feb-2006 08:30 AM Page: 3267 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prolixin Decanoate SS ORAL SEE IMAGE Mirtazapine C Date:04/21/05ISR Number: 4642192-5Report Type:Expedited (15-DaCompany Report #2005S1001229 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional (100 Mg) PS ORAL 400 MG; HS; Other PO Atorvastatin C Avandamet C Hydrochlorothiazide C Ranitidine C Insulin Human/Insulin Human Injection C Date:04/21/05ISR Number: 4642196-2Report Type:Expedited (15-DaCompany Report #2005S1001288 Age:61 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acquired Diaphragmatic Health Clozapine Tablets Eventration Professional (25 Mg) PS ORAL 50 MG; HS; PO Back Pain Other Clozapine Tablets Cardio-Respiratory Arrest (100 Mg) SS ORAL 400 MG; HS; Cough PO Dyspnoea Geodon SS 160 MG; BID; Oxygen Saturation Escitalopram C Decreased Lansoprazole C Restlessness Psyllium Hydrophilic C Mucilloid C Valproate Semisodium C Benzatropine Mesilate C Ascorbic Acid/Tocopherol/Reti nol C Macrogol C Date:04/21/05ISR Number: 4642206-2Report Type:Expedited (15-DaCompany Report #2005S1001294 Age:79 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional (25 Mg) PS ORAL 25 MG; HS; PO Other Furosemide C Glipizide C Valsartan C Levodopa/Carbidopa C Date:04/21/05ISR Number: 4642218-9Report Type:Expedited (15-DaCompany Report #05-04-0620 Age:49 YR Gender:Male I/FU:I Outcome PT Hospitalization - Appendicitis Initial or Prolonged Bowel Sounds Abnormal 22-Feb-2006 08:30 AM Page: 3268 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Delirium Intestinal Obstruction Report Source Product Role Manufacturer Route Dose Duration Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 250-300MG QD ORAL Date:04/21/05ISR Number: 4642219-0Report Type:Expedited (15-DaCompany Report #05-04-0649 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 200-400MG QD ORAL Lipitor C Date:04/21/05ISR Number: 4642221-9Report Type:Expedited (15-DaCompany Report #05-04-0625 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Urinary Tract Infection Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 12.5-200MG QD ORAL Date:04/21/05ISR Number: 4642222-0Report Type:Expedited (15-DaCompany Report #05-04-0626 Age:69 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Choking Health Clozapine - Ivax Injury Asphyxiation Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc ORAL 800MG QD ORAL Date:04/21/05ISR Number: 4642224-4Report Type:Expedited (15-DaCompany Report #05-04-0621 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Choking Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL ORAL 22-Feb-2006 08:30 AM Page: 3269 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/21/05ISR Number: 4642228-1Report Type:Expedited (15-DaCompany Report #01-11-0616 Age:58 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Breast Cancer Health Clozapine - Ivax Hospitalization - Professional Pharmaceuticals, Initial or Prolonged Other Inc. Tablets PS Ivax Other Pharmaceuticals, Inc. ORAL 625MG QD ORAL Glucophage C Actos C Prevacid C Celebrex C Prempro C Zoloft C Trimox C Fluocinonide Cream C Hydroxyzine Hydrochloride C Sucralfate C Propoxyphene Napsylate/Acetaminop hen C Vioxx C Benzonatate C Docusate Sodium C Clonidine C Date:04/22/05ISR Number: 4642472-3Report Type:Expedited (15-DaCompany Report #FR-ROCHE-402266 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukocytosis Rivotril PS Roche ORAL 55 DAY Initial or Prolonged Xanax SS ORAL 1 DAY Leponex SS ORAL 4 DAY Leponex SS ORAL DOSE WAS REPORTED TO HAVE BEEN PROGRESSIVELY INCREASED 31 DAY Leponex SS ORAL STOPPED DUE TO FLU (FEVER UP TO 38 DEGREES C) 47 DAY Fraxiparine SS SUBCUTANEOUS 1 DOSE PER DAY. 3 DAY Motilium SS ORAL 9 DAY Lanzor SS ORAL 1 DOSE PER DAY. 9 DAY Gaviscon C 3 DOSES PER DAY. 9 DAY Tranxene C INTRAMUSCULAR GIVEN IN CASE OF AGITATION. Forlax C 2 DOSES PER DAY. 1 DAY Duofilm C 11 DAY 22-Feb-2006 08:30 AM Page: 3270 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/22/05ISR Number: 4642591-1Report Type:Expedited (15-DaCompany Report #PHFR2005GB01542 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthma Clozapine PS Novartis Sector: Pharma ORAL Date:04/22/05ISR Number: 4642611-4Report Type:Expedited (15-DaCompany Report #PHBS2005NZ05716 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Lymphoma Clozaril PS Novartis Sector: Lymphopenia Pharma ORAL 2872 DAY Clozaril SS Novartis Sector: Pharma ORAL 200 mg mane and 400 mg nocte Clozaril SS Novartis Sector: Pharma ORAL 200 mg/d Seroquel C 600 mg/d Date:04/22/05ISR Number: 4642612-6Report Type:Expedited (15-DaCompany Report #PHEH2005US02626 Age:35 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Clozaril PS Novartis Sector: Initial or Prolonged Antipsychotic Drug Level Pharma ORAL 150 mg, BID 20160MIN Other Increased Depakote C ORAL 500 mg, BID Band Neutrophil Count Zoloft C ORAL 150 mg, QD Increased Motrin C Blood Chloride Decreased Imodium C Blood Glucose Increased Ativan I UNK, PRN Blood Potassium Decreased Blood Sodium Decreased Diarrhoea Infectious Enterococcal Infection Eosinophil Count Increased Hepatomegaly Hypovolaemia Leukocytosis Lymphocyte Count Decreased Nausea Neutrophil Count Increased Pericardial Effusion Pleural Effusion Pyrexia Urinary Tract Infection Vomiting Date:04/22/05ISR Number: 4642649-7Report Type:Expedited (15-DaCompany Report #PHFR2002GB04398 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Choking Clozaril PS Novartis Sector: Respiratory Failure Pharma 22-Feb-2006 08:30 AM Page: 3271 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/22/05ISR Number: 4642674-6Report Type:Expedited (15-DaCompany Report #PHFR2005GB00480 Age:60 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Eosinophil Count Clozaril PS Novartis Sector: Initial or Prolonged Increased Pharma ORAL UNK, UNK 43200MIN Other Hypoaesthesia Clozaril SS Novartis Sector: Hypotension Pharma 1440 MIN Infection Mirtazapine C ORAL 45mg/day Ischaemic Limb Pain Pravastatin C ORAL 30mg/day Medication Error Quetiapine C UNKNOWN 100mg/day Pain Peripheral Embolism Thrombosis Date:04/22/05ISR Number: 4642675-8Report Type:Expedited (15-DaCompany Report #PHFR2004GB04761 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Murder Clozaril PS Novartis Sector: Pharma Date:04/22/05ISR Number: 4642692-8Report Type:Expedited (15-DaCompany Report #PHRM2005FR01321 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebellar Syndrome Leponex PS Novartis Sector: Initial or Prolonged Convulsion Pharma ORAL UNK, UNK Hypotension Leponex SS Novartis Sector: White Blood Cell Count Pharma Increased Date:04/22/05ISR Number: 4642694-1Report Type:Expedited (15-DaCompany Report #PHFR2005GB00663 Age:67 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Clozaril PS Novartis Sector: Initial or Prolonged Blood Glucose Increased Pharma ORAL 225mg/day 24480MIN Other Bradykinesia Clozaril SS Novartis Sector: Dehydration Pharma ORAL UNK, UNK Extrapyramidal Disorder Clozaril SS Novartis Sector: Gait Disturbance Pharma 25 mg, BID Heart Rate Increased Valproate Sodium C UNKNOWN 400 mg/day Hypotension Metformin C ORAL 500 mg, BID Lymphocyte Count Senna C ORAL 2 nocte Decreased Pantoprazole C 40mg Muscle Rigidity Neutrophil Count Increased Salivary Hypersecretion Sedation Somnolence Tachycardia Tremor Urinary Incontinence White Blood Cell Count Increased 22-Feb-2006 08:30 AM Page: 3272 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/22/05ISR Number: 4642702-8Report Type:Expedited (15-DaCompany Report #PHFR2004GB04764 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Full Blood Count Abnormal Clozaril PS Novartis Sector: Initial or Prolonged Pharma Date:04/22/05ISR Number: 4642747-8Report Type:Expedited (15-DaCompany Report #PHBS2005CA05652 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cerebral Atrophy Clozaril PS Novartis Sector: Pharma ORAL Date:04/22/05ISR Number: 4642751-XReport Type:Expedited (15-DaCompany Report #PHNU2005DE01675 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Echocardiogram Abnormal Leponex / Clozaril Fatigue (Clozapine) PS Novartis Sector: Hypertensive Crisis Pharma ORAL 150 mg/day 47520MIN Ventricular Hypertrophy Risperdal C ORAL 6 mg/day Weight Increased Date:04/22/05ISR Number: 4646174-9Report Type:Expedited (15-DaCompany Report #CHPA2005US01069 Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Health Control Step 3 7 Mg Initial or Prolonged Delirium Professional (Nch) (Nicotine) Trans-Therapeutic-Sy stem PS Nch TRANSDERMAL 7 MG, TRANSDERMAL Clozapine (Clozapine) Tablet SS ORAL 300-400MG QD, ORAL Effexor -Xr (Venlafaxine Hydrochloride) C Vitamin E (Tocopherol) C Lopid (Gemfibrozil) C Abilify (Aripiprazole) C Date:04/25/05ISR Number: 4643643-2Report Type:Expedited (15-DaCompany Report #PHBS2005CH05811 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Clozapine PS Novartis Sector: Drug Level Increased Pharma ORAL 400 mg/d Urinary Tract Infection Ciprofloxacin SS ORAL 1500 mg/d Ciprofloxacin SS ORAL 3000 mg/d Clozapine SS Novartis Sector: Pharma ORAL 500 mg/d Clozapine SS Novartis Sector: Pharma ORAL 600 mg/d Clozapine SS Novartis Sector: 22-Feb-2006 08:30 AM Page: 3273 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pharma ORAL 775 mg/d Omeprazole C Valproic Acid C Date:04/25/05ISR Number: 4643645-6Report Type:Expedited (15-DaCompany Report #PHFR2004GB04550 Age:31 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Aggression Clozaril PS Novartis Sector: Hospitalization - Blood Ph Decreased Pharma ORAL 200mg/mane Initial or Prolonged Confusional State 400mg/nocte 1016 DAY Other Convulsion Clozaril SS Novartis Sector: Cough Pharma Crepitations Clozaril SS Novartis Sector: Glasgow Coma Scale Pharma ORAL 70x100mg Abnormal overdose Hallucination Lorazepam C ORAL UNK, UNK 896 DAY Hypokalaemic Syndrome Zopiclone C ORAL 7.5mg 896 DAY Incontinence Muscle Twitching Overdose Salivary Hypersecretion Tachycardia Date:04/25/05ISR Number: 4643646-8Report Type:Expedited (15-DaCompany Report #PHFR2005GB01561 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Compartment Syndrome Clozaril PS Novartis Sector: Initial or Prolonged Neuroleptic Malignant Pharma ORAL 200 mg/day 112 DAY Syndrome Depixol C Date:04/25/05ISR Number: 4643652-3Report Type:Expedited (15-DaCompany Report #PHNU2005DE01429 Age:32 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Leponex / Clozaril Dyspnoea (Clozapine) PS Novartis Sector: Tachycardia Pharma ORAL up to 100mg/day Nebilet SS ORAL 0.5 mg, QD Abilify SS ORAL 25 mg, QD Date:04/25/05ISR Number: 4644159-XReport Type:Expedited (15-DaCompany Report #PHFR2005GB01418 Age:47 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Level Increased Lithium PS Glaxosmithkline UNKNOWN Initial or Prolonged Renal Failure Clozaril SS ORAL Therapeutic Agent Toxicity 22-Feb-2006 08:30 AM Page: 3274 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/26/05ISR Number: 4644972-9Report Type:Expedited (15-DaCompany Report #PHBS2005IE02398 Age:66 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Exposure Clozaril PS Novartis Sector: Initial or Prolonged Wrong Drug Administered Pharma UNKNOWN 525 mg over a 3-4day period Date:04/26/05ISR Number: 4645205-XReport Type:Expedited (15-DaCompany Report #05-03-0532 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Lithium PS Glaxosmithkline UNKNOWN Initial or Prolonged Blood Creatine Haldol SS UNKNOWN Other Phosphokinase Increased Clozapine SS ORAL Body Temperature Increased Confusional State Drooling Drug Interaction Dyspnoea Neuroleptic Malignant Syndrome Date:04/26/05ISR Number: 4646435-3Report Type:Expedited (15-DaCompany Report #05-04-0654 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neoplasm Malignant Health Clozapine Tablets - White Blood Cell Count Professional Ivax Decreased Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 300-550MG QD ORAL Date:04/26/05ISR Number: 4646436-5Report Type:Expedited (15-DaCompany Report #05-04-0620 Age:49 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Distension Health Clozapine Tablets - Initial or Prolonged Appendicitis Professional Ivax Bowel Sounds Abnormal Other Pharmaceuticals, Delirium Inc. PS Ivax Intestinal Obstruction Pharmaceuticals, Inc. ORAL 250-300MG QD ORAL Date:04/26/05ISR Number: 4646438-9Report Type:Expedited (15-DaCompany Report #05-04-0670 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Urinary Tract Infection Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 400-600MG QD 22-Feb-2006 08:30 AM Page: 3275 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL Date:04/26/05ISR Number: 4646460-2Report Type:Expedited (15-DaCompany Report #05-04-0552 Age:69 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 200MG QHS ORAL Clonazepam C Furosemide C Levothyroxine C Mirtazapine C Zyprexa C Prevacid C Plavix C Pentoxifylline C Date:04/26/05ISR Number: 4646605-4Report Type:Expedited (15-DaCompany Report #2005S1001103 Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Laryngeal Cancer Health Clozapine Tablets Metastatic Neoplasm Professional (100 Mg) PS ORAL SEE IMAGE Other Glycopyronium Bromide C Risperidone C Nicotine C Lorazepam C Senna C Paracetamol C Pseudoephedrine Hydrochloride C Date:04/26/05ISR Number: 4646625-XReport Type:Expedited (15-DaCompany Report #2005S1001338 Age:79 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Renal Failure Health Clozapine Tablets Professional (25mg) PS ORAL 100 MG; Q8H; Other PO Levodopa/Carbidopa C Metoprolol Succinate C Flecainide Acetate C Montelukast Sodium C Finasteride C Atorvastatin C Date:04/26/05ISR Number: 4646633-9Report Type:Expedited (15-DaCompany Report #2005S1001490 Age:69 YR Gender:Male I/FU:F Outcome PT Report Source Death Hospitalisation Health Professional 22-Feb-2006 08:30 AM Page: 3276 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Product Role Manufacturer Route Dose Duration Clozapine Tablets (100 Mg) PS ORAL 300 MG; HS; PO Citalopram Hydrobromide C Lisinopril C Date:04/26/05ISR Number: 4646637-6Report Type:Expedited (15-DaCompany Report #2005S1002233 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional (100 Mg) PS ORAL 100 MG; BID; Other PO Morphine C Lorazepam C Hyoscyamine Sulfate C Paracetamol C Bisacodyl C Levofloxacin C Cirpofloxacin C Ferrous Sulfate C Vitamin Nos C Acetylsalicylic Acid/Dipyridamole C Albuterol C Ipratropium C Date:04/26/05ISR Number: 4646638-8Report Type:Expedited (15-DaCompany Report #2005S1002223 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Neoplasm Malignant Health Clozapine Tablets Professional (25 Mg) PS ORAL 75 MG; QD; PO Other Clozapine Tablets (100 Mg) SS ORAL 500 MG; HS; PO Date:04/26/05ISR Number: 4646640-6Report Type:Expedited (15-DaCompany Report #2005S1000985 Age:57 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Fall Health Clozapine Tablets Lung Injury Professional (100 Mg) PS ORAL SEE IMAGE Multiple Drug Overdose Other Clomipramine SS ORAL 200 MG; HS; Pneumonia PO Rib Fracture Olanzapine C Lorazepam C 22-Feb-2006 08:30 AM Page: 3277 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/26/05ISR Number: 4647181-2Report Type:Direct Company Report #CTU 247147 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Level Changed Clozaril 100 Mg PS ORAL 2 AM / 5 PM TAKEN P.O. DAILY GP/ INDIV WKLY RESIDES RRP Date:04/26/05ISR Number: 4647411-7Report Type:Expedited (15-DaCompany Report #S05-FRA-01403-01 Age:78 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Iron Decreased Foreign Ebixa (Memantine) PS ORAL 20 MG QD PO Initial or Prolonged C-Reactive Protein Health Depakine (Valproate Increased Professional Sodium) SS Inflammation Other Depakine (Valproate Normochromic Normocytic Sodium) SS ORAL 1 G QD PO Anaemia Verapamil SS ORAL 240 MG QD PO Serum Ferritin Increased Athymil (Mianserin Hydrochloride) SS ORAL 30 MG QD PO Plavix (Clopidogrel Sulfate) SS ORAL 1 QD PO Clozapine SS ORAL 50 MG QD PO Augmentin C Date:04/27/05ISR Number: 4646352-9Report Type:Expedited (15-DaCompany Report #PHEH2005US04615 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Exposure Clozaril PS Novartis Sector: Initial or Prolonged Accidental Overdose Pharma ORAL Blood Pressure Decreased Alcohol SS Somnolence Ibuprofen SS ORAL Unk, Unk White Blood Cell Count Increased Date:04/27/05ISR Number: 4646373-6Report Type:Expedited (15-DaCompany Report #PHFR2005GB00457 Age:58 YR Gender:Not SpecifiI/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Grand Mal Convulsion Clozaril PS Novartis Sector: Haematemesis Pharma ORAL 650mg/day 4559 DAY Pyrexia Hydroxyzine C ORAL 25mg/day Rash Erythematous Valproate Sodium C UNK, UNK Date:04/27/05ISR Number: 4646374-8Report Type:Expedited (15-DaCompany Report #PHFR2005IE01226 Age:20 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Lactate Clozaril PS Novartis Sector: Dehydrogenase Increased Pharma ORAL UNK, UNK Chest Pain Clozaril SS Novartis Sector: Hypotension Pharma ORAL 650 mg/day Tachycardia Chlorpromazine C ORAL 25 mg/day 41760MIN Risperidone C ORAL 3 mg/day 95040MIN Cipramil 22-Feb-2006 08:30 AM Page: 3278 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report /Net/ C ORAL 30 mg/day Amisulpride C ORAL 400 mg, BID Akineton /Aus/ C ORAL 1 mg, BID 40320MIN Date:04/27/05ISR Number: 4646375-XReport Type:Expedited (15-DaCompany Report #PHFR2002GB04356 Age:51 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Infection Clozaril (Clozapine) PS Novartis Sector: Lymphocyte Count Pharma ORAL Increased White Blood Cell Count Increased Date:04/27/05ISR Number: 4646385-2Report Type:Expedited (15-DaCompany Report #PHFR2002GB04356 Age:51 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Infection Clozaril (Clozapine) PS Novartis Sector: Lymphocyte Count Pharma ORAL Increased White Blood Cell Count Increased Date:04/27/05ISR Number: 4647588-3Report Type:Direct Company Report #CTU 247211 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Lethargy Clozapine 100mg Tabs PS TAPERED DOSE Hospitalization - Oral Intake Reduced UP TO 300MG Initial or Prolonged Pyrexia Risperdal C Required Apap C Intervention to Rocephin C Prevent Permanent Vpa C Impairment/Damage Lamictal C Cogentin C Date:04/27/05ISR Number: 4647678-5Report Type:Expedited (15-DaCompany Report #05-03-0457 Age:39 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pulmonary Mass Health Clozapine - Ivax Initial or Prolonged Scar Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 550MG HS ORAL Gemfibrozil C Date:04/27/05ISR Number: 4647680-3Report Type:Expedited (15-DaCompany Report #05-04-0671 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Gastrointestinal Other Clozapine - Ivax Initial or Prolonged Haemorrhage Pharmaceuticals, 22-Feb-2006 08:30 AM Page: 3279 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 150-300MG QD ORAL Date:04/27/05ISR Number: 4647681-5Report Type:Expedited (15-DaCompany Report #05-04-0676 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hepatic Neoplasm Health Clozapine - Ivax Malignant Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 400MG QD ORAL Date:04/27/05ISR Number: 4647716-XReport Type:Direct Company Report #CTU 247222 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Level Changed Clozaril 100mg PS ORAL 2AM / 5 PM TAKEN PO Date:04/27/05ISR Number: 4648648-3Report Type:Expedited (15-DaCompany Report #PAR_0009_2005 Age:78 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Iron Decreased Foreign Isoptine PS ORAL 240 MG PO Initial or Prolonged Inflammation Health Acide Valproique SS ORAL 1 G PO Normochromic Normocytic Professional Mianserine Anaemia Other Chlorhydrate SS ORAL 30 MG PO Serum Ferritin Increased Mehantine Chlorhydrate SS ORAL 20 MG PO Clopidegrel Hydrogenosulf SS ORAL DF PO Clozapine SS ORAL 50 MG PO Clavulin C Date:04/28/05ISR Number: 4649626-0Report Type:Expedited (15-DaCompany Report #2005S1001328 Age:57 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neoplasm Malignant Health Clozapine Tablets Professional (100 Mg) PS ORAL SEE IMAGE Other Tiopropium Bromide C Lansoprazole C Docusate Calcium C Salmeterol Xinafoate C Escitalopram C Gefitinib C Prochlorperazine C Dexamethasone C Ensure C 22-Feb-2006 08:30 AM Page: 3280 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/28/05ISR Number: 4649627-2Report Type:Expedited (15-DaCompany Report #2005S1001568 Age:60 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death General Physical Health Health Clozapine Tablets Deterioration Professional (25 Mg) PS ORAL 25 MG;QD; PO Sepsis Other Clozapine Tablet (100 Mg) SS ORAL 150 MG; HS; PO Lisinopril C Estrogens Conjugated C Calcitonin, Salmon C Multivitamins, Plain C Vitamin E C Mometasne Furoate C Trazodone C Loxapine C Isosorbide Mononitrate C Docusate Sodium C Valproate Semisodium C Salmuterol Xinafoate C Alcium/Vitamin D Nos C Glyceryl Trinitrate C Fluticasone Propionate C Ipratropoum Bromide/Salbutamol Sulfate C Magnesium Hydroxide/Aluminium Hydroxide Gel, Dried/Simeticone C Paracetamol C Date:04/28/05ISR Number: 4649636-3Report Type:Expedited (15-DaCompany Report #2005S1002373 Age:84 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional (25 Mg) PS ORAL 12.5 MG; QD; Other PO Ipratropium Bromide C Escitalopram C Levodopa/Carbidopa C Cyanocobalamin C Lorazepam C Furosemide C Ranitidine Hydrochloride C Lisinopril C Fluticasone Propionate/Salmetero l Xinafoate C Potassium Chloride C 22-Feb-2006 08:30 AM Page: 3281 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/28/05ISR Number: 4649649-1Report Type:Expedited (15-DaCompany Report #2005S1002394 Age:80 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional (25 Mg) PS ORAL 25 MG; BID; Other PO Clozapine Tabelts (100 Mg) SS ORAL 25 MG; BID; PO Clonidine C Docusate Sodium C Date:04/28/05ISR Number: 4649660-0Report Type:Expedited (15-DaCompany Report #2005S1002427 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Fall Health Clozapine Tablets Injury Professional (25 Mg) PS ORAL 75 MG; QD; PO Other Clozapine Tablets (100 Mg) SS ORAL 400 MG; QD; PO Date:04/28/05ISR Number: 4649661-2Report Type:Expedited (15-DaCompany Report #2005S1002429 Age:84 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional (100 Mg) PS ORAL 200 MG ; HS; Other PO Levodopa/Carbidopa C Entacapone C Pramipexole C Dihydrochloride C Mematine C Verapamil C Seroquel C Donepezil Hydrochloride C Clopidogrel Sulfate C Date:04/28/05ISR Number: 4649662-4Report Type:Expedited (15-DaCompany Report #2005S1002463 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional (100 Mg) PS ORAL 300 MG; QD; Other PO Oxygen C Date:04/28/05ISR Number: 4650037-2Report Type:Expedited (15-DaCompany Report #05-04-0689 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Neoplasm Malignant Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax 22-Feb-2006 08:30 AM Page: 3282 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pharmaceuticals, Inc. ORAL 250-550MG QD ORAL Date:04/29/05ISR Number: 4648499-XReport Type:Expedited (15-DaCompany Report #PHFR2005GB01285 Age:58 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Distension Clozaril PS Novartis Sector: Hospitalization - Abdominal Pain Pharma ORAL 200mg/day Initial or Prolonged Abdominal Tenderness Other Blood Glucose Increased Cardiac Arrest Cardiac Failure Cholelithiasis Circulatory Collapse Diabetes Mellitus Malaise Pancreatitis Date:04/29/05ISR Number: 4648507-6Report Type:Expedited (15-DaCompany Report #PHFR2005GB01573 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Mean Cell Volume Clozaril PS Novartis Sector: Increased Pharma ORAL Date:04/29/05ISR Number: 4648508-8Report Type:Expedited (15-DaCompany Report #PHFR2005GB01561 Age:23 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Compartment Syndrome Clozaril PS Novartis Sector: Initial or Prolonged Malaise Pharma ORAL 200 mg/day 112 DAY Neuroleptic Malignant Depixol C Syndrome Date:04/29/05ISR Number: 4648513-1Report Type:Expedited (15-DaCompany Report #PHFR2005GB01634 Age:88 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abnormal Behaviour Clozaril PS Novartis Sector: Confusional State Pharma ORAL Mobility Decreased Psychotic Disorder Date:04/29/05ISR Number: 4648526-XReport Type:Expedited (15-DaCompany Report #PHFR2005GB00898 Age:34 YR Gender:Female I/FU:F Outcome PT Hospitalization - Drug Exposure During Initial or Prolonged Pregnancy Fatigue General Physical Health Deterioration Nasopharyngitis Neutrophil Count Decreased 22-Feb-2006 08:30 AM Page: 3283 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Normal Newborn White Blood Cell Count Decreased Report Source Product Role Manufacturer Route Dose Duration Clozaril PS Novartis Sector: Pharma ORAL 400 mg/day Date:04/29/05ISR Number: 4648527-1Report Type:Expedited (15-DaCompany Report #PHNU2005DE01654 Age:58 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Exposure Leponex / Clozaril Initial or Prolonged Depressed Level Of (Clozapine) PS Novartis Sector: Other Consciousness Pharma ORAL UNK, UNK 1440 MIN Poisoning Cipralex C Somnolence Unresponsive To Verbal Stimuli Date:04/29/05ISR Number: 4648528-3Report Type:Expedited (15-DaCompany Report #PHNR2005AU00782 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Clozaril PS Novartis Sector: Anaesthesia Pharma 0 - 575 mg, Aspiration Bone Marrow daily 4168 DAY Back Injury Amisulpride C Biopsy Bone Marrow Nexium C Blood Disorder Atenolol C Bone Marrow Disorder Fall Haematocrit Decreased Haemoglobin Decreased Lymphocyte Count Decreased Mean Cell Haemoglobin Decreased Mean Cell Volume Decreased Microcytic Anaemia Neutrophil Count Decreased Pancytopenia Splenomegaly Thrombocytopenia Vomiting White Blood Cell Count Decreased Date:04/29/05ISR Number: 4650374-1Report Type:Expedited (15-DaCompany Report #2005SE01927 Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Abdomen Foreign Seroquel PS ORAL 300 MG BID PO Cardio-Respiratory Arrest Health Clozapine SS ORAL 100 MG QID PO Epistaxis Professional Valproic Acid C Hypotension Other Fluphenazine C Thrombocytopenia 22-Feb-2006 08:30 AM Page: 3284 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/02/05ISR Number: 4649538-2Report Type:Expedited (15-DaCompany Report #PHBS2005NZ06106 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumothorax Clozaril PS Novartis Sector: Initial or Prolonged Pharma ORAL 300 mg/d Marijuana SS Date:05/02/05ISR Number: 4649547-3Report Type:Expedited (15-DaCompany Report #PHNR2005AU00806 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agranulocytosis Clozapine PS Novartis Sector: Chest Discomfort Pharma Heart Rate Increased Hypersensitivity Influenza Like Illness Myocarditis Pyrexia Respiratory Rate Increased Troponin Increased Date:05/02/05ISR Number: 4649548-5Report Type:Expedited (15-DaCompany Report #PHBS2005NZ06107 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Appendicectomy Clozaril PS Novartis Sector: Initial or Prolonged Constipation Pharma ORAL 300 mg/d Small Intestinal Obstruction Date:05/02/05ISR Number: 4649549-7Report Type:Expedited (15-DaCompany Report #PHBS2005BE06117 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Lactate Leponex PS Novartis Sector: Dehydrogenase Increased Pharma ORAL 25 mg/day 10080MIN Haematocrit Decreased Leponex SS Novartis Sector: Haemoglobin Decreased Pharma ORAL 37.5 mg/day 11520MIN Haemolytic Anaemia Leponex SS Novartis Sector: Haptoglobin Decreased Pharma ORAL 100 mg/day 18720MIN Mean Cell Volume Leponex SS Novartis Sector: Increased Pharma ORAL 50 mg/day 12960MIN Red Blood Cell Count Temesta C Decreased Loramet C Red Blood Cell Morphology Magneton C Abnormal Antabuse C Impromen Decanoas C Omeprazole C Serlain C Akineton C Maalox C 22-Feb-2006 08:30 AM Page: 3285 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/02/05ISR Number: 4649557-6Report Type:Expedited (15-DaCompany Report #PHNU2005DE01197 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Leponex / Clozaril Initial or Prolonged Increased (Clozapine) PS Novartis Sector: Other Aphasia Pharma ORAL Electroencephalogram Leponex / Clozaril Abnormal (Clozapine) SS Novartis Sector: Gamma-Glutamyltransferase Pharma ORAL 300 to 450 mg 46080MIN Increased Leponex / Clozaril Glutamate Dehydrogenase (Clozapine) SS Novartis Sector: Increased Pharma ORAL 44640MIN Hepatic Enzyme Abnormal Leponex / Clozaril Hypotonia (Clozapine) SS Novartis Sector: Speech Disorder Pharma ORAL 12960MIN Tremor Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL Trevilor C Date:05/02/05ISR Number: 4649570-9Report Type:Expedited (15-DaCompany Report #PHNU2005DE01790 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebral Artery Occlusion Leponex / Clozaril Initial or Prolonged (Clozapine) PS Novartis Sector: Other Pharma ORAL 50 mg, QD Date:05/02/05ISR Number: 4649984-7Report Type:Expedited (15-DaCompany Report #PHNU2005DE01755 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Triglycerides Leponex / Clozaril Increased (Clozapine) PS Novartis Sector: Hypertriglyceridaemia Pharma ORAL up to 175mg/day Haldol C ORAL 10 mg, QD Date:05/02/05ISR Number: 4649985-9Report Type:Expedited (15-DaCompany Report #PHNR2005AU00667 Age:26 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Clozaril PS Novartis Sector: Drug Interaction Pharma UNK, UNK Dysmenorrhoea Solian SS Galactorrhoea Hyperprolactinaemia Oligomenorrhoea Date:05/02/05ISR Number: 4652025-9Report Type:Direct Company Report #CTU 247536 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drooling Clozapine Twice Pharmaceutical Product Daily PS 200 MG BID Complaint 22-Feb-2006 08:30 AM Page: 3286 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/02/05ISR Number: 4652252-0Report Type:Expedited (15-DaCompany Report #05-04-0669 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Intestinal Perforation Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 700MG QD ORAL Date:05/02/05ISR Number: 4652415-4Report Type:Expedited (15-DaCompany Report #05-04-0616 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Health Clozapine - Ivax Cardio-Respiratory Arrest Professional Pharmaceuticals, Loss Of Consciousness Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 150-600MG QD ORAL Date:05/02/05ISR Number: 4652424-5Report Type:Expedited (15-DaCompany Report #05-04-0681 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Skin Ulcer Health Clozapine - Ivax Initial or Prolonged Wound Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 400MG QD ORAL Date:05/02/05ISR Number: 4652425-7Report Type:Expedited (15-DaCompany Report #04-12-1777 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Death Health Clozapine - Ivax Drug Toxicity Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 700MG QD ORAL Paxil Cr C Date:05/03/05ISR Number: 4650707-6Report Type:Expedited (15-DaCompany Report #PHNR2005AU00806 Age:25 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Chest Discomfort Clozapine PS Novartis Sector: Heart Rate Increased Pharma Influenza Like Illness Myocarditis Pyrexia Respiratory Rate Increased Troponin Increased 22-Feb-2006 08:30 AM Page: 3287 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/03/05ISR Number: 4650710-6Report Type:Expedited (15-DaCompany Report #PHNU2005DE01200 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Leponex / Clozaril Initial or Prolonged Increased (Clozapine) PS Novartis Sector: Arthralgia Pharma ORAL 12.5 to 225 Aspartate mg 31680MIN Aminotransferase Leponex / Clozaril Increased (Clozapine) SS Novartis Sector: Body Temperature Pharma 33120MIN Increased Leponex / Clozaril C-Reactive Protein (Clozapine) SS Novartis Sector: Increased Pharma ORAL 7200 MIN Fatigue Leponex / Clozaril Leukocytosis (Clozapine) SS Novartis Sector: Pain Pharma ORAL 8640 MIN White Blood Cell Count Leponex / Clozaril Increased (Clozapine) SS Novartis Sector: Pharma ORAL 20160MIN Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL 2880 MIN Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL UNK, UNK 8640 MIN Zoloft C ORAL 21600MIN Beloc Zok C Date:05/03/05ISR Number: 4650794-5Report Type:Expedited (15-DaCompany Report #CH-GLAXOSMITHKLINE-B0296700A Age:64 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Blood Creatinine Quilonorm PS Glaxosmithkline ORAL 13 YR Increased Clozapine SS ORAL 150MG Per day YR Nephritis Interstitial Nephropathy Toxic Renal Failure Chronic Renal Interstitial Fibrosis Tubulointerstitial Nephritis Date:05/03/05ISR Number: 4650795-7Report Type:Expedited (15-DaCompany Report #CH-GLAXOSMITHKLINE-B0305947A Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Arrhythmia Lithium Carbonate PS Glaxosmithkline Depressed Level Of Clozapine SS Consciousness Sodium Valproate SS Electroencephalogram Lorazepam SS Abnormal Laxative C Hyperventilation Overdose Somnolence Transient Ischaemic Attack 22-Feb-2006 08:30 AM Page: 3288 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/03/05ISR Number: 4650814-8Report Type:Expedited (15-DaCompany Report #2002-0356 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Drug Interaction Lithium PS Glaxosmithkline ORAL 1 DAY Hypothermia Clozapine SS ORAL 1 DAY Miosis Metformin C ORAL 1700MG per Stupor day MON Acetylsalicylsaure C Glaxosmithkline ORAL MON Alendronate C ORAL MON Calcium + Vitamin D C ORAL 500MG per day MON Lactitol C ORAL 20ML per day MON Latanoprost C SUBCONJUNCTIVAL MON Amiodarone C ORAL MON Nitroglycerin C Glaxosmithkline TRANSDERMAL MON Date:05/03/05ISR Number: 4652745-6Report Type:Expedited (15-DaCompany Report #05-04-0617 Age:50 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neoplasm Malignant Health Clozapine - Ivax Hospitalization - Professional Pharmaceuticals, Initial or Prolonged Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 500MG QD ORAL Date:05/03/05ISR Number: 4652748-1Report Type:Expedited (15-DaCompany Report #2005S1001377 Age:54 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional (25 Mg) PS ORAL 75 MG; BID; Other PO Clozapine Tablets (100 Mg) SS ORAL 200 MG; BID; PO Diphenydramine C Ferrous Fulfate C Lorazepam C Escitalopram C Sertraline C Gemfibrozil C Date:05/03/05ISR Number: 4652749-3Report Type:Expedited (15-DaCompany Report #2005S1001447 Age:58 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Faecal Incontinence Health Clozapine Tablets Loss Of Consciousness Professional (100 Mg) PS ORAL 400 MG; BID; Respiratory Arrest Other PO Clozapine Tablets (25 Mg) SS ORAL 50 MG; Q24; PO Bupropion Hydrochloride C Clonazepam C Fexofenadine Hydrochloride C Docusate Sodium C 22-Feb-2006 08:30 AM Page: 3289 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lansoprazole C Metoclopramide Hydrochloride C Date:05/03/05ISR Number: 4652750-XReport Type:Expedited (15-DaCompany Report #2005S1000940 Age:56 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozapine Tablets Gastrointestinal Professional (25 Mg) PS ORAL 25 MG; TID; Haemorrhage Other PO Clozapine Tablets (100 Mg) SS ORAL 100 MG; TID; PO Date:05/03/05ISR Number: 4652751-1Report Type:Expedited (15-DaCompany Report #2005S1001035 Age:84 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Clozapine Tablets Dyspnoea Professional (25 Mg) PS ORAL 12.5 MG; QD; Other PO Coreg C Luvox C Benzonatate C Levaquin C Trazodone C Furosemide C Prevacid C Plavix C Avelox C Guaifenesin/Dextrome thorphan C Date:05/03/05ISR Number: 4652753-5Report Type:Expedited (15-DaCompany Report #2005S1001108 Age:79 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional (25 Mg) PS ORAL SEE IMAGE Other Date:05/03/05ISR Number: 4652754-7Report Type:Expedited (15-DaCompany Report #2005S1001288 Age:61 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Back Pain Health Clozapine Tablets Cardio-Respiratory Arrest Professional (25 Mg) PS ORAL 50 MG; HS; PO Cough Other Clozapine Tablets Dyspnoea (100 Mg) SS ORAL 400 MG; HS; Loss Of Consciousness PO Restlessness Geodon SS 160 MG; BID; Wheezing Escitalopram C Lansoprazole C Psyllium Hydrophilic C Mucilloid C Valproate Semisodium C 22-Feb-2006 08:30 AM Page: 3290 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Benzatropine Mesilate C Ascorbic Acid/Tocopherol/Reti nol C Mcrogol C Albuterol C Magnesium C Date:05/03/05ISR Number: 4653170-4Report Type:Direct Company Report #CTU 247668 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Clozapine (Used Several Years) PS 100MG Trileptal (Added 17 Days Before Death) SS 150 MG Date:05/03/05ISR Number: 4655083-0Report Type:Expedited (15-DaCompany Report #2005UW06454 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Seroquel PS Professional Clozapine SS Date:05/04/05ISR Number: 4652588-3Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20041007637 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Risperdal PS OROPHARINGEAL 1.5MG 21 DAY Risperdal SS OROPHARINGEAL 21 DAY Clozapine SS OROPHARINGEAL Ranitidine SS Gabapentin SS OROPHARINGEAL Lamotrigine SS OROPHARINGEAL Lamotrigine SS OROPHARINGEAL Date:05/04/05ISR Number: 4653555-6Report Type:Expedited (15-DaCompany Report #05-04-0718 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 350-625MG QD ORAL Date:05/04/05ISR Number: 4653556-8Report Type:Expedited (15-DaCompany Report #05-04-0714 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asthma Health Clozapine - Ivax Cardiac Failure Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, 22-Feb-2006 08:30 AM Page: 3291 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Inc. ORAL 450-500MG QD ORAL Date:05/04/05ISR Number: 4654125-6Report Type:Expedited (15-DaCompany Report #2005042029 Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Gabapentin Health (Gabapentin) PS ORAL 100 MG (100 Professional MG, 1 IN 1 D), ORAL Clozapine (Clozapine) SS ORAL ORAL Ranitidine Hydrochloride (Ranitidine Hydrochloride) SS 150 MG (150 MG, 1 IN 1 D) Risperidone (Risperidone) SS ORAL 100 MG (100 MG, 1 IN 1 D), ORAL Lamotrigine (Lamotrigine) SS ORAL 50 MG (50 MG, 1 IN 1 D), ORAL Date:05/05/05ISR Number: 4654813-1Report Type:Expedited (15-DaCompany Report #05-04-0579 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Health Clozapine Tablets - Electrocardiogram Professional Ivax Abnormal Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 600MG QD ORAL Haloperidol C Lamictal C Date:05/05/05ISR Number: 4654820-9Report Type:Expedited (15-DaCompany Report #2005S1002775 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional (25 Mg) PS ORAL 25 MG; TID; Other PO Date:05/05/05ISR Number: 4654823-4Report Type:Expedited (15-DaCompany Report #2005S1002695 Age:76 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional (25 Mg) PS ORAL 12.5 MG;HS;PO Other Levodopa/Carbidopa C Mystatin C 22-Feb-2006 08:30 AM Page: 3292 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/05/05ISR Number: 4654839-8Report Type:Expedited (15-DaCompany Report #2005S1001759 Age:81 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Aspiration Health Clozapine Tablets Professional (25 Mg) PS ORAL 12.5 MG;QD; Other PO Hyoscine C Morphine Sulfate C Clindamycin C Oriciprenaline C Moxifloxacin Hydrochloride C Alprazolam C Levodopa/Carbidopa C Levodopa/Carbidopa C Folic Acid C Levetiracetam C Donepezil Hydrochloride C Acetylsalicylic Acid C Docusate Sodium/Senna C Multivitamins, Plain C Date:05/05/05ISR Number: 4654842-8Report Type:Expedited (15-DaCompany Report #2005S1001773 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Pain Upper Health Clozapine Tablets Hospitalization - Jaundice Professional (100 Mg) PS ORAL 100 MG;HS;PO Initial or Prolonged Metastasis Other Codeine White Blood Cell Count Phosphate/Paracetamo Decreased l C Lorazepam C Date:05/05/05ISR Number: 4654845-3Report Type:Expedited (15-DaCompany Report #2005S1002662 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional (100 Mg) PS ORAL 100 MG;HS;PO Other Insulin C Date:05/05/05ISR Number: 4654857-XReport Type:Expedited (15-DaCompany Report #05-05-0731 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Colon Cancer Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 400-600MG QD ORAL 22-Feb-2006 08:30 AM Page: 3293 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/05/05ISR Number: 4654858-1Report Type:Expedited (15-DaCompany Report #05-04-0620 Age:49 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Appendicitis Health Clozapine Tablets - Initial or Prolonged Delirium Professional Ivax Necrosis Other Pharmaceuticals, Small Intestinal Inc. PS Ivax Obstruction Pharmaceuticals, Inc. ORAL 100MG QAM ORAL Depakote C Cogentin C Synthroid C Date:05/05/05ISR Number: 4654860-XReport Type:Expedited (15-DaCompany Report #05-05-0724 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sepsis Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 100-300MG QD ORAL Date:05/05/05ISR Number: 4654875-1Report Type:Expedited (15-DaCompany Report #05-04-0717 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 75-500MG QD ORAL Date:05/05/05ISR Number: 4654877-5Report Type:Expedited (15-DaCompany Report #05-05-0725 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Respiratory Failure Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 400-500MG QD ORAL Date:05/06/05ISR Number: 4654988-4Report Type:Expedited (15-DaCompany Report #PHFR2004GB01028 Age:40 YR Gender:Male I/FU:F Outcome PT Other Anxiety Dysphemia Hyperhidrosis 22-Feb-2006 08:30 AM Page: 3294 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Myoclonus Tic Report Source Product Role Manufacturer Route Dose Duration Clozaril PS Novartis Sector: Pharma ORAL UNK, UNK Disulfiram C UNKNOWN Antidepressants C UNKNOWN Cipramil C ORAL 30 mg, QD Acamprosate C ORAL 666mg/day Date:05/06/05ISR Number: 4654989-6Report Type:Expedited (15-DaCompany Report #PHFR2004GB03974 Age:53 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Full Blood Count Clozaril PS Novartis Sector: Initial or Prolonged Decreased Pharma ORAL UNK, UNK Other Haemoglobin Decreased Nausea Oesophageal Carcinoma Regurgitation Of Food Throat Cancer Vomiting Date:05/06/05ISR Number: 4654996-3Report Type:Expedited (15-DaCompany Report #PHFR2005IE01085 Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Arteriospasm Coronary Clozaril PS Novartis Sector: Blood Creatine Pharma ORAL UNK, UNK 24480MIN Phosphokinase Increased Bisoprolol C 7.5 mg, QD Chest Pain Aspirine C 75 mg, QD Electrocardiogram St Zoton C 30 mg, QD Segment Elevation Atorvastatin C 20 mg nocte Eosinophil Count Nicotine C Increased Imdur C 30 mg, QD Pyrexia Solian C 400 mg, BID Troponin Increased Date:05/06/05ISR Number: 4657140-1Report Type:Expedited (15-DaCompany Report #006 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Fazaclo Odt PS Alamo Life-Threatening Congestive Professional Pharmaceuticals, Llc ORAL 100 MG TID PO Hospitalization - General Physical Health Company Glucophage C Initial or Prolonged Deterioration Representative Humulin C Zonegram C Asa C Kcl C Haldol C Actonel C 22-Feb-2006 08:30 AM Page: 3295 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/09/05ISR Number: 4655918-1Report Type:Expedited (15-DaCompany Report #PHFR2005GB01429 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatinine Clozapine PS Novartis Sector: Increased Pharma Creatinine Renal Clearance Decreased Renal Impairment Date:05/09/05ISR Number: 4656148-XReport Type:Expedited (15-DaCompany Report #FR-ROCHE-402266 Age:31 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukocytosis Rivotril PS Roche ORAL 55 DAY Initial or Prolonged Leponex SS ORAL 4 DAY Leponex SS ORAL DOSE WAS REPORTED TO HAVE BEEN PROGRESSIVELY INCREASED 31 DAY Leponex SS ORAL STOPPED DUE TO FLU (FEVER UP TO 38 DEGREES C) 47 DAY Xanax C ORAL 1 DAY Fraxiparine C SUBCUTANEOUS 1 DOSE PER DAY. 3 DAY Motilium C ORAL 9 DAY Lanzor C ORAL 1 DOSE PER DAY. 9 DAY Gaviscon C 3 DOSES PER DAY. 9 DAY Tranxene C INTRAMUSCULAR GIVEN IN CASE OF AGITATION. Forlax C 2 DOSES PER DAY. 1 DAY Duofilm C 11 DAY Date:05/09/05ISR Number: 4656490-2Report Type:Expedited (15-DaCompany Report #PHEH2005US05184 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Clozaril PS Novartis Sector: Pharma ORAL 12.5 mg, QOD Date:05/09/05ISR Number: 4656502-6Report Type:Expedited (15-DaCompany Report #PHFR2005GB01561 Age:23 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Compartment Syndrome Clozaril PS Novartis Sector: Initial or Prolonged Malaise Pharma Neuroleptic Malignant Depixol C Syndrome Platelet Count Increased Skin Graft 22-Feb-2006 08:30 AM Page: 3296 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/09/05ISR Number: 4656511-7Report Type:Expedited (15-DaCompany Report #PHFR2005GB01653 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Iritis Clozaril PS Novartis Sector: Pharma Neomycin C Cyclopentolate C Betamethasone C OPHTHALMIC Date:05/09/05ISR Number: 4656512-9Report Type:Expedited (15-DaCompany Report #PHFR2005GB01685 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Azoospermia Clozaril PS Novartis Sector: Pharma Date:05/09/05ISR Number: 4658719-3Report Type:Expedited (15-DaCompany Report #006 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death General Physical Health Health Fazaclo Odt PS Alamo Life-Threatening Deterioration Professional Pharmaceuticals, Llc ORAL 100 MG TID PO Hospitalization - Company Glucophage C Initial or Prolonged Representative Humulin C Zonegran C Asa C Kcl C Haldol C Actonel C Date:05/10/05ISR Number: 4657880-4Report Type:Expedited (15-DaCompany Report #PHBS2005NZ06428 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aortic Valve Incompetence Clozaril PS Novartis Sector: Cardiac Failure Pharma ORAL 0.5 mg PRN Congestive Clonazepam C 0.5 mg, QHS Dilatation Ventricular Ventricular Dysfunction Date:05/10/05ISR Number: 4657882-8Report Type:Expedited (15-DaCompany Report #PHEH2005US04686 Age:40 YR Gender:Male I/FU:F Outcome PT Death Abscess Drainage Hospitalization - Bacterial Infection Initial or Prolonged Chest Wall Abscess Other Convulsion Coronary Artery Disease Cough Deep Vein Thrombosis Drug Level Increased Intubation Loss Of Consciousness Lung Infiltration Pneumonia Bacterial Pulmonary Embolism 22-Feb-2006 08:30 AM Page: 3297 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Purulent Discharge Pyrexia Sputum Abnormal Report Source Product Role Manufacturer Route Dose Duration Tachycardia Clozaril PS Novartis Sector: White Blood Cell Count Pharma ORAL 125mg Qam, Increased 250mg Qpm Date:05/10/05ISR Number: 4657883-XReport Type:Expedited (15-DaCompany Report #PHFR2005GB01477 Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Medication Error Clozaril PS Novartis Sector: Initial or Prolonged Salivary Hypersecretion Pharma ORAL 300MG PER DAY Other Sedation Clozaril SS Novartis Sector: Somnolence Pharma UNK, UNK Tachycardia Treatment Noncompliance Date:05/10/05ISR Number: 4657884-1Report Type:Expedited (15-DaCompany Report #PHHO2005CA06973 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Choking Clozaril PS Novartis Sector: Obesity Pharma ORAL 744 DAY Salivary Hypersecretion Sleep Apnoea Syndrome Date:05/10/05ISR Number: 4657893-2Report Type:Expedited (15-DaCompany Report #PHNU2005DE01755 Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Leponex / Clozaril Hypertriglyceridaemia (Clozapine) PS Novartis Sector: Pharma ORAL 175 mg, QD 10080MIN Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL 125 mg, QD Haldol SS ORAL 10 mg, QD Date:05/10/05ISR Number: 4658312-2Report Type:Direct Company Report #CTU 248103 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Level Changed Clozaril 100mg PS ORAL 2 AM /5 PM TAKEN PO Date:05/10/05ISR Number: 4658596-0Report Type:Expedited (15-DaCompany Report #2004S1003044 Age:51 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bronchitis Health Clozapine Tablets Cardiac Failure Professional (100 Mg) PS ORAL 300 MG;HS;PO Congestive Other Clarithromycin C Pneumonia Promethazine Weight Increased Hydrochoride C Phenylephrine 22-Feb-2006 08:30 AM Page: 3298 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride C Paroxetine Cr C Date:05/10/05ISR Number: 4658602-3Report Type:Expedited (15-DaCompany Report #2004S1000488 Age:42 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Company Clozapine Tablets Weight Increased Representative (100 Mg) PS ORAL SEE IMAGE Venlafaxine Er C Risperidone C Citalopram C Furosemide C Warfarin C Omeprazole C Olanzapine C Potassium Chloride C Topiramate C Lamotrigine C Oxybutynin Hydrochloride Xl C Triamcinolone Inhaler C Date:05/10/05ISR Number: 4658648-5Report Type:Expedited (15-DaCompany Report #2005S1001884 Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Clozapine Tablets Treatment Noncompliance Professional (100 Mg) PS ORAL 300 MG; HS; Other PO Abilify SS UNKNOWN 10 MG;QD;UNKNOWN Zoloft SS UNKNOWN 100 MG;QD;UNKNOWN Date:05/10/05ISR Number: 4658650-3Report Type:Expedited (15-DaCompany Report #2005S1001715 Age:62 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional (25 Mg) PS ORAL 25 MG;BID;PO Other Clozapine Tablets (100 Mcg) SS ORAL SEE IMAGE Risperidone C Famotidine C Captopril C Valproate Sodium C Insulin C Hydrochlorothiazide C Date:05/10/05ISR Number: 4658652-7Report Type:Expedited (15-DaCompany Report #2005S1001323 Age:59 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Hospitalization - Professional (100 Mg) PS UNKNOWN UNKNOWN Initial or Prolonged Other 22-Feb-2006 08:30 AM Page: 3299 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/10/05ISR Number: 4658669-2Report Type:Direct Company Report #CTU 248111 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Hyperhidrosis Clozapine 100mg Intervention to Neuroleptic Malignant Zenith PS Zenith ORAL 350MG Prevent Permanent Syndrome BEDTIME ORAL Impairment/Damage Olanzapine 20mg Lilly SS Lilly ORAL 20MG BEDTIME ORAL Fluoxetine C Lorazepam C Multivitamin C Risperidone C Date:05/10/05ISR Number: 4659163-5Report Type:Expedited (15-DaCompany Report #2005S1000207 Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Toxicity Health Clozapine Tablets Professional (100 Mg) PS ORAL 600 MG; HS; Other PO Glipizide Xl C Date:05/10/05ISR Number: 4659164-7Report Type:Expedited (15-DaCompany Report #2005S1001202 Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional (100 Mg) PS ORAL SEE IMAGE Other Omeprazole C Ranitidine Hydrochloride C .. C Docusate Sodium C Fluoxetine Hydrochloride C Olazanpine C Risperidone C Benzatropine Mesilate C Date:05/10/05ISR Number: 4664885-6Report Type:Direct Company Report #CTU 248811 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Constipation Clozapine PS Date:05/11/05ISR Number: 4658686-2Report Type:Expedited (15-DaCompany Report #PHFR2004GB04761 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Murder Clozaril PS Novartis Sector: Pharma 22-Feb-2006 08:30 AM Page: 3300 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/11/05ISR Number: 4658687-4Report Type:Expedited (15-DaCompany Report #PHBS2005BG06367 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspartate Leponex PS Novartis Sector: Hospitalization - Aminotransferase Pharma ORAL UNK, UNK Initial or Prolonged Increased Other Asthenia Blood Bilirubin Increased Fatigue Haemoglobin Increased Hepatic Enzyme Increased Jaundice Pneumonia Date:05/11/05ISR Number: 4658829-0Report Type:Expedited (15-DaCompany Report #PHEH2005US05184 Age:72 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Clozaril PS Novartis Sector: Dementia Alzheimer'S Type Pharma ORAL 12.5 mg, QOD Disease Progression Date:05/11/05ISR Number: 4658831-9Report Type:Expedited (15-DaCompany Report #PHFR2005IE01293 Age:58 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aortic Valve Incompetence Clozaril PS Novartis Sector: Initial or Prolonged Blood Gases Abnormal Pharma 450mg/day Body Temperature Increased Cardiac Failure Cardiac Failure Congestive Chronic Obstructive Pulmonary Disease Constipation Cough Crepitations Diabetes Mellitus Non-Insulin-Dependent Dyspnoea Echocardiogram Abnormal Electrocardiogram Abnormal Hyperhidrosis Hypertension Lower Respiratory Tract Infection Mitral Valve Incompetence Oedema Peripheral Overweight Pericardial Effusion Pitting Oedema Ventricular Hypertrophy Wheezing 22-Feb-2006 08:30 AM Page: 3301 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/11/05ISR Number: 4659006-XReport Type:Expedited (15-DaCompany Report #05-03-0532 Age:14 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Aggression Lithium Sr PS Glaxosmithkline ORAL 300MG Three Hospitalization - Blood Creatine times per day 7 DAY Initial or Prolonged Phosphokinase Increased Lithium Citrate SS ORAL 300MG per day 118 DAY Other Body Temperature Haloperidol SS INTRAMUSCULAR 10MG Weekly Increased Clozapine SS ORAL 12 DAY Confusional State Benztropine C ORAL 2MG Twice per Developmental day Coordination Disorder Ddavp C ORAL .2MG At night Difficulty In Walking Guanfacine C ORAL 1MG Three Drooling times per day Drug Interaction Synthroid C Glaxosmithkline ORAL 50MCG In the Dysphagia morning Dyspnoea Valproic Acid C ORAL 500MG Three Eating Disorder times per day Hyperventilation Docusate Sodium C ORAL 100MG Twice Lethargy per day Neuroleptic Malignant Diphenhydramine C INTRAMUSCULAR Syndrome Lorazepam C INTRAMUSCULAR 2MG Weekly Somnolence Trileptal C ORAL 300MG Three Unresponsive To Verbal times per day 21 DAY Stimuli Risperdal C Urinary Incontinence Bromocriptine C 2.5MG Three White Blood Cell Count times per day Increased Date:05/11/05ISR Number: 4660975-2Report Type:Expedited (15-DaCompany Report #8010302 Age:2 DY Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Neonatal Health Levetiracetam "Ucb" PS Ucb TRANSPLACENTAL TRP Initial or Prolonged Drug Exposure During Professional Tegretol SS TRANSPLACENTAL TRP Pregnancy Klonopin SS TRANSPLACENTAL TRP Clozaril SS TRANSPLACENTAL TRP Diazepam SS TRANSPLACENTAL TRP Neurontin SS TRANSPLACENTAL TRP Lamictal SS TRANSPLACENTAL TRP Trileptal SS TRANSPLACENTAL TRP Phenobarbital SS TRANSPLACENTAL TRP Dilantin SS TRANSPLACENTAL TRP Topamax SS TRANSPLACENTAL TRP Tridione SS TRANSPLACENTAL TRP Depakote SS TRANSPLACENTAL TRP Date:05/11/05ISR Number: 4661713-XReport Type:Direct Company Report #CTU 248293 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Grand Mal Convulsion Clozapine PS ORAL 200MG PO QAM Initial or Prolonged , 450 MG PO Other QPM ; TITRATED UP SINCE 10/03 22-Feb-2006 08:30 AM Page: 3302 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/12/05ISR Number: 4659883-2Report Type:Expedited (15-DaCompany Report #PHNR2005AU00468 Age:30 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Clozaril PS Novartis Sector: Phosphokinase Increased Pharma 12.5 - 150 Cardiac Disorder mg, daily 31680MIN Myocarditis Quetiapine C 400 mg, QD Thyroxine Decreased Troponin Increased Date:05/12/05ISR Number: 4659886-8Report Type:Expedited (15-DaCompany Report #PHNU2005DE01917 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Leponex / Clozaril Initial or Prolonged Antinuclear Antibody (Clozapine) PS Novartis Sector: Other Negative Pharma ORAL Hepatic Enzyme Abnormal Leukocytosis Pleural Effusion Pyrexia Systemic Lupus Erythematosus Date:05/12/05ISR Number: 4660349-4Report Type:Expedited (15-DaCompany Report #PHFR2005GB01561 Age:23 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Creatine Clozaril PS Novartis Sector: Hospitalization - Phosphokinase Increased Pharma ORAL 500mg per day Initial or Prolonged Body Temperature Clozaril SS Novartis Sector: Other Increased Pharma ORAL 300mg per day 33120MIN Compartment Syndrome Clozaril SS Novartis Sector: Eye Rolling Pharma ORAL 200mg per day 7200 MIN Malaise Depixol C INTRAMUSCULAR 20mg/day Muscle Contractions Depixol C INTRAMUSCULAR 40mg/day Involuntary Depixol C INTRAMUSCULAR 80mg/day Musculoskeletal Stiffness Neuroleptic Malignant Syndrome Platelet Count Increased Skin Graft Date:05/12/05ISR Number: 4660350-0Report Type:Expedited (15-DaCompany Report #PHBS2005FI06579 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Obsessive-Compulsive Leponex PS Novartis Sector: Disorder Pharma ORAL Leponex SS Novartis Sector: Pharma Lowered dose 22-Feb-2006 08:30 AM Page: 3303 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/12/05ISR Number: 4660351-2Report Type:Expedited (15-DaCompany Report #PHBS2005HR06519 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukocytosis Leponex PS Novartis Sector: Lymphopenia Pharma ORAL UNK, UNK Nozinan C UNKNOWN 100 mg/d Rivotril C UNKNOWN 3 mg/d Date:05/12/05ISR Number: 4661467-7Report Type:Expedited (15-DaCompany Report #05-05-0738 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neoplasm Malignant Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 100-150MG QD ORAL Date:05/12/05ISR Number: 4661470-7Report Type:Expedited (15-DaCompany Report #05-05-0798 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neoplasm Malignant Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 25-475MG QD ORAL Date:05/12/05ISR Number: 4661487-2Report Type:Expedited (15-DaCompany Report #05-05-0805 Age:71 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine Tablets - Other Septic Shock Professional Ivax Urinary Tract Infection Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 50-825MG QD ORAL Date:05/12/05ISR Number: 4661490-2Report Type:Expedited (15-DaCompany Report #05-05-0806 Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 125-250MG QD ORAL 22-Feb-2006 08:30 AM Page: 3304 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/12/05ISR Number: 4661491-4Report Type:Expedited (15-DaCompany Report #05-04-0795 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 250-400MG QD ORAL Date:05/12/05ISR Number: 4661499-9Report Type:Direct Company Report #CTU 248327 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neutrophil Count Clozapine 100 Mg Decreased Ivax PS Ivax ORAL 100 MG BID ORAL Clozapine 25 Mg Ivax SS Ivax ORAL 50 MG QAM ORAL Benztropine C Guanfacine C Risperidone M C Clotrimazole Cream 1% C Date:05/12/05ISR Number: 4662566-6Report Type:Expedited (15-DaCompany Report #PAR_0009_2005 Age:78 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Foreign Isoptine PS ORAL 240 MG QDAY Initial or Prolonged Blood Iron Decreased Health PO Depression Professional Depakine SS ORAL 500 MG BID PO Inflammation Other Depakine SS 100 MG/ML Normochromic Normocytic Mianserin Anaemia Hydrochloride SS ORAL 30 MG QDAY PO Platelet Count Decreased Memantine SS ORAL 20 MG PO Serum Ferritin Increased Clopidogrel Sulfate SS ORAL 75 MG QDAY PO Clozapine SS ORAL 50 MG QDAY PO Date:05/13/05ISR Number: 4661218-6Report Type:Expedited (15-DaCompany Report #PHBS2005NZ01232 Age:42 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Level Decreased Clozaril PS Novartis Sector: Haemochromatosis Pharma ORAL 300 mg/d Platelet Count Decreased Kliogest C ORAL 1 tab/d Polycythaemia Ranitidine C UNKNOWN 150 mg/d Thrombocythaemia Weight Decreased 22-Feb-2006 08:30 AM Page: 3305 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/13/05ISR Number: 4661219-8Report Type:Expedited (15-DaCompany Report #PHFR2005GB01741 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Clozaril PS Novartis Sector: Initial or Prolonged Chest Discomfort Pharma ORAL 200mg/day Other Confusional State Clozaril SS Novartis Sector: Cyanosis Pharma ORAL 350mg/day Disturbance In Attention Dyspnoea Gait Disturbance Headache Hyperhidrosis Hypertension Malaise Muscle Tightness Psychomotor Hyperactivity Pulmonary Embolism Salivary Hypersecretion Somnolence Tremor Date:05/13/05ISR Number: 4661262-9Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050301645 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Brain Oedema Risperdal Consta PS INTRAMUSCULAR Cardiac Arrest Risperdal Consta SS INTRAMUSCULAR Coma Neurocil SS OROPHARINGEAL Drug Interaction Neurocil SS OROPHARINGEAL Hypoxic Encephalopathy Neurocil SS OROPHARINGEAL Pulmonary Embolism Risperdal C OROPHARINGEAL Respiratory Arrest Akineton C Tavor C Tavor C Tavor C Leponex I OROPHARINGEAL Date:05/13/05ISR Number: 4661409-4Report Type:Expedited (15-DaCompany Report #2005S1000924 Age:46 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Paxil PS Glaxosmithkline ORAL 30MG Twice Hospitalization - Death per day Initial or Prolonged Clozapine SS ORAL 500MG At night 16 MON Buspar SS ORAL Tiagabine Hydrochloride C UNKNOWN Date:05/13/05ISR Number: 4662939-1Report Type:Expedited (15-DaCompany Report #2005S1000364 Age:86 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Health Clozapine Tablets Professional (25 Mg) PS ORAL 75 MG; HS; PO Other Clozapine Tablets (100 Mg) SS ORAL 100 MG; HS; PO 22-Feb-2006 08:30 AM Page: 3306 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Fentanyl C Morphine Sulfate C Levothyroxine Sodium C Quetiapine Fumarate C Zinc C Tocopherol C Calcitonin, Salmon C Senna Fruit C Levodopa/Carbidopa C Acetylsalicylic Acid C Mirtazapine C Ibuprofen C Date:05/13/05ISR Number: 4662942-1Report Type:Expedited (15-DaCompany Report #2005S1001360 Age:81 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Condition Aggravated Health Clozapine Tablets Prostate Cancer Professional (100 Mg) PS ORAL 100 MG; BID; Other PO Levodopa/Carbidopa C Ropinirole C Hydrochloride C Rabeprazole Sodium C Ascorbic Acid C Cyanocobalamin C Lovastatin C Bisacodyl C Digoxin C Zinc Sulfate C Ferrous Sulfate C Senna C Ipratropium Bromide/Salbutamol Sulfate C Clarithromycin C Paracetamol C Loperamide C Paracetamoil/Hydroco done Bitartrate C Furosemide C Citalopram Hydrobromide C Lorazepam C Quinine C Calcium C Date:05/13/05ISR Number: 4662943-3Report Type:Expedited (15-DaCompany Report #2005S1001481 Age:78 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Influenza Health Clozapine Tablets Pneumonia Professional (100 Mg) PS ORAL 200 MG; HS; Other PO Clozapine Tablets (25 Mg) SS ORAL SEE IMAGE 22-Feb-2006 08:30 AM Page: 3307 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/13/05ISR Number: 4662944-5Report Type:Expedited (15-DaCompany Report #2005S1001682 Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Disorder Health Clozapine Tablets Treatment Noncompliance Professional (100 Mg) PS ORAL SEE IMAGE Other Vitamin Nos C Date:05/16/05ISR Number: 4662757-4Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12956736 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Buspar PS Bristol-Myers Squibb Hospitalization - Death Company ORAL Initial or Prolonged Clozapine SS ORAL Clozapine SS ORAL Paxil SS Tiagabine C Date:05/16/05ISR Number: 4664061-7Report Type:Direct Company Report #CTU 248674 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Atorvastatin 20 Mg Initial or Prolonged Phosphokinase Increased O.D. PS 20 MG O.D. Hyponatraemia Clozapine 500 Mg Po Polydipsia Hs SS ORAL 500 MG PO HS Renal Failure Acute Anafranil 50 Mg Bid Po SS ORAL 50 MG BID PO Date:05/17/05ISR Number: 4663631-XReport Type:Expedited (15-DaCompany Report #PHEH2005US05498 Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Clozaril PS Novartis Sector: Pharma ORAL 400 mg, QD Date:05/17/05ISR Number: 4663632-1Report Type:Expedited (15-DaCompany Report #PHFR2003GB02133 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Clozaril PS Novartis Sector: Initial or Prolonged Constipation Pharma ORAL UNK, UNK 2878 DAY Other Convulsion Clozaril SS Novartis Sector: Exfoliative Rash Pharma ORAL UNK, UNK 617 DAY Gastrointestinal Disorder Clozaril SS Novartis Sector: Glomerular Filtration Pharma ORAL UNK, UNK Rate Decreased Iron C UNKNOWN Haemodialysis Haemoglobin Decreased Hyperkalaemia Liver Disorder Nausea Obstructive Uropathy Post Procedural Complication Renal Failure Renal Failure Chronic 22-Feb-2006 08:30 AM Page: 3308 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/17/05ISR Number: 4663636-9Report Type:Expedited (15-DaCompany Report #PHFR2005IE00862 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Clozaril PS Novartis Sector: Increased Pharma ORAL 400 mg/day 2226 DAY Aspartate Lithium Carbonate C ORAL 1200 mg/day 1680 DAY Aminotransferase Increased Blood Albumin Decreased Blood Alkaline Phosphatase Increased Blood Bilirubin Increased Gamma-Glutamyltransferase Increased Influenza Like Illness Liver Function Test Abnormal Malaise Skin Discolouration Date:05/17/05ISR Number: 4663641-2Report Type:Expedited (15-DaCompany Report #PHNR2005AU00857 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Clozaril PS Novartis Sector: Initial or Prolonged Phosphokinase Increased Pharma 0 - 175 Blood Creatinine mg/day 36000MIN Increased Lithium C Dehydration Valproate Sodium C Diarrhoea Fluvoxamine C In reducing Gastroenteritis dose (not Hyperhidrosis specified) Myoglobin Urine Present Neuroleptic Malignant Syndrome Renal Failure Tremor Vomiting Date:05/17/05ISR Number: 4663648-5Report Type:Expedited (15-DaCompany Report #PHHO2005CA07613 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiotoxicity Clozaril PS Novartis Sector: Pharma 50400MIN Date:05/17/05ISR Number: 4663649-7Report Type:Expedited (15-DaCompany Report #PHBS2005FI06751 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Pressure Increased Leponex PS Novartis Sector: Bundle Branch Block Left Pharma ORAL 22-Feb-2006 08:30 AM Page: 3309 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/17/05ISR Number: 4663674-6Report Type:Expedited (15-DaCompany Report #2005S1001890 Age:85 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Choking Health Clozapine Tablets Professional (25 Mg) PS ORAL 75 MG; HS; PO Other Date:05/17/05ISR Number: 4663675-8Report Type:Expedited (15-DaCompany Report #2005S1001906 Age:41 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional (25 Mg) PS 25 MG Other Clozapine Tablets (100 Mg) SS 100 MG Disulfiram C Buspirone Hydrochloride C Vnlafaxine C Hydrochloride C Clonazepam C Omeprazole C Date:05/17/05ISR Number: 4663677-1Report Type:Expedited (15-DaCompany Report #05-05-0811 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akinesia Foreign Clozapine Unknown PS 12.5-200MG QD Initial or Prolonged Aphasia Literature Mirtazapine C Drug Toxicity Health Escherichia Urinary Tract Professional Infection Gait Disturbance Incoherent Refusal Of Treatment By Patient Date:05/17/05ISR Number: 4663683-7Report Type:Expedited (15-DaCompany Report #05-05-0812 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 350MG QD ORAL Date:05/17/05ISR Number: 4663684-9Report Type:Expedited (15-DaCompany Report #05-05-0808 Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Renal Failure Health Clozapine - Ivax Other Urinary Tract Infection Professional Pharmaceuticals, Urosepsis Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 25MG QD ORAL 22-Feb-2006 08:30 AM Page: 3310 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/17/05ISR Number: 4663685-0Report Type:Expedited (15-DaCompany Report #05-02-0164 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Distension Health Clozapine - Ivax Drug Level Above Professional Pharmaceuticals, Therapeutic Other Inc. Tablets PS Ivax Faecaloma Pharmaceuticals, Fall Inc. ORAL 25-700MG QD Liver Disorder ORAL Date:05/17/05ISR Number: 4663687-4Report Type:Expedited (15-DaCompany Report #2005S1002223 Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Cancer Metastatic Health Clozapine Tablets Metastases To Central Professional (25 Mg) PS ORAL 75 MG; QD; PO Nervous System Other Clozapine Tablets (100 Mg) SS ORAL 500 MG; HS; PO Date:05/17/05ISR Number: 4663692-8Report Type:Expedited (15-DaCompany Report #05-05-0813 Age:96 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death No Adverse Effect Health Cloazpine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 25-50MG QD ORAL Date:05/17/05ISR Number: 4663693-XReport Type:Expedited (15-DaCompany Report #05-05-0807 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 800-1000MG QD ORAL Date:05/17/05ISR Number: 4663694-1Report Type:Expedited (15-DaCompany Report #05-04-0649 Age:49 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 400MG QHS ORAL Lipitor C Lithium C Ativan C 22-Feb-2006 08:30 AM Page: 3311 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/17/05ISR Number: 4665051-0Report Type:Expedited (15-DaCompany Report #GBR-2004-0001251 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Foreign Morphine Sulfate PS ORAL 100 MG, BID, Electrocardiogram Qt Health ORAL Corrected Interval Professional Clozaril Prolonged Other (Clozapine) SS ORAL 50 MG, BID, Hypotension ORAL Pulse Abnormal Venlafaxine Tachycardia (Venlafaxine) C Diazepam (Diazepam) C Date:05/18/05ISR Number: 4664294-XReport Type:Expedited (15-DaCompany Report #PHNU2005DE01947 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Benign Prostatic Leponex / Clozaril Hyperplasia (Clozapine) PS Novartis Sector: Weight Increased Pharma ORAL UNK, UNK Sifrol C Cipralex C Date:05/18/05ISR Number: 4664648-1Report Type:Expedited (15-DaCompany Report #PHBS2005NZ06735 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Insulin Increased Clozaril PS Novartis Sector: Hypertension Pharma ORAL 125 mg, BID Insulin Resistance Olanzapine C UNKNOWN 5 mg, QHS Ovarian Disorder Flixotide C UNKNOWN Aalbutamol C UNKNOWN Date:05/18/05ISR Number: 4666993-2Report Type:Periodic Company Report #PHEH2004US08646 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Grand Mal Convulsion Health Tegretol-Xr Leukopenia Professional (Carbamazepine) Neutropenia Extended Release Tablet PS ORAL ORAL Clozaril (Clozapine) Tablet SS ORAL 25 MG, QD, ORAL Abilify (Aripiprazole) C Zyprexa (Olanzapine) C Keppra (Levetiracetam) C Date:05/19/05ISR Number: 4665467-2Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12555793 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Cytoxan PS Bristol-Myers Squibb Company Adriamycin SS 22-Feb-2006 08:30 AM Page: 3312 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Oncovin SS Rituxan SS Clozapine SS ORAL Dose = 800-350 mg Date:05/19/05ISR Number: 4665478-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12601720 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Cytoxan PS Bristol-Myers Squibb Company Clozapine SS ORAL Date:05/19/05ISR Number: 4665496-9Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12827929 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Cytoxan PS Bristol-Myers Squibb Initial or Prolonged Anaemia Company Other Ewing'S Sarcoma Etoposide SS Bristol-Myers Squibb Metastatic Company Thrombocytopenia Cisplatin SS Bristol-Myers Squibb Company Ifosfamide SS Bristol-Myers Squibb Company Adriamycin SS Vincristine SS Clozapine SS ORAL dose range from 300-75 mg Date:05/19/05ISR Number: 4665602-6Report Type:Expedited (15-DaCompany Report #PHFR2004GB03974 Age:53 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Full Blood Count Clozaril PS Novartis Sector: Initial or Prolonged Decreased Pharma ORAL 350 mg/day Other Haemoglobin Decreased Nausea Oesophageal Carcinoma Regurgitation Of Food Throat Cancer Vomiting Date:05/19/05ISR Number: 4665603-8Report Type:Expedited (15-DaCompany Report #PHFR2005GB01634 Age:88 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abnormal Behaviour Clozaril PS Novartis Sector: Confusional State Pharma ORAL Mobility Decreased Psychotic Disorder 22-Feb-2006 08:30 AM Page: 3313 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/19/05ISR Number: 4665604-XReport Type:Expedited (15-DaCompany Report #PHFR2005GB01685 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Azoospermia Clozaril PS Novartis Sector: Pharma ORAL 225mg/day Date:05/19/05ISR Number: 4665605-1Report Type:Expedited (15-DaCompany Report #PHFR2005GB01741 Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Clozaril PS Novartis Sector: Initial or Prolonged Chest Discomfort Pharma ORAL 200mg/day Other Confusional State Clozaril SS Novartis Sector: Cyanosis Pharma ORAL 350mg/day Disturbance In Attention Dyspnoea Gait Disturbance Headache Hyperhidrosis Hypertension Malaise Muscle Tightness Psychomotor Hyperactivity Pulmonary Embolism Salivary Hypersecretion Somnolence Tremor Date:05/20/05ISR Number: 4667906-XReport Type:Expedited (15-DaCompany Report #PHBS2005CH06689 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Withdrawal Syndrome Leponex PS Novartis Sector: Initial or Prolonged Grand Mal Convulsion Pharma UNKNOWN 700 mg/d Leponex SS Novartis Sector: Pharma UNKNOWN Solian SS UNKNOWN 800 mg/d Tranxilium SS UNKNOWN Nervifene C UNKNOWN 5 mg/d Sortis C UNKNOWN 20 mg/d Norvasc C UNKNOWN 5 mg/d Date:05/20/05ISR Number: 4667908-3Report Type:Expedited (15-DaCompany Report #PHRM2005FR01321 Age:52 YR Gender:Male I/FU:F Outcome PT Hospitalization - Abnormal Behaviour Initial or Prolonged Cerebellar Syndrome Disability Confusional State Disorientation Dysarthria Epilepsy Fall Gait Disturbance Hypotension Orthostatic Hypotension Tremor White Blood Cell Count 22-Feb-2006 08:30 AM Page: 3314 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Increased Report Source Product Role Manufacturer Route Dose Duration Leponex PS Novartis Sector: Pharma ORAL UNK, UNK Leponex SS Novartis Sector: Pharma Date:05/20/05ISR Number: 4667915-0Report Type:Expedited (15-DaCompany Report #PHNR2005AU00872 Age:25 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Acquired Cardiac Septal Clozaril PS Novartis Sector: Defect Pharma ORAL 550 mg daily Drug Toxicity Echocardiogram Abnormal Ejection Fraction Decreased Date:05/20/05ISR Number: 4669496-4Report Type:Expedited (15-DaCompany Report #05-05-0853 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Neoplasm Malignant Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 375MG QD ORAL Date:05/20/05ISR Number: 4669497-6Report Type:Expedited (15-DaCompany Report #05-05-0847 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 575MG QD ORAL Date:05/20/05ISR Number: 4669578-7Report Type:Expedited (15-DaCompany Report #2005S1002373 Age:84 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine Tablets Professional (25 Mg) PS ORAL 12.5 MG; QD; Other PO Ipratropium Bromide C Escitalopram C Levodopa/Carbidopa C Cyanocobalamin C Lorazepam C Furosemide C Ranitidine Hydrochloride C Lisinopril C Fluticasone Propionate/Salmetero 22-Feb-2006 08:30 AM Page: 3315 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report l Xinafoate C Potassium Chloride C Salbutamol C Sorbitol C Hyoscyamine Sulfate C Date:05/20/05ISR Number: 4669580-5Report Type:Expedited (15-DaCompany Report #2005S1003168 Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional (100 Mg) PS ORAL 200 MG; QD; Other PO Simvastatin C Folgard Rx 2.2 C Date:05/20/05ISR Number: 4669611-2Report Type:Expedited (15-DaCompany Report #2005S1003277 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Other Clozapine Tablets (25 Mg) PS ORAL 50 MG; QAM; PO Clozapine Tablets (100 Mg) SS ORAL SEE IMAGE Date:05/20/05ISR Number: 4669651-3Report Type:Expedited (15-DaCompany Report #05-02-0295 Age:46 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Loss Of Consciousness Health Clozapine - Ivax Myocardial Infarction Professional Pharmaceuticals, Weight Increased Other Inc. Tablets PS ORAL 100MG TID ORAL Geodon SS 80MG BID Date:05/20/05ISR Number: 4669652-5Report Type:Expedited (15-DaCompany Report #05-05-0809 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Health Clozapine - Ivax Initial or Prolonged Immeasurable Professional Pharmaceuticals, Other Loss Of Consciousness Other Inc. Tablets PS Ivax Urinary Incontinence Pharmaceuticals, Inc ORAL ORAL Date:05/20/05ISR Number: 4669653-7Report Type:Expedited (15-DaCompany Report #05-05-0848 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc ORAL ORAL Interferon C 22-Feb-2006 08:30 AM Page: 3316 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/20/05ISR Number: 4669658-6Report Type:Expedited (15-DaCompany Report #05-05-0846 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Cancer Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc ORAL 300-500MG QD ORAL Chemotherapy For Breast Cancer C Date:05/20/05ISR Number: 4669670-7Report Type:Expedited (15-DaCompany Report #05-05-0832 Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Lung Neoplasm Malignant Consumer Clozapine - Ivax White Blood Cell Count Health Pharmaceuticals, Decreased Professional Inc. Tablets PS Ivax Other Pharmaceuticals, Inc ORAL 100-25MG QD ORAL Date:05/21/05ISR Number: 4672457-2Report Type:Expedited (15-DaCompany Report #05-04-0554 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Alcohol Use Health Clozapine - Ivax Atherosclerosis Professional Pharmaceuticals, Congestive Cardiomyopathy Inc. Tablets PS Ivax Coronary Artery Disease Pharmaceuticals, Drug Toxicity Inc. ORAL 600MG QD ORAL Hypertensive Heart Naprosyn 500 Mg C Disease Lortab C Colace C Aspirin C Vasotec C Multivitamins C Prolixin Decanoate C Wellbutrin- Slow Release C Depakote C Amantadine C Seroquel C Tivan C Date:05/23/05ISR Number: 4669550-7Report Type:Expedited (15-DaCompany Report #PHBS2005NZ02123 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Clozaril PS Novartis Sector: Initial or Prolonged Phosphokinase Increased Pharma ORAL 700 mg/day 894 DAY Dysstasia Antihistaminics C Muscle Rigidity Chlorpromazine C Neuroleptic Malignant Syndrome Pneumonia Aspiration Pyrexia 22-Feb-2006 08:30 AM Page: 3317 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/23/05ISR Number: 4669559-3Report Type:Expedited (15-DaCompany Report #PHNU2005DE01965 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cognitive Disorder Leponex / Clozaril Initial or Prolonged Somatosensory Evoked (Clozapine) PS Novartis Sector: Other Potentials Abnormal Pharma ORAL up to 50mg/day Date:05/23/05ISR Number: 4669561-1Report Type:Expedited (15-DaCompany Report #PHBS2005CH07189 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ophthalmoplegia Leponex PS Novartis Sector: Initial or Prolonged Psychotic Disorder Pharma ORAL 600 mg/d Risperdal SS ORAL 4 mg/d Nozinan SS ORAL 125 mg/d Date:05/23/05ISR Number: 4669583-0Report Type:Expedited (15-DaCompany Report #PHEH2005US05643 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Neoplasm Malignant Clozaril PS Novartis Sector: Respiratory Failure Pharma ORAL 300 mg, QD Date:05/23/05ISR Number: 4669586-6Report Type:Expedited (15-DaCompany Report #PHNU2005DE01966 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cognitive Disorder Leponex / Clozaril Initial or Prolonged Somatosensory Evoked (Clozapine) PS Novartis Sector: Other Potentials Abnormal Pharma ORAL up to 500mg/day Date:05/23/05ISR Number: 4669920-7Report Type:Expedited (15-DaCompany Report #PHNR2005AU00857 Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Clozaril PS Novartis Sector: Initial or Prolonged Phosphokinase Increased Pharma 0 - 175 Blood Creatinine mg/day 36000MIN Increased Lithium C Dehydration Valproate Sodium C Diarrhoea Fluvoxamine C In reducing Gastroenteritis dose (not Hyperhidrosis specified) Myoglobin Urine Present Neuroleptic Malignant Syndrome Renal Failure Tremor Vomiting 22-Feb-2006 08:30 AM Page: 3318 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/23/05ISR Number: 4669923-2Report Type:Expedited (15-DaCompany Report #PHNU2005DE00866 Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Catecholamines Urine Leponex / Clozaril Catecholamines Urine (Clozapine) PS Novartis Sector: Increased Pharma ORAL up to Epinephrine Increased 600mg/day Headache Propranolol C ORAL 100 mg/day Hyperhidrosis Tavor C ORAL 1 to 3 mg/day 145 DAY Hypertension Delix C ORAL 7.5 mg/day Hypertensive Crisis Norepinephrine Increased Palpitations Phaeochromocytoma Date:05/23/05ISR Number: 4672455-9Report Type:Expedited (15-DaCompany Report #05-05-0838 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Colon Cancer Metastatic Consumer Clozapine - Ivax Other Metastases To Liver Other Pharmaceuticals, Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 150-300MG QD ORAL Date:05/23/05ISR Number: 4672456-0Report Type:Expedited (15-DaCompany Report #05-05-0854 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc ORAL 150-300MG QD ORAL Date:05/23/05ISR Number: 4673724-9Report Type:Expedited (15-DaCompany Report #2005073716 Age:40 YR Gender:Male I/FU:I Outcome PT Hospitalization - Blood Glucose Increased Initial or Prolonged Blood Pressure Increased Body Temperature Increased Catatonia Central Nervous System Infection Delirium Drug Toxicity Heart Rate Increased Hyperhidrosis Hypertonia Loss Of Consciousness Mental Status Changes Muscle Rigidity Musculoskeletal Stiffness Mydriasis Neuroleptic Malignant 22-Feb-2006 08:30 AM Page: 3319 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Syndrome Respiratory Rate Increased Serotonin Syndrome Report Source Product Role Manufacturer Route Dose Duration Tachycardia Literature Ziprasidone (Caps) Treatment Noncompliance Health (Ziprasidone) PS 80 MG (2 IN 1 Weight Increased Professional D) White Blood Cell Count Clozapine Increased (Clozapine) SS 400 MG (1 IN 1 D) Citalopram (Citalopram) SS 80 MG (1 IN 1 D) Valproic Acid (Valproic Acid) SS 2000 MG (1 IN 1 D) Date:05/24/05ISR Number: 4672640-6Report Type:Expedited (15-DaCompany Report #PHEH2005US05625 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiomegaly Clozaril PS Novartis Sector: Other Drug Abuser Pharma Unk, Unk Drug Interaction Biaxin SS UNK, Hypertensive Heart ONCE/SINGLE Disease Clozaril SS Novartis Sector: Laboratory Test Abnormal Pharma ORAL 200mg at 4am, Muscle Rigidity 250mg at Obesity 3:30pm Toxicologic Test Abnormal Ventricular Arrhythmia Ventricular Hypertrophy Date:05/24/05ISR Number: 4672966-6Report Type:Expedited (15-DaCompany Report #2005S1001573 Age:83 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Chronic Obstructive Health Clozapine Tablets Pulmonary Disease Professional (25 Mg) PS ORAL 75 MG; HS; PO Pneumonia Other Date:05/24/05ISR Number: 4672973-3Report Type:Expedited (15-DaCompany Report #2005SI001202 Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Health Clozapine Tablets Professional (100 Mg) PS ORAL 300 MG QAM Other PO; 500 MG HS PO Omeprazole C Ranitidine Hydrochloride C Docusate Sodium C Fluoxetine Hydrochloride C Olanzapine C Risperidone C Benzatropine Mesilate C 22-Feb-2006 08:30 AM Page: 3320 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Macrogol C Fiber Tax C Date:05/24/05ISR Number: 4672976-9Report Type:Expedited (15-DaCompany Report #2005S1001107 Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetes Mellitus Health Clozapine Tablets Non-Insulin-Dependent Professional (100 Mg) PS ORAL 400 MG HS PO Myocardial Infarction Other Glimepiride C Renal Failure Trazodone C Benzatropine Mesilate C Docusate Sodium C Sertraline C Valproic Acid C Date:05/24/05ISR Number: 4672979-4Report Type:Expedited (15-DaCompany Report #2005SI000629 Age:71 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Self Injurious Behaviour Health Clozapine Tablets Professional (100 Mg) PS ORAL 50 MG QAM PO; Other 250 MG HS PO Salbutamol Sulfate C Lorazepam C Paracetamol C Promethazine Hydrochloride C Magnesium Hydroxide C Folic Acid C Pyridoxine Hydrochloride/Thiami ne Hydrochloride/Ribofl avin/Nicotinamide/Ca C Ferrous Sulfate C Mometasone Furoate C Esomeprazole C Loratadine C Metoclopramide Hydrochloride C Hyoscine C Morphine Sulfate C Bisacodyl C Sodium Phosphate Dibasic/Sodium Phosphate C Paracetamol C Hyocyamine Sulfate C Date:05/24/05ISR Number: 4673001-6Report Type:Expedited (15-DaCompany Report #05-05-0912 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Health Clozapine Tablets Professional -Ivax Other Pharmaceuticals, Inc PS Ivax 22-Feb-2006 08:30 AM Page: 3321 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pharmaceuticals, Inc. ORAL ORAL Date:05/24/05ISR Number: 4673003-XReport Type:Expedited (15-DaCompany Report #05-04-0717 Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozapine Tablets - Myocardial Infarction Professional Ivax Other Pharmaceuticals, Inc PS Ivax Pharmaceuticals, Inc. ORAL 400MG QD ORAL Zoloft C Enalapril C Lipitor C Glipizide C Metformin C Date:05/24/05ISR Number: 4673005-3Report Type:Expedited (15-DaCompany Report #05-05-0855 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Glomerulonephritis Acute Health Clozapine Tablets - Hospitalization - Renal Failure Professional Ivax Initial or Prolonged Other Pharmaceuticals, Inc PS Ivax Required Pharmaceuticals, Intervention to Inc. ORAL 50MG HS ORAL Prevent Permanent Ibuprofen SS 600-800MG TID 1 YR Impairment/Damage Depakote C Zoloft C Date:05/24/05ISR Number: 4673008-9Report Type:Expedited (15-DaCompany Report #2005S1003387 Age:81 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional (25 Mg) PS ORAL 25 MG BID PO Other Thyroid C Olanzapine C Metoclopramide C Hydrochloride C Colecalciferol/Calci um C Omeprazole C Prednisone C Date:05/24/05ISR Number: 4673015-6Report Type:Expedited (15-DaCompany Report #2005S1002662 Age:78 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neoplasm Malignant Health Clozapine Tablets Small Intestinal Professional (100 Mg) PS ORAL 100 MG HS PO Obstruction Other Insulin C Metformin C Vitamin E C Docusate Sodium C Atorvastatin C Lisinopril C 22-Feb-2006 08:30 AM Page: 3322 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/24/05ISR Number: 4673017-XReport Type:Expedited (15-DaCompany Report #2005S1002427 Age:38 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Fall Health Clozapine Tablets Gastrooesophageal Reflux Professional (25 Mg) PS ORAL 75 MG QD PO Disease Other Clozapine Tablets Hypothyroidism (100 Mg) SS ORAL 400 MG HS PO Injury Date:05/24/05ISR Number: 4674089-9Report Type:Direct Company Report #CTU 249427 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Level Changed Clozaril 100 Mg PS 2AM / 5 PM TAKEN P.O. (DAILY GP/ INDIV WKLY RESIDES RRP Date:05/25/05ISR Number: 4674583-0Report Type:Expedited (15-DaCompany Report #05-05-0926 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Health Clozapine - Ivax Non-Small Cell Lung Professional Pharmaceuticals, Cancer Stage I Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 25MG QD ORAL Chemotherapy SS Date:05/25/05ISR Number: 4674585-4Report Type:Expedited (15-DaCompany Report #05-05-0928 Age:76 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Health Clozapine - Ivax Hospitalization - Lethargy Professional Pharmaceuticals, Initial or Prolonged Loss Of Consciousness Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 400MG QD ORAL Date:05/25/05ISR Number: 4674586-6Report Type:Expedited (15-DaCompany Report #05-05-0932 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozapine - Ivax Neoplasm Malignant Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 600MG QD ORAL Chemotherapy SS 22-Feb-2006 08:30 AM Page: 3323 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/25/05ISR Number: 4674587-8Report Type:Expedited (15-DaCompany Report #05-05-0913 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Wound Infection Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 400MG QD ORAL Date:05/26/05ISR Number: 4674230-8Report Type:Expedited (15-DaCompany Report #PHFR2005GB01795 Age:59 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Urine Present Clozaril PS Novartis Sector: Initial or Prolonged Confusional State Pharma ORAL 650mg/day Other Constipation Metformin C Dyskinesia Malaise Muscle Spasms Polyuria Renal Failure Date:05/26/05ISR Number: 4674231-XReport Type:Expedited (15-DaCompany Report #PHNR2005AU00572 Age:67 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Clozaril PS Novartis Sector: Initial or Prolonged Drug Level Increased Pharma 12 - 700 Sedation mg/day 1806 DAY Clozaril SS Novartis Sector: Pharma 12 mg, QD Lithium SS Celebrex SS Sertraline SS Date:05/26/05ISR Number: 4676535-3Report Type:Expedited (15-DaCompany Report #2005S1002429 Age:84 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Health Clozapine Tablets Dyspnoea Professional (100 Mg) PS ORAL 200 MG; HS; Fall Other PO Levodopa/Carbidopa C Entacapone C Pramipexole C Dihydrochloride C Mematine C Verapamil C Seroquel C Donepezil Hydrochloride C Clopidogrel Sulfate C 22-Feb-2006 08:30 AM Page: 3324 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/26/05ISR Number: 4676546-8Report Type:Expedited (15-DaCompany Report #2005S1003724 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozapine Tablets Professional (25 Mg) PS ORAL 25 MG; QAM; Other PO Clozapine Tablets (100 Mg0 SS ORAL 300 MG; HS; PO Clonazepam C Symbyax C Buspirone C Trifluoperazine C Hydrochloride C Benzatropine Mesilate C Lisinopril C Date:05/26/05ISR Number: 4676555-9Report Type:Expedited (15-DaCompany Report #2005S1000572 Age:67 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agranulocytosis Health Clozapine Tablets Hypotension Professional (25 Mg) PS ORAL 50 MG; QAM; Jaundice Cholestatic Other PO Muscle Necrosis Clozapine Tablets Septic Necrosis (100 Mg) SS ORAL SEE IMAGE Wound Complication Senna Fruit C Zolpidem Tartrate C Triamcinolone Acetonide C Cetirizine Hydrochloride C Dephenhydramine C Hydrocortisone C Furosemide C Perphenazine C Clark'S Solution C Magnesium Hydroxide/Aluminium Hydroxide Gel C Teribinafine Hydrochloride C Pantoprazole C Gatifloxacin C Paracetamol C Trazodone C Tamsulosin Hydrochloride C Diclofenac C Baclofen C Date:05/26/05ISR Number: 4676558-4Report Type:Expedited (15-DaCompany Report #05-05-0935 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Collapse Of Lung Health Clozapine Tablets - Difficult To Wean From Professional Ivax Ventilator Other Pharmaceuticals, 22-Feb-2006 08:30 AM Page: 3325 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Inc. PS Ivax Pharmaceuticals, Inc. ORAL 300-700MG QD ORAL Oxygen C Date:05/26/05ISR Number: 4676559-6Report Type:Expedited (15-DaCompany Report #05-05-0839 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Neoplasm Malignant Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 50-1050MG QD ORAL Date:05/27/05ISR Number: 4675229-8Report Type:Expedited (15-DaCompany Report #PHBS2005BE06117 Age:25 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Lactate Leponex PS Novartis Sector: Dehydrogenase Increased Pharma ORAL 25 mg/day 10080MIN Haematocrit Decreased Amyl Nitrite SS Haemoglobin Decreased Leponex SS Novartis Sector: Haemolysis Pharma ORAL 50 mg/day 12960MIN Haemolytic Anaemia Leponex SS Novartis Sector: Haptoglobin Decreased Pharma ORAL 37.5 mg/day 11520MIN Mean Cell Volume Leponex SS Novartis Sector: Increased Pharma ORAL 100 mg/day 18720MIN Red Blood Cell Count Temesta C Decreased Loramet C Red Blood Cell Morphology Magneton C Abnormal Antabuse C Impromen Decanoas C Omeprazole C Serlain C Akineton C Maalox C Date:05/27/05ISR Number: 4675230-4Report Type:Expedited (15-DaCompany Report #PHFR2005IE01770 Age:41 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abnormal Behaviour Clozaril PS Novartis Sector: Condition Aggravated Pharma ORAL 505 DAY Obsessive-Compulsive Clozaril SS Novartis Sector: Disorder Pharma ORAL 150 mg/day Amisulpride C ORAL upto 1200mg/day Diazepam C ORAL upto 20 mg/day Baclofen C upto 40 mg/day Lexapro C ORAL 20 mg/day Escitalopram C 22-Feb-2006 08:30 AM Page: 3326 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/27/05ISR Number: 4675232-8Report Type:Expedited (15-DaCompany Report #PHEH2005US05701 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Ear Infection Clozaril PS Novartis Sector: Neutrophil Count Abnormal Pharma ORAL 300 mg, QD Neutrophil Count Increased White Blood Cell Count Increased Date:05/27/05ISR Number: 4675235-3Report Type:Expedited (15-DaCompany Report #PHFR2004GB02585 Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aspiration Clozaril PS Novartis Sector: Initial or Prolonged Dysphagia Pharma ORAL 100 mg, BID Disability Lower Respiratory Tract Zopiclone C 2.7mg nocte Other Infection Procyclidine C 22.5mg Neutrophil Count Increased Pneumonia White Blood Cell Count Increased Date:05/27/05ISR Number: 4675236-5Report Type:Expedited (15-DaCompany Report #PHBS2005BR04691 Age:70 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Acute Sinusitis Leponex PS Novartis Sector: Colonoscopy Pharma ORAL 200 mg/d Helicobacter Infection Risperidone C ORAL UNK, QD Pneumonia Frisium C ORAL UNK, QD Selozok C ORAL 50 mg/d Detrusitol C ORAL 2 mg, Q48H Date:05/27/05ISR Number: 4675240-7Report Type:Expedited (15-DaCompany Report #PHFR2005GB01391 Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Ankle Fracture Clozaril PS Novartis Sector: Hospitalization - Fall Pharma ORAL 400mg/day Initial or Prolonged Immobile Other Obesity Pulmonary Embolism Sedation Date:05/27/05ISR Number: 4675241-9Report Type:Expedited (15-DaCompany Report #PHBS2005NO07346 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypercholesterolaemia Leponex PS Novartis Sector: Pharma ORAL 500 mg/d Lipitor C 22-Feb-2006 08:30 AM Page: 3327 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/27/05ISR Number: 4675249-3Report Type:Expedited (15-DaCompany Report #PHFR2005IE01097 Age:31 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Cholesterol Clozaril PS Novartis Sector: Increased Pharma ORAL UNK, UNK Blood Triglycerides Increased Diabetes Mellitus Electrocardiogram T Wave Amplitude Decreased Electrocardiogram T Wave Inversion Hypertension Low Density Lipoprotein Increased Metabolic Syndrome Pseudophaeochromocytoma Salivary Hypersecretion Tachycardia Weight Increased Date:05/27/05ISR Number: 4675251-1Report Type:Expedited (15-DaCompany Report #PHRM2005FR01630 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Lung Neoplasm Malignant Leponex PS Novartis Sector: Pharma ORAL Date:05/27/05ISR Number: 4675252-3Report Type:Expedited (15-DaCompany Report #PHFR2005GB01290 Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Colectomy Clozaril PS Novartis Sector: Initial or Prolonged Constipation Pharma ORAL 100mg mane & Faecaloma 200mg nocte 4048 DAY Intestinal Functional Clozaril SS Novartis Sector: Disorder Pharma ORAL 100mg/day Platelet Count Decreased Clozaril SS Novartis Sector: Stupor Pharma Date:05/27/05ISR Number: 4675255-9Report Type:Expedited (15-DaCompany Report #PHFR2005GB01837 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperprolactinaemia Clozaril PS Novartis Sector: Pharma Date:05/27/05ISR Number: 4675256-0Report Type:Expedited (15-DaCompany Report #PHFR2005GB01561 Age:23 YR Gender:Male I/FU:F Outcome PT Life-Threatening Blood Creatine Hospitalization - Phosphokinase Increased Initial or Prolonged Body Temperature Disability Increased Other Compartment Syndrome Eye Rolling 22-Feb-2006 08:30 AM Page: 3328 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Malaise Muscle Contractions Involuntary Report Source Product Role Manufacturer Route Dose Duration Musculoskeletal Stiffness Clozaril PS Novartis Sector: Necrosis Pharma ORAL 500mg per day Neuroleptic Malignant Depixol SS INTRAMUSCULAR 20mg/day Syndrome Depixol SS INTRAMUSCULAR 40mg/day Platelet Count Increased Clozaril SS Novartis Sector: Skin Graft Pharma ORAL 300mg per day 33120MIN Clozaril SS Novartis Sector: Pharma ORAL 200mg per day 7200 MIN Depixol SS INTRAMUSCULAR 80mg/day Zopiclone C ORAL 7.5mg/day Date:05/27/05ISR Number: 4675345-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12825915 Age:57 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delusion Abilify PS Otsuka Initial or Prolonged Dizziness Pharmaceutical Other Fall Company, Ltd. ORAL Dose lowered, Lower Limb Fracture pt relapsed Schizophrenia Clozapine SS ORAL White Blood Cell Count Neurontin C Increased Eskalith C Date:05/27/05ISR Number: 4676373-1Report Type:Periodic Company Report #05-01-0123 Age:44 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Amnesia Wellbutrin Xl PS Glaxosmithkline ORAL 300MG Per day Initial or Prolonged Grand Mal Convulsion Clozapine SS ORAL 400MG Per day 5 YR Date:05/27/05ISR Number: 4676643-7Report Type:Expedited (15-DaCompany Report #US-ROCHE-405250 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aphasia Klonopin PS Roche ORAL Confusional State Gabitril I ORAL AT BEDTIME 1 WK Delusion Gabitril I ORAL AT BEDTIME Disorientation Lithium I ORAL Drug Interaction Trileptal I ORAL Sedation Seroquel I ORAL Clozaril I ORAL Date:05/27/05ISR Number: 4676671-1Report Type:Expedited (15-DaCompany Report #PHNR2005AU00760 Age:30 YR Gender:Male I/FU:F Outcome PT Hospitalization - Blood Cholesterol Initial or Prolonged Increased Other Blood Creatine Phosphokinase Mb Increased Blood Pressure Decreased Blood Triglycerides Increased 22-Feb-2006 08:30 AM Page: 3329 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Cardiomegaly Cardiomyopathy Dilatation Atrial Report Source Product Role Manufacturer Route Dose Duration Dilatation Ventricular Clozaril PS Novartis Sector: Eosinophilia Pharma 12.5 -200 mg, Fatigue daily 27360MIN Low Density Lipoprotein Increased Neutrophil Count Increased Red Blood Cell Sedimentation Rate Increased Syncope Vasovagal Troponin Increased Ventricular Dysfunction Date:05/27/05ISR Number: 4676672-3Report Type:Expedited (15-DaCompany Report #PHFR2004GB02625 Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Clozaril PS Novartis Sector: Blood Creatine Pharma ORAL 36000MIN Phosphokinase Increased Clozaril SS Novartis Sector: Blood Glucose Increased Pharma ORAL 250 mg/day Blood Triglycerides Valproate Sodium C ORAL 1400 mg/day Increased Valproate Sodium C ORAL 800 mg, BID C-Reactive Protein Clonazepam C ORAL 1 mg, BID Increased Lactulose C ORAL Circulatory Collapse Metformin C ORAL 1500 mg/day Cognitive Disorder Oxybutynin C ORAL 10 mg/day Constipation Omeprazole C ORAL 10 mg/day Diabetes Mellitus Enalapril C ORAL 7.5 mg/day Diarrhoea Difficulty In Walking Disorientation Dizziness Dysarthria Faecal Incontinence Gamma-Glutamyltransferase Increased Gastroenteritis Viral Glycosuria Grand Mal Convulsion Hypertension Infection Labile Blood Pressure Nausea Oxygen Saturation Decreased Pyrexia Syncope Syncope Vasovagal Tachycardia Urinary Tract Infection White Blood Cell Count Increased 22-Feb-2006 08:30 AM Page: 3330 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/27/05ISR Number: 4676673-5Report Type:Expedited (15-DaCompany Report #PHFR2005GB01422 Age:56 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Haemoglobin Decreased Clozaril PS Novartis Sector: Hypochromic Anaemia Pharma ORAL Date:05/27/05ISR Number: 4676674-7Report Type:Expedited (15-DaCompany Report #PHNR2005AU00833 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiomyopathy Clozaril PS Novartis Sector: Echocardiogram Pharma 12.5-350 mg Tachycardia Lithium C ORAL 2000 mg, QD Olanzapine C 15 g, UNK Epilim C 1500 mg, UNK Date:05/27/05ISR Number: 4676691-7Report Type:Expedited (15-DaCompany Report #PHNU2005DE00589 Age:26 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Interaction Leponex / Clozaril Other Drug Level Increased (Clozapine) PS Novartis Sector: Myocardial Fibrosis Pharma ORAL UNK, UNK Sudden Death Cipramil SS ORAL UNK, UNK Tachycardia Cipramil SS ORAL UNK, UNK Date:05/27/05ISR Number: 4676695-4Report Type:Expedited (15-DaCompany Report #PHNU2005DE02058 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acute Respiratory Leponex / Clozaril Initial or Prolonged Distress Syndrome (Clozapine) PS Novartis Sector: Life Support Pharma ORAL Mycoplasma Infection Date:05/27/05ISR Number: 4678663-5Report Type:Expedited (15-DaCompany Report #008 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Pressure Abnormal Health Fazaclo PS Alamo Life-Threatening Colitis Professional Pharmaceuticals 150 MG PO Hospitalization - Oxygen Saturation Company DAILY Initial or Prolonged Decreased Representative Tylenol W/Codeine #3 C Respiratory Distress Albuterol C Sedation Prozac C Septic Shock Depakote C Dexedrine C Levothyroxine C Senna C Date:05/31/05ISR Number: 4678784-7Report Type:Expedited (15-DaCompany Report #008 Age: Gender:Female I/FU:I Outcome Death Life-Threatening 22-Feb-2006 08:30 AM Page: 3331 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hospitalization - Initial or Prolonged PT Report Source Product Role Manufacturer Route Dose Duration Colitis Health Fazaclo PS Alamo Pharm ORAL 150 MG PO Condition Aggravated Professional DAILY Cough Company Tylenol W/Codeine #3 C Respiratory Distress Representative Albuterol C Sedation Prozac C Septic Shock Depakote C Dexedrine C Levothyroxine C Senna C Date:05/31/05ISR Number: 4679300-6Report Type:Expedited (15-DaCompany Report #B0373429A Age:58 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Foreign Paxil Tablet Bone Marrow Depression (Paroxetine Bone Marrow Toxicity Hydrochloride) PS ORAL 20 MG/PER Major Depression DAY/ORAL Pyrexia Trimeprazine Tartrate (Trimeprazine Tartrate) SS ORAL 20 MG/PER DAY/ORAL Clozapine (Clozapine) SS ORAL 450 MG/PER DAY/ORAL Diosmectite C Movicol C Date:05/31/05ISR Number: 4680933-1Report Type:Direct Company Report #CTU 250029 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Clozapine 100 Mg Required Ivex PS Ivex ORAL P.O. 100 MG Intervention to A.M. 150 MG Prevent Permanent P.M. Impairment/Damage Lithium Carbonate C Loxapine C Benztropine C Date:06/01/05ISR Number: 4678225-XReport Type:Expedited (15-DaCompany Report #PHFR2005GB01498 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Fall Clozaril PS Novartis Sector: Pallor Pharma ORAL 300mg per day Petit Mal Epilepsy Orphenadrine C ORAL 300mg per day 366 DAY Syncope Clonazepam C ORAL 2mg per day 366 DAY Valproate Sodium C ORAL 1500mg per day 549 DAY 22-Feb-2006 08:30 AM Page: 3332 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/01/05ISR Number: 4678226-1Report Type:Expedited (15-DaCompany Report #PHFR2005GB00871 Age:31 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Clozaril PS Novartis Sector: Initial or Prolonged Coronary Artery Occlusion Pharma ORAL UNK, UNK Other Diabetes Mellitus Metformin C Non-Insulin-Dependent Hypercholesterolaemia Myocardial Infarction Overweight Date:06/01/05ISR Number: 4678618-0Report Type:Expedited (15-DaCompany Report #PHFR2002GB00509 Age:57 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Clozaril PS Novartis Sector: Hospitalization - Blood Albumin Decreased Pharma ORAL 500mg/day Initial or Prolonged Blood Chloride Increased Tacrolimus SS ORAL 4 mg, BID Other Blood Creatinine Paroxetine SS ORAL 50mg/day Increased Clozaril SS Novartis Sector: Blood Urea Increased Pharma ORAL 300mg/day Haemodialysis Mycophenolate Sodium SS ORAL 250 mg, BID Haemoglobin Decreased Clozaril SS Novartis Sector: Liver Function Test Pharma ORAL Abnormal Cefradine C ORAL 500mg/day Nephrotic Syndrome Ramipril C ORAL 10mg/day Renal Failure Renal Transplant Urinary Retention Urinary Tract Disorder Date:06/02/05ISR Number: 4679540-6Report Type:Expedited (15-DaCompany Report #PHBS2005NZ07551 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Clozaril PS Novartis Sector: Phosphokinase Increased Pharma ORAL UNK, UNK 15840MIN Blood Creatine Olanzapine C 20 mg/d Phosphokinase Mm Olanzapine C 10 mg/d Constipation Steroids Nos C Dermatomyositis Muscle Rigidity Muscular Weakness Date:06/02/05ISR Number: 4679546-7Report Type:Expedited (15-DaCompany Report #PHFR2004GB03974 Age:53 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Full Blood Count Clozaril PS Novartis Sector: Initial or Prolonged Decreased Pharma ORAL 350 mg/day Other Haemoglobin Decreased Nausea Oesophageal Carcinoma Platelet Count Increased Regurgitation Of Food Throat Cancer Vomiting 22-Feb-2006 08:30 AM Page: 3333 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/02/05ISR Number: 4679934-9Report Type:Expedited (15-DaCompany Report #PHNU2005DE01912 Age:33 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pyrexia Clozapine PS Novartis Sector: Initial or Prolonged Rash Pharma ORAL 75 mg, TID Varicella Orfiril C ORAL 450 mg, QD Lorazepam C ORAL 1 mg, QD Date:06/02/05ISR Number: 4679936-2Report Type:Expedited (15-DaCompany Report #PHFR2005GB01996 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Pain Clozapine PS Novartis Sector: Other Balance Disorder Pharma ORAL 550mg/day Constipation Clozapine SS Novartis Sector: Cyanosis Pharma ORAL 525mg/day Gastrointestinal Clozapine SS Novartis Sector: Haemorrhage Pharma ORAL 200mg Heart Rate Decreased mane/300mg Hyperhidrosis nocte Hypotension Omeprazole C UNKNOWN 20mg/day Loss Of Consciousness Atorvastatin C UNKNOWN 10 mg, QD Malaise Acetylsalicylate C UNKNOWN 75 mg, QD Myoclonus Metoclopramide C UNKNOWN 10 mg, TID Sudden Death Pirenzepine C UNKNOWN 25 mg, TID Date:06/02/05ISR Number: 4679937-4Report Type:Expedited (15-DaCompany Report #PHBS2005ES07521 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Clozapine PS Novartis Sector: Phosphokinase Increased Pharma UNKNOWN 50 mg/d Delirium Clozapine SS Novartis Sector: Drug Withdrawal Syndrome Pharma UNKNOWN 700 mg/d Date:06/02/05ISR Number: 4679946-5Report Type:Expedited (15-DaCompany Report #PHEH2005US06100 Age:91 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Clozaril PS Novartis Sector: Other General Physical Health Pharma ORAL Unk, Unk Deterioration Date:06/02/05ISR Number: 4681150-1Report Type:Expedited (15-DaCompany Report #2005S1001890 Age:85 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Choking Health Clozapine Tablets Professional (25 Mg) PS ORAL 75 MG; HS; PO Other 22-Feb-2006 08:30 AM Page: 3334 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/02/05ISR Number: 4681191-4Report Type:Expedited (15-DaCompany Report #2005S1002695 Age:76 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Metastasis Health Clozapine Tablets Professional (25 Mg) PS ORAL 12.5 MG; HS; Other PO Levodopa / Carbidopa C Nystatin C Sucralfate C Ibuprofen C Megestrol C Date:06/03/05ISR Number: 4680778-2Report Type:Expedited (15-DaCompany Report #PHFR2005IE01978 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Incorrect Dose Clozaril PS Novartis Sector: Initial or Prolonged Administered Pharma UNKNOWN 50mg mane, Medication Error 100mg nocte Clozaril SS Novartis Sector: Pharma UNKNOWN 150mg mane, 200mg nocte Clozaril SS Novartis Sector: Pharma UNKNOWN 300 mg mane Date:06/03/05ISR Number: 4680779-4Report Type:Expedited (15-DaCompany Report #PHBS2005CA07723 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Obsessive Thoughts Clozaril PS Novartis Sector: Pharma ORAL Date:06/06/05ISR Number: 4682240-XReport Type:Expedited (15-DaCompany Report #PHNU2005DE02150 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypochromic Anaemia Leponex / Clozaril (Clozapine) PS Novartis Sector: Pharma ORAL Date:06/06/05ISR Number: 4682851-1Report Type:Expedited (15-DaCompany Report #PHFR2002GB00509 Age:57 YR Gender:Male I/FU:F Outcome PT Life-Threatening Agranulocytosis Hospitalization - Blood Albumin Decreased Initial or Prolonged Blood Chloride Increased Other Blood Creatinine Increased Blood Potassium Increased Blood Urea Increased Haemoglobin Decreased Hepatic Failure Liver Function Test Abnormal Nephrotic Syndrome Neutrophil Count 22-Feb-2006 08:30 AM Page: 3335 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Decreased Renal Failure Renal Transplant Urinary Retention Report Source Product Role Manufacturer Route Dose Duration Urinary Tract Disorder Clozaril PS Novartis Sector: White Blood Cell Count Pharma ORAL 500mg/day Decreased Tacrolimus SS ORAL 4 mg, BID Clozaril SS Novartis Sector: Pharma ORAL Clozaril SS Novartis Sector: Pharma ORAL 300mg/day Mycophenolate Sodium SS ORAL 250 mg, BID Cefradine C ORAL 500mg/day Ramipril C ORAL 10mg/day Olanzapine C Paroxetine C ORAL 50mg/day Date:06/06/05ISR Number: 4684474-7Report Type:Expedited (15-DaCompany Report #05-05-0943 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Abuser Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 100-300MG QD ORAL Date:06/06/05ISR Number: 4684476-0Report Type:Expedited (15-DaCompany Report #05-06-0960 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 300-500MG QD ORAL Date:06/06/05ISR Number: 4684478-4Report Type:Expedited (15-DaCompany Report #05-06-0958 Age:69 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Respiratory Arrest Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 200MG QD ORAL Date:06/06/05ISR Number: 4684479-6Report Type:Expedited (15-DaCompany Report #05-04-0795 Age:36 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine - Ivax Treatment Noncompliance Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 400MG QHS ORAL 22-Feb-2006 08:30 AM Page: 3336 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/07/05ISR Number: 4684053-1Report Type:Expedited (15-DaCompany Report #PHFR2002GB04398 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Choking Clozaril PS Novartis Sector: Respiratory Failure Pharma Date:06/07/05ISR Number: 4684055-5Report Type:Expedited (15-DaCompany Report #PHFR2005IE02005 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Balance Disorder Clozaril PS Novartis Sector: Initial or Prolonged Convulsion Pharma ORAL 700mg per day Fall Clozaril SS Novartis Sector: Joint Dislocation Pharma ORAL 1000mg/day Syncope Date:06/07/05ISR Number: 4685162-3Report Type:Expedited (15-DaCompany Report #2005S1003956 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Other Clozapine Tablets (25 Mg) PS ORAL 200 MG; HS; PO Clozapine Tablets (100 Mg) SS ORAL 75 MG; HS; PO Valproate Semisodium C Benzatropine Mesilate C Fluoxetine C Hydrochloride C Date:06/07/05ISR Number: 4685163-5Report Type:Expedited (15-DaCompany Report #2005S1000924 Age:46 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Health Clozapine Tablets Professional (100 Mg) PS ORAL 500 MG; HS; Other PO Buspar SS ORAL 15 MG; BID; PO Paxil SS 30 MG; BID; Tiagabine Hydrochloride C Date:06/07/05ISR Number: 4685164-7Report Type:Expedited (15-DaCompany Report #2005S1002394 Age:80 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional (25 Mg) PS ORAL 25 MG; BID; Other PO Clozapine Tablets (100 Mg) SS ORAL 200 MG; BID; PO Clonidine C Docusate Sodium C Sodium Phosphate C 22-Feb-2006 08:30 AM Page: 3337 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dibasic/Sodium C Phosphate C Paracetamol C Bisacodyl C Phenol C Date:06/07/05ISR Number: 4685176-3Report Type:Expedited (15-DaCompany Report #05-06-0967 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Colon Cancer Health Clozapine - Ivax Other Large Intestine Professional Pharmaceuticals, Perforation Other Inc. Tablets PS ORAL 375-450MG QD Peritonitis ORAL Date:06/07/05ISR Number: 4685186-6Report Type:Expedited (15-DaCompany Report #05-06-0962 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Health Clozapine - Ivax Cardiac Arrest Professional Pharmaceuticals, Loss Of Consciousness Inc. Tablets PS ORAL 300-375MG QD ORAL Prandin "Kuhn" C Asa C Celexa C Dilantin C Protonix C Date:06/07/05ISR Number: 4685188-XReport Type:Expedited (15-DaCompany Report #05-05-0807 Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Health Clozapine - Ivax Dyspnoea Professional Pharmaceuticals, Respiratory Disorder Other Inc. Tablets PS ORAL 800-1000MG QD ORAL Docusate Sodium C Ambien Tablets C Fluphenazine Tablets C Depakote Er C Mirtazapine Tablets C Seroquel Tablets C Advair C Hydrochlorothiazide C Atenolol Tablets C Ipratropium C Albuterol Sulfate C Prednisone C Cebocap Capsules C Date:06/08/05ISR Number: 4685426-3Report Type:Expedited (15-DaCompany Report #PHFR2005GB02039 Age:45 YR Gender:Male I/FU:I Outcome PT Death Hypertension Left Ventricular Failure 22-Feb-2006 08:30 AM Page: 3338 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Ventricular Hypertrophy Report Source Product Role Manufacturer Route Dose Duration Clozapine PS Novartis Sector: Pharma UNKNOWN Warfarin C UNKNOWN Date:06/08/05ISR Number: 4685429-9Report Type:Expedited (15-DaCompany Report #PHFR2005GB02037 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mania Leponex / Clozaril Initial or Prolonged Mental Disorder (Clozapine) Lex+Tab PS Novartis Sector: Pharma ORAL 25mg/day Date:06/08/05ISR Number: 4685430-5Report Type:Expedited (15-DaCompany Report #PHFR2004GB01028 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drooling Clozaril PS Novartis Sector: Dysphemia Pharma ORAL 325mg/day Hyperhidrosis Disulfiram C UNKNOWN Myoclonus Antidepressants C UNKNOWN Tic Cipramil C ORAL 30 mg, QD Acamprosate C ORAL 666mg/day Amisulpride C ORAL 50 mg, BID Date:06/08/05ISR Number: 4685431-7Report Type:Expedited (15-DaCompany Report #PHHO2005CA08930 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Clozaril PS Novartis Sector: Obesity Pharma ORAL 114 DAY Date:06/08/05ISR Number: 4685718-8Report Type:Expedited (15-DaCompany Report #DSA_26466_2005 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Decreased Foreign Ativan PS ORAL 1 MG PO Initial or Prolonged Drug Interaction Health Clozapine SS ORAL 12.5 MG Q DAY Heart Rate Decreased Professional PO Other Cipramil C Procyclidine C Fluphenazine C Date:06/08/05ISR Number: 4687341-8Report Type:Expedited (15-DaCompany Report #2005S1004005 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional (25 Mg) PS ORAL 25 MG; QD; PO Other 22-Feb-2006 08:30 AM Page: 3339 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/08/05ISR Number: 4687745-3Report Type:Direct Company Report #CTU 250658 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Level Fluctuating Clozaril 100 Mg PS ORAL 2AM / 5PM Pharmaceutical Product TAKEN PO Complaint Date:06/08/05ISR Number: 4688068-9Report Type:Expedited (15-DaCompany Report #05-03-0412 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 600-1000MG QD ORAL Date:06/08/05ISR Number: 4688074-4Report Type:Expedited (15-DaCompany Report #05-06-0974 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Health Clozapine - Ivax Initial or Prolonged Urosepsis Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 600-700 MG QD ORAL Date:06/08/05ISR Number: 4703497-2Report Type:Direct Company Report #CTU 239714 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abnormal Behaviour Clozapine PS 100MG 1 TAB Required Anger AM & 3 TABS Intervention to Hallucination, Auditory HS Prevent Permanent Irritability Impairment/Damage Job Dissatisfaction Therapeutic Response Unexpected With Drug Substitution Thinking Abnormal Date:06/09/05ISR Number: 4686060-1Report Type:Expedited (15-DaCompany Report #PHFR2005GB01131 Age:49 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Arthralgia Clozaril PS Novartis Sector: Arthritis Pharma 200 mg/day 268 DAY Arthropathy Constipation Liver Function Test Abnormal Pain In Extremity Weight Increased 22-Feb-2006 08:30 AM Page: 3340 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/09/05ISR Number: 4686061-3Report Type:Expedited (15-DaCompany Report #PHFR2001GB03039 Age:27 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Clozaril PS Novartis Sector: Pharma ORAL 400mg/day Zolpidem C ORAL 10mg/day Hyoscine C ORAL nocte Salbutamol C UNK, QID Becotide C UNK, QID Date:06/09/05ISR Number: 4686063-7Report Type:Expedited (15-DaCompany Report #PHNU2005DE01917 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Leponex / Clozaril Antinuclear Antibody (Clozapine) PS Novartis Sector: Negative Pharma ORAL Hepatic Enzyme Abnormal Leponex / Clozaril Leukocytosis (Clozapine) SS Novartis Sector: Pleural Effusion Pharma ORAL Pyrexia Date:06/09/05ISR Number: 4686362-9Report Type:Expedited (15-DaCompany Report #PHNR2005AU00872 Age:25 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Acquired Cardiac Septal Clozaril PS Novartis Sector: Defect Pharma ORAL 550 mg daily Drug Toxicity Echocardiogram Abnormal Ejection Fraction Decreased Psychotic Disorder Date:06/09/05ISR Number: 4687325-XReport Type:Expedited (15-DaCompany Report #2005S1004142 Age:79 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Other Clozapine Tablets (25 Mg) PS ORAL 25 MG QD PO Hyoscyamine C Lorazepam C Hyoscyamine Sulfate C Morphine Sulfate C Clindamycin C Ciprofloxacin C Lidocaine Hydrochloride/Ceftri axone Sodium C Polymyxin B Sulfate/Gramicidin C Levodopa/Carbidopa C Ariprazole C Tamsulosin Hydrochloride C Midodrine C Donepezil Hydrochloride C 22-Feb-2006 08:30 AM Page: 3341 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Bisacodyl C Potassium C Fludrocortisone C Salbutamol C Rimantadine C Levofloxacin C Date:06/09/05ISR Number: 4687329-7Report Type:Expedited (15-DaCompany Report #05-06-0983 Age:67 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozapine-Ivax Professional Pharmaceuticals, Inc Other Tablets PS ORAL 500-750 MG QD ORAL Date:06/09/05ISR Number: 4687330-3Report Type:Expedited (15-DaCompany Report #2005S1004039 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Other Clozapine Tablets (100 Mg) PS ORAL 150 MG QAM PO; 300 MG HS PO Date:06/09/05ISR Number: 4687331-5Report Type:Expedited (15-DaCompany Report #2005S1004059 Age:77 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Failure To Thrive Health Clozapine Tablets Professional (25 Mg) PS ORAL 25 MG QD PO Other Morphine C Lorazepam C Vancomycin C Levodopa/Carbidopa C Heparin-Fraction, C Sodium Salt C Date:06/09/05ISR Number: 4687332-7Report Type:Expedited (15-DaCompany Report #2005S1004121 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Other Clozapine Tablets (100 Mg) PS ORAL 100 MG QAM PO; 400 MG HS PO Date:06/09/05ISR Number: 4688033-1Report Type:Expedited (15-DaCompany Report #2005081677 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Fall Health Geodon (Ziprasidone) PS 160 MG (80 Other Myocardial Infarction Professional MG, 2 IN 1 D) Weight Increased Clozapine White Blood Cell Count (Clozapine) SS ORAL 300 MG (100 Increased MG, 3 IN 1 22-Feb-2006 08:30 AM Page: 3342 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report D), ORAL Date:06/10/05ISR Number: 4687837-9Report Type:Expedited (15-DaCompany Report #AU-ABBOTT-05P-008-0302259-00 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Suicide Attempt Epilim PS UNKNOWN Initial or Prolonged Clozapine SS ORAL Citalopram Hydrobromide SS UNKNOWN Date:06/10/05ISR Number: 4687962-2Report Type:Expedited (15-DaCompany Report #PHFR2002GB00509 Age:57 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Clozaril PS Novartis Sector: Hospitalization - Blood Albumin Decreased Pharma ORAL 500mg/day Initial or Prolonged Blood Chloride Increased Tacrolimus SS ORAL 4 mg, BID Other Blood Creatinine Clozaril SS Novartis Sector: Increased Pharma ORAL Blood Potassium Increased Clozaril SS Novartis Sector: Blood Urea Increased Pharma ORAL 300mg/day Haemoglobin Decreased Mycophenolate Sodium SS ORAL 250 mg, BID Hepatic Failure Cefradine C ORAL 500mg/day Liver Function Test Ramipril C ORAL 10mg/day Abnormal Olanzapine C Nephrotic Syndrome Paroxetine C ORAL 50mg/day Neutrophil Count Decreased Renal Failure Renal Transplant Urinary Retention Urinary Tract Disorder White Blood Cell Count Decreased Date:06/10/05ISR Number: 4687968-3Report Type:Expedited (15-DaCompany Report #PHNR2005AU00956 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Endocarditis Clozaril (Clozapine) PS Novartis Sector: Tachycardia Pharma ORAL 28800MIN Troponin Increased Date:06/10/05ISR Number: 4687969-5Report Type:Expedited (15-DaCompany Report #PHFR2005GB01331 Age:57 YR Gender:Female I/FU:F Outcome PT Life-Threatening Agitation Hospitalization - Asthma Initial or Prolonged Chronic Obstructive Pulmonary Disease Cyanosis Depressed Level Of Consciousness Diarrhoea Emphysema Lower Respiratory Tract 22-Feb-2006 08:30 AM Page: 3343 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Infection Respiratory Disorder Respiratory Distress Somnolence Report Source Product Role Manufacturer Route Dose Duration Clozaril PS Novartis Sector: Pharma ORAL 400mg/day 1323 DAY Oxybutynin C ORAL 6mg/day Beclometasone C Amitriptyline C 20mg/day Bricanyl Turbuhaler C 2 puffs QDS Symbicort Turbuhaler C 2 puffs BID Salbutamol C Serevent C Date:06/10/05ISR Number: 4687971-3Report Type:Expedited (15-DaCompany Report #PHNR2005AU00857 Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Acute Psychosis Clozaril PS Novartis Sector: Hospitalization - Blood Creatine Pharma 0 - 175 Initial or Prolonged Phosphokinase Increased mg/day 36000MIN Blood Creatinine Lithium C Increased Valproate Sodium C Dehydration Fluvoxamine C In reducing Diarrhoea dose (not Gastroenteritis specified) Hyperhidrosis Irbesartan C Myoglobin Urine Present Omeprazole C Neuroleptic Malignant Syndrome Renal Failure Tremor Vomiting Date:06/10/05ISR Number: 4687972-5Report Type:Expedited (15-DaCompany Report #PHFR2005GB02062 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Cholesterol Clozaril PS Novartis Sector: Increased Pharma ORAL UNK, UNK 632 DAY Diabetes Mellitus Lipids Increased Weight Increased Date:06/10/05ISR Number: 4688219-6Report Type:Expedited (15-DaCompany Report #AU-ABBOTT-05P-008-0302253-00 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Epilim PS UNKNOWN Initial or Prolonged Suicide Attempt Epilim SS Clozapine SS ORAL Date:06/10/05ISR Number: 4688863-6Report Type:Expedited (15-DaCompany Report #05-06-1015 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Death Pneumonia Bacterial Health Staphylococcal Infection Professional 22-Feb-2006 08:30 AM Page: 3344 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Product Role Manufacturer Route Dose Duration Clozapine - Ivax Pharmaceuticals, Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 600MG QD ORAL Date:06/10/05ISR Number: 4688865-XReport Type:Expedited (15-DaCompany Report #05-06-1002 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Nephrolithiasis Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL ORAL Date:06/14/05ISR Number: 4689852-8Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050602634 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Glomerulonephritis Acute Ibuprofen PS 600-800mg tid Hospitalization - Renal Failure Clozapine SS OROPHARINGEAL Initial or Prolonged Depakote C Zoloft C Date:06/14/05ISR Number: 4690828-5Report Type:Expedited (15-DaCompany Report #05-06-1016 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aneurysm Health Clozapine - Ivax Myocardial Infarction Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 300-800MG QD ORAL Date:06/14/05ISR Number: 4690868-6Report Type:Expedited (15-DaCompany Report #05-04-0552 Age:69 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozapine Tablets - Myocardial Infarction Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL SEE IMAGE, ORAL Clonazepam C Furosemide C Levothyroxine C Mirtazapine C Zyprexa C Prevacid C Plavix C 22-Feb-2006 08:30 AM Page: 3345 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pentoxifylline C Date:06/14/05ISR Number: 4690870-4Report Type:Expedited (15-DaCompany Report #05-06-1003 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetes Mellitus Health Clozapine Tablets - Pancreatitis Professional Ivax Refusal Of Treatment By Other Pharmaceuticals, Patient Inc. PS Ivax Pharmaceuticals ORAL 25-500MG QD ORAL Date:06/14/05ISR Number: 4690871-6Report Type:Expedited (15-DaCompany Report #05-05-0848 Age:54 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozapine Tablets PS Ivax Renal Cancer Metastatic Professional Pharmaceuticals, Other Inc. ORAL 625MG QHS ORAL Interferonx-2b C Date:06/14/05ISR Number: 4690872-8Report Type:Expedited (15-DaCompany Report #05-06-1014 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS ORAL 100-400MG QD ORAL Date:06/14/05ISR Number: 4692151-1Report Type:Expedited (15-DaCompany Report #009 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Catheter Site Infection Health Fazaclo PS Alamo Pharceuticals ORAL 400 MG PO Life-Threatening Professional DAILY Hospitalization - Company Chemotherapy C Initial or Prolonged Representative Levothyroxine C Aranesp C Senakot C Mg Oxide C Mscontin C Prevacid C Depakote C Lactulose C Ativan C Ambien C Neurontin C 22-Feb-2006 08:30 AM Page: 3346 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/15/05ISR Number: 4690610-9Report Type:Expedited (15-DaCompany Report #PHEH2005US06632 Age:57 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatitis C Clozaril PS Novartis Sector: Leukopenia Pharma ORAL UNK, UNK Interferon SS Date:06/15/05ISR Number: 4690613-4Report Type:Expedited (15-DaCompany Report #PHBS2005IT07981 Age:17 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperpyrexia Leponex PS Novartis Sector: Initial or Prolonged Tachycardia Pharma ORAL 200 mg/day 21600MIN Tachypnoea Clozapine SS ORAL 200 mg/day 21600MIN Viral Myocarditis Clotiapine C ORAL 150 mg/day 28800MIN Chlordesmethyldiazep am C ORAL 3 mg/day 43200MIN Orphenadrine C ORAL 50 mg/day 43200MIN Date:06/15/05ISR Number: 4690615-8Report Type:Expedited (15-DaCompany Report #PHFR2001GB01091 Age:31 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Clozaril PS Novartis Sector: Drug Exposure During Pharma ORAL 500 mg/day Pregnancy Folic Acid C ORAL 5mg/day Gestational Diabetes Premature Baby Date:06/16/05ISR Number: 4694174-5Report Type:Direct Company Report #CTU 251301 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Clozaril 730 Mg PS BID Depression Abilify 10 Mg SS DAILY Drowning Date:06/17/05ISR Number: 4692765-9Report Type:Expedited (15-DaCompany Report #PHBS2005NL08391 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dilatation Ventricular Leponex PS Novartis Sector: Initial or Prolonged Leukocytosis Pharma ORAL 400 mg/d Myocarditis Peritonitis Pulmonary Embolism Date:06/17/05ISR Number: 4692853-7Report Type:Expedited (15-DaCompany Report #PHBS2005CH08243 Age:47 YR Gender:Male I/FU:I Outcome PT Hospitalization - Balance Disorder Initial or Prolonged Drug Interaction Dystonia Fatigue Hypertension 22-Feb-2006 08:30 AM Page: 3347 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Muscular Weakness Pleurothotonus Salivary Hypersecretion Report Source Product Role Manufacturer Route Dose Duration Sinus Tachycardia Leponex PS Novartis Sector: Pharma ORAL 900 mg/d Leponex SS Novartis Sector: Pharma ORAL 500 mg/d Leponex SS Novartis Sector: Pharma ORAL 600 mg/d Leponex SS Novartis Sector: Pharma ORAL 400 mg/d Floxyfral SS ORAL 50 mg/d Floxyfral SS ORAL 25 mg/d Solian C ORAL 200 mg, QID Date:06/17/05ISR Number: 4692855-0Report Type:Expedited (15-DaCompany Report #PHNR2005AU00956 Age:23 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Clozaril (Clozapine) PS Novartis Sector: Phosphokinase Increased Pharma ORAL 28800MIN Myocarditis Tachycardia Troponin Increased Date:06/17/05ISR Number: 4693489-4Report Type:Expedited (15-DaCompany Report #PHBS2005ES08574 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Ischaemic Cardiomyopathy Leponex PS Novartis Sector: Other Pneumonia Pharma ORAL Sertraline C ORAL 200 mg/d Date:06/17/05ISR Number: 4693490-0Report Type:Expedited (15-DaCompany Report #PHFR2002GB00509 Age:57 YR Gender:Male I/FU:F Outcome PT Life-Threatening Agranulocytosis Hospitalization - Blood Albumin Decreased Initial or Prolonged Blood Chloride Increased Other Blood Creatinine Increased Blood Potassium Increased Blood Urea Increased Haemoglobin Decreased Hepatic Failure Liver Function Test Abnormal Malaise Nephrotic Syndrome Neutropenia Neutrophil Count Decreased Renal Failure Renal Transplant Urinary Retention Urinary Tract Disorder White Blood Cell Count 22-Feb-2006 08:30 AM Page: 3348 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Decreased Report Source Product Role Manufacturer Route Dose Duration Clozaril PS Novartis Sector: Pharma ORAL 500mg/day Tacrolimus SS ORAL 4 mg, BID Clozaril SS Novartis Sector: Pharma ORAL Clozaril SS Novartis Sector: Pharma ORAL 300mg/day Mycophenolate Sodium SS ORAL 250 mg, BID Cefradine C ORAL 500mg/day Ramipril C ORAL 10mg/day Olanzapine C Paroxetine C ORAL 50mg/day Date:06/17/05ISR Number: 4693492-4Report Type:Expedited (15-DaCompany Report #PHNR2005AU00975 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiomyopathy Clozaril PS Novartis Sector: Drug Level Increased Pharma 200-700 mg Ejection Fraction daily Decreased Risperidone C 75 mg q2wk Hypertension Pantoprazole C 40 mg qd Hypokinesia Lithium C Neutrophilia Buspirone C 10 mg tds Ventricular Dysfunction Date:06/17/05ISR Number: 4694091-0Report Type:Expedited (15-DaCompany Report #2005S1001759 Age:81 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Aspiration Health Clozapine Tablets Professional (25 Mg) PS ORAL 12.5 MG; QD; Other PO Hyoscine C Morphine Sulfate C Clindamycin C Orciprenaline C Moxifloxacin C Hydrochloride Alprazolam C Levodopa/Carbidopa C Folic Acid C Levetiracetam C Donepezil Hydrochloride C Acetylsalicylic Acid C Docusate Sodium/Senna C Multivitamins, Plain C Memantine C Paracetamol C 22-Feb-2006 08:30 AM Page: 3349 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/17/05ISR Number: 4694095-8Report Type:Expedited (15-DaCompany Report #2005S1002463 Age:52 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional (100 Mg) PS ORAL 300 MG; QD; Other PO Oxygen C Trazodone C Venlafaxine C Hydrochloride C Oxcarbazepine C Mirtazapine C Date:06/17/05ISR Number: 4694096-XReport Type:Expedited (15-DaCompany Report #2005S1002429 Age:84 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Health Clozapine Tablets Dyspnoea Professional (100 Mg) PS ORAL 200 MG; HS; Fall Other PO Levodopa/Carbidopa C Entacapone C Pramipexole C Dihydrochloride C Mematine C Verapamil C Seroquel C Donepezil Hydrochloride C Clopidogrel Sulfate C Date:06/17/05ISR Number: 4694097-1Report Type:Expedited (15-DaCompany Report #2005S1002015 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional (25 Mg) PS ORAL 25 MG; QAM; Other PO; 50 MG; HS; PO Glbenclamide C Levofloxacin C Rosiglitazone Maleate C Potassium C Furosemide C Levothyroxine Sodium C Date:06/17/05ISR Number: 4694098-3Report Type:Expedited (15-DaCompany Report #2005S1004364 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional (100 Mg) PS ORAL 100 MG; QD; Other PO; 200 MG; HS; PO 22-Feb-2006 08:30 AM Page: 3350 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/17/05ISR Number: 4694100-9Report Type:Expedited (15-DaCompany Report #2005S1002775 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional (25 Mg) PS ORAL 25 MG; TID; Other PO Date:06/17/05ISR Number: 4694101-0Report Type:Expedited (15-DaCompany Report #2005S1004366 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Other Clozapine Tablets (100 Mg) PS ORAL 200 MG; HS; PO Clozapine Tablets (25 Mg) SS ORAL 25 MG; QAM; PO; 25 MG; HS; PO Date:06/20/05ISR Number: 4694286-6Report Type:Expedited (15-DaCompany Report #PHFR2004GB03438 Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Overdose Clozaril PS Novartis Sector: Hospitalization - Convulsion Pharma ORAL Initial or Prolonged Drug Level Increased Date:06/20/05ISR Number: 4694287-8Report Type:Expedited (15-DaCompany Report #PHNU2005DE02287 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bowel Movement Leponex / Clozaril Irregularity (Clozapine) PS Novartis Sector: Colitis Ulcerative Pharma ORAL up to Colonoscopy Abnormal 300mg/day Haematochezia Date:06/20/05ISR Number: 4694288-XReport Type:Expedited (15-DaCompany Report #PHFR2005GB01498 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drop Attacks Clozaril PS Novartis Sector: Fall Pharma 300mg/day Loss Of Consciousness Clozaril SS Novartis Sector: Orthostatic Hypotension Pharma ORAL 600 mg/day Pallor Orphenadrine C ORAL 300mg per day 366 DAY Petit Mal Epilepsy Clonazepam C ORAL 2mg per day 366 DAY Syncope Valproate Sodium C ORAL 1500mg per day 549 DAY Date:06/20/05ISR Number: 4694302-1Report Type:Expedited (15-DaCompany Report #PHNU2005DE02287 Age: Gender:Male I/FU:I Outcome PT Other Bowel Movement Irregularity 22-Feb-2006 08:30 AM Page: 3351 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Colitis Ulcerative Colonoscopy Abnormal Haematochezia Report Source Product Role Manufacturer Route Dose Duration Leponex / Clozaril (Clozapine) PS Novartis Sector: Pharma ORAL up to 300mg/day Date:06/20/05ISR Number: 4694703-1Report Type:Expedited (15-DaCompany Report #PHBS2004BR07756 Age:51 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Amnesia Leponex PS Novartis Sector: Initial or Prolonged Arthropathy Pharma ORAL 300 mg/d Other Coordination Abnormal Leponex SS Novartis Sector: Delusion Pharma ORAL 500 mg/d Disturbance In Attention Leponex SS Novartis Sector: Hypertension Pharma ORAL 600 mg/d Increased Appetite Leponex SS Novartis Sector: Myoclonus Pharma ORAL 400 mg/d Pneumonia Lithium SS UNKNOWN 600 mg/d Schizophrenia Lithium SS UNKNOWN 300 mg/d Thrombosis Geodon C Venous Insufficiency Aluminium Hydroxide C UNKNOWN Weight Decreased Norvasc C ORAL 15 mg/d Weight Increased Moduretic C ORAL 50 mg, Q48H Omeprazole C UNKNOWN Ketoprofen C Magnesium Hydroxide C UNKNOWN Folic Acid C ORAL 5 mg/d Valproic Acid C ORAL 2000 mg/d Exelon C ORAL 6 mg, BID Haloperidol C UNKNOWN Date:06/20/05ISR Number: 4694712-2Report Type:Expedited (15-DaCompany Report #PHFR2005GB02157 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Back Pain Clozaril PS Novartis Sector: Influenza Like Illness Pharma ORAL 400mg/day Pericardial Effusion Atenolol C Tachycardia Viral Pericarditis Date:06/21/05ISR Number: 4696244-4Report Type:Expedited (15-DaCompany Report #05-06-1024 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Nasopharyngeal Cancer Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc ORAL 200-800-MG QD ORAL 22-Feb-2006 08:30 AM Page: 3352 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/21/05ISR Number: 4696246-8Report Type:Expedited (15-DaCompany Report #05-06-1039 Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 62.5-112.5MG ORAL Date:06/21/05ISR Number: 4696247-XReport Type:Expedited (15-DaCompany Report #05-06-1043 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Health Clozapine - Ivax Dehydration Professional Pharmaceuticals, Heat Stroke Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 200-500MG QD ORAL Date:06/21/05ISR Number: 4696249-3Report Type:Expedited (15-DaCompany Report #05-06-1042 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozapine - Ivax Neoplasm Malignant Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 100-700MG QD ORAL Chemotherapy SS Date:06/21/05ISR Number: 4696251-1Report Type:Expedited (15-DaCompany Report #05-06-1045 Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Clozapine - Ivax Other Congestive Professional Pharmaceuticals, Cerebrovascular Accident Other Inc. Tablets PS Ivax Pneumonia Pharmaceuticals, Inc. ORAL 125-400MG QD ORAL Date:06/21/05ISR Number: 4696252-3Report Type:Expedited (15-DaCompany Report #05-06-1046 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Breast Cancer Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 100-900MG QD ORAL 22-Feb-2006 08:30 AM Page: 3353 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/21/05ISR Number: 4696253-5Report Type:Expedited (15-DaCompany Report #05-04-0552 Age:69 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Myocardial Health Clozapine - Ivax Infarction Professional Pharmaceuticals, Cardiac Failure Other Inc. Tablets PS Ivax Congestive Pharmaceuticals, Cardio-Respiratory Arrest Inc. ORAL SEE Diastolic Dysfunction IMAGE,ORAL Fall Clonazepam C Feeling Abnormal Furosemide C Haemodynamic Instability Levothyroxine C Malaise Mirtazapine C Ventricular Fibrillation Zyprexa C Prevacid C Plavix C Pentoxifylline C Date:06/21/05ISR Number: 4696256-0Report Type:Expedited (15-DaCompany Report #2005S1004489 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional (100 Mg) PS ORAL 400 MG; BID; Other PO Escitalopram C Atenolol C Nifedipine C Amitriptyline C Date:06/21/05ISR Number: 4696257-2Report Type:Expedited (15-DaCompany Report #2005S1004570 Age:67 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hypoglycaemia Health Clozapine Tablets Hospitalization - Sepsis Professional (25 Mg) PS ORAL 75 MG; HS; PO Initial or Prolonged Other Clozapine Tablets (100 Mg) SS ORAL 100 MG; HS; PO Date:06/21/05ISR Number: 4696258-4Report Type:Expedited (15-DaCompany Report #2005S1000357 Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pulmonary Embolism Health Clozapine Tablets Professional (100 Mg) PS ORAL 200 MG; BID; Other PO Paroxetine C Hydrochloride C Clonazepam C Docusate Sodium C 22-Feb-2006 08:30 AM Page: 3354 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/21/05ISR Number: 4696260-2Report Type:Expedited (15-DaCompany Report #05-06-1027 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Lower Health Clozapine - Ivax Initial or Prolonged Fluid Intake Reduced Professional Pharmaceuticals, Moaning Other Inc. Tablets PS ORAL 225-300MG QD Oral Intake Reduced ORAL Renal Colic Date:06/21/05ISR Number: 4697180-XReport Type:Direct Company Report #CTU 251646 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Pressure Increased Clozapine 25 Mg & Congestive Cardiomyopathy 100 Mg PS ORAL 150 MG PO BID Coxsackie Virus Serology Depakote C Test Positive Concerta C Eosinophil Count Benztropine C Increased Zyprexa C Hyperhidrosis Malaise Pharyngolaryngeal Pain Pyrexia Tachycardia Vomiting Date:06/22/05ISR Number: 4696850-7Report Type:Expedited (15-DaCompany Report #PHFR2005GB01996 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Pain Clozapine PS Novartis Sector: Other Balance Disorder Pharma ORAL 550mg/day Constipation Clozapine SS Novartis Sector: Cyanosis Pharma ORAL 525mg/day Gastrointestinal Clozapine SS Novartis Sector: Haemorrhage Pharma ORAL 200mg Heart Rate Decreased mane/300mg Hyperhidrosis nocte Hypotension Omeprazole C UNKNOWN 20mg/day Loss Of Consciousness Atorvastatin C UNKNOWN 10 mg, QD Malaise Acetylsalicylate C UNKNOWN 75 mg, QD Myoclonus Metoclopramide C UNKNOWN 10 mg, TID Pulmonary Oedema Pirenzepine C UNKNOWN 25 mg, TID Sudden Death Date:06/22/05ISR Number: 4696851-9Report Type:Expedited (15-DaCompany Report #PHBS2005NL08391 Age:18 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dilatation Ventricular Leponex PS Novartis Sector: Initial or Prolonged Effusion Pharma ORAL 400 mg/d Leukocytosis Cipramil C 20 mg, QD Myocarditis Nadroparina C Obstruction Pericarditis Peritonitis Pulmonary Embolism 22-Feb-2006 08:30 AM Page: 3355 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/22/05ISR Number: 4696854-4Report Type:Expedited (15-DaCompany Report #PHBS2004NL14709 Age:60 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Angina Pectoris Leponex PS Novartis Sector: Hospitalization - Arrhythmia Pharma ORAL 425 mg/d Initial or Prolonged Blood Creatine Oxazepam I UNKNOWN 25 mg, BID Phosphokinase Increased Paroxetine I ORAL 60 mg/d Blood Creatinine Increased Cardiac Failure Disorientation Drug Level Increased Ischaemia Myocardial Infarction Nephritis Pericardial Effusion Pericarditis Renal Impairment Syncope Tachycardia Ventricular Dysfunction Date:06/22/05ISR Number: 4696860-XReport Type:Expedited (15-DaCompany Report #PHFR2005GB01996 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Pain Clozapine PS Novartis Sector: Other Balance Disorder Pharma ORAL 550mg/day Constipation Clozapine SS Novartis Sector: Cyanosis Pharma ORAL 525mg/day Gastrointestinal Clozapine SS Novartis Sector: Haemorrhage Pharma ORAL 200mg Heart Rate Decreased mane/300mg Hyperhidrosis nocte Hypotension Omeprazole C UNKNOWN 20mg/day Loss Of Consciousness Atorvastatin C UNKNOWN 10 mg, QD Malaise Acetylsalicylate C UNKNOWN 75 mg, QD Myoclonus Metoclopramide C UNKNOWN 10 mg, TID Pulmonary Oedema Pirenzepine C UNKNOWN 25 mg, TID Date:06/22/05ISR Number: 4697091-XReport Type:Expedited (15-DaCompany Report #PHFR2005GB02168 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Clozapine PS Novartis Sector: Abnormal Pharma Ventricular Pre-Excitation Date:06/22/05ISR Number: 4698840-7Report Type:Expedited (15-DaCompany Report #05-06-1060 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Ulcer Haemorrhage Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS ORAL 300-700 MG QD ORAL 22-Feb-2006 08:30 AM Page: 3356 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/22/05ISR Number: 4698952-8Report Type:Direct Company Report #CTU 251688 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Level Fluctuating Clozaril PS ORAL 2 AM / 5 PM Pharmaceutical Product TAKEN PO Complaint Date:06/23/05ISR Number: 4697874-6Report Type:Expedited (15-DaCompany Report #PHFR2005GB02187 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Exposure Clozaril PS Novartis Sector: Initial or Prolonged Medication Error Pharma ORAL 175mg/day Clozaril SS Novartis Sector: Pharma ORAL 675mg overdose Date:06/23/05ISR Number: 4698180-6Report Type:Expedited (15-DaCompany Report #PHBS2005GR08682 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Trileptal PS Novartis Sector: Initial or Prolonged Leukopenia Pharma ORAL Leponex SS ORAL Date:06/23/05ISR Number: 4698181-8Report Type:Expedited (15-DaCompany Report #PHBS2005CA08858 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Clostridial Infection Clozaril PS Novartis Sector: Diarrhoea Pharma ORAL 100-275 mg/d Dizziness Eosinophil Count Increased Fatigue Pyrexia Tachycardia White Blood Cell Count Increased Date:06/23/05ISR Number: 4698823-7Report Type:Expedited (15-DaCompany Report #05-05-0943 Age:22 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Abuser Health Clozapine - Ivax Initial or Prolonged Pelvic Fracture Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 100-300MG QD ORAL 22-Feb-2006 08:30 AM Page: 3357 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/23/05ISR Number: 4698824-9Report Type:Expedited (15-DaCompany Report #05-05-0738 Age:65 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neoplasm Malignant Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 100-150MG QD ORAL Date:06/23/05ISR Number: 4698830-4Report Type:Expedited (15-DaCompany Report #05-05-0833 Age:71 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Aspiration Health Clozapine - Ivax Hospitalization - Sepsis Professional Pharmaceuticals, Initial or Prolonged Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 75MG QHS ORAL Namenda C Aricept C Aspirin C Fosamax C Ambien C Cogentin C Haldol Prn C Heparin C Flagyl C Date:06/23/05ISR Number: 4698831-6Report Type:Expedited (15-DaCompany Report #05-06-1069 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Gastrointestinal Health Clozapine - Ivax Haemorrhage Professional Pharmaceuticals, Renal Failure Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 300-350MG QD ORAL Date:06/23/05ISR Number: 4698832-8Report Type:Expedited (15-DaCompany Report #05-05-0925 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozapine - Ivax Hospitalization - Pneumonia Pneumococcal Professional Pharmaceuticals, Initial or Prolonged Sepsis Other Inc. Tablets PS Ivax Upper Respiratory Tract Pharmaceuticals, Infection Inc. ORAL 175MG QD ORAL Atenolol C Diltiazem C Lipitor C Metformin C Paroxetine C Lorazepam C Trazodone C Lasix C Glyburide C 22-Feb-2006 08:30 AM Page: 3358 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Zithromax C Date:06/23/05ISR Number: 4698833-XReport Type:Expedited (15-DaCompany Report #05-06-1047 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sepsis Health Clozapine - Ivax Other Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 12.5-175MG QD ORAL Date:06/23/05ISR Number: 4698834-1Report Type:Expedited (15-DaCompany Report #05-06-1048 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Urosepsis Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 500MG QD ORAL Date:06/23/05ISR Number: 4698835-3Report Type:Expedited (15-DaCompany Report #05-05-0923 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Chronic Obstructive Health Clozapine - Ivax Pulmonary Disease Professional Pharmaceuticals, Congestive Cardiomyopathy Other Inc. Tablets PS Ivax Hyperlipidaemia Pharmaceuticals, Hypothyroidism Inc. ORAL 150MG QAM Obesity ORAL; 300MG Schizophrenia QHS Loxitane C Depakote C Date:06/23/05ISR Number: 4700024-0Report Type:Periodic Company Report #US-JNJFOC-20050405803 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Health Haldol (Haloperidol) Initial or Prolonged Drooling Professional Unspecified PS Other Neuroleptic Malignant Lithium (Lithium) SS Syndrome Clozapine (Clozapine) SS 150-300 MG DAILY Date:06/23/05ISR Number: 4700025-2Report Type:Periodic Company Report #US-JNJFOC-20050306925 Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Health Haldol (Haloperidol) Initial or Prolonged Syndrome Professional Tablets PS ORAL 60 MG, 1 IN 1 Other DAY, ORAL Clozapine 22-Feb-2006 08:30 AM Page: 3359 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Clozapine) SS 200 MG, 1 IN 1 DAY Zyprexa (Olanzapine) SS PRN EVERY 6 HOURS Date:06/24/05ISR Number: 4699444-2Report Type:Expedited (15-DaCompany Report #PHEH2005US06981 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthma Clozaril PS Novartis Sector: Initial or Prolonged Dyspnoea Pharma ORAL approximately Empyema 200mg/day Empyema Drainage Clozapine SS ORAL approximately Leukopenia 200mg/day 17280MIN Pleural Effusion Date:06/24/05ISR Number: 4699905-6Report Type:Expedited (15-DaCompany Report #2005S1004857 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets PS ORAL PO Professional Other Date:06/24/05ISR Number: 4699906-8Report Type:Expedited (15-DaCompany Report #2005S1004709 Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional (100 Mg) PS ORAL 300 MG; HS; Other PO Diltiazem C Dihydroergotoxine C Mesilate C Phenytoin Sodium C Risperidone C Potassium Chloride C Lisinopril C Morphine C Date:06/27/05ISR Number: 4700009-4Report Type:Expedited (15-DaCompany Report #PHFR2005GB02157 Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Back Pain Clozaril PS Novartis Sector: Influenza Like Illness Pharma ORAL 400mg/day 159 DAY Pericardial Effusion Atenolol C Pyrexia Tachycardia Viral Pericarditis Date:06/27/05ISR Number: 4700010-0Report Type:Expedited (15-DaCompany Report #PHEH2005US05701 Age:16 YR Gender:Male I/FU:F Outcome PT Other Ear Infection Neutrophil Count Abnormal 22-Feb-2006 08:30 AM Page: 3360 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Neutrophil Count Increased White Blood Cell Count Report Source Product Role Manufacturer Route Dose Duration Increased Clozaril PS Novartis Sector: Pharma ORAL 300 mg, QD Clozaril SS Novartis Sector: Pharma 400 mg, QD Date:06/27/05ISR Number: 4700011-2Report Type:Expedited (15-DaCompany Report #PHFR2005GB02211 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Mean Cell Volume Clozaril PS Novartis Sector: Increased Pharma Date:06/27/05ISR Number: 4700012-4Report Type:Expedited (15-DaCompany Report #PHHO2003CA03752 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Axillary Mass Clozaril PS Novartis Sector: Other Death Pharma ORAL 600 mg, QD Lymphoma Lorazepam C Date:06/27/05ISR Number: 4700013-6Report Type:Expedited (15-DaCompany Report #PHBS2005FI06751 Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Affective Disorder Leponex PS Novartis Sector: Blood Pressure Increased Pharma ORAL 12.5 mg, QD Bundle Branch Block Left Leponex SS Novartis Sector: Restlessness Pharma ORAL 300 mg/d Leponex SS Novartis Sector: Pharma ORAL 200 mg/d Zyprexa C UNKNOWN Seroquel C UNKNOWN Diapam C UNKNOWN Melaton C UNKNOWN Orgametril C UNKNOWN Movicol C UNKNOWN Date:06/27/05ISR Number: 4700014-8Report Type:Expedited (15-DaCompany Report #PHNR2005AU00922 Age:21 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Clozaril PS Novartis Sector: Initial or Prolonged Mental Disorder Pharma 13-500 Other Neutrophil Count mg,daily 632 DAY Decreased Amisulpride SS 200 mg White Blood Cell Count Amisulpride SS 400 mg Decreased Diazepam C Haloperidol C 22-Feb-2006 08:30 AM Page: 3361 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/27/05ISR Number: 4700424-9Report Type:Expedited (15-DaCompany Report #PHNU2005DE02017 Age:32 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Leponex / Clozaril Alanine Aminotransferase (Clozapine) PS Novartis Sector: Increased Pharma ORAL UNK, UNK 59040MIN Aspartate Leponex / Clozaril Aminotransferase (Clozapine) SS Novartis Sector: Increased Pharma ORAL UNK, UNK 47520MIN C-Reactive Protein Risperdal C Increased Ergenyl Chrono C Cholecystitis Acute Ergenyl Chrono C 8640 MIN Cholestasis Ergenyl Chrono C 51840MIN Gamma-Glutamyltransferase Ergenyl Chrono C 56160MIN Increased Diazepam C 161 DAY Lipase Increased Date:06/27/05ISR Number: 4700431-6Report Type:Expedited (15-DaCompany Report #PHBS2005BR08991 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Panic Disorder Leponex PS Novartis Sector: Pharma ORAL UNK, UNK Date:06/28/05ISR Number: 4700921-6Report Type:Expedited (15-DaCompany Report #PHFR2005GB02062 Age:36 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Cholesterol Clozaril PS Novartis Sector: Increased Pharma ORAL 550mg/day 632 DAY Blood Glucose Increased Venlafaxine SS ORAL 300mg/day Diabetes Mellitus Thyroxine SS 75ug/day Lipids Increased Weight Increased Date:06/28/05ISR Number: 4701563-9Report Type:Expedited (15-DaCompany Report #2005PK01089 Age:80 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Seroquel PS Zeneca Hospitalization - Escherichia Sepsis Pharmaceutical ORAL 11 DAY Initial or Prolonged General Physical Health Leponex SS ORAL 0-37,5 MG 11 DAY Deterioration Leponex SS ORAL 4 DAY Leponex SS ORAL 3 DAY Leponex SS ORAL 7 DAY Leponex SS ORAL 16 DAY Remergil C ORAL Cipralex C ORAL 24 DAY Madopar C ORAL Alna C Date:06/28/05ISR Number: 4702188-1Report Type:Direct Company Report #CTU 252050 Age:35 YR Gender:Male I/FU:I Outcome PT Other Chest X-Ray Abnormal Electrocardiogram 22-Feb-2006 08:30 AM Page: 3362 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Abnormal Pyrexia Respiratory Distress Report Source Product Role Manufacturer Route Dose Duration Clozapine 100mg Ivax PS Ivax ORAL 150MG AM 200MG BEDTIME ORAL Date:06/28/05ISR Number: 4702189-3Report Type:Direct Company Report #CTU 252051 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Clozapine 100mg Abnormal Ivmax PS Ivmax ORAL 600MG Electrocardiogram T Wave BEDTIME Abnormal ORAL; 200MG AM ORAL Date:06/28/05ISR Number: 4702273-4Report Type:Direct Company Report #CTU 252052 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram T Wave Clozapine 100mg Abnormal Ivmax PS Ivmax ORAL 200MG AM ORAL; 300MG BEDTIME ORAL Date:06/28/05ISR Number: 4702283-7Report Type:Direct Company Report #CTU 252054 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram T Wave Clozapine 100mg Abnormal Ivmax PS Ivmax ORAL 500MG Sinus Tachycardia BEDTIME ORAL; 100MG AM ORAL Date:06/29/05ISR Number: 4702223-0Report Type:Expedited (15-DaCompany Report #PHNU2005DE02388 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Abdomen Leponex / Clozaril Hospitalization - Gastrointestinal Necrosis (Clozapine) PS Novartis Sector: Initial or Prolonged General Physical Health Pharma ORAL UNK, UNK Deterioration Tavor C Intubation Laparotomy Date:06/29/05ISR Number: 4702224-2Report Type:Expedited (15-DaCompany Report #PHEH2005US07057 Age:25 YR Gender:Female I/FU:I Outcome PT Other Activities Of Daily Living Impaired Cerebral Artery Embolism Cerebrovascular Accident 22-Feb-2006 08:30 AM Page: 3363 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Convulsion Neutropenia White Blood Cell Count Report Source Product Role Manufacturer Route Dose Duration Decreased Clozaril PS Novartis Sector: Pharma ORAL UNK mg, UNK Contraceptives Uns SS Cogentin C Haldol C Avandia C Paxil C Detrol C Phenytoin C Date:06/29/05ISR Number: 4702992-XReport Type:Expedited (15-DaCompany Report #PHRM2005FR01899 Age:69 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrioventricular Block Leponex PS Novartis Sector: Initial or Prolonged Complete Pharma ORAL 75 mg/day Cardiac Pacemaker Tegretol Lp SS ORAL 800 mg/day Insertion Levothyrox C ORAL 50 ug/day Dizziness Equanil C ORAL 2 tabs/day Heart Rate Decreased Kardegic C ORAL 1 DF/day Malaise Seropram C ORAL 20 mg/day Date:06/29/05ISR Number: 4703078-0Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-13006044 Age:69 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Abilify Tabs 5 Mg PS Otsuka Life-Threatening Drug Interaction Pharmaceutical Hospitalization - Hepatic Mass Company, Ltd. ORAL Initial or Prolonged Loss Of Consciousness Clozaril I Other Nausea Somnolence Urinary Tract Infection Vomiting Date:06/29/05ISR Number: 4705236-8Report Type:Expedited (15-DaCompany Report #05-06-1079 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 150-450MG QD ORAL Date:06/29/05ISR Number: 4705241-1Report Type:Expedited (15-DaCompany Report #05-03-0370 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Health Clozapine Tablets - Other Dyspnoea Professional Ivax Respiratory Arrest Other Pharmaceuticals, 22-Feb-2006 08:30 AM Page: 3364 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Inc. PS Ivax Pharmaceuticals, Inc. ORAL 400 MG HS ORAL Depakote C Date:06/29/05ISR Number: 4705268-XReport Type:Expedited (15-DaCompany Report #05-06-1080 Age:80 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Metastases To Bone Health Clozapine - Tablets Other Prostate Cancer Professional Ivax Metastatic Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 200-350NG QD ORAL Date:06/29/05ISR Number: 4705278-2Report Type:Expedited (15-DaCompany Report #05-06-1068 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acute Respiratory Health Clozapine Tablets - Initial or Prolonged Distress Syndrome Professional Ivax Other Antipsychotic Drug Level Other Pharmaceuticals, Required Above Therapeutic Inc. PS Ivax Intervention to Delirium Pharmaceuticals, Prevent Permanent Discomfort Inc. ORAL 300-25MG ORAL Impairment/Damage Drug Toxicity Geodon C Encephalopathy Topamax C Incorrect Dose Administered Date:06/29/05ISR Number: 4705289-7Report Type:Expedited (15-DaCompany Report #05-06-1088 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Small Intestinal Health Clozapine Tablets - Initial or Prolonged Perforation Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 25-225MG QD ORAL Date:06/29/05ISR Number: 4705291-5Report Type:Expedited (15-DaCompany Report #2005S1002695 Age:76 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Breast Cancer Metastatic Health Clozapine Tablets Breast Cancer Stage Iv Professional (25 Mg) PS ORAL 12.5 MG; HS; Other PO Levodopa/Carbidopa C Nystatin C Sucralfate C Ibuprofen C Megestrol C 22-Feb-2006 08:30 AM Page: 3365 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/29/05ISR Number: 4705294-0Report Type:Expedited (15-DaCompany Report #2005S1004962 Age:79 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional (25 Mg) PS ORAL 75 MG;HS; PO Other Clozapine Tablets (100 Mg) SS ORAL 100 MG; QD; PO Sertraline Hydrochloride C Date:06/29/05ISR Number: 4705299-XReport Type:Expedited (15-DaCompany Report #05-06-1104 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Upper Gastrointestinal Health Clozapine Tablets - Haemorrhage Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 100-500MG QD ORAL Date:06/30/05ISR Number: 4703587-4Report Type:Expedited (15-DaCompany Report #PHEH2005US07193 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Clozaril PS Novartis Sector: Other Lung Neoplasm Malignant Pharma Unk, Unk Date:06/30/05ISR Number: 4703588-6Report Type:Expedited (15-DaCompany Report #PHBS2005CA04559 Age:23 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Toxicity Clozaril PS ORAL 600 mg/d Initial or Prolonged Electrocardiogram T Wave Clozaril SS ORAL 550 mg/d Other Abnormal Buspirone C Tachycardia Rivotril C Tremor Ativan C Ventricular Hypokinesia Date:06/30/05ISR Number: 4703592-8Report Type:Expedited (15-DaCompany Report #PHEH2005US07248 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Test Abnormal Clozaril PS Novartis Sector: Initial or Prolonged Pharma Unk, Unk Date:06/30/05ISR Number: 4704081-7Report Type:Expedited (15-DaCompany Report #IE-BRISTOL-MYERS SQUIBB COMPANY-13010269 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Abilify PS Otsuka Erythema Multiforme Pharmaceutical Company, Ltd. Clozaril I ORAL 16 DAY 22-Feb-2006 08:30 AM Page: 3366 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Olanzapine I ORAL Date:06/30/05ISR Number: 4706928-7Report Type:Expedited (15-DaCompany Report #2005S1002775 Age:87 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional (25 Mg) PS ORAL 25 MG; TID; Other PO Date:06/30/05ISR Number: 4706958-5Report Type:Expedited (15-DaCompany Report #2005S1005163 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional (100 Mg) PS ORAL 100 MG; QAM; Other PO; 350 MG; HS; PO Valproate Semisodium C Date:06/30/05ISR Number: 4706959-7Report Type:Expedited (15-DaCompany Report #2005S1005230 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional (25 Mg) PS ORAL 50 MG, TID; Other PO Clozapine Tablets (100 Mg) SS ORAL 500 MG; HS; PO Atenolol C Clonazepam C Medroxyprogesterone C Acetate C Docusate Sodium C Ferrous Sulfate C Insulin Human Injection, Isophane/Insulin Human C Zinc Suspension C Levothyroxine Sodium C Atorvastatin C Lithium Carbonate C Melatonin C Omeprazole C Docusate Sodium/Senna C Quetiapine Fumarate C Topiramate C Warfarin C 22-Feb-2006 08:30 AM Page: 3367 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/30/05ISR Number: 4706991-3Report Type:Expedited (15-DaCompany Report #05-06-0959 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neoplasm Malignant Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 100-1000MG QD ORAL Date:06/30/05ISR Number: 4706992-5Report Type:Expedited (15-DaCompany Report #05-06-0961 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Myocardial Health Clozapine - Ivax Infarction Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 100MG QD ORAL Date:07/01/05ISR Number: 4704839-4Report Type:Expedited (15-DaCompany Report #PHFR2005GB02223 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Mean Cell Volume Abnormal Clozaril PS Novartis Sector: Pharma ORAL UNK, UNK Date:07/01/05ISR Number: 4704866-7Report Type:Expedited (15-DaCompany Report #PHBS2005NZ07551 Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Clozaril PS Novartis Sector: Phosphokinase Increased Pharma ORAL UNK, UNK 15840MIN Blood Creatine Olanzapine C 20 mg/d Phosphokinase Mm Olanzapine C 10 mg/d Constipation Prednisone C Dermatomyositis Muscle Rigidity Muscular Weakness Date:07/01/05ISR Number: 4704870-9Report Type:Expedited (15-DaCompany Report #PHNU2005DE02376 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bundle Branch Block Left Leponex / Clozaril Initial or Prolonged Cardiac Disorder (Clozapine) PS Novartis Sector: Pharma ORAL Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL 2880 MIN Risperdal C ORAL Orfiril C ORAL Resonium A C ORAL 22-Feb-2006 08:30 AM Page: 3368 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/01/05ISR Number: 4704871-0Report Type:Expedited (15-DaCompany Report #PHHO2005BR10116 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Clozapine PS Novartis Sector: Drug Toxicity Pharma 100mg 1/2 tab Hypertension daily Vomiting Anafranil SS 75mg 3 tabs daily Oxcarbazepine SS ORAL 1 tab am, 1 tab pm Oxcarbazepine SS ORAL 2 tabs am, 2 tabs pm Oxcarbazepine SS 3 tabs a day Carbolitium C UNK, UNK Propranolol C 40mg 3 tabs daily Date:07/01/05ISR Number: 4704992-2Report Type:Expedited (15-DaCompany Report #IE-BRISTOL-MYERS SQUIBB COMPANY-13010269 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Abilify PS Otsuka Erythema Multiforme Pharmaceutical Company, Ltd. Clozaril I ORAL 16 DAY Olanzapine I ORAL Date:07/01/05ISR Number: 4705044-8Report Type:Expedited (15-DaCompany Report #PHBS2005ES07521 Age:31 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Clozapine PS Novartis Sector: Initial or Prolonged Blood Creatine Pharma UNKNOWN 50 mg/d Other Phosphokinase Increased Clozapine SS Novartis Sector: Clonus Pharma UNKNOWN 700 mg/d Confusional State Clozapine SS Novartis Sector: Delirium Pharma UNKNOWN 25 mg, Q8H Depression Clozapine SS Novartis Sector: Drug Withdrawal Syndrome Pharma UNKNOWN 125 mg/d Eating Disorder Echolalia Fear Hallucination, Visual Hyperhidrosis Hyperreflexia Speech Disorder Stupor Tachycardia Tremor Unresponsive To Verbal Stimuli Vomiting 22-Feb-2006 08:30 AM Page: 3369 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/01/05ISR Number: 4705142-9Report Type:Expedited (15-DaCompany Report #PHBS2005NL09304 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Leponex PS Novartis Sector: Initial or Prolonged Candidiasis Pharma ORAL 500 mg/d Neutropenia Lithium C 800 mg, QD Respiratory Tract Clonazepam C 0.5 mg, BID Infection Amitriptyline C 75 mg, TID Temazepam C Pantoprazole C Date:07/01/05ISR Number: 4705144-2Report Type:Expedited (15-DaCompany Report #PHEH2005US07193 Age:58 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Neoplasm Malignant Clozaril PS Novartis Sector: Other Pharma Unk, Unk Date:07/05/05ISR Number: 4708001-0Report Type:Direct Company Report #CTU 252571 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Level Fluctuating Clozaril 100 Mg PS ORAL 2 AM/5 PM Pharmaceutical Product TAKEN PO Complaint Date:07/05/05ISR Number: 4708134-9Report Type:Direct Company Report #CTU 252492 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Increased Clozaril 100 Mg Initial or Prolonged Circulatory Collapse Novartis PS Novartis ORAL 600 MG ORAL Convulsion Haldol C Drug Administration Error Ativan C Dyskinesia Cogentin C Heart Rate Increased Artane C Loss Of Consciousness Medication Error Date:07/05/05ISR Number: 4709480-5Report Type:Expedited (15-DaCompany Report #S05-USA-03295-01 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tardive Dyskinesia Consumer Lexapro (Escitalopram) PS ORAL 30 MG QD PO Lexapro (Escitalopram) SS ORAL 15 MG QD PO Clozapine SS ORAL 300 MG QD PO Clozapine SS ORAL 150 MG QD PO Lorazepam C 22-Feb-2006 08:30 AM Page: 3370 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/05/05ISR Number: 4709482-9Report Type:Expedited (15-DaCompany Report #012 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Feeling Abnormal Health Fazaclo Odt PS Alamo Professional Pharmaceuticals ORAL 650 MG PO PER Company DAY Representative Date:07/06/05ISR Number: 4707360-2Report Type:Expedited (15-DaCompany Report #PHFR2005GB01741 Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Clozaril PS Novartis Sector: Initial or Prolonged Chest Discomfort Pharma ORAL 200mg/day Other Confusional State Clozaril SS Novartis Sector: Cyanosis Pharma ORAL 350mg/day Disturbance In Attention Dyspnoea Eosinophil Count Increased Gait Disturbance Headache Hyperhidrosis Hypertension Malaise Muscle Tightness Pericardial Effusion Platelet Count Increased Psychomotor Hyperactivity Red Blood Cell Sedimentation Rate Increased Salivary Hypersecretion Somnolence Tremor Date:07/06/05ISR Number: 4707362-6Report Type:Expedited (15-DaCompany Report #PHRM2005FR02016 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Leponex PS Novartis Sector: Hospitalization - Pharyngitis Pharma ORAL Initial or Prolonged White Blood Cell Count Athymil C ORAL Decreased Date:07/06/05ISR Number: 4707363-8Report Type:Expedited (15-DaCompany Report #PHHO2005CA10361 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Catatonia Clozapine PS Novartis Sector: Hypotension Pharma ORAL 725 DAY 22-Feb-2006 08:30 AM Page: 3371 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/07/05ISR Number: 4707994-5Report Type:Expedited (15-DaCompany Report #PHFR2005GB01718 Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Obsessive-Compulsive Clozaril PS Novartis Sector: Disorder Pharma ORAL 500mg per day Clozaril SS Novartis Sector: Pharma 625mg/day Date:07/07/05ISR Number: 4707996-9Report Type:Expedited (15-DaCompany Report #PHNU2005DE02404 Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aphasia Leponex / Clozaril Cerebral Infarction (Clozapine) PS Novartis Sector: Computerised Tomogram Pharma ORAL Abnormal Confusional State Lumbar Puncture Abnormal Neuroborreliosis Date:07/07/05ISR Number: 4707997-0Report Type:Expedited (15-DaCompany Report #PHNR2005AU00975 Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Cardiomyopathy Clozaril PS Novartis Sector: Drug Level Increased Pharma 200-700 mg Ejection Fraction daily Decreased Risperidone C 75 mg q2wk Hypertension Pantoprazole C 40 mg qd Hypokinesia Lithium C Neutrophilia Buspirone C 10 mg tds Ventricular Dysfunction Date:07/07/05ISR Number: 4708503-7Report Type:Expedited (15-DaCompany Report #PHFR2001GB01191 Age:25 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Amnesia Clozaril PS Novartis Sector: Disability Depressed Level Of Pharma ORAL 250 mg/day Consciousness Clozaril SS Novartis Sector: Dyspnoea Pharma 300mg/day Erythema Grand Mal Convulsion Muscle Contractions Involuntary Myoclonus Date:07/07/05ISR Number: 4708507-4Report Type:Expedited (15-DaCompany Report #PHFR2004GB02585 Age:48 YR Gender:Male I/FU:F Outcome PT Hospitalization - Aspiration Initial or Prolonged Dysphagia Disability Lower Respiratory Tract Other Infection Neutrophil Count Increased 22-Feb-2006 08:30 AM Page: 3372 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pneumonia White Blood Cell Count Increased Report Source Product Role Manufacturer Route Dose Duration Clozaril PS Novartis Sector: Pharma ORAL 100 mg, BID Zopiclone C 2.7mg nocte Procyclidine C 22.5mg Date:07/07/05ISR Number: 4708509-8Report Type:Expedited (15-DaCompany Report #PHRM2005FR01982 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Leponex PS Novartis Sector: Initial or Prolonged C-Reactive Protein Pharma ORAL 300 mg daily Increased Ileus Paralytic Date:07/07/05ISR Number: 4709630-0Report Type:Expedited (15-DaCompany Report #013 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Fazaclo Odt PS Alamo Cyanosis Professional Pharmaceuticals ORAL 200 MG PO HS Depressed Level Of Company Haldol C Consciousness Representative Lamisil C Sleep Apnoea Syndrome Date:07/07/05ISR Number: 4710290-3Report Type:Expedited (15-DaCompany Report #2005S1005331 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional (100 Mg) PS ORAL SEE IMAGE Other Mortphine C Potassiim Chloride C Lamotrigine C Tolterodine C Omeprazole C Date:07/08/05ISR Number: 4709111-4Report Type:Expedited (15-DaCompany Report #PHFR2005IE01985 Age:53 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Clozaril PS Novartis Sector: Initial or Prolonged Blood Pressure Decreased Pharma ORAL 250mg/day 18720MIN Other Eosinophil Count Increased Fibrin D Dimer Increased Hyperhidrosis Influenza Like Illness Malaise Platelet Count Increased Pneumonia Pyrexia Vomiting 22-Feb-2006 08:30 AM Page: 3373 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/08/05ISR Number: 4709122-9Report Type:Expedited (15-DaCompany Report #PHNR2005AU00956 Age:23 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Clozaril (Clozapine) PS Novartis Sector: Increased Pharma ORAL 28800MIN Antinuclear Antibody Positive Blood Albumin Increased Blood Creatine Phosphokinase Increased C-Reactive Protein Increased Drug Effect Decreased Electrocardiogram Abnormal Electrocardiogram St Segment Elevation Mental Status Changes Neutrophil Count Increased Red Blood Cell Sedimentation Rate Increased Sinus Bradycardia Sinus Tachycardia Troponin Increased Ventricular Hypertrophy White Blood Cell Count Increased Date:07/08/05ISR Number: 4709151-5Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050607093 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Haldol PS OROPHARINGEAL Increased Haldol SS OROPHARINGEAL Aspartate Leponex SS OROPHARINGEAL Aminotransferase Neurocil SS OROPHARINGEAL Increased Tavor C OROPHARINGEAL Drug Interaction Tavor C OROPHARINGEAL Gamma-Glutamyltransferase Bvk Vitamin C 1 Kps = 1 Increased Dose Liver Function Test Neurocil I OROPHARINGEAL Abnormal Leponex I OROPHARINGEAL Leponex I OROPHARINGEAL Leponex I OROPHARINGEAL Leponex I OROPHARINGEAL Neurocil I OROPHARINGEAL Leponex I OROPHARINGEAL Neurocil I OROPHARINGEAL Date:07/08/05ISR Number: 4709205-3Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050602634 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Glomerulonephritis Acute Ibuprofen PS 600-800mg Hospitalization - Renal Failure tid-qid Initial or Prolonged Clozapine SS OROPHARINGEAL Depakote C 22-Feb-2006 08:30 AM Page: 3374 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Zoloft C Seroquel C Prevacid C Nifedipine Xr C Date:07/08/05ISR Number: 4709858-XReport Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050606946 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aspartate Risperdal PS OROPHARINGEAL Aminotransferase Leponex SS OROPHARINGEAL Increased Leponex SS OROPHARINGEAL Rhabdomyolysis Leponex SS OROPHARINGEAL Orfiril C OROPHARINGEAL Resonium C OROPHARINGEAL Date:07/08/05ISR Number: 4709911-0Report Type:Expedited (15-DaCompany Report #PHRM2005FR02045 Age:80 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Electroencephalogram Leponex PS Novartis Sector: Hospitalization - Abnormal Pharma ORAL 50 mg/day 1440 MIN Initial or Prolonged Epilepsy Leponex SS Novartis Sector: Eye Movement Disorder Pharma ORAL 150 mg/day 2880 MIN Myoclonus Petit Mal Epilepsy Date:07/08/05ISR Number: 4709913-4Report Type:Expedited (15-DaCompany Report #PHFR2005GB01741 Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Clozaril PS Novartis Sector: Initial or Prolonged Chest Discomfort Pharma ORAL 200mg/day Other Confusional State Clozaril SS Novartis Sector: Cyanosis Pharma ORAL 350mg/day Disturbance In Attention Dyspnoea Eosinophil Count Increased Gait Disturbance Headache Hyperhidrosis Hypertension Malaise Muscle Tightness Pericardial Effusion Pericarditis Platelet Count Increased Psychomotor Hyperactivity Red Blood Cell Sedimentation Rate Increased Salivary Hypersecretion Somnolence Tremor 22-Feb-2006 08:30 AM Page: 3375 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/08/05ISR Number: 4710826-2Report Type:Expedited (15-DaCompany Report #05-03-0349 Age:71 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Myocardial Health Clozapine - Ivax Infarction Professional Pharmaceuticals, Chronic Obstructive Other Inc. Tablets PS ORAL 300MG QD Pulmonary Disease ORAL Lasix C Actos C Serevent C Azmacort C Combivent C Zantac C Lipitor C Oxygen C Multivitamins C Calcium C Date:07/08/05ISR Number: 4710858-4Report Type:Expedited (15-DaCompany Report #05-05-0923 Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Congestive Cardiomyopathy Health Clozapine - Ivax Obesity Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 150MG QAM ORAL; 300MG QHS ORAL Loxitane C Depakote C Date:07/08/05ISR Number: 4710881-XReport Type:Expedited (15-DaCompany Report #05-06-1134 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Health Clozapine - Ivax Initial or Prolonged Gastrointestinal Professional Pharmaceuticals, Haemorrhage Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 25-400MG QD ORAL Date:07/08/05ISR Number: 4710891-2Report Type:Expedited (15-DaCompany Report #05-06-1120 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 100-250MG QD ORAL 22-Feb-2006 08:30 AM Page: 3376 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/08/05ISR Number: 4710892-4Report Type:Expedited (15-DaCompany Report #05-05-0832 Age:63 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Lung Neoplasm Malignant Health Clozapine - Ivax White Blood Cell Count Professional Pharmaceuticals, Decreased Other Inc. Tab;Ets PS Ivax Pharmaceuticals, Inc. ORAL 100-250MG QD ORAL Lexapro C Klonopin C Date:07/11/05ISR Number: 4710778-5Report Type:Expedited (15-DaCompany Report #PHFR2005GB02341 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Pressure Increased Clozaril PS Novartis Sector: Heart Rate Increased Pharma ORAL Medication Error Clozaril SS Novartis Sector: Sedation Pharma ORAL 300mg medication error Date:07/11/05ISR Number: 4711300-XReport Type:Expedited (15-DaCompany Report #05-04-0596 Age:47 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neoplasm Malignant Health Clozapine - Ivax White Blood Cell Count Professional Pharmaceuticals, Decreased Other Inc. Tablets PS Ivax Pharmaceuticals, Inc ORAL 600MG QD ORAL Chemotherapy SS Lithium C Lexapro C Xanax C Date:07/11/05ISR Number: 4711303-5Report Type:Expedited (15-DaCompany Report #05-07-1148 Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Health Clozapine - Ivax Initial or Prolonged General Physical Health Professional Pharmaceuticals, Deterioration Other Inc. Tablets PS Ivax Head Injury Pharmaceuticals, Inc ORAL 75MG QD ORAL Date:07/11/05ISR Number: 4711304-7Report Type:Expedited (15-DaCompany Report #05-07-1147 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Gastrointestinal Health Clozapine - Ivax Initial or Prolonged Haemorrhage Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc ORAL 150-300MG QD ORAL 22-Feb-2006 08:30 AM Page: 3377 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/11/05ISR Number: 4711306-0Report Type:Expedited (15-DaCompany Report #05-07-1146 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dehydration Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceutical, Inc ORAL ORAL Date:07/12/05ISR Number: 4712218-9Report Type:Expedited (15-DaCompany Report #PHBS2005BR09781 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Leponex PS Novartis Sector: Initial or Prolonged Constipation Pharma ORAL 50 mg, BID 11520MIN Convulsion Leponex SS Novartis Sector: Faecal Incontinence Pharma ORAL 25 mg, BID 14400MIN Fall Carbolitium SS ORAL 300 mg, QD 25920MIN Infection Urinary Incontinence White Blood Cell Count Increased Date:07/12/05ISR Number: 4712219-0Report Type:Expedited (15-DaCompany Report #PHFR2005GB02223 Age:27 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Mean Cell Volume Abnormal Clozaril PS Novartis Sector: Pharma ORAL 12.5mg per day Amisulpride C ORAL 400mg per day Zopiclone C ORAL 7.5mg per day Mirtazapine C ORAL 30mg per day Date:07/12/05ISR Number: 4712220-7Report Type:Expedited (15-DaCompany Report #PHEH2005US06350 Age:16 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atelectasis Leponex / Clozaril Initial or Prolonged C-Reactive Protein (Clozapine) Lex+Tab PS Novartis Sector: Increased Pharma ORAL 25 mg, QD 4320 MIN Chills Leponex / Clozaril Feeling Cold (Clozapine) Lex+Tab SS Novartis Sector: Heart Sounds Abnormal Pharma ORAL 50mg Qam, Myocarditis 25mg Q8pm 5760 MIN Pneumonitis Leponex / Clozaril Pyrexia (Clozapine) Lex+Tab SS Novartis Sector: Red Blood Cell Pharma ORAL 75mg Qam, Sedimentation Rate 50mg Q8pm 5760 MIN Increased Leponex / Clozaril Sedation (Clozapine) Lex+Tab SS Novartis Sector: Somnolence Pharma ORAL 75mg Qam, Troponin T Increased 100mg Qpm 5760 MIN Viral Infection Abilify C ORAL 10 mg, QD 23040MIN Abilify C 10 mg, Qpm 56160MIN Dulcolax C ORAL 10 mg, QD 15840MIN Colace C ORAL 100 mg, QD 89280MIN 22-Feb-2006 08:30 AM Page: 3378 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/12/05ISR Number: 4712222-0Report Type:Expedited (15-DaCompany Report #PHEH2005US07057 Age:25 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Activities Of Daily Clozaril PS Novartis Sector: Living Impaired Pharma ORAL UNK mg, UNK Cerebral Artery Embolism Contraceptives Uns SS Cerebrovascular Accident Cogentin C Convulsion Haldol C Neutropenia Avandia C Platelet Count Increased Paxil C White Blood Cell Count Detrol C Decreased Phenytoin C Date:07/12/05ISR Number: 4713480-9Report Type:Expedited (15-DaCompany Report #2005S1004005 Age:75 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abnormal Behaviour Health Clozapine Tablets Agitation Professional (25 Mg) PS ORAL 25 MG; QD; PO Condition Aggravated Other Confusional State Dementia Alzheimer'S Type Depression Hallucination Leukocytosis Pharmaceutical Product Complaint Pneumonia Psychotic Disorder Syncope Date:07/12/05ISR Number: 4713565-7Report Type:Expedited (15-DaCompany Report #2005S1005539 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine Tablets Professional (25 Mg) PS ORAL 25 MG;HS;PO Other Clozapine Tablets (100 Mg) SS ORAL 200 MG;HS;PO Escitalopram C Clonazepam C Trihexyphenidyl C Hydrochloride C Chlorpromazine C Hydrochloride C Smvastatin C Lisinopril C Metoprolol Succinate C Acetylsalicylic Acid C Pantoprazole C Glyceryl Trinitrate C Date:07/13/05ISR Number: 4713136-2Report Type:Direct Company Report #CTU 253109 Age: Gender: I/FU:I Outcome PT Abnormal Behaviour Appendix Disorder 22-Feb-2006 08:30 AM Page: 3379 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Poisoning Renal Failure Stomach Discomfort Report Source Product Role Manufacturer Route Dose Duration Clozaril PS Date:07/13/05ISR Number: 4713297-5Report Type:Expedited (15-DaCompany Report #PHBS2005CA08120 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Clozaril PS Novartis Sector: Initial or Prolonged Phosphokinase Increased Pharma ORAL 450 mg/d Other Feeling Abnormal Zoloft C Viral Myositis Trazodone C Clonazepam C Neurontin C Kemadrin C Asa C Senokot C Corgard C Date:07/13/05ISR Number: 4713352-XReport Type:Expedited (15-DaCompany Report #PHFR2005GB02168 Age:25 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Clozapine PS Novartis Sector: Abnormal Pharma ORAL Ventricular Haloperidol C Pre-Excitation Procyclidine C Wolff-Parkinson-White Aripiprazole C Syndrome Date:07/13/05ISR Number: 4713356-7Report Type:Expedited (15-DaCompany Report #PHBS2005CA09811 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Psoriasis Clozaril PS Novartis Sector: Pharma ORAL Date:07/13/05ISR Number: 4713357-9Report Type:Expedited (15-DaCompany Report #PHFR2005GB02211 Age:25 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Mean Cell Haemoglobin Clozaril PS Novartis Sector: Increased Pharma ORAL 500mg/day Mean Cell Volume Valproate Sodium C ORAL 1200mg/day Increased Reboxetine C ORAL 4mg/day Zolpidem C 10mg PRN Diazepam C ORAL 10mg PRN Date:07/13/05ISR Number: 4713363-4Report Type:Expedited (15-DaCompany Report #PHFR2005GB01076 Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Alcohol Increased Clozaril PS Novartis Sector: Drug Level Increased Pharma ORAL 400mg/day Alcohol SS 22-Feb-2006 08:30 AM Page: 3380 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/13/05ISR Number: 4713364-6Report Type:Expedited (15-DaCompany Report #PHBS2005CA09811 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Psoriasis Clozaril PS Novartis Sector: Pharma ORAL Date:07/13/05ISR Number: 4713376-2Report Type:Expedited (15-DaCompany Report #PHNU2005DE02388 Age:31 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Abdomen Leponex / Clozaril Hospitalization - Flatulence (Clozapine) PS Novartis Sector: Initial or Prolonged Gastrointestinal Necrosis Pharma ORAL UNK, UNK 1460 DAY General Physical Health Tavor C Deterioration Intubation Laparotomy Thrombosis Date:07/13/05ISR Number: 4713379-8Report Type:Expedited (15-DaCompany Report #PHNU2005DE01675 Age:16 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Echocardiogram Abnormal Leponex / Clozaril Fatigue (Clozapine) PS Novartis Sector: Hypertensive Crisis Pharma ORAL 150 mg/day 77760MIN Ventricular Hypertrophy Risperdal SS ORAL 6 mg/day Weight Increased Akineton /Sch/ SS Haldol SS Tavor SS Date:07/13/05ISR Number: 4713381-6Report Type:Expedited (15-DaCompany Report #PHFR2005IE01985 Age:53 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Clozaril PS Novartis Sector: Initial or Prolonged Blood Pressure Decreased Pharma ORAL 250mg/day 18720MIN Other Eosinophil Count Increased Fibrin D Dimer Increased Hyperhidrosis Influenza Like Illness Malaise Platelet Count Increased Pneumonia Pyrexia Vomiting Date:07/13/05ISR Number: 4713383-XReport Type:Expedited (15-DaCompany Report #PHNR2005AU00903 Age:53 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiac Arrest Clozaril PS Novartis Sector: Echocardiogram Abnormal Pharma UNK, UNK 34560MIN Lung Disorder Troponin Increased 22-Feb-2006 08:30 AM Page: 3381 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/13/05ISR Number: 4713386-5Report Type:Expedited (15-DaCompany Report #PHRM2005FR02043 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neoplasm Malignant Leponex PS Novartis Sector: Initial or Prolonged Pharma ORAL Date:07/13/05ISR Number: 4714035-2Report Type:Expedited (15-DaCompany Report #2005S1003724 Age:60 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozapine PS ORAL 25 MG;QAM;PO Professional Clozapine SS ORAL 300MG; HS; PO Other Clonazepam C Symbyax C Busiprone C Trifluoperazine Hydrochloride C Benzatropine Mesilate C Lisinopril C Citalopram C Date:07/13/05ISR Number: 4714037-6Report Type:Expedited (15-DaCompany Report #2005S1005598 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS ORAL 300 MG;HS;PO Professional Mirtazapine C Other Lisinopril C Acetylsalicylic Acid C Escitalopram C Lansoprazole C Carvedilol C Docusate Sodium C Date:07/13/05ISR Number: 4714038-8Report Type:Expedited (15-DaCompany Report #05-03-0497 Age:38 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Infection Health Clozapine PS Ivax Professional Pharmaceuticals, Other Inc. ORAL 100-500MG QD ORAL Zantac C Morphine C Duragesic C Date:07/13/05ISR Number: 4714044-3Report Type:Expedited (15-DaCompany Report #05-01-0040 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asthma Health Clozapine PS Ivax Hospitalization - Pneumonia Professional Pharmaceuticals, Initial or Prolonged Other Inc. ORAL 200MG QHS ORAL Buspar C Klonopin C 22-Feb-2006 08:30 AM Page: 3382 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/14/05ISR Number: 4714028-5Report Type:Expedited (15-DaCompany Report #PHNU2005DE01272 Age:3 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Exposure Leponex / Clozaril Initial or Prolonged Lethargy (Clozapine) PS Novartis Sector: Pallor Pharma ORAL 75 mg, Somnolence ONCE/SINGLE 1440 MIN Date:07/14/05ISR Number: 4714187-4Report Type:Expedited (15-DaCompany Report #PHNU2005DE02477 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Leponex / Clozaril Drug Level Increased (Clozapine) PS Novartis Sector: Pleurothotonus Pharma ORAL 475 mg/day Fevarin SS Date:07/14/05ISR Number: 4714623-3Report Type:Expedited (15-DaCompany Report #2005S1005758 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional (100 Mg) PS ORAL 100 MG; HS; Other PO; 75 MG; QAM; PO Neostigmine Bromide C Fentanyl C Morphine Sulfate C Date:07/14/05ISR Number: 4714625-7Report Type:Expedited (15-DaCompany Report #2005S1005665 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Loss Of Consciousness Other Clozapine Tablets Myocardial Infarction (25 Mg) PS ORAL 50 MG; HS; PO Clozapine Tablets (100 Mg) SS ORAL SEE IMAGE Atenolol C Simvastatin C Amlodipine Besilate C Benazepril Hydrochloride C Clonazepam C Olanzapine C Metformin C Date:07/14/05ISR Number: 4714627-0Report Type:Expedited (15-DaCompany Report #2005S1005652 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional (100 Mg) PS ORAL 350 MG; HS; Other PO; 200 MG; QAM; PO 22-Feb-2006 08:30 AM Page: 3383 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/14/05ISR Number: 4714628-2Report Type:Expedited (15-DaCompany Report #2005S1005663 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Breast Cancer Female Health Clozapine Tablets Initial or Prolonged Leukopenia Professional (100 Mg) PS ORAL 100 MG; BID; Mental Disorder Other PO Adriamycin SS Date:07/14/05ISR Number: 4716376-1Report Type:Expedited (15-DaCompany Report #05-07-1175 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hip Fracture Health Clozapine - Ivax Initial or Prolonged Pelvic Fracture Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 75-100MG QD ORAL Date:07/14/05ISR Number: 4716377-3Report Type:Expedited (15-DaCompany Report #05-06-1178 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Complications Of Health Clozapine - Ivax Initial or Prolonged Transplanted Kidney Professional Pharmaceuticals, Leukopenia Other Inc. Tablets PS Ivax Renal Transplant Pharmaceuticals, Inc. ORAL 75MG QD ORAL Date:07/15/05ISR Number: 4715264-4Report Type:Expedited (15-DaCompany Report #PHBS2005NZ09807 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Accidental Exposure Clozaril PS Novartis Sector: Dermatitis Contact Pharma Eczema Erythema Oedema Mouth Rash Erythematous Swelling Swelling Face Date:07/15/05ISR Number: 4715270-XReport Type:Expedited (15-DaCompany Report #PHBS2005NZ09810 Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Amyotrophic Lateral Clozaril PS Novartis Sector: Initial or Prolonged Sclerosis Pharma ORAL 300 mg/day 626 DAY Cardiomyopathy Dementia Ejection Fraction Decreased Respiratory Failure 22-Feb-2006 08:30 AM Page: 3384 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/18/05ISR Number: 4716534-6Report Type:Expedited (15-DaCompany Report #2005S1004857 Age:18 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Clozapine Tablets PS ORAL 200 MG;QD;PO Multiple Drug Overdose Professional Other Date:07/18/05ISR Number: 4716543-7Report Type:Expedited (15-DaCompany Report #05-07-1176 Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Localised Infection Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 600-700MG QD ORAL Date:07/18/05ISR Number: 4716545-0Report Type:Expedited (15-DaCompany Report #05-07-1180 Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hepatic Failure Health Clozapine - Ivax Other Sepsis Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 12.5-125MG QD ORAL Date:07/18/05ISR Number: 4716546-2Report Type:Expedited (15-DaCompany Report #74-949 Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Confusional State Health Clozapine - Ivax Other Dyspnoea Professional Pharmaceuticals, Lung Neoplasm Malignant Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 250 MG BID ORAL Geodon C Remeron C Depakote C Date:07/18/05ISR Number: 4716554-1Report Type:Expedited (15-DaCompany Report #05-03-0412 Age:49 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 600-1000MG QD ORAL 22-Feb-2006 08:30 AM Page: 3385 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/18/05ISR Number: 4716555-3Report Type:Expedited (15-DaCompany Report #05-06-1039 Age:63 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Health Clozapine - Ivax Cardio-Respiratory Arrest Professional Pharmaceuticals, Sudden Cardiac Death Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 62.5-112.5MG ORAL Multiple Vitamins Qd C Insulin C Aspirin (E.C.) C Cogentin C Wellbutrin C Prolixin C Isosorbide C Lisinopril C Senna Tablets Hs C Restoril C Date:07/18/05ISR Number: 4717337-9Report Type:Expedited (15-DaCompany Report #05-07-1181 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cellulitis Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 150 MG QD; ORAL Date:07/18/05ISR Number: 4718206-0Report Type:Direct Company Report #CTU 253504 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Clozaril -Dosage 500 Mg/Day PS 600 M/G DAY; 500 MG/DY ONE DAY A WEEK Date:07/18/05ISR Number: 4718324-7Report Type:Direct Company Report #CTU 253450 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Clozapine PS ORAL ORAL Initial or Prolonged Disorientation Risperidone SS ORAL ORAL Grand Mal Convulsion Lethargy Neuroleptic Malignant Syndrome Pyrexia Rhabdomyolysis 22-Feb-2006 08:30 AM Page: 3386 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/19/05ISR Number: 4717158-7Report Type:Expedited (15-DaCompany Report #A01200504369 Age:69 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Renal Failure Chronic Lithium PS Glaxosmithkline UNKNOWN YR Clozaril SS UNKNOWN Date:07/19/05ISR Number: 4717185-XReport Type:Expedited (15-DaCompany Report #PHFR2005GB02000 Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Chest Pain Clozapine PS Novartis Sector: Other Circulatory Collapse Pharma ORAL 575mg/day Coronary Artery Disease Valproate Sodium C ORAL 1g/day Myocardial Infarction Citalopram C ORAL 20mg/day Pulse Absent Vitamin B Complex C ORAL Respiratory Arrest Ascorbic Acid C ORAL 200mg/day Thiamine C ORAL 200mg/day Date:07/19/05ISR Number: 4717214-3Report Type:Expedited (15-DaCompany Report #PHNU2005DE02527 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hodgkin'S Disease Leponex / Clozaril Laryngospasm (Clozapine) PS Novartis Sector: Leukopenia Pharma ORAL Lymphadenopathy Olanzapine SS ORAL 30 mg/day Oculogyration Risperidone SS ORAL 6 mg/day Pyrexia Aripiprazole SS ORAL 10 mg/day Date:07/19/05ISR Number: 4717300-8Report Type:Expedited (15-DaCompany Report #05-07-1195 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Decubitus Ulcer Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 300-350MG QD ORAL Date:07/19/05ISR Number: 4718707-5Report Type:Expedited (15-DaCompany Report #S05-USA-03295-01 Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tardive Dyskinesia Consumer Lexapro (Escitalopram) PS ORAL 30 MG QD PO; Lexapro (Escitalopram) SS ORAL 15 MG QD PO Clozapine SS ORAL 300 MG QD PO; 150 MG QD PO; 100 MG QD PO Lorazepam C 22-Feb-2006 08:30 AM Page: 3387 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/20/05ISR Number: 4718210-2Report Type:Expedited (15-DaCompany Report #PHNR2005AU00956 Age:23 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Clozaril (Clozapine) PS Novartis Sector: Increased Pharma ORAL 28800MIN Antinuclear Antibody Positive Blood Albumin Increased Blood Creatine Phosphokinase Increased C-Reactive Protein Increased Drug Effect Decreased Electrocardiogram Abnormal Electrocardiogram St Segment Elevation Mental Status Changes Myocarditis Neutrophil Count Increased Red Blood Cell Sedimentation Rate Increased Sinus Bradycardia Sinus Tachycardia Troponin Increased Ventricular Hypertrophy White Blood Cell Count Increased Date:07/20/05ISR Number: 4718211-4Report Type:Expedited (15-DaCompany Report #PHHO2005CA08930 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Obesity Clozaril PS Novartis Sector: Pharma ORAL 300 mg, QD 111 DAY Clozaril SS Novartis Sector: Pharma ORAL Risperdal C Artane C Depo Provera C Date:07/20/05ISR Number: 4720826-4Report Type:Expedited (15-DaCompany Report #2005S1005862 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tardive Dyskinesia Consumer Lexapro Health (Escitalopram) (15 Professional Mg) PS ORAL 15 MG; QD; PO Other Lexapro (Escitalopram) (30 Mg) SS ORAL 30 MG; QD; PO Clozapine (25 Mg) SS ORAL 50 MG; QD; PO Clozapine (100 Mg) SS ORAL SEE IMAGE PO Lorazepam C 22-Feb-2006 08:30 AM Page: 3388 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/20/05ISR Number: 4724285-7Report Type:Direct Company Report #CTU 253824 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Level Changed Clozaril 100 Mg PS ORAL 2 AM / 5 PM Pharmaceutical Product TAKEN PO Complaint DAILY GP INDIV WKLY Date:07/21/05ISR Number: 4720267-XReport Type:Expedited (15-DaCompany Report #PHFR2001GB03506 Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Distension Clozaril PS Novartis Sector: Hospitalization - Abdominal Pain Pharma ORAL 12.5mg/day 37440MIN Initial or Prolonged Blood Pressure Decreased Clozaril SS Novartis Sector: Cardiac Arrest Pharma ORAL 200mg/day 5760 MIN Colectomy Diazepam C ORAL 4mg/day 67680MIN Colitis Ulcerative Ranitidine C ORAL 300mg/day 91 DAY Hypovolaemia Lactulose C UNKNOWN 10ml/day Intestinal Ischaemia Haloperidol C UNKNOWN 5 mg, TID Intestinal Obstruction Olanzapine C ORAL 20mg/day Multi-Organ Failure reducing to Necrotising Colitis zero 100 DAY Sepsis Lansoprazole C ORAL 30mg/day 30240MIN Date:07/21/05ISR Number: 4720813-6Report Type:Expedited (15-DaCompany Report #PHFR2005MT02493 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Viral Pharyngitis Leponex PS Novartis Sector: White Blood Cell Count Pharma ORAL 100mg/day Decreased Date:07/21/05ISR Number: 4720814-8Report Type:Expedited (15-DaCompany Report #PHBS2005IT10195 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Carbamazepine PS Novartis Sector: Initial or Prolonged Drug Interaction Pharma UNKNOWN 1200 mg/d Other Electroencephalogram Leponex SS Abnormal Carbamazepine SS Novartis Sector: Grand Mal Convulsion Pharma UNKNOWN Leponex SS ORAL 600 mg/d 53280MIN Date:07/21/05ISR Number: 4720816-1Report Type:Expedited (15-DaCompany Report #PHFR2005GB02157 Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Back Pain Clozaril PS Novartis Sector: Influenza Like Illness Pharma ORAL 400mg/day 159 DAY Pericardial Effusion Atenolol C Pyrexia Tachycardia Viral Pericarditis 22-Feb-2006 08:30 AM Page: 3389 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/21/05ISR Number: 4720818-5Report Type:Expedited (15-DaCompany Report #PHNU2005DE02547 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other C-Reactive Protein Leponex / Clozaril Increased (Clozapine) PS Novartis Sector: Cholelithiasis Pharma ORAL 550 mg/day Parotid Gland Enlargement Pantozol C Parotitis Gastrozepin C Date:07/21/05ISR Number: 4720820-3Report Type:Expedited (15-DaCompany Report #PHEH2005US07859 Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Feeling Abnormal Clozaril PS Novartis Sector: Myocardial Infarction Pharma ORAL 400 mg, QD Lithium C Date:07/21/05ISR Number: 4720849-5Report Type:Expedited (15-DaCompany Report #05-07-1207 Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Colon Neoplasm Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS ORAL 150-65MG QD ORAL Date:07/21/05ISR Number: 4724505-9Report Type:Expedited (15-DaCompany Report #S05-CAN-02456-01 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Coma Foreign Citalopram Suicide Attempt Health Hydrobromide Professional (Citalopram) PS Other Clozapine SS Gabapentin SS Seroquel (Quetiapine Fumarate) SS Date:07/22/05ISR Number: 4722535-4Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20050702150 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Grand Mal Convulsion Haloperidol PS UNKNOWN taken when Initial or Prolonged Obstructive Airways required Disorder Clozaril SS ORAL Olanzapine SS UNKNOWN dose reduced Olanzapine SS UNKNOWN nocte Date:07/22/05ISR Number: 4723629-XReport Type:Expedited (15-DaCompany Report #05-07-1182 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Lymphoma Health Clozapine - Ivax Initial or Prolonged Professional Pharmaceuticals, Other Inc. Tablets PS Ivax 22-Feb-2006 08:30 AM Page: 3390 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pharmaceuticals, Inc. ORAL 200-600MG QD ORAL Date:07/22/05ISR Number: 4723640-9Report Type:Expedited (15-DaCompany Report #05-06-1104 Age:49 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Upper Gastrointestinal Health Clozapine - Ivax Haemorrhage Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 100-500MG QD ORAL Geodon C Elavil C Neurontin C Lexapro C Inderal C Date:07/22/05ISR Number: 4723656-2Report Type:Expedited (15-DaCompany Report #2005S1005812 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Treatment Noncompliance Health Clozapine Tablets Professional (100 Mg) PS ORAL 300 MG;HS;PO Other Date:07/22/05ISR Number: 4723659-8Report Type:Expedited (15-DaCompany Report #2005S1006023 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional (100 Mg) PS ORAL 650 MG;QD; PO Other Date:07/22/05ISR Number: 4723660-4Report Type:Expedited (15-DaCompany Report #03-09-1238 Age:53 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Antipsychotic Drug Level Health Clozapine - Ivax Life-Threatening Above Therapeutic Professional Pharmaceuticals, Other Blood Caffeine Other Inc. Tablets PS ORAL 400MG QD ORAL Convulsion Accupril SS 20MG QD Drug Interaction Hydrochlorothiazide SS 12.5MG QD Drug Toxicity Depakote C Piroxicam C Oxybutynin C Bisacodyl C Baclofen C Miralax Powder C Lactulose C 22-Feb-2006 08:30 AM Page: 3391 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/22/05ISR Number: 4723661-6Report Type:Expedited (15-DaCompany Report #05-07-1188 Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Health Clozapine - Ivax Initial or Prolonged Urinary Tract Infection Professional Pharmaceuticals, Other Other Inc. Tablets PS Ivas Pharmaceuticals, Inc. ORAL 150-300MG QD ORAL Date:07/22/05ISR Number: 4723662-8Report Type:Expedited (15-DaCompany Report #05-07-1208 Age:69 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Fall Health Clozapine - Ivax Hospitalization - Injury Professional Pharmaceuticals, Initial or Prolonged Other Inc. PS Ivax Pharmaceuticals, Inc. ORAL 175-425MG QD ORAL Date:07/22/05ISR Number: 4723663-XReport Type:Expedited (15-DaCompany Report #05-07-1230 Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Myocardial Health Clozapine - Ivax Infarction Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 50-350MGG QD ORAL Date:07/22/05ISR Number: 4723664-1Report Type:Expedited (15-DaCompany Report #05-07-1232 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Health Clozapine - Ivax Other Infection Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 800MG QD ORAL Date:07/22/05ISR Number: 4724374-7Report Type:Direct Company Report #CTU 253998 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Toxicity Clozaril PS WEEKLY ONCE PER WEEK Date:07/25/05ISR Number: 4723410-1Report Type:Expedited (15-DaCompany Report #PHBS2003DE13394 Age:18 MON Gender:Female I/FU:F Outcome PT Death Asthenia Hospitalization - Cardiopulmonary Failure Initial or Prolonged Choking 22-Feb-2006 08:30 AM Page: 3392 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Drug Toxicity Dyspnoea Dysstasia Report Source Product Role Manufacturer Route Dose Duration Fatigue Clozapine PS Novartis Sector: Feeling Abnormal Pharma UNKNOWN 50-150 mg/d Loss Of Consciousness Overdose Paralysis Respiratory Arrest Urine Analysis Abnormal Date:07/25/05ISR Number: 4723416-2Report Type:Expedited (15-DaCompany Report #PHFR2002GB04377 Age:61 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chronic Lymphocytic Clozaril PS Novartis Sector: Leukaemia Pharma ORAL 35mg/day Drug Level Below Lansoprazole C Therapeutic Lymphocyte Count Increased Overweight White Blood Cell Count Increased Date:07/25/05ISR Number: 4723417-4Report Type:Expedited (15-DaCompany Report #PHBS2003DE13397 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Areflexia Clozapine PS Novartis Sector: Initial or Prolonged Asthenia Pharma UNKNOWN Drug Screen Positive Clozapine SS Novartis Sector: Drug Toxicity Pharma UNKNOWN 50-100 mg/d Dyspnoea Dysstasia Fatigue Feeling Abnormal Overdose Paralytic Gait Pyrexia Somnolence Victim Of Crime Date:07/25/05ISR Number: 4723424-1Report Type:Expedited (15-DaCompany Report #PHNU2005DE02559 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Leponex / Clozaril Phosphokinase Increased (Clozapine) PS Novartis Sector: C-Reactive Protein Pharma ORAL 400 mg/day Increased Leponex / Clozaril Drug Level Increased (Clozapine) SS Novartis Sector: Polymyalgia Pharma ORAL 200 mg/day Pyrexia Euglucon C Red Blood Cell Sedimentation Rate Increased 22-Feb-2006 08:30 AM Page: 3393 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/25/05ISR Number: 4725083-0Report Type:Expedited (15-DaCompany Report #05-07-1249 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neoplasm Malignant Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 600-700MG QD ORAL Date:07/25/05ISR Number: 4725084-2Report Type:Expedited (15-DaCompany Report #05-07-1257 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 350-900MG QD ORAL Date:07/26/05ISR Number: 4724214-6Report Type:Expedited (15-DaCompany Report #PHBS2005CH08243 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Balance Disorder Leponex PS Novartis Sector: Initial or Prolonged Drug Interaction Pharma ORAL 600 mg/d Drug Level Below Leponex SS Novartis Sector: Therapeutic Pharma ORAL 500 mg/d Drug Level Increased Leponex SS Novartis Sector: Dystonia Pharma ORAL 400 mg/d Fatigue Leponex SS Novartis Sector: Hypertension Pharma ORAL 900 mg/d Muscular Weakness Floxyfral SS ORAL 50 mg/d Pleurothotonus Floxyfral SS ORAL 25 mg/d Salivary Hypersecretion Solian C ORAL 200 mg, QID Sinus Tachycardia Therapy Non-Responder Date:07/26/05ISR Number: 4724215-8Report Type:Expedited (15-DaCompany Report #PHBS2005NZ10040 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Appendicectomy Clozaril PS Novartis Sector: Initial or Prolonged Asthenia Pharma ORAL 400 mg/d 172 DAY Other Sedation Clozaril SS Novartis Sector: Unresponsive To Verbal Pharma ORAL 400 mg/d 179 DAY Stimuli Clozaril SS Novartis Sector: Pharma non-complianc e 89280MIN Clozaril SS Novartis Sector: Pharma 400 mg/d 22-Feb-2006 08:30 AM Page: 3394 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/26/05ISR Number: 4724216-XReport Type:Expedited (15-DaCompany Report #PHBS2005US10248 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diarrhoea Clozapine PS Novartis Sector: Eosinophilia Pharma UNKNOWN Eosinophilic Colitis Clozapine SS Novartis Sector: Pyrexia Pharma UNKNOWN 200 mg/d Red Blood Cell Haloperidol C UNKNOWN Sedimentation Rate Risperidone C UNKNOWN Increased Lorazepam C UNKNOWN White Blood Cell Count Aspirin C UNKNOWN Increased Metoprolol C UNKNOWN Date:07/26/05ISR Number: 4724219-5Report Type:Expedited (15-DaCompany Report #PHBS2005NZ10261 Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Albumin Decreased Clozaril PS Novartis Sector: Initial or Prolonged Cerebrovascular Accident Pharma ORAL 150 mg/d Circulatory Collapse Drug Toxicity Malnutrition Date:07/26/05ISR Number: 4724220-1Report Type:Expedited (15-DaCompany Report #PHBS2005AR10470 Age:5 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Drug Intake By Lapenax PS Novartis Sector: Initial or Prolonged Child Pharma UNKNOWN UNK, Other Accidental Exposure ONCE/SINGLE 1440 MIN Bladder Catheterisation Coma Drug Toxicity Hyporeflexia Loss Of Consciousness Miosis Salivary Hypersecretion Date:07/26/05ISR Number: 4724221-3Report Type:Expedited (15-DaCompany Report #PHBS2005CA08858 Age:21 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Clostridial Infection Clozaril PS Novartis Sector: Initial or Prolonged Colitis Pharma ORAL 100-275 mg/d 37440MIN Other Diarrhoea Zithromax C UNKNOWN 250 mg/d Dizziness Clonazepam C UNKNOWN 0.5 mg, BID Eosinophil Count Increased Eosinophilia Fatigue Pyrexia Tachycardia White Blood Cell Count Increased 22-Feb-2006 08:30 AM Page: 3395 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/26/05ISR Number: 4724998-7Report Type:Expedited (15-DaCompany Report #PHNU2005DE02477 Age:23 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Leponex / Clozaril Drug Level Increased (Clozapine) PS Novartis Sector: Pleurothotonus Pharma ORAL 475 mg/day Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL Unknown Fevarin SS ORAL 50 mg/day Date:07/26/05ISR Number: 4727126-7Report Type:Direct Company Report #CTU 254271 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Convulsion Clozapine (Clozaril) PS Hospitalization - Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage Date:07/27/05ISR Number: 4725575-4Report Type:Expedited (15-DaCompany Report #PHFR2005GB02349 Age:57 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Pressure Decreased Clozaril PS Novartis Sector: Blood Pressure Increased Pharma ORAL 25mg per day 23040MIN Dizziness Tolterodine C ORAL 4mg/day Prostatism Sinus Tachycardia Date:07/27/05ISR Number: 4726154-5Report Type:Expedited (15-DaCompany Report #PHFR2005GB01076 Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Alcohol Increased Clozaril PS Novartis Sector: Drug Level Increased Pharma ORAL 400mg/day Alcohol SS Date:07/28/05ISR Number: 4727466-1Report Type:Expedited (15-DaCompany Report #PHEH2004US10375 Age:34 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Exposure During Clozaril PS Novartis Sector: Pregnancy Pharma ORAL 400 mg, QD Premature Labour Clozaril SS Novartis Sector: Pharma ORAL 300 mg, QD 83 DAY Clozaril SS Novartis Sector: Pharma ORAL 200 mg, QD 22-Feb-2006 08:30 AM Page: 3396 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/28/05ISR Number: 4727493-4Report Type:Expedited (15-DaCompany Report #PHEH2005US07057 Age:25 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Activities Of Daily Clozaril PS Novartis Sector: Living Impaired Pharma ORAL 400 mg, QD Cerebral Artery Embolism Contraceptives Uns SS Cerebrovascular Accident Cogentin C Convulsion Haldol C Neutropenia Avandia C Platelet Count Increased Paxil C White Blood Cell Count Detrol C Decreased Phenytoin C Date:07/28/05ISR Number: 4727495-8Report Type:Expedited (15-DaCompany Report #PHEH2005US08153 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chordee Clozaril PS Novartis Sector: Initial or Prolonged Jaundice Pharma TRANSPLACENTAL Other Penis Disorder Premature Baby Date:07/29/05ISR Number: 4728083-XReport Type:Expedited (15-DaCompany Report #PHBS2003US04724 Age:22 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Breast Tenderness Clozapine PS Novartis Sector: Initial or Prolonged Chest Discomfort Pharma UNKNOWN 25 mg/d Diabetic Ketoacidosis Clozapine SS Novartis Sector: Dyspnoea Pharma UNKNOWN 125 mg/d Hyperventilation Clozapine SS Novartis Sector: Lethargy Pharma UNKNOWN 150 mg/d Menstrual Disorder Risperidone (Ngx) SS UNKNOWN 2 mg/d Nausea Risperidone (Ngx) SS UNKNOWN 5 mg/d Vomiting Risperidone (Ngx) SS UNKNOWN 5 mg/d Weight Decreased Lorazepam C UNKNOWN 3 mg/d Benztropeine C UNKNOWN 2 mg/d Benztropeine C UNKNOWN 1 mg/d Multivitamins C UNKNOWN Calcium C UNKNOWN Date:07/29/05ISR Number: 4728087-7Report Type:Expedited (15-DaCompany Report #PHNR2005AU01166 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Pressure Clozaril PS Novartis Sector: Fluctuation Pharma 0 - 300 Chest Pain mg/day Dysarthria Aripiprazole C Electrocardiogram Venlafaxine Xr C Abnormal Electrocardiogram Qrs Complex Abnormal Electrocardiogram T Wave Amplitude Decreased Troponin I Increased 22-Feb-2006 08:30 AM Page: 3397 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/29/05ISR Number: 4728092-0Report Type:Expedited (15-DaCompany Report #PHBS2004US01841 Age:82 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cogwheel Rigidity Clozapine PS Novartis Sector: Dysarthria Pharma UNKNOWN UNK, UNK Pleurothotonus Clozapine SS Novartis Sector: Tremor Pharma UNKNOWN 150 mg/d Venlafaxine (Ngx) SS UNKNOWN 375 mg/d Aripiprazole (Ngx) SS UNKNOWN 15 mg/d Lithium C UNKNOWN 450 mg/d Date:07/29/05ISR Number: 4730109-4Report Type:Direct Company Report #CTU 254730 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocarditis Clozapine (Ivax) PS Ivax 100 MG QAM / 150MG QHS Depakote C Colace C Lopid C Zoloft C Protonix C Date:07/29/05ISR Number: 4730296-8Report Type:Expedited (15-DaCompany Report #2005S1004142 Age:79 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Parkinson'S Disease Health Clozapine Tablets Professional (25 Mg) PS ORAL 25 MG;QD; PO Other Hyoscymine C Lorazepam C Hyoscyamine Sulfate C Morphine Sulfate C Clindamycin C Ciprofloxacin C Lidocaine Hydrochloride/Ceftri axone Sodium C Polymyxin B Sulfate/Gramidicin C Levodopa/Carbidopa C Aripiprazole C Tamsulosin Hydrochloride C Midodrine C Donepezil Hydrochloride C Biscaodyl C Potassium C Fludrocortisone C Salbutamol C Rimantadine C Levofloxacin C 22-Feb-2006 08:30 AM Page: 3398 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/29/05ISR Number: 4730298-1Report Type:Expedited (15-DaCompany Report #05-07-1288 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine Tablets - Other Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 175-400MG QD ORAL Date:07/29/05ISR Number: 4730336-6Report Type:Expedited (15-DaCompany Report #05-07-1268 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Parotid Gland Enlargement Foreign Metformin PS 500 MG BD Health Zaponex Unknown SS ORAL 100MG BD ORAL Professional Gliclazide SS 80 MG BD Other Ferrous Sulphate SS 200 MG TDS Amisulpride C Chlorpheniramine C Date:07/29/05ISR Number: 4731200-9Report Type:Expedited (15-DaCompany Report #2005S1006312 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional (100 Mg) PS ORAL 250 MG; QD; Other PO Date:07/29/05ISR Number: 4731201-0Report Type:Expedited (15-DaCompany Report #2005S1006351 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional (25 Mg) PS ORAL SEE IMAGE Other Levodopa/Carbidopa C Alprazolam C Valproate Semisodium C Phenytoin Sodium C Furosemide C Escitalopram C Lisinopril C Pramipexole Dihydrochloride C Morphine C Date:07/29/05ISR Number: 4731207-1Report Type:Expedited (15-DaCompany Report #05-06-1104 Age:49 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Respiratory Arrest Health Clozapine-Ivax Upper Gastrointestinal Professional Pharmaceuticals, Haemorrhage Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 475MG QD ORAL Geodon C 22-Feb-2006 08:30 AM Page: 3399 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Elavil C Neurontin C Lexapro C Inderal C Prevacid C Phenergan C Date:07/29/05ISR Number: 4731208-3Report Type:Expedited (15-DaCompany Report #05-07-1269 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diarrhoea Health Clozapine - Ivax Initial or Prolonged Gallbladder Operation Professional Pharmaceuticals, Nausea Other Inc. Tablets PS Ivax White Blood Cell Count Pharmaceuticals, Increased Inc. ORAL 25-125MG QD ORAL Date:07/29/05ISR Number: 4731273-3Report Type:Expedited (15-DaCompany Report #05-07-1299 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Physical Assault Health Clozapine - Ivax Initial or Prolonged Schizophrenia Professional Pharmaceuticals, Other Inc. Tablets PS ORAL 400-600MG QD ORAL Date:08/01/05ISR Number: 4730418-9Report Type:Expedited (15-DaCompany Report #PHFR2005GB02556 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sleep Walking Clozapine PS Novartis Sector: Pharma ORAL 350mg/day Date:08/01/05ISR Number: 4730426-8Report Type:Expedited (15-DaCompany Report #PHBS2005NZ09807 Age:25 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Accidental Exposure Clozaril PS Novartis Sector: Dermatitis Contact Pharma Eczema Erythema Oedema Mouth Rash Erythematous Swelling Swelling Face Date:08/01/05ISR Number: 4730427-XReport Type:Expedited (15-DaCompany Report #PHNR2005AU01160 Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chest Pain Clozaril PS Novartis Sector: Echocardiogram Abnormal Pharma ORAL 125 mg, daily 18720MIN Influenza Like Illness Olanzapine C 10 mg, daily Troponin Increased Citalopram Hydrobromide C ORAL 20 mg, daily 22-Feb-2006 08:30 AM Page: 3400 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/01/05ISR Number: 4730434-7Report Type:Expedited (15-DaCompany Report #PHBS2005NZ10261 Age:64 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Albumin Decreased Clozaril PS Novartis Sector: Initial or Prolonged Cerebrovascular Accident Pharma ORAL 150 mg/d 1766 DAY Circulatory Collapse Drug Toxicity Malnutrition Date:08/01/05ISR Number: 4733014-2Report Type:Direct Company Report #CTU 254892 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dizziness Clozapine 100 Mg PS ORAL 100 MG QPM Initial or Prolonged Dyspnoea ORAL Hypoxia Clozapine 25 Mg SS ORAL 25 MG QAM Influenza Like Illness ORAL Pneumonitis Divalproex C Pyrexia Albuterol C Metformin Hcl C Haloperidol Decaonate C Ranitidine Hcl C Date:08/02/05ISR Number: 4731720-7Report Type:Expedited (15-DaCompany Report #PHBS2005ID10961 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hyperglycaemia Clozaril PS Novartis Sector: Other Neuroleptic Malignant Pharma ORAL 100 mg, TID Syndrome Olanzapine C 8640 MIN Haloperidol C 5 mg, TID Trileptal "Novartis" C ORAL 300 mg, TID Trihexyphenidyl Hydrochloride C 2 mg, TID Chlorpromazine C 25 mg, QD Date:08/02/05ISR Number: 4731738-4Report Type:Expedited (15-DaCompany Report #PHNR2005AU01172 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrial Flutter Clozaril PS Novartis Sector: Initial or Prolonged Blood Creatine Increased Pharma ORAL 550 mg, QD 600 DAY Headache Solian SS ORAL 300 mg, QD 15840MIN Hyperhidrosis Epilim C ORAL 600 mg, QD Incontinence Anafranil C 100 mg, QD Joint Stiffness Myoclonus Neuroleptic Malignant Syndrome Pyrexia Rash Tremor 22-Feb-2006 08:30 AM Page: 3401 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/02/05ISR Number: 4731760-8Report Type:Direct Company Report #CTU 255187 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Level Changed Clozaril 100mg -> Total 700 Mg Qd PS ORAL 2AM/5 PM TAKEN PO Date:08/02/05ISR Number: 4731761-XReport Type:Expedited (15-DaCompany Report #PHEH2005US08240 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chronic Myeloid Leukaemia Clozaril PS Novartis Sector: Thrombocytopenia Pharma Unk, Unk Date:08/02/05ISR Number: 4733291-8Report Type:Expedited (15-DaCompany Report #2005S1006401 Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional (25 Mg) PS ORAL 25 MG; BID; Other PO Clopidogrel Sulfate C Fluvoxamine Maleate C Lansoprazole C ...... C Galantamine Hydrobromide C Date:08/03/05ISR Number: 4732627-1Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050704917 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Topamax PS ORAL Intraocular Pressure Valproic Acid C ORAL Increased Leponex I ORAL Date:08/03/05ISR Number: 4733156-1Report Type:Expedited (15-DaCompany Report #PHBS2005IT10195 Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electroencephalogram Leponex PS Initial or Prolonged Abnormal Leponex SS ORAL 600 mg/d 53280MIN Grand Mal Convulsion Carbamazepine C UNKNOWN 1200 mg/d Carbamazepine C UNKNOWN Date:08/03/05ISR Number: 4733157-3Report Type:Expedited (15-DaCompany Report #PHFR2005GB02157 Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Back Pain Clozaril PS Novartis Sector: Influenza Like Illness Pharma ORAL 400mg/day 159 DAY Pericardial Effusion Clozaril SS Novartis Sector: Pyrexia Pharma ORAL 7200 MIN Tachycardia Atenolol C Viral Pericarditis 22-Feb-2006 08:30 AM Page: 3402 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/03/05ISR Number: 4733158-5Report Type:Expedited (15-DaCompany Report #PHEH2005US08364 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiolipin Antibody Clozaril PS Novartis Sector: Positive Pharma Unk, Unk Myalgia Depakote C Systemic Lupus Zoloft C Erythematosus Transient Ischaemic Attack Date:08/03/05ISR Number: 4736980-4Report Type:Expedited (15-DaCompany Report #05-07-1286 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Multi-Organ Failure Health Clozapine - Ivax Professional Pharmaceuticals,Inc. Other Tablets PS Ivax Pharmaceuticals, Inc ORAL 50-250MG QD ORAL Date:08/03/05ISR Number: 4736981-6Report Type:Expedited (15-DaCompany Report #05-07-1291 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pericarditis Health Clozapine - Ivax Other Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc ORAL 600-1500MG QD ORAL Date:08/03/05ISR Number: 4736983-XReport Type:Expedited (15-DaCompany Report #05-07-1287 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Health Clozapine - Ivax Initial or Prolonged Urinary Tract Infection Professional Pharmaceuticals, Other Other Inc. Tablets PS Ivax Pharmaceuticals, Inc ORAL 200-800MG QD ORAL Date:08/03/05ISR Number: 4737785-0Report Type:Expedited (15-DaCompany Report #KII-2005-0017664 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Study Oxycontin Tablets Initial or Prolonged Cyanosis Health (Oxycodone Other Drug Abuser Professional Hydrochloride) Cr Multiple Drug Overdose Other Tablet PS ORAL ORAL Acetaminophen W/Oxycodone (Oxycodone Hydrochloride, Paracetamol) SS ORAL ORAL Benzodiazepine Derivatives () SS ORAL ORAL 22-Feb-2006 08:30 AM Page: 3403 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/04/05ISR Number: 4734364-6Report Type:Expedited (15-DaCompany Report #PHEH2005US08318 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amnesia Clozaril PS Novartis Sector: Condition Aggravated Pharma Unk, Unk Depressed Mood Clozaril SS Novartis Sector: Drug Ineffective Pharma Unk, Unk Impaired Work Ability Date:08/04/05ISR Number: 4734375-0Report Type:Expedited (15-DaCompany Report #PHFR2005GB02590 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Exposure Clozaril PS Novartis Sector: Initial or Prolonged Medication Error Pharma ORAL 200 mg Somnolence overdose Carbamazepine C Olanzapine C Lorazepam C Tetrabenazine C Date:08/04/05ISR Number: 4734741-3Report Type:Expedited (15-DaCompany Report #05-07-1183 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Rash Lamictal PS Glaxosmithkline ORAL Initial or Prolonged Social Problem Clozapine SS ORAL Date:08/04/05ISR Number: 4734887-XReport Type:Expedited (15-DaCompany Report #PHEH2005US00537 Age:75 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dementia Clozaril PS Novartis Sector: Other Dementia Alzheimer'S Type Pharma ORAL 25 mg, QD Pneumonia Clozaril SS Novartis Sector: Pharma ORAL 25 mg, QD Clozaril SS Novartis Sector: Pharma ORAL 12.5 mg, QD Sinemet C ORAL 25/100, QID2SDO Namenda C 10 mg, BID Vitamin B12 C 1000 mg, QD Vitamin E C 400 UNK, QD Trazodone C 25 mg, PRN Oxycodone C ORAL UNK, PRN Date:08/04/05ISR Number: 4737384-0Report Type:Expedited (15-DaCompany Report #2005S1004364 Age:54 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Brain Neoplasm Health Clozapine Tablets Professional (100 Mg) PS ORAL SEE IMAGE Other Lorazepam C Benzatropine Mesilate C Valproate Semisodium C Folic Acid C 22-Feb-2006 08:30 AM Page: 3404 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Levothyroxine Sodium C Lithium Carbonate C Date:08/04/05ISR Number: 4737386-4Report Type:Expedited (15-DaCompany Report #2005S1003724 Age:60 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anoxic Encephalopathy Health Clozapine Tablets Cardiac Arrest Professional (25 Mg) PS ORAL 25 MG; QAM; Fall Other PO Urinary Tract Infection Clozapine Tablets (100 Mg) SS ORAL 300 MG;HS; PO Clonazepam C Symbax C Buspirone C Trifluoperazone C Hydrochloride C Benzatropine Mesilate C Lisinopril C Citalopram C Date:08/04/05ISR Number: 4737387-6Report Type:Expedited (15-DaCompany Report #2005S1006471 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional (100 Mg) PS ORAL 250 MG; QD; Other PO Date:08/04/05ISR Number: 4737388-8Report Type:Expedited (15-DaCompany Report #2005S1006690 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Other Clozapine Tablets (100 Mg) PS ORAL 300 MG; HS; PO Date:08/04/05ISR Number: 4738151-4Report Type:Expedited (15-DaCompany Report #2005S1006655 Age:69 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Breast Cancer Health Clozapine Tablets Professional (100 Mg) PS ORAL 200 MG; QAM; Other PO ; 300 MG; HS; PO Olanzapine C Tolterodine L-Tartrate C Ibuprofen C Magnesium Hydroxide C Docusate Sodium C Lithium Carbonate C Anastrozole C Acetylsalicylic Acid C Nitrofurantoin C 22-Feb-2006 08:30 AM Page: 3405 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/04/05ISR Number: 4738157-5Report Type:Expedited (15-DaCompany Report #2005S1006457 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets PS ORAL PO Professional Other Date:08/04/05ISR Number: 4738165-4Report Type:Expedited (15-DaCompany Report #2005S1006673 Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Health Clozapine Tablets Respiratory Arrest Professional (25 Mg) PS ORAL 12.5 MG; HS; Other PO Botox (Allergan) SS INTRAMUSCULAR IM Fluoxetine C Hydrochloride C Levodopa/Carbidopa C Tramadol C Morphine C Pantoprazole C Estrogen Nos C Oxycodone C Date:08/04/05ISR Number: 4738167-8Report Type:Expedited (15-DaCompany Report #2005S1005862 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tardive Dyskinesia Consumer Lexapro Health (Escitalopram) (30 Professional Mg) PS ORAL 30 MG QD PO Other Lexapro (Escitalopram) 15 Mg SS ORAL 15 MG QD PO Clozapine Tablets (25 Mg) SS ORAL 50 MG QD PO Clozapine Tablets (100 Mg) SS ORAL 100 MG; QD; PO ; 300 MG; QD; PO Lorazepam C Date:08/05/05ISR Number: 4737918-6Report Type:Direct Company Report #CTU 255534 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Pulmonary Embolism Clozapine PS 200 MG Q AM -400 MG HS Date:08/05/05ISR Number: 4738911-XReport Type:Expedited (15-DaCompany Report #05-08-1336 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Fatigue Health Clozapine - Ivax Other Heat Stroke Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 300-450MG QD 22-Feb-2006 08:30 AM Page: 3406 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL Date:08/05/05ISR Number: 4739871-8Report Type:Expedited (15-DaCompany Report #05-08-1337 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmacetuicals, Inc. ORAL 450-500MG QD ORAL Date:08/05/05ISR Number: 4739873-1Report Type:Expedited (15-DaCompany Report #05-06-1047 Age:64 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Infection Health Clozapine Tablets - Other Sepsis Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 12.5-175MG QD ORAL Date:08/05/05ISR Number: 4739874-3Report Type:Expedited (15-DaCompany Report #2005S1007047 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional (100 Mg) PS ORAL 600 MG; HS; Other PO Paroxetine C Hydrochloride C Benzatropine Mesilate C Docusate Sodium C Date:08/05/05ISR Number: 4739881-0Report Type:Expedited (15-DaCompany Report #05-07-1324 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Health Clozapine Tablets - Initial or Prolonged Mania Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 150-275MG QD ORAL Date:08/05/05ISR Number: 4739882-2Report Type:Expedited (15-DaCompany Report #05-07-1318 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Death Asthma Health Professional 22-Feb-2006 08:30 AM Page: 3407 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Product Role Manufacturer Route Dose Duration Clozapine Tablets - Ivax Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 400-750MG QD ORAL Date:08/05/05ISR Number: 4739886-XReport Type:Expedited (15-DaCompany Report #05-07-1319 Age:86 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 62.5-100MG QD ORAL Date:08/05/05ISR Number: 4739972-4Report Type:Expedited (15-DaCompany Report #05-07-1148 Age:72 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Health Clozapine Tablets - Initial or Prolonged General Physical Health Professional Ivax Deterioration Other Pharmaceuticals, Head Injury Inc. PS Ivax Pharmaceuticals, Inc. ORAL 25MG BID ORAL Date:08/05/05ISR Number: 4740361-7Report Type:Expedited (15-DaCompany Report #PAR_0009_2005 Age:78 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Foreign Isoptine PS ORAL 240 MG QDAY Initial or Prolonged Depression Health PO Inflammation Professional Isoptine SS INTRAVENOUS DF Q1HR IV Normochromic Normocytic Other Depakine SS ORAL 500 MG BID PO Anaemia Depakine SS 100 MG/ML Mianserin Hydrochloride SS ORAL 30 MG QDAY PO Memantine SS ORAL 20 MG PO Clopidogrel Sulfate SS ORAL 75 MG QDAY PO Clozapine SS ORAL 50 MG QDAY PO Date:08/06/05ISR Number: 4736204-8Report Type:Expedited (15-DaCompany Report #PHRM2005FR02207 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coma Carbamazepine PS Novartis Sector: Hospitalization - Pharma ORAL Initial or Prolonged Clozapine SS ORAL 22-Feb-2006 08:30 AM Page: 3408 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/08/05ISR Number: 4736218-8Report Type:Expedited (15-DaCompany Report #PHBS2005NZ10261 Age:64 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Albumin Decreased Clozaril PS Novartis Sector: Initial or Prolonged Cerebrovascular Accident Pharma ORAL 150 mg/d 1766 DAY Circulatory Collapse Clozaril SS Novartis Sector: Drug Toxicity Pharma No treatment 5760 MIN Malnutrition Clozaril SS Novartis Sector: Pharma ORAL 150 mg daily 7200 MIN Date:08/08/05ISR Number: 4736219-XReport Type:Expedited (15-DaCompany Report #PHFR2005GB02187 Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Overdose Clozaril PS Novartis Sector: Initial or Prolonged Medication Error Pharma ORAL 175mg/day Clozaril SS Novartis Sector: Pharma ORAL 5x100mg Clozaril SS Novartis Sector: Pharma ORAL 125mg/day Zopiclone C ORAL 3.75 mg, PRN Date:08/08/05ISR Number: 4736347-9Report Type:Expedited (15-DaCompany Report #2005AP04258 Age:20412 DYGender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diarrhoea Quetiapine PS Zeneca Initial or Prolonged Hepatic Enzyme Increased Pharmaceutical ORAL Leukocytosis Clozaril SS ORAL Neutrophilia Clozaril SS ORAL Psychotic Disorder Valium SS Tardive Dyskinesia Efexor SS ORAL Treatment Noncompliance Vomiting Date:08/08/05ISR Number: 4737163-4Report Type:Expedited (15-DaCompany Report #PHBS2005CA05652 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cerebral Atrophy Clozaril PS Novartis Sector: Convulsion Pharma ORAL Date:08/08/05ISR Number: 4737168-3Report Type:Expedited (15-DaCompany Report #PHBS2005CZ10971 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Exposure During Leponex PS Novartis Sector: Pregnancy Pharma ORAL 350 mg/d Hallucination Leponex SS Novartis Sector: Pregnancy Pharma ORAL UNK, UNK Sterilisation 22-Feb-2006 08:30 AM Page: 3409 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/08/05ISR Number: 4737173-7Report Type:Expedited (15-DaCompany Report #PHNR2005AU01166 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Pressure Clozaril PS Novartis Sector: Fluctuation Pharma 0 - 300 Chest Pain mg/day Dysarthria Aripiprazole C Electrocardiogram Venlafaxine Xr C Abnormal Electrocardiogram Q Waves Electrocardiogram Qrs Complex Abnormal Electrocardiogram T Wave Amplitude Decreased Myocardial Infarction Troponin I Increased Date:08/08/05ISR Number: 4737175-0Report Type:Expedited (15-DaCompany Report #PHFR2005GB01391 Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Ankle Fracture Clozaril PS Novartis Sector: Hospitalization - Fall Pharma ORAL 400mg/day Initial or Prolonged Immobile Clozaril SS Novartis Sector: Other Muscle Contractions Pharma ORAL 400 mg/day Involuntary Clopixol Depot C INTRAMUSCULAR UNK, UNK Muscle Twitching Clopixol Depot C INTRAMUSCULAR Myoclonus Obesity Pulmonary Embolism Sedation Thrombosis Date:08/08/05ISR Number: 4737177-4Report Type:Expedited (15-DaCompany Report #PHBS2005CZ11258 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Congenital Central Leponex PS Novartis Sector: Nervous System Anomaly Pharma TRANSPLACENTAL Congenital Hydrocephalus Drug Exposure During Pregnancy Date:08/08/05ISR Number: 4737196-8Report Type:Expedited (15-DaCompany Report #PHRM2005FR02041 Age:67 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Exposure Leponex PS Novartis Sector: Initial or Prolonged Blood Pressure Decreased Pharma ORAL 300 mg, Confusional State ONCE/SINGLE 1440 MIN Sedation Sulpiride C ORAL 50 mg, TID Somnolence Lexomil C ORAL UNK, UNK Speech Disorder 22-Feb-2006 08:30 AM Page: 3410 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/09/05ISR Number: 4738249-0Report Type:Expedited (15-DaCompany Report #PHFR2005GB02538 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Clozaril PS Novartis Sector: Corrected Interval Pharma ORAL 600 mg/day Prolonged Clozaril SS Novartis Sector: Pharma ORAL 650mg/day Venlafaxine C ORAL 150mg/day Date:08/09/05ISR Number: 4738253-2Report Type:Expedited (15-DaCompany Report #PHBS2005FI10966 Age:59 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Leponex PS Novartis Sector: Hospitalization - C-Reactive Protein Pharma ORAL UNK, UNK 72000MIN Initial or Prolonged Increased Tenox C ORAL 40 mg/d Ear Infection Divina C ORAL 21 days then Neutrophil Count break 1 week Decreased Movicol C ORAL UNK, TID Oral Pain Diapam C ORAL 5 mg, PRN Palatal Oedema Risperdal C ORAL 1 mg, PRN Sepsis Orudis C UNKNOWN Staphylococcal Infection Nicorette "Hoechst White Blood Cell Count Marion Roussel" C UNKNOWN 40 mg/d Decreased Date:08/09/05ISR Number: 4743699-2Report Type:Expedited (15-DaCompany Report #142683USA Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Atrial Fibrillation Foreign Pimozide PS ORAL 2 MILLIGRAM 9 DAY Electrocardiogram Qt Health Clozapine SS ORAL 25 MILLIGRAM Prolonged Professional ORAL Other Risperadone SS ORAL ORAL Haloperidol SS ORAL ORAL Desloratadine C Procyclidine C Lorazepam C Date:08/09/05ISR Number: 4744232-1Report Type:Expedited (15-DaCompany Report #PAR_0009_2005 Age:78 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Foreign Isoptine PS ORAL 240 MG QDAY Initial or Prolonged Inflammation Health PO Normochromic Normocytic Professional Isoptine SS INTRAVENOUS DF Q1HR IV Anaemia Other Depakine SS ORAL 500 MG BID PO Depakine SS 100 MG/ML Mianserin Hydrochloride SS ORAL 30 MG QDAY PO Memantine SS ORAL 20 MG PO Clopidogrel Sulfate SS ORAL 75 MG QDAY PO Clozapine SS ORAL 50 MG QDAY PO 22-Feb-2006 08:30 AM Page: 3411 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/10/05ISR Number: 4741094-3Report Type:Expedited (15-DaCompany Report #US-ROCHE-405250 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aphasia Klonopin PS Roche ORAL Confusional State Gabitril I ORAL AT BEDTIME 1 WK Coordination Abnormal Gabitril I ORAL AT BEDTIME Delusion Lithium I ORAL Disorientation Trileptal I ORAL Drug Interaction Seroquel I ORAL Sedation Clozaril I ORAL Date:08/10/05ISR Number: 4741353-4Report Type:Expedited (15-DaCompany Report #PHBS2005CH08243 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Balance Disorder Leponex PS Novartis Sector: Initial or Prolonged Drug Interaction Pharma ORAL 600 mg/d Drug Level Increased Leponex SS Novartis Sector: Dystonia Pharma ORAL 500 mg/d Fatigue Leponex SS Novartis Sector: Hypertension Pharma ORAL 400 mg/d Muscular Weakness Leponex SS Novartis Sector: Pleurothotonus Pharma ORAL 900 mg/d Salivary Hypersecretion Floxyfral SS ORAL 50 mg/d Sinus Tachycardia Floxyfral SS ORAL 25 mg/d Solian C ORAL 200 mg, QID Date:08/10/05ISR Number: 4741368-6Report Type:Expedited (15-DaCompany Report #PHBS2005FR11060 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Clozapine PS Novartis Sector: Neutropenia Pharma UNKNOWN 600 mg/d Neutrophil Count Viraferonpeg SS SUBCUTANEOUS 0.5 ml/d Decreased Rebetol SS UNKNOWN 800 mg/d White Blood Cell Count Lepticur C UNKNOWN 10 mg/d Decreased Heptaminol C UNKNOWN 380 mg/d Driptane C UNKNOWN 5 mg/d Date:08/10/05ISR Number: 4742092-6Report Type:Expedited (15-DaCompany Report #2005S1004366 Age:54 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neoplasm Malignant Other Clozapine Tablets (100 Mg) PS ORAL 200 MG; HS; PO Clozapine Tablets (25 Mg) SS ORAL SEE IMAGE Date:08/10/05ISR Number: 4742093-8Report Type:Expedited (15-DaCompany Report #2005S1004059 Age:77 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dementia Health Clozapine Tablets Failure To Thrive Professional (25 Mg) PS ORAL 25 MG; QD; PO Other Morphine C Lorazepam C 22-Feb-2006 08:30 AM Page: 3412 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Vancomycin C Levodopa/Carbidopa C Heparin-Fraction C Sodium Salt C Famotidine C Atropine Sulfate C Trazodone C Sertraline C Potassium Chloride C Furosemide C Bimatoprost C Ipratropium Bromide/Salbutamol Sulfate) C Enoxoporin C Date:08/10/05ISR Number: 4744237-0Report Type:Direct Company Report #CTU 255940 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiac Failure Clozapine 25 Mg Ivax Congestive Generic PS Ivax 50 MG Q AM , Ventricular Dysfunction 100 QHS Remeron C Seroquel C Wellbutrin Xl C Date:08/11/05ISR Number: 4742879-XReport Type:Expedited (15-DaCompany Report #PHBS2005CH11410 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Accommodation Disorder Leponex PS Novartis Sector: Constipation Pharma ORAL 300 mg/d Drug Interaction Floxyfral SS ORAL 250 mg/d Drug Level Increased Enuresis Hyperventilation Somnolence Tachycardia Tremor Date:08/11/05ISR Number: 4742891-0Report Type:Expedited (15-DaCompany Report #PHNU2005DE02784 Age:67 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acute Pulmonary Oedema Leponex / Clozaril Initial or Prolonged Dyspnoea (Clozapine) PS Novartis Sector: Left Ventricular Failure Pharma ORAL up to 175 mg, Leukocytosis QD Captohexal C ORAL Reboxetine C ORAL Omnic C ORAL Mirtazapine C UNKNOWN 40 mg, QD 22-Feb-2006 08:30 AM Page: 3413 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/11/05ISR Number: 4742892-2Report Type:Expedited (15-DaCompany Report #PHNU2005DE02388 Age:31 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Abdomen Leponex / Clozaril Hospitalization - Blood Potassium Increased (Clozapine) PS Novartis Sector: Initial or Prolonged Flatulence Pharma ORAL alternating Other Gastrointestinal Necrosis between 250 General Physical Health and 400 Deterioration mg/day 1460 DAY Haemoglobin Increased Tavor C ORAL Intubation Laparotomy Leukocytosis Subileus Thrombosis Date:08/11/05ISR Number: 4744277-1Report Type:Direct Company Report #CTU 255993 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Infection Clozapine PS ORAL 100 MG BOD Initial or Prolonged Leukocytosis ORAL Pyrexia Date:08/12/05ISR Number: 4743500-7Report Type:Expedited (15-DaCompany Report #PHFR2005GB02168 Age:25 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Clozapine PS Novartis Sector: Abnormal Pharma ORAL 150 mg/day Ventricular Clozapine SS Novartis Sector: Pre-Excitation Pharma Wolff-Parkinson-White Aripiprazole SS Syndrome Haloperidol C Procyclidine C Date:08/12/05ISR Number: 4743501-9Report Type:Expedited (15-DaCompany Report #PHEH2005US08745 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiomegaly Clozaril PS Novartis Sector: Initial or Prolonged Feeling Abnormal Pharma Weight Increased Abilify C UNK, UNK Date:08/12/05ISR Number: 4744103-0Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050801813 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Risperdal PS ORAL Increased Clozapine SS Aspartate Aminotransferase Increased Platelet Count Decreased 22-Feb-2006 08:30 AM Page: 3414 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/12/05ISR Number: 4748764-1Report Type:Periodic Company Report #408060 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Consumer Pegasys Initial or Prolonged Fear (Peg-Interferon Alfa Self-Injurious Ideation 2a) PS White Blood Cell Count Copegus (Ribavirin) Decreased 200 Mg SS ORAL ORAL Clozapine (Clozapine) SS Seroquel (Quetapine Fumarate) C Date:08/15/05ISR Number: 4744632-XReport Type:Expedited (15-DaCompany Report #PHHO2005CA07613 Age:42 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiotoxicity Clozaril PS Novartis Sector: Diarrhoea Pharma ORAL 25 mg / day Myalgia Clozaril SS Novartis Sector: Oedema Peripheral Pharma ORAL 150 mg / day Pyrexia Lorazepam C Renal Disorder Divalproex Sodium C Tachycardia Levothyroxine C Olanzapine C Ibuprofen C Acetaminophen C Date:08/15/05ISR Number: 4745242-0Report Type:Expedited (15-DaCompany Report #PHEH2005US08829 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Clozaril PS Novartis Sector: Pharma 400 mg, QD Date:08/15/05ISR Number: 4745243-2Report Type:Expedited (15-DaCompany Report #PHBS2005IT07981 Age:17 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperpyrexia Leponex PS Novartis Sector: Initial or Prolonged Tachycardia Pharma ORAL 200 mg/day 21600MIN Tachypnoea Clozapine SS ORAL 200 mg/day 21600MIN Viral Myocarditis Clotiapine C ORAL 150 mg/day 28800MIN Chlordesmethyldiazep am C ORAL 3 mg/day 43200MIN Orphenadrine C ORAL 50 mg/day 43200MIN Date:08/15/05ISR Number: 4745369-3Report Type:Expedited (15-DaCompany Report #2005S1006933 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional (100 Mg) PS ORAL SEE IMAGE Other 22-Feb-2006 08:30 AM Page: 3415 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/15/05ISR Number: 4745370-XReport Type:Expedited (15-DaCompany Report #2005S1005598 Age:78 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Professional Tablets (100 Other Mg) PS ORAL 300 MG; HS; PO Mirtazapine C Lisinopril C Acetylsalicylic Acid C Escitalopram C Lansoprazole C Carvedilol C Docusate Sodium C Benztropeine C Date:08/15/05ISR Number: 4745374-7Report Type:Expedited (15-DaCompany Report #05-08-1398 Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Urinary Tract Infection Consumer Clozapine PS Ivax Initial or Prolonged Other Pharmaceuticals, Inc. ORAL 87.5-88 MG QD ORAL Date:08/15/05ISR Number: 4745375-9Report Type:Expedited (15-DaCompany Report #05-06-1079 Age:70 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine PS Ivax Other Pulmonary Embolism Professional Pharmaceuticals, Other Inc. ORAL 175 MG QD ORAL Venlafaxine SS ORAL 225 MG QD ORAL 5 YR Furosemide C Glyburide C Toprol Xl C Ranitidine C Albuterol C Date:08/15/05ISR Number: 4745376-0Report Type:Expedited (15-DaCompany Report #05-07-1170 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Aspiration Health Clozapine PS Ivax Professional Pharmaceuticals, Other Inc. ORAL 50-75MG QD ORAL Date:08/15/05ISR Number: 4745383-8Report Type:Expedited (15-DaCompany Report #2005S1007086 Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional (100 Mg) PS ORAL 200 MG; HS; Other PO 22-Feb-2006 08:30 AM Page: 3416 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Salbutamol C Prednisone C Atenolol C Lorazepam C Quetiapine Fumarate C Nicotine C Venlafaxine Hydrochloride C Paracetamol/Hydrocod one Bitartrate C Ipratropium Bromide/Salbutamol Sulfate C Date:08/15/05ISR Number: 4745412-1Report Type:Expedited (15-DaCompany Report #05-08-1397 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Neoplasm Malignant Health Clozapine - Ivax Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 300-550MG QD ORAL Date:08/15/05ISR Number: 4745415-7Report Type:Expedited (15-DaCompany Report #05-08-1393 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hip Fracture Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS ORAL 250MG QD ORAL Date:08/15/05ISR Number: 4745416-9Report Type:Expedited (15-DaCompany Report #05-08-1391 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cryptogenic Organizing Health Clozapine Tablets - Initial or Prolonged Pneumonia Professional Ivax Other Other Pharmaceuticals, Inc. PS ORAL 400-625MG QD ORAL Date:08/15/05ISR Number: 4745417-0Report Type:Expedited (15-DaCompany Report #05-08-1392 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Metastatic Carcinoma Of Health Clozapine Tablets - Other The Bladder Professional Ivax Other Pharmaceuticals, Inc. PS ORAL 25-500MG QD ORAL 22-Feb-2006 08:30 AM Page: 3417 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/15/05ISR Number: 4746675-9Report Type:Expedited (15-DaCompany Report #2005112461 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dizziness Consumer Sinequan (Doxepin) PS 400 MG (500 Initial or Prolonged Drug Withdrawal Syndrome MG, 1 IN 1 D) Other Dysarthria Clozaril (Clozapine) SS (400 MG, 1 IN Fall 1D) General Physical Health Glucophage Deterioration (Metformin Somnolence Hydrochloride) C Wrong Drug Administered Antidepressants (Antidepressants) C Date:08/16/05ISR Number: 4746085-4Report Type:Expedited (15-DaCompany Report #PHBS2005CO11601 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Clozapine PS Novartis Sector: Initial or Prolonged Hypotension Pharma ORAL 100 mg/d 15840MIN Leukopenia Rivotril C 2 mg, UNK Neutropenia Lexapro C Pain In Extremity Topamax C 2.5 mg, UNK Pyrexia Primidone C 1500 mg, UNK Tachycardia Date:08/16/05ISR Number: 4746086-6Report Type:Expedited (15-DaCompany Report #PHFR2005GB02753 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Pain Clozapine PS Novartis Sector: Constipation Pharma ORAL 525-550 Cyanosis mg/day Feeling Abnormal Atorvastatin C 10 mg/day Gait Disturbance Aspirine C UNKNOWN Gastrointestinal Metoclopramide C UNKNOWN 10 mg, TID Haemorrhage Pirenzepine C UNKNOWN 25 mg, TID Heart Rate Decreased Omeprazole C UNKNOWN 20 mg/day Hyperhidrosis Loss Of Consciousness Myoclonus Orthostatic Hypotension Date:08/16/05ISR Number: 4746087-8Report Type:Expedited (15-DaCompany Report #PHBS2005NL11492 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Disturbance In Attention Clozapine PS Novartis Sector: Drop Attacks Pharma 100-700 Dyskinesia mg/day Hyperhidrosis Amitriptyline C 50 mg, QID Myoclonus Biperiden C 2 mg, TID Tremor 22-Feb-2006 08:30 AM Page: 3418 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/16/05ISR Number: 4746088-XReport Type:Expedited (15-DaCompany Report #PHRM2005FR02043 Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Colon Cancer Leponex PS Novartis Sector: Initial or Prolonged Metastases To Liver Pharma ORAL 400 mg daily Other Date:08/16/05ISR Number: 4746090-8Report Type:Expedited (15-DaCompany Report #PHBS2003NZ09807 Age:21 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hodgkin'S Disease Clozaril PS Novartis Sector: Initial or Prolonged Lymphopenia Pharma ORAL 350 mg/day Other Neutropenia Clozaril SS Novartis Sector: White Blood Cell Count Pharma ORAL 300 mg nocte Decreased Date:08/16/05ISR Number: 4746128-8Report Type:Expedited (15-DaCompany Report #2005S1007278 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional (25 Mg) PS ORAL 25 MG; HS; PO Other Clozapine Tablets (100 Mg) SS ORAL 100 MG; HS; PO Ipratropium Bromide C Prednisone C Levofloxacin C Date:08/16/05ISR Number: 4746135-5Report Type:Expedited (15-DaCompany Report #05-08-1414 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozapine - Ivax Professional Pharmaceuticals Inc. Other Tablets PS Ivax Pharmaceuticals, Inc. ORAL 18.7 -100MG QD ORAL Date:08/16/05ISR Number: 4746136-7Report Type:Expedited (15-DaCompany Report #05-08-1410 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Health Clozapine - Ivax Initial or Prolonged Dehydration Professional Pharmaceuticals Inc. Other Renal Failure Acute Tablets PS Ivax Rhabdomyolysis Pharmaceuticals, Inc. ORAL 50-225MG QD ORAL 22-Feb-2006 08:30 AM Page: 3419 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/16/05ISR Number: 4746704-2Report Type:Direct Company Report #CTU 256271 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Laboratory Test Abnormal Clozaril 100 Mg -> Total 700 Mg Qd PS ORAL 2 AM /5 PM TAKEN PO Date:08/16/05ISR Number: 4747373-8Report Type:Expedited (15-DaCompany Report #2005-BP-13373RO Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Citalopram Poisoning Literature (Citalopram Health Hydrobromide) PS Professional Clozapine (Clozapine) SS Ethanol (Ethanol) SS Date:08/17/05ISR Number: 4746810-2Report Type:Expedited (15-DaCompany Report #PHBS2005CA11674 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Glucose Decreased Clozaril PS Novartis Sector: Dyspepsia Pharma ORAL 125 mg, BID Hypoglycaemia Haloperidol C UNKNOWN UNK, PRN Nausea Date:08/17/05ISR Number: 4746880-1Report Type:Expedited (15-DaCompany Report #PHFR2004GB03974 Age:53 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Full Blood Count Clozaril PS Novartis Sector: Initial or Prolonged Decreased Pharma ORAL 350 mg/day Other Haemoglobin Decreased Nausea Oesophageal Carcinoma Platelet Count Increased Regurgitation Of Food Throat Cancer Vomiting Date:08/17/05ISR Number: 4746903-XReport Type:Expedited (15-DaCompany Report #PHFR2005GB02704 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Clozaril PS Novartis Sector: Initial or Prolonged Diarrhoea Pharma ORAL 400mg/day Haemoglobin Decreased Clozaril SS Novartis Sector: Melaena Pharma Vomiting White Blood Cell Count Increased 22-Feb-2006 08:30 AM Page: 3420 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/18/05ISR Number: 4748029-8Report Type:Expedited (15-DaCompany Report #2005GB01523 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neutrophil Count Quetiapine PS Zeneca Decreased Pharmaceutical ORAL Zaponex SS ORAL 100 AM AND 125 MG PM Diazepam C UNKNOWN 20 MG/DAY /PRN Ibuprofen C UNKNOWN Haloperidol C UNKNOWN Hyoscine C UNKNOWN Date:08/18/05ISR Number: 4748206-6Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-13075130 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Parotid Gland Enlargement Metformin Hcl PS Bristol-Myers Squibb Company ORAL Gliclazide SS ORAL Clozapine SS ORAL Ferrous Sulfate SS ORAL Amisulpride C Chlorpheniramine C Date:08/18/05ISR Number: 4748221-2Report Type:Expedited (15-DaCompany Report #PHBS2005FR11060 Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Clozapine PS Novartis Sector: Neutropenia Pharma UNKNOWN 600 mg/d Neutrophil Count Viraferonpeg SS SUBCUTANEOUS 0.5 ml/d Decreased Rebetol SS UNKNOWN 800 mg/d White Blood Cell Count Lepticur C UNKNOWN 10 mg/d Decreased Heptaminol C UNKNOWN 380 mg/d Driptane C UNKNOWN 5 mg/d Date:08/18/05ISR Number: 4748731-8Report Type:Expedited (15-DaCompany Report #05-07-1430 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Clozapine Tablets - Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 700MG QD, ORAL Date:08/18/05ISR Number: 4748741-0Report Type:Expedited (15-DaCompany Report #05-08-1418 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Clostridium Colitis Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax 22-Feb-2006 08:30 AM Page: 3421 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pharmaceuticals, Inc. ORAL 250MG QD, ORAL Antibiotics SS Date:08/18/05ISR Number: 4748743-4Report Type:Expedited (15-DaCompany Report #05-07-1232 Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Infection Health Clozapine Tablets - Myocardial Infarction Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 800MG QD, ORAL Zoloft C Date:08/18/05ISR Number: 4748745-8Report Type:Expedited (15-DaCompany Report #2005S1003277 Age:47 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Other Clozapine Tablets (25 Mg) PS ORAL 50 MG; QAM;PO Clozapine Tablets 1(100 Mg) SS ORAL 200 MG; QAM; PO ; 300 MG; HS; PO Benzatropine C Date:08/18/05ISR Number: 4748747-1Report Type:Expedited (15-DaCompany Report #2005S1005812 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Treatment Noncompliance Health Clozapine Tablets Professional (100 Mg) PS ORAL 300 MG; HS; Other PO Date:08/18/05ISR Number: 4748749-5Report Type:Expedited (15-DaCompany Report #2005S1005812 Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Treatment Noncompliance Health Clozapine Tablets Professional (100 Mg) PS ORAL 300 MG; HS; Other PO Date:08/19/05ISR Number: 4749123-8Report Type:Expedited (15-DaCompany Report #PHFR2005GB02757 Age:25 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Clozaril PS Novartis Sector: Prolonged Pharma ORAL Sinus Tachycardia 22-Feb-2006 08:30 AM Page: 3422 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/19/05ISR Number: 4749125-1Report Type:Expedited (15-DaCompany Report #PHBS2005CH11762 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Leponex PS Novartis Sector: Initial or Prolonged Dyspnoea Pharma UNKNOWN 150 mg/d 131 DAY Ejection Fraction Anafranil C ORAL 300 mg/d Decreased Tolvon C ORAL 240 mg/d Fatigue Saroten C ORAL 200 mg/d Hypokinesia Xanax C ORAL 2.5 mg/d Orthopnoea Performance Status Decreased Date:08/19/05ISR Number: 4749126-3Report Type:Expedited (15-DaCompany Report #PHBS2005NZ09810 Age:61 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Amyotrophic Lateral Clozaril PS Novartis Sector: Hospitalization - Sclerosis Pharma ORAL 300 mg/day 626 DAY Initial or Prolonged Cardiomyopathy Dementia Ejection Fraction Decreased Respiratory Failure Date:08/19/05ISR Number: 4749127-5Report Type:Expedited (15-DaCompany Report #PHEH2005US08944 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Exposure Clozaril PS Novartis Sector: Initial or Prolonged Anger Pharma UNK, Other Hallucination ONCE/SINGLE 1440 MIN Loss Of Consciousness Neurontin C Nervous System Disorder Crestor C Valtrex C Toprol Xl C Celebrex C Date:08/19/05ISR Number: 4749491-7Report Type:Expedited (15-DaCompany Report #2005S1005665 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozapine Tablets Fall Professional (25 Mg) PS ORAL 50 MG; HS; PO Myocardial Infarction Other Clozapine Tablets (100 Mg) SS ORAL 100 MG; QAM; PO; 400; MG; HS; PO Atenolol C Simvastatin C Amlodipine Besilate C Benazepril C Hydrochloride C Clonazepam C Olanzapine C Metformin C 22-Feb-2006 08:30 AM Page: 3423 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/19/05ISR Number: 4749503-0Report Type:Expedited (15-DaCompany Report #2005S1005663 Age:54 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Breast Cancer Health Clozapine Tablets Initial or Prolonged Leukopenia Professional (100 Mg) PS ORAL 100 MG; BID; Mental Disorder Other PO Adriamicin SS Date:08/19/05ISR Number: 4749506-6Report Type:Expedited (15-DaCompany Report #05-07-1195 Age:70 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Decubitus Ulcer Health Clozapine - Tablets Hospitalization - Respiratory Distress Professional Ivax Initial or Prolonged Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 300-350MG QD ORAL Date:08/22/05ISR Number: 4749647-3Report Type:Expedited (15-DaCompany Report #PHBS2005US11900 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukocytoclastic Clozapine PS Novartis Sector: Initial or Prolonged Vasculitis Pharma UNKNOWN Other Purpura Clozapine SS Novartis Sector: Pharma UNKNOWN 137.5 mg/d Benztropeine C UNKNOWN Divalproex Sodium C UNKNOWN Lorazepam C UNKNOWN Trazodone C UNKNOWN Levothyroxine C UNKNOWN Haloperidol C UNKNOWN Date:08/22/05ISR Number: 4749677-1Report Type:Expedited (15-DaCompany Report #PHNU2005DE02527 Age:46 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Hodgkin'S Disease Leponex / Clozaril Hospitalization - Laryngospasm (Clozapine) PS Novartis Sector: Initial or Prolonged Leukopenia Pharma ORAL up to 600 mg, Other Lymphadenopathy QD Neutropenia Olanzapine SS ORAL 30 mg/day Neutrophilia Risperdal SS ORAL 3 mg, QD 98 DAY Oculogyration Aripiprazole SS ORAL 10 mg/day Pyrexia Tavor C UNKNOWN 1.5 mg - 3 Surgery mg/day Agopton C ORAL 30 mg, QD 100 DAY Gastrozepin C ORAL 50 mg, QD 28800MIN Date:08/22/05ISR Number: 4749687-4Report Type:Expedited (15-DaCompany Report #PHFR2005GB02781 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Clozaril PS Novartis Sector: Erectile Dysfunction Pharma ORAL 22-Feb-2006 08:30 AM Page: 3424 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Cialis SS UNKNOWN Date:08/22/05ISR Number: 4749702-8Report Type:Expedited (15-DaCompany Report #PHFR2005GB02764 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Clozapine PS Novartis Sector: Mental Impairment Pharma ORAL 400mg/day Metformin SS ORAL 1.5g/day Date:08/22/05ISR Number: 4749705-3Report Type:Expedited (15-DaCompany Report #PHFR2005GB02781 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Clozaril PS Novartis Sector: Erectile Dysfunction Pharma ORAL Cialis SS UNKNOWN Date:08/22/05ISR Number: 4751733-9Report Type:Direct Company Report #CTU 256645 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Systolic Clozapine 100 Mg PS ORAL 300 MG QAM Initial or Prolonged Increased PO; 400 MG Disability Cardiomyopathy QHS PO 3 YR Other Cerebral Infarction Vitamin E C Heart Rate Increased Protonix C Respiratory Rate Depo-Provera C Increased Stelazine C Date:08/23/05ISR Number: 4750204-3Report Type:Expedited (15-DaCompany Report #PHBS2005CH11762 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Leponex PS Novartis Sector: Initial or Prolonged Dyspnoea Pharma UNKNOWN 150 mg/d 131 DAY Ejection Fraction Anafranil C ORAL 300 mg/d Decreased Tolvon C ORAL 240 mg/d Fatigue Saroten C ORAL 200 mg/d Hypokinesia Xanax C ORAL 2.5 mg/d Orthopnoea Performance Status Decreased Date:08/23/05ISR Number: 4750452-2Report Type:Expedited (15-DaCompany Report #05-07-1183 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Rash Lamictal PS Glaxosmithkline ORAL Initial or Prolonged Social Problem Clozapine SS ORAL 22-Feb-2006 08:30 AM Page: 3425 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/23/05ISR Number: 4750495-9Report Type:Expedited (15-DaCompany Report #DE-GLAXOSMITHKLINE-D0047295A Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Delirium Seroxat PS Glaxosmithkline ORAL 112 DAY Disorientation Taxilan SS ORAL 105 DAY Drug Interaction Leponex SS ORAL 7 DAY Dysarthria Tavor C ORAL 1.5MG per day Memory Impairment Stilnox C ORAL 10MG Unknown Ass C Glaxosmithkline ORAL 50MG per day Date:08/23/05ISR Number: 4750565-5Report Type:Expedited (15-DaCompany Report #PHBS2005NZ12082 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Level Increased Clozaril PS Novartis Sector: Electrocardiogram Qt Pharma UNKNOWN 500 mg/d Prolonged Clozaril SS Novartis Sector: Pharma UNKNOWN 350 mg/d Valproate Sodium C UNKNOWN 800 mg/d Thyroxine C UNKNOWN 200 ug/d Date:08/23/05ISR Number: 4750575-8Report Type:Expedited (15-DaCompany Report #PHEH2005US09173 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dementia Alzheimer'S Type Clozaril PS Novartis Sector: Lymphocytic Leukaemia Pharma ORAL 100mg BID, Neutropenia 50mg QD White Blood Cell Count Aricept C Increased Aspirin C Lasix C Potassium C Levothyroxine C Ditropan C Docusate Sodium C Toprol Xl C Namenda C Lactulose C Date:08/23/05ISR Number: 4750576-XReport Type:Expedited (15-DaCompany Report #PHFR2004GB03974 Age:53 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Full Blood Count Clozaril PS Novartis Sector: Initial or Prolonged Decreased Pharma ORAL 350 mg/day Other Haemoglobin Decreased Nausea Oesophageal Carcinoma Platelet Count Increased Regurgitation Of Food Throat Cancer Vomiting 22-Feb-2006 08:30 AM Page: 3426 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/23/05ISR Number: 4750580-1Report Type:Expedited (15-DaCompany Report #PHFR2005GB02637 Age:27 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chest Discomfort Clozaril PS Novartis Sector: Dizziness Postural Pharma ORAL 550 mg/day 67680MIN Dyspnoea Benzhexol C ORAL Electrocardiogram Abnormal Nocturnal Dyspnoea Palpitations Panic Attack Tachycardia Ventricular Hypertrophy Date:08/23/05ISR Number: 4750581-3Report Type:Expedited (15-DaCompany Report #PHBS2005BE06117 Age:25 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Lactate Leponex PS Novartis Sector: Dehydrogenase Increased Pharma ORAL 25 mg/day 10080MIN Haematocrit Decreased Amyl Nitrite SS Haemoglobin Decreased Leponex SS Novartis Sector: Haemolysis Pharma ORAL 50 mg/day 12960MIN Haemolytic Anaemia Leponex SS Novartis Sector: Haptoglobin Decreased Pharma ORAL 37.5 mg/day 11520MIN Mean Cell Volume Leponex SS Novartis Sector: Increased Pharma ORAL 100 mg/day 18720MIN Red Blood Cell Count Temesta C Decreased Loramet C Red Blood Cell Morphology Magneton C Abnormal Antabuse C Impromen Decanoas C Omeprazole C Serlain C Akineton C Maalox C Date:08/23/05ISR Number: 4750585-0Report Type:Expedited (15-DaCompany Report #PHNU2005DE02885 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Leponex / Clozaril Fracture (Clozapine) PS Novartis Sector: Prothrombin Time Pharma ORAL up to 200 mg, Shortened QD Thrombosis Marcumar SS ORAL Perazine C UNKNOWN Date:08/23/05ISR Number: 4750586-2Report Type:Expedited (15-DaCompany Report #PHBS2005FI11929 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebellar Infarction Leponex PS Novartis Sector: Initial or Prolonged Pharma UNKNOWN 22-Feb-2006 08:30 AM Page: 3427 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/23/05ISR Number: 4751110-0Report Type:Expedited (15-DaCompany Report #05-08-1417 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Neoplasm Malignant Company Clozapine - Tablets PS Ivax Representative Pharmaceuticals, Other Inc. ORAL 350MG QD ORAL Date:08/23/05ISR Number: 4751112-4Report Type:Expedited (15-DaCompany Report #2005S1005256 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pulmonary Fibrosis Health Clozapine Tablets PS ORAL 475 MG;QD;PO White Blood Cell Count Professional Lithium Carbonate C Decreased Other Mirtazapine C Oxcarbazepine C Date:08/23/05ISR Number: 4751113-6Report Type:Expedited (15-DaCompany Report #2005S1004364 Age:54 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Brain Neoplasm Health Clozapine Tablets Professional (100 Mg) PS ORAL SEE IMAGE Other Lorazepam C Benzatropine Mesilate C Valproate Semisodium C Folic Acid C Levothyroxine Sodium C Lithium Carbonate C Date:08/23/05ISR Number: 4751115-XReport Type:Expedited (15-DaCompany Report #2005S1001515 Age:25 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Health Clozapine Tablets Haemorrhoid Operation Professional (100 Mg) PS ORAL SEE IMAGE Pneumonia Other Lithium C Post Procedural Clonazepam C Complication Morphine Sulfate C Respiratory Arrest Date:08/23/05ISR Number: 4751211-7Report Type:Direct Company Report #CTU 256810 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutrophil Count Abnormal Clozapine 100- Mylan PS Mylan ORAL ONE PO HS Haldol C Lisinopril C Zoloft C Primidone C Ativan C 22-Feb-2006 08:30 AM Page: 3428 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/24/05ISR Number: 4751093-3Report Type:Expedited (15-DaCompany Report #PHBS2005FI12097 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Leponex PS Novartis Sector: Initial or Prolonged Fatigue Pharma ORAL Hepatocellular Damage Zoloft SS UNKNOWN Jaundice Date:08/24/05ISR Number: 4751104-5Report Type:Expedited (15-DaCompany Report #PHEH2005US09222 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Upper Clozaril PS Novartis Sector: Dyspepsia Pharma ORAL 250 mg, QD Gastric Ulcer Impaired Gastric Emptying Date:08/24/05ISR Number: 4751675-9Report Type:Expedited (15-DaCompany Report #PHEH2005US09308 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Clozaril PS Novartis Sector: Heat Exhaustion Pharma Zoloft C Date:08/25/05ISR Number: 4752367-2Report Type:Expedited (15-DaCompany Report #PHBS2005FI12194 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abscess Leponex PS Novartis Sector: Hospitalization - Acquired Cardiac Septal Pharma ORAL 400 mg/d 95040MIN Initial or Prolonged Defect Lamictal C ORAL 50 mg/d Agranulocytosis Scopoderm C TRANSDERMAL Blood Creatinine Cipramil C ORAL 20 mg/d Increased C-Reactive Protein Increased Diarrhoea Hypokalaemia Nephropathy Toxic Neutrophil Count Decreased Pleural Effusion Pneumonia Fungal Pruritus Rash Generalised Sepsis Skin Infection Date:08/25/05ISR Number: 4752369-6Report Type:Expedited (15-DaCompany Report #PHNR2005AU00743 Age:46 YR Gender:Female I/FU:F Outcome PT Death Acute Pulmonary Oedema Blood Creatine Phosphokinase Increased Cardiomegaly 22-Feb-2006 08:30 AM Page: 3429 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Cardiomyopathy Congestive Cardiomyopathy Eosinophil Count Report Source Product Role Manufacturer Route Dose Duration Increased Clozapine PS Novartis Sector: Obesity Pharma 161 DAY Restrictive Cardiomyopathy Sudden Death Date:08/25/05ISR Number: 4753754-9Report Type:Expedited (15-DaCompany Report #2005S1007448 Age:90 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional (25 Mg) PS ORAL 12.5 MG; QD; Other PO Glyceryl Trinitrate C Levofloxacin C Scopolamine C Hydrochloride C Pethidine Hydrochloride C Date:08/25/05ISR Number: 4753779-3Report Type:Expedited (15-DaCompany Report #2005S1007575 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional (25 Mg) PS ORAL SEE IMAGE Other Clozapine Tablets (100 Mg) SS ORAL 100 MG; HS; PO Morphine C Paracetamol /Hydrocodone C Bitartrate C Escitalopram C Lansoprazole C Paracetamol C Ipratropium Bromide/Salbutamol Sulfate C Date:08/25/05ISR Number: 4753780-XReport Type:Expedited (15-DaCompany Report #2005S1007470 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Neoplasm Malignant Health Clozapine Tablets Professional (100 Mg) PS ORAL SEE IMAGE Other Date:08/25/05ISR Number: 4755004-6Report Type:Expedited (15-DaCompany Report #2005116431 Age:56 YR Gender:Female I/FU:I Outcome PT Hospitalization - Delirium Initial or Prolonged Depression 22-Feb-2006 08:30 AM Page: 3430 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Depressive Delusion Disorientation Drug Interaction Report Source Product Role Manufacturer Route Dose Duration Foreign Zoloft (Sertraline) PS ORAL 50 MG (1 D), Health ORAL Professional Leponex "Novartis" (Clozapine) SS ORAL 125 MG (1 D), ORAL Temesta (Lorazepam) C Date:08/26/05ISR Number: 4753239-XReport Type:Expedited (15-DaCompany Report #PHFR2005GB02590 Age:53 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Exposure Clozaril PS Novartis Sector: Initial or Prolonged Accidental Overdose Pharma ORAL 200 mg Other Sedation accidental Somnolence O/D Carbamazepine C ORAL 1200 mg/day Olanzapine C ORAL 10 mg/day Lorazepam C ORAL 3 mg/day Tetrabenazine C ORAL 100 mg/day Venlafaxine C ORAL 75 mg/day Zopiclone C ORAL 7.5 mg/day Levothyroxine C ORAL 75 ug/day Date:08/26/05ISR Number: 4753244-3Report Type:Expedited (15-DaCompany Report #PHRM2005FR02312 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bronchial Carcinoma Leponex PS Novartis Sector: Initial or Prolonged Cardiomyopathy Pharma ORAL 50 mg, BID Hypertension Lung Disorder Pleural Effusion Pulmonary Mass Renal Failure Date:08/26/05ISR Number: 4753245-5Report Type:Expedited (15-DaCompany Report #PHFR2005GB02604 Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Clozaril PS Novartis Sector: Corrected Interval Pharma UNKNOWN UNK, UNK Prolonged Sertraline C ORAL 200 unk/day Lamotrigine C ORAL 100 unk/day Lansoprazole C ORAL 30 unk/day Zopiclone C ORAL 7.5 unk/day Date:08/26/05ISR Number: 4753564-2Report Type:Expedited (15-DaCompany Report #PHBS2005NO12367 Age:34 YR Gender:Female I/FU:I Outcome PT Death Gastroenteritis Escherichia Coli Nausea Peritonitis 22-Feb-2006 08:30 AM Page: 3431 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Staphylococcal Infection Vomiting Report Source Product Role Manufacturer Route Dose Duration Leponex PS Novartis Sector: Pharma ORAL 100 mg, QID Date:08/26/05ISR Number: 4755102-7Report Type:Expedited (15-DaCompany Report #05-08-1448 Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dysphagia Health Clozapine - Ivax Hospitalization - Pneumonia Aspiration Professional Pharmaceuticals, Initial or Prolonged Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 400MG QD ORAL Cogentin C Xanax C Date:08/26/05ISR Number: 4755103-9Report Type:Expedited (15-DaCompany Report #05-08-1336 Age:56 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Heat Stroke Health Clozapine - Ivax Other Hyperthermia Professional Pharmaceuticals, Loss Of Consciousness Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 450MG QD ORAL Naproxen C Patanol C Date:08/29/05ISR Number: 4755088-5Report Type:Expedited (15-DaCompany Report #PHFR2005GB01422 Age:56 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Haemoglobin Decreased Clozaril PS Novartis Sector: Hypochromic Anaemia Pharma ORAL Date:08/29/05ISR Number: 4755089-7Report Type:Expedited (15-DaCompany Report #PHEH2005US09426 Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Clozaril PS Novartis Sector: Initial or Prolonged Mental Status Changes Pharma ORAL 25 mg, BID Other Ovarian Cancer Date:08/29/05ISR Number: 4755090-3Report Type:Expedited (15-DaCompany Report #PHFR2004GB03974 Age:53 YR Gender:Male I/FU:F Outcome PT Hospitalization - Full Blood Count Initial or Prolonged Decreased Other Haemoglobin Decreased Nausea Oesophageal Carcinoma Platelet Count Increased Regurgitation Of Food 22-Feb-2006 08:30 AM Page: 3432 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Throat Cancer Vomiting Report Source Product Role Manufacturer Route Dose Duration Clozaril PS Novartis Sector: Pharma ORAL 350 mg/day Date:08/29/05ISR Number: 4755099-XReport Type:Expedited (15-DaCompany Report #PHNU2005DE02972 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Leponex / Clozaril Initial or Prolonged (Clozapine) PS Novartis Sector: Other Pharma ORAL 50 mg/day Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL 100 mg/day Date:08/29/05ISR Number: 4755480-9Report Type:Expedited (15-DaCompany Report #2005S1007696 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional (25 Mg) PS ORAL 50 MG; QD; PO Other Clozapine Tablets (100 Mg) SS ORAL 200 MG; QD; PO Date:08/29/05ISR Number: 4755481-0Report Type:Expedited (15-DaCompany Report #2005S1007698 Age:82 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine Tablets Professional (25 Mg) PS ORAL SEE IMAGE, PO Other Date:08/29/05ISR Number: 4755482-2Report Type:Expedited (15-DaCompany Report #2005S1004489 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional (100 Mg) PS ORAL 400 MG; BID; Other PO Escitalopram C Atenolol C Nifedipine C Amitriptyline C Valproate Semisodium C Date:08/29/05ISR Number: 4755484-6Report Type:Expedited (15-DaCompany Report #2005S1006401 Age:63 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional (25 Mg) PS ORAL 25 MG; BID; Other PO Clopidogrel Sulfate C 22-Feb-2006 08:30 AM Page: 3433 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Fluvoxamine Maleate C Lansoprazole C Galantamine C Hydrobromide C Date:08/29/05ISR Number: 4755487-1Report Type:Expedited (15-DaCompany Report #2005S1006673 Age:71 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Living In Residential Health Clozapine Tablets Institution Professional (25 Mg) PS ORAL 12.5 MG; HS; Overdose Other PO Respiratory Arrest Botox (Allergan) SS Allergan INTRAMUSCULAR IM Fluoxetine C Hydrochloride C Levodopa/Carbidopa C Tramadol C Morphine C Pantoprazole C Estrogen Nos C Oxycodone C Terazosin C Celecoxib C Date:08/29/05ISR Number: 4755488-3Report Type:Expedited (15-DaCompany Report #2005S1007595 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Health Clozapine Tablets Professional (25 Mg) PS ORAL 25 MG; BID; Other PO Pantoprazole Sodium C Tolterodine L-Tartrate C Atorvastatin C Levodopa/Carbidopa C Date:08/30/05ISR Number: 4756625-7Report Type:Expedited (15-DaCompany Report #PHNR2005AU01303 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Exposure Clozaril PS Novartis Sector: Initial or Prolonged Circulatory Collapse Pharma UNK, Somnolence ONCE/SINGLE 1440 MIN Date:08/30/05ISR Number: 4756630-0Report Type:Expedited (15-DaCompany Report #PHNR2005AU01305 Age:66 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bronchiectasis Clozaril PS Novartis Sector: Initial or Prolonged Haemophilus Infection Pharma 0 - 150 Leukopenia mg/day Neutropenia Ostelin C Pyrexia Caltrate C Troponin Increased Lactulose C Aspirin C Thiamine C 22-Feb-2006 08:30 AM Page: 3434 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Omeprazole C Date:08/30/05ISR Number: 4756727-5Report Type:Expedited (15-DaCompany Report #FR-SANOFI-SYNTHELABO-A02200500844 Age:78 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Normochromic Normocytic Plavix PS ORAL Initial or Prolonged Anaemia Depakine SS ORAL Isoptine SS ORAL Ebixa SS ORAL 1 WK Clozapine SS ORAL 95 DAY Athymil SS ORAL 43 DAY Depakine SS INTRAVENOUS 5 DAY Augmentin C UNKNOWN UNK Date:08/30/05ISR Number: 4758520-6Report Type:Direct Company Report #CTU 257264 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Level Changed Clozaril 100 Mg -> Total 200 Mg Qd PS ORAL 2AM /5 PM TAKEN PO Date:08/31/05ISR Number: 4757102-XReport Type:Expedited (15-DaCompany Report #PHBS2005CH08243 Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Balance Disorder Leponex PS Novartis Sector: Initial or Prolonged Drug Interaction Pharma ORAL 600 mg/d Drug Level Increased Leponex SS Novartis Sector: Dystonia Pharma ORAL 500 mg/d Fatigue Leponex SS Novartis Sector: Hypertension Pharma ORAL 400 mg/d Muscular Weakness Leponex SS Novartis Sector: Pleurothotonus Pharma ORAL 900 mg/d Salivary Hypersecretion Floxyfral SS ORAL 50 mg/d Sinus Tachycardia Floxyfral SS ORAL 25 mg/d Solian C ORAL 200 mg, QID Date:08/31/05ISR Number: 4757107-9Report Type:Expedited (15-DaCompany Report #PHBS2005NO12483 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bladder Disorder Leponex PS Novartis Sector: Initial or Prolonged Blood Creatinine Pharma ORAL 500 mg/d Increased Leponex SS Novartis Sector: Blood Lactate Pharma ORAL Dehydrogenase Increased Alopam C ORAL 15 mg/d Blood Urea Increased Zeldox C ORAL 160 mg/d Haemolytic Anaemia Hydronephrosis Renal Failure Reticulocyte Count Increased Urinary Retention 22-Feb-2006 08:30 AM Page: 3435 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/31/05ISR Number: 4757433-3Report Type:Expedited (15-DaCompany Report #200517544GDDC Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyponatraemia Desmopressin PS Aventis Somnolence Pharmaceuticals Inc. Clozaril SS ORAL Date:08/31/05ISR Number: 4757771-4Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-13090014 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Aripiprazole PS Otsuka Abnormal Pharmaceutical Ventricular Company, Ltd. Pre-Excitation Clozaril SS ORAL 3 YR Wolff-Parkinson-White Haloperidol C UNKNOWN Syndrome Procyclidine C UNKNOWN Date:08/31/05ISR Number: 4758874-0Report Type:Expedited (15-DaCompany Report #2005S1006471 Age:66 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine Tablets Professional (100 Mg) PS ORAL 250 MG ; QD; Other PO Date:08/31/05ISR Number: 4758875-2Report Type:Expedited (15-DaCompany Report #05-08-1449 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Health Clozapine - Ivax Other Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 25-125MG QD ORAL Date:08/31/05ISR Number: 4758877-6Report Type:Expedited (15-DaCompany Report #05-08-1466 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Choking Health Clozapine - Ivax Hospitalization - Loss Of Consciousness Professional Pharmaceuticals, Initial or Prolonged Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 450MG QD ORAL Date:08/31/05ISR Number: 4758878-8Report Type:Expedited (15-DaCompany Report #05-08-1385 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anoxic Encephalopathy Health Clozapine - Ivax Aspiration Professional Pharmaceuticals, Other Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 600-700MG QD 22-Feb-2006 08:30 AM Page: 3436 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL Date:08/31/05ISR Number: 4758880-6Report Type:Expedited (15-DaCompany Report #2005S1007774 Age:81 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional (100 Mg) PS ORAL SEE IMAGE Other Date:08/31/05ISR Number: 4758900-9Report Type:Expedited (15-DaCompany Report #05-08-1455 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Clozapine - Ivax Initial or Prolonged Drug Abuser Professional Pharmaceuticals, Schizophrenia, Other Inc. Tablets PS Ivax Disorganised Type Pharmaceuticals, Treatment Noncompliance Inc. ORAL 100-200MG QD ORAL Date:08/31/05ISR Number: 4758901-0Report Type:Expedited (15-DaCompany Report #05-08-1415 Age:69 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Health Clozapine - Ivax Hospitalization - Pneumonia Aspiration Professional Pharmaceuticals, Initial or Prolonged Other Inc. Tablets PS Ivax Other Pharmaceuticals, Inc. ORAL 300MG QD ORAL Date:08/31/05ISR Number: 4759217-9Report Type:Expedited (15-DaCompany Report #DSA_26907_2005 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Foreign Temesta PS ORAL VAR Q DAY PO Initial or Prolonged Agitation Health Leponex "Novartis" SS Novartis ORAL 125 MG Q DAY Brain Damage Professional PO Cerebral Atrophy Other Leponex "Novartis" SS Novartis ORAL 75 MG Q DAY Confusional State PO Delusion Zoloft SS ORAL 50 MG Q DAY Depersonalisation PO Depression Zoloft SS ORAL 100 MG Q DAY Disorientation PO Fear Noroxin C Sleep Disorder Tranxilium C Somnolence Thinking Abnormal Date:09/01/05ISR Number: 4758814-4Report Type:Expedited (15-DaCompany Report #PHEH2005US09555 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Culture Positive Clozaril PS Novartis Sector: Initial or Prolonged Pneumonia Staphylococcal Pharma ORAL 375 mg, QD Clozapine SS 375 mg, QD 22-Feb-2006 08:30 AM Page: 3437 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/01/05ISR Number: 4758840-5Report Type:Expedited (15-DaCompany Report #PHFR2005GB02260 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Left Ventricular Clozaril PS Novartis Sector: Failure Pharma ORAL Myocardial Fibrosis Myocardial Infarction Pericarditis Pyrexia Date:09/01/05ISR Number: 4759045-4Report Type:Expedited (15-DaCompany Report #NLGE0000873-08/02/2005 Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutrophil Count Lithium Carbonate PS Glaxosmithkline ORAL 1G Per day Decreased Sertraline SS ORAL 75MG Per day Nortriptyline SS ORAL 200MG Per day Clozapine SS ORAL 175MG Per day Haloperidol C UNKNOWN 20MG Per day Zopiclone C UNKNOWN 15MG Per day Procyclidine C Glaxosmithkline UNKNOWN 15MG Per day Thyroxine C Glaxosmithkline UNKNOWN Date:09/01/05ISR Number: 4761124-2Report Type:Expedited (15-DaCompany Report #2005S1005758 Age:70 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Breast Cancer Health Clozapine Tablets Professional (100 Mg) PS ORAL SEE IMAGE Other Neostigmine Bromide C Fentanyl C Morphine Sulfate C Date:09/01/05ISR Number: 4761150-3Report Type:Expedited (15-DaCompany Report #2005S1004570 Age:67 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hypoglycaemia Health Clozapine Tablets Hospitalization - Sepsis Professional (25 Mg) PS ORAL 75 MG HS PO Initial or Prolonged Other Clozapine Tablets (100 Mg) SS ORAL 100 MG HS PO Ranitidine C Furosemide C Valproic Acid C Spironolactone C Acetylsalicylic Acid C Ferrous Sulfate C Ferrous Sulfate/Vitamins Nos C Potassium Chloride C Docusate Sodium C Insulin Human/Insulin Human Injection, Isophane C Pioglitazone Hydrochloride C Carvedilol C Insulin Glargine C 22-Feb-2006 08:30 AM Page: 3438 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Magnesium Hydroxide C Hydroxyzine Hydrochloride C Date:09/01/05ISR Number: 4761424-6Report Type:Direct Company Report #CTU 257484 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pyrexia Clozapine 25mg Ivax PS Ivax ORAL 12.5MG TWICE Initial or Prolonged Urinary Tract Disorder DAILY PO Clozapine C Litium C Levothyroxine C Propranolol C Haloperidol C Date:09/02/05ISR Number: 4760062-9Report Type:Expedited (15-DaCompany Report #PHRM2005FR02344 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Fatigue Leponex PS Novartis Sector: Fibroadenoma Of Breast Pharma ORAL Gamma-Glutamyltransferase Zoloft C ORAL 2 DF daily Increased Monocytosis Nausea Transaminases Increased Date:09/02/05ISR Number: 4760063-0Report Type:Expedited (15-DaCompany Report #PHBS2005CO11601 Age:27 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Clozapine PS Novartis Sector: Initial or Prolonged Hypotension Pharma ORAL 100 mg/d 15840MIN Leukopenia Rivotril C 2 mg, UNK Neutropenia Lexapro C Pain In Extremity Topamax C 2.5 mg, UNK Pyrexia Primidone C 1500 mg, UNK Tachycardia Date:09/06/05ISR Number: 4761643-9Report Type:Expedited (15-DaCompany Report #PHHO2005CA12813 Age:54 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Myocardial Clozaril PS Novartis Sector: Infarction Pharma ORAL 200 mg, BID 3026 DAY Atherosclerosis Novolin C Cardiac Death Avapro C Sudden Cardiac Death Metformin C Lipitor C Flovent C Novasen C Insulin C 22-Feb-2006 08:30 AM Page: 3439 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/06/05ISR Number: 4761648-8Report Type:Expedited (15-DaCompany Report #PHHO2005CA13514 Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Clonus Clozaril PS Novartis Sector: Pharma ORAL 12960MIN Date:09/06/05ISR Number: 4761662-2Report Type:Expedited (15-DaCompany Report #PHFR2005GB02886 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Lung Cancer Metastatic Clozapine PS Novartis Sector: Lymphadenopathy Pharma ORAL Date:09/06/05ISR Number: 4761675-0Report Type:Expedited (15-DaCompany Report #PHFR2005GB02906 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Clozaril PS Novartis Sector: Corrected Interval Pharma ORAL UNK, UNK Prolonged Date:09/06/05ISR Number: 4761686-5Report Type:Expedited (15-DaCompany Report #PHBS2005CH12455 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Agitation Leponex PS Novartis Sector: Aspiration Bronchial Pharma 300 mg/d Bronchopneumonia Depakine C UNKNOWN 2000 mg/d Cerebrovascular Accident Imovane C UNKNOWN 7.5 mg/d Dysphagia Gastrostomy Infection Lung Disorder Date:09/06/05ISR Number: 4761784-6Report Type:Expedited (15-DaCompany Report #GB-GLAXOSMITHKLINE-B0392162A Age:25 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypotension Paracetamol PS Glaxosmithkline UNKNOWN Initial or Prolonged Overdose Clozaril SS ORAL 8 DAY Valproate Sodium C UNKNOWN 500MG Twice per day Clonazepam C UNKNOWN .25MG per day Date:09/06/05ISR Number: 4762809-4Report Type:Expedited (15-DaCompany Report #05-07-1249 Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Malignant Melanoma Health Clozapine - Tablets Other Professional - Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 600-700MG QD ORAL 22-Feb-2006 08:30 AM Page: 3440 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/06/05ISR Number: 4762834-3Report Type:Expedited (15-DaCompany Report #05-08-1473 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cellulitis Health Clozapine Tablets - Initial or Prolonged Professional Ivax Other Pharmaceuticals, Inc. PS Ivax Pharmaceuticals, Inc. ORAL 275-400MG QD ORAL Date:09/06/05ISR Number: 4764463-4Report Type:Expedited (15-DaCompany Report #016 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Fazaclo Odt PS Alamo Professional Pharmaceuticals ORAL 450 MG PO Company DAILY Representative Date:09/06/05ISR Number: 4765542-8Report Type:Expedited (15-DaCompany Report #2005120145 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutrophil Count Foreign Sertraline Decreased Health (Sertraline) PS ORAL 75 MG (5 MG, White Blood Cell Count Professional 1 IN 1 D), Decreased ORAL Lithium (Lithium) SS ORAL 1 GRAM (1 GRAM, 1 IN 1 D), ORAL Zaponex (Clozapine) SS ORAL 175 MG (175 MG, 1 IN 1 D), ORAL Nortriptyline Hydrochloride (Nortriptyline Hydrochloride) C ORAL 200 MG (200 MG, 1 IN 1 D),ORAL Haloperidol (Haloperidol) C Zopiclone (Zopiclone) C Thyroxine (Levothyroxine) C Date:09/07/05ISR Number: 4762252-8Report Type:Expedited (15-DaCompany Report #PHBS2005CH11410 Age:17 YR Gender:Male I/FU:F Outcome PT Other Accommodation Disorder Constipation Drug Interaction Drug Level Increased Enuresis Fatigue Hyperventilation 22-Feb-2006 08:30 AM Page: 3441 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Somnolence Tachycardia Tremor Report Source Product Role Manufacturer Route Dose Duration Leponex PS Novartis Sector: Pharma ORAL 300 mg/d 67680MIN Leponex SS Novartis Sector: Pharma ORAL 50 mg/d Floxyfral SS ORAL 250 mg/d 100 DAY Floxyfral SS ORAL 150 mg/d Date:09/07/05ISR Number: 4762254-1Report Type:Expedited (15-DaCompany Report #PHFR2004GB03974 Age:53 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Full Blood Count Clozaril PS Novartis Sector: Initial or Prolonged Decreased Pharma ORAL 350 mg/day Other Haemoglobin Decreased Nausea Oesophageal Carcinoma Platelet Count Increased Regurgitation Of Food Throat Cancer Vomiting Date:09/07/05ISR Number: 4762255-3Report Type:Expedited (15-DaCompany Report #PHFR2005GB02704 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Clozaril PS Novartis Sector: Initial or Prolonged Diarrhoea Pharma ORAL 400mg/day Haemoglobin Decreased Clozaril SS Novartis Sector: Melaena Pharma Vomiting White Blood Cell Count Increased Date:09/07/05ISR Number: 4762256-5Report Type:Expedited (15-DaCompany Report #PHEH2005US09222 Age:18 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Upper Clozaril PS Novartis Sector: Dyspepsia Pharma ORAL 100mg BID, Gastric Ulcer 25mg BID Gastrointestinal Motility Disorder Impaired Gastric Emptying Date:09/08/05ISR Number: 4763449-3Report Type:Expedited (15-DaCompany Report #PHBS2005CA12871 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chest Discomfort Clozaril PS Novartis Sector: Ejection Fraction Pharma ORAL Decreased 22-Feb-2006 08:30 AM Page: 3442 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/08/05ISR Number: 4763518-8Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050900725 Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Amnesia Risperdal Consta PS INTRAMUSCULAR Hospitalization - Chills Risperdal Consta SS INTRAMUSCULAR Initial or Prolonged Drug Ineffective Clozapin SS UNKNOWN Fall General Physical Health Deterioration Incontinence Pneumonia Salivary Hypersecretion Speech Disorder Stupor Tachyarrhythmia Therapeutic Response Decreased Urinary Incontinence Waxy Flexibility Date:09/08/05ISR Number: 4765382-XReport Type:Direct Company Report #CTU 257873 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Grand Mal Convulsion Clozapine 100 Mg Loss Of Consciousness Mylan PS Mylan ORAL TWO PO BID Myocardial Infarction Venlafaxine Xr C Lisinopril C Date:09/09/05ISR Number: 4764726-2Report Type:Expedited (15-DaCompany Report #2005GB01523 Age:25 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neutrophil Count Quetiapine PS Zeneca Decreased Pharmaceutical ORAL Zaponex SS ORAL 100 AM AND 125 MG PM Diazepam C UNKNOWN 20 MG/DAY /PRN Ibuprofen C UNKNOWN Haloperidol C UNKNOWN Hyoscine C UNKNOWN Date:09/09/05ISR Number: 4766669-7Report Type:Expedited (15-DaCompany Report #05-08-1494 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Heat Exposure Injury Health Clozapine Professional (Clozapine) Other (Tablets) PS ORAL 200-500 MG QD, ORAL 22-Feb-2006 08:30 AM Page: 3443 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/09/05ISR Number: 4766684-3Report Type:Expedited (15-DaCompany Report #05-08-1385 Age:51 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anoxic Encephalopathy Health Clozapine Apallic Syndrome Professional (Clozapine) Aspiration Other (Tablets) PS ORAL 700MG QD, Brain Damage ORAL Risperdal (Risperidone0 C Zyprexa (Olanzapine0 C Prevacid (Lansoprazole) C Hyoscyamine (Hyoscyamine) C Clarinex C Micardis (Telmisartan) C Verelan (Verapamil Hydrochloride) C Lipitor (Atorvastatin) C Date:09/09/05ISR Number: 4766685-5Report Type:Expedited (15-DaCompany Report #05-08-1493 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Health Clozapine Initial or Prolonged Hip Fracture Professional (Clozapine) Tablets PS ORAL 12.5-375MG, Other QD, ORAL Date:09/09/05ISR Number: 4766687-9Report Type:Expedited (15-DaCompany Report #05-08-1487 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozapine Professional (Clozapine) Tablets PS ORAL 25-475MG QD, Other ORAL Chemotherapy (Methyldopa) SS Date:09/09/05ISR Number: 4766688-0Report Type:Expedited (15-DaCompany Report #05-09-1498 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Breast Cancer Female Health Clozapine Initial or Prolonged Professional (Clozapine) Tablets PS ORAL 150-800MG QD, Other Other ORAL Date:09/09/05ISR Number: 4766690-9Report Type:Expedited (15-DaCompany Report #05-08-1495 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Metastatic Neoplasm Health Clozapine Professional (Clozapine) Other (Tablets) PS ORAL 400MG QD, ORAL 22-Feb-2006 08:30 AM Page: 3444 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/09/05ISR Number: 4766692-2Report Type:Expedited (15-DaCompany Report #05-09-1499 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chronic Obstructive Health Clozapine Initial or Prolonged Pulmonary Disease Professional (Clozapine) Tablets PS ORAL 250-300MG QD, Other ORAL Date:09/09/05ISR Number: 4766903-3Report Type:Periodic Company Report #2004061397 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - White Blood Cell Count Health Lopid (Gemfibrozil) PS Initial or Prolonged Decreased Professional Clozapine (Clozapine) SS 150-200 MG (1 IN 1 D), Date:09/09/05ISR Number: 4767043-XReport Type:Periodic Company Report #010 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Sinus Tachycardia Health Fazaclo PS Alamo Initial or Prolonged Ventricular Extrasystoles Professional Pharmaceuticals 75MG HS Company Navane C Representative Cogentin C Relafen C Metformin C Glipizide Xl C Depakote C Lisinopril C Prevacid C Date:09/09/05ISR Number: 4767048-9Report Type:Periodic Company Report #011 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Convulsion Health Fazaclo Odt PS Alamo Required Professional Pharmaceuticals ORAL 225MG BID, Intervention to Company 400MG HS PO Prevent Permanent Representative Celexa C Impairment/Damage Inh C Cogentin C Colace C Fish Oil C Metamucil C Multivitamin C Vitamin C C Vitamin E C Date:09/09/05ISR Number: 4767051-9Report Type:Periodic Company Report #014 Age: Gender:Female I/FU:I Outcome Hospitalization - Initial or Prolonged Required Intervention to Prevent Permanent 22-Feb-2006 08:30 AM Page: 3445 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Idiopathic Health Fazaclo 25 Mg And Thrombocytopenic Purpura Professional 100 Mg Odt Alamo Company Pharmaceuticals PS Alamo Representative Pharmaceuticals ORAL 425 MG PO HS Haldol C Date:09/09/05ISR Number: 4767052-0Report Type:Periodic Company Report #015 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Granulocytopenia Health Fazaclo 100 Mg Odt Professional Alamo Company Pharmaceuticals PS Alamo Representative Pharmaceuticals 300 MG DAILY Date:09/09/05ISR Number: 4767136-7Report Type:Direct Company Report #CTU 257898 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pain Clozapine 100mg Initial or Prolonged Post Procedural Tablets PS ORAL 300MG Q HS PO 1 YR Required Complication Digoxin C Intervention to Priapism Colace C Prevent Permanent Cosopt C Impairment/Damage Metoprolol C Nifedipine C K-Dur C Zantac C Diovan C Pseudophedrine C Lactulose C Meperidine C Date:09/12/05ISR Number: 4765654-9Report Type:Expedited (15-DaCompany Report #PHNR2005AU00851 Age:60 YR Gender:Female I/FU:F Outcome PT Other Albumin Urine Present Alpha 1 Microglobulin Urine Increased Anaemia Antinuclear Antibody Positive Blood Bicarbonate Decreased Blood Calcium Increased Blood Chloride Decreased Blood Creatine Phosphokinase Increased Blood Creatinine Increased Blood Disorder Blood Osmolarity Increased Blood Potassium Increased 22-Feb-2006 08:30 AM Page: 3446 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Blood Sodium Decreased Blood Test Abnormal Blood Urea Increased Report Source Product Role Manufacturer Route Dose Duration Blood Uric Acid Increased Clozaril PS Novartis Sector: C-Reactive Protein Pharma 75-175 mg Increased daily 40320MIN Chest Pain Effexor C Complement Factor C3 Amisulpride C Increased Creatinine Urine Decreased Deep Vein Thrombosis Disorientation Dizziness Drug Level Below Therapeutic Electroencephalogram Abnormal Eosinophil Count Increased Globulins Decreased Haematocrit Decreased Haemoglobin Decreased Immunoglobulins Abnormal Lymphocyte Count Decreased Memory Impairment Mental Disorder Metamyelocyte Count Increased Monocyte Count Increased Musculoskeletal Stiffness Nausea Nephritis Interstitial Protein Total Decreased Pulmonary Embolism Pyrexia Red Blood Cell Count Decreased Red Blood Cell Sedimentation Rate Increased Renal Impairment Scan Myocardial Perfusion Abnormal Serotonin Syndrome Troponin I Increased Urine Albumin/Creatinine Ratio Increased Vasculitis Vomiting Date:09/12/05ISR Number: 4766334-6Report Type:Expedited (15-DaCompany Report #PHEH2005US09686 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Lung Disorder Clozaril PS Novartis Sector: White Blood Cell Count Pharma ORAL Increased 22-Feb-2006 08:30 AM Page: 3447 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/12/05ISR Number: 4766335-8Report Type:Expedited (15-DaCompany Report #PHEH2005US09703 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Upper Clozaril PS Novartis Sector: Alopecia Pharma Balance Disorder Serentil SS Benign Breast Neoplasm Maalox C Constipation Nitroglycerin C SUBLINGUAL Cough Diarrhoea Disturbance In Attention Dysphagia Electrocardiogram Abnormal Fall Gait Disturbance Haemoptysis Haemorrhage Head Injury Increased Upper Airway Secretion Insomnia Memory Impairment Muscle Spasms Oesophageal Spasm Psychomotor Hyperactivity Retching Rhinorrhoea Surgery Weight Decreased Date:09/12/05ISR Number: 4766336-XReport Type:Expedited (15-DaCompany Report #PHFR2005GB02930 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Clozaril PS Novartis Sector: Obsessive-Compulsive Pharma 125mg/day Disorder Clozaril SS Novartis Sector: Pharma 200mg/day Clozaril SS Novartis Sector: Pharma 300mg/day Seroxat C 60 mg/day Date:09/12/05ISR Number: 4766338-3Report Type:Expedited (15-DaCompany Report #PHNR2005AU00872 Age:25 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Acquired Cardiac Septal Clozaril PS Novartis Sector: Defect Pharma ORAL 550 mg daily Drug Toxicity Echocardiogram Abnormal Ejection Fraction Decreased Psychotic Disorder 22-Feb-2006 08:30 AM Page: 3448 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/12/05ISR Number: 4766358-9Report Type:Expedited (15-DaCompany Report #PHNR2005AU01305 Age:66 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bronchiectasis Clozaril PS Novartis Sector: Initial or Prolonged Haemophilus Infection Pharma 0 - 150 Other Leukopenia mg/day Myocarditis Ostelin C Neutropenia Caltrate C Pyrexia Lactulose C Troponin Increased Aspirin C Thiamine C Omeprazole C Date:09/12/05ISR Number: 4766362-0Report Type:Expedited (15-DaCompany Report #PHNU2005DE03034 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Exposure Leponex / Clozaril Initial or Prolonged Accidental Overdose (Clozapine) PS Novartis Sector: Tachycardia Pharma ORAL 200 mg, ONCE/SINGLE Seroquel SS ORAL 200 mg, ONCE/SINGLE Tavor SS ORAL 2 mg, ONCE/SINGLE Date:09/12/05ISR Number: 4766363-2Report Type:Expedited (15-DaCompany Report #PHNU2005DE02547 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other C-Reactive Protein Leponex / Clozaril Increased (Clozapine) PS Novartis Sector: Cholelithiasis Pharma ORAL 12.5 mg/day 78 DAY Leukocytosis Leponex / Clozaril Parotid Gland Enlargement (Clozapine) SS Novartis Sector: Parotitis Pharma ORAL uptitrated to 550 mg/day 24480MIN Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL 400 mg/day Pantozol C Gastrozepin C Solian C ORAL 50 mg/day 17280MIN Solian C ORAL uptitrated to 200mg, BID Date:09/12/05ISR Number: 4767435-9Report Type:Expedited (15-DaCompany Report #2005S1008261 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Heat Exhaustion Health Clozapine Tablets Professional (25 Mg) PS ORAL 50 MG; HS; PO Other Clozapine Tablets (100 Mg) SS ORAL 100 MG; HS; PO 22-Feb-2006 08:30 AM Page: 3449 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/12/05ISR Number: 4767436-0Report Type:Expedited (15-DaCompany Report #2005S1008344 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional (25 Mg) PS ORAL 50 MG; HS; PO Other Clozapine Tablets (100 Mg) SS ORAL 300 MG; HS; PO Benzatropine Mesilate C Alprazolam C Haloperidol C Ibuprofen C Docusate Sodium C Acetylsalicylic Acid C Morphine Sulfate C Date:09/12/05ISR Number: 4767467-0Report Type:Expedited (15-DaCompany Report #2005S1008256 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional (25 Mg) PS ORAL 25 MG; HS; PO Other Clozapine Tablets (100 Mg) SS ORAL 400 MG; HS; PO Date:09/12/05ISR Number: 4767468-2Report Type:Expedited (15-DaCompany Report #2005S1007448 Age:90 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional (25 Mg) PS ORAL 12.5 MG; QD; Other PO Glyceryl Trinitrate C Levofloxacin C Scopolamine C Hydrochloride Pethidine Hydrochloride C Atenolol C Escitalopram C Vitamins C Lovodopa/Carbidopa C Rivastigmine Tartrate C Pantoprazole Sodium C Date:09/12/05ISR Number: 4767469-4Report Type:Expedited (15-DaCompany Report #2005S1006655 Age:69 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Breast Cancer Health Clozapine Tablets Metastatic Neoplasm Professional (100 Mg) PS ORAL 200 MG; QAM; Other PO; 300 MG; HS; PO Olanzapine C Tolterodine 22-Feb-2006 08:30 AM Page: 3450 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report L-Tartrate C Ibuprofen C Magnesium Hydroxide C Docusate Sodium C Lithium Carbonate C Asantrozole C Acetylsalicylic Acid C Nitrofurantoin C Ergocalciferol/Ascor bic Acid/Folic Acid/Thiamiine Hydrochloride/Retino l/Riboflavin/Nicotin C Date:09/12/05ISR Number: 4767488-8Report Type:Expedited (15-DaCompany Report #2005S1005652 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional (100 Mg) PS ORAL SEE IMAGE Other Trihexyphenidyl Hydrochloride C Imipramine C Oxybutynin C Date:09/12/05ISR Number: 4767825-4Report Type:Expedited (15-DaCompany Report #2005122010 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Death Health Accupril (Quinapril Life-Threatening Convulsion Professional Hydrochloride) PS 20 MG (20 MG, Other Drug Interaction 1 IN 1 D) Drug Level Increased Hydrochlorothiazide Drug Toxicity (Hydrochlorothiazide ) SS 12.5 MG (25 MG, 1 IN 1 D) Clozapine (Clozapine) SS 400 MG (400 MG, 1 IN 1 D) Depakote (Valproate Semisodium) C Piroxicam (Piroxicam) C Oxybutynin (Oxybutynin) C Bisacodyl (Bisacodyl) C Baclofen (Baclofen) C Miralax (Macrogol) C Lactulose (Lactulose) C Date:09/13/05ISR Number: 4767165-3Report Type:Expedited (15-DaCompany Report #PHNR2005AU01348 Age:49 YR Gender:Female I/FU:I Outcome PT Hospitalization - Dysphagia Initial or Prolonged Dystonia Other Hypotension 22-Feb-2006 08:30 AM Page: 3451 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Joint Stiffness Sedation Report Source Product Role Manufacturer Route Dose Duration Clozaril PS Novartis Sector: Pharma 0 - 12.5 mg/day 5760 MIN Date:09/13/05ISR Number: 4767311-1Report Type:Expedited (15-DaCompany Report #NLGE000895 Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Paroxetine PS Glaxosmithkline ORAL 60MG Per day Clozapine SS Zaponex C ORAL 275MG Per day Date:09/13/05ISR Number: 4767819-9Report Type:Expedited (15-DaCompany Report #DSA_26922_2005 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Decreased Health Ativan PS 0.5 MG BID Initial or Prolonged Incorrect Dose Professional Clozapine SS ORAL 12.5 MG Q DAY Administered PO Sinus Bradycardia Trazodone SS ORAL 50 MG QHS PO 1 YR Somnolence White Blood Cell Count Decreased Date:09/13/05ISR Number: 4768213-7Report Type:Expedited (15-DaCompany Report #2005S1006312 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drowning Health Clozapine Tablets Professional (100 Mg) PS ORAL 350 MG; QD; Other PO Date:09/13/05ISR Number: 4768217-4Report Type:Expedited (15-DaCompany Report #2005S1008496 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sepsis Health Clozapine Tablets Professional (100 Mg) PS ORAL 150 MG; BID; Other PO Digoxin C Lansoprazole C Docusate Calcium C Lithium Carbonate C Ipratropium Bromide/Salbutamol Sulfate C Hyoscine Butylbromide/Metamiz ole Sodium Monohydrate C Venlafaxine Hydrochloride C Doxazosin Mesilate C 22-Feb-2006 08:30 AM Page: 3452 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/13/05ISR Number: 4768221-6Report Type:Expedited (15-DaCompany Report #2005S1008447 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional (100 Mg) PS ORAL 300 MG;QD; PO Other Date:09/13/05ISR Number: 4768222-8Report Type:Expedited (15-DaCompany Report #2005-US-00009 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eosinophilic Colitis Literature Clozapine Tablets, Health 12.5mg, 25mg, 50mg, Professional 100mg PS ORAL 200 MG, QD, ORAL Acetylsalicylic Acid C Metoprolol C Lorazepam C Date:09/13/05ISR Number: 4768225-3Report Type:Expedited (15-DaCompany Report #2005S1004366 Age:54 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Cancer Metastatic Other Clozapine Tablets (100mg) PS ORAL 200 MG;HS;PO Clozapine Tablets (25 Mg) SS ORAL SEE IMAGE Date:09/13/05ISR Number: 4770589-1Report Type:Direct Company Report #CTU 258050 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Level Changed Clozaril 100 Mg -> Therapeutic Response Total 200 Mg Qd PS ORAL 2 AM /5 PM Unexpected With Drug TAKEN PO Substitution Date:09/13/05ISR Number: 4771476-5Report Type:Direct Company Report #CTU 258051 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bone Marrow Depression Clozapine 25 Mg Pharmaceutical Product Mylan PS Mylan ORAL 25 AND 50 BID Complaint PO Date:09/14/05ISR Number: 4768132-6Report Type:Expedited (15-DaCompany Report #PHNU2005DE03058 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abortion Spontaneous Leponex / Clozaril Initial or Prolonged Drug Exposure During (Clozapine) PS Novartis Sector: Other Pregnancy Pharma ORAL Metrorrhagia Vaginal Haemorrhage 22-Feb-2006 08:30 AM Page: 3453 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/14/05ISR Number: 4768613-5Report Type:Expedited (15-DaCompany Report #PHFR2005GB02157 Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Back Pain Clozaril PS Novartis Sector: Influenza Like Illness Pharma ORAL 400mg/day 159 DAY Pericardial Effusion Clozaril SS Novartis Sector: Pyrexia Pharma ORAL 7200 MIN Tachycardia Atenolol C ORAL 50mg per day Viral Pericarditis Mirtazapine C ORAL 45mg per day White Blood Cell Count Diazepam C ORAL 5mg per day Increased Date:09/14/05ISR Number: 4768615-9Report Type:Expedited (15-DaCompany Report #PHEH2005US09533 Age:57 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Haematocrit Decreased Clozaril PS Novartis Sector: Haemoglobin Decreased Pharma ORAL 25 mg Qam, Hepatitis C 400mg Qpm Leukopenia Interferon SS UNK, UNK Neutropenia Platelet Count Decreased Red Blood Cell Count Decreased Date:09/14/05ISR Number: 4769046-8Report Type:Expedited (15-DaCompany Report #05-07-1319 Age:86 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Health Clozapine Tablets, Initial or Prolonged Professional 12.5mg, 25mg, 50 Mg, Other Other 100mg PS ORAL 62.5-100MG QD, ORAL Sinemet C Furosemide C Omeprazole C Risperidone C Donepezil Hydrochloride C Gabapentin C Nitrofurantoin C Folic Acid C Breva C Cefalexin C Clopidogrel Sulfate C Citalopram (Tablets) C Memantine Hydrochloride C Date:09/14/05ISR Number: 4769051-1Report Type:Expedited (15-DaCompany Report #2005-US-00014 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Appendicectomy Other Clozapine Tablets, Initial or Prolonged 12.5mg, 25mg, 50 Mg 100mg (Tablets) PS ORAL 400 MG QD, ORAL 22-Feb-2006 08:30 AM Page: 3454 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/14/05ISR Number: 4769052-3Report Type:Expedited (15-DaCompany Report #2005-US-00002 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neoplasm Malignant Health Clozapine Tablets, Professional 12.5mg, 25mg, 50 Mg Other 100mg (Tablets) PS ORAL 100 MG QD, ORAL Date:09/14/05ISR Number: 4769054-7Report Type:Expedited (15-DaCompany Report #2005-US-00012 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Osteomyelitis Health Clozapine Tablets, Initial or Prolonged Professional 12.5mg, 25mg, 50 Mg Other 100mg (Tablets) PS ORAL 850 MG QD, ORAL Date:09/14/05ISR Number: 4770875-5Report Type:Expedited (15-DaCompany Report #S05-FRA-01403-01 Age:78 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Iron Decreased Foreign Ebixa (Memantine) PS ORAL 20 MG QD PO Hospitalization - Inflammation Health Depakine (Valproate Initial or Prolonged Normochromic Normocytic Professional Sodium) SS Anaemia Other Depakine (Valproate Serum Ferritin Increased Sodium) SS ORAL 1 G QD PO Verapamil SS ORAL 240 MG QD PO Athymil (Mianserin Hydrochloride) SS ORAL 30 MG QD PO Plavix (Clopidogrel Sulfate) SS ORAL 1 QD PO Clozapine SS ORAL 50 MG QD PO Augmentin C Date:09/15/05ISR Number: 4769098-5Report Type:Expedited (15-DaCompany Report #PHFR2005GB02704 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Clozaril PS Novartis Sector: Initial or Prolonged Diarrhoea Pharma ORAL 400mg/day Haemoglobin Decreased Clozaril SS Novartis Sector: Melaena Pharma Vomiting White Blood Cell Count Increased Date:09/15/05ISR Number: 4770860-3Report Type:Expedited (15-DaCompany Report #PHFR2005GB02930 Age:20 YR Gender:Male I/FU:F Outcome PT Life-Threatening Compulsions Disability Condition Aggravated Intentional Self-Injury Obsessive Thoughts Obsessive-Compulsive Disorder 22-Feb-2006 08:30 AM Page: 3455 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Psychotic Disorder Social Avoidant Behaviour Stress Report Source Product Role Manufacturer Route Dose Duration Suicidal Ideation Clozaril PS Novartis Sector: Pharma ORAL 125mg/day Clozaril SS Novartis Sector: Pharma 200mg/day Clozaril SS Novartis Sector: Pharma 300mg/day Clozaril SS Novartis Sector: Pharma ORAL 225mg/day Seroxat C ORAL 60 mg/day Date:09/15/05ISR Number: 4770867-6Report Type:Expedited (15-DaCompany Report #PHFR2005IE02005 Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Clozaril PS Novartis Sector: Initial or Prolonged Fall Pharma ORAL 700mg per day Joint Dislocation Clozaril SS Novartis Sector: Syncope Pharma ORAL 1000mg/day Date:09/15/05ISR Number: 4771634-XReport Type:Expedited (15-DaCompany Report #2005S1006673 Age:71 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Health Clozapine Tablets Respiratory Failure Professional (25 Mg) PS ORAL 12.5 MG; HS; Other PO Botox (Allergan) SS INTRAMUSCULAR IM Fluoxetine Hydrochloride C Levodopa/Carbidopa C Tramadol C Morphine C Pantoprazole C Estrogen Nos C Oxycodone C Terazosin C Celecoxib C Date:09/15/05ISR Number: 4771636-3Report Type:Expedited (15-DaCompany Report #2005S1007774 Age:81 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Oesophageal Perforation Health Clozapine Tablets Professional (100 Mg) PS ORAL SEE IMAGE Other Date:09/15/05ISR Number: 4771642-9Report Type:Expedited (15-DaCompany Report #2005S1007086 Age:61 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Non-Small Cell Lung Health Clozapine Tablets Cancer Metastatic Professional (100 Mg) PS ORAL 200 MG; HS; Other PO Salbutamol C 22-Feb-2006 08:30 AM Page: 3456 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prednisone C Atenolol C Lorazepam C Quetiapine Fumarate C Nicotine C Venlafaxine Hydrochloride C Paracetamol/Hydrocod one Bitartrate C Ipratropium Bromide/Salbutamol Sulfate C Date:09/15/05ISR Number: 4771654-5Report Type:Expedited (15-DaCompany Report #2005S1008499 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Grand Mal Convulsion Health Clozapine Tablets Myocardial Infarction Professional (100 Mg) PS ORAL SEE IMAGE Other Venlafaxine C Hydrochloride C Date:09/16/05ISR Number: 4771630-2Report Type:Expedited (15-DaCompany Report #PHNR2005AU01303 Age:77 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Exposure Clozaril PS Novartis Sector: Initial or Prolonged Circulatory Collapse Pharma UNK, Incorrect Dose ONCE/SINGLE 1440 MIN Administered Haloperidol C Somnolence Temazepam C Ostelin C Caltrate C Date:09/16/05ISR Number: 4771631-4Report Type:Expedited (15-DaCompany Report #PHNU2005DE01344 Age:44 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Brief Psychotic Disorder, Leponex / Clozaril Initial or Prolonged With Postpartum Onset (Clozapine) PS Novartis Sector: Other Caesarean Section Pharma ORAL 400 mg/day Diabetes Mellitus Drug Exposure During Pregnancy Normal Newborn Date:09/16/05ISR Number: 4771632-6Report Type:Expedited (15-DaCompany Report #PHBS2005CA13468 Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cerebrovascular Accident Clozaril PS Novartis Sector: Hospitalization - Pharma ORAL 225 mg/d Initial or Prolonged 22-Feb-2006 08:30 AM Page: 3457 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/16/05ISR Number: 4771633-8Report Type:Expedited (15-DaCompany Report #PHNU2005DE03100 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Catatonia Leponex / Clozaril Drug Withdrawal Syndrome (Clozapine) PS Novartis Sector: Pharma ORAL Date:09/16/05ISR Number: 4771635-1Report Type:Expedited (15-DaCompany Report #2005S1007595 Age:75 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Health Clozapine Tablets Professional (25 Mg) PS ORAL 25 MG; QAM; Other PO Pantoprazole Sodium C Tolterodine L-Tartrate C Atorvastatin C Levodopa/Carbidopa C Rivastigmine Tartrate C Alprazolam C Pramipexole Dihydrochloride C Date:09/16/05ISR Number: 4771967-7Report Type:Expedited (15-DaCompany Report #PHNR2003AU01214 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Clozaril PS Novartis Sector: Initial or Prolonged Drug Level Increased Pharma ORAL 25 - 750 Pneumonia mg/day Pneumonia Pneumococcal Clozaril SS Novartis Sector: Renal Failure Pharma ORAL 400 - 600 mg/day Date:09/16/05ISR Number: 4771969-0Report Type:Expedited (15-DaCompany Report #PHEH2005US10137 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Penile Operation Clozaril PS Novartis Sector: Initial or Prolonged Penile Pain Pharma ORAL 300 mg, QD Other Priapism Date:09/16/05ISR Number: 4772043-XReport Type:Expedited (15-DaCompany Report #2005-US-00028 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Neoplasm Malignant Health Clozapine Tablets, Other Professional 12.5mg, 25mg, 50mg Other 100 Mg (Tablets) PS ORAL ORAL 22-Feb-2006 08:30 AM Page: 3458 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/16/05ISR Number: 4772328-7Report Type:Expedited (15-DaCompany Report #2005S1007575 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional (25 Mg) PS ORAL SEE IMAGE Other Clozapine Tablets (100 Mg) SS ORAL 100 MG, HS, PO Morphine C Paracetamol/Hydrocod one Bitartrate C Escitalopram C Lansoprazole C Paracetamol C Ipratropium Bromide/Salbutamol Sulfate C Vitamins C Date:09/16/05ISR Number: 4772344-5Report Type:Expedited (15-DaCompany Report #2005S1005331 Age:76 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional (100 Mg) PS ORAL SEE IMAGE Other Morphine C Potassiuim Chloride C Lamotrigine C Tolterodine C Omeprazole C Date:09/16/05ISR Number: 4772352-4Report Type:Expedited (15-DaCompany Report #2005S1004962 Age:79 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Pain Health Clozapine Tablets Professional (25 Mg) PS ORAL 75 MG; HS; PO Other Clozapine Tablets (100 Mg) SS ORAL 75 MG; HS; PO Clozapine Tablets (100 Mg) SS ORAL 100 MG; HS; PO Sertraline C Hydrochloride C Date:09/16/05ISR Number: 4772477-3Report Type:Direct Company Report #CTU 258370 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Priapism Clozaril PS 900 MG/DAY 11 YR Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage 22-Feb-2006 08:30 AM Page: 3459 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/16/05ISR Number: 4772585-7Report Type:Direct Company Report #CTU 258335 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neutrophil Count Clozapine 100 Mg Decreased Ivax PS Ivax ORAL SEE IMAGE 4 MON Fenofibrate C Ketoconazole Cream C Lactulose C Levothyroxine C Quetiapine C Omeprazole C Senna C Tretinoin-A C Date:09/19/05ISR Number: 4772435-9Report Type:Expedited (15-DaCompany Report #PHFR2005GB02757 Age:25 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Increased Clozaril PS Novartis Sector: Electrocardiogram Qt Pharma ORAL 300 mg/day Prolonged Clozaril SS Novartis Sector: Sinus Tachycardia Pharma ORAL 400 mg/day Haloperidol C ORAL 10 mg/day Procyclidine C ORAL 10 mg/day Lorazepam C ORAL 1-2 mg Max 4mg/24 hrs Lorazepam C INTRAMUSCULAR 1-2 mg Max 4mg/24 hrs Date:09/19/05ISR Number: 4772443-8Report Type:Expedited (15-DaCompany Report #PHNU2005DE03137 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other C-Reactive Protein Leponex / Clozaril Increased (Clozapine) PS Novartis Sector: Lymphopenia Pharma ORAL 100 mg/day Neutrophilia Upper Respiratory Tract Infection Date:09/19/05ISR Number: 4772447-5Report Type:Expedited (15-DaCompany Report #PHNU2005DE03144 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cough Leponex / Clozaril Respiratory Tract (Clozapine) PS Novartis Sector: Infection Pharma ORAL 300 mg/day Date:09/19/05ISR Number: 4772946-6Report Type:Expedited (15-DaCompany Report #PHBS2005CA13655 Age:33 YR Gender: I/FU:I Outcome PT Death Cardiac Valve Disease Other Death Ecchymosis Pyrexia White Blood Cell Count 22-Feb-2006 08:30 AM Page: 3460 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Decreased Report Source Product Role Manufacturer Route Dose Duration Clozaril PS Novartis Sector: Pharma ORAL Date:09/19/05ISR Number: 4772961-2Report Type:Expedited (15-DaCompany Report #PHEH2005US10283 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Clozaril PS Novartis Sector: Other Oedema Peripheral Pharma ORAL 12.5 mg, QD Surgery Baclofen C Haldol C Date:09/19/05ISR Number: 4773121-1Report Type:Expedited (15-DaCompany Report #2005-US-00036 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Autonomic Nervous System Health Clozapine Tablets, Initial or Prolonged Imbalance Professional 12.5mg, 25mg, 50 Mg Blood Pressure Other 100mg (Tablets) PS ORAL 25 MG QD, Orthostatic ORAL Dehydration Hypotension Date:09/19/05ISR Number: 4773124-7Report Type:Expedited (15-DaCompany Report #2005-US-00008 Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Health Clozapine Tablets, Other Professional 12.5mg, 25mg, 50mg Other 100mg (Tablets) PS ORAL 300 MG QHS, ORAL Date:09/19/05ISR Number: 4774538-1Report Type:Direct Company Report #CTU 258437 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neutrophil Count Clozapine 100 Mg Decreased Ivax PS Ivax ORAL SEE IMAGE 3 MON Benztropine C Filgrastim C Haloperidol C Lithium Carbonate C Loperimide C Lorazepam C Metoclopramide C Ribavirin C Zolpidem C 22-Feb-2006 08:30 AM Page: 3461 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/20/05ISR Number: 4773385-4Report Type:Expedited (15-DaCompany Report #PHFR2005GB02704 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Clozaril PS Novartis Sector: Initial or Prolonged Diarrhoea Pharma ORAL 400mg/day Haemoglobin Decreased Clozaril SS Novartis Sector: Melaena Pharma Vomiting White Blood Cell Count Increased Date:09/20/05ISR Number: 4773990-5Report Type:Expedited (15-DaCompany Report #2005PK01710 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Seroquel PS Zeneca Initial or Prolonged Pharmaceutical ORAL 56 DAY Leponex SS ORAL 39 DAY Date:09/20/05ISR Number: 4775667-9Report Type:Direct Company Report #CTU 258508 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pericardial Haemorrhage Clozapine 100mg PS ORAL 400MG Q AM, Initial or Prolonged 500MG Q PM BID PO 5 YR Ativan C .. C Depakote C Cogentin C Multivitamin C Clonidine C Lipitor C Atropine 1% Eyedrops C Wellbutrin C Haldol C Miralax C Senna C Zyprexa C Benadryl C Date:09/21/05ISR Number: 4774281-9Report Type:Expedited (15-DaCompany Report #PHEH2005US09555 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Culture Positive Clozaril PS Novartis Sector: Initial or Prolonged Pneumonia Staphylococcal Pharma ORAL 375 mg, QD Clozapine SS 375 mg, QD Date:09/21/05ISR Number: 4774597-6Report Type:Expedited (15-DaCompany Report #PHBS2005BR13463 Age:33 YR Gender:Male I/FU:I Outcome PT Other Asthenia Dizziness Headache Hypersomnia 22-Feb-2006 08:30 AM Page: 3462 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Monoplegia Movement Disorder Report Source Product Role Manufacturer Route Dose Duration Leponex PS Novartis Sector: Pharma ORAL 50 mg, TID 5760 MIN Leponex SS Novartis Sector: Pharma ORAL 50 mg, BID Carbolitium C ORAL 300 mg/d Chlorpromazine C ORAL 100 mg/d Lorax C ORAL 4 mg, QHS Haloperidol C ORAL 2.5 mg, QHS Diazepan C ORAL 5 mg, QD Date:09/21/05ISR Number: 4774606-4Report Type:Expedited (15-DaCompany Report #PHNU2005DE03234 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Leponex / Clozaril Other Drug Level Increased (Clozapine) PS Novartis Sector: Drug Toxicity Pharma ORAL Unknown Cipramil SS ORAL Unknown Date:09/21/05ISR Number: 4774610-6Report Type:Expedited (15-DaCompany Report #2005SE05242 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arteriosclerosis Seroquel PS Zeneca Cardiomyopathy Pharmaceutical ORAL Death Stesolid C Drug Interaction Imovane C Drug Toxicity Leponex I ORAL Intentional Misuse Muscle Spasms Muscle Twitching Overdose Petit Mal Epilepsy Date:09/21/05ISR Number: 4775430-9Report Type:Direct Company Report #CTU 258618 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Leukopenia Clozapine 100 Mg Hospitalization - Mylan PS Mylan ORAL 100 MG AT 1 Initial or Prolonged PM, 400 MG PO Quetiapine C Lorazepam C Demeclocyline C Date:09/21/05ISR Number: 4775431-0Report Type:Direct Company Report #CTU 258619 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Granulocyte Count Clozapine 100 Mg Hospitalization - Decreased Mylan PS Mylan ORAL 100 MGAM, 200 Initial or Prolonged White Blood Cell Count MG TID PO Decreased Clozapine 25 Mg Mylan SS Myaln ORAL 75 MG AM PO 22-Feb-2006 08:30 AM Page: 3463 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Aspirin C Diocusate C Gemfibrozil C Ibuprofen C Lactulose C Lorazepam C Metoprolol C Omeprazole C Risperidone C Vitamin B C Complex With Vit B12 C Date:09/21/05ISR Number: 4775693-XReport Type:Expedited (15-DaCompany Report #2005S1006690 Age:36 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Other Clozapine Tablets (100 Mg) PS ORAL 300 MG; HS; PO Date:09/21/05ISR Number: 4777498-2Report Type:Expedited (15-DaCompany Report #GBR-2005-0001879 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Heart Rate Increased Foreign Dihydrocodeine Initial or Prolonged Multiple Drug Overdose Health Bitartrate PS Sedation Professional Clozaril Other (Clozapine) SS ORAL ORAL Hyoscine (Hyoscine) C Topiramate (Topiramate) C Date:09/22/05ISR Number: 4775740-5Report Type:Expedited (15-DaCompany Report #PHFR2005GB03056 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Congenital Cystic Lung Clozaril (Clozapine) PS Novartis Sector: Drug Exposure During Pharma TRANSPLACENTAL Pregnancy Amisulpride C TRANSPLACENTAL Ventoline C TRANSPLACENTAL Seretide C TRANSPLACENTAL Date:09/22/05ISR Number: 4775743-0Report Type:Expedited (15-DaCompany Report #PHFR2004GB02769 Age:29 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Exposure During Clozaril PS Novartis Sector: Pregnancy Pharma ORAL 600 mg, QD Ultrasound Antenatal Amisulpride C ORAL 100 mg, QD Screen Abnormal Ventoline C Seretide C 22-Feb-2006 08:30 AM Page: 3464 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/22/05ISR Number: 4775749-1Report Type:Expedited (15-DaCompany Report #PHNU2005DE03058 Age:35 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abortion Missed Leponex / Clozaril Initial or Prolonged Abortion Spontaneous (Clozapine) PS Novartis Sector: Other Drug Exposure During Pharma ORAL 150 mg/day Pregnancy Metrorrhagia Vaginal Haemorrhage Date:09/22/05ISR Number: 4775750-8Report Type:Expedited (15-DaCompany Report #PHNU2005DE01790 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebral Artery Occlusion Leponex / Clozaril Initial or Prolonged Constipation (Clozapine) PS Novartis Sector: Disability Convulsion Pharma ORAL 25 mg/day Other Euthyrox C ORAL 100 A?g/d Date:09/23/05ISR Number: 4777213-2Report Type:Expedited (15-DaCompany Report #PHFR2005GB03010 Age:46 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Clozaril PS Novartis Sector: Anxiety Pharma ORAL 50 mg/day 8640 MIN Electrocardiogram Qt Corrected Interval Prolonged Malaise Tachycardia Date:09/23/05ISR Number: 4777243-0Report Type:Expedited (15-DaCompany Report #PHFR2005GB02659 Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Catecholamines Urine Clozaril PS Novartis Sector: Increased Pharma ORAL 300mg/day Hypertension Depakote C ORAL 1500mg/day Lipids Increased Citalopram C ORAL 20mg/day Malaise Amisulpride C ORAL 1200mg/day Pseudophaeochromocytoma Amisulpride C ORAL Weight Increased Hyoscine C ORAL 300ug/day Date:09/23/05ISR Number: 4777262-4Report Type:Expedited (15-DaCompany Report #PHEH2005US10491 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Clozaril PS Novartis Sector: Pharma Unk, Unk Date:09/26/05ISR Number: 4778329-7Report Type:Expedited (15-DaCompany Report #PHNR2005AU00872 Age:25 YR Gender:Male I/FU:F Outcome PT Other Acquired Cardiac Septal Defect 22-Feb-2006 08:30 AM Page: 3465 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Drug Toxicity Echocardiogram Abnormal Ejection Fraction Report Source Product Role Manufacturer Route Dose Duration Decreased Clozaril PS Novartis Sector: Psychotic Disorder Pharma ORAL 550 mg daily Date:09/26/05ISR Number: 4778433-3Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20050901536 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Risperdal PS ORAL 8 DAY Initial or Prolonged Risperdal SS ORAL 8 DAY Other Clozapine SS Date:09/26/05ISR Number: 4778866-5Report Type:Expedited (15-DaCompany Report #2005UW14172 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Seroquel PS Zeneca Asthenia Pharmaceutical ORAL Atherosclerosis Clozaril SS Cardiac Arrest Orap SS Hepatic Steatosis Carbamazepine C Myocardial Ischaemia Clonazepam C Obesity Flurazepam Pulmonary Congestion Hydrochloride C Pulmonary Oedema Gabapentin C Pulmonary Thrombosis Kemadrin C Respiratory Arrest Topamax C Somnolence Date:09/27/05ISR Number: 4779620-0Report Type:Expedited (15-DaCompany Report #2005UW14048 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Coma Seroquel PS Zeneca Suicide Attempt Pharmaceutical ORAL Citalopram SS ORAL Gabapentin SS ORAL Clozapine SS ORAL Date:09/27/05ISR Number: 4779829-6Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050900725 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Chills Risperdal Consta PS INTRAMUSCULAR Hospitalization - Drug Ineffective Risperdal Consta SS INTRAMUSCULAR Initial or Prolonged Fall Clozapin SS UNKNOWN General Physical Health Deterioration Pneumonia Salivary Hypersecretion Speech Disorder Tachyarrhythmia Urinary Incontinence Waxy Flexibility 22-Feb-2006 08:30 AM Page: 3466 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/27/05ISR Number: 4781587-6Report Type:Expedited (15-DaCompany Report #2005120145 Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutrophil Count Foreign Sertraline Decreased Health (Sertraline) PS ORAL 75 MG (75 MG, White Blood Cell Count Professional 1 IN 1 D), Decreased ORAL Lithium (Lithium) SS ORAL 1 GRAM (1 GRAM, 1 IN 1 D), ORAL Nortriptyline Hydrochloride (Nortriptyline Hydrochloride) SS ORAL 200 MG (200 MG, 1 IN 1 D), ORAL Zaponex (Clozapine) SS ORAL 175 MG (175 MG, 1 IN 1 D), ORAL Haloperidol (Haloperidol) C Zopiclone (Zopiclone) C Procyclidine (Procyclidine) C Thyroxine (Levothyroxine) C Date:09/28/05ISR Number: 4781026-5Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20050905553 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutrophil Count Risperdal PS ORAL Decreased Zaponex SS ORAL Date:09/28/05ISR Number: 4781383-XReport Type:Expedited (15-DaCompany Report #PHFR2004GB03974 Age:53 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Full Blood Count Clozaril PS Novartis Sector: Initial or Prolonged Decreased Pharma ORAL 350 mg/day Other Haemoglobin Decreased Nausea Oesophageal Carcinoma Platelet Count Increased Regurgitation Of Food Throat Cancer Vomiting Date:09/28/05ISR Number: 4781389-0Report Type:Expedited (15-DaCompany Report #PHFR2004GB00834 Age:41 YR Gender:Male I/FU:F Outcome PT Death Antipsychotic Drug Level Other Above Therapeutic Arrhythmia Arteritis Cardio-Respiratory Arrest 22-Feb-2006 08:30 AM Page: 3467 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Carditis Dehydration Diarrhoea Report Source Product Role Manufacturer Route Dose Duration Drug Interaction Clozaril PS Novartis Sector: Myocarditis Pharma ORAL 200mg/day Orthostatic Hypotension Chlorpromazine SS 300 mg, TID Renal Impairment Procyclidine SS 5 mg, QD Zopiclone SS 7.5mg at night Clonazepam SS .5 mg, BID Date:09/28/05ISR Number: 4781401-9Report Type:Expedited (15-DaCompany Report #PHFR2004GB03974 Age:53 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Full Blood Count Clozaril PS Novartis Sector: Initial or Prolonged Decreased Pharma ORAL 350 mg/day Other Haemoglobin Decreased Nausea Oesophageal Carcinoma Platelet Count Increased Regurgitation Of Food Throat Cancer Vomiting Date:09/28/05ISR Number: 4781405-6Report Type:Expedited (15-DaCompany Report #PHFR2005GB01741 Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Clozaril PS Novartis Sector: Initial or Prolonged Chest Discomfort Pharma ORAL 200mg/day 36000MIN Other Confusional State Clozaril SS Novartis Sector: Cyanosis Pharma ORAL 350mg/day Disturbance In Attention Dyspnoea Eosinophil Count Increased Gait Disturbance Headache Hyperhidrosis Hypertension Malaise Muscle Tightness Myocardial Infarction Pericardial Effusion Pericarditis Platelet Count Increased Psychomotor Hyperactivity Pulmonary Thrombosis Red Blood Cell Sedimentation Rate Increased Salivary Hypersecretion Somnolence Tremor 22-Feb-2006 08:30 AM Page: 3468 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/28/05ISR Number: 4784302-5Report Type:Expedited (15-DaCompany Report #2005-US-00090 Age:76 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cerebrovascular Accident Health Clozapine Tablets, Professional 12.5 Mg, 25mg, 50 Other Mg, 100 Mg (Clozapine) PS ORAL 325 MG, QD, ORAL Date:09/28/05ISR Number: 4784552-8Report Type:Expedited (15-DaCompany Report #2005S1005652 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Antipsychotic Drug Level Health Clozapine Tablets Increased Professional (100 Mg) PS ORAL 350 MG;HS;PO; Exposure To Extreme Other SEE IMAGE Temperature Trihexphenidyl C Hydrochloride C Imipramine C Oxybutynin C Date:09/29/05ISR Number: 4782810-4Report Type:Expedited (15-DaCompany Report #PHNR2005AU01434 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Endocarditis Clozaril PS Novartis Sector: Pharma 0 - 200 mg/day 33120MIN Date:09/29/05ISR Number: 4782826-8Report Type:Expedited (15-DaCompany Report #PHNU2005DE03034 Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Overdose Leponex / Clozaril Initial or Prolonged Dysarthria (Clozapine) PS Novartis Sector: Dyspnoea Pharma ORAL 300 mg, Hypotension ONCE/SINGLE Tachycardia Tavor SS ORAL 2 mg, ONCE/SINGLE Seroquel C ORAL 200 mg, ONCE/SINGLE Date:09/29/05ISR Number: 4783511-9Report Type:Expedited (15-DaCompany Report #PHHO2005CA14988 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Antinuclear Antibody Clozaril PS Novartis Sector: Positive Pharma Apathy Cardiomegaly Cardiomyopathy Communication Disorder Lupus-Like Syndrome Obsessive-Compulsive Disorder Social Avoidant Behaviour Tachycardia 22-Feb-2006 08:30 AM Page: 3469 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/29/05ISR Number: 4784787-4Report Type:Direct Company Report #CTU 259144 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Clozapine PS 200MG Q AM & Somnolence 250 MG HS Benztropine C Fluoxetine C Hctz C Levothyroxine C Date:09/29/05ISR Number: 4785326-4Report Type:Expedited (15-DaCompany Report #2005130569 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mood Swings Foreign Amlodipine Initial or Prolonged Neutrophil Count Health (Amlodipine) PS ORAL 5 MG (DAILY), Other Decreased Professional ORAL Zaponex (Clozapine) SS ORAL 375 MG (DAILY), ORAL Valproic Acid (Valproic Acid) SS ORAL 900 MG (DAILY), ORAL Amisulpride (Amisulpride) C Paracetamol (Paracetamol) C Codeine (Codeine) C Date:09/29/05ISR Number: 4785677-3Report Type:Expedited (15-DaCompany Report #05-08-1410 Age:43 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Health Clozapine Tablets, Initial or Prolonged Dehydration Professional 12.5 Mg, 25mg, 50 Mg Other Mental Status Changes 100mg (Clozapine) PS ORAL 50-225MG QD, Renal Failure Acute ORAL Rhabdomyolysis Date:09/29/05ISR Number: 4785679-7Report Type:Expedited (15-DaCompany Report #05-07-1318 Age:44 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asthma Health Clozapine Tablets, Respiratory Arrest Professional 12.5mg, 25mg, 50 Mg Other 100 Mg (Clozapine) PS ORAL 400-750MG QD, 600MG QD, ORAL Nicotinic Acid C Glibomet C Lansoprazole C Docusate Sodium C Plantago Ovata C Quetiapine C Quetiapine C Escitalopram Oxalate C 22-Feb-2006 08:30 AM Page: 3470 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/29/05ISR Number: 4785680-3Report Type:Expedited (15-DaCompany Report #05-08-1487 Age:43 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Clozapine Tablets, Professional 12.5mg, 25mg, 50mg Other 100mg (Clozapine) PS ORAL 25-475MG QD, ORAL Chemotherapy (Unknown) SS UNKNOWN UNKNOWN Date:09/29/05ISR Number: 4785681-5Report Type:Expedited (15-DaCompany Report #2005-US-00132 Age:82 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Health Clozapine Tablets, Professional 12.5mg, 25mg, 50 Mg Other 100mg (Clozapine) PS ORAL 100 MG, QD, ORAL Date:09/29/05ISR Number: 4785682-7Report Type:Expedited (15-DaCompany Report #2005-US-00069 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Abscess Health Clozapine Tablets, Procedural Complication Professional 12.5mg, 25mg, 50 Mg Other 100mg (Clozapine) PS ORAL 450 MG, QD, ORAL Date:09/29/05ISR Number: 4785818-8Report Type:Expedited (15-DaCompany Report #2005-US-00096 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebral Haemorrhage Health Clozapine Tablets, Professional 12.5mg, 25mg, 50mg Other 100mg (Clozapine) PS ORAL ORAL Date:09/29/05ISR Number: 4785824-3Report Type:Expedited (15-DaCompany Report #2005-US-00098 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Arrest Health Clozapine Tabelts, Initial or Prolonged Pneumonia Professional 12.5mg,25mg,50mg,100 Respiratory Arrest Other mg (Clozapine) PS ORAL 300 MG, QD, ORAL Date:09/29/05ISR Number: 4785828-0Report Type:Expedited (15-DaCompany Report #05-08-1448 Age:64 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dysphagia Health Clozapine Tablets, Hospitalization - Pneumonia Aspiration Professional 12.5mg,25mg,50mg, Initial or Prolonged Other 100 Mg (Clozapine) PS ORAL 400MG QD, ORAL Cogentin (Benzatropine Mesilate) C 22-Feb-2006 08:30 AM Page: 3471 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Xanax (Alprazolam) C Date:09/29/05ISR Number: 4785831-0Report Type:Expedited (15-DaCompany Report #05-08-1455 Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Clozapine Tablets, Initial or Prolonged Drug Abuser Professional 12.5mg,25mg,50mg,100 Schizophrenia Other mg (Clozapine) PS ORAL 100-500MG QD, Treatment Noncompliance Q HS, ORAL Amitriptyline Hydrochloride SS 150 MG, Q HS Date:09/29/05ISR Number: 4785833-4Report Type:Expedited (15-DaCompany Report #05-07-1324 Age:60 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Health Clozapine Tablets, Initial or Prolonged Mania Professional 12.5 Mg, 25mg, 50mg, Other 100mg (Clozapine) PS ORAL 150-275MG QD, ORAL Date:09/30/05ISR Number: 4784464-XReport Type:Expedited (15-DaCompany Report #2005GB01302 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperglycaemia Seroquel PS Zeneca Liver Function Test Pharmaceutical ORAL Abnormal Anafranil SS ORAL Microcytic Anaemia Normison SS 1 MON White Blood Cell Count Clozaril SS ORAL Decreased Date:09/30/05ISR Number: 4784973-3Report Type:Expedited (15-DaCompany Report #PHFR2005GB00851 Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Clozaril PS Novartis Sector: Body Temperature Pharma ORAL 400mg/day 36000MIN Increased Clozaril SS Novartis Sector: Cardiac Disorder Pharma ORAL 41760MIN Chest Pain Depakote C ORAL 1000mg/day 135 DAY Crepitations Acetylsalicylic Acid C ORAL 75mg/day Diarrhoea Clopidogrel C ORAL 25920MIN Electrocardiogram Abnormal Electrocardiogram St Segment Depression Infection Neutropenia Rash Red Blood Cell Count Decreased Wheezing 22-Feb-2006 08:30 AM Page: 3472 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/30/05ISR Number: 4784975-7Report Type:Expedited (15-DaCompany Report #PHBS2005DE14220 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Amnesia Clozapine PS Novartis Sector: Hospitalization - Bedridden Pharma UNKNOWN 50 mg/d Initial or Prolonged Chills Risperdal SS INTRAMUSCULAR 37.5 mg 1 in Fall 2 week 87840MIN General Physical Health Risperdal SS INTRAMUSCULAR 50 mg 1 in 2 Deterioration week 153 DAY Pneumonia Salivary Hypersecretion Speech Disorder Stupor Tachyarrhythmia Urinary Incontinence Waxy Flexibility Date:09/30/05ISR Number: 4786898-6Report Type:Expedited (15-DaCompany Report #2005S1008447 Age:78 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pancreatic Carcinoma Health Clozapine Tablets Professional (100 Mg) PS ORAL 300 MG;HS; PO Other Date:09/30/05ISR Number: 4786909-8Report Type:Expedited (15-DaCompany Report #2005S1009248 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional (100 Mg) PS ORAL SEE IMAGE Other Topiramate C Levofloxacin C Guaifenesin C Fluoxetine Hydrochloride C Benzatropine Mesilate C Haloperidol C Clonazepam C Date:09/30/05ISR Number: 4786912-8Report Type:Expedited (15-DaCompany Report #2005S1009328 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiomegaly Health Clozapine Tablets Professional (100 Mg) PS ORAL 300 MG; HS; Other PO Fosinopril C Venlafaxine C Hydrochloride C Rosiglitazone Maleate C 22-Feb-2006 08:30 AM Page: 3473 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/03/05ISR Number: 4785844-9Report Type:Expedited (15-DaCompany Report #PHEH2005US10522 Age:62 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Overdose Clozaril PS Novartis Sector: Other Arteriosclerosis Pharma Unk, Unk Atherosclerosis Cardiac Failure Congestive Cardiomegaly Circulatory Collapse Coronary Artery Atherosclerosis Emphysema Myocardial Fibrosis Myocardial Infarction Poisoning Pulmonary Oedema Splenomegaly Date:10/03/05ISR Number: 4787626-0Report Type:Expedited (15-DaCompany Report #2005131906 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutrophil Count Foreign Amlodipine Decreased Health (Amlodipine) PS ORAL 5 MG (5 MG, Professional DAILY INTERVAL: EVERY DAY), ORAL Clozapine (Clozapine) SS ORAL 100 TO 275 MG (DAILY INTERVAL: EVERY DAY), ORAL Valproic Acid (Valproic Acid) SS ORAL 900 MG (900 MG, DAILY INTERNAL: EVERY DAY), ORAL Amisulpride (Amisulpride) C Co-Codamol (Codeine Phosphate, Paracetamol) C Date:10/03/05ISR Number: 4788081-7Report Type:Expedited (15-DaCompany Report #2005131917 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Amlodipine Health (Amlodipine) PS ORAL 5 MG (5 MG, Professional DAILY INTERVAL: EVERY DAY), ORAL L Clozapine (Clozapine) SS ORAL 100MG PLUS 22-Feb-2006 08:30 AM Page: 3474 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report 275MG ONCE DAILY (DAILY INTERVAL: EVERY DAY), Valproic Acid (Valproic Acid) SS ORAL 900 MG (900 MG, DAILY INTERVAL: EVERY DAY), ORAL Amisulpride (Amisulpride) C Co-Codamol (Codeine Phosphate, Paracetamol) C Date:10/04/05ISR Number: 4787234-1Report Type:Expedited (15-DaCompany Report #PHFR2005GB03268 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cerebrovascular Accident Clozapine PS Novartis Sector: Pharma UNK, UNK 106 DAY Zaponex SS ORAL Date:10/04/05ISR Number: 4787250-XReport Type:Expedited (15-DaCompany Report #PHBS2005DK14276 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebral Venous Leponex PS Novartis Sector: Initial or Prolonged Thrombosis Pharma ORAL 550 mg/d 266 DAY Zyprexa C Nozinan C 271 DAY Disipal C Zolpidem C Neogynon C Movicol C 27360MIN Date:10/04/05ISR Number: 4789001-1Report Type:Expedited (15-DaCompany Report #2004025316 Age:41 YR Gender:Female I/FU:F Outcome PT Hospitalization - Acute Respiratory Failure Initial or Prolonged Agitation Other Anorexia Asthenia Blood Bicarbonate Increased Blood Bilirubin Increased Blood Calcium Decreased Blood Chloride Decreased Blood Creatine Phosphokinase Increased Blood Glucose Increased Blood Pressure Increased Bowel Sounds Abnormal Calcinosis Confusional State Crying Depression 22-Feb-2006 08:30 AM Page: 3475 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Disorientation Drug Screen Positive Electrocardiogram Qt Report Source Product Role Manufacturer Route Dose Duration Corrected Interval Consumer Neurontin Prolonged (Gabapentin) PS ORAL ORAL Fall Benzodiazepine Haematocrit Decreased Derivatives Hypokalaemia (Benzodiazepine Intentional Misuse Derivatives) SS Irritability All Other Loss Of Consciousness Therapeutic Products Lymphocyte Count (All Other Increased Therapeutic Mydriasis Products) SS Ovarian Enlargement Amitriptyline Overdose Hydrochloride Red Blood Cell Count (Amitriptyline Decreased Hydrochloride) C Respiratory Depression Carisoprodol Soft Tissue Disorder (Carisoprodol) C Stress Vicodin (Hydrocodone Suicidal Ideation Bitartrate, Suicide Attempt Paracetamol) C Tachycardia White Blood Cell Count Increased Date:10/05/05ISR Number: 4790529-9Report Type:Expedited (15-DaCompany Report #2005S1007448 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiovascular Disorder Health Clozapine Tablets Disease Progression Professional (25 Mg) PS ORAL 12.5 MG; QD; Other PO Glyceryl Trinitrate C Levofloxacin C Scopolamine C Hydrochloride C Pethidine Hydrochloride C Atenolol C Escitalopram C Vitamins C Levodopa/Carbidopa C Rivastigmine Tartrate C Pantoprazole Sodium C Date:10/05/05ISR Number: 4790531-7Report Type:Expedited (15-DaCompany Report #2005S1000985 Age:57 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Fall Health Clozapine Tablets Limb Injury Professional (100 Mg) PS ORAL SEE IMAGE Lung Injury Other Clopiramine SS ORAL 200 MG HS PO Overdose Olanzapine C Pneumonia Lorazepam C Rib Fracture Skeletal Injury 22-Feb-2006 08:30 AM Page: 3476 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/05/05ISR Number: 4791168-6Report Type:Expedited (15-DaCompany Report #2005-DE-03959GD Age:74 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Atrioventricular Block Foreign Lorazepam First Degree Literature (Lorazepam) PS 1 OR 2.5 MG Body Temperature (AS Increased NECESSARY) Coma Clozapine Drug Ineffective (Clozapine) SS 100 MG Incorrect Dose Temazepam Administered (Temazepam) SS 10 MG (AT Miosis NIGHT-TIME) Myocardial Infarction Pimozide (Pimozide) C Overdose Lithium Carbonate Red Blood Cell (Lithium Carbonate) Sedimentation Rate (Lithium Carbonate) C Increased Paracetamol Somnolence (Paracetamol) (Paracetamol) C Date:10/05/05ISR Number: 4791197-2Report Type:Expedited (15-DaCompany Report #2005-DE-03971GD Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Pressure Increased Foreign Oxazepam (Oxazepam) PS 75 MG (IN THE Cold Sweat Literature MORNING) Coma Diazepam (Diazepam) SS 6 MG (TID) Drug Level Decreased Clozapine Heart Rate Decreased (Clozapine) SS 175 MG Miosis Haloperidol Muscular Weakness (Haloperidol) C Pallor Ibuprofen Salivary Hypersecretion (Ibuprofen) (Ibuprofen) C Pantozol (Pantoprazole Sodium) C Date:10/06/05ISR Number: 4789548-8Report Type:Expedited (15-DaCompany Report #PHBS2005CA14309 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Balance Disorder Clozaril PS Novartis Sector: Bite Pharma ORAL UNK, UNK Blood Pressure Increased Clozaril SS Novartis Sector: Convulsion Pharma ORAL 600 mg/d Ecchymosis Clozaril SS Novartis Sector: Fall Pharma ORAL Swelling Face Epival C UNKNOWN Frisium C UNKNOWN 10 mg, QHS Dilantin C ORAL 1 DF, QID Valproic Acid C UNKNOWN 3500 mg/d Procyclidine C UNKNOWN 5 mg, BID 22-Feb-2006 08:30 AM Page: 3477 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/06/05ISR Number: 4789570-1Report Type:Expedited (15-DaCompany Report #PHNR2005AU01467 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - C-Reactive Protein Clozaril PS Novartis Sector: Initial or Prolonged Increased Pharma ORAL 12.5-350 mg 41760MIN Other Mental Disorder Risperidone C Palpitations Sinus Tachycardia Troponin I Increased Date:10/06/05ISR Number: 4789581-6Report Type:Expedited (15-DaCompany Report #PHNU2005DE03289 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Leponex / Clozaril Increased (Clozapine) PS Novartis Sector: Aspartate Pharma ORAL increasing Aminotransferase dosages Increased Leponex / Clozaril Bacteriuria (Clozapine) SS Novartis Sector: C-Reactive Protein Pharma ORAL 300 mg/day Increased Glianimon C Gamma-Glutamyltransferase Increased Hepatic Enzyme Abnormal Neutrophilia Pyrexia Date:10/06/05ISR Number: 4793537-7Report Type:Periodic Company Report #2005000293 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Health Doxorubicin Initial or Prolonged Anaemia Professional (Doxorubicin Other Thrombocytopenia Hydrochloride) PS Clozapine (Clozapine) SS ORAL 300 - 75 MILLIGRAM (QD), ORAL Vincristine (Vincristine) SS Cyclophosphamide (Cyclophosphamide) SS Etoposide (Etoposide) SS Cisplatin (Cisplatin) SS Ifosfamide (Ifosfamide) SS Date:10/06/05ISR Number: 4796725-9Report Type:Periodic Company Report #2005000293 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Health Doxorubicin Initial or Prolonged Anaemia Professional (Doxorubicin Other Thrombocytopenia Hydrochloride) PS Clozapine 22-Feb-2006 08:30 AM Page: 3478 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Clozapine) SS ORAL 300 - 75 MILLIGRAM (QD), ORAL Vincristine (Vincristine) SS Cyclophosphamide (Cyclophosphamide) SS Etoposide (Etoposide) SS Cisplatin (Cisplatin) SS Ifosfamide (Ifosfamide) SS Date:10/06/05ISR Number: 4796743-0Report Type:Periodic Company Report #2005000293 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Health Doxorubicin Initial or Prolonged Anaemia Professional (Doxorubicin Other Thrombocytopenia Hydrochloride) PS Clozapine (Clozapine) SS ORAL 300 - 75 MILLIGRAM (QD), ORAL Vincristine (Vincristine) SS Cyclophosphamide (Cyclophosphamide) SS Etoposide (Etoposide) SS Cisplatin (Cisplatin) SS Ifosfamide (Ifosfamide) SS Date:10/07/05ISR Number: 4791775-0Report Type:Expedited (15-DaCompany Report #PHBS2005CA14469 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Clozaril PS Novartis Sector: Initial or Prolonged Atrophy Pharma ORAL 225 mg/d Dizziness Infarction Ischaemic Stroke Somnolence Date:10/07/05ISR Number: 4791786-5Report Type:Expedited (15-DaCompany Report #PHEH2005US11047 Age:69 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Chronic Obstructive Clozaril PS Novartis Sector: Pulmonary Disease Pharma ORAL 100 mg, QD 22-Feb-2006 08:30 AM Page: 3479 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/07/05ISR Number: 4791787-7Report Type:Expedited (15-DaCompany Report #PHEH2005US10838 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Clozaril PS Novartis Sector: Initial or Prolonged Full Blood Count Abnormal Pharma ORAL 50 mg, QD Pericardial Effusion Depakote C Pyrexia Seroquel C Sinus Tachycardia Viral Infection Date:10/07/05ISR Number: 4791790-7Report Type:Expedited (15-DaCompany Report #PHEH2005US09222 Age:18 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Upper Clozaril PS Novartis Sector: Dyspepsia Pharma ORAL 100mg BID, Gastric Ulcer 25mg BID Gastrointestinal Motility Disorder Impaired Gastric Emptying Date:10/07/05ISR Number: 4791795-6Report Type:Expedited (15-DaCompany Report #PHNR2005AU01434 Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Clozaril PS Novartis Sector: Phosphokinase Increased Pharma 0 - 200 Myocarditis mg/day 33120MIN Valproate Sodium C Date:10/07/05ISR Number: 4791800-7Report Type:Expedited (15-DaCompany Report #PHNR2005AU01434 Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Clozaril PS Novartis Sector: Phosphokinase Increased Pharma 0 - 200 Myocarditis mg/day 33120MIN Valproate Sodium C Date:10/07/05ISR Number: 4791809-3Report Type:Expedited (15-DaCompany Report #PHNU2005DE03137 Age:69 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other C-Reactive Protein Leponex / Clozaril Increased (Clozapine) PS Novartis Sector: Leukocytosis Pharma ORAL 100 mg/day 23040MIN Lymphopenia Digitoxin C ORAL 0.07 mg/day Neutrophilia Bisohexal C ORAL 5 mg/day Pneumonia Aldactone C ORAL 50 mg/day Date:10/07/05ISR Number: 4791826-3Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20051000010 Age:71 YR Gender:Male I/FU:I Outcome PT Hospitalization - Blood Sodium Decreased Initial or Prolonged Confusional State 22-Feb-2006 08:30 AM Page: 3480 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Convulsion Full Blood Count Increased Report Source Product Role Manufacturer Route Dose Duration Glasgow Coma Scale Haloperidol PS ORAL Abnormal Clozaril SS ORAL Pneumonia Aspiration Vomiting Date:10/07/05ISR Number: 4796302-XReport Type:Expedited (15-DaCompany Report #2005S1009366 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Other Clozapine Tablets (100 Mg) PS ORAL 400 MG;HS;PO Propranolol C Date:10/07/05ISR Number: 4796312-2Report Type:Expedited (15-DaCompany Report #2005S1006673 Age:71 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Health Clozapine Tablets Respiratory Arrest Professional (25 Mg) PS ORAL 12.5 MG;HS;PO Respiratory Failure Other Botox (Allergan) SS INTRAMUSCULAR IM Fluoxetine C Hydrochloride C Levodopa/Carbidopa C Tramadol C Morphine C Pantoprazole C Estrogen Nos C Oxycodone C Terazosin C Celecoxib C Paracetamol C Date:10/07/05ISR Number: 4796716-8Report Type:Periodic Company Report #2005000293 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Health Doxorubicin Initial or Prolonged Anaemia Professional (Doxorubicin Other Thrombocytopenia Hydrochloride) PS Clozapine (Clozapine) SS ORAL 300 - 75 MILLIGRAM (QD), ORAL Vincristine (Vincristine) SS Cyclophosphamide (Cyclophosphamide) SS Etoposide (Etoposide) SS Cisplatin (Cisplatin) SS Ifosfamide (Ifosfamide) SS 22-Feb-2006 08:30 AM Page: 3481 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/10/05ISR Number: 4792512-6Report Type:Expedited (15-DaCompany Report #PHEH2005US10943 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Clozaril PS Novartis Sector: Initial or Prolonged Hypersomnia Pharma Unk, Unk Date:10/10/05ISR Number: 4792517-5Report Type:Expedited (15-DaCompany Report #PHEH2005US10942 Age:0 DY Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Caesarean Section Clozaril PS Novartis Sector: Initial or Prolonged Chorioamnionitis Pharma TRANSPLACENTAL Other Drug Exposure During Pregnancy Tachycardia Foetal Date:10/10/05ISR Number: 4792592-8Report Type:Expedited (15-DaCompany Report #PHEH2005US10886 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Caesarean Section Clozaril PS Novartis Sector: Chorioamnionitis Pharma ORAL Drug Exposure During Pregnancy White Blood Cell Count Increased Date:10/10/05ISR Number: 4792596-5Report Type:Expedited (15-DaCompany Report #PHNU2005DE03300 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Leponex / Clozaril Initial or Prolonged Drug Level Increased (Clozapine) PS Novartis Sector: Other Psychotic Disorder Pharma ORAL 400 mg/day Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL 300 mg/day Taxilan /Gfr/ SS Lyogen SS Gastrozepin C Dipiperon C Date:10/10/05ISR Number: 4792936-7Report Type:Expedited (15-DaCompany Report #PHNU2005DE03386 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Hepatic Failure Leponex / Clozaril Hospitalization - Renal Failure (Clozapine) PS Novartis Sector: Initial or Prolonged Pharma ORAL Date:10/10/05ISR Number: 4792938-0Report Type:Expedited (15-DaCompany Report #PHNR2005AU01305 Age:66 YR Gender:Male I/FU:F Outcome Hospitalization - Initial or Prolonged 22-Feb-2006 08:30 AM Page: 3482 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other PT Report Source Product Role Manufacturer Route Dose Duration Bronchiectasis Clozaril PS Novartis Sector: Haemophilus Infection Pharma 0 - 150 Leukopenia mg/day 30240MIN Myocarditis Ostelin C Neutropenia Caltrate C Pyrexia Lactulose C Troponin Increased Aspirin C Thiamine C Omeprazole C Date:10/11/05ISR Number: 4794398-2Report Type:Expedited (15-DaCompany Report #PHFR2005GB01592 Age:23 YR Gender:Male I/FU:F Outcome PT Death Anaemia Hospitalization - Blood Creatine Initial or Prolonged Phosphokinase Increased Other Blood Creatinine Increased Blood Electrolytes Abnormal Blood Urea Increased Bronchopneumonia C-Reactive Protein Increased Cardio-Respiratory Arrest Confusional State Contusion Dehydration Delirium Tremens Disorientation Dyspnoea Excoriation Face Injury Facial Bones Fracture Gait Disturbance Haemoglobin Decreased Hallucination Hepatic Congestion Hepatic Enzyme Abnormal Hepatic Necrosis Hepatorenal Failure Infection Injury Liver Disorder Lower Respiratory Tract Infection Lung Consolidation Mouth Injury Neutrophil Count Increased Oral Mucosal Disorder Periorbital Haematoma Psychotic Disorder Pulmonary Congestion Pulmonary Oedema Purulent Discharge 22-Feb-2006 08:30 AM Page: 3483 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Renal Function Test Abnormal Renal Impairment Report Source Product Role Manufacturer Route Dose Duration Schizophrenia Clozaril PS Novartis Sector: Sepsis Pharma ORAL 550mg/day White Blood Cell Count Haloperidol C UNK, PRN Increased Alcohol C Citalopram C Date:10/11/05ISR Number: 4797263-XReport Type:Direct Company Report #CTU 260176 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Rash Clozapine PS ORAL 400MG, Initial or Prolonged 50/50/30, ORAL Date:10/11/05ISR Number: 4797402-0Report Type:Direct Company Report #CTU 260197 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Clozaril PS ORAL 250MG,125MGBI D,ORAL Date:10/11/05ISR Number: 4799754-4Report Type:Direct Company Report #CTU 260411 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dysphagia Clozaril PS ORAL 375MG PO QD Initial or Prolonged Pneumonia Aspiration (THERAPY Rhabdomyolysis DATES: PRIOR TO ADMISSION) Colace C Klonopin C Depakote Er C Mvi C Lactulose C Claritin C Date:10/11/05ISR Number: 4799820-3Report Type:Direct Company Report #CTU 260388 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Level Changed Clozaril 100 Mg -> Total 700 Mg Qd PS ORAL 2 AM /5 PM TAKEN PO Date:10/12/05ISR Number: 4795387-4Report Type:Expedited (15-DaCompany Report #2005GB01302 Age:31 YR Gender:Female I/FU:I Outcome PT Other Hyperglycaemia Liver Function Test Abnormal Microcytic Anaemia White Blood Cell Count 22-Feb-2006 08:30 AM Page: 3484 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Decreased Report Source Product Role Manufacturer Route Dose Duration Seroquel PS Zeneca Pharmaceutical ORAL Seroquel SS Zeneca Pharmaceutical ORAL Anafranil SS ORAL Anafranil SS ORAL Normison SS 1 MON Clozaril SS ORAL Date:10/12/05ISR Number: 4795728-8Report Type:Expedited (15-DaCompany Report #PHEH2005US10970 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cast Application Clozapine PS Novartis Sector: Initial or Prolonged Fall Pharma ORAL Other Leukocytosis Clozapine SS Novartis Sector: Lower Limb Fracture Pharma ORAL 200mg Qam, Schizophrenia 350mg Qpm Date:10/12/05ISR Number: 4795739-2Report Type:Expedited (15-DaCompany Report #PHEH2005US11047 Age:69 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Chronic Obstructive Clozaril PS Novartis Sector: Pulmonary Disease Pharma ORAL 100 mg, QD Date:10/12/05ISR Number: 4799811-2Report Type:Expedited (15-DaCompany Report #HQWYE935010OCT05 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diarrhoea Health Efexor (Venlafaxine Initial or Prolonged Hepatic Enzyme Increased Professional Hydrochloride, Other Leukocytosis Other Tablet) PS ORAL 75MG , ORAL Neutrophilia Clozaril (Clozapine, Psychotic Disorder ) SS ORAL SEE IMAGE Tardive Dyskinesia Quetiapine Treatment Noncompliance (Quetiapine) SS ORAL 100 MG, ORAL Vomiting Valium (Diazepam, ) SS . C . C . C Date:10/12/05ISR Number: 4801174-0Report Type:Expedited (15-DaCompany Report #2005-UK-01981UK Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Muscle Spasms Foreign Morphine Initial or Prolonged Overdose Health (0015/0122/0208/0157 Pain In Extremity Professional ) (Morphine) PS Restless Legs Syndrome Clozaril (Clozapine) SS ORAL 800 MG, PO Self-Medication Omeprazole (Omeprazole) C 22-Feb-2006 08:30 AM Page: 3485 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/12/05ISR Number: 4801953-XReport Type:Expedited (15-DaCompany Report #2005-US-00262 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diet Refusal Health Clozapine Tablets, Initial or Prolonged Professional 12.5mg, 25mg, 50 Mg Other Other 100mg(Clozapine) PS ORAL ORAL Ferrous Sulfate C Fluphenazine Hydrochloride C Ranitidine C Benzatropine Mesilate C Lisinopril C Levothyroxine Sodium C Date:10/12/05ISR Number: 4801968-1Report Type:Expedited (15-DaCompany Report #2005-US-00374 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine Tablets, Professional 12.5 Mg, 25 Mg, 50 Other Mg 100mg (Clozapine) PS ORAL ORAL Date:10/12/05ISR Number: 4802082-1Report Type:Expedited (15-DaCompany Report #2005-US-00377 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Gastrointestinal Health Clozapine Tablets, Hospitalization - Haemorrhage Professional 12.5mg, 25mg, 50 Mg Initial or Prolonged Other 100mg (Clozapine) PS ORAL 600 MG, QD, ORAL Date:10/12/05ISR Number: 4802083-3Report Type:Expedited (15-DaCompany Report #2005-US-00421 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine Tablets, Professional 12.5mg, 25mg, 50 Mg Other 100mg PS ORAL 300 MG, QD, ORAL Date:10/12/05ISR Number: 4802172-3Report Type:Expedited (15-DaCompany Report #2005-US-00233 Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dehydration Health Clozapine Tablets, Initial or Prolonged Malaise Professional 12.5mg, 25mg, 50 Mg Other 100mg (Clozapine) PS ORAL 50 MG, QD, ORAL 22-Feb-2006 08:30 AM Page: 3486 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/12/05ISR Number: 4802174-7Report Type:Expedited (15-DaCompany Report #05-04-0611 Age:35 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiomegaly Consumer Clozapine Tablets, Initial or Prolonged Dehydration Health 12.5mg, 25mg, 50 Mg Other Delusion Professional 100mg (Clozapine) PS ORAL 300MG QD, Diarrhoea ORAL Ear Infection Zyprexa (Olanzapine) C Enterococcal Infection Zoloft (Sertraline Eosinophilia Hydrochloride) C Lung Disorder Depakote (Valproate Oral Intake Reduced Semisodium) C Pericardial Effusion Pulmonary Oedema Respiratory Rate Increased Scar Date:10/12/05ISR Number: 4802177-2Report Type:Expedited (15-DaCompany Report #2005-US-00376 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozapine Tablets, Diabetes Mellitus Professional 12.5mg, 25mg, 50 Mg Inadequate Control Other 100mg (Clozapine) PS ORAL 800 MG, QD, ORAL Date:10/12/05ISR Number: 4802180-2Report Type:Expedited (15-DaCompany Report #2005-US-00375 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypotension Health Clozapine Tablets, Initial or Prolonged Syncope Professional 12.5mg, 25mg, 50 Mg Urinary Tract Infection Other 100mg (Clozapine) PS 200 MG, QD Date:10/12/05ISR Number: 4802324-2Report Type:Expedited (15-DaCompany Report #001#1#2005-01657 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatic Steatosis Foreign Clozapin Hexal Transaminases Increased Health Professional (Clozapine) PS Other Date:10/12/05ISR Number: 4802330-8Report Type:Expedited (15-DaCompany Report #GBWYE032805OCT05 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Foreign Efexor Confusional State Health (Venlafaxine Disorientation Professional Hydrochloride) PS Drug Interaction Other Clozaril (Clozapine, Drug Level Increased , 0) SS ORAL ORAL Epilepsy Mirtazapine Fall (Mirtazapine) C Sleep Disorder 22-Feb-2006 08:30 AM Page: 3487 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/13/05ISR Number: 4799570-3Report Type:Expedited (15-DaCompany Report #2005130569 Age:57 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutropenia Foreign Amlodipine Initial or Prolonged Health (Amlodipine) PS ORAL 5 MG (DAILY), Other Professional ORAL Zaponex (Clozapine) SS ORAL 5 MG 9DAILY), ORAL Zaponex (Clozapine) SS ORAL 375 MG (DAILY), ORAL Valproic Acid (Valproic Acid) SS ORAL 900 MG (DAILY), ORAL Amisulpride (Amisulpride) C Paracetamol (Paracetamol) C Codeine (Codeine) C Date:10/13/05ISR Number: 4802539-3Report Type:Expedited (15-DaCompany Report #2005S1008344 Age:62 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neoplasm Malignant Health Clozapine Tablets Professional (25 Mg) PS ORAL 50 MG; HS; PO Other Clozapine Tablets (100 Mg) SS ORAL 300 MG; HS; PO Benzatropine Mesilate C Alprazolam C Haloperidol C Ibuprofen C Docusate Sodium C Acetylsalicylic Acid C Morphine Sulfate C Date:10/13/05ISR Number: 4803293-1Report Type:Expedited (15-DaCompany Report #2005-US-00378 Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Neoplasm Malignant Health Clozapine Tablets, Professional 12.5 Mg, 25mg, 50 Mg Other 100mg (Clozapine) PS ORAL QD, ORAL Date:10/14/05ISR Number: 4798196-5Report Type:Expedited (15-DaCompany Report #US-ABBOTT-05P-163-0312862-00 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Interaction Biaxin Xl 500mg PS Clozapine I 22-Feb-2006 08:30 AM Page: 3488 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/14/05ISR Number: 4798372-1Report Type:Expedited (15-DaCompany Report #PHBS2005NZ14690 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Motor Neurone Disease Clozaril PS Novartis Sector: Pharma ORAL Date:10/14/05ISR Number: 4798373-3Report Type:Expedited (15-DaCompany Report #PHFR2005GB03307 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diarrhoea Clozapine PS Novartis Sector: Photosensitivity Reaction Pharma ORAL 200mg/day 24480MIN Systemic Lupus Ciprofloxacin C ORAL 500mg/day Erythematosus Amoxicillin C ORAL 500mg/day Date:10/14/05ISR Number: 4798377-0Report Type:Expedited (15-DaCompany Report #PHBS2005FR14673 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Discomfort Clozapine PS Novartis Sector: Initial or Prolonged Abdominal Pain Pharma UNKNOWN UNK, UNK Blood Creatine Clozapine SS Novartis Sector: Phosphokinase Increased Pharma UNKNOWN 200 mg/d Blood Pressure Systolic Clozapine SS Novartis Sector: Decreased Pharma UNKNOWN 400 mg/d 87840MIN Body Temperature Amisulpride C UNKNOWN 1200 mg/d Increased Laudanum C UNKNOWN 21.42 mg, TID Colectomy Valpromide C UNKNOWN 300 mg/d Constipation Diarrhoea Faecal Disimpaction Faecaloma Ileectomy Laparotomy Large Intestinal Ulcer Large Intestinal Ulcer Haemorrhage Malaise Metabolic Acidosis Necrosis Necrotising Colitis Oedema Mucosal Renal Failure Sedation Shock Date:10/14/05ISR Number: 4798380-0Report Type:Expedited (15-DaCompany Report #PHEH2005US11125 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyspnoea Clozaril PS Novartis Sector: Initial or Prolonged Panic Attack Pharma ORAL 25 mg, QD Clozaril SS Novartis Sector: Pharma ORAL 50 mg Qam, 150mg Qpm Clozaril SS Novartis Sector: Pharma ORAL 25mg Qam, 100mg Qpm 22-Feb-2006 08:30 AM Page: 3489 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Depakote C Trazodone C Date:10/14/05ISR Number: 4798381-2Report Type:Expedited (15-DaCompany Report #PHEH2005US10886 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Caesarean Section Clozaril PS Novartis Sector: Chorioamnionitis Pharma ORAL 400 mg, QD Drug Exposure During Pregnancy White Blood Cell Count Increased Date:10/14/05ISR Number: 4798382-4Report Type:Expedited (15-DaCompany Report #PHNU2005DE03300 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Leponex / Clozaril Initial or Prolonged Dizziness (Clozapine) PS Novartis Sector: Other Drug Interaction Pharma ORAL up to 400 Drug Level Increased mg/day Fatigue Leponex / Clozaril Psychotic Disorder (Clozapine) SS Novartis Sector: Salivary Hypersecretion Pharma ORAL 300 mg/day Taxilan SS UNKNOWN Lyogen SS UNKNOWN Gastrozepin C UNKNOWN Dipiperon C ORAL Date:10/14/05ISR Number: 4798395-2Report Type:Expedited (15-DaCompany Report #PHNU2005DE03344 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anticholinergic Syndrome Leponex / Clozaril Bradyphrenia (Clozapine) PS Novartis Sector: Delusion Pharma ORAL dosage Disorientation increased Drug Interaction Leponex / Clozaril Restlessness (Clozapine) SS Novartis Sector: Pharma ORAL 75 mg/day 5760 MIN Trevilor SS 4320 MIN Date:10/14/05ISR Number: 4803393-6Report Type:Expedited (15-DaCompany Report #GBWYE032805OCT05 Age:39 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Foreign Efexor PS Confusional State Health Clozaril Disorientation Professional (Clozapine, Drug Interaction Other ) SS ORAL ORAL Drug Level Increased Mirtazapine Epilepsy Fall (Mirtazapine) C Sleep Disorder 22-Feb-2006 08:30 AM Page: 3490 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/17/05ISR Number: 4800404-9Report Type:Expedited (15-DaCompany Report #PHHO2005CA15774 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Body Temperature Clozaril (Clozapine) PS Novartis Sector: Increased Pharma 8640 MIN Flushing Malaise Tachycardia Date:10/17/05ISR Number: 4800405-0Report Type:Expedited (15-DaCompany Report #PHRM2005FR02657 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebellar Syndrome Leponex PS Novartis Sector: Initial or Prolonged Confusional State Pharma ORAL 750 mg daily Myoclonus Date:10/17/05ISR Number: 4800471-2Report Type:Expedited (15-DaCompany Report #PHEH2005US07603 Age:82 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Clozaril PS Novartis Sector: Pneumonia Pharma ORAL 75 mg, QD Allopurinol C Cleocin C Depakote C Miacalcin C Neurontin C Proventil C Rocephin C Date:10/17/05ISR Number: 4800474-8Report Type:Expedited (15-DaCompany Report #PHBS2005US14889 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diarrhoea Haemorrhagic Clozapine PS Novartis Sector: Eosinophilia Pharma UNKNOWN 200 mg/d Eosinophilic Colitis Lorazepam C UNKNOWN Pyrexia Aspirin C UNKNOWN Red Blood Cell Metoprolol C UNKNOWN Sedimentation Rate Increased White Blood Cell Count Increased Date:10/17/05ISR Number: 4800518-3Report Type:Expedited (15-DaCompany Report #PHEH2005US09960 Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Multiple Sclerosis Clozaril PS Novartis Sector: White Blood Cell Count Pharma ORAL 500 mg, QD Decreased Phenytoin C ORAL 100 mg, TID 22-Feb-2006 08:30 AM Page: 3491 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/17/05ISR Number: 4800521-3Report Type:Expedited (15-DaCompany Report #PHNR2005AU01348 Age:49 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dysphagia Clozaril PS Novartis Sector: Initial or Prolonged Dystonia Pharma 0 - 12.5 Other Hypotension mg/day 5760 MIN Joint Stiffness Sedation Date:10/17/05ISR Number: 4800564-XReport Type:Expedited (15-DaCompany Report #PHNR2005AU01467 Age:25 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - C-Reactive Protein Clozaril PS Novartis Sector: Initial or Prolonged Increased Pharma ORAL 12.5-350 mg 41760MIN Other Mental Disorder Risperidone C Mental Status Changes Palpitations Sinus Tachycardia Troponin I Increased Date:10/17/05ISR Number: 4801379-9Report Type:Expedited (15-DaCompany Report #AU-ABBOTT-05P-008-0313172-00 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatomegaly Epilim PS Platelet Count Decreased Clozapine SS White Blood Cell Count Abnormal Date:10/18/05ISR Number: 4805896-7Report Type:Expedited (15-DaCompany Report #2005-US-00487 Age:77 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine PS ORAL 300 MG, QD, Professional ORAL Other Date:10/18/05ISR Number: 4805900-6Report Type:Expedited (15-DaCompany Report #2005-US-00453 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Abuser Health Clozapine PS ORAL 250 MG, QD, Initial or Prolonged Professional ORAL Other Date:10/19/05ISR Number: 4802823-3Report Type:Expedited (15-DaCompany Report #PHEH2005US09960 Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Clozaril PS Novartis Sector: Multiple Sclerosis Pharma ORAL 500 mg, QD White Blood Cell Count Decreased 22-Feb-2006 08:30 AM Page: 3492 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/19/05ISR Number: 4803376-6Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20051001593 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Risperdal PS ORAL 173 DAY Initial or Prolonged Pyrexia Leponex SS ORAL Leponex SS ORAL Leponex SS ORAL Leponex SS ORAL Leponex SS ORAL Leponex SS ORAL Lepticur C Nozinan C Seresta C Date:10/19/05ISR Number: 4805973-0Report Type:Direct Company Report #CTU 260975 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dysphagia Clozapine 350 Mg Po Qhs PS ORAL 350 MG PO QHS Date:10/19/05ISR Number: 4806734-9Report Type:Expedited (15-DaCompany Report #FRWYE050212OCT05 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypotension Foreign Seresta Initial or Prolonged Health (Oxazepam, Tablet) PS ORAL 50 MG 1X PER Other Professional 1 DAY, ORAL Other Clozapine (Clozapine, 0) SS ORAL SEE IMAGE 55 DAY Depamide (Valpromide, 0) SS ORAL 600 MG 1X PER 1 DAY, ORAL Equanil (Meprobamate) SS ORAL ORAL Imovane (Zoplicone, 0) SS ORAL ORAL Sulfarlem (Anethole Trithione) SS ORAL 25 MG 1X PER 1 DAY, ORAL Date:10/19/05ISR Number: 4807754-0Report Type:Expedited (15-DaCompany Report #2005RR-00907 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutrophil Count Foreign Ibuprofen Tablets Bp Decreased Health 600mg(Ibuprofen) PS ORAL 1200 MG, QD, Professional ORAL Other Zaponex(Clozapine) SS ORAL ORAL Valproate Sodium(Valporic Acid) SS ORAL 500 MG, ORAL Procyclidine C Becotide C Hyoscine C 22-Feb-2006 08:30 AM Page: 3493 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/20/05ISR Number: 4804709-7Report Type:Expedited (15-DaCompany Report #GB/96/00037/LEX Age:23 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Clozaril PS ORAL 175 mg, UNK 280 DAY Hospitalization - Neutropenia Initial or Prolonged Respiratory Tract Infection Date:10/20/05ISR Number: 4804711-5Report Type:Expedited (15-DaCompany Report #PHNU2004DE03484 Age:41 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Caesarean Section Leponex / Clozaril Drug Exposure During (Clozapine) PS Novartis Sector: Pregnancy Pharma ORAL 300 mg/day Normal Newborn Pregnancy Date:10/20/05ISR Number: 4804720-6Report Type:Expedited (15-DaCompany Report #PHNU2004DE01799 Age:39 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Antepartum Haemorrhage Leponex / Clozaril Initial or Prolonged Caesarean Section (Clozapine) PS Novartis Sector: Other Drug Exposure During Pharma ORAL 25 mg/day Pregnancy Antibiotics C UNKNOWN 10080MIN Haematoma Magnesium C ORAL Unknown Haemorrhage Normal Newborn Pregnancy Retroplacental Haematoma Umbilical Cord Around Neck Date:10/20/05ISR Number: 4807446-8Report Type:Expedited (15-DaCompany Report #2005S1004570 Age:67 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Pain Health Clozapine Tablets Hospitalization - Aneurysm Professional (25 Mg) PS ORAL 75 MG;HS;PO Initial or Prolonged Asthenia Other Clozapine Tablets Dehydration (100 Mg) SS ORAL 100 MG;HS;PO Dysphagia Ranitidine C Hypoglycaemia Furosemide C Pneumonia Valproic Acid C Renal Failure Spironolactone C Sepsis Acetylsalicylic Acid C Ferrous Sulfate C Ferrus Sulfate/Vitamins Nos C Potassium Chloride C Docusate Sodium C Insulin Human/Insulin Human Injection, Isophane C Pioglitazone Hydrochloride C Carvedilol C 22-Feb-2006 08:30 AM Page: 3494 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Insulin Glargine C Magnesium Hydroxide C Hydroxyzine Hydrochloride C Date:10/20/05ISR Number: 4807456-0Report Type:Direct Company Report #CTU 261070 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Toxicity Clozaril (Clozapine ) PS Novartis Consumer Health Date:10/20/05ISR Number: 4807513-9Report Type:Expedited (15-DaCompany Report #2005-US-00112 Age:71 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiopulmonary Failure Health Clozapine Tablets, Hospitalization - Professional 12.5mg, 25mg, 50 Mg Initial or Prolonged Other 100mg(Clozapine) PS ORAL 300 MG, QD, ORAL Date:10/21/05ISR Number: 4805631-2Report Type:Expedited (15-DaCompany Report #2005UW14172 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Seroquel PS Zeneca Asthenia Pharmaceutical ORAL Atherosclerosis Clozaril SS Cardiac Arrest Orap SS Hepatic Steatosis Carbamazepine C Myocardial Ischaemia Clonazepam C Obesity Flurazepam Pulmonary Congestion Hydrochloride C Pulmonary Oedema Gabapentin C Pulmonary Thrombosis Kemadrin C Respiratory Arrest Topamax C Somnolence Date:10/21/05ISR Number: 4805649-XReport Type:Expedited (15-DaCompany Report #PHFR2005GB03379 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypersomnia Clozaril PS Novartis Sector: Overdose Pharma ORAL 450 mg/day Cipralex /Den/ SS Clozaril SS Novartis Sector: Pharma ORAL 1700 mg overdose 22-Feb-2006 08:30 AM Page: 3495 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/21/05ISR Number: 4805651-8Report Type:Expedited (15-DaCompany Report #PHNR2004AU00855 Age:56 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abdominal Sepsis Clozaril PS Novartis Sector: Hospitalization - Blood Albumin Decreased Pharma ORAL 12.5 - 525 Initial or Prolonged Blood Glucose Increased mg/day Other Colostomy Clozaril SS Novartis Sector: Deep Vein Thrombosis Pharma PARENTERAL 500 mg via Gastrointestinal Necrosis gastric tube Haemoglobin Decreased Neutrophil Count Increased Protein Total Decreased Pyrexia Subcutaneous Abscess White Blood Cell Count Increased Date:10/21/05ISR Number: 4805672-5Report Type:Expedited (15-DaCompany Report #PHBS2005AU15050 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Akathisia Clozapine PS Novartis Sector: Bradykinesia Pharma UNKNOWN Catatonia Disturbance In Attention Masked Facies Movement Disorder Muscle Rigidity Myoclonus Nerve Stimulation Test Abnormal Posture Abnormal Speech Disorder Unresponsive To Pain Stimuli Date:10/21/05ISR Number: 4805708-1Report Type:Expedited (15-DaCompany Report #PHBS2005GR15042 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Leponex PS Novartis Sector: Initial or Prolonged Pyrexia Pharma ORAL Respiratory Tract Haloperidol C UNKNOWN Infection Kineton C UNKNOWN Upper Respiratory Tract Infection White Blood Cell Count Decreased Date:10/21/05ISR Number: 4806133-XReport Type:Expedited (15-DaCompany Report #PHEH2005US09533 Age:57 YR Gender:Male I/FU:F Outcome PT Other Haematocrit Decreased Haemoglobin Decreased Hepatitis C Leukopenia 22-Feb-2006 08:30 AM Page: 3496 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Neutropenia Platelet Count Decreased Red Blood Cell Count Report Source Product Role Manufacturer Route Dose Duration Decreased Clozaril PS Novartis Sector: Pharma ORAL 425 mg, QHS 1332 DAY Interferon SS UNK, UNK Effexor-Xr C ORAL 75 mg, BID Date:10/21/05ISR Number: 4806145-6Report Type:Expedited (15-DaCompany Report #PHFR2005GB03288 Age:51 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Clozaril PS Novartis Sector: Drug Level Increased Pharma ORAL 250mg/day Fall Clozaril SS Novartis Sector: Transient Ischaemic Pharma 225mg/day Attack Atorvastatin C ORAL 20mg daily Hyoscine Hydrobromide C ORAL 600mg daily Propanolol C ORAL 60mg daily Aspirin C ORAL 75mg daily Date:10/21/05ISR Number: 4807833-8Report Type:Expedited (15-DaCompany Report #2005-US-00480 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anorexia Health Clozapine Tablets, Initial or Prolonged Leukaemia Professional 12.5mg, 25mg, 50mg. Weight Decreased Other 100mg (Clozapine) PS ORAL 625 MG QD, ORAL Date:10/21/05ISR Number: 4807834-XReport Type:Expedited (15-DaCompany Report #2005S1006690 Age:36 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Fall Health Clozapine Tablets Loss Of Consciousness Professional (100 Mg) PS ORAL 300 MG; HS; Pulmonary Embolism Other PO Aripiprazole C Date:10/21/05ISR Number: 4807839-9Report Type:Expedited (15-DaCompany Report #2005S1009967 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Other Clozapine Tablets (100 Mg) PS ORAL SEE IMAGE Albuterol C Warfarin Sodium C Spironolactone C Furosemide C Insulin C Potassium C Magnesium C Triamcinolone Actonide C Prednisone C Famotidine C 22-Feb-2006 08:30 AM Page: 3497 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/21/05ISR Number: 4807865-XReport Type:Expedited (15-DaCompany Report #2005-US-00482 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozapine Tablets, Professional 12.5mg, 25mg, 50 Mg Other 100mg (Clozapine) PS ORAL 800 MG QD, ORAL Date:10/21/05ISR Number: 4807869-7Report Type:Expedited (15-DaCompany Report #2005-US-00476 Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Clozapine Tablets, Other Congestive Professional 12.5mg, 25mg, 50 Mg Other 100mg (Clozapine) PS ORAL 100 MG, QD, ORAL Date:10/21/05ISR Number: 4807900-9Report Type:Expedited (15-DaCompany Report #2005S1009916 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aggression Health Clozapine Talbets Refusal Of Treatment By Professional (25 Mg) PS ORAL 50 Patient Other MG;BID;ORAL Olanzapine C Lorazepam C Valproate Semisodium C Clonazepam C Levofloxacin C Metformin Hydrochloride C Rosiglitazone Maleate C Simvastatin C Date:10/21/05ISR Number: 4807919-8Report Type:Expedited (15-DaCompany Report #2005S1009921 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pancreatic Carcinoma Health Clozapine Tablets Professional (100 Mg) PS ORAL 300 Other MG;BID;ORAL Insulin C Citalopram Hydrobromide C Date:10/21/05ISR Number: 4807929-0Report Type:Expedited (15-DaCompany Report #2005S1009252 Age:74 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Atrial Fibrillation Health Clozapine Tablets Granulocytopenia Professional (100 Mg) PS ORAL SEE IMAGE Hypotension Other Ferrous Sulfate C Loss Of Consciousness Acetylsalicylic Acid C Pulse Absent Valproate Semisodium C Sudden Cardiac Death Thiamine C Docusate Sodium C 22-Feb-2006 08:30 AM Page: 3498 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Azithromycin C Ceftriaxone Sodium C Date:10/24/05ISR Number: 4807573-5Report Type:Expedited (15-DaCompany Report #PHBS2005CA15097 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alcoholism Clozaril PS Novartis Sector: Drug Interaction Pharma ORAL 800 to 825 Drug Level Increased mg/d Laboratory Test Abnormal Zyprexa SS UNKNOWN 10 mg, QHS Rhinorrhoea Largactil SS UNKNOWN 150 mg, QHS Nozinan SS 25 mg, PRN Date:10/24/05ISR Number: 4807575-9Report Type:Expedited (15-DaCompany Report #PHBS2005CA13594 Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cerebral Haemorrhage Clozaril PS Novartis Sector: Drug Level Below Pharma ORAL 700 mg/day Therapeutic Clozaril SS Novartis Sector: Electroencephalogram Pharma ORAL 600 mg/day Abnormal Fall Status Epilepticus Date:10/24/05ISR Number: 4807592-9Report Type:Expedited (15-DaCompany Report #PHNR2005AU01299 Age:35 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other C-Reactive Protein Clozaril PS Novartis Sector: Increased Pharma 200 mg, QD 17280MIN Cough Lamotrigine C Lethargy Valproate Sodium C Lymphocyte Count Clonazepam C Decreased Olanzapine C Monocyte Count Decreased Pneumonitis Pulmonary Sepsis Pyrexia Sepsis Thrombocytopenia Viral Infection Date:10/25/05ISR Number: 4809338-7Report Type:Expedited (15-DaCompany Report #AU-ABBOTT-05P-008-0313172-00 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatic Function Abnormal Epilim PS ORAL 10 YR Hepatomegaly Clozapine SS Platelet Count Decreased White Blood Cell Count Abnormal 22-Feb-2006 08:30 AM Page: 3499 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/25/05ISR Number: 4810964-XReport Type:Expedited (15-DaCompany Report #2005-US-00059 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aortic Valve Replacement Health Clozapine Tablets, Other Fall Professional 12.5mg, 25mg, 50 Mg Incisional Drainage Other 100mg PS ORAL 400 MG, QD, Postoperative Wound ORAL Complication Date:10/25/05ISR Number: 4810965-1Report Type:Expedited (15-DaCompany Report #2005-US-00647 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Appendicitis Perforated Other Clozapine Tablets, 12.5mg, 25mg, 50mg 100mg (Clozapine) PS ORAL 375 MG, QD, ORAL Date:10/25/05ISR Number: 4810967-5Report Type:Expedited (15-DaCompany Report #2005-US-00262 Age:72 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dehydration Health Clozapine Tablets, Initial or Prolonged Oral Intake Reduced Professional 12.5mg, 25mg, 50 Mg Other Other 100mg (Clozapine) PS ORAL ORAL Ferrous Sulfate C Fluphenazine Hydrochloride C Ranitidine C Benzatropine Mesilate C Lisinopril C Levothyroxine Sodium C Os-Cal C Date:10/25/05ISR Number: 4810969-9Report Type:Expedited (15-DaCompany Report #2005-US-00645 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine Tablets, Other Professional 12.5 Mg, 25mg, 50 Mg Other 100 Mg (Clozapine) PS ORAL 300 MG, QD, ORAL Date:10/25/05ISR Number: 4811220-6Report Type:Expedited (15-DaCompany Report #GBR-2005-0001924 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Muscle Spasms Foreign Morphine Sulfate Initial or Prolonged Overdose Health (Morphine Sulfate) PS Other Pain In Extremity Professional Clorazil (Clozapine) SS ORAL 800 MG, Restless Legs Syndrome Other DAILY, ORAL Omeprazole (Omeprazole) C 22-Feb-2006 08:30 AM Page: 3500 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/25/05ISR Number: 4811587-9Report Type:Expedited (15-DaCompany Report #12569 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Muscle Spasms Foreign Morphine PS Initial or Prolonged Overdose Other Clozaril SS ORAL 800 MG DAILY Pain In Extremity PO Restless Legs Syndrome Omeprazole C Self-Medication Date:10/26/05ISR Number: 4810050-9Report Type:Expedited (15-DaCompany Report #PHEH2005US11508 Age:77 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Clozaril PS Novartis Sector: Choking Pharma UNK, UNK Pneumonia Aspiration Sudden Death Date:10/26/05ISR Number: 4811435-7Report Type:Direct Company Report #CTU 261477 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dysphagia Clozapine Ivax PS Ivax ORAL 400MG PO Q Initial or Prolonged DAY Other Hydrochlorothiazide C Protonix C Date:10/27/05ISR Number: 4810935-3Report Type:Expedited (15-DaCompany Report #2005UW15673 Age:17611 DYGender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Abuser Elavil PS Zeneca Initial or Prolonged Treatment Noncompliance Pharmaceutical ORAL Clozapine SS ORAL 100-500 MG Date:10/27/05ISR Number: 4815621-1Report Type:Expedited (15-DaCompany Report #2005131906 Age:57 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutropenia Foreign Amlodipine Initial or Prolonged Health (Amlodipine) PS ORAL 5 MG (5 MG, 1 Other Professional IN D), ORAL Clozapine (Clozapine) SS ORAL 100 MG PLUS 275 MG ( 1 IN 1 D), ORAL Valproic Acid (Valproic Acid) SS ORAL 900 MG (900 MG, 1 IN 1 D), ORAL Amisulpride (Amisulpride) C Co-Codamol (Codeine Phosphate, Paracetamol) C 22-Feb-2006 08:30 AM Page: 3501 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/27/05ISR Number: 4815652-1Report Type:Expedited (15-DaCompany Report #2005RR-00969 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Ibuprofen Tablets Bp Neutrophil Count Health 400mg (Ibuprofen) Decreased Professional Unknown PS ORAL 500 MG, QD, Other ORAL Zaponex (Clozapine) SS ORAL ORAL Valproate Sodium (Valporic Acid) SS ORAL 800 MG, QD, ORAL Mesalazine (Mesalazine) SS PARENTERAL PARENTERAL Hyoscine (Hyoscine) SS ORAL 600 UG, QD, ORAL Date:10/28/05ISR Number: 4814910-4Report Type:Expedited (15-DaCompany Report #PHEH2005US11712 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukocytosis Clozaril PS Novartis Sector: Non-Hodgkin'S Lymphoma Pharma ORAL Unk, Unk Date:10/28/05ISR Number: 4814912-8Report Type:Expedited (15-DaCompany Report #PHFR2005GB03183 Age:14 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Body Temperature Clozaril PS Novartis Sector: Increased Pharma ORAL 100mg/mane Drug Level Increased 150mg/nocte Electrocardiogram Qt Hyoscine C ORAL 300 mg, BID Prolonged Heart Rate Increased Somnolence Tachycardia Date:10/28/05ISR Number: 4814916-5Report Type:Expedited (15-DaCompany Report #PHFR2005IE03483 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Circulatory Collapse Clozaril PS Novartis Sector: Initial or Prolonged Diabetes Mellitus Pharma ORAL UNK, UNK Other Insulin-Dependent Overweight Thirst Date:10/28/05ISR Number: 4814924-4Report Type:Expedited (15-DaCompany Report #PHNU2005DE02376 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bundle Branch Block Left Leponex / Clozaril Initial or Prolonged Cardiac Disorder (Clozapine) PS Novartis Sector: Drug Interaction Pharma ORAL up to 500 mg, Drug Level QD Rhabdomyolysis Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL 625 mg, QD 22-Feb-2006 08:30 AM Page: 3502 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL 550 mg, QD 4320 MIN Risperdal SS ORAL 4 mg, QD Orfiril C ORAL 1500 mg, QD Resonium A C ORAL 45 g, QD Date:10/28/05ISR Number: 4816582-1Report Type:Expedited (15-DaCompany Report #2005S1008408 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Granulocytopenia Health Clozapine Tablets Initial or Prolonged Hypotension Professional (25 Mg) PS ORAL 25 MG; QAM; Required Neutropenia Other PO Intervention to Pyrexia Clozapine Tablets Prevent Permanent Weight Decreased (100 Mg) SS ORAL SEE IMAGE Impairment/Damage Strattera (Eli-Lilly) SS Eli-Lilly ORAL 25 MG; QD; PO Quetiapine Fumarate C Cymbalta C Nicotinic Acid C Lorazepam C Cetirizine C Hydrochloride C Valproate Semisodium C Acetylsalicylic Acid C Date:10/28/05ISR Number: 4816601-2Report Type:Expedited (15-DaCompany Report #2005S1010244 Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine Tablets Professional (100 Mg) PS ORAL 100 MG; QAM; Other ORAL; 200 MG; HS; ORAL Paroxetine Hydrochloride C Lorazepam C Glyceryl Trinitrate C Oxybutynin Hydrochloride C Sucralfate C Date:10/28/05ISR Number: 4816603-6Report Type:Expedited (15-DaCompany Report #2005S1010113 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional (100 Mg) PS ORAL 200 MG; HS; Other PO; 300 MG; HS; PO Morphine Sulfate C Valproate Semisodium C Benzatropine Mesilate C Paracetamol/Dextropr opoxyphene Napsilate C Cyclobenzaprine C 22-Feb-2006 08:30 AM Page: 3503 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Atenolol C Lorazepam C Date:10/28/05ISR Number: 4816605-XReport Type:Expedited (15-DaCompany Report #2005S1010085 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Other Clozapine Tablets (25 Mg) PS ORAL 50 MG; QD; ORAL Clozapine Tablets (100 Mg) SS ORAL 100 MG; BID; ORAL Budesonide C Vitamins Nos C Ferrous Gluconate C Date:10/28/05ISR Number: 4816607-3Report Type:Expedited (15-DaCompany Report #2005S1010112 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dementia Alzheimer'S Type Health Clozapine Tablets Professional (25 Mg) PS ORAL 50 MG; BID; Other ORAL Lithium C Morphine C Galantamine C Mirtazapine C Venlafaxine Hydrochloride C Date:10/28/05ISR Number: 4816608-5Report Type:Expedited (15-DaCompany Report #2005S1010179 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional (100 Mg) PS ORAL 300 MG; HS; Other ORAL Date:10/28/05ISR Number: 4816610-3Report Type:Expedited (15-DaCompany Report #2005S1010024 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional (25 Mg) PS ORAL 50 MG; QAM; Other ORAL Clozapine Tablets (100 Mg) SS ORAL 700 MG; QD; ORAL ... SS 22-Feb-2006 08:30 AM Page: 3504 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/28/05ISR Number: 4816614-0Report Type:Expedited (15-DaCompany Report #2005S1009328 Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiomegaly Health Clozapine Tablets Obesity Professional (100 Mg) PS ORAL 300 MG; HS; Other PO Fosinopril C Venlafaxine Hydrochloride C Rosiglitazone Maleate C Date:10/28/05ISR Number: 4816712-1Report Type:Expedited (15-DaCompany Report #2005S1008646 Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bedridden Health Clozapine Tablets Required Dyskinesia Professional (25 Mg) PS ORAL 50 MG; BID; Intervention to Granulocytopenia Other PO Prevent Permanent Oral Intake Reduced Lithium SS ORAL 300 MG, Impairment/Damage BID;PO Glucosamine Hydrochloride/Chondr oitin Sulfate C Furosemide C Enalapril C Docusate Sodium/Senna C Celecoxib C Polycarbophil Calcium C Colecalciferol/Calci um C Tramadol C Paracetamol C Potassium Chloride C Lansoprazole C Morphine Sulfate C Lithium C Ergocalciferol/Calci um C Date:10/31/05ISR Number: 4815797-6Report Type:Expedited (15-DaCompany Report #D-05-028 Age:29 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Amnesia Seroxat PS Glaxosmithkline ORAL 10MG Per day 21 DAY Initial or Prolonged Cyanosis Atosil SS Glaxosmithkline ORAL 125MG per day 144 DAY Grand Mal Convulsion Leponex SS ORAL 300MG per day Head Discomfort Sodium Valproate C ORAL 750MG per day Muscle Twitching Ximovan C ORAL 3.75TAB per Postictal State day Somnolence Tavor C ORAL 3MG per day 91 DAY Tongue Biting 22-Feb-2006 08:30 AM Page: 3505 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/31/05ISR Number: 4816730-3Report Type:Direct Company Report #CTU 261795 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Back Pain Clozapine 100mg PS ORAL 400MG BID PO 6 MON Hospitalization - Dyspnoea Initial or Prolonged Escherichia Bacteraemia Malaise Neutropenia Neutropenic Sepsis Date:10/31/05ISR Number: 4818889-0Report Type:Expedited (15-DaCompany Report #GBWYE091726OCT05 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Health Efexor (Venlafaxine Anxiety Professional Hydrochloride, Cardiac Arrest Other Tablet) PS ORAL Depressed Level Of Clozaril (Clozapine) SS ORAL 725 MG 1X PER Consciousness 1 DAY Pallor Valproate (Valproate Sodium) C Lamotrigine (Lamotrigine) C Pirenzepine (Pirenzepine) C Senna (Senna) C Ranitidine (Ranitidine) C Date:11/01/05ISR Number: 4816684-XReport Type:Expedited (15-DaCompany Report #PHFR2005GB00851 Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Clozaril PS Novartis Sector: Body Temperature Pharma ORAL 400mg/day 36000MIN Increased Clozaril SS Novartis Sector: Cardiac Disorder Pharma ORAL 75mg mane & Chest Pain 62.5mg nocte 41760MIN Crepitations Depakote C ORAL 1000mg/day 135 DAY Diarrhoea Acetylsalicylic Acid C ORAL 75mg/day Electrocardiogram Clopidogrel C ORAL 25920MIN Abnormal Risperidone C UNKNOWN UNK, UNK Electrocardiogram St Regurin C UNKNOWN 20 mg, BID Segment Depression Lamotrigine C UNKNOWN 200 mg, BID Infection Neutropenia Platelet Count Increased Rash Red Blood Cell Count Decreased Wheezing White Blood Cell Count Decreased 22-Feb-2006 08:30 AM Page: 3506 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/01/05ISR Number: 4816687-5Report Type:Expedited (15-DaCompany Report #PHBS2005FI15788 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bulimia Nervosa Leponex PS Novartis Sector: Weight Increased Pharma ORAL 125 mg/d Efexor - Slow Release C UNKNOWN 75 mg/d Date:11/01/05ISR Number: 4818192-9Report Type:Direct Company Report #CTU 261955 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Lobar Pneumonia Clozapine 100 Mg Initial or Prolonged Pulmonary Embolism Ivax PS Ivax ORAL 300 MG DAILY PO Apap C Amox/Clav C Divalproex Acid C Docustae C Doxycycline C Ibuprofen C Isoniazid C Maalox Plus C Milk Of Magnesium C Pyridoxine C Date:11/01/05ISR Number: 4819144-5Report Type:Expedited (15-DaCompany Report #2005RR-00991 Age:35 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutrophil Count Foreign Fluoxetine Capsules Decreased Health 20mg (Fluoxetine) PS ORAL 60 MG, QD, Professional ORAL Other Zaponex (Clonapine) SS ORAL 150 MG, BID, ORAL Haloperidol (Haloperidol) SS ORAL 15 MG, BID, ORAL Omeprazole C Date:11/01/05ISR Number: 4819154-8Report Type:Expedited (15-DaCompany Report #2005RR-00990 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Ibuprofen Tablets Bp Neutrophil Count Health 400mg (Ibuprofen) PS ORAL 500 MG, PRN, Decreased Professional ORAL Other Aponex (Clozapine) SS ORAL ORAL Valproate Sodium (Valporic Acid) SS ORAL 800 MG, PRN, ORAL Mesalazine (Mesalazine) SS PARENTERAL PARENTERAL Hyoscine (Hyoscine) SS ORAL 600 UG, PRN, ORAL Becotide C Procyclidine C 22-Feb-2006 08:30 AM Page: 3507 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/01/05ISR Number: 4849939-3Report Type:Periodic Company Report #2005S1003086 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozapine Tablets Required Professional (100 Mg) PS ORAL PO Intervention to Other Prevent Permanent Impairment/Damage Date:11/01/05ISR Number: 4849940-XReport Type:Periodic Company Report #2005S1002038 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intestinal Obstruction Health Clozapine Tablets Initial or Prolonged Professional (100 Mg) PS ORAL 600 MG;HS;PO Other Valproate Semisodium C Date:11/01/05ISR Number: 4849941-1Report Type:Periodic Company Report #2005S1000902 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Overdose Other Clozapine Tablets Initial or Prolonged Syncope (100 Mg) PS ORAL 100 MG;QAM;PO ; 200 MG;HS;PO Date:11/01/05ISR Number: 4849942-3Report Type:Periodic Company Report #2005S1000220 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Health Clozapine Tablets Initial or Prolonged Professional (25 Mg) PS ORAL 25 MG;BID;PO Other Clozapine Tablets (100 Mg) SS ORAL 300 MG;HS;PO Lorazepam C Levothyroxine Sodium C Oxybutynin C Albuterol C Phenazopyridine C Date:11/01/05ISR Number: 4849943-5Report Type:Periodic Company Report #2004S1003343 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozapine Tablets 25 Leukopenia Professional Mg Mylan PS Mylan OPHTHALMIC 50MG QD, ORAL Neutropenia Other Clozapine Tablets Salivary Hypersecretion 100mg Mylan SS Mylan ORAL 300MG QD, Tachycardia ORAL Risperidone C 22-Feb-2006 08:30 AM Page: 3508 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/01/05ISR Number: 4849944-7Report Type:Periodic Company Report #2004S1001190 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Foreign Clozapine Tablets PS Initial or Prolonged Neutropenia Health Professional Other Date:11/02/05ISR Number: 4817832-8Report Type:Expedited (15-DaCompany Report #PHNR2005AU00665 Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Cholesterol Clozaril PS Novartis Sector: Increased Pharma ORAL 700 mg, QD Blood Triglycerides Increased Hypercholesterolaemia Date:11/02/05ISR Number: 4818936-6Report Type:Direct Company Report #CTU 262029 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Myocarditis Clozapine PS Hospitalization - Pyrexia Clozapine (Generic) C Initial or Prolonged Divalproex C Multivitamin/ Minerals C Olanzapine C Omeprazole C Simvastatin C Date:11/02/05ISR Number: 4819585-6Report Type:Expedited (15-DaCompany Report #2005S1008496 Age:65 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Colitis Ischaemic Health Clozapine Tablets Sepsis Professional (100 Mg) PS ORAL 150 & 200 Other MG/QAM & QD & PO Digoxin C Lansoprazole C Docusate Calcium C Lithium Carbonate C Ipratorpium Bromode/Salbutamol Sulfate Monohydrate C Venlafaxine Hydrochloride C Doxazosin Mesilate C Date:11/02/05ISR Number: 4819589-3Report Type:Expedited (15-DaCompany Report #2005S1009248 Age:44 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional (100 Mg) PS ORAL 100 & 400 Other MG;QAM/HS; PO 22-Feb-2006 08:30 AM Page: 3509 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Topiramate C Levofloxacin C Fuaifenesin C Fluoxetine C Hydrochloride Benzatropien Mesilate C Haloperidol C Clonazepam C Date:11/03/05ISR Number: 4819423-1Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050606946 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aspartate Risperdal PS ORAL Initial or Prolonged Aminotransferase Leponex SS ORAL Other Increased Orfiril C ORAL Bundle Branch Block Left Resonium C ORAL Drug Interaction Leponex I ORAL Rhabdomyolysis Leponex I ORAL Date:11/03/05ISR Number: 4821760-1Report Type:Expedited (15-DaCompany Report #2005S1010531 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death No Adverse Drug Effect Health Clozapine Tablets Professional (100 Mg) PS ORAL SEE IMAGE Other Sertraline Hydrochloride C Zonisamide C Alprazolam C Lisinopril C Levothyroxine C Desmopressin C Atorvastatin C Date:11/03/05ISR Number: 4821761-3Report Type:Expedited (15-DaCompany Report #2005S1010423 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Clozapine Tablets Congestive Professional (100 Mg) PS ORAL 400 MG ;QD; Other ORAL Date:11/03/05ISR Number: 4821762-5Report Type:Expedited (15-DaCompany Report #2005S1010341 Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional (100 Mg) PS ORAL SEE IMAGE Other Sertralide Hydrochloride C Lorazepam C Clonazepam C Risperidone C Mirtazapine C 22-Feb-2006 08:30 AM Page: 3510 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/04/05ISR Number: 4820522-9Report Type:Expedited (15-DaCompany Report #GB-GLAXOSMITHKLINE-B0399084A Age:55 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bundle Branch Block Left Nytol PS Glaxosmithkline ORAL Initial or Prolonged Electrocardiogram Clozaril SS ORAL 400MG per day Abnormal Electrocardiogram T Wave Inversion Overdose Somnolence Suicide Attempt Date:11/04/05ISR Number: 4822862-6Report Type:Expedited (15-DaCompany Report #2005-US-00813 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Health Clozapine Tablets, Papilloedema Professional 12.5mg, 25mg, 50 Mg Other 100mg (Clozapine) PS ORAL 275 MG, QD, ORAL Date:11/04/05ISR Number: 4823211-XReport Type:Expedited (15-DaCompany Report #2005-126683-NL Age:31 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Mirtazapine PS DF Feeling Abnormal Health Clozapine SS ORAL DF ORAL Loss Of Consciousness Professional Alcohol SS DF Multiple Drug Overdose Other Intentional Pulmonary Oedema Suicidal Ideation Date:11/07/05ISR Number: 4821236-1Report Type:Expedited (15-DaCompany Report #PHBS2005IN16050 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypothyroidism Clozapine PS Novartis Sector: Lethargy Pharma 100 mg/d Weight Increased Date:11/07/05ISR Number: 4821249-XReport Type:Expedited (15-DaCompany Report #PHFR2005GB03606 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Hyperthermia Clozapine PS Novartis Sector: Other Meningitis Pharma ORAL 100mg om, Muscle Rigidity 200mg nocte Neuroleptic Malignant Pabrinex C INTRAVENOUS UNK, UNK 5760 MIN Syndrome 22-Feb-2006 08:30 AM Page: 3511 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/07/05ISR Number: 4821250-6Report Type:Expedited (15-DaCompany Report #PHEH2005US11968 Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Clozaril PS Novartis Sector: Initial or Prolonged Subdural Haematoma Pharma ORAL 100 mg, BID Subdural Haematoma Evacuation Date:11/07/05ISR Number: 4821251-8Report Type:Expedited (15-DaCompany Report #PHFR2004GB00467 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asthenia Clozaril PS Novartis Sector: Hospitalization - Hepatic Encephalopathy Pharma ORAL 1579 DAY Initial or Prolonged Hepatitis Clozaril SS Novartis Sector: Other Liver Function Test Pharma ORAL 350mg/day Abnormal Lower Respiratory Tract Infection Pneumonia White Blood Cell Count Increased Date:11/07/05ISR Number: 4821252-XReport Type:Expedited (15-DaCompany Report #PHEH2005US11956 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Back Pain Clozaril PS Novartis Sector: Initial or Prolonged Bone Infection Pharma ORAL 600 mg, QD Lexapro C Klonopin C Aricept C Actigall C Vitamin E C Asacol C Rowasa C Ditropan Xl C Miralax C Metamucil C Peri-Colace C Ferrous Sulfate C Mvi C Date:11/07/05ISR Number: 4821258-0Report Type:Expedited (15-DaCompany Report #PHFR2004GB03974 Age:53 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Full Blood Count Clozaril PS Novartis Sector: Initial or Prolonged Decreased Pharma ORAL 350 mg/day Other Haemoglobin Decreased Nausea Oesophageal Carcinoma Platelet Count Increased Regurgitation Of Food Throat Cancer Vomiting 22-Feb-2006 08:30 AM Page: 3512 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/07/05ISR Number: 4821259-2Report Type:Expedited (15-DaCompany Report #PHFR2005GB00623 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Pain Clozaril PS Novartis Sector: Other Arrhythmia Pharma ORAL UNK, UNK Balance Disorder Clozaril SS Novartis Sector: Circulatory Collapse Pharma ORAL 200 mg OM, Constipation 300 mg ON Cyanosis Clozaril SS Novartis Sector: Depressed Level Of Pharma ORAL 550 mg/day Consciousness Clozaril SS Novartis Sector: Heart Rate Decreased Pharma ORAL 525 mg/day Hyperhidrosis Atorvastatin C ORAL 10 mg, QD Hypotension Acetylsalicylic Acid C ORAL 75 mg/day Inflammation Pirenzepine C ORAL 75mg/day Large Intestinal Metoclopramide Obstruction Hydrochloride C ORAL 30mg/day Myoclonus Omeprazole C ORAL 20mg/day Pallor Vomiting Date:11/07/05ISR Number: 4821266-XReport Type:Expedited (15-DaCompany Report #PHHO2005NZ16786 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Level Increased Clozaril (Clozapine) PS Novartis Sector: Initial or Prolonged Megacolon Pharma 375mg daily 112 DAY Lithium C 1 g, BID Paroxetine C 20 mg, QD Omeprazole C 20 mg, QD Zopiclone C Date:11/07/05ISR Number: 4821267-1Report Type:Expedited (15-DaCompany Report #PHFR2000GB02159 Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Glucose Increased Clozaril (Clozapine) PS Novartis Sector: Hospitalization - Diabetes Mellitus Pharma ORAL 400 mg/day Initial or Prolonged Insulin-Dependent Benztropeine C ORAL 1 mg/day Other Diabetic Ketoacidosis Intestinal Obstruction Thirst Date:11/07/05ISR Number: 4821269-5Report Type:Expedited (15-DaCompany Report #PHFR2005GB00851 Age:48 YR Gender:Female I/FU:F Outcome PT Other Agranulocytosis Body Temperature Increased Cardiac Disorder Chest Pain Crepitations Diarrhoea Electrocardiogram Abnormal Electrocardiogram St Segment Depression 22-Feb-2006 08:30 AM Page: 3513 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Infection Neutropenia Platelet Count Increased Report Source Product Role Manufacturer Route Dose Duration Rash Clozaril PS Novartis Sector: Red Blood Cell Count Pharma ORAL 400mg/day 36000MIN Decreased Clozaril SS Novartis Sector: Wheezing Pharma ORAL 75mg mane & White Blood Cell Count 62.5mg nocte 41760MIN Decreased Depakote C ORAL 1000mg/day 135 DAY Acetylsalicylic Acid C ORAL 75mg/day Clopidogrel C ORAL 25920MIN Risperidone C UNKNOWN UNK, UNK Regurin C UNKNOWN 20 mg, BID Lamotrigine C UNKNOWN 200 mg, BID Date:11/07/05ISR Number: 4821275-0Report Type:Expedited (15-DaCompany Report #PHRM2005FR02837 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypogammaglobulinaemia Leponex PS Novartis Sector: Initial or Prolonged Lung Disorder Pharma ORAL 400mg, daily Nasopharyngitis Solian C Date:11/07/05ISR Number: 4821753-4Report Type:Expedited (15-DaCompany Report #PHFR2005GB03605 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Congestive Cardiomyopathy Clozapine PS Novartis Sector: Ventricular Failure Pharma ORAL 100mg/125mg Gliclazide C ORAL 160 mg, BID Date:11/07/05ISR Number: 4821757-1Report Type:Expedited (15-DaCompany Report #PHFR2005GB03292 Age:44 YR Gender:Female I/FU:F Outcome PT Life-Threatening Alanine Aminotransferase Other Increased Aspartate Aminotransferase Increased Blood Albumin Decreased Blood Alkaline Phosphatase Increased Blood Bilirubin Increased Blood Glucose Increased Blood Lactate Dehydrogenase Increased Blood Potassium Decreased Blood Sodium Decreased Blood Urea Decreased C-Reactive Protein Increased Carbon Dioxide Increased Constipation Gamma-Glutamyltransferase Increased Globulins Decreased Haematocrit Decreased 22-Feb-2006 08:30 AM Page: 3514 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lethargy Liver Function Test Abnormal Report Source Product Role Manufacturer Route Dose Duration Lower Respiratory Tract Clozaril PS Novartis Sector: Infection Pharma ORAL UNK, UNK 60480MIN Lymphocyte Count Clozaril SS Novartis Sector: Increased Pharma ORAL 175 mg/day 5760 MIN Malaise Clozaril SS Novartis Sector: Monocyte Count Increased Pharma 100 mg/day 7200 MIN Nausea Neutrophil Count Increased Platelet Count Increased Protein Total Increased Prothrombin Level Increased Respiratory Depth Decreased Sedation Somnolence White Blood Cell Count Increased Date:11/07/05ISR Number: 4823465-XReport Type:Expedited (15-DaCompany Report #2005S1005539 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine Tablets Professional (25 Mg) PS ORAL 25 MG;HS;PO Other Clozapine Tablets (100 Mg) SS ORAL 200 MG; HS; PO Escitalopram C Clonazepam C Trihexyphenidyl Hydrochloride C Chlorpromazine Hydrochloride C Simvastatin C Lisinopril C Metroprolol Succinate C Acetylsalicylic Acid C Pantoprazole C Glyceryl Trinitrate C Date:11/07/05ISR Number: 4823466-1Report Type:Expedited (15-DaCompany Report #2005S1001377 Age:54 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Clozapine Tablets (25 Mg) PS ORAL 75 MG;BID; PO Clozapine Tablets (100 Mg) SS ORAL 200 MG; BID, PO Diphenhydramine C Ferrous Sulfate C Lorazepam C Escitalopram C 22-Feb-2006 08:30 AM Page: 3515 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sertraline C Gemfibrozil C Date:11/08/05ISR Number: 4822676-7Report Type:Expedited (15-DaCompany Report #GB-GLAXOSMITHKLINE-B0388407A Age:32 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Depression Paroxetine PS Glaxosmithkline 50MG Per day Dizziness Sulpiride SS Drug Interaction Fluoxetine SS Fatigue Clozapine SS Grand Mal Convulsion Olanzapine SS ORAL 15MG per day Hallucination, Auditory Flupenthixol C Incontinence Zopiclone C Mental Impairment Citalopram C Orthostatic Hypotension Clonazepam C Persecutory Delusion Salivary Hypersecretion Schizophrenia Syncope Vasovagal Tongue Biting Date:11/08/05ISR Number: 4822893-6Report Type:Expedited (15-DaCompany Report #PHNR2005AU01588 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Body Mass Index Decreased Clozaril PS Novartis Sector: Cognitive Disorder Pharma 0 - 300 Constipation mg/day Mental Impairment Nausea Somnolence Weight Decreased Date:11/08/05ISR Number: 4822894-8Report Type:Expedited (15-DaCompany Report #PHHO2005CA14988 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Antinuclear Antibody Clozaril PS Novartis Sector: Positive Pharma 350 mg am, Apathy 400 mg qhs Cardiomegaly Cardiomyopathy Communication Disorder Heart Rate Irregular Obsessive-Compulsive Disorder Social Avoidant Behaviour Speech Disorder Systemic Lupus Erythematosus Tachycardia 22-Feb-2006 08:30 AM Page: 3516 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/08/05ISR Number: 4822908-5Report Type:Expedited (15-DaCompany Report #PHHO2005CA14988 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Antinuclear Antibody Clozaril PS Novartis Sector: Positive Pharma 350 mg am, Apathy 400 mg qhs Cardiomegaly Cardiomyopathy Communication Disorder Heart Rate Irregular Obsessive-Compulsive Disorder Palpitations Social Avoidant Behaviour Systemic Lupus Erythematosus Tachycardia Date:11/08/05ISR Number: 4823217-0Report Type:Direct Company Report #CTU 262625 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - White Blood Cell Count Clozaril 350mg Bid PS ORAL 350MG PO BID Initial or Prolonged Increased Date:11/08/05ISR Number: 4823218-2Report Type:Direct Company Report #CTU 262626 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Level Changed Clozaril 100mg -> Total 200mg Qd PS ORAL 2 AM / 5 PM TAKEN PO Date:11/08/05ISR Number: 4823365-5Report Type:Direct Company Report #CTU 262595 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Heart Rate Increased Clozapine -Fazaclo- Initial or Prolonged Malaise 100mg Alamo PS Alamo ORAL 200MG TOTAL Other Neuroleptic Malignant DAILY DOSE Syndrome PO Pyrexia Clozapine -Fazaclo- Vomiting 25mg Alamo SS Alamo ORAL 25MG TOTAL DAILY DOSE PO Date:11/08/05ISR Number: 4824395-XReport Type:Expedited (15-DaCompany Report #2005S1010179 Age:56 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional (100 Mg) PS ORAL 300 MG; HS; Other ORAL Risperidone C Gabapentin C Oxcarbazepine C Enalapril C 22-Feb-2006 08:30 AM Page: 3517 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Phenytoin C Phenytoin C Trazodone C Levothyroxine C Date:11/09/05ISR Number: 4823702-1Report Type:Expedited (15-DaCompany Report #2005AP05739 Age:12783 DYGender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Joint Stiffness Seroquel PS Zeneca Initial or Prolonged Musculoskeletal Stiffness Pharmaceutical ORAL Trismus Clozapine SS ORAL 5 DAY Date:11/09/05ISR Number: 4823887-7Report Type:Expedited (15-DaCompany Report #PHEH2005US10445 Age:50 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Clozaril PS Novartis Sector: Initial or Prolonged Leukocytosis Pharma ORAL 250mg Qam, Lung Infiltration 275mg Qhs Lung Neoplasm Clozaril SS Novartis Sector: Pneumonia Pharma ORAL 250 mg, BID Pneumonitis Combivent C Tachycardia Lorazepam C ORAL 2 mg, QHS Benztropeine C ORAL 2 mg, QHS Zyprexa C ORAL 5 mg, QHS Enalapril C ORAL 5 mg, BID Date:11/09/05ISR Number: 4823907-XReport Type:Expedited (15-DaCompany Report #PHFR2005GB03169 Age:68 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Mass Clozaril PS Novartis Sector: Initial or Prolonged Blood Creatinine Pharma ORAL 400mg/day Other Increased Clozaril SS Novartis Sector: Blood Urea Increased Pharma ORAL 400 mg/day Bronchopneumonia Venlafaxine C ORAL 150mg/day Confusional State Diazepam C ORAL 5mg/day Constipation Omeprazole C ORAL 20mg/day Delirium Vitamin E C ORAL 400 mg, TID Dyspnoea Exacerbated Fall Gait Disturbance Lymphocyte Count Decreased Malaise Neutropenia Neutrophil Count Increased Pyrexia Weight Decreased White Blood Cell Count Increased 22-Feb-2006 08:30 AM Page: 3518 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/09/05ISR Number: 4825127-1Report Type:Direct Company Report #CTU 262641 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Depressed Level Of Clozapine PS 300 MG Q AM Hospitalization - Consciousness 350 MG Q PM Initial or Prolonged Sedation Date:11/09/05ISR Number: 4825182-9Report Type:Expedited (15-DaCompany Report #PHBS2005US15930 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Literature Clozapine Initial or Prolonged Complex Partial Seizures Health (Clozapine) PS 500 MG/D, Depressed Level Of Professional Olanzapine Consciousness Drug Interaction (Olanzapine) SS Ngx 30 MG/D, Drug Level Increased Paroxetine Dysarthria Electroencephalogram (Paroxetine) SS Ngx 40 MG/D, Abnormal Encephalopathy Hypokinesia Salivary Hypersecretion Sinus Tachycardia Somnolence Date:11/09/05ISR Number: 4825185-4Report Type:Expedited (15-DaCompany Report #PHBS2005US15931 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Literature Clozapine Depressed Mood Health (Clozapine) PS SEE IMAGE Depressive Symptom Professional Paroxetine Disturbance In Attention Dizziness (Paroxetine) SS Ngx SEE IMAGE Drug Interaction Drug Level Increased General Physical Health Deterioration Hallucination, Auditory Sedation Sleep Disorder Date:11/09/05ISR Number: 4825752-8Report Type:Expedited (15-DaCompany Report #2005-US-00816 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine Tablets, Professional 12.5 Mg, 25 Mg, 50 Other Mg, 100 Mg (Clozapine) PS ORAL 750 MG QD, ORAL 22-Feb-2006 08:30 AM Page: 3519 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/09/05ISR Number: 4826097-2Report Type:Expedited (15-DaCompany Report #2005149177 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Constipation Consumer Accupril (Quinapril Other Convulsion Hydrochloride) PS Drooling Clozapine Drug Interaction (Clozapine) SS Drug Toxicity General Physical Health Deterioration Malaise Mental Impairment Date:11/09/05ISR Number: 4826354-XReport Type:Expedited (15-DaCompany Report #S05-USA-03295-01 Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Health Lexapro Tardive Dyskinesia Professional (Escitalopram) PS ORAL 30 MG QD PO Lexapro (Escitalopram) SS ORAL 15 MG QD PO Lexapro (Escitalopram) SS ORAL 10 MG QD PO Clozapine SS ORAL 300 MG QD PO Clozapine SS ORAL 150 MG QD PO Clozapine SS ORAL 100 MG QD PO Lorazepam C Date:11/10/05ISR Number: 4825916-3Report Type:Direct Company Report #CTU 262827 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Clozapine (Clozaril) PS Date:11/10/05ISR Number: 4827614-9Report Type:Expedited (15-DaCompany Report #2005S1009967 Age:78 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Other Clozapine Tablets (100 Mg) PS ORAL 100 MG; QAM; ORAL; 150 MG; QOD; ORAL Albuterol C Warfarin Sodium C Spironolactone C Furosemide C Potassium C Magnesium Oxide C Triamcinolone Acetonide C Prednisone C Famotidine C Digoxin C Humalog Lantus C 22-Feb-2006 08:30 AM Page: 3520 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/10/05ISR Number: 4827616-2Report Type:Expedited (15-DaCompany Report #2005S1010522 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Other Clozapine Tablets (100 Mg) PS ORAL 15 MG; QD, ORAL; 200 MG; HS; ORAL Date:11/10/05ISR Number: 4828104-XReport Type:Expedited (15-DaCompany Report #2005131906 Age:57 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutropenia Foreign Amlodipine Initial or Prolonged Health (Amlodipine) PS ORAL 5 MG (5 MG, 1 Other Professional IN 1 D), ORAL Clozapine (Clozapine) SS ORAL 100 MG PLUS 275 MG (1 IN 1 D), ORAL Valproic Acid (Valproic Acid) SS ORAL 900 MG (900 MG, 1 IN 1 D), ORAL Amisulpride (Amisulpride) C Co-Codamol (Codeine Phosphate, Paracetamol) C Date:11/10/05ISR Number: 4828109-9Report Type:Expedited (15-DaCompany Report #2005S1010536 Age:81 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional (25 Mg) PS ORAL 12.5 MG; QD; Other ORAL Date:11/10/05ISR Number: 4828552-8Report Type:Expedited (15-DaCompany Report #2005S1005758 Age:70 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Breast Cancer Health Clozapine PS ORAL SEE IMAGE Professional Neostigmine Bromide C Other Fentanyl C Morphine Sulfate C Date:11/10/05ISR Number: 4828553-XReport Type:Expedited (15-DaCompany Report #2005S1009705 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Lower Health Clozapine PS ORAL SEE IMAGE Initial or Prolonged Appendicectomy Professional Ranitidine Granulocytopenia Other Hydrochloride C Pyrexia Loratadine C Vomiting Docusate Sodium C Medroxyprogesterone Acetate C 22-Feb-2006 08:30 AM Page: 3521 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Valproate Semisodium C Vitamins C Date:11/10/05ISR Number: 4828565-6Report Type:Expedited (15-DaCompany Report #2005AL004467 Age:53 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Serax (Oxazepam) Initial or Prolonged Increased Health Tablets, 15 Mg Aspartate Professional (Alpharma) (Serax Aminotransferase Other (Oxazepam) Tablets, Increased 15 Mg (Alpharma) PS ORAL SEE IMAGE Gamma-Glutamyltransferase Leponex "Novartis" Increased () SS Novartis ORAL 75 MG; QD; PO Hypercholesterolaemia Venlafaxine Hypertriglyceridaemia Hydrochloride SS 300 MG; QD Date:11/11/05ISR Number: 4825739-5Report Type:Expedited (15-DaCompany Report #PHFR2005GB03690 Age:27 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiomegaly Clozapine PS Novartis Sector: Pharma ORAL 100mg am/250 mg pm Reboxetine C ORAL 4 mg/am 2 mg prn Moclobemide C ORAL 300 mg/am 450 mg/prn Date:11/11/05ISR Number: 4825747-4Report Type:Expedited (15-DaCompany Report #PHFR2003GB02518 Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arteritis Clozaril PS Novartis Sector: Eosinophilic Myocarditis Pharma ORAL Fluid Retention Benzhexol C Pulmonary Oedema Date:11/11/05ISR Number: 4825764-4Report Type:Expedited (15-DaCompany Report #PHEH2005US12326 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dyspnoea Clozaril PS Novartis Sector: Other Neoplasm Malignant Pharma Unk, Unk Date:11/14/05ISR Number: 4827497-7Report Type:Expedited (15-DaCompany Report #PHEH2005US12326 Age:55 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dyspnoea Clozaril PS Novartis Sector: Other Neoplasm Malignant Pharma Unk, Unk 22-Feb-2006 08:30 AM Page: 3522 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/14/05ISR Number: 4827498-9Report Type:Expedited (15-DaCompany Report #PHBS2005GR16206 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Clozapine PS Novartis Sector: Initial or Prolonged Phosphokinase Increased Pharma UNKNOWN 900 mg/d Dizziness Clozapine SS Novartis Sector: Dysarthria Pharma UNKNOWN 700 mg/d Dysphagia Fluvoxamine SS UNKNOWN 100 mg/d Dystonia Electrocardiogram St Segment Electrocardiogram T Wave Inversion Obsessive-Compulsive Disorder Salivary Hypersecretion Date:11/14/05ISR Number: 4827499-0Report Type:Expedited (15-DaCompany Report #PHFR2005GB03632 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Exposure During Clozaril PS Novartis Sector: Pregnancy Pharma ORAL Premature Labour Date:11/14/05ISR Number: 4827500-4Report Type:Expedited (15-DaCompany Report #PHBS2005GR15042 Age:42 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Leponex PS Novartis Sector: Initial or Prolonged Pyrexia Pharma ORAL Respiratory Tract Haloperidol C UNKNOWN Infection Kineton C UNKNOWN Date:11/14/05ISR Number: 4827501-6Report Type:Expedited (15-DaCompany Report #PHFR2005GB03652 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Exposure During Clozaril PS Novartis Sector: Pregnancy Pharma TRANSPLACENTAL Premature Baby Date:11/14/05ISR Number: 4827502-8Report Type:Expedited (15-DaCompany Report #PHEH2005US12326 Age:55 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dyspnoea Clozaril PS Novartis Sector: Other Neoplasm Malignant Pharma Unk, Unk Date:11/14/05ISR Number: 4827514-4Report Type:Expedited (15-DaCompany Report #PHBS2005PT16456 Age:67 YR Gender:Male I/FU:I Outcome PT Death Agitation Hospitalization - Asthenia Initial or Prolonged Blood Creatinine 22-Feb-2006 08:30 AM Page: 3523 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Increased Cardiac Failure Confusional State Dyskinesia Report Source Product Role Manufacturer Route Dose Duration Dyspnoea Leponex PS Novartis Sector: Hyperhidrosis Pharma ORAL 50 +100 mg/d 5760 MIN Hypotension Folic Acid C ORAL Incoherent Indapamide C ORAL Neuroleptic Malignant Vitamin B12 C ORAL Syndrome Carbidopa W/Levodopa C ORAL Tremor Alopurinol C ORAL Tansulosine C ORAL Risperidone C ORAL UNK, UNK Levomepromazine C ORAL Date:11/14/05ISR Number: 4827857-4Report Type:Direct Company Report #CTU 262968 Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Clozaril 25 Mg PS ORAL 50 MG BID Decreased PO 3 DAY Cogentin C Zocor C Zoloft C Date:11/14/05ISR Number: 4831152-7Report Type:Expedited (15-DaCompany Report #DSA_27209_2005 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bowel Sounds Abnormal Foreign Tavor PS ORAL 7 MG ONCE PO Initial or Prolonged Fatigue Health Atosil SS ORAL 1600 MG ONCE Multiple Drug Overdose Professional PO Intentional Other Leponex SS ORAL 1000 MG ONCE Tachycardia PO Date:11/14/05ISR Number: 4831528-8Report Type:Expedited (15-DaCompany Report #2005130569 Age:57 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mood Swings Foreign Amlodipine Initial or Prolonged Neutropenia Health (Amlodipine) PS ORAL 5 MG (DAILY), Other Professional ORAL Zaponex (Clozapine) SS ORAL 375 MG (DAILY), ORAL Valproic Acid (Valproic Acid) SS ORAL 900 MG (DAILY), ORAL Amisulpride (Amisulpride) C Paracetamol (Paracetamol) C Codeine (Codeine) C 22-Feb-2006 08:30 AM Page: 3524 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/14/05ISR Number: 4835349-1Report Type:Expedited (15-DaCompany Report #2005-US-00266 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Loss Of Consciousness Health Clozapine Tablets, Pain In Extremity Professional 12.5 Mg, 25mg, 50 Mg Pulmonary Thrombosis Other 100mg (Clozapine) PS ORAL 300 MG QHS, ORAL Aripiprazole C Valproate Semisodium C Clonazepam C Propranolol Hydrochloride C Benzatropine Mesialte C Date:11/14/05ISR Number: 4835350-8Report Type:Expedited (15-DaCompany Report #2005-US-00873 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine Tablets, Professional 12.5 Mg, 25mg, 50mg, Other 100mg (Clozapine) PS ORAL 400 MG, QD, ORAL Date:11/14/05ISR Number: 4835351-XReport Type:Expedited (15-DaCompany Report #2005-US-00855 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Clozapine Tablets, Professional 12.5 Mg, 25 Mg, 50 Other Mg, 100 Mg(Clozapine) PS ORAL 400 MG, QD, ORAL Date:11/14/05ISR Number: 4835359-4Report Type:Expedited (15-DaCompany Report #200509557 Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Health Botox PS Hospitalization - Respiratory Failure Professional Clozapine SS ORAL 25 MG QHS PO Initial or Prolonged Fluoxetine Hydrochloride C Levodopa/Carbidopa C Tramadol C Morphine C Pantoprazole C Estrogen C Oxycodone C Terazosin C Celecoxib C Paracetamol C 22-Feb-2006 08:30 AM Page: 3525 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/15/05ISR Number: 4828601-7Report Type:Expedited (15-DaCompany Report #PHEH2005US10886 Age:41 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Caesarean Section Clozaril PS Novartis Sector: Initial or Prolonged Chorioamnionitis Pharma UNK, UNK Other Drug Exposure During Acyclovir C ORAL 400 mg, BID Pregnancy Prenatal Vitamins C Granulocyte Count Increased Neutrophil Percentage Increased Premature Rupture Of Membranes White Blood Cell Count Increased Date:11/15/05ISR Number: 4828602-9Report Type:Expedited (15-DaCompany Report #PHEH2005US10942 Age:0 DY Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Caesarean Section Clozaril PS Novartis Sector: Initial or Prolonged Drug Exposure During Pharma TRANSPLACENTAL Other Pregnancy Tachycardia Foetal White Blood Cell Count Increased Date:11/15/05ISR Number: 4828603-0Report Type:Expedited (15-DaCompany Report #PHFR2005IE03483 Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Circulatory Collapse Clozaril PS Novartis Sector: Initial or Prolonged Diabetes Mellitus Pharma ORAL 100 mg/day Other Non-Insulin-Dependent Cipramil Fall Hyperglycaemia /Net/ C ORAL 40 mg/day Overweight Thirst Date:11/15/05ISR Number: 4828687-XReport Type:Expedited (15-DaCompany Report #PHHO2005NZ16786 Age:35 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Level Increased Clozaril (Clozapine) PS Novartis Sector: Initial or Prolonged Gastrointestinal Necrosis Pharma ORAL 375mg daily 112 DAY Intestinal Ischaemia Lithium C 1 g, BID Megacolon Paroxetine C 20 mg, QD Omeprazole C 20 mg, QD Zopiclone C Date:11/15/05ISR Number: 4828688-1Report Type:Expedited (15-DaCompany Report #PHNU2005DE03743 Age: Gender:Female I/FU:I Outcome PT Life-Threatening Extubation Hospitalization - Intentional Misuse Initial or Prolonged Respiratory Depression 22-Feb-2006 08:30 AM Page: 3526 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Suicide Attempt Report Source Product Role Manufacturer Route Dose Duration Leponex PS Novartis Sector: Pharma ORAL 1440 MIN Lorazepam SS ORAL 1440 MIN Digitalis Glycosides SS ORAL 1440 MIN Theophylline SS ORAL 1440 MIN Date:11/15/05ISR Number: 4830054-XReport Type:Direct Company Report #CTU 263079 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Convulsion Clozaril (Generic) PS Date:11/15/05ISR Number: 4834079-XReport Type:Expedited (15-DaCompany Report #2005S1010244 Age:63 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine Tablets Professional (100 Mg) PS ORAL 100 MG; QAM; Other ORAL; 200 MG; HS; ORAL Paroxetine Hydrochloride C Lorazepam C Glyceryl Trinitrate C Oxybutynin Hydrochloride C Sucralfate C Date:11/15/05ISR Number: 4834088-0Report Type:Expedited (15-DaCompany Report #2005S1008675 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Granulocytopenia Health Clozapine Tablets Hepatic Failure Professional (100 Mg) PS ORAL 200 MG; QAM; Hepatitis Other PO; 200 MG; HS; PO Tiotixene C Spironolactone C Date:11/15/05ISR Number: 4834093-4Report Type:Expedited (15-DaCompany Report #2005S1010668 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening General Physical Health Health Clozapine Tablets Hospitalization - Deterioration Professional (100 Mg) PS ORAL 300 MG; HS; Initial or Prolonged Hyponatraemia Other ORAL Required Infection Benzatropine Intervention to Lethargy Mesilate C Prevent Permanent Multi-Organ Failure Valproic Acid C Impairment/Damage Polydipsia Levofloxacin C Vasculitis Lorazepam C White Blood Cell Count Increased 22-Feb-2006 08:30 AM Page: 3527 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/16/05ISR Number: 4829497-XReport Type:Expedited (15-DaCompany Report #PHBS2005BR16174 Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diarrhoea Leponex PS Novartis Sector: Dizziness Pharma ORAL UNK, UNK Labyrinthitis Leponex SS Novartis Sector: Tic Pharma ORAL 100 mg/d Vertigo Date:11/16/05ISR Number: 4829525-1Report Type:Expedited (15-DaCompany Report #PHFR2005GB03550 Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiac Disorder Clozaril PS Novartis Sector: Chest Pain Pharma ORAL 250mg daily 54720MIN Date:11/16/05ISR Number: 4831237-5Report Type:Expedited (15-DaCompany Report #2005-US-00888 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Choking Health Clozapine Tablets, Professional 12.5 Mg, 25 Mg, 50 Other Mg, 100 Mg (Clozapine) PS ORAL ORAL Date:11/16/05ISR Number: 4831241-7Report Type:Expedited (15-DaCompany Report #2005-US-00881 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Lip And/Or Oral Cavity Health Clozapine Tablets, Initial or Prolonged Cancer Professional 12.5 Mg, 25 Mg, 50 Other Other Mg, 100 Mg (Clozapine) PS ORAL 200 MG QD ORAL Date:11/16/05ISR Number: 4831454-4Report Type:Expedited (15-DaCompany Report #2005-US-00934 Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Transient Ischaemic Health Clozapine Tablets, Initial or Prolonged Attack Professional 12.5mg, 25mg, 50 Mg Company 100mg (Clozapine) PS ORAL 400 MG, QD, Representative ORAL Fluoxetine Hydrochloride C Ferrous Sulfate C Date:11/16/05ISR Number: 4831656-7Report Type:Expedited (15-DaCompany Report #05-08-1387 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Toxicity Health Clozapine Tablets, Professional 12.5mg, 25mg, 50 Mg Other 100mg (Clozapine) PS ORAL UNKNOWN, ORAL 22-Feb-2006 08:30 AM Page: 3528 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/16/05ISR Number: 4831657-9Report Type:Expedited (15-DaCompany Report #2005-US-00098 Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Apnoea Health Clozapine Tablets, Initial or Prolonged Cardiac Arrest Professional 12.5mg, 25mg, 50 Mg Chronic Obstructive Other 100mg (Clozapine) PS ORAL 300 MG, QD, Pulmonary Disease ORAL Pneumonia Bupropion SS ORAL XL 450 MG Respiratory Arrest BID, ORAL Lithium Carbonate C Ipratropium C Salbutamol C Benztropeine C Date:11/16/05ISR Number: 4831891-8Report Type:Expedited (15-DaCompany Report #2005RR-01118 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Depression Foreign Fluoxetine Dizziness Health (Fluoxetine) Unknown PS ORAL 40 MG, QD, Drug Interaction Professional ORAL Fatigue Other Sulpiride Grand Mal Convulsion (Sulpiride) SS 400 MG, TID Hallucination, Auditory Paroxetine Headache (Paroxetine) SS Loss Of Consciousness Clozapin (Clozapine) SS 175 MG, QD Malaise Olanzapine Mental Impairment (Olanzapine) SS ORAL 15 MG, Orthostatic Hypotension QD,ORAL Persecutory Delusion Flupenthixol C Salivary Hypersecretion Venlafaxine C Schizophrenia Risperidone C Schizophrenia, Paranoid Zopiclone C Type Citalopram Tablet 20 Syncope Vasovagal Mg (Citalopram) C Tongue Biting Clonazepam C Urinary Incontinence Date:11/16/05ISR Number: 4832042-6Report Type:Expedited (15-DaCompany Report #05-06-1043 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Sodium Increased Health Clozapine Tablets, Convulsion Professional 12.5mg, 25mg, 50 Mg Dehydration Other 100mg (Clozapine) PS ORAL 200-500 MG Heat Stroke QD, ORAL Loss Of Consciousness Lithium C Date:11/16/05ISR Number: 4832043-8Report Type:Expedited (15-DaCompany Report #2005-US-00099 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Level Increased Health Clozapine Tablets, Initial or Prolonged Leukocytosis Professional 12.5mg, 25mg, 50 Mg Nephritis Interstitial 100mg (Clozapine) PS ORAL 250 MG, QD, Pyrexia ORAL Levothyroxine C Valproate Semisodium C 22-Feb-2006 08:30 AM Page: 3529 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/16/05ISR Number: 4833657-1Report Type:Expedited (15-DaCompany Report #2005-US-00892 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetic Coma Health Clozapine Tablets, Professional 12.5mg, 25mg, 50 Mg Other 100mg (Clozapine) PS ORAL ORAL Date:11/18/05ISR Number: 4831135-7Report Type:Expedited (15-DaCompany Report #PHFR2005GB03223 Age:25 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyskinesia Clozaril PS Novartis Sector: Fall Pharma ORAL 275mg daily Loss Of Consciousness Clozaril SS Novartis Sector: Photopsia Pharma ORAL 550mg/day Mirtazapine C ORAL 30mg daily Movicol C ORAL 1 sachet Date:11/18/05ISR Number: 4831137-0Report Type:Expedited (15-DaCompany Report #PHFR2005GB03169 Age:68 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Mass Clozaril PS Novartis Sector: Initial or Prolonged Blood Creatinine Pharma ORAL 300mg/day Other Increased Venlafaxine C ORAL 150mg/day Blood Urea Increased Venlafaxine C ORAL 75 mg/day Bronchopneumonia Diazepam C ORAL 5mg/day Confusional State Diazepam C ORAL 6 mg/day Constipation Omeprazole C ORAL 20mg/day Delirium Vitamin E C ORAL 400 mg, TID Diabetes Mellitus Vitamin E C ORAL 400 mg, QID Non-Insulin-Dependent Dyspnoea Exacerbated Fall Gait Disturbance Lymphocyte Count Decreased Malaise Neutropenia Neutrophil Count Increased Pyrexia Weight Decreased White Blood Cell Count Increased Date:11/18/05ISR Number: 4836222-5Report Type:Expedited (15-DaCompany Report #2005S1008261 Age:74 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Heat Exhaustion Health Clozapine Tablets Professional (25 Mg) PS ORAL 25 MG;HS;PO Other Clozapine Tablets (100 Mg) SS ORAL 100 MG;HS;PO 22-Feb-2006 08:30 AM Page: 3530 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/18/05ISR Number: 4836224-9Report Type:Expedited (15-DaCompany Report #2005S1010887 Age:71 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Hospitalization - Professional (100 Mg) PS ORAL SEE IMAGE Initial or Prolonged Other Benzatropine Mesilate C Warfarin C Aripiprazole C Clonidine C Temazepam C Lisinopril C Ferrous Gluconate C Date:11/18/05ISR Number: 4836229-8Report Type:Expedited (15-DaCompany Report #2005S1010844 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Other Clozapine Tablets (25 Mg) PS ORAL 50 MG;HS;ORAL Clozapine Tablets (100 Mg) SS ORAL 200 MG;HS;ORAL Insulin C Labetalol Hydrochloride C Metformin Hydrochloride C Spironolactone/Hydro chlorothiazide C Lisinopril C Rosiglitazone Maleate C Atorvastatin C Glipizide C Famotidine C Methysergide C Valproate Semisodium C Aripiprazole C Furosemide C Lorazepam C Date:11/18/05ISR Number: 4836250-XReport Type:Direct Company Report #CTU 263462 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Level Fluctuating Clozaril 100 Mg -> Therapeutic Response Total 700 Mg Qd PS ORAL 2 AM /5 PM Unexpected With Drug /TAKEN PO Substitution (SEE IMAGE) Date:11/21/05ISR Number: 4833616-9Report Type:Expedited (15-DaCompany Report #PHNU2005DE03344 Age:54 YR Gender:Male I/FU:F Outcome PT Other Anticholinergic Syndrome Aspartate Aminotransferase 22-Feb-2006 08:30 AM Page: 3531 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Increased Blood Creatine Phosphokinase Increased Bradyphrenia Report Source Product Role Manufacturer Route Dose Duration Delusion Leponex / Clozaril Disorientation (Clozapine) PS Novartis Sector: Drug Interaction Pharma ORAL up to Restlessness 75mg/day 5760 MIN Trevilor SS ORAL up to 112.5 mg, QD 5760 MIN Danical C ORAL 120 mg, QD 5760 MIN Date:11/21/05ISR Number: 4833617-0Report Type:Expedited (15-DaCompany Report #PHMT2005CA00600 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Uterine Cancer Clozaril PS Novartis Sector: Pharma 300 mg, QD Date:11/21/05ISR Number: 4833618-2Report Type:Expedited (15-DaCompany Report #PHBS2005ID15778 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dengue Fever Clozaril PS Novartis Sector: Initial or Prolonged Platelet Count Decreased Pharma ORAL 25 mg/day 4320 MIN White Blood Cell Count Decreased Date:11/21/05ISR Number: 4833627-3Report Type:Expedited (15-DaCompany Report #PHEH2005US09533 Age:57 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Haematocrit Decreased Clozaril PS Novartis Sector: Haemoglobin Decreased Pharma ORAL 425 mg, QHS 1332 DAY Hepatitis C Interferon SS UNK, UNK Leukopenia Effexor-Xr C ORAL 75 mg, BID Neutropenia Platelet Count Decreased Red Blood Cell Count Decreased Date:11/21/05ISR Number: 4833628-5Report Type:Expedited (15-DaCompany Report #PHEH2004US12007 Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Clozaril PS Novartis Sector: Initial or Prolonged Autism Spectrum Disorder Pharma ORAL 600 mg, QD Hyperhidrosis Hyperventilation Logorrhoea Date:11/21/05ISR Number: 4833629-7Report Type:Expedited (15-DaCompany Report #PHNU2005DE03712 Age: Gender:Male I/FU:I Outcome PT Hospitalization - Blood Sodium Decreased Initial or Prolonged Cerebral Atrophy 22-Feb-2006 08:30 AM Page: 3532 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Communication Disorder Computerised Tomogram Abnormal Report Source Product Role Manufacturer Route Dose Duration Electroencephalogram Leponex / Clozaril Abnormal (Clozapine) PS Novartis Sector: Fall Pharma ORAL up to 100 mg, Grand Mal Convulsion QD 27360MIN Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL up to 150 mg, QD 4320 MIN Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL up to 175 mg, QD 4320 MIN Nipolept SS ORAL 250 mg, QD Nipolept SS ORAL 200 mg, QD 1440 MIN Nipolept SS ORAL 175 mg, QD 1440 MIN Nipolept SS ORAL 150 mg, QD 7200 MIN Nipolept SS ORAL 100 mg, QD 2880 MIN Nipolept SS ORAL 50 mg, QD 5760 MIN Nipolept SS ORAL 300 mg, QD Zyprexa SS ORAL 20 mg, QD Zyprexa SS ORAL 25 mg, QD Zyprexa SS ORAL Ciatyl-Z SS 400 mg, BIW Risperdal SS 25 mg, BIW Date:11/21/05ISR Number: 4833631-5Report Type:Expedited (15-DaCompany Report #PHEH2005US09173 Age:72 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dementia Alzheimer'S Type Clozaril PS Novartis Sector: Lymphocytic Leukaemia Pharma ORAL 100mg BID, Neutropenia 50mg QD White Blood Cell Count Aricept C Increased Aspirin C Lasix C Potassium C Levothyroxine C Ditropan C Docusate Sodium C Toprol Xl C Namenda C Lactulose C Date:11/21/05ISR Number: 4833634-0Report Type:Expedited (15-DaCompany Report #PHMT2005CA00595 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Helicobacter Infection Clozaril PS Novartis Sector: Ulcer Pharma 22-Feb-2006 08:30 AM Page: 3533 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/21/05ISR Number: 4836660-0Report Type:Expedited (15-DaCompany Report #2005131906 Age:57 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutropenia Foreign Amlodipine Initial or Prolonged Health (Amlodipine) PS ORAL 5 MG (5 MG, 1 Other Professional IN1 D), ORAL Clozapine (Clozapine) SS ORAL 100 MG PLUS 275 MG (1 IN 1 D), ORAL Amisulpride (Amisulpride) C Co-Codamol (Codeine Phosphate, Paracetamol) C Date:11/22/05ISR Number: 4834709-2Report Type:Expedited (15-DaCompany Report #PHNR2005AU01588 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Body Mass Index Decreased Clozaril PS Novartis Sector: Other Cognitive Disorder Pharma 300 mg/day Constipation Clozaril SS Novartis Sector: Mental Impairment Pharma 250 mg daily Nausea Aspirin C Somnolence Benztropeine C Weight Decreased Ramipril C Diaformin C Diamicron C Lipitor C Nexium C Zanidip C Date:11/22/05ISR Number: 4834792-4Report Type:Expedited (15-DaCompany Report #PHNU2005DE02017 Age:32 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Leponex / Clozaril Initial or Prolonged Alanine Aminotransferase (Clozapine) PS Novartis Sector: Other Increased Pharma ORAL up to 400 mg, Aspartate QD 59040MIN Aminotransferase Leponex / Clozaril Increased (Clozapine) SS Novartis Sector: C-Reactive Protein Pharma ORAL 300 mg, QD 47520MIN Increased Risperdal C ORAL Cholecystitis Acute Ergenyl Chrono C ORAL 2000 mg, QD Cholestasis Ergenyl Chrono C ORAL 2500 mg, QD 8640 MIN Diarrhoea Ergenyl Chrono C ORAL 2750 mg, QD 51840MIN Gamma-Glutamyltransferase Ergenyl Chrono C ORAL 2250 mg, QD 56160MIN Increased Diazepam C ORAL 10 mg, QD 161 DAY General Physical Condition Abnormal Lipase Increased 22-Feb-2006 08:30 AM Page: 3534 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/22/05ISR Number: 4834794-8Report Type:Expedited (15-DaCompany Report #PHEH2005US10943 Age:49 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Clozaril PS Novartis Sector: Initial or Prolonged Hypersomnia Pharma Unk, Unk Other Psychotic Disorder Paroxetine Mesilate C ORAL 20 mg, QD Sedation Klonopin C ORAL 1 mg, QHS Date:11/22/05ISR Number: 4834802-4Report Type:Expedited (15-DaCompany Report #PHNU2005DE03817 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Obsessive Thoughts Leponex / Clozaril Other Obsessive-Compulsive (Clozapine) PS Novartis Sector: Disorder Pharma ORAL Unknown Road Traffic Accident Date:11/22/05ISR Number: 4834821-8Report Type:Expedited (15-DaCompany Report #PHNU2005DE03816 Age:66 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Adrenal Insufficiency Leponex / Clozaril Atrial Fibrillation (Clozapine) PS Novartis Sector: Brain Contusion Pharma 50/25/50mg/da Coronary Artery Disease y 2920 DAY Fall Digimerck C 0.5mg/week Grand Mal Convulsion Acetylsalicylic Acid C 100 mg, QD Hyponatraemia Astonin-H C 0.2 mg, QD Sodium Chloride C 2 DF, TID Ergenyl Chrono C 150 mg, QD Date:11/22/05ISR Number: 4837172-0Report Type:Expedited (15-DaCompany Report #05-06-1083 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hypertensive Heart Health Clozapine PS ORAL 150-200MG QD, Disease Professional ORAL Other Valproate Semisodium C Clonazepam C Nifedipine C Bupropion C Date:11/22/05ISR Number: 4837217-8Report Type:Expedited (15-DaCompany Report #2005S1010341 Age:68 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hepatic Neoplasm Health Clozapine PS ORAL SEE IMAGE Malignant Professional Sertraline Other Hydrochloride C ................... C Lorazepam C Clonazepam C Risperidone C Mirtazapine C 22-Feb-2006 08:30 AM Page: 3535 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/22/05ISR Number: 4837325-1Report Type:Expedited (15-DaCompany Report #2005156941 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutrophil Count Foreign Amlodipine Decreased Health (Amlodipine) PS ORAL 5 MG (5 MG, Professional DAILY), ORAL Clozapine (Clozapine) SS ORAL 375 MG (DAILY), ORAL Valproic Acid (Valproic Acid) SS ORAL 900 MG (DAILY), ORAL Amisulpride (Amisulpride) C Co-Codamol (Codeine Phosphate, Paracetamol) C Date:11/23/05ISR Number: 4835606-9Report Type:Expedited (15-DaCompany Report #GR-SOLVAY-00305003836 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Fluvoxamine PS UNKNOWN Daily dose: Initial or Prolonged Phosphokinase Increased 100 Dizziness milligram(s) Drug Interaction Clozapine I UNKNOWN Gradually Dysarthria increasing up Dysphagia to 900 mg/day Dystonia Clozapine I UNKNOWN Daily dose: Electrocardiogram St-T 700 Segment Abnormal milligram(s) Salivary Hypersecretion Date:11/23/05ISR Number: 4836272-9Report Type:Expedited (15-DaCompany Report #PHRM2005FR02533 Age:68 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Leponex PS Novartis Sector: Initial or Prolonged Dehydration Pharma ORAL Ecg Signs Of Myocardial Seloken C ORAL Ischaemia Hyzaar C ORAL Lung Disorder Plavix C ORAL Myocarditis Kardegic C ORAL Pericardial Effusion Renal Failure Troponin Increased Date:11/23/05ISR Number: 4836291-2Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20051103846 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Risperdal Consta PS INTRAMUSCULAR Initial or Prolonged Fall Nipolept SS ORAL Grand Mal Convulsion Leponex SS ORAL 125-150mg Hyponatraemia daily Motor Dysfunction Leponex SS ORAL 25-100mg Postictal State daily Zyprexia SS ORAL 22-Feb-2006 08:30 AM Page: 3536 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Ciatyl-Z - Slow Release SS Date:11/23/05ISR Number: 4836304-8Report Type:Expedited (15-DaCompany Report #PHFR2005GB03748 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Angioneurotic Oedema Clozaril PS Novartis Sector: Pharma UNKNOWN 125mg daily Date:11/23/05ISR Number: 4836431-5Report Type:Expedited (15-DaCompany Report #PHBS1992BR03443 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eosinophilia Leponex PS Novartis Sector: Lymphocyte Count Pharma Decreased Monocyte Count Increased Date:11/23/05ISR Number: 4836467-4Report Type:Expedited (15-DaCompany Report #PHEH2005US12727 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Optic Neuritis Clozaril PS Novartis Sector: Papillitis Pharma ORAL 275 mg, QD Vision Blurred Visual Acuity Reduced Date:11/23/05ISR Number: 4836731-9Report Type:Expedited (15-DaCompany Report #GB-ABBOTT-05P-167-0311181-00 Age:44 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diarrhoea Hytrin PS ORAL Initial or Prolonged Myoclonus Sodium Valproate SS Pneumonia Ibuprofen SS Clozapine SS Benzatropine SS Date:11/23/05ISR Number: 4836749-6Report Type:Expedited (15-DaCompany Report #DE-ABBOTT-05P-062-0317348-00 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Nipolept PS ORAL Initial or Prolonged Communication Disorder Nipolept SS ORAL Depressed Level Of Nipolept SS ORAL Consciousness Nipolept SS ORAL Fall Nipolept SS ORAL Grand Mal Convulsion Nipolept SS ORAL Masked Facies Clozapine SS ORAL 22 DAY Clozapine SS ORAL 22 DAY Clozapine SS ORAL 22 DAY Olanzapine SS ORAL Olanzapine SS ORAL Olanzapine SS ORAL Zuclopenthixol Hydrochloride SS 22-Feb-2006 08:30 AM Page: 3537 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Risperidone SS Chlorprothixene Hydrochloride C Saroten C Lorazepam C Haloperidol C Isopromethazine Hydrochloride C Flunitrazepam C Lorazepam C Date:11/23/05ISR Number: 4838488-4Report Type:Expedited (15-DaCompany Report #2005S1010024 Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Histiocytosis Health Clozapine Tablets Haematophagic Professional (25 Mg) PS ORAL 50 MG; QAM; Lymphohistiocytosis Other ORAL Viral Infection Clozapine Tablets (100 Mg) SS ORAL 700 MG; QD; ORAL Chlorpromazine Hydrochloride C Paroxetine C Clonazepam C Date:11/23/05ISR Number: 4838559-2Report Type:Expedited (15-DaCompany Report #2005S1010989 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional (100 Mg) PS ORAL 300 MG; BID; Other ORAL Sertraline C Hydrochloride C Date:11/23/05ISR Number: 4838563-4Report Type:Expedited (15-DaCompany Report #2005S1010956 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional (100 Mg) PS ORAL 500 Other MG;HS;ORAL Date:11/23/05ISR Number: 4838906-1Report Type:Direct Company Report #CTU 263694 Age:13 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Accidental Exposure Clozaril PS Medication Error Poor Quality Drug Administered 22-Feb-2006 08:30 AM Page: 3538 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/24/05ISR Number: 4837035-0Report Type:Expedited (15-DaCompany Report #PHBS2005US16644 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Antipsychotic Drug Level Clozapine PS Novartis Sector: Increased Pharma UNKNOWN 450 mg/d Confusional State Clozapine SS Novartis Sector: Delirium Pharma UNKNOWN 350 mg/d Dizziness Clozapine SS Novartis Sector: Drug Toxicity Pharma UNKNOWN 375 mg/d Dry Mouth Clozapine SS Novartis Sector: Flat Affect Pharma UNKNOWN 250 mg/d Muscle Spasms Clozapine SS Novartis Sector: Pupil Fixed Pharma UNKNOWN 225 mg/d Pupillary Reflex Impaired Clozapine SS Novartis Sector: Salivary Hypersecretion Pharma UNKNOWN 325 mg/d Sedation Nicotine SS UNKNOWN Vision Blurred Clozapine SS Novartis Sector: Weight Increased Pharma UNKNOWN 300 mg/d Clozapine SS Novartis Sector: Pharma UNKNOWN 200 mg/d Aripiprazole C Lithium C Date:11/25/05ISR Number: 4839673-8Report Type:Expedited (15-DaCompany Report #GBWYE138114NOV05 Age:3 MON Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Congenital Anomaly Health Efexor (Venlafaxine Drug Exposure During Professional Hydrochloride, 0) PS TRANSPLACENTAL TRANSPLACENTA Pregnancy Other L Foetal Growth Retardation Clozapine Haemangioma Congenital (Clozapine, , 0) SS TRANSPLACENTAL TRANSPLACENTA L Date:11/25/05ISR Number: 4843636-6Report Type:Expedited (15-DaCompany Report #05-07-1207 Age:68 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hospitalisation Health Clozapine Tablets, Initial or Prolonged Professional 12.5 Mg, 25 Mg, 50 Other Mg, 100 Mg (Clozapine) (Tablets) PS ORAL 150-650 MG QD ORAL Date:11/25/05ISR Number: 4843645-7Report Type:Expedited (15-DaCompany Report #2005-US-00057 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aortic Atherosclerosis Health Clozapine Tablets, Cardio-Respiratory Arrest Professional 12.5mg, 25mg, 50 Mg, Cardiomegaly Other 100mg (Clozapine) PS ORAL 400 MG QD Foreign Body Trauma ORAL Obesity Pulmonary Congestion 22-Feb-2006 08:30 AM Page: 3539 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/25/05ISR Number: 4843646-9Report Type:Expedited (15-DaCompany Report #2005-US-01060 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Choking Health Clozapine Tablets, Professional 12.5mg, 25mg, 50mg, Other 100mg (Clozapine) PS ORAL 600 MG QD ORAL Date:11/25/05ISR Number: 4843647-0Report Type:Expedited (15-DaCompany Report #2005-US-01061 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Ovarian Cancer Health Clozapine Tablets, Professional 12.5 Mg, 25mg, 50mg, Other 100mg (Clozapine) PS ORAL 700 MG QD ORAL Chemotherapeutics Nos C Date:11/25/05ISR Number: 4843648-2Report Type:Expedited (15-DaCompany Report #2005-US-01066 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Clozapine Tablets, Professional 12.5mg, 25mg, 50mg, Other 100mg (Clozapine) PS ORAL 650 MG QD ORAL Date:11/25/05ISR Number: 4844566-6Report Type:Expedited (15-DaCompany Report #2005-US-01108 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Lung Abscess Health Clozapine Tablets, Initial or Prolonged Pyothorax Professional 12.5 Mg, 25mg, 50 Other Mg, 100mg (Clozapine) PS ORAL 675 MG, QD, ORAL Date:11/25/05ISR Number: 4844567-8Report Type:Expedited (15-DaCompany Report #2005-US-01063 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Other Clozapine Tablets, 12.5mg, 25mg, 50 Mg, 100mg (Clozapine) PS ORAL 100 MG, QD, ORAL Date:11/25/05ISR Number: 4844568-XReport Type:Expedited (15-DaCompany Report #2005-US-01072 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Viral Health Clozapine Tablets, Professional 12.5mg, 25mg, 50 Mg, Other 100mg (Clozapine) PS ORAL 50 MG, QD, ORAL 22-Feb-2006 08:30 AM Page: 3540 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/25/05ISR Number: 4844569-1Report Type:Expedited (15-DaCompany Report #2005-US-01073 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Potassium Decreased Health Clozapine Tablets, Cardiac Disorder Professional 12.5mg, 25mg, 50 Mg, Other 100mg (Clozapine) PS ORAL 500 MG, ORAL Date:11/25/05ISR Number: 4844571-XReport Type:Expedited (15-DaCompany Report #2005-US-01062 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Cancer Metastatic Health Clozapine Tablets, Professional 12.5mg, 25mg, 50 Mg, Other 100mg (Clozapine) PS ORAL 900 MG, QD, ORAL Date:11/28/05ISR Number: 4837415-3Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20051103849 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dysarthria Haldol PS ORAL Initial or Prolonged Gait Disturbance Haldol SS ORAL Myoclonus Leponex SS ORAL Pneumonia Leponex SS ORAL Psychotic Disorder Leponex SS ORAL Thinking Abnormal Risperdal C ORAL 2-4 mg Risperdal C ORAL Eunerpan C Lasix C Adalat C Micardis C Catapresan C L-Thyroxin C Beloc-Zok C Beloc-Zok C Date:11/28/05ISR Number: 4837421-9Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20051104650 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pneumonia Haldol PS UNKNOWN Leponex SS Zyprexa C Tavor C Convulex C Date:11/28/05ISR Number: 4837453-0Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20051103885 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Granulocytosis Risperdal PS ORAL Initial or Prolonged Pyrexia Risperdal SS ORAL Risperdal SS ORAL Leponex SS ORAL Leponex SS ORAL Leponex SS ORAL Leponex SS ORAL 22-Feb-2006 08:30 AM Page: 3541 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Leponex SS ORAL Leponex SS ORAL Leponex SS ORAL Leponex SS ORAL Leponex SS ORAL Leponex SS ORAL Risperdal SS ORAL Date:11/28/05ISR Number: 4838063-1Report Type:Expedited (15-DaCompany Report #GB-ABBOTT-05P-167-0317716-00 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Renal Failure Acute Epilim PS UNKNOWN Initial or Prolonged Clozapine SS ORAL 437 DAY Orphenadrine C UNKNOWN Propranolol C UNKNOWN Senna C UNKNOWN Lamotrigine C UNKNOWN Aspirin C UNKNOWN Date:11/28/05ISR Number: 4839185-1Report Type:Direct Company Report #CTU 263916 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Accidental Exposure Clozapine 25mg, Intervention to Oedema Peripheral 100mg PS Prevent Permanent Pain Impairment/Damage Pharyngeal Oedema Rash Swelling Swelling Face Date:11/28/05ISR Number: 4842343-3Report Type:Expedited (15-DaCompany Report #2005-US-01149 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Lung Abscess Health Clozapine Tablets, Initial or Prolonged Pneumonia Professional 12.5mg, 25mg, 50 Mg Other Other 100mg (Clozapine) PS ORAL 200 MG, ORAL Date:11/28/05ISR Number: 4842346-9Report Type:Expedited (15-DaCompany Report #2005-US-01150 Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Alcoholism Health Clozapine Tablets, Exposure To Chemical Professional 12.5mg, 25mg, 50 Mg Pollution Other 100mg (Clozapine) PS ORAL 200 MG, QD, Hepatic Failure ORAL Multi-Organ Failure Renal Failure Respiratory Failure Smoker 22-Feb-2006 08:30 AM Page: 3542 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/28/05ISR Number: 4842348-2Report Type:Expedited (15-DaCompany Report #2005-US-01151 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arthritis Infective Other Clozapine Tablets, Initial or Prolonged Knee Arthroplasty 12.5mg, 25mg, 50 Mg 100mg (Clozapine) PS ORAL 650 MG, QD, ORAL Date:11/28/05ISR Number: 4845262-1Report Type:Expedited (15-DaCompany Report #2005-US-00026 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Multi-Organ Disorder Health Clozapine Tablets, Other Pancytopenia Professional 12.5mg, 25mg, 50 Mg Other 100mg (Tablets) PS ORAL 500 MG, ORAL Date:11/29/05ISR Number: 4838459-8Report Type:Expedited (15-DaCompany Report #PHEH2005US11712 Age:54 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukocytosis Clozaril PS Novartis Sector: Neutrophil Count Pharma ORAL 200mg Qam, Increased 400mg Qhs Non-Hodgkin'S Lymphoma Risperdal C 4 mg, QHS Cogentin C 0.5 mg, BID Date:11/29/05ISR Number: 4838463-XReport Type:Expedited (15-DaCompany Report #PHEH2005US12779 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Road Traffic Accident Clozaril PS Novartis Sector: Pharma Unk, Unk Date:11/29/05ISR Number: 4838464-1Report Type:Expedited (15-DaCompany Report #PHBS2005PT16456 Age:67 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Leponex PS Novartis Sector: Hospitalization - Asthenia Pharma ORAL 25+25+100 mg 5760 MIN Initial or Prolonged Blood Creatinine Folic Acid C ORAL Increased Indapamide C ORAL Cardiac Failure Vitamin B12 C ORAL Confusional State Carbidopa W/Levodopa C ORAL Dyskinesia Alopurinol C ORAL Dyspnoea Tansulosine C ORAL Hyperhidrosis Risperidone C ORAL UNK, UNK Hypotension Levomepromazine C ORAL Incoherent Neuroleptic Malignant Syndrome Tremor 22-Feb-2006 08:30 AM Page: 3543 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/05ISR Number: 4838465-3Report Type:Expedited (15-DaCompany Report #PHNR2005AU01635 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anisocytosis Clozaril PS Novartis Sector: Basophilia Pharma 12.5-300 mg Lymphocytosis daily Microcytic Anaemia Microcytosis Poikilocytosis Red Blood Cell Abnormality Red Blood Cell Elliptocytes Present Date:11/29/05ISR Number: 4838466-5Report Type:Expedited (15-DaCompany Report #PHRM2005FR02837 Age:59 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypogammaglobulinaemia Leponex PS Novartis Sector: Initial or Prolonged Lung Disorder Pharma ORAL 400mg, daily Other Nasopharyngitis Solian SS UNK, UNK Sinusitis Date:11/29/05ISR Number: 4838467-7Report Type:Expedited (15-DaCompany Report #PHNU2005DE03807 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Lymphopenia Leponex / Clozaril White Blood Cell Count (Clozapine) PS Novartis Sector: Increased Pharma Date:11/29/05ISR Number: 4838468-9Report Type:Expedited (15-DaCompany Report #PHBS2005DK17029 Age:46 YR Gender:Male I/FU:I Outcome PT Death Abscess Hospitalization - Asthma Initial or Prolonged Back Pain Other Blood Immunoglobulin M Decreased Bronchitis Chronic Cardiac Disorder Cerebral Disorder Chest Pain Chronic Obstructive Pulmonary Disease Conjunctivitis Allergic Cough Drug Level Increased Drug Toxicity Fungal Infection Hypertension Hyponatraemia Leukocytosis Platelet Count Increased Pneumonia Polydipsia Pruritus Generalised 22-Feb-2006 08:30 AM Page: 3544 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report White Blood Cell Count Increased Report Source Product Role Manufacturer Route Dose Duration Leponex PS Novartis Sector: Pharma ORAL 300 mg, TID 77760MIN Leponex SS Novartis Sector: Pharma ORAL 850 mg/d 43200MIN Leponex SS Novartis Sector: Pharma ORAL 875 mg/d 20160MIN Leponex SS Novartis Sector: Pharma ORAL 300 mg, TID 377 DAY Leponex SS Novartis Sector: Pharma ORAL 825 mg/d 350 DAY Leponex SS Novartis Sector: Pharma ORAL 850 mg/d Leponex SS Novartis Sector: Pharma ORAL 800 mg/d 266 DAY Leponex SS Novartis Sector: Pharma ORAL 850 mg/d 84 DAY Serevent C UNKNOWN 50 ug, BID Cisordinol C INTRAMUSCULAR 500 mg, BIW Berodual C ORAL 1 DF, QID Influenza Vaccine C 0.5 ml Oxazepam C ORAL 15 mg/d + 15 mg if necessary Truxal C 50-100 max 200 mg/d Akineton C ORAL 2 mg/d Alminox C ORAL 1 DF, QID Panodil C ORAL 1 g, QID B-Combin Forte Tablet C ORAL 2 tablets/d Peragit C ORAL 2 mg, TID Deprakine C ORAL 500 mg, TID Lanzo C ORAL 30 mg/d Magnesia C ORAL 1 g, BID Atropin C ORAL 0.25 mg, BID Tafil C ORAL 0.25 mg, TID Date:11/29/05ISR Number: 4838469-0Report Type:Expedited (15-DaCompany Report #PHNU2005DE03819 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Obsessive Thoughts Leponex / Clozaril Obsessive-Compulsive (Clozapine) PS Novartis Sector: Disorder Pharma ORAL Unknown Date:11/29/05ISR Number: 4838471-9Report Type:Expedited (15-DaCompany Report #PHNU2005DE03818 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Obsessive Thoughts Leponex / Clozaril Obsessive-Compulsive (Clozapine) PS Novartis Sector: Disorder Pharma ORAL Unknown 22-Feb-2006 08:30 AM Page: 3545 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/05ISR Number: 4838877-8Report Type:Expedited (15-DaCompany Report #PHBS2005NZ07551 Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Clozaril PS Novartis Sector: Phosphokinase Increased Pharma ORAL 175 mg/d 15840MIN Blood Creatine Clozaril SS Novartis Sector: Phosphokinase Mm Pharma Constipation Olanzapine C 20 mg/d Dermatomyositis Olanzapine C 10 mg/d Muscle Rigidity Prednisone C Muscular Weakness Date:11/29/05ISR Number: 4838879-1Report Type:Expedited (15-DaCompany Report #PHFR2005GB03730 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Congenital Anomaly Clozapine PS Novartis Sector: Drug Exposure During Pharma TRANSPLACENTAL Pregnancy Venlafaxine SS TRANSPLACENTAL Growth Retardation Haemangioma Date:11/29/05ISR Number: 4838897-3Report Type:Expedited (15-DaCompany Report #PHBS2004SE14720 Age:58 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arteriosclerosis Leponex PS Novartis Sector: Hospitalization - Cardiac Failure Acute Pharma ORAL 25 mg/d since Initial or Prolonged Cough a few years Pneumonia Aricept C ORAL 10 mg/d Pulmonary Embolism Madopar Quick C ORAL Shoulder Pain Madopar Mite C ORAL Detrusitol C ORAL 2 mg/d Remeron C ORAL 30 mg/d Edronax C ORAL 4 mg/d Comtess C ORAL 200 mg/d Triobe C ORAL Losec Mups C ORAL 10 mg/d Date:11/29/05ISR Number: 4839075-4Report Type:Expedited (15-DaCompany Report #PHBS2005SE01249 Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bronchitis Leponex PS Novartis Sector: Cardiomegaly Pharma ORAL 600 mg/d Cardiopulmonary Failure Cisordinol SS ORAL 5 mg/d Coronary Artery Cipralex SS ORAL 20 mg/d Atherosclerosis Atarax C ORAL Myocardial Ischaemia Akineton C ORAL 2 mg/d Stesolid C ORAL Date:11/29/05ISR Number: 4839869-5Report Type:Expedited (15-DaCompany Report #PHFR2005GB03774 Age:79 YR Gender:Male I/FU:I Outcome PT Other Asthenia Dysarthria 22-Feb-2006 08:30 AM Page: 3546 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hypotonia Report Source Product Role Manufacturer Route Dose Duration Clozaril PS Novartis Sector: Pharma UNKNOWN Date:11/29/05ISR Number: 4839870-1Report Type:Expedited (15-DaCompany Report #PHFR2005GB02906 Age:60 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Clozaril PS Novartis Sector: Corrected Interval Pharma ORAL 300 mg/day Prolonged Cyproterone Acetate C ORAL 50 mg, BID Co-Amilofruse C ORAL 1 tab/day Procyclidine C ORAL 5 mg, TID Benperidol C ORAL 750 mg, BID Amisulpride C ORAL 600 mg, BID Date:11/29/05ISR Number: 4840066-8Report Type:Expedited (15-DaCompany Report #PHBS2005NL11557 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Albumin Increased Leponex PS Novartis Sector: Initial or Prolonged Blood Creatine Pharma ORAL 75 mg/d Phosphokinase Increased Risperdal C UNKNOWN 6 mg, QD 82 DAY Blood Thyroid Stimulating Folic Acid C UNKNOWN 0.5 mg, QD Hormone Decreased Body Temperature Increased C-Reactive Protein Increased Eosinophil Count Increased Eosinophilia Haematocrit Decreased Haemoglobin Decreased Hepatic Enzyme Increased Leukocytosis Mean Cell Haemoglobin Concentration Decreased Mean Cell Haemoglobin Increased Proteinuria Pyrexia Tachycardia Date:11/29/05ISR Number: 4843755-4Report Type:Expedited (15-DaCompany Report #200513987GDS Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Level Increased Foreign Cipro Tremor Health (Ciprofloxican Professional Hydrochloride) PS 2 DAY Other Clozaril (Cloazapine) SS ORAL 400 MG, TOTAL DAILY, ORAL Levaquin (Levofloxacin) SS 22-Feb-2006 08:30 AM Page: 3547 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/30/05ISR Number: 4840700-2Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20051103885 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Risperdal PS ORAL Initial or Prolonged Pyrexia Risperdal SS ORAL Risperdal SS ORAL Leponex SS ORAL Leponex SS ORAL Leponex SS ORAL Leponex SS ORAL Leponex SS ORAL Leponex SS ORAL Leponex SS ORAL Leponex SS ORAL Leponex SS ORAL Leponex SS ORAL Risperdal SS ORAL Date:11/30/05ISR Number: 4841252-3Report Type:Expedited (15-DaCompany Report #PHBS2005YU17442 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Leponex PS Novartis Sector: Hospitalization - Aphthous Stomatitis Pharma ORAL 100 mg/day 63360MIN Initial or Prolonged Oral Mucosal Disorder Pyrexia Date:11/30/05ISR Number: 4841253-5Report Type:Expedited (15-DaCompany Report #PHBS2005KR17080 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Fatigue Clozaril PS Novartis Sector: Headache Pharma ORAL Hypothalamo-Pituitary Disorders Date:11/30/05ISR Number: 4841254-7Report Type:Expedited (15-DaCompany Report #PHEH2005US12606 Age:77 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Chronic Obstructive Clozaril PS Novartis Sector: Pulmonary Disease Pharma ORAL 12.5 mg, QD Dementia Aricept C 10 mg, QHS Weight Decreased Mirtazapine C 7.5 mg, QHS Milk Of Magnesia C UNK, PRN Tylenol C UNK, PRN Date:11/30/05ISR Number: 4841268-7Report Type:Expedited (15-DaCompany Report #PHEH2005US10838 Age:23 YR Gender:Male I/FU:F Outcome PT Hospitalization - Chest Pain Initial or Prolonged Dyspnoea Full Blood Count Abnormal Pericardial Effusion Pyrexia Sinus Tachycardia 22-Feb-2006 08:30 AM Page: 3548 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Troponin Increased Viral Infection White Blood Cell Count Report Source Product Role Manufacturer Route Dose Duration Increased Clozaril PS Novartis Sector: Pharma ORAL 25mg Qam, 50mg Qhs 24480MIN Depakote C ORAL 500 mg, BID 92160MIN Seroquel C ORAL 200mg Qam, 600mg Qhs Date:11/30/05ISR Number: 4841270-5Report Type:Expedited (15-DaCompany Report #PHBS2005YU16984 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Leponex PS Novartis Sector: Constipation Pharma ORAL 200 mg/d Hyperprolactinaemia Leponex SS Novartis Sector: Pharma ORAL 75 mg/d Anafranil C UNKNOWN Date:11/30/05ISR Number: 4841273-0Report Type:Expedited (15-DaCompany Report #PHMT2005CA00675 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Lymphadenopathy Clozaril PS Novartis Sector: Pharma Date:11/30/05ISR Number: 4841274-2Report Type:Expedited (15-DaCompany Report #PHFR2005GB03778 Age:67 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiac Failure Clozaril PS Novartis Sector: Fatigue Pharma ORAL Oedema Peripheral Orthostatic Hypotension Date:11/30/05ISR Number: 4842027-1Report Type:Expedited (15-DaCompany Report #2005PK02224 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Brain Stem Infarction Beloc-Zok PS 47 DAY Drug Interaction Leponex I 47 DAY Fluninoc I 47 DAY Truxal I 47 DAY Captohexal I 47 DAY Godamed I 47 DAY Ranitic I 47 DAY Haldol Decanoat I 47 DAY Myxofat I 47 DAY Date:11/30/05ISR Number: 4842042-8Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20051105519 Age:66 YR Gender:Female I/FU:I Outcome PT Disability Brain Stem Infarction Cerebrovascular Accident 22-Feb-2006 08:30 AM Page: 3549 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Drug Interaction Report Source Product Role Manufacturer Route Dose Duration Haldol Decanoate PS UNKNOWN Leponex SS UNKNOWN Fluninoc SS UNKNOWN Truxal SS UNKNOWN Captohexal SS UNKNOWN Belok Zoc SS UNKNOWN Godamed SS UNKNOWN Ranitic SS UNKNOWN Myxofat SS UNKNOWN Date:11/30/05ISR Number: 4846065-4Report Type:Expedited (15-DaCompany Report #2005S1010668 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiac Failure Health Clozapine Tablets Hospitalization - Coma Professional (100 Mg) PS ORAL SEE IMAGE Initial or Prolonged Convulsion Other Benzatropine Required Dialysis Mesilate C Intervention to General Physical Health Valproic Acid C Prevent Permanent Deterioration Levofloxacin C Impairment/Damage Hyponatraemia Lorazepam C Infection Ergocalciferol C Lethargy Ascorbic Acid C Pneumonia Aspiration Thiamine Polydipsia Hydrochloride C Renal Failure Retinol C Respiratory Failure Riboflavin C Vasculitis Nicotinamide C White Blood Cell Count Increased Date:11/30/05ISR Number: 4861646-XReport Type:Periodic Company Report #200510286BWH Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Health Cipro (Ciprofloxacin Professional Hydrochloride) PS ORAL 500 MG, BID, ORAL Clozapine SS ORAL 500 MG, TOTAL DAILY, ORAL Clindamycin SS ORAL 450 MG, TID, ORAL Ciprofloxacin Otic Hcl C Effexor C Ddavp C Artane C Multivitamin C Colace C Ciprofloxacin Ophthalmologic Solution C 22-Feb-2006 08:30 AM Page: 3550 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/01/05ISR Number: 4842634-6Report Type:Expedited (15-DaCompany Report #FI-GLAXOSMITHKLINE-B0402181A Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Antipsychotic Drug Level Lamictal PS Glaxosmithkline ORAL 200MG per day Increased Leponex SS ORAL 150MG per day Hypersomnia Temesta C Somnolence Cipralex C Movicol C Date:12/01/05ISR Number: 4842987-9Report Type:Expedited (15-DaCompany Report #AU-ROCHE-425787 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Pulmonary Oedema Valium PS Roche UNKNOWN UP TO 300 MG. Cardiomyopathy Clozapine SS ORAL Sudden Death Epilim SS UNKNOWN Date:12/01/05ISR Number: 4843017-5Report Type:Expedited (15-DaCompany Report #AU-ROCHE-426018 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chest Pain Valium PS Roche UNKNOWN Dyspnoea Clozapine SS ORAL Myocarditis Tachycardia Date:12/01/05ISR Number: 4845505-4Report Type:Expedited (15-DaCompany Report #2005S1011267 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aneurysm Health Clozapine Tablets Professional (100 Mg) PS ORAL SEE IMAGE Other Benzatropine Mesilate C Haloperidol C Hydroxyzine Hydrochloride C Gemfibrozil C Docusate Sodium C Valproate Semisodium C Lansoprazole C Metoprolol Tartrate C Lithium C Atorvastatin C Levothyroxine Sodium C Diazepam C Paracetamol/Hydrocod one Bitartrate C Date:12/01/05ISR Number: 4845512-1Report Type:Expedited (15-DaCompany Report #2005S1010112 Age:70 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dementia Alzheimer'S Type Health Clozapine Tablets Professional (25 Mg) PS ORAL 50 Other MG;BID;ORAL Lithium C 22-Feb-2006 08:30 AM Page: 3551 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Morphine C Galantamine C Mirtazapine C Ibuprofen C Venlafaxine Hydrochloride C Sulfadiazine Silver C Paracetamol/Hydrocod one Bitartrate C Melatonin C Date:12/02/05ISR Number: 4843504-XReport Type:Expedited (15-DaCompany Report #PHBS2005US17427 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Body Mass Index Increased Clozapine PS Novartis Sector: Other Diabetes Mellitus Pharma UNKNOWN 400 mg/d Myocardial Infarction Weight Increased Date:12/02/05ISR Number: 4843507-5Report Type:Expedited (15-DaCompany Report #PHFR2005GB03404 Age:57 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Thyroid Stimulating Clozaril PS Novartis Sector: Initial or Prolonged Hormone Increased Pharma ORAL UNK, UNK Body Temperature Clozaril SS Novartis Sector: Fluctuation Pharma Dose changed C-Reactive Protein Lithium C UNKNOWN Increased Cardiac Failure Cardiomegaly Confusional State Diarrhoea Dyspnoea Electrocardiogram T Wave Inversion Eosinophil Count Increased Lower Respiratory Tract Infection Malaise Myocarditis Neutrophil Count Increased Pericardial Effusion Pleural Effusion Pyrexia Red Blood Cell Sedimentation Rate Increased Sedation Troponin T Increased Venous Pressure Increased Vomiting Wheezing White Blood Cell Count Increased 22-Feb-2006 08:30 AM Page: 3552 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/02/05ISR Number: 4843508-7Report Type:Expedited (15-DaCompany Report #PHBS2005US17427 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Body Mass Index Increased Clozapine PS Novartis Sector: Other Diabetes Mellitus Pharma UNKNOWN 400 mg/d Myocardial Infarction Weight Increased Date:12/02/05ISR Number: 4843510-5Report Type:Expedited (15-DaCompany Report #PHBS2005US17422 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Body Mass Index Increased Clozapine PS Novartis Sector: Other Diabetes Mellitus Pharma UNKNOWN 175 mg/d Myocardial Infarction Atenolol C Weight Increased Ipratropium C Date:12/02/05ISR Number: 4843514-2Report Type:Expedited (15-DaCompany Report #PHBS2005US17423 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Body Mass Index Increased Clozapine PS Novartis Sector: Other Myocardial Infarction Pharma UNKNOWN 300 mg/d Weight Increased Date:12/02/05ISR Number: 4843515-4Report Type:Expedited (15-DaCompany Report #PHBS2005US17426 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Body Mass Index Increased Clozapine PS Novartis Sector: Other Diabetes Mellitus Pharma UNKNOWN 425 mg/d Myocardial Infarction Valproate Sodium C Weight Increased Haloperidol Decanoate C Date:12/02/05ISR Number: 4843518-XReport Type:Expedited (15-DaCompany Report #PHBS2005US17424 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Body Mass Index Increased Clozapine PS Novartis Sector: Other Myocardial Infarction Pharma UNKNOWN 500 mg/d Weight Increased Valproate Sodium C Date:12/02/05ISR Number: 4843519-1Report Type:Expedited (15-DaCompany Report #PHBS2005US17428 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Body Mass Index Increased Clozapine PS Novartis Sector: Other Myocardial Infarction Pharma UNKNOWN 550 mg/d Weight Increased Lorazepam C Sertraline C 22-Feb-2006 08:30 AM Page: 3553 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/02/05ISR Number: 4843520-8Report Type:Expedited (15-DaCompany Report #PHBS2005US17425 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Body Mass Index Increased Clozapine PS Novartis Sector: Other Myocardial Infarction Pharma UNKNOWN 400 mg/d Weight Increased Date:12/02/05ISR Number: 4843521-XReport Type:Expedited (15-DaCompany Report #PHFR2004GB03974 Age:53 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Full Blood Count Clozaril PS Novartis Sector: Initial or Prolonged Decreased Pharma ORAL 350 mg/day Other Haemoglobin Decreased Nausea Oesophageal Carcinoma Platelet Count Increased Regurgitation Of Food Throat Cancer Vomiting Date:12/02/05ISR Number: 4846311-7Report Type:Direct Company Report #CTU 264262 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutropenic Sepsis Clozaril PS ORAL 275 MG Q HS Initial or Prolonged Pneumonia PO White Blood Cell Count Risperdal C Decreased Benztropine C Depakote C Gabitril C Lamictal C Temazepam C Date:12/02/05ISR Number: 4846694-8Report Type:Expedited (15-DaCompany Report #2005131906 Age:57 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutropenia Foreign Amlodipine Initial or Prolonged Health (Amlodipine) PS ORAL 5 MG (5 MG, 1 Other Professional IN 1 D), ORAL Clozapine (Clozapine) SS ORAL 100 MG PLUS 275 MG (1 IN 1 D), ORAL Valproic Acid (Valproic Acid) SS ORAL 900 MG (900 MG, 1 IN 1 D), ORAL Amilsulpride (Amilsulpride) C Co-Codamol (Codeine Phosphate, Paracetamol) C 22-Feb-2006 08:30 AM Page: 3554 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/03/05ISR Number: 4844497-1Report Type:Expedited (15-DaCompany Report #PHFR2003GB02145 Age:58 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Calcium Decreased Clozaril PS Novartis Sector: Initial or Prolonged Blood Creatinine Pharma ORAL 100 mg, BID 54720MIN Increased Hyoscine SS ORAL 24480MIN Blood Urea Increased Clozaril SS Novartis Sector: Bronchopneumonia Pharma ORAL 300mg/day Chest X-Ray Abnormal Valproate Sodium C ORAL UNK, UNK Crackles Lung Diarrhoea Hypotension Neutrophil Count Increased Pyrexia Renal Impairment Tachycardia Vomiting White Blood Cell Count Increased Date:12/03/05ISR Number: 4844500-9Report Type:Expedited (15-DaCompany Report #PHBS2005US17430 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Body Mass Index Increased Clozapine PS Novartis Sector: Cerebrovascular Accident Pharma UNKNOWN 400 mg/d Weight Increased Lithium C Date:12/03/05ISR Number: 4844501-0Report Type:Expedited (15-DaCompany Report #PHFR2005GB03858 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Activated Partial Clozaril PS Novartis Sector: Initial or Prolonged Thromboplastin Time Pharma ORAL 75mg/day Other Abnormal Clozaril SS Novartis Sector: Hepatocellular Damage Pharma Overdose Overdose Paracetamol SS UNKNOWN Overdose Date:12/03/05ISR Number: 4844503-4Report Type:Expedited (15-DaCompany Report #PHBS2005CA17300 Age:16 YR Gender:Male I/FU:I Outcome PT Hospitalization - Apathy Initial or Prolonged Autonomic Nervous System Imbalance Blood Creatine Phosphokinase Increased Blood Pressure Increased Cogwheel Rigidity Confusional State Depressed Level Of Consciousness Dystonia Flushing Heart Rate Increased Hypertension Muscle Rigidity 22-Feb-2006 08:30 AM Page: 3555 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Neuroleptic Malignant Syndrome Pyrexia Report Source Product Role Manufacturer Route Dose Duration Respiratory Rate Clozapine PS Novartis Sector: Decreased Pharma ORAL 12.5 mg, Somnolence ONCE/SINGLE Olanzapine SS INTRAMUSCULAR 5 mg, ONCE/SINGLE Oxcarbazepine C 300mg am + 150mg pm Oxcarbazepine C 150mg Date:12/03/05ISR Number: 4844515-0Report Type:Expedited (15-DaCompany Report #PHBS2005NZ01232 Age:42 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Level Decreased Clozaril PS Novartis Sector: Haemochromatosis Pharma ORAL 300 mg/d Lymphocyte Count Kliogest C ORAL 1 tab/d Decreased Ranitidine C UNKNOWN 150 mg/d Neutrophil Count Increased Platelet Count Decreased Polycythaemia Thrombocythaemia Weight Decreased White Blood Cell Count Increased Date:12/03/05ISR Number: 4844517-4Report Type:Expedited (15-DaCompany Report #PHBS2005NZ17413 Age:89 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other C-Reactive Protein Clozaril PS Novartis Sector: Increased Pharma ORAL Orthostatic Hypotension Pyrexia Red Blood Cell Sedimentation Rate Increased Sinus Tachycardia Date:12/03/05ISR Number: 4844519-8Report Type:Expedited (15-DaCompany Report #PHFR2005GB03379 Age:49 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypersomnia Clozaril PS Novartis Sector: Overdose Pharma ORAL 450 mg/day Sedation Cipralex SS Clozaril SS Novartis Sector: Pharma ORAL 1700 mg overdose 22-Feb-2006 08:30 AM Page: 3556 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/05/05ISR Number: 4845472-3Report Type:Expedited (15-DaCompany Report #PHEH2005US09686 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Lung Disorder Clozaril PS Novartis Sector: White Blood Cell Count Pharma ORAL 650 mg, UNK Increased Date:12/05/05ISR Number: 4845486-3Report Type:Expedited (15-DaCompany Report #PHHO2005CA13514 Age:68 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Clonus Clozaril PS Novartis Sector: Initial or Prolonged Hypertension Pharma ORAL 0.625 mg, UNK 12960MIN Other Sinemet C 200/50, half tablet QID Ferrous Sulfate C 300 mg, TID Florinef C 0.1 mg, QD Amatine C 2.5 mg, BID Escitalopram C 5 mg, QD Lactulose C ORAL 5 mg, 1 tsp. QD Pulmicort C 0.25 mg, QD Ventolin C 0.5 mg, BID Date:12/05/05ISR Number: 4845499-1Report Type:Expedited (15-DaCompany Report #PHNR2005AU01666 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - C-Reactive Protein Clozaril PS Novartis Sector: Initial or Prolonged Increased Pharma 0 - 100 Cardiac Disorder mg/day 43200MIN Pyrexia Red Blood Cell Sedimentation Rate Increased Troponin Increased Date:12/05/05ISR Number: 4845500-5Report Type:Expedited (15-DaCompany Report #PHFR2005GB03748 Age:43 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Angioneurotic Oedema Clozaril PS Novartis Sector: Pharma ORAL 300mg daily 30240MIN Date:12/05/05ISR Number: 4845517-0Report Type:Expedited (15-DaCompany Report #PHEH2005US11968 Age:63 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Clozaril PS Novartis Sector: Initial or Prolonged Subdural Haematoma Pharma ORAL 100 mg, BID Subdural Haematoma Evacuation 22-Feb-2006 08:30 AM Page: 3557 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/05/05ISR Number: 4845519-4Report Type:Expedited (15-DaCompany Report #PHEH2005US12934 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatitis C Clozaril PS Novartis Sector: Pharma ORAL 250 mg, QD Date:12/06/05ISR Number: 4847126-6Report Type:Direct Company Report #CTU 264445 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Level Fluctuating Clozaril 100 Mg PS ORAL 2 AM /5 PM TAKEN PO ( SEE IMAGE) Date:12/06/05ISR Number: 4848556-9Report Type:Expedited (15-DaCompany Report #108222ISR Age:88 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Anaemia Health Citalopram PS 60 MILLIGRAM 643 DAY Faeces Discoloured Professional Clozapine SS 30 WK Inflammation Acetysalicylic Acid C Leukocytosis Chlortalidone C Serotonin Syndrome Enalapril C Nitrazepam C Paracetamol C Diltiazem Hydrochloride C Ipratropium Bromide C Glyceryl Trinitrate C Domperidone C Psyllium C Date:12/06/05ISR Number: 4848557-0Report Type:Expedited (15-DaCompany Report #2005-US-01212 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Gastrointestinal Necrosis Other Clozapine Tablets, Initial or Prolonged 12.5mg, 25mg, 50 Mg 100mg (Clozapine) PS ORAL 300 MG, QD, ORAL Date:12/07/05ISR Number: 4846795-4Report Type:Expedited (15-DaCompany Report #PHRM2005FR03096 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Face Oedema Leponex PS Novartis Sector: Urticaria Pharma ORAL 150 mg, daily Date:12/07/05ISR Number: 4846828-5Report Type:Expedited (15-DaCompany Report #PHNR2005AU01610 Age:24 YR Gender:Male I/FU:F Outcome PT Hospitalization - Agitation Initial or Prolonged Blood Creatine Other Phosphokinase Increased Hodgkin'S Disease 22-Feb-2006 08:30 AM Page: 3558 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Muscle Injury Myalgia Neuroleptic Malignant Report Source Product Role Manufacturer Route Dose Duration Syndrome Clozaril PS Novartis Sector: Pharma 0 - 150 mg/day 40320MIN Sertraline C 100 g, QD Sorbolene C Date:12/07/05ISR Number: 4846829-7Report Type:Expedited (15-DaCompany Report #PHEH2005US11125 Age:49 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyspnoea Clozaril PS Novartis Sector: Initial or Prolonged Panic Attack Pharma ORAL 25 mg, QD Clozaril SS Novartis Sector: Pharma ORAL 50 mg Qam, 150mg Qpm Clozaril SS Novartis Sector: Pharma ORAL 25mg Qam, 100mg Qpm Depakote C Trazodone C Date:12/07/05ISR Number: 4846833-9Report Type:Expedited (15-DaCompany Report #PHBS2005YU17443 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatic Enzyme Abnormal Leponex PS Novartis Sector: Hyperkalaemia Pharma ORAL 100 mg/d Metabolic Syndrome Sedation Weight Increased Date:12/07/05ISR Number: 4849368-2Report Type:Expedited (15-DaCompany Report #2005S1011365 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Toxicity Consumer Clozapine Tablets White Blood Cell Count Health (25 Mg) PS ORAL ORAL Increased Professional Other Date:12/08/05ISR Number: 4847866-9Report Type:Expedited (15-DaCompany Report #PHFR2005GB03913 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatitis C Clozaril PS Novartis Sector: Pharma ORAL Buprenorphine C UNKNOWN 22-Feb-2006 08:30 AM Page: 3559 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/08/05ISR Number: 4847870-0Report Type:Expedited (15-DaCompany Report #PHFR2005IE03896 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Clozaril PS Novartis Sector: Corrected Interval Pharma ORAL Prolonged Date:12/08/05ISR Number: 4847873-6Report Type:Expedited (15-DaCompany Report #PHFR2005IE03897 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Clozaril PS Novartis Sector: Corrected Interval Pharma ORAL Prolonged Date:12/08/05ISR Number: 4848477-1Report Type:Expedited (15-DaCompany Report #PHHO2005NZ16786 Age:35 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Level Increased Clozaril (Clozapine) PS Novartis Sector: Initial or Prolonged Gastrointestinal Necrosis Pharma ORAL 375mg daily 112 DAY Thrombosis Lithium C 1 g, BID Paroxetine C 20 mg, QD Omeprazole C 20 mg, QD Zopiclone C Date:12/08/05ISR Number: 4848488-6Report Type:Expedited (15-DaCompany Report #PHNR2005AU01655 Age:33 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acute Psychosis Clozaril PS Novartis Sector: Initial or Prolonged Anion Gap Increased Pharma 0 - 800 Other Blood Creatine mg/day Phosphokinase Increased Blood Lactate Dehydrogenase Increased Bundle Branch Block Right Cognitive Disorder Electrocardiogram Abnormal Eosinophil Count Abnormal Lymphocyte Count Increased Mental Impairment Platelet Count Decreased Treatment Noncompliance White Blood Cell Count Increased Date:12/08/05ISR Number: 4848490-4Report Type:Expedited (15-DaCompany Report #PHFR2005GB03958 Age:40 YR Gender:Male I/FU:I Outcome PT Hospitalization - Dysarthria Initial or Prolonged Medication Error Salivary Hypersecretion Somnolence 22-Feb-2006 08:30 AM Page: 3560 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tachycardia Report Source Product Role Manufacturer Route Dose Duration Clozaril PS Novartis Sector: Pharma 450 mg/day Clozaril SS Novartis Sector: Pharma 900 mg/day Date:12/08/05ISR Number: 4850541-8Report Type:Expedited (15-DaCompany Report #DSA_27459_2005 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Foreign Tavor PS ORAL 3 MG ONCE PO Initial or Prolonged Somnolence Health Atosil SS ORAL DF ONCE PO Tachycardia Professional Clozapine SS ORAL DF ONCE PO Other Solian SS ORAL DF ONCE PO Date:12/08/05ISR Number: 4851204-5Report Type:Expedited (15-DaCompany Report #MK200512-0013-1 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Intestinal Obstruction Health Anafranil Capsules Professional (Strength Unknown) PS ORAL 100 MG, QHS, Other PO 2 YR Clozapine Tablets SS ORAL 700 MG, QD, PO Ziprasidone Hydrochloride C Escitalopram Oxalate C Date:12/08/05ISR Number: 4851236-7Report Type:Expedited (15-DaCompany Report #DSA_26922_2005 Age:64 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Diastolic Health Ativan PS ORAL 0.5 MG Q DAY Initial or Prolonged Decreased Professional PO Sinus Bradycardia Ativan SS ORAL 0.5 MG BID PO Somnolence Clozapine SS ORAL 12.5 MG Q DAY White Blood Cell Count PO Decreased Trazodone SS ORAL 50 MG QHS PO Prevacid C Neurontin C Milk Of Magnesia C Levoxyl C Colace C Micaderm C Senokot C Date:12/08/05ISR Number: 4851266-5Report Type:Expedited (15-DaCompany Report #2005S1011495 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dyspnoea Health Clozapine Tablets Professional (25 Mg) PS ORAL 25MG;QD;PO Other 22-Feb-2006 08:30 AM Page: 3561 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/08/05ISR Number: 4876208-8Report Type:Periodic Company Report #018 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Health Fazaclo 100mg Odt Initial or Prolonged Professional Alamo Pharmaceuticals PS Alamo Pharmaceuticals 400 MG DAILY Levothyroxine C Naltrexone C Clonidine C Topamax C Colace C Lamictal C Ditropan C Date:12/09/05ISR Number: 4849573-5Report Type:Expedited (15-DaCompany Report #US-ABBOTT-05P-163-0318525-00 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Clarithromycin 500mg Drooling Tablets PS ORAL 8 DAY Dysarthria Clozapine SS ORAL Lethargy Clozapine SS ORAL Tachycardia Date:12/09/05ISR Number: 4851701-2Report Type:Direct Company Report #CTU 264749 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neutrophil Count Clozapine 100mg PS ORAL 300MG DAILY Decreased PO White Blood Cell Count Decreased Date:12/12/05ISR Number: 4851333-6Report Type:Expedited (15-DaCompany Report #GB-ABBOTT-05P-167-0317716-00 Age:51 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Renal Failure Acute Epilim PS UNKNOWN Initial or Prolonged Renal Tubular Necrosis Clozapine SS ORAL 919 DAY Other Clozapine SS 919 DAY Orphenadrine C UNKNOWN Propranolol C UNKNOWN Senna C UNKNOWN Lamotrigine C UNKNOWN Aspirin C UNKNOWN Date:12/13/05ISR Number: 4851665-1Report Type:Expedited (15-DaCompany Report #PHEH2004US12007 Age:39 YR Gender:Male I/FU:F Outcome PT Hospitalization - Abnormal Behaviour Initial or Prolonged Autism Spectrum Disorder Hyperhidrosis Hyperventilation Logorrhoea Therapeutic Response 22-Feb-2006 08:30 AM Page: 3562 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Decreased Report Source Product Role Manufacturer Route Dose Duration Clozaril PS Novartis Sector: Pharma ORAL 600 mg, QD Date:12/13/05ISR Number: 4851666-3Report Type:Expedited (15-DaCompany Report #PHNR2005AU01666 Age:74 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - C-Reactive Protein Clozaril PS Novartis Sector: Initial or Prolonged Increased Pharma 0 - 100 Cardiac Disorder mg/day 33120MIN Pyrexia Red Blood Cell Sedimentation Rate Increased Troponin Increased Date:12/13/05ISR Number: 4851667-5Report Type:Expedited (15-DaCompany Report #PHEH2005US12934 Age:64 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatitis C Clozaril PS Novartis Sector: Pharma ORAL 100mg Qam, 150mg Qhs Clozaril SS Novartis Sector: Pharma "gradually" decreasing Risperdal C ORAL 2mg Qam, 4mg Qhs Paxil C ORAL 25 mg, QD Ativan C ORAL 1 mg, QHS Date:12/13/05ISR Number: 4851671-7Report Type:Expedited (15-DaCompany Report #PHEH2005US12326 Age:55 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dyspnoea Clozaril PS Novartis Sector: Other Renal Cancer Metastatic Pharma ORAL 100 mg BID Respiratory Failure Date:12/13/05ISR Number: 4851672-9Report Type:Expedited (15-DaCompany Report #PHBS2005CA08655 Age:33 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Caesarean Section Clozaril PS Novartis Sector: Drug Exposure During Pharma ORAL UNK, UNK Pregnancy Clozaril SS Novartis Sector: Normal Newborn Pharma 200 mg/day Clozapine SS Senokot C 22-Feb-2006 08:30 AM Page: 3563 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/13/05ISR Number: 4852717-2Report Type:Expedited (15-DaCompany Report #PHBS2005NZ17413 Age:89 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Distension Clozaril PS Novartis Sector: Abdominal Pain Upper Pharma ORAL C-Reactive Protein Increased Eosinophilia Leukocytosis Liver Function Test Abnormal Orthostatic Hypotension Pyrexia Red Blood Cell Sedimentation Rate Increased Sinus Tachycardia Ultrasound Scan Abnormal Urinary Tract Infection Urogenital Trichomoniasis Date:12/13/05ISR Number: 4852722-6Report Type:Expedited (15-DaCompany Report #PHFR2005GB03430 Age:49 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Clozaril PS Novartis Sector: Initial or Prolonged Increased Pharma ORAL 350 mg/day Other Blood Alkaline Clozaril SS Novartis Sector: Phosphatase Increased Pharma ORAL 40 x 100 mg Electrocardiogram Qt overdose Prolonged Clozaril SS Novartis Sector: Gamma-Glutamyltransferase Pharma ORAL 450mg/day Increased Trazodone C ORAL 450mg/day Overdose Orlistat C ORAL 360mg/day Date:12/13/05ISR Number: 4852723-8Report Type:Expedited (15-DaCompany Report #PHNU2005DE04000 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Leponex / Clozaril Initial or Prolonged Surgery (Clozapine) PS Novartis Sector: Other Thyroid Operation Pharma ORAL UNK, UNK Clindamycin SS Staphylex SS Beloc Zok C Melperone C Oxazepam C Corangin C Pantozol C Euthyrox C Detrusitol C Calcium C Lorazepam C 22-Feb-2006 08:30 AM Page: 3564 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/13/05ISR Number: 4852726-3Report Type:Expedited (15-DaCompany Report #PHNR2005AU01610 Age:24 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Clozaril PS Novartis Sector: Initial or Prolonged Blood Creatine Pharma 0 - 150 Other Phosphokinase Increased mg/day 40320MIN Hodgkin'S Disease Chemotherapeutics,Ot Muscle Injury her SS Myalgia Sertraline C 100 g, QD Neuroleptic Malignant Sorbolene C Syndrome Date:12/13/05ISR Number: 4852728-7Report Type:Expedited (15-DaCompany Report #PHNU2005DE03978 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatinine Leponex / Clozaril Initial or Prolonged Increased (Clozapine) PS Novartis Sector: Other Dialysis Pharma ORAL 300 mg/day Loss Of Consciousness Renal Failure Retrograde Amnesia Rhabdomyolysis Date:12/13/05ISR Number: 4853986-5Report Type:Expedited (15-DaCompany Report #2005S1010676 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Dizziness Health Clozapine Tablets Required Granulocytopenia Professional (100 Mg) PS ORAL 400 MG; HS; Intervention to Leukopenia Other ORAL Prevent Permanent Loss Of Consciousness Fluoxetine C Impairment/Damage Nausea Methylphenidate Vomiting Hydrochloride C Furosemide C Lansoprazole C Potassium Chloride C Date:12/13/05ISR Number: 4854300-1Report Type:Direct Company Report #CTU 264955 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Disorder Clozapine 100mg PS ORAL 400MG Q HS Initial or Prolonged Echocardiogram Abnormal PO Respiratory Distress Colace C Tricuspid Valve Senna C Incompetence Protonix C Cogentin C Multivitamin C Clozaril C Date:12/13/05ISR Number: 4854508-5Report Type:Expedited (15-DaCompany Report #2005164007 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Other Tachycardia Foreign Health 22-Feb-2006 08:30 AM Page: 3565 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Product Role Manufacturer Route Dose Duration Nicotine (Nicotine) PS TRANSDERMAL TRANSDERMAL Clozapine (Clozapine) SS 150 MG BID, Date:12/14/05ISR Number: 4853483-7Report Type:Expedited (15-DaCompany Report #PHNU2005DE03807 Age:70 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Lymphopenia Leponex / Clozaril White Blood Cell Count (Clozapine) PS Novartis Sector: Increased Pharma ORAL 12.5 mg, QD Tasmar C ORAL 300 mg, QD Isicom "Desitin" C ORAL 900 mg, QD Pentalong C ORAL 80 mg, QD Nacom - Slow Release C ORAL 200 mg, QD Cabaseril C ORAL 4 mg, QD Date:12/14/05ISR Number: 4853681-2Report Type:Expedited (15-DaCompany Report #PHHO2005BR10116 Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bipolar Disorder Leponex PS Novartis Sector: Concomitant Disease Pharma 100mg 1/2 tab Progression daily Dizziness Anafranil SS 75mg 3 tabs Drug Toxicity daily Hypertension Oxcarbazepine SS ORAL 1 tab am, 1 Vomiting tab pm Oxcarbazepine SS ORAL 2 tabs am, 2 tabs pm Oxcarbazepine SS 3 tabs a day Carbolitium C UNK, UNK Abilify C Propranolol C 40mg 3 tabs daily Date:12/14/05ISR Number: 4855139-3Report Type:Expedited (15-DaCompany Report #2005-US-01348 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Renal Failure Other Clozapine Tablets, 12.5mg, 25mg, 50mg, 100mg (Clozapine) PS ORAL ORAL Date:12/14/05ISR Number: 4855140-XReport Type:Expedited (15-DaCompany Report #2005-US-01304 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Oesophageal Rupture Health Clozapine Tablets, Initial or Prolonged Professional 12.5mg, 25mg, 50mg, Other Other 100mg (Clozapine) PS ORAL 37.5 MG, QD, ORAL 22-Feb-2006 08:30 AM Page: 3566 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/14/05ISR Number: 4855141-1Report Type:Expedited (15-DaCompany Report #2005-US-00549 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Colon Cancer Health Clozapine Tablets, Hospitalization - Signet-Ring Cell Professional 12.5mg, 25mg, 50 Mg, Initial or Prolonged Carcinoma Other 100 Mg (Clozapine) PS ORAL 550 MG, QD, Other ORAL Date:12/14/05ISR Number: 4855176-9Report Type:Expedited (15-DaCompany Report #2005-US-01349 Age:67 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Renal Failure Health Clozapine Tablets, Professional 12.5mg, 25mg, 50 Mg Other 100mg (Clozapine) PS ORAL ORAL Date:12/14/05ISR Number: 4855177-0Report Type:Expedited (15-DaCompany Report #2005-US-01346 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine Tablets, Professional 12.5 Mg, 25mg, 50 Mg Other 100mg (Clozapine) PS ORAL 75 MG, QD, ORAL Date:12/15/05ISR Number: 4854307-4Report Type:Expedited (15-DaCompany Report #PHEH2005US13346 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anorexia Nervosa Clozaril PS Novartis Sector: Food Poisoning Pharma Unk, Unk Neutropenia Date:12/15/05ISR Number: 4854308-6Report Type:Expedited (15-DaCompany Report #PHFR2005GB03967 Age:69 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Exposure Clozaril PS Novartis Sector: Initial or Prolonged Depressed Level Of Pharma ORAL 1 x 100mg Consciousness tablet Date:12/15/05ISR Number: 4854311-6Report Type:Expedited (15-DaCompany Report #PHRM2005FR03210 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Confusional State Leponex PS Novartis Sector: Dermatitis Bullous Pharma ORAL 300mg, daily 365 DAY Inflammation Loxapac C Pyrexia Depakine C Lysanxia C 22-Feb-2006 08:30 AM Page: 3567 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/15/05ISR Number: 4854312-8Report Type:Expedited (15-DaCompany Report #PHRM2005FR03223 Age:82 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Leponex PS Novartis Sector: Initial or Prolonged Csf Cell Count Increased Pharma ORAL 25 mg, QD Csf Lymphocyte Count Noctamid SS ORAL 1 mg, QD 8640 MIN Increased Seropram SS ORAL 40 mg, QD Csf Protein Increased Seropram SS ORAL 40 mg, QD Inflammation Valium SS ORAL 20 DF, QD 17280MIN Lumbar Puncture Leponex SS Novartis Sector: Meningitis Listeria Pharma ORAL 25 mg, QD Myoclonus Stilnox /Sch/ SS ORAL 10 mg, QD Red Blood Cells Csf Stilnox /Sch/ SS ORAL 10 mg, QD Positive Xanax C ORAL 0.5 mg, QD Casodex C Date:12/15/05ISR Number: 4854313-XReport Type:Expedited (15-DaCompany Report #PHBS2005BR13463 Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anorexia Leponex PS Novartis Sector: Asthenia Pharma ORAL 50 mg, TID 5760 MIN Confusional State Leponex SS Novartis Sector: Delirium Pharma ORAL 50 mg, BID Dizziness Carbolitium C ORAL 300 mg/d Fall Chlorpromazine C ORAL 100 mg/d Fatigue Lorax C ORAL 4 mg, QHS Headache Haloperidol C ORAL 2.5 mg, QHS Hypersomnia Diazepan C ORAL 5 mg, QD Monoplegia Movement Disorder Nausea Salivary Hypersecretion Somnolence Suicidal Ideation Urinary Retention Visual Acuity Reduced Date:12/15/05ISR Number: 4854335-9Report Type:Expedited (15-DaCompany Report #PHNU2005DE04010 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Accidental Exposure Leponex / Clozaril Sedation (Clozapine) PS Novartis Sector: Pharma ORAL 150 mg, ONCE/SINGLE 1440 MIN Date:12/15/05ISR Number: 4854409-2Report Type:Expedited (15-DaCompany Report #PHBS2005CA12871 Age:21 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Clozaril PS Novartis Sector: Chest Discomfort Pharma ORAL 500 mg, QD 739 DAY Ejection Fraction Clonazepam C 0.5 mg, PRN Decreased Haloperidol C 2 mg, QMO Palpitations 22-Feb-2006 08:30 AM Page: 3568 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/15/05ISR Number: 4855102-2Report Type:Expedited (15-DaCompany Report #FR-SANOFI-SYNTHELABO-A02200503213 Age:82 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Meningitis Aseptic Stilnox PS ORAL 1 MON Initial or Prolonged Stilnox SS ORAL Noctamide SS ORAL 6 DAY Valium SS ORAL 6.6 mg 12 DAY Seropram SS ORAL 1 MON Seropram SS ORAL Leponex SS ORAL 1 MON Leponex SS ORAL Xanax C ORAL Casodex C ORAL UNK Date:12/15/05ISR Number: 4859852-3Report Type:Expedited (15-DaCompany Report #2005S1010522 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Clozapine Tablets Professional (100 Mg) PS ORAL 150 MG; QD; Other ORAL; 200 MG; HS; ORAL Date:12/15/05ISR Number: 4859853-5Report Type:Expedited (15-DaCompany Report #2005S1010531 Age:56 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dyspnoea Health Clozapine Tablets Gastric Cancer Professional (100 Mg) PS ORAL 100 MG; QAM; Other ORAL 250 MG; HS; ORAL Sertraline C Hydrochloride C Zonisamide C Alprazolam C Lisinopril C Levothyroxine C Desmopressin C Atorvastatin C Date:12/15/05ISR Number: 4859856-0Report Type:Expedited (15-DaCompany Report #2005S1011511 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neoplasm Malignant Health Clozapine Tablets Professional (100 Mg) PS ORAL 100 MG; TID; Other ORAL Lithium C Morphine C Fentanyl C Date:12/15/05ISR Number: 4859911-5Report Type:Expedited (15-DaCompany Report #2005S1010113 Age:55 YR Gender:Female I/FU:F Outcome PT Report Source Death Death Health Professional 22-Feb-2006 08:30 AM Page: 3569 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Product Role Manufacturer Route Dose Duration Clozapine Tablets (100 Mg) PS ORAL SEE IMAGE Morphine Sulfate C Valproate Semisodium C Benzatropine Mesilate C Paracetamol/Dextropr opoxyphene Napsilate C Cyclobenzaprine C Atenolol C Lorazepam C Lidocaine C Citalopram C Date:12/15/05ISR Number: 4860255-6Report Type:Expedited (15-DaCompany Report #2005S1011590 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional (100 Mg) PS ORAL 300 MG; BID; Other ORAL Date:12/15/05ISR Number: 4860410-5Report Type:Expedited (15-DaCompany Report #2005S1011587 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neoplasm Malignant Health Clozapine Tablets Professional (25 Mg) PS ORAL 25 MG; QD; Other ORAL Metoprolol Succinate C Carbamazepine C Benzatropine Mesilate C Clonazepam C Olanzapine C Fenofibrate C Ranitidine Hydrochloride C Rosuvastatin C Date:12/16/05ISR Number: 4855658-XReport Type:Expedited (15-DaCompany Report #PHEH2005US09222 Age:18 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Upper Clozaril PS Novartis Sector: Dyspepsia Pharma ORAL 100mg BID, Gastric Ulcer 25mg BID Gastrointestinal Motility Disorder Impaired Gastric Emptying 22-Feb-2006 08:30 AM Page: 3570 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/16/05ISR Number: 4855854-1Report Type:Expedited (15-DaCompany Report #GB-GLAXOSMITHKLINE-B0403525A Age:39 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tachycardia Nicotine PS Glaxosmithkline TRANSDERMAL Clozapine SS 150MG Twice per day Date:12/16/05ISR Number: 4860522-6Report Type:Expedited (15-DaCompany Report #2005-US-01150 Age:61 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Distension Health Clozapine Tablets, Alcoholism Professional 12.5 Mg, 25 Mg, 50 Chemical Poisoning Other Mg, 100 Mg Chronic Obstructive (Clozapine) PS ORAL 200 MG, QD, Pulmonary Disease ORAL Drug Abuser Hepatic Failure Hypothyroidism Metabolic Acidosis Multi-Organ Failure Refusal Of Treatment By Relative Renal Failure Respiratory Failure Schizophrenia Smoker Date:12/16/05ISR Number: 4860523-8Report Type:Expedited (15-DaCompany Report #2005-US-00816 Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death General Physical Health Health Clozapine Tablets, Hospitalization - Deterioration Professional 12.5mg, 25mg, 50mg, Initial or Prolonged Pneumonia Other 100mg (Clozapine) PS ORAL 750 MG, QD, Smoker ORAL Date:12/16/05ISR Number: 4860784-5Report Type:Direct Company Report #CTU 265212 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Creatine Clozapine PS 600 MG/D IN Phosphokinase Increased DIVIDED DOSES Body Temperature Aripiprazole C Increased Heparin Drip C Nuchal Rigidity Gemfibrozil C Furosemide C Escitalopram C Ergocalciferol C Digoxin C Piperacillin/Tazobac tam C Pantoprazole C Nafcillin C Vancomycin C Dexamethasone C Sodium Bicarbonate C Metoprolol C 22-Feb-2006 08:30 AM Page: 3571 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Atorvastatin C Date:12/19/05ISR Number: 4859837-7Report Type:Expedited (15-DaCompany Report #PHNU2005DE04056 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Leponex / Clozaril Initial or Prolonged Drug Level Increased (Clozapine) PS Novartis Sector: Other General Physical Pharma ORAL up to Condition Abnormal 500mg/day Jaundice Cholestatic Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL 200mg/day Abilify SS UNKNOWN 10 mg, QD 148 DAY Date:12/19/05ISR Number: 4859998-XReport Type:Expedited (15-DaCompany Report #GB-MERCK-0512GBR00081 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diarrhoea Cogentin PS Merck & Co., Inc UNKNOWN Initial or Prolonged Myoclonus Valproate Sodium SS UNKNOWN Pneumonia Terazosin Hydrochloride SS ORAL Clozapine SS UNKNOWN Ibuprofen SS UNKNOWN Date:12/19/05ISR Number: 4864026-6Report Type:Direct Company Report #CTU 265361 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blood Creatine Clozapine (Ivax) PS Ivax TITRATED TO Intervention to Phosphokinase Increased 300G/DAY Prevent Permanent Body Temperature Impairment/Damage Increased Chest Pain Malaise Myocarditis Pericarditis Troponin Increased White Blood Cell Count Increased Date:12/20/05ISR Number: 4860898-XReport Type:Expedited (15-DaCompany Report #PHRM2005FR03242 Age:82 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Leponex PS Novartis Sector: Hospitalization - Confusional State Pharma ORAL 12.5 mg, QD 81 DAY Initial or Prolonged Leukopenia Levodopa C Other Myeloid Maturation Arrest Valsartan C Neutrophil Count Atenolol C Decreased Paroxetine C Psychomotor Retardation Acarbose C Pyrexia Clopidogrel C Omeprazole C Lormetazepam C Gliclazide C 22-Feb-2006 08:30 AM Page: 3572 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/20/05ISR Number: 4860900-5Report Type:Expedited (15-DaCompany Report #PHFR2005GB03607 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Clozaril PS Novartis Sector: Initial or Prolonged Blood Creatine Pharma ORAL 300 mg/day 391 DAY Other Phosphokinase Increased Clozaril SS Novartis Sector: Confusional State Pharma ORAL 12.5mg/day Delirium Disorientation Drug Withdrawal Syndrome Hallucination, Visual Hyperhidrosis Malaise Date:12/20/05ISR Number: 4865258-3Report Type:Expedited (15-DaCompany Report #2005-US-01359 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypoxia Health Clozapine Tablets, Initial or Prolonged Myocardial Infarction Professional 12.5mg, 25mg, 50 Mg, Other Other 100mg (Clozapine) PS 150 MG, QD Date:12/20/05ISR Number: 4865265-0Report Type:Expedited (15-DaCompany Report #2005-US-01393 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Clozapine Tablets, Professional 12.5mg, 25mg, 50 Mg, Other 100mg (Clozapine) PS ORAL 150 MG, QD, ORAL Date:12/20/05ISR Number: 4865266-2Report Type:Expedited (15-DaCompany Report #2005-US-00873 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine Tablets, Other Professional 12.5mg, 25mg, 50 Mg, Other 100mg (Clozapine) PS ORAL 400 MG, QD, ORAL Azithromycin C Ziprasidone C Lorazepam C Aludrox /00082501/ C Trazodone C Magnesium Hydroxide C Paracetamol C Diltiazem C Pantoprazole C Docusate Sodium C Ziprasidone C Salbutamol W/Ipratropium C Terbinafine C Ceftriaxone C Salbutamol C Oxygen C Seretide C Nicotine C 22-Feb-2006 08:30 AM Page: 3573 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Breva C Date:12/20/05ISR Number: 4865268-6Report Type:Expedited (15-DaCompany Report #2005-US-00549 Age:57 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abdominal Distension Health Clozapine Tablets, Hospitalization - Colon Cancer Professional 12.5mg, 25mg, 50 Mg, Initial or Prolonged Constipation Other 100mg (Clozapine) PS ORAL 550 MG, QD, Other Faecaloma ORAL Signet-Ring Cell Carcinoma Date:12/20/05ISR Number: 4865405-3Report Type:Expedited (15-DaCompany Report #2005-US-00028 Age:47 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozapine Tablets, Hospitalization - Dyspnoea Professional 12.5mg, 25mg, 50 Mg Initial or Prolonged Loss Of Consciousness Other 100mg (Tablets) PS ORAL 575 MG, QD, Required Lung Neoplasm Malignant ORAL Intervention to Myocardial Infarction Valproate Semisodium SS ORAL 1500 MG, QD, Prevent Permanent Pulmonary Thrombosis ORAL 10 YR Impairment/Damage Docusate Sodium C Folic Acid C Date:12/20/05ISR Number: 4865407-7Report Type:Expedited (15-DaCompany Report #2005-US-00645 Age:70 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine Tablets, Other Professional 12.5mg, 25mg, 50 Mg, Other 100mg (Clozapine) PS ORAL 300 MG, QD, ORAL Temazepam C Date:12/20/05ISR Number: 4865519-8Report Type:Expedited (15-DaCompany Report #2005S1011698 Age:69 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozapine Tablets Professional (25 Mg) PS ORAL 75 MG; HS; Other ORAL Date:12/20/05ISR Number: 4865526-5Report Type:Expedited (15-DaCompany Report #2005-US-00480 Age:47 YR Gender:Male I/FU:F Outcome PT Hospitalization - Anorexia Initial or Prolonged Convulsion Other Intentional Overdose Leukaemia Mental Status Changes Pulmonary Embolism Pyrexia Treatment Noncompliance 22-Feb-2006 08:30 AM Page: 3574 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Weight Decreased Report Source Product Role Manufacturer Route Dose Duration Health Clozapine Tablets, Professional 12.5mg, 25mg, 50 Mg, Other 100mg (Clozapine) PS ORAL 625 MG QD, ORAL Date:12/20/05ISR Number: 4865580-0Report Type:Expedited (15-DaCompany Report #2005-US-01076 Age:67 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Gastrointestinal Health Clozapine Tablets, Initial or Prolonged Haemorrhage Professional 12.5mg, 25mg, 50mg Other Pneumonia Aspiration Other 100mg (Clozapine) PS ORAL 450 MG, QD, ORAL Tocopherol C Laxatives C Metoprolol C Folic Acid C Pantoprazole C Fluvoxamine C Valproic Acid C Atorvastatin C Date:12/20/05ISR Number: 4865602-7Report Type:Expedited (15-DaCompany Report #2005-US-01420 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets, Professional 12.5mg, 25mg, 50mg Other 100mg (Clozapine) PS ORAL 350 MG, QD, ORAL Date:12/20/05ISR Number: 4865604-0Report Type:Expedited (15-DaCompany Report #2005-US-01423 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine Tablets, Professional 12.5mg, 25mg, 50mg Other 100mg(Clozapine) PS ORAL 50 MG, QD, ORAL Date:12/20/05ISR Number: 4885691-3Report Type:Periodic Company Report #HQWYE274628DEC04 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatic Steatosis Health Effexor Xr Hepatitis Professional (Venlafaxine Liver Function Test Hydrochloride, Abnormal Capsule, Extended Nausea Release) PS 450 MG 1 X Vomiting PER 1 DAY Weight Increased Clozaril (Clozapine) SS ORAL 400 MG 1 X PER 1 DAY, ORAL 22-Feb-2006 08:30 AM Page: 3575 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/21/05ISR Number: 4862429-7Report Type:Expedited (15-DaCompany Report #PHNR2005AU01348 Age:49 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dysphagia Clozaril PS Novartis Sector: Initial or Prolonged Dystonia Pharma 0 - 12.5 Other Hypotension mg/day 5760 MIN Joint Stiffness Sedation Date:12/21/05ISR Number: 4862430-3Report Type:Expedited (15-DaCompany Report #PHFR2005GB03913 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatitis C Clozaril PS Novartis Sector: Pharma ORAL Buprenorphine C UNKNOWN Date:12/21/05ISR Number: 4862432-7Report Type:Expedited (15-DaCompany Report #PHNR2005AU01698 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Creatine Clozaril PS Novartis Sector: Hospitalization - Phosphokinase Increased Pharma 0 - 500 Initial or Prolonged Chest Discomfort mg/day Other Coordination Abnormal Clozaril SS Novartis Sector: Difficulty In Walking Pharma Disorientation Clozaril SS Novartis Sector: Dizziness Pharma Drug Interaction Clozaril SS Novartis Sector: Drug Level Above Pharma Therapeutic Valproate Sodium SS 300 mg, BID Febrile Infection Valium SS Headache Clozaril SS Novartis Sector: Nasal Congestion Pharma UNK, UNK Nausea Ventolin Pharyngolaryngeal Pain Productive Cough /00139501/ C Psychotic Disorder Lithium C 500 mg, BID Pyrexia Rash Generalised Respiratory Tract Infection Sedation Somnolence Sudden Death Viral Infection Vomiting Date:12/21/05ISR Number: 4862439-XReport Type:Expedited (15-DaCompany Report #PHFR2005GB04019 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Test Abnormal Clozapine PS Novartis Sector: Breast Cancer Pharma ORAL 400 mg/day Amisulpride SS ORAL 400 mg/day Paroxetine C ORAL 30 mg/day Kwells C ORAL UNK, TID 22-Feb-2006 08:30 AM Page: 3576 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/21/05ISR Number: 4862446-7Report Type:Expedited (15-DaCompany Report #PHBS2005BE18358 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Cholesterol Leponex PS Novartis Sector: Initial or Prolonged Increased Pharma ORAL 250 mg/d Blood Glucose Increased Blood Triglycerides Increased Dyslipidaemia Glucose Tolerance Impaired Date:12/21/05ISR Number: 4862447-9Report Type:Expedited (15-DaCompany Report #PHBS2005BE18373 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Cholesterol Leponex PS Novartis Sector: Initial or Prolonged Increased Pharma ORAL 400 mg/d Blood Glucose Increased Blood Triglycerides Increased Dyslipidaemia Glucose Tolerance Impaired Date:12/21/05ISR Number: 4862448-0Report Type:Expedited (15-DaCompany Report #PHBS2005BE18325 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Cholesterol Leponex PS Novartis Sector: Initial or Prolonged Increased Pharma ORAL 300 mg/d Blood Triglycerides Increased Dyslipidaemia Glucose Tolerance Impaired Date:12/21/05ISR Number: 4862459-5Report Type:Expedited (15-DaCompany Report #PHRM2005FR02533 Age:68 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Leponex PS Novartis Sector: Initial or Prolonged Dehydration Pharma ORAL 100 mg, BID Ecg Signs Of Myocardial Seloken C ORAL Ischaemia Hyzaar C ORAL Lung Disorder Plavix C ORAL Myocarditis Kardegic C ORAL Pericardial Effusion Novonorm C ORAL Renal Failure Troponin Increased Date:12/21/05ISR Number: 4862461-3Report Type:Expedited (15-DaCompany Report #PHBS2005BR18370 Age:4 YR Gender:Female I/FU:I Outcome PT Hospitalization - Accidental Exposure Initial or Prolonged Gastric Lavage 22-Feb-2006 08:30 AM Page: 3577 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Somnolence Report Source Product Role Manufacturer Route Dose Duration Leponex PS Novartis Sector: Pharma ORAL 50 mg, ONCE/SINGLE 1440 MIN Date:12/21/05ISR Number: 4862473-XReport Type:Expedited (15-DaCompany Report #PHBS2005BE18375 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Cholesterol Leponex PS Novartis Sector: Initial or Prolonged Increased Pharma ORAL 400 mg/d Other Blood Triglycerides Increased Dyslipidaemia Glucose Tolerance Impaired Glucose Tolerance Increased Date:12/21/05ISR Number: 4862491-1Report Type:Expedited (15-DaCompany Report #PHBS2005BE18508 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Cholesterol Leponex PS Novartis Sector: Initial or Prolonged Increased Pharma ORAL 500 mg/day Blood Triglycerides Increased Dyslipidaemia Date:12/21/05ISR Number: 4862493-5Report Type:Expedited (15-DaCompany Report #PHBS2005BE18503 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Cholesterol Leponex PS Novartis Sector: Initial or Prolonged Increased Pharma ORAL 300 mg/day Blood Triglycerides Increased Dyslipidaemia Date:12/21/05ISR Number: 4862498-4Report Type:Expedited (15-DaCompany Report #PHBS2005BE18475 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Cholesterol Leponex PS Novartis Sector: Initial or Prolonged Increased Pharma ORAL 100 mg/day Blood Triglycerides Increased Dyslipidaemia 22-Feb-2006 08:30 AM Page: 3578 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/21/05ISR Number: 4862502-3Report Type:Expedited (15-DaCompany Report #PHBS2005BE18515 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Cholesterol Leponex PS Novartis Sector: Initial or Prolonged Increased Pharma ORAL 400 mg/day Blood Triglycerides Increased Dyslipidaemia Date:12/21/05ISR Number: 4862512-6Report Type:Expedited (15-DaCompany Report #PHBS2005BE18516 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Cholesterol Leponex PS Novartis Sector: Initial or Prolonged Increased Pharma ORAL 300 mg/day Blood Triglycerides Increased Dyslipidaemia Date:12/21/05ISR Number: 4862595-3Report Type:Expedited (15-DaCompany Report #FR-ROCHE-428071 Age:82 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Meningitis Aseptic Valium PS Roche ORAL STRENGTH Initial or Prolonged REPORTED AS 2MG/5ML 12 DAY Leponex SS ORAL Seropram SS ORAL Noctamide SS ORAL 6 DAY Stilnox SS ORAL Xanax C ORAL Date:12/21/05ISR Number: 4865411-9Report Type:Direct Company Report #CTU 265530 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neutrophil Count Clozapine 25 Mg, 100 Increased Mg (Ivax) PS Ivax ORAL 12.5 - 300 MG White Blood Cell Count (TITRATION Increased UP) BID PO Date:12/21/05ISR Number: 4866441-3Report Type:Expedited (15-DaCompany Report #GBWYE235414DEC05 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diarrhoea Health Anadin Ibuprofen Initial or Prolonged Myoclonus Professional (Ibuprofen, Unspec) PS Pneumonia Other Benzatropine (Benzatropine, , 0) SS Clozapine (Clozapine, , 0) SS Hytrin (Terazosin Hydrochloride, , 0) SS ORAL Valproate Sodium (Valproate Sodium, , 0) SS 22-Feb-2006 08:30 AM Page: 3579 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/21/05ISR Number: 4866531-5Report Type:Expedited (15-DaCompany Report #2005-US-00879 Age:77 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Condition Aggravated Health Clozapine Tablets, Dyskinesia Professional 12.5mg, 25mg, 50 Mg Gait Disturbance Other 100mg (Clozapine) PS ORAL 50 MG QD, Hallucination ORAL Myocardial Infarction Sinemet C Somnolence Entacapone C Speech Disorder Pergolide Mesilate C Amantadine C Ibuprofen C Donepezil Hydrochloride C Levothyroxine Sodium C Pravastatin Sodium C Date:12/21/05ISR Number: 4866592-3Report Type:Expedited (15-DaCompany Report #2005149177 Age:53 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abnormal Behaviour Consumer Accupril (Quinapril Other Constipation Hydrochloride) PS Convulsion Clozapine Drooling (Clozapine) SS Drug Toxicity Hydrochlorothiazide Malaise (Hydrochlorothiazide ) C Date:12/21/05ISR Number: 4866680-1Report Type:Expedited (15-DaCompany Report #2005168251 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyponatraemia Foreign Atarax (Tablet) Initial or Prolonged Overdose Health (Hydroxyzine Rhabdomyolysis Professional Hydrochloride) PS ORAL ORAL Clonazepam (Clonazepam) SS ORAL 40 DROP, ORAL Lamisil (Terbinafine Hydrochloride) SS ORAL ORAL Depakine (Valproate Sodium) SS ORAL ORAL Leponex "Novartis" (Clozapine) SS Novartis ORAL ORAL Date:12/21/05ISR Number: 4866700-4Report Type:Expedited (15-DaCompany Report #S05-FRA-05670-01 Age:82 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cognitive Disorder Foreign Seropram (Citalopram Initial or Prolonged Condition Aggravated Health Hydrobromide) PS ORAL 40 MG QD PO Hallucination Professional Seropram (Citalopram Meningitis Aseptic Other Hydrobromide) SS ORAL 40 MG QD PO Myoclonus Stilnox (Zolpidem) SS ORAL 10 MG QD PO Stilnox (Zolpidem) SS ORAL 10 MG QD PO Lormetazepam SS ORAL 1 MG QD PO Valium (Diazepam) SS ORAL 20 QD PO Leponex "Novartis" 22-Feb-2006 08:30 AM Page: 3580 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Clozapine) SS Novartis ORAL 25 MG QD PO Leponex "Novartis" (Clozapine) SS Novartis ORAL 25 MG QD PO Casodex (Bicalutamide) SS Xanax (Alprazolam) C Date:12/22/05ISR Number: 4864484-7Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12929816 Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aneurysm Prolixin Decanoate Other Myocardial Infarction Inj PS Apothecon INTRAMUSCULAR Clozapine SS ORAL 3 YR Remeron C Date:12/22/05ISR Number: 4864508-7Report Type:Expedited (15-DaCompany Report #AU-ROCHE-428558 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Valium PS Roche UNKNOWN Completed Suicide Clozaril SS ORAL FROM 28 OCT Malaise 1996 ON THE Weight Increased PATIENT TOOK 25 MG DAILY. ON 18 JANUARY Date:12/22/05ISR Number: 4867169-6Report Type:Expedited (15-DaCompany Report #2005169224 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dizziness Health Geodon (Ziprasidone) PS 120 MG (1 IN Hospitalization - Nausea Professional 1 D), UNKNOWN Initial or Prolonged Vomiting Clozapine (Clozapine) SS ORAL 600 MG, ORAL Macrogol (Macrogol) C Docusate (Docusate) C Haldol (Haloperidol) C Trihexyphenidyl (Trihexyphenidyl) C Gemfibrozil (Gemfibrozil) C Metoclopramide (Metoclopramide) C Pantoprazole (Pantoprazole) C Magnesium Oxide (Magnesium Oxide) C Date:12/22/05ISR Number: 4867477-9Report Type:Expedited (15-DaCompany Report #2005S1011783 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional (100 Mg) PS ORAL 200 Other MG;QD;ORAL, 400 MG;QD;ORAL 22-Feb-2006 08:30 AM Page: 3581 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tamsulosin Hydrochloride C .. C Tolterodine L-Tartrate C Propranolol C Quetiapine Fumarate C Date:12/22/05ISR Number: 4867479-2Report Type:Expedited (15-DaCompany Report #2005S1007142 Age:87 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Granulocytopenia Health Clozapine Talbets Professional (25 Mg) PS ORAL 12.5 MG;QD;PO Other Aripiprazole C Levothyroxine Sodium C Donepezil Hydrochloride C Valproate Semisodium C Quetiapine Fumarate C Venlafaxine C Propranolol Hydrochloride C Date:12/22/05ISR Number: 4867488-3Report Type:Expedited (15-DaCompany Report #2005S1011365 Age:55 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Consumer Clozapine Tablets White Blood Cell Count Health (25 Mg) PS ORAL ORAL Increased Professional Other Date:12/22/05ISR Number: 4867494-9Report Type:Expedited (15-DaCompany Report #2005S1011932 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebral Haemorrhage Health Clozapine Tablets Professional (25 Mg) PS ORAL 75 MG; HS; Other ORAL Paroxetine Hydrochloride C Quetiapine Fumarate C Levodopa/Carbidopa C Midodrine C Donepezil Hydrochloride C Date:12/23/05ISR Number: 4864977-2Report Type:Expedited (15-DaCompany Report #PHFR2005IE03943 Age:61 YR Gender:Female I/FU:F Outcome PT Life-Threatening Cellulitis Hospitalization - Dyspnoea Initial or Prolonged Neutrophil Count Other Increased Pain In Extremity 22-Feb-2006 08:30 AM Page: 3582 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Platelet Count Increased Pulmonary Embolism Swelling Report Source Product Role Manufacturer Route Dose Duration White Blood Cell Count Clozaril PS Novartis Sector: Increased Pharma ORAL 300mg/day Clozaril SS Novartis Sector: Pharma ORAL 400mg/day Aspirin C ORAL 75mg/day Date:12/23/05ISR Number: 4864978-4Report Type:Expedited (15-DaCompany Report #PHNR2005AU01666 Age:74 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Bicarbonate Clozaril PS Novartis Sector: Initial or Prolonged Increased Pharma 0 - 100 Other Blood Chloride Decreased mg/day 46080MIN Blood Sodium Decreased Clozaril SS Novartis Sector: Bradycardia Pharma UNK, C-Reactive Protein ONCE/SINGLE Increased Cardiac Disorder Depressed Level Of Consciousness Faecal Incontinence Haematocrit Decreased Haemoglobin Increased Hypotension Lymphocyte Morphology Abnormal Mean Cell Haemoglobin Decreased Mean Cell Volume Decreased Pyrexia Red Blood Cell Sedimentation Rate Increased Troponin Increased Urinary Incontinence Vomiting Date:12/23/05ISR Number: 4864984-XReport Type:Expedited (15-DaCompany Report #PHEH2005US13528 Age:69 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hilar Lymphadenopathy Clozaril PS Novartis Sector: Lymphadenopathy Pharma ORAL 200 mg, BID Mediastinal Clozapine SS ORAL 200 mg, BID Neutrophil Count Multivitamins C Decreased Non-Small Cell Lung Cancer Stage Iiib Radiotherapy Weight Decreased White Blood Cell Count Decreased 22-Feb-2006 08:30 AM Page: 3583 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/23/05ISR Number: 4864985-1Report Type:Expedited (15-DaCompany Report #PHBS2005NZ18523 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Clozaril PS Novartis Sector: Initial or Prolonged Phosphokinase Increased Pharma 300 mg/d 99360MIN Hyponatraemia Clozaril SS Novartis Sector: Lower Respiratory Tract Pharma 75 mg/d Infection Clonazepam C 4.5 mg/d Neutrophil Count Tetrabenazine C 12.5 mg, TID Increased Polydipsia White Blood Cell Count Increased Date:12/23/05ISR Number: 4865000-6Report Type:Expedited (15-DaCompany Report #PHNR2005AU01716 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alcoholism Clozaril PS Novartis Sector: Drug Interaction Pharma 250-450 mg Salivary Hypersecretion daily Sedation Naltrexone SS Luvox SS Date:12/23/05ISR Number: 4865143-7Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-13196753 Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Schizophrenia Aripiprazole PS Otsuka Pharmaceuticals Europe Limited ORAL Clozapine SS ORAL Date:12/23/05ISR Number: 4865886-5Report Type:Expedited (15-DaCompany Report #PHFR2005GB03958 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Overdose Clozaril PS Novartis Sector: Initial or Prolonged Drug Level Increased Pharma ORAL 450 mg/day Other Dysarthria Clozaril SS Novartis Sector: Salivary Hypersecretion Pharma 900 mg/day Sedation Venlafaxine C ORAL 112.5mg/day Somnolence Valproate Sodium C ORAL 1g/day Tachycardia Priadel C ORAL 700mg/day Lamotrigine C ORAL 100 mg, BID Date:12/23/05ISR Number: 4865888-9Report Type:Expedited (15-DaCompany Report #PHBS2004NZ15754 Age:47 YR Gender:Male I/FU:F Outcome PT Death Agitation Blood Creatine Phosphokinase Increased Circulatory Collapse Fall Myocardial Infarction Myocarditis 22-Feb-2006 08:30 AM Page: 3584 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pyrexia Troponin I Increased Report Source Product Role Manufacturer Route Dose Duration Clozaril PS Novartis Sector: Pharma ORAL Date:12/23/05ISR Number: 4865890-7Report Type:Expedited (15-DaCompany Report #PHNR2004AU00450 Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Cholesterol Clozaril PS Novartis Sector: Initial or Prolonged Increased Pharma 12 - 500 Blood Glucose Increased mg/day Blood Triglycerides Clozaril SS Novartis Sector: Increased Pharma 12 - 600 Malaise mg/day 2410 DAY Nausea Sertraline C ORAL 200 mg, QD Polydipsia Esomeprazole C ORAL 20 mg, QD Polyuria Psychiatric Symptom Tremor Vomiting Weight Increased Date:12/23/05ISR Number: 4865892-0Report Type:Expedited (15-DaCompany Report #PHNU2005DE04233 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Encephalitis Leponex / Clozaril Initial or Prolonged Surgery (Clozapine) PS Novartis Sector: Other Pharma ORAL Date:12/23/05ISR Number: 4865894-4Report Type:Expedited (15-DaCompany Report #PHNU2005DE04235 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Leponex / Clozaril Drug Level Increased (Clozapine) PS Novartis Sector: Hallucination, Auditory Pharma ORAL 400 mg/day Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL more than 400 mg/day Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL between 25 to 50 mg/day Diazepam C UNKNOWN Haldol C UNKNOWN Seroquel C UNKNOWN Date:12/23/05ISR Number: 4867366-XReport Type:Direct Company Report #CTU 265673 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neutrophil Count Clozapine 100 Mg PS ORAL 100 MG AMHS Decreased PO 22-Feb-2006 08:30 AM Page: 3585 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Valproic Acid 250 Mg SS ORAL 500 MG AMHS PO Date:12/23/05ISR Number: 4868161-8Report Type:Expedited (15-DaCompany Report #2005S1009916 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aggression Health Clozapine Tablets Cardio-Respiratory Arrest Professional (25 Mg) PS ORAL 50 MG; BID; Coronary Artery Other ORAL Atherosclerosis Olanzapine C Fall Lorazepam C Pulmonary Embolism Valproate Semisodium C Refusal Of Treatment By Clonazepam C Patient Levofloxacin C Treatment Noncompliance Metformin Venous Stasis Hydrochloride C Rosiglitazone Maleate C Simvastatin C Acetylsalicylic Acid C Vitamins Nos C Enalapril C Date:12/23/05ISR Number: 4868162-XReport Type:Expedited (15-DaCompany Report #2005S1011587 Age:51 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Neoplasm Malignant Health Clozapine Tablets Professional (25 Mg) PS ORAL 25 MG; QD; Other ORAL Clozapine Tablets (100 Mg) SS ORAL 800 MG; QD; ORAL Metoprolol Succinate C Carbamazepine C Benzatropine Mesilate C Clonazepam C Olanzapine C Fenofibrate C Ranitidine Hydrochloride C Rosuvastatin C Date:12/23/05ISR Number: 4868634-8Report Type:Expedited (15-DaCompany Report #2005S1011911 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional (100 Mg) PS ORAL 100 MG QAM Other ORAL; 300 MG HS ORAL 22-Feb-2006 08:30 AM Page: 3586 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/23/05ISR Number: 4869029-3Report Type:Expedited (15-DaCompany Report #2005RR-01325 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Activated Partial Foreign Paracetamol Initial or Prolonged Thromboplastin Time Health Abnormal Professional (Paracetamol) Hepatocellular Damage Other Unknown PS Overdose Clozaril (Clozapine) Unknown SS ORAL 75 MG, QD, ORAL Date:12/23/05ISR Number: 4892872-1Report Type:Periodic Company Report #PHEH2005US00809 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukocytosis Health Clozaril (Clozapine) Initial or Prolonged Pneumonia Professional Tablet PS ORAL 500 MG, QD, ORAL Prozac (Fluoxetine Hydrochloride) C Amantadine (Amantadine) C Haldol (Haloperidol Decanoate) C Date:12/23/05ISR Number: 4892878-2Report Type:Periodic Company Report #PHEH2005US00811 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blindness Transient Health Clozaril (Clozapine) Dizziness Professional Tablet PS ORAL 175 MG, QHS, Headache ORAL Hypotension Lexapro Migraine (Escitalopram Nausea Oxalate) C Sinusitis Klonopin Tinnitus (Clonazepam) C Visual Field Defect Nexium (Esomeprazole) C Allegra-D (Fexofenadine Hydrochloride, Pseudoephedrine Hydrochloride) C Date:12/23/05ISR Number: 4892889-7Report Type:Periodic Company Report #PHEH2005US00846 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Health Clozaril (Clozapine) Initial or Prolonged Leukopenia Professional Tablet PS Other 22-Feb-2006 08:30 AM Page: 3587 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/23/05ISR Number: 4892894-0Report Type:Periodic Company Report #PHEH2005US00937 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hallucination, Auditory Health Clozaril (Clozapine) Professional Tablet PS ORAL ORAL Date:12/23/05ISR Number: 4892911-8Report Type:Periodic Company Report #PHEH2005US01567 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Grand Mal Convulsion Health Clozaril (Clozapine) Initial or Prolonged Petit Mal Epilepsy Professional Tablet PS ORAL ORAL 3650 DAY Other Date:12/23/05ISR Number: 4892927-1Report Type:Periodic Company Report #PHEH2005US01913 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chest Pain Health Clozaril (Clozapine) Diabetes Mellitus Professional Tablet PS ORAL 100 MG BID & Dilatation Atrial 150MG Q Dyspnoea Exertional MID-DAY, ORAL Pericardial Effusion Effexor (Venlafaxine Pericarditis Hydrochloride) C Pleural Effusion Benztropine Mesylate Weight Increased (Benzatropine Mesilate) C Zetia (Ezetimibe) C Accupril (Quinapril Hydrochloride) C Nexium (Esomeprazole Magnesium) C Duragesic (Fentanyl) C Date:12/23/05ISR Number: 4892931-3Report Type:Periodic Company Report #PHEH2005US02631 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Clozaril (Clozapine) Obsessive Thoughts Professional Tablet PS Luvox(Fluvoxamine Maleate) SS Date:12/23/05ISR Number: 4892939-8Report Type:Periodic Company Report #PHEH2005US03076 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Clozaril (Clozapine) Initial or Prolonged Confusional State Professional Tablet PS ORAL 400 MG, QD, Other Neutrophil Count ORAL Decreased Paroxetine Hcl (Ngx) Psychotic Disorder (Paroxetine) C White Blood Cell Count Valproic Acid Decreased (Valproic Acid) C Clonazepam (Clonazepam) C 22-Feb-2006 08:30 AM Page: 3588 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/23/05ISR Number: 4892963-5Report Type:Periodic Company Report #PHEH2005US03175 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) Professional Tablet PS ORAL 200 MG, QD, ORAL Date:12/23/05ISR Number: 4892965-9Report Type:Periodic Company Report #PHEH2005US03323 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Clozaril (Clozapine) Professional Tablet PS ORAL 600 MG, QD, ORAL 3650 DAY Date:12/23/05ISR Number: 4892969-6Report Type:Periodic Company Report #PHEH2005US03715 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pancreatitis Health Clozaril (Clozapine) Professional Tablet PS Valproic Acid(Valproic Acid) SS Date:12/23/05ISR Number: 4892977-5Report Type:Periodic Company Report #PHEH2005US03735 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Petit Mal Epilepsy Health Clozaril (Clozapine) Initial or Prolonged Professional Tablet PS ORAL 400 MG, QD, ORAL Thorazine (Chlorpromazine Hydrochloride) C Abilify (Aripiprazole) C Ativan (Lorazepam) C Keppra (Levetiracetam) C Depakote (Valproate Semisodium) C Antiepileptics (No Ingredients/Substanc es) C Date:12/23/05ISR Number: 4892981-7Report Type:Periodic Company Report #PHEH2005US04342 Age:23 YR Gender:Male I/FU:I Outcome PT Other Agranulocytosis Alanine Aminotransferase Increased Aspartate Aminotransferase Increased Band Neutrophil Percentage Increased 22-Feb-2006 08:30 AM Page: 3589 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Blood Triglycerides Increased Cough Report Source Product Role Manufacturer Route Dose Duration Haematocrit Decreased Health Clozaril (Clozapine) Haemoglobin Decreased Professional Tablet PS ORAL 200 MG, BID, Lymphadenopathy ORAL Monocyte Count Abnormal Depakote (Valproate Neutrophil Percentage Semisodium) C Decreased Chloral Hydrate Pyrexia (Chloral Hydrate) C Red Blood Cell Count Clonidine Decreased (Clonidine) C White Blood Cell Count Miralax (Macrogol) C Increased Propanolol (Propranolol) C Date:12/23/05ISR Number: 4892983-0Report Type:Periodic Company Report #PHEH2005US04535 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Deep Vein Thrombosis Health Clozaril (Clozapine) Initial or Prolonged Eosinophil Count Professional Tablet PS ORAL 75 MG, QHS, Other Decreased ORAL Haematocrit Decreased Prevacid Haemoglobin Decreased (Lansoprazole) C Influenza Abilify Leukopenia (Aripiprazole) C Lower Respiratory Tract Verapamil Infection (Verapamil) C Lymphocyte Count Methadone Decreased (Methadone) C Lymphocyte Percentage Lactulose Decreased (Lactulose) C Mean Cell Volume Klor-Con (Potassium Decreased Chloride) C Monocyte Count Decreased Lasix (Furosemide) C Neutrophil Percentage Novolin Nph (Insulin Decreased Human Injection, Pulmonary Embolism Isophane) C Red Blood Cell Count Novolin R (Insulin Decreased Human) C Red Cell Distribution Flexeril Width Increased (Cyclobenazaprine Hydrochloride) C Plaquenil (Hydroxychloroquine Sulfate) C Imuran (Azathioprine) C Aldactone (Spironolactone) C Date:12/23/05ISR Number: 4892985-4Report Type:Periodic Company Report #PHEH2005US04873 Age:22 YR Gender:Male I/FU:I Outcome PT Hospitalization - Convulsion Initial or Prolonged Delusion Other Dizziness 22-Feb-2006 08:30 AM Page: 3590 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hallucination Insomnia Loss Of Consciousness Report Source Product Role Manufacturer Route Dose Duration Psychomotor Hyperactivity Health Clozaril (Clozapine) Professional Tablet PS ORAL 600 MG, QD, ORAL Lithium (Lithium) C Seroquel (Quetiapine Fumarate) C Date:12/23/05ISR Number: 4892989-1Report Type:Periodic Company Report #PHEH2005US04982 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Health Clozaril (Clozapine) Initial or Prolonged Professional Tablet PS ORAL 300 MG, QD, ORAL Luvox (Fluvoxamine Maleate) C Topamax (Topiramate) C Lamictal (Lamotrigine) C Date:12/23/05ISR Number: 4892990-8Report Type:Periodic Company Report #PHEH2005US05030 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Eosinophilia Health Clozaril (Clozapine) Initial or Prolonged Psychotic Disorder Professional Tablet PS ORAL ORAL Date:12/23/05ISR Number: 4892991-XReport Type:Periodic Company Report #PHEH2005US05143 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aphasia Health Clozaril (Clozapine) Confusional State Professional Unknown PS ORAL 800MG, QD, Coordination Abnormal ORAL Delusion Trileptal Disorientation (Oxcarbazepine) Drug Interaction Unknown SS ORAL 600 MG, BID, Sedation ORAL Gabitril (Tiagabine Hydrochloride) SS ORAL 2 MG, QHS FOR 7 DAYS, ORAL; 4 MG, QHS, ORAL Lithium (Lithium) SS ORAL 600 MG, BID, ORAL Klonopin (Clonazepam) SS ORAL 0.5 MG, TID, ORAL Seroquel (Quetiapine Fumarate) SS 600 MG, TID, ORAL 22-Feb-2006 08:30 AM Page: 3591 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/23/05ISR Number: 4892992-1Report Type:Periodic Company Report #PHEH2005US05283 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Deep Vein Thrombosis Health Clozaril (Clozapine) Initial or Prolonged Pain In Extremity Professional Tablet PS ORAL ORAL; 100 MG QAM, 300MG QHS, ORAL Valproic Acid (Valproic Acid) C Imitrex (Sumatriptan) C Date:12/23/05ISR Number: 4892993-3Report Type:Periodic Company Report #PHEH2005US05724 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Myocarditis Health Clozaril (Clozapine) Professional Unknown PS Date:12/23/05ISR Number: 4892996-9Report Type:Periodic Company Report #PHEH2004US01024 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Muscle Disorder Clozaril (Clozapine) Overdose Tablet PS ORAL 300 MG, QD, ORAL Abilify (Aripiprazole) C Neurontin (Gabapentin) C Lexapro (Escitalopram) C Prolixin (Fluphenazine Hydrochloride) C Date:12/23/05ISR Number: 4893000-9Report Type:Periodic Company Report #PHEH2004US04322 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Triglycerides Health Clozaril (Clozapine) Increased Professional Tablet PS ORAL 200 MG, QD, Diabetes Mellitus ORAL Lipids Increased Seroquel (Quetiapine Weight Increased Fumarate) C Lithium (Lithium) C Synthroid (Levothyroxine Sodium) C Vitamins Nos (Vitamins Nos) C 22-Feb-2006 08:30 AM Page: 3592 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/23/05ISR Number: 4893004-6Report Type:Periodic Company Report #PHEH2004US08129 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Health Clozaril (Clozapine) Initial or Prolonged Phosphokinase Increased Professional Tablet PS ORAL 300 MG, QHS, Dizziness ORAL Fall Prolixin Hypotension (Fluphenazine Tachycardia Hydrochloride) SS Paxil (Paroxetine Hydrochloride) SS ORAL 30 MG, QHS, ORAL Atenolol (Atenolol) C Calcium (Calcium) C Divalproex Sodium (Valproate Semisodium) C Date:12/23/05ISR Number: 4893008-3Report Type:Periodic Company Report #PHEH2004US09241 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arthralgia Health Clozaril (Clozapine) Initial or Prolonged Muscle Rigidity Professional Tablet PS ORAL 125 MG, QD, Neuroleptic Malignant ORAL Syndrome Risperdal Pyrexia (Risperidone) C Geodon (Ziprasidone Hydrochloride) C Gabitril (Tiagabine Hydrochloride) C Depakote (Valproate Semisodium) C Date:12/23/05ISR Number: 4893012-5Report Type:Periodic Company Report #PHEH2004US10191 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Health Clozaril (Clozapine) Increased Professional Tablet PS ORAL 425 MG, QD, Aspartate ORAL Aminotransferase Metformin Increased (Metformin) SS Biopsy Liver Abnormal Hepatic Enzyme Increased Hepatic Fibrosis Hepatitis Date:12/23/05ISR Number: 4893015-0Report Type:Periodic Company Report #PHEH2004US10973 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Grand Mal Convulsion Health Clozaril (Clozapine) Initial or Prolonged Professional Tablet PS ORAL 700 MG, QD, ORAL; 900 MG, QD, ORAL Propanolol (Propranolol) C 22-Feb-2006 08:30 AM Page: 3593 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Abilify (Aripiprazole) C Date:12/23/05ISR Number: 4893018-6Report Type:Periodic Company Report #PHEH2004US11069 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Leukopenia Health Clozaril (Clozapine) Hospitalization - Mental Disorder Professional Tablet PS ORAL 200 MG, QHS, Initial or Prolonged Neutropenia ORAL Tachycardia Date:12/23/05ISR Number: 4893024-1Report Type:Periodic Company Report #PHEH2004US11570 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Myoclonus Health Clozaril (Clozapine) Initial or Prolonged Psychotic Disorder Professional Tablet PS ORAL 500 MG, QD, Tic ORAL; 400 MG, QD, ORAL Vistaril (Hydroxyzine Embonate) C Tofranil (Imipramine Hydrochloride) C Geodon (Ziprasidone Hydrochloride) C Date:12/23/05ISR Number: 4893028-9Report Type:Periodic Company Report #PHEH2004US11894 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Clozaril (Clozapine) Initial or Prolonged Leukocytosis Professional Tablet PS ORAL 300MG BID & 75MG QHS, ORAL Prevacid (Lansoprazole) C Seroquel (Quetiapine Fumarate) C Zetia (Ezetimibe) C Lexapro (Escitalopram Oxalate) C Trazodone (Trazodone) C Depakote (Valproate Semisodium) C Alternagel (Aluminium Hydroxide Gel, Dried) C 22-Feb-2006 08:30 AM Page: 3594 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/23/05ISR Number: 4893031-9Report Type:Periodic Company Report #PHEH2004US12372 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Clozaril (Clozapine) Initial or Prolonged Neutrophil Count Professional Tablet PS ORAL 700-800MG QD, Decreased ORAL Thrombocythaemia Topamax (Topiramate) C Dilantin (Phenytoin Sodium) C Date:12/23/05ISR Number: 4893116-7Report Type:Periodic Company Report #PHEH2004US12595 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Weight Decreased Health Clozaril (Clozapine) White Blood Cell Count Professional Tablet PS ORAL 350 MG, QD, Decreased ORAL Zyprexa (Olanzapine) C Seroquel (Quetiapine Fumarate) C Date:12/23/05ISR Number: 4893118-0Report Type:Periodic Company Report #PHEH2004US13185 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diarrhoea Health Clozaril (Clozapine) Incontinence Professional Tablet PS ORAL 125 MG, TID, Malaise ORAL Memory Impairment Pamelor Tremor (Nortriptyline Hydrochloride) C Lithium (Lithium) C Date:12/23/05ISR Number: 4893120-9Report Type:Periodic Company Report #PHEH2004US13593 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypotension Health Clozaril (Clozapine) Initial or Prolonged Treatment Noncompliance Professional Tablet PS ORAL 600 MG, QD, Other ORAL Depakote (Valproate Semisodium) SS ORAL 250 MG, BID, ORAL Date:12/23/05ISR Number: 4893121-0Report Type:Periodic Company Report #PHEH2004US13748 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyponatraemia Health Clozaril (Clozapine) Professional Tablet PS ORAL 450 MG, QD, ORAL Zyprexa (Olanzapine) C 22-Feb-2006 08:30 AM Page: 3595 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/23/05ISR Number: 4893122-2Report Type:Periodic Company Report #PHEH2005US00469 Age:18 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Balance Disorder Health Clozaril (Clozapine) Confusional State Professional Tablet PS ORAL 175 MG, QD, Disturbance In Attention ORAL; 150 MG, Drooling QD, ORAL Dysarthria Xanax (Alprazolam) C Dysphagia Lithium (Lithium) C Extrapyramidal Disorder Cogentin Fatigue (Benzatropine Gait Disturbance Mesilate) C Lethargy Psychotic Disorder Date:12/23/05ISR Number: 4893125-8Report Type:Periodic Company Report #PHEH2005US00783 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Health Clozaril (Clozapine) Initial or Prolonged Professional Tablet PS Other Date:12/23/05ISR Number: 4893126-XReport Type:Periodic Company Report #PHEH2005US09825 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Health Clozaril (Clozapine) Initial or Prolonged Neutropenia Professional Tablet PS Psychotic Disorder Date:12/23/05ISR Number: 4893128-3Report Type:Periodic Company Report #PHEH2005US09909 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Consumer Clozaril (Clozapine) Anorexia Tablet PS ORAL 300MG QAM & Arthralgia QHS, 200MG Blood Cholesterol Q12PM, ORAL Increased Hydroxyzine Contusion (Hydroxyzine) C Convulsion Ferromax (Ferrous Dermatitis Sulfate) C Hypertension Claritin Infection (Loratadine) C Nausea Multivitamins And Rash Iron (No Vertigo Ingredients/Substanc Vomiting es) C Prevacid (Lansoprazole) C Lotrisone (Betamethasone Dipropionate, Clotrimazole) C Lithium (Lithium) C Docusate Calcium (Docusate Calcium) C 22-Feb-2006 08:30 AM Page: 3596 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Naproxen (Naproxen) C Triamcinolone Acetonide W/Nystatin (Nystatin, Triamcinolone Acetonide) C Norvasc (Amlodipine Besilate) C Risperdal (Risperidone) C Triamterene And Hydrochlorithaizid (Hydrochlorothiazide , Triamterene) C Protonix (Pantoprazole) C Clarinex (Loratadine, Pseudoephedrine Sulfate) C Selenium Sulfide (Selenium Sulfide) Shampoo C Atarax (Hydroxyzine Hydrochloride) C Serentil (Mesoridazine) C Lithobid (Lithium Carbonate) C Dilantin (Phenytoin) C Vasotec (Enalapril Maleate) C Trazodone (Trazodone) C Date:12/23/05ISR Number: 4893132-5Report Type:Periodic Company Report #PHEH2005US09921 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pericardial Effusion Health Clozaril (Clozapine) Initial or Prolonged Pneumonia Professional Tablet PS Other Psychotic Disorder Date:12/23/05ISR Number: 4893140-4Report Type:Periodic Company Report #PHEH2005US10235 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Glucose Increased Health Clozaril (Clozapine) Blood Pressure Increased Professional Tablet PS ORAL 250 MG, QD; Blood Triglycerides 150 MG, BID Increased : ORAL Chest Pain Buspirone Dizziness (Buspirone) SS ORAL 5 MG, BID, Tachycardia ORAL 22-Feb-2006 08:30 AM Page: 3597 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/23/05ISR Number: 4893141-6Report Type:Periodic Company Report #PHEH2005US10271 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eosinophilia Health Clozaril (Clozapine) Professional Tablet PS Date:12/23/05ISR Number: 4893143-XReport Type:Periodic Company Report #PHEH2005US10827 Age:18 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Clozaril (Clozapine) Electroencephalogram Professional Tablet PS ORAL 100 MG, BID, Abnormal ORAL Clozaril (Clozapine) Tablet SS ORAL GRADUAL TITRATION, ORAL Celexa (Citalopram Hydrobromide) C Seroquel (Quetiapine Fumarate) C Haldol (Haloperidol Decanoate) C Vitamin B6 (Pyridoxine Hydrochloride) C Antipsychotics (No Ingredients/Substanc es) C Date:12/23/05ISR Number: 4893148-9Report Type:Periodic Company Report #PHEH2005US11026 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Clozaril (Clozapine) Initial or Prolonged Leukocytosis Professional Tablet PS ORAL 250 MG, QD, Neutrophil Count Abnormal ORAL Lamictal (Lamotrigine) C Effexor (Venlafaxine Hydrochloride) C Date:12/23/05ISR Number: 4893152-0Report Type:Periodic Company Report #PHEH2005US08019 Age:89 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozaril (Clozapine) Professional Tablet PS ORAL ORAL Date:12/23/05ISR Number: 4893155-6Report Type:Periodic Company Report #PHEH2005US08102 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Level Increased Consumer Clozaril (Clozapine) PS Drug Toxicity Overdose 22-Feb-2006 08:30 AM Page: 3598 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/23/05ISR Number: 4893159-3Report Type:Periodic Company Report #PHEH2005US08674 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Health Clozaril (Clozapine) Initial or Prolonged Diabetes Mellitus Professional Tablet PS ORAL 200 MG, BID, Other Ketosis ORAL Leukopenia Neutropenia Pneumonia Date:12/23/05ISR Number: 4893160-XReport Type:Periodic Company Report #PHEH2005US08700 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Constipation Health Clozaril (Clozapine) Hallucination Professional Tablet PS ORAL SEE IMAGE Hallucination, Auditory Date:12/23/05ISR Number: 4893161-1Report Type:Periodic Company Report #PHEH2005US09119 Age:12 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dialysis Clozaril (Clozapine) PS Initial or Prolonged Nephritis Other Date:12/23/05ISR Number: 4893162-3Report Type:Periodic Company Report #PHEH2005US09140 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Health Clozaril (Clozapine) PS ORAL 300 OR 400 Leukopenia Professional MG, QD, ORAL Clomipramine (Clomipramine) C Loxapine (Loxapine) C Lamictal (Lamotrigine) C Ativan (Lorazepam) C Date:12/23/05ISR Number: 4893163-5Report Type:Periodic Company Report #PHEH2005US09239 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Clozaril (Clozapine) Initial or Prolonged Drooling Professional Tablet PS 200MG BID, 300MG, QHS Clozaril (Clozapine) Tablet SS ORAL 200MG BID, 350MG QHS, ORAL 22-Feb-2006 08:30 AM Page: 3599 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/23/05ISR Number: 4893165-9Report Type:Periodic Company Report #PHEH2005US09336 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperhidrosis Health Clozaril (Clozapine) PS Hypertension Professional Augmentin Tachycardia (Amoxicillin Sodium, Clavulanate Potassium) C Enalapril (Enalapril) C Glucophage (Metformin) C Date:12/23/05ISR Number: 4893168-4Report Type:Periodic Company Report #PHEH2005US09591 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Health Clozaril (Clozapine) Granulocyte Count Professional Tablet PS ORAL ORAL Decreased Depakote (Valproate Leukopenia Semisodium) C Date:12/26/05ISR Number: 4865964-0Report Type:Expedited (15-DaCompany Report #PHBS2005US18711 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Clozapine PS Novartis Sector: Initial or Prolonged Agitation Pharma UNKNOWN 700 mg/d Blood Sodium Decreased Desmopressin SS 10 ug, QHS Confusional State Depressed Level Of Consciousness Disorientation Drug Level Increased Enuresis Gait Disturbance Hyperhidrosis Hyponatraemia Hyporeflexia Polydipsia Psychogenic Pupil Fixed Respiratory Rate Increased Restlessness Speech Disorder Tachycardia Vomiting Date:12/26/05ISR Number: 4865973-1Report Type:Expedited (15-DaCompany Report #PHEH2005US09308 Age:54 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Alcohol Poisoning Clozaril PS Novartis Sector: Heat Exhaustion Pharma UNK, UNK Alcohol SS Zoloft C 22-Feb-2006 08:30 AM Page: 3600 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/27/05ISR Number: 4866187-1Report Type:Expedited (15-DaCompany Report #PHEH2005US13789 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Clozaril PS Novartis Sector: Pharma Unk, Unk Date:12/27/05ISR Number: 4866192-5Report Type:Expedited (15-DaCompany Report #PHBS2005DE18815 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Clozapine PS Novartis Sector: Initial or Prolonged Agranulocytosis Pharma UNKNOWN 650 mg/d Blood Immunoglobulin M Increased Bronchopneumonia Conduction Disorder Coordination Abnormal Csf Protein Increased Csf Test Abnormal Electroencephalogram Abnormal Fungus Serology Test Positive Guillain-Barre Syndrome Hypoaesthesia Motor Dysfunction Pain In Extremity Paresis Pleural Effusion Polyneuropathy Pyrexia Serratia Infection Subcutaneous Abscess Surgery Urinary Incontinence Urinary Tract Infection Date:12/27/05ISR Number: 4866257-8Report Type:Expedited (15-DaCompany Report #PHEH2005US10491 Age:51 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Clozaril PS Novartis Sector: Myocardial Infarction Pharma ORAL 100mg Q8am, 400mg Q8pm Atenolol C ORAL 25 mg, QD Prolixin C ORAL 10 mg, QHS Prolixin C INTRAMUSCULAR 50 mg, Q 2weeks Cogentin C ORAL 0.5 mg, BID Trileptal C ORAL 300 mg, BID Eskalith C ORAL 450 mg, QHS Synthroid C ORAL 150 ug, QD Lipitor C ORAL 20 mg, QD Prevacid C ORAL 30 mg, QHS 22-Feb-2006 08:30 AM Page: 3601 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/28/05ISR Number: 4867277-XReport Type:Expedited (15-DaCompany Report #PHEH2005US10491 Age:51 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Clozaril PS Novartis Sector: Myocardial Infarction Pharma ORAL 100mg Q8am, 400mg Q8pm Atenolol C ORAL 25 mg, QD Prolixin C ORAL 10 mg, QHS Prolixin C INTRAMUSCULAR 50 mg, Q 2weeks Cogentin C ORAL 0.5 mg, BID Trileptal C ORAL 300 mg, BID Eskalith C ORAL 450 mg, QHS Synthroid C ORAL 150 ug, QD Lipitor C ORAL 20 mg, QD Prevacid C ORAL 30 mg, QHS Date:12/28/05ISR Number: 4870337-0Report Type:Expedited (15-DaCompany Report #2005-US-01066 Age:54 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Clozapine Tablets, Injury Asphyxiation Professional 12.5mg, 25mg, 50 Mg Other 100mg (Clozapine) PS ORAL 650 MG, QD, ORAL Clonazepam C Lithium C Date:12/28/05ISR Number: 4870338-2Report Type:Expedited (15-DaCompany Report #2005-US-01304 Age:38 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Oesophageal Perforation Health Clozapine Tablets, Initial or Prolonged Oesophageal Rupture Professional 12.5mg, 25mg, 50 Mg Other Self Injurious Behaviour Other 100mg (Clozapine) PS ORAL 37.5 MG, QD, ORAL Date:12/28/05ISR Number: 4870339-4Report Type:Expedited (15-DaCompany Report #2005-US-00813 Age:56 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cavernous Sinus Health Clozapine Tablets, Initial or Prolonged Thrombosis Professional 12.5mg, 25mg, 50 Mg Other Dizziness Other 100mg (Clozapine) PS ORAL 300 MG, QD, Required Meningioma ORAL Intervention to Papilloedema Hydrochlorothiazide C Prevent Permanent Renal Cell Carcinoma Famotidine C Impairment/Damage Stage Unspecified Renal Failure Date:12/28/05ISR Number: 4870340-0Report Type:Expedited (15-DaCompany Report #2005-US-01421 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Gastric Bypass Health Clozapine Tablets, Initial or Prolonged Hypokalaemia Professional 12.5mg, 25mg, 50 Mg Other 100mg (Clozapine) PS ORAL 50 MG, QD, 22-Feb-2006 08:30 AM Page: 3602 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL Date:12/28/05ISR Number: 4870341-2Report Type:Expedited (15-DaCompany Report #2005-US-00925 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozapine Tablets, Professional 12.5mg, 25mg, 50 Mg Other 100mg (Clozapine) PS ORAL 50 MG, QD, ORAL 6 MON Date:12/28/05ISR Number: 4870342-4Report Type:Expedited (15-DaCompany Report #05-08-1481 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine Tablets, Professional 12.5mg, 25mg, 50 Mg Other 100mg (Clozapine) (Tablets) PS ORAL 400MG, QD, ORAL Date:12/28/05ISR Number: 4870413-2Report Type:Expedited (15-DaCompany Report #2005-US-01493 Age:67 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine Tablets, Professional 12.5mg, 25mg, 50 Mg Other 100mg (Clozapine) PS ORAL 50 MG, QD, ORAL Date:12/28/05ISR Number: 4870475-2Report Type:Expedited (15-DaCompany Report #2005-US-00101 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lymphoma Health Clozapine Tablets, Hospitalization - Professional 12.5mg, 25mg, 50 Mg Initial or Prolonged Other 100mg (Clozapine) PS ORAL 800 MG, QD, Other ORAL Bupropion C Clonazepam C Haloperidol C Aripiprazole C Escitalopram Oxalate C Date:12/28/05ISR Number: 4870476-4Report Type:Expedited (15-DaCompany Report #2005-US-01522 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Neoplasm Malignant Health Clozapine Tablets, Hospitalization - Professional 12.5mg, 25mg, 50 Mg Initial or Prolonged Other 100mg (Clozapine) PS ORAL 900 MG, QD, ORAL 22-Feb-2006 08:30 AM Page: 3603 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/28/05ISR Number: 4870477-6Report Type:Expedited (15-DaCompany Report #2005-US-01524 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pulmonary Mass Health Clozapine Tablets, Hospitalization - Respiratory Failure Professional 12.5mg, 25mg, 50 Mg Initial or Prolonged Other 100mg (Clozapine) PS ORAL 250 MG, QD, ORAL Date:12/28/05ISR Number: 4870479-XReport Type:Expedited (15-DaCompany Report #2005-US-00912 Age:73 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Pain Upper Health Clozapine Tablets, Other Dehydration Professional 12.5mg, 25mg, 50 Mg Gastritis Haemorrhagic Other 100mg (Clozapine) PS ORAL 35 MG, QD, Nausea ORAL Vomiting Gabapentin C Pantoprazole C Acetylsalicylic Acid C Tocopherol C Docusate C Lactulose C Enalapril C Date:12/29/05ISR Number: 4868091-1Report Type:Expedited (15-DaCompany Report #PHFR2005GB03858 Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Activated Partial Clozaril PS Novartis Sector: Initial or Prolonged Thromboplastin Time Pharma ORAL 75mg/day Other Abnormal Clozaril SS Novartis Sector: Antiphospholipid Pharma 14 x 25 mg Antibodies Positive Paracetamol SS UNKNOWN 16 doses Hepatocellular Damage Co-Tenidone C ORAL 100/25 mg Overdose Mirtazapine C ORAL 45 mg/day Zopiclone C ORAL 7.5 mg/day Date:12/29/05ISR Number: 4868092-3Report Type:Expedited (15-DaCompany Report #PHMT2005CA00675 Age:42 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Lymphadenopathy Clozaril PS Novartis Sector: Lymphoma Pharma 300 mg, QD Seroquel C 100 mg, UNK Diane - 35 "Schering Ag" C Date:12/29/05ISR Number: 4868093-5Report Type:Expedited (15-DaCompany Report #PHEH2005US13787 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Polycythaemia Vera Clozaril PS Novartis Sector: Pharma Unk, Unk 22-Feb-2006 08:30 AM Page: 3604 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/29/05ISR Number: 4868097-2Report Type:Expedited (15-DaCompany Report #PHRM2005FR03365 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Pneumococcal Leponex PS Novartis Sector: Initial or Prolonged Pharma ORAL Other Date:12/29/05ISR Number: 4868098-4Report Type:Expedited (15-DaCompany Report #PHNU2005DE04010 Age:79 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Accidental Exposure Leponex / Clozaril Muscular Weakness (Clozapine) PS Novartis Sector: Sedation Pharma ORAL 150 mg, ONCE/SINGLE 1440 MIN Dipiperon SS UNKNOWN 240 mg, QD Date:12/30/05ISR Number: 4869303-0Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20051204491 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Angina Pectoris Topamax PS ORAL Apnoea Valproinacid SS UNKNOWN Cardiac Failure Clozapin SS UNKNOWN Cyanosis Date:12/30/05ISR Number: 4869658-7Report Type:Expedited (15-DaCompany Report #US-ABBOTT-05P-163-0320544-00 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Divalproex Sodium PS ORAL Hospitalization - Loss Of Consciousness Clozapine SS ORAL 4 YR Initial or Prolonged Myocardial Infarction Docusate Sodium C Other Pulmonary Embolism Folic Acid C Date:12/30/05ISR Number: 4871564-9Report Type:Expedited (15-DaCompany Report #2005RR-01345 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diarrhoea Foreign Valproic Initial or Prolonged Myoclonus Other Acid(Valproic Acid) PS Pneumonia Hytrin (Terazosin) SS ORAL ORAL Clozapine (Clozapine) SS Ibuprofen (Ibuprofen) SS Benzatropine (Benzatropine) SS Date:12/30/05ISR Number: 4872007-1Report Type:Expedited (15-DaCompany Report #2005S1012094 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional (100 Mg) PS OPHTHALMIC SEE IMAGE Other Ziprasidone C 22-Feb-2006 08:30 AM Page: 3605 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride C Sertraline C . C Levothyroxine Sodium C Potassium C Levofloxacin C Date:12/30/05ISR Number: 4872010-1Report Type:Expedited (15-DaCompany Report #2005S1008685 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Chest Pain Health Clozapine Tablets Intervention to Drooling Professional (25 Mg) PS ORAL 50 MG; HS; PO Prevent Permanent Granulocytopenia Other Clonazapine Tablets Impairment/Damage Somnolence (100 Mg) SS ORAL SEE IMAGE Weight Increased Aripiprazole C Valproate Semisodium C Polycarbophil Calcium C Docusate Sodium C Duloxetine C Atorvastatin C Hydrochlorothiazide C Lisinopril C Propranolol C Metformin C Vitamins C Date:01/04/06ISR Number: 4871631-XReport Type:Expedited (15-DaCompany Report #PHNU2005DE02371 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aspartate Leponex / Clozaril Initial or Prolonged Aminotransferase (Clozapine) PS Novartis Sector: Increased Pharma ORAL up to 500 Blood Creatine mg/day Phosphokinase Increased Leponex / Clozaril Drug Interaction (Clozapine) SS Novartis Sector: Rhabdomyolysis Pharma ORAL up to 625 mg/day Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL up to 550 mg/day 2880 MIN Risperdal SS ORAL 4 mg, QD Orfiril C ORAL 1500 mg/day Resonium A C ORAL 45 g/day Date:01/04/06ISR Number: 4871632-1Report Type:Expedited (15-DaCompany Report #PHNU2005DE04283 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypotonia Leponex / Clozaril Initial or Prolonged Pleurothotonus (Clozapine) PS Novartis Sector: Pharma ORAL 25 to 350mg/day 117 DAY Leponex / Clozaril (Clozapine) SS Novartis Sector: 22-Feb-2006 08:30 AM Page: 3606 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pharma ORAL 375 mg/day 5760 MIN Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL 400 mg/day Cipramil /Net/ SS ORAL 20 mg, QD 18720MIN Cipramil /Net/ SS ORAL 30 mg/day 20160MIN Cipramil /Net/ SS ORAL 40 mg/day Lioresal SS ORAL 62.5 mg/day Lioresal SS ORAL 75 mg/day Dipiperon SS ORAL 40 mg/day 21600MIN Dipiperon SS ORAL 20 mg/day Tavor C ORAL 0.5 mg, QD Nexium C ORAL 20 mg, QD Date:01/04/06ISR Number: 4871634-5Report Type:Expedited (15-DaCompany Report #PHFR2005GB02341 Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Pressure Increased Clozaril PS Novartis Sector: Heart Rate Increased Pharma ORAL Medication Error Clozaril SS Novartis Sector: Sedation Pharma ORAL 300mg medication error Clozaril SS Novartis Sector: Pharma Date:01/04/06ISR Number: 4871635-7Report Type:Expedited (15-DaCompany Report #PHEH2005US13789 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Clozaril PS Novartis Sector: Drug Ineffective Pharma Unk, Unk 3285 DAY Somnolence Abilify SS Date:01/04/06ISR Number: 4871636-9Report Type:Expedited (15-DaCompany Report #PHEH2004US12007 Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Clozaril PS Novartis Sector: Initial or Prolonged Autism Spectrum Disorder Pharma ORAL 600 mg, QD Hyperhidrosis Hyperventilation Logorrhoea Therapeutic Response Decreased Date:01/04/06ISR Number: 4874447-3Report Type:Expedited (15-DaCompany Report #2005S1012069 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Neoplasm Malignant Health Clozapine Tablets Professional (100 Mg) PS ORAL 100 MG; QAM; Other ORAL; 300 MG; HS; ORAL Valproate Semisodium C 22-Feb-2006 08:30 AM Page: 3607 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/04/06ISR Number: 4874455-2Report Type:Expedited (15-DaCompany Report #2005S1012098 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional (100 Mg) PS ORAL 100 MG; QAM; Other ORAL; 200 MG; HS; ORAL Levofloxacin C Ziprasidone H Ydrochloride C Sertraline Hydrochloride C Levothyroxine C Date:01/05/06ISR Number: 4873071-6Report Type:Expedited (15-DaCompany Report #PHFR2005GB03774 Age:79 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Clozaril PS Novartis Sector: Coordination Abnormal Pharma ORAL 200mg/day Dizziness Dysarthria Hypotonia Orthostatic Hypotension Sedation Date:01/05/06ISR Number: 4873696-8Report Type:Direct Company Report #USP 57590 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Dispensing Error Clozapine 100 Mg Medication Error Tablet PS Mylan TABLET Clozapine 25 Mg Tablet SS Mylan TABLET Date:01/05/06ISR Number: 4874976-2Report Type:Expedited (15-DaCompany Report #2005-US-01527 Age:67 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tabelts, Professional 12.5mg, 25mg, 50 Mg Other 100mg(Clozapine) PS ORAL 550 MG, QD, ORAL Date:01/06/06ISR Number: 4874372-8Report Type:Expedited (15-DaCompany Report #PHRM2005FR03428 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiac Failure Leponex PS Novartis Sector: Cardiac Flutter Pharma ORAL Condition Aggravated 22-Feb-2006 08:30 AM Page: 3608 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/06/06ISR Number: 4874918-XReport Type:Expedited (15-DaCompany Report #2005-US-01548 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Health Clozapine Tablets, Professional 12.5 Mg, 25mg, 50 Mg Other 100mg (Clozapine) PS ORAL 50 MG, QD, ORAL Date:01/06/06ISR Number: 4875818-1Report Type:Expedited (15-DaCompany Report #2005-US-00924 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine Tablets, Hospitalization - Professional 12.5 Mg, 25 Mg, 50 Initial or Prolonged Other Mg 100mg (Clozapine) PS ORAL 750 MG QD, ORAL Venlafaxine Hydrochloride C Oxcarbazepine C Quetiapine C Date:01/09/06ISR Number: 4875503-6Report Type:Expedited (15-DaCompany Report #PHEH2003US05717 Age:36 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Ascites Clozaril PS Novartis Sector: Hospitalization - Blood Pressure Pharma ORAL 25-300 mg, Initial or Prolonged Orthostatic Abnormal QHS 24480MIN Cardiac Tamponade Depakote C ORAL 1500 mg, QD Dermatomyositis Dysarthria Dyspnoea Erythema Hypoxia Leukocytoclastic Vasculitis Lung Consolidation Paranoia Pericardial Drainage Pericardial Effusion Pericardial Excision Pericarditis Pleural Effusion Rash Maculo-Papular Swan Ganz Catheter Placement Tachycardia Tachypnoea Date:01/09/06ISR Number: 4875504-8Report Type:Expedited (15-DaCompany Report #PHEH2005US13992 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Clozapine PS Novartis Sector: Unresponsive To Verbal Pharma ORAL UNK, Stimuli ONCE/SINGLE 1440 MIN 22-Feb-2006 08:30 AM Page: 3609 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/09/06ISR Number: 4875507-3Report Type:Expedited (15-DaCompany Report #PHFR2004GB00923 Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Clozaril PS Novartis Sector: Hospitalization - Circulatory Collapse Pharma ORAL 225mg/day 1155 DAY Initial or Prolonged Congestive Cardiomyopathy Haloperidol C UNKNOWN Ejection Fraction Metformin C ORAL 1500 mg/day Decreased Gliclazide C ORAL 320 mg/day Exercise Tolerance Salbutamol Inhalant Decreased "Ratiopharm" C Date:01/09/06ISR Number: 4875508-5Report Type:Expedited (15-DaCompany Report #PHRM2006FR00447 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Dolichocolon Acquired Leponex PS Novartis Sector: Intestinal Perforation Pharma ORAL 200mg, daily Shock Haemorrhagic Surgery Date:01/09/06ISR Number: 4875538-3Report Type:Expedited (15-DaCompany Report #PHEH2005US13954 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Upper Serentil PS Novartis Sector: Alopecia Pharma Balance Disorder Clozapine SS Benign Breast Lump Maalox /Usa/ C Removal Nitroglycerin C SUBLINGUAL Benign Breast Neoplasm Constipation Cough Diarrhoea Dysphagia Dysstasia Electrocardiogram Abnormal Fall Gait Disturbance Gastrooesophageal Reflux Disease Haemoptysis Head Injury Increased Upper Airway Secretion Insomnia Memory Impairment Muscle Spasms Oesophageal Spasm Psychomotor Hyperactivity Retching Rhinorrhoea Skin Haemorrhage Sleep Disorder Weight Decreased 22-Feb-2006 08:30 AM Page: 3610 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/09/06ISR Number: 4875769-2Report Type:Expedited (15-DaCompany Report #GB-ABBOTT-05P-167-0317716-00 Age:51 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Renal Failure Acute Epilim PS UNKNOWN Initial or Prolonged Renal Tubular Necrosis Clozapine SS ORAL 919 DAY Other Clozapine SS 919 DAY Orphenadrine C UNKNOWN Propranolol C UNKNOWN Senna C UNKNOWN Lamotrigine C UNKNOWN Aspirin C UNKNOWN Date:01/10/06ISR Number: 4876203-9Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20060100941 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diarrhoea Ibuprofen PS Initial or Prolonged Myoclonus Benztropine Mesylate SS Pneumonia Hytrin SS ORAL Clozapine SS Valproate Sodium SS Date:01/10/06ISR Number: 4876376-8Report Type:Expedited (15-DaCompany Report #PHFR2005GB03920 Age:56 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Clozaril PS Novartis Sector: Initial or Prolonged Electrocardiogram Pharma ORAL 100 mg, BID 53280MIN Other Abnormal Headache Myocardial Ischaemia Tachyarrhythmia Tachycardia Date:01/10/06ISR Number: 4876378-1Report Type:Expedited (15-DaCompany Report #PHEH2006US00450 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Renal Function Test Clozaril PS Novartis Sector: Initial or Prolonged Abnormal Pharma Unk, Unk Stress Lithium SS Unk, Unk Date:01/10/06ISR Number: 4876379-3Report Type:Expedited (15-DaCompany Report #PHNR2005AU01635 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anisocytosis Clozaril PS Novartis Sector: Basophilia Pharma 200-250 mg Lymphocytosis daily Microcytic Anaemia Clopine SS 12.5-300 mg Microcytosis daily Poikilocytosis Clopine SS 12.5-300 mg Red Blood Cell daily Abnormality Red Blood Cell Elliptocytes Present 22-Feb-2006 08:30 AM Page: 3611 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/10/06ISR Number: 4878005-6Report Type:Expedited (15-DaCompany Report #2005168251 Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyponatraemia Foreign Atarax (Tablet) Initial or Prolonged Overdose Health (Hydroxyzine Rhabdomyolysis Professional Hydrochloride) PS ORAL ORAL Clonazepam (Clonazepam) SS ORAL 40 DROP, ORAL Lamisil (Terbinafine Hydrochloride) SS ORAL ORAL Depakine (Valproate Sodium) SS ORAL ORAL Leponex "Novartis" (Clozapine) SS Novartis ORAL ORAL Date:01/11/06ISR Number: 4877301-6Report Type:Expedited (15-DaCompany Report #PHFR2002GB04377 Age:61 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chronic Lymphocytic Clozaril PS Novartis Sector: Leukaemia Pharma ORAL 35mg/day Drug Level Below Lansoprazole C Therapeutic Haemoglobin Decreased Lymphocyte Count Increased Overweight White Blood Cell Count Increased Date:01/11/06ISR Number: 4879694-2Report Type:Expedited (15-DaCompany Report #2006-US-00039 Age:69 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Depression Other Clozapine Tablets, Dysphagia 12.5mg, 25mg, 50mg Schizoaffective Disorder 100mg (Clozapine) PS ORAL 250 MG, QD, ORAL Date:01/11/06ISR Number: 4879696-6Report Type:Expedited (15-DaCompany Report #2006-US-00158 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Constipation Health Clozapine Tablets, Initial or Prolonged Faecaloma Professional 12.5mg, 25mg, 50 Mg Hip Fracture Other 100mg (Clozapine) PS ORAL 300 MG, QD, ORAL Date:01/11/06ISR Number: 4879700-5Report Type:Expedited (15-DaCompany Report #2006-US-00159 Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Clozapine Tablets, Professional 12.5mg, 25mg, 50 Mg Other 100mg(Clozapine) PS ORAL QD, ORAL 22-Feb-2006 08:30 AM Page: 3612 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/11/06ISR Number: 4879702-9Report Type:Expedited (15-DaCompany Report #2006-US-00157 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Renal Failure Health Clozapine Tablets, Initial or Prolonged Professional 12.5mg, 25mg, 50 Mg Other 100mg (Clozapine) PS Date:01/11/06ISR Number: 4879828-XReport Type:Expedited (15-DaCompany Report #2005-US-00227 Age:47 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Health Clozapine Tablets, Initial or Prolonged Chest Pain Professional 12.5mg, 25mg, 50 Mg Other Drug Level Increased Other 100mg(Clozapine) PS ORAL 600 MG, QD, Dyspnoea ORAL Electrocardiogram St-T Change Hyperhidrosis Lethargy Palpitations Pyrexia Rash Tachycardia Urinary Tract Infection Urosepsis Date:01/12/06ISR Number: 4878670-3Report Type:Expedited (15-DaCompany Report #PHNU2005DE04189 Age:61 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bronchopneumonia Leponex PS Novartis Sector: C-Reactive Protein Pharma ORAL up to 75 mg, Increased TID Leukocytosis Leponex SS Novartis Sector: Neutrophilia Pharma ORAL Dosage Pyrexia reduced Tachycardia Beloc-Zok C ORAL 0.5 DF, BID Faustan C ORAL 10 mg, TID Date:01/12/06ISR Number: 4878675-2Report Type:Expedited (15-DaCompany Report #PHHO2005CA14141 Age:39 YR Gender:Female I/FU:F Outcome PT Other Anorexia Asthenia Decreased Appetite Dehydration Hypokalaemia Lethargy Neutropenia Oesophagitis Pharyngolaryngeal Pain Platelet Count Decreased Psychotic Disorder Red Blood Cell Count Decreased Restlessness Retching 22-Feb-2006 08:30 AM Page: 3613 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Schizophrenia Viral Infection Vomiting Report Source Product Role Manufacturer Route Dose Duration Weight Decreased Clozaril (Clozapine) PS Novartis Sector: White Blood Cell Count Pharma ORAL 37.5 mg QPM, Decreased 125 mg QHS Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL 50 mg QPM, 125 mg QHS Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL 62.5 mg QPM, 125 mg QHS Levothyroxine C 0.112 mg, UNK Lorazepam C 1 mg, PRN (0-2 daily) Vitamin D C 800 IU, for many years Multivitamins C UNK, UNK for many years Date:01/12/06ISR Number: 4878676-4Report Type:Expedited (15-DaCompany Report #PHNR2006AU00445 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Clozaril PS Novartis Sector: Initial or Prolonged Electrocardiogram Pharma 0 - 300 Abnormal mg/day 21600MIN Electrocardiogram Qt Corrected Interval Prolonged Date:01/12/06ISR Number: 4878677-6Report Type:Expedited (15-DaCompany Report #PHBS2005BR17749 Age:27 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Distension Leponex PS Novartis Sector: Initial or Prolonged Bipolar Disorder Pharma ORAL 200 mg/d Condition Aggravated Neozine C Drug Ineffective Depakene C Hallucination Depakote C Influenza Liver Disorder Persecutory Delusion Vomiting Weight Increased Date:01/12/06ISR Number: 4878678-8Report Type:Expedited (15-DaCompany Report #PHFR2006GB00478 Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Exposure Clozaril PS Novartis Sector: Initial or Prolonged Overdose Pharma 14 x 100mg tabs 22-Feb-2006 08:30 AM Page: 3614 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/12/06ISR Number: 4878680-6Report Type:Expedited (15-DaCompany Report #PHRM2006FR00447 Age:49 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dolichocolon Acquired Leponex PS Novartis Sector: Life-Threatening Intestinal Perforation Pharma ORAL 200mg, daily 70560MIN Pneumonia Aspiration Leponex SS Novartis Sector: Shock Haemorrhagic Pharma ORAL 25 mg, daily Surgery Date:01/12/06ISR Number: 4881918-2Report Type:Expedited (15-DaCompany Report #2005-US-01426 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Staphylococcal Infection Health Clozapine Tablets, Professional 12.5mg, 25mg, 50 Mg Other 100mg (Clozapine) PS ORAL 500 MG, QD, ORAL Sertraline Hydrochloride C Aripiprazole C Levothyroxine Sodium C Metoclopramide C Omeparazole C Date:01/12/06ISR Number: 4881940-6Report Type:Expedited (15-DaCompany Report #2005S1012222 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional (100 Mg) PS ORAL 400 Other MG;QD;ORAL Date:01/12/06ISR Number: 4881999-6Report Type:Expedited (15-DaCompany Report #2005S1011267 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aneurysm Health Clozapine Tablets Professional (100 Mg) PS ORAL SEE IMAGE Other Benzatropine Mesilate C Haloperidol C Hydroxyzine C Hydrochloride C Gemfibrozil C Docusate Sodium C Valproate Semisodium C Lansoprazole C Metoprolol Tartrate C Lithium C Atorvastatin C Levothyroxine Sodium C Diazepam C Paracetamol/Hydrocod one Bitartrate C 22-Feb-2006 08:30 AM Page: 3615 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/12/06ISR Number: 4882000-0Report Type:Expedited (15-DaCompany Report #2005S1011434 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Clozapine Tablets Initial or Prolonged Condition Aggravated Professional (25 Mg) PS ORAL SEE IMAGE Required Psychotic Disorder Other Intervention to Restlessness Prevent Permanent Impairment/Damage Date:01/13/06ISR Number: 4879555-9Report Type:Expedited (15-DaCompany Report #PHFR2005GB03930 Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Amnesia Clozaril PS Novartis Sector: Initial or Prolonged Barrett'S Oesophagus Pharma ORAL 300 mg/day Other Biopsy Oesophagus Clozaril SS Novartis Sector: Blood Cholesterol Pharma ORAL 175 mg/day Increased Blood Folate Abnormal Confusional State Coombs Positive Haemolytic Anaemia Eosinophil Count Decreased Gastrooesophageal Reflux Disease Haematocrit Decreased Haemoglobin Decreased Lymphocyte Count Increased Nasopharyngitis Neutrophil Count Increased Platelet Count Increased Red Blood Cell Count Decreased Red Blood Cell Sedimentation Rate Increased Reticulocyte Count Increased Syncope White Blood Cell Count Increased Date:01/13/06ISR Number: 4883846-5Report Type:Expedited (15-DaCompany Report #2006-US-00306 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Papilloedema Health Clozapine Tablets, Professional 12.5mg, 25mg, 50 Mg Other 100mg (Clozapine) PS 22-Feb-2006 08:30 AM Page: 3616 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/16/06ISR Number: 4881634-7Report Type:Expedited (15-DaCompany Report #PHFR2005GB03616 Age:44 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abdominal Distension Clozapine PS Novartis Sector: Hospitalization - Abdominal Pain Pharma ORAL 700 mg/day Initial or Prolonged Abdominal Pain Upper Clozapine SS Novartis Sector: Agitation Pharma Blood Urea Increased Clozapine SS Novartis Sector: C-Reactive Protein Pharma ORAL 50 mg, BID Increased Lithium C Circulatory Collapse Procyclidine C ORAL 10 mg/day Colitis Sulpiride C ORAL 800 mg/day Colonic Epilim Chrono C ORAL 1 g/day Pseudo-Obstruction Priadel C ORAL 800 mg/day Confusional State Iron C ORAL Constipation Dysarthria Hypotension Ileus Lung Consolidation Malaise Melaena Neutrophil Count Increased Pleural Effusion Pneumonia Respiratory Failure Vomiting White Blood Cell Count Increased X-Ray Gastrointestinal Tract Abnormal Date:01/16/06ISR Number: 4881636-0Report Type:Expedited (15-DaCompany Report #PHMT2006CA00459 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chest Pain Clozaril PS Novartis Sector: Conduction Disorder Pharma 60480MIN Date:01/16/06ISR Number: 4881639-6Report Type:Expedited (15-DaCompany Report #PHEH2006US00702 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Small Cell Lung Cancer Clozaril PS Novartis Sector: Stage Unspecified Pharma ORAL 300 mg, QD Xanax C Date:01/16/06ISR Number: 4881640-2Report Type:Expedited (15-DaCompany Report #PHEH2006US00780 Age:93 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Clozaril PS Novartis Sector: Pharma 12.5 mg, QHS Acetaminophen C 500 mg, QD Prilosec C 20 mg, QD Ferrous Sulfate C 325 mg, QD Oyster Shell Calcium C 500 mg, QD 22-Feb-2006 08:30 AM Page: 3617 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Plavix C 75 mg, QD Synthroid C 0.112 mg, QD Furosemide C 40 mg, QD Klor-Con C 10 MEq, QD Multivitamins C 1 UNK, QD Diltiazem C 180 mg, QD Metoprolol C 12.5 mg, QD Mysoline C 50 mg, QD Procanbid C 500 mg, QD Date:01/16/06ISR Number: 4881641-4Report Type:Expedited (15-DaCompany Report #PHEH2006US00826 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Chronic Obstructive Clozaril PS Novartis Sector: Other Pulmonary Disease Pharma 400 mg, QD Lung Neoplasm Malignant Vicodin C 10/500 mg, Non-Small Cell Lung TID prn Cancer Geodon C 80 mg, BID Non-Small Cell Lung Morphine Sulfate C 15 mg, BID Cancer Metastatic Zoloft C 50 mg, QD Radiotherapy Furosemide C 40 mg, QOD 20160MIN Ibuprofen C 200 mg, Q4-6h PRN Date:01/16/06ISR Number: 4881684-0Report Type:Expedited (15-DaCompany Report #CH-JNJFOC-20060101377 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Risperdal Consta PS INTRAMUSCULAR Abnormal Leponex SS ORAL Sinus Tachycardia Date:01/17/06ISR Number: 4881855-3Report Type:Expedited (15-DaCompany Report #PHNU2005DE04056 Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Leponex / Clozaril Initial or Prolonged Drug Level Increased (Clozapine) PS Novartis Sector: Other Gamma-Glutamyltransferase Pharma ORAL up to Increased 400mg/day General Physical Abilify SS UNKNOWN up to 20 Condition Abnormal mg/day Jaundice Cholestatic Leukocytosis Date:01/17/06ISR Number: 4881866-8Report Type:Expedited (15-DaCompany Report #PHBS2006PT00790 Age:75 YR Gender:Female I/FU:I Outcome PT Death Bone Marrow Depression Hospitalization - Confusional State Initial or Prolonged Dyspnoea Erythropoiesis Abnormal Gait Disturbance Granulocytopenia Macrophages Increased 22-Feb-2006 08:30 AM Page: 3618 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Megakaryocytes Abnormal Odynophagia Peritonsillar Abscess Report Source Product Role Manufacturer Route Dose Duration Plasmacytosis Leponex PS Novartis Sector: Pneumococcal Sepsis Pharma ORAL 25 mg/day Pyrexia Levodopa-Carbidopa C ORAL Septic Shock Omeprazole C Aas C Carbamazepine C Pravastatin C Clomipramine Hydrochloride C Date:01/17/06ISR Number: 4883139-6Report Type:Direct Company Report #CTU 266983 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neutrophil Count Clozapine 100 Mg Decreased Ivax PS Ivax ORAL 100 MG BID White Blood Cell Count PO 27 DAY Decreased Benztropine C Divalproex C Docusate C Milk Of Magnesia C Date:01/17/06ISR Number: 4884505-5Report Type:Expedited (15-DaCompany Report #2005003898 Age:53 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accident Consumer Accupril (Quinapril Life-Threatening Convulsion Hydrochloride) PS 20 MG (1 D) Other Drug Interaction Hydrochlorothiazide Drug Toxicity (Hydrochlorothiazide Pulmonary Congestion ) SS ORAL 12.5 MG (12.5 MG, 1 IN 1 D); 6.25 MG (12.5 MG, 1/2 TABLET Clozaril (Clozapine) SS ORAL 500 MG (100 MG, 100 MG AM, 400 MG PM), ORAL Depakote (Valproate Semisodium) C Feldene (Piroxicam) C Ditropan (Oxybutynin) C Bisacodyl (Bisacodyl) C Baclofen (Baclofen) C Lactulose (Lactulose) C Asa (Acetylsalicylic Acid) C Vitamins (Vitamins) C Calcium (Calcium) C Metamucil "Proctor & Gamble" (Glucose Monohydrate, 22-Feb-2006 08:30 AM Page: 3619 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Ispaghula Husk) C Proctor & Gamble Date:01/17/06ISR Number: 4884534-1Report Type:Expedited (15-DaCompany Report #2006S1000017 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Disorder Health Clozapine Tablets Neoplasm Malignant Professional (25mg) PS ORAL 150 MG; QD; Other ORAL Entacapone C Atorvastatin C Levodopa/Carbidopa C Citalopram Hydrobromide C Oxybutynin C Date:01/17/06ISR Number: 4884537-7Report Type:Expedited (15-DaCompany Report #2006S1000071 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiomegaly Health Clozapine Tablets Professional (100 Mg) PS ORAL SEE IMAGE, Other ORAL Escitalopram C Levothyroxine Sodium C Caffeine/Butalbital/ Paracetamol C Temazepam C Topiramate C Lorazepam C Date:01/17/06ISR Number: 4884541-9Report Type:Expedited (15-DaCompany Report #2006S1000004 Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Respiratory Disorder Health Clozapine Tablets Professional (25 Mg) PS ORAL 75 MG; BID; Other ORAL Clozapine Tablets (100 Mg) SS ORAL 100 MG; BID; ORAL Gabapentin C Simvastatin C Tamsulosin Hydrochloride C Finasteride C Lansoprazole C Escitalopram C Haloperidol C Benzatropine Mesilate C Date:01/17/06ISR Number: 4885937-1Report Type:Expedited (15-DaCompany Report #GXKR2006GB00446 Age:39 YR Gender:Male I/FU:I Outcome PT Hospitalization - Blood Glucose Decreased Initial or Prolonged Diabetes Mellitus 22-Feb-2006 08:30 AM Page: 3620 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Insulin-Dependent Report Source Product Role Manufacturer Route Dose Duration Foreign Atenolol Health (Ngx)(Atenolol) PS ORAL 50 MG, QD, Professional ORAL Other Clozapine(Clozapine) SS ORAL 700 MG, QD, ORAL Zaponex(Clozapine) SS ORAL 700 MG, QD, ORAL Bendrofluazide(Bendr oflumethiazide) SS ORAL 2.5 MG, QD, ORAL Aspirine 9acetylsalicylic Acid) C Simvastatin (Simvastatin) C Hyoscine (Hyoscine) C Amisulpride (Amisulpride) C Date:01/18/06ISR Number: 4883016-0Report Type:Expedited (15-DaCompany Report #AU-ABBOTT-06P-008-0321754-00 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Akineton PS Initial or Prolonged Phosphokinase Increased Trifluoperazine Liver Function Test Hydrochloride SS ORAL Abnormal Lithium SS Neuroleptic Malignant Clozapine SS ORAL 40 DAY Syndrome Date:01/18/06ISR Number: 4883046-9Report Type:Expedited (15-DaCompany Report #PHFR2005GB02781 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Erectile Dysfunction Clozaril PS Novartis Sector: Pharma ORAL Date:01/18/06ISR Number: 4883052-4Report Type:Expedited (15-DaCompany Report #PHRM2005FR01321 Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Leponex PS Novartis Sector: Initial or Prolonged Cerebellar Syndrome Pharma ORAL 325 mg, daily Disability Confusional State Leponex SS Novartis Sector: Disorientation Pharma ORAL 225 mg, daily Dysarthria Epilepsy Fall Gait Disturbance Hypotension Tremor White Blood Cell Count Increased 22-Feb-2006 08:30 AM Page: 3621 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/18/06ISR Number: 4883054-8Report Type:Expedited (15-DaCompany Report #PHBS2006NZ00729 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Basophil Count Increased Clozaril PS Novartis Sector: Eosinophil Count Pharma ORAL 300 mg/day Increased Neutrophil Count Increased Splenomegaly White Blood Cell Count Increased Date:01/18/06ISR Number: 4883196-7Report Type:Expedited (15-DaCompany Report #2006GB00002 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Atenolol PS Zeneca Initial or Prolonged Insulin-Dependent Pharmaceutical ORAL Zaponex SS ORAL 300 + 400 MG DAILY 140 DAY Bendrofluazide SS ORAL Clozapine SS 853 DAY Aspirin C UNKNOWN Simvastatin C UNKNOWN Hyoscine C UNKNOWN Amisulpride C UNKNOWN 200 - 400 MG DAILY Date:01/18/06ISR Number: 4886429-6Report Type:Expedited (15-DaCompany Report #2006006178 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutrophil Count Health Azithromycin Decreased Professional (Azithromycin) PS Clozapine (Clozapine) SS ORAL 100 MG, ORAL Date:01/19/06ISR Number: 4884981-8Report Type:Expedited (15-DaCompany Report #PHBS2006NL00940 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Cardiac Death Leponex PS Novartis Sector: Pharma ORAL 37.5 mg, QD Tranylcypromine C 10 mg, BID Date:01/19/06ISR Number: 4885266-6Report Type:Expedited (15-DaCompany Report #PHRM2006FR00485 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Leponex PS Novartis Sector: Initial or Prolonged Lung Disorder Pharma Pyrexia 22-Feb-2006 08:30 AM Page: 3622 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/19/06ISR Number: 4885274-5Report Type:Expedited (15-DaCompany Report #PHEH2006US00882 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Terminal State Clozaril PS Novartis Sector: Other Pharma Unk, Unk Date:01/19/06ISR Number: 4885277-0Report Type:Expedited (15-DaCompany Report #PHBS2005NL17280 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cognitive Deterioration Leponex PS Novartis Sector: Drug Level Increased Pharma ORAL 300 mg, BID 89 DAY Intracranial Venous Sinus Ascal Cardio C 100 mg, QD Thrombosis Hydrochlorothiazide C 25 mg, QD Orthostatic Hypotension Seloken C 50 mg, QD Date:01/19/06ISR Number: 4885280-0Report Type:Expedited (15-DaCompany Report #PHFR2005GB03598 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Atrial Tachycardia Clozaril PS Novartis Sector: Atrioventricular Block Pharma ORAL 275 mg/day First Degree Heart Rate Increased Salivary Hypersecretion Date:01/19/06ISR Number: 4886629-5Report Type:Expedited (15-DaCompany Report #2006-US-00342 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Foreign Clozapine Tablets, Initial or Prolonged Agranulocytosis Literature 12.5mg, 25mg, 50 Mg Aspergillosis Health 100mg (Clozapine) PS ORAL 650 MG, QD, Bronchopneumonia Professional ORAL Guillain-Barre Syndrome Immunoglobulins Abnormal Infection Pleural Effusion Serratia Infection Subcutaneous Abscess Urinary Incontinence Urogenital Disorder Date:01/19/06ISR Number: 4886777-XReport Type:Direct Company Report #CTU 267258 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Glucose Increased Clozapine 100mg, Blood Triglycerides 12.5mg Ivax PS Ivax ORAL 312.5MG Increased DAILY PO 10 MON Glycosylated Haemoglobin Divalproex Sodium C Increased Propranolol C Weight Increased Clonazepam C 22-Feb-2006 08:30 AM Page: 3623 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/19/06ISR Number: 4888401-9Report Type:Expedited (15-DaCompany Report #2006-US-00340 Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine Tablets, Professional 12.5mg, 25mg, 50 Mg Other 100mg (Clozapine) PS ORAL 200 MG, QD, ORAL Date:01/19/06ISR Number: 4888402-0Report Type:Expedited (15-DaCompany Report #2005-US-00893 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Potassium Increased Health Clozapine Tablets, Cardiac Failure Professional 12.5mg, 25mg, 50 Mg Renal Failure Other 100mg (Clozapine) PS ORAL 250 MG, QD, ORAL Date:01/19/06ISR Number: 4888404-4Report Type:Expedited (15-DaCompany Report #2006-US-00339 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hypoxia Health Clozapine Tablets, Hospitalization - Incorrect Dose Professional 12.5mg, 25mg, 50 Mg Initial or Prolonged Administered Other 100mg (Clozapine) PS ORAL D, ORAL Respiratory Failure Date:01/20/06ISR Number: 4885828-6Report Type:Expedited (15-DaCompany Report #PHEH2006US01010 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Cancer In Situ Clozaril PS Novartis Sector: Lymphadenopathy Pharma ORAL 350 mg, QD Risperdal C Lamictal C Keppra C Date:01/20/06ISR Number: 4885830-4Report Type:Expedited (15-DaCompany Report #PHNR2006AU00465 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Depression Clozaril PS Novartis Sector: Drug Interaction Pharma 0 - 475 Drug Level Increased mg/day Obsessive-Compulsive Fluvoxamine SS Disorder Date:01/20/06ISR Number: 4885831-6Report Type:Expedited (15-DaCompany Report #PHEH2006US00739 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Anaemia Clozaril PS Novartis Sector: Cyanosis Pharma 100mg BID, Lung Neoplasm Malignant 500mg QHS Pneumonectomy Zyprexa C 30 mg, QHS Terminal State Zoloft C 150 mg, QD Depakote - Slow 22-Feb-2006 08:30 AM Page: 3624 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Release C 1000 mg, QHS Date:01/20/06ISR Number: 4885978-4Report Type:Expedited (15-DaCompany Report #US-ABBOTT-05P-163-0320544-00 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Divalproex Sodium PS ORAL Hospitalization - Loss Of Consciousness Clozapine SS ORAL 4 YR Initial or Prolonged Myocardial Infarction Docusate Sodium C ORAL Other Pulmonary Embolism Folic Acid C ORAL Date:01/20/06ISR Number: 4886162-0Report Type:Expedited (15-DaCompany Report #US-GLAXOSMITHKLINE-A0590108A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Apnoea Bupropion PS Glaxosmithkline 300MG Per day Initial or Prolonged Cardiac Murmur Lithium SS Glaxosmithkline Drug Exposure During Clozaril SS Pregnancy Folic Acid C Gastrooesophageal Reflux Colace C Disease Milk Allergy Date:01/20/06ISR Number: 4889245-4Report Type:Direct Company Report #CTU 267425 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Alanine Aminotransferase Clozapine 100mg Hospitalization - Increased Mylan PS Mylan ORAL 100MG AM AND Initial or Prolonged Aspartate 200MG HS PO Aminotransferase Increased Eosinophil Count Increased Haematocrit Decreased Haemoglobin Decreased Hepatotoxicity Hypoalbuminaemia Hyponatraemia Hypotension Red Blood Cell Count Decreased Date:01/20/06ISR Number: 4889416-7Report Type:Expedited (15-DaCompany Report #026 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Fazaclo 25mg Odt Professional Alamo Company Pharmaceuticals PS Alamo Representative Pharmaceuticals 75 MG DAILY 22-Feb-2006 08:30 AM Page: 3625 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/20/06ISR Number: 4889564-1Report Type:Expedited (15-DaCompany Report #2006S1000187 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional (25 Mg) PS ORAL 25MG; HS;ORAL Other Clozapine Tablets (100 Mg) SS ORAL 100 MG;HS;ORAL Date:01/20/06ISR Number: 4889685-3Report Type:Expedited (15-DaCompany Report #2006S1000177 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional (25 Mg) PS ORAL 62.5 MG; QD; Other ORAL Simvastatin C Zonisamide C Date:01/20/06ISR Number: 4889687-7Report Type:Expedited (15-DaCompany Report #2006S1000183 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozapine Tablets Professional (100 Mg) PS ORAL 100 MG; QAM; Other ORAL Lansoprazole C Atenolol C Acetylsalicylic Acid C Lorazepam C Nifedipine C Gabapentin C Paroxetine Hydrochloride C Date:01/20/06ISR Number: 4889711-1Report Type:Expedited (15-DaCompany Report #2006S1000111 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional (25 Mg) PS ORAL 50 MG; HS; Other ORAL Date:01/23/06ISR Number: 4887451-6Report Type:Expedited (15-DaCompany Report #PHRM2006FR00507 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Appendicectomy Leponex PS Novartis Sector: Initial or Prolonged Appendicitis Pharma ORAL 900 mg, daily Leukocytosis Leponex SS Novartis Sector: Neutrophilia Pharma ORAL 300 mg, daily Pyrexia Floxyfral C 22-Feb-2006 08:30 AM Page: 3626 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/23/06ISR Number: 4887453-XReport Type:Expedited (15-DaCompany Report #PHBS2005FI01962 Age:49 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agranulocytosis Clozapine PS Novartis Sector: Other Blood Disorder Pharma ORAL 450 mg/d Infection Myelodysplastic Syndrome White Blood Cell Count Decreased Date:01/24/06ISR Number: 4889433-7Report Type:Expedited (15-DaCompany Report #PHEH2006US00923 Age:72 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arthralgia Clozaril PS Novartis Sector: Hospitalization - Back Pain Pharma ORAL 12.5 QAM, Initial or Prolonged Convulsion 62.5 QPM Other Pneumonia Sinemet C Pneumonia Aspiration Comtan C Lotrel C Galantamine C Remeron C Date:01/24/06ISR Number: 4889434-9Report Type:Expedited (15-DaCompany Report #PHBS2006NZ01019 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Level Increased Clozaril PS Novartis Sector: Initial or Prolonged Fatigue Pharma ORAL 400 mg, QHS 2783 DAY Hysterectomy Clozaril SS Novartis Sector: Infection Pharma ORAL 300 mg, QHS Malaise Cefaclor C ORAL 500 mg tid or qid Valproate Sodium C ORAL 500 mg, BID Loperamide C 2 mg, PRN Procyclidine C 5 mg/d Date:01/24/06ISR Number: 4891926-3Report Type:Expedited (15-DaCompany Report #2006S1000214 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional (25 Mg) PS ORAL 100 MG; QD; Other ORAL Date:01/24/06ISR Number: 4892156-1Report Type:Expedited (15-DaCompany Report #2006-US-00396 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pulmonary Hypertension Health Clozapine Tablets, Professional 12.5 Mg, 25mg, 50 Other Mg, 100 Mg (Clozapine) PS ORAL 175 MG , QD, ORAL 22-Feb-2006 08:30 AM Page: 3627 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/24/06ISR Number: 4892157-3Report Type:Expedited (15-DaCompany Report #2006-US-00395 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Tongue Neoplasm Malignant Health Clozapine Tablets, Stage Unspecified Professional 12.5 Mg, 25 Mg, 50 Other Mg, 100 Mg (Clozapine) PS ORAL 550 MG, QD, ORAL Date:01/24/06ISR Number: 4892158-5Report Type:Expedited (15-DaCompany Report #2006-US-00401 Age:73 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Clozapine Tablets, Professional 12.5mg, 25mg, 50mg, Other 100mg (Clozapine) PS ORAL 75 MG, QD, ORAL Date:01/24/06ISR Number: 4892162-7Report Type:Expedited (15-DaCompany Report #2006-US-00397 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Urinary Tract Infection Health Clozapine Tablets, Initial or Prolonged Professional 12.5 Mg, 25mg, 50mg, Other 100mg (Clozapine) PS ORAL 200 MG, QD, ORAL Date:01/24/06ISR Number: 4892207-4Report Type:Expedited (15-DaCompany Report #2006S1000212 Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Clozapine Tablets Professional (100 Mg) PS ORAL 100 MG; HS; Other ORAL Date:01/24/06ISR Number: 4893241-0Report Type:Expedited (15-DaCompany Report #2006-US-00400 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Clozapine PS ORAL 50 MG , QD, Congestive Professional ORAL Other Date:01/24/06ISR Number: 4893242-2Report Type:Expedited (15-DaCompany Report #2006-US-00398 Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Clozapine PS ORAL 850 MG, QD, Professional ORAL Other 22-Feb-2006 08:30 AM Page: 3628 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/24/06ISR Number: 4893243-4Report Type:Expedited (15-DaCompany Report #2006-US-00399 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Health Clozapine PS ORAL QD, ORAL Initial or Prolonged Head Injury Professional Loss Of Consciousness Other Date:01/25/06ISR Number: 4891074-2Report Type:Expedited (15-DaCompany Report #GB-ABBOTT-05P-167-0314915-00 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiomyopathy Depakote PS UNKNOWN Myositis Clozapine SS UNKNOWN Unspecified Concomitant Medications C Date:01/25/06ISR Number: 4891176-0Report Type:Expedited (15-DaCompany Report #2005-US-00098 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Arrest Wellbutrin Xl PS Glaxosmithkline ORAL 450MG Twice Initial or Prolonged Pneumonia per day Respiratory Arrest Clozapine SS ORAL 300MG Per day Lithium Carbonate C Glaxosmithkline ORAL 450MG Twice per day Ipratropium C Glaxosmithkline UNKNOWN Salbutamol C Glaxosmithkline UNKNOWN Benztropine C Date:01/25/06ISR Number: 4895594-6Report Type:Expedited (15-DaCompany Report #2005S1011783 Age:56 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Health Clozapine Tablets Convulsion Professional (100 Mg) PS ORAL SEE IMAGE Other Tamsulosin Hydrochloride C Tolterodine L-Tartrate C Propranolol C Quetiapine Fumarate C Escitalopram C Lactulose C Macrogol C Date:01/26/06ISR Number: 4892333-XReport Type:Expedited (15-DaCompany Report #2005-US-00301 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Wellbutrin PS Glaxosmithkline ORAL 300MG Per day 85 DAY Initial or Prolonged Drug Interaction Clozapine SS ORAL 700MG Per day Other Mental Status Changes Quetiapine C 300MG Per day Paroxetine Hcl C Glaxosmithkline ORAL Simvastatin C 250MG Per day 22-Feb-2006 08:30 AM Page: 3629 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/26/06ISR Number: 4892426-7Report Type:Expedited (15-DaCompany Report #PHFR2006GB00608 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Pain Clozapine PS Novartis Sector: Other Circulatory Collapse Pharma ORAL 600 mg/day Convulsion Fluoxetine C ORAL Drug Level Increased Procyclidine C ORAL Hepatitis Diazepam C ORAL Ileus Paralytic Omeprazole C ORAL Chlorpromazine C ORAL Date:01/26/06ISR Number: 4892427-9Report Type:Expedited (15-DaCompany Report #PHBS2006SG01000 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Distension Clozapine PS Novartis Sector: Clostridium Colitis Pharma UNKNOWN 350 mg/d Colectomy Valproate Sodium C UNKNOWN Diarrhoea Benzhexol C UNKNOWN 6 mg/d Electroencephalogram Lorazepam C UNKNOWN 3 mg/d Abnormal Faeces Discoloured Fibrin Abnormal Grand Mal Convulsion Haemoglobin Decreased Hypotension Ileus Intestinal Anastomosis Mucosal Erosion Necrosis Date:01/26/06ISR Number: 4892430-9Report Type:Expedited (15-DaCompany Report #PHEH2006US01059 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Fear Clozaril PS Novartis Sector: Hallucination, Auditory Pharma ORAL titrated up Incorrect Dose 25mg/week to Administered 350mg/day 138 DAY Paranoia Clozaril SS Novartis Sector: Psychiatric Symptom Pharma ORAL UNK, UNK Schizophrenia Clozaril SS Novartis Sector: Pharma ORAL "Re-titration " Remeron C Glucotrol Xl C Date:01/26/06ISR Number: 4892431-0Report Type:Expedited (15-DaCompany Report #PHEH2006US01199 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiac Disorder Clozaril PS Novartis Sector: Cardiac Stress Test Pharma 900 mg, QD Abnormal Clozaril SS Novartis Sector: Drug Withdrawal Syndrome Pharma 300 mg, QD Schizophrenia Geodon C Weight Increased 22-Feb-2006 08:30 AM Page: 3630 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/26/06ISR Number: 4892432-2Report Type:Expedited (15-DaCompany Report #PHEH2006US01288 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Clozaril PS Novartis Sector: Pharma ORAL 950 mg, QD Date:01/26/06ISR Number: 4892433-4Report Type:Expedited (15-DaCompany Report #PHNR2005AU01666 Age:74 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Bicarbonate Clozaril PS Novartis Sector: Initial or Prolonged Increased Pharma 0 - 100 Other Blood Chloride Decreased mg/day 46080MIN Blood Sodium Decreased Clozaril SS Novartis Sector: Bradycardia Pharma UNK, C-Reactive Protein ONCE/SINGLE Increased Cardiac Disorder Depressed Level Of Consciousness Diabetes Mellitus Non-Insulin-Dependent Faecal Incontinence Haematocrit Decreased Haemoglobin Increased Hypotension Lymphocyte Morphology Abnormal Mean Cell Haemoglobin Decreased Mean Cell Volume Decreased Pyrexia Red Blood Cell Sedimentation Rate Increased Troponin Increased Urinary Incontinence Vomiting Date:01/26/06ISR Number: 4892435-8Report Type:Expedited (15-DaCompany Report #PHNU2005DE02885 Age:31 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Leponex PS Novartis Sector: Fracture Pharma ORAL up to 200 mg, Prothrombin Time QD Shortened Marcumar SS ORAL Thrombosis Perazine C UNKNOWN Date:01/26/06ISR Number: 4892437-1Report Type:Expedited (15-DaCompany Report #PHRM2006FR00512 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Exposure Leponex PS Novartis Sector: Initial or Prolonged Depressed Level Of Pharma ORAL 300 mg, Consciousness ONCE/SINGLE 1440 MIN Somnolence Lodoz C ORAL 22-Feb-2006 08:30 AM Page: 3631 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pentoflux C ORAL Trivastal C Levothyrox C ORAL Zocor "Merck" C ORAL Date:01/26/06ISR Number: 4892441-3Report Type:Expedited (15-DaCompany Report #PHRM2006FR00531 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Cancer Leponex PS Novartis Sector: Pharma ORAL 350 mg, daily Date:01/27/06ISR Number: 4893352-XReport Type:Expedited (15-DaCompany Report #GB-ABBOTT-06P-167-0322943-00 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Influenza Epilim Tablets PS ORAL Nasopharyngitis Zaponex SS ORAL Neutropenia Salbutamol C UNKNOWN Date:01/27/06ISR Number: 4894722-6Report Type:Direct Company Report #CTU 267969 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Agitation Clozapine 100 Mg Dysarthria Mylan PS Mylan ORAL 600 MG QD PO Fall Simvistatin C Head Injury Ziprasidon C Laceration Hydroxyzine Pamoate C Musculoskeletal Stiffness Neuroleptic Malignant Syndrome Overdose Psychotic Disorder Sleep Disorder Date:01/30/06ISR Number: 4894780-9Report Type:Expedited (15-DaCompany Report #PHNR2005AU01724 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coagulopathy Clozaril PS Novartis Sector: Life-Threatening Deep Vein Thrombosis Pharma 0 - 500 Hospitalization - Multi-Organ Failure mg/day 2213 DAY Initial or Prolonged Date:01/30/06ISR Number: 4894781-0Report Type:Expedited (15-DaCompany Report #PHNR2005AU01728 Age:63 YR Gender:Female I/FU:F Outcome PT Life-Threatening Abdominal Distension Hospitalization - Anorexia Initial or Prolonged Bile Duct Cancer Other Blood Alkaline Phosphatase Increased Diarrhoea Eosinophil Count 22-Feb-2006 08:30 AM Page: 3632 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Increased Faeces Discoloured Intestinal Obstruction Jaundice Report Source Product Role Manufacturer Route Dose Duration Leukocytosis Clozaril PS Novartis Sector: Leukopenia Pharma 0 - 450 Neoplasm Malignant mg/day 1586 DAY Neutropenia Clozaril SS Novartis Sector: Neutrophil Toxic Pharma 40320MIN Granulation Present Heparin SS Neutrophilia Amitriptyline C Oral Intake Reduced Maxolon C Sepsis Morphine C Shift To The Left Augmentin /Unk/ C Terminal State Diltiazem C Troponin Increased Irbesartan C Date:01/30/06ISR Number: 4894782-2Report Type:Expedited (15-DaCompany Report #PHMT2006CA00546 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Exposure During Clozaril PS Novartis Sector: Pregnancy Pharma UNK, UNK Stillbirth Date:01/30/06ISR Number: 4895359-5Report Type:Expedited (15-DaCompany Report #PHNU2006DE00662 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetic Hyperglycaemic Leponex PS Novartis Sector: Coma Pharma ORAL up to 450 mg/day Solian C ORAL Date:01/30/06ISR Number: 4897539-1Report Type:Direct Company Report #CTU 268034 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Drug Toxicity Clozapine PS 300 MG Q AM ; Hospitalization - Ileus 500 MG Q PM 7 YR Initial or Prolonged Pericardial Effusion Valproic C Olanzapine C Date:01/31/06ISR Number: 4896138-5Report Type:Expedited (15-DaCompany Report #FR-RB-2694-2006 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Buprenorphine Initial or Prolonged Phosphokinase Increased Hydrochloride PS Reckitt Benckiser SUBLINGUAL C-Reactive Protein Cyamemazine SS ORAL Increased Clozapine SS ORAL Infection Clozapine SS ORAL Leukocytosis Tropatepine Myalgia Hydrochloride SS ORAL Pyrexia Diazepam SS ORAL Meprobamate SS ORAL 22-Feb-2006 08:30 AM Page: 3633 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/31/06ISR Number: 4896636-4Report Type:Expedited (15-DaCompany Report #PHEH2005US12727 Age:56 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Optic Neuritis Clozaril PS Novartis Sector: Papilloedema Pharma ORAL 275 mg, QD Paraneoplastic Syndrome Hydrochlorothiazide C ORAL 25 mg, QD Renal Cell Carcinoma Stage Unspecified Renal Tumour Excision Vision Blurred Visual Acuity Reduced Date:01/31/06ISR Number: 4896643-1Report Type:Expedited (15-DaCompany Report #PHFR2006GB00637 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eye Infection Clozapine PS Novartis Sector: Furuncle Pharma ORAL 300mg/day Date:01/31/06ISR Number: 4896652-2Report Type:Expedited (15-DaCompany Report #PHNR2005AU01728 Age:63 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Distension Clozaril PS Novartis Sector: Initial or Prolonged Anorexia Pharma 0 - 450 Other Bile Duct Cancer mg/day 1586 DAY Blood Alkaline Clozaril SS Novartis Sector: Phosphatase Increased Pharma 40320MIN Diarrhoea Heparin SS Eosinophil Count Amitriptyline C Increased Maxolon C Faeces Discoloured Morphine C Intestinal Obstruction Augmentin /Unk/ C Jaundice Diltiazem C Leukocytosis Irbesartan C Leukopenia Neoplasm Malignant Neutropenia Neutrophil Toxic Granulation Present Neutrophilia Oral Intake Reduced Sepsis Shift To The Left Terminal State Troponin Increased Date:01/31/06ISR Number: 4896661-3Report Type:Expedited (15-DaCompany Report #PHBS2006HU01511 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agranulocytosis Leponex PS Novartis Sector: Pyrexia Pharma ORAL Respiratory Failure Sepsis 22-Feb-2006 08:30 AM Page: 3634 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/31/06ISR Number: 4899718-6Report Type:Expedited (15-DaCompany Report #2006-US-00472 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Health Clozapine Tablets, Professional 12.5mg, 25mg, 50mg, Other 100mg (Clozapine) PS ORAL 475 MG, QD; ORAL Date:02/01/06ISR Number: 4897759-6Report Type:Expedited (15-DaCompany Report #2006GB00124 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Lymphocytosis Omeprazole PS ORAL Initial or Prolonged Neutrophilia Zaponex SS ORAL White Blood Cell Count Clozapine SS 450 DAY Increased Risperidone C UNKNOWN Valproate Sodium C UNKNOWN Olanzapine C UNKNOWN Date:02/01/06ISR Number: 4897760-2Report Type:Expedited (15-DaCompany Report #2006GB00084 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Quetiapine PS Zeneca Pharmaceutical ORAL Zaponex SS ORAL 5 DAY Olanzapine SS ORAL Citalopram C UNKNOWN Zopiclone C UNKNOWN Date:02/01/06ISR Number: 4897872-3Report Type:Expedited (15-DaCompany Report #AT-GLAXOSMITHKLINE-B0408416A Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Apnoea Lithium Carbonate PS Glaxosmithkline ORAL 625MG per day Initial or Prolonged Epilepsy Clozapine SS ORAL 400MG per day Venlafaxine C ORAL 300MG per day Pantaloc C ORAL 20MG per day Date:02/01/06ISR Number: 4897874-7Report Type:Expedited (15-DaCompany Report #AT-GLAXOSMITHKLINE-B0408468A Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delirium Augmentin PS Glaxosmithkline ORAL 3G per day 15 DAY Initial or Prolonged Disorientation Leponex SS Hallucination, Visual Solian C Restlessness Cipralex C Nexium C 40MG per day Aerius C 2TAB per day Zolpidem C 10MG per day 1 DAY 22-Feb-2006 08:30 AM Page: 3635 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/01/06ISR Number: 4897947-9Report Type:Expedited (15-DaCompany Report #PHBS2006NO01566 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Cardiac Death Leponex PS Novartis Sector: Pharma ORAL 400 mg/d Akineton C ORAL 1 mg, TID Lamictal C ORAL 200 mg, QD Date:02/01/06ISR Number: 4897968-6Report Type:Expedited (15-DaCompany Report #PHRM2006FR00447 Age:49 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dolichocolon Acquired Leponex PS Novartis Sector: Life-Threatening Intestinal Perforation Pharma ORAL 200mg, daily 70560MIN Pneumonia Aspiration Leponex SS Novartis Sector: Shock Haemorrhagic Pharma ORAL 25 mg, daily Surgery Date:02/01/06ISR Number: 4900564-5Report Type:Expedited (15-DaCompany Report #2006-US-00471 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pancreatitis Haemorrhagic Health Clozapine Tablets, Professional 12.5mg, 25mg, 50 Mg Other 100mg(Clozapine) PS ORAL 750 MG, QD, ORAL Date:02/01/06ISR Number: 4901222-3Report Type:Expedited (15-DaCompany Report #2005131906 Age:57 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutropenia Foreign Amlodipine Initial or Prolonged Health (Amlodipine) PS ORAL 5 MG (5 MG, 1 Other Professional IN 1 D), ORAL Clozapine (Clozapine) SS ORAL 100 MG PLUS 275 MG (1 IN 1 D), ORAL Valproic Acid (Valproic Acid) SS ORAL 900 MG (900 MG, 1 IN 1 D), ORAL Amisulpride (Amisulpride) C Co-Codamol (Codeine Phosphate, Paracetamol) C Date:02/02/06ISR Number: 4898531-3Report Type:Expedited (15-DaCompany Report #PHFR2005GB03928 Age:46 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Cholesterol Clozaril PS Novartis Sector: Increased Pharma ORAL Diabetes Mellitus Aspirine C UNKNOWN Hypertension Isosorbide Obesity Mononitrate C UNKNOWN 22-Feb-2006 08:30 AM Page: 3636 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/02/06ISR Number: 4898924-4Report Type:Expedited (15-DaCompany Report #PHEH2006US01530 Age:8 DY Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Apnoea Clozaril PS Novartis Sector: Hospitalization - Cardiac Murmur Pharma TRANSPLACENTAL Initial or Prolonged Drug Exposure During Wellbutrin SS TRANSPLACENTAL UNK, UNK Other Pregnancy Lithium SS TRANSPLACENTAL Gastrooesophageal Reflux Folic Acid C TRANSPLACENTAL Disease Docusate Sodium C TRANSPLACENTAL Milk Allergy Date:02/02/06ISR Number: 4899226-2Report Type:Expedited (15-DaCompany Report #GB-ROCHE-433914 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Ribavirin PS Roche UNKNOWN Initial or Prolonged Hepatitis Chronic Active Amisulpride C UNKNOWN Neutropenia Novomix C UNKNOWN White Blood Cell Count Pegasys C Decreased Zaponex I ORAL 261 DAY Zaponex I ORAL 559 DAY Date:02/02/06ISR Number: 4902374-1Report Type:Expedited (15-DaCompany Report #2006-01-1329 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chronic Hepatitis Foreign Ribavirin PS 600 MG BID Initial or Prolonged Condition Aggravated Health Zaponex (Olanzapine) Drug Interaction Professional Orals SS ORAL 300 MG/DAY Neutropenia Other ORAL White Blood Cell Count Clozapine Orals SS 325 MG/DAY Decreased Pegasys (Pegylated Interferon Alfa-2a) C Insulin Aspart Bid C Amisulpride C Date:02/03/06ISR Number: 4899935-5Report Type:Expedited (15-DaCompany Report #PHEH2006US01530 Age:8 DY Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Apnoea Clozaril PS Novartis Sector: Hospitalization - Cardiac Murmur Pharma TRANSPLACENTAL Initial or Prolonged Drug Exposure During Wellbutrin SS TRANSPLACENTAL UNK, UNK Other Pregnancy Lithium SS TRANSPLACENTAL Gastrooesophageal Reflux Folic Acid C TRANSPLACENTAL Disease Docusate Sodium C TRANSPLACENTAL Milk Allergy Date:02/03/06ISR Number: 4900402-0Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20060105940 Age:55 YR Gender:Male I/FU:I Outcome PT Hospitalization - Coma Initial or Prolonged Grand Mal Convulsion Loss Of Consciousness Meningitis Pneumococcal Wound Infection 22-Feb-2006 08:30 AM Page: 3637 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Staphylococcal Report Source Product Role Manufacturer Route Dose Duration Haloperidol PS INTRAMUSCULAR Clozaril SS ORAL Diazepam SS ORAL as needed Date:02/03/06ISR Number: 4905629-XReport Type:Expedited (15-DaCompany Report #2006S1000570 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Colon Cancer Metastatic Health Clozapine Tablets Professional (100 Mg) PS ORAL 100 MG; QAM; Other ORAL; 300 MG; QD; ORAL Date:02/06/06ISR Number: 4902171-7Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20060105915 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Brain Oedema Haldol PS ORAL Hospitalization - Closed Head Injury Clozapin SS ORAL Duration: for Initial or Prolonged Multiple Fractures a longer Suicide Attempt period of time Solian SS ORAL Date:02/06/06ISR Number: 4903337-2Report Type:Direct Company Report #CTU 268684 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Drug Toxicity Clozapine PS SEE IMAGE 7 YR Hospitalization - Ileus Valproic C Initial or Prolonged Pericardial Effusion Olanzapine C Date:02/07/06ISR Number: 4902217-6Report Type:Expedited (15-DaCompany Report #US-ABBOTT-06P-163-0323322-00 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Granulocytopenia Depakote Er 500mg PS ORAL Hospitalization - Depakote Er 500mg SS Initial or Prolonged Clozapine SS ORAL Other Clozapine SS ORAL Docusate C Date:02/07/06ISR Number: 4902467-9Report Type:Expedited (15-DaCompany Report #US-ABBOTT-06P-163-0323343-00 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Granulocytopenia Depakote Er 500mg PS ORAL Depakote Er 500mg SS ORAL Depakote Er 500mg SS ORAL Clozapine SS ORAL Docusate Sodium C ORAL Mineral Oil Emulsion C 30cc in am on Monday and 22-Feb-2006 08:30 AM Page: 3638 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/07/06ISR Number: 4902757-XReport Type:Expedited (15-DaCompany Report #FR-ABBOTT-05P-056-0317718-00 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Depakine PS Initial or Prolonged Phosphokinase Increased Hydroxyzine Myalgia Hydrochloride SS ORAL 27 DAY Clozapine SS ORAL 48 DAY Clonazepam C ORAL Terbinafine Hydrochloride C UNKNOWN 37 DAY Date:02/08/06ISR Number: 4903527-9Report Type:Expedited (15-DaCompany Report #PHRM2006FR00485 Age:56 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Leponex PS Novartis Sector: Initial or Prolonged Lung Disorder Pharma ORAL UNK, UNK 80640MIN Pyrexia Date:02/08/06ISR Number: 4903529-2Report Type:Expedited (15-DaCompany Report #PHBS2006CH01523 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Exposure Leponex PS Novartis Sector: Initial or Prolonged Agitation Pharma ORAL 100 mg, Hypertensive Crisis ONCE/SINGLE 1440 MIN Malignant Hypertension Zyprexa C ORAL 2.5 mg/d Restless Legs Syndrome Citalopram C ORAL 10 mg/d Sinus Tachycardia Tachycardia Date:02/08/06ISR Number: 4903530-9Report Type:Expedited (15-DaCompany Report #PHFR2006GB00480 Age:30 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Accidental Exposure Clozaril PS Novartis Sector: Pharma ORAL 300 mg in error 1440 MIN Zuclopenthixol Decanoate C INTRAMUSCULAR 600 mg/day Date:02/08/06ISR Number: 4903533-4Report Type:Expedited (15-DaCompany Report #PHEH2005US12727 Age:56 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Optic Neuritis Clozaril PS Novartis Sector: Papilloedema Pharma ORAL 275 mg, QD Paraneoplastic Syndrome Hydrochlorothiazide C ORAL 25 mg, QD Renal Cell Carcinoma Stage Unspecified Renal Tumour Excision Vision Blurred Visual Acuity Reduced 22-Feb-2006 08:30 AM Page: 3639 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/08/06ISR Number: 4903534-6Report Type:Expedited (15-DaCompany Report #PHBS2006NZ01672 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Overdose Clozaril PS Novartis Sector: Initial or Prolonged Liver Function Test Pharma ORAL 300 mg/day Abnormal Paracetamol SS Pneumonia Antibiotics C Fluoxetine C Clonazepam C UNK, QD Date:02/08/06ISR Number: 4903536-XReport Type:Expedited (15-DaCompany Report #PHBS2006PH01495 Age:49 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anaemia Leponex PS Novartis Sector: Other Haemoglobin Decreased Pharma ORAL 25 mg, QD 11520MIN Stevens-Johnson Syndrome Date:02/08/06ISR Number: 4904583-4Report Type:Expedited (15-DaCompany Report #FR-ROCHE-434068 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Valium PS Roche ORAL Initial or Prolonged Phosphokinase Increased Subutex SS ORAL Hyperthermia Clozapine SS ORAL DRUG NAME Infection REPORTED AS Leukocytosis CLOZAPINE Myalgia PANPHARMA. 21 DAY Clozapine SS ORAL Equanil SS ORAL Lepticur SS ORAL Tercian SS ORAL Tercian SS ORAL REPORTED TO BE TAKEN AS NEEDED. Date:02/09/06ISR Number: 4906105-0Report Type:Expedited (15-DaCompany Report #PHNR2006AU00465 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Atrial Hypertrophy Clozaril PS Novartis Sector: Bundle Branch Block Pharma 0 - 475 Depression mg/day Drug Interaction Fluvoxamine SS 150 mg Drug Level Decreased Fluvoxamine SS 100 mg Drug Level Increased Fluvoxamine SS 50 mg Obsessive-Compulsive Disorder Sinus Tachycardia Date:02/09/06ISR Number: 4906106-2Report Type:Expedited (15-DaCompany Report #PHBS2006PH01495 Age:49 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anaemia Leponex PS Novartis Sector: Other Haemoglobin Decreased Pharma ORAL 25 mg, QD 11520MIN Stevens-Johnson Syndrome 22-Feb-2006 08:30 AM Page: 3640 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/09/06ISR Number: 4906287-0Report Type:Expedited (15-DaCompany Report #GB-AVENTIS-200611144GDDC Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Loss Of Consciousness Hydrocortisone PS Aventis Initial or Prolonged Pharmaceuticals Inc. Clozapine SS ORAL Thyroxine SS Valproic Acid SS Ranitidine SS Ciprofloxacin SS Fluconazole SS Fentanyl SS Paracetamol SS Amisulpride C Lithium C Lactulose C Clexane C Propofol C Midazolam C Noradrenaline C Potassium C Insulin C Date:02/09/06ISR Number: 4906622-3Report Type:Expedited (15-DaCompany Report #NLGE0001642 Age:51 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Loss Of Consciousness Ranitidine PS Glaxosmithkline UNKNOWN Initial or Prolonged Zaponex SS ORAL Thyroxine SS Glaxosmithkline UNKNOWN Valproate Sodium SS UNKNOWN Hydrocortisone SS Glaxosmithkline UNKNOWN Ciprofloxacin SS UNKNOWN Fluconazole SS UNKNOWN Fentanyl SS UNKNOWN Paracetamol SS Glaxosmithkline UNKNOWN Amisulpride C UNKNOWN Lithium C Glaxosmithkline UNKNOWN Lactulose C UNKNOWN Clexane C UNKNOWN Propofol C UNKNOWN Midazolam C UNKNOWN Noradrenaline C UNKNOWN Potassium C UNKNOWN Insulin C UNKNOWN Date:02/10/06ISR Number: 4907642-5Report Type:Expedited (15-DaCompany Report #GB-MERCK-0602GBR00041 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Loss Of Consciousness Hydrocortone PS Merck & Co., Inc ORAL Initial or Prolonged Clozapine SS UNKNOWN Levothyroxine Sodium SS UNKNOWN Valproate Sodium SS UNKNOWN Ranitidine SS UNKNOWN Ciprofloxacin SS UNKNOWN Fluconazole SS UNKNOWN Fentanyl SS UNKNOWN Acetaminophen SS UNKNOWN 22-Feb-2006 08:30 AM Page: 3641 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Amisulpride C UNKNOWN Lithium Hydroxide C UNKNOWN Lactulose C UNKNOWN Enoxaparin Sodium C UNKNOWN Propofol C UNKNOWN Midazolam C UNKNOWN Norepinephrine Hydrochloride C UNKNOWN Potassium (Unspecified) C UNKNOWN Insulin C UNKNOWN Date:02/10/06ISR Number: 4907811-4Report Type:Expedited (15-DaCompany Report #PHEH2005US10522 Age:62 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Overdose Clozaril PS Novartis Sector: Other Arteriosclerosis Pharma ORAL 100mg Q12pm, Atherosclerosis 250mg Qhs Cardiac Failure Albuterol C 2 puffs, Q8H Congestive Verapamil C 180 mg, QD Cardiomegaly Lansoprazole C ORAL 30 mg, BID Circulatory Collapse Furosemide C ORAL 40 mg, QD Coronary Artery Risperidone C ORAL 1 mg, QD Atherosclerosis Valproic Acid C ORAL 500 mg, TID Drug Toxicity Emphysema Myocardial Fibrosis Myocardial Infarction Pulmonary Oedema Splenomegaly Date:02/10/06ISR Number: 4907835-7Report Type:Expedited (15-DaCompany Report #PHEH2006US01630 Age:54 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cognitive Deterioration Clozaril PS Novartis Sector: Myocardial Infarction Pharma ORAL 300 mg, QD Date:02/13/06ISR Number: 4909324-2Report Type:Expedited (15-DaCompany Report #2005-US-00301 Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Wellbutrin PS Glaxosmithkline ORAL 300MG Per day 85 DAY Initial or Prolonged Drug Interaction Clozapine SS ORAL 700MG Per day Other Mental Status Changes Quetiapine C 300MG Per day Paroxetine Hcl C Glaxosmithkline ORAL Simvastatin C 250MG Per day Dilantin C Date:02/13/06ISR Number: 4909384-9Report Type:Expedited (15-DaCompany Report #PHNR2006AU00521 Age: Gender:Male I/FU:I Outcome PT Hospitalization - Compartment Syndrome Initial or Prolonged Dysarthria Intentional Misuse 22-Feb-2006 08:30 AM Page: 3642 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Loss Of Consciousness Sedation Report Source Product Role Manufacturer Route Dose Duration Clozaril PS Novartis Sector: Pharma Clozaril SS Novartis Sector: Pharma UNK, UNK Oxycontin C Keflex C Valproate C Diazepam C Temazepam C Oxynorm C Olanzapine C Date:02/13/06ISR Number: 4909386-2Report Type:Expedited (15-DaCompany Report #PHEH2006US01630 Age:54 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asthenia Clozaril PS Novartis Sector: Hospitalization - Cognitive Deterioration Pharma ORAL 250 mg, QHS Initial or Prolonged Constipation Cogentin C 2 mg, QHS Other Decubitus Ulcer Eskalith - Slow Hypertension Release C 450 mg, BID Neuroleptic Malignant Geodon C 40 mg, BID Syndrome Psychotic Disorder Pulmonary Embolism Skin Infection Date:02/13/06ISR Number: 4909387-4Report Type:Expedited (15-DaCompany Report #PHEH2006US01816 Age:78 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Clozaril PS Novartis Sector: Pharma UNK, UNK Date:02/14/06ISR Number: 4910688-4Report Type:Expedited (15-DaCompany Report #PHNR2005AU01516 Age:33 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Clozaril PS Novartis Sector: Drug Toxicity Pharma 0 - 450 Intentional Overdose mg/day Clozaril SS Novartis Sector: Pharma UNKNOWN Chlorpromazine SS Zopiclone SS Methadone SS Date:02/14/06ISR Number: 4910695-1Report Type:Expedited (15-DaCompany Report #PHEH2006US01767 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Granulocytopenia Clozapine PS Novartis Sector: Leukopenia Pharma Unk, Unk Non-Hodgkin'S Lymphoma 22-Feb-2006 08:30 AM Page: 3643 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/14/06ISR Number: 4911135-9Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20060200982 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Loss Of Consciousness Fentanyl PS UNKNOWN Initial or Prolonged Zaponex SS ORAL Thyroxine SS UNKNOWN Valproate Sodium SS UNKNOWN Ranitidine SS UNKNOWN Hydrocortisone SS UNKNOWN Ciprofloxacin SS UNKNOWN Fluconazole SS UNKNOWN Paracetamol SS UNKNOWN Amisulpride C UNKNOWN Lithium C UNKNOWN Lactulose C UNKNOWN Clexane C UNKNOWN Propofol C UNKNOWN Midazolam C UNKNOWN Noradrenaline C UNKNOWN Potassium C UNKNOWN Insulin C UNKNOWN Date:02/15/06ISR Number: 4911958-6Report Type:Expedited (15-DaCompany Report #PHBS2006NZ00729 Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Basophil Count Increased Clozaril PS Novartis Sector: Eosinophil Count Pharma ORAL 300 mg/day Increased Valproate Sodium C 500 mg, QHS Neutrophil Count Losec C Increased Splenomegaly White Blood Cell Count Increased Date:02/15/06ISR Number: 4911961-6Report Type:Expedited (15-DaCompany Report #PHEH2006US01816 Age:78 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Clozaril PS Novartis Sector: Coronary Artery Disease Pharma UNK, UNK Date:02/15/06ISR Number: 4911963-XReport Type:Expedited (15-DaCompany Report #PHBS2006NL01629 Age:76 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bladder Catheter Leponex PS Novartis Sector: Life-Threatening Permanent Pharma ORAL 12.5 mg, BID 38880MIN Hospitalization - Circulatory Collapse Leponex SS Novartis Sector: Initial or Prolonged Pulmonary Embolism Pharma ORAL 12.5 mg, TID 17280MIN Pyelonephritis Simvastatin C 10 mg/d Respiratory Arrest Bisoprolol C 5 mg/d Sepsis Levodopa-Carbidopa C 200/50, TID Urinary Retention Pergolide C 0.05 mg, TID Urinary Tract Infection Acetylsalicylic Acid C 80 mg/d Zyprexa C 2.5 mg/d Lactulose C 20 ml, BID 22-Feb-2006 08:30 AM Page: 3644 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/16/06ISR Number: 4914023-7Report Type:Expedited (15-DaCompany Report #FR-ROCHE-424636 Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Rivotril PS Roche ORAL Initial or Prolonged Phosphokinase Increased Leponex SS UNKNOWN 49 DAY Myalgia Depakine SS ORAL Atarax SS ORAL 28 DAY Lamisil C Date:02/17/06ISR Number: 4914853-1Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20060202782 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diarrhoea Ibuprofen PS Initial or Prolonged Myoclonus Clozapine SS Pneumonia Valproic Acid SS Terazosin SS ORAL Benzatropine SS Date:02/17/06ISR Number: 4914943-3Report Type:Expedited (15-DaCompany Report #PHNU2006AU00850 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Echocardiogram Abnormal Clozaril PS Novartis Sector: Ejection Fraction Pharma ORAL 400 mg, UNK Decreased Clozaril SS Novartis Sector: Ventricular Hypokinesia Pharma 400 mg/day Mirtazapine C UNKNOWN 30 mg/day Risperidone C UNKNOWN 1 mg, QD Date:02/17/06ISR Number: 4914944-5Report Type:Expedited (15-DaCompany Report #PHFR2006GB00832 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Clozaril PS Novartis Sector: Non-Insulin-Dependent Pharma ORAL Overweight Date:02/17/06ISR Number: 4914945-7Report Type:Expedited (15-DaCompany Report #PHNR2006AU00530 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Clozaril PS Novartis Sector: Pharma 12-125 mg, daily Date:02/17/06ISR Number: 4914946-9Report Type:Expedited (15-DaCompany Report #PHBS2006US02402 Age:27 YR Gender:Male I/FU:I Outcome PT Life-Threatening Cardiac Failure Congestive Catheterisation Cardiac Chest Pain Disorientation Dysarthria 22-Feb-2006 08:30 AM Page: 3645 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Echocardiogram Abnormal Ejection Fraction Decreased Report Source Product Role Manufacturer Route Dose Duration Electrocardiogram T Wave Clozapine PS Novartis Sector: Inversion Pharma titrated to Eosinophil Percentage 200 mg b.i.d. Increased Clozapine SS Novartis Sector: Eosinophilia Pharma 300 mg/day Influenza Like Illness Clozapine SS Novartis Sector: Lethargy Pharma 400mg/day Leukocytosis Quetiapine C 800 mg/day Mental Status Changes Quetiapine C tapered to Myocarditis 800 mg/day Nasal Congestion Pain Pericardial Effusion Pericarditis Pyrexia Sedation Sinus Tachycardia Throat Irritation Troponin Increased Ventricular Hypertrophy Ventricular Hypokinesia Date:02/17/06ISR Number: 4914951-2Report Type:Expedited (15-DaCompany Report #PHFR2006GB00821 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Echocardiogram Abnormal Clozaril PS Novartis Sector: Sedation Pharma ORAL 300 mg/day Social Avoidant Behaviour Clozaril SS Novartis Sector: Syncope Pharma ORAL 275 mg/day Tachycardia Date:02/17/06ISR Number: 4915289-XReport Type:Expedited (15-DaCompany Report #US-GLAXOSMITHKLINE-A0589453A Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Zofran PS Glaxosmithkline ORAL 7 WK Akathisia Clozaril SS 200MG per day Drooling Luvox SS ORAL 150MG Per day Drug Interaction Depakote C ORAL 3375MG per Drug Toxicity day Energy Increased Prilosec C Glaxosmithkline 20MG Per day Extrapyramidal Disorder Zyprexa C 25MG per day Faecal Incontinence Xanax C .5MG Three Hypervigilance times per day Obsessive Thoughts Doxycycline C 100MG Twice Paranoia per day Posture Abnormal Miralax C ORAL Screaming Valium C 5MG Three Sedation times per day Therapeutic Response Cogentin C 1MG Twice per Unexpected day Urinary Incontinence Zoloft C 200MG per day 22-Feb-2006 08:30 AM Page: 3646 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/20/06ISR Number: 4916492-5Report Type:Expedited (15-DaCompany Report #FR-RB-2694-2006 Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Buprenorphine Initial or Prolonged Phosphokinase Increased Hydrochloride PS Reckitt Benckiser SUBLINGUAL C-Reactive Protein Cyamemazine SS ORAL Increased Clozapine SS ORAL Infection Clozapine SS ORAL Leukocytosis Tropatepine Myalgia Hydrochloride SS ORAL Diazepam SS ORAL Meprobamate SS ORAL Date:02/21/06ISR Number: 4916984-9Report Type:Expedited (15-DaCompany Report #PHBS2006CH02498 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Encephalopathy Leponex PS Novartis Sector: Initial or Prolonged Neuroleptic Malignant Pharma 75 mg/day Syndrome Leponex SS Novartis Sector: Pharma 125 mg/day Leponex SS Novartis Sector: Pharma 400 mg/day Seroquel SS 200 mg/day Haldol SS 10 mg/day Quilonorm /Sch/ SS ORAL 1-2 tablets/day Date:02/21/06ISR Number: 4916985-0Report Type:Expedited (15-DaCompany Report #PHHO2005CA14787 Age:68 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Ileus Paralytic Clozaril PS Novartis Sector: Pneumonia Aspiration Pharma ORAL 25 mg, QHS Respiratory Failure Clozapine SS Risperdal C Sinemet C Cogentin C Asa C 22-Feb-2006 08:30 AM Page: 3647 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Summary report for FOI selections: Selection by inexact search of active ingredient: CLOZAPINE% Selection by inexact search of Tradename/Verbatim: CLOZARIL% Total number of reports: 16,699 From: 01-NOV-1997 To: Present 22-Feb-2006 08:30 AM Page: 3648