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