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